Wearable kidney

• US 8,715,221 B2
• Filed: 03/08/2006
• Issued: 05/06/2014
• Est. Priority Date: 03/08/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Curtin, Conor, Lipps, Benjamin J., Ofsthun, Norma J., Sandford, Harold F.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US11/371,216
• Publication Number:
  US 20070213665A1
• Time in Patent Office: 2,981 Days
• Field of Search: 604/29, 604/5.01, 424/44
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 2209/088 on the body

Abstract

The present invention relates to a wearable peritoneal dialysis system and a replaceable cartridge in the wearable peritoneal dialysis system that regenerates the peritoneal dialysis solution without removing essential ions from the solution and, consequently, the patient. The invention also relates to methods of removing uremic waste metabolites from a patient using the wearable peritoneal dialysis system. A source of one or more enzymes that degrades uremic waste metabolites can be administered orally in conjunction with use of the wearable peritoneal dialysis system such that the load of toxins needing to be eliminated by the wearable peritoneal dialysis system is reduced. The wearable peritoneal dialysis system is meant to operate continuously or semi-continuously, its components small and light enough that it can be comfortably worn by a patient constantly, without burden.

Claims

1. A wearable peritoneal dialysis system for a patient comprising:

a volume of peritoneal dialysis solution that is infused into and moved out of the patient'"'"'s peritoneal cavity, thereby removing from the patient uremic waste metabolites that have diffused into the peritoneal dialysis solution;

a closed fluid system loop for circulating the peritoneal dialysis solution from the patient, throughout the system and back into the patient;

at least one pump for infusing the peritoneal dialysis solution into the patient'"'"'s peritoneal cavity and moving the peritoneal dialysis solution containing uremic waste metabolites out of the patient'"'"'s peritoneal cavity and into the fluid system loop; and

a replaceable cartridge in the fluid system loop for receiving the peritoneal dialysis solution containing uremic waste metabolites from the patient'"'"'s peritoneal cavity and for regenerating the peritoneal dialysis solution, said replaceable cartridge having an urea removal layer that includes an ion-selective element comprised of hollow fibers coated with an ion-selective material that prevents calcium from being removed from the peritoneal dialysis solution, the peritoneal dialysis solution flowing through the hollow fibers in the closed fluid system loop.

2. The wearable peritoneal dialysis system of claim 1, wherein the ion-selective element prevents calcium and magnesium from being removed from the peritoneal dialysis solution.

3. The wearable peritoneal dialysis system of claim 2, wherein the ion-selective element comprises:

a cation exchange sorbent to adsorb the urea; and

an anion exchange sorbent to adsorb the counter ions released by the adsorption of urea by said cation exchange sorbent.

4. The wearable peritoneal dialysis system of claim 3, wherein the cation exchange sorbent includes a strong acid cation exchange resin, and the anion exchange sorbent includes a weak base anion exchange resin.

5. The wearable peritoneal dialysis system of claim 3, wherein a dual-property sorbent is both the cation exchange sorbent and the anion exchange sorbent.

6. The wearable peritoneal dialysis system of claim 1, wherein the ion-selective material is cellulose acetate.

7. The wearable peritoneal dialysis system of claim 2, wherein the ion-selective element is an ion-selective nanofiltration material.

8. The wearable peritoneal dialysis system of claim 7, wherein the ion-selective nanofiltration material rejects calcium and magnesium ions.

9. The wearable peritoneal dialysis system of claim 2, wherein the ion-selective element is an ion-selective nanofiltration membrane.

10. The wearable peritoneal dialysis system of claim 9, wherein the ion-selective nanofiltration membrane rejects calcium and magnesium ions.

11. The wearable peritoneal dialysis system of claim 2, further including a replaceable drain container attached to the fluid system loop for draining excess fluid.

12. The wearable peritoneal dialysis system of claim 11, further including a filter attached to the fluid system loop for removing particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites.

13. The wearable peritoneal dialysis system of claim 2, wherein the system is used in conjunction with a source of one or more enzymes that degrade uremic waste metabolites, the source of one or more enzymes orally administered to the patient, thereby reducing the load of uremic waste metabolites to be removed from the patient by the system.

14. The wearable peritoneal dialysis system of claim 13, wherein the source of the one or more enzymes is a cell selected from the group consisting of a microbial cell, a yeast cell and a mammalian cell.

15. The wearable peritoneal dialysis system of claim 13, wherein the one or more enzymes are selected from the group consisting of urease, creatininase and uricase.

16. The wearable peritoneal dialysis system of claim 2, wherein the replaceable cartridge further includes:

a purification layer for removing heavy metals, oxidants and other uremic waste metabolites from said peritoneal dialysis solution; and

an ion-exchange layer for removing phosphate and sulfate from said peritoneal dialysis solution.

17. The wearable peritoneal dialysis system of claim 2, wherein the urea removal layer comprises urea removal components selected from the group consisting of:

a cation exchange sorbent together with an anion exchange sorbent, a dual-property sorbent and a urea-degradation enzyme together with an ion exchange sorbent.

18. The wearable peritoneal dialysis system of claim 17, wherein the ion exchange sorbent is zirconium phosphate.

19. The wearable peritoneal dialysis system of claim 17, wherein the cation exchange sorbent includes a strong acid cation exchange resin, and the anion exchange sorbent includes a weak base anion exchange resin.

20. The wearable peritoneal dialysis system of claim 17, wherein the dual-property sorbent is both the cation exchange sorbent and the anion exchange sorbent.

21. The wearable peritoneal dialysis system of claim 17, wherein the urea removal layer further comprises a composition that rejects calcium and magnesium ions selected from the group consisting of:

hollow fibers comprised of an ion-selective nanofiltration membrane, hollow fibers coated with a material that rejects calcium and magnesium ions and an encapsulation surrounding the urea removal components, the encapsulation comprised of a material that rejects calcium and magnesium ions.

22. The wearable peritoneal dialysis system of claim 21, wherein the hollow fibers are coated with cellulose acetate.

23. The wearable peritoneal dialysis system of claim 21, wherein each layer of the cartridge is removable and replaceable.

24. The wearable peritoneal dialysis system of claim 23, further comprising a mix container attached to the fluid system loop to re-mix the regenerated peritoneal dialysis solution with glucose.

25. The wearable peritoneal dialysis system of claim 24, further comprising a three-way valve to connect the flow of the re-mixed and regenerated peritoneal dialysis solution to an initial priming point of the fluid system loop.

26. The wearable peritoneal dialysis system of claim 25, further comprising a filter attached to the fluid system loop to remove bacterial contamination from the regenerated peritoneal dialysis solution.

27. The wearable peritoneal dialysis system of claim 26, further comprising a microprocessor in communication with the components of the fluid system loop, said microprocessor controlling the pump flow rates and the timing and sequencing of the components of the dialysis system.

28. In a wearable peritoneal dialysis system for a patient having

a volume of peritoneal dialysis solution that is infused into and moved out of the patient'"'"'s peritoneal cavity, thereby removing from the patient uremic waste metabolites that have diffused into the peritoneal dialysis solution,

a closed fluid system loop for circulating the peritoneal dialysis solution from the patient, throughout the system and back into the patient, and

at least one pump for infusing the peritoneal dialysis solution into the patient'"'"'s peritoneal cavity and moving the peritoneal dialysis solution containing uremic waste metabolites out of the patient'"'"'s peritoneal cavity and into the fluid system loop,

the improvement comprising a replaceable cartridge in the fluid system loop for receiving the peritoneal dialysis solution containing uremic waste metabolites from the patient'"'"'s peritoneal cavity and for regenerating the peritoneal dialysis solution, said replaceable cartridge having an urea removal layer that includes an ion-selective element comprised of hollow fibers coated with an ion-selective material that prevents calcium from being removed from the peritoneal dialysis solution, the peritoneal dialysis solution flowing through the hollow fibers in the closed fluid system loop.

29. The improvement of claim 28, wherein the ion-selective element prevents calcium and magnesium from being removed from the peritoneal dialysis solution.

30. The improvement of claim 29, wherein the ion-selective element is an ion-selective nanofiltration material.

31. The improvement of claim 30, wherein the ion-selective nanofiltration material rejects calcium and magnesium ions.

32. The improvement of claim 29, wherein the ion-selective element is an ion-selective nanofiltration membrane.

33. The improvement of claim 32, wherein the ion-selective nanofiltration membrane rejects calcium and magnesium ions.

34. A replaceable cartridge for regenerating peritoneal dialysis solution comprising:

a purification layer for removing heavy metals, oxidants and other uremic waste metabolites from said peritoneal dialysis solution;

a urea removal layer that includes an ion-selective element comprised of hollow fibers coated with an ion-selective material that prevents calcium from being removed from the peritoneal dialysis solution, the peritoneal dialysis solution flowing through the hollow fibers; and

an ion-exchange layer for removing phosphate and sulfate from said peritoneal dialysis solution.

35. The replaceable cartridge of claim 34, wherein the ion-selective element prevents calcium and magnesium from being removed from the peritoneal dialysis solution.

36. A method for the removal of uremic waste metabolites from a patient using a wearable peritoneal dialysis system comprising:

providing a volume of peritoneal dialysis solution;

pumping the peritoneal dialysis solution into the peritoneal cavity of the patient through an access port, allowing the patient'"'"'s uremic waste metabolites to diffuse across the peritoneal membrane into the peritoneal dialysis solution;

pumping the peritoneal dialysis solution containing uremic waste metabolites out of the patient and into the system;

regenerating the peritoneal dialysis solution containing uremic waste metabolites using a replaceable cartridge having an urea removal layer that includes an ion-selective element comprised of hollow fibers coated with an ion-selective material that prevents calcium from being removed from the peritoneal dialysis solution the peritoneal dialysis solution flowing through the hollow fibers; and

returning the regenerated peritoneal dialysis solution to the patient'"'"'s peritoneal cavity.

37. The method of claim 36, wherein the ion-selective element prevents calcium and magnesium from being removed from the peritoneal dialysis solution.

38. A wearable peritoneal dialysis system for a dialysis patient comprising:

a dialysis solution loop for circulating a peritoneal dialysis solution into the peritoneal cavity of the patient and from the patient'"'"'s peritoneal cavity through the system and back into the patient;

a replaceable cartridge in the dialysis solution loop for receiving the peritoneal dialysis solution containing uremic waste metabolites from the patient'"'"'s peritoneal cavity and for regenerating the peritoneal dialysis solution, said replaceable cartridge having an urea removal layer that includes an ion-selective element comprised of hollow fibers coated with an ion-selective material that reduces calcium removal from the peritoneal dialysis solution in the replaceable cartridge, the peritoneal dialysis solution flowing through the hollow fibers in the dialysis solution loop; and

at least one pump for infusing regenerated peritoneal dialysis solution into the patient'"'"'s peritoneal cavity and removing the peritoneal dialysis solution containing uremic waste metabolites from the patient'"'"'s peritoneal cavity and circulating it through the replaceable cartridge and back to the patient'"'"'s peritoneal cavity.