Nova Patents
EP1554990A2

Implantable medical device with enhanced biocompatibility and biostability

Abstract

An implantable medical device comprising a drug-loaded polymer overlaid with a fabric that promotes tissue ingrowth is useful in a wide variety of tissue engineering applications. The invention includes, for example, prosthetic heart valves, annuloplasty rings, and grafts, having enhanced biocompatibility and biostability. Methods of making and using the implantable medical devices of the invention are also included.

EP1554990A2, drawing sheet 1
Sheet 1 of 23

Term

Term ended

Projected expiry passed 28 January 2020, 6.7 years ago.

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34 claims: 19 independent, 15 dependent

  1. 1
    An implantable medical device comprising a body portion overlaid by a fabric overlayer, the body portion comprising a constituent material in intimate contact with a releasable therapeutic agent, and further wherein the constituent material comprises polyurethane.
  2. 2
    The implantable medical device of any preceding claim, wherein the fabric overlayer comprises a knitted or woven fabric of polymer fibers.
  3. 4
    The implantable medical device of any preceding claim, wherein the therapeutic agent comprises an anti-inflammatory agent.
  4. 6
    The implantable medical device of any preceding claim, wherein the therapeutic agent comprises an antimicrobial agent.
  5. 8
    The implantable medical device of any preceding claim, wherein the therapeutic agent is coated onto the body portion of the device.
  6. 9
    The implantable medical device of any of claims 1 to 7, wherein the therapeutic agent is compounded into the body portion of the device.
  7. 10
    The implantable medical device of any of claims 1 to 7, wherein the body portion of the device comprises a liquid core comprising the therapeutic agent.
  8. 11
    The implantable medical device of any preceding claim, selected from the group consisting of a bioprosthetic or mechanical prosthetic heart valve, an annuloplasty ring, a vascular graft, a sewing ring, a stent, a medical electrical lead, an indwelling catheter, a pacemaker and a drug infusion pump.
  9. 12
    The implantable medical device of any preceding claim, wherein the fabric overlayer takes the form of a sheath, pouch, an encasement, an enclosure, a layer, a film, or a coating.
  10. 13
    A bioprosthetic heart valve comprising a polymer insert containing struts attached to tissue leaflets to form a valve housing, wherein a fabric sheath encloses the polymer insert to form sewing ring, said sewing ring attached circumferentially to the base of the valve housing, the valve further comprising a releasable therapeutic agent in intimate contact with the polymer insert.
  11. 16
    A mechanical heart valve comprising a metallic ringed valve housing containing a central metallic strut along which a flow occluder disk moves, wherein a fabric sheath encloses a metal insert to form a sewing ring, the valve further comprising a releasable therapeutic agent in intimate contact with constituent material of the insert.
  12. 18
    The heart valve of any of claims 13 to 17, wherein the therapeutic agent comprises an anti-inflammatory agent.
  13. 20
    The heart valve of any of claims 13 to 19, wherein the therapeutic agent comprises an antimicrobial agent.
  14. 23
    A method of making an implantable medical device comprising:incorporating a therapeutic agent into an annular insert comprising a constituent material, such that the therapeutic agent is in intimate contact with the constituent material;enclosing the annular insert in a fabric sheath.
  15. 29
    The method of any of claims 23 to 28, wherein the fabric sheath comprises polyester.
  16. 30
    The method of any of claims 23 to 29, wherein the therapeutic agent comprises an anti-inflammatory agent.
  17. 32
    The method of any of claims 23 to 31, wherein the therapeutic agent comprises an antimicrobial agent.
  18. 33
    The method of any of claims 23 to 32, wherein incorporating a therapeutic agent into an annular insert comprises compounding the therapeutic agent into the annular insert.
  19. 34
    The method of any of claims 23 to 32, wherein incorporating a therapeutic agent into an annular insert comprises coating the therapeutic agent onto the annular insert.
Independent claims19