Wearable continuous renal replacement therapy device

• US 6,960,179 B2
• Filed: 11/16/2001
• Issued: 11/01/2005
• Est. Priority Date: 11/16/2001
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: National Quality Care Inc. (Fresenius SE & Co. KGaA)
• Inventors: Gura, Victor
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/085,349
• Publication Number:
  US 20030097086A1
• Time in Patent Office: 1,446 Days
• Field of Search: 604/5.04, 604/6.05, 604/6.06, 604/6.09, 604/6.11, 604/6.14, 604/6.15, 604/6.16, 604 65- 67, 210/645, 210/646, 210/739, 21032175- 81, 21032184- 9, 210/322, 210/500.1, 210/500.21
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2209/088 on the body

Abstract

A continuous renal replacement therapy device adapted to be worn on a portion of the body of a patient, including: a plurality of contoured dialyzers, which are connected in series and utilize dialysate to remove impurities from the blood of the patient; and a plurality of contoured sorbent device, which are connected in series and are for regenerating the spent dialysate.

Claims

1. A continuous renal replacement therapy device, comprising:

at least one dialyzer that utilizes a dialysate to remove impurities from the blood of a patient;

a microprocessor configured to control a rate of ultrafiltration at the same time said at least one dialyzer is removing impurities from the blood, wherein the device is configured to allow concurrent ultrafiltration and dialysis; and

at least one dialysate sorbent device for regenerating the dialysate, the entire continuous renal replacement device for being worn on the patient.

2. The continuous renal replacement therapy device of claim 1, wherein the at least one dialyzer is connected in series with at least one additional dialyzer.

3. The continuous renal replacement therapy device of claim 1, wherein at least one of the dialyzers comprises a plurality of cylindrical hollow fibers, wherein the patient'"'"'s blood is circulated within the hollow fibers in a first direction and wherein the dialysate is circulated around at least a portion of the exterior walls of the hollow fibers in a second direction.

4. The continuous renal replacement therapy device of claim 3, wherein the exterior walls of the hollow fibers are semiporous so that impurities can be moved from the blood and into the dialysate.

5. The continuous renal replacement therapy device of claim 1, wherein each of the at least one dialyzers have a flexible casing adapted to conform to the body contour of the patient.

6. The continuous renal replacement therapy device of claim 1, wherein the number of dialyzers in the at least one dialyzer may be varied to reflect different dialysis prescriptions.

7. The continuous renal replacement therapy device of claim 1, further including a blood inlet tube leading into a first dialyzer of the at least one dialyzer and a blood outlet tube leading out of a last dialyzer of said at least one dialyzer such that the at least one dialyzers are connected in series.

8. The continuous renal replacement therapy device of claim 7, wherein the blood inlet tube includes a side port for the infusion of anticoagulants into the blood.

9. The continuous renal replacement therapy device of claim 8, wherein the anticoagulant is chosen from the group consisting of:

heparin, prostacyclin, low molecular weight heparin, hirudin and sodium citrate.

10. The continuous renal replacement therapy device of claim 7, wherein the blood outlet tube includes a side port adapted for an infusion of at least one additive.

11. The continuous renal replacement therapy device of claim 10, wherein the at least one additive can be pumped into the blood by a plurality of additive pumps.

12. The continuous renal replacement therapy device of claim 11, wherein the rate of infusion of said at least one additive is controlled electronically.

13. The continuous renal replacement therapy device of claim 10, wherein said at least one additive is chosen from the group consisting of:

sodium citrate, calcium, potassium and sodium bicarbonate.

14. The continuous renal replacement therapy device of claim 1, wherein the at least one sorbent device comprises a plurality of sorbent devices connected in series.

15. The continuous renal replacement therapy device of claim 1, wherein the at least one sorbent device comprises a plurality of sorbent devices connected in parallel.

16. The continuous renal replacement therapy device of claim 1, wherein the at least one dialyzer is connected in parallel with at least one additional dialyzer.

17. The continuous renal replacement therapy device of claim 1, wherein at least one of said at least one dialyzer comprises a plurality of parallel sheets of semiporous material, wherein the patient'"'"'s blood is circulated on one side of the parallel sheets in a first direction and wherein the dialysate is circulated on the other side of the parallel sheets in a second direction.

18. A continuous renal replacement therapy device, comprising:

at least one dialyzer that utilizes a dialysate to remove impurities from the blood of a patient;

a microprocessor programmed to control a rate that excess fluid is removed from dialysate while said at least one dialyzer is removing impurities from the blood, wherein the device is programmed to allow concurrent ultrafiltration and dialysis; and

a plurality of dialysate sorbent devices for regenerating the dialysate wherein a first sorbent device contains a first sorbent and a second sorbent device that contains a second sorbent;

said first sorbent and said second sorbent being different compounds, said entire continuous renal replacement device to be worn on the patient.

19. The continuous renal replacement therapy device of claim 18, wherein the plurality of sorbent devices are connected at least in series.

20. The continuous renal replacement therapy device of claim 18, wherein each of the sorbent devices has a flexible casing adapted to conform to the body contour of the patient.

21. The continuous renal replacement therapy device of claim 18, wherein the number of sorbent devices may be varied to reflect different dialysis prescriptions.

22. The continuous renal replacement therapy device of claim 18, further including a regenerated dialysate inlet tube leading into the at least one dialyzer and a spent dialysate outlet tube leading out of the at least one dialyzer.

23. The continuous renal replacement therapy device of claim 22, wherein the regenerated dialysate inlet tube includes a side port for an infusion of at least one additive.

24. The continuous renal replacement therapy device of claim 23, wherein the at least one additive is pumped into the dialysate from a plurality of additive reservoirs.

25. The continuous renal replacement therapy device of claim 24, wherein the rate of infusion of each one of the at least one additive is controlled electronically.

26. The continuous renal replacement therapy device of claim 23, wherein the at least one additive is chosen from the group consisting of:

sodium citrate, calcium, potassium and sodium bicarbonate.

27. The continuous renal replacement therapy device of claim 22, wherein the spent dialysate tube leads into the plurality of sorbent devices and the regenerated dialysate tube leads out of the plurality of sorbent devices.

28. The continuous renal replacement therapy device of claim 19, wherein the series of sorbent devices comprises a series of replaceable cartridges.

29. The continuous renal replacement therapy device of claim 28, wherein the replaceable cartridges include at least one of:

activated charcoal, urease, zirconium phosphate, hydrous zirconium oxide and activated carbon.

30. The continuous renal replacement therapy device of claim 18, wherein the at least one sorbent device comprises a plurality of sorbent devices connected in parallel.

31. The continuous renal replacement therapy device of claim 18, wherein the at least one dialyzer comprises a plurality of dialyzers connected in parallel.

32. The continuous renal replacement therapy device of claim 18, wherein the at least one dialyzer comprises a plurality of dialyzers connected in series.

33. The continuous renal replacement therapy device of claim 32, wherein at least one of the at least one dialyzer comprises a plurality of parallel sheets of semiporous material, wherein the patient'"'"'s blood is circulated on one side of the parallel sheets in a first direction and wherein the dialysate is circulated on the other side of the parallel sheets in a second direction.