Artificial kidney dialysis system

• US 20080051696A1
• Filed: 08/23/2007
• Published: 02/28/2008
• Est. Priority Date: 03/08/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Ofsthun, Norma, Lipps, Benjamin, Sandford, Harold, Curtin, Conor, Stennett, Amanda, Updyke, David
• Granted Patent: US 8,012,118 B2
• Time in Patent Office: Days
• 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 fluid from a patient using a wearable peritoneal dialysis device and an implantable 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 across the peritoneal membrane into 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 fluid from said patient with a fluid removal device that is implanted in the patient.

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.

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, 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 implantable fluid removing device.

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, wherein the fluid removing device is adapted for the removal of fluid from the patient.

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

11. An integrated dialysis system for a patient comprising:

a) a wearable peritoneal dialysis device; and

b) an implantable fluid removing device.

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

13. The dialysis system of claim 11, wherein the implantable fluid removing device is adapted for removal of fluid from the patient.

14. The dialysis system of claim 11, further comprising sensors for monitoring the rate of fluid removal from a patient.

15. The dialysis system of claim 11, wherein the implantable fluid removal 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.

16. The system of claim 15, 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.

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

18. The system of claim 15 wherein the filter is substantially permeable to water and substantially impermeable to blood cells and proteins.

19. The system of claim 15, 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.

20. The system of claim 17, wherein the first header, the second header and the filter are each less than about 10 millimeters (mm) in thickness.