Tissue repair implant and delivery device and method

• US 9,050,065 B2
• Filed: 01/20/2011
• Issued: 06/09/2015
• 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., Datcuk, Peter
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/010,766
• Publication Number:
  US 20110178534A1
• Time in Patent Office: 1,601 Days
• Field of Search: 411/452, 411/451.2
• 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 for the repair of tissue and methods of use and manufacturing thereof are described herein. Applications for the use of the device include, e.g., repair of atrial septal defects (ASD), patent foramen ovale (PFO), left atrial appendage closure and stent graft fixation among other applications throughout the anatomy. The implant portion of the device is available in a variety of sizes and configurations to accommodate the vast complexity of the target anatomy.

Claims

1. A surgical device, comprising:

an elongated fastener body having a proximal end and a distal tip configured to pierce tissue, a portion of the proximal end extending radially from the elongated body; and

barbs integrally formed to the fastener body and configured to flex relative to the elongated fastener body in compliance with movement of living tissue, flex toward the elongated fastener body in response to a radially inward load to ease distal insertion into tissue, and flex away from the elongated fastener body in response to an axial load in the direction of the proximal end to engage the pierced tissue and resist proximal movement from the pierced tissue;

the barbs extending proximally to free ends and having longitudinally extending external corrugations formed of an alternating series of ridges and grooves, wherein each of the ridges and grooves extends along a longitudinal axis of the barb, providing at least one protrusion at the free end.

2. The surgical device of claim 1, comprising a proximal head disposed at a proximal portion of the fastener body, the proximal head being configured to limit the depth to which the fastener is proximally driven into one or more layers of tissue.

3. The surgical device of claim 2, wherein the proximal head is fixed to the elongated body.

4. The surgical device of claim 2, wherein the proximal head and the elongated body are formed together as a single monolithic piece.

5. The surgical device of claim 1, further comprising a proximal head configured to engage a proximal portion of the elongated body.

6. The surgical device of claim 5, the elongated fastener body having a longitudinal axis extending between the proximal end and a distal end, wherein the proximal head includes threads that engage corresponding threads on the proximal portion of the elongated body when the proximal head engages the proximal portion of the elongated body, rotation of the proximal head with respect to the threads of the proximal portion of the elongated body causing movement of the proximal head along a longitudinal axis of the elongated body.

7. The surgical device of claim 5, wherein the proximal head and the elongated body together form a ratchet when the proximal head engages the proximal portion of the elongated body, wherein the proximal head is moveable distally along the elongated body and restrained from proximal movement along the elongated body.

8. The surgical device of claim 1, wherein the surgical device is comprised of a bio-absorbable material.

9. The surgical device of claim 8, wherein the entire surgical device is bio-absorbable.

10. The surgical device of claim 1, wherein the distal tip is blunt.

11. The surgical device of claim 1, wherein the distal tip tapers to a sharp point.

12. The surgical device of claim 1, wherein the distal tip is tapered.

13. The surgical device of claim 12, wherein the distal tip is a cutting tip.

14. The surgical device of claim 13, wherein the distal tip includes at least one concave tapered cutting edge.

15. The surgical device of claim 13, wherein the distal tip includes three concave tapered cutting edges.

16. The surgical device of claim 15, wherein the three concave tapered cutting edges are equidistant from each other around a circumference of the fastener.

17. The surgical device of claim 13, wherein the distal tip is a reverse-cutting tip.

18. The surgical device of claim 1, the elongated fastener body having a length extending between the proximal end and the distal tip, wherein the body has longitudinally extending external corrugations.

19. The surgical device of claim 1, the barbs having a length extending between the fastener body and the free ends, wherein the external corrugations of the barbs extend axially along the length of the barbs.

20. The surgical device of claim 1, wherein the at least one protrusion extends along a curved surface.

21. The surgical device of claim 1, the elongated fastener body having a longitudinal axis extending between the proximal end and the distal tip, wherein at least one of the barbs is situated at a point along the longitudinal axis different from at least one of the other barbs.

22. The surgical device of claim 1, wherein the barbs include an underside facing the elongated fastener body, a portion of the underside of the barbs comprising a scalloped shape.

23. The surgical device of claim 1, further comprising a hooked end portion disposed on the proximal end of the fastener body, the hooked end portion configured to couple to another surgical device to exert an axial load in the proximal direction.