Tissue repair implant and delivery device and method

• US 9,138,211 B2
• Filed: 01/20/2011
• Issued: 09/22/2015
• Est. Priority Date: 01/20/2010
• Status: Active Grant

• Current Assignee: Micro Interventional Devices, Inc.
• Original Assignee: Micro Interventional Devices, Inc.
• Inventors: Whitman, Michael P.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/010,774
• Publication Number:
  US 20110178535A1
• Time in Patent Office: 1,706 Days
• Field of Search: 606/213, 606/139, 606142-143, 606/151, 606/219
• US Class Current: 1/1
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/0408 Rivets
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence

Abstract

A device having a temporary frame configured to carry an implant, the temporary frame being selectably movable between a retracted position and a deployed position, the implant being in a relaxed state when carried by the frame in the retracted position, the implant being in a taut state when carried by the frame in the deployed position.

Claims

1. An implant delivery device, comprising:

a device body;

an implant;

a fastening arm, extendable from a distal end of the device body, the fastening arm having a lumen;

at least one fastener situated in the lumen of the fastening arm;

a fastener driver situated in the lumen of the fastening arm, wherein the fastener driver is configured to drive the fastener distally from the lumen into tissue; and

a frame carrying the implant and extending within the device body, the frame being selectably movable between a retracted position in which the frame is collapsed and an extended position in which the frame is expanded to a predetermined shape to pull the implant taut and to conform the perimeter of the implant to the perimeter of the predetermined shape of the frame;

wherein the frame is configured to detach from the implant after moving from the retracted position to the extended position.

2. The device of claim 1, wherein the implant is a mesh.

3. The device of claim 1, wherein the implant is a graft.

4. The device of claim 1, wherein the implant is a film.

5. The device of claim 1, wherein the implant is relaxed when the frame is in the retracted position and taut when the frame is in the extended position.

6. The device of claim 1, wherein the fastener driver is configured to fasten the implant to a patient'"'"'s tissue when the frame is in the extended position.

7. The device of claim 6, wherein the frame is configured to detach from the implant when moving from the extended position to the retracted position after the implant has been fastened to the tissue.

8. The device of claim 1, wherein the device body includes a tubular portion that includes a distal opening.

9. The device of claim 8, wherein the tubular portion is a catheter.

10. The device of claim 9, wherein the frame moves distally through the distal opening of the tubular portion when the frame moves from the retracted position to the extended position.

11. The device of claim 8, further comprising a plurality of fastening arms extending through the tubular portion, each of the plurality of fastening arms having a retracted position and an extended position.

12. The device of claim 11, wherein, when the fastening arms are in their extended positions, the frame is slidable along the plurality of fastening arms when the frame moves from the retracted position to the extended position.

13. The device of claim 12, wherein a distal portion of each fastening arm includes a curved seat configured to receive and hold the frame when the frame is in the extended position.

14. The device of claim 13, wherein the curved seat of each fastening arm holds the frame at a position that allows the at least one fastener to be driven through the distal opening of the fastening arm into the implant supported by the frame.

15. The device of claim 14, wherein each of the fastening arms is configured to simultaneously drive one of the at least one fastener into the implant while the implant is held tautly by the frame.

16. The device of claim 11, wherein a distal end of each fastening arm is disposed adjacent a longitudinal axis of the tubular portion when the fastening arm is in the retracted position and the distal end of each fastening arm extends radially outwardly from the longitudinal axis of the tubular portion when the fastening arm is moved distally to the extended position.

17. The device of claim 1, wherein the frame is comprised of a shape memory alloy.

18. The device of claim 1, wherein the frame is comprised of nitinol.

19. The device of claim 1, wherein the frame is comprised of spring steel.

20. The device of claim 1, the fastener driver further comprising:

a spring; and

a firing pin having a proximal head and a distal end, the proximal head engaged with the spring;

wherein the firing pin is configured to slide axially within the lumen to impart an axial force from the spring to the fastener to drive the fastener distally from the lumen into tissue.

21. The device of claim 1, the fastener driver further comprising a drive shaft extending axially through the lumen configured to impart rotational force on the fastener to drive the fastener distally from the lumen into tissue.

22. The device of claim 1, the fastener driver further comprising a pushrod configured to impart an axial force to the fastener to drive the fastener distally from the lumen into tissue.

23. The device of claim 22, wherein the pushrod is externally threaded, the fastener driver further comprising an internally threaded pushrod driver configured to engage the externally threaded pushrod;

wherein the rotation of the internally threaded pushrod driver distally pushes the pushrod to impart an axial force to the fastener to drive the fastener distally from the lumen into tissue.

24. The device of claim 1, wherein the frame is configured to detach from the implant by slidably retracting along the perimeter of the implant.

25. An implant delivery device, comprising:

a device body;

a plurality of fastening arms extending from a distal end of the device body, each of the fastening arms having a lumen;

at least one fastener situated in the lumen of the fastening arm;

a fastener driver situated in the lumen of the fastening arm, wherein the fastener driver is configured to drive the fastener distally from the lumen into tissue;

an implant; and

a frame configured to carry the implant, the frame being extendible through the device body and slidably guided along the plurality of fastening arms between a retracted position in which the frame is collapsed and a deployed position in which the frame is expanded to form a perimeter shape of the implant and to pull the implant taut, the implant being relaxed when the frame is collapsed, the implant being taut when the frame is in the deployed position;

wherein the frame is configured to detach from the implant after moving from the retracted position to the deployed position.

26. The device of claim 25, wherein the implant is a mesh.

27. The device of claim 25, wherein the implant is a graft.

28. The device of claim 25, wherein the implant is a film.

29. The device of claim 25, wherein the fastener drivers are configured to drive fasteners into the implant when the frame is in the desired deployed position, thereby fastening the implant to an underlying tissue.

30. A medical device, comprising:

an implant;

a temporary frame configured to carry the implant, the temporary frame being selectably movable between a retracted position and a deployed position in which the temporary frame is expanded to a predetermined shape to conform the perimeter of the implant to the perimeter of the predetermined shape of the temporary frame, the implant being in a relaxed state when carried by the frame in the retracted position, the implant being in a taut state when carried by the frame in the deployed position;

a fastening arm having a lumen, wherein the frame is slidably guided along the fastening arm;

at least one fastener situated in the lumen of the fastening arm; and

a fastener driver situated in the lumen of the fastening arm, wherein the fastener driver is configured to drive the fastener distally from the lumen into tissue.

31. The device of claim 30, wherein the implant comprises at least one of a mesh, a graft, and a film.

32. A method, comprising:

deploying a temporary frame to tautly support an implant and to expand the temporary frame to a predetermined shape to conform the perimeter of the implant to the perimeter of the predetermined shape of the temporary frame;

positioning the implant in a predetermined location with respect to a tissue; and

fastening, by a fastener driver situated in a lumen of a fastening arm and at least one fastener situated in the lumen of the fastening arm, wherein the fastener driver is configured to drive the fastener distally from the lumen into tissue, the implant to the tissue in the predetermined location while the implant is tautly supported by the temporary frame.

33. The device of claim 32, wherein the implant comprises at least one of a mesh, a graft, and a film.

34. The method of claim 32, further comprising retracting the temporary frame after the implant has been fastened.

35. The method of claim 32, wherein the frame is comprised of a shape-memory material.

36. The method of claim 35, wherein the shape-memory material is nitinol.

37. The method of claim 32, wherein the fastening includes simultaneously driving a plurality of fasteners into the implant.

38. The method of claim 37, wherein the plurality of fasteners are simultaneously driven along a periphery of the implant.

39. A method, comprising:

supporting an implant with a temporary frame pulling the implant taut and expanding the temporary frame to a predetermined shape to conform the perimeter of the implant to the perimeter of the predetermined shape of the temporary frame;

positioning the temporary frame and the supported implant at a location with respect to a tissue; and

securing the implant to the tissue by a fastener driver situated in a lumen of a fastening arm and at least one fastener situated in the lumen of the fastening arm, wherein the fastener driver is configured to drive the fastener distally from the lumen into tissue, through the implant and into the tissue such that the fastener does not interfere with removal of the frame.

40. The method of claim 39, further comprising removing the temporary frame after the fasteners have been inserted.

41. The method of claim 39, wherein the implant is a mesh.

42. An implant delivery device, comprising:

a device body;

an implant; and

a frame carrying the implant and extending within the device body, the frame being selectably movable between a retracted position in which the frame is collapsed and an extended position in which the frame is expanded to a predetermined shape to pull the implant taut and to conform the perimeter of the implant to the perimeter of the predetermined shape of the frame;

wherein the frame is configured to detach from the implant by slidably retracting along the perimeter of the implant.