Dialysis device and method of dialysis

Abstract

The present disclosure relates to dialysis devices. In some embodiments, a dialysis device may include a disposable housing having a storage chamber in fluid communication with a dialysate flow path. Also included may be a controller, an interface capable of operably coupling the controller and the disposable housing, a fluid displacement structure, a pump configured to actuate a deformable diaphragm, and a pressure sensor to trigger the reversal of the pump. The flow path may be fluidly sealed from the controller and the interface.

Claims

1. A dialysis device, comprising: a disposable housing having a dialysate flow path along which dialysate received from a patient is subjected to contaminant removal when in operation, wherein said disposable housing comprises a storage chamber in fluid communication with the dialysate flow path for storing the dialysate therein for contaminant removal; a controller for controlling the operation of said disposable housing; an interface capable of operably coupling the controller and the disposable housing to enable the contaminant removal from the dialysate; a fluid displacement structure, comprising a deformable diaphragm integrally formed with at least one wall of the storage chamber, and configured to move the dialysate along the dialysate flow path; and a single pump configured to actuate the deformable diaphragm, wherein the flow path is fluidly sealed from the controller and the interface, and wherein the single pump is the only pump included in the dialysis device.

2. The dialysis device as claimed in claim 1, comprising a single pressure sensor to trigger the reversal of the pump from an outflow mode to an inflow mode, when the storage chamber is detected to be filled with dialysate, and from the inflow mode to the outflow mode, when the storage chamber is detected to be emptied of dialysate.

3. The dialysis device as claimed in claim 1, wherein the dialysis device is wearable.

4. The dialysis device as claimed in claim 1, wherein said deformable diaphragm is in fluid contact on one side with the dialysate flow path and, on another opposite side, in contact with a pressure chamber that is capable of receiving fluid therein.

5. The dialysis device as claimed in claim 4, wherein the deformable diaphragm is disposed in a rigid member in the disposable housing.

6. The dialysis device as claimed in claim 1, wherein the device is powered by a battery.

7. The dialysis device as claimed in claim 6, wherein the battery is a rechargeable battery, optionally wherein the rechargeable battery is a lithium polymer battery.

8. The dialysis device as claimed in claim 1, comprising an ammonia sensor configured to detect ammonia present in said dialysate.

9. The dialysis device as claimed in claim 8, wherein the ammonia sensor is disposed in the disposable housing.

10. The dialysis device as claimed in claim 8, wherein the ammonia sensor is configured to detect ammonia or ammonium ions.

11. The dialysis device as claimed in claim 8, wherein the ammonia sensor comprises a material which changes color in the presence of ammonia.

12. The dialysis device as claimed in claim 8, wherein the ammonia sensor comprises an ammonia-sensitive membrane.

13. The dialysis device as claimed in claim 1, wherein said disposable housing comprises a sorbent zone in fluid communication with the dialysate flow path for removing contaminants in the dialysate.

14. The dialysis device as claimed in claim 13, wherein the flow path comprises a fibrin trap located upstream of the sorbent zone.

15. The dialysis device as claimed in claim 13, wherein said storage chamber is upstream of said sorbent zone.

16. The dialysis device as claimed in claim 13, wherein said disposable housing further comprises valve means disposed along the dialysate flow path configured to control the direction of movement of the dialysate relative to the sorbent zone and storage chamber.

17. The dialysis device as claimed in claim 16, wherein said valve means is operative by the flow direction of dialysate along said flow path.

18. The dialysis device as claimed in claim 16, the controller further comprising an actuator for actuating said fluid displacement member and said valve means when said controller is connected to the disposable housing by said interface.

19. A kit comprising the dialysis device of claim 1, together with instructions for use.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) The accompanying drawings illustrate a disclosed embodiment and serve to explain the principles of the disclosed embodiment. It is to be understood, however, that the drawings are designed for purposes of illustration only, and not as a definition of the limits of the invention.

(2) FIG. 1A is a schematic diagram of one embodiment of the disclosed dialysis device.

(3) FIG. 1B is a schematic diagram of one embodiment of the disclosed dialysis device, wherein the flow of the dialysate is toward the storage chamber from the peritoneal cavity.

(4) FIG. 1C is a schematic diagram of one embodiment of the disclosed dialysis device, wherein the flow of the dialysate is from the storage chamber to the peritoneal cavity.

(5) FIG. 1D is a schematic diagram of one embodiment of the disclosed dialysis device.

(6) FIG. 1E is a schematic diagram of one embodiment of the disclosed dialysis device.

(7) FIG. 1F is a schematic diagram of one embodiment of the disclosed dialysis device.

(8) FIG. 2A is a schematic diagram of an alternative embodiment of the disclosed dialysis device, wherein the flow of the dialysate is toward the storage chamber from the peritoneal cavity.

(9) FIG. 2B is a schematic diagram of the embodiment of FIG. 2A, wherein the flow of the dialysate is from the storage chamber toward the peritoneal cavity.

(10) FIG. 3 is a graphic representation of the flow control of the dialysate according to an embodiment of the present disclosure.

(11) FIGS. 4A-D are cross sectional views of a prototype of a disposable housing in accordance with an embodiment of the present disclosure.

(12) FIG. 5 is a perspective view of a prototype of one embodiment of the dialysis device disclosed herein.

(13) FIG. 6 is a schematic diagram of one embodiment of the disclosed disposable housing comprising a discrete additive dispensing means.

(14) FIG. 7 is a schematic diagram of one embodiment of the disclosed dialysis device comprising a discrete additive dispensing means in locking engagement with a disposable housing in accordance with the disclosure.

(15) FIGS. 8A and 8B are cross sectional views of a sealed connector of the additive dispensing means in accordance with the disclosure.

(16) FIGS. 9A and 9B are cross sectional views of a sealed connector of the additive dispensing means in accordance with the disclosure.

(17) FIGS. 10A and 10B are cross sectional views of an embodiment of an additive dispensing means in accordance with the disclosure.

(18) FIG. 11 is a cross sectional view of an embodiment of an additive dispensing means in accordance with the disclosure.

(19) FIGS. 12A-C are cross sectional views of an embodiment of an automatic dispensing system in accordance with the disclosure.

(20) FIG. 13 is a graphic representation of the voltage drop of a rechargeable battery versus dialysis time in a dialysis device in accordance with the disclosure.

(21) FIG. 14 is a graphic representation of the voltage drop of a rechargeable battery versus dialysis time with constant pumping in a device in accordance with the disclosure.

(22) FIG. 15A is an exploded view of embodiment of a degasser in a device in accordance with the disclosure.

(23) FIG. 15B is an embodiment of a degasser in a device in accordance with the disclosure.

(24) FIG. 16 is an embodiment of a fibrin trap in a device in accordance with the disclosure.

(25) FIGS. 17A and 17B show an embodiment of a power-connecting switch in accordance with the disclosure.

(26) In the figures, like numerals denote like parts.

DETAILED DESCRIPTION OF DRAWINGS

(27) Referring to FIG. 1A, there is shown one embodiment of the disclosed dialysis device (200).

(28) The dialysis device comprises a disposable housing (10) having a flow path in the form of conduit (20), a controller (31) in the form of a control housing (30) for controlling the operation of the disposable housing (10). The dialysis device is powered by a battery (137). In this figure the disposable housing (10) and control housing (30) are not operably connected to each other. The disposable housing (10) and control housing (30) comprise interface in the form of a conduit connector (40a) disposed on said control housing (30) and (40b) disposed on the disposable housing (10) capable of connecting the control housing and the disposable housing. The disposable housing (10) and control housing (30) are brought into operative engagement when the conduit connector (40a) is brought into locking engagement with conduit connector (40b) The conduit (20) of the disposable housing (10) is fluidly sealed from the control housing (30) and conduit connector (40a,40b).

(29) The dialysis device comprises a flexible dialysate tube (50) which is capable of being in fluid communication with the peritoneal cavity (60) and a conduit (20). The dialysis device further comprises a storage chamber (70) located in a rigid compartment (180). The storage chamber (70) comprises a deformable diaphragm (71) integrally formed in one of the walls of the storage chamber (70). The deformable diaphragm (71) is in fluid communication on one side with the dialysate conduit (20) and, on another opposite side, in fluid communication with a pressure chamber (80). When the disposable housing (10) and control housing (30) are operably coupled to each other, the conduit connector (40a,40b) fluidly couples the pressure chamber (80) of the disposable housing (10) to a pump (90) located in the control housing (30). The conduit connector (40a,40b) comprises a first mating part (1314) and a second mating part (1315).

(30) The pump (90) is configured to actuate the deformable diaphragm (71), by inducing a pressure change in the pressure chamber (80) which deforms the deformable diaphragm (71) and thereby moves dialysate within said dialysate conduit (20). The controller (31) comprises a computer (135) configured to act on instructions for operation of the pump (90).

(31) Check valves (100,101,102,103) are disposed along the conduit (20) and are configured to, in the outflow mode, allow the dialysate to flow from the peritoneal cavity (60) to the storage chamber (70), and in the inflow mode allow the dialysate to flow from the storage chamber (70) to said sorbent zone (110) for removal of contaminants therein, and further permit the dialysate substantially free of said contaminants to flow back to the peritoneal cavity (60).

(32) The disposable housing is also provided with an enrichment module (120), for dispensing a preselected amount of an enrichment solution into the dialysate, in fluid communication with the conduit (20) via a conduit (130). The enrichment module is also in fluid communication with an enrichment solution reservoir (121). The pump (90) is in fluid communication with a deformable membrane (72) of the enrichment module 120 via conduit connector (40a,40b), when the disposable housing (10) and control housing (30) are in operable engagement. The conduit connector (40a,40b) comprises a first mating part (1334) and a second mating part (1335).

(33) An ammonia sensor (140) is also provided downstream of the sorbent zone (110) to detect any ammonia in the dialysate. Ammonia is detected by the ammonia detector (141) when the disposable housing (10) and control housing (30) are operably coupled to each other.

(34) A degasser in the form of a hydrophobic membrane (150) is also located downstream of the sorbent zone. The external side of the hydrophobic membrane (150) is in fluid communication with a vacuum pump (151) via the conduit connector (40a,40b) when the control housing and disposable housing are operably coupled.

(35) Referring now to FIG. 1B, there is the embodiment of FIG. 1A showing the disposable housing (10) and control housing (30) operably coupled with each other, operating in an outflow mode, wherein the flow of the dialysate is toward the storage chamber (70) from the peritoneal cavity (60) of a patient. The pump (90) actuates the deformable diaphragm (71), by inducing negative pressure in the pressure chamber (80). The negative pressure in the pressure chamber (80) deforms the deformable diaphragm (71) by biasing the deformable diaphragm (71) in the direction of arrow A and thereby moves dialysate from said peritoneal cavity (60) of the patient into the dialysate conduit (20) via bubble trap (51). The dialysate flows to the storage chamber (70) through check valve (100). A pressure sensor (170) is located in operable communication with the pump (90) to establish a preselected negative pressure within the pressure chamber (80) and to determine if the pressure of the dialysate being withdrawn from the peritoneal cavity (60) is within a safe limit.

(36) The pump (90) operates intermittently under the control of the pressure sensor (170) to maintain the negative pressure in the pressure chamber (80) within a preselected range. Once the storage chamber (70) is full of dialysate, this is detected by the pressure sensor (170), triggering the inversion of the pump direction and thus converting the system to an inflow mode.

(37) The pump 90 is also in fluid communication with a diaphragm (72) integrally formed in a wall of said enrichment module (120). At the same time as the storage chamber (70) is actuated under negative pressure, the enrichment module (120) is also actuated under negative pressure by the pump (90), such that a predetermined amount of an enrichment solution is withdrawn from an enrichment solution reservoir (121) though check valve (103) into the enrichment module (120). Check valve (102) ensures that no dialysate is withdrawn into the enrichment module (120) from the conduit (20).

(38) Referring to FIG. 1C, the flow system of FIG. 1B is shown in the inflow mode, wherein the flow of the dialysate is from the storage chamber (70) to the peritoneal cavity (60). Once the storage chamber (70) is full, the pump (90) actuates the deformable diaphragm (71), by inducing positive pressure in the pressure chamber (80).

(39) The positive pressure in the pressure chamber (80) deforms the deformable diaphragm (71) by biasing the deformable diaphragm (71) in the direction of arrow B and thereby moves dialysate from the storage chamber (70) and check valve (100) closes preventing dialysate from returning to the peritoneal cavity (60) before being treated to remove contaminants.

(40) The pressure sensor (170) monitors the pressure in the pressure chamber (80) to ensure that the pressure of the dialysate being returned to the peritoneal cavity (60) in the inflow mode is within a safe limit.

(41) The dialysate flows from the storage chamber (70) into the sorbent zone (110) through check valve (101). The regenerated dialysate from the sorbent zone (110) then flows past a degasser in the form of a hydrophobic membrane (150). The external side of the membrane is subjected to negative pressure by a vacuum pump (151) to aid the removal of gas generated during the dialysis procedure. The dialysate then flows through an ammonia sensor (140) which monitors the level of ammonia in the regenerated dialysate, to ensure that the ammonia level does not exceed a safe limit, prior to returning to the peritoneal cavity (60) of a patient. Ammonia is detected by the ammonia detector (141).

(42) The regenerated dialysate then flows past an enrichment module (120). In the inflow mode, the pump (90) actuates the diaphragm (72) of the enrichment module (120), which has previously been primed with a volume of enrichment solution from the enrichment solution reservoir (121), under positive pressure. As the enrichment module (120) is actuated, check valve (103) closes to ensure that the enrichment solution does not flow back into the enrichment solution reservoir (121). The enrichment module (120) then dispenses a preselected amount of enrichment solution containing desired substances, such as electrolytes, osmotic agents, nutrients, medication and the like, into the dialysate conduit (20) through check valve (102) and conduit (130).

(43) The regenerated dialysate then flows back to the peritoneal cavity (60) through the bubble trap (51) and flexible dialysate conduit (50).

(44) As in the outflow mode, the pump (90) is operated intermittently under the control of the pressure sensor (170) to maintain the positive pressure in the pressure chamber (80) within a preselected range. Once the storage chamber is empty of dialysate, the pressure sensor (170) detects this and inverts the pump direction and converts the system to the outflow mode to repeat the dialysis cycle.

(45) Referring to FIG. 1D, there is presented an alternative embodiment of the dialysis device according to the disclosure. The dialysis device (200) works in essentially the same way as the device described in FIGS. 1A-C. The regenerated dialysate from the sorbent zone (110) flows past a degasser in the form of a hydrophobic membrane (150). The external side of the membrane is subjected to negative pressure by a vacuum pump (151) in fluid communication with the hydrophobic membrane to aid the removal of gas generated during the dialysis procedure. Differing from FIGS. 1A-C, the gas vented from the dialysate is then passed through an ammonia sensor (140) located in the control housing (30). The ammonia sensor monitors the level of ammonia in the gas vented from the dialysate to ensure that the ammonia level does not exceed a safe limit, prior to returning the dialysate to the peritoneal cavity (60) of a patient.

(46) Referring to FIG. 1E, there is shown an alternative embodiment of the dialysis device according to the disclosure. The dialysis device (200) works in essentially the same way as the device described in FIGS. 1A-C. However, the pump (90) also subjects the hydrophobic membrane (150) via the conduit connector (not shown) and valve (104) to negative pressure during an outflow mode (where dialysate is received from a patient's peritoneal cavity (60) via a flexible dialysate tube (50)). Valve (104) ensures that no gas is introduced into the dialysate path via the hydrophobic membrane (150) during an inflow mode, when the pump (90) subjects the pressure chamber (80) to positive pressure. Ammonia gas released from the dialysate is then detected by the ammonia sensor (140).

(47) Referring to FIG. 1F, there is shown an alternative embodiment of the dialysis device according to the disclosure. The dialysis device (200) works in essentially the same way as the device described in FIGS. 1A-C. However, the pump (90) is in fluid communication with both the pressure chamber (80) and the enrichment module (120) via a single connection (41) in the disposable housing (10). The pump (90) also subjects the degasser in the form of a hydrophobic membrane (150) to negative pressure during an outflow mode (where dialysate is received from a patient's peritoneal cavity (60) via a flexible dialysate tube (50)). During an inflow mode the pump (90) subjects the pressure chamber (80) to positive pressure. Valve (104) ensures that no gas is introduced into the dialysate path via the hydrophobic membrane (150) during an inflow mode, when the pump (90) subjects the pressure chamber (80) to positive pressure. Ammonia gas released from the dialysate is then detected by the ammonia sensor (140).

(48) Referring to FIG. 2A, there is presented an alternative embodiment of the flow system (201) in accordance with the present disclosure wherein the flow of the dialysate is toward the storage chamber (70) from the peritoneal cavity (60), i.e. outflow mode. The pump (90) actuates the deformable diaphragm (71), by inducing negative pressure in the pressure chamber (80). The negative pressure in the pressure chamber (80) deforms the deformable diaphragm (71) by biasing the deformable diaphragm (71) in the direction of arrow A and thereby moves dialysate from said peritoneal cavity (60) of the patient into the dialysate conduit (20) via bubble trap (51). The dialysate flows to the storage chamber (70) located in a rigid compartment (180) through check valve (100). A pressure sensor (170) is located in operable communication with the pump (90) to establish a preselected negative pressure within the pressure chamber (80) and to determine if the pressure of the dialysate being withdrawn from the peritoneal cavity (60) is within a safe limit.

(49) The pump (90) operates intermittently under the control of the pressure sensor (170) to maintain the negative pressure in the pressure chamber (80) within a preselected range. Once the storage chamber (70) is full of dialysate, this is detected by the pressure sensor (170) which inverts the pump direction and converts the system to an inflow mode.

(50) An enrichment module (120) is provided in fluid communication with the conduit (20) via a conduit (130). The enrichment module (120) is configured to be actuated by a syringe pump (91) in the inflow mode.

(51) Referring to FIG. 2B, the flow system of FIG. 2A is shown in the inflow mode, wherein the flow of the dialysate is from the storage chamber (70) to the peritoneal cavity (60). Once the storage chamber (70) is full, the pump (90) actuates the deformable diaphragm (71), by inducing positive pressure in the pressure chamber (80). The positive pressure in the pressure chamber (80) deforms the deformable diaphragm (71) by biasing the deformable diaphragm (71) in the direction of arrow B and thereby moves dialysate from the storage chamber (70) and check valve (100) closes preventing dialysate from returning to the peritoneal cavity (60) before being treated to remove contaminants.

(52) The pressure sensor (170) monitors the pressure in the pressure chamber (80) to ensure that the pressure of the dialysate being returned to the peritoneal cavity (60) in the inflow mode is within a safe limit.

(53) The dialysate flows from the storage chamber (70) into the sorbent zone (110) through check valve (101). The regenerated dialysate from the sorbent zone (110) flows past a degasser in the form of a hydrophobic membrane (150) located upstream of a check valve (105). The presence of check valve (105) results in a positive pressure gradient across the hydrophobic membrane which permits the removal of any unwanted gas emitted during the dialysis operation. The dialysate then flows through an ammonia sensor (140) which monitors the level of ammonia in the regenerated dialysate, to ensure that the ammonia level does not exceed a safe limit, prior to returning to the peritoneal cavity (60) of a patient.

(54) The regenerated dialysate then flows past an enrichment module (120). In the inflow mode, the syringe pump (91) actuates the enrichment module (120), which contains a volume of enrichment solution under positive pressure. The enrichment module (120) then dispenses a preselected amount of enrichment solution containing desired substances, such as electrolytes, osmotic agents, nutrients, medication and the like, into the dialysate conduit (20) via conduit (130). The syringe pump (91) only operates in the inflow mode.

(55) The regenerated dialysate then flows back to the peritoneal cavity (60) through the bubble trap (51) and flexible dialysate conduit (50).

(56) As in the outflow mode, the pump (90) is operated intermittently under the control of the pressure sensor (170) to maintain the positive pressure in the pressure chamber (80) within a preselected range. Once the storage chamber is empty of dialysate, the pressure sensor (170) detects this and inverts the pump direction and converts the system to the outflow mode to repeat the dialysis cycle.

(57) FIG. 3, shows a graphic representation of the flow control of dialysate in an embodiment of the dialysis device according to the present disclosure. The phases of the flow control in FIG. 3 are separated into “outflow, “inflow” and “dwell”.

(58) In an outflow mode, a negative actuating pressure is produced by a pump, which is operated intermittently under the control of a pressure sensor. As can be seen in FIG. 3, the negative pressure in the pressure chamber is maintained within the limits of a preselected upper and lower pressure. Unobstructed flow of dialysate is indicated by continuous (rapid) relief of (negative) pressure during the off-times of the pump. The measurement of the time which passes during the pressure relief (t.sub.R—relaxation time) may be used to estimate the effected fluid flow speed. When the storage chamber is full of dialysate, the pressure cannot be relieved anymore and the pressure becomes static for a period of time (t.sub.S—static time). This is detected by a pressure sensor, which triggers the reversal of the pump to an inflow mode. The average “outflow” flow rate is equal to the volume of the storage chamber (“tidal volume”) divided by the time required to fill the storage chamber completely. This rate is dependent on the choice of preselected pressure limits and can be modified accordingly.

(59) During the inflow mode, a positive actuating pressure is produced by the pump. The dialysate contained in the storage chamber is subsequently forced through the sorbent zone of the device and is then returned to the patient. The pump is operated intermittently, such that the positive pressure is regulated between preselected upper and lower pressure limits. The fluid in the storage chamber is forced through the sorbent cartridge, thereby relieving the (positive) pressure. The duration of this relief can be used to estimate the flow rate (t.sub.R—relaxation time). When the pump chamber is empty, the pressure cannot be relieved anymore and the pressure becomes static for a period of time (t.sub.S—static time), indicating completion of the “inflow” phase. The average “inflow” flow rate equals the volume of the storage chamber divided by the time required to complete “inflow”.

(60) FIG. 3 also shows a wait time or “dwell” time (t.sub.W). This period is used to control the overall fluid exchange rate: overall flow rate equals storage chamber volume (tidal volume) divided by the total cycle time (t.sub.C=outflow+inflow+dwell). For example, if a specific overall exchange rate is desired, then the system can use the dwell time as a flexible wait time until the desired total cycle time has passed.

(61) FIG. 4A shows a prototype disposable housing (400) in accordance with an embodiment of the present disclosure. FIG. 4B shows a cross sectional view of the disposable housing taken along axis A-A of FIG. 4A. The disposable housing comprises an enclosure (401) defining an interior (402) for receiving a control housing (not shown) via a conduit connector (403). The disposable housing comprises a rigid compartment (404) defining a pressure chamber (405) in which a storage chamber (406) is disposed. The storage chamber has a deformable diaphragm (420) integrally formed in a wall thereof. The storage chamber (406) is in fluid communication with a sorbent zone (407), via a fluid channel (416).

(62) The sorbent zone (407) comprises a check valve (409, see FIGS. 4C and 4D) in fluid communication with a degasser in the form of a hydrophobic membrane (410).

(63) FIG. 4C provides a cross-sectional view of the sorbent module along axis C-C of FIG. 4A. An enrichment module (411) is in fluid communication with an enrichment solution reservoir (412) via a check valve (413). The enrichment module (411) is also in fluid communication with the conduit of dialysate via check valve (414).

(64) FIG. 4D provides a cross-sectional view of the sorbent module along axis D-D of FIG. 4A. The regenerated dialysate exits the disposable housing via check valve (409) and outlet (415).

(65) In use during an outflow mode, the control housing (not shown) is located in the interior (402) of the disposable housing (400, see FIGS. 4A and 4B). The pump in the control housing actuates the deformable diaphragm (420) located in the wall of the storage chamber (406), via the conduit connector (403, see FIG. 4B) by transmitting pump fluid from the conduit connector (403) thereby inducing negative pressure in the pressure chamber (405). The negative pressure in the pressure chamber (405) moves dialysate from the peritoneal cavity of the patient into the storage chamber (406) through check valve (408). At the same time as the storage chamber (406) is actuated under negative pressure, the enrichment module (411, see FIG. 4C) is also actuated under negative pressure by the pump such that a predetermined amount of an enrichment solution is withdrawn from an enrichment solution reservoir (412) though check valve (413) into the enrichment module (411).

(66) In use during the inflow mode once the storage chamber (406) is full, the pump actuates the deformable diaphragm (420) located in the wall of the storage chamber (406) via the conduit connector (403) by transmitting fluid to the conduit connector (403) and thereby inducing positive pressure in the pressure chamber (405). The positive pressure in the pressure chamber (405) moves dialysate from the storage chamber (406) and check valve (408) closes preventing dialysate from returning to the peritoneal cavity before being treated to remove contaminants. Dialysate flows from the storage chamber (406) into the sorbent zone (407) through channel (416). The regenerated dialysate exiting from the sorbent zone (407) flows past a hydrophobic membrane (410) to remove any unwanted gas emitted during the dialysis operation. The degassed dialysate then flows past an enrichment module (411), a check valve (409) and exits the disposable housing via tube connector (415).

(67) In the inflow mode, the pump also actuates the enrichment module (411) under positive pressure and check valve (413) closes. The enrichment module (411) dispenses a preselected amount of enrichment solution containing desired substances, such as electrolytes, osmotic agents, nutrients, medication and the like, into the dialysate through check valve (414). The dialysate is then returned to the peritoneal cavity via a check valve (409) and a tube connector (415).

(68) Referring now to FIG. 5, there is shown a picture of a prototype of one embodiment of the entire flow system disclosed herein, with a disposable housing (500) and the control housing (510). The embodiment of FIG. 5 shows a kit comprising the dialysis device according to the present disclosure, together with instructions (511) for use.

(69) Referring to FIG. 6, there is shown one embodiment of a disposable housing (601) having a flow path in the form of conduit (20). The disposable housing (601) comprises a flexible dialysate tube (50) which is capable of being in fluid communication with the peritoneal cavity (60) and a conduit (20). The dialysis device further comprises a storage chamber (70) located in a rigid compartment (180). The storage chamber (70) comprises a deformable diaphragm (71) integrally formed in one of the walls of the storage chamber (70). The deformable diaphragm (71) is in fluid communication on one side with the dialysate conduit (20) and, on another opposite side, in fluid communication with a pressure chamber (80).

(70) The pump (670) is configured to actuate the deformable diaphragm (71), by inducing a pressure change in the pressure chamber (80) which deforms the deformable diaphragm (71) and thereby moves dialysate within said dialysate conduit (20).

(71) Check valves (100,102,103,105) are disposed along the conduit (20) and are configured to, in the outflow mode, allow the dialysate to flow from the peritoneal cavity (60) to the storage chamber (70), and in the inflow mode allow the dialysate to flow from the storage chamber (70) to said sorbent zone (110) for removal of contaminants therein, and further permit the dialysate substantially free of said contaminants to flow back to the peritoneal cavity (60).

(72) The disposable housing is also provided with a discrete enrichment module (620), for dispensing a preselected amount of an enrichment solution into the dialysate. The enrichment module is not in fluid communication with the dialysate flow path in this figure. The enrichment module comprises an enrichment solution reservoir (621), a container in the form of a bag manufactured from a biocompatible material for holding the enrichment solution (not shown). The enrichment module (620) is provided with a connector (622) adapted for fluid communication with the dialysate conduit (20) of the disposable housing (601). The connector (622) is sealed prior to insertion into the disposable housing to maintain the sterility of the enrichment solution in the enrichment module (620). The disposable housing is provided with a male connector (623) of complementary configuration to the connector (622) located on the enrichment module (620). When in mating engagement (see FIG. 7) the male connector (623) serves to break the seal of the connector (622) to form a fluid connection between the enrichment reservoir (621) in the enrichment module (620) and the dialysate conduit (20) of the disposable housing (601).

(73) The disposable housing (601) also comprises an enrichment pump (660) for adding a predetermined amount of enrichment solution to the dialysate conduit (20).

(74) A degasser in the form of a hydrophobic membrane (150) is also located downstream of the sorbent zone (110). The external side of the hydrophobic membrane (150) is in fluid communication with air conduits (630 and 631).

(75) A hydrophilic membrane (610) is disposed in the degasser compartment, in the dialysate flow path and directly downstream of the hydrophobic degasser membrane (150). The hydrophilic membrane (610) serves as a barrier to prevent gas, particles and bacteria contained in the dialysate exiting the sorbent zone (110) from reaching the peritoneal cavity (60). The membrane also produces a backpressure facilitating the venting of gas through the degasser membrane (150).

(76) Referring to FIG. 7, there is shown an embodiment of the disclosed dialysis device (700). The dialysis device comprises a disposable housing (601) having a flow path in the form of conduit (20), a controller in the form of a control housing (690) for controlling the operation of the disposable housing (601). The disposable housing (601) and control housing (690) comprise interface in the form of conduit connectors (691a, 691b, 691c) that connect the control housing (690) and the disposable housing (601). The disposable housing (601) and control housing (690) are brought into operative engagement when the conduit connectors are brought into locking engagement. The conduit (20) of the disposable housing (601) is fluidly sealed from the control housing (690) and conduit connectors (691a, 691b, 691c).

(77) The dialysis device (700) comprises a flexible dialysate tube (50) which is capable of being in fluid communication with the peritoneal cavity (60) and a conduit (20). The dialysis device further comprises a storage chamber (70) located in a rigid compartment (180). The storage chamber (70) comprises a deformable diaphragm (71) integrally formed in one of the walls of the storage chamber (70). The deformable diaphragm (71) is in fluid communication on one side with the dialysate conduit (20) and, on another opposite side, in fluid communication with a pressure chamber (80). When the disposable housing (601) and control housing (690) are operably coupled to each other, the conduit connector (691a, 691b, 691c) fluidly couples the pressure chamber (80) of the disposable housing (601) to an air pump (670) located in the control housing (690).

(78) The air pump (670) is configured to actuate the deformable diaphragm (71), by inducing a pressure change in the pressure chamber (80) which deforms the deformable diaphragm (71) and thereby moves dialysate within said dialysate conduit (20).

(79) Check valves (100,102,103,105) are disposed along the conduit (20) and are configured to, in the outflow mode, allow the dialysate to flow from the peritoneal cavity (60) to the storage chamber (70), and in the inflow mode allow the dialysate to flow from the storage chamber (70) to said sorbent zone (110) for removal of contaminants therein, and further permit the dialysate substantially free of said contaminants to flow back to the peritoneal cavity (60).

(80) In this figure the discrete enrichment module (620), is located in the disposable housing (601). The connector (622) of the enrichment module (620) is in mating engagement with the male connector (623) of the disposable housing to form a fluid connection between the enrichment reservoir (621) in the enrichment module (620) and the dialysate conduit (20) of the disposable housing (601).

(81) The disposable housing (601) also comprises an enrichment pump (660) for adding a predetermined amount of enrichment solution to the dialysate conduit (20).

(82) The enrichment pump (660) is a fixed displacement pump comprising a diaphragm (661) in fluid communication with the air pump (670). The air pump (670) exerts a positive or a negative air pressure to the diaphragm (661) of the enrichment pump (660) and the deformable diaphragm (71) of the storage chamber (70), functioning as pneumatic pump for cycling dialysate through the dialysate conduit (20) at the same time. On one side of the diaphragm (661) in the enrichment pump (660) is an air compartment which fluidly connects to the air pump (670), and the other side is the enrichment solution compartment connecting to the enrichment reservoir (621) reservoir via the mated connectors (622,623). When the enrichment solution compartment is subjected to negative pressure enrichment solution is drawn from the enrichment reservoir (621). When a positive pressure is applied to the air compartment, the enrichment solution is forced out of the enrichment pump (660) into the dialysate conduit (20).

(83) A degasser in the form of a hydrophobic membrane (150) is also located downstream of the sorbent zone (110). The external side of the hydrophobic membrane (150) is in fluid communication with air conduits (630 and 631). In a normal dialysis operation, air conduit (630) is an outlet to the ammonia sensor (140) and air conduit (630) is in fluid communication with the air pump (670). During degassing, the air pump (670) in the control housing (690) exerts a negative pressure to remove any gas from the dialysate in the dialysate conduit (20). A check valve (680) prevents external air from entering air conduit (630).

(84) A hydrophilic membrane filter (610) downstream of the hydrophobic membrane (150), prevents gas, particles and bacteria contained in the dialysate from reaching the peritoneal cavity (60). The membrane (610) also produces a backpressure facilitating the venting of gas through the hydrophobic membrane (150).

(85) FIG. 8A and FIG. 8B show an embodiment of a sealed connector (622) in accordance with the present invention. The connector (622) on the enrichment module (620) is provided with a plug (800) that can be dislodged by the connector (623) located on the disposable housing (601). In FIG. 8B, the connector (622) on the enrichment module is brought into mating engagement with the connector (623) on the disposable housing (601) to dislodge the plug (800).

(86) FIG. 9A and FIG. 9B show an embodiment of a sealed connector (622) in accordance with the present invention. The connector (622) on the enrichment module (620) is provided with a plug (800) that can be pierced by the connector (623) located on the disposable housing (601). In FIG. 8B, the connector (622) on the enrichment module is brought into mating engagement with the connector (623) on the disposable housing (601) to pierce the plug (800).

(87) FIG. 10A and FIG. 10B show the embodiment of a sealed connector of FIG. 9A and FIG. 9B. The connector (622) on the enrichment module (620) is provided with a plug (800) that can be pierced by the connector (623) located on the disposable housing (601). In FIG. 10B, the connector (622) on the enrichment module is brought into mating engagement with the connector (623) on the disposable housing (601) to pierce the plug (800). The enrichment module is a rigid container for holding the additive solution, comprising a sponge (1001) located at an end of the container in communication with a connector (622). The sponge facilitates delivery of the enrichment solution from the enrichment reservoir (621) to the dialysate conduit (20).

(88) FIG. 11 shows another embodiment of a container in the enrichment module (620). In this figure the container is in the form of a resiliently deformable bottle (1101). The bottle on the left hand side is full of enrichment solution. The bottle on the right hand side of the figure is depleted.

(89) FIG. 12A shows a cross-sectional view of the enrichment pump (660). The enrichment module (620) comprises an enrichment reservoir (621) in fluid communication with the enrichment pump (660) via the mated connectors (622 and 623). The enrichment pump (660) is provided with a diaphragm (661) which defines an air chamber (662) in fluid communication with the air pump (not shown) and an enrichment solution chamber (663) in fluid communication with the enrichment reservoir (621).

(90) FIG. 12B shows a close up view of FIG. 12A in an outflow cycle. When the air pump exerts a negative pressure beyond 50 mmHg, in the dialysate outflow cycle, enrichment solution is drawn from the enrichment reservoir (621) into the enrichment solution chamber (663) of the enrichment pump (660).

(91) FIG. 12C shows the enrichment pump (660) in an inflow cycle. In the inflow cycle when a positive pressure greater than 200 mmHg is exerted in the air chamber (662), the enrichment solution chamber (663) will be emptied and a fixed volume of enrichment solution, VEP, will flow to and merge with the dialysate in the dialysate conduit via outlet (1201).

(92) FIG. 13 and FIG. 14 show the results of battery tests on a dialysis device in accordance with the disclosure. The purpose of the experiment was to determine the minimum capacity of the battery that is needed to support the operation of a high capacity dialysis cartridge for at least 12 hours. Based on an average power consumption of 153 mA of the system, for a 12 hour operation, the minimum battery capacity needed would be at least 1836 mAh. Thus, to retain at least 80% of the battery capacity over a year, the minimum battery needed will be 2203 mAH. This is according to the retentive specifications of the battery, where the battery capacity will drop to 80% of its overall capacity when its operation cycle is more than 300 cycles (1836 mAh×120%). To determine the actual usage duration for the system, 2 tests were performed using an 11.1V, 2250 mAH, Lithium Polymer battery.

(93) Test #1:

(94) Taking a representative operation scenario for a normal flow control, where the pump is being turned ON and OFF to maintain at either 400 mmHg (Inflow) or −100 mmHg (Outflow), without a relaxation of the pressure, the result showed that a 2250 mAh capacity battery was able to support the mentioned operation for 18 Hrs before it was shut down by the firmware at 10.5V. FIG. 13 shows the graph showing the voltage drop of the battery versus the operation time in this experiment.

(95) Test #2:

(96) In the second test, assuming the worst case scenario that the pump is constantly ON for the whole inflow and outflow cycle operation, the results show that the battery can last for 14.5 Hrs before it was shut down by the firmware at 10.5V. Below is the graph showing the voltage drop of the battery versus the operation time in this experiment.

(97) FIG. 15A shows an exploded view of a degasser (1501) in accordance with the disclosure. The degasser comprises a gas vent means in the form of two hydrophobic membranes (1502) and (1503). The hydrophobic membranes are arranged in parallel on either side of a hydrophilic membrane (1504). Each hydrophobic membrane (1502 and 1503) is located adjacent to air vents (1505 and 1506). The degasser is also provided with air inlets/outlets (1507 and 1508) and a dialysate outlet (1509). The hydrophilic membrane is curved to facilitate the flow of gas in the dialysate to the hydrophobic membranes and subsequently the air vents to remove gas from the dialysate in the dialysate conduit of the dialysis device. In use a 4 micro paper filter seals the top of the sorbent zone in the dialysis device and is covered by the degasser. The hydrophilic membrane is located adjacent to the paper filter by a spacer (not shown). The hydrophilic membrane reduces sorbent powder leakage from the sorbent zone and paper filter and also acts as a bacterial filter.

(98) Referring to FIG. 15B, in a normal dialysis operation, a first air outlet (1507) is in fluid communication with an ammonia sensor and a second air outlet (1508) is in fluid communication with a degassing exhaust via another connecting air-port (not shown). When detecting for ammonia gas presence in the case of sorbent cartridge exhaustion, atmospheric air flows through a throttle valve, or any stable flow constrained valves, in the controller, allowing a controlled amount of air to flow through the first air outlet (1507), to an air conduit above the hydrophobic membranes, and flow out from the other end of the air conduit to the second air outlet (1508), and circulate to an ammonia sensor in the controller. During degassing, the air pump in the controller exerts a negative pressure to remove any gas, in particular CO2, in the air conduit via the first air outlet (1507) back to an exhaust in the controller.

(99) Referring to FIG. 16, an exploded view of a fibrin trap (1601) is shown. During dialysis, it is possible that dialysate will contain some small amount of fibrin. The trap comprises an inlet valve (1602) and a filter (not shown) located opposite the inlet valve (1602). The inlet valve is in the form of a resiliently deformable disk hinged on a stud (1605) such that the hinge is located away from the dialysate flow into the trap and thus will not catch on any fibrin present in the dialysate. In use the dialysate enters the trap through an inlet (1604) and passes through the disk valve (1602). The disk valve is located on a stud (1605). During an outflow mode, the disk valve (1602) is closed against the inlet (1604) preventing the flow of dialysate from the sorbent zone to the patient. The dialysate that enters the sorbent zone may comprise fibrin. The fibrin is prevented from entering the sorbent zone by the filter (1603) and is therefore retained in the trap (1601).

(100) FIG. 17A shows a power-connecting switch in accordance with an embodiment of an invention. The switch (1701) is located in the controller (1702). The switch is in an open condition when the controller (1702) is not coupled to a disposable housing. A resiliently deformable material, in the form of a rubber tube (1703), is located in a channel (1704), immediately adjacent to the switch (1701).

(101) A pin (1705) is located on a breakable frame (1706) on the disposable housing (1707), which is of complementary configuration to the channel (1704) located on the controller (1702). When the disposable housing and controller are coupled together, the pin (1705) is received in the channel (1704) and the frame is deformed and broken (1708) by the controller (1702) (FIG. 17B).

(102) The pin (1705) when located in the channel (1704) exerts a positive compressing force on the rubber tube (1703) which closes the switch (1701). The frame continues to urge the pin toward the rubber tubing to actuate the switch (1701) into a closed condition (FIG. 17B). The switch (1701) now electrically connects the battery (not shown) to the controller to permit the dialysis device to be used by a patient. The fractured frame (1706) can no longer hold the pin (1705) rigidly upright for the pin (1705) to get inserted into the channel (1704) on the controller (1702) again.

(103) Applications

(104) It is an advantage of the device that as the flow path is fluidly sealed from the controller the sterility of the device can be maintained by daily disposal of disposable housing.

(105) It is a further advantage of the dialysis device that a single connector between the disposable housing and controller is required, thus reducing the complexity of setting the device up for operation.

(106) It is a further advantage that the size of the dialysis device according to the disclosure can be significantly reduced relative to other dialysis devices.

(107) It is a further advantage that the device according to the disclosure is energy efficient.

(108) It is an advantage of the device according to the disclosure that as the fluid displacement means is integrally formed with a wall of the storage chamber this permits the pumping mechanism of the dialysis device to be shared by the storage chamber thereby permitting a reduction in the size of the disposable housing. This is further advantageous as it permits the construction of a more portable and unobtrusive device to be used by a patient.

(109) It is a further advantage that the connector between the disposable housing and the controller is fluidly sealed to prevent biological or chemical contamination of the device. It is an advantage of the device that, as the flow path is fluidly sealed from the controller, the risk of biological and/or chemical contamination of the dialysate by the controller is significantly reduced.

(110) It is a further advantage of the device that as only one pump and only one interface connector is required this reduces the requirement for additional pumps and connections and thus results in a significant reduction in the size of the dialysis device relative to known dialysis devices.

(111) It is a further advantage of the device of the disclosure that as only one pump is required to activate a storage chamber, an additive dispensing means and a gas vent means, this further permits miniaturization of the device and enhances portability and energy efficiency.

(112) It is a further advantage that as only one pump is required to activate the storage chamber, the additive dispensing means and the gas vent means, there is a significant reduction in the complexity of the device, which results in a decrease in manufacturing costs relative to known dialysis devices.

(113) It is a further advantage of the device that the pressure sensor can also be used to measure a patient's intraperitoneal pressure, without additional pressure sensors.

(114) It will be apparent that various other modifications and adaptations of the invention will be apparent to the person skilled in the art after reading the foregoing disclosure without departing from the spirit and scope of the invention and it is intended that all such modifications and adaptations come within the scope of the appended claims.