Implant anchor systems

• US 6,986,784 B1
• Filed: 05/12/2000
• Issued: 01/17/2006
• Est. Priority Date: 05/14/1999
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Weiser, Michael F., Gambale, Richard A., Forcucci, Stephen J., Forde, Sean, Kan, Kellywan
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): Hamilton, Lalita M.
• Application Number:
  US09/743,695
• Time in Patent Office: 2,076 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.14, 623/1.15, 623/1.23, 623/1.33, 623 11- 12, 623/900, 623/1.3, 623/1.31, 623/23.7, 623/23.66, 623/23.64, 606/108, 606/185, 606/195, 606/198, 606/208
• US Class Current: 623/1.1
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

The present invention provides anchoring mechanisms for tissue implants. The anchors are integrated as part of the structure of the implant and serve to resist migration of the implant from highly dynamic muscle tissue such as the myocardium of the heart. In implant devices configured as a flexible coil, various attributes of the coil may be altered to increase the anchoring capability of the device. The flexibility of the device may be increased to resist migration by changing the coil filament thickness, pitch or filament material. Alternatively, the end coil may be altered to have a broader cross-sectional profile in engagement with the tissue or may include an anchoring barb. Additionally, methods of implanting a tissue implant device are provided.

Claims

1. A myocardial tissue implant device adapted to be implanted in a human myocardium having a predetermined thickness at an implant site, the implant being configured to resist migration and comprising:

an elongate flexible body having proximal and distal portions, the proximal portion, prior to implantation, having a larger profile than the distal portion,

the flexible body defining an exterior, a hollow interior, and at least one opening between the interior and exterior, and a tail at the proximal portion,

the length of the implant being less than said predetermined thickness whereby the implant device may be implanted within the myocardium with at least part of the tail disposed below the external surface of the myocardium and the distal portion being disposed proximally of the innermost surface of the myocardium.

2. A tissue implant device as defined in claim 1 wherein the device is configured to resist migration by exhibiting longitudinal flexibility to substantially absorb migratory forces placed on it by the surrounding tissue.

3. A tissue implant device as defined in claim 2 wherein the flexible body comprises a helical spring.

4. The myocardial tissue implant device of claim 1, further comprising a surgical adhesive applied to the device.

5. A tissue implant device as defined in claim 4 wherein the surgical adhesive is associated with the device after the device is implanted in tissue.

6. A myocardial tissue implant device adapted to be implanted in a human myocardium having a predetermined thickness at an implant site, the implant being configured to resist migration comprising:

an elongate flexible body having proximal and distal portions, the proximal portion, prior to implantation, having a larger profile than the distal portion,

a tail at the proximal portion,

the length of the implant being less than said predetermined thickness whereby the implant device may be implanted within the myocardium with at least part of the tail disposed below the external surface of the myocardium and the distal portion being disposed proximally of the innermost surface of the myocardium.

7. A tissue implant device as defined in claim 6 wherein the tail defines a profile that is larger than the distal portion of the body.

8. A tissue implant device as defined in claim 7 wherein the tail is configured to remain at the tissue surface when the device is implanted.

9. A tissue implant device as defined in claim 8 wherein the tail comprises a broadly wound most proximal coil of the spring having a diameter that is greater than the diameter of coils of the body of the device.

10. A tissue implant device as defined in claim 9 wherein the broadly wound coil is concentric with the body of the device.

11. A tissue implant device as defined in claim 9 wherein the broadly wound coil has a center which is offset from the longitudinal axis of the body of the device.

12. A tissue implant device as defined in claim 9 wherein the tail includes a proximal end of the spring and the proximal end is secured to the broadly wound coil.

13. A tissue implant device as defined in claim 12 wherein the proximal end is joined to the broadly wound coil by being wrapped around the loop.

14. A tissue implant device as defined in claim 13 wherein the proximal end of the spring extends distally from the broadly wound coil after it has been wrapped about the broadly wound coil to serve as a barb.

15. A tissue implant device as defined in claim 12 wherein the proximal end is joined to the broadly wound coil by welding.

16. A tissue implant device as defined in claim 12 wherein the proximal end of the spring is joined to the broadly wound coil by a malleable sleeve crimped around the proximal end and broadly wound coil to secure the proximal end to the coil.

17. A tissue implant device as defined in claim 12 wherein the broadly wound coil is joined to the body of the device by a neck portion.

18. A tissue implant device as defined in claim 17 wherein the neck comprises at least one straight segment.

19. A tissue implant device as defined in claim 17 wherein the neck comprises a coil lying in a plane that is substantially parallel to the longitudinal axis of the device.

20. A tissue implant device as defined in claim 9 wherein the broadly wound coil is non-circular.

21. A tissue implant device as defined in claim 7 wherein the tail is configured to be implanted in the tissue when the body of the device is implanted.

22. A tissue implant device as defined in claim 21 wherein the tail is formed by a more broadly wrapped coil adjacent to the proximal portion of the body forming an arm that extends laterally from the longitudinal axis of the device in the diameter of coils that comprise the body of the spring.

23. A tissue implant device as defined in claim 22 wherein the flexible body comprises a helical spring and the tail is deformed to be out of plane with the helical orientation of coils comprising the body of the spring.

24. A method of implanting a device in a wall of tissue comprising:

providing an implantable device having an elongate flexible body with proximal and distal ends and an anchoring tail at the proximal end that defines a larger profile than the distal end of the implant, the length of the implantable device being less than the thickness of the tissue wall whereby the device may be implanted within the wall with at least part of the tail disposed below one surface of the wall and the distal portion of the implant being disposed within the wall and spaced from the opposite surface of the wall;

providing an elongate implant delivery device having a sharp tip configured to penetrate tissue and releasably retain the tissue implant device;

associating the implantable device with the implant delivery device;

accessing the desired tissue implant site;

applying a penetrating force to the implant and implant delivery device combination such that the combination penetrates tissue to implant the device within the tissue wall;

withdrawing the implant delivery device from the implanted device.

25. A method as defined in claim 24 wherein the implant device and delivery device combination is rotated while penetrating forces are applied to screw the device into the tissue.

26. A method as defined in claim 25 wherein the tail of the implant device is submerged below the surface of the tissue after implantation.

27. A method as defined in claim 25 wherein the tail of the implant device remains exposed at the surface of the tissue after implantation.

28. A method of implanting a tissue implant device to promote angiogenesis within a tissue comprising:

providing an implantable device configured to be anchored within tissue so that it does not migrate from the tissue after implantation comprising an elongate flexible body having proximal and distal portions each defining a profile, the proximal portion having a larger profile than the distal portion and a tail,

inserting the distal portion of the device into the tissue and advancing the device to embed the device in the tissue with the distal end of the device covered by the tissue and the tail at the proximal portion being embedded below the tissue surface.

29. A method of implanting a tissue implant device as defined in claim 28 wherein the device is delivered percutaneously.

30. A method of implanting a tissue implant device as defined in claim 28 wherein the device is delivered transthoracically to the intended tissue location.

31. A method of delivering a tissue implant device as defined in claim 28 wherein the device is delivered surgically to the intended tissue location.

32. A method of anchoring a tissue implant device within tissue comprising:

providing an implantable body having a proximal portion and a distal portion each defining a profile and wherein the profile of the proximal portion is larger than that of the distal portion and the proximal portion comprises a tail;

providing a delivery device configured to carry the implantable body to an intended tissue location and implanting the device in tissue;

associating the body with the delivery device and implanting the body in tissue at the intended location to a depth so that the tail is embedded below the tissue surface and the distal end of the device is enclosed within tissue;

applying a surgical adhesive at the site of the implant to secure the body to the tissue.

33. A method of implanting an implant device as defined in claim 32 wherein the surgical adhesive is applied to the implant site by the delivery device after implantation.

34. A method of delivering an implant device as defined in claim 32 wherein the surgical adhesive is applied to the body prior to implantation.

35. A method of implanting an implant device configured to resist migration in tissue comprising:

providing a flexible spring body implant device having proximal and distal portions, the proximal portion, prior to implantation, having a larger profile than the distal portion, the implant device having sufficient longitudinal flexibility to absorb migratory forces applied on the device by surrounding tissue after implantation;

inserting the flexible spring body into tissue to a depth such that the distal portion is enclosed by the tissue.

36. A myocardial tissue implant device adapted to be implanted, at an implant site, in a human myocardium comprising:

an elongate flexible body having proximal and distal portions, the proximal portions, prior to implantation, having a larger profile than the distal portion, wherein the flexible body comprises a helical spring and a tail at the proximal portion, the length of the implant being less than the wall thickness of the myocardium at the implant site whereby the implant may be embedded in the myocardium at the implant site with the tail in engagement with the outer surface of the myocardium and the distal portion being fully enclosed by the myocardium.

37. A tissue implant device as defined in claim 36 wherein the helical spring has varying flexibility along its length.

38. A tissue implant device as defined in claim 37 wherein the filament is comprised of a plurality of materials of varying modulii of elasticity.

39. A tissue implant device as defined in claim 37 wherein the varying flexibility is created by varying the distance between individual coils of the helical spring.

40. The tissue implant device as defined in claim 37 wherein the helical spring is formed from a filament having a varying thickness along its length, which creates varying flexibility along the length of the helical spring.

41. A tissue implant device as defined in claim 36 wherein the helical spring is formed from a filament having varying modulus of elasticity.

42. A device as defined in claim 36 wherein individual coils of the helical spring have a constantly increasing diameter from the distal portion to the proximal portion.

43. A tissue implant device as defined in claim 36 wherein coils of the distal portion define a constant diameter and coils of the proximal portion define an increasing diameter in the proximal direction.

44. A tissue implant device as defined in claim 36 wherein the helical spring is formed from a filament having a non-circular cross-sectional shape.

45. A tissue implant device as defined in claim 44 wherein the cross-sectional shape of the filament is rectangular.

46. A tissue implant device as defined in claim 45 wherein the major axis of the rectangular cross-section is substantially perpendicular to the longitudinal axis of the device.

47. A tissue implant device as defined in claim 45 wherein the major axis of the rectangular cross-section is at an acute angle to the longitudinal axis of the device.