Wearable ultrafiltration device

• US 7,597,677 B2
• Filed: 09/19/2002
• Issued: 10/06/2009
• Est. Priority Date: 11/16/2001
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: National Quality Care Inc.
• Inventors: Gura, Victor, Rambod, Edmond
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US10/251,937
• Publication Number:
  US 20030097087A1
• Time in Patent Office: 2,574 Days
• Field of Search: 604/6.09, 604/6.11, 604/5.01, 604/5.04, 604/6.15, 604/6.16, 210645-646, 210/600, 210/634, 210/644, 210/195.2, 210/416.1, 210/433.1, 210/321.71, 210/500.21, 210/258, 210/259, 422/44
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• 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
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 61/18 Apparatus therefor

Abstract

An ultrafiltration device adapted to be worn on a portion of the body of a patient includes a blood inlet tube leading from a first blood vessel, a blood pump, an anticoagulant reservoir for infusing anticoagulants into the blood, a blood filter including a substrate through which the blood is circulated and filtered, a fluid bag for storing the excess fluid and a blood outlet tube leading to a second blood vessel.

Claims

1. An ultrafiltration device for wearing on a portion of the body of a patient, comprising:

a blood pump that is a shuttle pump;

an ultrafiltration filter for separating excess fluid from the blood, said ultrafiltration filter receives blood pumped by said blood pump and removes said excess fluid from said patient'"'"'s body via the patient'"'"'s blood, said ultrafiltration device constructed and configured to operate while in various three-dimensional orientations while being worn by the patient; and

a fluid bag in fluid communication with said ultrafiltration filter without a fluid pump there between, said fluid bag receives the excess fluid directly from the ultrafiltration filter without performing dialysis, said ultrafiltration device is sized to be completely worn on said patient'"'"'s body.

2. The ultrafiltration device of claim 1, wherein the device comprises a belt for wearing about the waist of the patient.

3. The ultrafiltration device of claim 2, wherein the belt includes a pair of end portions which are secured together by a belt fastening means.

4. The ultrafiltration device of claim 1, wherein the device comprises a belt for wearing about the shoulder of the patient.

5. The ultrafiltration device of claim 1, wherein the device comprises a belt for wearing about the thigh of the patient.

6. The ultrafiltration device of claim 1, further comprising a blood inlet tube, which carries the patient'"'"'s blood from a first blood vessel into the blood filter.

7. The ultrafiltration device of claim 6, further comprising a blood outlet tube, which carries the patient'"'"'s blood from the blood filter into a second blood vessel.

8. The ultrafiltration device of claim 6, wherein the blood inlet tube includes a port for the infusion of anticoagulants into the blood.

9. The ultrafiltration 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 ultrafiltration device of claim 1, wherein the blood pump pumps the patient'"'"'s blood through the ultrafiltration filter.

11. The ultrafiltration device of claim 10, wherein the blood pump is powered using at least one battery.

12. The ultrafiltration device of claim 1, wherein the ultrafiltration filter includes a semipermeable membrane for separating the excess fluid from the blood.

13. The ultrafiltration device of claim 12, further comprising a tap for periodically emptying the fluid bag.

14. The ultrafiltration device of claim 1, wherein the ultrafiltration filter has a flexible casing adapted to conform to the body contour of the patient.

15. The ultrafiltration device of claim 1, wherein said ultrafiltration device has a weight of less than two pounds.

16. The ultrafiltration device of claim 1, wherein said fluid communication between said fluid bag and said blood filter does not comprise a fluid valve.

17. An ultrafiltration device for wearing on a portion of the body of a patient, comprising:

a blood inlet tube leading from a first blood vessel;

a shuttle pump for pumping blood through said ultrafiltration device;

an anticoagulant reservoir for infusing anticoagulants into the blood;

a blood filter including a substrate through which the blood is circulated and filtered, wherein the blood filter is configured to separate ultrafiltrate from the blood, without using a dialysate liquid, while said shuttle pump is pumping said blood and while said ultrafiltration device is being worn in changing orientations on said portion of the body of a patient;

a fluid bag for receiving and storing the excess fluid directly from said blood filter without a fluid pump there between; and

a blood outlet tube leading to a second blood vessel.

18. The ultrafiltration device of claim 17, wherein the device further comprises a belt for wearing said ultrafiltration device about the waist of the patient.

19. The ultrafiltration device of claim 18, wherein the belt includes a pair of end portions which are secured together by a belt fastening means.

20. The ultrafiltration device of claim 17, wherein the device comprises a belt for wearing said ultrafiltration device about the shoulder of the patient.

21. The ultrafiltration device of claim 17, wherein the device comprises a belt for wearing said ultrafiltration device about the thigh of the patient.

22. The ultrafiltration device of claim 17, wherein the blood inlet tube carries the patient'"'"'s blood into the blood filter.

23. The ultrafiltration device of claim 22, wherein the blood outlet tube carries the patient'"'"'s blood from the blood filter.

24. The ultrafiltration device of claim 17, wherein the shuttle pump forces the patient'"'"'s blood through the filter at a shuttle pump flow rate that removes excess body fluid from said blood.

25. The ultrafiltration device of claim 24, wherein the shuttle pump is powered using at least one battery.

26. The ultrafiltration device of claim 17, further comprising a tap for emptying the fluid bag.

27. The ultrafiltration device of claim 17, wherein the blood filter has a flexible casing adapted to conform to the body contour of the patient.

28. The ultrafiltration device of claim 17, wherein the blood inlet tube includes a port for the infusion of anticoagulants into the blood.

29. The ultrafiltration device of claim 28, wherein the anticoagulant is chosen from the group consisting of heparin, prostacyclin, low molecular weight heparin, hirudin and sodium citrate.

30. The ultrafiltration device of claim 17, wherein said ultrafiltration device has a weight of less than two pounds.

31. An ultrafiltration device comprising:

a shuttle pump for pumping blood through said ultrafiltration device;

a blood filter that receives blood pumped from said shuttle pump at a shuttle pump flow rate, said blood filter is configured to remove excess body fluid from the blood while said ultrafiltration device is oriented in various non-stationary three-dimensional orientations that is not limited to a vertical orientation; and

a fluid bag connected to said blood filter without a fluid pump there between and configured to receive the excess body fluid directly from said blood filter without a dialysate liquid, said ultrafiltration device for being worn in its entirety on a patient.

32. The ultrafiltration device of claim 31, wherein said ultrafiltration device has a weight of less than two pounds.

33. A single fluid loop ultra filtration device for removing ultrafiltrate from a congestive heart failure patient'"'"'s blood comprising:

a shuttle pump that pumps blood from a congestive heart failure (CHF) patient through said ultrafiltration device, the shuttle pump pumps said blood at a shuttle pump flow rate, said shuttle pump flow rate being high enough to remove excess body fluid from the CHF patient'"'"'s blood and low enough for a potential twenty four hour continuous ultra filtration processing time;

a blood filter that removes said excess body fluid from the CHF patient'"'"'s blood as blood is pumped by said shuttle pump through said blood filter, said blood filter configured to function without a dialysate liquid and in changing orientations that can be other than a vertical orientation;

a fluid receptacle in fluid communication with said blood filter without a fluid pump there between, said fluid receptacle configured to collect said excess fluid directly from said blood filter without said dialysate liquid; and

the single fluid loop ultra filtration device being adapted to contain a battery that provides energy to said blood pump.

34. The single fluid loop ultra filtration device of claim 33, wherein said single fluid loop ultra filtration device weighs less than two pounds.

35. A completely wearable ultrafiltration device comprising:

a shuttle style blood pump for pumping a wearer'"'"'s blood through said completely wearable ultrafiltration device;

a blood filter configured to filter the wearer'"'"'s blood by removing a bodily fluid overload from a patient'"'"'s blood without performing dialysis and without adding a replacement body fluid to the blood prior to reintroducing said filtered blood to said wearer;

said blood filter configured to function in various three-dimensional orientations that can be other than vertical;

said shuttle style blood pump pumps said blood through said blood filter at a slow enough rate such that said blood filter removes bodily fluid overload from the patient at a slow enough rate that the completely wearable ultrafiltration device can operate continuously for 24 hours, 7 days a week and provide steady smooth removal of the overload fluid;

said ultrafiltration device being completely wearable by the patient.

36. The completely wearable ultrafiltration device of claim 35, wherein said blood filter has at least one of a rigid, semi rigid, and flexible casing adapted to conform a body contour of the patient.

37. A completely wearable ultrafiltration device comprising:

a shuttle pump for pumping a congestive heart failure patient'"'"'s blood through said completely wearable ultrafiltration device;

an ultrafiltration filter configured to operate in various three-dimensional orientations, receive blood from said shuttle pump, said ultrafiltration filter configured to filter overload fluid from said congestive heart failure patient'"'"'s blood without performing dialysis and on a substantially continuous basis 24 hours a day, seven days a week;

a fluid receptacle for receiving the filtered overload fluid without aid from a pump;

said completely wearable ultrafiltration device having a weight of less than two pounds.