Ventricular assist conduit with externally supported tissue valve

• US 5,810,708 A
• Filed: 06/06/1995
• Issued: 09/22/1998
• Est. Priority Date: 02/07/1994
• Status: Expired due to Fees

• Current Assignee: World Heart Corporation (Medtronic Plc)
• Original Assignee: Baxter International Inc.
• Inventors: Nguyen, Than, Chen, Herbert, Woodard, John C., Romley, Richard M., Ness, Ronald A.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/471,438
• Time in Patent Office: 1,204 Days
• Field of Search: 606/194, 606/195, 623/2, 623/3, 623/900, 600/16
• 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 tubular conduit for blood flow having a one-way tissue valve therein supported externally by a stent structure which is isolated from blood flowing through the conduit, comprising:

a flexible composite tubular member including an inner tube of blood-permeable fabric defining an inner surface of the tubular member, and a blood impermeable polymeric coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface,

a prosthetic tissue valve having multiple leaflets and axially extending commissures positioned within the tubular member and contacting the inner surface of the fabric tube;

a stent structure positioned externally of the blood impermeable polymeric coating, the stent structure including a compliant metallic wireform having axially extending commissure supports aligned with the commissures of the tissue valve; and

sutures extending through the tubular member securing the stent structure to the tissue valve with the tubular member interposed therebetween, wherein the only blood contacting surfaces within the conduit are the inner surface, the tissue valve, and the sutures.

2. The conduit of claim 1, the stent structure further including a polymer support member coupled to the wireform.

3. The conduit of claim 2, the polymer support member and wireform being surrounded by a fabric drape of blood permeable material.

4. The conduit of claim 1, further including sinuses formed tubular member as outbulges beginning just downstream of the one-way tissue valve, wherein the sinuses have an aspect ratio of at least 1.3.

5. The conduit of claim 4, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.

6. The conduit of claim 1, further including a tubular metallic rigid housing surrounding the tubular member and having a plurality of perforations to allow body fluid to access the internal surfaces of the housing and avoid the formation of cavities or voids which are hidden from the immune system of a host in which the conduit is implanted.

7. The conduit of claim 1, wherein the inner tube of blood-permeable fabric is a polyethylene terephthalate fabric, and the blood impermeable polymeric coating is a silicon rubber.

8. An implantable ventricular assist device, comprising:

a pumping portion having an inflow port and outflow port;

an inflow conduit comprising a tubular conduit as in claim 1 attached to the inflow port of the pumping portion; and

an outflow conduit comprising a tubular conduit as in claim 1 attached to the outflow port of the pumping portion.

9. The ventricular assist device of claim 8, wherein the pumping portion includes a unitary liner extending to the ends of the inflow and outflow ports and in direct and sealing contact with, respectively, the inner surfaces of the conduit tubular members, so that blood contacts only the inner surfaces and the unitary liner across the junctions between the pumping portion and the inflow and outflow conduits.

10. A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, and increased aspect ratio sinuses downstream of the valve for vigorous vortex flow resulting in improved valve closure and elimination of blood stagnation, comprising;

a synthetic tubular wall having an inner surface and a nominal diameter, an inner tube of blood-permeable fabric defining the inner surface, and a blood impermeable polymeric, coating on the exterior surface of the inner tube penetrating into the fabric interstices toward but short of the inner surface;

a trifoliate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface;

a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve;

sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and

sinuses formed In the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.

11. The conduit of claim 10, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.

12. The conduit of claim 11, wherein the sinuses have an aspect ratio of about 1.45.

13. The conduit of claim 10, wherein the inner tube of blood-permeable fabric is a polyethylene terephthalate fabric, and the blood impermeable polymeric coating is a silicon rubber.

14. A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising:

a synthetic tubular wall having an inner surface and a nominal diameter;

a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface;

a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve, the stent further including a compliant wireform extending along the commissures, and a polymer support member coupled to the wireform; and

sutures formed in the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween; and

sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream or the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3.

15. The conduit of claim 14, the polymer support and wireform being surrounded by a fabric drape of blood permeable material.

16. The conduit of claim 14, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.

17. The conduit of claim 16, wherein the sinuses have an aspect ratio of about 1.45.

18. A reduced size blood conduit for use in implantable blood pump devices, the conduit having a prosthetic valve therein adapted to obstruct blood flow in an upstream direction, comprising;

a synthetic tubular wall having an inner surface and a nominal diameter;

a trifollate tissue valve positioned within the tubular wall, the tissue valve having a base and three axially extending commissures with attached leaflets, the valve being in contact with the tubular wall inner surface;

a stent structure positioned externally of tubular wall and including axially extending commissure supports aligned with the commissures of the tissue valve;

sutures extending through the tubular wall securing the stent structure to the tissue valve with the tubular wall interposed therebetween;

sinuses formed in the tubular wall as outbulges from the nominal diameter beginning just downstream of the valve, each sinus being axially aligned with one of the valve leaflets, each sinus having a maximum radius and extending downstream a predetermined distance from the valve to a point at which the nominal diameter of the tubular wall resumes, wherein an aspect ratio defined by the predetermined distance divided by the maximum radius is at least 1.3; and

further including a tubular metallic rigid housing surrounding the tubular member and having a plurality of perforations to allow body fluid to access the internal surfaces of the housing and avoid the formation of cavities or voids which are hidden from the immune system of a host in which the conduit is implanted.

19. The conduit of claim 18, wherein the sinuses have an aspect ratio in the range from about 1.3 to about 1.6.

20. The conduit of claim 19, wherein the sinuses have an aspect ratio of about 1.45.