Fluid circuit for delivery of renal replacement therapies

• US 10,010,663 B2
• Filed: 02/01/2013
• Issued: 07/03/2018
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Meyer, Thomas E., Lura, David B., Pudil, Bryant J., Gerber, Martin T.
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US13/757,693
• Publication Number:
  US 20140217029A1
• Time in Patent Office: 1,978 Days
• Field of Search: 210137, 210143, 210646, 210647
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/1566 Means for adding solutions or substances to the treating fluid
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/1652 Holding or locking systems for the membrane unit
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/3465 using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 using dialysate as priming or rinsing liquid

Abstract

A flow loop for hemodialysis, hemodiafiltration and hemofiltration for the treatment of pathological conditions such as End Stage Renal Disease (ESRD) that has a controlled compliant flow path for preparing fluids required for a hemodialysis therapy session from water. The controlled compliant flow path modifies water into any one of a solution for priming a hemodialysis system, a physiologically compatible solution for contacting blood, a physiologically compatible solution for infusion to a subject, and a solution for blood rinse back to a subject. The controlled compliant flow path has a means for selectively metering in and metering out fluid from the flow path.

Claims

1. A flow loop for hemodialysis, comprising:

a controlled compliant flow path for preparing fluids required for a hemodialysis therapy session from water wherein the controlled compliant flow path modifies water into any one of a solution for priming a hemodialysis system, a physiologically compatible solution for contacting blood, a physiologically compatible solution for infusion to a subject, and a solution for blood rinse back to a subject;

said controlled compliant flow path having a pump for selectively metering in and metering out fluid from the flow path and a solution regeneration system removing specific dissolved solutes from the dialysate;

a first bypass conduit recirculating dialysate having at least one control valve positioned upstream of the solution regeneration system that can be operated to selectively convey solution that has not passed through the solution regeneration system to a point upstream of the control valve without the solution first passing through a dialyzer; and

a second bypass conduit having at least one pump;

the second bypass conduit having an inlet positioned downstream of the solution regeneration system and upstream of the dialyzer; and

an outlet positioned downstream of the dialyzer and upstream of the solution regeneration system;

the second bypass conduit comprising a buffer source or a sodium source.

2. The flow loop for hemodialysis of claim 1, wherein the pump for selectively metering in and metering out fluid from the controlled compliant flow path is a fluid balance control pump in fluid communication with the controlled compliant flow path and a reservoir.

3. The flow loop for hemodialysis of claim 1, wherein the controlled compliant flow path has a first pump for circulating a dialysate from a dialysate outlet of the dialyzer to a dialysate inlet of the dialyzer, a one-way valve allowing only solution efflux from the dialyzer outlet, the solution regeneration system having at least one port for solution influx and at least one port for efflux of a solution, a second pump in fluid communication with the controlled compliant flow path and a reservoir containing a cation infusate source, a degassing module with at least one port for influx of a solution that may contain a gas and at least one port for efflux of a solution that can optionally have at least a portion of the gas removed and a gas port in fluid communication with a second control valve that can be operated to selectively allow gas ingress and egress through the gas port, a microbial filter with at least one port for receiving a solution that may contain microorganisms and endotoxins and at least one port for efflux of a solution to a dialysate inlet port of the dialyzer wherein at least a portion of the microorganisms and endotoxins are removed from the solution.

4. The flow loop for hemodialysis of claim 3, further comprising a third bypass conduit having at least a third control valve that can be operated to selectively convey solution that has passed through the solution regeneration system to a point downstream of the one way valve without the solution first passing through the dialyzer.

5. The flow loop for hemodialysis of claim 1, further comprising a pump in fluid communication with a conduit of the controlled compliant flow path and a water source.

19. A system for hemodialysis, comprising:

a dialyzer in fluid communication with an extracorporeal flow path, the extracorporeal flow path having a conduit for receiving blood from a subject and a conduit for returning blood to the subject; and

the dialyzer in fluid communication with the flow loop of claim 1.

20. The system for hemodialysis of claim 19, further comprising at least one valve that can be operated to selectively permit flow through any one of the conduits of the extracorporeal flow path, at least one gas detector to detect gas passing through the conduit for receiving blood from a subject of the extracorporeal flow path, at least one valve that can be operated to selectively permit flow through the conduit for returning blood to the subject, and at least one gas detector to detect gas passing through the conduit for returning blood to the subject, and an extracorporeal flow path pump to convey fluid through the extracorporeal flow path.

25. The system in any one of claims 19, 21 and 23 wherein a fluid source is contained in a reservoir and a bypass conduit returns the fluid to the reservoir and the reservoir is vented.

26. The system in any one of claims 19, 21 and 23 wherein the controlled compliant flow path further comprises a heater and at least one temperature sensor to control the temperature of the fluid.

27. The system in any one of claims 19, 21 and 23 wherein any pump is a bi-directional pump.

28. The system in any one of claims 19, 21 and 23 wherein any pump is not a bi-directional pump.

29. The system in any one of claims 19, 21 and 23 wherein the pump for selectively metering in and metering out fluid from the controlled compliant flow path is at least one bi-directional pump causing fluid to move bi-directionally between the controlled compliant flow path and the extracorporeal flow path.

30. The system in any one of claims 19, 21 and 23 wherein a microbial filter, or combination of microbial filters, reduces bacteria in fluid delivered to the inlet port of a dialyzer, hemofilter or to a conduit of an extracorporeal flow path to less than about 0.1 colony forming unit (cfu)/mL where cfu is the number of viable cells per unit volume, and detectable endotoxins in the dialysate to less than about 0.03 Endotoxin Units unit (EU/mL) prior to the fluid entering the dialyzer, hemofilter or conduit of the extracorporeal flow path.

31. The system in any one of claims 19, 21 and 23 wherein the controlled compliant flow path further comprises an ammonia detector and a controller that can operate a control valve to divert the solution flow through a second bypass conduit based on ammonia detection.

32. The system in any one of claims 19, 21 and 23 wherein the controlled compliant flow path further comprises a conductivity sensor and a controller that can operate a control valve to divert the solution flow through a second bypass conduit if the conductivity is outside of predetermined limits.

33. The systems of claim 29, wherein the control reservoir accepts fluid volume removed from a subject.

34. The systems of claim 28, wherein the control reservoir further accepts fluid volume removed from the system at conclusion of a therapy session, said fluid volume removed comprising any of:

fluid volume from an extracorporeal flow path, fluid volume from an infusate reservoir, fluid volume removed from a conditioning conduit flow path, fluid volume removed from a first bypass conduit, fluid volume removed from a solution flow conduit.

70. The flow loop of claim 1, the first bypass conduit further comprising a water reservoir in communication with a flow restriction, the water reservoir including thereupon a vent opening to allow release air bubbles out from the water reservoir.

71. The flow loop of claim 5, wherein the sodium source includes a sodium cartridge and the buffer source includes a bicarbonate cartridge.

76. The flow loop of claim 1, wherein the first bypass conduit further includes a flow restriction to induce de-aeration, the flow restriction including at least one of an orifice and a venturi.

77. The flow loop of claim 1, wherein the first bypass conduit is a de-aeration bypass conduit.

78. The flow loop of claim 1, wherein the sodium source is a dry sodium source, the buffer source is a dry buffer source, or combinations thereof.

79. The flow loop of claim 1, the second bypass conduit comprising both a buffer source and a sodium source;

and further comprising at least one valve controlling an amount of fluid that passes through each of the sodium source and buffer source.

6. A flow loop for hemodiafiltration, comprising:

a controlled compliant flow path for preparing fluids required for a hemodiafiltration therapy session from water wherein the flow path modifies water into any one of a solution for priming a hemodiafiltration system, a physiologically compatible solution for contacting blood, a physiologically compatible solution for infusion to a subject, and a solution for blood rinse back to a subject;

said controlled compliant flow path having a pump for selectively metering in and metering out fluid from the controlled compliant path and a solution regeneration system removing specific dissolved solutes from the dialysate;

a first bypass conduit recirculating dialysate having at least one control valve positioned upstream of the solution regeneration system that can be operated to selectively convey solution that has not passed through the solution regeneration system to a point upstream of the control valve without the solution first passing through a hemofilter; and

a second bypass conduit having at least one pump;

the second bypass conduit having an inlet positioned downstream of the solution regeneration system and upstream of the hemofilter; and

an outlet positioned downstream of the hemofilter and upstream of the solution regeneration system;

the second bypass conduit comprising a buffer source or a sodium source.

7. The flow loop for hemodiafiltration of claim 6, wherein the pump for selectively metering in and metering out fluid from the controlled compliant flow path is a fluid balance control pump in fluid communication with the controlled compliant flow path and a reservoir.

8. The flow loop for hemodiafiltration of claim 6, wherein the controlled compliant flow path has a first pump for circulating a dialysate from a dialysate outlet of the dialyzer to a dialysate inlet of the dialyzer, a one-way valve allowing only solution efflux from the dialyzer outlet, the solution regeneration system having least one port for solution influx and at least one port for efflux of a solution, a second pump in fluid communication with the controlled compliant flow path and a reservoir containing a cation infusate source, a degassing module with at least one port for influx of a solution that may contain a gas and at least one port for efflux of a solution that can optionally have at least a portion of the gas removed and a gas port in fluid communication with a second control valve that can be operated to selectively allow gas ingress and egress through the gas port, a first microbial filter with at least one port for receiving a solution that may contain microorganisms and endotoxins and at least one port for efflux of a solution to a dialysate inlet port of the dialyzer wherein at least a portion of the microorganisms and endotoxins are removed from the solution.

9. The flow loop for hemodiafiltration of claim 8, further comprising a pump in fluid communication with a dialysate inlet port of a dialyzer and an outlet port of the first microbial filter and an inlet port of a second microbial filter, the second microbial filter having at least one port for influx of a solution that may contain microorganisms and endotoxins and at least one port for efflux of a solution having at least a portion of the microorganisms or endotoxins removed wherein the outlet port of the second microbial filter is in fluid communication with an extracorporeal flow path, the extracorporeal flow path having a conduit for receiving blood from a subject and a conduit for returning blood to the subject.

10. The flow loop for hemodiafiltration of claim 8, further comprising a third bypass conduit having at least a third control valve that can be operated to selectively convey solution that has passed through the solution regeneration system to a point downstream of the one way valve without the solution first passing through the dialyzer.

11. The flow loop for hemodiafiltration of claim 6, further comprising a pump in fluid communication with a conduit of the controlled compliant flow path and a water source.

21. A system for hemofiltration comprising:

a hemofilter in fluid communication with an extracorporeal flow path, the extracorporeal flow path having a conduit for receiving blood from a subject and a conduit for returning blood to the subject; and

the hemofilter in fluid communication with the flow loop of claim 6.

22. The system for hemofiltration of claim 21, further comprising at least one valve that can be operated to selectively permit flow through any one of the conduits of the extracorporeal flow path, at least one gas detector to detect gas passing through the conduit for receiving blood from a subject of the extracorporeal flow path, at least one valve that can be operated to selectively permit flow through the conduit for returning blood to the subject, and at least one gas detector to detect gas passing through the conduit for returning blood to the subject, and a extracorporeal flow path pump to convey fluid through the extracorporeal flow path.

72. The flow loop of claim 6, the first bypass conduit further comprising a water reservoir in communication with a flow restriction, the water reservoir including thereupon a vent opening to allow release air bubbles out from the water reservoir.

73. The flow loop of claim 11, wherein the sodium source includes a sodium cartridge and the buffer source includes a bicarbonate cartridge.

12. A flow loop for hemofiltration, comprising:

a controlled compliant flow path for preparing fluids required for a hemofiltration therapy session from water wherein the controlled compliant flow path modifies water into any one of a solution for priming a hemofiltration system, a physiologically compatible solution for infusion to a subject, a physiologically compatible solution for contacting blood, and a solution for blood rinse back to a subject;

said controlled compliant flow path having a pump for selectively metering in and metering out fluid from the controlled compliant flow path and a solution regeneration system removing specific dissolved solutes from the dialysate;

a first bypass conduit recirculating dialysate having at least one control valve positioned upstream of the solution regeneration system that can be operated to selectively convey solution that has not passed through the solution regeneration system to a point upstream of the control valve without the solution first passing through a hemofilter; and

a second bypass conduit having at least one pump;

the second bypass conduit having an inlet positioned downstream of the solution regeneration system and upstream of the dialyzer; and

an outlet positioned downstream of the dialyzer and upstream of the solution regeneration system;

the second bypass conduit comprising a buffer source or a sodium source.

13. The flow loop for hemofiltration of claim 12, wherein the pump for selectively metering in and metering out fluid from the controlled compliant flow path is a fluid balance control pump in fluid communication with the controlled compliant flow path and a reservoir.

14. The flow loop for hemofiltration of claim 12, wherein the controlled compliant flow path has a first pump for circulating a filtrate from a filtrate outlet of the hemofilter to a filtrate inlet of the hemofilter, a one-way valve allowing only solution efflux from the hemofilter outlet, the solution regeneration system having at least one port for solution influx and at least one port for efflux of a solution, a second pump in fluid communication with the controlled compliant flow path and a reservoir containing a cation infusate source, a degassing module with at least one port for influx of a solution that may contain a gas and at least one port for efflux of a solution that can optionally have at least a portion of the gas removed and a gas port in fluid communication with a second control valve that can be operated to selectively allow gas ingress and egress through the gas port.

15. The flow loop for hemofiltration of claim 14, further comprising a first microbial filter with at least one port for receiving a solution that may contain microorganisms and endotoxins and at least one port for efflux of a solution in fluid communication with an inlet port of a second microbial filter, the second microbial filter having at least one port for influx of a solution that may contain microorganisms and endotoxins and at least one port for efflux of a solution that has at least a portion of the microorganisms or endotoxins removed wherein the efflux port of the second microbial filter is in fluid communication with a conduit of an extracorporeal flow path, the extracorporeal flow path having a conduit for receiving blood from a subject and a conduit for returning blood to the subject.

16. The flow loop for hemofiltration of claim 14, further comprising a third bypass conduit having at least a third control valve that can be operated to selectively convey solution that has passed through the solution regeneration system to a point downstream of the one way valve without the solution first passing to a port of an extracorporeal flow path.

17. The flow loop for hemofiltration of claim 12, further comprising a pump in fluid communication with a conduit of the controlled compliant flow path and a water source.

18. The flow loop of claim 3, 8, or 14 wherein the solution regeneration system is comprised of more than one sorbent cartridge or sorbent container.

23. A system for hemodiafiltration comprising:

a dialyzer in fluid communication with an extracorporeal flow path, the extracorporeal flow path having a conduit for receiving blood from a subject and a conduit for returning blood to the subject; and

the hemofilter in fluid communication with the flow loop of claim 12.

24. The system for hemodiafiltration of claim 23, further comprising at least one valve that can be operated to selectively permit flow through any one of the conduits of the extracorporeal flow path, at least one detector to detect gas passing through the conduit for receiving blood from a subject of the extracorporeal flow path, at least one valve that can be operated to selectively permit flow through the conduit for returning blood to the subject, and at least one detector to detect gas passing through the conduit for returning blood to the subject, and a extracorporeal flow path pump to convey fluid through the extracorporeal flow path.

74. The flow loop of claim 12, the first bypass conduit further comprising a water reservoir in communication with a flow restriction, the water reservoir including thereupon a vent opening to allow release air bubbles out from the water reservoir.

75. The flow loop of claim 17, wherein the sodium source includes a sodium cartridge and the buffer source includes a bicarbonate cartridge.

35. A method for preparing a fluid for conducting a hemodialysis, hemofiltration or hemodiafiltration treatment, comprising the steps of:

providing a source of water to a system, wherein the system comprises a controlled compliant flow path for any one or more of;

(a) preparing fluids required for a hemodialysis therapy session from water;

(b) preparing fluids required for a hemodiafiltration therapy session from water;

or (c) preparing fluids required for a hemofiltration therapy session from water;

wherein the system has a solution conduit flow path, an extracorporeal conduit flow path and a conditioning conduit flow path;

wherein the extracorporeal conduit flow path is in fluid communication with the solution conduit flow path through a semi-permeable membrane and the solution conduit flow path is in fluid communication with the conditioning conduit flow path; and

wherein the solution conduit flow path is a controlled compliant flow path having a pump for selectively metering in and metering out fluid from the controlled compliant flow path;

a solution regeneration system removing specific dissolved solutes from a fluid in the controlled compliant flow path;

a first bypass conduit recirculating dialysate having at least one control valve positioned upstream of the solution regeneration system that can be operated to selectively convey solution that has not passed through the solution regeneration system to a point upstream of the control valve without the solution first passing through a dialyzer or hemofilter; and

a second bypass conduit having at least one pump;

the second bypass conduit having an inlet positioned downstream of the solution regeneration system and upstream of the dialyzer or hemofilter; and

an outlet positioned downstream of the dialyzer or hemofilter and upstream of the solution regeneration system;

the second bypass conduit comprising a buffer source or a sodium source and;

configuring the system to bypass the extracorporeal conduit flow path, the system having a third bypass conduit flow path for conveyance of fluid through a first segment of the solution conduit flow path without contacting the semi-permeable membrane;

conveying water from the source through a reduced cross-sectional area conduit to separate a first portion of a dissolved gas from the water;

conveying water from the source through the conditioning conduit flow path;

reconstituting an electrolyte source to generate a physiologically compatible fluid;

conveying the physiologically compatible fluid through the first segment of the solution conduit flow path;

wherein the physiologically compatible fluid is any one of a priming fluid, a flushing fluid for a dialyzer and/or an extracorporeal flow path, dialysate, replacement fluid, a reserve for bolus infusion, or blood rinse back.

36. The method of claim 35, wherein the method does not include the step of conveying water from the source through a reduced cross-sectional area conduit to separate a first portion of a dissolved gas from the water.

37. The method of claim 35 wherein the semi-permeable membrane is a dialysis membrane or a microbial filter.

38. The method of claim 35, further comprising the step of controlling a flow of fluid through the conditioning conduit flow path based on an indication of a fluid conductivity in the first segment of the solution conduit flow path wherein the flow of water is controlled by a pump.

39. The method of claim 35, further comprising the step of controlling a salination pump rate based, at least in part, on an indication of a fluid conductivity in the first segment of the solution conduit flow path.

40. The method of claim 35, further comprising the step of controlling a salination pump rate based, at least in part, on the flow rate of fluid through the solution conduit flow path.

41. The method of claim 35, further comprising the step of collectively controlling a water pump rate, a control pump rate, and a salination pump rate based on an indication of a fluid conductivity in the first segment of the solution conduit flow path.

42. The method of claim 35, wherein the conditioning conduit flow path includes a sodium source.

43. The method of claim 42, further comprising the step of reconstituting the sodium source.

44. The method of claim 42, where the sodium source does not provide water to the system.

45. The method of claim 35, comprising removing an impurity from the water, where the solution conduit flow path includes a sorbent cartridge.

46. The method of claim 42, where the sodium source includes an interchangeable sodium chloride cartridge.

47. The method of claim 35, comprising controlling a flow of fluid through the conditioning conduit flow path based on an indication of a fluid conductivity in the first segment of the solution conduit flow path.

48. The method of claim 35, where the conditioning conduit flow path includes a buffer source.

49. The method of claim 48, comprising reconstituting the buffer source.

50. The method of claim 48, wherein the buffer source does not provide water to the system.

51. The method of claim 48, comprising removing an impurity from the water, wherein the solution conduit flow path includes a sorbent cartridge.

52. The method of claim 48, where the buffer source includes an interchangeable bicarbonate cartridge.

53. The method of claim 48, comprising controlling a flow of fluid through the conditioning conduit flow path based, at least in part, on an indication of a fluid conductivity in the first segment of the solution conduit flow path.

54. The method of claim 48, further comprising the step of controlling a salination pump rate based, at least in part, on the flow rate of fluid through the solution conduit flow path.

55. The method of claim 35, wherein the conditioning conduit flow path includes a sodium source and a buffer source.

56. The method of claim 55, wherein the sodium source comprises an interchangeable sodium chloride cartridge and the buffer source comprises an interchangeable bicarbonate cartridge.

57. The method of claim 55, wherein the conditioning conduit flow path has a sodium conduit flow path and a buffer conduit flow path, the sodium conduit flow path comprising the sodium source and the buffer conduit flow path comprising the buffer source, wherein the sodium conduit flow path and the buffer conduit flow path are configured in parallel.

58. The method of claim 57, comprising operating a single valve to control a first flow of fluid through the sodium conduit flow path and a second flow of fluid through the buffer conduit flow path.

59. The method of claim 58, comprising operating the single valve to control the first flow of fluid based, at least in part, on an indication of a fluid conductivity in the first segment of the solution conduit flow path.

60. The method of claim 55, further comprising the step of controlling a salination pump rate based, at least in part, on the flow rate of fluid through the solution conduit flow path.

61. The method of claim 57, where the sodium conduit flow path comprises the sodium chloride cartridge and the buffer conduit flow path comprises the bicarbonate cartridge.

62. The method of claim 61, comprising operating a single valve to interchange between conveying water through the sodium chloride cartridge and conveying water through the bicarbonate cartridge.

63. The method of claim 35, comprising removing an impurity from the water, where the solution conduit flow path includes a sorbent cartridge.

64. The method of claim 35, comprising augmenting the physiologically compatible fluid with a cation source to generate a dialysate or replacement fluid solution.

65. The method of claim 35, comprising transferring a first portion of the physiological-compatible fluid from the solution conduit flow path to a control reservoir, wherein the system includes a pump and the system has a controlled compliant solution flow path.

66. The method of claim 65, further comprising operating the pump to cause fluid volume to move from a subject to the control reservoir.

67. The method of claim 65, further comprising moving at least a portion of the fluid volume from the system to the control reservoir at conclusion of a therapy session, said fluid volume being selected from any of a fluid volume from an extracorporeal flow path, a fluid volume from an infusate reservoir, a fluid volume removed from a conditioning conduit flow path, a fluid volume removed from a first bypass conduit, and a fluid volume removed from a solution flow conduit.

68. The method of claim 65, where the first portion of the physiological-compatible solution has a reservoir volume approximately equal to any one of a priming volume of the extracorporeal flow path, a volume for additional rinsing of a dialyzer or an extracorporeal flow path, a blood rinse-back reserve volume and a physiological-compatible fluid bolus infusion reserve volume.

69. The method of claim 68 wherein the volume for additional rinsing of the extracorporeal flow path rinses residual sterilant or particulate.