Artificial kidney dialysis system

• US 8,012,118 B2
• Filed: 08/23/2007
• Issued: 09/06/2011
• Est. Priority Date: 03/08/2006
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Curtin, Conor, Stennett, Amanda, Updyke, David, Ofsthun, Norma J., Sandford, Harold F., Lipps, Benjamin J.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US11/895,075
• Publication Number:
  US 20080051696A1
• Time in Patent Office: 1,475 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 disclosure relates to a wearable dialysis system and method for removing uremic waste metabolites and fluid from a patient suffering from renal disease. Uremic waste metabolites can be removed by a wearable peritoneal dialysis device that regenerates the peritoneal dialysis solution without removing positively charged, essential ions from the solution and, consequently, the patient. Fluids can be removed from the blood of the patient by an implantable fluid removing device. Fluids are delivered to the bladder and preferably removed from the body of the patient through urination. The wearable dialysis system may be operated continuously or semi-continuously and be comfortably adapted to the body of the patient while allowing the patient to perform normal activities.

Claims

1. A method for the removal of uremic waste metabolites and excess fluid from a patient using a wearable peritoneal dialysis device and an implanted fluid removing device comprising:

a) providing a volume of peritoneal dialysis solution;

b) 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 through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution;

c) pumping the peritoneal dialysis solution containing uremic waste metabolites out of the patient and into the device;

d) filtering particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites;

e) regenerating the peritoneal dialysis solution containing uremic waste metabolites;

f) returning the regenerated peritoneal dialysis solution to the patient'"'"'s peritoneal cavity; and

g) removing excess fluid from the blood stream of said patient with the implanted fluid removing device that comprises a plurality of hollow fiber membranes, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

2. The method of claim 1, wherein regenerating the peritoneal dialysis solution is performed using a replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

3. The method of claim 1, further comprising controlling the pump flow rates and the timing and sequencing of the components of the device using a microprocessor.

24. The method of claim 1, wherein the fluid removing device includes a drain conduit configured to drain into the bladder of the patient, thereby enabling the patient to maintain a relatively normal, active lifestyle.

4. A dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device comprising;

i) a volume of peritoneal dialysis solution for infusion into and moving out of the patient'"'"'s peritoneal cavity, allowing the patient'"'"'s uremic waste metabolites to diffuse through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution, thereby removing from the patient uremic waste metabolites that have diffused into the peritoneal dialysis solution,

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

iii) at least one pump attached to the fluid system loop 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,

iv) a filter attached to the fluid system loop for removing particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites, and

v) a urea removal device attached to the fluid system loop for regenerating the peritoneal dialysis solution; and

b) an implanted fluid removing device that comprises a plurality of hollow fiber membranes, for removing excess fluid from the blood stream of said patient, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

5. The dialysis system of claim 4, wherein the urea removal device comprises a replaceable cartridge, said replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

6. The dialysis system of claim 5, wherein the replaceable cartridge comprises:

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

b) a urea removal layer that rejects calcium and magnesium ions; and

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

7. The dialysis system of claim 4, wherein the wearable peritoneal dialysis device further comprises 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 wearable peritoneal dialysis device.

8. The dialysis system of claim 4, wherein the wearable peritoneal dialysis device removes uremic waste metabolites from the patient.

9. The dialysis system of claim 4, further comprising sensors for monitoring the rate of fluid removal from a patient.

25. The method of claim 4, wherein the fluid removing device includes a drain conduit configured to drain into the bladder of the patient, thereby enabling the patient to maintain a relatively normal, active lifestyle.

10. An integrated dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device; and

b) an implanted fluid removing device comprising a plurality of hollow fiber membranes, for removing excess fluid from the blood stream of said patient, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

11. The dialysis system of claim 10, wherein the wearable peritoneal dialysis device is adapted for the removal of uremic waste metabolites from the patient.

12. The dialysis system of claim 10, further comprising sensors for monitoring the rate of fluid removal from a patient.

13. The dialysis system of claim 10, wherein the implanted fluid removing device comprises:

a) a first header;

b) a second header; and

c) a filter comprising a plurality of hollow fiber membranes, the filter in fluid communication with the first header and the second header, the first header, the second header and the filter being adapted to define a flow path that provides substantially uniform flow of blood through each of the hollow fiber membranes.

14. The system of claim 13, further comprising:

a) a first graft for connecting the vascular system of the patient to the first header;

b) a second graft for connecting the second header to the vascular system of the patient;

c) a housing adapted to collect fluid that passes through the filter; and

d) a drain conduit connected to the housing.

15. The system of claim 13 wherein the first header and the second header are elongated members, and the first header, the second header and the filter are substantially coplanar.

16. The system of claim 13 wherein the filter is substantially permeable to water and substantially impermeable to blood cells and proteins.

17. The system of claim 13, wherein the first header has multiple outlets and the second header has multiple inlets, and the flow path includes one or more neck regions near each of one or more of the multiple outlets and one or more of the multiple inlets.

18. The system of claim 15, wherein the first header, the second header and the filter are each less than about 10 millimeters (mm) in thickness.

26. The dialysis system of claim 10, wherein the fluid removing device includes a drain conduit configured to drain into the bladder of the patient, thereby enabling the patient to maintain a relatively normal, active lifestyle.

19. A method for the removal of uremic waste metabolites and excess fluid from a patient using a wearable peritoneal dialysis device and an implanted fluid removing device comprising:

a) providing a volume of peritoneal dialysis solution;

b) 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 through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution;

c) pumping the peritoneal dialysis solution containing uremic waste metabolites out of the patient and into the device;

d) filtering particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites;

e) regenerating the peritoneal dialysis solution containing uremic waste metabolites;

f) returning the regenerated peritoneal dialysis solution to the patient'"'"'s peritoneal cavity; and

g) removing excess fluid from the blood stream of said patient with the implanted fluid removing device connected to the blood stream of said patient by vascular grafts, said fluid removing device comprising;

i) a first header defining a first flow path having a single inlet and multiple outlets and a means for uniformly distributing fluid flow from the single inlet to the multiple outlets;

ii) a second header defining a second flow path having multiple inlets and a single outlet;

iii) a filter in fluid communication with said first header and said second header;

iv) a first graft for connecting the vascular system of the patient to the single inlet;

v) a second graft for connecting the single outlet to the vascular system of the patient;

vi) a housing adapted to collect fluid that passes through the filter; and

vii) a drain conduit connected to the housing.

20. The method of claim 19, wherein regenerating the peritoneal dialysis solution is performed using a replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

21. A dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device comprising;

i) a volume of peritoneal dialysis solution for infusion into and moving out of the patient'"'"'s peritoneal cavity, allowing the patient'"'"'s uremic waste metabolites to diffuse through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution, thereby removing from the patient uremic waste metabolites that have diffused into the peritoneal dialysis solution,

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

iii) at least one pump attached to the fluid system loop 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,

iv) a filter attached to the fluid system loop for removing particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites, and

v) a urea removal device attached to the fluid system loop for regenerating the peritoneal dialysis solution; and

b) an implanted fluid removing device for removing excess fluid from the blood stream of said patient, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts, said fluid removing device comprising;

i) a first header defining a first flow path having a single inlet and multiple outlets and a means for uniformly distributing fluid flow from the single inlet to the multiple outlets;

ii) a second header defining a second flow path having multiple inlets and a single outlet;

iii) a filter in fluid communication with said first header and said second header;

iv) a first graft for connecting the vascular system of the patient to the single inlet;

v) a second graft for connecting the single outlet to the vascular system of the patient;

vi) a housing adapted to collect fluid that passes through the filter; and

vii) a drain conduit connected to the housing.

22. The dialysis system of claim 21, wherein the urea removal device comprises a replaceable cartridge, said replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

23. The dialysis system of claim 22, wherein the replaceable cartridge comprises:

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

b) a urea removal layer that rejects calcium and magnesium ions; and

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

27. A method for the removal of uremic waste metabolites and excess fluid from a patient using a wearable peritoneal dialysis device and an implanted fluid removing device comprising:

a) providing a volume of peritoneal dialysis solution;

b) 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 through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution;

c) pumping the peritoneal dialysis solution containing uremic waste metabolites out of the patient and into the device;

d) filtering particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites;

e) regenerating the peritoneal dialysis solution containing uremic waste metabolites;

f) returning the regenerated peritoneal dialysis solution to the patient'"'"'s peritoneal cavity; and

g) removing excess fluid from the blood stream of said patient with the implanted fluid removing device that is connected to the blood stream of said patient by vascular grafts, and includes a drain conduit configured to drain into the bladder of the patient,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

28. The method of claim 27, wherein regenerating the peritoneal dialysis solution is performed using a replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

29. A dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device comprising;

i) a volume of peritoneal dialysis solution for infusion into and moving out of the patient'"'"'s peritoneal cavity, allowing the patient'"'"'s uremic waste metabolites to diffuse through the peritoneal membrane and thereby come into contact with and dissolve in the peritoneal dialysis solution, thereby removing from the patient uremic waste metabolites that have diffused into the peritoneal dialysis solution,

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

iii) at least one pump attached to the fluid system loop 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,

iv) a filter attached to the fluid system loop for removing particulates and debris from the peritoneal dialysis solution containing uremic waste metabolites, and

v) a urea removal device attached to the fluid system loop for regenerating the peritoneal dialysis solution; and

b) an implanted fluid removing device for removing excess fluid from the blood stream of said patient, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts and including a drain conduit configured to drain into the bladder of the patient,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

30. The dialysis system of claim 29, wherein the urea removal device comprises a replaceable cartridge, said replaceable cartridge having a urea removal layer that rejects calcium and magnesium ions.

31. An integrated dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device; and

b) an implanted fluid removing device that includes a drain conduit configured to drain into the bladder of the patient, for removing excess fluid from the blood stream of said patient, said implanted fluid removing device connected to the blood stream of said patient by vascular grafts,

thereby enabling the patient to maintain a relatively normal, active lifestyle.

32. The integrated dialysis system of claim 31, wherein the wearable peritoneal dialysis device is adapted for the removal of uremic waste metabolites from the patient.