Method and apparatus for cardiac blood flow assistance

• US 5,911,685 A
• Filed: 04/02/1997
• Issued: 06/15/1999
• Est. Priority Date: 04/04/1996
• Status: Expired due to Term

• Current Assignee: Impella Cardiosystems Gmbh
• Original Assignee: Guidant Corporation (Boston Scientific Corporation)
• Inventors: Rau, Gunther, Kast, Michael, Siess, Thorsten, Reul, Helmut
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/832,040
• Time in Patent Office: 804 Days
• Field of Search: 600/16, 600/17, 623/3, 415/900, 415/229, 415/230, 417/366, 417/423.3, 417/423.7, 417/423.12, 417/423.14
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/221 the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/416 transmitted directly by the motor rotor drive shaft
• CPC Class Codes: A61M 60/419 the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/88 : Percutaneous cables
• CPC Class Codes: F04D 29/0467 : Spherical bearings
• CPC Class Codes: F04D 29/047 : hydrostatic; hydrodynamic
• CPC Class Codes: F04D 29/048 : magnetic; electromagnetic
• CPC Class Codes: H02K 11/00 : Structural association of dynamo-electric machines with electric components or with devices for shielding, monitoring or protection casings, enclosures or supports H02K5/00
• CPC Class Codes: H02K 15/02 : of stator or rotor bodies
• CPC Class Codes: H02K 15/14 : Casings; Enclosures; Supports
• CPC Class Codes: H02K 21/14 : with magnets rotating within the armatures
• CPC Class Codes: H02K 49/104 : Magnetic couplings consisting of only two coaxial rotary elements, i.e. the driving element and the driven element
• CPC Class Codes: H02K 5/08 : Insulating casings
• CPC Class Codes: H02K 5/124 : Sealing of shafts
• CPC Class Codes: H02K 5/1285 : of the submersible type
• CPC Class Codes: H02K 5/132 : Submersible electric motors H02K5/128 takes precedence
• CPC Class Codes: H02K 7/145 : Hand-held machine tool
• CPC Class Codes: Y10S 415/90 : Rotary blood pump

Abstract

An intravascular microaxial pump has an integrated configuration that enables both the drive unit as well as the pumping segment to be advanced through a patient'"'"'s vasculature. The device includes elements that enhance pumping efficiency and performance while minimizing shear and cavitation. Cost reduction is achieved in the reusability of certain components while a manufacturing method reduces the labor involved in the pump'"'"'s assembly.

Claims

1. An intravascular microaxial flow pump, comprising:

a cylindrical drive unit of preselected outer diameter having an electric motor disposed therein driving a shaft distally extending therefrom wherein such shaft is supported solely by two bearings, one located at the extreme proximal end of said drive unit and another at the extreme distal end of said drive unit;

a cylindrical intravascular microaxial flow pump housing rigidly attached to said drive unit having essentially the same preselected outer diameter and oriented to be coaxially and distally disposed with respect to said drive unit; and

an impeller disposed within said pump housing, rigidly affixed to said shaft, and located immediately adjacent said distal bearing, operative to draw fluid into and through said housing and over said drive unit.

2. The pump of claim 1 further comprising a catheter proximally extending from said drive unit to facilitate transport of said pump through vasculature by manipulation of the proximal end of said catheter.

3. The pump of claim 2 further comprising conductors disposed in said catheter and connected to said electric motor by which said electric motor is powered and the operation of said motor is controlled.

4. The pump of claim 1, wherein said pump housing is attached to said drive unit exclusively by radially extending pump stator elements disposed proximally relative to said impeller.

5. The pump of claim 1, wherein said pump housing is attached to said drive unit by support members that are configured and positioned to minimize interference with fluid flowing thereby and wherein said pump is devoid of a fixed pump stator.

6. The pump of claim 1, wherein said distal bearing simultaneously serves as a seal.

7. The pump of claim 6, wherein said distal bearing comprises an annular cup configuration having a distally oriented open end.

8. The pump of claim 6 further comprising a secondary seal disposed proximally to said distal bearing.

9. The pump of claim 8, wherein an annular void space is formed in said drive unit, extending about said shaft between said distal bearing and said secondary seal.

10. The pump of claim 9, wherein said annular void contains a biocompatible lubricant.

11. The pump of claim 1, wherein said drive unit is charged with a fluid at a pressure less than that of fluid to be pumped by said fluid pump.

12. The pump of claim 11, wherein said fluid is chemically inert.

13. The pump of claim 12, wherein said fluid comprises a gas.

14. The pump of claim 13, wherein said gas comprises He.

15. The pump of claim 1, wherein said drive unit is charged with a fluid at a pressure that exceeds the pressure of fluid to be pumped by said fluid pump.

16. The pump of claim 15, wherein said fluid is biocompatible.

17. The pump of claim 16, wherein said fluid is chemically inert.

18. The pump of claim 15, wherein said fluid is chemically inert.

19. The pump of claim 15, wherein said fluid comprises a gas.

20. The pump of claim 15 further comprising a flexible diaphragm disposed on said drive unit'"'"'s exterior surface and in fluid communication with said internal void space, configured such that a positive internal pressure of said fluid imparts a domed appearance to said diaphragm to provide a visual indication as to the state of charge.

21. The pump of claim 15, wherein said charge pressure is selected to cause said fluid to slowly and continually discharge from said drive unit.

22. The pump of claim 21 further comprising a catheter proximally extending from said drive unit and in fluid communication therewith through which said fluid is supplied.

23. The pump of claim 22, wherein said fluid is biocompatible.

24. An intravascular microaxial flow pump, comprising:

a cylindrical drive unit of preselected outer diameter having an electric motor disposed therein driving a shaft distally extending therefrom wherein void space within said drive unit is separated from its exterior by a seal, fitted about said shaft;

a cylindrical pump housing rigidly attached to said drive unit having essentially the same preselected outer diameter and oriented to be coaxially and distally disposed with respect to said drive unit;

an impeller disposed within said pump housing, rigidly affixed to said shaft;

a biocompatible charge fluid contained within said void space and charged to a pressure that exceeds the pressure of fluid to be pumped by said fluid pump; and

, a flexible diaphragm disposed on an exterior surface of said drive unit and in fluid communication with said void space, configured such that a positive internal pressure of said fluid imparts a domed appearance to said diaphragm to provide a visual indication as to the state of charge.

25. The pump of claim 24, wherein said charge fluid is charged to a pressure that is selected to cause said fluid to slowly and continually breach said seal.

26. The pump of claim 25 further comprising a catheter proximally extending from said drive unit and in fluid communication with said void space through which said fluid is supplied.

27. An intravascular microaxial flow pump, comprising:

a cylindrical drive unit of preselected outer diameter having an electric motor disposed therein driving a shaft distally extending therefrom wherein such shaft is supported solely by two bearings, one located at the extreme proximal end of said drive unit and another at the extreme distal end of said drive unit;

a cylindrical intravascular microaxial flow pump housing rigidly attached to said drive unit having essentially the same preselected outer diameter and oriented to be coaxially and distally disposed with respect to said drive unit; and

an impeller disposed within said pump housing, rigidly affixed to said shaft, and located immediately adjacent said distal bearing, operative to draw fluid over said drive unit and through said housing.

28. The pump of claim 27 further comprising a catheter proximally extending from said drive unit to facilitate transport of said pump through vasculature by manipulation of the proximal end of said catheter.

29. The pump of claim 28 further comprising conductors disposed in said catheter and connected to said electric motor by which said electric motor is powered and the operation of said electric motor is controlled.

30. The pump of claim 27, wherein said pump housing is attached to said drive unit exclusively by radially extending pump stator elements disposed proximally relative to said impeller.

31. The pump of claim 27, wherein said pump housing is attached to said drive unit by support members that are configured and positioned to minimize interference with fluid flowing thereby and wherein said pump is devoid of a fixed pump stator.

32. The pump of claim 27, wherein said distal bearing simultaneously serves as a seal.

33. The pump of claim 32, wherein said distal bearing comprises an annular cup configuration having a distally oriented open end.

34. The pump of claim 32 further comprising a secondary seal disposed proximally to said distal bearing.

35. The pump of claim 34, wherein an annular void space is formed in said drive unit, extending about said shaft between said distal bearing and said secondary seal.

36. The pump of claim 35, wherein said annular void contains a biocompatible lubricant.

37. The pump of claim 27, wherein said drive unit is charged with a fluid at a pressure less than that of fluid to be pumped by said fluid pump.

38. The pump of claim 37, wherein said fluid is chemically inert.

39. The pump of claim 38, wherein said fluid comprises a gas.

40. The pump of claim 39, wherein said gas comprises He.

41. The pump of claim 27, wherein said drive unit is charged with a fluid at a pressure that exceeds the pressure of fluid to be pumped by said fluid pump.

42. The pump of claim 41, wherein said fluid is biocompatible.

43. The pump of claim 42, wherein said fluid is chemically inert.

44. The pump of claim 41, wherein said fluid is chemically inert.

45. The pump of claim 41, wherein said fluid comprises a gas.

46. The pump of claim 41 further comprising a flexible diaphragm disposed on said drive unit'"'"'s exterior surface and in fluid communication with said internal void space, configured such that a positive internal pressure of said fluid imparts a domed appearance to said diaphragm to provide a visual indication as to the state of charge.

47. The pump of claim 41, wherein said charge pressure is selected to cause said fluid to slowly and continually discharge from said drive unit.

48. The pump of claim 47 further comprising a catheter proximally extending from said drive unit and in fluid communication therewith through which said fluid is supplied.

49. The pump of claim 48, wherein said fluid is biocompatible.