Non-porous smooth ventricular assist device conduit

• US 6,994,666 B2
• Filed: 06/05/2001
• Issued: 02/07/2006
• Est. Priority Date: 06/05/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Shannon, Donald T., Kuo, Chris C.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/874,846
• Publication Number:
  US 20020183584A1
• Time in Patent Office: 1,708 Days
• Field of Search: 610 16- 18, 604/8, 623/1.44, 623/1.45, 623/1.39, 623/155, D24/155, 206/363, 206/364, 206/370, 600 16- 18
• US Class Current: 600/16
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 60/205 Non-positive displacement blood pumps
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

An improved inflow conduit for an implantable ventricular assist device comprising covering the flexible porous tubular graft body of the conduit with an attached non-porous polymer to produce a non-porous conduit. The flexible conduit has an upstream end and a downstream end, a ventricular attachment structure to which the upstream end of the body connects; and a coupling fitting on the downstream end of the body. Also taught is a combination of the improved inflow conduit with an implantable ventricular assist device. A method for the treatment of congestive heart failure, comprising implanting the implantable ventricular assist device in a patient in need of such treatment, as well as an article of manufacture, comprising packaging material and the implantable ventricular assist device contained within the packaging material are also provided.

Claims

1. An inflow conduit for an implantable ventricular assist device comprising:

a flexible, porous tubular graft body comprising a closed structured biocompatible polytetrafluoroethylene (PTFE) to resist tissue ingrowth having an upstream end and a downstream end, the graft body having a substantially smooth inner surface; and

a non-porous covering attached on the outside of said flexible, porous tubular graft body,

whereby said inflow conduit is rendered non-porous.

2. The inflow conduit of claim 1, wherein said non-porous covering is attached to the flexible, porous tubular graft body by thermal bonding.

3. The inflow conduit of claim 1, wherein said non-porous covering is attached to the flexible, porous tubular graft body by a biocompatible adhesive.

4. The inflow conduit of claim 1, wherein said PTFE has a pore size of less than about 20 μ

.

5. The inflow conduit of claim 1, wherein said PTFE has a pore size of less than about 15 μ

.

6. The inflow conduit of claim 1, wherein said PTFE has a pore size of less than about 2 μ

.

7. The inflow conduit of claim 1, wherein the water entry pressure for said flexible, tubular graft body is at least about 5 psi (0.34 atm).

8. An implantable ventricular assist device comprising:

an inflow conduit comprising a flexible, porous tubular graft body having an upstream end and a downstream end, the body having a substantially smooth inner surface for enhanced flow-through of blood with a minimum of surface-induced turbulence;

a ventricular attachment structure connected to the upstream end of the flexible, porous tubular graft body;

a coupling fitting connected to the downstream end of the flexible, porous tubular graft body;

an implantable pumping portion in flow communication with said inflow conduit;

an outflow conduit in flow communication with said implantable pumping portion; and

a non-porous covering comprising a polymer attached on the outside of said flexible, porous tubular graft body, whereby said inflow conduit is rendered non-porous.

9. A method for the treatment of congestive heart failure, comprising

implanting the device of claim 8 in a patient in need of such treatment wherein said implantation is effective to ameliorate one or more of the symptoms of said heart failure.

10. An inflow conduit for an implantable ventricular assist device comprising:

a flexible, porous tubular graft body having a lumen, an upstream end and a downstream end, the graft body having a substantially smooth inner surface; and

a covering attached on the outside of the tubular graft body that will not leak air therethrough when the lumen of the tubular graft body is placed under negative pressures present in ventricular assist device inflow conduits.

11. The inflow conduit of claim 10, wherein the tubular graft body comprises a biocompatible polymer.

12. The inflow conduit of claim 11, wherein the biocompatible polymer is polytetrafluoroethylene (PTFE).

13. The inflow conduit of claim 12, wherein the PTFE is closed structured to resist tissue ingrowth.

14. The inflow conduit of claim 13, wherein the PTFE has a pore size of less than about 20 μ

.

15. The inflow conduit of claim 14, wherein the biocompatible polymer is fluorinated ethylene propylene (FEP).

16. The inflow conduit of claim 10, wherein the water entry pressure for the tubular graft body is at least about 5 psi (0.34 atm).

17. The inflow conduit of claim 10, wherein the tubular graft body comprises at least one polymer selected from the group consisting of PTFE, FEP, perfluoroalkoxy (PFA), polyphenylenesulfide (PPS), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), polystyrene/polyethylstyrene (PS/PES), polychlorotetrafluoroethylene (PCTFE), and ethylenetetrafluoroethylene (ETFE).

18. The inflow conduit of claim 10, wherein the covering is non-porous.

19. The inflow conduit of claim 10, wherein the covering comprises a PTFE tape.

20. The inflow conduit of claim 10, wherein the covering comprises an FEP tape.

21. The inflow conduit of claim 10, wherein the covering comprises a polymer tape selected from the group consisting of PEA, PPS, PVDF, PEEK, PS/PES, PCTFE, and ETFE.

22. The inflow conduit of claim 10, wherein the covering comprises a polymer selected from the group consisting of vinylidene polymer plastics, polyethylene, polypropylene, polyesters, polyamides, polyethylene terephthalate, high density polyethylene, irradiated polyethylene, polycarbonates, polyurethanes, polyvinyl chloride, polyester copolymers and polyolefin copolymers.

23. The inflow conduit of claim 10, wherein the covering is attached to the tubular graft body by thermal bonding.

24. The inflow conduit of claim 10, wherein the covering is attached to the tubular graft body by a biocompatible adhesive.

25. An inflow conduit for an implantable ventricular assist device comprising:

a flexible, porous tubular graft body having an upstream end and a downstream end, the graft body having a substantially smooth inner surface; and

a non-porous covering comprising a non-porous PTFE tape attached on the outside of said flexible, porous tubular graft body,

whereby said inflow conduit is rendered non-porous.

26. An inflow conduit for an implantable ventricular assist device comprising:

a flexible, porous tubular graft body having an upstream end and a downstream end, the graft body having a substantially smooth inner surface; and

a non-porous covering comprising a non-porous FEP tape attached on the outside of said flexible, porous tubular graft body,

whereby said inflow conduit is rendered non-porous.

27. An inflow conduit for an implantable ventricular assist device comprising:

a flexible, porous tubular graft body having an upstream end and a downstream end, the graft body having a substantially smooth inner surface; and

a non-porous covering comprising a non-porous polymer tape selected from the group consisting of PFA, PPS, PVDF, PEEK, PS/PES, PCTFE, and ETFE, attached on the outside of said flexible, porous tubular graft body,

whereby said inflow conduit is rendered non-porous.