Implantable device fastening system and methods of use

• US 20060190039A1
• Filed: 09/15/2004
• Published: 08/24/2006
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Coe, Frederick L., Hoyt, Robert E. Jr., Birk, Janel
• Granted Patent: US 7,762,998 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members

Abstract

A surgical fastening system for implantable devices is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Claims

1. A method of securing a device to bodily tissue comprising:

providing a device having an associated attaching means, wherein the attaching means comprises a housing, wherein the housing surrounds the perimeter of the device and comprises a plurality of notches or openings, wherein the notches or openings comprise a fastening means pivotally attached to the housing;

positioning the device and attaching means on the bodily tissue;

covering the device and attaching means with a delivery system;

activating the delivery system such that the fastening means are pivotally rotated from a first position to a second position to secure the device in bodily tissue, wherein the pivotal rotation is accommodated by the notches or openings, and wherein the fastening means are locked into the second position by a locking tab; and

,

removing the delivery system from the secured device and attaching means.

2. The method of claim 1, wherein the housing is integral with the body of the device.

3. The method of claim 1, wherein the housing is detachable and surrounds the outside of the device, such that the device is securely contained within the housing after said activating step.

4. The method of claim 1, wherein the fastening means is a staple.

5. The method of claim 4, wherein the staple is shaped substantially in the shape of

6. The method of claim 5, wherein a first leg of the staple is pivotally attached to the housing.

7. The method of claim 6, wherein a second leg of the staple punctures the bodily tissue when pivotally rotating.

8. The method of claim 7, wherein the staple maintains its shape when pivotally rotating.

9. The method of claim 6, wherein the staple is locked into position by a locking tab.

10. The method of claim 9, wherein the bodily tissue is secured between the second leg of the staple and the device.

11. The method of claim 1, wherein the plurality of notches or openings are spaced equidistant around the housing.

12. The method of claim 4, wherein the staple is comprised of one or more of:

stainless steel, Elgiloy™

, cobalt-chromium alloy, or nickel-titanium alloy.

13. The method of claim 1, wherein the delivery system comprises a cover, a plunger, a slide pusher and a slide assembly, wherein the slide assembly comprises beams, wherein the beams are spaced so as to line up with the notches or openings on the housing of the attaching means.

14. The method of claim 13, wherein the plunger is activated via a pencil grip system, a palm grip system or a pistol grip system.

15. The method of claim 14, wherein the slide assembly moves towards the housing and device when the plunger is activated.

16. The method of claim 15, wherein the beams push against the fastening means when the plunger is activated, causing the fastening means to pivotally rotate.

17. An attaching means for attaching an associated device to bodily tissue, said attaching means comprising a housing, wherein said housing surrounds the perimeter of the device and comprises a plurality of notches or openings, wherein said notches or openings comprise fastening means pivotally attached to said housing, wherein said fastening means may be rotated from a first position to a second position to secure the device in bodily tissue.

18. The attaching means of claim 17 further comprising a locking tab for locking said fastening means after rotation into the second position.

19. The attaching means of claim 17, wherein said housing is integral with the body of the device.

20. The attaching means of claim 17, wherein said housing is detachable from and substantially surrounds the perimeter of the device.

21. The attaching means of claim 17, wherein said fastening means is a staple.

22. The attaching means of claim 21, wherein said staple is shaped as

23. The attaching means of claim 21, wherein a first leg of said staple is pivotally attached to said attaching means.

24. The attaching means of claim 21, wherein a second leg of said staple punctures the bodily tissue when pivotally rotating.

25. The attaching means of claim 24, wherein said staple maintains its shape when pivotally rotating.

26. The attaching means of claim 21, wherein said staple is locked into the second position by a locking tab.

27. The attaching means of claim 24, wherein the bodily tissue is secured between said second leg of said staple and the device.

28. The attaching means of claim 17, wherein said notches or openings are spaced equidistant around said attaching means.

29. The attaching means of claim 17, wherein said fastening means is comprised of one or more of:

stainless steel, Elgiloy™

, cobalt-chromium alloy, or nickel-titanium alloy.

36. The attaching means of claim 20, wherein said housing further comprises pegs to engage suture holes around the perimeter of the device.

38. The attaching means of claim 17 further comprising a rotating disc for rotating said fastening means from said first position to said second position.

30. A delivery system for securing a device and associated attaching means to bodily tissue, said delivery system comprising a cover, a plunger, a slide pusher and a slide assembly, wherein said slide assembly comprises beams spaced so as to line up with notches or openings on a housing of the attaching means.

31. The delivery system of claim 30, wherein said plunger is activated via a pencil grip system, a palm grip system or a pistol grip system.

32. The delivery system of claim 30, wherein said slide assembly moves towards the housing and device when said plunger is activated.

33. The delivery system of claim 30, wherein said beams push against a fastening means when said plunger is activated, causing the fastening means to pivotally rotate.

34. An implantable device having an outer surface, wherein said outer surface comprises a plurality of notches or openings, wherein said notches or openings house fastening means pivotally attached to said device.

35. A delivery system for use with the implantable device of claim 34, wherein said delivery system comprises a cover, a plunger, a slide pusher and a slide assembly, wherein said slide assembly further comprises beams spaced so as to line up with said notches or openings on said device.

37. A delivery system for securing a device and associated attaching means to bodily tissue, said delivery system comprising a cover, a plunger, and a slide pusher, and a transmission, wherein said transmission coverts inear motion of said plunger into rotational motion to deploy the attaching means of the device.