U.S. patent application number 16/288671 was filed with the patent office on 2019-08-29 for fluid preparation and treatment devices methods and systems.
This patent application is currently assigned to NxStage Medical, Inc.. The applicant listed for this patent is NxStage Medical, Inc.. Invention is credited to Goetz FRIEDERICHS, Mark T. WYETH, Gregory YANTZ.
Application Number | 20190262526 16/288671 |
Document ID | / |
Family ID | 67683818 |
Filed Date | 2019-08-29 |
![](/patent/app/20190262526/US20190262526A1-20190829-D00000.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00001.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00002.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00003.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00004.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00005.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00006.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00007.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00008.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00009.png)
![](/patent/app/20190262526/US20190262526A1-20190829-D00010.png)
View All Diagrams
United States Patent
Application |
20190262526 |
Kind Code |
A1 |
WYETH; Mark T. ; et
al. |
August 29, 2019 |
Fluid Preparation and Treatment Devices Methods and Systems
Abstract
Methods, device, and systems for preparing peritoneal dialysis
fluid and/or administering a peritoneal dialysis treatment are
disclosed. In embodiments, peritoneal dialysis fluid is prepared at
a point of use automatically using a daily sterile disposable fluid
circuit and one or more long-term concentrate containers that are
changed only after multiple days (e.g. weekly). The daily
disposable may have concentrate containers that are initially empty
and are filled from the long-term concentrate containers once per
day at the beginning of a treatment.
Inventors: |
WYETH; Mark T.; (Andover,
MA) ; YANTZ; Gregory; (Boxford, MA) ;
FRIEDERICHS; Goetz; (Boston, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NxStage Medical, Inc. |
Lawrence |
MA |
US |
|
|
Assignee: |
NxStage Medical, Inc.
Lawrence
MA
|
Family ID: |
67683818 |
Appl. No.: |
16/288671 |
Filed: |
February 28, 2019 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62676098 |
May 24, 2018 |
|
|
|
62636404 |
Feb 28, 2018 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/1674 20140204;
A61M 1/1664 20140204; C02F 2103/026 20130101; A61M 1/287 20130101;
A61M 2205/128 20130101; A61M 2205/15 20130101; A61M 1/1666
20140204; A61M 2205/3344 20130101; A61M 2205/702 20130101; A61M
2205/3569 20130101; C02F 2201/005 20130101; C02F 1/42 20130101;
C02F 1/444 20130101; A61M 1/1672 20140204; A61M 2205/127 20130101;
C02F 1/32 20130101; A61M 1/288 20140204; A61M 2205/215 20130101;
A61M 2205/3334 20130101; A61M 1/28 20130101; A61M 2205/12 20130101;
C02F 1/001 20130101; C02F 1/441 20130101; A61M 2205/8212 20130101;
C02F 2209/03 20130101; C02F 1/283 20130101; A61M 1/1696 20130101;
A61M 2205/126 20130101; A61M 1/267 20140204 |
International
Class: |
A61M 1/28 20060101
A61M001/28 |
Claims
1. A method for making a batch of peritoneal dialysis solution
sufficient for at least a single patient fill operation, the batch
being a final mixture of constituents, said constituents including
a final quantity of water, a final quantity of osmotic agent
concentrate, and a final quantity of electrolyte concentrate, the
method comprising: using a fluid proportioning device with a
controller, actuators, and a conductivity sensor; attaching a fluid
circuit to the actuators, the fluid circuit having a mixing
container; using the controller to control the actuators: pumping a
fraction of said final quantity of water into the mixing container;
pumping more than said final quantity, plus or minus an error, of
electrolyte concentrate into the mixing container; mixing contents
of the mixing container; sampling the contents of the mixing
container in a manner that reduces volume of fluid in the mixing
container and measuring the conductivity thereof; calculating and
storing data responsive to a deviation of the measured conductivity
from a predefined expected conductivity resulting from said error;
calculating an adjusted quantity of water and/or osmotic agent
concentrate required to achieve predefined proportions of said
constituent final quantities responsive to the data; and pumping
the adjusted quantity of water or osmotic agent concentrate into
the mixing container.
2. The method of claim 1, wherein the method is performed at a
location of a peritoneal dialysis treatment.
3. (canceled)
4. The method of claim 1, wherein the method is performed such that
it is completed within a day, within 12 hours, within 6 hours,
within 3 hours, or within an hour of a start of a peritoneal
dialysis treatment.
5. The method of claim 1, wherein the fluid proportioning device is
located in a same room, within 100 meters, within 10 meters, within
5 meters, or within 2 meters as a patient receiving a peritoneal
dialysis treatment.
6. The method of claim 1, wherein the electrolyte concentrate is
pumped into the mixing concentrate after the fraction of said final
quantity of water; the mixing takes place after the pumping of the
more than said final quantity of electrolyte concentrate; the
sampling takes place after the mixing; the calculating and storing
data take place after the sampling; the calculating the adjusted
quantity takes place after the calculating and storing the data;
and the pumping the adjusted quantity takes place after the
calculating the adjusted quantity.
7. The method of claim 1, wherein the using a fluid proportioning
device includes providing a peritoneal dialysis cycler.
8. The method of claim 1, further comprising, after pumping the
adjusted quantity of water and/or osmotic agent concentrate,
sampling the contents of the mixing container and measuring a final
conductivity thereof.
9. The method of claim 1, further comprising, comparing a final
conductivity to a predefined final conductivity and permitting use
of the batch or preventing use of the batch responsively to a
result thereof.
10. The method of claim 1, wherein said fraction of said final
quantity of water pumped into the mixing container is less than
60%.
11. The method of claim 1, wherein the controller samples the
mixing container contents by pumping a sample from the mixing
container across a conductivity sensor in a drain line.
12. The method of claim 1, wherein said fraction of said final
quantity of water pumped into the mixing container is less than
90%.
13. The method of claim 1, wherein the pumping more than said final
quantity, plus or minus an error, of electrolyte concentrate occurs
before the pumping the adjusted quantity of water or osmotic agent
concentrate into the mixing container.
14. A method for making a batch of peritoneal dialysis solution
sufficient for a patient fill operation, the batch being a mixture
of constituents in target proportions, said constituents including
water, osmotic agent concentrate, and electrolyte concentrate, the
method comprising: using a fluid proportioning device with a
controller, actuators, and a conductivity sensor; attaching a fluid
circuit to the actuators, the fluid circuit having a mixing
container; using the controller to control the actuators: pumping
water into the mixing container; pumping electrolyte concentrate
into the mixing container in an amount intended to create a
predefined ratio of said electrolyte concentrate and said water;
mixing contents of the mixing container; sampling the contents of
the mixing container and measuring a conductivity thereof;
calculating and storing data responsive to a deviation of a
measured conductivity of the mixing container contents from one
corresponding to said predefined ratio; calculating an adjusted
quantity of water or osmotic agent concentrate responsively to said
data; and pumping the adjusted quantity of water or osmotic agent
concentrate into the mixing container.
15. The method of claim 14, wherein the method is performed at a
time of a peritoneal dialysis treatment.
16. The method of claim 14, wherein the using a fluid proportioning
device includes providing a peritoneal dialysis cycler.
17. The method of claim 14, further comprising, after pumping the
adjusted quantity of water or osmotic agent concentrate, sampling
the contents of the mixing container and measuring a final
conductivity thereof.
18. The method of claim 17, further comprising, comparing the
measured final conductivity to a predefined final conductivity and
permitting use of the contents of the mixing container or
preventing use of the contents of the mixing responsively to a
result thereof.
19. The method of claim 14, further comprising adding further water
to said mixing container to create ready-to-use dialysate therein,
wherein said adding water into the mixing container transfers less
than 60% of the quantity of water in said ready-to-use dialysate in
said mixing container.
20. The method of claim 14, wherein the controller samples the
mixing container contents by pumping a sample from the mixing
container across a conductivity sensor in a drain.
21-67. (canceled)
68. A method of preparing a batch of treatment fluid, comprising:
adding a fraction of a final quantity of water plus a first
concentrate to a mixing container; mixing the contents of the
mixing container and testing a first conductivity of the contents;
if the first conductivity is below a first predefined range,
outputting an indication of a failure of the mixing container
contents; if the first conductivity is above the first predefined
range, calculating a first additional amount of water, to add to
the final quantity, responsive to the first conductivity, plus an
additional quantity beyond a final quantity of a second concentrate
and add the second concentrate to the mixing container; if the
first conductivity is in the first predefined range, add the second
concentrate to the mixing container; adding a remainder of the
final quantity of water plus the additional amount of water, if
calculated, to the mixing container; mixing the contents of the
mixing container and testing a second conductivity of the contents;
if the second conductivity is below a second predefined range,
outputting an indication of a failure of the mixing container
contents; and if the second conductivity is within the second
predefined range, making the contents of the mixing container
available for a treatment.
69. The method of claim 68, wherein, if the second conductivity is
above the second predefined range, adding the first additional
amount of water plus a second additional amount of water responsive
to the second conductivity.
70. The method of claim 68 or 69, further comprising using the
contents of the mixing container for a dialysis treatment.
71. The method of claim 68 or 69, further comprising using the
contents of the mixing container for a peritoneal dialysis
treatment.
72-80. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application 62/636,404, filed Feb. 28, 2018 and of U.S. Provisional
Application 62/676,098, filed on May 24, 2018, all of which are
hereby incorporated by reference in their entireties.
BACKGROUND
[0002] The disclosed subject matter relates generally to the
treatment of end stage renal failure and more specifically to
devices, methods, systems, improvements, and components for
performing peritoneal dialysis.
[0003] Peritoneal dialysis is a mature technology that has been in
use for many years. It is one of two common forms of dialysis, the
other being hemodialysis, which uses an artificial membrane to
directly cleanse the blood of a renal patient. Peritoneal dialysis
employs the natural membrane of the peritoneum to permit the
removal of excess water and toxins from the blood.
[0004] In peritoneal dialysis, sterile peritoneal dialysis fluid is
infused into a patient's peritoneal cavity using a catheter that
has been inserted through the abdominal wall. The fluid remains in
the peritoneal cavity for a dwell period. Osmotic exchange with the
patient's blood occurs across the peritoneal membrane, removing
urea and other toxins and excess water from the blood. Ions that
need to be regulated are also exchanged across the membrane. The
removal of excess water results in a higher volume of fluid being
removed from the patient than is infused. The net excess is called
ultrafiltrate, and the process of removal is called
ultrafiltration. After the dwell time, the dialysis fluid is
removed from the body cavity through the catheter.
[0005] Peritoneal dialysis requires the maintenance of strict
sterility because of the high risk of peritoneal infection.
[0006] In one form of peritoneal dialysis, which is sometimes
referred to as cycler-assisted peritoneal dialysis, an automated
cycler is used to infuse and drain dialysis fluid. This form of
treatment can be done automatically at night while the patient
sleeps. One of the safety mechanisms for such a treatment is the
monitoring by the cycler of the quantity of ultrafiltrate. The
cycler performs this monitoring function by measuring the amount of
fluid infused and the amount removed to compute the net fluid
removal.
[0007] The treatment sequence usually begins with an initial drain
cycle to empty the peritoneal cavity of spent dialysis fluid,
except on so-called "dry days" when the patient begins automated
treatment without the peritoneal cavity filled with dialysis fluid.
The cycler then performs a series of fill, dwell, and drain cycles,
typically finishing with a fill cycle.
[0008] The fill cycle presents a risk of over-filling or
over-pressurizing the peritoneal cavity, which has a low tolerance
for excess pressure. In traditional peritoneal dialysis, a dialysis
fluid container is elevated to certain level above the patient's
abdomen so that the fill pressure is determined by the height
difference. Automated systems sometimes employ pumps that cannot
generate a pressure beyond a certain level, but this system is not
foolproof since a fluid column height can arise due to a
patient-cycler level difference and cause an overpressure. A
reverse height difference can also introduce an error in the fluid
balance calculation as a result of incomplete draining.
[0009] Modern cyclers may fill by regulating fill volume during
each cycle. The volume may be entered into a controller based on a
prescription. The prescription, which also determines the
composition of the dialysis fluid, may be based upon the patient's
size, weight, and other criteria. Due to errors, prescriptions may
be incorrect or imperfectly implemented resulting in a detriment to
patient well-being and health.
SUMMARY
[0010] Embodiments of peritoneal dialysis systems, devices, and
methods are described herein. The features, in some cases, relate
to automated peritoneal dialysis and in particular to systems,
methods, and devices that prepare peritoneal dialysis fluid in a
safe and automated way at a point of care. Other features relate to
the precision, safety, and ease of use of such systems.
[0011] Objects and advantages of embodiments of the disclosed
subject matter will become apparent from the following description
when considered in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1A-1D show peritoneal dialysis fluid
proportioner/cyclers according to respective embodiments of the
disclosed subject matter.
[0013] FIG. 1E shows a series testable filter arrangement that may
be substituted for the filters employed in the embodiments of FIGS.
1A-1D.
[0014] FIGS. 1F-1H show embodiments similar to those of FIGS. 1A-1D
and elaborating further details thereof.
[0015] FIG. 2A shows a disposable fluid circuit for use with
peritoneal dialysis fluid proportioner/cyclers of certain
embodiments disclosed herein.
[0016] FIG. 2B shows an actuator portion of a peritoneal dialysis
fluid proportioner/cycler, according to embodiments of the
disclosed subject matter.
[0017] FIG. 2C shows a connection platform between a purified water
source and the peritoneal dialysis fluid proportioner/cycler,
according to embodiments of the disclosed subject matter.
[0018] FIG. 2D shows a peristaltic pumping actuator that permits
the use of a straight pumping tube segment in a generally planar
cartridge, employed as a feature of embodiments disclosed
herein.
[0019] FIG. 2E shows a disposable fluid circuit for a peritoneal
dialysis fluid proportioner/cycler according to embodiment of the
disclosed subject matter in which concentrates are extracted from a
disposable component that is separate from the cycler/preparation
fluid circuit.
[0020] FIGS. 2F and 2G show concentrate disposable components for
use with embodiments of the disclosed subject matter.
[0021] FIG. 2H shows a disposable fluid circuit for a peritoneal
dialysis fluid proportioner/cycler according to embodiments of the
disclosed subject matter in which concentrates are extracted from a
disposable component that is separate from the cycler/preparation
fluid circuit through respective filtered lines.
[0022] FIGS. 2I, 2J, and 2K show respective embodiments of
connection platforms between a purified water source and a separate
concentrate source and the peritoneal dialysis fluid
proportioner/cycler embodiments disclosed herein, according to
embodiments of the disclosed subject matter.
[0023] FIGS. 2L and 2M show details of variations of the
embodiments described with reference to FIG. 2K.
[0024] FIG. 3 shows a method of manufacturing a disposable circuit
such as is disclosed in FIG. 2A.
[0025] FIG. 4A shows a peritoneal dialysis fluid
proportioner/cycler according to embodiments of the disclosed
subject matter.
[0026] FIG. 4B shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a first phase of fluid
preparation in which osmotic agent concentrate is added to a mixing
container, according to embodiments of the disclosed subject
matter.
[0027] FIG. 4C shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a second phase of fluid
preparation in which a dialysis fluid precursor is obtained by
diluting and mixing the contents of the mixing container, according
to embodiments of the disclosed subject matter.
[0028] FIG. 4D shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a third phase of fluid
preparation in which the peritoneal dialysis fluid precursor
properties are verified, according to embodiments of the disclosed
subject matter.
[0029] FIG. 4E shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a fourth phase of fluid
preparation in which dialysis fluid precursor is further prepared
by addition of electrolyte concentrate to the mixing container,
according to embodiments of the disclosed subject matter.
[0030] FIG. 4F shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a fifth phase of fluid
preparation in which end-use dialysis fluid is prepared by
adjustment of the dilution of the mixing container contents,
according to embodiments of the disclosed subject matter.
[0031] FIG. 4G shows the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in a sixth phase of fluid
preparation in which dialysis fluid in the mixing container is
verified, according to embodiments of the disclosed subject
matter.
[0032] FIG. 4H and FIG. 4K show the peritoneal dialysis fluid
proportioner/cycler of FIG. 4A in various peritoneal dialysis
treatment modes, according to embodiments of the disclosed subject
matter.
[0033] FIG. 4L shows a peritoneal dialysis fluid
proportioner/cycler similar to that of FIG. 4A in which a single
mixing container line connects a valve network to the mixing
container.
[0034] FIGS. 5A-5D illustrate the structure and use of a
multifunction connector according to embodiments of the disclosed
subject matter.
[0035] FIG. 5E shows features for a variation of a double connector
500 that protects against contamination.
[0036] FIG. 6A shows mechanical aspects and a control and sensor
system for the cut-and-seal devices with actuation, temperature,
and force control features, according to embodiments of the
disclosed subject matter.
[0037] FIGS. 6B through 6G show various embodiments of cut-and-seal
devices.
[0038] FIGS. 7A through 7D show various jaw arrangements for
cut-and-seal devices according to different embodiments of the
disclosed subject matter.
[0039] FIGS. 8A and 8B show details of chamber portions of fluid
circuits according to embodiments of the disclosed subject
matter.
[0040] FIGS. 8C through 8G show various features to promote mixing
of fluids in a mixing container according to embodiments of the
disclosed subject matter.
[0041] FIG. 9A shows a manifold according to embodiments of the
disclosed subject matter.
[0042] FIG. 9B shows a peritoneal dialysis fill/drain line
according to embodiments of the disclosed subject matter.
[0043] FIGS. 10A and 10B show the structure of a valve network
portion of a fluid circuit according to embodiments of the
disclosed subject matter.
[0044] FIG. 11 shows a fluid circuit for peritoneal dialysis
according to embodiments of the disclosed subject matter.
[0045] FIG. 12 shows a method of priming a fluid circuit according
to embodiments of the disclosed subject matter.
[0046] FIGS. 13A and 13B show embodiments of a fluid circuit with
sources of concentrate where different compositions are provided
for priming.
[0047] FIG. 14 shows a block diagram of an example computer system
according to embodiments of the disclosed subject matter.
[0048] FIGS. 15A and 15B illustrate a mixing method according to
embodiments of the disclosed subject matter.
[0049] FIG. 15C illustrates an optimization point for a mixing
method according to embodiments of the disclosed subject
matter.
[0050] FIG. 15D illustrates a mixing method different from that of
FIG. 15A according to further embodiments of the disclosed subject
matter.
[0051] FIG. 15E is a flow chart in outline form for conductivity
error recovery for various mixing methods described herein.
[0052] FIGS. 16A through 16C are flow diagrams describing a method
for mixing a medicament in which electrolyte concentrate is added
first to a mixing container according to embodiments of the
disclosed subject matter.
[0053] FIGS. 17A through 17D show embodiments of
proportioning/treatment systems in which long-term, multi-treatment
containers of concentrate are used to form a ready-to-use
peritoneal dialysis fluid according to embodiments of the disclosed
subject matter.
[0054] FIG. 18A shows an embodiment of a proportioning/treatment
system in which long-term, multi-treatment containers of
concentrate are used to fill a disposable used during a treatment
to form a ready-to-use peritoneal dialysis fluid according to
embodiments of the disclosed subject matter.
[0055] FIG. 18B-18D show a single flow chart when linked together
to define a process for making a batch of dialysis fluid based on
the embodiment of FIG. 18A.
[0056] FIGS. 18E through 18H show variations of details of the
embodiment of FIG. 18A for supplying concentrate or water to the
fluid circuit according to embodiments of the disclosed subject
matter.
[0057] FIG. 19A through 19C describe a first device and
corresponding method of controlling the supply of water to a
peritoneal dialysis fluid treatment device, according to
embodiments of the disclosed subject matter.
[0058] FIG. 19D through 19F describe a second device and
corresponding method of controlling the supply of water to a
peritoneal dialysis fluid treatment device, according to
embodiments of the disclosed subject matter.
[0059] FIGS. 19G through 19H and 19J describe a third device and
corresponding method of controlling the supply of water to a
peritoneal dialysis fluid treatment device, according to
embodiments of the disclosed subject matter.
[0060] FIGS. 19K through 19M describe a fourth device and
corresponding method of controlling the supply of water to a
peritoneal dialysis fluid treatment device, according to
embodiments of the disclosed subject matter.
[0061] FIGS. 20A through 20E show mechanisms for providing sterile
filtration in the various peritoneal proportioning/treatment
systems of the various disclosed embodiments.
[0062] FIG. 20F shows a device for measuring conductivity with
minimal loss of fluid by locating a conductivity cell in the
disposable at a point where fluid exits the mixing container,
according to embodiments of the disclosed subject matter.
[0063] FIG. 20G shows a system and method that may be applied to
any of the embodiments in which a pressure sensor used for flow
control provides an additional function of pressure testing of a
filter membrane by opening a particular set of valves that define a
path from the fluid side of the filter to the pressure sensor.
[0064] FIGS. 21A through 21C show a flow chart for making and
correcting errors in water and concentrate mixtures according to
embodiments of the disclosed subject matter.
[0065] FIGS. 22A and 22B show a water filtration system with
flushing and priming modes controlled by a controller which is
commanded by a cycler controller according to embodiments of the
disclosed subject matter with FIGS. 22A and 22B showing production
with flushable filters.
[0066] FIG. 22C shows multiple additional features that may be
added to form variations of the various embodiments disclosed
herein, including those of FIGS. 22A and 22B.
[0067] FIG. 23 shows an embodiment of a proportioning and treatment
system in which sampling of spent dialysate is supplemented by a
mechanism to allow for the sampling and testing of spent dialys ate
aliquots rather than a full treatment volume of spent dialys
ate.
[0068] FIG. 24 shows a peritoneal dialysis system connected to a
remote device for purposes of describing various features that may
be used with the disclosed embodiments to form additional disclosed
embodiments.
[0069] FIG. 25 shows a flow chart for describing an embodiment
based on the premise that discrepancies between a measured
conductivity and the expected conductivity result from a reduction
in moisture content of one or both of the pre-packaged
concentrates, such as may result from moisture loss due to
evaporation, according to embodiments of the disclosed subject
matter.
[0070] FIGS. 26A through 26C illustrate a system and method for
using a proportioning system to infuse a medicament with a drug or
other substance.
[0071] Embodiments will hereinafter be described in detail below
with reference to the accompanying drawings, wherein like reference
numerals represent like elements. The accompanying drawings have
not necessarily been drawn to scale. Where applicable, some
features may not be illustrated to assist in the description of
underlying features.
DETAILED DESCRIPTION
[0072] FIGS. 1A-1D show peritoneal dialysis fluid
proportioner/cyclers according to respective embodiments of the
disclosed subject matter. Referring now to FIG. 1A, medical fluid
preparation and peritoneal dialysis fluid proportioner/cycler
system 90A includes a purified water source 104 that provides water
suitable for peritoneal dialysis to a peritoneal dialysis fluid
proportioner/cycler 103 which is connected to a disposable
component 100A. The purified water source 104 also provides a
connection to a drain (shown in FIG. 1A only, but similar in FIGS.
1B-1D). The peritoneal dialysis fluid proportioner/cycler 103
meters concentrate from one or more concentrate containers 101 (one
container is shown but multiple containers may be present) and adds
them to, and dilutes them with purified water in a mixing container
102. The concentrate containers 101 and mixing container 102 form
parts of a single disposable which may also contain a switchable
fluid circuit (not shown) that forms part of the disposable
component 100A. Mixed dialysis fluid (or other medicament) is
pumped by the peritoneal dialysis fluid proportioner/cycler 103
through a connected line to a patient 101A, for example for
peritoneal dialysis. The configuration of FIG. 1A allows the
sterile concentrate and the fluid circuit and containers used for
preparation, as well as short term storage, to be provided as a
single sealed sterile disposable with a small predefined number of
connections to external devices. These may include connections to
the purified water source 104 and connections to the external
medicament consumer. The small number of connections minimizes the
risk of contamination. By diluting and mixing concentrate at the
point of use, the volume of fluid that has to be stored at a
peritoneal dialysis treatment location is also minimized In a
peritoneal dialysis embodiment, the disposable component 100A may
be configured with sufficient concentrate to perform multiple
fill/drain cycles of a single peritoneal dialysis treatment. For
example, the disposable component 100A may have sufficient
concentrate for multiple fill cycles of a daily automated
peritoneal dialysis treatment (APD).
[0073] Referring now to FIG. 1B, a medical preparation and
peritoneal dialysis fluid proportioner/cycler system 90B is similar
to the medical fluid preparation and peritoneal dialysis fluid
proportioner/cycler system 90A except that the disposable component
100B that has a fluid circuit for proportioning and diluting as
well as delivering the product medicament does not contain the
concentrate. This allows the size of the disposable component 100B,
which is handled frequently, for example, daily, to be reduced in
mass and easier for a patient and/or user to handle and store. It
also can make the disposable component 100B more economical by
reducing waste and providing packaging and manufacturing economies.
To provide the concentrate, a separate disposable component 100E is
provided which contains one or more concentrate containers 101. The
disposable component 100E may have a large capacity and may be
changed on a schedule that is much less frequent than the frequency
of the replacement of the disposable component 100B. For example,
the disposable component 100B may be replaced each time a daily
peritoneal dialysis treatment is performed. It may be called a
"daily disposable component." For example, the disposable component
100E may be replaced once every month so it may be called a
"monthly disposable" or it may be replaced every week and called a
"weekly disposable". The precise capacity and the time the
disposable generally lasts is not a limiting feature of the
disclosed subject matter. What is relevant is that the disposable
component 100E (and others disclosed below) have sufficient
capacity for multiple treatments where each treatment includes
multiple fill/drain cycles of a peritoneal dialysis treatment.
[0074] The disposable component 100B may also have, as part of the
fluid circuit included therein, a sterilizing filter 115 of a type
that has an air-line 118 to permit the pressure testing of a
membrane thereof. The latter type of filter test may be performed
automatically by a controller of the peritoneal dialysis fluid
proportioner/cycler 103 on a schedule that is more frequent than
the replacement schedule for the disposable component 100E. In
embodiments, the sterilizing filter 115 may be integrated, and
therefore, replaced with, the disposable component 100B. This
allows the sterilizing filter 115 to be sealed and sterilized with
the disposable component 100B and mixing container 102 as a single
unit along with the switchable fluid circuit (not shown). Note
details of a suitable configuration for a switchable fluid circuit
may be found in International Patent Application Publication
WO2013141896 to Burbank, et al.
[0075] A function provided by the sterilizing filter 115 is to
provide safety given that a new sterile disposable component 100B
is attached to the concentrate 101 for each peritoneal dialysis
treatment. A similar filter may be employed in all the embodiments
for the line indicated at 107 conveying the purified water to the
peritoneal dialysis fluid proportioner/cycler 103. Since a new
connection is required each time the disposable component 100B is
replaced, there is a risk of contamination from the new connection.
The sterilizing filter 115 (and others) can be provided as a
sterile barrier to protect the sterile interior of the disposable
component 100B, thereby ensuring that any contamination resulting
from the newly-made connection does not enter the disposable
component 100B interior. In addition, the automatic testing of the
filter provides assurance that the sterilizing filter 115 integrity
has provided the expected sterile fluid. Thus, the testability
functions as a guarantee of the filter's sterilizing function.
Testing of sterilizing filters using pressurized air testing can be
done in various ways, for example, a bubble point test can be
performed. Alternatively, a pressure decay test can be done where
fluid is pumped across the membrane and the pressure drop measured
and compared with a pressure drop representative of an intact
filter or pressure is increased on one side, pumping stopped, and
the rate of decay of pressure compared to a predefined curve
representative of an intact filter. In other embodiments, the
filter is housed in an air-tight container and the container is
pressurized to a level that is below the expected bubble point, but
high enough to guarantee that the membrane is sterilizing grade.
The filter has air vents so this pressurizes the membrane. The rate
of (air) pressure decay is then measured and if the decay rate is
greater than a predefined threshold rate, the filter is indicated
to have failed. Other means of testing filter integrity may be
used, for example, concentrates can include a large-molecule
excipient whose presence can be detected using automatic chip-based
analyte detection (e.g., attachment of fluid samples to selective
fluorophore after flowing through the filter and optical detection
after concentration). A feature of the embodiments that use a
filter to provide the guarantee, as mentioned, is that the filter
forms part of a sterilized unit that is otherwise hermetically
sealed or protected by one or more additional sterilizing filters.
Thus, in embodiments, the entire sealed and sterilized circuit may
have sterilizing filters (1) at all openings to its interior or at
least (2) at all openings to which fluid is admitted from the
external environment.
[0076] Referring now to FIG. 1C, a medical preparation and
peritoneal dialysis fluid proportioner/cycler system 90C is similar
to the medical fluid preparation and peritoneal dialysis fluid
proportioner/cycler system 90B in that the disposable component
100C that has a fluid circuit for proportioning and diluting as
well as delivering the product medicament does not contain the
concentrate. As in peritoneal dialysis fluid proportioner/cycler
system 90B, a separate disposable component 100F is provided which
contains one or more concentrate containers 101, in this example, a
first concentrate container 105A and a second concentrate container
105B are shown. These may be in the form of canisters held by a
single packaging wrapper 105C or they may be replaced separately
when they expire or are exhausted. As in the peritoneal dialysis
fluid proportioner/cycler system 90B, the disposable component 100C
may have a large capacity and may be changed on a schedule that is
much less frequent than the frequency of the replacement of the
disposable component 100B. For example, the first concentrate
container 105A and/or second concentrate container 105B may be
sized to be replaced on a monthly basis. In the medical fluid
preparation and peritoneal dialysis fluid proportioner/cycler
system 90C, the disposable component 100C may also have, as part of
the fluid circuit included therein, two sterilizing filters
(collectively indicated as the sterilizing filter 115), each of the
type that has an air-line 118 to permit the pressure-testing of a
membrane thereof. Each of the concentrates from first concentrate
container 105A and second concentrate container 105B may thereby be
sterile-filtered and the filter tested for each separately. As in
the peritoneal dialysis fluid proportioner/cycler system 90B, this
configuration allows the sterilizing filters 115 to be sealed and
sterilized with the disposable component 100C and mixing container
102 as a single unit along with the switchable fluid circuit (not
shown). As in any of the embodiments a sterilizing filter may be
used in the water line as indicated at 107.
[0077] Referring now to FIG. 1D, a medical preparation and
peritoneal dialysis fluid proportioner/cycler system 90D is similar
to the medical fluid preparation and peritoneal dialysis fluid
proportioner/cycler system 90C in that the disposable component
100C that has a fluid circuit for proportioning and diluting as
well as delivering the product medicament does not contain the
concentrate. As in peritoneal dialysis fluid proportioner/cycler
system 90C, a separate disposable component 100G is provided which
contains a first concentrate container 105A and a second
concentrate container 105B. As in any of the embodiments, the
number of concentrates may be greater or fewer. The concentrates
may be held in the canisters which may have a single packaging
wrapper 105C or they may be replaced separately when they expire.
As in the peritoneal dialysis fluid proportioner/cycler system 90C,
the disposable component 100G may have a large capacity such that
it can be replaced on a schedule that is much less frequent than
the frequency of the replacement of the disposable component 100D.
For example, the first concentrate container 105A and/or second
concentrate container 105B may be sized to be replaced on a monthly
basis. In the medical fluid preparation and peritoneal dialysis
fluid proportioner/cycler system 90D, the disposable component 100D
may also have, as part of the fluid circuit included therein, the
sterilizing filter 115, also of the type that has an air-line 118
to permit the pressure testing of a membrane thereof. To
sterile-filter each of the concentrates from first concentrate
container 105A and second concentrate container 105B, a connection
platform allows the peritoneal dialysis fluid proportioner/cycler
103 to draw purified water, first concentrate container 105A or
second concentrate container 105B selectively by closing a valve on
all but one of these at a time by the connection platform 106 under
control of the peritoneal dialysis fluid proportioner/cycler 103.
As in the peritoneal dialysis fluid proportioner/cycler system 90B,
this configuration allows the sterilizing filter 115 to be sealed
and sterilized with the disposable component 100D and mixing
container 102 as a single unit along with the switchable fluid
circuit (not shown). The switching fluid circuit of the connection
platform 106 may be part of a disposable that is replaced with the
first concentrate container 105A and second concentrate container
105B.
[0078] In the present and any of the embodiments, the long-term
concentrate containers (e.g., monthly disposable) may be replaced
on separate schedules so they need not be packaged as a single
disposable. This may provide further economy when one concentrate
is used at a lower rate by some patients than others, thus allowing
the concentrate to be consumed fully before replacing.
[0079] It should be evident that there is the potential for the
reduction of waste of concentrate by structuring the batch
preparation components to permit the changing of concentrates
independently of each other and at intervals that cover multiple
peritoneal dialysis treatment sessions. Each concentrate container
can be used until exhaustion. For embodiments, exhaustion may be
defined to be a condition where insufficient concentrate remains in
a single container to permit the preparation of a full batch of
peritoneal dialysis fluid, a full batch, in embodiments, being a
quantity of concentrate component sufficient for a single fill
cycle. In other embodiments, a concentrate container may be
exhausted when there is insufficient concentrate to make a
predefined number of batches or enough to make sufficient dialysate
for a full treatment. If two concentrates are mixed to form a
batch, each component concentrate may be changed out when the
prescription's required contribution of that concentrate to make a
single batch exceeds the remaining volume in the particular
container. The residual volume threshold associated with this
insufficiency is a fixed volume, so that its percentage of the
total volume available from a full container is smaller for a large
container than for a smaller container. Thus, in embodiments where
the concentrate container is replaced only when the threshold is
reached, which container holds large total volume, for example,
enough for multiple fill cycles, or better, enough for multiple
peritoneal dialysis treatments each including multiple fill cycles,
the total waste is much smaller than a disposable component
containing concentrate for a single peritoneal dialysis treatment.
An example of the latter is discussed below with reference to FIGS.
8A and 8B. In addition, since each concentrate container can be
replaced separately, the fixed residual thresholds of the multiple
concentrate containers are independent of each other because each
container can be replaced independently of the other. In contrast,
in the embodiments of FIGS. 8A and 8B, if one container reaches the
minimum volume before the other, the contents of neither
concentrate container can be used further.
[0080] In embodiments, the concentrate containers are sized to
permit a single peritoneal dialysis treatment. For convenience and
convention, a single peritoneal dialysis treatment would be
considered a single day's worth of peritoneal dialysis treatment,
for example, a series of nocturnal PD cycles ending with a fill.
So, a single day's peritoneal dialysis treatment is equal to a
sufficient quantity of fluid to perform multiple fill and drain
cycles. Embodiments in which the concentrate containers are sized
for a single day's peritoneal dialysis treatment differ from those
described with reference to the embodiments of FIGS. 8A and 8B in
that the concentrates can be changed independently thereby
achieving a potential savings of a first concentrate that is used
at a rate such that a residual volume of the first concentrate can
be used more fully as described above. More specifically, if the
concentrate containers are sized such that batches of at least
predefined prescriptions require more of a first concentrate
component than of a second concentrate component and such that at
least one batch, or at least one day's worth of batches can be
completed while leaving sufficient residual concentrate of the
second component to make at least one additional batch, or one
additional day's worth of batches, after replacing the first
concentrate component, then a savings of the second concentrate may
be enjoyed. In embodiments, the total concentrate of the most
heavily used container of a multiple-component concentrate system
is at least sufficient for:
[0081] Multiple batches, a batch being sufficient for a single
peritoneal cycle (fill volume of a peritoneum of a predefined class
of patient (e.g., child, adult, adult of a certain size, etc.);
[0082] Same as 1, but where the multiple batches are sufficient for
a single peritoneal dialysis treatment of multiple fill-drain
cycles;
[0083] Same as 2, but the most heavily used concentrate container
is sufficient for making enough dialysis fluid for multiple
peritoneal dialysis treatments;
[0084] Same as 2, but the most heavily used concentrate container
is sufficient for making enough dialysis fluid for multiple days'
worth of peritoneal dialysis treatments if a single day's worth is
not identical to a single peritoneal dialysis treatment's
worth;
[0085] A full week's worth of peritoneal dialysis treatments;
or
[0086] A full month's worth of peritoneal dialysis treatments or
some other interval on the order of a month or multiple months.
[0087] FIGS. 1F-1H show embodiments similar to those of FIGS. 1A-1D
and elaborating further details thereof. Referring now to FIG. 1F,
a fluid circuit is indicated at 112. The fluid circuit 112 engages
with the peritoneal dialysis fluid proportioner/cycler 114 by means
of valve actuators 123 and one or more pumping actuators 125 which
engage the fluid circuit elements of the fluid circuit 112 without
wetting the actuator components. For example, a type of valve
actuator such as a linear-motor driven pinch clamp may close and
open tubing for flow therethrough and peristaltic pump rollers may
engage pumping tube segments. The configuration is not limited to
such examples, and many are known in the art, any of which may be
used in the present embodiment. The fluid circuit 112 has water
suitable for peritoneal dialysis and drain lines 126, 127. The
water suitable for peritoneal dialysis flows through a line with a
sterilizing filter 115 according to any of the disclosed
embodiments including a testable filter and two sterilizing filters
in series. The only connections that need to be made for supplying
fluid or draining fluid are connections indicated at 129. The water
suitable for peritoneal dialysis and drain lines 126, 127 may be
formed as part of the fluid circuit 112. In embodiments, the fluid
circuit 112, concentrate container(s) 101, and mixing container 102
may be pre-connected to form a complete disposable fluid circuit
100A including concentrate.
[0088] Referring now to FIG. 1G, further details of the peritoneal
dialysis fluid proportioner/cycler system 90C are shown. The
separate disposable component 100F contains concentrate containers
105A and 105B and connects to the peritoneal dialysis fluid
proportioner/cycler 114 by connectors 121, which may include a
double connector as described in embodiments described herein or
other types. The peritoneal dialysis fluid proportioner/cycler 114
has pumping actuators 125 and valve actuators 123 that engage the
fluid circuit 112. Here the peritoneal dialysis fluid
proportioner/cycler 114 provides a pass-through connection for the
concentrate while the sterilizing filters 115 on the concentrate
lines 130 form part of the disposable component 100C, which
includes the fluid circuit 112 and mixing container 102. That is,
the peritoneal dialysis fluid proportioner/cycler 114 connects the
concentrate lines 131 respectively to the concentrate lines 155A
and 155B of the fluid circuit 112. Here also, connectors for
air-lines 130A and 130B are provided to the peritoneal dialysis
fluid proportioner/cycler 114 where an air pump (not shown) can
generate a positive pressure and a pressure sensor can measure the
positive pressure. A filter integrity test may be done after
flowing fluid into the fluid circuit. During set-up, the disposable
component 100C may be connected by connecting water suitable for
peritoneal dialysis and drain lines 116, 117, concentrate lines
155A and 155B and air-lines 130A and 130B, while the connectors 121
can remain in place through the entire long-term disposable cycle,
that is, until the separate disposable component 100F is expired.
Since the latter is replaced much less frequently, the connectors
121 can remain in place for a relatively long period, and frequent
changes can be limited to changing connectors 122, 120, and
connectors for water suitable for peritoneal dialysis and drain
lines 116, 117 as well as the air-lines 130A and 130B. In
embodiments, for convenience, all of these connections can be
provided in the form of ganged connectors to make and unmake
multiple connections at once. The concentrate containers 105A and
105B may connect to a connection platform (not shown as a unit but
may include the connectors and a support for the concentrate
containers 105A and 105B) and a holder for the by the peritoneal
dialysis fluid proportioner/cycler 114. See further connection
platform embodiments for details.
[0089] Referring to FIG. 1H, a simplified arrangement becomes
possible if the disposable component 100G is connected to the
peritoneal dialysis fluid proportioner/cycler 114 by connectors
121, but all concentrates and water flow into the fluid circuit 112
via the fluid line 135 and all of these fluids are filtered by
sterilizing filter 115. To provide this, a connection platform with
its own controller (not shown separately) may be provided and
connected to a peritoneal dialysis fluid proportioner/cycler, the
combination being illustrated at 119. The connection platform
portion of the combined peritoneal dialysis fluid
proportioner/cycler and connection platform 119 may be as described
with reference to FIGS. 2K through 2M, for example. The connection
platform portion of the combined peritoneal dialysis fluid
proportioner/cycler and connection platform 119 selects one of the
fluids at a given time by closing off the others and opening a
fluid path to the selected one of water, concentrate A, and
concentrate B. As indicated, here and in any embodiments, further
or fewer concentrates may be used. A drain line 135 is present. A
communications interface may be provided to allow commands to be
sent from the fluid circuit 112 to the peritoneal dialysis fluid
proportioner/cycler and connection platform 119.
[0090] FIG. 2A shows a disposable fluid circuit 200 with fluid
lines and components 200A and a cartridge portion 205 containing a
fluid flow director portion 200B and a manifold portion 200E. The
disposable fluid circuit 200 is used as a replaceable disposable
component with a peritoneal dialysis fluid proportioner/cycler
according to embodiments disclosed herein. The present disposable
fluid circuit 200 may be used with the peritoneal dialysis fluid
proportioner/cycler system 90A, for example. Two concentrate
containers 111A and 111B and a mixing container 102 are connected
as a pre-connected unit with other parts of the fluid circuit. The
two concentrate containers 111A and 111B and mixing container 102
may be provided as a welded double panel sheet with welded seams
that define the respective chambers. The mixing container 102 has
two lines, an inflow line 165 and an outflow line 166. A first
concentrate container 111A container has 167, which may be
pre-connected and a second concentrate container 111B line 164,
which may be pre-connected. The present embodiment is for a
peritoneal dialysis fluid proportioner/cycler and has a
pre-connected fill-drain line 160 with a dialysis fluid line 172
attached to an air-line 129. The latter may be formed as a single
unit by co-extrusion. The air-line 129 attaches to a
pressure-sensing pod 162 located at a distal end of the
pre-connected fill-drain line 160. A connector 185 at the distal
end of the pre-connected fill-drain line 160 is sealed. Another
double line 161 has an air-line 129 and a fluid line 171. The fluid
line 171 receives fluid from peritoneal dialysis fluid
proportioner/cycler 114 and the air-line is used for testing the
membrane of the filter. The two air-lines 129 connect to respective
ports 191 that automatically connect in the actuator portion 140 of
any of the suitable peritoneal dialysis fluid proportioner/cycler
embodiments. The actuator portion 140 may be is described with
reference to FIG. 2B. Sample ports are provided at 168 at the ends
of sample fluid lines 132 and 133 for extracting fluid from
respective chambers 175 and 176 of a manifold 174. The two chambers
175 and 176 are separated by a barrier 134 and connected by a
pumping tube segment 137. Pressure pods 178 are installed in each
of the two chambers 175 and 176 to measure pressure on the suction
and pressure sides of the pumping tube segment 137. The dialysis
fluid line 172 has two branches 136 and 139. A waste line 128 and
the fluid line 171 connect via a double connector 181. Lines 132,
128, 165, and branch 136 connect to chamber 175. Lines 133, 164,
166, 167, 171 and branch 139 connect to chamber 176.
[0091] The double connector 181 supports lines 171 and 128 and
provides a pair of connectors 186 and 187 to permit connection of
lines 171 and 128 to water inlet and fluid drain line ports on the
peritoneal dialysis fluid proportioner/cycler 114. The connectors
186 and 187 are sealed by a cap 180. A recess 5251 (See FIGS. 5A,
5B) to engage a detente pin (not shown, but may be a spring-biased
pin in the opening that receives the double connector 181) provides
tactile confirmation of full engagement of the double connector
181. The double connector 181 has a window 183 that provides access
to a cut and seal actuator (not shown in this drawing but indicated
at 210 in FIGS. 21 through 2K). When the segments 182 and 184 of
lines 171 and 128 are cut, the double connector can remain in place
sealing the water inlet and fluid drain line ports until it is
removed immediately prior to connecting a fresh double connector
181. This provides a barrier to prevent contaminants from entering
the water inlet and fluid drain line ports, which in turn protects
the sterile fluid path used by the peritoneal dialysis fluid
proportioner/cycler or connection platform.
[0092] The first concentrate container 111A and concentrate
container 111B are both sealed by a frangible seal 154 in each of
the lines 164 and 167. The seal is fractured automatically by an
actuator after the manifold cartridge 205 is loaded into a receiver
that engages it with the interface shown in FIG. 1B. Holes 170 are
provided in a cartridge support 169 that holds the lines in
predefined positions. Holes 170 provide access to pinch actuators
that selectively close and open the lines 177. Certain lines such
as lines 177 engage with valve actuators so that they function as
valve segments. Holes 179 provide access to actuators that fracture
the frangible seals 154. Note that the cartridge support 169 is
bridged to the manifold 174 by a battery of tubes indicated
collectively at 200C. Even though the polymer of the tubes is
flexible, their lengths, number, are such that the overall
structure including the cartridge support 169 and the manifold 174
is sufficiently stiff may be readily inserted in a receiving
slot.
[0093] FIG. 2B shows an actuator portion 140 of a peritoneal
dialysis fluid proportioner/cycler, according to embodiments of the
disclosed subject matter. Referring to FIG. 2B, a receiving slot
158 receives the cartridge portion 205 and aligns it with the
various actuators and sensors now identified. The various actuators
and sensors include pinch clamp actuators 141 that selectively
press against selected tubes to provide a valve function. The
actuators and sensors further include frangible seal actuators 142
that fracture frangible seals 154 in the concentrate lines that
contain them. The frangible seal actuators 142 may be activated
simultaneously to open the lines between the pump and the
concentrate containers once the pump (e.g., eight-roller
peristaltic pump 143--note that the number of rollers can be any
number) is engaged with the pumping tube segment 137. The actuators
and sensors further include an air sensor 150, for example an
optical air sensor, that wraps partly around the tube segment of
branch 136 in the upper portion of the hole indicated at 124. Ports
146 and 147 connect a vacuum or pressure pump to the respective
ports 191.
[0094] FIG. 2C shows connection platform 219 that serves as an
interface between a purified water source and the peritoneal
dialysis fluid proportioner/cycler, according to embodiments of the
disclosed subject matter. Connection platform 219 is an embodiment
that may provide for connection to water and drain lines 116 and
117 of embodiments of FIGS. 1G and 1H as well as connectors for the
concentrate containers 105A and 105B for interfacing with the
peritoneal dialysis fluid proportioner/cycler 114. The connection
platform 219 permits the purified water source 104 to be connected
to different devices, such as different peritoneal dialysis
treatment devices. Shown here is a configuration adapted for
peritoneal dialysis medicament preparation, and optionally
peritoneal dialysis treatment also.
[0095] Water from the purified water source 104 is received in
water line 245 via connection 244 and flows through ultrafilters
237. Pressure of the water suitable for peritoneal dialysis supply
is monitored by a pressure sensor 218. A valve 234 selectively
controls the flow of water suitable for peritoneal dialysis to a
double connector 215. The purified water source terminates at a
purified water connector 224 of the double connector 215. The
double connector 215 also has a drain terminal connector 225 which
splits at a junction 220 into a path that flows to a pair of
conductivity sensors 230 and then merges at junction 238 to proceed
to a drain 236 and a path that flows directly to the drain 236. The
selected path is controlled by valves 232, 240, and 242 which are
controlled by a controller 210. The double connector 181 previously
described is received in a slot 214 where connections are made to
the purified water connector 224 and drain terminal connector 225.
A detente mechanism 216 provides tactile and audible feedback to
the operator when a home (fully connected) position of the double
connector 181 is realized by inserting into the receiving slot 214.
The receiving slot 214A has a cutting and sealing actuator 212
driven by a controller 210 that cuts the tubes through the window
of double connector 181. A connector 239 serves as an adapter to
permit connection to various types of drains. The connection
platform 219 is also provided with sensors including a moisture
sensor 249 located to detect leaking fluid in the connection
platform 219, a tilt sensor 226 to indicate the proper orientation
of the connection platform 219, and a user interface to interact
with the controller 210. The connection platform 219 may be
received in a receiving slot 231 and may be formed as a unitary
replaceable component. If sterility or leakage problems arise, the
connection platform 219 can be replaced easily.
[0096] FIG. 2D shows a peristaltic pumping actuator 143 that
permits the use of a straight pumping tube segment in a generally
planar cartridge, employed as a feature of embodiments disclosed
herein. The rollers 145 are attached to a rotor that has recesses
to permit clearance for the bulge of an adjacent pumping tube
segment positioned between a race 148 and the rollers 145. The
rollers 145 are unsprung, unlike other peristaltic pump rollers,
and rotate on fixed bearings 1472. Instead, the race 148 is sprung
by springs 144 which urge the race against a pumping tube segment
pinched by the rollers 145. This is a particular embodiment of a
pump and at least some of the embodiments are not limited based on
whether the rollers or race are sprung. Either the rotor 149 can be
moved toward the race 148 to engage a pumping tube segment, or the
race 148 can be moved toward the rotor 149. A sufficient gap at
1492 during loading allows a cartridge, such as cartridge portion
200B with a pumping tube segment to be slid in with no
interference. The race 148 is constrained to tilt (in the plane of
the drawing) and translate up and down in the plane of the drawing
by pins 152 received in guides 153.
[0097] FIG. 2E shows a disposable fluid circuit for a peritoneal
dialysis fluid proportioner/cycler according to an embodiment of
the disclosed subject matter in which concentrates are extracted
from a disposable component that is separate from the
cycler/preparation fluid circuit. A disposable fluid circuit 300
has fluid lines and components 300A and a cartridge portion 305
containing a fluid flow director portion 300B and a manifold
portion 300E. The disposable fluid circuit 300 is for use with
peritoneal dialysis fluid proportioner/cyclers of certain
embodiments disclosed herein. The present disposable is an
embodiment that may be used with the peritoneal dialysis fluid
proportioner/cycler system 90B or 90D, for example, where two
concentrate containers 105A and 105B (not shown in this drawing but
shown in FIGS. 1B and 1H--again, only as examples so other features
of the peritoneal dialysis fluid proportioner/cycler are not
limiting of the disposable fluid circuit 300) are provided as a
separate unit from disposable fluid circuit 300, which has a mixing
container 102 and no concentrate containers. The mixing container
102 may be provided as a welded double panel sheet with welded
seams that define the chambers. The mixing container 102 may have
two lines, an inflow line 165 and an outflow line 166. In
alternative embodiments, the mixing container 102 may have only a
single line for both inflow and outflow.
[0098] The present embodiment is for a peritoneal dialysis fluid
proportioner/cycler and has a pre-connected fill-drain line 160
with a dialysis fluid line 172 attached to an air-line 129. The
latter may be formed as a single unit by co-extrusion. In
alternative embodiments, the fill-drain line may be separate and
connectable with a separate connector. In the present embodiment,
the air-line 129 attaches to a pressure-sensing pod 162 located at
a distal end of the pre-connected fill-drain line 160. A connector
185 at the distal end of the pre-connected fill-drain line 160 is
sealed. Another double line 161 has an air-line 129 and a fluid
line 171. The fluid line 171 receives fluid from peritoneal
dialysis fluid proportioner/cycler 114 and the air-line is used for
testing the membrane of the filter. The two air-lines 129 connect
to respective ports 191 that automatically connect in an actuator
portion 140 as described with reference to FIG. 2B. Sample ports
are provided at 168 at the ends of sample fluid lines 132 and 133
for extracting fluid from respective chambers 175 and 176 of a
manifold 174. The two chambers 175 and 176 are separated by a
barrier 134 and connected by a pumping tube segment 137. Pressure
pods 178 are installed in each of the two chambers 175 and 176 to
measure pressure on the suction and pressure sides of the pumping
tube segment 137. The dialysis fluid line 172 has two branches 136
and 137. A waste line 128 and the fluid line 171 connect via a
double connector 181. Lines 132, 128, 165, and branch 136 connect
to chamber 175. Lines 133, 164, 166, 167, 171 and branch 139
connect to chamber 176.
[0099] The double connector 181 supports lines 171 and 128 and
provides a pair of connectors 186 and 187 to permit connection of
lines 171 and 128 to water inlet and fluid drain line ports on the
peritoneal dialysis fluid proportioner/cycler 114. The connectors
186 and 187 are sealed by a cap 180. A recess to engage a detente
pin provides tactile confirmation of full engagement of the double
connector 181. The double connector 181 has a window 183 that
provides access to a cut and seal actuator (not shown in this
drawing). When the segments 182 and 184 of lines 171 and 128 are
cut, the double connector can remain in place sealing the water
inlet and fluid drain line ports on the peritoneal dialysis fluid
proportioner/cycler 114 until it is removed immediately prior to
connecting a fresh double connector 181. This provides a barrier to
prevent contaminants from entering the connection platform 219
fluid path, which in turn protects the sterile fluid path used by
the peritoneal dialysis fluid proportioner/cycler 114. The
connection platform 219 selects the fluid to be delivered to the
fluid line 171. Holes 170 are provided in the cartridge support 169
that holds the lines in predefined positions. Holes 170 provide
access to pinch actuators that selectively close and open the lines
177. Note that the cartridge support 169 is bridged to the manifold
174 by a battery of tubes indicated collectively at 300C. Even
though the polymer of the tubes is flexible, the cartridge support
169 and the manifold 174 may be readily inserted in a receiving
slot.
[0100] FIGS. 2F and 2G show concentrate disposable components for
use with embodiments of the disclosed subject matter. Referring to
FIG. 2F, a concentrate package 206, for example a cardboard box,
contains a pair of concentrate containers 262 and 264. Each of the
concentrate containers 262 and 264 may be connected to a respective
port 265, 266 of a double connector 181B, the double connector 181B
may be as the one described above (FIGS. 2A, 2E) or below (e.g.,
5A-5E) or another type of connector or pair of connectors. For
example, a simple two-port connector 273 may be used. Separate
connectors may also be used to permit the containers to be replaced
independently of each other. In embodiments, the double port may be
connected to a receiving device 287 as shown in FIG. 2G so that
each concentrate 262 or 264 can be installed in the receiving
device 287 independently of the other while the double connector
181B remains connected to the receiving device 287. The receiving
device 287 has fluid connectors 285 for connecting to corresponding
connectors on the concentrate containers 262 and 264 such that once
a respective one of the containers 262 or 264 is installed, fluid
can be drawn through the ports 288A and 288B of the two-port
connector 273. The latter may be connected to the connection
platform 219, for example as shown in FIG. 21.
[0101] FIG. 2H shows a disposable fluid circuit 310 for a
peritoneal dialysis fluid proportioner/cycler according to
embodiments of the disclosed subject matter in which concentrates
are extracted from a disposable component that is separate from the
cycler/preparation fluid circuit through respective filtered lines.
The disposable fluid circuit 310 has fluid lines and components
310A and a cartridge portion 315 containing a fluid flow director
portion 310B and a manifold portion 310E. The disposable fluid
circuit 310 is for use with peritoneal dialysis fluid
proportioner/cyclers of certain embodiments disclosed herein. The
present disposable is an embodiment that may be used with the
peritoneal dialysis fluid proportioner/cycler system 90C where two
concentrate containers 105A and 105B are provided as a separate
disposable from one shown in 100C with a mixing container 102,
only. The mixing container 102 may be provided as a welded double
panel sheet with welded seams that define a chamber. The mixing
container 102 has two lines, an inflow line 165 and an outflow line
166. The present embodiment is for a peritoneal dialysis fluid
proportioner/cycler and has a pre-connected fill-drain line 160
with a dialysis fluid line 172 attached to an air-line 129. The
fill-drain line 160 with a dialysis fluid line 172 attached to an
air-line 129 may be formed as a single unit by co-extrusion of both
lines. The air-line 129 attaches to a pressure-sensing pod 162
located at a distal end of the pre-connected fill-drain line 160. A
connector 185 at the distal end of the pre-connected fill-drain
line 160 is sealed. Another double line 161 has an air-line 129 and
a fluid line 171. The fluid line 171 receives fluid from peritoneal
dialysis fluid proportioner/cycler 114 and the air-line is used for
testing the membrane of the filter. The two air-lines 129 connect
to respective ports 191 that automatically connect in an actuator
portion such as 140 as described with reference to FIG. 2B (see 146
and 147 of FIG. 2B). Sample ports are provided at 168 at the ends
of sample fluid lines 132 and 133 for extracting fluid from
respective chambers 175 and 176 of a manifold 174. The two chambers
175 and 176 are separated by a barrier 134 and connected by a
pumping tube segment 137. Pressure pods 178 are installed in each
of the two chambers 175 and 176 to measure pressure on the suction
and pressure sides of the pumping tube segment 137. The dialysis
fluid line 172 has two branches 136 and 139. A waste line 128 and
the fluid line 171 connect via a double connector 181. Lines 132,
128, 165, and branch 136 connect to chamber 175. Lines 133, 164,
166, 167, 171 and branch 139 connect to chamber 176. The fluid line
171 connects to a water source.
[0102] The double connector 181 supports lines 171 and 128 and
provides a pair of connectors 186 and 187 to permit connection of
lines 171 and 128 to water inlet and fluid drain line ports on the
peritoneal dialysis fluid proportioner/cycler 114. The connectors
186 and 187 are sealed by a cap 180. A recess to engage a detente
pin provides tactile confirmation of full engagement of the double
connector 181. The double connector 181 has a window 183 that
provides access to a cut and seal actuator (not shown in this
drawing). When the segments 182 and 184 of lines 171 and 128 are
cut, the double connector can remain in place sealing the water
inlet and fluid drain line ports on the peritoneal dialysis fluid
proportioner/cycler 114 until it is removed immediately prior to
connecting a fresh double connector 181. This provides a barrier to
prevent contaminants from entering the connection platform fluid
path, which in turn protects the sterile fluid path used by the
peritoneal dialysis fluid proportioner/cycler 114. The connection
platform 219 selects the fluid to be delivered to the fluid line
171. Holes 170 are provided in a cartridge support 169 (which may
be vacuum-formed) that holds the lines in predefined positions.
Holes 170 provide access to pinch actuators that selectively close
and open the lines 177. Note that the cartridge support 169 is
bridged to the manifold 174 by a battery of tubes indicated
collectively at 310C. Even though the polymer of the tubes is
flexible, the cartridge support 169 and the manifold 174 may be
readily inserted in a receiving slot. Two concentrates are received
through lines 164 and 167, respectively. Each of the lines is
filtered by a filter 115 as described with reference to FIG. 1G.
Respective holes 170 are provided to control the flow of
concentrate through each of the lines 164 and 167. FIGS. 21 and 2J
show examples of connection platforms 219 for connecting to a
double connector 181A to permit concentrate to be drawn through the
lines 164 and 167.
[0103] Note that the actuators and sensors of the embodiments of
FIGS. 2I, 2J, 2K, 2L, and 2M may be controlled by a single
controller, for example.
[0104] FIGS. 2I, 2J, and 2K show respective embodiments of
connection platforms that interface between a purified water source
and a separate concentrate source and the peritoneal dialysis fluid
proportioner/cycler embodiments disclosed herein, according to
embodiments of the disclosed subject matter. Referring now to FIG.
21 and connection platform 219 is an embodiment of the interface
providing the water supply and drain connections (116, 117, See
FIGS. 1G and 1H) between the purified water source 104 and the
peritoneal dialysis fluid proportioner/cycler 114. The connection
platform 219 permits the purified water source 104 (FIGS. 1F-1G) to
be connected to different devices, such as different peritoneal
dialysis treatment devices. Shown here is a configuration adapted
for peritoneal dialysis medicament preparation, and optionally
peritoneal dialysis treatment also. The present configuration
differs from that of FIG. 2C in that the present arrangement
includes a mechanism for connecting a circuit such as disposable
fluid circuit 310 of FIG. 2H which draws concentrate from a double
connector 181A which fits in slot 214A to receive concentrate
through ports 283. The double connector 181A also has a detente
mechanism 216 to provide feedback to the operator when a home
(fully connected) position of the double connector 181A is realized
by inserting into the receiving slot 214A. The receiving slot 214A
has a cutting and sealing actuator 212, driven by controller 210,
that cuts the tubes through the window of double connector 181,
181A. The ports 283 may be supported on a replaceable double
connector 273 as described in FIG. 2F so that these ports are
provided by a replaceable connector as part of a concentrate
package 260 as shown in FIG. 2F that includes concentrate
containers 262 and 264 or is fitted to the receiving device 287
described above with reference to FIG. 2G. In alternative
embodiments, the ports 283 may be part of the connection platform
219. In that case, the tubes 290 and 292 may be part of the
connection platform 219 and provided with separate connectors for
connecting the tubes 293 and 294 of the concentrate contains 262
and 264 (FIG. 2F) or similarly to connect the receiving device
287.
[0105] As in the FIG. 2C embodiment, water from the purified water
source 104 is received in water line 245 via connection 244 and
flows through ultrafilters 237. Pressure of the water suitable for
peritoneal dialysis supply is monitored by a pressure sensor 218. A
valve 234 selectively controls the flow of water suitable for
peritoneal dialysis to a double connector 215. The purified water
source terminates at a purified water connector 224 of the double
connector 215. The double connector 215 also has a drain terminal
connector 225, which splits at a junction 220 into a path that
flows to a pair of conductivity sensors 230, and then merges at
junction 238 to proceed to a drain 236 and a path that flows
directly to the drain 236. The selected path 247 is controlled by
valves 232, 240, and 242 which are controlled by a controller 210.
The double connector 181 previously described is received in a slot
214 where connections are made to the purified water connector 224
and drain terminal connector 225. A detente mechanism 216 provides
tactile and audible feedback to the operator when a home (fully
connected) position of the double connector 181 is realized by
inserting into the receiving slot 214. A connector 239 serves as an
adapter to permit connection to various types of drains. The
connection platform 219 is also provided with sensors including a
moisture sensor 249 located to detect leaking fluid in the
connection platform 219, a tilt sensor 226 to indicate the proper
orientation of the connection platform 219, and a user interface to
interact with the controller 210. The connection platform 219 may
be received in a receiving slot 231 and may be formed as a unitary
replaceable component. If sterility or leakage problems arise, the
connection platform 219 can be replaced easily.
[0106] Note that the configuration of FIG. 21 provides a simple and
clean connection between the large concentrate containers and the
disposable. However, there is no reason a direct connection could
not be provided. That is, the long-term concentrate disposable may
be provided with its own connector to connect to a double connector
181A or similar connector or pair of connectors. In another
variation, shown in FIG. 2J, the connection platform 219 provides a
receiving connector for the concentrate connector 181B, which may
be attached to the receiving device 287 of the concentrate
containers as shown in FIGS. 2F and 2G. In the connection platform
219 of FIG. 2J, a pair of lines 280 and 281 connect the double
connectors 181A and 181B so that concentrate can be drawn by the
peritoneal dialysis fluid proportioner/cycler 114 according to any
of the various embodiments. Effectively, the connection platform
219 in this case functions as a pass-through. The connection with
double 181B can be made on a low frequency basis according to the
size of the concentrate containers, and the connection with double
connector 181A can be made on a per-peritoneal dialysis treatment
basis (or other schedule) each time the mixing container 102 and
associated fluid circuit (e.g. 310) is replaced. FIG. 2K shows
another mechanism for connecting and controlling flow of
concentrate to the peritoneal dialysis fluid proportioner/cycler
114. Here connectors 289 connect to a manifold 297 with
controllable valves 279 which open and close under the control of a
controller 213 to permit only a selected one of the water suitable
for peritoneal dialysis from a water line 296, the first
concentrate from a first concentrate line 295A, and the second
concentrate from a second concentrate line 295B. Each of these may
be drawn through common fluid line 298 through connector 224. Thus,
the pumping actuator 125 of the peritoneal dialysis fluid
proportioner/cycler 114 (FIGS. 1F and 1G) is able to draw each of
the fluids. The controller of the peritoneal dialysis fluid
proportioner/cycler 114 can be made to control the valves 279 by
communicating with the controller 213 through a user interface 312.
The function of the controller 213 and user interface 312
(optional) may be the same except as otherwise indicated across
FIGS. 2I, 2J, and 2K. Note that a single controller of the
peritoneal dialysis fluid proportioner/cycler 103 (410, 109) or an
independent controller common to both (e.g. as indicated by 109 in
FIGS. 1A to 1H) may be employed for controlling the described
functions of the peritoneal dialysis fluid proportioner/cycler
systems 90A through 90D.
[0107] FIGS. 2L and 2M show modifications of the connection
platform of FIG. 2K to provide for water and concentrate to be
supplied through the common fluid line 298. Referring to FIG. 2L,
instead of a single manifold as in manifold 297, a pair of
junctions 222 is used, one to join the first concentrate line 295A
and the second concentrate line 295B. The concentrates are pumped
respectively, according to the selection of valves 250A and 250B
which are controlled automatically by a controller of the
peritoneal dialysis fluid proportioner/cycler 103 or through a
separate controller 109 or through an interface by a dedicated
controller 213 of the connection platform 219 (or variations as
illustrated in FIGS. 2L and 2M). If the fluid circuit 100B, 110D is
used which has a testable type of filter such as the filter 115
(e.g., FIGS. 1B, 1C) having an air side and a fluid side separated
by a membrane, then the fluid may advantageously be pumped by a
pump 221 in a push configuration with respect to the filter
(arranged downstream of the pump 221 as is filter 115) rather than
relying solely on a suction force provided by the pumping actuator
through pumping tube segment 137. A particular concentrate is
selected by valves 250A and 250B. A control valve 250C is also
operated by the controller to control flow in the water line 296.
In any of the embodiments, water may be advantageously pumped by a
push pump 246 if water is supplied through a filtration plant 223.
For example, water may be filtered through reverse osmosis,
deionization, activated carbon, and other types of filters in
filter plant 223 to generate water suitable for peritoneal dialysis
from potable water. The pumps 221, and 246 may be controlled as
indicated above with respect to the valves 250A and 250B to operate
in tandem with the pumping actuators of the peritoneal dialysis
fluid proportioner/cycler (e.g., 103). Thus, the present variant of
the connection platform of FIG. 2K, functions to select one of
multiple fluids among water and one or more concentrates thereby
allowing all fluids to pass into the fluid circuit through a single
inlet line (as in the fluid circuit of FIG. 2E, for example). This
allows a single filter to be used for sterilization. The embodiment
of FIG. 2M, another variant of the connection platform 219 of FIG.
2K, may be employed advantageously where a push pump such as push
pump 246 (as in FIG. 2L) is not required to draw water, for
example, if instead of using the cycler to prepare dialysis fluid,
a premixed dialysis fluid is connected to one of the inlets instead
with suitable programming of the controller to permit flow only
from one of the premixed containers at a time. Here, control valves
279 select the fluid to be drawn each time and the pump 221 draws
the selected fluid, pushing it through the filter. Note that in the
embodiment of FIG. 2L, the pressure sensor 218 may be used for
feedback control of the push pump 246.
[0108] FIG. 3 shows a method of manufacturing a disposable circuit
such as is disclosed in FIG. 2A. First, the concentrate containers
are filled at S10. The concentrate containers are then sealed with
frangible elements that form a hermetic seal at S12. This isolates
the contents of the concentrate containers from the outside
environment and causes them to be protected from intrusion of
contaminants. Then at S14, the concentrate containers are connected
to a remainder of the fluid circuit, for example the disposable
fluid circuit 200. The remaining portions of the fluid circuit are
sealed by ensuring that end caps are placed on any line
terminations that are not interconnected within the circuit. For
example, caps are present on connector 185, sample ports 168, and
connectors 186 and 187. Finally, optionally at S16, the entire
circuit assembly with the concentrates, may be radiation sterilized
or sterilized by other means.
[0109] FIG. 4A shows a peritoneal dialysis fluid
proportioner/cycler according to embodiments of the disclosed
subject matter. The present FIGS. 4A through 4K are generalizations
of the various embodiments disclosed above for purposes of
explaining the operational use thereof for preparing peritoneal
dialysis fluid and for treating a patient using the structures
described above. Referring now to FIG. 4A, a peritoneal dialysis
fluid proportioner/cycler 400 may correspond to any of the
foregoing embodiments described for generating dialysis fluid by
mixing concentrates and water. For example, note embodiments
90A-90D. Here, the peritoneal dialysis fluid proportioner/cycler
400 generates custom peritoneal dialysis fluid according to a
prescription stored in a controller 410 (corresponding to
controllers described above). The prescription may be entered in
the controller via a user interface 401, via a remote terminal
and/or server 403, or by other means such as a smart card or bar
code reader (not shown). The controller applies control signals to
a fluid conveyer and valve network 416 and a water purifier 420 and
receives signals from distal and proximal pressure sensors 413 and
414, respectively, on a fill/drain line 450 which may be in accord
with foregoing embodiments.
[0110] The fluid circuit with pump and valve network 416 is a fluid
circuit element with one or more sensors, actuators, and/or pumps
which is effective to convey fluid between selected lines 442, 444,
446, 448, 450 and 418 responsively to control signals from the
controller 410. Example embodiments are described herein, but many
details are known from the prior art for making such a device so
they are not elaborated here.
[0111] A multiple-container unit 441 includes a pre-filled,
pre-sterilized osmotic agent concentrate container for osmotic
agent concentrate 402 and another electrolyte concentrate container
404 for electrolyte concentrate. The multiple-container unit 441
also contains the mixing container 406 (which is empty) which is
large enough to hold a sufficient volume of dialysis fluid for the
completion of at least one fill cycle of an automated peritoneal
dialysis treatment. The containers 402, 404, and 406 may be
flexible bag-type containers that collapse when fluid is drawn from
them and therefore, do not require any means to vent air into them
when drained.
[0112] Osmotic agent concentrate container 402, electrolyte
concentrate container 404, and mixing container 406 are all
connected by respective lines 442, 448, 444, and 446 to the fluid
circuit with pump and valve network 416. The fill/drain line (or
multiple lines) 450 and a drain line 418 for spent fluid (and other
fluids) with a conductivity sensor 428 may also be connected to the
fluid circuit with pump and valve network 416. The fluid circuit
with pump and valve network 416 also has a purified water line 431
for receiving water. The water purifier 420 may be a purifier or
any source of sterile and purified water including a pre-sterilized
container of water or multiple containers. In a preferred
configuration, water purifier 420 may be configured as described in
WO2007/118235 (PCT/US2007/066251) and US20150005699, which are
hereby incorporated by reference in their entireties. For example,
the water purifier 420 may include the flow circuit components of
FIG. 22A of WO2007/118235 including the water purification stages
and conform generally to the mechanical packaging design shown in
FIG. 24 of WO2007/118235.
[0113] It should be evident that 416 is a generalization of the
peritoneal dialysis fluid proportioner/cycler 114 as well as
elements of a fluid circuit such as fluid circuit 112 and
connection platform 219. It should also be evident that 402 and 404
represent concentrate containers according to any of the disclosed
embodiments including the concentrate containers 101 and 102, 262
and 264, 105A and 105B. The mixing container 406 corresponds to any
of the mixing container embodiments (102) described above. Other
elements will be evident from their description with the
understanding that the figures represent generalizations thereof
for purposes of describing the function. It should also be
understood that the number and type of concentrates may differ from
the present figure which is disclosed as an example, only. It
should also be evident that the examples of concentrates discussed
herein are glucose and electrolyte concentrates but they could be
one or other multiples or other concentrates in other embodiments.
Also, the osmotic agent concentrate or glucose concentrate is
presumed here to include an electrolyte concentrate marker to
permit the concentration of osmotic agent to be inferred from a
measurement of conductivity of diluted agent with a priori
knowledge (stored in a memory used by the controller) of the ratio
of osmotic agent concentrate to electrolyte concentrate in the
osmotic agent concentrate. See US20150005699. In alternative
embodiments, the osmotic agent is not provided with an electrolyte
marker and the peritoneal dialysis fluid proportioner/cycler 400
may rely on volumetric proportioning for the transfer of osmotic
agent. Note also that the order of concentrate addition may be
reversed, with electrolyte being added first.
[0114] FIG. 4B shows a preliminary stage of fluid preparation prior
to peritoneal dialysis treatment according to an embodiment of the
disclosed subject matter. The controller 410 reads a prescription
and generates a command, responsive to a peritoneal dialysis
treatment preparation initiation command, to flow osmotic agent
concentrate from osmotic agent concentrate container 402 to the
mixing container 406. The command is applied to the fluid circuit
with pump and valve network 416 to connect the osmotic agent
concentrate line 442 to the batch fill line 444 and also to convey
the osmotic agent concentrate into the mixing container 406. This
may be done by one or more valve actuators and one or more pumps
that form the fluid circuit with pump and valve network 416. The
fluid circuit with pump and valve network 416 may be configured to
meter the quantity of osmotic agent concentrate precisely according
to a predicted amount of dilution by electrolyte concentrate and
water to produce the desired prescription fluid. The metering may
be performed by a positive displacement pump internal to the fluid
circuit with pump and valve network 416 or other means such as a
measurement of the weight of the osmotic agent concentrate
container 402 or the mixing container or a volumetric flow
measurement device.
[0115] In an alternative embodiment, part of the water (less than
the total used for dilution as discussed below with reference to
FIG. 4C) is added to the mixing container first, before the osmotic
agent concentrate and electrolyte concentrates (if needed) are
pumped into the mixing container.
[0116] Referring now to FIG. 4C, a dilution stage is performed
using the peritoneal dialysis fluid proportioner/cycler 400. The
controller 410, in response to the prescription, generates a
command to flow purified water from the water purifier 420 to the
mixing container 406. The command is applied to the fluid circuit
with pump and valve network 416 to connect the purified water line
431 to the mixing container 406 to add a measured quantity of water
to dilute the osmotic agent concentrate in the mixing container
406. The controller 410 may control the fluid circuit with pump and
valve network 416 to ensure the correct amount of water is
conveyed. Alternatively, the water purifier may incorporate a flow
measurement device or metering pump or other suitable mechanism to
convey the correct amount of water. The controller 410 may be
connected to the water purifier 420 to effectuate the dilution
result. The fluid circuit with pump and valve network 416 may also
be configured to circulate diluted osmotic agent concentrate
solution through lines 444 and 446 either simultaneously with the
dilution or after the diluting water has been transferred to the
mixing container 406 according to alternative embodiments. The
circulation mixes the contents of the mixing container 406.
[0117] The relative amounts of water, osmotic agent concentrate,
and electrolyte concentrate may be realized based on the
ratiometric proportioning properties of the pump. Since a single
pump tube is used to convey all the liquids into the mixing
container, most sources of offset from predicted pumping rate
(based on shaft rotations, for example) to actual pumping rate
affect all the fluids roughly equally.
[0118] Referring now to FIG. 4D, the diluted osmotic agent
concentrate solution in the mixing container 406 is tested to
ensure that the correct concentration of osmotic agent is achieved.
In an embodiment, the osmotic agent concentrate 402 has an amount
of electrolyte concentrate to generate a conductivity signal using
the conductivity sensor 428 when fluid from the mixing container
406 is conveyed by the fluid circuit with pump and valve network
416 to the drain line 418 past the conductivity sensor. The amount
of electrolyte concentrate pre-mixed with the osmotic agent
concentrate may be the lowest ratio of electrolyte concentrate to
osmotic agent concentrate that a predetermined prescription may
require. The fluid circuit with pump and valve network 416 may
perform the function using one or more valve actuators and one or
more pumps that form the fluid circuit with pump and valve network
416. The fluid circuit with pump and valve network 416 may be
configured to meter the quantity of water precisely or the function
may be provided by the water purifier 420. The controller 410 may
add additional water or osmotic agent concentrate and test the
conductivity again if the measured concentration of osmotic agent
and/or electrolytes, if applicable, is incorrect. In addition to
using a combined osmotic agent and electrolyte concentrate in
osmotic agent concentrate container 402, in an alternative
embodiment, the osmotic agent concentrate container 402 holds
osmotic agent concentrate with no electrolytes and osmotic agent
concentration is optionally measured directly by other means such
as specific gravity (hydrometer), refractive index (refractometer),
polarization, infrared absorption or other spectrographic
technique.
[0119] FIG. 4E shows an electrolyte concentrate addition stage of
fluid preparation prior to peritoneal dialysis treatment according
to an embodiment of the disclosed subject matter. The controller
410 reads a prescription and generates a command to flow
electrolyte concentrate from container 404 to the mixing container
406. The command is applied to the fluid circuit with pump and
valve network 416 to connect the electrolyte concentrate line 448
to the mixing container 406 fill line 444 and also to convey the
electrolyte concentrate into the mixing container 406. This may be
done by one or more valve actuators and one or more pumps that form
the fluid circuit with pump and valve network 416. The fluid
circuit with pump and valve network 416 may be configured to meter
the quantity of electrolyte concentrate precisely according to a
predicted amount of dilution by osmotic agent concentrate and water
that has been previously determined to be in the mixing container
406, to achieve the prescription. The metering may be performed by
a positive displacement pump internal to the fluid circuit with
pump and valve network 416 or other means such as a measurement of
the weight of the electrolyte concentrate container 404 or the
mixing container 406 or a volumetric flow measurement device.
[0120] Referring now to FIG. 4F, the electrolyte concentrate may be
mixed using the batch fill and drain lines 446 and 444 in a closed
loop. If necessary, depending on how much dilution was performed
during the osmotic agent concentrate dilution process, further
dilution may be performed as described above. The final formulation
may be achieved by the process illustrated in FIG. 4F. Then, as
illustrated in FIG. 4G, the final electrolyte concentration of the
mixture in mixing container 406 may be determined with a
conductivity sensor 428 by flowing a sample therethrough.
[0121] Although gravimetric and tracer/conductance sensing were
described as devices for ensuring proper proportioning and dilution
rates for achieving target prescriptions, it should be clear that
any embodiments of a peritoneal dialysis fluid proportioner/cycler
disclosed herein may employ ratiometric proportioning as well,
particularly where positive displacement pumping is employed.
Ratiometric proportioning takes advantage of the volumetric
repeatability and predictability of certain pumps. For example, a
particular pump can deliver a highly repeatable volume of fluid for
a given number of pumping cycles (pump rotations for a peristaltic
pump or cycles for a diaphragm pump, for example). If all dialysis
fluid components (water, osmotic agent concentrate, and electrolyte
concentrate, for example) are delivered to the mixing container
using the same pump, including, for example, the pumping tube
segment of a peristaltic pump, then the volume ratios of the
components will, after adjustment for potential flow path and/or
viscosity differences as described below, be fully determined by
the number of pump cycles used to convey each component.
[0122] Ratiometric proportioning may supplement or substitute for
measurement of the fluid conductance or density or other
measurements. To convert the number of pump cycles to actual
displaced mass or volume, a calibration may be performed and/or
flow path (including fluid properties) compensation parameters may
be employed. The flow path compensation parameters may be
respective to each particular fluid flow path and/or fluid type, or
may be identical for all fluid paths and fluid types. To provide
enhanced accuracy, one or more pump calibration and/or flow path
compensation parameters may be generated through a calibration
procedure. Typically, flow path compensation factors will be
established and stored in non-volatile memory. Typically, one or
more flow path calibration procedures will be performed when the
peritoneal dialysis fluid proportioner/cycler is used by a patient.
The calibration procedure may be performed after each new fluid set
is installed, or before each batch preparation cycle, or even
multiple times during the preparation of a single batch. A
disposable fluid set may be installed every day. The calibration
procedure may be done using water. The calibration may sequentially
pump fluid through one or more of the stages provided in Table
1.
TABLE-US-00001 TABLE 1 Example stages for sequentially pumping
fluid during calibration From To Water source Drain Mixing
container Drain Osmotic agent concentrate container Drain
Electrolyte concentrate container Drain Patient access Drain
Osmotic agent concentrate container Mixing container Electrolyte
concentrate container Mixing container Water source Mixing
container
[0123] In the calibration procedure, fluid is pumped between any or
all of the paths identified above. A separate calibration
coefficient may be generated for each of the paths. The calibration
coefficient may be stored in a memory or non-volatile data store,
for example, as a parameter representing the number of ml/per pump
rotation (or diaphragm pump cycle), or as a proportionality ratio
relative to a particular reference flow path. The actual fluid
quantity transported during the calibration step may be measured by
any suitable device (flow sensor) including volume or mass
measurement devices or direct flow rate measurement with
integration, for example, using laser Doppler velocimetry, thermal
transit time, magnetohydrodynamics, propeller hydrometer, positive
displacement flow measurement, differential pressure through a
resistance such as a venturi, nozzle, orifice plate, or other flow
obstruction, variable area or rotameter, pitot or impact tube,
vortex shedding frequency counting, ultrasonic, or other device. A
particularly advantageous device for flow calibration is to measure
the transit time of a fluid property perturbation between spaced
fluid property sensors as described below. Any of the disclosed
embodiments may employ a flow sensor in which at least the portion
of which that carries fluid is disposable so that the flow rate (or
total displaced fluid quantity) can be input to a controller while
allowing the use of a disposable fluid circuit. Examples include an
ultrasonic soft tube flowmeter made by Strain Measurement Devices
SMD that non-invasively measure flow in soft tubing by means of
slotted transducers in which a length of tubing can be inserted
during fluid circuit installation. For cartridge embodiments, the
PD cycler can employ a moving transducer stage that engages an
exposed tube length of the cartridge after passive insertion of the
cartridge.
[0124] The pumping system may also be sufficiently repeatable in a
way that allows precise ratios to be established without
calibration, depending on the predefined tolerances. If the
manufacturing tolerances, including materials, are sufficiently
controlled, a desired level of control over ratios may be achieved
without in situ (point of care) calibration. A particularly
sensitive component in terms of guaranteeing repeatability is the
pumping tube segment of a peristaltic pump. In a first embodiment,
the peristaltic pump tube segment is made from a material whose
mechanical and material tolerances are controlled within predefined
limits. The lengths of the tubing circuit elements and mechanical
parameters are also controlled within respective predefined limits.
A calibration may then be done outside the peritoneal dialysis
treatment context, e.g., in the laboratory, to calculate precise
values to convert pump cycles to fluid quantity transferred for a
single lot of replaceable fluid circuits. The calibration may be
done for multiple lots. The calibration may also be done for each
fluid circuit. The calibration may also be done by the peritoneal
dialysis fluid proportioner/cycler for each fluid circuit. The
calibration may also be done for each batch of peritoneal dialysis
fluid prepared by the fluid circuit.
[0125] Referring to FIG. 4H, subsequent to the preparation of the
contents of the mixing container 406 as described above, the fluid
circuit with pump and valve network 416 may be configured to drain
the patient 411 depending on the patient's prior status. Spent
dialysis fluid may be withdrawn by the fluid circuit with pump and
valve network 416 and conveyed through the drain line 418. Then,
the contents of the mixing container 406 may be conveyed as
illustrated in FIG. 4K to the patient. Here the controller 410 has
configured the fluid circuit with pump and valve network 416 to
flow fluid to a patient 412.
[0126] Referring now to FIG. 5A, the double connector of 181, 181A,
181B is shown in detail as the connector embodiment 500. A single
monolithic member has a shape with at least one window, where two
windows are shown one of which is indicated as window 512. The body
506 has a ridge 507 that overhangs the frame 506 to permit the
frame 506 overall to be grasped easily by a user, for pushing or
pulling, to connect ports 515, 516 to ports of a device (e.g., 219)
to which lines 508 and 510 of a fluid circuit 530 are to be
connected. A releasable port cover 502 (see also cap 180) seals
ports 525 and 526 to prevent contamination thereof. The window 512
provides access to cut and seal elements that seal and cut the
lines 508, 510 when the double connector 500 is to be replaced.
Lines 508 and 510 pass through holes 514 in the frame 506. FIG. 5B
shows the double connector 500 after cutting and sealing, the
sealed ends of one end of cut tubes forming stubs indicated at 520
and 521 and the opposing ends at 522, 523. The ends 522, 523 remain
attached to a fluid circuit 530 which is to be replaced. The stubs
520, 521 remain attached to a resulting stub connector 519 which
can remain attached to a connected device, after use, so as to act
as a cover and seal against environmental contamination of a
connected device, such as connection platform 219 connectors 224
and 225. Here, the protected ports of the connected device are
indicated at 525 and 526. Although two channels are shown, it
should be evident that the configuration may be modified to provide
connections for any number of channels including one or more than
two.
[0127] Referring to FIGS. 5C and 5D, the use of a connector 500
(which may be a double connector) including a cut and seal
operation in which a portion 540 of a connector (e.g., double
connector 181) is left in place to act as a sterile barrier begins
with the removal of a sterile barrier-type cap from the end of the
connector S32. For example, the sterile barrier may take the form
of the double releasable port cover 502. Next, as S33, the sterile
barrier formed by a previous connector which was cut and sealed
(see FIGS. 6A-7D and elsewhere in the present disclosure) is
removed, and a new replacement connector of the same form as the
connector 500 is attached S34. Then the circuit connected by means
of the new connector is used until it is expired S35. A cut and
seal operation is initiated at S36, resulting in the separation of
the fluid circuit (cut and sealed forming the stubs 520, 521 and
ends 522, 523) and a new portion 640 of the new connector to be
left in place to act as a sterile barrier. The cut and seal
operation may include cooling the cut ends of the tube to speed the
operation so that a delay for sufficient passive cooling is not
required. The latter may also permit the cutting heads to act as a
mechanism for gripping the stubs 520 and 521 to prevent them being
removed before cooling. See, for example, the embodiment of FIGS.
6E and 6F which have a broad flat interface for gripping the ends
of the cut tube 666.
[0128] FIG. 5E shows features for a variation of a double connector
501 that protects against contamination. A male connector portion
541 mates with a female connector portion 543. Ports 526 (male)
pass through openings 547 of female ports 548. A pin 545 is
provided on the male connector portion 541 that is received within
a recess 546. The female ports 548 open in a wall 524 as does an
access 549 of the recess 546. Lines 544 connect to the male
connector portion 541. The remainder of the double connector 501 is
as described with reference to connector 500 shown in FIGS. 5C and
5D. The pin 545 may be sized to prevent the ports 526 from
contacting a flat surface inadvertently and thereby prevent contact
contamination. The pin 545 may also be shaped asymmetrically to
prevent incorrect orientation of the connectors. In variations, the
double connector 501 may be modified such that it has a greater or
lesser number of tubes 508, 510, and connectors 547. Also, the
number of pins 545 and recesses 546 may differ from what is shown.
For example, two pins and recesses may be provided at the edges 527
with or without the illustrated pin and recess. Note that in
variations of the embodiments, the male and female connectors may
be swapped or mixed on a given side of the male connector portion
541 and the female connector portion 543. One or more pins 545 may
be provided on either side or mixed, as may openings 547.
[0129] FIG. 6A shows mechanical aspects and a control and sensor
system for the cut-and-seal devices with actuation, temperature,
and force control features, according to embodiments of the
disclosed subject matter. FIGS. 6B through 6D show a sealing and
cutting operation provided by the embodiment of FIG. 6A. A pair of
jaws 11 and 18 close on opposite sides of a tube 50 to cut and seal
the tube 50 such that the tube 50 is divided into two parts with
ends 54A and 54B sealed. The jaw 11 receives heating or cooling
through a conveyance 20A or multiple conveyances 20B which may be
electrical conductors for resistive heating element 14 or a
combination of heating and cooling heat transfer fluids such as
molten salt and refrigerant. The source of heat/cool or current
supply is provided by a source 6. Either jaw 11 or 18 may be heated
to achieve the described effect in alternative embodiments. A drive
2 under control of a controller 4 moves at least one of the jaws 11
and 18 toward the other or together. Temperature sensors 16 and 12
may be provided to regulate the temperature and provide feedback
control for a cutting and sealing operation. The controller 4 may
receive the temperature signals and control the drive 2. A force
sensor 40 may indicate to the controller the magnitude of force
applied through the tube 50 for feedback control of a cutting
operation or for error detection (out of bounds force, for
example). The cutting heads can have various shapes as shown in
FIGS. 7A-7D. FIG. 7A illustrates opposing jaw shapes with jaw 604
having a flattened tip 606 and jaw 602 having a flat surface. FIG.
7B illustrates opposing jaw shapes with jaw 614 having a sharp tip
616 and jaw 602 having a flat surface. FIG. 7C illustrates opposing
jaw shapes with jaw 624 having a rounded tip 626 and jaw 622 having
a flat surface. In FIG. 7D, a sharp ridge 636 is provided on jaw
634 and a recess 637 on jaw 635. An alternative jaw 632 that may be
used with the jaw 634 has a flat surface 638.
[0130] FIGS. 6E and 6F show a cut and seal arrangement in which the
cutting and sealing portions move partially independently. A
cutting knife 662 cuts a tube 666 when a jaw 658 pushes up against
it. The jaw 658 or the jaw 654 (or both) may be heated to melt the
tube 666 such that tube is cut and sealed in a single operation. A
spring 664 ensures that a predefined amount of force is maintained
for heating the tube 666 during the closing of the jaws. FIG. 6G
shows a configuration in which the jaws are rounded elements 670
and 672 which may cut and seal the tube 666 where either or both
jaws may be heated. Cooling in the above embodiments may be
provided to cool the jaws and the tubing cut ends for safety or
speed of completion. The arrangements of FIGS. 6A through 6F are
details that may apply to the cutting and sealing actuator 212.
[0131] Referring to FIGS. 8A and 8B, a multiple chamber portion
200D (e.g., FIG. 2A) of disposable fluid circuit 200 is shown in
greater detail. Features of the present embodiment may be applied
to other fluid circuit portions as well, including the single
mixing container 300C (FIG. 2E). Concentrate containers 953 and 954
and mixing container 952 are formed from a single pair of sheets by
welding seals 962, shown as a pair of lines all around the depicted
structure. Concentrate fill tubes 964, concentrate outlet tubes 956
and 957, mixing container inlet 948 and outlet line 9541, as well
as a mixing container sample tube 958 are all welded as the seals
962 are closed by solvent bonding, thermal welding, polymer
fill-bonding, ultrasonic welding, or other means. The entire
structure may then be folded as shown in FIG. 8B to form a compact
structure before or after a predefined quantity of concentrate is
conveyed through the concentrate fill tubes 964 and the latter
sealed.
[0132] A nozzle 950 may terminate the mixing container inlet 948
tube which extends into the chamber. This causes the extended part
of the tube to whip around to inject incoming fluid around the
mixing container 952 to agitate the contents and promote effective
mixing of the contents. The mixing container sample tube 958 may be
terminated by a septum to permit the insertion of a hypodermic
needle. The length of the extended part may be at least 3 diameters
into the container. The length may be five, 7.5, 10, or 15
diameters. The length may be between 3 diameters and 25 diameters.
The length may be at least 5 diameters. Here, the term diameter
refers to the tube outer diameter. Note that another alternative is
for the inlet line to have a nozzle but no extended part, that is,
the nozzle may be located at the wall of the mixing container and
be aimed toward the center of the mixing container.
[0133] FIGS. 8C through 8F show various features to promote mixing
of fluids in a mixing container according to embodiments of the
disclosed subject matter. A mixing container 952 uses a single
mixing container inlet and outlet line 949 that functions as a
mixing container 952 inlet and outlet line 949. FIG. 8C shows a
fluid outgoing from the mixing container 952 and FIG. 8D shows
fluid incoming into the mixing container 952. A two-way header 924
has a check valve 918 that allows outgoing fluid to be drawn
through an opening 920 into the mixing container 952 inlet and
outlet line 949 but blocks flow out of the opening 920. When fluid
is pumped into the mixing container 952, the check valve 918 closes
and all of the flow is forced through a nozzle 924 so that it
emerges at high velocity from a nozzle opening 922 as illustrated
in FIG. 8D. As result, mixing is promoted and a substantial
convective flow or jet is generated to transport the incoming flow
to locations remote from the opening 920, thereby promoting mixing.
A similar effect is obtained in the embodiment of FIG. 8E in which
incoming flow is released from a tube 937 inside the mixing
container 952 from an opening 930 remote from the opening 920. In
this embodiment, also, a check valve 918 causes the incoming and
outgoing flows to take different paths. Note that a check valve,
although not shown, may be incorporated in the flow path of the
tube 937 or the nozzle 924 to block flow through opening 922 or 930
when fluid is pumped out of the mixing container 952 to enhance the
separation effect between the ingoing and outgoing flows. FIG. 8F
shows an embodiment in which the container inlet and outlet line
949 attaches to a header tube 934 that is similar in structure to a
peritoneal catheter in that it has openings distributed along a
portion of its length such that ingoing flows are distributed. Such
a header tube 934 may be used as a single container inlet and
outlet line as for 949 or, in combination with a dedicated outlet
line 9542, as an inlet line. In the foregoing embodiments, instead
of a check valve, a flexible member such as a reed or flap valve as
indicated in FIG. 8G, which creates greater resistance for flow in
one direction than another, may be employed. So flow does not
necessarily need to be halted altogether in a selected direction to
achieve substantially the above effect. In FIG. 8G, a single part
that may be formed, for example, by 3D printing, assembled from
parts, or molded directly has a flap 921 that bends in response to
both suction and pressure resulting from pumping fluid from and to
the mixing container 952, causing flow out of the mixing container
to be drawn through the inlet covered by the flap 921 and to be
projected by the nozzle 924 when fluid is pumped into the mixing
container as described with reference to FIGS. 8C and 8D. Here the
flap 921 need not fully close or open but may, in embodiments,
merely create a differential resistance to ingoing and outgoing
flows such that fluid pumped into the mixing container is projected
away from the location where it is drawn in, thereby facilitating
the mixing process.
[0134] FIG. 4L illustrates schematically a variation of the
peritoneal dialysis fluid proportioner/cycler 400 of FIG. 4A with
the addition of an accumulator 447 connected by an accumulator line
449 to allow a pump such as a peristaltic pump according to any of
the disclosed embodiments, to provide mixing with a single mixing
container line 445 connecting the mixing container 406. The
controller 410 pumps fluid from the mixing container 406 to the
accumulator 447 back and forth multiple times to mix the contents
of the mixing container 406. This is in contrast to the disclosed
embodiments in which two lines connect the mixing container 406 to
the fluid circuit with pump and valve network 416. As indicated,
use of a pump that has the ability to accumulate fluid, such as a
diaphragm pump, may allow fluid to be pumped into and out of the
mixing container 406 without a separate accumulator 447, by pumping
fluid into the mixing container 406 from the diaphragm pump
internal volume. Reference numeral 451 points to the arrows
indicating spaced ingoing and outgoing flows to/from the mixing
container that may be provided by the foregoing embodiments of
devices for separating (at least partially) the ingoing and
outgoing flows.
[0135] Referring to FIG. 9A, a manifold 900, which functions as
manifold 174 (e.g., FIG. 2A), has two chambers 982 and 981 defined
by the shape of a rigid housing 989 that is sealed by a welded or
bonded film 986. Rigid housing 989 may be formed by casting and an
internal volume sealed by the bonded film. The film has regions 987
overlying the housing for pressure detection. Pressure transducers
(not shown) contact the regions 987 and detect a force applied by
pressure within the chambers 982 and 981 at either end of a pumping
tube segment 985 which connects the two chambers 982 and 981.
Respective ones of ports 983, for the various fluids described
herein according to the different embodiments, convey fluid to
respective ones of the chambers 982 and 981. Tubes may be friction
fitted or bonded to the ports 983. The ports 988 have air-lines
attached to them and these are respectively fluidly coupled to air
ports 990 which sealingly engage pressure transducers (See 146 and
147 of FIG. 2B). In other embodiments, the rigid housing 989 is
replaced with a fully enclosed housing (not shown) with pod type
pressure sensors embedded in them and there is no film required for
sealing the structure closed.
[0136] Referring to FIG. 9B, a dialysis fluid line 172 has a
pre-connected fill-drain line 160 and an air-line 129 as well as a
pressure-sensing pod 162 which has an internal diaphragm which is
displaced responsively to pressure changes in the pre-connected
fill-drain line 160 near the patient connector 995. Movement of the
internal diaphragm compresses or expands an air volume in the
air-line 129 which is conveyed to a connector 181. The patient
connector 995 connects to a peritoneal catheter. The proximal end
997 of the pre-connected fill-drain line 160 is attached or bonded
to a respective one of the ports 983.
[0137] Referring now to FIGS. 10A and 10B, a cartridge portion 910
of the fluid circuits according to the various embodiments provides
the manifold and the pumping and pressure sensing portions
previously described. The cartridge support 169 may be made from a
single panel 912 that is folded at a pair of creases indicated at
914. The panel 912 portions contain recesses for all the tubes held
between them precisely controlling their positions. A compartment
is defined by the shapes of the panels to hold the rigid housing
989. FIG. 2A shows an alternative embodiment in which the manifold
174 is connected by a battery of tubes indicated collectively at
200C so the double panel structure is not directly attached to the
manifold 174. FIG. 11 shows the single vacuum formed panel 912
before it is closed about the pair of creases 914. FIG. 11
otherwise shows a complete fluid circuit 909 including how the
features of 8A through 10B are assembled in a completed fluid
circuit 909.
[0138] In any and all of the foregoing disposable fluid circuits,
the components may be integrally-attached, meaning the components
may be permanently bonded or otherwise locked together as delivered
for use except for removable caps on inlets and outlets. In
embodiments, only a single cap may be required to connect one or
more concentrate inlets and a single cap may be required to connect
a peritoneal dialysis catheter to the integrally-attached
fill/drain line. This helps to ensure that a fluid circuit
as-delivered will have less of a chance of being contaminated as a
result of having only a small number of connections.
[0139] Generally, in systems that process or treat fluids and
return processed or treated fluids to a patient, it is necessary to
eliminate air from the fluid circuit prior to and/or during use to
avoid introduction of air into the individual undergoing treatment.
This may be accomplished by "priming" the fluid circuit which
refers to circulating a fluid in the fluid circuit so that the
fluid circuit is filled prior to treating a patient.
[0140] In the disclosed embodiments, preparing a complete batch for
a PD treatment cycle, which is hereinafter referred to as the
"main" batch, may take a certain minimum amount of time depending
on the number of components that need to be mixed, the amount of
fluid required for treatment of a patient, the need for
proportioning error recovery, etc. For example, preparing a full
batch of peritoneal dialysis fluid may take a significant fraction
of an hour. Generally, the full batch will also be used for priming
the fluid circuit when the new fluid circuit is loaded. Since the
fluid circuit generally should be primed before being connected to
the patient, the patient would have to start preparation of a full
batch and then wait until the full batch is prepared before
connecting and then either getting in bed or attending to some
other activity such as relaxing. Thus, a patient desiring to
connect to the cycler may be required to perform initial activities
including attachment of a new fluid circuit to the cycler and then
wait for a full treatment batch to be fully prepared before
connecting to the fluid circuit. In a situation where the patient
is tired and wishes to connect quickly in order to go to sleep or
perform some other activity, this delay may be inconvenient. In
particular, this delay may cause lost sleep and impact patient
health.
[0141] In embodiments, a priming batch which is considerably
smaller in volume than the treatment batch is first prepared and
used for priming the fluid circuit so that the patient does not
have to wait for the full batch to be prepared before the patient
connects to the fluid circuit. The smaller volume of the priming
batch may be just sufficient to prime the fluid circuit. In
alternative embodiments, the smaller batch has a different
composition which may be faster to generate than the composition of
the batch used for treatment. For example, in embodiments in which
multiple concentrate components are diluted by combining with water
to form a treatment batch, a subset of the multiple concentrates
and water is used to form the priming batch. In embodiments, the
subset may include only water. In further embodiments, the priming
fluid may be a blood-normal fluid, or formed from a concentrate
that is different from the composition of the treatment fluid. For
example, the single component may be a saline fluid or concentrate.
Since the priming fluid is used solely for priming, there is
minimal advantage to including an osmotic agent concentrate as does
regular PD fluid.
[0142] The disposable fluid circuit that includes a small priming
batch or concentrate container may be pre-attached and sealed to
the disposable. After priming, the priming fluid may be flushed
from the fluid circuit to the drain along with the spent dialysis
fluid during initial treatment stage so that the composition of the
dialysis fluid supplied to the patient is not altered by the
differing composition of the priming fluid. Thus, the method of
priming may include, following priming the fluid circuit, including
the fill-drain line, pumping spent dialysis fluid from the patient
immediately to the drain and flushing any portions of the fluid
circuit containing residual priming fluid with the first treatment
batch of fluid prior to filling the patient with a fresh batch. In
this way, the quantities and proportions of fluid for the treatment
do not have to account for any impact of the composition of the
priming fluid. This can be the case irrespective of the type of
fluid used, be it saline, pure electrolyte concentrate, purified
water, or some other fluid.
[0143] In further embodiments, the disposable fluid circuit is
provided with a container of priming fluid. The latter may be
filled with a single or multi-component concentrate which is
further diluted in preparation for priming or it may be provided
fully diluted and ready for use. The priming fluid container may be
pre-attached as described with reference to the concentrates
described in the disclosed embodiments. Note that a single
component concentrate container may be provided for priming-only
because the weight and volume-saving benefits of the embodiment may
be less important for the small volume of priming fluid than for
treatment.
[0144] Accordingly, embodiments allow for quick priming and patient
connection. In some embodiments, the quick priming may be provided
as a user-selectable option, and if the user does not select the
option, the system simply starts by preparing the treatment batch
and using it for priming the fluid circuit.
[0145] In embodiments, the priming batch is mixed in the same
disposable unit as used for the treatment batch. For example, with
reference to FIG. 1A, the dialysis fluid preparation/cycler unit
103 may generate the priming batch by metering concentrate from
concentrate containers 101 and adding them to, and diluting them
with purified water in, the mixing container 102. However, in
alternative embodiments, the priming batch may be stored separately
from the treatment batch. In embodiments, the priming batch is
formed from a subcombination of multiple components used for
preparing a treatment batch. For example, the priming fluid may be
formed from only the electrolyte concentrate component and water
without mixing the osmotic agent concentrate. In this way time may
be saved by only diluting and mixing a single component. In such
embodiments, the composition of the single component used to make
the priming batch may be selected such that when mixed with the
second component it forms a dialysis fluid that is suitable for
treatment and when mixed with water alone, it forms a desired
blood-normal fluid.
[0146] FIG. 12 shows a method of priming a fluid circuit according
to embodiments of the disclosed subject matter. At optional step
1202, a controller determines that the patient has selected an
option for quick priming, for example, by activating a soft or hard
key on a user interface in communication with the controller.
Alternatively, quick priming may be performed by default and
without receiving any explicit indication from the patient. If the
patient chooses not to do quick priming, the method of FIG. 12 is
not executed. In embodiments, the controller may request an
indication of whether the patient is full or dry, meaning whether
the patient's peritoneum is already full and therefore to be
drained initially, or empty (dry) in which case the peritoneum is
not to be emptied. If empty, the quick prime operation is skipped
and a full batch of treatment fluid is made. The purpose of quick
prime is to allow the drain cycle to be initiated quickly, so the
patient doesn't have to wait for the cycler to prepare a full batch
of treatment fluid. For example, this may be done at a time the
patient is going to bed.
[0147] At 1204, the controller determines a composition for the
priming fluid. For example, the composition may be based on a
prescription or other data stored on a memory device connected with
the controller. In embodiments, the composition may be configured
by a physician or other healthcare professional via the user
interface or over a network communication with a server or a
central control system at a medical facility. In embodiments, the
composition may be the same as used for the treatment of the
patient, another composition as discussed elsewhere, or it may be
water or saline solution.
[0148] At 1206, the controller determines a required volume of
priming fluid. The determination may be a predefined volume stored
in a non-volatile data store connected with the controller. In
embodiments, the required volume may be configured by a physician
or other healthcare professional via the user interface or over a
network communication with a server or a central control system at
a medical facility. In embodiments, the required volume may be
based on physical properties of the fluid circuit such as the
length and diameter of fluid lines.
[0149] At 1208, the controller operates a dialysis fluid
preparation/cycler unit and corresponding connections/valves/pumps
to prepare the required volume of the priming fluid according to
the composition. For example, with reference to FIG. 1A, the
dialysis fluid preparation/cycler unit 103 may generate the priming
batch by metering concentrate from concentrate containers 101 and
adding these to, and diluting them with purified water, in the
mixing container 102 according to methods described elsewhere in
the present disclosure or other methods such as described in US
2015-0005699A1, a copy of which is attached hereto as an
appendix.
[0150] At 1210, the controller primes the fluid circuit with the
priming fluid. The priming may be performed by pumping fluid as in
the preparation phases described above to generate a batch of
smaller size, and then pumping the resulting mixed batch through
the fill/drain line (e.g., 450, FIG. 4A) until some reaches a point
near the end of the fill/drain line. In embodiments in which water
is used alone, water may be pumped into the mixing container and
then into the fill/drain line, thereby filling the flow switching
mechanism. The described flow diverters may also permit the water
to flow from the mixing container to the drain thereafter, in
preparation for making the first batch of a sequence for
treatment.
[0151] At 1212, the controller indicates to the patient that the
fluid circuit is primed and ready to be connected. The indication
may be performed by generating a visual and/or audible alarm and
corresponding text on the user interface. At this time, the patient
may connect to the fluid circuit. Alternatively, the patient may
indicate when fluid has reached the end of the fill/drain line by
inputting a command through the user interface, the result of which
would be to ready the system to begin treatment after the patient
indicates s/he has made a connection to the peritoneal access.
[0152] At 1214, the controller may confirm that the patient has
connected the patient access to the fluid circuit, for example by
receiving an indication/confirmation via the user interface and/or
by receiving sensor inputs (proximity sensors, switches, etc.) that
indicate a physical connection of the fluid circuit to a catheter.
The distal pressure sensor may be used by the system to confirm
connection by having the controller detect and respond to pressure
signals from patient respiration or pulse. At this time, the
patient may place the system in a treatment mode at 1216 and allow
automated treatment to proceed without attending to the system any
longer. For example, the patient may go to sleep to receive a
nocturnal treatment.
[0153] Referring to FIG. 13A, a fluid circuit has an attached
priming fluid container 706. The fluid circuit includes a flow
switching circuit 708 with a manifold and a pre-attached fill/drain
line 710. Concentrate containers 703 and 704 are diluted as
described to form a treatment batch which fills a mixing container
702. A priming concentrate may be provided in container 706 or,
alternatively, a container of fully diluted priming fluid 707 is
attached. The latter may be used as described above. FIG. 13B shows
a fluid circuit that may be used to provide a priming batch by
mixing a special composition from larger containers 724 of
concentrate or fully diluted container 725 alternatively. The
configuration may employ a multiple connector 726 as described
elsewhere for connection to the long-term concentrate containers
720 and 722 for treatment batch preparation. In yet other
embodiments, the fluid circuit may have a pre-attached priming
fluid container (concentrate or diluted) and the multi-use
container 724 or 725 may be omitted.
[0154] In alternative embodiments, quick priming may be done with
priming fluid that remains in the mixing container after a normal
priming process is used to prime the fluid circuit. The normal
fluid circuit priming process begins with pumping water into and
through the fluid circuit including circulating fluid into and out
of the mixing container, at least partly in order to break-in the
pumping tube segment, ultimately leaving a volume of, for example,
four hundred ml. in the mixing container. The sterilizing filter
protecting the water inlet according to any of the foregoing
embodiments may then be tested to confirm its integrity after the
priming operation. If the filter integrity is confirmed by the
testing, this indicates the fluid in the mixing container which has
passed through the sterilizing filter, the mixing container and
fluid circuit being sterile as initially provided, must also be
sterile, at least with a high certainty. That is, the only means by
which contaminants can enter the mixing container, which is
pre-sterilized, is through at least one filter (see foregoing
embodiments), which essentially guarantees the contents are
sterile. The quick prime operation may be performed using a portion
of the contents of the mixing container. Other limitations of the
quick priming as discussed above may be as indicated except for the
use of concentrate.
[0155] Note that the quick prime procedure is contraindicated if
the patient begins a treatment without a full peritoneal cavity.
The term "full" in this context does not specify a particular
volume, except that it should be sufficient for the treatment
following the quick prime to begin with an initial drain cycle.
[0156] In any of the claimed embodiments identifying an element, it
is understood that the identification of an element does not
preclude the claims covering embodiments having multiple ones of
the elements. For example, in any of the claimed embodiments
identifying a concentrate line or concentrate container, it is
understood that the identification of a single concentrate line or
container does not preclude the claim covering multiple concentrate
lines or concentrate containers. Further embodiments are
contemplated in which multiple ones of the claimed elements may be
provided to form additional embodiments, for example, the
concentrate lines or containers. The same applies to method claims
where additional steps may be provided to form new embodiments,
where the additional steps repeat an operation performed by a
recited step and act upon another material or article in equivalent
fashion, for example, an additional concentrate.
[0157] Referring now to FIGS. 15A-15C, method and system
embodiments for proportioning concentrates and water are described.
FIG. 15A shows a flow chart of the proportioning procedure next to
a schematic diagram of the mixing container contents 320. The
diagram at each stage of processing has rows 321 through 336, each
of which shows a figurative representation of components of
electrolyte, osmotic agent, and the water contained by the
container after addition of a fluid. In this example, the osmotic
agent concentrate contains both osmotic agent with water so its
addition to the mixing container adds osmotic agent, electrolyte,
and the water contained in the osmotic agent concentrate. See row
322 column 338. Row 321 shows the mixing container contains water
alone after addition of water. Row 322 shows the components of
electrolyte and osmotic agent plus the water contained by the
osmotic agent concentrate all of which are combined to form the
osmotic agent concentrate plus electrolyte marker added at
S108.
[0158] The rows 322 through 336 are aligned with the process stages
S106 through S122 and each row shows a composition that exists, or
is achieved by, the corresponding process stage. Columns 338, 339,
and 340 show the concentrates and water components. The
concentrates are further broken down in the columns to indicate the
constituents thereof. Again, the osmotic agent concentrate 338 has
constituents water, osmotic agent, and electrolyte used as a
marker. These constituents are indicated by "E," "O," and "H2O."
The electrolyte concentrate 339 has constituents electrolyte and
water indicated by "E" and "H2O."
[0159] In an initial operation S100 the fluid circuit, including
the manifold, if one is present (the method is not exclusive to the
mechanical features of the foregoing embodiments as will be evident
from the presentation), is primed with water and the water is
circulated through the mixing container to break-in the pump tube
segment. The sterilizing filter, through which water is drawn, may
be tested at this point to ensure its integrity. At S102, if a
quick prime is to be performed, the batch contents may be used for
this purpose. Either way, the remaining batch contents are emptied
to the drain S104. The controller stores final target quantities of
water, osmotic agent concentrate, and electrolyte concentrate
ultimately to be transferred to the mixing container, mixed, and
tested. Initially the mixing container is empty. At S106, an
initial quantity of water is transferred to the mixing container.
Prior to S106, the mixing container is essentially empty, although
there may be a small residual trace from the priming operation. The
resulting batch contents are indicated in alignment with the S106
process in row 321. The quantity of water may be optimized to
minimize mixing time. In embodiments, the water quantity may be 50%
of the target water requirement. At S108 osmotic agent concentrate
is transferred to the mixing container as required by the target
composition. The transferred osmotic agent concentrate illustrated
at 322 indicates the that entire target quantity of concentrate is
transferred. Also illustrated at 322 is that a quantity of water
and a quantity of electrolyte concentrate are also transferred as
part of the osmotic agent concentrate 338.
[0160] Note that the target quantities of the electrolyte, the
osmotic agent, and water can be stored as the quantities of
electrolyte concentrate and osmotic agent concentrate or the
quantities of the undissolved species. The quantities can be
converted between each and can be stored as volume or mass or other
suitable measure.
[0161] In the present embodiment, the volume of osmotic agent
concentrate includes electrolyte as a marker, which contributes to
the amount of electrolyte of the target stored by the controller.
If a final dialysis fluid requires no more than the quantity of
electrolyte appearing in the osmotic agent concentrate to function
as a marker, then the quantity of electrolyte concentrate
transferred in this initial step is sufficient to form the final
dialysis fluid. Next, the mixing container contents are mixed by
pumping at S110. At S112, the batch content conductivity is tested
to determine if the concentration is as expected. The controller
may store a number indicating a number N of conductivity retests
that can be performed in the event the conductivity test result is
outside of an expected range. To retest, the controller mixes the
contents of the mixing container again. In embodiments, this latter
mixing may be for a shorter predefined interval than a predefined
interval of operation S110. The testing and mixing may be iterated
the N number (N being a predefined number) of times and if the
final test fails, the preparation is halted and a recovery
operation invoked, for example, halting pumping and outputting a
display to restart preparation with a new disposable fluid circuit.
Through S108 to S112, the contents of the mixing container remain
the same as indicated at 324 and 326.
[0162] If the final dialysate calls for a higher ratio of
electrolyte concentrate to osmotic agent concentrate than is in the
osmotic agent concentrate, then at S114, a corresponding quantity
of electrolyte concentrate is added to the mixing container.
Otherwise operations S114, S116, and S118 are skipped. Proceeding
with S114, the mixing container contents are mixed at S116 and a
conductivity check is performed at S118 with M iterations where M
may be any number including equal to N. The balance of the required
water for achieving the target is added at S120. At that point the
final composition indicated at 334 and 336 is obtained. Then, as
above, the mixing container contents are mixed at S122 and a
conductivity check is performed at S124 with L iterations where L
may be any number including equal to N or M. In a final operation
S126 the one or more filters used to protect against touch
contamination (depending on the configuration of the fluid circuit)
is tested to confirm its integrity during the fluid
proportioning.
[0163] The reason only a fraction of the water is added initially
at S106, even if the ratio of electrolyte to osmotic agent in the
osmotic agent concentrate is correct for the target dialysis fluid,
is that mixing initially with part of the water and then again with
the remainder of the water may reduce the total mixing time
compared to adding all of the water at once at S106.
[0164] In the foregoing methods, there were described three steps
of mixing and testing. Within any of these operations, a titration
process may be used to adjust the quantity of water or concentrate
added to the mixing container or for adjusting the accounting of
the total volume of water to be added in a final dilution
operation. At S112, for example, in embodiments, the amount of
osmotic agent concentrate may be increased if the conductivity
measurement indicates the quantity falls below a minimum mass of
osmotic agent (the solute) for the target dialysis fluid. Since
ratiometric proportioning is relied upon, such a correction would
assume that the amount of water transferred is validly quantified
and the osmotic agent concentrate quantity is inaccurate. If
testing indicates that the quantity of osmotic agent concentrate is
consistently less accurately or precisely metered by the pumping
than the water, then this correction would be valid for such
systems. In further embodiments, the controller may be programmed
so as to make an adjustment in the concentrate only after a
predefined number of mixing/testing reattempts. This will ensure
against any concentration bias resulting from incomplete mixing.
When a dialysis fluid is being made, whose ratio of electrolyte to
osmotic agent is identical to that in the osmotic agent concentrate
containing electrolyte concentrate as a marker, the testing of the
batch contents at S112 is sufficient to indicate the concentrations
of both the osmotic agent concentrate and electrolyte concentrate
because the ratio of electrolyte concentrate to osmotic agent
concentrate is fixed in the osmotic agent concentrate. Many
dialysis fluids are characterized by standard ratios of osmotic
agent concentrate to electrolyte concentrate. If the highest
osmotic agent/electrolyte ratio of such a fixed set is equal to the
proportion of electrolyte concentrate used as a marker in the
osmotic agent concentrate, then this ability to confirm the final
dialysis fluid quality by a conductivity test will be available. A
controller may be programmed to control the proportioning process
such that a final batch is cleared only after confirmation of the
final conductivity. For standard dialysis fluids having lower
ratios of osmotic agent to electrolyte, the system may rely on
ratiometric proportioning.
[0165] FIG. 15D shows a flow chart of another proportioning
procedure next to a corresponding schematic diagram of the mixing
container contents 320. As in FIG. 15A, the diagram at each stage
of processing has rows 351 through 366, each showing a figurative
representation of components of electrolyte concentrate, osmotic
agent concentrate with no electrolyte marker, and water. As
discussed with reference to FIG. 15A, the concentrates contribute
some water in addition to the respective electrolyte and osmotic
agent components they contribute. Also, the rows 351 through 366
are aligned with the process stages S206 through S222, with each
row showing a composition that exists at the corresponding stage.
Columns 368, 369, and 370 show the concentrates and water
components. The concentrates are further broken down in the columns
to indicate the constituents thereof. The osmotic agent concentrate
368 has as constituents osmotic agent and water only. No marker is
used. The electrolyte concentrate 339 has as constituents
electrolyte and water. The constituents are indicated by "E," "O,"
and "H2O" as in FIG. 15A.
[0166] In an initial operation S200, the fluid circuit including
the manifold, if present, is primed with water and the water is
circulated through the mixing container to break-in the pump tube
segment. The sterilizing filter through which water is drawn may be
tested at this point to ensure sterility. At S202, if a quick prime
is to be performed, the batch contents may be used for this
purpose. Either way, remaining batch contents are emptied to the
drain S204. The controller stores final target quantities of water,
osmotic agent concentrate and electrolyte concentrate ultimately to
be transferred to the mixing container, mixed, and tested.
Initially the mixing container is empty. At S206, an initial
quantity of water is transferred to the mixing container. Prior to
S206, the mixing container is essentially empty although there may
be a small residual trace from the priming operation. The resulting
batch contents are indicated in alignment with the S206 process in
row 351. The quantity of water may be optimized to minimize mixing
time. In embodiments, the water quantity may be 50% of the target
water requirement. At S208 electrolyte concentrate is transferred
to the mixing container as required by the target composition. This
may be the full quantity of electrolyte concentrate required in the
target composition. The transferred electrolyte concentrate
illustrated at 352 indicates the quantity of electrolyte solute
that is transferred. Also illustrated at 352 is that a quantity of
water is also transferred as part of the electrolyte concentrate
369.
[0167] Next, the mixing container contents are mixed by pumping at
S210. At S212, the batch content conductivity is tested to
determine if the concentration is as expected. The controller may
store a number indicating a number N of conductivity retests that
can be performed in the event the conductivity test result is
outside of an expected range. To retest, the controller mixes the
contents of the mixing container again. In embodiments, this latter
mixing may be for a shorter predefined interval than a predefined
interval of operation S210. The testing and mixing may be iterated
the N number of times and if the final test fails, the preparation
is halted and a recovery operation invoked, for example, halting
pumping and outputting a display to restart preparation with a new
disposable fluid circuit. Through S208 to S212, the contents of the
mixing container remain the same as indicated at 354 and 356.
[0168] Proceeding with S214, the osmotic agent is added to the
mixing container and the mixing container contents are mixed at
S216. Then a conductivity check is performed at S218 with M
iterations where M may be any number including equal to N. The
quantity of osmotic agent concentrate added can be verified at S218
because the combined effect of dilution by the water constituent
and the osmotic agent constituent is to lower the conductivity a
measurable amount which depends on how much water and osmotic agent
concentrate is added. This decrement in conductivity may be stored
as a predefined quantity by the controller and compared to measured
levels just as the other conductivity measurements are.
[0169] The balance of the required water for achieving the target
mixture is added at S220. At that point the final composition
indicated at 364 and 366 is obtained. Then, as above, the mixing
container contents are mixed at S222 and a conductivity check is
performed at S224 with L iterations where L may be any number
including equal to N or M. In a final operation S226 the one or
more filters used to protect against touch contamination (depending
on the configuration of the fluid circuit) is tested to confirm its
integrity during the fluid proportioning.
[0170] The reason only a fraction of the water is added initially
at S206 is that mixing initially with part of the water and then
again with the remainder of the water may reduce the total mixing
time compared to adding all of the water at once at S206. In
embodiments, however, mixing all the water at once is a possible
alternative embodiment.
[0171] In all of the foregoing conductivity measurement operations,
the conductivity and the temperature of the fluid may be converted
directly to concentration of the electrolytes in water, or for a
fluid that contains both electrolytes and an osmotic agent, to
concentration of either the electrolytes or the osmotic agent, or
both. A similar result may be achieved by correcting a measured
conductivity to account for a difference between a reference
temperature and the temperature of the fluid to obtain the
conductivity at the reference temperature. A table of
concentrations of the various admixtures vs conductivity at the
reference temperature can then be stored in the controller to
determine the concentration for purposes of making corrections in
the dialysis fluid composition. In embodiments of disclosed
proportioning systems, the reference temperature may be a human
body temperature and the proportioning process may include
controlling the temperature of the dialysis fluid to be at the body
temperature (e.g., 37 C) such that the actual temperature at the
time of conductivity measurement is close to the reference
temperature. This makes any errors in the corrected conductivity
measurement very small because the actual and reference
temperatures will be close due to the control of the dialysis fluid
temperatures.
[0172] In a method embodiment, the constituents are warmed to the
delivery temperature in advance of combining them. In alternative
embodiments, the constituents are warmed after combining but prior
to testing. In embodiments, the conductivity is used without
compensation for comparison to reference values. In embodiments,
the estimated temperature at which concentration or target
conductivity is taken is an estimated room temperature. This would
be relevant where the combining is done before warming the product
to a temperature for administration to the patient. Warming to body
temperature may be done at a later time. In embodiments, the
conductivity levels and associated temperature compensation
coefficients for each of the expected concentration targets are
taken at 37 C.
[0173] FIG. 15B shows, approximately, the relationship between
conductivity and concentration of dextrose during the proportioning
procedure described above with reference to FIG. 15A. Curves 1506A,
1506B, and 1506C represent dilution curves for each of three kinds
of dialysis fluid having final concentrations of osmotic agent in
the finally diluted dialysis fluid. The fully diluted concentrate
of each curve may represent, for example, 4.25% dextrose in curve
1506A, 2.5% dextrose in curve 1506B, and 1.5% dextrose in curve
1506C, respectively. The other constituents may be the same in all
three, i.e., the clinically accepted components of what is carried
in the electrolyte concentrate including sodium, magnesium, calcium
chloride, etc. In other words, at all points to the right of the
final diluted dialysis fluid (diluted to usable concentration) are
over-concentrated solutions for 4.25%, 2.5%, and 1.5% dialysis
fluid. By selecting the ratio of dextrose (osmotic agent
concentrate, more generally) to electrolyte concentrates to be in
the proportions of a final dialysis fluid characterized as a 4.25%
osmotic agent (dextrose) dialysis fluid, a usable dialysis fluid
can be formed without the addition of electrolyte concentrate and
other dialysis fluids can be formed by adding respective amounts of
electrolyte.
[0174] Presenting the dilution curves as shown in FIG. 15B
highlights what has been pointed out above, namely, that the steps
of mixing constituents in stages has implications for mixing
efficiency and also, as discussed now, for proper measurement of
conductivity. The ability to make unambiguous conductivity
measurements varies for different points in the dilution vs.
conductivity space. For example, curve 1506A illustrates the
dilution curve for a concentrate with lowest percentage of
electrolyte to osmotic agent and it can be seen that certain
conductivity values indicate two different dilution levels. Also
indicated at 1508 is a range for efficient mixing. The indications
are all figurative and the precise ranges would be determined by
experiment.
[0175] In the proportioning procedure of FIG. 15A outlined above,
the measurement zones are restricted to a range where conductivity
is single-valued and optimized mixing efficiency regions 1508.
Referring also to FIG. 15A, water S106 is combined with electrolyte
concentrate and osmotic agent concentrate S108 and mixed in the
mixing container and the conductivity measured at S112. This
corresponds to point 1500 where the composition corresponds to
4.25% dextrose that is partially diluted. Next, assume that the
target dialysis fluid is 2.5% dextrose dialysis fluid. The addition
of electrolyte concentrate S114 brings the composition of the
mixing container to point 1502 which is on curve 1506B which
corresponds to an overconcentrated 2.5% dextrose dialysis fluid.
The final dilution at S120 brings the composition to the point 1504
which is that for ready to use 2.5% dextrose dialysis fluid. The
measurement points 1500, 1502, and 1504 are all in desirable
regions of the dilution/conductivity space. In the graph the
osmotic agent concentrate is identified as dextrose but could be
other kinds of osmotic agent concentrate.
[0176] In all of the foregoing embodiments, the final product can
be obtained by ratiometrically balanced proportioning, relying
purely on the repeatability of volumes delivered by the pumping. In
such embodiments, the concentration need not be detected and
proportioning can be done independently of any concentration
measurements. In further embodiments, the final composition can be
verified through a single concentration sampling and
measurement.
[0177] Referring now to FIG. 15C, a graph shows mixing time versus
dextrose concentration (note that other osmotic agent concentrates
may be similarly represented) with a curve indicating total pumping
time required to transfer the required full water and concentrate
quantities and to mix the contents to a point that ensures complete
mixing. The latter may be determined experimentally by periodically
sampling the contents of a mixing container at times during mixing
and identifying the time required for full transfer and complete
mixing ("pumping time") as the point where the concentration reads
a constant value. The ratio of water and the osmotic agent (e.g.,
dextrose) concentrate in the initial combination at 1500 in FIG.
15B may affect the total time required to create the admixture
including time to pump water and concentrate and time to mix the
container contents. Requiring the point 1500 to lie in the range of
ratios of water and osmotic agent concentrate where the
concentration measurement is monotonic and requiring the point to
be remote from the solubility limit of the osmotic agent, a minimum
pumping time may be identified. Accordingly, an optimum initial
ratio of ratio of masses of osmotic agent concentrate and water may
be found and used to define the combination identified with the
point 1500 in FIG. 15B. In embodiments of the disclosed subject
matter, for example the method of FIG. 15D, the point 1500 may be
determined responsively to these conditions.
[0178] Note that in any of the embodiments, the use of peristaltic
pumps can be replaced by metering pumps that employ any of a
variety of pumping mechanisms that may provide sufficient absolute
accuracy to satisfy a prescribed treatment (i.e., a ratio of the
commanded quantity transferred to the actual is bounded by a
predefined range that further falls within the permitted
proportions of the admixture or final product dialysate
constituents). This is compared to a pumping mechanism that relies
on ratiometric accuracy in that the ratio of components is accurate
even if the ratio of commanded-to-actual rates (or volumes) is not
as accurate as the prescribed requirement.
[0179] Referring to FIG. 16A, in another method embodiment for
creating a batch of dialysis fluid, electrolyte concentrate is
pumped into the mixing container before osmotic agent concentrate
is added. This allows the testing and adjustment of the electrolyte
concentrate concentration to be performed on the mixed batch prior
to the addition of osmotic agent concentrate. Because the tolerance
of the dialysis fluid prescription to variation in the electrolyte
concentrate concentration is much tighter, for example +/-2.5%,
than the concentration of osmotic agent concentrate (+/-5%), the
addition, confirmation, and adjustment of electrolyte concentrate
alone allows the proportioning to be more tightly controlled. In
embodiments, additional water or concentrate may be added to ensure
the concentration is within the electrolyte concentrate limits. In
embodiments, the dose of osmotic agent concentrate is controlled
solely by volumetric control. In embodiments, the quantity of
osmotic agent concentrate added during proportioning is checked
with a conductivity measurement but the quantity is not titrated to
adjust it based on conductivity measurements.
[0180] The method begins with the pumping of all, or a fraction of
the required water for the batch into the mixing container 458. In
a variation, a quantity of water equal to a predefined fraction
required for the final batch is pumped into the mixing container.
For example, 50% of the target quantity of water may be added. As
noted elsewhere, the quantity may be selected to minimize overall
pumping time or at least responsively to overall mixing time. Next,
100% of the required dose of electrolyte concentrate is pumped into
the mixing container 459. The mixing container contents are then
mixed at 460 and a sample of the mixing container is withdrawn and
tested at 461 by pumping a sample through one or more conductivity
sensors, for example as described in the above embodiments. At 463,
the osmotic agent concentrate dose is pumped into the mixing
container and the batch contents are mixed 464. Mixing here, and in
all method embodiments, may be done by any of the mechanisms
identified above or by any suitable method. Magnetohydrodynamic
mixing (excitation circuits may be provided, for mixing and/or for
warming, in a support for the mixing container) may be employed
here to reduce the count of roller strikes on the fluid circuit
that would otherwise occur if pump mixing were used. A sample may
be pumped from the mixing container and tested at 465 by pumping a
sample through one or more conductivity sensors, for example as
described in the above embodiments. If additional water is
required, depending on the amount originally added at 458, then the
final balance of water is pumped into the mixing container at 467
and the final diluted concentration check as at 465 is done at
468.
[0181] At 469 a pressure test of one or more sterilizing filters
depending on the embodiment (e.g., 115 of any FIG. 1A-1D, 2A, 2E or
2H) may be performed and a result of the test may be made a
condition for the release of the batch for a treatment. That is, in
the method, all fluids added to the batch that are not otherwise
preconnected to the mixing container (as done in some but not all
disclosed embodiments) may have an inline sterilizing filter
preconnected between the outside source and the mixing container.
That is, the sterilizing filter is preconnected such that its
sterilizing filter membrane defines a barrier to the interior of
the mixing container such that any touch contamination resulting
from the making of a connection to the mixing container is blocked
by the filter membrane when a fluid transfer occurs through the
made connection. When the sterilizing filter or filters is/are
pressure tested--that is, one or more sterilizing filters relied
upon to define the sterile barrier are pressure tested--the
controller makes a determination as to whether they have passed the
pressure test and then either prevents or permits the batch to be
used. In a method, the controller generates a message indicating
the outcome of the pressure test or tests. The controller may
generate the message to be output on a display along with an
indication that the batch is not permitted to be used. The
controller may further prevent the transition to a treatment mode
in which the batch is used. The controller may, in an alternative
embodiment, transition to a mode for preparation of a new batch.
The controller, in the latter case, may output an instruction to
replace a failed disposable with a new one and to initiate
preparation of a new batch.
[0182] At 461, 465, and 468, the conductivity of the mixing
container is detected and compared to an expected value in order to
ensure the proportioning process is proceeding correctly. If a
comparison to an expected value stored in a controller fails to
pass, a recovery procedure may be performed as described with
reference to FIG. 15A and 15D, that is, the batch may be mixed (for
any time, or for an interval shorter or equal to a mixing time of
460) and the batch contents sampled and tested again. Thus, one
form of recovery is to recover from an invalid test rather than a
bad mixture. If, after some predefined number of remix/test
attempts, the conductivity differs from the stored expected value
by more than a predefined amount or percentage, the proportioning
process may stop, and the controller may output a message to
restart the proportioning process. In addition to stopping the
proportioning process, the controller may prevent access to the
batch by clamping a line or take some other safety precaution to
prevent misuse of the failed batch contents.
[0183] An additional recovery process may be implemented by the
controller to adjust the conductivity of the batch in a way that
corrects for a mixing error. When a conductivity test fails, i.e.,
the measured conductivity is outside a predefined range with
respect to a stored expected value, the controller may adjust the
proportions of the batch by adding water or one or both
concentrates in an amount that is in response to the magnitude of
the error. As an initial operation, the controller may compare the
magnitude of the error in combination with the stage of
proportioning in order to determine if an adjustment is permitted.
In embodiments, the controller stores a respective error magnitude
range of conductivity for each test (461, 465, and 468). The stored
error magnitude, which may be different for negative and positive
errors, may be compared with a detected error at 461, 465, or 468
and the controller may proceed with an adjustment process if the
error magnitude is below the stored error magnitude or terminate
proportioning if not. The error magnitude may be advantageously
based on the last remix/test cycle for the particular operation
461, 465, or 468.
[0184] The recovery procedure may also employ a scale that measures
the weight of the disposable unit. The disposable unit includes a
mixing container and one or more concentrate containers depending
on the embodiment. Only water is added and it is added to the
mixing container. After obtaining a baseline weight after the
disposable unit is rested on a scale, thereafter the quantity of
water added to the mixing container can be detected by weight. No
change in the total weight of the disposable unit occurs when
concentrate is transferred to the mixing container. Using the
conductivity plus the weight of the disposable unit, at each
operation 461, 465, or 468, the controller can determine precisely
the amount of added water or concentrate needed to achieve the
target ratios.
[0185] In embodiments without a scale, or in which a scale is not
used for proportioning control, the controller may perform
operations as follows to recover by changing the mixing container
contents to correct for an erroneous reading. Referring to FIG.
15E, a flow chart is shown in outline form. It repeats elements of
other mixing methods presented here but is not a separate
embodiment in that it can be added (with substitution, as
necessary) as a conductivity error recovery method to any of the
methods presented herein.
[0186] Referring to FIG. 15E, at 1.0 an initial water dose is added
to the mixing container. At 2.0 a first concentrate is added, which
can be, for example, osmotic agent concentrate or electrolyte
concentrate according to any of the embodiments. At 3.0 the batch
contents are mixed and at 4.0, the conductivity is measured. At 4.1
the controller determines if the conductivity measurement matches,
within a predefined tolerance, the expected value and if so,
operation proceeds to 5.0. Otherwise, at 4.2, an error recovery
method 4.2.1 calculates an actual first concentrate in the batch by
assuming that the correct quantity of water was pumped into the
container. This may be obtained because the relationship between
concentration and conductivity is stored. This relationship can be
stored as a lookup table, a power function fitted formula, or some
other way to allow a new quantity of concentrate to be calculated
from the given water quantity and the calculated concentration of
the first concentrate. The new quantity of concentrate (e.g.,
volume, but the units of the computation are not essential) is used
to calculate a new target quantity of the second concentrate at
4.2.2.
[0187] At S.0 the second concentrate is added, mixed 6.0, and the
batch contents conductivity measured 7.0. If the conductivity value
matches the expected conductivity based on the reset volume
transfer of concentrate from 4.2.2 if this operation was performed
previously, then control proceeds to 8.0. If the conductivity is
erroneous and was previously erroneous for the first concentrate,
then at 7.2 then the proportioning process is terminated and a
recovery process initiated. The batch is a failed batch at this
point. Control reaches 7.3 if the conductivity measurement at 4.0
was in range and the conductivity measurement at 7.0 was not in
range. At 7.3.1 if the conductivity indicates deficiency of the
second concentrate was added to the batch container at 5.0, then an
additional amount to be added is calculated based on the magnitude
of the conductivity measurement and thereafter added to the mixing
container. Control proceeds to 7.3.2.1. At 7.3.1 if the
conductivity indicates a surfeit of the second concentrate was
added to the mixing container at 5.0, then an additional amount the
first concentrate and water to be added are calculated based on the
magnitude of the conductivity measurement and thereafter added to
the mixing container. At 7.3.2.1 the batch contents are mixed and
conductivity measured again at 7.3.2.2. If the measurement is
within expected range, then at 7.3.2.2.1 control proceeds to 8.0;
otherwise the proportioning is terminated at 7.3.2.2.2.
[0188] If no hard termination of the proportioning has occurred,
then at 8.0 the balance of the water is added, at 9.0 the mixing
container contents are mixed, and at 10.0 the conductivity of the
batch fluid is measured. If the measurement is good, at 10.1, then
control proceeds to 11.0. If the conductivity measurement is within
the expected range, then control proceeds to 11.0, otherwise
control proceeds to 10.1.1 or 10.1.2 based on whether the
conductivity measurement indicated under-dilution or over-dilution
at 8.0. If over-dilution is indicated by the conductivity
measurement (i.e., measured conductivity is lower than the expected
threshold) then at 10.1.1 both concentrates are added in the
prescribed ratio as described in the present disclosure. If
under-dilution is indicated at 10.1.2, water is added as described
in the present disclosure. In both cases, the water deficit or
surfeit can be estimated from the conductivity measurement based on
the prescribed quantities of the concentrate constituents with any
adjustments stored due to preceding recovery operations. In this
final adjustment stage it is possible to add water or concentrates
in increments and test repeatedly to titrate the batch contents to
a final target level of conductivity. At 10.1.2.1 the batch
contents are mixed and conductivity measured again at 10.1.2.2. If
the measurement is within the expected range, then at 10.1.2.2.1
control proceeds to 11.0; otherwise, the proportioning is
terminated at 10.1.2.2.2.
[0189] At 11.0, the filter or filters that ensure sterility of all
fluids is/are tested and if the test fails, the batch is terminated
as discussed above. Otherwise the batch is released at 12.0.
[0190] Note that in all the relevant operations in FIG. 15E, a
magnitude of the error between the expected value of conductivity
and the measured value is compared to a permitted range and if
outside that range, control may proceed to a hard termination of
the proportioning, as in 7.2, for example and as described
elsewhere.
[0191] FIG. 17A shows a proportioning and treatment system for
peritoneal dialysis 700A. Two multi-treatment containers 736 and
738 contain electrolyte concentrates and osmotic agent
concentrates, respectively. They are connected by aseptic
connectors 730 to a fluid circuit 701A by respective osmotic agent
concentrate 744 and electrolyte concentrate 742 lines. Non-aseptic
connectors may also be used. In embodiments, where the connectors
are non-aseptic, the osmotic agent concentrate 744 and electrolyte
concentrate 742 lines may contain sterilizing filters. Due to the
cost and number of filters required this is not a preferred way to
ensure sterility. A last fill container 734 may also be connected
to the fluid circuit 701A via last fill line 740. The last fill
container 734 may contain a specific medicament for the last fill
cycle of a multi-cycle treatment. The fluid circuit 701A contains
first 758 and second 760 manifolds connected by a pumping tube 763.
The manifolds 758 and 760 define selectable fluid paths connecting
various sources of fluids to fluid consumers using clamps 751 under
control of a controller 739. The details of the flow switching may
be as discussed above with respect to similar embodiments. A
purified water source 766 supplies purified water to the manifold
758 through redundant sterilizing filters 731. The filters 731 may
be replaced by a single testable filter that is automatically
tested to confirm that a batch is sterile as described in method
embodiments in the present disclosure. Manifold 760 is connected by
a drain line 756 to a drain line circuit 765 through a non-aseptic
connector 729. The drain line circuit has a conductivity sensor 764
in its path to permit the measurement of conductivity of samples of
fluid conveyed through the manifold 760 under control of the
controller 739. The mixing container 732 is connected by inlet and
outlet lines 746 and 750 to the manifolds 758 and 760,
respectively, to allow fluid to be pumped into the mixing container
732, to be drawn from the mixing container 732, and to permit
mixing via recirculation of the contents of the mixing container
732. A pump 762 pumps fluid between the manifolds 758 and 760.
Pressure sensors 769 are positioned on either side of the pump 762
to detect pump inlet and outlet pressures in pump tube 763. Signals
corresponding to the pressures are applied to the controller 739
and used for pump pressure compensation and/or pump calibration as
discussed elsewhere and in US Patent Publication 2015-0005699,
hereby incorporated by reference in its entirety herein. A waste
container 768 may be attachable to the drain line circuit 765 by a
non-aseptic connector 729. A heater 770 contacts the mixing
container 732. In embodiments, the heater 770 forms a bed on which
the mixing container 732 rests. A patient line 754 is connected by
a Y-connector to separate lines 748 and 752 to permit the filling
and draining of a patient 718 through the patient line 754, which
is connected to a catheter (not shown) by means of another aseptic
connector 730.
[0192] The fluid circuit 701A connects to proportioning/cycler
machine 772 by a mechanism that aligns clamps 751 with respective
clamping portions of lines 741, 740, 742, 744, 750, 746, 752, and
756. Various such mechanisms are known in the art such as supports
that hold tubing portions at predefined positions in cassettes and
cartridges and compact fluid circuits that can be easily laid over
a set of actuators and sensors. The manifolds and clamps can be
replaced by a variety of different types of flow selector devices
known in the art, so the current system is not limited to using
flow selectors based on clamping of tubing. If the pump 762 is a
peristaltic pump, a pumping tube segment of line 763 may be aligned
by the connection of the fluid circuit 701A. The purified water
source 766 may be housed in an enclosure 767 together with the
drain line circuit 765 or portions of either. The waste container
768 may be housed in the same enclosure, or not, as illustrated.
The concentrate containers 736 and 738 may contain sufficient
concentrate for multiple fill/drain cycles, multiple days' worth of
treatments, each consisting of multiple fill/drain cycles, a week's
worth of treatments, a month's worth of treatments, or some other
schedule. The concentrate containers 736 and 738 may be
independently replaceable by use of the aseptic connectors. The
benefits of independent replacement are discussed elsewhere in the
present disclosure. The contents of the last fill medicament
container 734 may be fully diluted or may consist of, or include, a
concentrate that requires further dilution. The manifolds 758 and
760 may have a minimum volume to reduce waste when changing over
fluids. In embodiments, the maximum hydraulic diameters of the
manifolds 758 and 760 are each no more than 5 times the diameter of
the largest line connecting to them. In further embodiments, they
are no more than 3 times the diameter of the largest line and in
still further embodiments, no more than twice.
[0193] Referring to FIGS. 16B and 17A, in a method for creating a
batch of dialysis fluid, a set of priming operations is first
performed. The operations 485, 486, 487, 488 and 489 collectively
form an overall operation sequence that fills osmotic agent
concentrate, electrolyte concentrate and last fill lines 740, 742,
and 744 with the respective fluids and fills the mixing container
732 inlet 746 and outlet 750 lines as well as the manifold 758,
pumping tube 763, manifold 760, and water line 741 with purified
water. The operations can be in any order but in particular
embodiments, the water is primed through the manifold last.
[0194] At 485, a first concentrate 736 or 738 is conveyed to the
waste container 768 (which can be a sewage drain rather than a
container) by closing the valves 751 for all of the lines except
for the valves 751 that permit flow through the respective
concentrate line 742 or 744 and the valve 751 that permits flow
through the drain line 756. The pump 762 is operated to establish a
flow until a predefined condition is met. The predefined condition
may be detected by the controller 739. The predefined condition may
be a detected volume of concentrate determined by the controller
739, a number of cycles (e.g., rotations) of a pump actuator, or a
detected conductivity or rate of change thereof, indicated by the
conductivity sensor 764. The condition may be selected to ensure
that the respective concentrate line 742 or 744 is filled. The
condition may be further selected to ensure that the respective
concentrate line 742 or 744 is purged of any air. The absence of
any air in the respective concentrate line 742 or 744 may be
established by an air detector, for example one that is located at
the conductivity sensor 764 or located elsewhere along the path.
The condition may include a combination of a threshold level of (or
no) detected air combined with a predefined threshold of
conductivity.
[0195] At 486, a second concentrate 736 or 738 (other than the
first concentrate) is conveyed to the waste container 768 (which
can be a sewage drain rather than a container) by closing the
valves 751 for all of the lines except for the valves 751 that
permit flow through the respective concentrate line 742 or 744 and
the valve 751 that permits flow through the drain line 756. The
pump 762 is operated to establish a flow until a predefined
condition is met. The predefined condition may be detected by the
controller 739. The predefined condition may be a detected volume
of concentrate determined by the controller 739, a number of cycles
(e.g., rotations) of a pump actuator, or a detected conductivity or
rate of change thereof indicated by the conductivity sensor 764.
The condition may be selected to ensure that the respective
concentrate line 742 or 744 is filled. The condition may be further
selected to ensure that the respective concentrate line 742 or 744
is purged of any air. The absence of any air in the respective
concentrate line 742 or 744 may be established by an air detector,
for example one that is located at the conductivity sensor 764 or
located elsewhere along the path. The condition may include a
combination of a threshold level of (or no) detected air combined
with a predefined threshold of conductivity.
[0196] At 487, a last fill (either a concentrate or a ready for use
medicament) is conveyed to the waste container 768 (which can be a
sewage drain rather than a container) by closing the valves 751 for
all of the lines except for the valves 751 that permit flow through
the last fill line 740, and the valve 751 permits flow through the
drain line 756. The pump 762 is operated to establish a flow until
a predefined condition is met. The predefined condition may be
detected by the controller 739. The predefined condition may be a
detected volume of fluid determined by the controller 739, a number
of cycles (e.g., rotations) of a pump actuator, or a detected
conductivity or rate of change thereof indicated by the
conductivity sensor 764. The condition may be selected to ensure
that the last fill line 740 is filled. The condition may be further
selected to ensure that the last fill line 740 is purged of any
air. The absence of any air in the last fill line 740 may be
established by an air detector, for example one that is located at
the conductivity sensor 764 or located elsewhere along the path.
The condition may include a combination of a threshold level of (or
no) detected air combined with a predefined threshold of
conductivity.
[0197] At 488, purified water is conveyed to the waste container
768 (or sewage drain) by closing the valves 751 for all of the
lines except for the valves 751 that permit flow through the water
line 741 and the valve 751 that permits flow through the drain line
756. The pump 762 is operated to establish a flow until a
predefined condition is met. The predefined condition may be
detected by the controller 739. The predefined condition may be a
detected volume of water determined by the controller 739, a number
of cycles (e.g., rotations) of a pump actuator, or a detected
conductivity or rate of change thereof indicated by the
conductivity sensor 764. The condition may be selected to ensure
that the water line 741 is filled. The condition may be further
selected to ensure that the water line 741 is purged of any air.
The absence of any air in the water line 741 may be established by
an air detector, for example one that is located at the
conductivity sensor 764 or located elsewhere along the path. The
condition may include a combination of a threshold level of (or no)
detected air combined with a predefined threshold of
conductivity.
[0198] At 489, an optional step is performed of recirculating the
water through the mixing container 732. In embodiments, this may be
done before or in the middle of the operation at 488 as well as
after. The valves 751 opening inlet line 746 and the valve opening
water line 741 are opened while all other valves 751 are closed so
that when the pump 762 is operated, water is pumped into the mixing
container 732. Then the water line 741 valve 751 is closed and the
outlet line 750 valve 751 is opened so that when the pump 762 runs,
water can be continuously recirculated in the mixing container 732.
The controller implements this flow configuration for a
predetermined number of pump cycles or a predefined time (which may
depend on the flow rate). This operation breaks in the pump tube
763 for a peristaltic pump, thereby making the relationship between
pump cycle rate (e.g., RPM) and flow rate more consistent. This
operation is beneficial when a new fluid circuit 701A is installed.
After the pump tube 763 break-in is completed, the inlet line 746
may be closed by the respective valve 751 and the drain line 756
opened by the respective valve, after which the pump 762 operates
to drain the mixing container. Whether the pump break-in is
completed after, before, or during priming of the manifold and
drain line with water, the operation serves to prime the inlet 746
and outlet 750 lines and further prime the drain line 756 and
manifolds 758 and 760.
[0199] Note that instead of a conductivity detector at 764, other
types of sensors may be used to detect the filling of the
respective concentrate line. For example, a flow sensor may be
responsive to the density or viscosity of fluid flowing in the
drain line 756. Another alternative is a temperature sensor for
cases where the temperature of the fluid reaching the sensor is
different from the fluid being displaced.
[0200] In the embodiment of FIG. 16A, electrolyte concentrate is
pumped into the mixing container before osmotic agent concentrate
is added. However, in alternative embodiments, osmotic agent
concentrate (which may contain electrolytes that function as a
marker) is added to the mixing container before the remaining
electrolyte concentrate. The method begins with the pumping of 100%
or less of the required water for the treatment batch into the
mixing container 732. By closing all valves 751 except those
closing water line 741 and inlet line 750, a predefined volume of
water is pumped by the pump 762 from the purified water source 766
through sterilizing filters 731 (or a single testable filter if
present), through the optionally aseptic connector 730, through
water line 741, manifold 758, through pumping tube 763, into
manifold 760, through mixing container inlet line 746, and into the
mixing container 732. The volume displaced may be controlled by the
controller by controlling the number of cycles of the pump 762 to a
predefined number of cycles (e.g., rotations of a peristaltic
pump). The embodiment of FIG. 16B can be modified in a similar
manner, however, the osmotic agent concentrate pumped into the
mixing container first, may contain electrolyte concentrate in
sufficient quantity to serve as a marker in order to test the
admixture at 473.
[0201] For purposes of accounting for the precise quantities of
fluids that are pumped into the mixing container 732, the
controller's operations to the pump 762 are such that displacement
of residual volumes of fluids remaining in respective parts of the
fluid circuit are accounted for. In operation 470, the total
quantity entering the mixing container is equal to the quantity
displaced by the pump 762 in this operation because the manifolds
758 and 760 and the inlet line 746 were previously primed. So, no
additional accounting is reflected in the control of the pump in
that case. The pump is operated to displace a target volume of
water and the controller can be programmed to do calculations based
on the batch volume being equal to the displaced volume during
operation 470. For convenience in discussing the further operations
where displacement of a fluid also displaces another remaining in
the fluid circuit 701A, the following identifiers will be used:
[0202] MIMO, for the combined volume of the manifold 758, pump tube
763, and manifold 760;
[0203] MOTI, for the volume of the inlet line 746 between the
mixing container 732 and the manifold 760;
[0204] SOMI, for the volume of the outlet line 750 between the
mixing container 732 and the manifold 758.
[0205] At 471, electrolyte concentrate from electrolyte concentrate
container 736 is pumped to the mixing container 732 by opening
respective valves 751 for the electrolyte concentrate line 742 and
the inlet line 746 and closing other valves 751 to form a direct
path that includes MOTI and MIMO. The electrolyte concentrate is
pumped by the pump 762 from the electrolyte concentrate container
736, through the manifold 758 by opening only the clamp 751 that
closes the electrolyte concentrate line 742. The pump draws the
electrolyte concentrate from manifold 758 through the pump tube 763
and into manifold 760 through the inlet line 746 into the mixing
container 732. A volume equal to 100% of the required dose of
electrolyte concentrate is pumped toward the mixing container 471
but a predetermined fraction equal to MOTI and MIMO remains behind.
In addition, through the pumping of electrolyte concentrate, a
volume of water equal to MOTI and MIMO is added to the mixing
container 732. The controller uses a predetermined conductivity
threshold for a mixed diluted electrolyte concentrate based on the
added volume MOTI plus MIMO of water. This conductivity threshold
allows the testing at 473 and adjustment at 474 of the electrolyte
concentrate concentration to be performed on the mixed batch prior
to the addition of osmotic agent concentrate with the concomitant
tolerance benefits discussed above.
[0206] The mixing container contents are then mixed at 472 by
closing all valves 751 except those closing the inlet 746 and
outlet 750 lines to the mixing container 732 such that fluid is
circulated into and out of the mixing container 732. As a result,
the fraction of electrolyte concentrate equal to MOTI and MIMO is
integrated into the batch contents and the water left in SOMI is
integrated in as well. For concentration measurement purposes the
total pumped volume of concentrate conveyed at 471 is mixed with
the total pumped volume of water conveyed at 470 with the
additional dilution of a SOMI volume to determine the expected
concentration. A sample of the mixing container is withdrawn and
tested at 473 by pumping a sample through one or more conductivity
sensors, for example as described in the above embodiments. This is
done by closing all the valves 751 except for those controlling the
outlet line 750 and the drain line 756 and operating the pump 762
to convey a predetermined volume of fluid from the mixing container
732 to the conductivity sensor 764. The controller 739 may account
for the drained volume in making adjustments to its internal model
of the batch contents at 474 including total volume and proportions
of constituents. The concentration of electrolyte concentrate can
be determined by the controller 739 by the conductivity measurement
permitting the controller to add more water or electrolyte
concentrate to change the concentration to fit a target.
Alternatively, the internal model of composition of the mixing
container stored by the controller 739 may be adjusted responsively
to the measurement and accounted for later to change the amount of
osmotic agent concentrate and/or water added to the mixing
container 732 in later operations to generate the target
prescription fluid. At 474, if the batch contents are adjusted
immediately and responsively to the results of the concentration
test, then water or additional electrolyte concentrate may be
pumped into the mixing container 732 using the valve 751 settings
identified above, depending on whether the concentration
measurement indicated over-dilution or under-dilution. If less than
100% of the water dose is used in 470 (as in the embodiment
variation identified above), then additional water may be added up
to the requirement per prescription. Again, such a water balance
may be added after 475 and 454 at 455.
[0207] At 475, osmotic agent concentrate from osmotic agent
concentrate container 738 is pumped to the mixing container 732 by
opening respective valves 751 for opening the osmotic agent
concentrate line 744 and the inlet line 746 and closing other
valves 751 to form a direct path that includes MOTI and MIMO. The
osmotic agent concentrate is pumped by the pump 762 from the
osmotic agent concentrate container 738, through the manifold 758
by opening only the clamp 751 that control the osmotic agent
concentrate line 744 and the inlet line 746. The pump draws the
osmotic agent concentrate from manifold 758 through the pump tube
763 and into manifold 760 through the inlet line 746 into the
mixing container 732. A volume equal to 100% of the required dose
of osmotic agent concentrate is pumped toward the mixing container
471 but a predetermined fraction equal to MOTI and MIMO remains
behind. The required dose may be determined, in part, by the
results of the conductivity test at 473 as indicated above. The
volume transferred may also account for the volume of diluted
electrolyte concentrate of the prior batch contents which remains
in MOTI and MIMO before the osmotic agent concentrate is pumped.
Finally, the residual volume is transferred to the mixing container
732 in the final dilution at 455, if present, such that the volume
of osmotic agent concentrate transferred to the mixing container
732 is in part compensated to account for that additional volume.
The batch contents are mixed using the valve settings identified in
the discussion of operation 472. This mixes-in the residual MOTI
and MIMO volumes of osmotic agent concentrate remaining behind
after pumping the osmotic agent concentrate, as well as the SOMI
volume of the mixture, before addition of osmotic agent
concentrate.
[0208] At 454, the batch contents may be sampled as discussed in
relation to the operation 473 by setting appropriate valves 751 and
operating the pump 762. The conductivity determined from the sample
indicates to the controller whether the batch is good and can be
used for a treatment cycle or whether it is bad and should be
drained and remade or some other recovery cycle implemented. The
addition of osmotic agent concentrate and associated water has a
measurable effect on the conductivity. The addition of osmotic
agent concentrate, depending on the specific type (dextrose, for
example), tends to lower the conductivity. However the concentrate
impacts the conductivity, it can be predetermined and stored by the
controller so that the conductivity measurement at 454 can be used
to determine if the conductivity corresponds to the internal model
or is outside a predefined range thereabout. As stated, the
controller will enable the batch to be used for a treatment or
regenerated or it will prevent usage by preventing the advance of
the control system to treatment mode, generate an error signal,
drain and generate a new batch, or any combination thereof, based
on the conductivity result.
[0209] At 455, if less than 100% of the required water for a
complete batch was added to the mixing container 732 at 470, then
the remaining complement of water is added at 455 using the
settings described above with regard to operation 470. The total
amount of water displaced is ultimately added to the batch, even
though a fraction remains behind initially in MOTI and MIMO. This
is because of the additional mixing operation at 476, where the
MOTI and MIMO portions are mixed into the batch. The SOMI volume of
the previous mixture attained at the end of 475 is also mixed
in.
[0210] At 475, an osmotic agent concentrate volume is transferred
to the mixing container 732. A dose is pumped into the mixing
container 732 and the batch contents are mixed. At 454 the
conductivity of the batch contents is measured and if it is within
limits, control moves on to 455, and if not, the proportioning is
terminated. At 455, if less than 100% of the water was added at
470, then the final volume of water is added to the mixing
container 732. At 476, the batch contents are mixed and the MOTI
and MIMO volumes of water are mixed in as well as the prior mixture
from SOMI to form the final mixed batch. At 456, the conductivity
is tested using the procedure described above in reference to 473.
At 457, any sterilizing filters responsible for ensuring sterility
of fluids may be tested or redundant filters may be used. If the
filter(s) integrity is/are confirmed, then the batch will be
released; otherwise, the batch is not released. The possible
responses to an out-of-range reading of conductivity may be as
described with reference to operation 454.
[0211] Referring to FIG. 16C, in a further embodiment, suitable for
a pumping system and/or method that provides a high degree of
volumetric accuracy, water and osmotic agent concentrate and
electrolyte concentrates are transferred to the mixing container
and mixed 477-481 in a single set of operations relying on
volumetric control. At 477 100% or a fraction of a target water
volume is pumped into the mixing container. At 478, 100% of a
target volume of electrolyte is transferred to the mixing
container. At 479, a volume of osmotic agent is pumped into the
mixing container. At 480, if less than 100% of the water was
transferred at 477, then a complementary quantity of water is added
to bring the total to 100%. At 480 the conductivity of the mixing
container contents can be measured and if necessary additional
water added. Conductivity is measured after mixing. At 481 the
mixing container contents are mixed. The operations may be followed
by a pressure test of a sterilizing filter as discussed with
reference with the other embodiments.
[0212] FIG. 17B shows a proportioning and treatment system for
peritoneal dialysis 700B. Two multi-treatment containers 736 and
738 contain electrolyte concentrates and osmotic agent
concentrates, respectively. They are connected by aseptic
connectors 730 to a fluid circuit 701B by respective osmotic agent
concentrate 744 and electrolyte concentrate 742 lines. Non-aseptic
connectors may also be used. In embodiments where the connectors
are non-aseptic, the osmotic agent concentrate 744 and electrolyte
concentrate 742 lines contain sterilizing filters. Due to the cost
and number of filters required this is not a preferred way to
ensure sterility. A last fill container 734 may also be connected
to the fluid circuit 701B via last fill line 740. The last fill
container 734 may contain a specific medicament for the last fill
cycle of a multi-cycle treatment. The fluid circuit 701B contains
first 758 and second 760 manifolds connected by a pumping tube 763.
The manifolds 758 and 760 define selectable fluid paths connecting
various sources of fluids to fluid consumers using clamps 751 under
control of a controller 739. The details of the flow switching may
be as discussed above with respect to similar embodiments. A
purified water source 766 supplies purified water to the manifold
758 through redundant sterilizing filters 731. The filter 733 is a
single testable filter that is automatically tested by pumping air
by means of an air pump through an air line 737 and measuring
pressure, detecting whether the filter's bubble point has been
exceeded, and if not, confirming the integrity of a filter membrane
of the filter 733. Alternative filter integrity tests may also be
provided such as a pressure decay test. The test of the filter 733
is used by the controller 739 to confirm that a batch is sterile as
described in method embodiments in the present disclosure. Manifold
760 is connected by a drain line 756 to a conductivity sensor
module 714 through a non-aseptic connector 729. The conductivity
sensor module 714 is a replaceable component interconnectable
between outlet manifold 760 and a waste container 768 (or a waste
outlet such as a drain). The conductivity sensor module 714 has a
pair of conductivity sensors 764 in a drain channel 715. The
conductivity sensors 764 provide independent indications of
conductivity that can be compared to indicate a bad sensor and/or
to provide a mechanism for flow sensing based on a time of flight
of a conductivity perturbation in the flow through the drain
channel 715. The conductivity module 714 engages with the
proportioning/cycler machine 772 which houses a valve actuator 721.
The latter is not replaced when the conductivity module 714 is
replaced. The conductivity module 714 can be a low cost component
by employing plastic conductivity cells, a tube with connectors and
a pinching portion defining a valve 751 by separating the valve
actuator 721 (the one shown that controls flow through the drain
channel 715) from the tube pinching portion and selecting a low
cost arrangement for the conductivity cells 764, the tubing forming
the drain channel 715, the connectors 729 and a housing or support
indicated at 714.
[0213] A mixing container 732 is connected by inlet and outlet
lines 746 and 750 to the manifolds 758 and 760, respectively to
allow fluid to be pumped into the mixing container 732, to be drawn
from the mixing container 732, and to permit mixing via
recirculation of the contents of the mixing container 732. A pump
762 pumps fluid between the manifolds 758 and 760. A waste
container 768 may be attachable to the drain line circuit 765 by a
non-aseptic connector 729. A heater 770 contacts the mixing
container 732. In embodiments, the heater 770 forms a bed on which
the mixing container 732 rests. A patient line 754 is connected by
a Y-connector to separate lines 748 and 752 to permit the filling
and draining of a patient 718 through the patient line 754, which
is connected to a catheter (not shown) by means of another aseptic
connector 730.
[0214] In all embodiments, 17A through 17D and others, a sampling
arrangement, now described, may be provided. Although not shown in
FIG. 17A, a sample line may be provided stemming from header 760.
Referring to the embodiment of FIG. 17D presently, the sample line
774 is connected to a sample container 773 through a non-aseptic
connector 729. A valve 751 controlling flow through the sample line
757 is controlled to sample fluid from the header 760 automatically
by the controller 739. In embodiments, a temperature of draining
dialysis fluid is monitored for a condition indicating an infection
or some other condition for which a sample may be automatically
drawn and stored during draining according to the condition. See US
Patent Publication US20150005699, incorporated by reference
elsewhere herein and International Patent Publication WO2018045102,
for details of how parameter monitoring of the spent dialysis fluid
may be used to detect a condition.
[0215] In traditional peritoneal dialysis systems, all of the
patient effluent is collected in a large sample bag which may
contain, for example, 10 or more liters of fluid. In the present
embodiments, small samples (less than the total amount of effluent,
are routed to a small volume sample collection container. Thus, an
aliquot from each patient drain cycle may be generated
automatically in a small container (e.g., .about.200 ml, for
example, but it could be less or more). The collection container
may be a bag. At the end of a treatment, the system controller may
output instructions for removing, sealing, and delivering the
collected sample. For example, the container may be delivered to
the patient's dialysis center which would analyze it to assess the
adequacy of therapy.
[0216] According to a method, the following control scheme may be
implemented by the proportioner/cycler controller 739. The
controller 739 first initiates a drain cycle of a predefined number
of drain cycles of an entire treatment. A command indicating the
aliquot volume or mass may be generated and used to control the
pump 762 of the proportioner/cycler. A command may also be
generated to indicate an initial volume or mass to pass to waste
container or drain 768 before beginning a diversion of the drain
flow while metering the size of the cumulating sample and then
switching valves 751 to a configuration where the spent peritoneal
dialysis fluid is sent to waste container or drain 768. The
sequence may be implemented using valves 751 and pump 762. The
process of switching between patient line 754 to waste container or
drain 768 and patient line to sample container 773 may include
halting the pump while the relevant valves 751 are activated and
deactivated to define the correct flow path. The volume that is
drained before the aliquot is transferred to the sample container
773 may be determined by how long it takes to clear any residual
fluid (fresh peritoneal dialysis fluid, for example) in MIMO. In
embodiments, the sample container 773 may be changed at each drain
cycle in order to collect samples representative of multiple cycles
of a single treatment. The controller may also permit sampling to
be done in a manner that acquires multiple fractions throughout the
drain cycle to be stored in the sample container 773 by repeatedly,
over multiple instances, diverting to drain and diverting to the
sample container 773. This may allow for the sample to better
represent the composition of the entire drain volume which may
change through the drain cycle. These fractional samples can also
be stored in separate sample containers 773. Parameters of
collection, which may be set by the patient, nurse, or physician
accessing the controller 739 locally or remotely, include: [0217]
The volume of the sample; [0218] Spacing of samples (for example 1
spacing would be a sample for each drain cycle and 2 spacing would
refer to every other drain cycle); [0219] For spaced samples, the
first drain cycle to start sampling; [0220] The volume to be
discarded before beginning the diversion to the sample container
773; [0221] The days on which to take one or more samples and
according to a predefined cluster of the listed parameters; [0222]
A permitted number of reschedulings of samplings; [0223] A schedule
of samplings by date, day of week, day of month, or number of times
per time interval; [0224] The number of samples per drain cycle;
[0225] The number of samples per treatment; and [0226] The flow
rate of draining.
[0227] The controller 739 may store a specific schedule for the
taking of samples, for example a particular day of the week. The
controller 739 may output a reminder for the benefit of an operator
or patient to let that person know of an imminent scheduled sample
so that the user can prepare. For example, the system may let the
patient know that today is a day to take a sample. The notification
can be attended, or followed, by an input control that accepts
input indicating whether the patient desires to override, comply,
or reschedule. The controller 739 may reschedule automatically in
the event the patient or other user fails to acquire samples or
overrides. The controller 739 may store a guided instruction script
for helping the user to set up and store samples after acquisition.
The guided instruction may be stored on a web server and displayed
on the proportioner/cycler through a browser so that the script can
be updated centrally. The guided instruction may be prompted upon
entry of a user command indicating that the user will perform a
scheduled or unscheduled sampling procedure.
[0228] Referring now to FIG. 26A, an proportioning and treatment
system for peritoneal dialysis 700G has a fluid circuit 705 that is
identical to 701B except for the connection of a medication
container 759 at port 730 or port 729. Connections at both are
shown but it should be understood that it may be that only one may
be connected at a given time and the ports 730 and 729 may
otherwise be used for the purpose described above. Medication
container 759 may contain a medication (e.g., antibiotics), an
anticoagulant, or other substance to be mixed with peritoneal
dialysis fluid. The substance may be mixed with the contents of the
mixing container 732 in an automated way.
[0229] Referring to FIG. 26B, at S900 the substance container 759
is connected to the first manifold 758. Then at S902 the mixing
container 732 is filled by preparing a dialysis fluid. Then at S904
the valve 751 is opened and the pump operated to draw the substance
from substance container 759 into the mixing container 732. Then at
S906, the pump recirculates the contents of the mixing container
732 in a recirculating mixing mode to mix the substance with the
dialysis fluid.
[0230] Referring to FIG. 26C, at S908 the substance container 759
is connected to the second manifold 760. Then at S914 the mixing
container 732 is filled by preparing a dialysis fluid. Then at S916
the valve 751 is opened and the pump operated in reverse to draw
the substance from substance container 759 into the mixing
container 732. Then at S918, the pump recirculates the contents of
the mixing container 732 in a recirculating mixing mode to mix the
substance with the dialysis fluid.
[0231] Referring to FIG. 23, in embodiments, the drain is replaced
by a container connected to a scale 771 that generates a weight
indication that is stored by the controller 739. This total weight
can be combined with a detected measure of the volume captured in
the same container 773 to provide a cumulative total mass of
collected peritoneal dialysis fluid. For example, the total mass
can be taken as an average of the mass calculated from weight and
the mass calculated from volumetric measurement. These data may be
associated by a code with a code read from the sample container 773
such as by means of a bar code, smart chip, RFID tag, or other
means. The data indicative of cumulative total mass estimate may be
uploaded to a web site for a laboratory with data representing the
sample container 773 code. Alternatively, a chip attached to the
sample container 773 may hold the cumulative mass data so that when
shipped to a laboratory, the data can be read by the workers
analyzing the samples. In embodiments, the sample container 773 and
the waste container 768 can be attached to the scale 771 or may be
formed as a single disposable unit with the sample bag portion
being detachable from the waste container 768.
[0232] The fluid circuit 701F connects to proportioning/cycler
machine 772 by a mechanism that aligns clamps 751 with respective
clamping portions of lines 741, 740, 742, 744, 750, 746, 752, and
756. Various such mechanisms are known in the art such as supports
that hold tubing portions at predefined positions in cassettes and
cartridges and compact fluid circuits that can be easily laid over
a set of actuators and sensors. The manifolds and clamps can be
replaced by a variety of different types of flow selector devices
known in the art, so the current proportioning and treatment system
is not limited to using flow selectors based on clamping of tubing.
If the pump 762 is a peristaltic pump, a pumping tube segment of
line 763 may be aligned by the connection of the fluid circuit
701F. The purified water source 766 may be housed in an enclosure
767 together with the drain line circuit 765 or portions of either.
The waste container 768 may be housed in the same enclosure, or
not, as illustrated. The concentrate containers 736 and 738 may
contain sufficient concentrate for multiple fill/drain cycles,
multiple days' worth of treatments, each consisting of multiple
fill/drain cycles, a week's worth of treatments, a month's worth of
treatments, or some other schedule. The concentrate containers 736
and 738 may be independently replaceable by use of the aseptic
connectors. The benefits of independent replacement are discussed
elsewhere in the present disclosure. The contents of the last fill
medicament container 734 may be fully diluted or may consist of, or
include, a concentrate that requires further dilution. The
manifolds 758 and 760 may have a minimum volume to reduce waste
when changing over fluids. In embodiments, the maximum hydraulic
diameters of the manifolds 758 and 760 are each no more than 5
times the diameter of the largest line connecting to them. In
further embodiments, they are no more than 3 times the diameter of
the largest line and in still further embodiments, no more than
twice. In other respects, the embodiment of FIG. 23 is identical to
that of FIG. 18A.
[0233] FIG. 17C shows an proportioning and treatment system for
peritoneal dialysis 700C. Two multi-treatment containers 736 and
738 contain electrolyte concentrates and osmotic agent
concentrates, respectively. They are connected by aseptic
connectors 730 to a fluid circuit 701C by respective osmotic agent
concentrate 744 and electrolyte concentrate 742 lines. Non-aseptic
connectors may also be used. In embodiments, where the connectors
are non-aseptic, the osmotic agent concentrate 744 and electrolyte
concentrate 742 lines contain sterilizing filters. Due to the cost
and number of filters required this is not a preferred way to
ensure sterility. A last fill container 734 may also be connected
to the fluid circuit 701C via last fill line 740. The last fill
container 734 may contain a specific medicament for the last fill
cycle of a multi-cycle treatment. The fluid circuit 701E contains
first 758 and second 760 manifolds connected by a pumping tube 763.
The manifolds 758 and 760 define selectable fluid paths connecting
various sources of fluids to fluid consumers using clamps 751 under
control of a controller 739. The details of the flow switching may
be as discussed above with respect to similar embodiments. A
purified water source 766 supplies purified water to the manifold
758 through redundant sterilizing filters as shown FIG. 17A at 731,
or a testable filter may be used as shown in FIG. 17C. The filter
733 is a single testable filter that is automatically tested by
pumping air by means of an air pump through an air line 737 and
measuring pressure, detecting whether the filter's bubble point has
been exceeded, and if not, confirming the integrity of a filter
membrane of the filter 733. Alternative filter integrity tests may
also be provided such as a pressure decay test. The test of the
filter 733 is used by the controller 739 to confirm that a batch is
sterile as described in method embodiments in the present
disclosure Manifold 760 is connected by a drain line 756 to a
conductivity sensor module 714 through a non-aseptic connector 729.
The conductivity sensor module 714 is a replaceable component
interconnectable between outlet manifold 760 and a waste container
768 (or a waste outlet such as a drain). The conductivity sensor
module 714 has a pair of conductivity sensors 764 in a drain
channel 715. The conductivity sensors 764 provide independent
indications of conductivity that can be compared to indicate a bad
sensor and/or to provide a mechanism for flow sensing based on a
time of flight of a conductivity perturbation in the flow through
the drain channel 715. The conductivity module 714 engages with the
proportioning/cycler machine 772 which houses a valve actuator 721.
The latter is not replaced when the conductivity module 714 is
replaced. The conductivity module 714 can be a low-cost component
by employing plastic conductivity cells, a tube with connectors and
a pinching portion defining a valve 751 by separating the valve
actuator 721 (the one shown that controls flow through the drain
channel 715) from the tube pinching portion and employing
injection-molded rigid plastic for the conductivity cells 764,
tubing to define the drain channel 715, aseptic connectors 729 such
as locking luer-type, and a housing or support indicated at
714.
[0234] A mixing container 732 is connected by inlet and outlet
lines 746 and 750 to the manifolds 758 and 760, respectively, to
allow fluid to be pumped into the mixing container 732, to be drawn
from the mixing container 732, and to permit mixing via
recirculation of the contents of the mixing container 732. A pump
762 pumps fluid between the manifolds 758 and 760. A waste
container 768 may be attachable to the drain line circuit 756 by a
non-aseptic connector 729. A heater 770 contacts the mixing
container 732. In embodiments, the heater 770 forms a bed on which
the mixing container 732 rests.
[0235] A patient line 754 is connected to the fluid circuit in such
a manner as to ensure that fluid sent to the patient through fill
line 755 is sterile filtered by sterilizing filter 719, thereby
providing a sole, or additional, assurance against exposure of the
patient to unsterile fluid including fluids or fluids containing
pyrogens, which, as is known, may be removed by filter membranes
with a suitably small pore diameter, for example, 0.2 micron.
[0236] A patient fill/drain line 754 has an air detector 753. Fluid
is received through a junction from a fill line 755 and drained
through drain line 748, flow being controlled in each of the fill
line 755 and the drain line 748 by respective valves 751. Fluid is
supplied to a batch inlet line 746 and the fill line 755 from
header 760 through a common batch/fill line 716 from a respective
junction 717. The selection of the two branches of the junction,
namely the batch inlet line 746 and the fill line 752 is carried
out by respective valves 751 that control flow through these
branches. A sterile/pyrogen filter 733 filters all fluid flowing to
the patient by filtering all fluid flowing through the fill line
752. This may obviate the need for any other filters on fluid
entering the system such as water inlet 741 using filter 733 on the
patient fill line. A common fill/inlet line 716 feeds the inlet 746
and fill 755 lines. The line 755 which conveys fluid to the patient
718 has a testable sterile filter 719. Flow through lines 746 and
755 is controlled by respective valves 751.
[0237] The controller 739 may invoke a failsafe operation if air is
detected above a predefined threshold in the fill drain/line 754.
Flow in inlet line 746 is controlled with the additional function
that the valve 751 controlling flow in the fill line 755 is closed
when fluid is directed to the mixing container 732.
[0238] The fluid circuit 701C connects to proportioning/cycler
machine 772 by a mechanism that align clamps 751 with respective
clamping portions of lines 741, 740, 742, 744, 750, 746, 752, 755,
and 756. Various such mechanisms are known in the art such as
supports that hold tubing portions at predefined positions in
cassettes and cartridges and compact fluid circuits that can be
easily laid over a set of actuators and sensors. The manifolds and
clamps can be replaced by a variety of different types of flow
selector device known in the art, so the current proportioning and
treatment system is not limited to using flow selectors based on
clamping of tubing. If the pump 762 is a peristaltic pump, a
pumping tube segment of line 763 may be aligned by the connection
of the fluid circuit 701C. The purified water source 766 may be
housed in an enclosure 767 together with the drain line circuit 765
or portions of either. The waste container 768 may be housed in the
same enclosure, or not, as illustrated. The concentrate containers
736 and 738 may contain sufficient concentrate for multiple
fill/drain cycles, multiple days' worth of treatments, each
consisting of multiple fill/drain cycles, a week's worth of
treatments, a month's worth of treatments, or some other schedule.
The concentrate containers 736 and 738 may be independently
replaceable by use of the aseptic connectors. The benefits of
independent replacement are discussed elsewhere in the present
disclosure. The contents of the last fill medicament container 734
may be fully diluted or may consist of, or include, a concentrate
that requires further dilution. The manifolds 758 and 760 may have
a minimum volume to reduce waste when changing over fluids. In
embodiments, the maximum hydraulic diameters of the manifolds 758
and 760 are each no more than 5 times the diameter of the largest
line connecting to them. In further embodiments, they are no more
than 3 times the diameter of the largest line and in still further
embodiments, no more than twice. Pressure sensors 769 are
positioned on either side of the pump 762 to detect pump inlet and
outlet pressures in pump tube 763. Signals corresponding to the
pressures are applied to the controller 739 and used for pump
pressure compensation and/or pump calibration as discussed
elsewhere and in US Patent Publication 2015-0005699, hereby
incorporated by reference in its entirety herein.
[0239] FIG. 17D shows an proportioning and treatment system for
peritoneal dialysis 700D with a fluid circuit 701D. The system 700D
differs from 700C in that a testable sterilizing filter 719 is used
for the fill line 755 to ensure against infusion of pyrogens and/or
pathogens.
[0240] Note that instead of separate inlet 746 and outlet 750 lines
leading into and out of the mixing container 732, the mixing
container 732 may be attached by a single line. In such a case,
mixing of the contents may be accomplished by flowing fluid between
the mixing container 732 and an accumulator connected to one of the
manifolds. A flow switch could be used to interconnect the single
line of the mixing container to a selectable one of the manifolds.
Also, the pump 762 may be run in either direction so that the inlet
and outlet lines 746 and 750 can switch roles under control of the
controller. Thus, the modifiers "inlet" and "outlet" serve to
differentiate the two lines 746 and 750 but are not strictly
limiting in terms of structure or function and it should be evident
that the functionality of batch preparation, mixing, and treatment
can be carried out with the roles of inlet and outlet switched
during certain operations. For other operations, the manifolds may
be modified to permit a different fluid source and destination to
be selected that is not possible with the depicted configuration.
Such variations are contemplated within the scope of the disclosure
unless otherwise expressly limited.
[0241] FIG. 18A shows a fluid circuit 701E having a disposable unit
that is initially provided with empty, low-capacity concentrate
containers 780 and 781 which are filled from multi-treatment
concentrate containers 736 and 738 during a dialysis fluid
preparation cycle. A proportioning and treatment system for
peritoneal dialysis 700E has two multi-treatment concentrate
containers 736 and 738 that contain electrolyte concentrates and
osmotic agent concentrates, respectively. The multi-treatment
concentrate containers 736 and 738 are connected through a fluid
module 723 by means of a single fluid intake line 728 which has a
testable filter 733 that forms part of a disposable with a fluid
circuit 701E. The disposable unit is connected through the fluid
intake line 728 by an aseptic connector 743 (same type as 729) to
the fluid module 723. The fluid module 723 may be a permanent
structure that receives multi-treatment concentrate containers 736
and 738 as a replaceable unit or as separate containers according
to various embodiments. The fluid module 723 may also have a pump
788 and a purified water source 766 as well as a fluid switch
circuit 747 that provides for the selective flow of water and the
different concentrates into the fluid intake line 728.
[0242] The testable filter 733 may be preconnected to the fluid
circuit 701E and sterilized with the remainder of the fluid circuit
701E as a unit which may be sealed in a sterile package and
delivered for use. An air pump 735 and pressure sensor 727 may be
provided as a permanent fixture of the proportioning/cycler machine
772.
[0243] The initially empty low-capacity concentrate containers 780
and 781 are preconnected along with the initially empty mixing
container 732 to the remainder of the fluid circuit 701E. The
low-capacity concentrate containers 780 and 781 may be filled, as
discussed later, with osmotic agent concentrate and electrolyte
concentrate from multi-treatment concentrate containers 736 and
738, respectively. A last fill container 734 may also be connected
by an aseptic connector 730 to the fluid circuit 701E via last fill
line 740. The last fill container 734 may contain a specific
medicament for the last fill cycle of a multi-cycle treatment. The
contents of the last fill medicament container 734 may be fully
diluted or may consist of, or include, a concentrate that requires
further dilution.
[0244] The fluid circuit 701E contains first 758 and second 760
manifolds connected by a pumping tube 763. The manifolds 758 and
760 define selectable fluid paths connecting various sources of
fluids to fluid consumers using clamps 751 under control of a
controller 739. The details of the flow switching may be as
discussed above with respect to similar embodiments. The manifolds
758 and 760 may have a minimum volume to reduce waste when changing
over fluids. In embodiments, the maximum hydraulic diameters of the
manifolds 758 and 760 are each no more than 5 times the diameter of
the largest line connecting to them. In further embodiments, they
are no more than 3 times the diameter of the largest line and in
still further embodiments, no more than twice. Pressure sensors 769
are positioned on either side of the pump 762 to detect pump inlet
and outlet pressures in pump tube 763. Signals corresponding to the
pressures are applied to the controller 739 and used for pump
pressure compensation and/or pump calibration as discussed
elsewhere and in US Patent Publication 2015-0005699, hereby
incorporated by reference in its entirety herein. A waste container
768 may be attachable to the drain line circuit 765 by a
non-aseptic connector 729.
[0245] The filter 733 is a single testable filter that is
automatically tested by pumping air by means of an air pump 735
through an air line 737 and measuring pressure by means of pressure
sensor 727, detecting whether the filter's bubble point has been
exceeded, and if not, confirming the integrity of a filter membrane
of the filter 733. Alternative filter integrity tests may also be
provided such as a pressure decay test. The test of the filter 733
is used by the controller 739 to confirm that a batch is sterile as
described in method embodiments in the present disclosure.
[0246] Manifold 760 is connected by a drain line 756 to a
conductivity sensor module 714 through a non-aseptic connector 729.
The conductivity sensor module 714 is a replaceable component
interconnectable between the outlet manifold 760 and a waste
container 768 (or a waste outlet such as a drain). The conductivity
sensor module 714 has a pair of conductivity sensors 764 in a drain
channel 715. The conductivity sensors 764 provide independent
indications of conductivity that can be compared to indicate a bad
sensor and/or to provide a mechanism for flow sensing based on a
time of flight of a conductivity perturbation in the flow through
the drain channel 715. The conductivity module 714 engages with the
proportioning/cycler machine 772 which houses a valve actuator 721.
The latter is not replaced when the conductivity module 714 is
replaced. The conductivity module 714 can be a low-cost component
by employing plastic conductivity cells, a tube with connectors and
a pinching portion defining a valve 751 by separating the valve
actuator 721 (the one shown that controls flow through the drain
channel 715) from the tube pinching portion and selecting a low
cost arrangement for the conductivity cells 764, the tubing forming
the drain channel 715, the connectors 729, and a housing or support
indicated at 714.
[0247] A mixing container 732 is connected by inlet and outlet
lines 746 and 750 to the manifolds 758 and 760, respectively, to
allow fluid to be pumped into the mixing container 732, to be drawn
from the mixing container 732, and to permit mixing via
recirculation of the contents of the mixing container 732. A pump
762 pumps fluid between the manifolds 758 and 760. A waste
container 768 may be attachable to the drain line circuit 765 by a
non-aseptic connector 729. A heater 770 contacts the mixing
container 732. In embodiments, the heater 770 has a bed on which
the mixing container 732, in the form of a plastic bag, rests. A
patient line 754 is connected by a Y-connector to separate lines
748 and 752 to permit the filling and draining of a patient 718
through the patient line 754, which is connected to a catheter (not
shown) by means of another aseptic connector 730. A sample line 757
is connected to a sample container 773 through a non-aseptic
connector 729, or may be pre-attached. A valve 751 controlling flow
through the sample line 757 is controlled to sample fluid from the
header 760 automatically by the controller 739. In embodiments, a
temperature of draining dialysis fluid is monitored for a condition
indicating an infection or some other condition for which a sample
may be automatically drawn and stored during draining according to
the condition. See US 2015-0005699, incorporated by reference
elsewhere herein and International patent publication WO2018045102,
hereby incorporated by reference in its entirety for details of how
parameter monitoring of the spent dialysis fluid may be used to
detect a condition.
[0248] The fluid circuit 701E connects to proportioning/cycler
machine 772 by a mechanism that align clamps 751 with respective
clamping portions of lines 741, 740, 742, 744, 750, 746, 752, and
756. Various such mechanisms are known in the art such as supports
that hold tubing portions at predefined positions in cassettes and
cartridges and compact fluid circuits that can be easily laid over
a set of actuators and sensors. The manifolds and clamps can be
replaced by a variety of different types of flow selector devices
known in the art, so the current proportioning and treatment system
is not limited to using flow selectors based on clamping of tubing.
If the pump 762 is a peristaltic pump, a pumping tube segment of
line 763 may be aligned by the connection of the fluid circuit
701B.
[0249] The concentrate containers 736 and 738 may contain
sufficient concentrate for multiple fill/drain cycles, multiple
days' worth of treatments, each treatment consisting of multiple
fill/drain cycles. For example, concentrate containers 736 and 738
may contain sufficient concentrate a week's worth of treatments, a
month's worth of treatments, or some other schedule. The
concentrate containers 736 and 738 may be independently replaceable
by use of the aseptic connectors. The benefits of independent
replacement are discussed elsewhere in the present disclosure. The
pump 788 draws and pumps a concentrate selected by valves that
control flow through electrolyte concentrate line 790 and osmotic
agent concentrate line 789, respectively. The output of the pump
788 is pumped through a common concentrate line 791 through the
connector 743 into the fluid intake line 728. When water is
conveyed through the fluid intake line, it is pumped by the pump
762 with corresponding valves opened as in prior embodiments by
closing the valves 751 that control flow through electrolyte
concentrate line 790 and osmotic agent concentrate line 789,
respectively, and by opening the valve 751 that controls the flow
through a water source line 792. A pressure sensor 727 may be
provided in the water source line 792 to control the flow of water
as described with reference to FIGS. 19A through 19M.
[0250] Note that in all the embodiments having a water source such
as 766, the latter may be provided with a pump 794 that pumps water
independently of the pump of a downstream proportioning device
and/or cycler such as pump 762.
[0251] FIGS. 18B through 18D are a single flow chart illustrating a
method embodiment for controlling the embodiment of FIG. 18A. The
chart portion of FIG. 18B is linked at the end to the beginning of
the flow chart of FIG. 18C as indicated by the letter A in a
circle. The chart portion of FIG. 18C is linked at the end to the
beginning of the flow chart of FIG. 18D as indicated by the letter
B in a circle. At S502, the pump 762 is used to pump water from the
fluid source module 723 to the drain to prime the fluid circuit
manifolds 758 and 760 as well as the lines leading from the fluid
source module 723 to the waste container or drain 768. The
controller 739 stores a predefined value to indicate how much water
to pump at this stage. For example, the controller 739 may store a
predefined number of cycles of the pump 762 or a predefined volume.
The controller 739 may be programmed to translate the predefined
volume to a predefined number of cycles to implement a control
procedure to regulate the volume transferred responsively to the
predefined volume. Alternatively, the controller 739 may store a
predetermined speed and interval of operation that corresponds to
the predefined volume. Other alternatives are possible. In the
operation S502, only the valves 751 required to open the specified
path are opened and the others are closed to restrict flow to the
predefined path. This is the case for all the operations described
by the flow chart.
[0252] At S503, an optional operation is performed in which a
sample of each concentrate is pumped to the drain to generate a
pressure drop across the filter 733 and to use the pressure drop to
identify the type of concentrate solution by its viscosity. For
example, the osmotic agent concentrate is more viscous than the
electrolyte concentrate, and therefore the pressure drop for a
given flow rate will be higher. The pressure drop may be indicated
by a single downstream pressure by the pressure sensor 769 since
the upstream pressure may be assumed to be sufficiently identical
between the two test conditions to indicate a difference. Thus, a
lower pressure at sensor 769 would indicate the more viscous fluid.
The controller 739 may store the identity of the type of
concentrate associated with lines 789 and 790 and control the
corresponding valves 751 accordingly. Alternatively, if one type of
concentrate is required to be connected to a respective connector,
then the controller 739 may identify a misconnection and generate
an output from the controller indicating the misconnection so that
corrective action can be taken.
[0253] At S504, the valves 751 are opened to define a path from the
water source 766 to the waste container or drain 768. Water is
pumped by the pump 794 in tandem with the pump 762 to flush the
path with water. Optionally, the conductivity of the fluid passing
by conductivity sensors 764 may be detected to serve as an
indication that sufficient water has been flushed to prime and
clear the flow path. Alternatively, another criterion may be used
to stop the flow of water, such as a predetermined volume of water
being flushed.
[0254] At S505, a quantity of electrolyte concentrate sufficient to
prime the lines from the electrolyte concentrate container 736
through the manifold 758 and at least partly into the outflow line
750 is pumped by pump 788. This process may prime the sterilizing
filter 733. The total quantity may be selected to be sufficient to
ensure that the sterilizing filter 733 is primed and flushed of any
air. This priming step may be performed at a preselected flow rate
determined to be optimal for priming of the filter 733, for example
a flow rate of about 30 ml/min
[0255] At S506, a sufficient quantity of electrolyte concentrate
for a single cycle or for a full treatment (e.g., daily treatment)
including multiple fill cycles is pumped through the path 790, 791,
728, 745, 758, 742 with all valves 751 closed except those defining
this path. This has the effect of priming the electrolyte
concentrate line 742 as well as providing a sufficient amount of
electrolyte concentrate in the osmotic agent container 781 to
generate multiple batches each for respective fill cycles in
sufficient number for a full treatment, for example a single day's
treatment.
[0256] At S510, the pump 788 pumps sufficient osmotic agent
concentrate into mixing container 732 to prime the lines and the
header 760. The lines include batch outlet line 750, fluid line
745, and osmotic agent concentrate line 789, which are opened by
means of respective valves 751. The volume transferred may be
determined to be sufficient to prime the lines and header 760
leading to osmotic agent concentrate line 744.
[0257] At S514, a sufficient quantity of osmotic agent concentrate
for a single cycle or for a full treatment (e.g., daily treatment)
that includes multiple fill cycles, is pumped through the path 790,
791, 728, 745, 758, 744 with all valves 751 closed except those
defining this path. This has the effect of priming the osmotic
agent concentrate line 742 as well as providing a sufficient amount
of osmotic agent concentrate in the osmotic agent container 781 to
generate multiple batches each for a respective fill cycle and in
sufficient number for a full treatment, for example a single day's
treatment.
[0258] At S520, a flow channel is established by closing all valves
751 except ones required to flow from the water source 766 to
outlet line 750. Water is pumped from the water source 766 using
the pump 794 to prime the manifold 758 and the outlet line 750
thereby transferring a small amount of water into the mixing
container 732.
[0259] At S522, a recirculating channel between in the inflow 746
and outflow 750 lines through the pump 762 is established and the
mixing container 732 contents are pumped for a period of time or a
number of pump rotations sufficient to break in the pumping tube
segment of pump tube 763. The contents of the mixing container 732
may be mixed by this process.
[0260] At S528, if a special last fill, different from the
prescriptions generated from the concentrates, is to be used, a
special last fill medicament container 734 will be provided. At
S528, the last fill line 740 may be primed by flowing a portion of
the last fill container 734 contents to a waste container or drain
768 to prime the last fill line 740.
[0261] At S30, the pump 794 pumps a pre-determined volume of water
into the mixing container 732. The pump recirculates fluid from the
mixing container 732 through inflow and outflow lines 746 and 750
for a time sufficient to break in pump tube segment and mix
contents. This is a closed loop path that includes the manifolds
758 and 760, the inflow and outflow lines 746 and 750 and the
mixing container 732.
[0262] At S532, the controller 739 performs an integrity test of
the filter 733 on fluid intake line 728. This is to confirm that
all fluids that have flowed into the fluid circuit are
sterile/pyrogen-free. If the integrity of the filter membrane is
not confirmed, the controller 739 may perform an error recovery
operation by instructing the operator to replace fluid circuit
701E. The controller 739 is programmed at least to generate a
signal indicating a failed test. The controller 739 may prevent
fluid in the mixing container 732 from being used by pumping the
contents to the drain automatically and generating an output on the
user interface indicating a failed filter, along with instructions
for replacing the fluid circuit.
[0263] A S534, the controller 739 opens a circuit through manifolds
758 and 760 from the water source to drain and flows water through
the open circuit to rinse the conductivity sensors 764. The
conductivity may be monitored by the controller 739 to confirm that
a sufficient amount of water has been transferred to rinse the
conductivity cells to a predetermined threshold.
[0264] At S536, the controller 739 opens a circuit including line
742 through manifolds 758 and 760 through to drain and passes a
small bolus (e.g., 6-8 ml) from electrolyte concentrate container
780 into manifold 758. This stores a marker in the line that
ultimately gets pumped to the conductivity sensors 764 and is used
for calibration of the pump 762.
[0265] At S538, a circuit is opened by operating valves 751 that
includes water line 728 manifolds 758 and 760 and runs through to
the drain from the purified water source 766 to flow a small
purified water spacer (e.g. 10 ml.) from the fluid module 723 into
the open circuit such that it flows into it but does not reach the
conductivity sensors nor does it push the bolus formed at S536 to
the conductivity sensors. Rather, the bolus and the spacer are
queued in the fluid path waiting for S540 to perform a calibration
operation by measuring time of flight of the bolus. That is, with a
fixed volume of the channel between the conductivity sensors, the
system can be calibrated to determine the flow rate from the time
delay between the indications of the perturbation crossing the two
conductivity sensors.
[0266] At S540, the controller 739 opens a circuit including
outflow line 750 through manifolds 758 and 760 through to drain and
pumps sufficient fluid from mixing container 732 (about 50 ml) to
push the electrolyte concentrate bolus and the water spacer past
the conductivity sensors 764 to calibrate the pump. This system is
described in the US 2015-0005699 incorporated by reference. The
technique is for the controller to calculate the volume flow rate
of fluid by detecting the cross of a conductivity perturbation
across two spaced apart conductivity sensors. With a fixed volume
of the channel between the conductivity sensors, the system can be
calibrated to determine the flow rate from the time delay between
the indications of the perturbation crossing the two conductivity
sensors.
[0267] At S542, the controller 739 flows sufficient water toward
mixing container 732 (about 22.6 ml. for example) to fill inflow
line 746 with water. To ensure the inflow line 746 is completely
filled, an amount sufficient to transfer some water to the mixing
container 732 is pumped.
[0268] At S544 the controller 739 runs the pump 762 so as to drain
the mixing container 732 until a vacuum is detected on pressure
sensor 769. The controller then calculates a discounted value for
fluid accounting purposes accounting for the total volume of water
MOTI in 746 to account for effect of vacuum drawn on the inflow
line 746
[0269] At S546 the controller 739 pumps water to the drain to prime
the manifolds 758 and 760 with water. All valves 751 are closed
except those that define a path from the water source 766 to the
drain.
[0270] At S548 the controller 739 pumps 100% or less (e.g. 50%) of
a target volume of water into the mixing container 732. This is the
amount of water the controller 739 determines is required for a
ready-to-use PD dialysis fluid according to a current prescription
stored by the controller 739.
[0271] At S550 the controller 739 pumps a predetermined amount of
water from mixing container 732 to waste container or drain 768 to
fill the mixing container 732 outflow line 750 with water to fill
the volumes defined as MIMO, MOTI, and SOMI, that is, the inflow
and outflow lines 746 and 750, the manifolds 758 and 760 and the
pump tube 763.
[0272] At S552 the controller 739 pumps 100% of the electrolyte
concentrate required for the target prescription into the mixing
container 732 (noting that the reverse order of electrolyte and
osmotic agent is also possible, so osmotic agent with electrolyte
sufficient to act as a marker may be added first instead).
[0273] At S554 the controller 739 mixes the mixing container 732
contents by recirculating through the lines 746 and 750 and the
manifolds 758 and 760 using the pump 762.
[0274] At S556 the controller 739 opens a path from the mixing
container 732 to the drain and pumps a quantity of its contents
sufficient to test conductivity to confirm the level of dilution of
electrolyte. Any difference between the actual and expected
conductivity measurements is compared to a threshold and if the
threshold is exceeded, at S558, additional water or electrolyte
concentrate may be added to provide the target ratio.
[0275] At S558 the controller 739 conditionally pumps further water
or electrolyte concentrate responsively to the previous
conductivity test done at S556. This process may be iterative to
provide, effectively, a titration until the required ratio of
electrolyte to water is achieved. In embodiments, the total
measured water volume is used as ground truth by the controller 739
for purposes of adjusting the second concentrate (osmotic agent
concentrate in this example) to be added.
[0276] At S560 the controller 739 pumps osmotic agent concentrate
into the mixing container 732 using ratiometric control of
transferred concentrate (noting the reverse order of concentrates
is also possible).
[0277] At S562, the controller 739 mixes the mixing container 732
contents by recirculating through the lines 746 and 750 and the
manifolds 758 and 760 using the pump 762.
[0278] At S564 the controller 739 tests conductivity of mixing
container contents and passes or fails the batch based on the
result by passing a sample from the mixing container 732 to the
conductivity sensors 764.
[0279] At S566, the controller 739 determines and adds the
complement of water depending on the initial amount provided at
S548. In the example of 50% water, the 50% balance of water is
added. If the quantity of water was adjusted in S558, then the
balance is adjusted based on any additional quantity added to the
contents of the mixing container 732.
[0280] At S568, the mixing container contents are mixed by the
controller 739 by recirculating through the lines 746 and 750 and
the manifolds 758 and 760 using the pump 762.
[0281] At S570, the controller 739 tests conductivity of mixing
container 732 contents and passes or fails the batch based on the
result. At this point, the failure of the batch may not be
compensated by adjusting its constituents. If the contents do not
meet the predefined expected conductivity, the contents of the
mixing container 732 may be blocked from further use and a signal
may be generated to indicate the failure. In embodiments, the
contents of the mixing container 732 may be automatically flushed
to drain in the event of a failure.
[0282] At S572, the controller 739 tests the sterilizing filter(s)
and passes or fails the completed batch based on the result of the
filter test. At this point, the contents of the mixing container
732 may be blocked from further use and a signal may be generated
to indicate the failure. In embodiments, the contents of the mixing
container 732 may be automatically flushed to drain in the event of
a failure.
[0283] FIGS. 18E through 18H show various fluid circuit
configurations for the fluid module 723 of the foregoing
embodiments such as that of FIG. 18A. In the embodiment of FIG.
18E, a fluid module 723A has concentrate containers 736 and 738
which are preconnected to the respective concentrate lines 790 and
789 which are interconnected to a connector 798 for connection to
the water inlet of a fluid circuit such as that of FIG. 18A. In
this embodiment, the concentrate containers 736 and 738 may be
mechanically attached to each other or enclosed in a common housing
indicated at 795A to form a single unit that may be replaced, as a
unit, when one of the concentrate containers, 736 or 738, is
exhausted. FIG. 18F shows an embodiment in which the concentrate
containers 736 and 738 each has its own connector 799 which allows
each of the concentrate containers 736 and 738 to be replaced
independently of the other. The concentrate containers 736 and 738
may be housed, or held, in a permanent fixture 795B. FIG. 18G shows
a fluid module 723C where one of the concentrate containers 738 is
not disconnectable from a fluid line (here, osmotic agent
concentrate line 789) while the other concentrate container 736 is
connected by a removable connector 799. In embodiments, which of
the two concentrates is not disconnectable can be reversed so that
the electrolyte concentrate container 736 is not disconnectable and
the osmotic agent concentrate container 738 is disconnectable. In
this embodiment, only one of the types of concentrate is ever
preconnected to a line, such as line 789. The configuration of the
embodiment of FIG. 18G prevents connection of a respective one of
the lines 789 and 790 to the wrong type of concentrate container.
FIG. 18H shows an embodiment 723D in which separate testable
filters are provided for each of the concentrates 736 and 738. In
this case, the fluid module may have its own air pumps 735 and
pressure sensors 727.
[0284] Note that in any of the embodiments, the air pump's 735
functions may be provided by a single pump with multiple lines
stemming from a common output. Each may be controlled by a
respective valve under control of the controller.
[0285] Note that in any of the embodiments in which a fluid source
module is provided to actively pump fluid to a consuming appliance
such as proportioning and treatment systems for peritoneal dialysis
700A-700E, the fluid module may be controlled by direct electronic
communication such as wired or wireless. Such direct communication
may be used for closed loop control of the fluid module pump by the
proportioning and treatment system for peritoneal dialysis
controller, for example.
[0286] In any of the fluid module embodiments (723, 723A, 723B,
723C, 723D), the pump 794 that pumps water may be of a type that
pushes water through a filtration system and may be of a high
precision non-pulsatile type such as a gear pump or a screw pump.
This pump, indicated in embodiments at 794, may be closed-loop
controlled based on pressure by the pressure sensor 727A. In any of
the fluid module embodiments, the valve of the type 751 indicated
at 749 in FIG. 18A and corresponding locations in other embodiments
is controlled by the controller 739.
[0287] In embodiments in which the water pump 794 is activated and
deactivated in response to pressure (see for example FIG. 9A-19C
and associated discussion) and is also closed-loop controlled to
maintain a predefined pressure range, the control of the water pump
794 may be regulated by a control algorithm such that a pressure
rise above a predefined level or above a predefined rate due to the
halting of the cycler pump may be detected quickly. For example, if
the pressure rises above a predefined level or rises faster than a
predefined rate, the water pump controller may detect that
condition and halt the water pump rather than slewing to a low flow
rate in response to the close-loop control algorithm. The
controller may also terminate closed-loop control of the flow rate
if such a condition is detected.
[0288] The direct control of water and/or other fluid sources by
wired or wireless digital signals may be preferred. FIGS. 19A-19H
and 19J-19M show embodiments for control of a fluid source, here
exemplified by a water source 810, without direct data
communications applying control inputs from a medical treatment
device, here exemplified by a peritoneal dialysis fluid preparation
device 800, which may optionally have a cycler as well. Referring
to FIG. 19A, a peritoneal dialysis fluid preparation device 800 has
a pump 808 and a fluid circuit 802 for mixing fluids and for
performing a peritoneal dialysis treatment. The water source 810
has a pump 806 that conveys water to the peritoneal dialysis fluid
preparation device 800 through a water line 803. A pressure sensor
804 detects pressure in the water line and applies a corresponding
signal to a controller 807 of the water source 810. The controller
807 controls the pump 806. FIG. 19B shows a control loop executed
by a controller 809 of the peritoneal dialysis fluid preparation
device 800. At S400, the controller 809 receives or generates a
command for water. This may be as described in the foregoing
embodiments as incident to a concentrate dilution operation in the
preparation of a dialysis fluid by the peritoneal dialysis fluid
preparation device 800. At S402A the peritoneal dialysis fluid
preparation device 800 begins operating the pump 806 to draw water
through the water line 803. At S412, the peritoneal dialysis fluid
preparation device 800 pump 806 draws a quantity of water until a
command is received or generated at S414 to halt the pumping of
water whereupon at S416A, the pump 806 is deactivated. FIG. 19C
shows a control loop executed by the controller 807. At S404A, the
water source 810 controller detects a pressure below a
predetermined threshold indicated by the pressure sensor 804. A
drop in pressure is caused by the S402A operation which causes a
negative pressure in the water line 803. Note that instead of an
absolute (gauge or absolute pressure in absolute terms) pressure,
the controller 807 at S404A may respond to a predefined rate of
change of pressure or a predefined total pressure change over a
predefined interval of time. The predefined ranges may be stored in
a memory of the controller 807. S404A loops continuously until the
condition is met. At S405A, the controller 807 activates the water
pump 806 causing water to flow into the water line and alleviating
the negative pressure such that water flows freely under control of
the pump 808. At S406A, control loops until the pressure indicated
by the pressure sensor 804 rises above a threshold or increases a
predefined total amount or at a predefined rate whereupon the water
source pump 806 is halted at S409. The rise in pressure is caused
by the operation S414. Thus, the water source 810 is automatically
demand-controlled by the peritoneal dialysis fluid preparation
device 800 controller 809 without a signal connection between the
controllers 809 and the water source 810 controller 807.
[0289] Although the embodiments described with reference to FIGS.
19A through 19M described the peritoneal dialysis fluid preparation
device 800 as controlling the halting of the water source 810 pump
806, it is possible in variations of these embodiments to instead
cause the halting of the water source 810 pump to be controlled by
providing the controller 807 with a predefined volume of water or a
predefined pumping time. Water pump 806 will halt automatically
after being started so that the peritoneal dialysis fluid
preparation device 800 can halt operation of pump 808
independently.
[0290] Thus, in operation, the peritoneal dialysis fluid
preparation device 800 controller 809 start the water source 810
pump 806 as described in the embodiments 19A through 19M, but the
halting of the pump occurs automatically as a result of the
expiration of the predefined volume or running time.
[0291] Note also, that in the embodiment of FIGS. 19G, 19H, and 19J
the controller 809 may transmit, by means of pressure pulse
signals, the duration of pumping by the water pump 806 or the
amount to be pumped, by the peritoneal dialysis fluid preparation
device 800 controller 809 to the water source 810 controller. This
may allow the peritoneal dialysis fluid preparation device 800
controller 809 to establish the volume of fluid or the duration of
pumping.
[0292] In any of the embodiments, the pressure modulator may
generate pulses by modulating the peritoneal dialysis fluid
preparation device 800 pump 808. For example, such pumps may be
driven by motors that allow forward and reverse movement such as by
means of a stepper motor drive. Other means for creating pulses are
also possible such as an independent actuator such as a
solenoid-driven diaphragm pump. Further variations are described
elsewhere in the present application.
[0293] Note also in the embodiment of FIGS. 19A-19C, in alternative
embodiments, the water source 810 may halt the flow of water after
a certain quantity of water has been pumped by pump 806, instead of
receiving a command at S414. In other embodiments, the pump 808 may
generate a pressure spike when it is halted by the controller 809.
This spike may be detected by the pressure sensor 804 and cause the
controller 807 to halt the pump 806.
[0294] Referring now to FIG. 19D, as in the embodiment of FIG. 19A,
the peritoneal dialysis fluid preparation device 800 has a pump 808
and a fluid circuit 802 for mixing fluids and for performing a
peritoneal dialysis treatment. The water source 810 has a pump 806
that conveys water to the peritoneal dialysis fluid preparation
device 800 through a water line 803. The controller 807 controls
the pump 806. A power supply 815 provides power to the pump 808. In
the water source, a voltage detector 816 is connected to the power
supply 815 or power leads leading to the pump 808, to detect power
sent to the pump 808. Thus, the voltage detector 816 applies a
signal to the controller 807 indicating when the pump 808 is
activated. The pressure sensor 804 may be used for flow control of
the pump 806 to ensure the tandem operation of the pumps 808 and
806 are synchronized by flow such that the pump 806 does not unduly
resist the pumping of pump 808. A closed loop control of pump 806,
executed by controller 807, on a pressure set point may accomplish
this. This closed loop control may be provided in embodiments. FIG.
19E shows a control loop executed by a controller 809 of the
peritoneal dialysis fluid preparation device 800. At S400, the
controller 809 receives or generates a command for water. This may
be as described in the foregoing embodiments as incident to a
concentrate dilution operation in the preparation of a dialysis
fluid by the peritoneal dialysis fluid preparation device 800. At
S402A the peritoneal dialysis fluid preparation device 800 begins
operating the pump 806 to draw water through the water line 803. At
S412, the peritoneal dialysis fluid preparation device 800 pump 806
draws a quantity of water until a command is received or generated
at S414 to halt the pumping of water whereupon at S416A, the pump
806 is deactivated. FIG. 19F shows a control loop executed by the
controller 807. At S404B, the water source 810 controller detects a
voltage above a predetermined threshold indicated by the voltage
detector 816. The predefined threshold may be stored in a memory of
the controller 807. S404B loops continuously until the condition is
met. At S405B, the controller 807 activates the water pump 806
causing water to flow into the water line and alleviating the
negative pressure such that water flows freely under control of the
pump 808. At S406B, control loops until the voltage indicated by
the voltage detector 816 falls below a predefined threshold which
may be different from the one at S404B, whereupon the water source
pump 806 is halted at S409. The fall in voltage is caused by the
operation S414. Thus, the water source 810 is automatically
demand-controlled by the peritoneal dialysis fluid preparation
device 800 controller 809 without a signal connection between the
controllers 809 and the water source 810 controller 807.
[0295] Referring now to FIG. 19G, as in the embodiment of FIG. 19A,
the peritoneal dialysis fluid preparation device 800 has a pump 808
and a fluid circuit 802 for mixing fluids and for performing a
peritoneal dialysis treatment. The water source 810 has a pump 806
that conveys water to the peritoneal dialysis fluid preparation
device 800 through a water line 803. The controller 807 controls
the pump 806. A pressure modulator 818 generates pressure pulses in
the water line 803 that are detected by the pressure sensor 804 of
the water source 810 to apply resulting pressure pulse indications
to a decoder 819 which decodes them to generate command signals
that are applied to the controller 807. The controller 809 may
store pressure pulse patterns that are thus decoded by the decoder
819. Using pressure pulses, various commands can be encoded and
decoded to provide commands to the water source 810 from the
peritoneal dialysis fluid preparation device. Such commands may
include to start and stop the pump 806, or to command a speed of
the pump 806, for example. The pressure sensor 804 may be used for
flow control of the pump 806 to ensure the tandem operation of the
pumps 808 and 806 are synchronized by flow such that the pump 806
does not unduly resist the pumping of pump 808. A closed loop
control of pump 806, executed by controller 807, on a pressure set
point may accomplish this. The pressure pulse signal generated by
the pressure modulator may prescribe a pressure setpoint for such
closed loop control. The closed loop control may be provided in
embodiments. FIG. 19H shows a control loop executed by a controller
809 of the peritoneal dialysis fluid preparation device 800. At
S400, the controller 809 receives or generates a command for water.
This may be as described in the foregoing embodiments as incident
to a concentrate dilution operation in the preparation of a
dialysis fluid by the peritoneal dialysis fluid preparation device
800. At S402B the peritoneal dialysis fluid preparation device 800
begins operating the pump 806 to draw water through the water line
803 and simultaneously, shortly or immediately before or shortly or
immediately afterwards, generates a pulse command to turn on the
water pump 806. At this time, further commands such as a pressure
setpoint or a speed of the pump 806 may be generated using pressure
pulses through the pressure modulator 818. At S412, the peritoneal
dialysis fluid preparation device 800 pump 806 draws a quantity of
water until a command is received or generated at S414 to halt the
pumping of water whereupon at S416B, the pump 806 is deactivated
and simultaneously, shortly or immediately before or shortly or
immediately afterwards, generates a pulse command to turn off the
water pump 806. FIG. 19J shows a control loop executed by the
controller 807. At S404C, the water source 810 controller 807
detects a command from the decoder 819 to start the pump and
establish operating conditions if operating conditions are included
in the pulse train received by the decoder 819. S404C loops
continuously until the condition is met. At S405C, the controller
807 activates the water pump 806 causing water to flow into the
water line and alleviating the negative pressure such that water
flows freely under control of the pump 808. The controller 807 may
also set operating conditions as indicated by the received command.
At S406C, control loops until a further pressure pulse signal
command is received by the decoder 819 to halt the pump 806.
Thereupon, the water source pump 806 is halted at S409. Thus, the
water source 810 is automatically demand-controlled by the
peritoneal dialysis fluid preparation device 800 controller 809
without a wired or radio-based signal connection between the
controllers 809 and the water source 810 controller 807.
[0296] Referring now to FIG. 19K, as in the embodiment of FIG. 19A,
the peritoneal dialysis fluid preparation device 800 has a pump 808
and a fluid circuit 802 for mixing fluids and for performing a
peritoneal dialysis treatment. The water source 810 has a pump 806
that conveys water to the peritoneal dialysis fluid preparation
device 800 through a water line 803. The controller 807 controls
the pump 806. A valve actuator 822 opens and closes a valve 821
that provides for flow into the fluid circuit 802 from the water
line 803. Details of such operation and embodiments are disclosed
elsewhere herein. A voltage sensor 816 detects the activation of
the valve actuator 822 and applies a corresponding signal to the
controller 807. Both opening and closing indications may be applied
and interpreted by the controller 807 using known principles and
according to various valve types so details are not discussed. The
pressure sensor 804 may be used for flow control of the pump 806 to
ensure the tandem operation of the pumps 808 and 806 are
synchronized by flow such that the pump 806 does not unduly resist
the pumping of pump 808. A closed loop control of pump 806,
executed by controller 807, on a pressure set point may accomplish
this. This closed loop control may be provided in embodiments. FIG.
19L shows a control loop executed by a controller 809 of the
peritoneal dialysis fluid preparation device 800. At S400, the
controller 809 receives or generates a command for water. This may
be as described in the foregoing embodiments as incident to a
concentrate dilution operation in the preparation of a dialysis
fluid by the peritoneal dialysis fluid preparation device 800. At
S402C the peritoneal dialysis fluid preparation device 800
activates the valve actuator 822 to open the valve controlling the
fluid circuit 802 access to the water line 803 and then begins
operating the pump 806 to draw water through the water line 803. At
S412, the peritoneal dialysis fluid preparation device 800 pump 806
draws a quantity of water until a command is received or generated
at S414 to halt the pumping of water whereupon at S416C, the pump
806 is deactivated and the valve actuator 822 is activated to close
(or deactivated, depending on the type of valve, for example a
solenoid would be powered-down) the water inlet valve 821. FIG. 19M
shows a control loop executed by the controller 807. At S404D, the
water source 810 controller detects a voltage above a predetermined
threshold indicated by the voltage detector 816. This is one
example of the direct detection of the opening of a valve. In a
linear motor actuated pinch valve, a forward applied voltage may be
detected that runs the linear motor in a forward direction to close
the valve 821 and a reverse applied voltage may be detected that
runs the linear motor in the reverse direction to open the valve
821. For a solenoid valve, a predefined threshold voltage may be
stored in a memory of the controller 807 to indicate the valve open
position of the actuator 822. For other types of actuator, a
suitable mechanism for direct detection of the valve status (e.g.,
an encoder or other mechanism) may be employed. S404D loops
continuously until the condition is met. At S405D, the controller
807 activates the water pump 806 causing water to flow into the
water line such that water flows freely under control of the pump
808. At S406D, control loops until the valve actuator 822 close
condition is detected. Thereupon, the water source pump 806 is
halted at S409. The close condition is caused by the operation in
S416C. Thus, the water source 810 is automatically
demand-controlled by the peritoneal dialysis fluid preparation
device 800 controller 809 without a signal connection between the
controllers 809 and the water source 810 controller 807.
[0297] In any of the foregoing embodiments in which pressure,
voltage, or other indications are used to control the flow of a
fluid, such as water, the upstream source such as fluid source may
be placed in a demand mode to enable control by pressure, voltage,
or other indications. This may be done by a unique user command
through a connected user interface. Alternatively, the controller
(e.g. 807, 739) may generate a command using a unique pattern of
pressure or final control to a valve or pump power supply to
indicate the demand mode. When not in the demand mode, the fluid
source ability to respond to the commands for fluids is
disabled.
[0298] Referring now to FIGS. 20A through 20E, any of the foregoing
embodiments may be modified to employ any one of a variety of
locations for a filter that removes pyrogens and infectious agents
such as bacteria. Any of the filters 824 may be, or include, a
single filter, for example with a membrane having pores of 0.2
micron or smaller diameter. Any of the filters 824 may be, or
include, a single filter of the same type with additional apparatus
and/or controls suitable for testing. For example, a pressurized
line may permit the application of pressurized air below the bubble
point of the membrane to one side of the filter to measure the
membrane's ability to withstand the pressure and thereby indicate
its integrity. This type of filter integrity test is known in the
art and details are known to those skilled in the art. In other
embodiments, the filters 824 may be redundant to reduce the
probability of a failure to the joint probability of a failure in
both filters. In each of the FIGS. 20A through 20E, a patient 842
is filled and drained through a patient fill/drain line 841 via a
fluid circuit 856 which may be configured in accord with any of the
embodiments disclosed herein or in the embodiments disclosed in the
references referenced in the incorporation-by-reference statements.
A mixing chamber 855 is connected to the fluid circuit 856 where
the fluid circuit 856 prepares a batch using inflow 857 and outflow
858 lines with flow direction designated by arrows. As in the
foregoing and later embodiments, a water source 850, a first
long-term concentrate container 852, and a second long-term
concentrate container 863 are connected to the fluid circuit
856.
[0299] In the embodiment of FIG. 20A, each of the inlet lines for
water 826, the first concentrate 852, and the second concentrate
853 have a filter 824 to prevent contaminants from entering the
fluid circuit 856 and thereby prevent contaminants from entering
the patient 842. The guarantee against contamination provided by
the filters 824 is optimized if all other components are
permanently (or previously, as-delivered and sterilized) connected
within and to the fluid circuit 856 such that only connections to
the water 850, the first concentrate 852, and the second
concentrate 853 need to be made upstream of the filters 824. Thus,
the filters themselves are attached to the lines 826, 827, and 828.
Note that connectors are not separately shown, but may be provided
for connecting between each of the respective water 850, the first
concentrate 852, and the second concentrate 853 and the lines 826,
827, and 828 on the fluid-source side of the respective filter
824.
[0300] In the embodiment of FIG. 20B, a drain line 861 drains fluid
from the fill/drain line 841 and a fill line 862 fills the
fill/drain line. The fill line 862 has a filter 824. In this
embodiment, no other filters are used. The fill/drain line 841 is
permanently or previously attached to the fill line 862 prior to
sterilization such that when the fill/drain line 862 is connected
to the fluid circuit 856 (note that it could be previously attached
and sterilized as a unit with all or parts of the fluid circuit
856), any contamination, including touch contamination, is blocked
from reaching the patient 842 by the filter 824. Other elements are
as described above.
[0301] In the embodiment of FIG. 20C, a filter 824 is placed on the
mixing container 855 inflow line 857. The mixing container 855 is
presumed to be attached to the fluid circuit before sterilization
so that a sealed unit is formed and any touch contamination is
prevented from entering the mixing container 855. A filter may also
be provided on the fill line 862 as in the embodiment of FIG. 20B.
Alternatively, instead of a filter on the fill line 862, the fluid
circuit 856 may be designed such that a dedicated channel is
defined between the mixing container 855 and the fill line 862 so
that unsterile fluids, or fluids not protected by sterile
filtration, do not contact any part of the circuit connecting the
mixing container outflow line 858 and the fill line 862. As in
other embodiments, the filter 824 is connected to the downstream
portion and preattached to ensure sterility of the contents of the
mixing container 855.
[0302] In the embodiment of FIG. 20D, the water line 826 and a
common concentrate line 845 are protected by respective filters
824. The downstream side of the water line 826 and the filter 824
may be preattached to the fluid circuit 856, mixing container 855,
and the patient lines including fill, drain, and fill/drain 861,
862, and 841. The downstream side of the common concentrate line
845 and the filter 824 may be preattached to the fluid circuit 856,
mixing container 855, and the patient lines including fill, drain,
and fill/drain 861, 862, and 841. The preattachment specifies that
all these elements are sealed with each other before sterilization
(or during) to ensure the delivered disposable set is sterile and
protected from contamination ingress by the presence of the filters
824. In this case components upstream of the filters 824 can be
replaced without risk of contamination.
[0303] In the embodiment of FIG. 20E, which corresponds to the
embodiment of FIG. 18A, the filter 824 is placed in the common
fluid line 827 and preattached to the remainder of the fluid
handling components which are also interattached. That is the
filter 824, the portion of the common fluid line 827 downstream of
the filter 824, the fluid circuit 856, mixing container, and the
patient lines including fill, drain, and fill/drain 861, 862, and
841 are all interconnected to form a sealed unit prior to
sterilization. This ensures the delivered disposable set is sterile
and protected from contamination ingress by the presence of the
filter 824. In this case components upstream of the filter 824 can
be replaced without risk of contamination of the downstream
circuit.
[0304] FIG. 20F shows a generalized embodiment similar to that of
FIG. 18A in which a conductivity sensor 859 is provided on the
mixing container 855 outflow line 858. The configuration allows the
method embodiments herein to be modified to minimize the total
amount of fluid that must be drawn from the mixing container 855
toward the drain to measure conductivity of the mixing container
855 contents. The present embodiment may be modified to provide two
conductivity sensors connected in series to be used for volume flow
rate measurement as described herein. Note that in any of the
embodiments, identified conductivity cells may be of the direct
contact or capacitive type of conductivity cell.
[0305] FIG. 20G shows an embodiment similar to that of FIGS. 20E
and 20F in terms of the filter placement at a common fluid inlet
827. The filter 825, in the present embodiment, permits a membrane
integrity test which may be performed by pressurizing with air from
an air pump 835. The pump 832 has inlet and outlet pressure sensors
831 and 830 that are used by the controller 847 for pressure
compensation of a commanded rate of pump 832 as described with
reference to various embodiments including the incorporated
reference US Patent Publication 2015-0005699 also attached to the
provisional application. The pump 832 flows fluid between manifolds
833 which may as described in the various embodiments described
herein. In the present embodiment, the controller 847 is configured
to open any valves necessary to open a fluid channel from the
filter 825 to the pressure sensor 831 and to apply air pressure
from pump 835 while monitoring the pressure signal from pressure
sensor 831 for any change. A filter membrane with no compromise to
its integrity will hold the pressure from the air pump 835, which
may be controlled to be maintained below the bubble point of the
membrane. The controller 847 may generate a signal based on whether
a pressure change is indicated by the pressure sensor 831 or not.
By opening a channel to a pressure sensor that provides another
function, the need for an additional pressure sensor may be
avoided.
[0306] FIGS. 21A through 21C show, respectively, correction
procedures for recovering from incorrect conductivity measurements
in the preparation of a batch of dialysate by proportioning two
concentrates and water. FIG. 21A shows the flow from, after
initially adding up to 100% of the required amount of water to the
mixing container (Refer to FIG. 18A, for example, noting that the
method of FIGS. 21A through 21C can be used with other
embodiments). Initially, before S602, a fraction (less than 100% of
target quantity) of water is added to the mixing container, then at
S602, a first concentrate is added, mixed, and a conductivity
detected and determined to be within the expected range (C1 ok).
Note that S648 (FIG. 21B) corresponds to the condition where
conductivity after mixing the initial amount of water and the first
concentrate is out of the expected range such that the added
quantity of the first concentrate indicated to be too high and S688
(FIG. 21C) where the conductivity is out of range indicating the
added quantity of the first concentrate was too low. In all three
cases, water was added to the mixing chamber, the contents mixed,
and the conductivity tested.
[0307] At S606, 100% of the second concentrate C2 is added to the
mixing container. At S608 the mixing chamber contents, with the
added second concentrate C2, is tested and conductivity found to be
within the expected range. S628 corresponds to the condition where
conductivity is out of the expected range and the added quantity of
the second concentrate indicated to be too high and S634
corresponds to where the conductivity is out of range indicating
that the added quantity of the second concentrate was too low. At
S610, both the first and second concentrates were added in the
correct amounts and the balance, if any, of the water is added to
the mixing container and the mixing container conductivity tested
to confirm its usability. At S612, the conductivity is in the
expected range indicating proper dilution. If 100% of the water was
previously added prior to S602, then the test can be omitted. S616
and S622 correspond to over-diluted and under-diluted conditions,
respectively. If the batch is the correct dilution, then at S614 it
is made available for use. At S616, if the batch is over diluted,
there are two possible responses. The first response is that the
batch can be indicated as failed and an output corresponding to
recover operation can be output. Alternatively, additional
concentrates in the same proportion as the target, can be added
sequentially to the mixing container as indicated at S618, after
which, at S620, the batch is tested again for conductivity and if
it fails, the batch is failed or if the conductivity is in range,
the batch is made available for use.
[0308] Returning to S628, the condition where conductivity is out
of the expected range and the added quantity of the second
concentrate indicated to be too high, at S630 an additional
quantity (bolus) of each of the first concentrate and water are
calculated in the target proportions to bring the proportions of
these and bring the mixing container contents to the expected range
of conductivity. Then, at S632, the balance, if any, of the water
is added to the mixing container plus the water bolus plus the
first concentrate bolus (calculated at S630) and the batch's
conductivity tested S634 to confirm its usability. If the
conductivity is in range, the batch is made available for use
otherwise the batch is failed.
[0309] Returning to S634, the condition where conductivity is out
of the expected range with the added quantity of the second
concentrate indicated to be too low, at S636 an additional quantity
(bolus) of the second concentrate is calculated to achieve the
target proportion to bring the mixing container contents to the
expected range of conductivity. The conductivity is tested again.
If the conductivity is not in the expected range, then at S638, the
batch is failed, otherwise S642, the balance, if any, of the water
is added to the mixing container at S644 and the contents
conductivity tested S646 to confirm its usability. If the
conductivity is in range, the batch is made available for use
otherwise the batch is failed.
[0310] Returning to S648 and FIG. 21B, which corresponds to the
condition where conductivity after mixing the initial amount of
water and the first concentrate is out of the expected range such
that the added quantity of the first concentrate is indicated to be
too high, correction begins at S650. At S650, boluses of the second
concentrate and water are calculated to bring the proportions to
the target and at S652, the total quantity of the first concentrate
plus this bolus are added to the mixing container. The mixing
container contents are then tested at S654 and if in range, meaning
the second concentrate is in the correct proportion to the first,
S656, the balance of the water plus the water bolus are added and
the batch tested at S658. Note that the expected conductivity at
S656 corresponds to a higher concentration of the second
concentrate than if the first concentrate had been added in the
correct amount because the water bolus is not yet added at this
point. The reason for delaying the water addition is that optimally
additions to the mixing container contents are scheduled to
coincide with the point at which the fluid circuit is primed with
the fluid corresponding to the one to be added to minimize the time
spent priming between switchovers. If the batch conductivity is in
the expected range S660, then the batch is released for use. If the
batch is over-diluted S664, boluses of the first and second
concentrate in the required proportion may be added and the batch
further tested at S666 where, if it the conductivity is again out
of range, the batch will be failed. In an alternative embodiment,
at S664, the batch is simply failed without taking any step to
correct. If the batch is under diluted S668, a bolus of water may
be added and the batch further tested at S670 where, if it the
conductivity is again out of range, the batch will be failed. In an
alternative embodiment, at S668, the batch is simply failed without
taking any step to correct.
[0311] If the quantity of second concentrate added was indicated by
the conductivity measurement S654 to be too great at S672, then at
S674, the batch is failed. In alternative embodiments, a correction
may be performed by adding proportionate boluses of water and the
first concentrate. In the present embodiment, errors in the first
and second concentrate additions both occurred indicating the
potential for a system problem, so the system may fail the batch
and provide instructions for testing the system or replacing the
fluid circuit, which may be the source of the problem. The
controller may perform this as part of a batch fail recovery
process. If the quantity of second concentrate added was indicated
by the conductivity measurement S654 to be too low at S676, then at
S678, the batch proportions may be recovered by adding a bolus of
the second concentrate at S678 and testing again. If the
conductivity of the mixing container is again out of range, the
batch is failed at S682; otherwise, at 686, the balance, if any, of
the water is added to the mixing container and the contents
conductivity tested to confirm its usability and made available for
use, unless the batch failed based on the outcome of the
conductivity test.
[0312] Returning to S688 and FIG. 21C, where the first concentrate
added was found to be too low, at S690, since the system is already
primed with the first concentrate, an additional amount can be
calculated from the conductivity and added. No additional bolus of
water is required. The mixing container contents are sampled at
S690 and if the conductivity is out of range at S692, then the
batch is failed. If the conductivity is in the range S696, the
second concentrate target amount is added S698 and tested S700. If
the mixing container contents conductivity shows that the correct
amount of the second concentrate was added S702, then the balance,
if any, of the water S704 is added to the mixing container and the
batch contents' conductivity is tested to confirm its usability,
and is made available for use if within range S706. If the mixing
container contents conductivity is not in range, and the batch is
found to be too dilute S710, then boluses of the first and second
concentrates are calculated and added S712 and the batch is tested
and used or failed based on the result. If the batch is found at
S704 to be overly concentrated, then the conductivity measurement
is used to calculate a water bolus S724, which is added, and the
contents are tested and used or failed depending on the result.
[0313] If at S700, the second concentrate amount added to the
mixing container was found to be too high S726, then the batch is
failed at S728. Again, this would be caused by two concentrate
measurement failures. If at S700, the second concentrate amount
added to the mixing container was found to be too low S730, then
additional second concentrate is added at S734, the batch is
tested, and if the conductivity is out of range, the batch is
failed S736. If at S732, the conductivity is in range, then the
balance, if any, of the water S740 is added to the mixing container
and the contents conductivity is tested to confirm its usability
and is made available for use if within range.
[0314] In alternative embodiments, instead of the procedure being
based on the premise that the volume of concentrate is incorrect,
the error may be presumed to be the concentration (or "strength")
of the concentrate. The embodiment of FIG. 25 describes an example
of a procedure based on this presumption.
[0315] FIGS. 22A and 22B show a water filtration system 551 with
cleaning and priming modes controlled by a water system controller
550 which is commanded by a proportioner/cycler controller 576
according to embodiments of the disclosed subject matter. A source
of raw water 556, such as a source of potable water, is pumped by a
pump 552 through a primary filter 554 which is not cleaned or
regenerated, and then through a selected one of a pair of filters
558 and 560 which can be cleaned or regenerated. At any given time,
the water system controller 550 controls the pump, a four-way
reversing valve 570, and flow restrictors 571, 572, and 573 to
direct a forward flow of the output of primary filter 554 through
one of the filters 558 and 560, and directs a reverse output flow
through the other of the filters 558 and 560 to the drain 562,
depending on its setting. Output of one the filters 558 and 560 is
divided at a respective one of the junctions at flow restrictors
571 and 572 depending on settings of variable flow restrictors 571,
572, and 573 such that a fraction (from 0 to 100%) is directed
through the branch 574 and a remainder toward the outlet 578 so
that one filter can produce product water to clean the other and
for release through outlet 578 while the other is being cleaned
with product water. The settings of the flow restrictors 571, 572,
and 573 make it possible to clean one filter with all the product
water or for both filters to produce product water until a cleaning
is required. In FIG. 22A, the arrows show the flow for forward flow
through filter 558 and reverse flow of filtered product water from
valve 566 and 568 flowing through the filter 560. In FIG. 22B, the
arrows show the flow for forward flow through filter 560 and
reverse flow of filtered product water from valve 566 and 568
flowing through the filter 558. The flow restrictors 571, 572, and
573 may be controlled by the water system controller 550 which in
turn may be commanded by the proportioner/cycler controller 576 of
the proportioner/cycler 576 which may be configured according to
any of the embodiments disclosed or referenced herein or
others.
[0316] In addition to the cleaning mode, the water filtration
system 551 may also have a flushing mode in which water that has
remained for too long in the system is diverted by a diverting
valve 555 to the drain 562. This operation may be performed on a
periodic basis or in response to a condition (such as a time since
last use) under control of the water system controller 550 of the
cycler controller 576. In addition to cleaning and flushing modes,
the water filtration system 551 may also have priming mode wherein
raw water is pumped through both filters 558 and 560 in a forward
direction with flow restrictor 573 set to fully open and flow
restrictors 571 and 572 alternating between fully open and
partially restricting so that the branch line 574 is primed. In
this mode, all flow may be directed through the drain line 557 by a
diverting valve 555. An air or other type of detector may be
provided in the drain line 557 to indicate when the water passing
through has been sufficiently cleared by priming. The filters 558
and 560 may also be reverse flushed to drain during the priming
sequence.
[0317] The filtration system 551 may also have a primary filter
stage 554 with, for example, an ultraviolet lamp 559 that is
controlled by the water system controller 550. The water system
controller 550 may optimize lamp life by regulating the lamp's 559
output so that it is cycled on when required (e.g., when water is
flowing) and turned off when water is not flowing. The controller
550 or 576 may be configured to turn the ultraviolet lamp 559 on
just prior to the water pump activation to ensure that its output
is applied to all water flowing through the stage.
[0318] The filtration system 551 may have an off mode, a sleep
mode, and an operating mode. In the off mode, the water system
controller 550 and controlled flow restrictors 571, 572, and 573,
the pump 552, the valves 555 and 570 may all be powered down. From
the sleep mode, these may be powered up with the water system
controller 550 in a mode in which it can immediately accept
commands and act accordingly. The sleep mode may also include
regulating the pressure and primed state of the water lines such
that there is minimal delay from the receipt of the command to pump
and deliver product water and the actual output. The water source
controller 550 may transmit to the proportioner/cycler controller
576 a signal indicating a ready status. The water source controller
550 may transmit a signal, either unprompted or in response to a
request from the proportioner/cycler controller 576 indicating its
operating state. For unprompted signaling, the water source
controller 550 may transmit a heartbeat signal that contains the
state of the water filtration system 551. This heartbeat signal may
be periodically cast to the proportioner/cycler controller 576
where communication is unidirectional from the water source
controller 550 to the proportioner/cycler controller 576. Such
cases may be relevant for configurations in which the water source
controller responds to direct measurements such as pressure signals
as described in connection with FIGS. 19A through 19M embodiments.
A state signal can indicate various state information such when the
water filtration system 551 is performing a flushing or priming
operation or in another non-ready state, the water source
controller 550 may transmit a state signal indicating so.
Additional state information may include time left on the filters,
expiration of filters, diagnostic information such as time taken
for priming and flushing operations, smoothness of pressure
regulation, power consumption, duty cycle of the system over a
predefined period, and other information.
[0319] The water source controller 550 may regulate the pump and
flow restrictors 571, 572, and 573 to maintain a target pressure at
the product water outlet 578. This may be based on a closed loop
control method with a target pressure which may include and range
(deadband). At 569 a pressure sensor is indicated in the product
water outlet line 578.
[0320] The water source controller 550 and proportioner/cycler
controller 576 may communicate by any suitable device or system.
That communication may unidirectional or bidirectional as indicated
above. Either or both of the water source controller 550 and
proportioner/cycler controller 576 may be of the various forms
described with reference to FIG. 14.
[0321] The water source controller 550 may activate an alarm 575 in
response to any conditions indicating a need for intervention or
change of configuration. For example, the water source controller
550 may activate an alarm output 575 such as a general purpose user
interface (See for example, display 1018 and speaker 1024) or
special purpose output such as a lamp or annunciator. The water
source controller 550 may also, concurrently, output any alarms to
its communications link to the proportioner/cycler controller 576.
The latter may command the water source controller 550 to suppress
alarm outputs, delay alarm outputs by a predefined interval, or to
perform other actions associated with alarms such as the
suppression of the local output from the alarm output 575. In
addition to outputting alarms to the proportioner/cycler controller
576, the water source controller 550 may also transmit instructions
for use or instructions for alarm condition recovery to the
proportioner/cycler controller 576 for output and use by a user
interface of the proportioner/cycler controller 576. The user
interface of the proportioner/cycler controller 576 may transmit
commands back to water source controller 550 as well by generating
an alarm handler input/output session on the proportioner/cycler
controller 576. One mechanism for doing this is for the water
source controller 550 to generate a remote session on the user
interface of the proportioner/cycler controller 576 whereby the
water source controller 550 has an ability to control the output
and respond to inputs such as mouse and keyboard input, directly,
by replicating an adapted model of the user interface it generates
internally on the user interface of the proportioner/cycler
controller 576 functioning as a thin client, effectively. The user
interfaces of the water source controller 550 and
proportioner/cycler controller 576 are not shown but may be
understood to have one or more of the aspects described with
reference to FIG. 14. The water source controller 550 may also
generate a troubleshooting session on the proportioner/cycler
controller 576 in the same manner or by simply outputting
informational data and instructions in the form of a decision tree
for output and control by the water source controller 550.
[0322] In alternative embodiments, the water source controller 550
outputs a uniform resource locator (URL) with metadata indicating
the condition to which it pertains, for example, a set of
conditions may indicate an urgency or priority of the information
contained in the URL. The metadata may be sent in preceding message
or may be combined with the URL. The proportioner/cycler controller
576 may have a priority table stored within that indicates how the
proportioner/cycler controller 576 handles the URL (or other alarm
data) to allow the proportioner/cycler controller 576 to determine
whether the URL should be accessed and displayed immediately, right
after a current input/output session, or output only after a
certain condition is detected by the proportioner/cycler controller
576. In embodiments, the instructions for troubleshooting the water
filtration system 551 are stored in the proportioner/cycler
controller 576 and their output is initiated by the receipt of
alarm data from the water source controller 550.
[0323] In addition to the above functions, the proportioner/cycler
controller 576 may indirectly control the water source controller
550 to control a product water heater 553 according to certain
commands from the proportioner/cycler controller 576. For example,
the proportioner/cycler 577 may be provided with a fluid heater
579. Such a fluid heater, as known in various prior art embodiments
of peritoneal dialysis cyclers, may be provided to raise the
peritoneal dialysis fluid to body temperature. Such heaters as 579
may be instantaneous or batch heaters. The heater 579 may heat
incoming water, mixtures of concentrate and water such as
ready-to-use medicament, or precursor fluids such as partially
diluted concentrate, or combinations of these. The power
requirement of a cycler-based heater must be sufficient to raise
the temperature from room temperature to body temperature because
typically ready-to-use bagged dialysis fluid is used for treatment.
However, in the system of FIG. 22A/22B, the water temperature may
be lower than that, for example it may be at ground temperature or
even near freezing as may come from a domestic tap. In order to
reduce the peak power requirement of the proportioner/cycler 577
heater, at least part of the heating burden may be shared by the
product water heater 553. Note that product water heater 553 may be
located at other positions in the flow of water such as the raw
water inlet or elsewhere. The product water heater 553 may be
commanded indirectly by the proportioner/cycler controller 576 to
provide a predefined power output or delivery temperature. In the
case of the latter, the product water heater 553 may be closed-loop
controlled by the water source controller 550 or another controller
on a detected output temperature by a temperature sensor 580.
[0324] The proportioner/cycler controller 576 may also receive
status information from water source controller 550. Such
information may include indications that the water filtration
system 551 is in flushing, priming, or cleaning mode. Other
information may include water temperature, estimate of time till
ready, estimated time left till filter replacement (estimated time
to exhaustion), time on the UV lamp 559, time till next flush or
cleaning cycle, and whether the water filtration system 551 is in
sleep mode and how long the before it is available to produce
water. This information, because it may indicate reasons for delay,
may be useful to provide in real time to a connected patient
through the user interface of the proportioner/cycler controller
576. Additional information output to the proportioner/cycler
controller 576 user interface may also include forecasting of
maintenance tasks such as filter replacement and ultraviolet bulb
559 replacement. One or more resistivity sensors may be provided in
the product water outlet line 578, which may be connected to the
water source controller 550 with the resistivity transmitted as
status information to the proportioner/cycler controller 576 and
relevant synthesis of this information output on a user interface.
For example, such a synthesis may be the display of an alert when
the resistivity is out of bounds. The raw water resistivity may be
similarly monitored. Since the lifespan of the filters may be
affected by the raw water quality, this information may be provided
to the proportioner/cycler controller 576 and relevant outputs
generated in response to it. For example, the proportioner/cycler
controller 576 may alert the user to a low water quality level in
the supply which may be mitigated by changes in infrastructure and
at least warn the user that filter replacement may need to be
frequent.
[0325] Some of the functions of the water filtration system 551 can
be scheduled with some flexibility without seriously impairing its
ability provide purified water or causing premature exhaustion or
failure of components such as filters. For example, functions whose
timing may interfere with a patient's lifestyle may be moved up or
delayed in order to permit the patient to be treated on a schedule
that better fits the patient's life schedule. The user interface of
the water source controller 550 or the proportioner/cycler
controller 576 may provide a control to allow the user to enter
scheduled events such as treatment time, treatment duration (e.g.,
wakeup time), and time ready for treatment (which requires the line
to be primed and connected to the patient). In embodiments,
relevant data such as the patient's treatment schedule may be
entered in the controller, e.g., the proportioner/cycler controller
576. In further embodiments, the patient's treatment schedule may
be stored over time and used to estimate future treatment schedules
including connect time, bedtime, treatment start time, wake time,
treatment end time and any other events associated with treatment
and maintenance normally indicated by the respective controllers
(550, 576). The respective controllers 550 (or indirectly as
commanded through proportioner/cycler controller 576) may be
controlled to run flushing and cleaning modes at times that lie
between certain interfering events such as treatment or to prime
the water system a certain interval ahead of a predicted connection
of the patient to the proportioner/cycler 577. Note that in
embodiments, the water filtration system 551 may have a reservoir
to receive product water for use on-demand by the
proportioner/cycler 577. The heater 553 may, in such embodiments,
be a batch heater that applies heat to the reservoir. In such
embodiments, the water source controller 550 or proportioner/cycler
controller 576 may schedule production and storage of purified
water in the reservoir and heating thereof according to an
estimated time of use for treatment. Such a reservoir may be a
disposable component, for example a plastic bag. The reservoir may
be sized to receive water for a single cycle, part of a cycle, or
multiple cycles of a full treatment. A reservoir may be provided
with a sterilizing filter on its inlet (for touch contamination),
its outlet (to block back-growth contamination), or both. Check
valves may be provided on inlets or outlets or both to prevent
backflow. A predefined pressure at the outlet of the reservoir may
be maintained at a constant level by means of a recirculation loop
with a check valve having the predefined cracking pressure.
[0326] The water filtration system 551 illustrated shows a very
basic example. Many purifiers that create water suitable for
peritoneal dialysis involve many stages, each with filters having
different lifetimes which may be affected by the quality of the raw
water. In embodiments, the controllers 550, 576 indicate estimated
exhaustion events for filters such as reverse osmosis membranes,
carbon filters, ultrafilters, deionization resin beds, sediment
filters, or other consumable types of filters. The indications may
be based on time, raw water quality, number of cleaning cycles,
etc. Either controller 550 or 576 may be programmed to order
replacements for such consumable components and/or consumable
supplies used for treatment automatically. For example, commands
for ordering supplies may be sent to a server by means of the
network 1012 (which may include the Internet). Failed components
that are not consumables may also be reported and replacement parts
ordered automatically along with repair orders in the same way.
[0327] FIG. 22C shows the water source and associated systems
similar to the embodiment of water filtration system 551 described
with reference to FIGS. 21A and 21B. A reservoir 581 is fluidly
connected to receive product water filtered through a sterilizing
filter 582 and a check valve 583. The water is supplied to the
proportioner/cycler 577 through an outlet 578 under a predefined
pressure maintained by a loop 5851 containing a pump 585 and a
check valve 584 with cracking pressure set at the predefined
pressure. Pressure 569 and temperature 580 sensors may be located
at various positions, including one located to monitor the
predefined pressure. An error in the detected versus expected
predefined pressure may be output as an alarm condition. Other
filters 582 and check valves 583 may be provided to prevent
grow-back contamination and to prevent back flow, respectively.
[0328] Note that where both controllers are referenced together as
controllers 550, 576 it is intended to refer to either water source
controller 550 or the proportioner/cycler controller 576 acting as
a command controller and the other acting as a slave depending on
whether the function is performed directly or indirectly by the
controller and on whether the function is performed by the
proportioner/cycler 577 or the water filtration system 551.
[0329] Note that in all the embodiments herein where a cycler is
described, a proportioner/cycler may be substituted, i.e., a device
that performs as a peritoneal cycler as well as a fluid
proportioning device (aka a proportioning device). Note that in all
the embodiments herein where a proportioner/cycler is described or
identified, a cycler or proportioning device (also called
proportioner) may be substituted. Note that in all the embodiments
herein where a proportioner or proportioning device or system is
described or identified, a cycler or a proportioner/cycler may be
substituted.
[0330] Note that the present application has generally avoided the
terms such as "admixing" to make the present application clearer.
The term "admixing" is suggestive of an intermediate mixture of
fluids rather than a final mixture such as ready-to-use peritoneal
dialysis fluid.
[0331] For example, in the present application, applicants have
used the term proportioning instead admixing because admixing
implies the making of an intermediate product. The term
proportioning implies a more general process such as the making of
an intermediate product (an admixture) or a final product such as a
ready-to-use peritoneal dialysis fluid. Thus, the term
proportioning suggests something more general and is adopted in the
present application where in the priority application, the term
admixing was also used in this broader sense. Thus usages of terms
such as "admix," "admixing," and "admixer" in the priority
applications refer to corresponding terms such as "proportion,"
"proportioning," and "proportioner" in the present application. The
differences in the terms does not modify the subject matter
relative to the priority applications. The priority applications
simply used "admix," "admixing," and "admixer" and related terms in
a broader sense.
[0332] According to the above embodiments, especially those
discussed with reference to FIGS. 19A-19M and 22A-22C, there are
provided the following features and embodiments of a system that
includes a water source system with a controller in combination
with a proportioner/cycler or cycler, also with its own
controller.
[0333] The water system pumps water in response to a demand signal
communicated via a fluid connection between the water system and
the proportioner/cycler. The demand signal may be a detection by
the water system controller of a change in pressure generated by
the proportioner/cycler. The pressure change may be generated by
the cycler pump operation, where the cycler pump is one that is
used for fill and drain of a patient peritoneal cavity, or a pump
(if different) used for proportioning, or some other pump
controlled by a proportioner/cycler controller. The pressure may be
a draw-down of pressure caused by forward operation of the
proportioner/cycler pump. The water source may have a pump which
may start when a pressure sensor in a connection to the
proportioner/cycler water system passes a particular (negative)
threshold. The water source may have a pressure sensor that detects
and conveys signals by way of pressure pulses to the water source
controller which decodes them into specific predefined commands One
command may be for the water source to start pumping product water
into the connection to the proportioner/cycler. Another command may
communicate a value and command to which a closed-loop control
pressure target of the water source outlet should be reset. Other
aspects of the water source may be commanded, such as a time for
the water system to flush, clean, or prime, a future time of
treatment, and other parameters identified above. As for
closed-loop control of a water source pump, the speed of a water
pump that pushes water through one or more filters may be adjusted
automatically in response to an outlet (outlet being the interface
to the proportioner/cycler) or other intermediate pressure of the
water system. The pressure pulses may be generated by a selected
one (or more if present) cycler/admixer pump(s) that is/are
positioned to influence the pressure at the outlet of the water
source. For example, pulses may be generated by modulating driving
power of a pump actuator in a stepwise fashion.
[0334] In other embodiments, the water source receives commands
from the proportioner/cycler. In embodiments, such commands are
transmitted and/or exchanged between the water source and the
proportioner/cycler by any suitable means for exchanging digital
data including wired and wireless. In embodiments, the
proportioner/cycler may control the timing, duration, and type of
all water source functions including priming and flushing
operations. In embodiments, the water source controller indicates
to the proportioner/cycler controller its status including an
indication that it is ready to output product water. In
embodiments, the proportioner/cycler controller starts and stops
water production. In embodiments, the proportioner/cycler transmits
commands to start and stop an ultraviolet (germicidal) lamp in the
water source. In embodiments, the commands may be adapted for
extending the life of such an ultraviolet lamp by ensuring it is
operated and ready only when required for treatment of water. The
proportioner/cycler may use two-way communication with the water
source to place it in a sleep mode at end of a treatment such that
some or all power functions are switched off to save power and
reduce wear. The proportioner/cycler may send commands to wake up
the water source so that it is ready at a time of a predefined
treatment stored in the proportioner/cycler. Commands from the
proportioner/cycler may also be used to regulate the pressure and
flow rate at which product water is delivered. As indicated above,
closed loop control based on a pressure signal may be provided by
the water source controller. The two-way communication may support
the transmission of alarms generated by the water source and the
proportioner/cycler may respond by ceasing dialysate preparation in
response to predefined alarms. Alarm or status outputs of the water
source may be used to generate specific outputs through the
proportioner/cycler user interface which may have audio and visual
output capability. The proportioner/cycler user interface may
output guided troubleshooting steps in response to and related to
the water source outputs and alarms, and these may be output to a
patient or operator. The output may be attended by the presentation
of input controls to receive relevant feedback to create a guided
session. Feedback may include answers to questions about the system
such as the observations about the status of the parameters being
checked, such as closure of fluid connections, proper electrical
connections, proper mating of tubing with actuators, and
instructions to skip to certain steps.
[0335] The proportioner/cycler may control the water source heater
and receive indications of power output, temperature, and ready
status. The total heat required by the product dialysate may be
shared by the water source and the proportioner/cycler so that the
power required of either is split between the water source and the
proportioner/cycler. This may be relevant where the
proportioner/cycler heater power is sized to raise the temperature
of premixed dialysate from room temperature to body temperature so
that the additional power required to raise the temperature of
water from a tap temperature (which may be very low in some cases,
such as in northern climates where water mains can have
temperatures near freezing) to room temperature may be borne by the
water source heater. The water source consumable component status
(predicted or indicated by sensors) including carbon filters,
deionization resins, ultrafilters and others may be indicated by
the water source to the proportioner/cycler and output by the
latter's user interface to inform a user or patient of the need for
maintenance and resupply. The controller of the water source or
proportioner/cycler may be programmed to auto-order replacements
through the Internet. The timing of such auto-order replacements
may be done to effect the required change-out before exhaustion.
The estimated time for a needed replacement may be responsive to
the disposable consumption rate, therapy frequency, raw water
quality, and order processing/delivery lead times.
[0336] The priming of the proportioner/cycler may include priming
and flushing with water from the water source. The
proportioner/cycler controller may transmit commands to the water
source controller to output water at pressures and flow rates
required for the proportioner/cycler to perform these functions.
The priming may be preceded by a flushing operation with purified
water to reduce the potential presence of endotoxins in the
disposable fluid circuit.
[0337] The water source may include a reservoir sized to provide
water sufficient for a fill/drain cycle or for a full treatment
(multiple fill/drain cycles). The reservoir may have one or more
sterilizing-grade filters on its inlet (and/or outlet) lines to
prevent touch contamination or back-growth contamination. The
reservoir may include one or more check valves on its outlet lines
to prevent backflow. The disposable reservoir outlet may include a
recirculation loop with a pump that maintains a target head
pressure useful to maintain consistent dosing.
[0338] Referring now to FIG. 24, the proportioner/cycler 800 with
the pump 808 and fluid circuit 802 is provided for mixing fluids
and for performing a peritoneal dialysis treatment. The
proportioner/cycler 800 has a controller 809 for controlling
operations involving the fluid circuit directed at generating
dialysate and performing an automated treatment. The fluid source
810 pump 806 conveys fluid to the peritoneal dialysis fluid
preparation device 800 through a fluid line 803. A pressure sensor
804 detects pressure in the fluid line and applies a corresponding
signal to a controller 807 of the fluid source 810. The controller
807 controls a fluid multiplexer 814 that direct a selected one of
water, a first concentrate 811 and a second concentrate 812. The
multiplexer 814 may have a pump 813. The controller 807 also
controls the pump 806 or pumps 806, 813. It will be observed that
this is a generalization of embodiments described elsewhere herein.
Each of the controllers 807 and 809 has a respective communications
modem 668 to permit each to communicate wirelessly with a mobile
terminal 669 using a wireless protocol such as near field
communication (NFC). In other embodiments, the mobile terminal is
substituted with another type of data-bearing device such as a bar
code, a QR code, a radio frequency identification device (RFID), or
a battery powered transponder. Note that in embodiments, only one
modem is used to transfer information to one of the controllers
807, 809 which transfers information to the other of the
controllers 807, 809 by other means. The mobile terminal 669 may be
a general or special purpose device such as an embedded system
device, a tablet or a smart phone. The mobile terminal 669 may have
an internal modem to permit it to communicate with the controllers
807 and 809.
[0339] In embodiments, the mobile terminal 669 stores prescriptions
for a treatment that can be uploaded wirelessly to the controller
807 and 809. The prescriptions may contain parameters including
proportions and dilutions of concentrate, tolerance of the
proportions, and other information. The prescription may be encoded
with information specifying the identity of a particular patient. A
user of the mobile terminal 669 may be a patient, a caregiver, or a
doctor. The mobile terminal may have a biometric authentication
component such as an iris scanner, a fingerprint scanner, a face
recognition algorithm, or other. A user may authenticate himself to
enable the capability for a prescription transfer to a modem
668.
[0340] A token 659 may incorporate a NFC, Bluetooth, or other type
of communications device to identify and track a person. For
example, such a device may be worn by a patient. The controller(s)
807, 809 may confirm the identity of the patient before
implementing an uploaded prescription. Such tokens may take the
form of tags or labels. The token 659 may identify consumable
materials used for treatment such as concentrates and fluid
circuits.
[0341] As mentioned above, methods above may be based on the
premise that the volume of concentrate is incorrect if a
conductivity measurement indicates the target is not matched. This
may instead be changed to a presumption that the error arises in
the concentration (or strength) of the concentrates. Here the
presumption is based on the observation that a long storage
interval may cause evaporative loss from a typical bag-type
container. This causes the concentration of the concentrate to be
excessive. If the storage interval is much too high, the
concentration may be non-uniform or the conductivity measurement
may indicate excessive time in storage in which case the batch may
be failed. The embodiment of FIG. 25 describes an example of a
procedure based on this presumption.
[0342] Referring now to FIG. 25, at S802, after a command is
received or generated by a controller, a fraction (alternatively,
all) of a target quantity of purified water is added to a mixing
container. The apparatus may be as described according to any of
the embodiments disclosed or claimed herein. At S803, a quantity of
osmotic agent and partial electrolyte concentrate may be added. In
alternative embodiments, the electrolyte concentrate may be added
first and later the osmotic agent with or without electrolyte may
be added. As discussed above, since osmotic agent can have a
conductivity signal-suppressing effect, the osmotic agent
conductivity change can be used as an indicator of concentration.
At S806, the conductivity of the mixing container contents is
tested.
[0343] It is determined at S808 whether the concentration of the
mixing container contents is lower than an expected target (X) or
higher than X by a predefined amount, in which case the mixing
container contents may be failed and not used at S810. Although not
presently shown, it should be understood that an error output to a
user interface may be generated by the controller which may include
instructions for checking for certain faults in the system and
instructions for recovery. A measured conductivity that is too high
may also be identified and failed. If the concentration of the
mixing container surpasses such a threshold it may indicate that
the contents of the mixing container are insufficiently mixed.
Thus, in alternative embodiments a modification may be included to
retry mixing a predefined number of times. The batch may also be
subjected to remix trials if the mixing container contents have a
conductivity that is too low. This is not illustrated but may be
added readily as a short additional flow. If the mixing retry
attempts fail, the additional flow may terminate (after the
predefined number of retries) and proceed to S810. If the mixing
container contents conductivity is above X (in embodiments, within
a predefined conductivity range), then at S812 the water deficiency
may be calculated from the magnitude of the overage and used as a
basis for estimating the water loss for the first concentrate (in
this example, osmotic agent, but as indicated above, it could be
electrolyte concentrate instead), as well as the second
concentrate. The amount of the second concentrate (C2 in the
figure) is also adjusted by this measure since to maintain the
correct ratio of the two solutes, the amount of the second
concentrate needs to be adjusted as well. This is discussed above.
This overage estimate may thus be used to calculate the amount of
additional water required to add in a final completion step in
order to bring the conductivity to the desired level for a final
treatment fluid. That is, the same estimate for water deficiency
may be used to calculate a water deficiency for both concentrates
(or the total number of separate concentrates according to the
embodiment).
[0344] At S814, the proper quantity of the second concentrate, in
the present example, the electrolyte concentrate, is added to the
mixing container. As indicated, the quantity of the second
concentrate is adjusted to account for the first concentrate
overage as calculated in S812. At S816, water sufficient to make up
for any deficiency calculated in S812 is added to the mixing
container. Then at S818, the conductivity of the mixing container
contents is tested, and at S820 the flow branches responsively to
the result. The batch is failed if the target conductivity (Y) is
too low or, optionally higher than a predefined level beyond the
target Y. If the target Y is found, the batch is ready to use. If
the conductivity is too high, at S824, additional water may be
calculated and added. Then the conductivity may tested again and if
it fails(< >Y) S828, the batch may be failed. S824-S828 may
be omitted in embodiments.
[0345] Any of the methods for treatment fluid preparation described
herein may be modified based in part on an analysis of the
tolerance stacking. Such a stacking may take into account different
kinds of variability, some of which are not straightforward to
derive from the process itself. For example, the process analyzed
may be defined between the manufacture of the input constituents,
water and concentrates, and the provision of a final treatment
fluid. However, the analyzed process here is defined to include
detectable and correctable errors during the process that
provisions the final treatment fluid and errors that result in
alarms during treatment. The final impact of errors on the
patient's safety along with any correction techniques may also be
included in the analysis.
[0346] Tolerances may also include ranges resulting from
variability in the manufacture of concentrate, which cannot be
influenced, tolerances in testing of intermediate and final
conductivities, measurement error, and the required tolerance range
of the final product and any other sources of variability. The
analysis can benefit from creative input and ultimately may result
in an alteration of the methods. So, an effort was made to analyze
the above methods based on tolerances throughout.
[0347] Note that in the above processes, adjustments to the C2 as a
result of water loss may not be necessary. That is because the
upward adjustment due to the higher concentration of C1 may be
canceled by the downward adjustment due to predicted higher
concentration of C2. So, the adjustments may be removed from the
procedure of FIG. 25 in embodiments. However, in other embodiments,
the cancelation may be incomplete if differences in the propensity
for water loss of the two concentrates or their packaging are
different.
[0348] Note that in embodiments, average preparation time for
batches may be minimized by optimizing the initial quantity of
water added to the mixing container at S802. In embodiments,
adjustments may be found to be rare occurrences such that close to
100% of the water may be added initially with the expectation that
few adjustments and retries will be required. In practice, time
saved by adding 100% of the water at S802 may totally compensate
for any occasional failed batches that cannot be adjusted to the
expected concentration.
[0349] In any of the embodiments, where the description refers to
the conductivity being equal to the target, it should be understood
that "equal to" refers to a predefined range around the target. In
embodiments, the range may be +/-5%, for example.
[0350] In any of the embodiments in which conductivity is measured,
it should be understood that the conductivity may be numerically
compensated for temperature deviation from a standard conductivity.
In any embodiments in which the conductivity of the mixing
container is tested, a mixing operation may be inserted. In
addition, any mixing operation may include multiple mixing,
testing, and remixing trials until a predefined number of retries
is reached.
[0351] In any of the embodiments, any of the pumps may be, or
include, any of a variety of types including peristaltic pumps,
diaphragm pumps, screw pumps, gear pumps, centrifugal pumps,
turbine pumps, syringe pumps, or piston pumps. The foregoing is a
list of examples and is not intended to limit the scope of the
present disclosure or the claims below.
[0352] In any of the embodiments, the containers of concentrate may
be replaced with online sources of concentrate such as
proportioning systems in a large-scale installation that mixes
component ingredients to form concentrates and provides them from a
fixed connector. In any of the embodiments, other sources of fluids
may be connected to the fluid flow director embodiments described
herein. Examples include cleaning fluids, reference testing fluids
for calibrating the conductivity sensor or sensors, sample fluids,
and fluids for testing membranes such as air. In any of the
embodiments, such other fluids may flow through various parts of
the fluid circuit including the drain as described with reference
to other fluids.
[0353] As the term is used herein, "flow director" is a fluid
circuit and associated actuators effective for selectively creating
flow paths and moving fluids through the flow paths in order to
connect fluid channels or vessels including those connected to
sources and consumers, repositories, or other receiving elements. A
"fluid circuit" is may be any line or branching element and may
contain vessels, chambers, sensor portions, actuator portions, or
any other type of fluid confining and controlling element.
[0354] Any embodiment which recites or shows tubes as portions of a
fluid circuit, fluid channel, or other equivalent may have instead
other types of fluid channel elements such as channels defined in a
casting with a bonded film layer to close the channels, panels with
welded patterns to form fluid channels, non-round ducts, or other
types of elements. The disclosed tubes may be replaced with such
alternative elements to form additional embodiments.
[0355] Any embodiment which identifies peritoneal dialysis fluid
may be modified to form additional embodiments by replacing the
components identified with that particular fluid with corresponding
fluids to form other medicaments.
[0356] Any component or element identified herein as "disposable"
may be sterile. Sterility may be readily provided and assured at a
time of use, by providing components as disposable elements as is
known in the relevant field of medical devices.
[0357] As used herein, "pre-connected" may refer to the integral
combination of elements or to their connection in such a manner as
to form a sterile boundary or permit the provision of a sterile
boundary around their interior. For example, if a connection of
connectors of two elements is made (i.e., they are pre-connected or
pre-connected) and the connected elements are sterilized as a unit
thereafter, the pre-connected or pre-connected elements may protect
against the touch contamination that would be required if the
corresponding connection were made in the field, for example. When
elements are integral they may provide the same benefit.
[0358] As the terms are used herein, electrolyte concentrate may
include various ionic species as well as non-ionic species as
required. As used herein, osmotic agent concentrate may include any
osmotic agent such as glucose or dextrose and may include other
species including ionic species that may be characterized by the
term "electrolytes."
[0359] Any of the embodiments expressly limited to "peritoneal
dialysis fluid" may be modified to form additional embodiments by
substitution of the term "dialysate" and making appropriate
substitutions for the constituents. Any embodiments limited to
multiple concentrates, including two, may be changed to employ a
single concentrate that is diluted to form a ready-to-use
medicament.
[0360] Any of the valves or pumps recited herein may be substituted
for any of a variety of types of flow directing and fluid conveying
devices. For example, a variety of pump and valve types are known
and may be substituted for those described herein. Variations based
on substitutions of these elements may be made to form additional
embodiments.
[0361] As the term is used herein, "in-line" means that an element
is in a flow path. For example, a flow channel with an in-line
sterilizing filter is such that fluid flowing in the flow channel
is filtered by the in-line filter.
[0362] A port is any transition for a fluid conveyance such as a
channel, tube, integral connection, or connector. Any recitation of
"port" may be replaced with the term "connector" to form variations
of the disclosed embodiments.
[0363] As used herein, a window is any opening in a curved or flat
element. A drain is any outlet to an external element and may
include a storage vessel.
[0364] Any sterilizing filter may be embodied as a channel blocked
by a microporous membrane. Such a microporous membrane may have
pores whose maximum size is no greater than a minimum pathogen
size. Known threshold pore sizes are, for example, 0.2 microns.
[0365] Any embodiment element identified with the term "daily" may
be changed by substitution of other time intervals to form
additional embodiments.
[0366] Integral or integrally attached refers to elements that are
formed of a single piece or bonded together so as to create a
single unit. Elements identified as integral may be changed to
identify them as "connected" or "attached" to define additional
embodiments.
[0367] As used herein, a "source" is any container or plant capable
of supplying a recited fluid. A sink is any destination for a fluid
such as a container, a consuming device, or a drain.
[0368] As user herein, a "line" is tube or other type of fluid
channel. In any of the embodiments, lines may be tubes such as
polymer tubing commonly used for medical disposable devices.
[0369] A "recess" is any concavity. A recess has two ends, an
"access" which is the open end, and a "blind end," which is the
closed end.
[0370] Any detente mechanism identified herein may be substituted
with any type of frictional or interference-based mechanism for
locking or restraining one element relative to another to form
additional embodiments.
[0371] In any of the embodiments, including in the claims, where
the integrity of a sterilizing filter is tested, the filter
membrane may be subjected to a pressure-decay test or a
bubble-point test. Other types of tests such as diffusion test and
other known techniques may be used.
[0372] Any of the embodiments of a dialysis device may have a
digital controller that directs the sequence of operation to
perform a treatment on a patient may have a wireless interface that
communicates with a transmitter such as a radio frequency
identification (RFID) tag, Bluetooth, or a NFC device. Such a
device may communicate with a wireless-capable appliance such as a
cellular phone, tablet, or other computer. Using the transmitter,
the dialysis device may transfer a digital record of therapy data,
such as a treatment log, from the transmitter. If the transmitter
includes a receiver or if a separate receiver is provided, then the
dialysis device may be enabled to receive a prescription for a
therapy. For example, a NFC tag or mobile phone may be used to
upload data such as a prescription from a mobile or a passive NFC
tag to the dialysis device. The upload of a data to the dialysis
device may be accomplished using a passive tag such as an RFID or a
passive NFC device.
[0373] Other information that may be uploaded to the dialysis
device includes patient-identifying information as well as patient
classifying information. The dialysis device may upload information
about the dialysis system for diagnostic purposes using any of the
wireless protocols. The dialysis device may transfer data by
wireless protocols such as 802.11 a/b/g/ac/n and Bluetooth. The
dialysis device may download system logging or diagnostic data from
the dialysis device to the cellular phone, tablet, or other
computer using any of the wireless protocols. The dialysis device
may download treatment summary data to the cellular phone, tablet,
or other computer using any of the wireless protocols.
[0374] According to first embodiments, the disclosed subject matter
includes a method for making a batch of peritoneal dialysis
solution sufficient for at least a single patient fill operation,
the batch being a final mixture of constituents, the constituents
including a final quantity of water, a final quantity of osmotic
agent concentrate, and a final quantity of electrolyte concentrate.
The method includes using a fluid proportioning device with a
controller, actuators, and a conductivity sensor and attaching a
fluid circuit to the actuators, the fluid circuit having a mixing
container. The method includes using the controller to control the
actuators: pumping a fraction of the final quantity of water into
the mixing container; pumping more than the final quantity, plus or
minus an error, of electrolyte concentrate into the mixing
container; mixing contents of the mixing container; sampling the
contents of the mixing container in a manner that reduces volume of
fluid in the mixing container and measuring the conductivity
thereof; calculating and storing data responsive to a deviation of
the measured conductivity from a predefined expected conductivity
resulting from the error; calculating an adjusted quantity of water
and/or osmotic agent concentrate required to achieve predefined
proportions of the constituent final quantities responsive to the
data; and pumping the adjusted quantity of water or osmotic agent
concentrate into the mixing container.
[0375] In variations thereof, the first embodiments include ones in
which the method is performed at a location of a peritoneal
dialysis treatment. In variations thereof, the first embodiments
include ones in which the method is performed at a time of a
peritoneal dialysis treatment. In variations thereof, the first
embodiments include ones in which the method is performed such that
it is completed within a day, within 12 hours, within 6 hours,
within 3 hours, or within an hour of a start of a peritoneal
dialysis treatment. In variations thereof, the first embodiments
include ones in which the fluid proportioning device is located in
a same room, within 100 meters, within 10 meters, within 5 meters,
or within 2 meters as a patient receiving a peritoneal dialysis
treatment.
[0376] In variations thereof, the first embodiments include ones in
which the electrolyte concentrate is pumped into the mixing
concentrate after the fraction of the final quantity of water; the
mixing takes place after the pumping of the more than the final
quantity of electrolyte concentrate; the sampling takes place after
the mixing; the calculating and storing data take place after the
sampling; the calculating the adjusted quantity takes place after
the calculating and storing the data; and the pumping the adjusted
quantity takes place after the calculating the adjusted
quantity.
[0377] In variations thereof, the first embodiments include ones in
which the using a fluid proportioning device includes providing a
peritoneal dialysis cycler. In variations thereof, the first
embodiments include ones that include, after pumping the adjusted
quantity of water and/or osmotic agent concentrate, sampling the
contents of the mixing container and measuring a final conductivity
thereof. In variations thereof, the first embodiments include ones
that include comparing a final conductivity to a predefined final
conductivity and permitting use of the batch or preventing use of
the batch responsively to a result thereof. In variations thereof,
the first embodiments include ones in which the fraction of the
final quantity of water pumped into the mixing container is less
than 60%. In variations thereof, the first embodiments include ones
in which the controller samples the mixing container contents by
pumping a sample from the mixing container across a conductivity
sensor in a drain line. In variations thereof, the first
embodiments include ones in which the fraction of the final
quantity of water pumped into the mixing container is less than
90%. In variations thereof, the first embodiments include ones in
which the pumping more than the final quantity, plus or minus an
error, of electrolyte concentrate occurs before the pumping the
adjusted quantity of water or osmotic agent concentrate into the
mixing container.
[0378] According to second embodiments, the disclosed subject
matter includes a method for making a batch of peritoneal dialysis
solution sufficient for a patient fill operation, the batch being a
mixture of constituents in target proportions, the constituents
including water, osmotic agent concentrate, and electrolyte
concentrate. The method includes using a fluid proportioning device
with a controller, actuators, and a conductivity sensor. The method
includes attaching a fluid circuit to the actuators, the fluid
circuit having a mixing container. The method includes using the
controller to control the actuators: pumping water into the mixing
container; pumping electrolyte concentrate into the mixing
container in an amount intended to create a predefined ratio of the
electrolyte concentrate and the water; mixing contents of the
mixing container; sampling the contents of the mixing container and
measuring a conductivity thereof; calculating and storing data
responsive to a deviation of a measured conductivity of the mixing
container contents from one corresponding to the predefined ratio;
calculating an adjusted quantity of water or osmotic agent
concentrate responsively to the data; and pumping the adjusted
quantity of water or osmotic agent concentrate into the mixing
container.
[0379] In variations thereof, the second embodiments include ones
in which the method is performed at a time of a peritoneal dialysis
treatment. In variations thereof, the second embodiments include
ones in which the using a fluid proportioning device includes
providing a peritoneal dialysis cycler. In variations thereof, the
second embodiments include ones that include, after pumping the
adjusted quantity of water or osmotic agent concentrate, sampling
the contents of the mixing container and measuring a final
conductivity thereof. In variations thereof, the second embodiments
include ones that include, comparing the measured final
conductivity to a predefined final conductivity and permitting use
of the contents of the mixing container or preventing use of the
contents of the mixing responsively to a result thereof. In
variations thereof, the second embodiments include ones that
include adding further water to the mixing container to create
ready-to-use dialysate therein, wherein the adding water into the
mixing container transfers less than 60% of the quantity of water
in the ready-to-use dialysate in the mixing container. In
variations thereof, the second embodiments include ones in which
the controller samples the mixing container contents by pumping a
sample from the mixing container across a conductivity sensor in a
drain.
[0380] According to third embodiments, the disclosed subject matter
includes method for making a batch of peritoneal dialysis solution
sufficient for least a single patient fill operation, the batch
being a final mixture of constituents, the constituents including a
final quantity of water, a final quantity of osmotic agent
concentrate, and a final quantity electrolyte concentrate, wherein
the osmotic agent concentrate includes a predefined proportion of
electrolyte. The method includes providing a fluid proportioning
device with a controller, actuators, and a conductivity sensor. The
method includes attaching a fluid circuit to the actuators, the
fluid circuit having a mixing container. The method includes using
the controller to control the actuators: pumping a fraction of the
final quantity of water into the mixing container; pumping more
than the final quantity, plus or minus an error, of osmotic agent
concentrate into the mixing container; mixing contents of the
mixing container; sampling the contents of the mixing container in
a manner that reduces volume of fluid in the mixing container and
measuring the conductivity thereof; calculating and storing data
responsive to a deviation of the measured conductivity from a
predefined expected conductivity resulting from the error;
calculating an adjusted quantity of water and/or electrolyte
concentrate required to achieve predefined proportions of the
constituent final quantities; and pumping the adjusted quantity of
water and/or electrolyte concentrate into the mixing container.
[0381] In variations thereof, the third embodiments include ones in
which the method is performed at a location of a peritoneal
dialysis treatment. In variations thereof, the third embodiments
include ones in which the method is performed at a time of a
peritoneal dialysis treatment. In variations thereof, the third
embodiments include ones in which the method is performed such that
it is completed within a day, within 12 hours, within 6 hours,
within 3 hours, or within an hour of a start of a peritoneal
dialysis treatment. In variations thereof, the third embodiments
include ones in which the fluid proportioning device is located in
a same room, within 100 meters, within 10 meters, within 5 meters,
or within 2 meters as a patient receiving a peritoneal dialysis
treatment. In variations thereof, the third embodiments include
ones that include providing a peritoneal dialysis cycler. In
variations thereof, the third embodiments include ones that
include, after pumping the adjusted quantity of water and/or
electrolyte concentrate, sampling the contents of the mixing
container and measuring a final conductivity thereof. In variations
thereof, the third embodiments include ones that include comparing
the final conductivity to a predefined final conductivity and
permitting use of the batch or preventing use of the batch
responsively to a result thereof. In variations thereof, the third
embodiments include ones in which the fraction of the final
quantity of water pumped into the mixing container is less than
60%. In variations thereof, the third embodiments include ones in
which the controller samples the mixing container contents by
pumping a sample from the mixing container across a conductivity
sensor in a drain line. In variations thereof, the third
embodiments include ones in which the fraction of the final
quantity of water pumped into the mixing container is less than
90%. In variations thereof, the third embodiments include ones in
which the pumping more than the final quantity, plus or minus an
error, of osmotic agent concentrate occurs before occurs before the
pumping the adjusted quantity of water and/or electrolyte
concentrate into the mixing container.
[0382] According to fourth embodiments, the disclosed subject
matter includes method for making a batch of peritoneal dialysis
solution sufficient for at least a single patient fill operation,
the batch being a final mixture of constituents, the constituents
including a final quantity of water, a final quantity of osmotic
agent concentrate, and final quantity of electrolyte concentrate,
the method, using a controller of a peritoneal dialysis treatment
delivery system. The method includes
[0383] (a) adding a fraction of the final quantity of water and a
first concentrate, the first concentrate being one of osmotic agent
concentrate or electrolyte concentrate, to a mixing container and
mixing contents of the mixing container;
[0384] (b) measuring a conductivity of the contents of the mixing
container and if within a first predefined range, skipping to
(d);
[0385] (c) computing a new final quantity of a second concentrate,
the second concentrate being the other of osmotic agent concentrate
or electrolyte concentrate to add to the mixing container
responsively to an error of the measuring, the error being in a
proportion of the first concentrate detected and the fraction of
the final quantity of water measured in (b);
[0386] (d) adding the second concentrate to the mixing container
and mixing the contents of the mixing container;
[0387] (e) measuring a conductivity of the contents of the mixing
container and if the measured conductivity is within a second
predefined range, skipping to (h)
[0388] (f) generating a command to terminate the making of the
batch if a new final quantity of the second concentrate was
computed in (c); otherwise, computing a first supplemental amount
of the second concentrate or water to bring the conductivity to a
second predefined range;
[0389] (g) measuring a conductivity of the contents of the mixing
container and if not within a third predefined range, computing a
second supplemental amount of the first and second concentrates or
water to add to bring the conductivity within the predefined range;
and
[0390] (h) adding one or more further quantities of water, the
first concentrate, and/or the second concentrate sufficient to
achieve the proportions of the final mixture, responsively to the
first and/or second supplemental amounts if computed.
[0391] In variations thereof, the fourth embodiments include ones
in which the method is performed at a time of a peritoneal dialysis
treatment. In variations thereof, the fourth embodiments include
ones in which the method is performed at a location of a peritoneal
dialysis treatment. In variations thereof, the fourth embodiments
include ones in which, if the contents of the mixing container are
not within the third predefined range in (g) then generating a
command to terminate the making of the final mixture. In variations
thereof, the fourth embodiments include ones that include, in
response to the command to terminate the making of the batch,
preventing the use of the final mixture. In variations thereof, the
fourth embodiments include ones that include using the final
mixture to perform a fill cycle of a peritoneal dialysis treatment.
In variations thereof, the fourth embodiments include ones that
include testing a sterilizing filter through which at least one
component of the contents of the mixing container flows and
generating a command to terminate the method if the test indicates
a failure. In variations thereof, the fourth embodiments include
ones in which the testing includes applying pressurized air to a
wetted membrane and measuring a pressure.
[0392] According to fifth embodiments, the disclosed subject matter
includes method of making a dialysate. The method includes adding
water and a first concentrate (C1) to a mixing container, measuring
a first conductivity of the mixing container contents, and if the
first conductivity of the contents of the mixing container is in a
first range, adding a second concentrate (C2), measuring a second
conductivity of the contents of the mixing container, and if the
second conductivity is in a second range further diluting the
contents of the mixing container. The method includes measuring a
third conductivity of the contents of the mixing container and if
the third conductivity is in a third range, using the contents of
the mixing container for a treatment; otherwise, if the third
conductivity is lower than the third range, adding C1 and C2, and
if the third conductivity is higher than the third range, further
diluting the contents of the mixing container. The method includes,
if the second conductivity of the contents of the mixing container
is higher than the second range, adding C1 and water in amounts
that are responsive to the second conductivity and if the second
conductivity of the contents of the mixing container is lower than
the second range, adding C2 in an amount that is responsive to the
second conductivity.
[0393] In variations thereof, the fifth embodiments include ones
that include, if after adding C1 to the mixing container the first
conductivity higher than the first range, calculating an additional
amount of C2 to add to the mixing container responsive to the first
conductivity. In variations thereof, the fifth embodiments include
ones that include, if after adding C1 to the mixing container the
first conductivity higher than the first range, calculating an
additional amount of C1 to add to the mixing container responsive
to the first conductivity. In variations thereof, the fifth
embodiments includes ones that include if after adding C1 to the
mixing container the first conductivity higher than the first
range, calculating an additional amount of C1 to add to the mixing
container responsive to the first conductivity. In variations
thereof, the fifth embodiments include ones that include mixing the
contents of the mixing container prior to determining the first or
the second conductivity.
[0394] According to sixth embodiments, the disclosed subject matter
includes a method of generating a batch of treatment fluid, the
method including using a controller that stores a treatment
prescription, and according to the prescription, pumping a
calculated ratio of water and electrolyte concentrate into a mixing
container by regulating a pump to control a net volume of each that
is transferred to the mixing container. The controller further
stores reference data indicating conductivity of predefined
dilution ratios of water and the electrolyte concentrate. The
method includes testing a conductivity of the contents of the
mixing container resulting from the pumping and further pumping
water or electrolyte concentrate responsively to the testing if the
conductivity differs by more than a defined threshold from the
conductivity indicated by the stored reference data and controlling
a further use of a pump to permit the contents of the mixing
container to be used thereafter, or immediately controlling a
further use of the pump to permit the contents of the mixing
container to be used if the conductivity differs by less than the
defined threshold.
[0395] In variations thereof, the sixth embodiments include ones
that include, after the pumping a predefined quantity of water and
electrolyte concentrate, mixing contents of the mixing container.
In variations thereof, the sixth embodiments include ones that
include using the controller to measure temperature of the fluid
from the mixing container. In variations thereof, the sixth
embodiments include ones that include using the controller to
measure temperature of the fluid from the mixing container,
temperature-compensate the conductivity, calculate whether the
conductivity falls under the threshold to generate a pass/fail
result, and outputting one of a command to change a later addition
of water or concentrate responsively to the pass/fail result and a
command to stop preparation of the batch responsively to the
pass/fail result. In variations thereof, the sixth embodiments
include ones that include, using the controller to measure
temperature of the fluid from the mixing container,
temperature-compensating the conductivity, calculating whether the
conductivity falls under the threshold to generate a pass/fail
result, and outputting one of a command to change the later
addition of water or concentrate responsively the pass/fail result
and a command to stop preparation of the batch responsively to the
pass/fail result, wherein the threshold indicates a conductivity of
a diluted osmotic agent electrolyte concentrate.
[0396] According to seventh embodiments, the disclosed subject
matter includes method of making a batch of peritoneal dialysis
fluid. The method includes providing a controller connected to
receive signals from a conductivity sensor, the controller storing
target conductivities of predefined target ratios of first and
second fluids at a body temperature of a human, the controller
further storing a correction factor that indicates a rate of change
of conductivity with temperature. The method includes using the
controller, in no particular order, adding a predefined volume of
the first fluid to a container and adding the second fluid to the
container having a composition different from the first. The method
includes mixing the first and second fluids in the container to
create an in-process mixture. The method includes warming the first
and second fluids to a temperature within a predefined range of the
body temperature either prior to, during, or after the adding or
mixing. The method includes measuring a current conductivity and a
current temperature of the in-process mixture from the container.
The method includes using the controller, selecting one of the
predefined target ratios corresponding to a current target
in-process mixture and calculating an additional amount of the
first or second fluid to add to the container to achieve the
selected one of the predefined target ratios responsively to the
current conductivity, the current temperature, and the correction
factor; and adding the additional amount to the container.
[0397] In variations thereof, the seventh embodiments include ones
in which the controller stores correction factors for each of the
predefined target ratios and the calculating an additional amount
is responsive to a correction factor corresponding to the selected
one of the predefined target ratios. In variations thereof, the
seventh embodiments include ones in which the container stores a
batch of peritoneal dialysis fluid. In variations thereof, the
seventh embodiments include ones that include adding a predefined
volume of a third fluid at a time before, during, or after the
adding the additional amount. In variations thereof, the seventh
embodiments include ones in which the adding the additional amount
includes adding one of water and electrolyte concentrate. In
variations thereof, the seventh embodiments include ones in which
the adding the additional amount includes adding one of water and a
concentrate including an osmotic agent. In variations thereof, the
seventh embodiments include ones in which the osmotic agent
concentrate includes electrolyte. In variations thereof, the
seventh embodiments include ones in which the first fluid is water
and the second fluid is a mixture of electrolytes for peritoneal
dialysis fluid. In variations thereof, the seventh embodiments
include ones in which the first fluid is water and the second fluid
is a mixture of electrolytes and osmotic agent for peritoneal
dialysis fluid. In variations thereof, the seventh embodiments
include ones in which the predefined target ratios are
concentrations of electrolytes in water.
[0398] According to eighth embodiments, the disclosed subject
matter includes medicament preparation system. A proportioning
element that prepares medicament from concentrate and water. A
proportioning element controller connects to the proportioning
element and configured to control functions thereof. A water
preparation element is configured to purify water and has a product
water output connected to convey water to the proportioning
element. A water preparation element controller connects to the
water preparation element and is configured to control functions
thereof. The water preparation element controller is controlled by
the proportioning controller such that functions of the water
preparation element are controlled by the proportioning
controller.
[0399] In variations thereof, the eighth embodiments include ones
in which the water preparation element functions include a filter
regeneration function and the filter regeneration function is
controlled by the proportioning element controller. eighth the
water preparation element has a reversing valve and the
proportioning element controller controls the reversing valve.
[0400] In variations thereof, the eighth embodiments include ones
in which the water preparation element is configured to divert at
least a fraction of its product water through a one of multiple
filter units therein to regenerate the one of multiple filter
units. In variations thereof, the eighth embodiments include ones
in which the water preparation element includes an ultraviolet
lamp, the proportioning element controller being configured to
cycle the ultraviolet lamp in order to eliminate or reduce output
when water is not being filtered. In variations thereof, the eighth
embodiments include ones in which the water preparation element has
a product water heater and the proportioning element controller is
configured to regulate a temperature of product water received by
it by cycling the product water heater. In variations thereof, the
eighth embodiments include ones in which the proportioning element
has a proportioning heater that heats fluid flowing therethrough.
In variations thereof, the eighth embodiments include ones in which
the proportioning element controller controls the product water
heater and the proportioning heater to share a net heating demand
between the product water heater and the proportioning heater. In
variations thereof, the eighth embodiments include ones in which
the water preparation element has a product water heater and the
proportioning element controller is configured to regulate a
temperature of product water received by it by cycling the water
heater. In variations thereof, the eighth embodiments include ones
in which the proportioning element has a proportioning heater that
heats fluid flowing therethrough. In variations thereof, the eighth
embodiments include ones in which the proportioning element
controller controls the product water heater and the proportioning
heater to share a net heating demand between the product water
heater and the proportioning heater. In variations thereof, the
eighth embodiments include ones in which the proportioning element
includes a treatment element.
[0401] In variations thereof, the eighth embodiments include ones
in which the treatment element includes a dialysis machine. In
variations thereof, the eighth embodiments include ones in which
the treatment element includes a dialysis cycler. In variations
thereof, the eighth embodiments include ones in which the treatment
element includes a peritoneal dialysis cycler. In variations
thereof, the eighth embodiments include ones in which the
proportioning element controller receives status information from
the water preparation element controller. In variations thereof,
the eighth embodiments include ones in which the proportioning
element controller includes a user interface and the proportioning
element controller derives information from the status information
and outputs derived data on the user interface, the derived data
including indications that a filter of the water preparation
element is in a flushing, priming, or cleaning mode. In variations
thereof, the eighth embodiments include ones in which the
proportioning element controller includes a user interface and the
proportioning element controller derives information from the
status information and outputs derived data on the user interface,
the derived data including indications of water temperature or
estimate of time delay till product water is available. In
variations thereof, the eighth embodiments include ones in which
the proportioning element controller includes a user interface and
the proportioning element controller derives information from the
status information and outputs derived data on the user interface,
the derived data including indications of estimated time left till
filter replacement (estimated time to exhaustion).
[0402] In variations thereof, the eighth embodiments include ones
in which the proportioning element controller receives status
information from the water preparation element controller, the
proportioning element controller includes a user interface, and the
proportioning element controller derives information from the
status information and outputs derived data on the user interface,
the derived data including indications or amount of life left on
the ultraviolet lamp. In variations thereof, the eighth embodiments
include ones in which the proportioning element controller includes
a user interface and the proportioning element controller derives
information from the status information and outputs derived data on
the user interface, the derived data including indications time
till a next flush or a next cleaning cycle of the water preparation
element. In variations thereof, the eighth embodiments include ones
in which the proportioning element controller includes a user
interface and the proportioning element controller derives
information from the status information and outputs derived data on
the user interface, the derived data including an indication
whether the water preparation element is in a sleep mode and/or how
long the before it is available to produce water.
[0403] In variations thereof, the eighth embodiments include ones
in which the proportioning element controller includes a user
interface and the proportioning element controller derives
information from the status information and outputs derived data on
the user interface, the derived data including forecasts of
maintenance tasks such as filter replacement. In variations
thereof, the eighth embodiments include ones in which the
proportioning element controller receives status information from
the water preparation element controller, the proportioning element
controller includes a user interface, and the proportioning element
controller derives information from the status information and
outputs derived data on the user interface, the derived data
including a forecast of a time for ultraviolet lamp replacement. In
variations thereof, the eighth embodiments include ones in which
the proportioning element controller includes a user interface and
the proportioning element controller derives information from the
status information and outputs derived data on the user interface,
one or more resistivity sensors being provided in a product water
outlet line the derived data including resistivity of the product
water. In variations thereof, the eighth embodiments include ones
in which the proportioning element controller includes a user
interface and the proportioning element controller derives
information from the status information and outputs derived data on
the user interface, one or more resistivity sensors being provided
in a product water outlet line the derived data including an alert
when the resistivity is out of a predefined range.
[0404] In variations thereof, the eighth embodiments include ones
in which the proportioning element controller includes a user
interface and the proportioning element controller derives
information from the status information and outputs derived data on
the user interface, one or more resistivity sensors being provided
in a tap water inlet line the derived data including an alert when
the resistivity is out of a predefined range. In variations
thereof, the eighth embodiments include ones in which the derived
data may be an estimate of filter life based on resistivity of
water in the water inlet line. In variations thereof, the eighth
embodiments include ones in which the water preparation element has
an off mode, a sleep mode, and an operating mode. In variations
thereof, the eighth embodiments include ones in which the
proportioning element controller and the water preparation element
controller communicate over a network. In variations thereof, the
eighth embodiments include ones in which the proportioning element
controller and the water preparation element controller communicate
over a signal cable. In variations thereof, the eighth embodiments
include ones in which the proportioning element controller and the
water preparation element controller communicate over a wireless
connection. In variations thereof, the eighth embodiments include
ones in which the water preparation element controller indicates to
the proportioning element controller its status including an
indication that the water preparation element is ready to output
product water.
[0405] In variations thereof, the eighth embodiments include ones
in which the proportioning element controller starts and stops
water production by applying commands to the water preparation
element controller. In variations thereof, the eighth embodiments
include ones in which the proportioning element controller
transmits commands to start and stop an ultraviolet (germicidal)
lamp in the water preparation element. In variations thereof, the
eighth embodiments include ones in which the commands are effective
for extending a life of such an ultraviolet lamp by ensuring the
lamp is operated only when required for treatment of water. In
variations thereof, the eighth embodiments include ones in which
the commands are effective for extending a life of such an
ultraviolet lamp by ensuring the lamp is operated only when water
is being filtered. In variations thereof, the eighth embodiments
include ones in which the proportioning element controller employs
two-way communication with the water preparation element to place
the water preparation element in a sleep mode at an end of a
treatment such that some or all power functions thereof are
switched off to save power and reduce wear. In variations thereof,
the eighth embodiments include ones in which the proportioning
element controller may send commands to wake up the water
preparation element so that it is ready at a time of a predefined
treatment stored in the proportioning element controller. In
variations thereof, the eighth embodiments include ones in which
commands from the proportioning element controller regulate a
pressure and flow rate at which product water is delivered by the
water preparation element.
[0406] In variations thereof, the eighth embodiments include ones
in which closed loop control based on a pressure signal is provided
by the water preparation element controller. In variations thereof,
the eighth embodiments include ones in which the proportioning
element controller employs two-way communication with the water
preparation element to transmit alarms generated by the water
preparation element and the proportioning responds by ceasing
dialysate proportioning in response to predefined alarms. In
variations thereof, the eighth embodiments include ones in which
alarm or status outputs of the water preparation element are
effective to generate specific outputs through a user interface of
the proportioning element controller. In variations thereof, the
eighth embodiments include ones in which the proportioning element
controller has a user interface that outputs guided troubleshooting
steps in response to and related to outputs and alarms of the water
preparation element controller. In variations thereof, the eighth
embodiments include ones in which the water preparation element has
a water heater and the proportioning element controller controls
the water heater and receives indications from the water
preparation element controller of a power output of the water
heater, water temperature, and status of the water preparation
element.
[0407] In variations thereof, the eighth embodiments include ones
in which the water preparation element controller is configured to
auto-order replacements filters through the Internet. In variations
thereof, the eighth embodiments include ones in which a timing of
the auto-order replacements is such as to effect a required
change-out before exhaustion of the filters being replaced. In
variations thereof, the eighth embodiments include ones in which
the proportioning element has a priming mode in which flushes a
fluid circuit thereof with water from the water preparation
element. In variations thereof, the eighth embodiments include ones
in which the proportioning element controller transmits commands to
the water preparation element controller to output water at
pressures and flow rates required for the proportioning element. In
variations thereof, the eighth embodiments include ones in which
the priming is preceded by a flushing operation with purified water
to minimize endotoxins in the fluid circuit. In variations thereof,
the eighth embodiments include ones in which the water preparation
element includes a reservoir sized to provide water sufficient for
a fill/drain cycle or for a full treatment (multiple cycles). In
variations thereof, the eighth embodiments include ones in which
the reservoir has one or more sterilizing-grade filters on its
inlet (and/or outlet) lines to prevent touch contamination or
back-growth contamination. In variations thereof, the eighth
embodiments include ones in which the reservoir includes one or
more check valves on its outlet lines to prevent backflow. In
variations thereof, the eighth embodiments include ones in which an
outlet of the reservoir includes a recirculation loop with a pump
that maintains a target head pressure.
[0408] According to ninth embodiments, the disclosed subject matter
includes system for performing peritoneal dialysis with a fluid
circuit with at least one fluid inlet and a mixing container. A
peritoneal dialysis system has a peritoneal dialysis system
controller, valve actuators, one or more pumps, to pump and direct
concentrate and water selectively through at least at times and
through portions of the fluid circuit to transfer concentrate and
water, through the at least one fluid inlet, to the mixing
container to form dialysis fluid. A water supply source has a water
pump, the water pump being controlled by a water supply controller
and being connected to a purified water outlet which is in turn
connected to the at least one fluid inlet. A command interface is
between the peritoneal dialysis system controller and the water
supply controller, the peritoneal dialysis system controller
transmitting one or more commands to the water supply controller to
start and stop the water pump.
[0409] In variations thereof, the ninth embodiments include ones in
which the one or pumps are configured to pump concentrate and water
from one or more sources.
[0410] According to tenth embodiments, the disclosed subject matter
includes system for performing peritoneal dialysis. A fluid circuit
has a single fluid inlet and a mixing container. A peritoneal
dialysis system has a peritoneal dialysis system controller, valve
actuators, and a cycler pump that pumps concentrate and water
within the fluid circuit. A water source with a water pump and a
concentrate source with a concentrate pump are connected to pump
water and concentrate through the fluid inlet under control of a
fluid source controller connected to control the water and
concentrate pumps. A command interface is connected between the
peritoneal dialysis system controller and the fluid source
controller, the peritoneal dialysis system controller transmitting
one or more commands to the fluid source controller to start and
stop the water source and concentrate source pumps.
[0411] According to eleventh embodiments, the disclosed subject
matter includes system for performing peritoneal dialysis. A fluid
circuit has at least one fluid inlet and a mixing container. A
peritoneal dialysis system has a controller, valve actuators, one
or more pumps, to pump and direct concentrate and water selectively
through the fluid circuit to transfer concentrate and water,
through the fluid inlet, to the mixing container to form dialysis
fluid. A peritoneal dialysis cycler has actuators, including a
cycler pump actuator, to direct concentrate and water selectively
through the fluid circuit to transfer concentrate and water from
one or more external sources, through the fluid inlet, to the
mixing container to form dialysis fluid. A water supply source with
a water pump having a purified water outlet connected to the at
least one fluid inlet. The water supply source has a water source
controller that controls the water pump responsively to at least
one sensor that detects at least one operating condition of the
peritoneal dialysis cycler. The water source controller activates
the water pump when the operating condition indicates a requirement
for water by the peritoneal dialysis cycler.
[0412] In variations thereof, the eleventh embodiments include ones
in which operating condition includes an activation of an actuator
of the peritoneal dialysis cycler that controls the opening of the
fluid inlet. In variations thereof, the eleventh embodiments
include ones in which the operating condition includes the
activation of the peritoneal dialysis cycler pump actuator. In
variations thereof, the eleventh embodiments include ones in which
the at least one sensor includes a pressure sensor that provides
pressure signals to the water source controller, the water pump
being controlled responsively to the pressure signals such that
when the cycler pump actuator is activated to draw water from the
at least one fluid inlet thereby generating a reduction in pressure
in the at least one fluid inlet while the water pump is off, the
water pump is turned on by the water source controller In
variations thereof, the eleventh embodiments include ones in which
the water pump is turned on by the water source controller when the
reduction reaches a predefined magnitude stored by the water source
controller. In variations thereof, the eleventh embodiments include
ones in which the water source controller controls the water pump
to maintain the pressure of the at least one fluid inlet within a
predefined range of pressures.
[0413] According to twelfth embodiments, the disclosed subject
matter includes a system for performing peritoneal dialysis. A
fluid circuit has a fluid inlet and a mixing container. A
peritoneal dialysis cycler has a cycler controller, actuators,
including a cycler pump actuator, to direct concentrate and water
selectively through the fluid circuit to transfer concentrate and
water, through the fluid inlet, to the mixing container to form
dialysis fluid. A water supply source has a water pump having a
purified water outlet connected to the at least one fluid inlet.
The purified water outlet has a pressure sensor and a water source
controller that receives pressure signals from the pressure sensor
and controls the water pump responsively to the pressure signals,
the cycler pump actuator generating coded pressure pulses in the
fluid inlet that are received by the pressure sensor and decoded by
the water source controller to command the water source controller
to activate and deactivate the water pump responsively to decoded
commands encoded in the pressure signals.
[0414] In variations thereof, the twelfth embodiments include ones
in which the coded pressure pulses encode changes to operating
parameters of the water source controller including a closed-loop
pressure set point at the fluid inlet. In variations thereof, the
twelfth embodiments include ones in which the coded pressure pulses
encode changes to operating parameters of the water source
controller. In variations thereof, the twelfth embodiments include
ones in which the water source controller controls the water pump
to maintain the pressure of the at least one fluid inlet within a
predefined range of pressures.
[0415] According to thirteenth embodiments, the disclosed subject
matter includes method for making a peritoneal dialysis fluid, the
method including connecting a fluid circuit to a proportioning
machine, the fluid circuit including a mixing container. The
proportioning machine has actuators that engage with the fluid
circuit when received thereby. The method includes connecting a
water source and one or more fresh containers of concentrate to the
fluid circuit, each of the one or more fresh containers of
concentrate having sufficient concentrate for multiple treatments.
The method includes using a controller of the proportioning
machine, flowing purified water from the water source and
concentrate from the one or more containers through the fluid
circuit to the mixing container to prepare a dialysis fluid in the
mixing container by proportioning the water and concentrate. The
flowing includes flowing water and concentrate through at least one
sterilizing filter to ensure sterility of the water and
concentrate. The at least one sterilizing filter includes
serially-connected redundant sterilizing filters or the method
including, using the controller, testing the integrity of a
membrane of the at least one sterilizing filter and preventing a
use of contents of the mixing container responsively to a result of
the testing. The method includes using the controller, treating a
patient using the dialysis fluid from the mixing container, the
treating including performing multiple fill and drain cycles of a
peritoneal dialysis treatment. The method includes replacing the
fluid circuit with a new fluid circuit. The method includes
repeating the connecting a fluid circuit, flowing purified water
and concentrate, and repeating the treating a patient, without
replacing the one or more fresh containers of concentrate, whereby
the one or more fresh concentrate containers are replaced once
every multiple treatments.
[0416] In variations thereof, the thirteenth embodiments include
ones in which the at least one filter is integrally attached to the
fluid circuit. In variations thereof, the thirteenth embodiments
include ones in which the flowing water and concentrate through at
least one sterilizing filter includes flowing water and concentrate
through separate filters. In variations thereof, the thirteenth
embodiments include ones in which the at least one filter includes
a testable filter with an air line, the method including, using the
controller, applying a pressure to the air line to test an ability
of a wetted membrane of the testable filter to withstand pressure
and thereby indicate the membrane's integrity. In variations
thereof, the thirteenth embodiments include ones in which the
connecting a water source and one or more containers of concentrate
to the fluid circuit includes: at a first time, replacing one or
more spent containers of concentrate with the one or more fresh
containers of concentrate; at a second time, connecting a fluid
inlet line of the fluid circuit with the at least one sterilizing
filter to a common fluid outlet of a fluid source module; the fluid
source module having automatic valves connected to a water source
and the one or more fresh containers of concentrate, the automatic
valves selecting, under control of the controller, only one of the
water source and the one or more fresh containers of concentrate
for connection to the fluid inlet line at a given time.
[0417] In variations thereof, the thirteenth embodiments include
ones in which the flowing water and concentrate includes pumping
the water and concentrate by the fluid source module.
[0418] According to fourteenth embodiments, the disclosed subject
matter includes treatment method including connecting a fluid
circuit to a proportioning machine, the fluid circuit including a
mixing container. The proportioning machine has actuators that
engage with the fluid circuit when received thereby. The method
includes connecting one or more containers of medicament
concentrate to the fluid circuit, each container having sufficient
medicament concentrate for multiple treatments. The method includes
using the proportioning machine, flowing purified water and
concentrate through the fluid circuit to the mixing container to
prepare a medicament in the mixing container by proportioning the
purified water and medicament concentrate. The flowing includes
flowing water and concentrate through at least one sterilizing
filter to ensure sterility of the water and concentrate. The method
includes ensuring an integrity of the at least one sterilizing
filter by testing the at least one sterilizing filter or providing
serially-connected redundant sterilizing filters. The method
includes treating a patient using the prepared medicament in the
mixing container. The method includes replacing the fluid circuit
with a new fluid circuit and repeating the connecting a fluid
circuit, flowing purified water and concentrate, treating a
patient, without replacing the one or more containers of medicament
concentrate.
[0419] In variations thereof, the fourteenth embodiments include
ones in which the at least one filter is integrally attached to the
fluid circuit. In variations thereof, the fourteenth embodiments
include ones in which the flowing water and concentrate through at
least one sterilizing filter includes flowing water and concentrate
through separate filters.
[0420] According to fifteenth embodiments, the disclosed subject
matter includes a system for preparation of sterile medical
treatment fluid. The system includes t least one fluid circuit with
a pumping tube segment and multiple valve segments, at least one
pumping actuator, and multiple valve actuators positioned to engage
the multiple valve segments. The at least one pumping actuator
engages the at least one pumping tube segment. A controller is
connected to control the multiple valve actuators and the at least
one pumping actuator. A first of the multiple valve segments is
along a fluid inlet line with a sterilizing filter. A first
multi-treatment concentrate container has sufficient concentrate
for preparation of enough peritoneal dialysis fluid to perform
multiple peritoneal dialysis treatments, each treatment including
multiple fill/drain cycles. The system has a water source. The at
least one fluid circuit has, integrally-attached thereto, a first
single-treatment concentrate container and a mixing container, the
mixing container being sized to hold sufficient peritoneal dialysis
fluid for at least a single fill cycle. Ones of the multiple valve
segments is/are connected between the fluid inlet line and the
water source and between the first multi-treatment concentrate
container and the fluid inlet line. The controller, controlling the
ones of the multiple valve segments and the at least one pumping
actuator, sequentially connects the first single-treatment
concentrate container and the water source to the fluid inlet line
and controls flow such that water is conveyed from the water source
to the mixing container and concentrate is conveyed from the first
multi-treatment concentrate container to the first single-treatment
concentrate container, and subsequently incorporated in a dialysis
fluid formed in the mixing container.
[0421] In variations thereof, the fifteenth embodiments include
ones in which the controller is configured to perform a fill/drain
cycle including draining spent fluid from a patient line and
pumping the dialysis fluid from the mixing container to the patient
line. In variations thereof, the fifteenth embodiments include ones
that include a second multi-treatment concentrate container,
wherein, ones of the multiple valve segments are connected the
second multi-treatment concentrate container and the fluid inlet
line. In variations thereof, the fifteenth embodiments include ones
that include a second single-treatment concentrate container
connected to the fluid circuit, the controller transferring
concentrate from the second multi-treatment concentrate container
to the second single-treatment concentrate container to form the
dialysis fluid. In variations thereof, the fifteenth embodiments
include ones in which the sterilizing filter has an air port to
allow a membrane of the sterilizing filter to be pressure tested,
the controller being programmed to test the sterilizing filter
membrane by applying pressure to the air port and measuring the
pressure after pumping water therethrough. In variations thereof,
the fifteenth embodiments include ones in which controller
generates an alarm signal responsively to a result of a test of the
sterilizing filter membrane if the test indicates a loss of
integrity of the sterilizing filter membrane.
[0422] According to sixteenth embodiments, the disclosed subject
matter includes fluid circuit for dialysis solution preparation. A
valve network has interconnected channels that can be opened and
closed by opening and closing valve portions of the interconnected
channels. A fluid inlet line has an inline sterilizing filter, a
mixing container, a first concentrate container, a drain line, a
patient fill/drain line all empty and pre-connected to the valve
network to form a unit and sealed from an external environment. The
valve network has a pumping portion to pump fluid between the
interconnected channels.
[0423] In variations thereof, the sixteenth embodiments include
ones in which the patient fill/drain line includes separate branch
lines that connect to the valve network which branch lines merge to
form a single line that connects to a patient. In variations
thereof, the sixteenth embodiments include ones in which the inline
sterilizing filter has an air line attached thereto, the air line
being connected such that air forced through the air line applies
pressure to a membrane of the inline sterilizing filter to permit
an integrity test thereof. In variations thereof, the sixteenth
embodiments include ones in which the valve network is attached to
a rigid manifold member, the air line being connecting to a port
fixedly attached to the rigid manifold member. In variations
thereof, the sixteenth embodiments include ones in which the air
line is collinear with the fluid inlet line. In variations thereof,
the sixteenth embodiments include ones in which valve network is
supported by a panel. In variations thereof, the sixteenth
embodiments include ones in which the valve network is supported by
a panel, the pumping portion being supported by a rigid manifold
portion of the valve network which is spaced from the panel. In
variations thereof, the sixteenth embodiments include ones in which
the rigid manifold portion has pressure sensing diaphragms
integrated in and supported thereby.
[0424] In variations thereof, the sixteenth embodiments include
ones in which the air line is integral with at least a portion of
the fluid inlet line. In variations thereof, the sixteenth
embodiments include ones in which the rigid manifold portion
pressure sensing diaphragms are located one at each end of the
pumping portion. In variations thereof, the sixteenth embodiments
include ones in which the pumping portion is straight. In
variations thereof, the sixteenth embodiments include ones that
include a second concentrate container pre-connected to the valve
network. In variations thereof, the sixteenth embodiments include
ones in which the mixing container and first and second concentrate
containers are polymer bags. In variations thereof, the sixteenth
embodiments include ones in which the mixing container has a larger
internal volume than the first and second concentrate containers.
In variations thereof, the sixteenth embodiments include ones in
which the panel has windows that overlie the valve portions. In
variations thereof, the sixteenth embodiments include ones in which
the valve network includes a manifold portion with a pumping tube
segment. In variations thereof, the sixteenth embodiments include
ones in which the valve portions are portions of a bank of tubes
stemming from the manifold portion. In variations thereof, the
sixteenth embodiments include ones in which the valve portions are
portions of a bank of parallel tubes stemming from the manifold
portion. In variations thereof, the sixteenth embodiments include
ones that include a second sterilizing filter connected in series
with the inline sterilizing filter such that the second and inline
sterilizing filters are separated by a flow channel In variations
thereof, the sixteenth embodiments include ones in which the mixing
container and first concentrate container are defined by two bonded
flexible panels along seams to define the mixing container and
concentrate container. In variations thereof, the sixteenth
embodiments include ones in which the valve network fluidly
interconnects the fluid inlet line to the concentrate container. In
variations thereof, the sixteenth embodiments include ones in which
the valve network fluidly interconnects the concentrate container
with the mixing container. In variations thereof, the sixteenth
embodiments include ones in which the valve network fluidly
interconnects the mixing container with the patient fill and
patient drain lines.
[0425] According to seventeenth embodiments, the disclosed subject
matter includes system for performing a peritoneal dialysis
treatment. At least two multi-treatment concentrate containers have
concentrate supply connectors, the at least two multi-treatment
concentrate containers having sufficient concentrate to perform
multiple dialysis treatments, where each treatment includes
multiple fill/drain cycles. A valve network has interconnected
channels that can be opened and closed by opening and closing valve
portions of the interconnected channels. A fluid inlet line has an
inline sterilizing filter, a mixing container, first and second
single-treatment concentrate containers, a drain line, a patient
fill/drain line all empty and pre-connected to the valve network to
form a unit and sealed from an external environment. The valve
network has a pumping portion to pump fluid between the
interconnected channels.
[0426] In variations thereof, the seventeenth embodiments include
ones that include a connection platform that mechanically supports
the at least two multi-treatment concentrate containers and
selectively couples them to the fluid inlet line. In variations
thereof, the seventeenth embodiments include ones that include a
connection platform with a water source and attachments for the at
least two multi-treatment concentrate containers, the connection
platform having a valve system that fluidly couples the at least
two multi-treatment concentrate containers and the water source to
the fluid inlet line. In variations thereof, the seventeenth
embodiments include ones in which the inline sterilizing filter has
an air line attached thereto, the air line being connected such
that air forced through the air line applies pressure to a membrane
of the inline sterilizing filter to permit an integrity test
thereof. In variations thereof, the seventeenth embodiments include
ones in which the air lines are each collinear with at least a
portion of the fluid inlet line. In variations thereof, the
seventeenth embodiments include ones in which the air lines are
each attached along at least a portion of the fluid inlet line. In
variations thereof, the seventeenth embodiments include ones in
which the valve network is supported by a panel, the pumping
portion being supported by a rigid manifold portion of the valve
network which is spaced from the panel. In variations thereof, the
seventeenth embodiments include ones in which the manifold portion
has pressure sensors integrated therein, one at each end of a
pumping tube segment of the pumping portion. In variations thereof,
the seventeenth embodiments include ones in which the pumping tube
segment is straight. In variations thereof, the seventeenth
embodiments include ones in which the pressure sensor includes a
pressure pod with a diaphragm that serves as a portion of a wall of
a respective one of two separate chambers of the rigid manifold
portion. In variations thereof, the seventeenth embodiments include
ones in which the valve network is attached to a rigid manifold,
the air line being connecting to a port fixedly attached to the
rigid manifold. In variations thereof, the seventeenth embodiments
include ones in which the air line is collinear with the fluid
inlet line. In variations thereof, the seventeenth embodiments
include ones in which the valve network is supported by a panel. In
variations thereof, the seventeenth embodiments include ones that
include a second concentrate container pre-connected to the valve
network.
[0427] In variations thereof, the seventeenth embodiments include
ones in which the mixing container and first and second concentrate
containers are polymer bags. In variations thereof, the seventeenth
embodiments include ones in which the mixing container has a larger
internal volume than the first and second single-treatment
concentrate containers. In variations thereof, the seventeenth
embodiments include ones in which the panel has windows that
overlie the valve portions. In variations thereof, the seventeenth
embodiments include ones in which the valve network includes a
manifold portion with a pumping tube segment. In variations
thereof, the seventeenth embodiments include ones in which the
valve portions are portions of a bank of tubes stemming from the
manifold. In variations thereof, the seventeenth embodiments
include ones in which the valve portions are portions of a bank of
parallel tubes stemming from the manifold. In variations thereof,
the seventeenth embodiments include ones that include a second
sterilizing filter connected in series with the inline sterilizing
filter such that the second and inline sterilizing filters are
separated by a flow channel
[0428] In variations thereof, the seventeenth embodiments include
ones in which the mixing container and first and second
single-treatment concentrate containers are defined by two bonded
flexible panels along seams to define the mixing container and
first and second single-treatment concentrate containers. In
variations thereof, the seventeenth embodiments include ones in
which the valve network fluidly interconnects the fluid inlet line
to the first and second single-treatment concentrate containers. In
variations thereof, the seventeenth embodiments include ones in
which the valve network fluidly interconnects the first and second
single-treatment concentrate containers with the mixing container.
In variations thereof, the seventeenth embodiments include ones in
which the valve network fluidly interconnects the mixing container
with the patient fill/drain line. In variations thereof, the
seventeenth embodiments include ones in which the at least two
multi-treatment concentrate containers are contained in a single
package. In variations thereof, the seventeenth embodiments include
ones in which the single package is housed by a single box. In
variations thereof, the seventeenth embodiments include ones that
include a connection platform with a water source and attachments
for the at least two multi-treatment concentrate containers, the
connection platform fluidly coupling the at least two
multi-treatment concentrate containers and the water source to the
fluid inlet line using control valves that include one for each of
the at least two multi-treatment concentrates containers and one
the water source, the water source having a water pump. In
variations thereof, the seventeenth embodiments include ones that
include a connection platform with a water source and attachments
for the at least two multi-treatment concentrate containers, the
connection platform fluidly coupling the at least two
multi-treatment concentrate containers and the water source to the
fluid inlet line using control valves that include one for each of
the at least two concentrates and one the water source, the at
least two concentrates containers connecting to a common line
having a concentrate pump. In variations thereof, the seventeenth
embodiments include ones that include a connection platform with a
water source and attachments for the at least two multi-treatment
concentrate containers, the connection platform fluidly coupling
the at least two multi-treatment concentrate containers and the
water source to the fluid inlet line using control valves that
include one for each of the at least two concentrates and one the
water source, and the water source having a pump, the at least two
concentrates containers connecting to a common line having a
concentrate pump.
[0429] In variations thereof, the seventeenth embodiments include
ones that include a controller programmed to control the connection
platform controls valves to connect the at least two
multi-treatment concentrate containers sequentially to the fluid
inlet line to fill the at least two multi-treatment concentrate
containers with concentrate. In variations thereof, the seventeenth
embodiments include ones in which the controller controls the
connection platform water pump to convey water to the mixing
container through the fluid inlet line. In variations thereof, the
seventeenth embodiments include ones that include a controller
programmed to control the connection platform control valves and
the concentrate pump to connect the at least two multi-treatment
concentrate containers sequentially to the fluid inlet line to fill
the first and second single-treatment concentrate containers with
concentrate. In variations thereof, the seventeenth embodiments
include ones in which the controller controls the connection
platform water pump to convey water to the mixing container through
the fluid inlet line. In variations thereof, the seventeenth
embodiments include ones that include a controller programmed to
control the connection platform control valves and the concentrate
pump to connect the at least two multi-treatment concentrate
containers sequentially to the fluid inlet line to fill the first
and second single-treatment concentrate containers with concentrate
and to control the connection platform control valves and the
connection platform water pump to fill the mixing container with
water.
[0430] According to eighteenth embodiments, the disclosed subject
matter includes system for performing peritoneal dialysis. A
peritoneal dialysis cycler has a fluid circuit with a fluid inlet,
a mixing container, and at least two concentrate containers. The
peritoneal dialysis cycler has actuators to pump and direct
concentrate and water selectively through the fluid circuit to
transfer concentrate from an external source, through the fluid
inlet, to the at least two concentrate containers, to transfer
water through the fluid inlet to the mixing container, and to
transfer concentrate from the at least two concentrate containers
to the mixing container to form dialysis fluid. The peritoneal
dialysis cycler actuators also transferring dialysis fluid to a
patient line.
[0431] In variations thereof, the eighteenth embodiments include
ones in which the at least two concentrate containers are empty.
203. In variations thereof, the eighteenth embodiments include ones
that include a programmable controller that controls the actuators.
In variations thereof, the eighteenth embodiments include ones in
which the actuators include pumping and valve actuators. In
variations thereof, the eighteenth embodiments include ones in
which the fluid circuit includes valve segments that are pinched by
the valve actuators. In variations thereof, the eighteenth
embodiments include ones in which the fluid inlet has an inline
sterilizing filter. In variations thereof, the eighteenth
embodiments include ones in which the inline sterilizing filter
includes two filters or a single testable filter having an air line
for applying air pressure to a membrane thereof. In variations
thereof, the eighteenth embodiments include ones that include a
fluid source module with input connections for concentrate and
water and an outlet connection connectable to the fluid inlet. In
variations thereof, the eighteenth embodiments include ones in
which the fluid source module has actuators that sequentially
connect concentrate and water to the outlet connection. In
variations thereof, the eighteenth embodiments include ones in
which the peritoneal dialysis cycler controls the fluid source
module actuators. In variations thereof, the eighteenth embodiments
include ones in which the fluid source module actuators include
valve and pump actuators. In variations thereof, the eighteenth
embodiments include ones in which the fluid source pump actuators
include a water pump that pumps water through a filter system to
generate purified water flowing through a purified water supply
line connected to the outlet connection and the fluid source module
valve actuators include a water valve actuator that selectively
closes and opens the purified water supply line. In variations
thereof, the eighteenth embodiments include ones in which the fluid
source pump actuators include a concentrate pump that pumps
concentrate from concentrate containers connected through
respective concentrate feed lines to a common concentrate line that
connect to the outlet connection, the fluid source module valve
actuators including concentrate valve actuators that selectively
close and open the respective concentrate feed lines. In variations
thereof, the eighteenth embodiments include ones in which the
peritoneal dialysis cycler has a programmable controller that
controls the peritoneal dialysis cycler actuators.
[0432] In variations thereof, the eighteenth embodiments include
ones in which the fluid source module pump actuators include a
water pump, controlled by the programmable controller, that pumps
water through a filter system to generate purified water flowing
through a purified water supply line connected to the outlet
connection and the fluid source module valve actuators include a
water valve actuator that selectively closes and opens the purified
water supply line under control of the programmable controller. In
variations thereof, the eighteenth embodiments include ones in
which the fluid source module pump actuators include a concentrate
pump, controlled by the programmable controller, that pumps
concentrate from concentrate containers connected through
respective concentrate feed lines to a common concentrate line that
connect to the outlet connection, the fluid source module valve
actuators including concentrate valve actuators that selectively
close and open the respective concentrate feed lines under the
control of the programmable controller.
[0433] In variations thereof, the eighteenth embodiments include
ones in which the fluid source module pump actuators include a
concentrate pump, controlled by the programmable controller, that
pumps concentrate from concentrate containers connected through
respective concentrate feed lines to a common concentrate line that
connect to the outlet connection, the fluid source module valve
actuators including concentrate valve actuators that selectively
close and open the respective concentrate feed lines under the
control of the programmable controller and wherein the fluid source
pump actuators include a water pump, controlled by the programmable
controller, that pumps water through a filter system to generate
purified water flowing through a purified water supply line
connected to the outlet connection and the fluid source module
valve actuators include a water valve actuator that selectively
closes and opens the purified water supply line under the control
of the programmable controller.
[0434] According to nineteenth embodiments, the disclosed subject
matter includes fluid system for peritoneal dialysis and dialysis
solution preparation. A pre-connected fluid circuit has a
disposable mixing container of polymeric material, an empty
concentrate container of polymeric material, a fluid multiplexer
that includes a valve network that has junctions and valve portions
that mechanically interface with valve actuators to define
selectable flow paths in the valve network. The valve network
further includes a concentrate line connected to the concentrate
container, a fluid inlet line terminated by a fluid inlet line
connector, and a pair of lines connected to the mixing container to
permit simultaneous flow into, and flow out from, the mixing
container. The fluid circuit is preconnected and sealed as a unit
to isolate an internal volume thereof from an external environment
to preserve sterility. An actuator device has valve actuators,
sensors, and a pumping actuator. The fluid circuit has sensor and
pumping portions that engage, respectively, along with the valve
portions, with effecters of the actuator device.
[0435] In variations thereof, the nineteenth embodiments include
ones in which the fluid inlet line has an inline sterilizing filter
with an air line attached thereto, the air line being connected
such that air forced through the air line applies pressure to a
membrane of the inline sterilizing filter to permit an integrity
test thereof. In variations thereof, the nineteenth embodiments
include ones in which the fluid inlet line has respective
sterilizing filters serially-connected sterilizing filter elements.
In variations thereof, the nineteenth embodiments include ones in
which the valve network is positioned and held in a cartridge that
has a pumping portion supported by a rigid manifold member, the
manifold member being hollow and defining at least some of the
junctions and the air line connecting to a port fixedly attached to
the manifold member. In variations thereof, the nineteenth
embodiments include ones in which the valve network is in a
cartridge with the pumping portion held by a rigid manifold member
thereof, the manifold member being hollow and defining at least
some of the junctions. In variations thereof, the nineteenth
embodiments include ones in which the air line connects to a port
fixedly attached to the manifold member. In variations thereof, the
nineteenth embodiments include ones in which the manifold member is
rigid and has two separate chambers connected by the pumping
portion.
[0436] In variations thereof, the nineteenth embodiments include
ones in which the valve network is supported by a panel providing
support for the cartridge, the manifold member being connected to
the panel. In variations thereof, the nineteenth embodiments
include ones in which the valve network is supported by a panel,
the manifold member being spaced apart from the panel. In
variations thereof, the nineteenth embodiments include ones in
which at least one of the two separate chambers has pressure
sensors integrated therein, one at each end of the pumping portion.
In variations thereof, the nineteenth embodiments include ones in
which the pressure sensor includes a pressure pod with a diaphragm
that serves as a portion of a wall of a respective one of the two
separate chambers. In variations thereof, the nineteenth
embodiments include ones in which the respective concentrate line
connectors are connected by a frame that support a portion of the
concentrate line. In variations thereof, the nineteenth embodiments
include ones in which frame has a window and the portion of the
concentrate line passes across the window. In variations thereof,
the nineteenth embodiments include ones in which valve network has
a drain line. In variations thereof, the nineteenth embodiments
include ones in which valve network has a dialysis solution
fill/drain line connectable to a peritoneal catheter. In variations
thereof, the nineteenth embodiments include ones in which
fill/drain line is sealed by a removable end cap. In variations
thereof, the nineteenth embodiments include ones in which the
dialysis solution fill/drain line has a second air line collinear
with the dialysis solution fill/drain line, connected at an end of
the dialysis solution fill/drain line to a pressure pod connected
to the dialysis solution fill/drain line to measure a pressure
therewithin. In variations thereof, the nineteenth embodiments
include ones in which drain and fluid inlet lines are connected by
a frame that support portions of the drain and fluid inlet lines.
In variations thereof, the nineteenth embodiments include ones in
which frame has a window and portions of the drain and fluid inlet
lines pass across the window. In variations thereof, the nineteenth
embodiments include ones in which the valve portions are supported
by a planar element. In variations thereof, the nineteenth
embodiments include ones in which planar element includes a pair of
sheets shaped to hold the valve portions in predefined positions.
In variations thereof, the nineteenth embodiments include ones in
which the planar element includes a pair of sheets shaped to hold
the valve portions in predefined positions, at least one of the
pair of sheets having holes in it to permit valve actuators to
contact the valve portions. In variations thereof, the nineteenth
embodiments include ones in which the valve portions are tube
segments. In variations thereof, the nineteenth embodiments include
ones in which the valve portions are tube segments. In variations
thereof, the nineteenth embodiments include ones in which the
concentrate line is sealed by a frangible seal. In variations
thereof, the nineteenth embodiments include ones in which the
mixing container and concentrate container are defined by two
bonded flexible panels along seams to define the mixing container
and concentrate container. In variations thereof, the nineteenth
embodiments include ones in which the seams are a result of thermal
welding. In variations thereof, the nineteenth embodiments include
ones in which the fluid circuit encloses a sterile internal volume.
In variations thereof, the nineteenth embodiments include ones in
which the actuator device includes a peritoneal dialysis
cycler.
[0437] According to twentieth embodiments, the disclosed subject
matter includes a system for administering a peritoneal dialysis
treatment. A peritoneal dialysis system component is connectable to
one or more long-term containers of dialysis fluid concentrate and
a water source. A disposable fluid circuit has a pumping portion, a
mixing container, and one or more short-term concentrate
containers. Pumping and valve actuators are controlled by a
controller, which controls them to engage the disposable fluid
circuit to create a mixed batch of peritoneal dialysis fluid by
transferring sufficient concentrate for multiple cycles of a single
treatment from the one or more long-term containers of dialysis
fluid concentrate to the one or more short-term concentrate
containers and, for each cycle of a treatment, transferring
sufficient concentrate for a fill cycle from the one or more
short-term concentrate containers to the mixing container and
transferring sufficient water to form a ready-to-use dialysate to
the mixing container from the water source.
[0438] In variations thereof, the twentieth embodiments include
ones in which the mixing container and the short-term concentrate
containers are polymeric bags. In variations thereof, the twentieth
embodiments include ones in which the pumping and valve actuators
are controlled to perform a fill cycle of an automated peritoneal
dialysis treatment using the contents of the mixing container. In
variations thereof, the twentieth embodiments include ones that
include at least one conductivity sensor connected to a drain line
of the fluid circuit, wherein the pumping and valve actuators are
controlled to sample contents of the mixing container to obtain a
conductivity measurement thereof.
[0439] According to twenty-first embodiments, the disclosed subject
matter includes a fluid circuit for peritoneal dialysis and
dialysis solution preparation. A pre-connected fluid circuit has a
disposable mixing container of polymeric material, a concentrate
container of polymeric material, a fluid multiplexer that includes
a valve network that has junctions and valve portions that
mechanically interface with valve actuators to define selectable
flow paths in the valve network. The valve network further includes
a concentrate line connected to the concentrate container, a fluid
inlet line terminated by a fluid inlet line connector, and a pair
of lines connected to the mixing container to permit simultaneous
flow into, and flow out from, the mixing container. The fluid inlet
line has an inline sterilizing filter. The valve network is
positioned and held in a cartridge that has a pumping portion
supported by a manifold member, the manifold member being hollow
and defining at least some of the junctions. The fluid circuit is
preconnected and sealed as a unit to isolate an internal volume
thereof from an external environment to preserve sterility.
[0440] In variations thereof, the twenty-first embodiments include
ones in which the manifold member is rigid and defines two separate
chambers connected by the pumping portion. In variations thereof,
the twenty-first embodiments include ones in which fluid inlet line
has an air line that is collinear with the fluid inlet line and
connects to the inline sterilizing filter. In variations thereof,
the twenty-first embodiments include ones in which the valve
network is supported by a panel, the manifold member being
connected to the panel. In variations thereof, the twenty-first
embodiments include ones in which the valve network is supported by
a panel, the manifold member being spaced apart from the panel. In
variations thereof, the twenty-first embodiments include ones in
which the manifold has pressure sensors integrated therein, one at
each end of a pumping tube segment. In variations thereof, the
twenty-first embodiments include ones in which the pumping tube
segment is straight. In variations thereof, the twenty-first
embodiments include ones in which the pressure sensors include a
pressure pod with a diaphragm that serves as a portion of a wall of
a respective one of the two separate chambers. In variations
thereof, the twenty-first embodiments include ones in which the
valve network has a drain line. In variations thereof, the
twenty-first embodiments include ones in which the drain and fluid
lines are connected by a frame that support portions of the drain
and fluid lines. In variations thereof, the twenty-first
embodiments include ones in which the frame has a window and the
portion of the drain and fluid lines passes across the window. In
variations thereof, the twenty-first embodiments include ones in
which the valve network has a dialysis solution fill/drain line
connectable to a peritoneal catheter. In variations thereof, the
twenty-first embodiments include ones in which the fill/drain line
is sealed by a removable end cap. In variations thereof, the
twenty-first embodiments include ones in which the valve network
has a dialysis solution fill/drain line connectable to a peritoneal
catheter and the dialysis solution fill/drain line has a second air
line collinear with the dialysis solution fill/drain line,
connected at an end of the dialysis solution fill/drain line to a
pressure pod connected to the dialysis solution fill/drain line to
measure a pressure therewithin. In variations thereof, the
twenty-first embodiments include ones in which the drain and fluid
inlet lines are connected by a frame that support portions of the
drain and fluid inlet lines. In variations thereof, the
twenty-first embodiments include ones in which the frame has a
window and portions of the drain and fluid inlet lines pass across
the window. In variations thereof, the twenty-first embodiments
include ones in which the valve portions are supported by a planar
element. In variations thereof, the twenty-first embodiments
include ones in which the planar element includes a pair of sheets
shaped to hold the valve portions in predefined positions. In
variations thereof, the twenty-first embodiments include ones in
which the planar element includes a pair of sheets shaped to hold
the valve portions in predefined positions, at least one of the
pair of sheets having holes in it to permit valve actuators to
contact the valve portions. In variations thereof, the twenty-first
embodiments include ones in which the valve portions are tube
segments. In variations thereof, the twenty-first embodiments
include ones in which the valve portions are tube segments. In
variations thereof, the twenty-first embodiments include ones in
which the mixing container and concentrate container are defined by
two bonded flexible panels along seams to define the mixing
container and concentrate container. In variations thereof, the
twenty-first embodiments include ones in which the seams are a
result of thermal welding. In variations thereof, the twenty-first
embodiments include ones in which the fluid circuit encloses a
sterile internal volume.
[0441] According to twenty-second embodiments, the disclosed
subject matter includes a fluid circuit for peritoneal dialysis and
dialysate preparation. A disposable mixing container of polymeric
material has a pre-attached fluid circuit, the mixing container and
fluid circuit being sealed from an external environment. A
concentrate container of polymeric material is pre-attached to the
fluid circuit, the concentrate container being sealed from an
external environment. The fluid circuit includes a fluid
multiplexer that includes a valve network that has junctions and
valve portions that mechanically interface with valve actuators to
define selectable flow paths in the valve network. The valve
network further including a concentrate line connected to the
concentrate container, a water line terminated by a water line
connector, and a at least one mixing container line connected to
the mixing container to permit simultaneous flow into, and flow out
from, the mixing container. The water line has an inline
sterilizing filter. The valve network is positioned and held in a
cartridge that has a pumping portion supported by a manifold
member, the manifold member being hollow and defining at least some
of the junctions. The manifold member defines two separate chambers
connected by a pumping tube segment.
[0442] In variations thereof, the twenty-second embodiments include
ones in which the water line has an air line attached thereto, the
air line being connected such that air forced through the air line
applies pressure to a membrane of the inline sterilizing filter to
permit an integrity test thereof. In variations thereof, the
twenty-second embodiments include ones in which the valve network
is supported by a panel, the manifold member being connected to the
panel. In variations thereof, the twenty-second embodiments include
ones in which the valve network is supported by a panel, the
manifold member being spaced apart from the panel. In variations
thereof, the twenty-second embodiments include ones in which the
air line is integral with at least a portion of a respective one of
the concentrate and water lines. In variations thereof, the
twenty-second embodiments include ones in which the manifold has
pressure sensors integrated therein, one at each end of the pumping
portion. In variations thereof, the twenty-second embodiments
include ones in which the pumping portion is straight. In
variations thereof, the twenty-second embodiments include ones in
which the pressure sensor includes a pressure pod with a diaphragm
that serves as a portion of a wall of a respective one of the two
separate chambers. In variations thereof, the twenty-second
embodiments include ones in which the valve network has a drain
line and the respective water and drain lines are connected by a
frame that support portions thereof. In variations thereof, the
twenty-second embodiments include ones in which the frame has a
window and the portions pass across the window. In variations
thereof, the twenty-second embodiments include ones in which the
valve network has a drain line. In variations thereof, the
twenty-second embodiments include ones in which the valve network
has a dialysate fill/drain line connectable to a peritoneal
catheter. In variations thereof, the twenty-second embodiments
include ones in which the fill/drain line is sealed by a removable
end cap. In variations thereof, the twenty-second embodiments
include ones in which the valve network has a dialysate fill/drain
line connectable to a peritoneal catheter and wherein the dialysate
fill/drain line has a second air line collinear with the dialysate
fill/drain line, connected at an end of the dialysate fill/drain
line to a pressure pod connected to the dialysate fill/drain line
to measure a pressure therewithin. In variations thereof, the
twenty-second embodiments include ones in which the drain and water
lines are connected by a frame that support portions of the drain
and water lines. In variations thereof, the twenty-second
embodiments include ones in which the frame has a window and
portions of the drain and water lines pass across the window. In
variations thereof, the twenty-second embodiments include ones in
which the valve portions are supported by a planar element. In
variations thereof, the twenty-second embodiments include ones in
which the planar element includes a pair of sheets shaped to hold
the valve portions in predefined positions. In variations thereof,
the twenty-second embodiments include ones in which the planar
element includes a pair of sheets shaped to hold the valve portions
in predefined positions, at least one of the pair of sheets having
holes in it to permit valve actuators to contact the valve
portions.
[0443] In variations thereof, the twenty-second embodiments include
ones in which the valve portions are tube segments. In variations
thereof, the twenty-second embodiments include ones in which the
valve portions are tube segments. In variations thereof, the
twenty-second embodiments include ones in which the concentrate
line is sealed by a frangible seal. In variations thereof, the
twenty-second embodiments include ones in which the cartridge
includes parallel panels with the valve network sandwiched between
them, the frangible seal held in the cartridge aligned with windows
in at least one of the panels to permit an actuator to fracture
them prior to use thereby allowing the concentrate to flow through
the concentrate line. In variations thereof, the twenty-second
embodiments include ones in which the cartridge includes a single
folded panel forming parallel panel portions with the valve network
sandwiched between them, the frangible seal being held in the
cartridge aligned with windows in at least one of the panels to
permit an actuator to fracture them prior to use thereby allowing
the concentrate to flow through the concentrate line. In variations
thereof, the twenty-second embodiments include ones in which the
valve network includes the concentrate line which is sealed by a
frangible seal thereby separating the concentrate from the rest of
the fluid circuit until the frangible seal is fractured. In
variations thereof, the twenty-second embodiments include ones that
include a second sterilizing filter connected in series with the
inline sterilizing filter such that the second and inline
sterilizing filters are separated by a flow channel to prevent
grow-through contamination between membranes thereof. In variations
thereof, the twenty-second embodiments include ones in which the
mixing container and concentrate container are defined by two
bonded flexible panels along seams to define the mixing container
and concentrate container. In variations thereof, the twenty-second
embodiments include ones in which seams are a result of thermal
welding. In variations thereof, the twenty-second embodiments
include ones in which the fluid circuit encloses a sterile internal
volume.
[0444] According to twenty-third embodiments, the disclosed subject
matter includes a fluid system for peritoneal dialysis and
dialysate preparation. A disposable mixing container of polymeric
material has a pre-attached fluid circuit, the mixing container and
fluid circuit being sealed from an external environment. A
concentrate container of polymeric material is pre-attached to the
fluid circuit, the concentrate container being sealed from an
external environment. The fluid circuit includes a fluid
multiplexer that includes a valve network that has junctions and
valve portions that mechanically interface with valve actuators to
define selectable flow paths in the valve network. The valve
network further includes a concentrate line connected to the
concentrate container, a water line terminated by a water line
connector, and a pair of lines connected to the mixing container to
permit simultaneous flow into, and flow out from, the mixing
container. The water line has an inline sterilizing filter with an
air line attached thereto, the air line being connected such that
air forced through the air line applies pressure to a membrane of
the inline sterilizing filter to permit an integrity test thereof.
An actuator device has valve actuators, sensors, and a pumping
actuator. The fluid circuit has sensor and pumping portions that
engage, respectively, along with the valve portions, with effecters
of the actuator device.
[0445] In variations thereof, the twenty-third embodiments include
ones in which the valve network is in a cartridge with the pumping
portion held by a rigid manifold member thereof, the manifold
member being hollow and defining at least some of the junctions. In
variations thereof, the twenty-third embodiments include ones in
which the air line connects to a port fixedly attached to the
manifold member. In variations thereof, the twenty-third
embodiments include ones in which the manifold member is rigid and
has two separate chambers connected by the pumping portion. In
variations thereof, the twenty-third embodiments include ones in
which the valve network is supported by a panel providing support
for the cartridge, the manifold member being connected to the
panel. In variations thereof, the twenty-third embodiments include
ones in which the valve network is supported by a panel, the
manifold member being spaced apart from the panel. In variations
thereof, the twenty-third embodiments include ones in which the
manifold has pressure sensors integrated therein, one at each end
of the pumping portion. In variations thereof, the twenty-third
embodiments include ones in which pressure sensor includes a
pressure pod with a diaphragm that serves as a portion of a wall of
a respective one of the two separate chambers. In variations
thereof, the twenty-third embodiments include ones in which
respective concentrate line connectors are connected by a frame
that support a portion of the concentrate line. In variations
thereof, the twenty-third embodiments include ones in which frame
has a window and the portion of the concentrate line passes across
the window. In variations thereof, the twenty-third embodiments
include ones in which valve network has a drain line.
[0446] In variations thereof, the twenty-third embodiments include
ones in which valve network has a dialysate fill/drain line
connectable to a peritoneal catheter. In variations thereof, the
twenty-third embodiments include ones in which fill/drain line is
sealed by a removable end cap. In variations thereof, the
twenty-third embodiments include ones in which dialysate fill/drain
line has a second air line collinear with the dialysate fill/drain
line, connected at an end of the dialysate fill/drain line to a
pressure pod connected to the dialysate fill/drain line to measure
a pressure therewithin. In variations thereof, the twenty-third
embodiments include ones in which drain and water lines connected
by a frame that support portions of the drain and water lines. In
variations thereof, the twenty-third embodiments include ones in
which In variations thereof, the twenty-third embodiments include
ones in which frame has a window and portions of the drain and
water lines pass across the window. In variations thereof, the
twenty-third embodiments include ones in which the valve portions
are supported by a planar element. In variations thereof, the
twenty-third embodiments include ones in which the planar element
includes a pair of sheets shaped to hold the valve portions in
predefined positions. In variations thereof, the twenty-third
embodiments include ones in which planar element includes a pair of
sheets shaped to hold the valve portions in predefined positions,
at least one of the pair of sheets having holes in it to permit
valve actuators to contact the valve portions. In variations
thereof, the twenty-third embodiments include ones in which the
valve portions are tube segments. In variations thereof, the
twenty-third embodiments include ones in which valve portions are
tube segments. In variations thereof, the twenty-third embodiments
include ones in which the concentrate line is sealed by a frangible
seal. In variations thereof, the twenty-third embodiments include
ones in which the cartridge includes parallel panels with the valve
network sandwiched between them, the frangible seal held in the
cartridge aligned with windows in at least one of the panels to
permit an actuator to fracture them prior to use thereby allowing
the concentrate to flow through the concentrate line. In variations
thereof, the twenty-third embodiments include ones in which the
cartridge includes a single folded panel forming parallel panel
portions with the valve network sandwiched between them, the
frangible seal being held in the cartridge aligned with windows in
at least one of the panels to permit an actuator to fracture them
prior to use thereby allowing the concentrate to flow through the
concentrate line. In variations thereof, the twenty-third
embodiments include ones in which the valve network includes the
concentrate line which is sealed by a frangible seal thereby
separating the concentrate from the rest of the fluid circuit until
the frangible seal is fractured. In variations thereof, the
twenty-third embodiments include ones that include a second
sterilizing filter connected in series with the inline sterilizing
filter such that the second and inline sterilizing filters are
separated by a flow channel to prevent grow-through contamination
between membranes thereof. In variations thereof, the twenty-third
embodiments include ones in which the batch container and
concentrate container are defined by two bonded flexible panels
along seams to define the batch container and concentrate
container. In variations thereof, the twenty-third embodiments
include ones in which the seams are a result of thermal welding. In
variations thereof, the twenty-third embodiments include ones in
which the fluid circuit encloses a sterile internal volume. In
variations thereof, the twenty-third embodiments include ones in
which actuator device includes a peritoneal dialysis cycler. In
variations thereof, the twenty-third embodiments include ones in
which the drain and water lines connected by a frame that support
portions of the drain and water lines and the actuator device has a
cut-and-seal device and a receiving slot that receives the frame
and aligns a windows of the frame with the cut-and-seal device. In
variations thereof, the twenty-third embodiments include ones in
which the actuator device has a controller programmed to activate
the cut-and-seal device to cut and seal the concentrate line
thereby permitting the fluid circuit to be separated from the frame
and a concentrate line connector as well as a stub portion of the
concentrate line, which collectively remain in place on the
actuator device to act as a seal on connectors of the actuator
device.
[0447] According to twenty-fourth embodiments, the disclosed
subject matter includes a treatment method. The method includes
using a peritoneal cycler device with a fluid circuit having valve,
container, and pumping portions, the peritoneal cycler device
having actuators and sensors controlled by a controller that
interface with the valve and pumping portions for preparing
peritoneal dialysis fluid, and under control of the controller:
accessing a priming bolus comprising a first volume of a first
fluid; priming at least a patient fill line with the priming bolus;
preparing a treatment batch comprising a second volume of a second
fluid, wherein the second volume is larger than the first volume;
and performing at least one fill/drain cycle of a renal replacement
therapy through the fluid circuit and using the treatment
batch.
[0448] In variations thereof, the twenty-fourth embodiments include
ones in which the accessing a priming bolus and the preparing a
treatment batch both include diluting and mixing at least one
concentrate and the preparing the accessing a priming bolus takes
less time than the preparing of the treatment batch. In variations
thereof, the twenty-fourth embodiments include ones that include,
prior to the preparing a treatment batch, determining that a fluid
circuit is connected to a patient and preventing the preparing a
treatment batch until a fluid circuit is connected to a patient. In
variations thereof, the twenty-fourth embodiments include ones in
which the first fluid and the second fluid have a same composition
according to a same prescription. In variations thereof, the
twenty-fourth embodiments include ones in which first fluid and the
second fluid have different compositions. In variations thereof,
the twenty-fourth embodiments include ones in which first fluid is
a non-prescription fluid. In variations thereof, the twenty-fourth
embodiments include ones in which the first fluid is water or
saline.
[0449] In variations thereof, the twenty-fourth embodiments include
ones that include receiving by the controller an indication through
a user interface that quick priming is desired or determining
whether a patient is full or empty and if not, skipping the
accessing and the priming. In variations thereof, the twenty-fourth
embodiments include ones in which the priming bolus and the
treatment batch are stored in a same mixing container of the
container portions. In variations thereof, the twenty-fourth
embodiments include ones in which at least one of the priming bolus
and the treatment batch is prepared by flowing purified water and a
medicament concentrate to the mixing container to proportion and
dilute the medicament concentrate. In variations thereof, the
twenty-fourth embodiments include ones in which mixing container is
disposable. In variations thereof, the twenty-fourth embodiments
include ones in which fluid circuit is disposable and includes a
pumping tube segment and multiple valve segments of the valve
portions, wherein peritoneal cycler device includes at least one
pumping actuator positioned to engage the pumping tube segment,
wherein the peritoneal cycler device further includes multiple
valve actuators positioned to engage the valve segments. In
variations thereof, the twenty-fourth embodiments include ones in
which the preparing of the priming bolus comprises drawing a
concentrate and water through a sterilizing filter in predefined
quantities to make the first volume of the first fluid. In
variations thereof, the twenty-fourth embodiments include ones in
which the preparing of the treatment batch comprises drawing a
concentrate and water through a sterilizing filter in predefined
quantities to make the second volume of the second fluid, wherein
the second fluid is peritoneal dialysis fluid, wherein the second
volume provides a sufficient quantity of peritoneal dialysis fluid
for at least a single fill of a treatment cycle.
[0450] In variations thereof, the twenty-fourth embodiments include
ones in which the drawing includes, using an interconnection
module, connecting water and concentrate at different times to a
common inlet of the fluid circuit to which the sterilizing filter
is integrally attached. In variations thereof, the twenty-fourth
embodiments include ones that include testing the sterilizing
filter by an air pressure test and using, or preventing use of, the
quantity for a peritoneal dialysis fill and drain cycle depending
on a result of the testing. In variations thereof, the
twenty-fourth embodiments include ones that include connecting a
long-term concentrate container to the interconnection module once
every multiple peritoneal dialysis treatments. In variations
thereof, the twenty-fourth embodiments include ones in which the
fluid circuit, having a sterilizing filter integrally attached
thereto, is connected to the interconnection module once every
single peritoneal dialysis treatment.
[0451] According to twenty-fifth embodiments, the disclosed subject
matter includes a system for administering a peritoneal dialysis
treatment. A peritoneal dialysis cycler portion is connectable to a
source of priming fluid. A controller, with a user interface,
controls a fill/drain pump of the peritoneal dialysis cycler
portion. The controller requests input through the user interface
indicating whether a patient is full or empty. In response to the
controller receiving input through the user interface indicating
the patient is empty, preparing a full batch of peritoneal dialysis
fluid prior to beginning a treatment. In response to the controller
receiving input through the user interface indicating the patient
is full, initiating a quick prime mode prior to beginning a
treatment. The quick prime mode including preparing or accessing a
quick prime bolus and using it to prime a patient line.
[0452] In variations thereof, the twenty-fifth embodiments include
ones in which the quick prime bolus is of a different composition
from a peritoneal dialysis fluid. In variations thereof, the
twenty-fifth embodiments include ones in which the quick prime
bolus is of water. In variations thereof, the twenty-fifth
embodiments include ones that include, after the quick prime mode,
using the controller, draining a patient. In variations thereof,
the twenty-fifth embodiments include ones that include, in response
to the controller receiving input through the user interface
indicating the patient is empty, generating a command to prevent
access by a user to the quick prime mode.
[0453] According to twenty-sixth embodiments, the disclosed subject
matter includes a treatment method that includes preparing a
priming batch comprising a first volume of a first fluid and
priming a patient fill/drain line with the priming batch. The
method includes determining that a fluid circuit is connected to a
patient. The method includes preparing a treatment batch comprising
a second volume of a second fluid, wherein the second volume is
larger than the first volume. The method includes performing at
least one fill/drain cycle of a renal replacement therapy through
the fluid circuit and using the treatment batch.
[0454] In variations thereof, the twenty-sixth embodiments include
ones in which the preparing of the priming batch takes less time
than the preparing of the treatment batch. In variations thereof,
the twenty-sixth embodiments include ones in which the first fluid
and the second fluid have a same composition according to a same
prescription. In variations thereof, the twenty-sixth embodiments
include ones in which first fluid and the second fluid have
different compositions. In variations thereof, the twenty-sixth
embodiments include ones in which the first fluid is a
non-prescription fluid. In variations thereof, the twenty-sixth
embodiments include ones in which the first fluid is water or
saline. In variations thereof, the twenty-sixth embodiments include
ones in which the method is performed after receiving an indication
from the patient to perform quick priming. In variations thereof,
the twenty-sixth embodiments include ones in which the priming
batch and the treatment batch are stored in a same mixing
container. In variations thereof, the twenty-sixth embodiments
include ones in which at least one of the priming batch and the
treatment batch is prepared by flowing purified water and a
medicament concentrate to the mixing container to proportion and
dilute the medicament concentrate.
[0455] In variations thereof, the twenty-sixth embodiments include
ones in which the method is performed by a proportioning and
treatment device having actuators that engage with the fluid
circuit when received thereby. In variations thereof, the
twenty-sixth embodiments include ones in which the mixing container
is disposable. In variations thereof, the twenty-sixth embodiments
include ones in which the fluid circuit is disposable and includes
a pumping tube segment and multiple valve segments, wherein the
proportioning and treatment device includes at least one pumping
actuator positioned to engage the pumping tube segment, wherein the
proportioning and treatment device further includes multiple valve
actuators positioned to engage the valve segments. In variations
thereof, the twenty-sixth embodiments include ones in which the
preparing of the priming batch comprises drawing a concentrate and
water through a sterilizing filter in predefined quantities to make
the first volume of the first fluid. In variations thereof, the
twenty-sixth embodiments include ones in which the preparing of the
treatment batch comprises drawing a concentrate and water through a
sterilizing filter in predefined quantities to make the second
volume of the second fluid, wherein the second fluid is peritoneal
dialysate, wherein the second volume provides a sufficient quantity
of peritoneal dialysate for a single fill of a treatment cycle. In
variations thereof, the twenty-sixth embodiments include ones in
which the drawing includes, using an interconnection module,
connecting water and concentrate at different times to a common
inlet of the fluid circuit to which the sterilizing filter is
integrally attached. In variations thereof, the twenty-sixth
embodiments include ones that that include testing the sterilizing
filter by an air pressure test and using, or preventing use of, the
quantity for a peritoneal dialysis fill and drain cycle depending
on a result of the testing. In variations thereof, the twenty-sixth
embodiments include ones that include connecting a long-term
concentrate container to the interconnection module once every
multiple peritoneal dialysis treatments. In variations thereof, the
twenty-sixth embodiments include ones in which the fluid circuit
having the sterilizing filter integrally attached thereto is
connected to the interconnection module once every single
peritoneal dialysis treatment.
[0456] According to twenty-seventh embodiments, the disclosed
subject matter includes a system for preparation of sterile medical
treatment fluid with a disposable fluid circuit with a pumping tube
segment and multiple valve segments. A proportioning and treatment
device with a pumping actuator is shaped to engage the pumping tube
segment and multiple valve actuators positioned to engage the valve
segments. A first of the multiple valve segments is connected to a
water inlet. A second of the multiple valve segments being
connected to a first concentrate inlet. The disposable fluid
circuit has a sterilizing filter connected between each of the
water inlet and the first concentrate inlet and respective ones of
the first and second of the multiple valve segments. A first
concentrate container has sufficient concentrate for preparation of
enough peritoneal dialysate to perform multiple peritoneal dialysis
treatments, each treatment including multiple fill/drain cycles.
The disposable fluid circuit has a first concentrate inlet
connector for the first concentrate inlet which is adapted to be
connected to the first concentrate container. The disposable fluid
circuit having an integrally-attached mixing container sized to
hold sufficient peritoneal dialysate for at least a single
fill/drain cycle. The proportioning and treatment device has a
programmable controller programmed to control the pumping actuator
to pump concentrate and water into the mixing container to make a
batch of peritoneal dialysate and subsequently to perform a
fill/drain cycle including draining spent peritoneal dialysate and
pumping a fill of the peritoneal dialys ate from the mixing
container.
[0457] In variations thereof, the twenty-seventh embodiments
include ones in which the disposable fluid circuit has a second
concentrate inlet with a sterilizing filter connected between the
second concentrate inlet and a third of the multiple valve
segments. In variations thereof, the twenty-seventh embodiments
include ones that include a second concentrate container having
concentrate for the preparation of enough peritoneal dialys ate to
perform multiple peritoneal dialysis treatments each treatment
including multiple fill/drain cycles, wherein the first and second
concentrate inlets are connected to the first and second
concentrate containers by a double connector that carries the first
concentrate inlet connector and a second concentrate inlet
connector of the disposable fluid circuit, the double connector
making connections for the first concentrate inlet connector and
the second concentrate inlet simultaneously to the first and second
concentrate containers. In variations thereof, the twenty-seventh
embodiments include ones that include an interconnection module
that has a primary connector, to which the first concentrate
container is connected once every multiple treatments, and a
secondary connector to which the disposable fluid circuit first
concentrate inlet connector is connected once every treatment. In
variations thereof, the twenty-seventh embodiments include ones in
which the water inlet has a sterilizing filter with an air port
controller to allow a membrane of the sterilizing filter to be
pressure tested such as by a bubble point test, the controller
being programmed to test the sterilizing filter membrane by
applying pressure to the air port controller and measuring the
pressure after pumping water therethrough. In variations thereof,
the twenty-seventh embodiments include ones in which the controller
generates an alarm signal responsively to a result of a test of the
sterilizing filter membrane if the test indicates a disintegration
of the sterilizing filter membrane.
[0458] According to twenty-eighth embodiments, the disclosed
subject matter includes a fluid circuit for peritoneal dialysis and
dialysate preparation. A disposable mixing container of polymeric
material has a pre-attached fluid circuit, the mixing container and
fluid circuit being sealed from an external environment. The fluid
circuit includes a fluid multiplexer that has junctions and valve
portions that mechanically interface with valve actuators to define
selectable flow paths in the fluid circuit. The fluid circuit
includes at least two concentrate lines terminated by respective
concentrate line connectors, a water line terminated by a water
line connector, and one or more lines connected to permit flow into
and out of the mixing container. Each of the concentrate and water
lines has a testable inline sterilizing filter or a redundant
serially-connected pair of sterilizing filters. The fluid circuit
has a pumping portion.
[0459] In variations thereof, the twenty-eighth embodiments include
ones in which the testable inline sterilizing filters each have air
lines that are each collinear with at least a portion of a
respective one of the concentrate and water lines. In variations
thereof, the twenty-eighth embodiments include ones in which the
testable inline sterilizing filters each have air lines that are
each integral with at least a portion of a respective one of the
concentrate and water lines. In variations thereof, the
twenty-eighth embodiments include ones that include a rigid
manifold chamber with pressure sensors integrated therein, one at
each end of a pumping tube segment of the pumping portion. In
variations thereof, the twenty-eighth embodiments include ones in
which the pumping tube segment is straight. In variations thereof,
the twenty-eighth embodiments include ones in which the rigid
manifold has two separate chambers and the pressure sensor includes
a pressure pod with a diaphragm that serves as a portion of a wall
of a respective one of the two separate chambers. In variations
thereof, the twenty-eighth embodiments include ones in which the
respective concentrate line connectors are connected by a frame
that support portions of the concentrate lines. In variations
thereof, the twenty-eighth embodiments include ones in which the
frame has a window and the portions of the concentrate lines pass
across the window. In variations thereof, the twenty-eighth
embodiments include ones in which the fluid circuit has a drain
line. In variations thereof, the twenty-eighth embodiments include
ones in which the drain and water lines connected by a frame that
support portions of the drain and water lines. In variations
thereof, the twenty-eighth embodiments include ones in which the
frame has a window and portions of the drain and water lines pass
across the window. In variations thereof, the twenty-eighth
embodiments include ones in which the valve portions are supported
by a planar element. In variations thereof, the twenty-eighth
embodiments include ones in which the planar element includes a
pair of sheets shaped to hold the valve portions in predefined
positions. In variations thereof, the twenty-eighth embodiments
include ones in which the planar element includes a pair of sheets
shaped to hold the valve portions in predefined positions, at least
one of the pair of sheets having holes in it to permit valve
actuators to contact the valve portions. In variations thereof, the
twenty-eighth embodiments include ones in which the valve portions
are tube segments. In variations thereof, the twenty-eighth
embodiments include ones in which the valve portions are tube
segments.
[0460] In variations thereof, the twenty-eighth embodiments include
ones in which the fluid circuit is held by a cartridge that
includes parallel panels with the valve portions sandwiched between
them, at least two frangible seals being held in the cartridge
aligned with windows in at least one of the panels to permit an
actuator to fracture them prior to use thereby allowing the
concentrate to flow through the at least two concentrate lines.
[0461] According to twenty-ninth embodiments, the disclosed subject
matter includes a method of making a peritoneal dialysis fluid
including drawing a concentrate and water through a sterilizing
filter in predefined quantities and proportioning the concentrate
and water to make a sufficient quantity of peritoneal dialysis
fluid for at least a single fill of a peritoneal dialysis
treatment. The drawing includes, using an interconnection module,
connecting water and concentrate at different times to a common
inlet of a disposable fluid circuit to which the sterilizing filter
is integrally attached and testing the sterilizing filter by an air
pressure test and using, or preventing use of, the quantity for a
peritoneal dialysis fill and drain cycle depending on a result of
the testing.
[0462] In variations thereof, the twenty-ninth embodiments include
ones in which connecting a long-term concentrate container to the
interconnection module once every multiple peritoneal dialysis
treatments. In variations thereof, the twenty-ninth embodiments
include ones that include connecting a treatment circuit having the
sterilizing filter integrally attached thereto, to the
interconnection module once every single peritoneal dialysis
treatments. In variations thereof, the twenty-ninth embodiments
include ones that include mixing the water and the concentrate. In
variations thereof, the twenty-ninth embodiments include ones in
which the drawing and the mixing are performed using a single
common pump. In variations thereof, the twenty-ninth embodiments
include ones in which the disposable fluid circuit has at least one
concentrate container that is initially empty and the drawing a
concentrate includes filling the at least one concentrate container
with concentrate. In variations thereof, the twenty-ninth
embodiments include ones in which the proportioning includes
transferring concentrate from the at least one concentrate
container to a mixing container. In variations thereof, the
twenty-ninth embodiments include ones in which the proportioning
includes transferring water through the common inlet to a mixing
container. In variations thereof, the twenty-ninth embodiments
include ones in which the proportioning includes transferring
concentrate from the at least one concentrate container to a mixing
container and transferring water through the common inlet to a
mixing container.
[0463] According to thirtieth embodiments, the disclosed subject
matter includes a method of performing a peritoneal dialysis
treatment including drawing a concentrate and water through a
sterilizing filter in predefined quantities to make a sufficient
quantity of peritoneal dialysate for a single fill of a peritoneal
dialysis treatment. The drawing includes connecting water and
concentrate at different times to a common inlet of a disposable
fluid circuit to which the sterilizing filter is integrally
attached.
[0464] In variations thereof, the thirtieth embodiments include
ones in which the sterilizing filters includes separate filter
elements connected in series by a flow channel In variations
thereof, the thirtieth embodiments include ones that include
testing the sterilizing filter by an air pressure test and using,
or preventing use of, the quantity for a peritoneal dialysis fill
and drain cycle depending on a result of the testing. In variations
thereof, the thirtieth embodiments include ones that include
connecting a long term concentrate container to an interconnection
module once every multiple peritoneal dialysis treatments. In
variations thereof, the thirtieth embodiments include ones that
include connecting a treatment circuit having the sterilizing
filter integrally attached thereto, to the interconnection module
once every single peritoneal dialysis treatments. In variations
thereof, the thirtieth embodiments include ones that include mixing
the water and the concentrate. In variations thereof, the thirtieth
embodiments include ones in which the drawing and the mixing are
performed using a single common pump.
[0465] According to thirty-first embodiments, the disclosed subject
matter includes a method of performing a peritoneal dialysis
treatment including drawing a concentrate and water through
respective sterilizing filters in predefined quantities to make a
sufficient quantity of peritoneal dialys ate for a single fill of a
peritoneal dialysis treatment. The drawing includes, using an
interconnection module, flowing water and concentrate in succession
to a mixing container the flowing water and concentrate in
succession including switching flow paths in a peritoneal dialysis
cycler. The method includes ensuring an integrity of the respective
sterilizing filters by testing them or providing the respective
sterilizing filters as serially-connected redundant sterilizing
filter elements.
[0466] In variations thereof, the thirty-first embodiments include
ones that include connecting a long term concentrate container to
the interconnection module once every multiple peritoneal dialysis
treatments. In variations thereof, the thirty-first embodiments
include ones that include connecting a treatment circuit having the
respective sterilizing filters integrally attached thereto, to the
interconnection module once every single peritoneal dialysis
treatments. In variations thereof, the thirty-first embodiments
include ones that include mixing the water and the concentrate. In
variations thereof, the thirty-first embodiments include ones in
which the drawing and the mixing are performed using a single
common pump. In variations thereof, the thirty-first embodiments
include ones in which the connecting a treatment circuit includes
removing at least one sterile seal from water and concentrate
connectors and connecting one or more new connectors of the
treatment circuit to water and concentrate connectors and wherein
following the using the quantity, cutting one or more portions of
the one or more new connectors to create at least one new sterile
seal. In variations thereof, the thirty-first embodiments include
ones in which the interconnection module supports a connector of
the concentrate container, the connecting a long term concentrate
connector including replacing the connector of the concentrate
container and the connecting a treatment circuit includes
connecting the treatment circuit to the connector of the
concentrate container. In variations thereof, the thirty-first
embodiments include ones in which the flowing water and concentrate
in succession using the interconnection module includes washing a
fixed volume of concentrate from a common outlet of the
interconnection module and an inlet of a disposable fluid circuit,
the method further comprising, using a controller used to make the
sufficient quantity, calculating an amount of the fixed volume and
controlling an amount of water pumped to form the sufficient
quantity responsively to a result of the calculating.
[0467] According to thirty-second embodiments, the disclosed
subject matter includes a system for preparation of sterile medical
treatment fluid. A disposable fluid circuit has a pumping tube
segment and multiple valve segments. A proportioning and treatment
device has at least one pumping actuator positioned to engage the
at least one pumping tube segment and multiple valve actuators
positioned to engage the multiple valve segments. A first of the
multiple valve segments is connected to a fluid inlet. The
disposable fluid circuit has a sterilizing filter connected between
a fluid inlet connector and the first of the multiple valve
segments. A first concentrate container has sufficient concentrate
for preparation of enough peritoneal dialysate to perform multiple
peritoneal dialysis treatments, each treatment including multiple
fill/drain cycles. The disposable fluid circuit having an
integrally-attached mixing container sized to hold sufficient
peritoneal dialysate for at least a single fill/drain cycle. An
interconnection module has a primary concentrate connector and a
primary water connector, to which the first concentrate container
is connected once every multiple treatments. The interconnection
module also has a common secondary connector to which the
disposable fluid circuit fluid inlet connector is connected once
every treatment. The interconnection module has a valve network
controlled by a programmable controller that selects water or
concentrate to flow through the common secondary connector. The
proportioning and treatment device has a programmable controller
programmed to control the at least one pumping actuator to pump
concentrate and water into the mixing container to make a batch of
peritoneal dialysate and subsequently to perform a fill/drain cycle
including draining spent peritoneal dialysate and pumping a fill of
the peritoneal dialysate from the mixing container.
[0468] In variations thereof, the thirty-third embodiments include
ones that include a controller, the controller being programmed to
calculate and store data representing a volume of water or
concentrate remaining in a portion of the valve network after
selecting water or concentrate to be drawn by the proportioning and
treatment device and to control the pump responsively to the data
representing a volume of water or concentrate.
[0469] According to thirty-fourth embodiments, the disclosed
subject matter includes a method of making a fluid circuit having a
chamber prefilled with medicament concentrate. The method includes
integrally connecting a fluid circuit with a chamber and connecting
a sterilizing filter with the chamber. The integrally connecting
and connecting a sterilizing filter forms an assembly with a sealed
volume that is separated from an outside environment by walls
thereof, a frangible plug in a concentrate outlet line stemming
from the chamber, and a membrane of the sterilizing filter. The
method includes sterilizing the assembly. The method includes
sterile-filling the chamber with concentrate through the
sterilizing filter. The method includes permanently sealing and
then cutting a line connecting the sterilizing filter and the
chamber and subjecting the fluid circuit and chamber to gamma or
e-beam sterilization.
[0470] According to thirty-fifth embodiments, the disclosed subject
matter includes a method of making a fluid circuit having a chamber
prefilled with medicament concentrate. The method includes
integrally connecting a fluid circuit with a chamber. The method
includes connecting a sterilizing filter with the chamber. The
integrally connecting and connecting a sterilizing filter form an
assembly with a sealed volume that is separated from an outside
environment by walls thereof, a frangible plug in a concentrate
outlet line stemming from the chamber, and a membrane of the
sterilizing filter. The method includes sterilizing the assembly.
The method includes sterile-filling the chamber with concentrate
through the sterilizing filter. The method includes heat welding
and cutting a line connecting the sterilizing filter and the
chamber and subjecting the fluid circuit and chamber to gamma or
e-beam sterilization.
[0471] According to thirty-fifth embodiments, the disclosed subject
matter includes a fluid line connector with at least one
thermoplastic tube supported in a frame such that the at least one
thermoplastic tube is accessible from opposite sides of the frame.
The frame has an overhanging ridge at one end and at least one
connector that is fluidly coupled at an opposite end to the at
least one thermoplastic tube. A cap is fitted to the frame to cover
the at least one connector. The at least one tube extends through
holes in the frame at end thereof adjacent the overhanging
ridge.
[0472] In variations thereof, the thirty-fifth embodiments include
ones in which the frame has a recess shaped to engage a detente pin
along an elongate side thereof. In variations thereof, the
thirty-fifth embodiments include ones in which the frame has an
oval-shaped recess, the at least one connector being located within
the oval-shaped recess. In variations thereof, the thirty-fifth
embodiments include ones in which the cap fits in the oval-shaped
recess to define a tortuous path between the at least one connector
and an access of the oval-shaped recess. In variations thereof, the
thirty-fifth embodiments include ones in which at least one
connector and the at least one thermoplastic tubes are at least
two.
[0473] According to thirty-sixth embodiments, the disclosed subject
matter includes a connector system. A connector component has at
least one thermoplastic tube supported in a frame such that the at
least one thermoplastic tube is accessible from opposite sides of
the frame. The frame has an overhanging ridge at one end and at
least one connector that is fluidly coupled at an opposite end to
the at least one thermoplastic tube. A cap is fitted to the frame
to cover the at least one connector. The at least one tube extends
through holes in the frame at an end thereof adjacent the
overhanging ridge. A fluid supply device has at least one supply
connector that mates with the at least one connector, the fluid
supply device having a portion shaped to engage the frame to align
the at least one thermoplastic tube with a tube cut-and-seal
device.
[0474] In variations thereof, the thirty-sixth embodiments include
ones in which the cut-and-seal device cuts the at least one
thermoplastic tube and seals it at both ends, the connector
component being configured to permit the at least one thermoplastic
tube to be withdrawn from the one end leaving the frame and at
least one connector in place on the at least one supply connector
to cover and protect it from contamination until it is replaced by
another connector component. In variations thereof, the
thirty-sixth embodiments include ones in which the frame has a
recess shaped to engage a detente pin along an elongate side
thereof. In variations thereof, the thirty-sixth embodiments
include ones in which the frame has an oval-shaped recess, the at
least one connector being located within the oval-shaped recess. In
variations thereof, the thirty-sixth embodiments include ones in
which the cap fits in the oval-shaped recess to define a tortuous
path between the at least one connector and an access of the
oval-shaped recess. In variations thereof, the thirty-sixth
embodiments include ones in which at least one connector and the at
least one thermoplastic tubes are at least two. In variations
thereof, the thirty-sixth embodiments include ones in which the
frame has a recess shaped to engage a detente pin along an elongate
side thereof. In variations thereof, the thirty-sixth embodiments
include ones in which the frame has an oval-shaped recess, the at
least one connector being located within the oval-shaped
recess.
[0475] In variations thereof, the thirty-sixth embodiments include
ones in which the cap fits in the oval-shaped recess to define a
tortuous path between the at least one connector and an access of
the oval-shaped recess. In variations thereof, the thirty-sixth
embodiments include ones in which at least one connector and the at
least one thermoplastic tubes are at least two.
[0476] According to thirty-seventh embodiments, the disclosed
subject matter includes a fluid proportioning system with first and
second manifolds connected by a pump. A port on the first manifold
is provided for connection of a last-fill medicament and/or an
auxiliary fluid. A controller is programmed to control the pump to
draw, according to a command generated by the controller, a last
fill or an auxiliary fluid.
[0477] In variations thereof, the thirty-seventh embodiments
include ones that include a mixing container, the controller being
programmed to transfer the auxiliary fluid to the mixing container
and to use contents thereof to fill a peritoneum. In variations
thereof, the thirty-seventh embodiments include ones in which the
controller fills the mixing container with a fill of peritoneal
dialysate prior to controlling the pump to draw a last fill or an
auxiliary fluid. In variations thereof, the thirty-seventh
embodiments include ones in which the controller is programmed to
use contents of the mixing container to perform a peritoneal
dialysis treatment.
[0478] According to thirty-eighth embodiments, the disclosed
subject matter includes a method of mixing a medicament, the method
including using a controller, combining respective quantities of
water and liquid first medicament concentrate in a first target
concentration calculated by the controller responsively to a map of
allowed and disallowed ratios and a final prescribed concentration
of the first medicament to generate an initial mixture. The method
includes using the controller, testing the concentration of the
initial mixture including measuring a conductivity of thereof. The
method includes using the controller, responsively to the testing,
diluting the initial mixture to a second target concentration of
first medicament and further testing the concentration of a
resulting second mixture including measuring a conductivity
thereof.
[0479] In variations thereof, the thirty-eighth embodiments include
ones that include, using the controller, adding a second medicament
concentrate to the second mixture.
[0480] In variations thereof, the thirty-eighth embodiments include
ones in which the first target is based on an optimization of total
pumping time to minimize the time it to prepare a completed mixed
batch of medicament.
[0481] According to thirty-ninth embodiments, the disclosed subject
matter includes a system for making a peritoneal dialysis fluid.
The system includes a peritoneal dialysis system component
connectable to first and second containers of first and second
concentrates and a water source and a disposable fluid circuit with
a pumping portion and a mixing container. The system includes
pumping and valve actuators controlled by a controller, which
controls them to engage the disposable fluid circuit to create a
predefined mixture of water, a first concentrate, and a second
concentrate to form a ready-to-use peritoneal dialysate by:
[0482] (a) pumping a first quantity of water into the mixing
container;
[0483] (b) pumping an amount of the first concentrate into the
mixing container estimated to achieve a target conductivity of
contents of the mixing container;
[0484] (c) testing a conductivity of the mixing container contents
and, responsively to a result of the testing, adjusting a target
amount of water and a target amount of a second concentrate to add
to the mixing container if a result of the testing indicates a
conductivity above the target conductivity;
[0485] (d) outputting an indication of a failed in-process mixture
if the conductivity is below the target conductivity;
[0486] (e) adding an adjusted target amount of water and an
adjusted target amount of second concentrate to the mixing
container; and
[0487] (f) testing a conductivity of contents of the mixing
container and depending on a result of the testing, outputting an
indication of a successful or failed in-process mixture.
[0488] In variations thereof, the thirty-ninth embodiments include
ones in which, after the adding an adjusted target amount of water,
testing a conductivity of the contents of the mixing container and
adding a further amount of water if a conductivity resulting from
the testing is higher than a target. In variations thereof, the
thirty-ninth embodiments include ones in which an amount of water
added by the adding a further amount of water is responsive to the
conductivity resulting from the testing.
[0489] According to fortieth embodiments, the disclosed subject
matter includes a method of forming a batch of treatment fluid. The
method includes adding water to a mixing container. The method
includes adding a first concentrate to the mixing container and
testing a conductivity of its contents. The method includes
outputting an indication of a failed batch in the mixing container
if the conductivity is below a first predefined level. The method
includes, responsively to the conductivity, calculating an
additional quantity of water and an additional quantity of a second
concentrate to be added to the mixing container if the conductivity
is above the predefined level. The method includes adding water and
the second concentrate, including the additional quantities, to the
mixing container.
[0490] In variations thereof, the fortieth embodiments include ones
that include testing the conductivity of the mixing container
contents and responsively to the conductivity outputting an
indication of a failed batch in the mixing container if the
conductivity is below a second predefined level.
[0491] According to forty-first embodiments, the disclosed subject
matter includes a method of preparing a batch of treatment fluid.
The method includes adding a quantity of an osmotic agent to a
mixing container containing an electrolyte and detecting quantity
of the added osmotic agent by a reduction in a conductivity of a
solution in the mixing container.
[0492] In variations thereof, the forty-first embodiments includes
ones that include adjusting a concentration of water or electrolyte
responsively to a result of the detecting in order to achieve a
target mixture of electrolyte and osmotic agent.
[0493] According to forty-second embodiments, the disclosed subject
matter includes a method of preparing a batch of treatment fluid.
The method includes
[0494] adding a fraction of a final quantity of water plus a first
concentrate to a mixing container;
[0495] mixing the contents of the mixing container and testing a
first conductivity of the contents;
[0496] if the first conductivity is below a first predefined range,
outputting an indication of a failure of the mixing container
contents;
[0497] if the first conductivity is above the first predefined
range, calculating a first additional amount of water, to add to
the final quantity, responsive to the first conductivity, plus an
additional quantity beyond a final quantity of a second concentrate
and add the second concentrate to the mixing container;
[0498] if the first conductivity is in the first predefined range,
add the second concentrate to the mixing container;
[0499] adding a remainder of the final quantity of water plus the
additional amount of water, if calculated, to the mixing
container;
[0500] mixing the contents of the mixing container and testing a
second conductivity of the contents;
[0501] if the second conductivity is below a second predefined
range, outputting an indication of a failure of the mixing
container contents; and
[0502] if the second conductivity is within the second predefined
range, making the contents of the mixing container available for a
treatment.
[0503] In variations thereof, the forty-second embodiments include
ones in which, if the second conductivity is above the second
predefined range, adding the first additional amount of water plus
a second additional amount of water responsive to the second
conductivity. In variations thereof, the forty-second embodiments
include ones that include using the contents of the mixing
container for a dialysis treatment. In variations thereof, the
forty-second embodiments include ones that include using the
contents of the mixing container for a peritoneal dialysis
treatment.
[0504] According to forty-third embodiments, the disclosed subject
matter includes method of making a batch of peritoneal dialysis
fluid. The method includes:
[0505] (a) adding a first amount of water to a mixing container
that is less than required to make the batch of peritoneal dialysis
fluid;
[0506] (b) adding a first concentrate to the mixing container,
mixing the mixing container contents, measuring a resulting first
conductivity of the mixing container contents, and determining if
the first conductivity is in a first range;
[0507] (c) if the first conductivity is in the first range, adding
a second concentrate to the mixing container, mixing the mixing
container contents, and measuring a resulting second conductivity
of the mixing container contents;
[0508] (d) if the second conductivity is in a second range, adding
water to the mixing container, mixing and measuring a resulting
third conductivity of the mixing container contents;
[0509] (e) if the third conductivity falls in a third range,
generating a signal indicating the contents of the mixing container
form a usable batch of peritoneal dialysis fluid;
[0510] (f) if the first conductivity is outside the first range,
calculating an amount of water or first concentrate responsively to
the first conductivity and an estimated quantity of fluid in the
mixing container and adding the amount of water or first
concentrate to the mixing container, mixing the mixing container
contents, and measuring a resulting fourth conductivity of the
mixing container contents;
[0511] (g) if the fourth conductivity is in the first range, adding
the second concentrate to the mixing container, mixing the mixing
container contents, and measuring a resulting fifth conductivity of
the mixing container contents;
[0512] (h) if the fifth conductivity is in the second range, adding
water to the mixing container, mixing the mixing container
contents, measuring a resulting sixth conductivity of the mixing
container;
[0513] (i) if the sixth conductivity is in the third range,
generating a signal indicating the contents of the mixing container
form a usable batch of peritoneal dialysis fluid; and
[0514] (j) if the second conductivity is outside the second range,
the third conductivity is outside the third range, the fourth
conductivity is outside the first range, the fifth conductivity is
outside the second range, or the sixth conductivity is outside the
third range, generating a signal indicating to terminate the making
of a batch.
[0515] In variations thereof, the forty-third embodiments include
ones in which the first concentrate is electrolyte concentrate and
the second concentrate is osmotic agent concentrate. In variations
thereof, the forty-third embodiments include ones in which the
first concentrate is osmotic agent concentrate and the second
concentrate is electrolyte concentrate.
[0516] According to forty-fourth embodiments, the disclosed subject
matter includes a method for making a batch of peritoneal dialysis
fluid. The method includes:
[0517] (a) adding water to a mixing container;
[0518] (b) adding electrolyte concentrate to the mixing
container;
[0519] (c) mixing contents of the mixing container and measuring
the conductivity of its contents;
[0520] (d) if the conductivity measured at (c) is in a first range,
performing step (h) and if the conductivity measured at (c) is
outside the first range performing step (e);
[0521] (e) estimating an amount of water or electrolyte
concentrate, responsively to the conductivity measured in step (c),
to bring the conductivity of the contents of the mixing container
within the first range;
[0522] (f) adding the amount of water estimated in (e) to the
mixing container, mixing the contents of the mixing container, and
measuring the conductivity of its contents;
[0523] (g) if the conductivity measured in step (f) is outside a
second range, generating a command to abort the making of the batch
and performing step (p);
[0524] (h) calculating a quantity of a second concentrate according
to a predefined ratio of the first and second concentrates
responsively to a calculated quantity of fluid held by the mixing
container and the conductivity measured at step (d) if the
conductivity measured at step (c) was in the first range or the
conductivity measured at (f) if not;
[0525] (i) adding the quantity of the second concentrate calculated
at step (h) to the mixing container, mixing the contents of the
mixing container, and measuring the conductivity thereof;
[0526] (j) if the conductivity measured at step (i) is outside the
second range, generating a command to abort the making of the batch
and going to step (p);
[0527] (k) if the conductivity measured at step (i) is in the
second range, then calculating a quantity of water to add to the
mixing container responsively to the conductivity measured at step
(i) and a calculated quantity of fluid held by the mixing
container;
[0528] (m) adding the quantity of water calculated at step (k) to
the mixing container, mixing the contents of the mixing container,
and measuring the conductivity of its contents;
[0529] (n) if the conductivity measured at step (m) falls in a
third range, generating a command indicating the mixing container
contents are usable;
[0530] (o) if the conductivity measured at step (m) fall outside
the third range, generating a command to abort the making of the
batch; and
[0531] (p) terminating the method.
[0532] In variations thereof, the forty-fourth embodiments include
ones in which the first concentrate is electrolyte concentrate and
the second concentrate is osmotic agent concentrate. In variations
thereof, the forty-fourth embodiments include ones in which the
first concentrate is osmotic agent concentrate and the second
concentrate is electrolyte concentrate. In variations thereof, the
forty-fourth embodiments include ones in which a quantity of the
adding electrolyte at step (b) is responsive to an estimate of an
amount required for a completed batch. In variations thereof, the
forty-fourth embodiments include ones in which each of the
measuring the conductivity includes draining a portion of the
contents of the mixing container. In variations thereof, the
forty-fourth embodiments include ones in which the quantity of the
adding electrolyte at step (b) is responsive to an estimate of a
quantity of every instance of draining a portion.
[0533] According to forty-fifth embodiments, the disclosed subject
matter includes a method of preparing a batch of treatment fluid.
The method includes adding a quantity of an osmotic agent to a
mixing container containing an electrolyte and detecting quantity
of the added osmotic agent by a reduction in a conductivity of a
solution in the mixing container.
[0534] In variations thereof, the forty-fifth embodiments include
ones in which adjusting a concentration of water or electrolyte
responsively to a result of the detecting in order to achieve a
target mixture of electrolyte and osmotic agent.
[0535] According to forty-sixth embodiments, the disclosed subject
matter includes a method of performing a peritoneal dialysis
treatment. The method includes performing a fill cycle of a
peritoneal dialysis treatment. The method includes performing a
drain cycle of a peritoneal dialysis treatment and during the drain
cycle, diverting at least one fraction of spent peritoneal dialysis
fluid to a sample container to collect a sample.
[0536] In variations thereof, the forty-sixth embodiments include
ones in which the sample includes multiple fractions of spent
peritoneal dialysis diverted at different times during the drain
cycle. In variations thereof, the forty-sixth embodiments include
ones in which the different times, stored in a controller, are
calculated to make the sample representative of the composition of
all of the spent peritoneal dialysis fluid of a full drain cycle.
In variations thereof, the forty-sixth embodiments include ones in
which the diverting includes filling a container of less than 500
ml. In variations thereof, the forty-sixth embodiments include ones
that include, using a controller, outputting instructions for
handling the sample container. In variations thereof, the
forty-sixth embodiments include ones that include, using a
controller, outputting instructions for handling the sample
container. In variations thereof, the forty-sixth embodiments
include ones that include, using a controller, outputting
instructions for removing, sealing, and delivering a sample
collected in the sample container.
[0537] According to forty-seventh embodiments, the disclosed
subject matter includes a method of performing a peritoneal
dialysis treatment. The method includes using a controller, during
a peritoneal dialysis drain cycle, according to a schedule of
fractioning times stored in a controller, diverting fractions of
spent peritoneal dialysis fluid from spent peritoneal dialysis
fluid to a sample container. The schedule is responsive to
predicted variations in the composition of the spent peritoneal
dialysis fluid during a drain cycle and the fractioning times
indicate times and durations of the fractions.
[0538] In variations thereof, the forty-seventh embodiments include
ones in which the times and durations are independent of each
other. In variations thereof, the forty-seventh embodiments include
ones in which at least two of the durations are different from each
other. In variations thereof, the forty-seventh embodiments include
ones that include, diverting spent dialysis fluid other than the
fractions to a drain responsively to the schedule.
[0539] According to forty-eighth embodiments, the disclosed subject
matter includes a method of performing a peritoneal dialysis
treatment. The method includes, using a controller, performing
multiple drain cycles over the course of a peritoneal dialysis
treatment and, for at least one of the drain cycles, diverting one
or more fractions of spent peritoneal dialysis fluid from one or
more of the multiple drain cycles and to a respective sample
container for each of the multiple drain cycles. The method
includes diverting one or more portions of the spent peritoneal
dialysis fluid other than the one or more fractions, to a drain or
waste collection container. The timings of the diverting of the one
or more fractions are selected such that the resulting composition
of the contents of each sample represent a composition of all, or a
portion, of the entire contents of a respective one of the drain
cycles.
[0540] In variations thereof, the forty-eighth embodiments include
ones that include comparing the contents of one or more of the
respective sample containers to a model that estimates the
composition of all, or a portion, of the entire contents of a
respective one of the drain cycles. In variations thereof, the
forty-eighth embodiments include ones that include accepting input
from a user interface of the controller indicating a total volume
of the one or more fractions for each of the one or more of the
multiple drain cycles, the controller using the input to control
the total volume during the peritoneal dialysis treatment. In
variations thereof, the forty-eighth embodiments include ones that
include accepting input from a user interface of the controller
indicating spacings of timings of the one or more fractions for
each of the one or more of the multiple drain cycles, the
controller using the input to control the spacings of timings
during the peritoneal dialysis treatment.
[0541] In variations thereof, the forty-eighth embodiments include
ones in which the one or more fractions is a plurality of
fractions, the method further comprising accepting input from a
user interface of the controller indicating a timing of a first of
the plurality of fractions for each of the one or more of the
multiple drain cycles, the controller using the input to control
the timing of a first of the plurality of fractions during the
peritoneal dialysis treatment. In variations thereof, the
forty-eighth embodiments include ones in which the one or more
fractions is a single fraction, the method further comprising
accepting input from a user interface of the controller indicating
a timing of the single fraction for each of the one or more of the
multiple drain cycles, the controller using the input to control
the timing of the single fraction during the peritoneal dialysis
treatment. In variations thereof, the forty-eighth embodiments
include ones that include accepting input from a user interface of
the controller indicating a quantity of an initial one of the
portions of the spent peritoneal dialysis other than the one or
more fractions, the controller using the input to control the
quantity of an initial one of the portions during the peritoneal
dialysis treatment. In variations thereof, the forty-eighth
embodiments include ones that include accepting input from a user
interface of the controller indicating treatment days on which to
collect the one or more fractions and corresponding combinations of
parameters for each of the treatment days to create a sampling
schedule, the controller using the schedule to control the
collection of the one or more fractions according to corresponding
combinations of parameters over successive peritoneal dialysis
treatments.
[0542] In variations thereof, the forty-eighth embodiments include
ones in which a user interface of the controller accepts input
indicating a maximum number of reschedulings of days on which to
collect the one or more fractions, the method further comprising,
using the controller, preventing input attempting to reschedule
more than the maximum number of days on which to collect the one or
more fractions. In variations thereof, the forty-eighth embodiments
include ones in which a user interface of the controller accepts
input indicating a schedule of days on which to collect the one or
more fractions by date, day of week, day of month, or number of
times in a predefined interval, the method further comprising,
using the controller, controlling the days on which the one or more
fractions are collected over successive peritoneal dialysis
treatments. In variations thereof, the forty-eighth embodiments
include ones in which the controller controls a number of the one
or more fractions per drain cycle, a number of sample containers to
fill with corresponding ones of the one or more fractions during a
treatment, or a flow rate of draining, or any combination thereof,
responsively to input received from a user interface.
[0543] According to forty-ninth embodiments, the disclosed subject
matter includes a dialysis system. A dialysis device has a
proportioning element configured to generate dialysis fluid and a
cycler to deliver dialysis fluid to a patient to perform dialysis
therapy. The dialysis device further has a digital controller
configured to direct a sequence of operations for the therapy. The
dialysis device further includes a wireless interface configured to
communicate with a wireless device or to write to or read from a
data carrier including one of a near field communication (NFC)
device and a radio frequency identification (RFID) device.
[0544] In variations thereof, the forty-ninth embodiments include
ones in which the dialysis device is configured to upload a
prescription for a peritoneal dialysis therapy through the wireless
interface. In variations thereof, the forty-ninth embodiments
include ones in which the wireless interface is configured to
transfer a digital record of therapy data following a treatment to
the wireless device. In variations thereof, the forty-ninth
embodiments include ones in which the wireless interface is
configured to read a prescription or peritoneal dialysis therapy
from the wireless device. In variations thereof, the forty-ninth
embodiments include ones in which the wireless interface is
configured to read patient identifying information from a phone, a
tablet, a computer, NFC, or RFID device. In variations thereof, the
forty-ninth embodiments include ones in which the wireless
interface is configured to read patient information from the
wireless device. In variations thereof, the forty-ninth embodiments
include ones in which the wireless interface is configured to
transfer system logging information to the wireless device. In
variations thereof, the forty-ninth embodiments include ones in
which the wireless interface is configured to transfer diagnostic
system logging information to the wireless device. In variations
thereof, the forty-ninth embodiments include ones in which the
wireless device includes a phone, a tablet, and NFC device or an
RFID device or a computer.
[0545] According to fiftieth embodiments, the disclosed subject
matter includes a method of priming a dialysis fluid circuit. The
method includes priming a dialysis fluid circuit with priming fluid
using a pump having a pumping tube segment and running the pump
with priming fluid by recirculating the priming fluid for a
predetermined period of time beyond that required for priming the
dialysis fluid circuit.
[0546] In variations thereof, the fiftieth embodiments include ones
in which the pump is a peristaltic pump. In variations thereof, the
fiftieth embodiments include ones in which the predetermined period
of time is effective to break-in the pumping tube segment. In
variations thereof, the fiftieth embodiments include ones in which
the predetermined period of time is determined based on an estimate
of the time or number of pump rotations required to cause a
relationship between pump cycles and flow rate to vary by less than
a predetermined rate. In variations thereof, the fiftieth
embodiments include ones in which the priming includes
recirculating priming fluid in a loop through the pumping tube
segment. In variations thereof, the fiftieth embodiments include
ones in which the predetermined period of time is determined
responsive to an estimate of a relationship between pump cycles and
flow rate to vary by less than a predetermined rate.
[0547] It will be appreciated that the modules, processes, systems,
and sections described above can be implemented in hardware,
hardware programmed by software, software instruction stored on a
non-transitory computer readable medium or a combination of the
above. For example, a method for preparing a treatment fluid and/or
treating a patient can be implemented, for example, using a
processor configured to execute a sequence of programmed
instructions stored on a non-transitory computer readable medium.
For example, the processor can include, but not be limited to, a
personal computer or workstation or other such computing system
that includes a processor, microprocessor, microcontroller device,
or is comprised of control logic including integrated circuits such
as, for example, an Application Specific Integrated Circuit (ASIC).
The instructions can be compiled from source code instructions
provided in accordance with a programming language such as Java,
C++, C#.net or the like. The instructions can also comprise code
and data objects provided in accordance with, for example, the
Visual Basic.TM. language, LabVIEW, or another structured or
object-oriented programming language. The sequence of programmed
instructions and data associated therewith can be stored in a
non-transitory computer-readable medium such as a computer memory
or storage device which may be any suitable memory apparatus, such
as, but not limited to read-only memory (ROM), programmable
read-only memory (PROM), electrically erasable programmable
read-only memory (EEPROM), random-access memory (RAM), flash
memory, disk drive and the like.
[0548] Furthermore, the modules, processes, systems, and sections
can be implemented as a single processor or as a distributed
processor. Further, it should be appreciated that the steps
mentioned above may be performed on a single or distributed
processor (single and/or multi-core). Also, the processes, modules,
and sub-modules described in the various figures of and for
embodiments above may be distributed across multiple computers or
systems or may be co-located in a single processor or system.
Exemplary structural embodiment alternatives suitable for
implementing the modules, sections, systems, means, or processes
described herein are provided below.
[0549] The modules, processors or systems described above can be
implemented as a programmed general purpose computer, an electronic
device programmed with microcode, a hard-wired analog logic
circuit, software stored on a computer-readable medium or signal,
an optical computing device, a networked system of electronic
and/or optical devices, a special purpose computing device, an
integrated circuit device, a semiconductor chip, and a software
module or object stored on a computer-readable medium or signal,
for example.
[0550] Embodiments of the method and system (or their
sub-components or modules), may be implemented on a general-purpose
computer, a special-purpose computer, a programmed microprocessor
or microcontroller and peripheral integrated circuit element, an
ASIC or other integrated circuit, a digital signal processor, a
hardwired electronic or logic circuit such as a discrete element
circuit, a programmed logic circuit such as a programmable logic
device (PLD), programmable logic array (PLA), field-programmable
gate array (FPGA), programmable array logic (PAL) device, or the
like. In general, any process capable of implementing the functions
or steps described herein can be used to implement embodiments of
the method, system, or a computer program product (software program
stored on a non-transitory computer readable medium).
[0551] It will be evident from the context that in many instances
that a water source may be, or include, a water purifier or a water
filtration system. See for example, water filtration system 551 in
FIGS. 22A through 22C.
[0552] Furthermore, embodiments of the disclosed method, system,
and computer program product may be readily implemented, fully or
partially, in software using, for example, object or
object-oriented software development environments that provide
portable source code that can be used on a variety of computer
platforms. Alternatively, embodiments of the disclosed method,
system, and computer program product can be implemented partially
or fully in hardware using, for example, standard logic circuits or
a very-large-scale integration (VLSI) design. Other hardware or
software can be used to implement embodiments depending on the
speed and/or efficiency requirements of the systems, the particular
function, and/or particular software or hardware system,
microprocessor, or microcomputer being utilized. Embodiments of the
method, system, and computer program product can be implemented in
hardware and/or software using any known or later developed systems
or structures, devices and/or software by those of ordinary skill
in the applicable art from the function description provided herein
and with a general basic knowledge of control system, fluid
handling systems, medical treatment and/or computer programming
arts.
[0553] Moreover, embodiments of the disclosed method, system, and
computer program product can be implemented in software executed on
a programmed general purpose computer, a special purpose computer,
a microprocessor, or the like.
[0554] FIG. 14 shows a block diagram of an example computer system
according to embodiments of the disclosed subject matter. In
various embodiments, all or parts of system 1000 may be included in
a medical treatment device/system such as a renal replacement
therapy system. In these embodiments, all or parts of system 1000
may provide the functionality of a controller of the medical
treatment device/systems. In some embodiments, all or parts of
system 1000 may be implemented as a distributed system, for
example, as a cloud-based system.
[0555] System 1000 includes a computer 1002 such as a personal
computer or workstation or other such computing system that
includes a processor 1006. However, alternative embodiments may
implement more than one processor and/or one or more
microprocessors, microcontroller devices, or control logic
including integrated circuits such as ASIC.
[0556] Computer 1002 further includes a bus 1004 that provides
communication functionality among various modules of computer 1002.
For example, bus 1004 may allow for communicating information/data
between processor 1006 and a memory 1008 of computer 1002 so that
processor 1006 may retrieve stored data from memory 1008 and/or
execute instructions stored on memory 1008. In one embodiment, such
instructions may be compiled from source code/objects provided in
accordance with a programming language such as Java, C++, C#, .net,
Visual Basic.TM. language, LabVIEW, or another structured or
object-oriented programming language. In one embodiment, the
instructions include software modules that, when executed by
processor 1006, provide renal replacement therapy functionality
according to any of the embodiments disclosed herein.
[0557] Memory 1008 may include any volatile or non-volatile
computer-readable memory that can be read by computer 1002. For
example, memory 1008 may include a non-transitory computer-readable
medium such as ROM, PROM, EEPROM, RAM, flash memory, disk drive,
etc. Memory 1008 may be a removable or non-removable medium.
[0558] Bus 1004 may further allow for communication between
computer 1002 and a display 1018, a keyboard 1020, a mouse 1022,
and a speaker 1024, each providing respective functionality in
accordance with various embodiments disclosed herein, for example,
for configuring a treatment for a patient and monitoring a patient
during a treatment.
[0559] Computer 1002 may also implement a communication interface
1010 to communicate with a network 1012 to provide any
functionality disclosed herein, for example, for alerting a
healthcare professional and/or receiving instructions from a
healthcare professional, reporting patient/device conditions in a
distributed system for training a machine learning algorithm,
logging data to a remote repository, etc. Communication interface
1010 may be any such interface known in the art to provide wireless
and/or wired communication, such as a network card or a modem.
[0560] Bus 1004 may further allow for communication with a sensor
1014 and/or an actuator 1016, each providing respective
functionality in accordance with various embodiments disclosed
herein, for example, for measuring signals indicative of a
patient/device condition and for controlling the operation of the
device accordingly. For example, sensor 1014 may provide a signal
indicative of a viscosity of a fluid in a fluid circuit in a renal
replacement therapy device, and actuator 1016 may operate a pump
that controls the flow of the fluid responsively to the signals of
sensor 1014.
[0561] It is, thus, apparent that there is provided, in accordance
with the present disclosure, methods, devices, and system for
preparing fluids, managing fluids, sterilizing fluids, treating
patients and other functions. Many alternatives, modifications, and
variations are enabled by the present disclosure. Features of the
disclosed embodiments can be combined, rearranged, omitted, etc.,
within the scope of the invention to produce additional
embodiments. Furthermore, certain features may sometimes be used to
advantage without a corresponding use of other features.
Accordingly, Applicants intend to embrace all such alternatives,
modifications, equivalents, and variations that are within the
spirit and scope of the present invention.
* * * * *