Flexible vascular inducing implants

• US 6,432,126 B1
• Filed: 09/30/1998
• Issued: 08/13/2002
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Weiser, Michael F., Gambale, Richard A., Forcucci, Stephen J., Forde, Sean, Choh, Richard T.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/164,163
• Time in Patent Office: 1,413 Days
• Field of Search: 623/1.42, 623/1.43, 623/139, 623/23.64, 623/8, 623/14
• US Class Current: 623/1.1
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Implants and associated delivery systems for promoting angiogenesis in ischemic tissue are provided. The implants may be delivered percutaneously, thoracically or surgically and are particularly well suited for implantation into the myocardium of the heart. The implants are configured to be flexible so that they compress and expand with corresponding movement of the surrounding tissue into which they are implanted. The flow of blood into the implant and pooling of the blood in and around the implant leads to thrombosis and fibrin growth, a healing process that leads to angiogenesis in the tissue surrounding the implant. Additionally, the implants may contain an angiogenic substance or a thrombus of blood, preloaded or injected after implantation to aid in initiating angiogenesis.

Claims

1. An implant device comprising a flexible body formed from a single wall, which defines an interior with a volume, the flexible body constructed to have a first configuration having a first profile and a first volume and a second configuration that is compressed to define a second profile that is different from the profile of the first configuration, and a second volume that is substantially reduced from the first volume, the implant constructed so that movement of surrounding tissue in which it is implanted causes cyclical movement of the body between the two configurations.

2. An implant device as defined in claim 1 wherein the implant has at least one opening to the interior.

3. An implant as defined in claim 2 wherein an angiogenic substance is associated with the interior of the device.

4. An implant as defined in claim 3 wherein the angiogenic substance becomes associated with the interior of the implant prior to implantation.

5. An implant as defined in claim 3 wherein the angiogenic substance becomes associated with the interior of the implant after it is implanted.

6. An implant as defined in claim 2 wherein at least one of the openings comprises a check valve configured to permit inflow of blood.

7. An implant defined in claim 2 wherein the implant is configured to permit blood inflow into the interior while in the first configuration.

8. An implant as defined in claim 7 wherein the implant is configured to permit blood to collect and thrombose within the interior.

9. An implant as defined in claim 7 wherein the implant is configured to at least partially expel contents of the interior when it moves from its first to its second configuration.

10. An implant as defined in claim 2 wherein the implant further comprises a flexible capsule.

11. An implant as defined in claim 10 wherein the capsule is generally spherical.

12. An implant as defined in claim 10 wherein the interior is completely compressed while the implant is in the second configuration.

13. An implant as defined in claim 2 wherein the implant further comprises a tube.

14. An implant as defined in claim 13 wherein the tube comprises a polymer.

15. An implant as defined in claim 14 further comprising a spring located within the interior.

16. An implant as defined in claim 14 wherein the implant further comprises a thin polymer tube that collapses to produce a plurality of folds while in the second configuration whereby the folds serve to irritate the surrounding tissue.

17. An implant as defined in claim 14 wherein the polymer is aerated to produce an open cell structure in which the open cells are configured to receive blood and permit tissue ingrowth through the structure.

18. The implant defined in claim 1 wherein an angiogenic substance to promote angiogenesis is associated with the implant.

19. An implant as defined in claim 18 wherein at least a portion of the angiogenic substance is released from the implant as it moves from the first to the second configuration.

20. An implant as defined in claim 18 wherein the angiogenic substance comprises a human growth factor.

21. An implant as defined in claim 18 wherein the angiogenic substance comprises blood.

22. An implant as defined in claim 18 wherein the angiogenic substance comprises a pharmaceutical agent.

23. An implant as defined in claim 1 wherein the implant is configured to irritate the surrounding tissue as the implant moves between its first and second configurations.

24. An implant as defined in claim 23 further comprising a plurality of surfaces to contact and irritate the surround tissue.

25. An implant for implantation in the myocardium of a patient comprising;

a flexible body formed from a single wall of flexible material defining an interior and at least one opening to the interior, and the body being configured to pump blood into and out of the interior under the influence of the contraction and relaxation of the myocardial tissue into which it is implanted and the interior configured to promote thrombosis of entering blood.

26. A device for promoting angiogenesis in the myocardium comprising:

a carrier having a single wall defining a pump with a chamber implantable in the myocardium and having associated with it an angiogenic substance.

27. A device for promoting angiogenesis in the myocardium as defined in claim 26 wherein the angiogenic substance is located in the chamber.

28. A device for promoting angiogenesis in the myocardium as defined in claim 26 wherein the angiogenic substance is a thrombus of blood.