BLOOD TREATMENT SYSTEMS AND METHODS

• US 20150196699A9
• Filed: 03/14/2014
• Published: 07/16/2015
• Est. Priority Date: 03/15/2013
• Status: Abandoned Application

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Wilt, Michael J., van der Merwe, Dirk A., Dale, James D., Tracey, Brian D., Grant, Kevin L., Demers, Jason A., Flynn, Catharine N.
• Application Number:
  US14/213,702
• Publication Number:
  US 20140299544A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/14 : having plate-like flexible members

Abstract

The present invention generally relates to hemodialysis and similar dialysis systems, including a variety of systems and methods that would make hemodialysis more efficient, easier, and/or more affordable. One aspect of the invention is generally directed to new fluid circuits for fluid flow. According to one aspect, a blood pump is configured to pump blood to a dialyzer of a hemodialysis apparatus, the blood pump comprising a pneumatically actuated or controlled reciprocating diaphragm pump. In an embodiment, the diaphragm of the pump comprises a flexible membrane formed or molded to generally conform to a curved inner wall of a pumping chamber or control chamber of the pump, wherein the diaphragm is pre-formed or molded to have a control side taking a convex shape, so that any elastic tension on the diaphragm is minimized when fully extended into a control chamber of the pump. In another aspect, a system for monitoring the adequacy of blood flow in a blood line of the hemodialysis apparatus allows a controller to suspend dialysate pumping operations if the adequacy of blood flow in the blood line is sub-optimal, and to present information on a display on the quality of blood flow in the blood line.

Claims

1. A flexible diaphragm for use in a reciprocating diaphragm pump, the diaphragm pump comprising a first rigid body having a curved pumping chamber wall, a second rigid body having an opposing curved control chamber wall, the diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall, the diaphragm comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to generally conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and an opposing control side arranged to face the inner surface of the control chamber wall;

a transition region between the bead and the diaphragm body, the transition region arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is pre-formed or molded with its control side having a convex shape, such that any elastic tension in the diaphragm is reduced when the control side of the diaphragm body assumes a convex shape when positioned in the diaphragm pump.

2. The flexible diaphragm of claim 1, wherein any elastic tension near the transitional region of the diaphragm is minimized when the diaphragm is fully extended toward the control chamber wall of the diaphragm pump.

3. The flexible diaphragm of claim 1, wherein the pumping side of the diaphragm comprises a plurality of raised features, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended toward the pumping chamber wall.

4. The flexible diaphragm of claim 3, wherein the raised features comprise bumps or raised dots.

5. The flexible diaphragm of claim 1, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm is configured to be positioned between the mid-plate and the bottom plate.

6. The flexible diaphragm of claim 5, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

7. The flexible diaphragm of claim 6, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

8. The flexible diaphragm of claim 7, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.

9. A reciprocating diaphragm pump comprising a first rigid body having a pumping chamber wall, a second rigid body having an opposing control chamber wall, and a diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall to define a pumping chamber and a control chamber, the diaphragm comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to generally conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and a control side arranged to face the inner surface of the control chamber wall;

a transition region between the bead and the diaphragm body, the transition region arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is pre-formed or molded with its control side having a convex shape, such that any elastic tension in the diaphragm is reduced when the control side of the diaphragm body assumes a convex shape when positioned in the diaphragm pump.

10. The diaphragm pump of claim 9, wherein any elastic tension near the transitional region of the diaphragm is minimized when the diaphragm is fully extended into the control chamber of the diaphragm pump.

11. The diaphragm pump of claim 9, wherein the pumping side of the diaphragm comprises a plurality of raised features, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended into the pumping chamber.

12. The diaphragm pump of claim 11, wherein the raised features comprise bumps or raised dots.

13. The diaphragm pump of claim 9, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm configured to be positioned between the mid-plate and the bottom plate.

14. The diaphragm pump of claim 13, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

15. The diaphragm pump of claim 14, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

16. The diaphragm pump of claim 15, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.

17. A pump cassette for pumping fluid comprising a first rigid body having a pumping chamber wall, a second rigid body having an opposing control chamber wall, and a diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall to define a pumping chamber and a control chamber, the pumping chamber in fluid communication with a fluid inlet and fluid outlet of the cassette, the control chamber in fluid communication with a pneumatic control port for transmission of pneumatic pressure to the control chamber, the diaphragm comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to generally conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and an opposing control side arranged to face the inner surface of the control chamber wall;

a transition region between the bead and the diaphragm body, the transition region arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is pre-formed or molded with its control side having a convex shape, such that any elastic tension in the diaphragm is reduced when the control side of the diaphragm body assumes a convex shape when positioned in the diaphragm pump.

18. The pump cassette of claim 17, wherein any elastic tension near the transitional region of the diaphragm is minimized when the diaphragm is fully extended toward the control chamber wall of the diaphragm pump.

19. The pump cassette of claim 17, wherein the pumping side of the diaphragm comprises a plurality of raised features, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended toward the pumping chamber wall.

20. The pump cassette of claim 19, wherein the raised features comprise bumps or raised dots.

21. The pump cassette of claim 17, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm is configured to be positioned between the mid-plate and the bottom plate.

22. The pump cassette of claim 21, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

23. The pump cassette of claim 22, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

24. The pump cassette of claim 23, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.

25. A system for controlling fluid flow in a hemodialysis apparatus comprising:

a dialysate pump configured to receive a fluid from a dialysate outlet of the dialyzer;

a reciprocating diaphragm-based blood pump configured to deliver blood from an extracorporeal blood circuit to a blood inlet of the dialyzer, a pumping chamber of the blood pump separated from a control chamber of the blood pump by a flexible diaphragm, the control chamber configured to transmit positive or negative pressure to operate the diaphragm;

a pressure sensor configured to measure pressure in the control chamber of the blood pump;

a controller configured to receive information from the pressure sensor, and configured to control the delivery of pressure to the control chamber of the blood pump;

wherein the controller is configured to cause the application of a time-varying pressure waveform on the blood pump diaphragm during a fill-stroke of the blood pump, and to monitor a pressure variation in the control chamber measured by the pressure sensor, and wherein a magnitude of the measured pressure variation that deviates from a pre-determined value causes the controller to initiate a procedure to pause or stop the dialysate pump.

26. The system of claim 25, wherein the controller is configured to compare a pressure variation in the control chamber measured by the pressure sensor with a target signal or target pressure variation induced by the controller, and wherein a deviation between the measured pressure variation and the target signal or pressure variation that is greater than a pre-determined value causes the controller to initiate a procedure to pause or stop the dialysate pump.

27. The system of claim 25, wherein the controller is configured to compare a measured pressure in the control chamber with a target signal or pressure during time periods when an absolute value of the applied pressure is decreasing, and wherein a deviation between the measured pressure and the target signal or pressure that is greater than a pre-determined value causes the controller to initiate a procedure to pause or stop the dialysate pump.

28. The system of claim 26, wherein the comparison by the controller comprises calculating a cross-correlation value between the measured pressure variation and the target signal or pressure variation, and wherein a cross-correlation value that is less than a pre-determined value causes the controller to initiate the procedure to pause or stop the dialysate pump.

29. The system of claim 28, wherein the controller calculates a phase-insensitive cross-correlation value.

30. The system of claim 28 or 29, wherein the controller signals the dialysate pump to pause or stop only if the cross-correlation value is less than the pre-determined value for two or more consecutive blood pump fill-strokes.

31. The system of claim 28 or 29, wherein the controller calculates a filtered or averaged cross-correlation value during a fraction of a pump fill-stroke period, and re-calculates one or more additional filtered or averaged cross-correlation values during one or more successive fractions of the fill-stroke period, and wherein the controller compares a highest filtered or averaged cross-correlation value during said fill-stroke period with the pre-determined value to determine whether to initiate the procedure to pause or stop the dialysate pump.

32. The system of claim 25, wherein the time-varying pressure waveform comprises a sinusoidal pressure waveform.

33. The system of claim 25, wherein the controller controls the application of the pressure waveform by controlling a variable restriction valve interposed between the control chamber and a source of positive or negative pressure.

34. The system of claim 33, wherein the source of positive or negative pressure comprises a source of positive or negative pneumatic pressure.

35. The system of claim 25, wherein the dialysate pump comprises a reciprocating diaphragm-based pump, and wherein the pre-determined value is based on a pressure over a period of time generated by the blood pump that provides sufficient pressure in a blood compartment of the dialyzer to allow the dialysate pump to receive a full stroke-volume of fluid from the dialyzer.

36. A system for monitoring fluid flow in an extracorporeal blood circuit comprising:

a pumping chamber of the blood pump separated from a control chamber of the blood pump by a flexible diaphragm, the control chamber configured to transmit positive or negative pressure to operate the diaphragm;

a pressure sensor configured to measure pressure in the control chamber of the blood pump;

a controller configured to receive information from the pressure sensor, and configured to control the delivery of pressure to the control chamber of the blood pump;

wherein the controller is configured to cause the application of a time-varying pressure waveform on the blood pump diaphragm during a fill-stroke of the blood pump, and to monitor a pressure variation in the control chamber measured by the pressure sensor, and wherein the controller transmits a value representing a magnitude of the measured pressure variation to a display associated with the extracorporeal blood circuit.

37. The system of claim 36, wherein a magnitude of the measured pressure variation that deviates from a pre-determined value causes the controller to provide a notification to the display.

38. The system of claim 36, wherein the controller is configured to compare a pressure variation in the control chamber measured by the pressure sensor with a target signal variation or target pressure variation induced by the controller, and wherein a deviation between the measured pressure variation and the target signal or pressure variation that is greater than a pre-determined value causes the controller to provide a notification to the display.

39. The system of claim 38, wherein the controller compares the measured pressure variation with the target signal or pressure variation during time periods when the absolute value of the applied pressure is decreasing.

40. The system of claim 38, wherein the comparison by the controller comprises calculating a cross-correlation value between the measured pressure variation and the target signal or pressure variation.

41. The system of claim 36, wherein the time-varying pressure waveform comprises a sinusoidal pressure waveform.

42. The system of claim 36, wherein the controller controls the application of the pressure waveform by controlling a variable restriction valve interposed between the control chamber and a source of positive or negative pressure.

43. The system of claim 42, wherein the source of positive or negative pressure comprises a source of positive or negative pneumatic pressure.

44. The system of claim 36, wherein the value is displayed on a graphical user interface.

45. The system of claim 44, wherein the controller is configured to transmit one of a plurality of representative values to the graphical user interface, each said representative value representing a pre-determined range of values of the measured pressure variation.

46. A method for controlling fluid flow in a hemodialysis apparatus comprising:

a controller receiving information from a pressure sensor in a control chamber of a reciprocating diaphragm-based blood pump;

the controller causing the application of a time-varying pressure waveform on a diaphragm of the blood pump during a fill-stroke of the blood pump;

the controller monitoring a pressure variation in the control chamber measured by the pressure sensor;

the controller comparing the measured pressure variation to a pre-determined value; and

the controller initiating a procedure to pause or stop a dialysate pump of the hemodialysis apparatus if the magnitude of the measured pressure variation deviates from the pre-determined value.

47. The method of claim 46, further comprising the controller comparing a pressure variation in the control chamber measured by the pressure sensor with a target signal or target pressure variation induced by the controller, and the controller initiating a procedure to pause or stop the dialysate pump if a deviation between the measured pressure variation and the target signal or pressure variation is greater than a pre-determined value.

48. The method of claim 46, further comprising the controller comparing a measured pressure in the control chamber with a target signal or pressure during time periods when an absolute value of the applied pressure is decreasing, and the controller initiating a procedure to pause or stop the dialysate pump if a deviation between the measured pressure and the target signal or pressure is greater than a predetermined value.

49. The method of claim 47, wherein the controller performs the comparison by calculating a cross-correlation value between the measure pressure variation and the target signal or pressure variation, and the controller initiates the procedure to pause or stop the dialysate pump if the cross-correlation value is less than a pre-determined value.

50. The method of claim 49, wherein the controller calculates a phase-insensitive cross-correlation value.

51. The method of claims 49 or 50, wherein the controller signals the dialysate pump to pause or stop only if the cross-correlation value is less than the pre-determined value for two or more consecutive blood pump fill-strokes.

52. The method of claims 49 or 50, further comprising the controller calculating a filtered or averaged cross-correlation value during a fraction of a pump fill-stroke period, and re-calculating one or more additional filtered or averaged cross-correlation values during one or more successive fractions of the fill-stroke period, and determining whether to initiate the procedure to pause or stop the dialysate pump by comparing a highest filtered or averaged cross-correlation value during said fill-stroke period with the pre-determined value.

53. The method of claim 46, wherein the time-varying pressure waveform comprises a sinusoidal pressure waveform.

54. The method of claim 46, wherein the controller controls the application of the pressure waveform by controlling a variable restriction valve interposed between the control chamber and a source of positive or negative pressure.

55. The method of claim 54, wherein the source of positive or negative pressure comprises a source of positive or negative pneumatic pressure.

56. The method of claim 46, wherein the dialysate pump comprises a reciprocating diaphragm-based pump, wherein the pre-determined value is based on a pressure over a period of time generated by the blood pump that provides sufficient pressure in a blood compartment of the dialyzer to allow the dialysate pump to receive a full stroke-volume of fluid from the dialyzer.

57. A method for monitoring fluid flow in an extracorporeal blood circuit comprising:

a controller receiving information from a pressure sensor in a control chamber of a reciprocating diaphragm-based blood pump;

the controller causing the application of a time-varying pressure waveform on a diaphragm of the blood pump during a fill-stroke of the blood pump;

the controller monitoring a pressure variation in the control chamber measured by the pressure sensor; and

the controller transmitting a value representing a magnitude of the measured pressure variation to a display associated with the extracorporeal blood circuit.

58. The method of claim 57, wherein the controller provides a notification to the display if a magnitude of the measured pressure variation deviates from a pre-determined value.

59. The method of claim 57, wherein the controller compares a pressure variation in the control chamber measured by the pressure sensor with a target signal variation or target pressure variation induced by the controller, and provides a notification to the display if a deviation between the measured pressure variation and the target signal or pressure variation is greater than a pre-determined value.

60. The method of claim 59, wherein the controller compares the measured pressure variation with the target signal or pressure variation during time periods when the absolute value of the applied pressure is decreasing.

61. The method of claim 59, wherein the comparison by the controller comprises calculating a cross-correlation value between the measured pressure variation and the target signal or pressure variation.

62. The method of claim 57, wherein the time-varying pressure waveform comprises a sinusoidal pressure waveform.

63. The method of claim 57, wherein the controller controls the application of the pressure waveform by controlling a variable restriction valve interposed between the control chamber and a source of positive or negative pressure.

64. The method of claim 63, wherein the source of positive or negative pressure comprises a source of positive or negative pneumatic pressure.

65. The system of claim 57, wherein the value is displayed on a graphical user interface.

66. The method of claim 65, wherein the controller transmits one of a plurality of representative values to the graphical user interface, each said representative value representing a pre-determined range of values of the measured pressure variation.