Continuous flow-through peritoneal dialysis (CFPD) method with control of intraperitoneal pressure

• US 6,409,699 B1
• Filed: 06/28/1999
• Issued: 06/25/2002
• Est. Priority Date: 10/22/1996
• Status: Expired due to Fees

• Current Assignee: Renal Solutions, Inc. (Fresenius Medical Care AG)
• Original Assignee: Renal Solutions, Inc. (Fresenius Medical Care AG)
• Inventors: Ash, Stephen R.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US09/284,904
• Time in Patent Office: 1,093 Days
• Field of Search: 604/29, 435/289.1, 435/299.1
• 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 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/32 Oxygenators without membranes
• CPC Class Codes: A61M 1/3489 by biological cells, e.g. bioreactor

Abstract

The present invention relates generally to advantageous devices and methods for treating patients suffering from renal insufficiency and/or hepatic insufficiency. More particularly, the invention relates in certain aspects to devices and methods for performing continuous flow-through peritoneal dialysis (CFPD). In other aspects of the invention, peritoneal dialysis systems are provided which utilizes a bioreactor to regenerate peritoneal fluid for re-infusion into a peritoneal cavity. The invention, therefore, provides advantageous systems for passing fluid through a patient'"'"'s peritoneal cavity at a relatively high flow rate, while maintaining in the peritoneal cavity an optimal dialysate pressure, to thereby alter the contents of the patient'"'"'s blood by diffusion of molecules through the peritoneal membrane.

Claims

1. A device for performing continuous flow peritoneal dialysis, comprising:

a dialysate source;

a peritoneal fluid receptacle;

a flexible catheter having a first segment comprising a conduit which defines a first lumen and a second lumen, and a second segment comprising a first limb which defines a recess in fluid communication with the first lumen and a second limb which defines a recess in fluid communication with the second lumen, the first and second limbs being formed to move independently of one another and having distal ends opposite the first segment;

a first tube in fluid communication with the dialysate source and the first lumen;

a second tube in fluid communication with the second lumen and the peritoneal fluid receptacle; and

a pressure regulator in fluid communication with the second tube;

wherein the pressure regulator is formed to prevent fluid flow therethrough when the fluid in the second tube has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the second tube has a pressure at least as great as the predetermined threshold pressure; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

2. The device according to claim 1, further comprising a pumping device coupled to the first tube for moving the dialysate at a predetermined rate from the container to the peritoneal cavity through the first limb.

3. The device according to claim 1, further comprising a filter in fluid communication with the first tube such that fluid passing through the first tube passes through the filter.

4. The device according to claim 3, wherein the filter comprises a charcoal filter.

5. The device according to claim 1, further comprising a heater associated with the first tube such that fluid passing through the first lumen has a temperature of about 37°

C.

6. The device according to claim 1, further comprising means for measuring the weight of the dialysate source;

and means for measuring the weight of the peritoneal fluid receptacle.

7. The device in accordance with claim 1, wherein the second limb comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

8. A device for performing continuous flow peritoneal dialysis, comprising:

a dialysate source;

a peritoneal fluid receptacle;

a first catheter in fluid communication with the dialysate source, the first catheter defining a first lumen and comprising a first segment configured to be positioned across a patient'"'"'s abdominal wall and a second segment configured to reside in the patient'"'"'s peritoneal cavity;

a second catheter in fluid communication with the peritoneal fluid receptacle, the second catheter defining a second lumen and comprising a first segment configured to be positioned across a patient'"'"'s abdominal wall and a second segment configured to reside in the patient'"'"'s peritoneal cavity;

a first tube in fluid communication with and positioned between the dialysate source and the first lumen;

a second tube in fluid communication with and positioned between the second lumen and the peritoneal fluid receptacle; and

a pressure regulator in fluid communication with the second tube;

wherein the pressure regulator is formed to prevent fluid flow therethrough when the fluid in the second tube has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the second tube has a pressure at least as great as the predetermined threshold pressure; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

9. The device according to claim 8, wherein the second segment of the second catheter comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

10. The device according to claim 8, wherein the second segment of the first catheter is configured to be positioned substantially adjacent the patient'"'"'s liver such that inflowing dialysate enters the peritoneal cavity substantially adjacent the liver;

and wherein the second segment of the second catheter is configured to be positioned substantially adjacent the patient'"'"'s pelvis such that outflowing dialysate enters the second lumen substantially adjacent the pelvis.

16. The method according to claim 8, wherein a pumping device is associated with the first lumen for moving dialysate at a predetermined rate through the first lumen.

11. A method for removing toxins from a patient'"'"'s blood, comprising:

passing a dialysate into a patient'"'"'s peritoneal cavity through a first lumen of a flexible dual lumen catheter at a substantially continuous rate of from about 20 to about 300 ml/min; and

recovering peritoneal fluid from the peritoneal cavity through a second lumen of the catheter, provided that fluid is recovered only when fluid in the peritoneal cavity reaches a pressure of from about 6 to about 20 mm Hg;

wherein the catheter has a first segment comprising a conduit which defines a first lumen and a second lumen, and a second segment comprising a first limb which defines one or more recesses in fluid communication with the first lumen and a second limb which defines one or more recesses in fluid communication with the second lumen, the first and second limbs being formed to move independently of one another and having distal ends opposite the first segment;

wherein a pressure regulator in fluid communication with the second lumen remains closed when the fluid in the second lumen has a pressure less than a predetermined threshold pressure, thereby preventing fluid flow therethrough, and opens when the fluid in the second lumen has a pressure at least as great as the predetermined threshold pressure, thereby allowing fluid flow therethrough; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

12. The method according to claim 11, wherein the distal end of the first limb is placed substantially adjacent the patient'"'"'s liver and the distal end of the second limb is placed substantially adjacent the patient'"'"'s pelvis, thereby forming a closed fluid pathway for passing dialysate through the peritoneal cavity in a substantially unidirectional manner.

13. The method according to claim 11, wherein the second limb comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

14. The method according to claim 11, wherein the predetermined pressure is a pressure of from about 8 to about 14 mm Hg within the peritoneal cavity.

15. The method according to claim 11, wherein a filter is in fluid communication with the first lumen, the filter being placed between the dialysate source and the first lumen.

17. A method for removing toxins from a patient'"'"'s blood, comprising:

passing a dialysate into a patient'"'"'s peritoneal cavity through a first lumen of a first catheter at a substantially continuous rate of from about 20 to about 300 ml/min; and

recovering peritoneal fluid from the peritoneal cavity through a second lumen of a second catheter, provided that fluid is recovered only when fluid in the peritoneal cavity reaches a pressure of from about 6 to about 20 mm Hg;

wherein the first and second catheters are positioned across the patient'"'"'s abdominal wall, thereby providing access to the peritoneal cavity;

wherein a pressure regulator in fluid communication with the second lumen remains closed when the fluid in the second lumen has a pressure less than a predetermined threshold pressure, thereby preventing fluid flow therethrough, and opens when the fluid in the second lumen has a pressure at least as great as the predetermined threshold pressure, thereby allowing fluid flow therethrough; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

18. A device for performing continuous flow peritoneal dialysis, comprising:

a fluid container;

a flexible catheter having a first segment comprising a conduit which defines a first lumen and a second lumen, and a second segment comprising a first limb which defines a recess in fluid communication with the first lumen and a second limb which defines a recess in fluid communication with the second lumen, the first and second limbs being formed to move independently of one another and having distal ends opposite the first segment;

a first tube in fluid communication with the first lumen and in fluid communication with the fluid container;

a second tube in fluid communication with the second lumen and in fluid communication with the fluid container; and

a pressure regulator in fluid communication with the second tube;

wherein the pressure regulator is formed to prevent fluid flow therethrough when the fluid in the second tube has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the second tube has a pressure at least as great as the predetermined threshold pressure;

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg; and

wherein the catheter is configured such that the second segment may be positioned within the peritoneal cavity of a patient such that the distal end of the first limb may be placed anterior to the patient'"'"'s liver and the distal end of the second limb may be placed substantially adjacent the patient'"'"'s pelvis, thereby forming a closed fluid circuit for passing dialysate through the peritoneal cavity in a substantially unidirectional manner.

19. The device according to claim 18, further comprising a bioreactor in fluid communication with the second conduit, the bioreactor containing hepatocytes.

20. The device according to claim 19, wherein said bioreactor comprises means for contacting the fluid with hepatocytes.

21. The device according to claim 18, further comprising a regenerating device in fluid communication with the second conduit.

22. The device according to claim 18, further comprising means for measuring the weight of the container.

23. The device in accordance with claim 18, wherein the second limb comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

24. A device for performing continuous flow peritoneal dialysis, comprising:

a fluid container;

a first catheter in fluid communication with the fluid container, the first catheter defining a first lumen and comprising a first segment configured to be positioned across a patient'"'"'s abdominal wall and a second segment configured to reside in the patient'"'"'s peritoneal cavity;

a second catheter in fluid communication with the fluid container, the second catheter defining a second lumen and comprising a first segment configured to be positioned across a patient'"'"'s abdominal wall and a second segment configured to reside in the patient'"'"'s peritoneal cavity;

a first tube in fluid communication with and positioned between the container and the first lumen;

a second tube in fluid communication with and positioned between the second lumen and the container; and

a pressure regulator in fluid communication with the second tube;

wherein the pressure regulator is formed to prevent fluid flow therethrough when the fluid in the second tube has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the second tube has a pressure at least as great as the predetermined threshold pressure; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

25. The device according to claim 24, wherein the second segment of the second catheter comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

26. The device according to claim 24, wherein the second segment of the first catheter is configured to be positioned substantially adjacent the patient'"'"'s liver such that inflowing dialysate enters the peritoneal cavity substantially adjacent the liver;

and wherein the second segment of the second catheter is configured to be positioned substantially adjacent the patient'"'"'s pelvis such that outflowing dialysate enters the second lumen substantially adjacent the pelvis.

27. A method for removing toxins from a patient'"'"'s blood, comprising:

passing a dialysate into a patient'"'"'s peritoneal cavity from a fluid container through a first tube and a first lumen of a flexible dual lumen catheter at a substantially continuous rate of from about 20 to about 300 ml/min; and

recovering peritoneal fluid from the peritoneal cavity through a second lumen of the catheter, provided that fluid is recovered only when fluid in the peritoneal cavity reaches a pressure of from about 6 to about 20 mm Hg; and

passing the peritoneal fluid to the container through a second tube;

wherein the catheter has a first segment comprising a conduit which defines a first lumen and a second lumen, and a second segment comprising a first limb which defines one or more recesses in fluid communication with the first lumen and a second limb which defines one or more recesses in fluid communication with the second lumen, the first and second limbs being formed to move independently of one another and having distal ends opposite the first segment;

wherein a pressure regulator in fluid communication with the second lumen remains closed when the fluid in the second lumen has a pressure less than a predetermined threshold pressure, thereby preventing fluid flow therethrough, and opens when the fluid in the second lumen has a pressure at least as great as the predetermined threshold pressure, thereby allowing fluid flow therethrough; and

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg.

28. The method according to claim 27, wherein the distal end of the first limb is placed substantially adjacent the patient'"'"'s liver and the distal end of the second limb is placed substantially adjacent the patient'"'"'s pelvis, thereby forming a closed fluid circuit for passing dialysate through the peritoneal cavity in a substantially unidirectional manner.

29. The method according to claim 27, wherein the second limb comprises a T-fluted configuration defining recesses in fluid communication with the second lumen.

30. The method according to claim 27, wherein the predetermined threshold pressure is a pressure of from about 8 to about 14 mm Hg.

31. The method according to claim 27, further comprising conditioning the dialysate fluid before introducing the fluid into the container.

32. The method according to claim 31, wherein said conditioning comprises passing the fluid through a bioreactor containing hepatocytes.

33. The method according to claim 32, wherein the bioreactor comprises means for contacting the fluid with hepatocytes.

34. The method according to claim 31, wherein said conditioning comprises dialyzing the fluid.

35. A device for treating a patient for hepatic insufficiency, comprising:

a fluid container;

a first conduit having a proximal end in fluid communication with the container for passing fluid from the container into a patient'"'"'s peritoneal cavity through a distal end of the conduit;

a second conduit having a proximal end in fluid communication with the container and a distal end in fluid communication with the peritoneal cavity for moving fluid from the peritoneal cavity to the container; and

a bioreactor in fluid communication with the second conduit for conditioning the fluid;

wherein the bioreactor contains hepatocytes and is configured to contact the fluid with the hepatocytes.

36. A device for treating a patient for hepatic insufficiency, comprising:

a fluid container;

a first conduit in fluid communication with the container;

a second conduit in fluid communication with the container;

a catheter having a proximal end, a first lumen and a second lumen, wherein the proximal end of the first lumen is in fluid communication with the first conduit, wherein the proximal end of the second lumen is in fluid communication with the second conduit, and wherein the first and second lumens have distal ends positioned in a patient'"'"'s peritoneal cavity such that the first and second lumens are in fluid communication with the peritoneum, thereby providing a closed fluid circuit;

means for passing fluid from the container, through the first conduit and first lumen and into the peritoneal cavity; and

a bioreactor in fluid communication with the second conduit for conditioning fluid exiting the peritoneal cavity;

wherein the bioreactor contains hepatocytes and is configured to contact the fluid with the hepatocytes.

37. A method for treating a patient for hepatic insufficiency, comprising:

passing a fluid from a fluid container into a patient'"'"'s peritoneal cavity at a rate of from about 20 to about 300 ml/min, the fluid selected from the group consisting of fresh dialysate, conditioned peritoneal fluid and mixtures thereof;

removing peritoneal fluid from the peritoneal cavity at a rate which maintains a fluid pressure in the peritoneum of from about 6 to about 20 mm Hg;

conditioning the peritoneal fluid by contacting the fluid with hepatocytes to provide a conditioned peritoneal fluid; and

introducing the conditioned peritoneal fluid into the container.

38. A method for treating a patient for hepatic insufficiency, comprising:

providing a device comprising a fluid container, a first conduit having a proximal end in fluid communication with the container for passing fluid from the container into a patient'"'"'s peritoneal cavity through a distal end of the conduit, a second conduit having a proximal end in fluid communication with the container for moving fluid from the peritoneal cavity to the container and a bioreactor in fluid communication with the second conduit for conditioning the fluid, wherein the bioreactor contains hepatocytes and is configured to contact the fluid with the hepatocytes;

placing a distal end of the first conduit and a distal end of the second conduit into the peritoneal cavity, thereby providing a closed fluid circuit; and

passing fluid through the circuit, maintaining a fluid pressure within the peritoneal cavity of from about 6 to about 20 mm Hg.

39. A continuous flow peritoneal dialysis system comprising:

a source of peritoneal dialysis fluid;

an inflow line adapted for connection to a first lumen of a member selected from the group consisting of a double-lumen catheter implanted in the peritoneal cavity of a patient and a first single-lumen catheter implanted in the peritoneal cavity of a patient;

an outflow line adapted for connection to a second lumen of a member selected from the group consisting of the double-lumen catheter and a second single-lumen catheter implanted in the peritoneal cavity of a patient; and

a pressure regulator in fluid communication with said outflow line for allowing flow through the outflow line only when a pressure is reached within the peritoneal cavity of from about 6 to about 20 mm Hg, the pressure regulator formed to prevent fluid flow therethrough when the fluid in the second tube has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the second tube has a pressure at least as great as the predetermined threshold pressure;

wherein the predetermined threshold pressure is a pressure of from about 6 to about 20 mm Hg; and

wherein infusion of a dialysate from said dialysate source through said inflow line and into the peritoneal cavity is controlled independent of flow rate in the outflow line.

40. A process for performing continuous flow peritoneal dialysis, comprising:

providing a dialysate flow circuit in fluid communication with a patient'"'"'s peritoneal cavity, the circuit including a dialysate source, an inflow line, an outflow line and a pressure regulator in fluid communication with the outflow line, the pressure regulator being formed to prevent fluid flow therethrough when the fluid in the outflow line has a pressure less than a predetermined threshold pressure and to pass fluid therethrough when the fluid in the outflow line has a pressure at least as great as the predetermined threshold pressure;

passing dialysate into the patient'"'"'s peritoneal cavity through the inflow line at a rate of from about 20 to about 300 ml/min; and

recovering peritoneal fluid from the peritoneal cavity through the outflow line, provided that fluid is recovered only when fluid in the peritoneal cavity reaches the predetermined pressure.

41. The process in accordance with claim 40, wherein the rate that dialysate is passed into the patient'"'"'s peritoneal cavity is controlled independent of flow rate in the outflow line.