MODULAR FLUID THERAPY SYSTEM HAVING JUMPERED FLOW PATHS AND SYSTEMS AND METHODS FOR CLEANING AND DISINFECTION

• US 20140217020A1
• Filed: 02/01/2013
• Published: 08/07/2014
• 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., Daniels, Mark F.
• Granted Patent: US 10,850,016 B2
• Time in Patent Office: Days
• US Class Current: 210/636
• 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 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3437 downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• 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 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment

Abstract

Systems and methods for cleaning and disinfecting a medical therapy device that delivers any one of hemodialysis, hemodiafiltration and hemofiltration. The system has a base module that has at least one segment of a controlled compliant flow path and at least one pair of jumpered ports configured on the base module. One or more components have connections connectable to the jumpered ports of the base module to provide for fluid communication between the segment of the controlled compliant flow path in the base module and a flow path defined by the one or more components. The base module is connected to the one or more components that define a flow path configurable for carrying out in part at least one function performed during any one of hemodialysis, hemodiafiltration or hemofiltration.

Claims

1. A system, comprising:

a base module having at least one segment of a controlled compliant flow path and at least one pair of jumpered ports configured on the base module;

one or more components having connections connectable to the jumpered ports of the base module to provide for fluid communication between the segment of the controlled compliant flow path in the base module and a flow path defined by the one or more components;

wherein the base module connected to the one or more components defines a flow path configurable for carrying out in part at least one function performed during any one of hemodialysis, hemodiafiltration or hemofiltration.

2. The system of claim 1 wherein the one or more components are selected from a group consisting of a sorbent cartridge, a therapy cassette, a cleaning and/or disinfection concentrate cartridge, a concentrate reservoir, a cleaning manifold, a reservoir, a dialyzer, a hemofilter, a consumables cartridge, a degassing module, a sensor element, a microbial filter, a fluid port jumper, a fluid port cap or plug, a valve, a water source connection, a drain connection, and an extracorporeal flow path.

3. The system of claim 1, wherein the one or more components form the controlled compliant flow path by the inclusion of one or more segments selected from the group consisting of:

a first segment having a sorbent cartridge or a cleaning and/or disinfection concentrate cartridge;

a second segment having a concentrate pump in fluid communication with a concentrate reservoir for addition of a concentrate solution;

a third segment containing a degassing module and a vent control valve in fluid communication with a vent port of the degassing module;

a fourth segment having at least one salination pump or at least one salination valve, and a bypass pathway for conveyance of fluid through a concentrate cartridge to a sorbent cartridge without conveyance through a dialyzer;

a fifth segment having a dialyzer with blood inlet and outlet ports in fluid communication with an extracorporeal flow path and a dialysate inlet port in fluid communication with a first microbial filter and a dialysate outlet port in fluid communication with a one-way valve;

a sixth segment that is a priming or recirculation bypass for conveying fluid from the sorbent cartridge without contacting the dialyzer or passing through a concentrate cartridge;

a seventh segment having a control pump in fluid communication with both a control reservoir and the controlled compliant flow path;

an eighth segment having a water pump in fluid communication with both a water reservoir and the controlled compliant flow path;

a ninth segment having a pump in fluid communication with the controlled compliant flow path for recirculating fluid a de-aeration bypass valve and de-aeration bypass conduit in fluid communication with at least the controlled compliant flow path and an air vent, and a fluid intake bypass valve to direct or to cause fluid movement of fluid from a port of a water reservoir through a flow restriction and pump to de-aerate a fluid;

a tenth segment in fluid communication with both a port of a flush reservoir and a pump in fluid communication with the controlled compliant flow path;

an eleventh segment in fluid communication with at least a port of a water reservoir, a flow restriction and a fluid intake bypass valve;

a twelfth segment in fluid communication with a port of a water reservoir, a de-aeration bypass valve and a pump in fluid communication with the controlled compliant flow path;

a thirteenth segment having a hemofilter with blood inlet and outlet ports in fluid communication with an extracorporeal flow path and a filtrate port in fluid communication with a one-way valve;

a fourteenth segment having a second microbial filter in fluid communication with the extracorporeal flow path and a first microbial filter;

a fifteenth segment having a second microbial filter in fluid communication with the extracorporeal flow path and a replacement fluid pump, the replacement fluid pump being in fluid communication with a first microbial filter and a dialysate inlet port of a dialyzer; and

and combinations thereof.

4. The system of claim 3, wherein bi-directional operation of the pump of the seventh segment of the controlled compliant flow path in coordination with the pumps of the second and eighth segments causes fluid to move bi-directionally between the controlled compliant flow path and the extracorporeal flow path, wherein a flux of fluid moving between the extracorporeal flow path and a subject receiving a treatment is determined by the relationship:

Patient Fluid Balance+Control Pump+Water Pump+Concentrate Pump+Σ

_i=0ⁿX_i=0,

where a positive value for any term is a flux of fluid entering the controlled compliant flow path and the Patient Fluid Balance is the flux of fluid moving from the extracorporeal flow path and the subject;

where X is a volumetric pumping rate of a pump where n can range from 0 to 20.

5. The system of claim 3, wherein bi-directional operation of the pump of the seventh segment of the controlled compliant flow path in coordination with the pumps of the second, eighth and fifteenth segments causes fluid to move bi-directionally between the controlled compliant flow path and the extracorporeal flow path, wherein a flux of fluid moving between the extracorporeal flow path and a subject receiving a treatment is determined by to the relationship:

Patient Fluid Balance+Control Pump+Water Pump+Concentrate Pump+Replacement Fluid Pump+Σ

_i=0ⁿX_i=0,

wherein a positive value for any term is a flux of fluid entering the controlled compliant flow path and the Patient Fluid Balance is the flux of fluid moving from the extracorporeal flow path and the subject;

where X is a volumetric pumping rate of a pump where n can range from 0 to 20.

6. The system of claim 3, wherein the fourth segment or the sixth segment forms part of the controlled compliant flow path.

7. The system of claim 3, wherein the sixth segment further comprises a flow restriction to restrict fluid flow through the sixth segment such that a positive to atmosphere pressure is maintained in the liquid containing compartment of the degas module.

8. The system of claim 3, wherein fluid passes from the third segment to the fifth segment.

9. The system of claim 3, wherein fluid may pass from either the fifth segment or sixth segment to the seventh segment.

10. The system of claim 3, wherein fluid passes first from the fourth segment to the first, second, third, sixth, seventh eighth, or ninth segment, and combinations thereof.

11. The system of claim 3, wherein fluid enters the fourth segment from any one of the first, second, third, sixth, seventh, eighth, ninth segments, and combinations thereof.

12. The system of claim 1, wherein connection of a cleaning manifold to the fluid ports of the base module connects the segments of the controlled compliant flow path within the base module that have been opened by removal of one or more components selected from any of a sorbent cartridge, a therapy cassette, a reservoir, a dialyzer, a consumables cartridge, a concentrate reservoir, a degassing module, a sensor element, a microbial filter, a fluid port jumper, a fluid port cap or plug, a water source or drain connection wherein the controlled compliant flow pathways of the base module are connected to enable fluids to be conveyed through the ports, components and fluid conduits of the base module.

13. The system of claim 3, wherein any one of the tenth, eleventh, or twelfth segments further comprises a valve controlling flow through the segment.

14. The system of claim 3, wherein a cleaning manifold comprises any one of the tenth, eleventh, twelfth segments and combinations thereof.

15. The system of claim 14, wherein a valve is part of a cleaning manifold.

16. The system of claim 15, wherein a valve receives power or control signals by connection to the base module.

17. The system of claim 3, wherein a flush reservoir is integral to a cleaning manifold.

18. The system of claim 3, wherein any segment has a bubble detector to detect air in the segment.

19. The system of claim 1, wherein a fluid connection port of a cleaning manifold comprises a female configuration that seals against an outer, male surface of a mating port having both male and female surfaces wherein at least all female surfaces of the mating port that contact the fluid during therapy are exposed to a cleaning and/or disinfection solution when the cleaning and/or disinfection solution is passed through the system.

20. The system of claim 12, wherein the cleaning manifold connects to the base module to form a fluid flow path for conveying water through the fluid pathways of the ports, components and conduits of a base module and a cleaning and/or disinfection concentrate cartridge to form a disinfection fluid.

21. The system of claim 12, wherein water is metered into the system and the cleaning and/or disinfection fluid is circulated through a resulting fluid flow pathway such that the ports for connecting to the water reservoir are cleaned and/or disinfected without introducing the cleaning and/or disinfection fluid to a water reservoir or water source connection.

22. The system of claim 1, wherein the base module is integral to a main body having doors mounted thereon such that the doors form a protective case when closed and expose the ports of the base unit when opened.

23. The system of claim 22, further comprising a user interface module for receiving user input movably mounted on the main body, the user interface module having a user input surface that is not exposed when the user interface module is in a stowed position and a protective surface that is exposed in the stowed position.

24. The system of claim 23, wherein the user interface is movably mounted on the base module by one or more hinges.

25. The system of claim 22, wherein a water reservoir is mounted on a door that has been opened.

26. The system of claim 22, wherein a sorbent cartridge is mounted on a door that has been opened.

27. The system of claim 22, wherein one or more of a sorbent cartridge, a cleaning and/or disinfection concentrate cartridge, a reservoir, a dialyzer, a consumables cartridge, a concentrate reservoir, a degassing module, a sensor element, a microbial filter, and combinations thereof, are mounted on the system.

28. The system of claim 23, wherein a reservoir, or a portion of a reservoir, is mounted, at least in part, in a vacated space when the user interface module is deployed from the stowed position to a non-stowed position.

34. A method for operating the system of claim 1, comprising the step of operating a valve to control a first flow of fluid based on an indication of a conductivity in the first segment of the controlled compliant flow path.

50. A method of cleaning and disinfecting, comprising the steps of:

removing a component of the system of claim 1;

replacing the component with a cleaning manifold;

providing a source of water to the system; and

conveying water from the source through the controlled compliant flow path.

51. The method of claim 50, further comprising the steps of:

removing a sorbent cartridge from the system;

replacing the sorbent cartridge with a cleaning and/or disinfection cartridge; and

circulating water through the controlled compliant flow path and through the cleaning and/or disinfection cartridge, wherein the cleaning and/or disinfection cartridge contains a cleaning and/or disinfection concentrate.

52. The method of claim 51, further comprising the step of heating the cleaning or disinfecting solution to a predetermined temperature, wherein the temperature is sufficient to disinfect the system.

53. The method of claim 52, further comprising the step of storing the system with the cleaning manifold and cleaning and/or disinfection solution in place to prevent contamination of the system between uses.

54. The method of claim 50, wherein a flush reservoir is integral to a cleaning manifold.

55. The method of claim 54, wherein a fluid connection port of a cleaning manifold comprises a female configuration that seals against an male surface of a mating port having both male and female surfaces such that all female surfaces of the mating port are exposed to a cleaning and/or disinfection solution when the cleaning and/or disinfection solution is passed through the system.

56. The method of claim 55, wherein the cleaning manifold connects to the base module to form a flow path for conveying water through the fluid pathways of the ports, components and conduits of a base module and a cleaning and/or disinfection concentrate cartridge to form a disinfection fluid.

57. The method of claim 56, wherein water is metered into the system and the disinfection fluid is circulated through the flow pathways such that the ports for connecting to the water reservoir are cleaned and disinfected without introducing the disinfection fluid to a water reservoir or water source connection.

58. The method of claim 51, comprising heating the cleaning or disinfecting solution to a predetermined temperature wherein the temperature is sufficient to disinfect the system.

59. The method of claim 50, further comprising the step of storing the system with the cleaning manifold, water and cleaning and/or disinfection concentrate intact to prevent contamination of the system between uses.

60. The method of claim 51, wherein the valves coordinately operate with a cleaning manifold to control movement of the cleaning of disinfecting solution.

61. The method of claim 51, wherein the cleaning or disinfectant solution is citric acid.

62. The method of claim 61, wherein the citric acid is at a concentration of about 2% by weight.

64. The method of claim 50, wherein a sorbent cartridge is not removed from the fluid flow path prior to filling the fluid circuit with water that contains at least one impurity and the water transferred into the fluid circuit contacts a sorbent material to remove at least a portion of an impurity contained in the water.

65. The method of claim 50, wherein the cleaning manifold further comprises a compartment having a cleaning and/or disinfection concentrate and connecting the cleaning manifold to a jumpered port of the base module causes the compartment containing cleaning and/or disinfection concentrate to be in fluid communication with the fluid flow path of the base module such that a cleaning and/or disinfection solution is reconstituted.

66. The method of claim 54, wherein selectively opening a valve in the system of claim 15 allows gas to escape from the flush reservoir when the flow path is being filled with a liquid.

67. The method of claim 54, wherein selectively opening a valve in the system of claim 15 allows gas to enter the flow path when a liquid is being drained from the controlled compliant flow path.

68. The method of claim 59 wherein a valve in the system of claim 15 allows gas to escape from the flush reservoir when the flush reservoir is closed.

29. A base module comprising,

a controlled compliant flow path and at least one pair of jumpered ports configurable for fluid communication with one or more components selected from a group consisting of a sorbent cartridge, a therapy cassette, a cleaning and/or disinfection concentrate cartridge, a cleaning manifold, a reservoir, a dialyzer, a hemofilter, a consumables cartridge, a degassing module, a sensor element, a microbial filter, a fluid port jumper, a fluid port cap or plug, a water source connection, a valve, a drain connection, an extracorporeal flow path, and combinations thereof.

30. The base module of claim 29, wherein the controlled compliant flow path has a sorbent cartridge, a degas module, a dialyzer or hemofilter in fluid communication with the extracorporeal flow path, and a bypass circuit for conveying a fluid from the sorbent cartridge for return to the sorbent cartridge without contacting the dialyzer or hemofilter.

31. The base module of claim 29, further comprising a control pump for causing fluid to move bi-directionally between the controlled compliant flow path and the extracorporeal flow path, and wherein a flux of fluid moving between the extracorporeal flow path and the controlled compliant flow path is modified by the rate at which the control pump is operating.

32. The base module of claim 29, wherein bi-directional operation of a control pump in fluid communication with a control reservoir and the controlled compliant flow path in coordination, with a concentrate pump in fluid communication with a concentrate reservoir for addition of a concentrate solution and a water pump in fluid communication with a water reservoir and the controlled compliant flow path causes fluid to move bi-directionally between the controlled compliant flow path and the extracorporeal flow path,

33. The base module of claim 29, further comprising:

a replacement fluid pump in fluid communication with a microbial filter and a dialysate inlet port of a dialyzer;

wherein coordinate operation of the control pump, the concentrate pump, the water pump, and the replacement fluid pump provides a flux of fluid moving between an extracorporeal flow path a subject receiving a treatment wherein the extracorporeal flow path and the controlled compliant flow path are in fluid communication across a semipermeable membrane. determined by the formula;

Patient Fluid Balance+Control Pump+Water Pump+Concentrate Pump+Replacement Fluid Pump+Σ

_i=0ⁿX_i=0,

wherein a positive value for any term is a flux of fluid entering the controlled compliant flow path and the Patient Fluid Balance is the flux of fluid moving from the extracorporeal flow path and the subject; and

where X is a volumetric pumping rate of a pump where n can range from 0 to 20.

35. A system for volumetric control of a fluid therapy, comprising:

a control pump in fluid communication with a control reservoir and a controlled compliant flow path;

a concentrate pump in fluid communication with a concentrate reservoir for addition of a concentrate solution and the controlled compliant flow path;

a water pump in fluid communication with a water reservoir and the controlled compliant flow path;

wherein coordinate operation of the control pump, the concentrate pump and the water pump provides a flux of fluid moving between an extracorporeal flow path of a subject receiving a treatment wherein the extracorporeal flow path and the controlled compliant flow path are in fluid communication across a semipermeable membrane determined by the formula;

Patient Fluid Balance+Control Pump+Water Pump+Concentrate Pump+Σ

_i=0ⁿX_i=0,

wherein a positive value for any term is a flux of fluid entering the controlled compliant flow path and the Patient Fluid Balance is the flux of fluid moving from the extracorporeal flow path and the subject; and

where X is a volumetric pumping rate of a pump where n can range from 0 to 20.

36. The system of claim 35, further comprising:

a replacement fluid pump in fluid communication with a microbial filter and a dialysate inlet port of a dialyzer;

wherein coordinate operation of the control pump, the concentrate pump, the water pump, and the replacement fluid pump provides a flux of fluid moving between an extracorporeal flow path a subject receiving a treatment wherein the extracorporeal flow path and the controlled compliant flow path are in fluid communication across a semipermeable membrane determined by the formula;

Patient Fluid Balance+Control Pump+Water Pump+Concentrate Pump+Replacement Fluid Pump+Σ

_i=0ⁿX_i=0,

wherein a positive value for any term is a flux of fluid entering the controlled compliant flow path and the Patient Fluid Balance is the flux of fluid moving from the extracorporeal flow path and the subject; and

where X is a volumetric pumping rate of a pump where n can range from 0 to 20.

37. The system of claim 35 wherein any one of the control pump, the concentrate pump, the water pump, and the pump X is a bidirectional pump.

38. The system of claim 36 wherein any one of the control pump, the concentrate pump, the water pump, the replacement fluid pump, and the pump X is a bidirectional pump.

39. The system of claim 35, further comprising one or more components selected from a group consisting of a sorbent cartridge, a therapy cassette, a cleaning and/or disinfection concentrate cartridge, a cleaning manifold, a dialyzer, a hemofilter, a consumables cartridge, a degassing module, a sensor element, a microbial filter, a fluid port jumper, a fluid port cap or plug, a valve, a water source connection, a drain connection, and combinations thereof.

40. The system of claim 35, wherein the controlled compliant flow path has a sorbent cartridge, a degas module, a dialyzer or hemofilter in fluid communication with the extracorporeal flow path, and a bypass circuit for conveying a fluid from the sorbent cartridge for return to the sorbent cartridge without contacting the dialyzer or hemofilter.

41. The base module of claim 35, wherein the flux of fluid moving between the extracorporeal flow path and the controlled compliant flow path is modified by the rate at which the control pump is operating.

42. The base module of claim 35, wherein any of the control pump, the concentrate pump, the water pump, and the pump X has a volumetric pumping rate wherein the volumetric pumping rate is independently adjustable.

43. The base module of claim 35, wherein the concentrate pump is adjusted based upon a control pump rate and water pump rate in order to maintain a constant concentration.

44. The base module of claim 36, wherein any of the control pump, the concentrate pump, the water pump, the replacement fluid pump, and the pump X has a volumetric pumping rate wherein the volumetric pumping rate is independently adjustable.

45. The base module of claim 35, wherein the control pump, the concentrate pump, and the water pump, and the pump X can be independently turned on and off as required to achieve a prescribed fluid composition and a prescribed fluid removal from the subject undergoing therapy.

46. The base module of claim 36, wherein the control pump, the concentrate pump, the water pump, the replacement fluid pump, and the pump X can be independently turned on and off as required to achieve a prescribed fluid composition and a prescribed fluid removal from the subject undergoing therapy.

47. A method of removing a solution from a fluid therapy system, comprising the steps of:

evacuating a first volume of a solution from a first segment of an extracorporeal flow path;

evacuating a second volume of the solution from a second segment of the extracorporeal flow path;

wherein transferring the first volume of the solution from a controlled compliant flow path to a control reservoir causes a first equal volume of the solution to transverse a semipermeable membrane from the extracorporeal flow path to the controlled compliant flow path, and transferring the second volume of the solution from the control reservoir to the controlled compliant flow path causes a second equal volume of the solution to transverse the semipermeable membrane from the extracorporeal flow path to the controlled compliant flow path.

48. The method of claim 47, wherein the first volume of the solution approximately equals a first evacuation volume of the first segment of the extracorporeal flow path and the second volume of the solution approximately equals a second evacuation volume of a combination of the second segment of the extracorporeal flow path and a first segment of the controlled compliant flow path.

49. The method of claim 48, further comprising the steps of:

opening a vent control valve to allow air to enter the controlled compliant flow path; and

transferring a third volume of the solution from the controlled compliant flow path to the control reservoir, wherein the third evacuation volume approximately equals a remnant volume of the controlled compliant flow path.

63. The method of claim 47, wherein the fluid in the control reservoir is water.