U.S. patent application number 13/020254 was filed with the patent office on 2012-08-09 for system for preparing a medical fluid and method for preparing a medical fluid.
This patent application is currently assigned to FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH. Invention is credited to Thierry EYRARD, Philippe Laffay, Beno t Luaire.
Application Number | 20120199205 13/020254 |
Document ID | / |
Family ID | 46599839 |
Filed Date | 2012-08-09 |
United States Patent
Application |
20120199205 |
Kind Code |
A1 |
EYRARD; Thierry ; et
al. |
August 9, 2012 |
SYSTEM FOR PREPARING A MEDICAL FLUID AND METHOD FOR PREPARING A
MEDICAL FLUID
Abstract
A concentrate container for preparing a medical fluid,
preferably for preparing a dialysis solution, is provided, the
concentrate container including at least two concentrate
compartments, wherein at least one of the concentrate compartments
has a medical fluid outlet, and at least one of the concentrate
compartments has a diluent inlet. Further, systems for preparing a
medical fluid and a method for preparing a medical fluid are
described.
Inventors: |
EYRARD; Thierry; (Lyon,
FR) ; Laffay; Philippe; (Sainte-Foy-les-Lyon, FR)
; Luaire; Beno t; (Pontcharra-sur-Turdine, FR) |
Assignee: |
FRESENIUS MEDICAL CARE DEUTSCHLAND
GMBH
Bad Homburg
DE
|
Family ID: |
46599839 |
Appl. No.: |
13/020254 |
Filed: |
February 3, 2011 |
Current U.S.
Class: |
137/1 ;
206/216 |
Current CPC
Class: |
A61M 1/1668 20140204;
A61M 1/1666 20140204; A61M 1/167 20140204; A61M 1/287 20130101;
A61M 1/1656 20130101; Y10T 137/0318 20150401 |
Class at
Publication: |
137/1 ;
206/216 |
International
Class: |
B65D 81/00 20060101
B65D081/00 |
Claims
1. A concentrate container for preparing a medical fluid,
preferably for preparing a dialysis solution, the concentrate
container (10; 20; 30; 40; 50; 60; 70) comprising at least two
concentrate compartments (12, 14; 22, 24; 33, 34) wherein at least
one of the concentrate compartments has a medical fluid outlet (16;
26; 36; 46), and at least one of the concentrate compartments has a
diluent inlet (18; 28; 38; 48).
2. The concentrate container of claim 1, wherein a first
concentrate compartment (22) and a second concentrate compartment
(24) of the concentrate compartments are separated from each other
by permanent barrier means (25), and each of the first and second
concentrate compartments has a diluent inlet (28) and a medical
fluid outlet (26); or wherein a first concentrate compartment (33)
and a second concentrate compartment (34) of the concentrate
compartments are separated from each other by releasable barrier
means (35), the first concentrate compartment has a diluent inlet
(18) and the second concentrate compartment has a medical fluid
outlet (16).
3. The concentrate container of claim 1, wherein a first
concentrate compartment (32) and a second concentrate (33)
compartment of the concentrate compartments are separated from each
other by permanent barrier means (25), and each of the first and
second concentrate compartments has a diluent inlet (18) and the
first concentrate compartment has a medical fluid outlet (16); and
a third concentrate compartment (34) of the concentrate
compartments is separated from the second concentrate compartment
(33) by releasable barrier means (35) and has a medical fluid
outlet (16).
4. The concentrate container of claim 1, wherein the at least one
medical fluid outlet (16) and the at least one diluent inlet (18)
are separate from each other; and/or wherein the concentrate
container has an angled or V-shaped inner surface (19); and/or
wherein the concentrate container has an angled or V-shaped inner
surface (19) and is adapted such that it is positionable and
operable having the angle of the angled or V-shaped surface at the
bottom; and/or wherein the concentrate container has at least one
fluid transmission means (49); and/or wherein one or more of the
medical fluid outlets (16) is each fluidly connected to a long
channel (150) having at least one outlet (160; 160a, 160b); and/or
wherein the concentrate container (302) has a channel (150) being
fluidly connected to one or more of the medical fluid outlets (16)
and having at least one outlet (160; 160a, 160b); and/or wherein
the concentrate container (303) includes a first channel (150a)
being fluidly connected to one of the medical fluid outlets (16)
and having an outlet (160a), and a second channel (150b) being
fluidly connected to another one of the medical fluid outlets (16)
and having another outlet (160b), wherein the first and the second
channels (150a, 150b) are fluidly separated by separating means
(313).
5. The concentrate container of claim 1, wherein the first
concentrate compartment includes at least one restrictor means (52)
or at least one restrictor means subdividing the first concentrate
compartment into sub-compartments (53, 54); and/or wherein the
concentrate container includes at least one filter means (55)
provided at the at least one medical fluid outlet and/or at the at
least one diluent inlet; and/or wherein the concentrate container
includes a lid (61) or a sealable lid, adapted to close at least
one of the concentrate compartments.
6. The concentrate container of claim 1, wherein at least two
different components of a concentrate are provided in different
concentrate compartments; and/or wherein one of the concentrate
compartments includes glucose; and/or wherein the at least two
different concentrate components include at least one element
chosen from sodium bicarbonate, sodium chloride, magnesium
chloride, potassium chloride, calcium chloride, and citric acid;
and/or wherein a first component of a concentrate includes sodium
bicarbonate and sodium chloride; a second component of the
concentrate includes sodium chloride, magnesium
chloride.times.6H.sub.2O, potassium chloride, calcium
chloride.times.6H.sub.2O, and anhydrous citric acid; and a third
component of the concentrate includes glucose.times.H.sub.2O;
and/or wherein a first component of a dry concentrate includes
187.5 g sodium bicarbonate and 327.5 g sodium chloride; a second
component of the dry concentrate includes 35 g sodium chloride, 6.1
g magnesium chloride.times.6H.sub.2O, 8.95 g potassium chloride,
13.2 g calcium chloride.times.6H.sub.2O, and 11.5 g anhydrous
citric acid; and a third component of the dry concentrate includes
66 g glucose.times.H.sub.2O.
7. Fluid container system for preparing a medical fluid, preferably
for preparing a dialysis solution, comprising a fluid container
(110) for collecting a prepared medical fluid, the fluid container
having a medical fluid drainage line (111, 1111), and another fluid
container (120) for collecting a consumed medical fluid, the fluid
container (110) being insertable into the another fluid container
(120).
8. The system of claim 7, wherein at least one element chosen from
the fluid container (110) and the another fluid container (120) is
a flexible container, a disposable, a bag, a bag having a gusset
(71) on each side and/or a bag having a bottom including two
outwardly bendable folds (72); and/or wherein the medical fluid
drainage line (111) and/or the another fluid container each include
a tube (111; 121) extending into the interior or to the bottom of
the respective fluid container; and/or wherein the fluid container
includes at least one first line connection means (1140; 1140a,
1140b) for at least one fluid transfer line (114) and a second line
connection means (1111) which is connectable to, connected to or
included in the medical fluid drainage line (111); and/or wherein
the another fluid container includes at the tube a third line
connection means (1221) for a consumed medical fluid collection
line (122).
9. Kit of parts for preparing a medical fluid, comprising at least
two elements chosen from a concentrate container (10; 20; 30; 40;
50; 60; 70) according to claim 1, a fluid container (110), a fluid
container system (110, 120) comprising a fluid container (110) for
collecting a prepared medical fluid, the fluid container having a
medical fluid drainage line (111, 1111), and another fluid
container (120) for collecting a consumed medical fluid, the fluid
container (110) being insertable into the another fluid container
(120), and a transport means (200) adapted to support and/or to
include at least one of the concentrate container, the fluid
container, and the fluid container system.
10. A system for preparing a medical fluid, preferably for
preparing a dialysis solution, the system (100) comprising a
concentrate container (10; 20; 30; 40; 50; 60; 70) according to
claim 1, a fluid container (110) fluidly connected to a medical
fluid removal line (112), at least one fluid transfer line (114)
fluidly connecting the at least one medical fluid outlet (16) of
the concentrate container and the fluid container.
11. The system of claim 10, wherein the fluid container includes a
medical fluid drainage line (111); and/or wherein the system
includes another fluid container connected to a consumed medical
fluid collection line (122), the fluid container being insertable
into the another fluid container; and/or wherein the concentrate
container has at least one fluid transmission means (49), one of
the fluid transmission means being connectable or weldable to the
medical fluid drainage line (111) and/or another one of the fluid
transmission means being connectable or weldable to the consumed
medical fluid collection line (122).
12. The system of claim 10, wherein the at least one diluent inlet
(18) of the concentrate container is fluidly connected to a diluent
feed line (118); and/or wherein the fluid container and the another
fluid container are the fluid container and the another fluid
container of the fluid container system comprising a fluid
container (110) for collecting a prepared medical fluid, the fluid
container having a medical fluid drainage line (111, 1111), and
another fluid container (120) for collecting a consumed medical
fluid, the fluid container (110) being insertable into the another
fluid container (120); and/or wherein at least one of the
concentrate container, the fluid container, and the fluid container
system is tiltably and/or removably installed in the system.
13. The system of claim 10, wherein the concentrate container is
positioned at the top or at the bottom of at least one of the fluid
container and of the another fluid container; and/or wherein the
system comprises a transport means (200) adapted to support and/or
to include at least one of the concentrate container, the fluid
container and the another fluid container.
14. The system of claim 10, wherein the system is adapted to be a
mobile and/or modular system; and/or wherein at least two elements
chosen from the concentrate container, the fluid container, the
another fluid container and the transport means are modular
components of the system; and/or wherein the concentrate container
is rigid; and/or wherein the fluid container and the another fluid
container are flexible.
15. A method comprising using a kit of parts according to claim 9,
the concentrate container thereof and/or the fluid container system
thereof in dialysis, acute dialysis, hemodialysis,
hemodiafiltration, peritoneal dialysis, or for preparing a dialysis
solution.
16. A method for preparing a medical fluid, preferably for
preparing a medical fluid or a dialysis solution in a system
according to claim 10, the method comprising providing a
concentrate container (10; 20; 30; 40; 50; 60; 70) including at
least one concentrate compartment 12, 14), wherein a first
compartment (12) of the concentrate compartments contains a first
concentrate component; feeding a diluent into the first
compartment; rinsing the first compartment by the diluent and
diluting the first concentrate component; and transferring the
diluted first concentrate component into a fluid container.
17. The method of claim 16, wherein a second compartment (14) of
the concentrate compartments contains a second concentrate
component; the method comprising feeding the diluent into the
second compartment; rinsing the second compartment by the diluent
and diluting the second concentrate component; and transferring the
diluted second concentrate component into the fluid container.
18. The method of claim 17, wherein each of the first and second
compartments is separately fed with the diluent and rinsed; or
wherein the feeding and rinsing of the second compartment is
performed by passing the diluent from the first compartment into
the second compartment.
19. The method of claim 17, wherein the concentrate container
further includes a third compartment (34) containing a third
concentrate component; each of the first and second compartments
(32, 33) is separately fed with the diluent and rinsed; and the
feeding and rinsing of the third compartment and the diluting of
the third concentrate component is performed by passing the diluent
from the second compartment into the third compartment.
20. The method of claim 16, wherein during feeding the diluent a
first diluent is fed into the first compartment and a second
diluent is fed into the second compartment, the first diluent and
the second diluent being different from each other.
Description
[0001] The present invention is directed to a concentrate container
for preparing a medical fluid, to a system for preparing a medical
fluid, to a fluid container system, to a kit of parts for preparing
a medical fluid, to a use of a system for preparing a medical
fluid, and to a method for preparing a medical fluid. In
particular, the concentrate container for preparing a medical
fluid, the system for preparing a medical fluid, the fluid
container system, the kit of parts for preparing a medical fluid,
and the method for preparing a medical fluid may be used in
dialysis, e.g. acute dialysis, or in hemodiafiltration.
[0002] Typically, patients with chronic renal failure receive
medical treatment three to four times a week either in a dialysis
clinic or at home. During hemodialysis, a dialysis machine pumps
blood from a vascular access in the patient into a dialyzer. The
dialyzer filters metabolic waste products and removes excess water
from the blood. These waste products are then flushed out with
dialysis solution and the filtered blood is returned to the
patient's body. During hemodiafiltration, the machine removes more
water from the blood than during hemodialysis. The additional
liquid is continually replaced with an ultra-pure electrolyte
solution. Thus, the machine exchanges a high volume of fluid during
treatment and removes the liquid together with metabolic toxins
from the blood.
[0003] In peritoneal dialysis, the peritoneum of the patient acts
as the filter for cleaning the blood. The peritoneum has
characteristics similar to those of the dialyzer: pores in the
membrane allow passage of certain substances while retaining
others. A catheter is used to introduce dialysis solution into the
abdominal cavity. The blood-rich peritoneum is surrounded by the
dialysis solution and metabolic toxins flow from the blood through
pores in the peritoneum into the dialysis solution. Further,
glucose in the dialysis solution pulls excess water out of the
body. The solution containing the toxins and excess water is
removed through the catheter and replaced with fresh solution. In
Continuous Ambulant Peritoneal Dialysis (CAPD), patients change the
dialysis solution with the help of bag systems four to five times a
day. In Automatic Peritoneal Dialysis (APD), a dialysis machine
(cycler) takes over the exchange of fluid, making overnight
treatment possible.
[0004] Typically, dialysis systems for patients with chronic renal
failure are provided with an individual system, in order to supply
"reverse osmosis" water (RO water), fresh dialysis solution or
concentrate for dialysis solution to the dialysis machine. However,
such systems are not practicable for intensive care in hospitals,
since in intensive care dialysis machines are used in irregular
time intervals and at varying places. Therefore, previous
developments aimed at providing dialysis machines with a huge
reservoir of dialysis solution, such that the dialysis machines can
be used location-independently at any time. Such reservoirs may be
provided with an internal container, in order to accommodate
dialysis solution. Preferably, the internal container is a bag or
pouch having a high volume and which can be disposed after dialysis
treatment. If disposables are used, a time consuming disinfection
of the reservoir can be omitted.
[0005] It is known to use bags for storing a high volume of
dialysis solution. Previously, it was necessary to produce the
dialysate contained in the bag in a separate device and to transfer
the dialysate produced into the bag for storing.
[0006] DE 10 2009 058 445 describes a bag for preparing and
providing a dialysate batch having a high volume, the bag including
concentrate compartments.
[0007] AU 570100 B2, DE 195 10 759 A1, U.S. Pat. No. 4,386,634 A
and DE 198 25 158 C1 disclose examples, in which a high volume of
dialysate is provided in a storage container. The dialysate is
contained in a bag having a high volume, which is supported by the
storage container.
[0008] In DE 10 2007 009 269 A1 a glass tank is provided, in which
the dialysate is stored.
[0009] EP 1 120 099 B1 describes a cartridge for accommodating
concentrates, the cartridge having sub-compartments. The
concentrates are dissolved by RO water.
[0010] DE 10 2010 014 785 is directed to a plastic film which can
be used for the production of a bag having a high capacity for
accommodating a dialysate.
[0011] Object of the invention is to provide a device and a method
for preparing a medical fluid.
[0012] This object is achieved by a concentrate container according
to claim 1, a fluid container system according to claim 7, a kit of
parts according to claim 9, a system for preparing a medical fluid
according to claim 10, a use according to claim 15, and a method
for preparing a medical fluid according to claim 16.
[0013] In one embodiment, a concentrate container for preparing a
medical fluid is provided, preferably for preparing a dialysis
solution, the concentrate container including at least two
concentrate compartments, wherein at least one of the concentrate
compartments has a medical fluid outlet, and at least one of the
concentrate compartments has a diluent inlet.
[0014] In another embodiment, a fluid container system for
preparing a medical fluid is provided, preferably for preparing a
dialysis solution, including a fluid container for collecting a
prepared medical fluid, the fluid container having a medical fluid
drainage line, and another fluid container for collecting a
consumed medical fluid, the fluid container being insertable into
the another fluid container.
[0015] A further embodiment is directed to a kit of parts for
preparing a medical fluid, including at least two elements chosen
from a concentrate container according to above one embodiment, a
fluid container, a fluid container system according to above
another embodiment, and a transport means adapted to support and/or
to include at least one of the concentrate container, the fluid
container, and the fluid container system.
[0016] According to a further embodiment, a system for preparing a
medical fluid, preferably for preparing a dialysis solution, is
provided, the system including a concentrate container according to
above one embodiment, a fluid container fluidly connected to a
medical fluid removal line, at least one fluid transfer line
fluidly connecting the at least one medical fluid outlet of the
concentrate container and the fluid container.
[0017] According to a yet further embodiment, the concentrate
container, the fluid container system, the kit of parts and/or the
system for preparing a medical fluid of above embodiments are used
in dialysis, acute dialysis, hemodialysis, hemodiafiltration,
peritoneal dialysis, or for preparing a dialysis solution.
[0018] In another embodiment, a method for preparing a medical
fluid, preferably for preparing a medical fluid in a system
according to above one embodiment, the method includes providing a
concentrate container including at least one concentrate
compartment, wherein a first compartment of the concentrate
compartments contains a first concentrate; feeding a diluent into
the first compartment; rinsing the first compartment by the diluent
and diluting the concentrate; and transferring the diluted first
concentrate into a fluid container.
[0019] Some of the above mentioned embodiments will be described in
more detail in the following description of typical embodiments
with reference to the following drawings in which:
[0020] FIG. 1a, 1b schematically illustrate concentrate containers
for preparing a medical fluid, according to embodiments of the
invention;
[0021] FIG. 2a, 2b schematically illustrate concentrate containers
according to embodiments of the invention;
[0022] FIG. 3 schematically illustrates a concentrate container
according to an embodiment of the invention;
[0023] FIG. 4 schematically illustrates a concentrate container
according to an embodiment of the invention;
[0024] FIG. 5 schematically illustrates a concentrate container
according to an embodiment of the invention;
[0025] FIG. 6 schematically illustrates a concentrate container
according to an embodiment of the invention;
[0026] FIG. 7 schematically illustrates a system for preparing a
medical fluid, according to an embodiment of the invention;
[0027] FIG. 8 schematically illustrates a system for preparing a
medical fluid, according to an embodiment of the invention;
[0028] FIG. 9a schematically illustrates a system for preparing a
medical fluid, according to an embodiment of the invention;
[0029] FIG. 9b schematically illustrates a fluid container system
for preparing a medical fluid, according to an embodiment of the
invention;
[0030] FIG. 9c schematically illustrates a fluid container system
for preparing a medical fluid, connected to a concentrate
container, according to an embodiment of the invention;
[0031] FIG. 9d schematically illustrates a fluid container system
for preparing a medical fluid, connected to a concentrate
container, according to an embodiment of the invention;
[0032] FIG. 10a, 10b schematically illustrate a system for
preparing a medical fluid, according to an embodiment of the
invention; and
[0033] FIG. 11 schematically illustrates a system for preparing a
medical fluid, according to an embodiment of the invention.
[0034] Within the following description of the drawings, the same
reference numbers refer to the same components. Generally, only the
differences with respect to the individual embodiments are
described. In the following description, embodiments of the
invention are described referring to a preparation of a dialysis
solution, also referred to herein as dialysate, without limiting
the scope of the invention. Other medical fluids may be prepared
using embodiments described herein. Further, the terms "concentrate
compartment" and "compartment" are used synonymously. Moreover, in
embodiments, a concentrate component may also be referred to as a
concentrate.
[0035] The term "diluent" refers to fluids by which concentrates,
e.g. dry concentrates, can be diluted, dissolved or suspended. Some
embodiments described herein refer to a solvent as a "diluent", but
are not restricted thereto. Further, embodiments described herein
using the term "diluent" encompass examples in which in at least
two of the concentrate compartments different diluents or solvents
can be or are introduced. In addition, in some embodiments, the
term "diluting" or "dilution" may encompass dissolution and/or
suspension processes.
[0036] FIG. 1a schematically illustrates a concentrate container 10
for preparing a medical fluid, according to an embodiment of the
invention. The concentrate container 10 is in the present
embodiment formed by four side walls 11 and a bottom wall 13.
However, other spatial forms of the concentrate container 10 may be
contemplated. Two concentrate compartments 12 and 14 are formed
inside the container 10 by barrier means, which in the present
embodiment is a partition wall 15 partially dividing the interior
of the box into the two compartments 12 and 14. For instance,
partition wall 15 may include an opening (not shown) for passing a
fluid and solutes contained in the fluid. Concentrate compartment
12 includes an opening 16 as the medical fluid outlet, whereas
concentrate compartment 14 is provided with an opening 18 forming a
solvent inlet as the diluent inlet. Since partition wall 15 allows
that fluids pass from compartment 14 to compartment 12, a solvent
fed into compartment 14 through opening 18 may flow from
compartment 14 into compartment 12, dissolve different concentrates
contained in the different compartments and may leave the
concentrate container 10 through opening 16.
[0037] The concentrates may be filled into the different
compartments through the top openings of the concentrate
compartments shown in FIG. 1a. In another example, the solvent
inlets of concentrate container 10 may be formed simply by the top
openings of the concentrate compartments and an opening 18 is not
provided.
[0038] Hence, in one embodiment, a concentrate container for
preparing a medical fluid, preferably for preparing a dialysis
solution, includes at least two concentrate compartments, wherein
at least one of the concentrate compartments has a medical fluid
outlet, and at least one of the concentrate compartments has a
diluent inlet. The compartments may be separated from each other in
a permanent or semi-permanent manner. According to embodiments, the
at least one medical fluid outlet and the at least one diluent
inlet are separate from each other.
[0039] Embodiments of the invention allow for filling into each
compartment a concentrate different from the concentrates of the
other compartments and storing them substantially separate from
each other. As a result, concentrate components for forming a
medical fluid, such as dry concentrate components of a dialysate,
may be filled, transported and stored in one container avoiding or
without mixing the different components. This is especially useful
for concentrate components which are liable to degradation and/or
caking or clump together when intermixed. Further, the different
concentrates or concentrate components can be dissolved or
suspended using the concentrate container of embodiments, thereby
forming a medical fluid or partial fluids of a medical fluid
directly in the concentrate container in which they are provided or
stored. Hence, the dilution, suspension or dissolution of the
concentrates or concentrate components can be performed in
different steps and/or in an efficient way, even for bicarbonate
granules. Moreover, the concentrate container can be formed in a
simple production process, by molding, and as just one disposable
part.
[0040] Therefore, the concentrate container according to
embodiments allows a physical separation between dry concentrates,
a dissolution of the concentrates in different steps with a high
efficiency, and an efficient waste disposal and can be formed by a
simple production process. Moreover, using the concentrate
container of embodiments, a medical fluid can be prepared in situ
in a container, in which the concentrates can be stored and which
can be directly coupled to a system for applying the medical fluid
to a patient. Further, by performing a suitable dilution sequence
for the different concentrate components, degassing and
precipitation of concentrate components during dilution can be
reduced or avoided. Consequently, a complete dissolution of the
concentrate components or concentrates contained in the concentrate
container can be achieved, in order to form the medical fluid.
[0041] In other examples of embodiments, the concentrate container
has an angled or V-shaped inner surface. An example of a
concentrate container having an angled inner surface is one of the
concentrate containers 10 to 30. Each of them has edges, which
promote during shaking of the concentrate container dissolution of
the concentrates by the solvent.
[0042] In one embodiment, the concentrate container has an angled
or V-shaped inner surface and is adapted such that it is
positionable and operable having the angle of the angled or
V-shaped inner surface at the bottom. One example of this
embodiment is concentrate container 17 shown in FIG. 1b in a
perspective bottom view. Concentrate container 17 has a so-called
tilted design. The medical fluid outlet 16 of concentrate container
17 as compared to concentrate container 10 is located in the bottom
wall 13. Hence, an edge 19 of the concentrate container 17, which
is formed by the bottom wall 13 and the sidewall 11 which includes
the solvent inlet 18, is located between the solvent inlet 18 and
the medical fluid outlet 16. As a result, the edge 19 between
solvent inlet 18 and medical fluid outlet 16 is preferably filled
with solvent, if the concentrate container 17 is held in a
correspondingly tilted way such that the edge 11 is positioned at
the bottommost position. In this arrangement of the concentrate
container, the solvent and the concentrate filled in the container
17 accumulate in the angled part of the inner surface, i.e. in the
present example in the V-shape of the edge 19 between the solvent
inlet 18 and the medical fluid outlet 16, thereby promoting
dissolution of the concentrate. Since in some embodiments, the
concentrate container 17 is substantially rigid, the tilted design
results in a high mechanical resistance, since a rigid edge can be
positioned at the top. Further, the concentrate container 17 of the
tilted design can easily and accurately be arranged on a
correspondingly angled or V-shaped support. Moreover, a plurality
of concentrate containers 17 can be stacked one above the
other.
[0043] According to a further embodiment, a first concentrate
compartment and a second concentrate compartment of the concentrate
compartments are separated from each other by permanent barrier
means, and each of the first and second concentrate compartments
has a diluent inlet and a medical fluid outlet.
[0044] FIG. 2a schematically shows as an example of above further
embodiment a concentrate container 20. Therein, compartments 22 and
24 are separated by a permanent barrier means, which in the present
example is a wall 25 completely separating compartments 22 and 24.
Further, compartments 22 and 24 each include one solvent inlet 18
and one medical fluid outlet 16.
[0045] In another embodiment, a first concentrate compartment and a
second concentrate compartment of the concentrate compartments are
separated from each other by releasable barrier means, e.g. a
semi-permanent barrier, the first concentrate compartment has a
diluent inlet and the second concentrate compartment has a medical
fluid outlet. This embodiment is based on concentrate container 20
of FIG. 2a, wherein, however, wall 25 is replaced by a releasable
barrier means (not shown), e.g. a plate slide which may be operated
manually or automatically from outside of the concentrate
container. Another example for a releasable barrier means is a
piston valve (not shown) which can be opened by the diluent or
solvent due to the fluid pressure and/or due to the flow of the
diluent or solvent. Alternatively, the piston valve may be actuated
from outside of the concentrate container.
[0046] According to a further embodiment, a first concentrate
compartment and a second concentrate compartment of the concentrate
compartments are separated from each other by permanent barrier
means, and each of the first and second concentrate compartments
has a diluent inlet and the first concentrate compartment has a
medical fluid outlet; and a third concentrate compartment of the
concentrate compartments is separated from the second concentrate
compartment by releasable barrier means and has a medical fluid
outlet.
[0047] FIG. 2b schematically illustrates as an example a
concentrate container 30 including three concentrate compartments
32, 33 and 34. Compartments 33 and 34 are separated by a releasable
barrier means, which is in the present example a piston valve 35
which may be opened due to the flow and/or the fluid pressure of
the diluent or solvent. Compartment 33 includes one solvent inlet
18 and compartment 34 includes one medical fluid outlet 16.
Compartments 32 and 33 are separated by wall 25 as a permanent and
complete barrier means. Compartment 32 further includes one solvent
inlet 18 and one medical fluid outlet 16.
[0048] In embodiments described herein, one or more of the medical
fluid outlets 16 may each be fluidly connected to a long channel
having at least one outlet, e.g. a central outlet. An example of
such an embodiment is illustrated in FIG. 3 in a top view. Therein,
a concentrate container 300 is shown which is based on concentrate
container 30 of FIG. 2b. Concentrate container 300 further includes
a channel 150 extending along the sidewall 11 in which the medical
fluid outlets 16 of the concentrate container are formed. The
channel 150 has a central outlet 160 through which the two
fractions of the medical fluid originating from medical fluid
outlet 16 of the compartment 32 on the one hand and from medical
fluid outlet 16 of the compartments 33 and 34 on the other hand can
pass and combine. Thereby, connectivity to a medical fluid transfer
line is simplified, since just one medical fluid transfer line is
required and can be connected to the central outlet 160 of the
concentrate container 300.
[0049] The material of the concentrate containers may, according to
embodiments, include Polyamide or Polyethylene, e.g. PEHD. The
concentrate container may be formed by injection molding. The
internal volume of the concentrate container compartments may be in
a range to contain concentrates for the preparation of aimed volume
of the medical fluid. For the preparation of a 60 l batch of
dialysis fluid a concentrate container volume of 2 l is in some
examples sufficient. This depends on the kind of diluents which may
already contain several solutes. These solutes then do not have to
be provided by concentrates in the concentrate container. In
general a concentrate volume of 0.5 to 3 l may be appropriate for a
broad range of applications. The concentrate container according to
embodiments may be formed from a material including Polypropylene
(PP), Polyethylene terephtalate (PET), Polyurethane (PU),
Polysulfone (PSU), Polyvinylchloride (PVC), Polyethylene (PE),
Polystyrene (PS), Polyalphaolefins, Copolymers of propylene,
ethylene, butylenes, octane, Polymer blends of the aforementioned
Polymers.
[0050] Further, the concentrate container of embodiments may have
at least one fluid transmission means. The fluid transmission means
is sealed off from the compartments. An example of a container 40
having a fluid transmission means is shown in FIG. 4. Concentrate
container 40 includes a tube 49 as fluid transmission means passing
through compartment 12 and allowing passage of fluids through
compartment 12 without mixing with concentrates, suspensions or
fluids contained in compartment 12. The inner lumen of the fluid
transmission means may be in a range from 3 to 20 mm, the wall
thickness of the fluid transmission means may be from 1 to 2.5
mm.
[0051] In a further embodiment, the first concentrate compartment
includes at least one restrictor means or at least one restrictor
means subdividing the first concentrate compartment into
sub-compartments. For instance, as shown in FIG. 5, concentrate
compartment 12 includes a partial wall 52 allowing passage of a
fluid or of a concentrate between two sub-compartments 53 and 54
separated by partial wall 52. The restrictors promote diluting
and/or dissolving the concentrates during filling of diluent into
the first concentrate compartment, since they increase the water
speed and the turbulences. At least one of the restrictors can be
or include a nozzle or a frit, which may cause turbulences.
[0052] According to examples of embodiments, the concentrate
container includes at least one filter means provided at the at
least one medical fluid outlet and/or at the at least one diluent
inlet. For instance, in the concentrate container shown in FIG. 5,
a filter means 55 is provided at solvent inlet 18. A further filter
means (not shown in FIG. 5) may be installed at medical fluid
outlet 16 of compartment 12. Thereby, outflow of undissolved
particles out of the concentrate container can be avoided.
Furthermore, a filtering of the medical fluid or dialysate can be
achieved. The filter means can be formed from a material including
Polyethylene. In one example, the filter means 55 is a microporous
filter from Porex having an average porosity of 180 to 300 .mu.m
and a thickness of 2.9 mm. For example, the filter can be a sterile
filter with average pore size of 0.22 .mu.m to 5 .mu.m.
[0053] The concentrate container of embodiments may include a lid
or a sealable lid, adapted to close at least one of the concentrate
compartments. An example of such an embodiment is shown in FIG. 6,
wherein concentrate container 60 includes a lid 61 for closure of
all compartments. Thereby, contamination of concentrates contained
in the closed concentrate compartments may be prevented. Further,
concentrate container 60 may be shaken or tilted without loss of
concentrates and/or diluent contained. Lid 61 may be a 6 mm thick
Poly(methyl methacrylate) (PMMA) window hinged to one sidewall 11
of the concentrate container. According to another example, the lid
may be formed from a Polyamide/Polyethylene (PA/PE) foil welded on
the concentrate container. Further, a PA/PE foil can be applied as
a lid. In one embodiment PA/PE foil is formed from a two-layer or
multilayer film, whereby one layer is formed from PE Polymers for
welding purposes. The other layer is formed from PA Polymers for
establishing a high tear resistance and adequate gas barrier of the
multilayer film. The multilayer thickness may be about 200 .mu.m
and the dimension of the lid may be about 40.times.10 cm depending
on concentrate container dimensions.
[0054] According to one embodiment, a system for preparing a
medical fluid, preferably for preparing a dialysis solution, is
provided, the system including a concentrate container according to
embodiments described herein, a fluid container fluidly connected
to a medical fluid removal line, at least one fluid transfer line
fluidly connecting the at least one medical fluid outlet of the
concentrate container and the fluid container.
[0055] The system for preparing a medical fluid, according to
embodiments, allows a physical separation between dry concentrates,
a dissolution of the concentrates in different steps with a high
efficiency, and an efficient waste disposal. Further, the parts of
the system can be formed by simple production processes and the
system can easily be assembled and disassembled. Moreover, using
the system of embodiments, a medical fluid can be prepared in situ
in a container, in which the concentrates have been stored and
while the container is provided in the system.
[0056] FIG. 7 illustrates a system 100 as an example of a system
for preparing a medical fluid according to embodiments. System 100
includes concentrate container 20 of FIG. 2a, wherein wall 25 is
replaced by a releasable barrier means 35, e.g. a plate slide which
may be opened and closed. In addition, system 100 has a fluid
container 110 which is fluidly connected to concentrate container
20 via a fluid transfer line 114. In the present example, fluid
transfer line 114 is a tube connecting medical fluid outlet 16 of
the concentrate container 20 and fluid container 110. The latter is
shown in FIG. 7 as a non-transparent bag. Fluid container 110 has
an opening, which in the present example is the medical fluid
drainage line 111 and is fluidly connected to a medical fluid
removal line 112 for withdrawing a medical fluid collected in fluid
container 110. According to other embodiments, the medical fluid
drainage line 111 may include a tube extending into the interior of
the fluid container. In this example, the internal volume of the
concentrate container compartments may be in a range to contain
concentrates for the preparation of aimed volume of the medical
fluid. For the preparation of a 60 l batch of dialysis fluid a
concentrate container volume of 2 l is in some examples sufficient.
This depends on the kind of diluents which may already contain
several solutes. These solutes then do not have to be provided by
concentrates in the concentrate container. In general a concentrate
volume of 0.5 to 3 l may be appropriate for a broad range of
applications. The third container 110 may have an inner dimension
of about 70 l.
[0057] For forming a medical fluid, concentrate container 20
including releasable barrier means 35 is provided with two
different concentrates, e.g. dry concentrates, separately contained
in concentrate compartments 12 and 14. A solvent is introduced
through opening 18 into compartment 14, dissolving and/or
suspending the concentrate provided in compartment 14.
[0058] Then, the solvent including dissolved and/or suspended
concentrate from compartment 14 passes into compartment 12 after
release of the barrier means 35, thereby dissolving and/or
suspending the concentrate contained therein. Thereafter, a medical
fluid formed by the solvent and the concentrates dissolved or
suspended therein leaves concentrate compartment 12 through opening
16 and fluid transfer line 114 and is collected in fluid container
110. The medical fluid may then be withdrawn from fluid container
110, e.g. by a pump installed in medical fluid removal line
112.
[0059] Examples of diluents or solvents used in embodiments
described herein are diluents for forming medical fluids, such as
water from Reverse Osmosis (RO) processing, diluted solutions which
contain solutes or parts of solutes necessary for the final
concentrated medical solution. The amounts of diluents used in
examples correspond to the final volumes of the medical solutions
to be prepared. The preparation of volumes of diluents may be
adapted depending on the solution volume to be prepared. For
example, solution volumes may be 2-120 l, 5 to 80 l, preferred 30
to 80 l, more preferred 50 to 70 l.
[0060] In the example of FIG. 7, solvent inlet 18 may be connected
to a solvent feed line 118 as a diluent feed line, as shown in FIG.
8. Hence, according to embodiments, at least one diluent inlet of
the concentrate container is fluidly connected to a diluent feed
line.
[0061] Further, according to embodiments, at least one of the
concentrate container, the fluid container and the fluid container
system is tiltably and/or removably installable or tiltably and/or
removably installed in the system. By tilting the concentrate
container, dissolution of the concentrates in the solvent may be
promoted. Further, because the concentrate container and/or the
fluid container(s) are removable, a simple replacement of the
containers is feasible, in order to provide fresh concentrates
contained in the concentrate container, and/or in order to avoid
contamination of the system by providing fresh containers.
[0062] According to further examples of embodiments, the fluid
container may include a medical fluid drainage line 111, which may
include a tube (not shown in FIG. 7) and an opening at the top of
the fluid container, the tube extending from the opening to the
bottom of the fluid container. Thereby, withdrawal of the medical
fluid from the fluid container is easier.
[0063] In another embodiment, the system may include another fluid
container connected to a consumed medical fluid collection line,
the fluid container being insertable into the another fluid
container. An example of this embodiment is illustrated in FIG. 8
as part of an embodiment of a system 101 having the concentrate
container 10 of FIG. 1a fluidly connected via fluid transfer line
114 to fluid container 110 shown in FIG. 7. The concentrate
container 10 further has the solvent feed line 118 connected to
solvent inlet 18 as an optional feature. In addition, another fluid
container 120 is provided encompassing fluid container 110. In FIG.
8, fluid container 120 is transparent, but is not restricted
thereto according to embodiments described herein. Fluid container
120 is fluidly connected to a tube 122 which is a consumed medical
fluid collection line, which is for instance connected to a
dialysis machine (not shown). As an optional feature, fluid
container 120 includes a tube 121 fluidly connected to tube 122,
for guidance and/or withdrawal of consumed medical fluid into/out
of the fluid container 122.
[0064] The concentrate container of the system for preparing a
medical fluid, according to embodiments, may have at least one
fluid transmission means, one of the fluid transmission means being
connectable or weldable to the medical fluid drainage line and/or
another one of the fluid transmission means being connectable or
weldable to the consumed medical fluid collection line. An example
of this embodiment is shown in FIG. 9a, wherein a concentrate
container 70 has two fluid transmission means 49, one of which is
fluidly connected to the medical fluid drainage line 111 of the
fluid container 110 and another one of which is fluidly connected
to tube 121 provided in fluid container 120. A port of the
concentrate container shown in FIG. 9a, the port positioned between
the two fluid transmission means 49, may be a solvent inlet.
[0065] In FIGS. 9a, 9b, 9c, 9d, 10a and 10b, the fluid containers
110 and 120 are illustrated as transparent bags, but according to
embodiments described herein the fluid containers are not
restricted thereto.
[0066] Materials and dimensions of tubes used for fluid transfer
line 114, consumed medical collection line 122, medical fluid
drainage line 112, solvent feed line 118 may include PP, Styrene
block copolymers from Styrene butadiene, ethylene, isoprene (SEBS;
SIS; SEPS), PVC, silicone, PE, Polyalphaolefines.
[0067] According to embodiments, the concentrate container may be
positioned at the top or at the bottom of at least one of the fluid
container and of the another fluid container. An example of the
concentrate container positioned at the top of at least one of the
fluid containers is shown in FIGS. 10a and 10b. If the concentrate
container is positioned below the fluid container(s), inside of the
fluid container no tubes are necessary for drainage or for
agitation.
[0068] In further examples of embodiments, the system for preparing
a medical fluid includes a transport means adapted to support
and/or to include at least one of the concentrate container, the
fluid container and the another fluid container, as schematically
illustrated in FIG. 11. Therein, according to an example, as a
transport means a trolley 200 is schematically shown, which
includes the fluid container system arranged at the concentrate
container as shown in FIGS. 10a and 10b. For instance, the trolley
200 may be a transparent container having bottom wheels. For
installation, the concentrate container 70 may include supports 201
for mounting at the top of the trolley 200. Thereby, the system for
preparing a medical fluid can be used location-independently at any
time. The trolley 200 may be adapted for transporting high amounts
of solution, such as about 50 to 100 l, e.g. about 72 l.
[0069] In examples of embodiments, the system for preparing a
medical fluid may be adapted to be a mobile and/or modular system.
Further, the concentrate container, the fluid container, the
another fluid container and/or the transport means may be modular
components of the system. Moreover, the concentrate container may
be substantially rigid or substantially non-flexible. In some
embodiments, the fluid container and the another fluid container
are substantially flexible, for instance flexible pouches.
[0070] The fluid container and/or the another fluid container of
embodiments described herein can have an internal capacity of about
60 to 70 liters, in order to accommodate high volumes of fluids.
The another fluid container can in some examples be also used for
accommodating ultra filtrate from a patient.
[0071] The fluid container and the another fluid container of
embodiments described herein can each be formed from PET, PA, PE,
PP, PVC, preferably as multi layered films. For instance, the fluid
container and the another fluid container can be formed from a
multi layered film including PA or PET and PE. Thereby, an
excellent weldability of the inner layers of the container films
and a superior compatibility with medical solutions can be
achieved.
[0072] In some embodiments, at least two different components of a
concentrate, e.g. components of a dry concentrate, are provided in
different concentrate compartments of the concentrate container.
For instance, each concentrate component is filled in a concentrate
compartment of its own. Thereby, a mixing of different
concentrates, e.g. different dry concentrates, contained in
different concentrate compartments can be avoided during providing
and storing the concentrates in the compartments. Further,
degradation and caking of components of the dialysate can be
prevented or at least reduced.
[0073] For instance, one of the concentrate compartments, e.g. the
second or third compartment, includes glucose, preferably
separately from other concentrate components. Further, at least two
different other concentrate components filled in the concentrate
container include at least one element chosen from sodium
bicarbonate, sodium chloride, magnesium chloride, potassium
chloride, calcium chloride, and citric acid. For instance, a first
component of a concentrate includes sodium bicarbonate and sodium
chloride, a second component of the concentrate includes sodium
chloride, magnesium chloride.times.6 H.sub.2O, potassium chloride,
calcium chloride.times.6H.sub.2O, and anhydrous citric acid, and a
third component of the concentrate includes
glucose.times.H.sub.2O.
[0074] In one example of a concentrate container, the first
compartment contains granules formed of 37% NaCl and 63% sodium
bicarbonate, e.g. 515 g, the second compartment contains
monohydrate glucose, e.g. 66 g, and the third compartment contains
minor ions and citric acid, e.g. 75 g. Minor ions are, for
instance, NaCl, KCl, MgCl.sub.2, CaCl.sub.2. In a variation of this
example, the contents of the second and third compartment can be
exchanged, such that the second compartment contains minor ions and
citric acid, and the third compartment contains monohydrate
glucose. Minor ions are for instance ions of minor concentration
present in dialysis fluid compared to bicarbonate ions or sodium
ions.
[0075] According to an example, a first component of a dry
concentrate includes 187.5 g sodium bicarbonate and 327.5 g sodium
chloride; a second component of the dry concentrate includes 35 g
sodium chloride, 6.1 g magnesium chloride.times.6 H.sub.2O, 8.95 g
potassium chloride, 13.2 g calcium chloride.times.6 H.sub.2O, and
11.5 g anhydrous citric acid; and a third component of the dry
concentrate includes 66 g glucose.times.H.sub.2O. The first to
third components may be provided separately in different
compartments of the concentrate container of embodiments. By
addition of a corresponding amount of RO water to the first to
third components and combining the resulting solutions, a dialysate
is obtained which is useful for hemodialyis, having the following
ratio of components:
Na.sup.+:K.sup.+:Mg.sup.2+:Ca.sup.2+:Cl.sup.-:HCO.sub.3.sup.-=140:2:0.5:1-
.5:108:35.
[0076] According to embodiments, glucose may be provided separately
in one of the compartments of a concentrate container for forming a
dialysate. If glucose is provided in admixture with dry
bicarbonate, it may be degraded, resulting in byproducts which may
have undesired effects when administered to patients. Caking of
glucose admixed with other components of the dialysate further
typically causes an imperfect dissolution of the components in RO
water. Using embodiments described herein, these undesired effects
can be prevented.
[0077] In a further embodiment, a fluid container system for
preparing a medical fluid, preferably for preparing a dialysis
solution, is provided, including a fluid container for collecting a
prepared medical fluid, the fluid container having a medical fluid
drainage line, and another fluid container for collecting a
consumed medical fluid, the fluid container being insertable into
the another fluid container. The medical fluid drainage line may
include an opening, a port and/or a tube, each adapted for drainage
of the medical fluid from the fluid container.
[0078] An example of this embodiment is described above referring
to the two fluid containers 110, 120 shown in FIG. 8. FIG. 9b
illustrates another example of this embodiment, wherein the fluid
container 110 and the fluid container 120 are flexible transparent
plastic bags. These bags may further be disposables for easy
maintenance of a contamination-free system. As shown in FIG. 9b,
the bags 110 and 120 may each have gussets 71 on each side of the
bag. Bag 120 has a higher internal volume than the bag 110, such
that the latter can be inserted into bag 120. FIG. 9a illustrates
the fluid container system illustrated in FIG. 9b mounted at
concentrate container 70.
[0079] FIGS. 10a and 10b show another example of a fluid container
system of embodiments, wherein the two fluid containers 110 and 120
each include a bottom including two outwardly bendable folds. This
example is useful if the fluid container and the another fluid
container are flexible bags which have to be put on a rigid
support, such as a transport means, for instance because of a high
weight of the contents filled in the fluid containers. Thereby,
reduced fluid volumes can be stored inside the bags, since the
spatial volume of the bags can also be reduced due to the bendable
fold and their flexibility. Further, the bags can be opened
symmetrically and homogeneously during filling. In addition, a
constant height of the bags during filling and use can be
maintained.
[0080] In this example the fluid container system may also be
mounted at concentrate container 70. FIG. 10a shows the fluid
container system of this example having the folds bent upwards,
whereas FIG. 10b illustrates the fluid container system having the
folds bent sidewards.
[0081] Hence, in examples of the fluid container system at least
one element chosen from the fluid container and the another fluid
container may be a flexible container, a disposable, a bag, e.g. a
stand-up-pouch, a bag having a gusset on each side and/or a bag
having a bottom including two outwardly bendable folds.
[0082] According to further embodiments, the medical fluid drainage
line and/or the another fluid container may each include a tube
extending into the interior or to the bottom of the respective
fluid container. In some examples, the tube may include at its free
end inside the respective container a nozzle as a restrictor, e.g.
for producing turbulences. The material of the tube may include PP,
Styrene block copolymers from Styrene butadiene, ethylene, isoprene
(SEBS; SIS; SEPS), PVC, silicone, PE, Polyalphaolefines. Thereby,
withdrawal of fluids from the fluid containers is facilitated and
the tubes further may provide agitation of the fluid inside of the
fluid containers. The tube of medical fluid drainage line 111 and
the tube of the another fluid container 120 are shown e.g. in FIG.
9a.
[0083] In embodiments, the fluid container includes at least one
first line connection means for at least one fluid transfer line
and a second line connection means which is connectable to,
connected to or included in the medical fluid drainage line.
[0084] In further embodiments of the fluid container system
described herein, the inner fluid container includes a first line
connection means 1140 for the fluid transfer line 114 and a second
line connection means 1111 included in the medical fluid drainage
line 111, and/or the outer fluid container includes at the tube a
third line connection means 1221 for the consumed medical fluid
collection line, as shown in FIG. 9b. This allows an easy
interconnection of the fluid container and the another fluid
container with the concentrate container via the fluid transfer
line 114, with medical fluid removal line 112 and/or with consumed
medical fluid collection line 122. The material of the line
connection means may include PP, Styrene block copolymers from
Styrene butadiene, ethylene, isoprene (SEBS; SIS; SEPS), PVC,
silicone, PE, Polyalphaolefines.
[0085] In embodiments, the concentrate container may have a channel
being fluidly connected to one or more of the medical fluid outlets
and having at least one outlet.
[0086] According to another embodiment, the inner fluid container
110 includes two first line connection means 1140a and 1140b for
two fluid transfer lines 114a and 114b and a second line connection
means 1111 included in or connected to the medical fluid drainage
line 111, as shown in FIG. 9c. Line connection means 1140a may be
connected to a tube 115 extending to the bottom of the inner fluid
container, as shown in FIG. 9c. In the present embodiment, the
inner fluid container 110 is connected to a concentrate container
302, which differs from concentrate container 300 shown in FIG. 3
in that instead of the central outlet 160, two outlets 160a and
160b are provided in channel 150. Outlet 160a is connected via
fluid transfer line 114a and line connection means 1140a to the
inner fluid container 110. Outlet 160b is connected via fluid
transfer line 114b and line connection means 1140b to the inner
fluid container. Further, concentrate container 302 has a tube 49
as fluid transmission means passing through compartment 32 and
allowing passage of fluids through compartment 32 without mixing
with concentrates, suspensions or fluids contained in compartment
32. In the present embodiment, medical fluid drainage line 111 is
fluidly connected via second line connection means 1111 and medical
fluid removal line 112 to tube 49 for passage of drained medical
fluid through concentrate container 302. The outer fluid container
120 may include at its tube (not shown) a third line connection
means for the consumed medical fluid collection line (not shown in
FIG. 9c). This embodiment allows an easy interconnection of the
fluid container with the concentrate container via two fluid
transfer lines and one medical fluid removal line.
[0087] In some embodiments, the concentrate container includes a
first channel being fluidly connected to one of the medical fluid
outlets and having an outlet, and a second channel being fluidly
connected to another one of the medical fluid outlets and having
another outlet, wherein the first and the second channels are
fluidly separated by separating means.
[0088] FIG. 9d illustrates a further embodiment of a system for
preparing a medical fluid, including a concentrate container 303
according to an embodiment. The system of FIG. 9d differs from the
system of FIG. 9c in that the inner fluid container 110 is
connected to a concentrate container 303. The concentrate container
303 differs from the concentrate container 302 of FIG. 9c in that
channel 150 has a separating means 313 between the outlets 160a and
160b. Thereby, channel 150 is subdivided into two separate channels
150a and 150b. The separating means 313 may be a separating wall or
a separating strip, which completely separates the fluids passing
through openings 16 into outlets 160a and 160b from each other.
This means that the fluid originating from concentrate compartment
34 and flowing through outlet 160b is not mixed with the fluid
originating from concentrate compartment 32 and flowing through
outlet 160a. Thereby, an undesired gas formation caused by
intermixing of the two fluids is prevented. Such gas formation may
hinder or prevent discharge of the concentrates and/or of the
fluids containing the concentrates from channel 150.
[0089] For instance, using concentrate container 303 of the present
embodiment, CO.sub.2 gas evolution due to contact or mixing of a
fluid, which contains bicarbonate and originates from concentrate
compartment 32, and a fluid, which contains an acid and originates
from concentrate compartments 33 and 34 is avoided and/or prevented
inside channel 150 and inside fluid transfer lines 114a and 114b
due to separating means 313.
[0090] Further, using the embodiment of the system of FIG. 9d, the
fluid containing bicarbonate and originating from compartment 32
may be directed via fluid transfer line 114a and tube 115 to the
bottom of inner fluid container 110. The fluid containing an acid
and originating from compartments 33 and 34 may be directed through
fluid transfer line 114b and first line connection means 1140b into
inner fluid container 110 from above. Thereby, CO.sub.2 gas
evolution caused by contact or mixing of the two fluids happens in
the inner fluid container 110. Moreover, guiding the fluid which
contains bicarbonate to the bottom of the inner fluid container 110
and adding the fluid which contains the acid from above results in
a quick intermixing of the two fluids. This allows avoiding or
preventing local variations of the concentrations of the dissolved
concentrates. The CO.sub.2 gas developed by mixing the two fluids
can be discharged through medical fluid removal line 112 or through
another port of the inner fluid container 110, in order to
depressurize.
[0091] A further embodiment is directed to a kit of parts for
preparing a medical fluid, including at least two elements chosen
from the concentrate container according to any example or
embodiment described herein, a fluid container, the fluid container
system according to any example or embodiment described herein, and
a transport means adapted to support and/or to include at least one
of the concentrate container, the fluid container, and the fluid
container system. The transport means of the kit of parts can be
the trolley 200 shown in FIG. 11.
[0092] The concentrate container, the kit of parts and/or any
system according to embodiments described herein may be used in
dialysis, acute dialysis, hemodialysis, hemodiafiltration,
peritoneal dialysis, or for preparing a dialysis solution.
[0093] A yet further embodiment is directed to a method for
preparing a medical fluid, preferably for preparing a medical fluid
or a dialysis solution in a system for preparing a medical fluid
according to any embodiment described herein, the method including
providing a concentrate container including at least one
concentrate compartment, wherein a first compartment of the
concentrate compartments contains a first concentrate component;
feeding a diluent into the first compartment; rinsing the first
compartment by the diluent and diluting the concentrate component;
and transferring the diluted first concentrate component into a
fluid container. Thereby, undesired contamination or degradation of
the concentrate component contained in the first concentrate
compartment of the concentrate container may be avoided.
[0094] In the method of embodiments, the concentrate container may
further include a second concentrate component in a second
compartment of the concentrate compartments; the method further
including feeding the diluent into the second compartment; rinsing
the second compartment by the diluent and diluting the second
concentrate component; and transferring the diluted second
concentrate component into the fluid container. That means that
different concentrate components contained in two different
compartments of the concentrate container may be diluted, dissolved
or suspended individually and without mixing, and/or one after the
other.
[0095] Moreover, in an example of the method according to
embodiments, each of the first and second compartments may be
separately fed with the diluent and rinsed. In other embodiments,
the feeding and rinsing of the second compartment may be performed
by passing the diluent from the first compartment into the second
compartment. This may, for instance, be achieved by passing the
diluent through an opening between the first and the second
compartment or by releasing a releasable barrier means between the
first and second compartment.
[0096] In some embodiments, the concentrate container further
includes a third compartment containing a third concentrate
component, each of the first and second compartments is separately
fed with the diluent and rinsed, and the feeding and rinsing of the
third compartment and the diluting of the third concentrate
component is performed by passing the diluent from the second
compartment into the third compartment, e.g. by opening a
releasable barrier means between the second and the third
compartment. For instance, the concentrate container further
includes a third compartment containing a third concentrate
component; each of the first and second compartments is separately
fed with the diluent and rinsed; and the method further includes,
before transferring the diluted second concentrate component into
the fluid container, feeding the diluent into the third compartment
by opening a releasable barrier means between the second and the
third compartment and passing the diluent from the second
compartment into the third compartment, and rinsing the third
concentrate compartment and diluting the third concentrate
component. Thereafter, the diluted second and third concentrate
components are transferred into the fluid container.
[0097] For instance, the first and second concentrate compartments
are separated by permanent barrier means and the second and third
concentrate compartment are separated by releasable barrier means.
The latter may be a piston valve which can be openend due to the
flow and/or the fluid pressure of the diluent. In one example, into
the first compartment containing sodium bicarbonate as a
concentrate component, RO water is introduced in a first step and
sodium bicarbonate is dissolved separately form other concentrate
components contained in the other compartments. Then, in a second
step RO water is fed into the second compartment which contains
anhydrous citric acid as a concentrate component. The RO water
dissolves the citric acid and passes from the second concentrate
compartment into the third concentrate compartment, which contains
calcium chloride as a concentrate component, by opening the piston
valve due to the flow and/or the fluid pressure. Thereby, the
calcium chloride is dissolved. Using this step sequence, undesired
effects arising from degassing and/or precipitation of one or more
of the concentrate components due to intermixing of the concentrate
components and due to the dilution process can be avoided.
[0098] The method according to embodiments of the invention allows
providing and/or storing different concentrate components in
separate concentrate compartments before preparing the medical
fluid. Further, preparation of the medical fluid may be performed
in separate compartments of the concentrate container by
individually diluting, dissolving and/or suspending different
concentrate components of the medical fluid and combining them
subsequently. Thereby, degradation and caking of the concentrate
components due to mixing of the components before dilution by the
diluent may be avoided. Further, by performing a suitable dilution
sequence for the different concentrate components, degassing and
precipitation of concentrate components during dilution can be
reduced or avoided. Consequently, a complete dissolution of the
concentrate components or concentrates, respectively, contained in
the concentrate container can be achieved, in order to form the
medical fluid.
[0099] According to embodiments of the method for preparing a
medical fluid, during feeding the diluent a first diluent is fed
into the first compartment and a second diluent is fed into the
second compartment, the first diluents and the second diluent being
different from each other. Thereby, different solvents can be used
for different concentrates of concentrate components depending on
the solubility thereof.
[0100] In the method of embodiments, feeding of the diluents may be
performed via at least one diluent inlet and transferring of the
diluted concentrate components may be performed via at least one
medical fluid outlet, the at least one diluent inlet and the at
least one medical fluid outlet being separate from each other.
[0101] While the foregoing is directed to examples and embodiments
of the invention, other and further embodiments of the invention
may be devised. Especially, mutually non-exclusive features of the
examples and embodiments described above may be combined with each
other.
[0102] Without further elaboration, it is believed that one skilled
in the art can, using the preceding description, utilize the
present invention to its fullest extent. The preceding preferred
specific embodiments are, therefore, to be construed as merely
illustrative, and not limitative of the remainder of the disclosure
in any way whatsoever.
[0103] From the foregoing description, one skilled in the art can
easily ascertain the essential characteristics of this invention
and, without departing from the spirit and scope thereof, can make
various changes and modifications of the invention to adapt it to
various usages and conditions.
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