Apparatus and method for peritoneal dialysis

• US 20020123715A1
• Filed: 09/24/2001
• Published: 09/05/2002
• Est. Priority Date: 09/22/2000
• Status: Active Grant

• Current Assignee: Sorenson Development, Incorporated
• Original Assignee: Sorenson Development, Incorporated
• Inventors: Sorenson, James LeVoy, Winterton, Reed F., Smith, Gloria, Haight, LeVoy G., McNeil, Frank
• Granted Patent: US 6,913,590 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 1/285 Catheters therefor
• CPC Class Codes: A61M 2209/088 on the body

Abstract

An apparatus and method for treatment of end stage renal decline and failure through peritoneal dialysis enabling ambulatory transfer of dialysate to and from the peritoneum of a renal patient, this in synthesis and coordination with normal physiological rhythms of the patient. The system remains unobtrusive and less restrictive of patient ambulation and orientation. The present invention includes expendables disposability of which facilitates safe reuse of more expensive portions and is sufficiently simple for use in a home care environment. It may be designed to incorporate real-time, interactive or remote monitoring and regulation and visual or audible indication of system pressures, chemical balances and other important variables.

Claims

1. A device system for treatment of and support during renal decline or failure, comprising:

a portable pump including a disposable cartridge interface;

a receptacle system comprising exhausted dialysate storage capacity and unused or recycled dialysate storage capacity, designed selectively to be worn by a patient;

a conduit structured and arranged to support passage of unused or recycled dialysate to and exhausted dialysate from a peritoneum of the patient;

a filter assembly associated with the conduit and structured and arranged to permit filtering of both air and contaminants from unused or recycled dialysate; and

indicator means whereby at least one physiological, therapeutic or diagnostic variable but potentially any of a plurality of variables may be monitored or regulated to determine and establish any or all of an optimal dynamic dosage or optimal dynamic regime or optimal dynamic protocol, thereby to achieve a desired therapeutic balance.

2. The system of claim 1, wherein said indicator means enables detection of achievement of the desired therapeutic balance.

3. The system of claim 1, wherein said variables may be monitored or regulated selectively automatically or by direct intervention.

4. The system of claim 1, wherein said variables may be monitored or regulated from a source remote from the patient.

5. The system of claim 1, wherein said variables may comprise, alone or in combination, dialysate temperature or dialysate flow volume or dialysate flow direction or dialysate flow timing or dialysate chemistry balance including albumen, urea, uric acid, creatinine, creatine, pH, ions or electrolytes.

6. The system of claim 5, wherein said variables may further comprise body temperature, residual pressure or blood content of the patient and be monitored or regulated with detection structure located proximal or within the body of the patient.

7. The system of claim 5, wherein said variables may be monitored or regulated with detection structure associated with the conduit.

8. The system of claim 5, wherein said variables may be monitored or regulated with detection structure associated with the pump.

9. The system of claim 5, wherein said variables may be monitored or regulated with detection structure associated with the receptacle system.

10. The system of claim 1, wherein the conduit comprises a plurality of lumens, a first of which lumens is structured and arranged to support passage of exhausted dialysate from a peritoneum of the patient, and a second of which lumens is structured and arranged to support passage of unused or recycled dialysate to the peritoneum.

11. The system of claim 10, wherein said exhausted dialysate is admitted and said unused or recycled dialysate is delivered in alternating sequence.

12. The system of claim 10, wherein the first of which lumens comprises a corresponding first distal orifice, and the second of which lumens comprises a corresponding second distal orifice, wherein said first and second distal orifices may be located within the peritoneum at respective sites remote from each other.

13. The system of claim 10, wherein said passage of dialysate may be in the form of a pulsating flow.

14. The system of claim 13, wherein said pulsating flow through the first and second distal orifices may be coordinated to increase dialysate circulation within the peritoneum.

15. The system of claim 10, wherein said exhausted dialysate is admitted and said unused or recycled dialysate is delivered simultaneously.

16. The system of claim 1, wherein said receptacle system comprises a polymer bag comprising a first wall and an opposing second wall, and includes at least one opening in fluid communication with said conduit.

17. The system of claim 1, wherein said receptacle system includes structure attached to an inner side of the first wall and to an opposing inner side of the second wall to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

18. The system of claim 1, wherein said receptacle system includes a dimensionally stable or a semi-rigid encasement structured and arranged to abut the bag against at least one of said walls to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

19. The system of claim 18, wherein said encasement comprises a single plate in combination with a patient vest.

20. The system of claim 18, wherein said encasement comprises a single plate in combination with a pocket.

21. The system of claim 19, wherein said patient vest comprises any of at least two sides which may include a front side, back side, left side and right side.

22. A device system for treatment and support during renal decline or failure, comprising:

a portable pump including a disposable cartridge interface;

a receptacle system comprising exhausted dialysate storage capacity and unused or recycled dialysate storage capacity, designed selectively to be worn by a patient;

a conduit;

a filter assembly associated with the delivery conduit and structured and arranged to permit filtering of both air and contaminants from unused or recycled dialysate;

wherein the conduit comprises a plurality of lumens, a first of which lumens is structured and arranged to support passage of exhaused dialysate from a peritoneum of the patient, and a second of which lumens is structured and arranged to support passage of unused or recycled dialysate to the peritoneum.

23. The system of claim 22, wherein said exhausted dialysate is admitted and said unused or recycled dialysate is delivered in alternating sequence.

24. The system of claim 22, wherein the first of which lumens comprises a corresponding first distal orifice, and the second of which lumens comprises a corresponding second distal orifice, wherein said first and second distal orifices may be located within the peritoneum at respective sites remote from each other.

25. The system of claim 22, wherein said passage of dialysate may be in the form of a pulsating flow.

26. The system of claim 25, wherein said pulsating flow through the first and second distal orifices may be coordinated to increase rate, frequency and magnitude of dialysate circulation along, against and among epithelial and other tissues of and within the peritoneum.

27. The system of claim 22, wherein said exhausted dialysate is admitted and said unused or recycled dialysate is delivered simultaneously.

28. The system of claim 22, further comprising indicator means whereby at least one but potentially any of a plurality of therapeutic variables may be monitored or regulated to determine and establish any or all of an optimal dynamic dosage or optimal dynamic regime or optimal dynamic protocol, thereby to achieve a desired therapeutic balance.

29. The system of claim 28, wherein said therapeutic variables may be monitored or regulated with detection structure associated with the conduit.

30. The system of claim 28, wherein said therapeutic variables may further comprise body temperature or blood content of the patient and be monitored or regulated with detection structure located within the body of the patient.

31. The system of claim 22, wherein said receptacle system comprises a polymer bag comprising a first wall and an opposing second wall, and includes at least one opening in fluid communication with said conduit.

32. The system of claim 22, wherein said receptacle system includes structure attached to an inner side of the first wall and to an opposing inner side of the second wall to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

33. The system of claim 22, wherein said receptacle system includes a dimensionally stable or a semi-rigid encasement structured and arranged to abut the bag against at least one of said walls to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

34. The system of claim 33, wherein said encasement comprises a single plate in combination with a patient vest.

35. The system of claim 33, wherein said encasement comprises a single plate in combination with a pocket.

36. The system of claim 34, wherein said patient vest comprises any of at least two sides which may include a front side, back side, left side and right side.

38. The system of claim 37, wherein said vest may be configured to support said receptacle system irrespective of location, orientation or movement of the patient.

39. The system of claim 37, wherein said receptacle system comprises a polymer bag comprising a first wall and an opposing second wall, and includes at least one opening in fluid communication with said conduit.

40. The system of claim 37, wherein said receptacle system includes structure attached to an inner side of the first wall and to an opposing inner side of the second wall to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

41. The system of claim 37, wherein said receptacle system includes a dimensionally stable or a semi-rigid encasement structured and arranged to abut the bag against at least one of said walls to retain the cross-sectional dimension of the bag within a limited range of distention of the bag when a dialysate is in the bag without limiting flow of the dialysate therein or therethrough.

42. The system of claim 41, wherein said encasement comprises a single plate in combination with the vest.

43. The system of claim 41, wherein said encasement comprises a single plate in combination with a pocket.

44. The system of claim 37, wherein said patient vest comprises any of at least two sides which may include a front side, back side, left side and right side.

45. The system of claim 44, wherein said patient vest further comprises means of affixing the vest in close proximity to the body of said patient.

46. The system of claim 45, wherein said affixing means comprise, alone or in combination, any of either Velcro®

or buckles or straps or button structure with corresponding eye structure or ties or zipper or belt or at least one hole through which an arm of a patient may be placed.

47. The system of claim 44, wherein a pouch is associated with at least one of said sides whereby at least a portion of said receptacle system may be enveloped within the pouch.

48. The system of claim 37, further comprising indicator means whereby at least one therapeutic variable but potentially any of a plurality of therapeutic variables may be monitored or regulated to determine and establish any or all of an optimal dynamic dosage or optimal dynamic regime or optimal dynamic protocol, thereby to achieve a desired therapeutic balance.

49. The system of claim 37, wherein said indicator means enables detection of achievement of the desired therapeutic balance.

50. The system of claim 37, wherein said therapeutic variables may be monitored or regulated selectively automatically or by direct intervention.

51. The system of claim 37, wherein said therapeutic variables may be monitored or regulated from a source remote from the patient.

52. The system of claim 37, wherein said therapeutic variables may comprise, alone or in combination, dialysate temperature or dialysate flow volume or dialysate flow direction or dialysate flow timing or dialysate chemistry balance including albumen, urea, uric acid, creatinine, creatine, pH, ions or electrolytes.

53. The system of claim 52, wherein said therapeutic variables may further comprise body temperature, residual pressure or blood content of the patient and be monitored or regulated with detection structure located proximal or within the body of the patient.

54. The system of claim 52, wherein said therapeutic variables may be monitored or regulated with detection structure associated with the conduit.

55. The system of claim 52, wherein said therapeutic variables may be monitored or regulated with detection structure associated with the pump.

56. The system of claim 52, wherein said therapeutic variables may be monitored or regulated with detection structure associated with the receptacle system.

58. The method of claim 57, wherein a selected volume of unused or recycled dialysate, which is in excess of the therapeutic volume and is sufficient to accomplish dialysis through an extended period of time during which the patient may be in a sleeping condition, may be selectively introduced to the peritoneum of the patient.

59. The method of claim 57, wherein said bag further includes structure attached to one inner side of the bag and to the opposing inner side of the bag to retain the cross-sectional dimension of the bag at a limited degree of distention without limiting flow of a dialysate within or through the bag.

60. The method of claim 57, wherein said exhausted dialysate may be removed and said unused or recycled dialysate may be infused simultaneously.

61. The method of claim 57, wherein said exhausted dialysate undergoes a process that extends its useful life.

62. The method of claim 61, wherein said process comprises subjection to a pulsating flow pattern.

63. The method of claim 61, wherein said process comprises, alone or in combination, filtration or chemical modification.

64. The method of claim 57, wherein said delivery conduit is structured and arranged to permit said passage or reciprocal circulation of exhausted dialysate from and unused or recycled dialysate to the peritoneum selectively either simultaneously or sequentially.

65. The method of claim 57, wherein said delivery conduit includes a plurality of lumens, a first of which lumens comprises a corresponding first distal orifice and is structured and arranged to permit passage of exhausted dialysate from the peritoneum and a second of which lumens, comprises a corresponding second distal orifice and permits passage of unused or recycled dialysate to the peritoneum.

66. The method of claim 65, wherein said first distal orifice may be located within the peritoneum at a site remote from said second distal orifice.

67. The method of claim 57, wherein said therapeutic variables may comprise, alone or in combination, body temperature or blood content of the patient or dialysate temperature or dialysate flow volume or dialysate flow direction or dialysate flow timing or dialysate chemistry balance including albumen, urea, uric acid, creatinine, creatine, pH, ions or electrolytes.

68. The method of claim 57, wherein said therapeutic variables may be monitored or regulated selectively automatically or by direct intervention.

69. The method of claim 57, wherein said operating conditions may be monitored or regulated from a source remote from the patient.

70. The method of claim 57, wherein said device system further comprises a patient vest structured and arranged to support the receptacle system proximal to and with minimal cross-sectional extension from the patient.

71. The method of claim 57, wherein said method may be performed irrespective of the location, orientation or movement of the patient.

72. The system of claim 22, further comprising a third lumen that carries circuitry to deliver data from at least one probe that measures therapeutic or physiologic or diagnostic parameters of the fluid adjacent the peritoneum.

37. A device system for treatment and support during renal decline or failure, comprising:

a portable pump including a disposable cartridge interface;

a receptacle system comprising exhausted dialysate storage capacity and unused or recycled dialysate storage capacity, designed selectively to be worn by a patient;

a conduit structured and arranged to support passage of unused or recycled dialysate to and exhausted dialysate from a peritoneum of the patient;

a filter assembly associated with the delivery conduit and structured and arranged to permit filtering of both air and contaminants from unused or recycled dialysate; and

a patient vest structured and arranged to support the receptacle system proximal to and with minimal cross-sectional extension from the patient.

57. A method of performing peritoneal dialysis, comprising:

A. selection of a device system for treatment of renal decline or failure, wherein said device system comprises;

1. a portable pump including a disposable cartridge interface;

2. a receptacle system comprising exhausted dialysate storage capacity and unused or recycled dialysate storage capacity designed selectively to be worn by a renal patient, wherein said receptacle may comprise a polymer bag with at least one opening in fluid communication with said conduit;

3. a delivery conduit structured and arranged to support passage of exhausted dialysate from and unused dialysate to the peritoneum of the patient;

4. a filter assembly associated with the delivery conduit and structured and arranged to permit filtering of both air and contaminants from unused or recycled dialysate; and

5. indicator means whereby at least one but potentially any of a plurality of therapeutic variables may be monitored and regulated to achieve a desired therapeutic balance;

B. association of said device system with an indwelling dialysis catheter such that substantially all of an amount of exhausted dialysate within a peritoneum of the patient may be removed; and

C. infusion of a therapeutic volume of unused or recycled dialysate optimal for treatment of the patient.