Method and apparatus for continuous peritoneal cascade dialysis and hemofiltration (CPCD/H)

• US 6,234,991 B1
• Filed: 08/24/1999
• Issued: 05/22/2001
• Est. Priority Date: 05/08/1997
• Status: Expired due to Fees

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Gorsuch, Reynolds G.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thompson, Michael M
• Application Number:
  US09/382,237
• Time in Patent Office: 637 Days
• Field of Search: 604/4, 604/5, 604/29, 604/266, 210/321.6, 210/321.71, 210/321.62, 210/4.01, 210/5.01, 210/5.04
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1625 Dialyser of the outside perfusion type, i.e. blood flow outside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• 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 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: B01D 2313/23 Specific membrane protectors, e.g. sleeves or screens
• CPC Class Codes: B01D 2313/243 Pumps
• CPC Class Codes: B01D 61/28 Apparatus therefor
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: B01D 63/084 at least one flow duct intersecting the membranes

Abstract

A continuous peritoneal dialysis is carried out by providing a dialyzer element having a filter membrane for being exposed within the peritoneal cavity and an interior dialysate passageway, the membrane having pores sufficient to allow diffusion of blood toxins, implanting the dialyzer element in the peritoneal cavity of a patient, infusing a transfer fluid into the patient'"'"'s peritoneal cavity and continuously supplying substantially fresh dialysate fluid into interior dialysate passageway of the dialyzer element, directing the fluid along the passageway whereby it is exposed to the transfer fluid by diffusion through the membrane and whereby toxins from said transfer fluid are diffused into the dialysate in the dialyzer element to form toxic dialysate fluid, and continuously removing the toxic dialysate from said dialyzer element.

Claims

1. A system for continuous intraperitoneal dialysis comprising:

a dialyzer element for being implanted within the peritoneal cavity of a patient and comprising a filter membrane comprising a plurality of elongated hollow microporous fibers having an exterior membrane surface for being exposed to fluid within said peritoneal cavity and an interior membrane surface forming an interior dialysate passageway, said filter membrane having pores sufficient to allow diffusion of blood toxins therethrough;

an inlet for directing dialysate fluid into said dialyzer element and an outlet for directing dialysate fluid from said dialyzer element;

a tube having a first conduit connected to said inlet and a second conduit connected to said outlet; and

one or more pumps cooperating with said tube for pumping dialysate fluid in and/or out of said dialyzer element.

2. A system of claim 1 further comprising one or more bacteria filters cooperating with said outlet or said second conduit for filtering dialysate fluid directed from said dialyzer element.

3. A system of claim 1 wherein said inlet comprises a header secured to said tube, said header having an inlet channel for directing dialysate from said first conduit to said interior dialysate passageway and an outlet channel for directing dialysate fluid from said interior dialysate passageway to said second conduit.

4. A system of claim 1 wherein said tube includes a third conduit for supplying transfer fluid to a patient'"'"'s peritoneal cavity exteriorly of said interior dialysate passageway.

5. A system of claim 1 wherein said dialyzer element includes a porous guard secured around the exterior of said element and forming a protective envelope for said hollow fibers.

6. A system of claim 1 wherein each of said hollow fibers has a first end secured to said inlet and a second end secured to said outlet.

7. A system of claim 1 comprising a plurality of layers of said hollow fibers and including a porous guard separating adjacent fiber layers.

8. A system of claim 1 comprising a woven mesh of said hollow fibers.

9. A system of claim 1 wherein said fibers are coated with one or more compositions selected from polyethylene glycols, siloxanes and heparin.

10. A system for continuous intraperitoneal dialysis comprising:

a dialyzer element for being implanted within the peritoneal cavity of a patient, and capable of filtering blood and plasma toxins exclusively by direct diffusive contact with peritoneal fluid present in the peritoneal cavity, said dialyzer element comprising;

(i) a filter membrane consisting of a plurality of elongated hollow microporous fibers or one or more microporous membrane sheets, said filter membrane having pores of a size for selective removal or retention of toxins and components of between 10³ and 10⁵ daltons molecular weight, said filter membrane having an exterior membrane surface for being a direct diffusive contact with peritoneal fluid present in the peritoneal cavity, and an interior dialysate passageway for receiving dialysate fluid,

(ii) an inlet for directing dialysate fluid to the interior dialysate passageway and an outlet for directing dialysate fluid from the dialyzer element, and

(iii) a tube assembly comprising a first conduit connected to said inlet and a second conduit to said outlet.

11. A system of claim 10 wherein said inlet comprises a header secured to said tube, said header having an inlet channel for directing dialysate from said first conduit to said interior dialysate passageway and an outlet channel for directing dialysate fluid from said interior dialysate passageway to said second conduit.

12. A system of claim 11 wherein said filter membrane comprises a plurality of elongated hollow microporous fibers the hollow interior thereof forming said interior dialysate passageway, each of said hollow fibers having a first end secured to said inlet channel of said header and a second end secured to said outlet channel of said header.

13. A system of claim 12 wherein said dialyzer element includes a porous guard secured around the exterior of said element and forming a protective envelope for said hollow fiber.

14. A system of claim 13 comprising a plurality of layers of said hollow fibers and including a porous guard separating adjacent fiber layers.

15. A system of claim 12 wherein said fibers are coated with one or more compositions selected from polyethylene glycols, siloxanes and heparin.

16. A system of claim 10 wherein said filter membrane comprises a plurality of elongated hollow microporous fibers and wherein the hollow interior of said fibers comprises said interior dialysate passageway.

17. A system of claim 16 wherein said dialyzer element includes a porous guard secured around the exterior of said element and forming a protective envelope for said hollow fibers.

18. A system of claim 17 comprising a plurality of layers of said hollow fibers and including a porous guard separating adjacent fiber layers.

19. A system of claim 16 wherein each of said hollow fibers has a first end secured to said inlet means and a second end secured to said outlet means.

20. A system of claim 16 comprising a woven mesh of said hollow fibers.

21. A system of claim 16 wherein said fibers are coated with one or more compositions selected from polyethylene glycols, siloxanes and heparin.

22. A system of claim 10 wherein said filter membrane comprises one or more microporous membrane sheets and wherein said interior dialysate passageway is formed therebetween.

23. A system of claim 22 wherein said interior dialysate passageway includes means for creating a tortuous passageway for said dialysate fluid for at least a portion of the length of said interior dialysate passageway.

24. A system of claim 23 wherein said means comprises a plurality of plates forming a plurality of channels along said passageway.

25. A system of claim 23 wherein said means comprises a plurality of baffles positioned along said passageway.

26. A system of claim 22 wherein said inlet means comprises a header secured to said tube, said header having an inlet channel for directing dialysate from said first conduit to said interior dialysate passageway and an outlet channel for directing dialysate fluid from said interior dialysate passageway to said second conduit.

27. A system of claim 22 wherein said one or more membrane sheets are coated with one or more compositions selected from polyethylene glycols, siloxanes and heparin.

28. A system of claim 10 further comprising one or more bacteria filters cooperating with said inlet or said first conduit for filtering dialysate fluid directed into said dialyzer element.

29. A system of claim 28 further comprising one or more bacteria filters cooperating with said outlet or said second conduit for filtering dialysate fluid directed from said dialyzer element.

30. A system of claim 28 wherein said one or more pumps comprises a peristolic pump.

31. A system of claim 10 wherein said filter membrane has a pore size allowing passage of blood and plasma toxins having a molecular weight of less than 10⁵ daltons and selected plasma proteins having a molecular weight between 10³ and 10⁵ daltons.

32. A system of claim 31 wherein said selected molecular weight is less than about 7.0×

10⁴ for preventing passage of albumin through said membrane.

33. A system of claim 10 further comprising:

one or more pumps cooperating with said tube assembly for pumping dialysate fluid in and/or out of said dialyzer element.

34. A system of claim 10 including a dialysate fluid supply cooperating with said first conduit for supplying fresh dialysate fluid thereto.

35. A system of claim 10 including a receptacle cooperating with said second conduit for receiving toxic dialysate fluid from said dialyzer element.

36. A system of claim 10 wherein said dialyzer element comprises a filter membrane having a pore size allowing passage only of materials having a molecular weight of less than 10³ daltons.

37. A system of claim 10 wherein said tube includes a third conduit for supplying transfer fluid to a patient'"'"'s peritoneal cavity exteriorly of said interior dialysate passageway.

38. A system of claim 10 wherein said tube comprises a triple lumen catheter having a third conduit therein terminating exteriorly from said interior dialysate passageway.