U.S. patent application number 15/478562 was filed with the patent office on 2017-10-05 for peritoneal dialysate fluid generation system.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Martin T. Gerber, Christopher M. Hobot, VenKatesh R. Manda.
Application Number | 20170281845 15/478562 |
Document ID | / |
Family ID | 58549271 |
Filed Date | 2017-10-05 |
United States Patent
Application |
20170281845 |
Kind Code |
A1 |
Manda; VenKatesh R. ; et
al. |
October 5, 2017 |
PERITONEAL DIALYSATE FLUID GENERATION SYSTEM
Abstract
Systems and methods of generating peritoneal dialysate are
provided. The systems and methods use a water purification module,
a sterilization module and concentrates to prepare a bolus of
peritoneal dialysate from source water for use with an
non-integrated cycler.
Inventors: |
Manda; VenKatesh R.;
(Stillwater, MN) ; Gerber; Martin T.; (Maple
Grove, MN) ; Hobot; Christopher M.; (Rogers,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
58549271 |
Appl. No.: |
15/478562 |
Filed: |
April 4, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62318169 |
Apr 4, 2016 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 31/716 20130101;
C02F 1/442 20130101; A61M 1/287 20130101; A61M 2205/3584 20130101;
A61L 2202/21 20130101; A61M 2209/10 20130101; C02F 1/42 20130101;
C02F 1/325 20130101; A61M 2205/7518 20130101; A61M 1/1656 20130101;
A61M 2205/75 20130101; C02F 2303/04 20130101; A61K 31/19 20130101;
A61M 1/28 20130101; A61L 2/0023 20130101; C02F 1/02 20130101; A61M
1/1686 20130101; A61K 33/14 20130101; A61M 1/282 20140204; A61M
2205/502 20130101; A61M 1/1674 20140204; C02F 1/001 20130101; C02F
1/28 20130101; C02F 1/444 20130101; C02F 1/441 20130101; A61M
2205/3337 20130101; A61K 33/06 20130101; C02F 1/283 20130101; A61M
1/1666 20140204; A61M 1/1672 20140204; A61K 33/00 20130101; A61L
2/0017 20130101; A61L 2/0047 20130101; A61M 2205/50 20130101; A61K
31/7004 20130101 |
International
Class: |
A61M 1/28 20060101
A61M001/28; A61K 33/14 20060101 A61K033/14; A61L 2/00 20060101
A61L002/00; A61K 33/06 20060101 A61K033/06; A61K 33/00 20060101
A61K033/00; A61K 31/716 20060101 A61K031/716; A61K 31/7004 20060101
A61K031/7004; A61K 31/19 20060101 A61K031/19 |
Claims
1. A system, comprising: a water source; a peritoneal dialysate
generation flow path; wherein the peritoneal dialysate generation
flow path is fluidly connectable to the water source; one or more
water purification modules fluidly connectable to the peritoneal
dialysate generation flow path; a concentrate source fluidly
connectable to the peritoneal dialysate generation flow path; the
concentrate source containing one or more solutes; and a
sterilization module fluidly connectable to the peritoneal
dialysate generation flow path.
2. The system of claim 1, further comprising one or more dialysate
containers fluidly connectable to the peritoneal dialysate
generation flow path downstream of the sterilization module.
3. (canceled)
4. The system of claim 1, wherein the concentrate source comprises
at least an osmotic agent source and an ion concentrate source.
5. The system of claim 4, wherein the concentrate source comprises
multiple osmotic agent sources, and/or multiple ion concentrate
sources.
6. The system of claim 5, wherein the osmotic agent sources contain
osmotic agents selected from the group consisting of dextrose,
icodextrin, glucose, and amino acids.
7. The system of claim 4, wherein the ion concentrate source
comprises one or more from the group consisting of sodium chloride,
sodium lactate, magnesium chloride, calcium chloride, potassium
chloride, and sodium bicarbonate.
8. (canceled)
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. The system of claim 1, further comprising a control system,
wherein the control system operates one or more pumps and valves to
control movement of fluid through the system; wherein the control
system either (a) comprises a timer, wherein the timer causes the
control system to generate peritoneal dialysate at a predetermined
time; and/or (b) comprises a user interface, wherein the user
interface causes the control system to generate peritoneal
dialysate at a selected time.
15. (canceled)
16. (canceled)
17. The system of claim 1 wherein the sterilization module
comprises one or more selected from the group of one or more
ultrafilters, a UV light source, a heater, a flash pasteurization
module, a microbial filter, and combinations thereof.
18. The system claim 17, wherein the sterilization module comprises
either or both of: a UV light source positioned downstream of an
ultrafilter; and/or at least two ultrafilters.
19. (canceled)
20. The system of claim 1, wherein the water purification module
comprises one or more selected from the group consisting of a
sorbent cartridge, activated carbon, a reverse osmosis module, a
carbon filter, and a nanofilter.
21. A method, comprising the steps of: pumping fluid from a water
source to a water purification module in a peritoneal dialysate
generation flow path; adding one or more concentrate solutions to
the fluid; and pumping the fluid through a sterilization
module.
22. The method of claim 21, further comprising the step of pumping
the fluid into one or more dialysate containers.
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. The method of claim 21, wherein the step of adding one or more
concentrate solutions to the fluids comprises adding at least an
osmotic agent and an ion concentrate to the fluid; wherein the
osmotic agent and ion concentrate are added to the fluid from a
single concentrate source; or wherein the osmotic agent and ion
concentrate are added to the fluid from separate concentrate
sources.
30. (canceled)
31. The method of claim 29, wherein the osmotic agent is one or
more selected from the group consisting of glucose, dextrin, and
icodextrin.
32. (canceled)
33. The method of claim 29, wherein multiple osmotic agents are
added to the fluid from a single osmotic agent source or wherein
multiple osmotic agents are added to the fluid from separate
osmotic agent sources; and wherein each of the ion concentrates are
added to the fluid from a single ion concentrate source or wherein
multiple ion concentrates are added to the fluid from separate ion
concentrate sources.
34. (canceled)
35. The method of claim 29, wherein the ion concentrate is added
from one or more ion concentrate sources and comprises one or more
from the group consisting of sodium chloride, sodium lactate,
magnesium chloride, calcium chloride, potassium chloride, and
sodium bicarbonate.
36. (canceled)
37. (canceled)
38. (canceled)
39. The method of claim 21, wherein the method is carried out by a
peritoneal dialysate generation system; wherein the peritoneal
dialysate generation system comprises either or both of (a) a
timer, wherein the peritoneal dialysate generation system carries
out the method at predetermined times; and/or (b) a user interface,
wherein the method is carried out based on input from the user
interface.
40. (canceled)
41. (canceled)
42. The method of claim 21, wherein the water purification module
comprises one or more selected from the group consisting of a
sorbent cartridge, activated carbon, a reverse osmosis module, a
carbon filter and a nanofilter.
43. The method of claim 21, wherein the sterilization module
comprises one or more selected from the group of one or more
ultrafilters, a UV light source, a microbial filter, and
combinations thereof.
44. The method of claim 43, wherein the sterilization module
comprises either or both of the UV light source positioned
downstream of the ultrafilter, and/or at least two
ultrafilters.
45. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of and priority to U.S.
Provisional Patent Application No. 62/318,169 filed Apr. 4, 2016,
the entire disclosure of which is incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The invention relates to devices, systems, and methods for
generating a peritoneal dialysate having purity and sterility
characteristics suitable for Peritoneal Dialysis (PD). The
peritoneal dialysate can be generated from water of variable
quality using a dialysate generation flow path containing a
sterilization module. The sterilization module can be any one or
more of an ultrafilter, Ultraviolet (UV) light source, microbial
filter, dialyzer, and combinations thereof. Peritoneal dialysate
generation system and related methods are described that can
automatically generate peritoneal dialysate fluid.
BACKGROUND
[0003] Peritoneal Dialysis (PD), including Automated Peritoneal
Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis
(CAPD), is a dialysis treatment that can be performed at home,
either by the patient alone or with a care-giver. PD differs from
Hemodialysis (HD) in that blood is not removed from the body and
passed through a dialyzer, but rather a catheter is placed in the
peritoneal cavity and dialysate introduced directly into the
peritoneal cavity. Blood is cleaned inside the patient using the
patient's own peritoneum as a type of dialysis membrane. However,
because fluid is directly introduced into a human body, the fluid
used for peritoneal dialysate is generally required to be free of
biological and chemical contaminants. The peritoneal dialysate
should also contain specified concentrations of solutes, buffer,
osmotic agent and cations for biocompatibility and for performing
membrane exchange.
[0004] Peritonitis is a serious and common problem in the PD
population that results in abdominal pain, fever, and cloudy
dialysate. Peritonitis remains a leading complication of PD with
around 18% of infection-related mortality in PD patients resulting
from peritonitis (Fried et al., "Peritonitis influences mortality
in peritoneal dialysis patients," J. Am. Soc. Nephrol. 1996;
7:2176-2182). Moreover, peritonitis is a contributing factor to
death in 16% of deaths on PD, and remains a major cause for
patients discontinuing PD and switching to HD. Peritonitis and
other peritoneal dialysis complications can oftentimes be traced to
non-sterile techniques and/or contaminated starting dialysate.
[0005] The US FDA regulates pre-packaged dialysate for use in PD as
a Class II drug if the pre-packaged dialysate is used in either an
automatic or semi-automated PD system (e.g., cycler system). See 21
C.F.R. Sec. 876.5630. If the peritoneal dialysate is not
pre-packaged, the US FDA requires the dialysate be prepared from a
dialysate concentrate and "sterile purified water," which is
defined by the FDA in 21 C.F.R. Sec. 165.110(a)(2)(iv) and (vii).
Some possible contaminants present in water used to prepare
dialysis fluid can be (i) particles, (ii) chemicals, and (iii)
microbial contaminants such as bacteria, fungi and yeasts, and
microbial derivatives or fragments (e.g., endotoxins released
during active growth and lysis of micro-organisms). In additional
to meeting purity and sterility requirements, peritoneal dialysate
must also contain specific and precise amounts of solutes, such as
sodium chloride, sodium bicarbonate, and cation infusates.
[0006] Because traditional peritoneal dialysis systems require
FDA-approved, pre-packaged dialysate, the dialysate can be
expensive due to high manufacturing, shipping, and storage costs.
Shortages can also occur. These problems are not mitigated by
on-site dialysate preparation because the source water must still
meet high fluid purity and sterility characteristics. Such
standards may be difficult to meet, particularly for continuous,
automatic peritoneal dialysis machines designed for home use.
Further, traditional systems usually require storage of hundreds of
liters of dialysate bags, including 300 L or more of peritoneal
dialysate and over 300 kg of fluid per month.
[0007] Known systems and methods require significant space to store
peritoneal dialysate prior to use. Continuous ambulatory peritoneal
dialysis (CAPD) traditionally uses 1-4 exchanges of peritoneal
dialysate a day, with an overnight dwell. Because each exchange
requires approximately 2-4 L of peritoneal dialysate, use of
prepackaged dialysate requires storing about 8-16 L of dialysate
per day, or 56-112 L of dialysate per week. Automated peritoneal
dialysis uses a cycler to cycle peritoneal dialysis into and out of
the peritoneal cavity of the patient, generally at night. APD
generally uses 3-5 exchanges daily, requiring up to 20 L of
dialysate per day and up to 140 L of dialysate per week. Tidal
Peritoneal Dialysis (TPD) is similar to APD with the exception that
a between 250 mL to 1000 mL of the peritoneal dialysate is left in
the peritoneal cavity of the patient between infusions. The known
systems and methods require significant storage space and can deter
the adoption of CAPD, APD, or TPD.
[0008] There is a need for systems and methods that can generate
peritoneal dialysate using water of varying quality. The need
includes generating peritoneal dialysate on-demand, so that no
extra space is required for storing peritoneal dialysate.
Generating the peritoneal dialysate can be any one or more of
automatic, selective, or continuous. The need includes peritoneal
dialysate having purity and sterility requirements such that
patients will not contract an infection due to bacteria or other
pathogens in fluid used for peritoneal dialysate. The need is acute
for automated fluid generation for continuous dialysis machines for
use at home where a water source can be tap water or other
non-sterile source. There is also a need for systems and methods
that allow for automatically generating dialysate suitable for
peritoneal dialysis containing proper amounts of solutes and
cations.
[0009] There is further a need for a system that uses filtration,
as opposed to heat, in sterilization of the dialysate, which
reduces the generation of glucose degradation products. There is
also a need for a system that can generate peritoneal dialysate on
demand, or for direct infusion into the patient, reducing the
storage time and space requirements, as well as lowering the
probability of loss of sterility of the dialysate.
SUMMARY OF THE INVENTION
[0010] The first aspect of the invention relates to a peritoneal
dialysis system. In any embodiment of the first aspect of the
invention, the system has a water source; a peritoneal dialysate
generation flow path; wherein the peritoneal dialysate generation
flow path is fluidly connectable to the water source; one or more
water purification modules fluidly connectable to the peritoneal
dialysate generation flow path; a concentrate source fluidly
connectable to the peritoneal dialysate generation flow path; the
concentrate source containing one or more solutes; and a
sterilization module fluidly connectable to the peritoneal
dialysate generation flow path.
[0011] In any embodiment of the first aspect of the invention, the
system has one or more dialysate containers fluidly connectable to
the peritoneal dialysate generation flow path downstream of the
sterilization module.
[0012] In any embodiment of the first aspect of the invention, the
concentrate source includes one or more of an osmotic agent and an
ion concentrate.
[0013] In any embodiment of the first aspect of the invention, the
concentrate source includes at least an osmotic agent source and an
ion concentrate source.
[0014] In any embodiment of the first aspect of the invention, the
concentrate source includes multiple osmotic agent sources.
[0015] In any embodiment of the first aspect of the invention, the
osmotic agent sources contain osmotic agents selected from the
group of dextrose, icodextrin, amino acids and glucose.
[0016] In any embodiment of the first aspect of the invention, the
ion concentrate source includes one or more from the group of
sodium chloride, sodium lactate, magnesium chloride, calcium
chloride, potassium chloride, and sodium bicarbonate.
[0017] In any embodiment of the first aspect of the invention, the
concentrate source includes multiple ion concentrate sources.
[0018] In any embodiment of the first aspect of the invention, the
system includes a concentrate pump positioned between the
concentrate source and the peritoneal dialysate generation flow
path for controlled addition of fluid from the concentrate source
to the peritoneal dialysate generation flow path.
[0019] In any embodiment of the first aspect of the invention, the
system includes multiple dialysate containers fluidly connectable
to the peritoneal dialysate generation flow path.
[0020] In any embodiment of the first aspect of the invention, a
volume of the dialysate container is between any of 1 to 20 L, 1 to
2 L, 1 to 3 L, 2 to 6 L, 2 to 4 L, 6 to 10 L, 8 to 10 L, 8 to 12 L,
10 to 12 L, 10 to 15 L, or 12 to 20 L.
[0021] In any embodiment of the first aspect of the invention, each
dialysate container has a volume between any of 1 to 6 L, 1 to 3 L,
1.5 to 3 L, 2 and 4 L, or 3 to 6 L.
[0022] In any embodiment of the first aspect of the invention, the
system includes one or more valves and one or more flow meters to
control addition of peritoneal dialysate to each of the dialysate
containers.
[0023] In any embodiment of the first aspect of the invention, the
system includes a control system, wherein the control system
operates one or more pumps and valves to control movement of fluid
through the system.
[0024] In any embodiment of the first aspect of the invention, the
control system has a timer, and wherein the timer causes the
control system to generate peritoneal dialysate at a predetermined
time.
[0025] In any embodiment of the first aspect of the invention, the
control system has a user interface, wherein the user interface
causes the control system to generate peritoneal dialysate at a
selected time.
[0026] In any embodiment of the first aspect of the invention, the
sterilization module can include one or more ultrafilters; a UV
light source; a heater, a flash pasteurization module, a microbial
filter; or combinations thereof.
[0027] In any embodiment of the first aspect of the invention, the
sterilization module can include a UV light source positioned
downstream of the ultrafilter.
[0028] In any embodiment of the first aspect of the invention, the
sterilization module can include at least two ultrafilters.
[0029] In any embodiment of the first aspect of the invention, the
water purification module includes one or more selected from the
group of a sorbent cartridge, activated carbon, a reverse osmosis
module, a carbon filter, and a nanofilter.
[0030] The features disclosed as being part of the first aspect of
the invention can be in the first aspect of the invention, either
alone or in combination, or follow a preferred arrangement of one
or more of the described elements.
[0031] The second aspect of the invention is directed to a method.
In any embodiment of the second aspect of the invention, the method
includes the steps of pumping fluid from a water source to a water
purification module in a peritoneal dialysate generation flow path;
adding one or more concentrate solutions to the fluid; and pumping
the fluid through a sterilization module.
[0032] In any embodiment of the second aspect of the invention, the
method includes the step of pumping the fluid into one or more
dialysate containers.
[0033] In any embodiment of the second aspect of the invention, the
step of pumping the fluid into one or more dialysate containers
includes pumping the fluid into multiple dialysate containers.
[0034] In any embodiment of the second aspect of the invention,
wherein the step pumping the fluid into multiple dialysate
containers includes pumping between any of 1 to 6 L, 1 to 3 L, 1.5
to 3 L, 2 to 4L, or 3 L to 6 L into each dialysate container.
[0035] In any embodiment of the second aspect of the invention, the
step of pumping the fluid into one or more dialysate containers
includes pumping the fluid into a single dialysate container.
[0036] In any embodiment of the second aspect of the invention, the
step pumping the fluid into a single dialysate container includes
pumping between any of 1 to 6 L, 1 to 3 L, 1.5 to 3 L, 2 to 4L, or
3 to 6 L into the single dialysate container.
[0037] In any embodiment of the second aspect of the invention, the
step pumping the fluid into a single dialysate container includes
pumping between any of 6 to 20 L, 6 to 10 L, 8 to 10 L, 8 to 12 L,
10 to 12 L, 10 to 15 L, or 12 to 20 L into the single dialysate
container.
[0038] In any embodiment of the second aspect of the invention, the
step of adding one or more concentrate solutions to the fluid
includes adding at least an osmotic agent and an ion concentrate to
the fluid.
[0039] In any embodiment of the second aspect of the invention, the
osmotic agent and ion concentrate are added to the fluid from a
single concentrate source.
[0040] In any embodiment of the second aspect of the invention, the
osmotic agent and ion concentrate are added from separate
concentrate sources.
[0041] In any embodiment of the second aspect of the invention, the
osmotic agent is one or more selected from the group of glucose,
dextrin, and icodextrin.
[0042] In any embodiment of the second aspect of the invention, the
osmotic agent includes multiple osmotic agents.
[0043] In any embodiment of the second aspect of the invention, the
multiple osmotic agents are added from a single source.
[0044] In any embodiment of the second aspect of the invention,
each of the multiple osmotic agents are added from separate
sources.
[0045] In any embodiment of the second aspect of the invention, the
ion concentrate is added from one or more ion concentrate sources
and includes one or more from the group of sodium chloride, sodium
lactate, magnesium chloride, calcium chloride, potassium chloride,
and sodium bicarbonate.
[0046] In any embodiment of the second aspect of the invention,
each of the ion concentrates are added to the fluid from a single
ion concentrate source.
[0047] In any embodiment of the second aspect of the invention, the
ion concentrate source includes multiple ion concentrate sources;
and wherein each of the multiple ion concentrate sources has
different solutes.
[0048] In any embodiment of the second aspect of the invention, the
step of adding one or more concentrate solutions to the fluid
includes controlling an addition of concentrate from each of the
ion concentrate sources to generate a fluid with a prescribed
solute concentration.
[0049] In any embodiment of the second aspect of the invention, the
method is carried out by a peritoneal dialysate generation
system.
[0050] In any embodiment of the second aspect of the invention, the
peritoneal dialysate generation system includes a timer; wherein
the peritoneal dialysate generation system carries out the method
at predetermined times.
[0051] In any embodiment of the second aspect of the invention, the
peritoneal dialysate generation system includes a user interface,
and the method is carried out based on input from the user
interface.
[0052] In any embodiment of the second aspect of the invention, the
water purification module includes one or more selected from the
group of a sorbent cartridge, activated carbon, a reverse osmosis
module, a carbon filter, and a nanofilter.
[0053] In any embodiment of the second aspect of the invention, the
sterilization module can include one or more ultrafilters; a UV
light source; a microbial filter; or combinations thereof.
[0054] In any embodiment of the first aspect of the invention, the
sterilization module can include a UV light source positioned
downstream of the ultrafilter.
[0055] In any embodiment of the first aspect of the invention, the
sterilization module can include at least two ultrafilters.
[0056] The features disclosed as being part of the second aspect of
the invention can be in the second aspect of the invention, either
alone or in combination, or follow a preferred arrangement of one
or more of the described elements.
BRIEF DESCRIPTION OF THE DRAWINGS
[0057] FIG. 1 shows a flow path for generating peritoneal
dialysate.
[0058] FIG. 2 shows a system for adding concentrates to a
peritoneal dialysate generation flow path.
[0059] FIG. 3 shows a system for peritoneal dialysate having
multiple dialysate containers.
[0060] FIG. 4 shows an overview of a system for generating and
using peritoneal dialysate with a single concentrate source.
[0061] FIG. 5 shows an overview of a system for generating and
using peritoneal dialysate with multiple concentrate sources.
[0062] FIG. 6 shows an alternative flow path for generating
peritoneal dialysate.
[0063] FIG. 7A shows a perspective view of a peritoneal dialysate
generation cabinet with a bag as a dialysate container.
[0064] FIG. 7B shows a front view of a peritoneal dialysate
generation cabinet with a bag as a dialysate container.
[0065] FIG. 7C shows a peritoneal dialysate generation cabinet with
the doors shut.
[0066] FIG. 8 shows a peritoneal dialysate generation cabinet with
a reusable dialysate container.
[0067] FIGS. 9A-D show a peritoneal dialysate generation cabinet
for generation of peritoneal dialysate.
[0068] FIG. 10 shows a peritoneal dialysate generation cabinet
connected to a sink and drain.
[0069] FIG. 11 shows a dialysis caddy for use in a peritoneal
dialysate generation flow path.
[0070] FIG. 12 shows optional dispensing options for using
peritoneal dialysate generated by the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0071] Unless defined otherwise, all technical and scientific terms
used have the same meaning as commonly understood by one of
ordinary skill in the art.
[0072] The articles "a" and "an" are used to refer to one or to
over one (i.e., to at least one) of the grammatical object of the
article. For example, "an element" means one element or over one
element.
[0073] "Activated carbon" refers to a form of carbon processed to
have small pores, increasing the surface area available for
adsorption.
[0074] The term "amino acid," as used herein, refers to any
nitrogen containing organic acid or peptide that can be used as an
osmotic agent to generate peritoneal dialysate.
[0075] The term "calcium chloride source" refers to a source of
calcium chloride in solid and/or solution form. The calcium
chloride source can contain at least one fluid pathway and include
components such as conduits, valves, filters or fluid connection
ports, any of which are fluidly connectable to each other or to a
fluid flow path. The calcium chloride source can either be formed
as a stand-alone enclosure or a compartment integrally formed with
an apparatus for dialysis for containing the calcium chloride
source.
[0076] A "carbon filter" is a bed of activated carbon.
[0077] The term "comprising" includes, but is not limited to,
whatever follows the word "comprising." Use of the term indicates
the listed elements are required or mandatory but that other
elements are optional and may be present.
[0078] A "concentrate pump" is a pump configured to move fluid
between a concentrate source and a flow path.
[0079] A "concentrate solution" is a solution of one or more
solutes in water. The concentrate solution can have a solute
concentration greater than that to be used in dialysis.
[0080] A "concentrate source" is a source of one or more solutes.
The concentrate source can have one or more solutes that has a
solute concentration greater than the solute concentration to be
used for dialysis.
[0081] A "connector" and "for connection" describe the concept of
forming a fluid connection between two components wherein fluid,
gas, or mixture of both gas and fluid can flow from one component,
through a connector or a component for connection, to another
component. The connector provides for a fluid connection in its
broadest sense and can include any type of tubing, fluid or gas
passageway, or conduit between any one or more components of the
invention.
[0082] The term "consisting of" includes and is limited to whatever
follows the phrase "consisting of." The phrase indicates the
limited elements are required or mandatory and that no other
elements may be present.
[0083] The term "consisting essentially of" includes whatever
follows the term "consisting essentially of" and additional
elements, structures, acts or features that do not affect the basic
operation of the apparatus, structure or method described.
[0084] The terms "control," "controlling," or "controls" refers to
the ability of one component to direct the actions of a second
component.
[0085] A "control system" can be a combination of components acting
together to maintain a system to a desired set of performance
specifications. The control system can use processors, memory and
computer components configured to interoperate to maintain the
desired performance specifications. The control system can also
include fluid or gas control components, and solute control
components as known within the art to maintain the performance
specifications.
[0086] The terms "controlled addition," to "control addition," or
"controlling addition" refer to the ability to add one or more
substances or fluids to a flow path or container in an accurately
controllable amount.
[0087] The phrase "controlling the movement of fluid" refers to
directing fluid through a flow path, container, receptacle, or
reservoir of any type.
[0088] The term "dextrose source" refers to a source of dextrose in
solid and/or solution form. The dextrose source can interface with
at least one other module found in systems for dialysis. The
dextrose source can contain at least one fluid pathway and include
components such as conduits, valves, filters or fluid connection
ports, any of which are fluidly connectable to each other or to a
fluid flow path. The dextrose source can either be formed as a
stand-alone enclosure or a compartment integrally formed with an
apparatus for dialysis for containing a dextrose source.
[0089] The term "dialysate" describes a fluid into or out of which
solutes from a fluid to be dialyzed diffuse through a membrane.
Dialysate can differ depending on the type of dialysis to be
carried out. For example, dialysate for peritoneal dialysis may
include different solutes or different concentrations of solutes
than dialysate for hemodialysis.
[0090] A "dialysate container" is any container capable of storing
or containing dialysate for dialysis. The container any be of any
suitable, size, geometry, or configuration.
[0091] The term "dialysis caddy" refers to a container detachably
removable from a dialysis system, the caddy configured to hold one
or more other containers. In any embodiment, the caddy can include
one or more connectors for fluid connection from the containers to
the dialysis system.
[0092] The term "downstream" refers to a position of a first
component in a flow path relative to a second component wherein
fluid will pass by the second component prior to the first
component during normal operation. The first component can be said
to be "downstream" of the second component, while the second
component is "upstream" of the first component.
[0093] A "fitting feature" is any protrusion, indentation, groove,
ridge, having any shape, size, or geometry that ensures that only a
corresponding fitting feature complementary to the fitting feature
can form a connection or fit to the corresponding fitting feature.
The fitting feature can also include non-mechanical means for
ensuring complementary connection such as magnets placed at
particular locations, or visual or aural indicators such as color,
lettering, or sound. The fitting feature can be affixed, integral,
or labeled on a component or surface to ensure a corresponding
feature on a desired component or surface can mate or connect to
the component or surface having the fitting feature.
[0094] A "flash pasteurization module" is a component or set of
components capable of heating a fluid to a high temperature and
recirculating the fluid for sterilization.
[0095] A "flow meter" is a device capable of measuring an amount or
rate of fluid moving past or through a particular location.
[0096] The term "fluid" can be any substance without a fixed shape
that yields easily to external pressure such as a gas or a liquid.
Specifically, the fluid can be water containing any solutes at any
concentration. The fluid can also be dialysate of any type
including fresh, partially used, or spent.
[0097] The terms "fluid connection," "fluidly connectable," or
"fluidly connected" refer to the ability to pass fluid or gas from
one point to another point. The two points can be within or between
any one or more of compartments, modules, systems, and components,
all of any type.
[0098] The terms "to generate peritoneal dialysate" or "peritoneal
dialysate generation" refers to creating a peritoneal dialysate
solution from constituent parts.
[0099] The term "glucose source" refers to a source of glucose in
solid and/or solution form. The glucose source can interface with
at least one other module found in systems for dialysis. The
glucose source can contain at least one fluid pathway and include
components such as conduits, valves, filters or fluid connection
ports, any of which are fluidly connectable to each other or to a
fluid flow path. The glucose source can either be formed as a
stand-alone enclosure or a compartment integrally formed with an
apparatus for dialysis for containing a glucose source.
[0100] A "heater" is a component capable of raising the temperature
of a substance, container, or fluid.
[0101] An "ion concentrate" refers to one or more ionic compounds.
The ion concentrate can have one or more ionic compounds in the ion
concentrate. Further, the ion concentrate can have an ion
concentration greater than an ion concentration to be used in
dialysis.
[0102] An "ion concentrate source" refers to a source of one or
more ionic compounds. The ion concentrate source can be in water or
solid form. The ion concentrate source can further have one or more
ionic compounds that are at a higher ion concentration greater than
generally used in dialysis.
[0103] The term "level of sterility" refers to an estimated
probability of viable organisms surviving a sterilization
process.
[0104] The term "magnesium chloride source" refers to a source of
magnesium chloride in solid and/or solution form. The magnesium
chloride source can interface with at least one other module found
in systems for dialysis. The magnesium chloride source can contain
at least one fluid pathway and include components such as conduits,
valves, filters or fluid connection ports, any of which are fluidly
connectable to each other or to a fluid flow path. The magnesium
chloride source can either be formed as a stand-alone enclosure or
a compartment integrally formed with an apparatus for dialysis for
containing a magnesium chloride source.
[0105] The term "microbial filter" refers to a device inhibiting
passage of microbes or fragments of microbes such as endotoxins in
a fluid or solution while allowing the passage of the fluid or
solution.
[0106] A "nanofilter" is a filter membrane having nanometer sized
pores.
[0107] An "osmotic agent" is a substance dissolved in water capable
of driving a net movement of water by osmosis across a
semi-permeable membrane due to concentration differences of the
osmotic agent on each side of the semi-permeable membrane.
[0108] An "osmotic agent source" refers to a source of osmotic
agents in solid and/or solution form. The osmotic agent source can
interface with at least one other module found in systems for
dialysis. The osmotic agent source can contain at least one fluid
pathway and include components such as conduits, valves, filters or
fluid connection ports, any of which are fluidly connectable to
each other or to a fluid flow path. The osmotic agent source can
either be formed as a stand-alone enclosure or a compartment
integrally formed with an apparatus for dialysis for containing an
osmotic agent source.
[0109] "Peritoneal dialysate" is a dialysis solution to be used in
peritoneal dialysis having specified parameters for purity and
sterility. Peritoneal dialysate is not the same as dialysate used
in hemodialysis although peritoneal dialysate may be used in
hemodialysis.
[0110] "Peritoneal dialysis" is a therapy wherein a dialysate is
infused into the peritoneal cavity, which serves as a natural
dialyzer. In general, waste components diffuse from a patient's
bloodstream across a peritoneal membrane into the dialysis solution
via a concentration gradient. In general, excess fluid in the form
of plasma water flows from a patient's bloodstream across a
peritoneal membrane into the dialysis solution via an osmotic
gradient. Once the infused peritoneal dialysis solution has
captured sufficient amounts of the waste components the fluid is
removed. This cycle can be repeated for several cycles each day or
as needed.
[0111] A "peritoneal dialysate generation flow path" is a path used
in generating dialysate suitable for peritoneal dialysis.
[0112] The term "prescribed solute concentration" refers to the
concentration of one or more solutes in peritoneal dialysate
intended for use by a patient.
[0113] A "predetermined time" is a set time for an event to occur,
such as a set time of day, or a set length of time from a previous
event.
[0114] The term "pump" refers to any device which causes the
movement of fluids or gases by applying suction or pressure.
[0115] The terms "pumping fluid" or to "pump fluid" refer to moving
a fluid through a flow path with a pump.
[0116] A "purified water source" is a water source containing
purified water.
[0117] "Purified water" can be defined as water produced by
distillation, deionization, reverse osmosis, or other suitable
processes and meets the definition of "purified water" in the
United States Pharmacopeia, 23d Revision, Jan. 1, 1995, and the FDA
at 21 CFR Section .sctn.165.110(a)(2)(iv). Other criteria for
purified water can be determined by those of skill in the art,
particularly as relating to purified water suitable for peritoneal
dialysis.
[0118] A "reverse osmosis module" is a set of components to drive
fluid through one or more semipermeable membranes, wherein pressure
is used to move the fluid from a side of the semipermeable membrane
with a higher concentration of one or more solutes to a side of the
semipermeable membrane with a lower concentration of the one or
more solutes.
[0119] The term "sodium chloride source" refers to a source of
sodium chloride in solid and/or solution form. The sodium chloride
source can interface with at least one other module found in
systems for dialysis. The sodium chloride source can contain at
least one fluid pathway and include components such as conduits,
valves, filters or fluid connection ports, any of which are fluidly
connectable to each other or to a fluid flow path. The sodium
chloride source can either be formed as a stand-alone enclosure or
a compartment integrally formed with an apparatus for dialysis for
containing a sodium chloride source.
[0120] The term "sodium lactate source" refers to a source of
sodium lactate in solid and/or solution form. The sodium lactate
source can interface with at least one other module found in
systems for dialysis. The sodium lactate source can contain at
least one fluid pathway and include components such as conduits,
valves, filters or fluid connection ports, any of which are fluidly
connectable to each other or to a fluid flow path. The sodium
lactate source can either be formed as a stand-alone enclosure or a
compartment integrally formed with an apparatus for dialysis for
containing a sodium lactate source.
[0121] A "solute" is a substance dissolved in a solvent, such as
water.
[0122] The term "sorbent cartridge" refers to a cartridge
containing one or more sorbent materials for removing specific
solutes from solution. The term "sorbent cartridge" does not
require the contents in the cartridge be sorbent based, and the
contents of the sorbent cartridge can be any contents capable of
removing solutes from a dialysate. The sorbent cartridge may
include any suitable amount of one or more sorbent materials. In
certain instances, the term "sorbent cartridge" refers to a
cartridge which includes one or more sorbent materials besides one
or more other materials capable of removing solutes from dialysate.
"Sorbent cartridge" can include configurations where at least some
materials in the cartridge do not act by mechanisms of adsorption
or absorption.
[0123] A "sterilization module" is a component or set of components
to sterilize a fluid by removing or destroying chemical or
biological contaminants.
[0124] A "timer" is a device capable of determining the time of
day, or the time elapsed between multiple events.
[0125] An "ultrafilter" is a semi permeable membrane through which
a fluid can pass with removal of one or more solutes or particles
from the fluid.
[0126] The term "upstream" refers to a position of a first
component in a flow path relative to a second component wherein
fluid will pass by the first component prior to the second
component during normal operation. The first component can be said
to be "upstream" of the second component, while the second
component is "downstream" of the first component.
[0127] A "user interface" is a component that allows a user to
communicate information or instructions to a processor or a memory
device and to receive information or instructions from the
processor or memory device.
[0128] A "UV light source" is a component which uses ultraviolet
light to kill biological contaminants in a fluid.
[0129] A "valve" is a device capable of directing the flow of fluid
or gas by opening, closing or obstructing one or more pathways to
allow the fluid or gas to travel in a path. One or more valves
configured to accomplish a desired flow can be configured into a
"valve assembly."
[0130] The term "water purification module" refers to a component
or components capable of removing biological or chemical
contaminants from water.
[0131] The term "water source" refers to a source from which
potable water can be obtained.
[0132] "Zirconium oxide" refers to a polymer of the form ZrO.sub.2
with one or more anionic molecules adsorbed onto the surface of the
zirconium oxide polymer. In any embodiment, the zirconium oxide
polymer can act as an anion exchange material, removing anions from
a fluid for the anions originally adsorbed onto the surface of the
zirconium oxide.
[0133] "Zirconium phosphate" refers to a material of the form
Zr(HPO.sub.4).sub.2, with or without water molecules associated as
hydrates. The zirconium phosphate material can have one or more
cationic species adsorbed into the material, which can be exchanged
with cations present in a fluid to which the zirconium phosphate is
exposed.
Peritoneal Dialysis System
[0134] The first and second aspects of the invention relate to
systems and methods for generating a peritoneal dialysate solution.
The solution can be generated continuously or in a bolus. The
peritoneal dialysate can be generated in advance of peritoneal
dialysis and stored for later use with a non-integrated cycler. In
any embodiment of the first or second aspects of the invention, a
system for generating peritoneal dialysate can be configured as
illustrated in FIG. 1. The system includes a peritoneal dialysate
generation flow path 101. Fluid from a water source 102 can be
pumped into the peritoneal dialysate generation flow path 101.
System pump 108 can control the movement of fluid through the
peritoneal dialysate generation flow path 101. The system pumps the
fluid from water source 102 through a water purification module 103
to remove chemical contaminants in the fluid in preparation for
creating peritoneal dialysate.
[0135] In any embodiment of the first or second aspects of the
invention, the water source 102 can be a source of potable water
including a purified water source. Purified water can refer to
water meeting the definition of "purified water" in the United
States Pharmacopeia, 23d Revision, Jan. 1, 1995. Alternatively,
purified water can refer to any source of water treated to remove
at least some biological or chemical contaminants, whether or not
the water meets the definition of purified water in United States
Pharmacopeia, 23d Revision, Jan. 1, 1995. In any embodiment of the
first or second aspects of the invention, the water source 102 can
be a non-purified water source, such as tap water, wherein the
water from the water source 102 can be purified by the system as
described. The system can be directly connected to a tap or faucet
to provide non-purified water that can be purified by the system. A
non-purified water source can provide water without additional
purification, such as tap water from a municipal water source,
water that has undergone some level of purification, but does not
meet the definition of "purified water" provided, such as bottled
water or filtered water. In any embodiment, the water source can
contain water meeting the WHO drinkable water standards provided in
Guidelines for Drinking Water Quality, World Health Organization,
Geneva, Switzerland, 4th edition, 2011. The peritoneal dialysate
generation flow path 101 can also be connected to a purified or
non-purified water source such as a tap or faucet line. The water
source can be any source of water, whether from a tap, faucet, or a
separate container or reservoir. The water source 102 can be any
size usable with the system, including between 12 and 20 L. A water
source 102 of 15 L can generally generate the necessary peritoneal
dialysate for multiple cycles.
[0136] In any embodiment of the first or second aspects of the
invention, the water purification module 103 can be a sorbent
cartridge. The sorbent cartridge includes an anion exchange
material such as zirconium oxide. The zirconium oxide can remove
anionic species from the fluid, such as phosphate or fluoride
molecules, replacing the anionic species with acetate or hydroxide
ions. The sorbent cartridge can have any anion exchange material
known in the art capable of removing anionic species from the
fluid. In any embodiment, the sorbent cartridge can include
aluminum oxide for removal of fluoride and heavy metals.
Alternatively, the water purification module 103 can be a
combination of ion and anion exchange materials. The sorbent
cartridge can be sized depending on the needs of the user, with a
larger sized sorbent cartridge allowing for more exchanges before
the sorbent cartridge must be replaced.
[0137] The sorbent cartridge can include a cation exchange
material, such as zirconium phosphate. The zirconium phosphate can
remove cationic species from the fluid, such as potassium, calcium,
magnesium, or other cations, replacing the cationic species with
hydrogen or sodium. The sorbent cartridge can include any cation
exchange material capable of removing cations from the fluid.
[0138] The sorbent cartridge can also include activated carbon. The
activated carbon operates to adsorb non-ionic molecules, organic
molecules, and chlorine from the water, along with some endotoxins
or bacterial contaminants. The activated carbon can be present in
the sorbent cartridge in the form of a carbon filter or pad, or as
a material layer in the sorbent cartridge. A carbon filter or pad
is a bed of activated carbon. The carbon filter can be in a
self-contained packaging, or present as a layer of activated carbon
within the sorbent cartridge. The sorbent cartridge can purify up
to 3 L of water per exchange for a single infusion, with flow rates
of up to 300 ml/min. A larger sorbent cartridge can be used when
generating peritoneal dialysate for multiple infusions, including a
sorbent cartridge that can purify between 3 and 20 L, between 3 and
5 L, between 3 and 10 L, between 5 and 12 L, between 10 and 15 L,
or between 10 and 20 L of water, or more.
[0139] In any embodiment, the sorbent cartridge can be a single use
component or a rechargeable component. Recharging can refer to the
process of treating a sorbent material to restore the functional
capacity of the sorbent material so as to put the sorbent material
back into a condition for use or reuse in a new dialysis session.
In some instances, recharging also includes treating a sorbent
material so as to clean the sorbent material so that the sorbent
material can be stored and used in a subsequent dialysis session.
In some instances, the total mass, weight and/or amount of
"rechargeable" sorbent materials remain the same. In some
instances, the total mass, weight and/or amount of "rechargeable"
sorbent materials change. Without being limited to any one theory
of invention, the recharging process may involve exchanging ions
bound to the sorbent material with different ions, which in some
instances may increase or decrease the total mass of the system.
However, the total amount of the sorbent material will in some
instances be unchanged by the recharging process. Upon a sorbent
material undergoing "recharging," the sorbent material can then be
said to be "recharged."
[0140] The sorbent cartridge can additionally include a microbial
filter and/or a particulate filter. A microbial filter can further
reduce the amount of endotoxins or bacterial contaminants present
in the fluid from the water source 102. A particulate filter can
remove particulate matter from the fluid.
[0141] Alternatively, the water purification module 103 can be any
component capable of removing contaminants from the water in the
water source 102, including any one or more of a sorbent cartridge,
reverse osmosis module, nanofilter, combination of ion and anion
exchange materials, activated carbon, silica, or silica based
columns.
[0142] Upon passing through water purification module 103, fluid
can be pumped to a concentrate source 104 where necessary
components for carrying out peritoneal dialysis can be added from
the concentrate source 104. The concentrates in the concentrate
source 104 are utilized to create a peritoneal dialysis fluid that
matches a dialysis prescription. Concentrate pump 105 can control
the movement of concentrates from the concentrate source 104 to the
peritoneal dialysate generation flow path 101 in a controlled
addition. The concentrates added from the concentrate source 104 to
the peritoneal dialysate generation flow path 101 can include any
component prescribed for use in peritoneal dialysate. Table 1
provides non-limiting exemplary ranges of commonly used components
of peritoneal dialysate.
TABLE-US-00001 TABLE 1 Component Concentration Sodium chloride
132-134 mmol/L Calcium chloride dehydrate 1.25-1.75 mmol/L
Magnesium chloride hexahydrate 0.25-0.75 mmol/L Sodium Lactate
35-40 mmol/L Dextrose (D-glucose) monohydrate 0.55-4.25 g/dL pH 5-6
Osmolality 346-485 (hypertonic)
[0143] To reduce the glucose degradation products (GDP) formed by
heating conventional peritoneal dialysate, some peritoneal
dialysate systems use a low GDP formulation. Exemplary peritoneal
dialysate concentrations for low GDP formulations are provided in
Table 2. Generally, the low GDP peritoneal dialysate is provided in
two separate bags, with one bag containing calcium chloride,
magnesium chloride and glucose maintained at low pH, and the second
bag containing sodium chloride and the buffer components, including
sodium lactate and sodium bicarbonate. The two bags are mixed prior
to use to generate a peritoneal dialysate with a neutral pH.
Alternatively, a two chamber bag is used, the chambers separated by
a divider which is broken to mix the fluids prior to use.
TABLE-US-00002 TABLE 2 Low GDP peritoneal dialysate formulations
Component Concentration Sodium 132-134 mEq/L Calcium 2.5-3.5 mEq/L
Magnesium 0.5-1.0 mEq/L Lactate 0-40 mEq/L Bicarbonate 0-34 mEq/L
pH 6.3-7.4 % glucose (g/dL) 1.5-4.25
[0144] One of skill in the art will understand other components can
be used in place of the components listed in Tables 1-2. For
example, dextrose as listed in Table 1 is commonly used as an
osmotic agent. In any embodiment of the first or second aspects of
the invention, other osmotic agents can be used in addition to, or
in place of, the dextrose, including glucose, icodextrin or amino
acids, including dialysate with multiple osmotic agents. Although
the sources of sodium, calcium, and magnesium listed in Table 1 are
chloride salts, other sodium, magnesium, and calcium salts can be
used, such as lactate or acetate salts. Peritoneal dialysate may
also contain buffers for maintaining pH of the peritoneal
dialysate. Exemplary, non-limiting examples of suitable buffers
include bicarbonate buffer, acetate buffer or lactate buffer.
Although not generally used in peritoneal dialysis, potassium
chloride can be used for hypokalemic patients who don't receive
sufficient potassium through diet. The concentrate source 104 can
contain one or more osmotic agents, as well as one or more ion
concentrates, such as concentrated sodium chloride, sodium lactate,
magnesium chloride, calcium chloride, and/or sodium bicarbonate.
The concentrate source 104 can be a single source of concentrates,
including both osmotic agents and ion concentrates, or can include
multiple sources of concentrates, with separate sources for the
osmotic agents and ion concentrates. In any embodiment, the system
can have a single concentrate that has all components mixed for a
daytime or overnight treatment for use in a home by a single
patient. Alternatively, the concentrate source 104 can include
separate sources for any one or more of the solutes to be used in
the peritoneal dialysate each with a separate concentrate pump to
add each component needed to create the peritoneal dialysate.
Concentrate pump 105 pumps concentrated solutions from the
concentrate source or sources 104 to the peritoneal dialysate
generation flow path 101 in a controlled addition. Where more than
one concentrate source is used, separate concentrate pumps can move
each of the concentrates into the peritoneal dialysate generation
flow path 101, or a single concentrate pump can be used, with
valves configured allow individual control over the movement of
each of the concentrate solutions to the peritoneal dialysate
generation flow path 101.
[0145] After addition of solutes from the concentrate source 104,
the fluid in the peritoneal dialysate generation flow path 101 can
contain all the necessary solutes for peritoneal dialysis. The
peritoneal dialysate should reach a level of sterility suitable for
peritoneal dialysis. The level of sterility can be any level
meeting an applicable regulatory requirement, such as a sterility
assurance level of 10.sup.-6 required by the FDA, meaning the
chance of a viable organism present after sterilization is 1 in
1,000,000. The system can pump the fluid to a sterilization module
106 for sterilization of the peritoneal dialysate. A sterilization
module recirculation line 109 can convey the fluid through the
sterilization module 106 multiple times. Valve 110 and pump 111 can
control the movement of fluid through the sterilization module
recirculation line 109.
[0146] The sterilization module 106 can be any component or set of
components capable of sterilizing the peritoneal dialysate. In any
embodiment, the sterilization module can be one or more
ultrafilters to provide redundancy of the system to protect against
sterilization failure A secondary component, such as a UV light
source or microbial filter, can be included in the sterilization
module 106 to provide additional sterilization of the peritoneal
dialysate. The UV light source can be positioned at any location in
the peritoneal dialysate generation flow path 101, including
between the first and second ultrafilters, upstream of the one or
more ultrafilters, or downstream of the one or more ultrafilters.
The sterilization module can also include a microbial filter. The
ultrafilters used in the sterilization module can be replaced as
necessary. In any embodiment, the ultrafilters can have a 3-6-month
lifetime before replacement. The ultrafilters can be any
ultrafilter known in the art capable of sterilizing the peritoneal
dialysate. A non-limiting example of an ultrafilter that can be
used in the systems described is the hollow fiber ForClean
ultrafilter, available from Bellco, Mirandola (MO), Italy. In
certain embodiments, the sterilization module 106 can use heat
sterilization. The sterilization module 106 can include a heater to
heat the prepared dialysate. Alternatively or additionally, the
sterilization module 106 can include a flash pasteurization module
to sterilize the dialysate through flash pasteurization. The
sterilization module 106 can include both heat-based sterilization
components and filtration based sterilization components, with the
user adjusting the mode of sterilization based on the mode of use.
For example, a heat based sterilization can be used when the
peritoneal dialysate is generated for later use, while a filtration
based sterilization can be used when the peritoneal dialysate is
generated for immediate use.
[0147] After sterilization of the fluid by the sterilization module
106, the generated peritoneal dialysate can be pumped to a
dialysate container 107 for storage until ready for use by a
patient. The dialysate container 107 can include one or more
sterilized dialysate bags. The dialysate bags, once filled with
peritoneal dialysate, can be stored until needed by the patient.
The filled dialysate container 107 can be removed from the system
and connected to a catheter or a non-integrated cycler for infusion
of the peritoneal dialysate into a patient. The dialysate container
can alternatively be a reusable sterilized container or bag. The
reusable container or bag can be cleaned and sterilized daily, or
at set time periods. Alternatively, the dialysate container 107 can
be any type of storage container, such as a stainless steel
container. The connectors to the dialysate container 107 can be any
type of connector known in the art.
[0148] The dialysate container 107 can store peritoneal dialysate
sufficient for a single infusion of peritoneal dialysate into the
patient. By generating peritoneal dialysate for a single infusion
in real-time, and then immediately using the peritoneal dialysate,
the dialysate storage time can be reduced, reducing the possibility
of bacterial growth. A user interface can be included on the
peritoneal dialysis generation machine, allowing a patient to
direct the generation of peritoneal dialysate as needed.
Additionally, or alternatively, the peritoneal dialysate machine
can include a timer, and the timer can cause the peritoneal
dialysate machine to generate peritoneal dialysate at predetermined
times according to the patient's peritoneal dialysis schedule.
Alternatively, the peritoneal dialysate generation machine can be
equipped with wireless communication, such as Wi-Fi, BlueTooth,
Ethernet, or any other wireless communication system known in the
art. The user can direct the peritoneal dialysis machine to
generate peritoneal dialysate at a specified time from any
location. By using a timer, user interface, or wireless
communication to control the generation of peritoneal dialysate,
the peritoneal dialysate storage time can be reduced, lowering the
chances of generating significant amounts of degradation products
or allowing bacterial growth. In the case of power failure, an
optional battery back-up can be included in the system.
[0149] In any embodiment of the first or second aspects of the
invention, the dialysate container 107 can store enough peritoneal
dialysate for multiple infusions into the patient, including enough
peritoneal dialysate for one day or more of treatment. A timer can
cause the machine to generate fresh peritoneal dialysate each day
or at set times.
[0150] The dialysate container 107 can include multiple dialysate
containers, each large enough to store enough peritoneal dialysate
for a single infusion into the patient including between any of 1
to 6 L, 1 to 3 L, 1.5 to 3 L, 2 to 4L, or 3 L to 6 L of dialysate.
Alternatively, each of the one or more dialysate containers 107 can
store enough peritoneal dialysate for multiple infusions into a
patient, such as an entire day's amount of peritoneal dialysate
including between any of 1 to 20 L, 1 to 2 L, 1 to 3 L, 2 to 6 L, 2
to 4 L, 6 to 10 L, 8 to 10 L, 8 to 12 L, 10 to 12 L, 10 to 15 L, or
12 to 20 L of peritoneal dialysate. If the dialysate containers 107
store peritoneal dialysate for multiple infusions into the patient,
the same container can be used for each infusion with any suitable
peritoneal dialysate cycler known in the art that can be fluidly
connected to and used with the described system. Additional or
alternative storage containers can be included at other locations
in the peritoneal dialysate generation flow path 101. A storage
container can be included upstream of the sterilization module, and
downstream of the water purification module. Before the fluid is
utilized in the cycler stage, the fluid can be pumped through the
sterilization module, eliminating issues related to storage of
sterile fluid. The storage containers can be either upstream or
downstream of the concentrate source 104. The addition of
concentrates to the fluid can happen either before storage of the
fluid, or after storage of the fluid just before sterilization in
the sterilization module.
[0151] As illustrated in FIG. 1, the necessary solutes can be added
to the peritoneal dialysate generation flow path 101 from a single
concentrate source 104. The solutes can be present in concentrated
from within the concentrate source 104 in a fixed ratio for
peritoneal dialysis, as shown in Table 1. Using a single
concentrate source 104 for all solutes results in peritoneal
dialysate having a fixed ratio of each of the solutes.
[0152] Table 3 provides exemplary non-limiting ranges of solutes
for addition from a single concentrate source to the peritoneal
dialysate generation flow loop, including the starting
concentration of the solutes in the concentrate source, as well as
exemplary final volumes of the solutes in the dialysate and the
exemplary flow rates of both the solutes and the water in the
dialysate generation flow loop to achieve the listed
concentrations. The solutes shown in Table 3 are traditional
peritoneal dialysate solutes. Table 4 shows exemplary ranges of
solutes for a low GDP formulation. Table 5 shows exemplary ranges
of solutes with icodextrin as the osmotic agent. Icodextrin is
sometimes used as an osmotic agent for a long dwell period. If
dextrose or glucose is used in a long dwell period, reabsorption of
the ultrafiltrate can occur, reducing the net volume of fluid
removed. Icodextrin results in a long sustained ultrafiltration,
and can provide improved ultrafiltration efficiency over a long
dwell period. One of skill in the art will understand the
concentrations of any of the solutes shown in Tables 3-5 can be
altered by altering--the flow rates of the system pump or
concentrate pump. However, the ratio of the solutes included is
fixed when using a single concentrate source. If the ratio of the
solutes needs to be altered for any reason, a new concentrate
solution may be needed.
TABLE-US-00003 TABLE 3 Exemplary solutes for addition from a single
concentrate source Solution volume Flow rate Component
Concentration (g/l) (ml/L) (ml/min) Glucose 100-850 50-400 1-18
Sodium Chloride 13-108 50-400 1-18 Sodium Lactate 11-90 50-400 1-18
MgCl.sub.2.cndot.6H.sub.2O 0.13-1.02 50-400 1-18
CaCl.sub.2.cndot.2H.sub.2O 0.6-5.1 50-400 1-18 Water 600-950
50-1000
TABLE-US-00004 TABLE 4 Exemplary solute ranges in a low GDP
solution Solution volume Flow rate Component Concentration (g/l)
(ml/L) (ml/min) Glucose 100-900 50-400 1-18 Sodium Chloride 13-108
50-400 1-18 Sodium Lactate 11-90 50-400 1-18
MgCl.sub.2.cndot.6H.sub.2O 0.13-1.02 50-400 1-18
CaCl.sub.2.cndot.2H.sub.2O 0.6-5.1 50-400 1-18 Water 600-950
50-1000
TABLE-US-00005 TABLE 5 Exemplary solute ranges in icodextrin
solution Solution volume Flow rate Component Concentration (g/l)
(ml/L) (ml/min) Icodextrin 100-850 100-400 2-37 Sodium Chloride
13-108 100-400 1-18 Sodium Lactate 11-90 100-400 2-37
MgCl.sub.2.cndot.6H.sub.2O 0.13-1.02 100-400 2-37
CaCl.sub.2.cndot.2H.sub.2O 0.6-5.1 100-400 2-37 Water 600-900
50-1000
[0153] Although using a single concentrate source in the system
requires a fixed ratio of solutes in the generated peritoneal
dialysate, a single concentrate source provides certain advantages.
Storage requirements are decreased, as only a single concentrate
solution needs to be stored for a given dialysate prescription.
There is also a lower risk of patient error in adding solutes to
the dialysate in the proper amounts. A single concentrate source
also requires less supplies, less pumps, and less hardware.
Further, because fewer containers are needed, the containers are
easier to manage, clean, and disinfect. One of skill in the art
will understand a higher concentration of solutes in the
concentrate source will allow minimization of the container size
and maximization of the source water used in PD solution
preparation, lowering costs. The limiting factor is mutual
solubility of the components, which is generally limited by glucose
or icodextrin solubility. The flow rate for the source water can be
optimized to adjust the time required to prepare the solution. In
the case of on-demand dialysate preparation, a high flow rate is
desired to minimize the time needed to prepare the solution. The
flow rate limit will be controlled by the metering accuracy of the
concentrate pump at the rate required to match the water feed. With
a single concentrate source, about 150 ml/exchange can be needed,
corresponding to about 600 ml/day or 4.2 L/week. The concentrate
source can be sized depending on the needs of the user, with a
larger concentrate source requiring less frequent refilling.
[0154] The system can also include a waste container (not shown in
FIG. 1) to collect any generated waste fluid as well as used
peritoneal dialysate. The waste container collects effluent
generated during disinfection and/or effluent generated by the
purification modules, such as a reverse osmosis system.
Alternatively, the waste fluid and used peritoneal dialysate can be
directed to a drain for disposal.
[0155] In any embodiment of the first or second aspects of the
invention, the peritoneal dialysate generation flow path 101 can be
disinfected with a disinfection solution through on-board
disinfection. The peritoneal dialysate generation flow path 101 can
be configured to form a loop by connecting the portion of the
peritoneal dialysate generation flow path 101 connecting to water
source 102 to the portion of the peritoneal dialysate generation
flow path 101 connecting to dialysate container 107. The
disinfection solution can be introduced into the peritoneal
dialysate generation flow path 101 and recirculated through the
fluid lines by system pump 108. The disinfection solution can be a
peracetic acid solution, a citric acid solution, a bleach solution,
or any other suitable disinfection solution known in the art. The
disinfectant can be heated by a heater (not shown) to any
temperature capable of disinfecting the system, including
temperatures of 90.degree. C. or greater. The disinfectant can be
introduced to the flow loop and recirculated at elevated
temperatures to ensure complete disinfection. The connectors and
components of the system can be gamma and autoclave compatible to
resist the high temperatures used during disinfection. The system
can be primed by introducing a priming fluid to the peritoneal
dialysate generation flow path 101.
[0156] The peritoneal dialysate generation flow path illustrated in
FIG. 1 can be part of a modular peritoneal dialysate system. Once
generated, the peritoneal dialysate can be used by any
non-integrated cycler. The patient can remove the filled peritoneal
dialysate container and attach the container to a non-integrated
cycler of any type. Alternatively, a hemostatic connection to a
non-integrated cycler or peritoneal dialysate fluid infusion
catheter can be included for infusion of the peritoneal dialysate.
If using a hemostatic connection to a non-integrated cycler or
peritoneal dialysate fluid infusion catheter, any one of a heater
and temperature sensor can also be included. The temperature sensor
can be positioned in the flow path to monitor the peritoneal
dialysate after being generated and heated. The modularity of the
system allows the patient to generate peritoneal dialysate as
needed and to use the peritoneal dialysate with any suitable cycler
known in the art.
[0157] In any embodiment of the first or second aspects of the
invention, solutes can be added to the peritoneal dialysate
generation flow path from two or more separate concentrate sources,
as shown in FIG. 2. The peritoneal dialysate generation flow path
201 can be fluidly connected to a water source and a water
purification module upstream of the concentrate sources 202-206,
and fluidly connected to a sterilization module and dialysate
container downstream of the concentrate sources 202-206, as
illustrated in FIG. 1.
[0158] As illustrated in FIG. 2, the concentrate source can include
one or more ion concentrate sources, such as sodium chloride source
202 containing sodium chloride to be added in a controlled addition
to the peritoneal dialysate generation flow path 201 by concentrate
pump 207 through valve 212, sodium lactate source 203 containing
sodium lactate to be added in a controlled addition to the
peritoneal dialysate generation flow path 201 by concentrate pump
208 through valve 213, magnesium chloride source 204 containing
magnesium chloride to be added in a controlled addition to the
peritoneal dialysate generation flow path 201 by concentrate pump
209 through valve 214, and calcium chloride source 205 containing
calcium chloride to be added in a controlled addition to the
peritoneal dialysate generation flow path 201 by concentrate pump
210 through valve 215. One of skill in the art will understand
other ions can be used in formulation of peritoneal dialysate, and
each can be contained in a separate ion concentrate source or
combined into one or more combined ion concentrate sources. The
concentrate source also includes one or more osmotic agent sources,
such as dextrose source 206 containing dextrose to be added to the
peritoneal dialysate generation flow path 201 by concentrate pump
211 through valve 216. Any of the concentrate pumps can include
flow meters to control the addition of the solutes. A glucose
source and/or an icodextrin source can be used in addition to, or
in place of, dextrose source 206. Multiple osmotic agents can be
added to the peritoneal dialysate generation flow path 201 from one
or more osmotic agent sources. One of skill in the art will
understand other solutes can be used alternatively to, or in
addition to, the solutes illustrated in FIG. 2. Any set of solutes
used for peritoneal dialysate is within the scope of the invention.
A control system in electronic communication with each of the
concentrate pumps can control the movement of fluid from the
concentrate sources to the peritoneal dialysate generation flow
path 201. The amount of each of the concentrates moved into the
peritoneal dialysate generation flow path 201 can be controlled to
result in peritoneal dialysate having a prescribed solute
concentration, as determined by a doctor or health care provider.
The valves 212-216 can optionally be replaced with hose T junctions
with additional components for preventing backflow into the
concentrate source line if that particular line was not being used.
A hose T is a fluid connector in a T-shape, with a port at each end
for fluid to enter or exit the hose T. Optional sensors 217, 218,
219, and 220 ensure the solute concentration in the dialysate is at
the correct level after each addition. The sensors 217-220 can be
any type of sensor appropriate to confirm delivery of the
concentrate, such as conductivity sensors. Optional pH sensor 221
ensures the pH is a proper level after addition of sodium lactate
or other buffer. Optional refractive index meter 222 ensures the
dextrose or other osmotic agent concentration in the dialysate is
at the prescribed level. An additional sensor can be included
upstream of sodium chloride source 202 for sensing the conductivity
of the water prior to addition of concentrates. One of skill in the
art will understand that additional sensor arrangements can be used
in the described system. Any number of sensors can be included to
monitor the peritoneal dialysate concentration, including 1, 2, 3,
4, 5, 6, 7, or more sensors. The concentrate sources can contain
the solutes in either solid, powdered, or solution form. A solid or
powdered source of solutes can be dissolved by the system by
drawing fluid from the peritoneal dialysate generation flow path
201 into the concentrate source to generate a solution with a known
concentration, such as a saturated solution of the solutes. The
resulting solution is added to the peritoneal dialysate generation
flow path as explained. Optionally, a heater (not shown) can
periodically disinfect peritoneal dialysate generation flow path
201 at a temperature of at least 90.degree. C. During periodic
disinfection, the peritoneal dialysate generation flow path 201 can
also be formed into a closed loop to circulate a disinfectant.
[0159] Although shown as a refractive index meter 222 in FIG. 2,
one of skill in the art will understand alternative methods of
measuring the osmotic agent concentration can be used. In any
embodiment, enzyme-based sensors can detect the concentration of
the osmotic agent in the dialysate. Enzyme based sensors use an
enzyme capable of oxidizing the osmotic agent, such as glucose or
dextrose. The enzyme is immobilized on an electrode and covered in
a membrane through which the osmotic agent can pass. The electrode
is used to electrochemically measure the change in either the
oxidant, such as oxygen, or the product of glucose oxidation, such
as hydrogen peroxide. Alternatively, electron transfer between the
electrode and the enzyme can be detected with mediators, such as
ferrocene to facilitate electron transfer. The osmotic agents can
alternatively be detected through pulsed amperometric detection
(PAD). PAD can detect glucose by applying a positive potential to a
sample, resulting in oxidation of the glucose. The oxidation
products are adsorbed onto the electrode and then desorbed by
applying a more positive potential. Applying the more positive
potential results in formation of an oxide layer on the electrode
leading to passivation of the electrode surface. The catalytic
activity of the electrode is then restored by application of a more
negative potential, resulting in dissolution of the oxide
layer.
[0160] Although illustrated as a single concentrate source in FIG.
1, and five separate concentrate sources in FIG. 2, one of skill in
the art will understand that any number of concentrate sources can
generate the peritoneal dialysate, including 1, 2, 3, 4, 5, 6, 7,
or more concentrate sources. Any two or more of the separate
concentrate sources illustrated in FIG. 2 can be combined into a
single solute source, such as by combining all or some of the ion
concentrate sources into a single ion concentrate source, where the
mixed contents do not cause precipitation of the mixed
concentrates.
[0161] Although each concentrate source is illustrated in FIG. 2
with a separate concentrate pump and fluid line, one of skill in
the art will understand that more than one concentrate source can
use a single pump and fluid line, with valves arranged thereon for
controlled addition to the peritoneal dialysate generation flow
path 201.
[0162] The concentrate sources 202-206 can be single use
concentrate sources or disposable concentrate sources. The
disposable concentrate sources are used in a single peritoneal
dialysate generation process and then disposed. Multiple use
concentrate sources are used repeatedly, and refilled as necessary
with the solute.
[0163] Table 6 provides exemplary, non-limiting, ranges of for
addition to the peritoneal dialysate using a separate osmotic agent
source, glucose in Table 6, and a separate ion concentrate source
containing sodium chloride, sodium lactate, magnesium chloride,
calcium chloride and sodium bicarbonate. Because the glucose is
added separately from the ion concentrates, the ratio of glucose to
the other solutes can be varied depending on the needs of the
patient.
TABLE-US-00006 TABLE 6 Exemplary ranges of solutes in a
two-concentrate source system Concentration Solution volume
Dialysate Component (g/l) (ml/L) composition Part A Glucose 850
6-53 0.55-4.5 g/dL Part B NaCl 269 20 92 mmol/L Sodium Lactate 84
20 15 mmol/L MgCl.sub.2.cndot.6H.sub.2O 5 20 0.5 mmol/L
CaCl.sub.2.cndot.2H.sub.2O 18 20 2.5 mmol/L NaHCO.sub.3 105 20 25
mmol/L Water 927-979 56.10
[0164] By using multiple concentrate sources, greater
individualization and therapy customization can be achieved for
each patient. With a single concentrate source, all solutes in the
generated peritoneal dialysate must be present in a fixed ratio. By
using more than one concentrate source, the ratio of solutes used
in the peritoneal dialysate can be altered as the concentration of
each of the osmotic agent and ion solutes can be individually
controlled. For example, as illustrated by Table 6, with a single
ion concentrate source and a single osmotic agent source,
peritoneal dialysate with greater or less osmotic agent per
concentration of ions can be generated, providing the ability to
adjust the tonicity of the peritoneal dialysate solution
independently of the electrolyte composition to meet the UF needs
of any patient with a single set of solutions and allowing greater
control over ultrafiltration. The ultrafiltration rate resulting
from using the peritoneal dialysate solutions can be altered by
altering the concentration of the osmotic agent independently of
the ionic solutes, or by changing the osmotic agent used. For
example, typical ultrafiltration volumes using dextrose as the
osmotic agent vary with the dextrose concentration of the
peritoneal dialysate. With a 1.5% dextrose solution, the typical
ultrafiltration volume is about 150 mL. With a 2.5% dextrose
solution, the typical ultrafiltration volume is about 250 mL. With
a 4.25% dextrose solution, the typical ultrafiltration volume can
exceed 600 mL. For a single exchange using separate concentrate
sources for the ion concentrates and the osmotic agent, about 50 mL
of the ion concentrate and 150 mL of the osmotic agent may be
needed, corresponding to about 200 ml/day or 1.4 L/week of the ion
concentrate and 600 ml/day or 4.2 L/week of the osmotic agent.
[0165] Because the system is not limited to discrete glucose or
other osmotic agent concentrations like known commercial solutions;
the system can customize the peritoneal dialysate solutions to meet
the ultrafiltration needs of patient as determined by a healthcare
provider. As illustrated in Table 6, the glucose level in the
peritoneal dialysate solution can be varied from 0.55 g/dL to 4.5
g/dL, while maintaining the electrolytes and buffer components
constant. Varying the glucose level while maintaining the
electrolyte and buffer components constant allows the system to
cover the range of glucose formulations currently offered
commercially using a single Part A and Part B composition.
[0166] In any embodiment of the first or second aspects of the
invention, two osmotic agent sources can be used, such as a
dextrose source and an icodextrin source. With two osmotic agent
sources one could use dextrose during the daytime exchanges for
CAPD and icodextrin during the night dwell to take advantage of the
higher UF removal from icodextrin. Conversely, dextrose could be
used during the night dwell and icodextrin for the extended daytime
dwell in APD systems.
[0167] By using separate concentrate sources for each solute,
complete individualization of the concentrations and ratios of
solutes in the peritoneal dialysate can be achieved. Table 7
provides exemplary ranges of solutes for peritoneal dialysate as
made by a system with each solute in a separate concentrate source.
With separate concentrate sources for each solute virtually any
peritoneal dialysate solution composition can be prepared from a
single set of component formulations. The system is useful for
patients whose prescriptions change periodically due to diet or
other factors. Such patients would need to store multiple
formulations if using only one or two concentrate sources, and the
risk of errors would be increased.
TABLE-US-00007 TABLE 7 Exemplary dialysate composition from a
multi-source system Solution Concentration volume Dialysate
Component (g/l) (ml/L) composition Part A: Glucose 850 6-53
0.55-4.5 g/dL Part B: NaCl 320 15-18 132-134 mmol/L Part C: Na
Lactate 1000 2-4 15-40 mmol/L Part D: MgCl2.cndot.6H2O 500 0.2-0.4
0.5-1.0 mmol/L Part E: CaCl2.cndot.2H2O 700 0.5-1.0 2.5-3.5 mmol/L
Part F: NaHCO3 85 0-34 0-34 mmol/L Part G: Icodextrin 1000 0-75
0-7.5 g/dL Water 820-971
[0168] In any embodiment of the first or second aspects of the
invention, the one or more concentrate sources can be detachable
from the rest of the system for sterilization. The concentrate
sources can also be sterilized each time the concentrate sources
are filled with new concentrate solutions. Further, the concentrate
sources can be sterilized after a set number of uses, or after a
set period of time. Moreover, the concentrate sources and the rest
of the peritoneal dialysate generation system can be sterilized
without any of the components by passing a disinfection solution,
such as a citric acid, peracetic acid, or bleach solution, through
all of the lines and containers of the system.
[0169] As described, in any embodiment of the first or second
aspects of the invention, the system can be configured to generate
enough peritoneal dialysate for multiple infusions of peritoneal
dialysis into a patient in a single step, such as entire day's
requirements of peritoneal dialysate. The peritoneal dialysate
generated by the system can be stored in a single dialysate
container, and then the patient can use the same peritoneal
dialysate container for each exchange of peritoneal dialysate. As
illustrated in FIG. 3, the system can be configured to separate
portions of peritoneal dialysate into separate dialysate
containers, and the patient can use each container only once.
Peritoneal dialysate generation flow path 301 can be fluidly
connected to a water source, a water purification module, a
concentrate source, and a sterilization module, each upstream of
dialysate containers 302-307. For clarity, these components are not
shown in FIG. 3.
[0170] Peritoneal dialysate can be generated through a peritoneal
dialysate generation flow path 301 as described herein. The
peritoneal dialysate generation flow path 301 can be fluidly
connected to a valve 308, which can selectively distribute
peritoneal dialysate to each of the dialysate containers 302-307.
Valve 308 can be controlled to direct peritoneal dialysate from
peritoneal dialysate generation flow path 301 to valve 309. Valve
309 can be controlled to direct the peritoneal dialysate into
either of dialysate containers 302 or 303. Once dialysate
containers 302 and 303 are filled, valve 308 can be switched to
direct the peritoneal dialysate to valve 310. Valve 310 can be
controlled to direct the peritoneal dialysate into either of
dialysate containers 304 or 305. After filling dialysate containers
304 and 305, valve 308 can be switched to direct peritoneal
dialysate to valve 311. Valve 311 can be controlled to direct the
peritoneal dialysate to either dialysate container 306 or 307,
allowing six separate dialysate containers to be filled with
peritoneal dialysate. The patient can then store the generated
dialysate in dialysate containers 302-307 until needed. Although
six dialysate containers are illustrated in FIG. 3, one of skill in
the art will understand that any number of dialysate containers can
be used with the systems described herein by modification of the
lines and valves. The system can include any number of dialysate
containers, including 1, 2, 3, 4, 5, 6, 7, or more dialysate
containers. Although illustrated in FIG. 3 as including one
four-way valve 308 and three three-way valves 309, 310, and 311,
one of skill in the art will understand that several alternative
arrangements of valves and fluid lines can selectively fill
multiple dialysate containers with the generated peritoneal
dialysate. In any embodiment of the first or second aspects of the
invention, the dialysate containers 302-307 can be sized to hold
dialysate for a single infusion into the patient. In any embodiment
of the first or second aspects of the invention, the dialysate
containers 302-307 can be sized to hold enough dialysate for
multiple infusions of dialysate into the patient. In any embodiment
of the first or second aspects of the invention, each dialysate
container 302-307 can be between any of 1 and 4 L, 1 and 3 L, 1.5
and 3 L, or 2 and 4 L, storing enough peritoneal dialysate for a
single infusion into the patient. In any embodiment of the first or
second aspects of the invention, larger or smaller dialysate
containers can be used. In any embodiment of the first or second
aspects of the invention, the dialysate containers can be between
any of 1 and 20 L, 1 and 2 L, 1 and 3 L, 2 and 6 L, 2 and 4 L, 6
and 10 L, 8 and 10 L, 8 and 12 L, 10 and 12 L, 10 to 15 L, or 12 to
20 L. In any embodiment of the first or second aspects of the
invention, one or more flow meters (not shown) can be provided for
determining the amount of peritoneal dialysate pumped into each
dialysate container. A single flow meter can be positioned upstream
of valve 308. Multiple flow meters can also be provided between
valve 308 and each of valves 309-311. Flow meters can be provided
individually for each of the dialysate containers 302-307. A
control system (not shown) can be in communication with the flow
meters and can be utilized to operate each of the pumps and valves
and thereby control the movement of dialysate into each dialysate
container.
[0171] In any embodiment of the first or second aspects of the
invention, different formulations of peritoneal dialysate can be
pumped to each of the dialysate containers 302-307. For example,
the system can generate peritoneal dialysate for 3-4 day time
exchanges and pump the peritoneal dialysate to dialysate containers
302-305. A different formulation of solutes, such as with a
different concentration or type of osmotic agent, can be used for
an overnight dwell, and the second formulation of peritoneal
dialysate can be transferred to dialysate containers 306-307.
[0172] FIG. 4 illustrates an overview of generating peritoneal
dialysate in accordance with any embodiment of the first or second
aspects of the invention. Water from a water source 401 can be
purified by a water purification module 402, as explained.
Concentrates from a single concentrate source 403, which can
contain both ion concentrates and one or more osmotic agents, can
be added to the purified water to generate a non-sterile peritoneal
dialysate solution 404. The non-sterile peritoneal dialysate
solution 404 is sterilized by a sterilization module 405, which may
include an ultrafilter. As explained, the peritoneal dialysate can
be further purified by additional components in the sterilization
module 406, such as by ultrafiltration with a second ultrafilter,
by re circulating the peritoneal dialysate through the same
ultrafilter multiple times, or by a UV light source, to generate a
sterilized peritoneal dialysate 407. The sterilized peritoneal
dialysate 407 can be stored or used by any method described herein,
including dispensing an entire day's use of the peritoneal
dialysate into a single dialysate container 408, as illustrated in
FIG. 1; dispensing the peritoneal dialysate into multiple dialysate
containers each large enough for a single treatment 409, as
illustrated in FIG. 3, or dispensing the peritoneal dialysate into
a single or multiple dialysate containers for immediate use
410.
[0173] FIG. 5 illustrates an overview of generating peritoneal
dialysate with multiple concentrate sources. Water from a water
source 501 can be purified by a water purification module 502, as
explained. Concentrates from an ion concentrate source 503, which
can contain sodium, magnesium, calcium, and bicarbonate, as well as
any other ions to be used in peritoneal dialysis, can be added to
the purified fluid. An osmotic agent, such as dextrose, can be
added from a first osmotic agent concentrate source 504. A second
osmotic agent, such as icodextrin, can be added from a second
osmotic agent concentrate source 505. As illustrated in FIG. 2, any
number of concentrate sources can be used for further
individualization of the peritoneal dialysate, including separate
sources for each of the ions used. After addition of the ion and
osmotic agent concentrates, the fluid contains all necessary
components for use in peritoneal dialysis as non-sterilized
peritoneal dialysate 506. The non-sterile peritoneal dialysate
solution 506 can be sterilized by a sterilization module 507, which
can include an ultrafilter or other sterilization components. The
peritoneal dialysate can be further sterilized by the sterilization
module 508, either by ultrafiltration with a second ultrafilter,
recirculation through the same ultrafilter, or further sterilized
with a UV light source, to generate a sterilized peritoneal
dialysate 509. The sterilized peritoneal dialysate 509 can be
stored or used by any method described herein, including dispensing
an entire days use of the peritoneal dialysate into a single
dialysate container 510, as illustrated in FIG. 1; dispensing the
peritoneal dialysate into multiple dialysate containers each large
enough for a single treatment 511, as illustrated in FIG. 3, or
dispensing the peritoneal dialysate into a single or multiple
dialysate containers for immediate use 512.
[0174] FIG. 6 illustrates an alternative peritoneal dialysate
generation flow path 601. Water from a water source 602 can be
pumped through filter 603 by system pump 604. The filter 603 can
remove any particulate matter from the water prior to entering the
peritoneal dialysate generation flow path 601. Pressure sensor 605
measures the pressure of the incoming water to ensure the pressure
within the peritoneal dialysate generation flow path 601 is within
predetermined ranges. The water can then be pumped through a water
purification module, illustrated as a sorbent cartridge 606 in FIG.
6. As described, the water purification module can alternatively or
additionally include activated carbon, a reverse osmosis module, a
carbon filter, an ion exchange resin, and/or a nanofilter. The
water enters the sorbent cartridge 606 through sorbent cartridge
inlet 607 and exits through sorbent cartridge outlet 608. Filter
609 removes any particulate matter in the fluid after exiting
sorbent cartridge 606. A conductivity sensor 610 determines the
conductivity of the fluid exiting sorbent cartridge 606 to ensure
the water has been purified. Flow sensor 611 determines the flow
rate of the fluid exiting sorbent cartridge 606. To generate
peritoneal dialysate, concentrates can be added from concentrate
source 613 through concentrate connector 614 by concentrate pump
615. Although shown as a single concentrate source 613 in FIG. 6,
concentrates can be added from two or more concentrate sources
wherein at least one concentrate source is a source for
independently providing glucose to separately control addition of
osmotic agents such as glucose. Concentrate filter 612 removes any
particulate matter from the concentrate before entering the
peritoneal dialysate generation flow path 601. A conductivity
sensor 616 determines the conductivity of the generated peritoneal
dialysate after addition of the concentrates to ensure the
peritoneal dialysate has the correct solute concentrations.
Pressure sensor 617 measures the fluid pressure prior to the fluid
entering the sterilization module, shown as ultrafilters 618 and
620. pH sensor 624 can determine the pH of the peritoneal dialysate
to ensure the peritoneal dialysate has a proper pH.
[0175] As described, the peritoneal dialysate is sterilized by
pumping the peritoneal dialysate through a sterilization module
which can include a first ultrafilter 618, and optionally a second
ultrafilter 620. Valves 621 and 622, as well as connector 623 are
used in disinfection and backflushing of the ultrafilters. The
fluid can then be pumped into dialysate container 625 for storage
until needed by the patient. As described, the system can include
any number of dialysate containers, and is not limited to the
single dialysate container 625 illustrated in FIG. 6. Valves 621
and 622, as well as three way valve 619 allow for back flushing of
the ultrafilters 618 and 620 during disinfection.
[0176] FIGS. 7A-C illustrate a non-limiting embodiment of a
peritoneal dialysate generation cabinet 701. FIG. 7A illustrates a
perspective view of the peritoneal dialysate generation cabinet
701, while FIG. 7B illustrates a front view of the peritoneal
dialysate generation cabinet 701. FIG. 7C shows the peritoneal
dialysate generation cabinet 701 with door panels closed. A fluid
line 702 can connect a water source to the peritoneal dialysate
generation cabinet 701. System pump 703 provides a driving force
for the movement of fluid throughout the peritoneal dialysate
generation flow path. The water is pumped through the peritoneal
dialysate generation cabinet 701 to a water purification module,
shown as sorbent cartridge 704 in FIG. 7. The water enters the
sorbent cartridge 704 through tubing (not shown) connected to the
bottom of the sorbent cartridge through the base of the peritoneal
dialysate generation cabinet 701, and exits through tubing 714 at a
top of the sorbent cartridge. Concentrates from concentrate source
705 are added to the fluid through tubing 713 as described to
generate non-sterilized peritoneal dialysate. A concentrate pump
(not shown) can provide a driving force to move fluid from the
concentrate source 705 into the peritoneal dialysate generation
flow path inside of the peritoneal dialysate generation cabinet
701. The generated peritoneal dialysate can then be pumped through
a sterilization module, shown as ultrafilter 706, for
sterilization. The peritoneal dialysate enters the ultrafilter 706
through tubing 715 in a base of the ultrafilter 706 and exits
through tubing 716 at a top of the ultrafilter 706. A second
ultrafilter and/or a UV light source (not shown in FIG. 7) can also
be included. The peritoneal dialysate can then be pumped through
dialysate line 717 into a dialysate container, shown as bag 707,
for storage until used by the patient. As described, the peritoneal
dialysate generation flow path can include various sensors for
detection of conductivity, pH, refractive index, or other dialysate
parameters. The sensors can be included either inside or outside of
the body of the peritoneal dialysate generation cabinet 701. The
fluid lines and valves connecting the components of the peritoneal
dialysate generation flow path can likewise be positioned inside of
the cabinet body. As described, peritoneal dialysate generation
cabinet 701 can have a graphical user interface including screen
709 and keyboard 708. Messages from the control system to the user,
or from the user to the control system, can be generated and read
through the graphical user interface. The user can direct the
generation of peritoneal dialysate through keyboard 708, and can
receive messages from the system through screen 709. The system can
generate alerts to the user, including any problems detected by any
of the sensors, as well as the progress of peritoneal dialysate
generation. Any type of user interface can be used in place of the
keyboard 708 and screen 709 in FIGS. 7A-C. Alternatively, other
interfaces can be included, such as lights, dials, buttons,
switches or the like. In any embodiment, a single button can be
used for directing the generation of peritoneal dialysate in place
of the keyboard. In any embodiment, either keyboard 708 or screen
709 can be used alone, as with a single touch screen for both data
entry and display to enable simple operation.
[0177] When not in use, the concentrate source 705, the sorbent
cartridge 704, and dialysate bag 707 can be removed, and the doors
710 and 711 of the peritoneal dialysate generation cabinet 701 can
be closed to minimize the space required as shown in FIG. 7C.
Additionally, the screen 709 can be folded down into the top of the
peritoneal dialysate generation cabinet 701, further minimizing the
space needed. The doors can be open and closed by any method known
in the art, including magnets, handles, indentations, hooks, or any
other method of opening and closing the doors. The peritoneal
dialysate generation cabinet 701 can have a small size and
portability optimized for in-home or beside use. Although shown on
table 712, the peritoneal dialysate generation cabinet 701 can be
used on any stable flat surface.
[0178] FIG. 8 illustrates a similar cabinet 801 to the system of
FIG. 7, with a reusable dialysate container, shown as stainless
steel container 807. A fluid line 802 can connect a water source to
the cabinet 801. System pump 803 provides a driving force for the
movement of fluid throughout a peritoneal dialysate generation flow
path. The water can be pumped through the cabinet 801 to a water
purification module, shown as sorbent cartridge 804 in FIG. 8. The
water enters the sorbent cartridge 804 through tubing (not shown)
connected to the bottom of the sorbent cartridge 804 through the
base of the cabinet 801. Concentrates from concentrate source 805
are added to the fluid as described to generate non-sterilized
peritoneal dialysate. A concentrate pump (not shown) can provide a
driving force to move fluid from the concentrate source 805 into
the peritoneal dialysate generation flow path inside of the cabinet
801. The generated peritoneal dialysate can then be pumped through
a sterilization module, shown as ultrafilter 806 for sterilization.
A second ultrafilter or UV light source (not shown in FIG. 8) can
also be included. The peritoneal dialysate can then be pumped into
a dialysate container, shown as a reusable dialysate container 807
in FIG. 8, for storage until use. As described, the peritoneal
dialysate generation flow path can include various sensors for
detection of conductivity, pH, refractive index, or other dialysate
parameters. The sensors can be included either inside or outside of
the body of the cabinet 801. The fluid lines and valves connecting
the components of the peritoneal dialysate generation flow path can
likewise be positioned inside of the cabinet body. As described,
cabinet 801 can have a graphical user interface including screen
809 and keyboard 808. The user can direct the generation of
peritoneal dialysate through keyboard 808, and can receive messages
from the system through screen 809.
[0179] FIGS. 9A-D illustrate a non-limiting embodiment of the
peritoneal dialysate generation system arranged as a peritoneal
dialysate generation cabinet 901. FIG. 9A illustrates a perspective
view of the peritoneal dialysate generation cabinet 901, FIG. 9B
illustrates a front view of the peritoneal dialysate generation
cabinet 901, FIG. 9C illustrates a side view of the peritoneal
dialysate generation cabinet 901, and FIG. 9D illustrates a back
view of the peritoneal dialysate generation cabinet 901.
[0180] A fluid line 905 can connect a water source 904 to the
peritoneal dialysate generation cabinet 901. The fluid line 905 can
enter through a connector 928 in a top 906 of the water source 904.
The fluid line 905 connects to the peritoneal dialysate generation
flow path as described with reference to FIGS. 1-3 and 6, through a
back of the peritoneal dialysate generation cabinet 901 through
connector 932 having a fitting 933 for holding the fluid line 905,
as illustrated in FIG. 9D. Any of the fluid lines illustrated can
be disconnected and removed from the system for cleaning and
replacement. A pump (not shown) can provide a driving force for the
movement of fluid throughout the peritoneal dialysate generation
flow path if required. Water is pumped through the peritoneal
dialysate generation cabinet 901 to a water purification module,
shown as sorbent cartridge 912 in FIGS. 9A-B. The water can enter
the sorbent cartridge 912 through tubing (not shown) connected to a
bottom of the sorbent cartridge 912 within the peritoneal dialysate
generation cabinet 901. The water exits the sorbent cartridge 912
through connector 913 and tubing 914. An osmotic agent from osmotic
agent source 915 and an ion concentrate from an ion concentrate
source 917 are added to the fluid as described to generate
non-sterilized peritoneal dialysate. The osmotic agent concentrate
is added to the fluid through a connector shown as paddle connector
916. The ion concentrate is added to the fluid through paddle
connector 918. A concentrate pump (not shown) can provide a driving
force to move fluid from the concentrate sources into the
peritoneal dialysate generation flow path inside of the peritoneal
dialysate generation cabinet 901. As described, the system can use
a single ion concentrate source in place of the two sources shown
in FIGS. 9A-B, or more than two concentrate sources. The generated
peritoneal dialysate can then be pumped through a sterilization
module (not shown), such as an ultrafilter. A second ultrafilter
and/or a UV light source can also be included. The peritoneal
dialysate can then be pumped into dialysate line 919 through
connector 920 and into a dialysate container (not shown in FIGS.
9A-D), for storage until used by the patient, or into a
non-integrated cycler for immediate use by the patient. Fitting 925
allows the dialysate line 919 to be removed from the system for
cleaning or replacement. Waste fluids can be pumped out of the
system through waste line 907, which connects to the peritoneal
dialysate generation cabinet 901 through connector 930 having
fitting 931. The waste line 907 enters waste container 908 through
a connector 929 in the top 909 of the waste container 908. Handles
910 and 911 can be included on water source 904 and waste container
908 for easy movement and storage. Although the peritoneal
dialysate generation cabinet 901 is illustrated on top of table 926
in FIGS. 9A-D, the peritoneal dialysate generation cabinet 901 can
be used on any stable flat surface.
[0181] As described, the peritoneal dialysate generation flow path
can include various sensors for detection of conductivity, pH,
refractive index, or other dialysate parameters. The sensors can be
included either inside or outside of the body of the peritoneal
dialysate generation cabinet 901. The fluid lines and valves
connecting the components of the peritoneal dialysate generation
flow path can likewise be positioned inside of the cabinet body. As
described, a top of the peritoneal dialysate generation cabinet 901
can have a graphical user interface 902 including screen 903.
Messages from the control system to the user, or from the user to
the control system, can be generated and read through the graphical
user interface. The user can direct the generation of peritoneal
dialysate through the graphical user interface 902, and can receive
messages from the system through screen 903. The system can
generate alerts to the user, including any problems detected by any
of the sensors, as well as the progress of peritoneal dialysate
generation. A handle 924 can be included for opening the peritoneal
dialysate generation cabinet 901 to allow access to components on
the inside of the cabinet. Handles 921 and 923 can be included to
hold the fluid lines and power cord when not in use.
[0182] Disinfection connector 922 illustrated in FIGS. 9A and 9C
can be included for disinfection of the waste line 907. During
disinfection, the waste line 907 can be disconnected from waste
container 908 and connected to disinfection connector 922.
Disinfectant solution from a disinfectant source (not shown in
FIGS. 9A-D) can then be circulated through the waste line 907 to
disinfect the waste line 907. Disinfection connector 927 can be
included for disinfection of fluid line 905. Fluid line 905 can be
connected to disinfection connector 922 and disinfection solution
can be circulated through the fluid line 905. Drain 934 on water
source 904 and drain 935 on waste container 908, allow the water
source 904 and waste container 908 to be drained without inverting
the containers.
[0183] FIG. 10 illustrates a peritoneal dialysate generation
cabinet 1001 using a non-purified water source, faucet 1005 in sink
1004. Although illustrated as faucet 1005 and sink 1004, one of
ordinary skill in the art will understand that any water source can
be used. The ability to use municipal or other non-purified sources
of water allow the peritoneal dialysate generation system to work
at a patient's home without the need to store large amounts of
purified water or dialysate. Fitting 1006 connects the water line
1007 to the faucet 1005 or other water source, allowing the water
line 1007 to be connected or disconnected as necessary. A pump (not
shown) provides a driving force for the movement of fluid
throughout the peritoneal dialysate generation flow path. The water
is pumped through the peritoneal dialysate generation cabinet 1001
to a water purification module, shown as sorbent cartridge 1011 in
FIG. 10. The water enters the sorbent cartridge 1011 through tubing
(not shown) connected to the bottom of the sorbent cartridge within
the peritoneal dialysate generation cabinet 1001. The water exits
the sorbent cartridge 1011 through connector 1026 and tubing 1012.
An osmotic agent from osmotic agent source 1013 and an ion
concentrate from an ion concentrate source 1014 are added to the
fluid as described to generate non-sterilized peritoneal dialysate.
The osmotic agent concentrate is added to the fluid through a
connector shown as paddle connector 1016. The ion concentrate is
added to the fluid through paddle connector 1015. A concentrate
pump (not shown) can provide a driving force to move fluid from the
concentrate sources into the peritoneal dialysate generation flow
path inside of the peritoneal dialysate generation cabinet 1001. As
described, the system can use a single ion concentrate source in
place of the two sources shown in FIG. 10, or more than two
concentrate sources. The generated peritoneal dialysate can then be
pumped through a sterilization module (not shown), such as an
ultrafilter. A second ultrafilter and/or a UV light source can also
be included. The peritoneal dialysate can then be pumped into
dialysate line 1017 through connector 1018 and into a dialysate
container (not shown in FIG. 10), for storage until used by the
patient, or into a non-integrated cycler for immediate use by the
patient. Fitting 1019 allows the dialysate line 1017 to be removed
from the system for cleaning or replacement. Waste fluids can be
pumped out of the system through waste line 1008, which can connect
to a drain 1009 shown in bathtub 1010. Although shown as a bathtub
drain 1009 in FIG. 10, the waste fluids can be conveyed to any type
of drain, or alternatively to a waste container as illustrated in
FIGS. 9A-D. Although the peritoneal dialysate generation cabinet
1001 is illustrated on top of table 1024 in FIG. 10, the peritoneal
dialysate generation cabinet 1001 can be used on any stable flat
surface. In certain embodiments, the peritoneal dialysate
generation cabinet 1001 and dialysate container or non-integrated
cycler can be used in the same room as the water source and drain
1009. Alternatively, a non-integrated cycler or dialysate container
can be placed in a separate room, with tubing long enough to reach
the non-integrated cycler or dialysate container. For longer
distances, the tubing should be strong enough to withstand the
pressures necessary in pumping fluid over longer distances.
[0184] As described, a top of the peritoneal dialysate generation
cabinet 1001 can have a graphical user interface 1002 including
screen 1003. Messages from the control system to the user, or from
the user to the control system, can be generated and read through
the graphical user interface. The user can direct the generation of
peritoneal dialysate through the graphical user interface 1002, and
can receive messages from the system through screen 1003. The
system can generate alerts to the user, including any problems
detected by any of the sensors, as well as the progress of
peritoneal dialysate generation. A handle 1020 can be included for
opening the peritoneal dialysate generation cabinet 1001 to allow
access to components on the inside of the cabinet. Handles 1021 and
1023 can be included to hold the fluid lines and power cord when
not in use.
[0185] Disinfection connector 1022 can be included for disinfection
of the waste line 1008. During disinfection, the waste line 1008
can be disconnected from the drain 1009 and connected to
disinfection connector 1022. Disinfectant solution from a
disinfectant source (not shown in FIG. 10) can then be circulated
through the waste line 1008 to disinfect the waste line 1008.
Disinfection connector 1025 can be included for disinfection of
water line 1007. The water line 1007 can be disconnected from
faucet 1005 and connected to disinfection connector 1025.
Disinfectant solution can be circulate through the water line 1007
for disinfection.
[0186] In any embodiment of the first, second, or third aspects of
the invention, the solute sources included in the dialysate
generation module can be provided in a dialysis caddy. A dialysis
caddy is a container adapted to contain one or more other
containers, each having one or more solute sources. One
non-limiting example of a dialysis caddy is shown in FIG. 11. The
dialysis caddy 1101 can contain some or all of the solute sources
necessary for peritoneal dialysis. In any embodiment of the first
or second aspects of the invention, the dialysis caddy 1101 can
contain an ion concentrate source 1103, osmotic agent source 1104,
and sodium chloride source 1105. As explained, the ion concentrate
source 1103 can contain any one or more of ion concentrates, such
as magnesium chloride, calcium chloride or potassium chloride, or
any other solutes used in peritoneal dialysis. Osmotic agent source
1104 can contain one or more osmotic agents, such as glucose,
dextrose, or icodextrin. One of skill in the art will understand
that any of the solutes can be contained in separate sources, and
that the dialysis caddy 1101 can be adapted for any number of
concentrate sources. In use, the dialysis caddy 1101 can be placed
in a receiving slot of a dialysis system 1102. As shown in FIG. 11,
the dialysis caddy 1101 can be configured so each of the ion
concentrate source 1103, osmotic agent source 1104, and sodium
chloride source 1105 are aligned with connectors for connection to
the peritoneal dialysate generation flow path, such as the
connectors on paddle assemblies 1113 and 1114. In any embodiment of
the first or second aspect of the invention, the dialysis caddy
1101 can also contain a disinfectant source 1106, which may contain
a disinfectant, such as citric acid. To disinfect the system, the
dialysis caddy 1101 can be turned so container connectors 1110 and
1111 on the disinfectant source 1106 can connect to the connectors
on paddle assemblies 1113 and 1114.
[0187] If dialysis caddy 1101 is configured to generate peritoneal
dialysate, container connector 1107 on ion concentrate source 1103
and container connector 1108 on osmotic agent source 1104 can
connect to caddy connectors 1115 on paddle assembly 1113 and caddy
connector 1116 on paddle assembly 1114. Container connector 1109 on
sodium chloride source 1105 can also connect to a caddy connector
(not shown in FIG. 11). The paddles can form a part of a paddle
assembly 1112. To connect the sources to the paddles, the paddles
can be rotated downward on hinge 1117 and the caddy connectors 1115
and 1116 can connect to ion concentrate source 1103 and osmotic
agent source 1104 respectively. In any embodiment of the first or
second aspects of the invention, as shown in FIG. 11, the dialysis
caddy 1101 and the sources within the caddy have one or more
fitting feature to ensure the sources are connected to the correct
paddle. The fitting features can also have the additional benefit
of ensuring a tight fit within the dialysis caddy 1101, and resist
inadvertent movement. The one or more fitting features can ensure
each source occupies a unique position within the dialysis caddy
1101. Moreover, in any embodiment, the interior of the dialysis
caddy 1101 can itself be a shaped fitting feature so each source
can only be placed within a specific position or receiving
compartment within the dialysis caddy 1101. In any embodiment of
the first or second aspects of the invention, fitting features can
be included on any connection surface of the caddy, where any
source contacts the interior of the caddy. The shape of a caddy
surface can include fitting feature protrusion 1120, which is a
protrusion on the base of the dialysis caddy 1101. The base of
sodium chloride source 1105 can be designed with a corresponding
complementary indentation, such as a similarly sized recess, while
the other sources lack the complimentary indentation. Sodium
chloride source 1105 will be the only source that can properly fit
into the position in the caddy above the fitting feature of
protrusion 1120. Similarly, fitting feature protrusion 1122 is a
protrusion in the side of the dialysis caddy 1101 interior. The
protrusion 1122 separates the sidewall of the dialysis caddy 1101
interior into two sections. Osmotic agent source 1104 can be the
only source with the proper size, shape, or geometry to fit within
one of the sections on the sidewall, whereas sodium chloride source
1105 can be the only source with the proper size, shape, or
geometry to fit within the other section. Each concentrate source
can be positioned in one particular location within the dialysis
caddy 1101. In any embodiment, the concentrate sources themselves
can have fitting features to ensure the proper arrangement of the
concentrate sources within the dialysis caddy 1101. In FIG. 11
disinfectant (e.g. citric acid) source 1106 includes flange 1118.
Ion concentrate source 1103 has a corresponding slot. The
disinfectant (e.g. citric acid) source 1106 can only be placed
within the dialysis caddy 1101 at the precise position above ion
concentrate source 1103. By sizing and shaping the interior of the
cavity and the concentrate sources, the concentrate sources can
only be placed within the dialysis caddy 1101 in a single
arrangement. If the dialysis caddy 1101 is attached to the rest of
the dialysis system 1102, the concentrate sources and connectors
line up with the proper paddles for connection to the dialysis
system. The alignment ensures the proper solutes from the
concentrate sources enter the dialysate flow path at the correct
locations, and that the proper pumps and valves are controlling the
correct solute additions. In any embodiment of the first or second
aspects of the invention, handle 1121 can be included for easy of
carrying and removal of the dialysis caddy 1101 from the dialysis
system 1102. During use, fluid lines, such as line 1119 in
disinfectant (e.g. citric acid) source 1106, can move fluids from
the concentrate sources into the paddles.
[0188] Alternatively, any method of loading the peritoneal
dialysate concentrates can be included in the described systems.
For example, the peritoneal dialysate concentrates can be added
using a disposable cassette. The disposable cassette can be
multi-use or single-use with disposal of the cassette after
therapy.
[0189] As illustrated in FIG. 12, the described systems can be used
with alternative dispensing options. The sterile peritoneal
dialysate 1201 can be dispensed through connectors 1202 to a
sterile dialysate bag 1203 or other sterile dialysate container.
The connectors 1202 can be single use or disposable connectors that
provide transfer of sterile fluids. A non-limiting example of
connectors that can be used with the described system is the
Lynx.RTM.-Millipore connectors available from Merck KGaA,
Darmstadt, Germany. Alternatively, the system can include a direct
connection through connectors 1204 to an external cycler 1205 for
immediate use of the generated peritoneal dialysate. The direct
connection to an external cycler can use any type of connectors
1204 known in the art. The connectors 1204 can be single-use or
reusable connectors and should provide for sterile transfer of
fluids. The connectors 1204 should preferably be closed connectors,
to avoid contact between the fluids and the external environment. A
non-limiting example of a connector that can be used for a direct
connection to an external cycler is the INTACT.RTM. connectors
provided by Medinstill Development LLC Delaware, US.
[0190] The connectors can include connectors for connection to
reservoirs, containers, or a tap or faucet. FIG. 11 illustrates
non-limiting embodiments of connectors for connection to one or
more containers. The connectors can be any type of connector that
can form a seal with a container, tap, or faucet that serve as the
fluid sources in the system. The connectors can be screw-type
connectors that screw onto the containers, faucet or tap, snap-type
connectors that snap onto the containers, faucet, or tap, or any
other type of connector known in the art. O-rings or other sealing
members can be included in the connectors to form a water-tight
seal with the containers, faucet, or tap.
[0191] For connection to a tap or faucet, the connectors should be
able to form a seal with standard at-home faucets. Further to this
end, the connectors can include an adjustable bore, wherein the
size of the opening of the connector for connection to the tap or
faucet can be increased or decreased to adjust to different size
faucets. Nuts, screws, or other tightenable components can be
included on the sides of the connectors allowing a user to tighten
the connector around the faucet or tap regardless of the
circumference of the faucet or tap. An o-ring or other sealing
member can be placed on the faucet or tap to increase the
effectiveness of the seal formed with the connectors.
[0192] Alternatively, a fitting can be screwed onto, or otherwise
affixed to the faucet with a male end of the fitting extending
outwardly from the faucet. The male end of the fitting can be
inserted into the water line, and secured with an adjustable bolt,
wire, or other tightening mechanism to ensure a proper seal.
[0193] For connection to a drain as illustrated in FIG. 10, the
tubing for carrying waste fluids can simply be placed into the
drain, bathtub, or other receptacle containing a drain for
disposal. Alternatively, the tubing can include a connector for
forming a sealable connection to a drain, ensuring that all waste
fluids are directed into the drain.
[0194] One skilled in the art will understand that various
combinations and/or modifications and variations can be made in the
described systems and methods depending upon the specific needs for
operation. Moreover, features illustrated or described as being
part of an aspect of the invention may be used in the aspect of the
invention, either alone or in combination, or follow a preferred
arrangement of one or more of the described elements.
* * * * *