Devices and methods for treating ischemia by creating a fibrin plug

• US 6,620,170 B1
• Filed: 04/26/1999
• Issued: 09/16/2003
• Est. Priority Date: 04/26/1999
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ahern, John E.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US09/299,795
• Time in Patent Office: 1,604 Days
• Field of Search: 623/1, 623/1.42, 128/898, 264/485, 264/279, 264/279.1, 606/108
• US Class Current: 606/108
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention provides devices and methods for inducing fibrin growth in tissue to promote revascularization of that tissue. The devices and methods are useful in ischemic tissue occurring anywhere in the body, and are particularly useful in treating ischemic myocardial tissue of the heart. The device may comprise a frame configured to foster a fibrin growth and configured to permit communication between the fibrin and the tissue into which the frame is implanted. The fibrin may be positioned internally or externally on the frame. The implant should be capable of becoming anchored in the tissue to prevent the formed fibrin from dislodging from the tissue. A fibrin producing substance may be associated with the implant device to help promote and sustain the fibrin growth. Alternatively, a thrombophilic or fibrin producing substance may be introduced into ischemic tissue alone, without an associated device, to induce fibrin growth in vivo. In another aspect of the invention, a thrombus formed ex vivo may be associated with the device prior to implantation to aid in revascularization by initiating angiogenesis and vessel recruitment. A thrombus formed ex vivo also may be introduced into the subject tissue without an associated implant device.

Claims

1. A device for promoting fibrin growth in tissue comprising:

a frame, implantable in tissue, having a fibrin retention region configured to permit communication between fibrin associated with the frame and the surrounding tissue;

the frame being securely implantable in the tissue such that the frame and associated fibrin resist migration; and

a fibrin promoting substance associated with the frame prior to implantation.

2. A device as defined in claim 1 wherein

the fibrin promoting substance comprises thrombin.

3. A device as defined in claim 1 wherein

the fibrin promoting substance comprises a growth factor.

4. A device as defined in claim 1 wherein the frame further comprises:

a hollow interior chamber, which serves as the retention region and the interior chamber is configured to permit communication between the associated fibrin and tissue that surrounds the device when implanted.

5. A device as defined in claim 1 wherein

the frame is comprised of a biodegradable substance.

6. A device as defined in claim 5 wherein

the biodegradable substance includes a substance that includes the fibrin promoting substance that is released as the frame degrades.

7. A device as defined in claim 1 wherein the frame further comprises:

an exterior surface, which comprises a fibrin retention region.

8. A device as defined in claim 1 wherein

formed fibrin is associated with the fibrin retention region prior to implantation.

9. A device as defined in claim 1 further comprising:

a thrombophilic substance associated with the device.

10. A method of promoting fibrin growth within tissue comprising:

providing an implant configured to promote fibrin growth;

associating formed fibrin with the implant; and

implanting the implant in tissue.

11. A method of promoting revascularization of biological tissue comprising:

providing a device having a fibrin retention region configured to be in communication with tissue in which the device is implanted;

treating the device with a fibrin promoting substance; and

securely implanting the device within a region of tissue so that it does not migrate from its implant site.

12. A method of promoting revascularization of biological tissue comprising:

the step of manipulating tissue to initiate fibrin growth within the tissue.

13. A method of promoting revascularization as defined in claim 12 wherein

multiple tissue sites are manipulated to initiate fibrin growth within an area of tissue.

14. A method of promoting revascularization as defined in claim 12 further comprising:

placing a fibrin producing substance in the tissue.

15. A method of promoting revascularization as defined in claim 14 wherein

the fibrin producing substance is injected into the tissue.

16. A method of promoting revascularization as defined in claim 14 wherein

the fibrin producing substance is associated with a device which is implanted into the tissue.

17. A method of promoting revascularization as defined in claim 16 wherein

the device is biodegradable and the associated fibrin producing substance is released with the degradation of the device.

18. A method of promoting revascularization as defined in claim 12 further comprising:

implanting a device having a fibrin retention region to foster fibrin growth.

19. A method of promoting revascularization as defined in claim 18 further comprising:

associating a formed thrombus with the device.

20. A device for treating ischemic biological tissue comprising:

a frame implantable in tissue and configured to foster fibrin growth in the area of the frame while permitting communication between the fibrin growth and surrounding tissue into which the device is implanted;

the frame being securely implantable in the tissue such that the frame and associated fibrin resist migration.

21. A method of treating ischemia comprising:

providing an implant device having a fibrin retention region;

associating a formed thrombus with the fibrin retention region of the device; and

implanting the device in tissue.

22. A method as defined in claim 21 wherein

the device has an interior chamber, which comprises the fibrin retention region and the thrombus is captured within the interior chamber.

23. A method as defined in claim 22 wherein

the thrombus is not adhered to the fibrin retention region.

24. A method as defined in claim 21 wherein

the thrombus is adhered to the fibrin retention region.

25. A method of revascularizing biological tissue comprising:

providing an implant device configured to promote fibrin growth;

implanting the device in tissue.

26. A method of revascularizing tissue as defined inclaim 25 wherein

the tissue is revascularized by angiogenesis and recruitment of existing vessels to the tissue.

27. A device for promoting fibrin growth in tissue comprising a frame, implantable in tissue, having a solid exterior surface that serves as a fibrin retention region and a fibrin promoting substance associated with the exterior surface prior to implantation of the frame.

28. A device for promoting fibrin growth in tissue comprising a frame, implantable in tissue, having a solid exterior surface that serves as a fibrin retention region and formed fibrin associated with the fibrin retention region prior to implantation.

29. A device for promoting fibrin growth in tissue comprising a frame, implantable in tissue, having a solid exterior surface that serves as a fibrin retention region and a thrombophilic substance associated with the fibrin retention region prior to implantation.