U.S. patent application number 17/504826 was filed with the patent office on 2022-02-17 for systems and methods for onsite sorbent material reuse.
The applicant listed for this patent is Baxter Healthcare SA, Baxter International Inc.. Invention is credited to Yuanpang Samuel Ding, Ieng Kin Lao, Cristian Adolfo Menzel Bueno, Rosa Hung-Chen Yeh.
Application Number | 20220048021 17/504826 |
Document ID | / |
Family ID | |
Filed Date | 2022-02-17 |
United States Patent
Application |
20220048021 |
Kind Code |
A1 |
Ding; Yuanpang Samuel ; et
al. |
February 17, 2022 |
SYSTEMS AND METHODS FOR ONSITE SORBENT MATERIAL REUSE
Abstract
Methods, sorbent cartridges and cleaning devices are disclosed
for refurbishing sorbent materials. In one implementation among
multiple implementations, a medical fluid delivery method includes:
providing a sorbent cartridge including H.sup.+ZP within a casing
for a treatment; and after the treatment, refurbishing the
H.sup.+ZP while maintained within the casing via (i) regenerating
the non-disinfected H.sup.+ZP by flowing an acid solution through
the casing, (ii) rinsing the regenerated H.sup.+ZP while maintained
within the casing, (iii) disinfecting the regenerated and rinsed
H.sup.+ZP by flowing a disinfecting agent through the casing, and
(iv) rinsing the regenerated and disinfected H.sup.+ZP while
maintained within the casing. Multiple batch sorbent refurbishing
implementations are also disclosed.
Inventors: |
Ding; Yuanpang Samuel; (Long
Grove, IL) ; Yeh; Rosa Hung-Chen; (Libertyville,
IL) ; Menzel Bueno; Cristian Adolfo; (Gurnee, IL)
; Lao; Ieng Kin; (Taipa, MO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baxter International Inc.
Baxter Healthcare SA |
Deerfield
Glattpark (Opfikon) |
IL |
US
CH |
|
|
Appl. No.: |
17/504826 |
Filed: |
October 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16203119 |
Nov 28, 2018 |
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17504826 |
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International
Class: |
B01J 49/53 20060101
B01J049/53; B01J 47/016 20060101 B01J047/016; B01J 49/60 20060101
B01J049/60; B01J 49/06 20060101 B01J049/06; A61L 2/18 20060101
A61L002/18; A61L 2/26 20060101 A61L002/26; A61M 1/16 20060101
A61M001/16; B01D 15/20 20060101 B01D015/20; B01D 15/36 20060101
B01D015/36; B01J 39/02 20060101 B01J039/02; B01J 39/12 20060101
B01J039/12; B01J 47/024 20060101 B01J047/024 |
Claims
1. A medical fluid delivery method comprising: providing a sorbent
cartridge including H.sup.+ZP within a casing for a treatment; and
after the treatment, refurbishing the H.sup.+ZP while maintained
within the casing via regenerating the non-disinfected H.sup.+ZP by
flowing an acid solution through the casing, rinsing the
regenerated H.sup.+ZP while maintained within the casing,
disinfecting the regenerated and rinsed H.sup.+ZP by flowing a
disinfecting agent through the casing, and rinsing the regenerated
and disinfected H.sup.+ZP while maintained within the casing.
2. The medical fluid delivery method of claim 1, wherein at least
one of the rinsing procedures includes rinsing the H.sup.+ZP with
water through the casing until a desired conductivity is
reached.
3. The medical fluid delivery method of claim 1, wherein the first
rinsing procedure includes rinsing the H.sup.+ZP with water through
the casing in a reverse-to-treatment flow direction and the second
rinsing procedure includes rinsing the H.sup.+ZP with water through
the casing in a normal treatment flow direction.
4. The medical fluid delivery method of claim 1, wherein
disinfecting the rinsed and regenerated H.sup.+ZP includes flowing
the disinfecting agent through the casing in a reverse-to-treatment
flow direction.
5. The medical fluid delivery method of claim 1, wherein
regenerating the non-disinfected H.sup.+ZP includes flowing the
acid solution through the casing in a reverse-to-treatment flow
direction.
6. The medical fluid delivery method of claim 1, wherein
regenerating the non-disinfected H.sup.+ZP includes at least one of
flowing the acid solution through the casing (i) at a flowrate of
0.1 ml/min to 5 ml/min, (ii) at a temperature from about 20.degree.
C. to about 80.degree. C., or (iii) until eluent acid used to
contact the H.sup.+ZP has a pH that equals or substantially equals
a pH of incoming acid solution.
7. The medical fluid delivery method of claim 1, wherein at least
one of (a) the acid solution is HCl, H.sub.2SO.sub.4,
H.sub.3PO.sub.4, HNO.sub.3 or acetic acid or (b) the disinfecting
agent (i) is a hydrogen based chemical, such as including HOCl or
(ii) includes isopropyl alcohol ("IPA").
8. The medical fluid delivery method of claim 1, wherein the casing
including the refurbished H.sup.+ZP is replaced within the sorbent
cartridge with at least one new and different type of casing.
9. A medical fluid delivery method comprising: providing a sorbent
cartridge including Na.sup.+ZP within a casing for a treatment; and
after the treatment, refurbishing the Na.sup.+ZP while maintained
within the casing via regenerating the non-disinfected NA.sup.+ZP
using by flowing a sodium based alkaline solution or a sodium salt
solution through the casing, rinsing the regenerated NA.sup.+ZP
while maintained within the casing, disinfecting the regenerated
and rinsed NA.sup.+ZP by flowing a disinfecting agent through the
casing, and rinsing the regenerated and disinfected NA.sup.+ZP
while maintained within the casing.
10. The medical fluid delivery method of claim 9, wherein at least
one of the rinsing procedures includes rinsing the NA.sup.+ZP with
water through the casing until a desired conductivity is
reached.
11. The medical fluid delivery method of claim 9, wherein the first
rinsing procedure includes rinsing the NA.sup.+ZP with water
through the casing in a reverse-to-treatment flow direction and the
second rinsing procedure includes rinsing the NA.sup.+ZP with water
through the casing in a normal treatment flow direction.
12. The medical fluid delivery method of claim 9, wherein
disinfecting the rinsed and regenerated NA.sup.+ZP includes flowing
the disinfecting agent through the casing in a reverse-to-treatment
flow direction.
13. The medical fluid delivery method of claim 9, wherein
regenerating the non-disinfected NA.sup.+ZP includes flowing the
sodium based alkaline solution or the sodium salt solution through
the casing in a reverse-to-treatment flow direction.
14. The medical fluid delivery method of claim 9, wherein
regenerating the non-disinfected NA.sup.+ZP includes at least one
of flowing the sodium based alkaline solution or the sodium salt
solution through the casing (i) at a flowrate of 0.1 ml/min to 5
ml/min, (ii) at a temperature from about 20.degree. C. to about
80.degree. C., or (iii) until eluent sodium solution used to
contact the NA.sup.+ZP has a conductivity that equals or
substantially equals a conductivity of incoming sodium
solution.
15. The medical fluid delivery method of claim 9, wherein the
disinfecting agent (i) is a sodium based chemical, such as
including NaOCl or (ii) includes isopropyl alcohol ("IPA").
16. The medical fluid delivery method of claim 9, wherein the
casing including the refurbished NA.sup.+ZP is replaced within the
sorbent cartridge with at least one new and different type of
casing.
17. A medical fluid delivery method comprising: providing a sorbent
cartridge including Na.sup.+ZP within a casing for a treatment; and
after the treatment, refurbishing the Na.sup.+ZP while maintained
within the casing via disinfecting the non-regenerated NA.sup.+ZP
by flowing a disinfecting agent through the casing, rinsing the
disinfected NA.sup.+ZP while maintained within the casing,
regenerating the disinfected and rinsed NA.sup.+ZP by flowing a
sodium based alkaline solution or a sodium salt solution through
the casing, and rinsing the disinfected and regenerated NA.sup.+ZP
while maintained within the casing.
18. The medical fluid delivery method of claim 17, wherein at least
one of the rinsing procedures includes rinsing the NA.sup.+ZP with
water through the casing until a desired conductivity is
reached.
19. The medical fluid delivery method of claim 17, wherein
regenerating the non-disinfected NA.sup.+ZP includes flowing the
sodium based alkaline solution or the sodium salt solution through
the casing in a reverse-to-treatment flow direction.
20. The medical fluid delivery method of claim 19, wherein the
second rinsing procedure includes rinsing the NA.sup.+ZP with water
through the casing in a normal treatment flow direction.
21. The medical fluid delivery method of claim 17, wherein
regenerating the disinfected NA.sup.+ZP includes at least one of
flowing the sodium based alkaline solution or the sodium salt
solution through the casing (i) at a flowrate of 0.1 ml/min to 5
ml/min, (ii) at a temperature from about 20.degree. C. to about
80.degree. C., or (iii) until eluent sodium solution used to
contact the NA.sup.+ZP has a conductivity that equals or
substantially equals a conductivity of incoming sodium
solution.
22. The medical fluid delivery method of claim 17, wherein the
disinfecting agent (i) is a sodium based chemical, such as
including NaOCl or (ii) includes isopropyl alcohol ("IPA").
23. The medical fluid delivery method of claim 17, wherein the
casing including the refurbished NA.sup.+ZP is replaced within the
sorbent cartridge with at least one new and different type of
casing.
24. A sorbent cartridge comprising: a housing sized and shaped to
accept multiple sorbent cartridge casings in a desired order; a
zirconium casing located within the housing; at least one
additional casing located within the housing and selected from a
second zirconium casing, a mechanical filter casing, an activated
carbon and filter casing, a urease casing, or an anion exchange
resin casing; and wherein each casing includes a seal that seals to
another one of the casings or to the housing when the housing is
closed for treatment, such that fluid traveling through the housing
during treatment is prevented from leaking between the casings and
between the housing and the casings.
25. The sorbent cartridge of claim 24, wherein the housing is
conically sized and shaped to accept multiple sorbent cartridge
casings in a desired order and orientation.
26. The sorbent cartridge of claim 24, wherein each zirconium
casing provided includes a refurbished zirconium compound.
27. The sorbent cartridge of claim 24, wherein the first zirconium
casing and the second zirconium casing if provided include an
Na.sup.+ZP casing and an H.sup.+ZP casing.
28. The sorbent cartridge of claim 24, wherein the first zirconium
casing and the second zirconium casing if provided are located in
parallel within the housing.
29. The sorbent cartridge of claim 24, wherein the first zirconium
casing and the second zirconium casing if provided are located in
series within the housing.
30. The sorbent cartridge of claim 24, wherein the housing is
closed at its exit end and openable at its inlet end via a
removable cap.
31. A sorbent refurbishing device comprising: a cleaning chamber
sized and arranged to accept at least one sorbent cartridge casing
for refurbishing; a disinfecting agent source in fluid
communication with the cleaning chamber; a regeneration solution
source in fluid communication with the cleaning chamber; a water
source or water connection in fluid communication with the cleaning
chamber; at least one pump positioned and arranged to pump at least
one of disinfecting agent, regeneration solution, or water to the
cleaning chamber; at least one first valve located between the
disinfecting agent source and the cleaning chamber; at least one
second valve located between the regeneration solution source and
the cleaning chamber; at least one third valve located between the
water source or water connection and the cleaning chamber; and a
control unit configured to operate the at least one pump, the at
least one first valve, the at least one second valve and the at
least one third valve to perform a refurbishing procedure on the at
least one cartridge casing.
32. The sorbent refurbishing device of claim 31, wherein the
cleaning chamber is configured to accept the at least one sorbent
cartridge in a particular orientation so that a normal treatment
fluid direction and an opposite to normal treatment fluid direction
is known.
33. The sorbent refurbishing device of claim 31, wherein the at
least one first valve is positioned and arranged to enable
disinfecting agent to be delivered to either of two opposing sides
of the cleaning chamber.
34. The sorbent refurbishing device of claim 31, wherein the at
least one second valve is positioned and arranged to enable
regeneration solution to be delivered to either of two opposing
sides of the cleaning chamber.
35. The sorbent refurbishing device of claim 31, wherein the at
least one third valve is positioned and arranged to enable water to
be delivered to either of two opposing sides of the cleaning
chamber.
36. The sorbent refurbishing device of claim 31, which includes at
least one of a conductivity sensor, a temperature sensor, or a pH
sensor positioned to sense at least one of the disinfecting agent,
the regeneration solution or water, the at least one sensor
providing an output to the control unit.
37. The sorbent refurbishing device of claim 36, wherein the
control unit is configured to use the output to control duration of
flow of at least one of the disinfecting agent, the regeneration
solution or water.
38. The sorbent refurbishing device of claim 36, which further
includes at least one heating coil, the control unit configured to
use the output from the temperature sensor to operate the at least
one heating coil.
39. The sorbent refurbishing device of claim 31, which further
includes a hot air blower under control of the control unit to dry
to the at least one sorbent cartridge casing.
Description
BACKGROUND
[0001] The present invention relates generally to medical fluid
systems and more particularly to the operation and reuse of sorbent
materials for dialysis.
[0002] One drawback for known hemodialysis machines that produce
treatment fluid online or at the time of treatment is water usage.
Hi-dose dialysis is preferred by certain clinicians, and may use
200 liters or more of water per treatment. 200 liters is a lot of
water for a clinic and may be especially taxing for a home dialysis
treatment, where water may be scarce and/or expensive. The
equipment associated with purifying the water and the energy
associated with heating that much water or dialysis fluid also add
to the treatment cost.
[0003] Sorbent technology provides a solution to the high water
usage of known online dialysis systems. Here, instead of discarding
the used dialysis fluid exiting the dialyzer, the used dialysis
fluid or effluent is pumped through a sorbent cartridge, which
cleans the used dialysis fluid, removing toxic waste by-products
from the used fluid. Infusate is pumped into the cleaned fluid to
add back removed electrolytes and other constituents to restore the
regenerated dialysis fluid to the same or similar chemical and
physiological condition as fresh dialysis fluid.
[0004] Sorbent technology allows a same initial amount of water,
e.g., ten liters or less, to be used over and over, to achieve the
same or similar effective patient solute clearance as achieved
under a single use hi-dose treatment. Thus, sorbent treatment can
greatly reduce the amount of water needed for dialysis
treatment.
[0005] Sorbent cartridges typically have multiple layers. The
multiple layers may include (i) a mechanical purification layer
that binds or removes heavy metals, oxidants and chloramines, (ii)
a urease layer that converts urea removed from the patient into
ammonium, (iii) a zirconium phosphate layer that binds or removes
ammonium, calcium, magnesium, potassium and others, (iv) a
zirconium oxide layer that binds or removes phosphate, chloride and
heavy metals, and (v) an activated carbon layer that binds or
removes creatinine, uric acid and middle molecules.
[0006] The materials of the sorbent layers may be expensive,
especially the sorbent layers including zirconium phosphate and
zirconium oxide. The cost of the sorbent cartridge may exceed the
cost of treatment for single use hi-dose machines. It is
accordingly desirable to reuse the materials of the sorbent column,
especially the sorbent layers including zirconium phosphate and
oxide. U.S. Pat. No. 9,707,329 ("the '329 patent") describes
routines for regenerating zirconium from a used sorbent cartridge.
FIG. 2 from the '329 patent shows that in the illustrated example,
three different filtering and washing steps are required. The
multiple washing and filtering steps are costly and labor
intensive, and at some point, may cost more than the money saved in
reusing the zirconium.
[0007] A need exists accordingly to provide an improved way to
regenerate used sorbent column zirconium materials.
SUMMARY
[0008] The examples described herein disclose systems and methods
to improve any treatment that uses sorbent materials to clean an
effluent fluid. In particular, the systems and methods refurbish
used sorbent materials, reducing the overall cost of the sorbent
treatment. The treatment systems generally involve hemodialysis
("HD") systems. The HD systems of the present disclosure in various
embodiments include a dialysis fluid circuit separated from a blood
circuit by a dialyzer. The blood circuit includes one or more blood
pump, e.g., a blood pump pumping along the arterial line. The blood
circuit includes one or more air trap, e.g., an airtrap located in
the venous line. The arterial line connects to a blood inlet of the
dialyzer, while the venous line connects to a blood outlet of the
dialyzer. Other blood circuit components are described herein.
[0009] The dialysis fluid circuit in an embodiment includes a fresh
dialysis fluid pump pumping fresh and regenerated dialysis fluid to
a dialysis fluid inlet of the dialyzer and a used dialysis fluid
pump pumping used dialysis fluid from a dialysis fluid outlet of
the dialyzer to and through a sorbent cartridge, which removes the
waste products listed above and acquired from the patient's blood
via transfer through semi-permeable membranes located within the
dialyzer. An infusate pump pumps infusate from an infusate source
into the dialysis fluid circuit at a point downstream of the
sorbent cartridge. The infusate replenishes the cleansed dialysis
fluid, restoring the dialysis fluid into a form that may be pumped
again to the dialyzer to treat the patient's blood.
[0010] The dialysis fluid circuit also includes a drain line, which
enables used dialysis fluid at the end of treatment to be pumped to
drain. Various valves are located in the blood and dialysis fluid
circuits to control fluid flow as desired during treatment. All
blood and dialysis fluid pumps and valves are operated under
control of a control unit, which also accepts inputs from various
sensors operating with the blood and dialysis fluid circuits, such
as pressure sensors, conductivity sensors, air detection sensors,
blood detection sensors, ammonia and other chemical sensors.
[0011] Structure and methodology are provided for removing a
controlled amount of ultrafiltration ("UF") from the patient, such
as a separate UF pump or one or more weigh scales outputting to the
control unit. Volumetric UF control, such as balance chambers in
the dialysis fluid circuit, may be provided alternatively. Any of
the blood and dialysis fluid pumps and valves may be operated
electrometrically, e.g., via peristaltic pumps and electrically
actuated solenoid valves, or alternatively pneumatically, e.g., via
volumetric pumps and pneumatic valves.
[0012] At the end of treatment using the above-described HD system,
the sorbent cartridge is removed from the dialysis fluid circuit
and at least some of the layers of material within the sorbent
column are cleaned and regenerated according to the embodiments
described below. It is contemplated to regenerate the sorbent
materials in at least two different manners. In a first manner, the
patient or caregiver collects the used sorbent cartridges. The
collected used cartridges are either picked up or delivered
periodically to a facility where they are cleaned and regenerated
in a batch manner along with used sorbent materials from other
patients. Here, the patient or caregiver receives a delivery of
fresh sorbent cartridges periodically. In a second manner, at least
a portion of the used sorbent cartridges are cleaned and
regenerated onsite, either in a clinic or at home. In one example,
any zirconium containing layers are cleaned and regenerated and
then repacked into the sorbent column along with new single use
layers. Single use layers in various embodiments include any one or
more of a mechanical purification layer, a urease layer, an anion
exchange layer and/or an activated carbon layer.
[0013] As discussed in detail below, the sorbent conditioning of
the present disclosure may also be employed to refurbish used
sorbent materials from peritoneal dialysis ("PD") systems and
treatments.
[0014] With the above in mind, two primary embodiments are
contemplated for cleaning and regenerating at least a portion of
the sorbent layers, such as the zirconium containing layers.
Batch Refurbishing
[0015] In one primary embodiment, sorbent material refurbishing is
performed in a batch operation in which used sorbent materials from
multiple sorbent cartridges are combined and cleaned together. The
sorbent refurbishing process in one embodiment provides an adequate
ammonium removal capacity of zirconium phosphate containing greater
than 90% sodium or hydrogen exchange sites. The sorbent
refurbishing in various implementations involves the use of a
disinfecting agent in combination with an acid, base or sodium salt
treatment. The sorbent refurbishing is applicable to sorbent
cartridges having different zirconium containing compartments
provided in a serial (e.g., layered) or parallel (e.g., used
dialysis fluid flows through one or the other compartment)
configuration.
[0016] It is contemplated to provide the batch sorbent refurbishing
process in any one of several different implementations of the
first primary embodiment. In each case, used zirconium containing
sorbent materials from multiple sorbent cartridges for a single or
multiple patients are collected at a refurbishing facility. The
total batch to be refurbished in one procedure may be in the range
of 10 lbs. to 10000 lbs. In a first implementation, (i)
non-disinfected zirconium phosphate ("ZP") is refurbished using an
acid solution, (ii) the regenerated ZP is disinfected using a
disinfecting agent, (iii) the disinfected and acid regenerated ZP
is washed and filtered, (iv) the washed ZP is titrated to a desired
pH, for example between and including 5.5 to 8.5, (v) the titrated
ZP is washed and filtered to a conductivity below 50 .mu.S/cm, (vi)
the washed ZP is dried, e.g., in a vacuum oven, and (vii) the dried
ZP is sieved using one or more sieves for one or more sorbent uses.
The ZP is now ready to be reused.
[0017] In a second implementation, the titration and second washing
procedures above are removed, such that non-disinfected zirconium
phosphate ("ZP") is (i) regenerated using an acid solution, (ii)
disinfected using a disinfecting agent, (iii) washed and filtered,
(iv) dried, e.g., in a vacuum oven, and (v) sieved using one or
more sieves for one or more sorbent uses. The ZP is now ready to be
reused.
[0018] In a third implementation, the acid solution of the first
implementation is replaced with a sodium based alkaline solution or
a sodium salt solution, such that (i) non-disinfected zirconium
phosphate ("ZP") is regenerated using a sodium based alkaline
solution or a sodium salt solution, (ii) the regenerated ZP is
disinfected using a disinfecting agent, (iii) the disinfected and
sodium regenerated ZP is washed and filtered, (iv) the washed ZP is
titrated to a desired pH, for example between and including 5.5 to
8.5, (v) the titrated ZP is washed and filtered to a conductivity
below 50 .mu.S/cm, (vi) the washed ZP is dried, e.g., in a vacuum
oven, and (vii) the dried ZP is sieved using one or more sieves for
one or more sorbent uses. The ZP is now ready to be reused.
[0019] In a fourth implementation, the acid solution of the second
implementation is replaced with a sodium based alkaline solution or
a sodium salt solution, such that (i) non-disinfected zirconium
phosphate ("ZP") is regenerated using a sodium based alkaline
solution or a sodium salt solution, (ii) the regenerated ZP is
disinfected using a disinfecting agent, (iii) the disinfected and
sodium regenerated ZP is washed and filtered, (iv) the washed ZP is
dried, e.g., in a vacuum oven, and (v) the dried ZP is sieved using
one or more sieves for one or more sorbent uses. The ZP is now
ready to be reused.
[0020] In a fifth implementation, the regenerating and disinfecting
procedures of the third implementation are reversed, such that (i)
non-regenerated ZP is disinfected using a disinfecting agent, (ii)
disinfected zirconium phosphate ("ZP") is regenerated using a
sodium based alkaline solution or a sodium salt solution, (iii) the
disinfected and sodium regenerated ZP is washed and filtered, (iv)
the washed ZP is titrated to a desired pH, for example between and
including 5.5 to 8.5, (v) the titrated ZP is washed and filtered to
a conductivity below 50 .mu.S/cm, (vi) the washed ZP is dried,
e.g., in a vacuum oven, and (vii) the dried ZP is sieved using one
or more sieves for one or more sorbent uses. The ZP is now ready to
be reused.
[0021] In a sixth implementation, the regenerating and disinfecting
procedures of the fourth embodiment are revered, such that (i)
non-regenerated ZP is disinfected using a disinfecting agent, (ii)
disinfected zirconium phosphate ("ZP") is regenerated using a
sodium based alkaline solution or a sodium salt solution, (iii) the
disinfected and sodium regenerated ZP is washed and filtered, (iv)
the washed ZP is dried, e.g., in a vacuum oven, and (v) the dried
ZP is sieved using one or more sieves for one or more sorbent uses.
The ZP is now ready to be reused.
[0022] In any of the above implementations, the disinfecting agent
may contain different types of chemicals. In one example, the
chemical is sodium based, such as NaOCl in isopropyl alcohol
("IPA"). In another example, the chemical is a hydrogen based
chemical, such as HOCl in IPA. A third example includes IPA as the
primary disinfecting agent. Also, any of the above embodiments for
preparing ZP for reuse is applicable to other zirconium containing
materials, such as zirconium oxide ("ZO") and to different types of
ZP, such as H.sup.+ZP and Na.sup.+ZP. Additionally, the acid
solution may be HCl, H.sub.2SO.sub.4, H.sub.3PO.sub.4, HNO.sub.3 or
acetic acid, and the sodium based alkaline solution or a sodium
salt solution may be NaOH, NaHCO.sub.3, Na.sub.2CO.sub.3 or
NaCl.
[0023] The ZP made ready for reuse via any of the implementations
above is placed within the column of a sorbent cartridge, e.g., in
serial or parallel fashion with other zirconium containing
materials, and with reused and/or new non-zirconium layers, such as
mechanical filtration, urease and activated carbon layers. The
layers form a refurbished sorbent cartridge that is deliverable to
the patient along with other refurbished cartridges to be used over
multiple treatments.
Onsite Refurbishing
[0024] In a second primary embodiment, sorbent material
refurbishing is performed in an onsite operation in which at least
the zirconium containing materials (e.g., ZO, H.sup.+ZP and
Na.sup.+ZP) are conditioned for reuse. As with the previous primary
embodiment, the sorbent refurbishing process of the second primary
embodiment may provide an adequate ammonium removal capacity of
zirconium phosphate containing greater than 90% sodium or hydrogen
exchange sites. The sorbent refurbishing cleaning in various
implementations again involves the use of a disinfecting agent in
combination with an acid, base or sodium salt treatment. The
sorbent refurbishing is applicable to sorbent cartridges having
different zirconium containing compartments provided in a serial
(e.g., layered) or in parallel (e.g., used dialysis fluid flows
through one or the other compartment).
[0025] A major difference between the first and second primary
embodiments is that in the batch process, the sorbent materials are
removed from their layering casing, so that the materials from
multiple sorbent cartridges may be mixed together and refurbished
at once. In the onsite embodiment, on the other hand, the sorbent
materials are left to reside within their casing, for ease of
handling and so that the patient or caregiver does not have to
handle the sorbent materials directly.
[0026] Another difference between the first and second primary
embodiments may be that the same conditioning implementations are
used for both H.sup.+ZP and Na.sup.+ZP in the first primary
embodiment, while a first conditioning implementation is used for
H.sup.+ZP versus a second conditioning implementation used for
Na.sup.+ZP in the second primary embodiment. It should be
appreciated however that the reverse may be true, namely, different
conditioning implementations may be developed for H.sup.+ZP versus
Na.sup.+ZP for the batch embodiment, while the same conditioning
implementation may be developed for H.sup.+ZP and Na.sup.+ZP for
the onsite embodiment.
[0027] It is contemplated to provide the onsite sorbent
refurbishing cleaning process in any one of several different
implementations. In each case, used zirconium containing sorbent
layer casings are removed from the patient's sorbent cartridge
along with the non-zirconium layer casings (e.g., mechanical
filtration casing, urease casing and activated carbon casing(s)).
The non-zirconium layer casings may also be conditioned for reuse
or discarded.
[0028] In a first implementation, which may be specific to
conditioning H.sup.+ZP, (i) non-disinfected H.sup.+ZP is
regenerated within its casing in a reverse flow direction, such
that the casing inlet during treatment becomes the casing outlet
during regeneration and vice versa, using an acid solution through
the casing at a flow rate of for example 0.1 ml/min to 5 ml/min and
at a temperature from about 20.degree. C. to about 80.degree. C.,
which may be performed until the pH of the eluent (acid used to
contact H.sup.+ZP) equals or approaches the pH of the incoming acid
solution, (ii) water is rinsed through the regenerated H.sup.+ZP
within its casing (e.g., in the reverse flow direction) until
conductivity of the effluent (water used to wash regenerated
H.sup.+ZP) reaches a conductivity of 100 .mu.S/cm or less, (iii)
the regenerated and rinsed H.sup.+ZP is disinfected via a
disinfecting agent (which may contain a hydrogen based chemical
such as HOCl in IPA) flowed, e.g., pumped, through the H.sup.+ZP
casing (e.g., in the reverse flow direction); and (iv) flow is
reversed and water is rinsed through the regenerated and
disinfected H.sup.+ZP though its casing in the normal treatment
flow direction until conductivity of the eluent (water used to wash
regenerated and disinfected H.sup.+ZP) reaches a conductivity of
100 .mu.S/cm or less. The H.sup.+ZP casing, e.g., after drying, is
ready to be reintroduced into the sorbent cartridge and reused.
[0029] In a second implementation, which may be specific to
conditioning Na.sup.+ZP, (i) non-disinfected Na.sup.+ZP is
regenerated within its casing in a reverse flow direction, such
that the casing inlet during treatment becomes the casing outlet
during regeneration and vice versa, and a sodium based alkaline
solution or a sodium salt solution is flowed, e.g., pumped, through
the casing at a flow rate of for example 0.1 ml/min to 5 ml/min and
at a temperature from about 20.degree. C. to about 80.degree. C.,
which may be performed until the conductivity of the conductivity
of the eluent (sodium solution used to contact Na.sup.+ZP) equals
or approaches the conductivity of the incoming sodium solution,
(ii) water is rinsed through the regenerated Na.sup.+ZP within its
casing (e.g., in the reverse flow direction) for a determined time
(conductivity already controlled in (i)), (iii) the regenerated and
rinsed Na.sup.+ZP is disinfected via a disinfecting agent (may
contain a sodium based chemical such as NaOCl in IPA) flowed, e.g.,
pumped, through the Na.sup.+ZP casing (e.g., in the reverse flow
direction); and (iv) flow is reversed and water is rinsed through
the regenerated and disinfected Na.sup.+ZP casing in the normal
treatment flow direction until conductivity of the eluent (water
used to wash regenerated and disinfected Na.sup.+ZP) reaches a
conductivity of 100 .mu.S/cm or less. The Na.sup.+ZP casing, e.g.,
after drying, is ready to be reintroduced into the sorbent
cartridge and reused.
[0030] In a third implementation, which may also be specific to
conditioning Na.sup.+ZP, the regeneration and disinfection
procedures of the second implementation are reversed, such that (i)
used and non-regenerated Na.sup.+ZP is disinfected within its
casing in a normal treatment or reverse flow direction using a
disinfecting agent that may contain a sodium based chemical such as
NaOCl in IPA, (ii) water is rinsed through the disinfected
Na.sup.+ZP within its casing (in normal treatment or reverse flow
direction) to remove residual chemicals until the conductivity of
the eluent (water used to wash disinfected Na.sup.+ZP) reaches a
conductivity of 100 .mu.S/cm or less; (iii) disinfected Na.sup.+ZP
is regenerated within its casing in the reverse flow direction,
such that the casing inlet during treatment becomes the casing
outlet during regeneration and vice versa, and a sodium based
alkaline solution or a sodium salt solution is flowed, e.g.,
pumped, through the casing at a flow rate of for example 0.1 ml/min
to 5 ml/min and at a temperature from about 20.degree. C. to about
80.degree. C., which may be performed until the conductivity of the
eluent (sodium solution used to contact Na.sup.+ZP) equals or
almost equals the conductivity of the incoming sodium solution; and
(iv) flow is reversed and water is rinsed through the disinfected
and regenerated Na.sup.+ZP though its casing in the normal
treatment flow direction, e.g., for a determined amount of time
(conductivity already controlled in (ii) and (iii)). The Na.sup.+ZP
casing, e.g., after drying, is now ready to be reintroduced into
the sorbent cartridge and reused.
[0031] Once any or all of the H.sup.+ZP and Na.sup.+ZP casings are
conditioned for reuse, the patient or caregiver inserts the
reusable casings into the sorbent cartridge along with any
additional casings, e.g., mechanical filtration casing, urease
casing and/or activated carbon casing(s), which may themselves have
been conditioned for reuse or opened from a sterile package as a
new casing. The patient or caregiver inserts the casings in a
proper order and orientation, which may be aided by markings
provided on the outside of sorbent cartridge. Alternatively or
additionally, the cartridge and casings may be somewhat conical in
shape so that the casings only fit snugly within the cartridge when
stacked in the proper order and orientation.
[0032] In an embodiment, the sorbent cartridge is closed at one
end, e.g., the outlet end, and openable at the other end, e.g., the
inlet end, such that the user (e.g., patient, caregiver, clinician
or technician) in one embodiment only has to (i) open one side of
the cartridge to remove all inner sorbent casings, (ii) condition
the casings to be reused, (iii) replace the casings to be
discarded, (iv) rinse the cartridge itself, (v) reinsert the
refurbished and new casings into the rinsed cartridge, and (vi)
close the opened end of the cartridge. In various embodiments, the
inlet lid or cap may thread onto the remainder of the cartridge
housing or be held removeably fixed to the housing via releasable
clips, such as spring clips. In either case, it is contemplated
that the action of applying the lid or cap to the remainder of the
cartridge in turn compresses the sorbent casings together,
compressing seals (e.g., o-ring seals) between the casings, such
that patient effluent cannot leak between the casings and the inner
cartridge. The seals may be captured and carried by the casings for
ease of handling when the casings are removed from the sorbent
cartridge.
[0033] The onsite operation may be performed in a dialysis clinic,
at a hospital, or at a patient's home, for example. At a clinic,
the sorbent casing removal and replacement may be performed by a
clinician or technician. At a hospital, the sorbent casing removal
and replacement may be performed by a nurse or technician. At home,
the sorbent casing removal and replacement may be performed by the
patient or a caregiver for the patient.
[0034] It is further contemplated to provide at the clinic,
hospital, patient's home or offsite one or more sorbent
conditioning or refurbishing device. The device may be configured
to condition or refurbish (i) one sorbent casing at a time, (ii)
multiple sorbent casings of a same type at the same time, (iii)
multiple sorbent casings of different types at the same time, (iv)
multiple sorbent casings of a same type sequentially, or (v)
multiple sorbent casings of different types sequentially. The
sorbent conditioning or refurbishing device accepts the one or more
sorbent casing in a sealed manner, conditions or refurbishes the
one or more sorbent casing according to any of the implementations
discussed above for the onsite primary embodiment, and informs the
user when the casing is ready to be removed from the conditioning
or refurbishing device and reused.
[0035] In light of the disclosure herein and without limiting the
disclosure in any way, in a first aspect of the present disclosure,
which may be combined with any other aspect listed herein unless
specified otherwise, a medical fluid delivery method includes
providing a sorbent cartridge including H.sup.+ZP within a casing
for a treatment; and after the treatment, refurbishing the
H.sup.+ZP while maintained within the casing via (i) regenerating
the non-disinfected H.sup.+ZP by flowing an acid solution through
the casing, (ii) rinsing the regenerated H.sup.+ZP while maintained
within the casing, (iii) disinfecting the regenerated and rinsed
H.sup.+ZP by flowing a disinfecting agent through the casing, and
(iv) rinsing the regenerated and disinfected H.sup.+ZP while
maintained within the casing.
[0036] In a second aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, at least one of the rinsing procedures includes rinsing
the H.sup.+ZP with water through the casing until a desired
conductivity is reached.
[0037] In a third aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, the first rinsing procedure includes rinsing the
H.sup.+ZP with water through the casing in a reverse-to-treatment
flow direction and the second rinsing procedure includes rinsing
the H.sup.+ZP with water through the casing in a normal treatment
flow direction.
[0038] In a fourth aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, disinfecting the rinsed and regenerated H.sup.+ZP
includes flowing the disinfecting agent through the casing in a
reverse-to-treatment flow direction.
[0039] In a fifth aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, regenerating the non-disinfected H.sup.+ZP includes
flowing the acid solution through the casing in a
reverse-to-treatment flow direction.
[0040] In a sixth aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, regenerating the non-disinfected H.sup.+ZP includes at
least one of flowing the acid solution through the casing (i) at a
flowrate of 0.1 ml/min to 5 ml/min, (ii) at a temperature from
about 20.degree. C. to about 80.degree. C., or (iii) until eluent
acid used to contact the H.sup.+ZP has a pH that equals or
substantially equals a pH of incoming acid solution.
[0041] In a seventh aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, at least one of (a) the acid solution is HCl,
H.sub.2SO.sub.4, H.sub.3PO.sub.4, HNO.sub.3 or acetic acid or (b)
the disinfecting agent (i) is a hydrogen based chemical, such as
including HOCl or (ii) includes isopropyl alcohol ("IPA").
[0042] In an eighth aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, the casing including the refurbished H.sup.+ZP is
replaced within the sorbent cartridge with at least one new and
different type of casing.
[0043] In a ninth aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, a medical fluid delivery method includes providing a
sorbent cartridge including Na.sup.+ZP within a casing for a
treatment; and after the treatment, refurbishing the Na.sup.+ZP
while maintained within the casing via (i) regenerating the
non-disinfected NA.sup.+ZP using by flowing a sodium based alkaline
solution or a sodium salt solution through the casing, (ii) rinsing
the regenerated NA.sup.+ZP while maintained within the casing,
(iii) disinfecting the regenerated and rinsed NA.sup.+ZP by flowing
a disinfecting agent through the casing, and (iv) rinsing the
regenerated and disinfected NA.sup.+ZP while maintained within the
casing.
[0044] In a tenth aspect of the present disclosure, which may be
combined with the ninth aspect any other aspect listed herein
unless specified otherwise, at least one of the rinsing procedures
includes rinsing the NA.sup.+ZP with water through the casing until
a desired conductivity is reached.
[0045] In an eleventh aspect of the present disclosure, which may
be combined with the ninth aspect any other aspect listed herein
unless specified otherwise, the first rinsing procedure includes
rinsing the NA.sup.+ZP with water through the casing in a
reverse-to-treatment flow direction and the second rinsing
procedure includes rinsing the NA.sup.+ZP with water through the
casing in a normal treatment flow direction.
[0046] In a twelfth aspect of the present disclosure, which may be
combined with the ninth aspect any other aspect listed herein
unless specified otherwise, disinfecting the rinsed and regenerated
NA.sup.+ZP includes flowing the disinfecting agent through the
casing in a reverse-to-treatment flow direction.
[0047] In a thirteenth aspect of the present disclosure, which may
be combined with the ninth aspect any other aspect listed herein
unless specified otherwise, regenerating the non-disinfected
NA.sup.+ZP includes flowing the sodium based alkaline solution or
the sodium salt solution through the casing in a
reverse-to-treatment flow direction.
[0048] In a fourteenth aspect of the present disclosure, which may
be combined with the ninth aspect any other aspect listed herein
unless specified otherwise, regenerating the non-disinfected
NA.sup.+ZP includes at least one of flowing the sodium based
alkaline solution or the sodium salt solution through the casing
(i) at a flowrate of 0.1 ml/min to 5 ml/min, (ii) at a temperature
from about 20.degree. C. to about 80.degree. C., or (iii) until
eluent sodium solution used to contact the NA.sup.+ZP has a
conductivity that equals or substantially equals a conductivity of
incoming sodium solution.
[0049] In a fifteenth aspect of the present disclosure, which may
be combined with the ninth aspect any other aspect listed herein
unless specified otherwise, the disinfecting agent (i) is a sodium
based chemical, such as including NaOCl or (ii) includes isopropyl
alcohol ("IPA").
[0050] In a sixteenth aspect of the present disclosure, which may
be combined with the ninth aspect any other aspect listed herein
unless specified otherwise, the casing including the refurbished
NA.sup.+ZP is replaced within the sorbent cartridge with at least
one new and different type of casing.
[0051] In a seventeenth aspect of the present disclosure, which may
be combined with any other aspect listed herein unless specified
otherwise, a medical fluid delivery method includes: providing a
sorbent cartridge including Na.sup.+ZP within a casing for a
treatment; and after the treatment, refurbishing the Na.sup.+ZP
while maintained within the casing via (i) disinfecting the
non-regenerated NA.sup.+ZP by flowing a disinfecting agent through
the casing, (ii) rinsing the disinfected NA.sup.+ZP while
maintained within the casing, (iii) regenerating the disinfected
and rinsed NA.sup.+ZP by flowing a sodium based alkaline solution
or a sodium salt solution through the casing, and (iv) rinsing the
disinfected and regenerated NA.sup.+ZP while maintained within the
casing.
[0052] In an eighteenth aspect of the present disclosure, which may
be combined with the seventeenth aspect and any other aspect listed
herein unless specified otherwise, at least one of the rinsing
procedures includes rinsing the NA.sup.+ZP with water through the
casing until a desired conductivity is reached.
[0053] In a nineteenth aspect of the present disclosure, which may
be combined with the seventeenth aspect and any other aspect listed
herein unless specified otherwise, regenerating the non-disinfected
NA.sup.+ZP includes flowing the sodium based alkaline solution or
the sodium salt solution through the casing in a
reverse-to-treatment flow direction.
[0054] In a twentieth aspect of the present disclosure, which may
be combined with the nineteenth aspect and any other aspect listed
herein unless specified otherwise, the second rinsing procedure
includes rinsing the NA.sup.+ZP with water through the casing in a
normal treatment flow direction.
[0055] In a twenty-first aspect of the present disclosure, which
may be combined with the seventeenth aspect and any other aspect
listed herein unless specified otherwise, regenerating the
disinfected NA.sup.+ZP includes at least one of flowing the sodium
based alkaline solution or the sodium salt solution through the
casing (i) at a flowrate of 0.1 ml/min to 5 ml/min, (ii) at a
temperature from about 20.degree. C. to about 80.degree. C., or
(iii) until eluent sodium solution used to contact the NA.sup.+ZP
has a conductivity that equals or substantially equals a
conductivity of incoming sodium solution.
[0056] In a twenty-second aspect of the present disclosure, which
may be combined with the seventeenth aspect and any other aspect
listed herein unless specified otherwise, the disinfecting agent
(i) is a sodium based chemical, such as including NaOCl or (ii)
includes isopropyl alcohol ("IPA").
[0057] In a twenty-third aspect of the present disclosure, which
may be combined with the seventeenth aspect and any other aspect
listed herein unless specified otherwise, the casing including the
refurbished NA.sup.+ZP is replaced within the sorbent cartridge
with at least one new and different type of casing.
[0058] In a twenty-fourth aspect of the present disclosure, which
may be combined with any other aspect listed herein unless
specified otherwise, a sorbent cartridge includes (i) a housing
sized and shaped to accept multiple sorbent cartridge casings in a
desired order; (ii) a zirconium casing located within the housing;
(iii) at least one additional casing located within the housing and
selected from a second zirconium casing, a mechanical filter
casing, an activated carbon and filter casing, a urease casing, or
an anion exchange resin casing; and (iv) wherein each casing
includes a seal that seals to another one of the casings or to the
housing when the housing is closed for treatment, such that fluid
traveling through the housing during treatment is prevented from
leaking between the casings and between the housing and the
casings.
[0059] In a twenty-fifth aspect of the present disclosure, which
may be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, the housing is conically
sized and shaped to accept multiple sorbent cartridge casings in a
desired order and orientation.
[0060] In a twenty-sixth aspect of the present disclosure, which
may be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, each zirconium casing
provided includes a refurbished zirconium compound.
[0061] In a twenty-seventh aspect of the present disclosure, which
may be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, the first and second
zirconium casings include an Na.sup.+ZP casing and an H.sup.+ZP
casing.
[0062] In a twenty-eighth aspect of the present disclosure, which
may be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, the first and second
zirconium casings are located in parallel within the housing.
[0063] In a twenty-ninth aspect of the present disclosure, which
may be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, the first and second
zirconium casings are located in series within the housing.
[0064] In a thirtieth aspect of the present disclosure, which may
be combined with the twenty-fourth aspect and any other aspect
listed herein unless specified otherwise, the housing is closed at
its exit end and openable at its inlet end via a removable cap. In
a thirty-first aspect of the present disclosure, which may be
combined with any other aspect listed herein unless specified
otherwise, a sorbent refurbishing device includes (i) a cleaning
chamber sized and arranged to accept at least one sorbent cartridge
casing for refurbishing; (ii) a disinfecting agent source in fluid
communication with the cleaning chamber; (iii) a regeneration
solution source in fluid communication with the cleaning chamber;
(iv) a water source or water connection in fluid communication with
the cleaning chamber; (v) at least one pump positioned and arranged
to pump at least one of disinfecting agent, regeneration solution,
or water to the cleaning chamber; (vi) at least one first valve
located between the disinfecting agent source and the cleaning
chamber; (vii) at least one second valve located between the
regeneration solution source and the cleaning chamber; (viii) at
least one third valve located between the water source or water
connection and the cleaning chamber; and (ix) a control unit
configured to operate the at least one pump, the at least one first
valve, the at least one second valve and the at least one third
valve to perform a refurbishing procedure on the at least one
cartridge casing.
[0065] In a thirty-second aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the cleaning chamber is
configured to accept the at least one sorbent cartridge in a
particular orientation so that a normal treatment fluid direction
and an opposite to normal treatment fluid direction is known.
[0066] In a thirty-third aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the at least one first
valve is positioned and arranged to enable disinfecting agent to be
delivered to either of two opposing sides of the cleaning
chamber.
[0067] In a thirty-fourth aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the at least one second
valve is positioned and arranged to enable regeneration solution to
be delivered to either of two opposing sides of the cleaning
chamber.
[0068] In a thirty-fifth aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the at least one third
valve is positioned and arranged to enable water to be delivered to
either of two opposing sides of the cleaning chamber.
[0069] In a thirty-sixth aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the sorbent refurbishing
device includes at least one of a conductivity sensor, a
temperature sensor, or a pH sensor positioned to sense at least one
of the disinfecting agent, the regeneration solution or water, the
at least one sensor providing an output to the control unit.
[0070] In a thirty-seventh aspect of the present disclosure, which
may be combined with the thirty-sixth aspect and any other aspect
listed herein unless specified otherwise, the control unit is
configured to use the output to control duration of flow of at
least one of the disinfecting agent, the regeneration solution or
water.
[0071] In a thirty-eighth aspect of the present disclosure, which
may be combined with the thirty-sixth aspect and any other aspect
listed herein unless specified otherwise, the sorbent refurbishing
device further includes at least one heating coil, the control unit
configured to use the output from the temperature sensor to operate
the at least one heating coil.
[0072] In a thirty-ninth aspect of the present disclosure, which
may be combined with the thirty-first aspect and any other aspect
listed herein unless specified otherwise, the sorbent refurbishing
device further includes a hot air blower under control of the
control unit to dry to the at least one sorbent cartridge
casing.
[0073] In a fortieth aspect of the present disclosure, any of the
structure and functionality disclosed in connection with FIGS. 1 to
15 may be included or combined with any of the other structure and
functionality disclosed in connection with FIGS. 1 to 15.
[0074] In light of the present disclosure and the above aspects, it
is therefore an advantage of the present disclosure to provide an
improved used sorbent material regeneration system and method.
[0075] It is another advantage of the present disclosure to provide
an improved used sorbent material regeneration system and method
operable in a batch manner.
[0076] It is a further advantage of the present disclosure to
provide an improved used sorbent material regeneration system and
method that is operable onsite.
[0077] It is still another advantage of the present disclosure to
provide a sorbent cartridge that is readily disassembled and
reassembled to remove used sorbent material casings and replace
refurbished or new sorbent material casings.
[0078] It is a further advantage of the present disclosure to
provide an improved used sorbent material regeneration system and
method having a sorbent conditioning or refurbishing device that
accepts used sorbent material casings and generates refurbished
sorbent material casings.
[0079] The advantages discussed herein may be found in one, or
some, and perhaps not all of the embodiments disclosed herein.
Additional features and advantages are described herein, and will
be apparent from, the following Detailed Description and the
figures.
BRIEF DESCRIPTION OF THE FIGURES
[0080] FIG. 1 is a schematic view of one embodiment of a sorbent
hemodialysis ("HD") system that may employ any of the sorbent
refurbishing techniques of the present disclosure.
[0081] FIG. 2 is a schematic view of one embodiment of a sorbent
peritoneal dialysis ("PD") system that may employ any of the
sorbent refurbishing techniques of the present disclosure.
[0082] FIG. 3 is a schematic diagram of a first batch sorbent
implementation of the present disclosure.
[0083] FIG. 4 is a schematic diagram of a second batch sorbent
refurbishing implementation of the present disclosure.
[0084] FIG. 5 is a schematic diagram of a third batch sorbent
refurbishing implementation of the present disclosure.
[0085] FIG. 6 is a schematic diagram of a fourth batch sorbent
refurbishing implementation of the present disclosure.
[0086] FIG. 7 is a schematic diagram of a fifth batch sorbent
refurbishing implementation of the present disclosure.
[0087] FIG. 8 is a schematic diagram of a sixth batch sorbent
refurbishing implementation of the present disclosure.
[0088] FIG. 9 is a schematic diagram of an example parallel path
sorbent cartridge formed via certain implementations of the batch
refurbishing of the present disclosure.
[0089] FIG. 10 is a schematic diagram of an example parallel path
sorbent cartridge formed via certain implementations of the onsite
refurbishing of the present disclosure.
[0090] FIG. 11 is a schematic diagram of an onsite H.sup.+ZP
sorbent refurbishing implementation of the present disclosure.
[0091] FIG. 12 is a schematic diagram of a first onsite Na.sup.+ZP
sorbent refurbishing implementation of the present disclosure.
[0092] FIG. 13 is a schematic diagram of a second onsite Na.sup.+ZP
sorbent refurbishing of the present disclosure.
[0093] FIG. 14 is an exploded perspective view of one embodiment of
a sorbent cartridge that may be used with the onsite sorbent
refurbishing of the present disclosure.
[0094] FIG. 15 is a fluid schematic view of one embodiment of an
onsite sorbent casing refurbishing device of the present
disclosure.
DETAILED DESCRIPTION
System Overview
[0095] Referring now to the drawings and in particular to FIG. 1, a
medical fluid delivery system, such as a hemodialysis ("HD") system
10 is illustrated. In the illustrated embodiment, HD system 10
includes a blood circuit 20 separated from a dialysis fluid circuit
40 by a dialyzer 18. Blood circuit 20 connects to the vascular
system of patient 12. In particular, blood circuit 20 includes an
arterial line 22 having an arterial needle that allows blood to be
removed from patient 12. Arterial line 22 runs to an inlet of the
blood compartment of dialyzer 18. Blood circuit 20 also includes a
venous line 24 having an venous needle that allows blood cleansed
via dialyzer 18 to be retuned to patient 12. Venous line 24 runs to
an outlet of the blood compartment of dialyzer 18.
[0096] In the illustrated embodiment, a blood pump 26 is provided
along arterial line 22. Blood pump 26 removes blood from patient 12
via arterial line 22 under negative pressure and pumps the blood
under positive pressure through the reminder of the arterial line,
the blood compartment of dialyzer 18, and venous line 24, back to
patient 12. Blood pump 26 may be an electromechanical peristaltic
pump or a volumetric or diaphragm pump, e.g., driven via pneumatic
pressure. Blood circuit 20 includes one or more air trap, e.g.,
airtrap 28, located in venous line 24, to remove any air from the
blood before it is returned to patient 12. A venous line air
detector 30 and occluder or valve 32 are provided to clamp or
occlude venous line 24 in the case that air is detected via air
detector 30. Pressure sensors 34a to 34c are provided to monitor
arterial line negative pressure, arterial line positive pressure
and venous line positive pressure, respectively. Blood circuit 20
may also include a hematocrit or blood consistency sensor (not
illustrated).
[0097] FIG. 1 further illustrates that dialysis fluid circuit 40
includes a fresh dialysis fluid line 42, which delivers fresh
dialysis fluid (e.g., dialysis fluid cleansed via sorbent cartridge
100) to an inlet of a dialysis fluid compartment of dialyzer 18.
Dialysis fluid circuit 40 includes a used dialysis fluid line 44,
which removes used dialysis fluid from an outlet of the dialysis
fluid compartment of dialyzer 18. Sorbent cartridge 100 separates
fresh dialysis fluid line 42 from used dialysis fluid line 44. One
or both of the fresh and used dialysis fluid lines may be provided
with a pump. In the illustrated embodiment, a fresh dialysis fluid
pump 46 operates with or along fresh dialysis fluid line 42, while
used dialysis fluid pump 48 operates with or along used dialysis
fluid line 44. Fresh and used dialysis fluid pumps 46 and 48 may be
electromechanical peristaltic pumps or volumetric or diaphragm
pumps, e.g., driven via pneumatic pressure.
[0098] Pressure sensors 52a to 52d are located along dialysis fluid
circuit 40 to detect, respectively, (a) negative pressure between
dialyzer 18 and used dialysis fluid pump 48, (b) positive pressure
between used dialysis fluid pump 48 and sorbent cartridge 100, (c)
negative pressure between sorbent cartridge 100 and fresh dialysis
fluid pump 46, and (d) positive pressure between fresh dialysis
fluid pump 46 and dialyzer 18. A blood leak detector 54 is located
in used dialysis fluid line 44 just downstream of dialyzer 18 to
look for leaks in the hollow fiber microporous membranes of the
dialyzer 18. An ammonia sensor 74 (and/or other physiological
sensor) is located along fresh dialysis fluid line 42 and is used
to ensure that regenerated dialysis fluid from sorbent cartridge
100 will be effective to remove toxins from patient 12 when
returned to the patient.
[0099] An initial fluid supply and UF container 56 is connected
fluidly via line 58 to used dialysis fluid line 44 upstream of used
dialysis fluid pump 48. Used dialysis fluid pump 48 pulls an
initial supply of dialysis fluid from container 56 into dialysis
fluid circuit 40 to prime the circuit and then for use to clean the
blood of patient 12. The initial supply of HD dialysis fluid is
prepared in one embodiment by administering liquid or dried HD
concentrate (e.g., acid and bicarbonate) into container 56 and then
pouring a specified amount of potable water, e.g., six to ten
liters, into container 56 to mix (and dissolve if needed) the
concentrate. Pumps 46 and 48 are operated to pump the initial
supply of dialysis fluid through sorbent cartridge 100 to purify
the initial supply to an appropriate level before the initial
supply reaches dialyzer 18. A valve 60a is located along supply
line 58 to selectively allow or not allow initial fluid supply and
UF container 56 to communicate fluidly with dialysis fluid circuit
40.
[0100] An infusate container 62 is connected fluidly via line 64 to
fresh dialysis fluid line 42 downstream of sorbent cartridge 100.
An infusate pump 66, such as a peristaltic or a volumetric pump, is
located along infusate line 64 between infusate container 62 and
fresh dialysis fluid line 42. Sorbent cartridge 100 also absorbs
desirable components that need to be replenished. Infusate pump 66
meters a desired amount of infusate (containing electrolytes and
other constituents) that places the dialysis fluid regenerated via
sorbent cartridge 100 in the same or similar chemical and
physiological condition as fresh dialysis fluid from container 56.
A valve 60b is located along infusate line 64 to selectively allow
or not allow infusate container 62 to communicate fluidly with
dialysis fluid circuit 40.
[0101] In the illustrated embodiment, dialysis fluid circuit 40
includes a drain line 68, which extends from used dialysis fluid
line 44 and enables used dialysis fluid at the end of treatment to
be pumped to a drain 70, such as a drain bag or a house drain
(e.g., a toilet or bath tub). A valve 60c is located along drain
line 68, which along with valves 60d and 60e, selectively allows or
occludes flow through the drain line to drain 70.
[0102] Valves 60d and 60e are located in fresh dialysis fluid line
42 and used dialysis fluid line 44, respectively, to selectively
allow or occlude flow through those lines. Any valve discussed
herein, including any of valves 60a to 60e may be an electrically
actuated solenoid pinch valve that operates directly with the
associated tube or line or be a disposable-cassette based valve
that is opened or closed pneumatically or electromechanically.
[0103] Structure and methodology are provided for removing a
controlled amount of ultrafiltration ("UF") from patient 12, such
as a separate UF pump or one or more weigh scales outputting to
control unit 50. In the illustrated embodiment, a weigh scale 72 is
located beneath initial fluid supply and UF container 56. Weigh
scale 72 at the beginning of treatment weighs the initial supply of
fresh dialysis fluid within container 56 to know that the fresh
dialysis fluid has been proportioned properly with the amount of
wet or dry dialysis fluid concentrate provided and delivered into
fresh dialysis fluid supply container 56. During treatment, valves
60a and 60e are toggled periodically to enable a prescribed amount
of used dialysis fluid to be diverted as UF into now UF container
56, wherein the prescribed amount is obtained using weigh scale 72.
At the end of treatment, the remaining used dialysis fluid is
delivered instead to drain 70 via drain line 68 and drain valve
60c. Other types of volumetric control, such as balance chambers in
dialysis fluid circuit 40 may be used alternatively to control UF
and the amount of fresh and used dialysis fluid delivered to and
removed from dialyzer 18.
[0104] In the illustrated embodiment as indicated by the dashed
electrical and/or signal lines, all blood and dialysis fluid pumps
and valves (such as valves 32 and 60a to 60e) are operated under
control of a control unit 50, which also accepts inputs from each
of the sensors described above operating with blood circuit 20 and
dialysis fluid circuit 40, such as, pressure sensors 34a to 34c and
52a to 52d, conductivity sensors, air detection sensor 30, blood
detection sensor 54, ammonia 74 and/or other chemical sensors.
[0105] At the end of treatment using above-described HD system 10,
sorbent cartridge 100 is removed from dialysis fluid circuit 40 and
at least some of the layers of material within a sorbent column of
the cartridge are cleaned and regenerated according to the
embodiments described below.
[0106] Referring now to FIG. 2, the sorbent conditioning of the
present disclosure may also be employed to refurbish used sorbent
materials from peritoneal dialysis ("PD") treatments using a PD
system, such as PD system 110. PD system 110 operates with a
patient 112. In system 110, dialyzer 18 is not used, however,
sorbent column 100 is used. PD system 110 is described as a
continuous flow peritoneal dialysis ("CFPD"), however, the sorbent
cleaning of the present disclosure is equally applicable to
continuous cycling peritoneal dialysis ("CCPD") and tidal PD. With
CFPD, patient 112 is provided with a dual lumen catheter 114, which
allows fresh or regenerated dialysis fluid to be pumped along fresh
dialysis fluid line 116 to one lumen of dual lumen catheter 114,
while used dialysis fluid is removed via the other lumen of dual
lumen catheter 114 into used dialysis fluid line 118. Fresh
dialysis fluid line 116 is separated from used dialysis fluid line
118 via sorbent cartridge 100.
[0107] In the illustrated embodiment, a single PD fluid pump 120 is
provided along used dialysis fluid line 118 to pull used dialysis
fluid from patient 112 via dual lumen catheter 114, and to push the
used dialysis fluid through sorbent cartridge 100, and cleansed
dialysis fluid from cartridge 100, through fresh dialysis fluid
line 116, back to patient 112 via dual lumen catheter 114. A
separate infusate pump 122 is used to meter a desired amount of PD
electrolytes and make-up constituents into fresh dialysis fluid
line 116 via a PD infusate container 124 and an infusate line 126
leading to the fresh dialysis fluid line.
[0108] A supply and UF line 128 leads from an initial fluid supply
and UF container 130 to used dialysis fluid line 118 upstream of PD
fluid pump 120. An initial supply of PD dialysis fluid is prepared
in one embodiment by administering liquid or dried PD concentrate
(e.g., dextrose/glucose and buffer) into container 130 and then
delivering a specified amount of potable water, e.g., six to ten
liters, into the container to mix (and dissolve if needed) the
concentrate. PD fluid pump 120 is operated so as to pump the
initial supply of dialysis fluid through sorbent cartridge 100 to
purify the initial supply to an appropriate level before the
initial supply reaches patient 112.
[0109] A weigh scale 132 is located beneath initial fluid supply
and UF container 130 to proportion the PD concentrate and added
potable water correctly and to allow a desired amount of UF to be
removed from patient 112 over the course of treatment as described
above for HD system 10. Weigh scale 132 as illustrated may be used
additionally if needed (or a different scale may be used) with
drain bag 136, so that with valves 140b and 140d closed and valve
140c open, PD fluid pump 120 can drive a desired amount of UF into
the drain bag. The alternative UF control embodiments described
above for HD system 10 may also be used with present PD system
110.
[0110] In the illustrated embodiment, system 110 also includes a
drain line 134 leading to a drain container 136. Drain line 134 in
one embodiment extends from used dialysis fluid line 118 at a
location downstream of PD fluid pump 120. At the end of treatment,
whatever dialysis fluid has not been pumped to UF container 130 is
pumped instead to drain container 136. Drain line 134 leads
alternatively to a house drain, such as a toilet or bathtub.
Alternatively, all PD fluid and patient UF is delivered to drain
bag 136 at the end of treatment.
[0111] PD system 110 in the illustrated embodiment includes
multiple sensors, such as pressure sensors 138a and 138b located
along fresh dialysis fluid line 116 and used dialysis fluid line
118, respectively, which are used to ensure that the negative
pressure (pressure sensor 138b) and the positive pressure (pressure
sensor 138a) applied to patient 112 via PD fluid pump 120 are
within acceptable limits. An ammonia sensor 142 (and/or other
physiological sensor) is located along fresh dialysis fluid line
116 and is used to ensure that regenerated dialysis fluid from
sorbent cartridge 100 will be effective to remove toxins from
patient 112 when returned to the patient.
[0112] Valve 140a is located along supply and UF line 128 to
selectively allow or not allow initial fluid supply and UF
container 130 to communicate fluidly with used dialysis fluid line
118. A valve 140b is located along infusate line 126 to selectively
allow or not allow infusate container 124 to communicate fluidly
with fresh dialysis fluid line 116. A valve 140c is located along
drain line 134 to selectively allow or occlude flow through the
drain line. Valves 140d and 140e are located in fresh dialysis
fluid line 116 and used dialysis fluid lines 118, respectively, to
selectively allow or occlude flow through those lines. As mentioned
above, any valve discussed herein, including any of valves 140a to
140e may be an electrically actuated solenoid pinch valve that
operates directly with the associated tube or line, or be a
disposable-cassette based valve that is opened or closed
pneumatically or electromechanically.
[0113] In the illustrated embodiment as indicated by the dashed
electrical and/or signal lines, all dialysis fluid pumps and valves
(such as valves 140a to 140e) are operated under control of a
control unit 150, which also accepts inputs from each of the
sensors described above operating with fresh dialysis fluid line
116 and used dialysis fluid lines 118, such as, pressure sensors
138a and 138b, conductivity sensors, air detection sensors, ammonia
142 and/or other chemical sensors.
[0114] An alternative PD system (not illustrated) uses a structure
similar to HD system 10, which includes dialyzer 18. Here, blood
circuit 20 is replaced with a patient PD fluid circuit. Dialysis
fluid circuit 40 uses PD dialysis fluid to clean the patient PD
fluid in circuit 20. Sorbent cartridge 100 is located in PD
dialysis fluid circuit 40 to cleanse waste and toxins from the PD
dialysis fluid, which receives waste and toxins from the patient PD
fluid in circuit 20 via dialyzer 18 through osmosis. All structure
and functionality described above for HD system 10, such as for the
pumps, valves and sensors, is applicable to the alternative dual
loop CFPD system.
[0115] At the end of treatment using above-described HD system 10,
sorbent cartridge 100 is removed from dialysis fluid circuit 40 and
at least some of the layers of material within a sorbent column of
the cartridge are cleaned and regenerated according to the
embodiments described below.
Sorbent Material Refurbishing
[0116] With any of HD system 10, PD system 110 or the PD system
using the structure of HD system 10 just described, it is
contemplated to refurbished the sorbent materials in at least two
different manners. In a first manner, patient 12, 112 or the
caregiver collects used sorbent cartridges 100. The collected used
cartridges are either picked up or delivered periodically to a
facility where they are cleaned and regenerated in a batch manner
along with used sorbent materials from other patients. Here,
patient 12, 112 or the caregiver receives a delivery of fresh
sorbent cartridges 100 periodically. In a second manner, at least a
portion of used sorbent cartridges 100 are cleaned and regenerated
onsite, either in a clinic or at home. In one example, any
zirconium containing layers are cleaned and regenerated and then
repacked into the sorbent column of cartridge 100 along with new
single use layers. Single use layers in various embodiments include
any one or more of a mechanical purification layer, a urease layer,
an anion exchange layer and/or an activated carbon layer.
Batch Refurbishing
[0117] In the batch refurbishing primary embodiment, used sorbent
materials from multiple sorbent cartridges 100 are combined and
cleaned together. The sorbent cleaning process in one embodiment
provides an adequate ammonium removal capacity of zirconium
phosphate containing greater than 90% sodium or hydrogen exchange
sites. The sorbent cleaning in various implementations involves the
use of a disinfecting agent in combination with an acid, base or
sodium salt treatment. The sorbent cleaning is applicable to
sorbent cartridges 100 having different zirconium containing
compartments provided in a serial (e.g., layered) or in parallel
(e.g., used dialysis fluid flows through one or the other
compartment).
[0118] It is contemplated to provide the batch sorbent refurbishing
process in any one of a plurality of different implementations of
the first primary embodiment. In each case, used zirconium
containing sorbent materials from multiple sorbent cartridges 100
used by a single or multiple patients 12, 112 is collected at a
refurbishing facility. The total batch to be refurbishing one
procedure may be in the range of 10 lbs. to 1000 lbs.
[0119] In each of the batch refurbishing implementations discussed
below, example reagents include: [0120] 10 mM NH4Cl/PD solution
(NH4Cl spiked PD Dianeal.RTM. solution), [0121] 30 mM NH4Cl/PD
solution (NH4Cl spiked PD Dianeal.RTM. solution), [0122] 7 mM
NH4Cl/PD solution (NH4Cl spiked PD Dianeal.RTM. solution), [0123]
0.1N NaCl, [0124] 0.1N HCL, [0125] 0.1N NaOH, and [0126] 0.5M
NaHCO3+0.1N NaOH [0127] The Dianeal.RTM. low calcium (2.5 mEq/L)
peritoneal dialysis solution with 2.5% dextrose, catalog #5B9776.
Each 100 ml contains [0128] 2.5 g dextrose hydrous USP, [0129] 538
mg sodium chloride USP, [0130] 448 mg sodium lactate, [0131] 18.3
mg calcium chloride USP, [0132] 5.08 mg magnesium chloride USP, and
[0133] pH 5.2 [0134] mEq/L: [0135] sodium--132, [0136]
calcium--2.5, [0137] magnesium--0.5, [0138] chloride--95, [0139]
lactate 40, and [0140] osmolarity 395 mOsmol/L
[0141] In each of the batch refurbishing implementations discussed
below, example sorbents include:
TABLE-US-00001 Bottle Sorbent Lot 1 Terio ZP 40051 commercial
zirconium phospahte batch 2 JiangXi Zp 20160113 commercial
zirconium phospahte batch 3 Baxter ZP NA commercial zirconium
phospahte batch 4 REDY ZP B-488 commercial zirconium phospahte
batch 5 Terio ZP 40054 commercial zirconium phospahte batch 6 Terio
ZP 40055 commercial zirconium phospahte batch 7 JiangXi Zp 20160116
commercial zirconium phospahte batch 8 JiangXi Zp 20160228
commercial zirconium phospahte batch 9 CarboChem 100316-1
commercial zirconium phospahte batch
[0142] In each of the batch refurbishing implementations discussed
below, example equipment includes: [0143] three VWR tube rotator,
10136-084, [0144] one Rotoflex rotator, Argos, cat #R2000, [0145]
50 ml Centrifuge tube, VWR, [0146] 2 ml Micro tube, VWR, catalog
#211-0092, [0147] universal fit screw caps with O-ring, VWR,
catalog #211-0131, 211-0129, [0148] balance, L13831, L25833, [0149]
pipette, RL-10532, [0150] stop watch, L31016, [0151] HPLC pump,
[0152] bio-scale MT columns, bio-rad catalog number: 751-0081,
[0153] 1M NaCl, 0.5M NaHCO3, 2M NaHCO3, 1M CH3COONa, [0154] 1M HCl,
0.5M HCl, and [0155] 1M NaOH, 0.5M NaOH
[0156] One example static sorbent sorption capacity test for the
batch refurbishing embodiment includes: [0157] 1. Dry zirconium
phosphate (ZP) is contacted with PD low calcium dialysate solution
at the ration of 7 g sorbent in 1 L PD solution containing 10 mM of
ammonium chloride. [0158] 2. The suspension is mixed using stirring
bar at room temperature for 1 hr. [0159] 3. 1.0 ml control samples
were taken from the 10 mM NH4Cl/PD. [0160] 4. Three test samples
were collected from supernatant at time=1 hour. [0161] 5. The
control and test samples were sent for chemical analysis to measure
the concentration of NH.sub.4.sup.+, BUN, Bicarbonate, Na.sup.+,
phosphorus, Ca.sup.2+ and Mg.sup.2+, K.sup.+ and pH. [0162] 6.
NH.sub.4.sup.+ sorption capacity in zirconium phosphate is
calculated.
[0163] Example data analysis for a static sorbent sorption capacity
test for the batch refurbishing embodiment includes:
[0164] Static Sorption Test [0165] NH.sub.4.sup.+ adsorption is
obtained by equation 1:
[0165] q = ( C i - C e ) L Z .times. P Equation .times. .times. 1
##EQU00001## [0166] where: [0167] q: adsorbed NH.sub.4.sup.+ (mmol
NH.sub.4.sup.+/g ZP), [0168] C.sub.i: initial concentration of
NH.sub.4.sup.+ in dialysate solution (mmol/L), [0169] C.sub.e:
concentration of NH.sub.4.sup.+ at equilibrium (mmol/L), [0170] L:
volume of test solution, and [0171] ZP: dosage of ZP added to the
bottle (grams)
[0172] Dynamic Sorption Test [0173] NH.sub.4.sup.+ adsorption is
obtained by equation 2:
[0173] q = [ NH .times. .times. 4 + ] .times. Q .times. B .times. T
.times. 0.001 Z .times. P Equation .times. .times. 2 ##EQU00002##
[0174] where: [0175] q: adsorbed NH4+ (mmol NH.sub.4.sup.+/g ZP),
[0176] [NH.sub.4.sup.+]: feed concentration of NH.sub.4.sup.+ in
dialysate solution (mmol/L), [0177] Q: flow rate (ml/min), [0178]
BT: NH.sub.4.sup.+ break through time (min), and [0179] ZP: dosage
of ZP added to the bottle (grams)
[0180] Referring now to FIG. 3, a first batch sorbent refurbishing
implementation is illustrated by method 160. At oval 162, method
160 begins. At block 164, non-disinfected zirconium phosphate
("ZP") is removed and collected from the relevant casings in the
columns of each of a plurality of used sorbent cartridges 100
returned to the sorbent refurbishing facility. The collected and
combined non-disinfected ZP is regenerated using an acid
solution.
[0181] At block 166, the regenerated ZP is disinfected using a
disinfecting agent. The disinfecting agent in various examples
includes any one or more of various types of chemicals. One is a
sodium based chemical such as NaOCl in isopropyl alcohol ("IPA").
The other is hydrogen based chemical such as HOCl in IPA. A third
includes IPA as the primary disinfecting agent.
[0182] At block 168, the disinfected and acid regenerated ZP is
washed and filtered. Washing and filtering is performed in one
example by flowing water through the disinfected and acid
refurbished ZP, rinsing any residue from the disinfection and the
acid regeneration.
[0183] At block 170, the washed ZP is titrated to a desired pH, for
example, to a pH between and including 5.5 to 8.5. Titration may be
performed using an analyte, an indicator and a pH meter. The
titration is performed to the entire batch in one embodiment. The
washed ZP is stirred in aqueous suspension at room temperature and
the pH is continuously monitored. The pH of the suspension is
adjusted by adding small aliquots of diluted basic solution (e.g.
0.1 N NaOH and/or 0.5 M NaHCO3) If the pH rises above the desired
range, small aliquots of diluted acid solution (e.g. 0.1 N HCl) can
be added.
[0184] At block 172, the titrated ZP is washed and filtered to a
conductivity below 50 .mu.S/cm. Washing and filtering is performed
again in one example using water, which subsequent to washing and
filtering the ZP is flowed, e.g., pumped, past a
temperature-compensated conductivity probe that reads out to a
conductivity meter. Once the meter reads below 50 .mu.S/cm, the
washing and filtering at block 172 may be stopped.
[0185] At block 174, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0186] At block 176, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. Sieving produces ZP granules
having at least a minimum desired smallest diameter needed for the
intended use. The sieved ZP granules are then placed back into a
casing, which may have also been disinfected. The casing is placed
in a desired order within a column of a refurbished sorbent
cartridge 100, which is now ready to be used again in treatment,
and may be shipped to a patient's home or clinic.
[0187] At oval 178, method 160 ends.
[0188] Referring now to FIG. 4, a second batch sorbent refurbishing
implementation is illustrated by method 180. In method 180, the
titration at block 170 and the second washing procedure at block
172 of method 170 are removed. At oval 182, method 180 begins.
[0189] At block 184, non-disinfected zirconium phosphate ("ZP") is
removed and collected from the relevant casings in the columns of
each of a plurality of used sorbent cartridges 100 returned to the
sorbent refurbishing facility. The collected and combined
non-disinfected ZP is regenerated using an acid solution.
[0190] At block 186, the regenerated ZP is disinfected using a
disinfecting agent. The disinfecting agent includes any one or more
of (i) a sodium based chemical such as NaOCl in isopropyl alcohol
("IPA"), (ii) a hydrogen based chemical such as HOCl in IPA or
(iii) IPA as the primary disinfectant.
[0191] At block 188, the disinfected and acid regenerated ZP is
washed and filtered, which in an example is performed by flowing
water through the disinfected and acid regenerated ZP, rinsing any
residue from the disinfection and the acid regeneration.
[0192] At block 190, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0193] At block 192, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. The sieved ZP granules are
then placed back into a casing, which may have also been
disinfected. The casing is placed in a desired order within a
column of a refurbished sorbent cartridge 100, which is now ready
to be used again in treatment, and may be shipped to a patient's
home or clinic.
[0194] At oval 194, method 180 ends.
[0195] Referring now to FIG. 5, a third batch sorbent refurbishing
implementation is illustrated by method 200. In method 200, the
acid solution of method 160 is replaced with a sodium based
alkaline solution or a sodium salt solution. At oval 202, method
200 begins.
[0196] At block 204, non-disinfected zirconium phosphate ("ZP") is
removed and collected from the relevant casings in the columns of
each of a plurality of used sorbent cartridges 100 returned to the
sorbent refurbishing facility. The collected and combined
non-disinfected ZP is regenerated using a sodium based alkaline
solution or a sodium salt solution.
[0197] At block 206, the regenerated ZP is disinfected using a
disinfecting agent. The disinfecting agent includes any one or more
of (i) a sodium based chemical such as NaOCl in isopropyl alcohol
("IPA"), (ii) a hydrogen based chemical such as HOCl in IPA, or
(iii) IPA as the primary disinfecting agent.
[0198] At block 208, the disinfected and sodium regenerated ZP is
washed and filtered, which in an example is performed by flowing
water through the disinfected and sodium regenerated ZP, rinsing
any residue from the disinfection and the acid regeneration.
[0199] At block 210, the washed ZP is titrated to a desired pH, for
example, to a pH between and including 5.5 to 8.5. Titration may be
performed using an analyte, an indicator and a pH meter. The
titration is performed to the entire batch in one embodiment. The
washed ZP is stirred in aqueous suspension at room temperature and
the pH is continuously monitored. The pH of the suspension is
adjusted by adding small aliquots of diluted basic solution (e.g.
0.1 N NaOH and/or 0.5 M NaHCO3) If the pH rises above the desired
range, small aliquots of diluted acid solution (e.g. 0.1 N HCl) can
be added.
[0200] At block 212, the titrated ZP is washed and filtered to a
conductivity below 50 .mu.S/cm. Washing and filtering is performed
again in one example using water, which subsequent to washing and
filtering the ZP is flowed, e.g., pumped, past a
temperature-compensated conductivity probe that reads out to a
conductivity meter. Once the meter reads below 50 .mu.S/cm, the
washing and filtering at block 172 may be stopped.
[0201] At block 214, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0202] At block 216, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. The sieved ZP granules are
then placed back into a casing, which may have also been
disinfected. The casing is placed in a desired order within a
column of a refurbished sorbent cartridge 100, which is now ready
to be used again in treatment, and may be shipped to a patient's
home or clinic.
[0203] At oval 218, method 200 ends.
[0204] Referring now to FIG. 6, a fourth batch sorbent refurbishing
implementation is illustrated by method 220. In method 220, the
acid solution of method 180 is replaced with a sodium based
alkaline solution or a sodium salt solution. At oval 222, method
220 begins.
[0205] At block 224, non-disinfected zirconium phosphate ("ZP") is
removed and collected from the relevant casings in the columns of
each of a plurality of used sorbent cartridges 100 returned to the
sorbent refurbishing facility. The collected and combined
non-disinfected ZP is regenerated using a sodium based alkaline
solution or a sodium salt solution.
[0206] At block 226, the regenerated ZP is disinfected using a
disinfecting agent. The disinfecting agent includes any one or both
of (i) a sodium based chemical such as NaOCl in isopropyl alcohol
("IPA"), (ii) a hydrogen based chemical such as HOCl in IPA, or
(iii) IPA as the primary disinfecting agent.
[0207] At block 228, the disinfected and sodium regenerated ZP is
washed and filtered, which in an example is performed by flowing
water through the disinfected and sodium regenerated ZP, rinsing
any residue from the disinfection and the sodium regeneration.
[0208] At block 230, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0209] At block 232, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. The sieved ZP granules are
then placed back into a casing, which may have also been
disinfected. The casing is placed in a desired order within a
column of a refurbished sorbent cartridge 100, which is now ready
to be used again in treatment, and may be shipped to a patient's
home or clinic.
[0210] At oval 234, method 220 ends.
[0211] Referring now to FIG. 7, a fifth batch sorbent refurbishing
implementation is illustrated by method 240. In method 240, the
regenerating and disinfecting procedures at blocks 204 and 206 of
method 200 are reversed. At oval 242, method 240 begins.
[0212] At block 244, non-regenerated zirconium phosphate ("ZP") is
removed and collected from the relevant casings in the columns of
each of a plurality of used sorbent cartridges 100 returned to the
sorbent refurbishing facility. The collected and combined
non-regenerated ZP is disinfected using a disinfecting agent. The
disinfecting agent includes any one or both of (i) a sodium based
chemical such as NaOCl in isopropyl alcohol ("IPA"), (ii) a
hydrogen based chemical such as HOCl in IPA, or (iii) IPA as the
primary disinfecting agent.
[0213] At block 246, the disinfected ZP is regenerated using a
sodium based alkaline solution or a sodium salt solution.
[0214] At block 248, the disinfected and sodium regenerated ZP is
washed and filtered, which in an example is performed by flowing
water through the disinfected and sodium regenerated ZP, rinsing
any residue from the disinfection and the sodium regeneration.
[0215] At block 250, the washed ZP is titrated to a desired pH, for
example, to a pH between and including 5.5 to 8.5. Titration may be
performed using an analyte, an indicator and a pH meter. The
titration is performed to the entire batch in one embodiment. The
washed ZP is stirred in aqueous suspension at room temperature and
the pH is continuously monitored. The pH of the suspension is
adjusted by adding small aliquots of diluted basic solution (e.g.
0.1 N NaOH and/or 0.5 M NaHCO3) If the pH rises above the desired
range, small aliquots of diluted acid solution (e.g. 0.1 N HCl) can
be added.
[0216] At block 252, the titrated ZP is washed and filtered to a
conductivity below 50 .mu.S/cm. Washing and filtering is performed
again in one example using water, which subsequent to washing and
filtering the ZP is flowed, e.g., pumped, past a
temperature-compensated conductivity probe that reads out to a
conductivity meter. Once the meter reads below 50 .mu.S/cm, the
washing and filtering at block 172 may be stopped.
[0217] At block 254, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0218] At block 256, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. The sieved ZP granules are
then placed back into a casing, which may have also been
disinfected. The casing is placed in a desired order within a
column of a refurbished cartridge 100, which is now ready to be
used again in treatment, and may be shipped to a patient's home or
clinic.
[0219] At oval 258, method 240 ends.
[0220] Referring now to FIG. 8, a sixth batch sorbent refurbishing
implementation is illustrated by method 260. In method 260, the
regenerating and disinfecting procedures at blocks 224 and 226 of
method 220 are reversed. At oval 262, method 260 begins.
[0221] At block 264, non-regenerated zirconium phosphate ("ZP") is
removed and collected from the relevant casings in the columns of
each of a plurality of used sorbent cartridges 100 returned to the
sorbent refurbishing facility. The collected and combined
non-regenerated ZP is disinfected using a disinfecting agent. The
disinfecting agent includes any one or both of (i) a sodium based
chemical such as NaOCl in isopropyl alcohol ("IPA"), (ii) a
hydrogen based chemical such as HOCl in IPA, or (iii) IPA as the
primary disinfecting agent.
[0222] At block 266, the disinfected ZP is regenerated using a
sodium based alkaline solution or a sodium salt solution.
[0223] At block 268, the disinfected and sodium regenerated ZP is
washed and filtered, which in an example is performed by flowing
water through the disinfected and sodium regenerated ZP, rinsing
any residue from the disinfection and the sodium regeneration.
[0224] At block 270, the washed ZP is dried, e.g., in a vacuum oven
at 120.degree. C. or greater for a duration known to completely dry
the washed mass of ZP.
[0225] At block 272, the dried ZP is sieved using one or more
sieves for one or more sorbent uses. The sieved ZP granules are
then placed back into a casing, which may have also been
disinfected. The casing is placed in a desired order within a
column of a refurbished sorbent cartridge 100, which is now ready
to be used again in treatment, and may be shipped to a patient's
home or clinic.
[0226] At oval 274, method 260 ends.
[0227] In any of the above implementations for refurbishing ZP for
reuse is applicable to other zirconium containing materials, such
as zirconium oxide ("ZO") and to different types of ZP, such as
H.sup.+ZP and Na.sup.+ZP. The layers form a refurbished sorbent
cartridge 100 that is deliverable to the patient along with other
refurbished cartridges 100 to be used over multiple treatments.
[0228] Moreover, the ZP made ready for reuse via any of the
implementations above may be placed within the column of sorbent
cartridge 100 in a serial or parallel fashion with other zirconium
containing materials, and with reused and/or new non-zirconium
layers, such as mechanical filtration, urease, anion and activated
carbon exchange layers. For example, ZP from any of methods 160,
200 or 240 forms an Na/H refurbished sorbent, which may be packed
in a casing spanning the entire diameter of the column of sorbent
cartridge 100 for reuse.
[0229] In any of the batch implementations, the acid solution may
be HCl, H.sub.2SO.sub.4, H.sub.3PO.sub.4, HNO.sub.3 or acetic acid,
while the sodium based alkaline solution or a sodium salt solution
may be NaOH, NaHCO.sub.3, Na.sub.2CO.sub.3 or NaCl.
[0230] ZP from method 180 contains greater than 90% hydrogen ion
exchange sites. The ZP from method 180 may be packed in an H+ZP
casing for a parallel cartridge 100 as shown in FIG. 9. ZP from
methods 220 and 260 contains greater than 90% sodium ion exchange
sites. The ZP from methods 220 and 260 may be packed in Na+ZP
column for parallel cartridge as shown in FIG. 9.
Onsite Refurbishing
[0231] In a second primary embodiment, sorbent material
refurbishing is performed in an onsite operation in which at least
the zirconium containing materials (e.g., ZO, H.sup.+ZP and
Na.sup.+ZP) are conditioned for reuse. As with the previous primary
embodiment, the sorbent refurbishing process of the second primary
embodiment may provide an adequate ammonium removal capacity of
zirconium phosphate containing greater than 90% sodium or hydrogen
exchange sites. The sorbent refurbishing in various implementations
again involves the use of a disinfecting agent in combination with
an acid, base or sodium salt treatment. The sorbent refurbishing is
applicable to sorbent cartridges 100 having different zirconium
containing compartments provided in a serial (e.g., layered) or in
parallel (e.g., used dialysis fluid flows through one or the other
compartment).
[0232] A primary difference between the first and second primary
embodiments is that in the batch process, the sorbent materials are
removed from their layering casing, so that the materials from
multiple sorbent cartridges 100 may be mixed together and cleaned
at once. In the onsite embodiment, on the other hand, the sorbent
materials are left to reside within their casings, for ease of
handling and so that the patient or caregiver does not have to
handle the sorbent materials directly.
[0233] In each of the onsite refurbishing implementations discussed
below, example reagents include: [0234] 7 mM NH4Cl/PD solution
(NH4Cl spiked PD Dianeal.RTM. solution), [0235] 0.1N NaCl, [0236]
0.1N HCL, [0237] 0.1N NaOH, and [0238] 0.5M NaHCO.sub.3+0.1N NaOH
[0239] The Dianeal.RTM. low calcium (2.5 mEq/L) peritoneal dialysis
solution with 2.5% dextrose, catalog #5B9776. Each 100 ml contains:
[0240] 2.5 g dextrose hydrous USP, [0241] 538 mg sodium chloride
USP, [0242] 448 mg sodium lactate, [0243] 18.3 mg calcium chloride
USP, [0244] 5.08 mg magnesium chloride USP, and [0245] pH 5.2
[0246] mEq/L: [0247] sodium 132, [0248] calcium 2.5, [0249]
magnesium 0.5, [0250] chloride 95, [0251] lactate 40, and [0252]
osmolarity 395 mOsmol/L
[0253] In each of the onsite refurbishing implementations discussed
below, example sorbents include:
TABLE-US-00002 Bottle Sorbent Lot 1 Terio ZP 40051 commercial
zirconium phospahte batch 2 JiangXi Zp 20160113 commercial
zirconium phospahte batch 3 Baxter ZP NA commercial zirconium
phospahte batch 4 REDY ZP B-488 commercial zirconium phospahte
batch 5 Terio ZP 40054 commercial zirconium phospahte batch 6 Terio
ZP 40055 commercial zirconium phospahte batch 7 JiangXi Zp 20160116
commercial zirconium phospahte batch 8 JiangXi Zp 20160228
commercial zirconium phospahte batch 9 CarboChem 100316-1
commercial zirconium phospahte batch
[0254] In each of the onsite refurbishing implementations discussed
below, example equipment includes: [0255] 2 ml Micro tube, VWR,
catalog #211-0092, [0256] universal fit screw caps with O-ring,
VWR, catalog #211-0131, 211-0129, [0257] balance, L13831, L25833,
[0258] pipette, RL-10532, [0259] stop watch, L31016, [0260] HPLC
pump, [0261] bio-Scale MT columns, Bio-Rad catalog number:
751-0081, [0262] 1M NaCl, 0.5M NaHCO3, 2M NaHCO3, 1M CH3COONa,
[0263] 0.1 N HCl, and [0264] 0.1N NaOH
[0265] One example sorbent sorption capacity test for the onsite
refurbishing embodiment uses a parallel chamber sorbent cartridge
100 illustrated in FIG. 10. Here, sorbent cartridge 100 includes a
cartridge housing 80 forming the column of the cartridge. Housing
80 holds an inlet activated carbon and filter casing 96 and an
outlet activated carbon and filter casing 98. A urease casing 102
is located just downstream from inlet activated carbon and filter
casing 96. An anion exchange resin casing 104 is located just
upstream from outlet activated carbon and filter casing 98. In
between urease casing 102 and anion exchange resin casing 104 are
two parallel ZP casings, namely, an H.sup.+ZP casing 106 and an
Na.sup.+ZP casing 108.
[0266] It should be appreciated that H.sup.+ZP casing 106 and an
Na.sup.+ZP casing 108 may be moved collectively to a different
order, e.g., downstream of anion exchange resin casing 104 or
upstream of urease casing 102. It should also be appreciated that
parallel ZP casings do not have to be provided and that a single
H.sup.+ZP casing 106 or Na.sup.+ZP casing 108 sized to span the
entire diameter of housing 80 may be provided instead. The analysis
below applies equally to a sorbent cartridge 100 having only one of
H.sup.+ZP casing 106 or Na.sup.+ZP casing 108, or a sorbent
cartridge 100 having serially juxtaposed H.sup.+ZP and Na.sup.+ZP
casings 106 and 108.
[0267] One example sorption capacity test for sorbent cartridge 100
illustrated in FIG. 10 includes: [0268] 1. 7 mM NH.sub.4Cl/PD
solution is passed through the ZP column/cartridge at 1.5 ml/min
flow rate. [0269] 2. 1 ml eluent samples are collected at different
time points and are sent for chemical analysis to measure the
concentration of NH.sub.4.sup.+, BUN, Bicarb, Na.sup.+, P,
Ca.sup.2+ and Mg.sup.2+, K.sup.+ and pH. [0270] 3. Ammonia break
through point is determined at the time point where [NH.sub.3]
concentration of eluent sample reaches 1 mmol/L. NH.sub.3 sorption
capacity is calculated according to equation 3 below.
[0271] One example column regeneration procedure for sorbent
cartridge 100 illustrated in FIG. 10 includes: [0272] 1. Rinse
parallel columns, e.g., pump water through both columns to rinse
the excess sugar, debris and ion. [0273] 2. Regenerate and
disinfect both columns, e.g., reverse flow path for regeneration.
[0274] 3. The regeneration and disinfection solution for H.sup.+ZP
contains acid. [0275] 4. The regeneration and disinfection solution
for Na.sup.+ZP contains sodium.
[0276] Example data analysis for a static sorbent sorption capacity
test for the onsite refurbishing embodiment includes:
[0277] Dynamic Sorption Test [0278] NH.sub.4.sup.+ adsorption is
obtained by equation 3:
[0278] q = [ N .times. H .times. 4 + ] .times. Q .times. B .times.
T .times. 0.001 Z .times. P Equation .times. .times. 3 ##EQU00003##
[0279] where: [0280] q: Adsorbed NH.sub.3 (mmol NH.sub.4.sup.+/g
ZP), [0281] [NH.sub.4.sup.+]: feed concentration of NH.sub.4.sup.+
in dialysate solution (mmol/L), [0282] Q: flow rate (ml/min),
[0283] BT: NH.sub.4.sup.+ break through time (min), and [0284] ZP:
dosage of ZP added to the bottle (grams)
[0285] Referring now to FIG. 11, one onsite sorbent refurbishing
implementation for H.sup.+ZP casing 106 is illustrated by method
280. At oval 282, method 280 begins. At block 284, non-disinfected
H.sup.+ZP is regenerated within casing 106 in a reverse flow
direction to operational flow through sorbent cartridge 100. Here,
an inlet of casing 106 during treatment becomes instead the outlet
of casing 106 outlet during regeneration and vice versa. An acid
solution is flowed, e.g., pumped, through casing 106 at a flow rate
of for example 0.1 ml/min to 5 ml/min and at a temperature from
about 20.degree. C. to about 80.degree. C. The acid wash is
performed in one example until the pH of the eluent (acid that has
contacted H.sup.+ZP) equals or almost equals the pH of the incoming
acid solution.
[0286] At block 286, water is rinsed (e.g., pumped) through the
regenerated H.sup.+ZP within casing 106 (e.g., in the reverse flow
direction) until a conductivity of the effluent (water used to wash
regenerated H.sup.+ZP) reaches a conductivity of 100 .mu.S/cm or
less.
[0287] At block 288, the regenerated and rinsed H.sup.+ZP is
disinfected via a disinfecting agent, which in various examples
includes a hydrogen based chemical, such as HOCl in IPA, flowed,
e.g., pumped, through the H.sup.+ZP casing 106 (e.g., in the
reverse flow direction).
[0288] At block 290, flow is reversed and water is rinsed, e.g.,
pumped through the regenerated and disinfected H.sup.+ZP casing 106
in the normal treatment flow direction until conductivity of the
eluent (water used to wash regenerated and disinfected H.sup.+ZP)
reaches a conductivity of 100 .mu.S/cm or less.
[0289] At block 292, H.sup.+ZP casing 106 is dried and is ready to
be reintroduced into sorbent cartridge 100 and reused. At oval 294,
method 280 ends.
[0290] Referring now to FIG. 12, one onsite sorbent refurbishing
implementation for Na.sup.+ZP casing 108 is illustrated by method
300. At oval 302, method 300 begins. At block 304, non-disinfected
Na.sup.+ZP is regenerated within its casing in a
reverse-to-operational flow direction, such that an inlet of
Na.sup.+ZP casing 108 during treatment becomes the outlet of
Na.sup.+ZP casing 108 during regeneration and vice versa. A sodium
based alkaline solution or a sodium salt solution is flowed, e.g.,
pumped, through Na.sup.+ZP casing 108 at a flow rate of for example
0.1 ml/min to 5 ml/min, and at a temperature from about 20.degree.
C. to about 80.degree. C. The sodium regeneration may be performed
until the conductivity of the eluent (sodium solution that has
contacted Na.sup.+ZP) equals or almost equals the conductivity of
the incoming sodium solution.
[0291] At block 306, water is rinsed through the regenerated
Na.sup.+ZP within its casing 108 (e.g., in the reverse flow
direction) for a determined time knowing that the conductivity has
already been controlled at block 384.
[0292] At block 308, the regenerated and rinsed Na.sup.+ZP is
disinfected via a disinfecting agent, which in various examples
includes a sodium based chemical, such as NaOCl in IPA, flowed,
e.g., pumped, through the Na.sup.+ZP casing (e.g., in the reverse
flow direction).
[0293] At block 310, flow is reversed and water is rinsed, e.g.,
pumped, through the regenerated and disinfected Na.sup.+ZP within
its casing 108 in the normal treatment flow direction until
conductivity of the eluent (water used to wash regenerated and
disinfected Na.sup.+ZP) reaches a conductivity of 100 .mu.S/cm or
less.
[0294] At block 312, Na.sup.+ZP casing 108 is dried and is ready to
be reintroduced into sorbent cartridge 100 and reused. At oval 314,
method 300 ends.
[0295] Referring now to FIG. 13, a second onsite sorbent
refurbishing implementation for Na.sup.+ZP casing 108 is
illustrated by method 320. Here, the regeneration and disinfection
procedures of method 300 are reversed. At oval 322, method 300
begins. At block 324, used and non-regenerated Na.sup.+ZP is
disinfected within its casing 108 in a normal treatment or reverse
flow direction, e.g., via pumping, using a disinfecting agent that
may contain a sodium based chemical such as NaOCl in IPA.
[0296] At block 326, water is rinsed, e.g., pumped, through the
disinfected Na.sup.+ZP within its casing 108, in a normal treatment
or reverse flow direction, to remove residual disinfecting
chemicals until the conductivity of the eluent (water used to wash
disinfected Na.sup.+ZP) reaches a conductivity of 100 .mu.S/cm or
less.
[0297] At block 328, disinfected Na.sup.+ZP is regenerated within
its casing 108 in the reverse flow direction, such that the inlet
of casing 108 during treatment becomes the outlet of casing 108
during regeneration and vice versa. A sodium based alkaline
solution or a sodium salt solution is flowed, e.g., pumped, through
casing 108 at a flow rate of for example 0.1 ml/min to 5 ml/min and
at a temperature from about 20.degree. C. to about 80.degree. C.
Regeneration is performed in one embodiment until the conductivity
of the eluent (sodium solution that has contacted Na.sup.+ZP)
equals or almost equals the conductivity of the incoming sodium
solution.
[0298] At block 330, flow is reversed and water is rinsed, e.g.,
pumped, through the disinfected and regenerated Na.sup.+ZP within
its casing 108 in the normal treatment flow direction, e.g., for a
determined amount of time (knowing that conductivity has already
been controlled at blocks 326 and 328.
[0299] At block 332, Na.sup.+ZP casing 108 is dried and is ready to
be reintroduced into sorbent cartridge 100 and reused. At oval 334,
method 300 ends.
[0300] Once any or all of the H.sup.+ZP and Na.sup.+ZP casings 106
and 108 are refurbished or conditioned for reuse, patient 12, 112
or caregiver inserts the reusable casings into cartridge housing 80
of sorbent cartridge 100 along with any additional casings, e.g.,
mechanical filtration casing, urease casing, anion exchange casing,
and/or activated carbon casing(s), which may themselves have been
conditioned for reuse or opened from a sterile package as a new
casing. Patient 12, 112 or caregiver inserts all casings in a
proper order and orientation, which may be aided by markings
provided on the outside of sorbent cartridge. Alternatively or
additionally, housing 80 of cartridge 100 and the casings may be
somewhat conical in shape so that the casings only fit snugly
within the cartridge when stacked in the proper order and
orientation.
[0301] In any of the onsite implementations, the acid solution may
be HCl, H.sub.2SO.sub.4, H.sub.3PO.sub.4, HNO.sub.3 or acetic acid,
while the sodium based alkaline solution or a sodium salt solution
may be NaOH, NaHCO.sub.3, Na.sub.2CO.sub.3 or NaCl.
[0302] Referring now to FIG. 14, in an embodiment, housing 80 of
sorbent cartridge 100 is closed at one end 82, e.g., the fluid
outlet end, and openable at the other end via a lid or cap 84,
e.g., the fluid inlet end, such that the user (e.g., patient 12,
112, caregiver, clinician or technician) in one embodiment only has
to (i) open one side of cartridge 100 to remove all inner sorbent
casings, e.g., casings 106 and 108, (ii) condition the casings 106
and 108, to be reused, (iii) replace the casings to be discarded,
(iv) rinse housing 80 itself, (v) reinsert the refurbished casings,
e.g., casings 106 and 108, and new casings into rinsed housing 80,
and (vi) close the lid or cap 84 onto the open end of housing
80.
[0303] In various embodiments, inlet lid or cap 84 of the opened
end may thread onto the remainder of cartridge housing 80 via
threads 86 or translate onto the remainder of housing 80 and be
held removeably fixed to housing via releasable clips or latches
88, such as spring clips or latches. In either case, an o-ring seal
90 may be provided between lid or cap 84 and housing 80, which is
compressed when lid or cap 84 is fitted to housing 80. Further, in
either case it is contemplated that the action of applying the lid
or cap 84 to the remainder of the housing 80 in turn compresses the
sorbent casings 94, 96, 102, 106, 108, 104 and 98 together,
compressing seals 92 (e.g., o-ring seals) between the casings, such
that patient effluent cannot leak between the casings and the inner
cartridge. Seals 92 as illustrated may be captured and carried by
the casings for ease of handling when the casings are removed from
the sorbent cartridge. Exit end casing 98 may have or capture seals
92 on both sides, wherein the seal on the downstream side seals
against closed end 82. Alternatively, closed end 82 includes a seal
92 for sealing against exit end casing 98. Seal 92 of inlet end
casing 94 in an embodiment seals against an inside of cap 84.
[0304] In FIG. 14, housing 80 of sorbent cartridge 100 holds seven
casings, including a mechanical filter casing 94, followed by inlet
activated carbon and filter casing 96, followed by urease casing
102, followed by H.sup.+ZP casing 106, followed by Na.sup.+ZP
casing 108 (or casings 106 and 108 could be placed in parallel as
illustrated above), followed by anion exchange resin casing 104,
followed by outlet activated carbon and filter casing 98. Sorbent
cartridge 100 alternatively holds more or less and/or different
casings and/or in different orders. The casings as illustrated are
slightly conical in shape and fit together in logical order and
orientation to form an overall conical shape, which is the only
shape that will fit into like sized and shaped conical housing 80.
As mentioned above, sorbent cartridge 100 is configured such that
threading or compressing lid or cap 84 onto the remainder of
housing 80 compresses (i) seal 90 between lid or cap 84 and the
remainder of housing 80 and (ii) seals 92 between casings 94, 96,
102, 106, 108, 104 and 98 (and casing 94 to lid or cap 84 and
casing 98 to closed end 82).
[0305] In the illustrated embodiment, cap 84 includes an inlet 76
for used dialysis fluid, an initial batch of dialysis fluid, or
water needing purification. Closed end 82 of housing 80 includes an
outlet 78 for outputting cleansed dialysis fluid (or water). Seals
92 ensure that fluid entering through inlet 76 cannot flow around
the outside of the casings between the casings and housing 80.
Inlet 76 and outlet 78 may be of the same or different type,
including a straight or tapered port to which a tube compression
fits, a luer fitting, a threaded fitting, or a ferruled compression
fitting. FIG. 14 also illustrates that the circular inlet and
outlet faces of casings 94, 96, 102, 106, 108, 104 and 98, within
seals 92, may each be made of a mesh material (same or different
mesh sizes for the different casings) that allow fluid to flow
through the faces, but that trap the sorbent or filter material
located within the casings. The mesh material also allows at least
some of the casings to be regenerated after use.
[0306] The onsite operation may be performed in a dialysis clinic,
at a hospital, or at a patient's home, for example. At a clinic,
the sorbent casing removal and replacement may be performed by a
clinician or technician. At a hospital, the sorbent casing removal
and replacement may be performed by a nurse or technician. At home,
the sorbent casing removal and replacement may be performed by
patient 12, 112 or a caregiver for the patient.
[0307] Referring now to FIG. 15, it is further contemplated to
provide at the clinic, hospital, or patient's home one or more
sorbent conditioning or refurbishing device 350. Device 350 may be
configured to condition or refurbish (i) one sorbent casing at a
time, (ii) multiple sorbent casings of a same type at the same
time, (iii) multiple sorbent casings of different types at the same
time (as illustrated in FIG. 15), (iv) multiple sorbent casings of
a same type sequentially, or (v) multiple sorbent casings of
different types sequentially. Sorbent conditioning or refurbishing
device 350 accepts the one or more sorbent casing 106, 108 in a
sealed manner, conditions or refurbishes the one or more sorbent
casing according to any of the implementations discussed above for
the onsite primary embodiment, and informs the user or patient 12,
112 when the casing is ready to be removed from the conditioning or
refurbishing device and reused within housing 80 of sorbent
cartridge 100.
[0308] In the illustrated embodiment, user or patient 12, 112 loads
sorbent casings 106 and 108 into a cleaning chamber 352, which
surrounds the casings and holds them in a restrained manner.
Although not illustrated, cleaning chamber 352 may provide a hinged
lid that user or patient 12, 112 opens to insert or remove casings
106 and 108. The lid is lockable to condition or refurbish the
casings. In an embodiment, one or more sensor, such as a contact
switch or proximity sensor is provided to ensure that the lid is
locked prior to any fluid flow through cleaning chamber 352. In the
illustrated embodiment, cleaning chamber 352 provides tapered or
conical insert areas to form fit casings 106 and 108, prevent
leakage and to ensure that the casings are placed into cleaning
chamber 352 in a desired orientation. In the illustrated
embodiment, casings 106 and 108 are positioned so as to be tapered
in the same direction but could alternatively be positioned so as
to be tapered in opposite or otherwise different directions.
Cleaning chamber 352 introduces fluids to and recovers fluids from
casings 106 and 108 via nozzles 354 and funneled openings 356, so
that the fluid is spread to the entire intended surface of the
casings.
[0309] At least one source of disinfectant 358 and at least one
source of regeneration fluid 360 are provided and in one embodiment
housed within sorbent conditioning or refurbishing device 350. In
alternative embodiments one or both of sources 358 or 360 is/are
located outside device 350. Disinfectant 358 and regenerated fluid
360 may be any of any type described herein. Device 350 in the
illustrated embodiment is further provided with a water, e.g., tap
water, hookup 362 and a hot air blower 364. Fluids are drained to a
drain 366.
[0310] In the illustrated embodiment, conditioning or refurbishing
device 350 is arranged fluidly such that disinfectant 358,
regeneration fluid 360, water from hookup 362 and hot air from
blower 364 may be directed to casings 106 and 108 in either normal
flow or reverse flow directions. In alternative embodiments, some
of these flow paths may be eliminated as desired.
[0311] As illustrated: (i) valve 368 and pump 370 enable water to
be selectively delivered to the upper side of cleaning chamber 352,
wherein valves 372 and 374 determine which (or both) casings 106
and 108 receive pressurized water from above; (ii) valve 376 and
pump 378 enable water to be selectively delivered to the lower side
of cleaning chamber 352, wherein valves 380 and 382 determine which
(or both) casings 106 and 108 receive pressurized water from below;
(iii) valve 384 and pump 386 enable disinfectant to be selectively
delivered to the upper side of cleaning chamber 352, wherein valves
372 and 374 determine which (or both) casings 106 and 108 receive
pressurized disinfectant from above; (iv) valve 388 and pump 400
enable disinfectant to be selectively delivered to the lower side
of cleaning chamber 352, wherein valves 380 and 382 determine which
(or both) casings 106 and 108 receive pressurized disinfectant from
below; (v) valve 402 and pump 404 enable regeneration fluid to be
selectively delivered to the upper side of cleaning chamber 352,
wherein valves 372 and 374 determine which (or both) casings 106
and 108 receive pressurized regeneration fluid from above; (vi)
valve 406 and pump 408 enable regeneration fluid to be selectively
delivered to the lower side of cleaning chamber 352, wherein valves
380 and 382 determine which (or both) casings 106 and 108 receive
pressurized regeneration fluid from below; (vii) valves 410 and 412
selectively allow hot air from blower 364 to be delivered to the
upper and lower sides of cleaning chamber 352, respectively,
wherein valves 372, 374, 380 and 382 determine which one or both
casings 106 and 108 receive hot air for drying; and (viii) drain
valves 414 and 416 in combination with valves 372, 374, 380 and 382
selectively allow any fluid or hot air to be exhausted from either
casing 106 and 108 and from upper and/or lower sides, respectively,
of cleaning chamber 352.
[0312] As illustrated, conductivity sensors 392, temperature
sensors 394 and pH sensors 396 are located in strategic locations
to sense desired fluid flow characteristics, e.g., to know when to
stop a particular fluid flow as described in numerous ones of the
implementations discussed above. In the illustrated embodiment,
conductivity sensors 392, temperature sensors 394 and pH sensors
396 are located along the branches leading to drain 366. Sensors
392, 394 and 396 include dashed lines indicating power and signal
connections to control unit 420.
[0313] Sorbent conditioning or refurbishing device 350 is also
illustrated as having heating coils 426, which may be electrically
resistive heating coils under control of control unit 420. Feedback
from temperature sensors 394 to control unit 420 allows a heating
algorithm employed by the control unit to determine which heating
coils 426 if any to energize to heat the corresponding fluid to a
deserted temperature, e.g., up to about 80.degree. C.
[0314] In the illustrated embodiment, all pumps, valves, hot air
blower 364 and heating coils 426 are operated by a control unit 420
of conditioning or refurbishing device 350 as indicated by the
dashed electrical lines. The pumps are illustrated as peristaltic
pumps but may alternatively be volumetric or diaphragm pumps, gear
pumps or other suitable fluid pump. A user interface 422 operating
with control unit 420 is provided to enable user or patient 12, 112
to operate refurbishing device 350. Sensors 392, 394 and 396
likewise output to, and may receive power from, control unit
420.
[0315] In alternative embodiments sorbent conditioning or
refurbishing device 350 uses less pumps, e.g., (i) a single pump
(two total) for each of the upper and lower sides of cleaning
chamber 352 to handle all three of water, disinfecting agent and
regeneration solution flow, or (ii) a single pump for both of the
upper and lower sides of cleaning chamber 352 to handle all three
of water, disinfecting agent and regeneration solution flow on both
upper and lower sides. Valves are arranged accordingly to
selectively allow water, disinfecting agent or regeneration
solution flow at a given time.
[0316] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present subject matter and without diminishing its
intended advantages. It is therefore intended that such changes and
modifications be covered by the appended claims. For example, while
the specification has concentrated on the regeneration of zirconium
sorbent materials, the conditioning or refurbishing device 350,
sorbent cartridge 100 and their associated methods of use
(including any implementation method 160, 180, 200, 220, 240, 260,
280, 300 and 320) may be applied to other materials that perform
the same or similar function as zirconium sorbent materials, such
as titanium-based sorbent materials.
* * * * *