Ventricular assist device with minimal blood contacting surfaces

• US 6,102,845 A
• Filed: 02/07/1994
• Issued: 08/15/2000
• Est. Priority Date: 02/07/1994
• Status: Expired due to Fees

• Current Assignee: World Heart Corporation (Medtronic Plc)
• Original Assignee: Baxter International Inc.
• Inventors: Chen, Herbert, Woodard, John C., Ness, Ronald A., Nguyen, Than, Romley, Richard M.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/192,894
• Time in Patent Office: 2,381 Days
• Field of Search: 623/3, 623/2, 623/900, 600/16, 606/153
• US Class Current: 600/16
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• 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 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/89 Valves
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A ventricular assist device includes a pair of valved conduits and a pumping portion connected by these conduits into the circulatory system of a host patient. The pumping portion and valved conduits are constructed and configured to minimize the number of material-surface transitions which blood must cross in flowing through the device. Also, the valved conduits include porcine xenograft valves, which are externally supported by stenting structure located outside of the blood-contacting flow path of the device. A flexible shape-retaining inner wall member of the valved conduits is impervious to blood, but defines a porous inner surface on which a stable biological interface may form. Also, this inner wall member is shaped with sinuses which do not replicate either the porcine sinuses from which the xenograft valves were taken, or human aortic sinuses. However, the sinuses of the inner wall member are configured to provide effective valve action by the formation of vigorous vortices in the blood flow downstream of these valves, and to avoid the formation of clots on the blood-contacting surfaces of the valved conduits.

Claims

1. A ventricular assist device for implantation in a human host, comprising:

a pump including a rigid housings and a flexible unitary liner within the housing defining a variable volume chamber;

inflow and outflow openings to the variable volume chamber defined by tubular co-extensions of the pump housing and inner unitary liner, each of the inflow and outflow openings terminating in a circular first sealing surface formed by wrapping the unitary liner back upon the housing;

inflow and outflow conduits attached, respectively, to the inflow and outflow openings of the pump, each conduit having opposed open ends and being adapted to channel blood between the variable volume chamber and a host circulatory system, each conduit having a rigid, generally tubular housing, a flexible tubular wall member within the conduit housing, and a circular second sealing surface on one end having approximately the same diameter as the first sealing surface and formed by wrapping the wall member back upon the conduit housing; and

attachment structures for connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening so that the first sealing surfaces axially abut and compress against the second scaling surfaces to define therebetween conduit/pump inflow and outflow sealing lines, wherein blood flowing from the inflow conduit across the conduit/pump inflow sealing line into the variable volume chamber and then across the conduit/pump outflow sealing line to the outflow conduit only contacts the flexible tubular wall members of the conduits and the unitary liner of the pump.

2. The device of claim 1, further including a biasing member provided as part of each of the attachment structures connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening, the biasing member positioned to apply an elastic force urging each pair of first and second sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/pump inflow and outflow sealing lines.

3. The device of claim 2, wherein the attachment structures each include a pump coupling member connected to the pump housing aid a conduit coupling member connected to the conduit housing, wherein one of the pump coupling member or conduit coupling member has a pair of axially facing and relatively displaceable surfaces, and wherein the biasing members are axially elastic and placed in compression between the axially facing surfaces to apply the elastic force.

4. The device of claim 3, wherein the biasing members are wave washers.

5. The device of claim 3, wherein the pump coupling member and conduit coupling member include mating threads and are screwed together.

6. The device of claim 1, wherein each conduit includes a circular third sealing surface on the opposite end from the second sealing surface, the third sealing surface being formed by wrapping the wall member back upon the conduit housing and wherein the device further includes:

inflow and outflow flexible conduit extensions adapted to communicate blood between the host circulatory system and the inflow and outflow conduits, respectively, each extension comprising an inner flexible blood conduit coaxially disposed within an outer plastic sheath terminating in a rigid circular end portion, and including a circular fourth sealing surface having approximately the same diameter as the third sealing surface and formed by wrapping the flexible blood conduit back upon the end portion; and

attachment structures for connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit so that the third sealing surfaces abut and compress against the fourth sealing surfaces to define therebetween conduit/extension inflow and outflow sealing lines, wherein blood flowing across each of the conduit/extension inflow and outflow sealing lines only contacts the flexible tubular wall members of the conduits and the flexible blood conduits of the extensions.

7. The device of claim 6, further including a biasing member provided as part of each of the attachment structures connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit, the biasing member positioned to apply an elastic force urging each pair of third and fourth sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/extension inflow and outflow sealing lines.

8. The device of claim 7, wherein the attachment structures each include an extension coupling member connected to the circular end portion and a conduit coupling member connected to the conduit housing, wherein one of the extension coupling member or conduit coupling member has a pair of axially facing and relatively displaceable surfaces, and wherein the biasing members are axially elastic and placed in compression between the axially facing surfaces to apply the elastic force.

9. The device of claim 8, wherein the biasing members are wave washers.

10. The device of claim 8, wherein the extension coupling member and conduit coupling member include mating threads and are screwed together.

11. The device of claim 1, further including a prosthetic valve disposed within each of the inflow and outflow conduits and sutured to the wall member so that blood flowing through either of the inflow or outflow conduits contacts only the flexible tubular wall member, the prosthetic valve, and the sutures.

12. The device of claim 11, further including a flexible external stent provided for each of the inflow and outflow conduits between the respective conduit housings and flexible wall members, the stent being sutured to the flexible wall members and to the prosthetic valve within the conduit to support the valve therein.

13. The device of claim 12, wherein the prosthetic valve is a trifoliate natural tissue valve, having three commissures, and wherein the external stent includes a metallic wireform having three axially-extending commissure supports aligned with each commissure of the natural tissue valve.

14. The device of claim 1, wherein the wall member is a fabric sheet material having an outer surface coated with a blood-impermeable biologically-compatible material and an inner porous surface to provide a site for growth of a biological interface.

15. A ventricular assist device for implantation in a human host, comprising:

a pump including a rigid housing and a flexible unitary liner within the housing defining a variable volume chamber;

inflow and outflow openings to the variable volume chamber defined by tubular co-extensions of the pump housing and inner unitary liner, each of the inflow and outflow openings terminating in a circular first sealing surface formed by the unitary liner;

inflow and outflow conduits attached, respectively, to the inflow and outflow openings of the pump, each conduit having opposed open ends and being adapted to channel blood between the variable volume chamber and a host circulatory system, each conduit having a rigid, generally tubular housing, a flexible tubular wall member within the conduit housing, and a circular second sealing surface on one end formed by the wall member;

attachment structures for connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening so that the first sealing surfaces abut and axially compress against the second sealing surfaces to define therebetween conduit/pump inflow and outflow sealing, lines, wherein blood flowing from the inflow conduit across the conduit/pump inflow sealing line into the variable volume chamber and then across the conduit/pump outflow sealing line to the outflow conduit only contacts the flexible tubular wall members of the conduits and the unitary liner of the pump; and

a biasing member provided as part of each of the attachment structures connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening, the biasing member positioned to apply an elastic force urging each pair of first and second sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/pump inflow and outflow sealing lines, wherein the attachment structures each include a pump coupling member connected to the pump housing and a conduit coupling member connected to the conduit housing, wherein one of the pump coupling member or conduit coupling member has a pair of axially facing and relatively displaceable surfaces, and wherein the biasing members are axially elastic and placed in compression between the axially facing surfaces to apply the elastic force.

16. The device of claim 15, wherein the biasing members are wave washers.

17. The device of claim 15, wherein the pump coupling member and conduit coupling member include mating threads and are screwed together.

18. The device of claim 15, wherein each conduit includes a circular third sealing surface on the opposite end from the second sealing surface, the third sealing surface formed by the wall member, and wherein the device further includes:

inflow and outflow flexible conduit extensions adapted to communicate blood between the host circulatory system and the inflow and outflow conduits, respectively, each extension comprising an inner flexible blood conduit coaxially disposed within an outer plastic sheath terminating in a rigid circular end portion, and including a circular fourth sealing surface formed by the flexible blood conduit; and

attachment structures for connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit so that the third sealing surfaces abut and compress against the fourth sealing surfaces to define therebetween conduit/extension inflow and outflow sealing lines, wherein blood flowing across each of the conduit/extension inflow and outflow sealing lines only contacts the flexible tubular wall members of the conduits and the flexible blood conduits of the extensions.

19. The device of claim 18, further including a biasing member provided as part of each of the attachment structures connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit, the biasing member positioned to apply an elastic force urging each pair of third and fourth sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/extension inflow and outflow sealing lines.

20. The device of claim 19, wherein the attachment structures each include an extension coupling member connected to the circular end portion and a conduit coupling member connected to the conduit housing, wherein one of the extension coupling member or conduit coupling member has a pair of axially facing and relatively displaceable surfaces, and wherein the biasing members are axially elastic and placed in compression between the axially facing surfaces to apply the elastic force.

21. The device of claim 20, wherein the biasing members are wave washers.

22. The device of claim 20, wherein the extension coupling member and conduit coupling member include mating threads and are screwed together.

23. The device of claim 15, further including a prosthetic valve disposed within each of the inflow and outflow conduits and sutured to tie wall member so that blood flowing through either of the inflow or outflow conduits contacts only the flexible tubular wall member, the prosthetic valve, and the sutures.

24. The device of claim 23, further including a flexible external stent provided for each of the inflow and outflow conduits between the respective conduit housings and flexible wall members, the stent being sutured to the flexible wall members and to the prosthetic valve within the conduit to support the valve therein.

25. The device of claim 24, wherein the prosthetic valve is a trifoliate natural tissue valve, having three commissures, and wherein the external stent includes a metallic wireform having three axially-extending commissure supports aligned with each commissure of the natural tissue valve.

26. The device of claim 15, wherein the wall member is a fabric sheet material having an outer surface coated with a blood-impermeable biologically-compatible material and an inner porous surface to provide a site for growth of a biological interface.

27. A ventricular assist device for implantation in a human host, comprising:

a pump including a rigid housing and a flexible unitary liner within the housing defining a variable volume chamber;

inflow and outflow openings to the variable volume chamber defined by tubular co-extensions of the pump housing and inner unitary liner, each of the inflow and outflow openings terminating in a circular first sealing surface formed by the unitary liner;

inflow and outflow conduits attached, respectively, to the inflow and outflow openings of the pump, each conduit having opposed open ends and being adapted to channel blood between the variable volume chamber and a host circulatory system, each conduit having a rigid, generally tubular housing, a flexible tubular wall member within the conduit housing, and a circular second sealing surface on one end formed by the wall member and a circular third sealing surface on the opposite end from the second sealing surface and also formed by the wall member;

attachment structures for connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening so that the first sealing surfaces abut and compress against the second sealing surfaces to define therebetween conduit/pump inflow and outflow sealing lines, wherein blood flowing from the inflow conduit across the conduit/pump inflow sealing line into the variable volume chamber and then across the conduit/pump outflow sealing line to the outflow conduit only contacts the flexible tubular wall members of the conduits and the unitary liner of the pump;

inflow and outflow flexible conduit extensions adapted to communicate blood between the host circulatory system and the inflow and outflow conduits, respectively, each extension comprising an inner flexible blood conduit coaxially disposed within an outer plastic sheath terminating in a rigid circular end portion, and including a circular fourth sealing surface formed by the flexible blood conduit; and

attachment structures for connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit so that the third sealing surfaces abut and compress against the fourth sealing surfaces to define therebetween conduit/extension inflow and outflow sealing lines, wherein blood flowing across each of the conduit/extension inflow and outflow sealing lines only contacts the flexible tubular wall members of the conduits and the flexible blood conduits of the extensions.

28. The device of claim 27, further including a prosthetic valve disposed within each of the inflow and outflow conduits and sutured to the wall member so that blood flowing through the device only contacts the flexible blood conduits, the flexible tubular wall members, the prosthetic valves, and the sutures.

29. The device of claim 28, further including a flexible external stent provided for each of the inflow and outflow conduits between the respective conduit housings and flexible wall members, the stent being sutured to the flexible wall members and to the prosthetic valve within the conduit to support the valve therein.

30. The device of claim 29, wherein the prosthetic valve is a trifoliate natural tissue valve, having three commissures, and wherein the external stent includes a metallic wireform having three axially-extending commissure supports aligned with each commissure of the natural tissue valve.

31. The device of claim 27, wherein the wall member is a fabric sheet material having an outer surface coated with a blood-impermeable biologically-compatible material and an inner porous surface to provide a site for growth of a biological interface.

32. A ventricular assist device for implantation in a human host, comprising:

a pump including a rigid housing and a flexible unitary liner within the housing defining a variable volume chamber;

inflow and outflow openings to the variable volume chamber defined by tubular co-extensions of the pump housing and inner unitary liner, each of the inflow and outflow openings terminating in a circular first sealing surface formed by the unitary liner;

inflow and outflow conduits attached, respectively, to the inflow and outflow openings of the pump, each conduit having opposed open ends and being adapted to channel blood between the variable volume chamber and a host circulatory system, each conduit having a rigid, generally tubular housing, a flexible tubular wall member within the conduit housing, a circular second sealing surface on one end formed by the wall member, and a circular third sealing surface on the opposite end from the second sealing surface, the third sealing surface formed by the wall member;

attachment structures for connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening so that the first sealing surfaces abut and axially compress against the second sealing surfaces to define therebetween conduit/pump inflow and outflow sealing;

lines, wherein blood flowing from the inflow conduit across the conduit/pump inflow sealing line into the variable volume chamber and then across the conduit/pump outflow sealing line to the outflow conduit only contacts the flexible tubular wall members of the conduits and the unitary liner of the pump;

a biasing member provided as part of each of the, attachment structures connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening, the biasing member positioned to apply an elastic force urging each pair of first and second sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/pump inflow and outflow sealing lines;

inflow and outflow flexible conduit extensions adapted to communicate blood between the host circulatory system and the inflow and outflow conduits, respectively, each extension comprising an inner flexible blood conduit coaxially disposed within an outer plastic sheath terminating in a rigid circular end portion, and including a circular fourth sealing surface formed by the flexible blood conduit; and

attachment structures for connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit so that the third sealing surfaces abut and compress against the fourth sealing surfaces to define therebetween conduit/extension inflow and outflow sealing lines, wherein blood flowing across each of the conduit/extension inflow and outflow sealing lines only contacts the flexible tubular wall members of the conduits and the flexible blood conduits of the extensions.

33. The device of claim 32, further including a biasing member provided as part of each of the attachment structures connecting the inflow conduit extension to the inflow conduit and the outflow conduit extension to the outflow conduit, the biasing member positioned to apply an elastic force urging each pair of third and fourth sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/extension inflow and outflow sealing lines.

34. The device of claim 32, wherein the attachment structures each include an extension coupling member connected to the circular end portion and a conduit coupling member connected to the conduit housing, wherein one of the extension coupling member or conduit coupling member has a pair of axially facing and relatively displaceable surfaces, and wherein the biasing members are axially elastic and placed in compression between the axially facing surfaces to apply the elastic force.

35. The device of claim 34, wherein the biasing members are wave washers.

36. The device of claim 34, wherein the extension coupling member and conduit coupling member include mating threads and are screwed together.

37. The device of claim 32, wherein the wall member is a fabric sheet material having an outer surface coated with a blood-impermeable biologically-compatible material and an inner porous surface to provide a site for growth of a biological interface.

38. A ventricular assist device for implantation in a human host, comprising:

a pump including a rigid housing and a flexible unitary liner within the housing defining a variable volume chamber;

inflow and outflow openings to the variable volume chamber defined by tubular co-extensions of the pump housing and inner unitary liner, each of the inflow and outflow openings terminating in a circular first sealing surface formed by the unitary liner;

inflow and outflow conduits attached, respectively, to the inflow and outflow openings of the pump, each conduit having opposed open ends and being adapted to channel blood between the variable volume chamber and a host circulatory system, each conduit having a rigid, generally tubular housing, a flexible tubular wall member within the conduit housing, and a circular second sealing surface on one end formed by the wall member;

attachment structures for connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening so that the first sealing surfaces abut and axially compress against the second sealing surfaces to define therebetween conduit/pump inflow and outflow sealing, lines, wherein blood flowing from the inflow conduit across the conduit/pump inflow sealing line into the variable volume chamber and then across the conduit/pump outflow sealing line to the outflow conduit only contacts the flexible tubular wall members of the conduits and the unitary liner of the pump;

a biasing member provided as part of each of the attachment structures connecting the inflow conduit to the inflow opening and the outflow conduit to the outflow opening, the biasing member positioned to apply an elastic force urging each pair of first and second sealing surfaces toward one another and maintain a consistent blood-tight seal at the conduit/pump inflow and outflow sealing lines;

a prosthetic valve disposed within each of the inflow and outflow conduits and sutured to the wall member so that blood flowing through either of the inflow or outflow conduits contacts only the flexible tubular wall member, the prosthetic valve, and the sutures; and

a flexible external stent provided for each of the inflow and outflow conduits between the respective conduit housings and flexible wall members, the stent being sutured to the flexible wall members and to the prosthetic valve within the conduit to support the valve therein.

39. The device of claim 38, wherein the prosthetic valve is a trifoliate natural tissue valve, having three commissures, and wherein the external stent includes a metallic wireform having three axially-extending commissure supports aligned with each commissure of the natural tissue valve.

40. The device of claim 38, wherein the wall member is a fabric sheet material having an outer surface coated with a blood-impermeable biologically-compatible material and an inner porous surface to provide a site for growth of a biological interface.