DEGASSING MODULE FOR A CONTROLLED COMPLIANT FLOW PATH

• US 20140216250A1
• 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.
• Granted Patent: US 9,173,987 B2
• Time in Patent Office: Days
• US Class Current: 95/22
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• 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 1/16 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 1/1658 Degasification
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• 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 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 2205/502 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 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2209/00 : Ancillary equipment
• CPC Class Codes: A61M 5/36 : with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: B01D 19/0031 : by filtration

Abstract

A degassing module for removal of air and other gases during operation of a medical therapy device that delivers any one of hemodialysis, hemodiafiltration and hemofiltration. The degassing module has a flow-through first chamber that has a hydrophobic vent membrane that has an exterior and interior side forming a portion of the flow-through chamber. The hydrophobic vent membrane is positioned at a higher elevation on the flow-through chamber than a fluid outlet. Fluid flows through the flow-through chamber in a downward direction relative to the hydrophobic vent membrane. A flow-through chamber has a cross sectional area configured to provide for a downward flow velocity of the fluid to be less than the upward rise velocity of a smallest bubble to be removed from the fluid.

Claims

1. A degassing module, comprising:

a flow-through first chamber having a hydrophobic vent membrane having an exterior and interior side forming a portion of the flow-through chamber wherein the hydrophobic vent membrane is positioned at a higher elevation on the flow-through chamber than a fluid outlet wherein fluid flows through the flow-through chamber in a downward direction relative to the hydrophobic vent membrane;

the flow-through chamber having a cross sectional area configured to provide for a downward flow velocity of the fluid to be less than an upward rise velocity of a smallest bubble to be removed from the fluid.

2. The degassing module of claim 1 wherein an internal fluid pressure inside the flow-through chamber is greater than the atmospheric pressure on the exterior side of the hydrophobic vent membrane.

3. The degassing module of claim 1 wherein fluid enters the flow-through chamber through a fluid inlet at an upper position and exits the flow-through chamber through the fluid outlet at a lower position wherein the upper position is at a higher elevation than the lower position.

4. The degassing module of claim 3 wherein the hydrophobic vent membrane is positioned closer to a top-side than a bottom side of the flow-through chamber.

5. The degassing module of claim 1, further comprising:

a second chamber, wherein a portion of the second chamber is comprised of an exterior surface of the hydrophobic vent membrane, and

the second chamber further comprising an opening to permit ingress and egress of a gas.

6. The degassing module of claim 5, further comprising a vent control valve operable to permit or allow gas to enter or exit the second chamber.

7. The degassing module of claim 6, wherein the vent control valve is operable to permit or allow gas to enter or exit the first chamber via the hydrophobic vent membrane.

8. The degassing module of claim 6, wherein the vent control valve is closed to prevent air entry into the flow-through chamber through the hydrophobic vent membrane.

9. The degassing module of claim 5, wherein the vent control valve is opened to allow gas to exit out of the flow-through chamber through the hydrophobic vent membrane.

10. The degassing module of claim 1, wherein the hydrophobic vent membrane has specified membrane permeability.

11. The degassing module of claim 1, wherein at least a portion of the gas exhausted through the hydrophobic vent membrane is a byproduct of the decomposition of urea.

12. The degassing module of claim 1, wherein at least a portion of the gas exhausted through the hydrophobic vent membrane is a byproduct of hydrolysis of urea by an enzyme.

13. The degassing module of claim 12, wherein an enzyme is urease.

14. The degassing module of claim 1, wherein at least a portion of the gas exhausted through the hydrophobic vent membrane is carbon dioxide.

15. The degassing module of claim 1, wherein the specified membrane permeability is dependent upon the type of gas to be exhausted, the rate at which gas must be exhausted, and the fluid pressure relative to atmospheric pressure at which the degassing module is operated.

16. The degassing module of claim 1, wherein the first chamber comprises a non-compliant volume.

17. The degassing module of claim 1, wherein the first chamber is part of a controlled compliant flow path.

18. The degassing module of claim 1, wherein the degassing module forms part of a flow path wherein a dialysate effluent flow stream from a dialyzer contains at least one waste species that is removed, at least in part, by passing the dialysate through a sorbent system.

19. The degassing module of claim 1, wherein the degassing module forms part of a flow path wherein a filtrate effluent flow stream from a hemofilter contains at least one waste species that is removed, at least in part, by passing the filtrate through a sorbent system.

21. The system of claim 19, wherein fluid required for a therapy session is prepared from water, wherein the flow loop modifies water into any one of a solution for priming the system, a physiologically compatible solution for contacting blood, and a solution for blood rinse back to a subject.

22. The system of claim 19, wherein the means for selectively metering in and metering out fluid from the flow loop is a fluid balance control pump in fluid communication with the controlled compliant flow loop and a reservoir.

23. The system of claim 19, wherein the degassing module is the degassing module of claim 1.

24. The system of claim 19, wherein the degassing module has a flow-through chamber having a float that causes a seal to be pressed against an escape orifice when the flow-through chamber is full or nearly full of fluid and when the chamber has a trapped quantity of gas sufficient to cause the fluid level to drop so that the float no longer presses the seal onto the orifice, gas is allowed to escape from the chamber.

25. The system of claim 23, further comprising a microbial vent filter over the escape orifice.

26. The system of claim 19, wherein the degassing module is a parallel or wound hollow fiber assembly.

27. The system of claim 19, further comprising a vacuum means applied to an exterior side of the degassing module to selectively draw dissolved gas from the fluid or to remove gas bubbles from the fluid.

28. The system of claim 19, wherein if the gas being removed is carbon dioxide, the pH of the fluid in the controlled compliant flow path is increased by not adding buffer or by adding less buffer to the controlled compliant flow path.

29. The system of claim 19, further comprising a flow restrictor in a bypass pathway on the controlled compliant flow path that is selectively operable to ensure a sufficient back pressure in the controlled compliant flow path to maintain an adequate pressure inside the degassing module relative to atmospheric pressure during system operation.

30. The system of claim 28, wherein a fluid flow in the controlled compliant flow path is diverted to bypass a dialyzer through the bypass pathway.

31. The system of claim 28, wherein the flow restrictor is an orifice having a sufficiently small inside diameter to create a necessary restriction.

32. The system of claim 28, wherein the flow restrictor is a conduit or tube having a sufficiently small inside diameter to create a necessary restriction.

33. The system of claim 19, wherein at least a portion of the controlled flow path is contained in a base module, and wherein the degassing module further comprises a gas outlet port connectable to a port on the base module, said port controlling gas ingress/egress by means of a valve in the base module.

34. The system of claim 19, wherein at least a portion of the controlled flow path is contained in a base module, said base module coordinately operating with the degassing module to ensure gas removal at a specified rate.

35. The system of claim 19, wherein the degassing module of claim 0 wherein the fluid flow through the flow-through chamber aids air removal from an controlled compliant flow path used in a fluid therapy system during a priming step.

37. The method of claim 35, wherein the degassing module is the degassing module of claim 1.

38. The method of claim 35, wherein the degassing module is a parallel or wound hollow fiber assembly.

39. The method of claim 35, further comprising the steps of:

determining if a gas being removed from the fluid is carbon dioxide; and

adjusting the pH based on the determination that only carbon dioxide is being removed by not adding buffer or by adding less buffer to the controlled compliant flow path.

40. The method of claim 35, further comprising the steps of:

determining a value of a back pressure in the controlled compliant flow loop; and

selectively operating a flow restrictor in a bypass pathway on the controlled compliant flow path to ensure a sufficient back pressure value in the controlled compliant flow path to maintain an adequate pressure inside the degassing module relative to atmospheric pressure during system operation.

41. The method of claim 35, further comprising the step of:

diverting a fluid flow in the controlled compliant flow path to the extracorporeal circuit to bypass a dialyzer through a bypass pathway.

42. The method of claim 35, further comprising the step of:

applying a vacuum an exterior side of the degassing module to selectively draw dissolved gas from the fluid or to remove gas bubbles from the fluid.

43. The method of claim 35, further comprising the step of:

detecting the dissolved gas in the fluid conveyed through the controlled compliant flow path.

45. The method of claim 35, further comprising the step of:

providing for ingress and/or egress of gas from a reservoir in fluid communication with the controlled compliant flow path to equilibrate pressure within the reservoir to atmospheric pressure.

47. The de-aeration flow path of claim 45, further comprising a fluid intake bypass valve in fluid communication with the de-aeration flow path and controlled compliant path wherein the fluid intake bypass valve can enable a reservoir pump to withdraw fluid from the reservoir.

48. The de-aeration flow path of claim 45, further comprising a positive displacement pump in fluid communication with the de-aeration flow path and controlled compliant path wherein fluid flow is prevented when the pump is not in operation and allows flow from the reservoir to the de-aeration flow path when the pump is in operation.

49. The de-aeration flow path of claim 45, further comprising a de-aeration bypass valve directing flow from an outlet of a reservoir pump through a return line segment of the controlled compliant flow path to the reservoir.

50. The de-aeration flow path of claim 45, further comprising a flow restrictor coordinately operating with a reservoir pump to adjust the pressure of fluid flowing through the flow restrictor drop to a low absolute pressure to cause dissolved air in the fluid to be released from solution and form gas bubbles.

51. The de-aeration flow path of claim 45, further comprising a heater for increasing the temperature of the fluid to reduce the solubility of any gas in the fluid.

52. The de-aeration flow path of claim 45, wherein the reservoir has a vent for exhausting gas through a vent opening.

53. The de-aeration flow path of claim 45, further comprising a first control valve in fluid communication with each of a fluid source, a conduit of the controlled compliant flow loop, and an inlet of a pump;

the first valve operable to convey fluid from the fluid source through a flow restriction to the inlet of the pump wherein the pressure of the fluid passing through the flow restrictor is sufficiently reduced to cause at least a portion of the gas contained in the fluid to be released from solution.

54. The de-aeration flow path of claim 52, wherein the fluid flowing out of the pump passes a vent that allows at least a portion of the gas that has been released from solution to be exhausted from the system.

55. The de-aeration flow path of claim 52, further comprising a second control valve in fluid communication with each of the outlet of a pump, a conduit of the controlled compliant dialysate loop, and a bypass conduit;

the second control valve being operable to direct flow to the bypass conduit, and the bypass conduit being in fluid communication with a vent that allows at least a portion of the gas that has been released from solution to be exhausted from the system.

56. The de-aeration flow path of claim 52, wherein the fluid source is contained in a reservoir and the bypass conduit returns the fluid to the reservoir and the reservoir is vented.

20. A system for controlling fluid movement between a subject and an extracorporeal flow path, comprising:

a controlled compliant flow loop, said controlled compliant flow loop selectively metering in and metering out fluid from the flow loop;

an extracorporeal flow path in fluid communication with a subject wherein the controlled compliant flow path and the extracorporeal flow path are in fluid communication across a semipermeable membrane; and

a degassing module.

36. A method for degassing a system, comprising the step of:

removing dissolved gas from fluid in a controlled compliant flow path with a degassing module.

44. The method of claim 36, further comprising the step of:

selectively allowing gas inflow through the hydrophobic vent membrane during draining of the system.

46. A de-aeration flow path for removing dissolved gases, comprising:

a reservoir in fluid communication with the de-aeration flow path;

one or more pumps in fluid communication with the de-aeration flow path wherein the de-aeration flow path is in fluid communication with a controlled compliant flow loop for preparing fluids required for a therapy session;

wherein the fluids prepared include any one of a dialysate, a filtrate, a physiologically compatible priming solution, a physiologically compatible solution to provide a bolus of fluid to a subject receiving treatment, a physiologically compatible solution for returning blood from an extracorporeal flow path to a subject;

wherein the flow loop modifies water into any one of a solution for priming the system, a physiologically compatible solution for contacting blood, and a solution for blood rinse back to a subject, said controlled compliant flow loop having a means for selectively metering in and metering out fluid from the dialysate flow path.