Tissue repair implant and delivery device and method

• US 9,427,220 B2
• Filed: 03/14/2013
• Issued: 08/30/2016
• 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): Scherbel, Todd J
• Application Number:
  US13/828,256
• Publication Number:
  US 20130211426A1
• Time in Patent Office: 1,265 Days
• 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 other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• 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 lateral eyelet for attaching suture to needle A61B2017/06019
• 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 for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• 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:

a fastener including a proximal head having a locking mechanism, an elongated body having proximally directed anchoring filaments and a corresponding locking mechanism configured to interlock with the locking mechanism, and a distal tip;

a filament secured to the fastener and extending proximally from a proximal end of the elongated body;

a single device body;

a fastener driver coupled to the single device body and configured to drive the fastener with sufficient impulse through a first unsupported soft tissue or prosthesis and into a second unsupported soft tissue, anchoring the fastener within the second soft tissue; and

a retraction mechanism coupled to the single device body and configured to proximally reel the filament after the fastener has been driven by the fastener driver of the single device body such that the second unsupported soft tissue is drawn towards the first unsupported soft tissue or prosthesis, the retraction mechanism being configured to apply a sufficient retraction force utilizing the proximal head to the fastener to bring the elongated body into the proximal head thereby engaging the locking mechanism of the proximal head to the corresponding locking mechanism of the elongated body and bringing a proximal surface of the second unsupported soft tissue in direct apposition to a distal surface of the first unsupported soft tissue or prosthesis.

2. The surgical device of claim 1, wherein the fastener driver is configured to drive the fastener at a predetermined distance and velocity based on a determined distance between the first tissue or prosthesis and the second tissue.

3. The surgical device of claim 2, wherein the fastener driver is adjustable to drive the fastener at different distances and velocities based on the determined distances between the first tissue or prosthesis and the second tissue.

4. The surgical device of claim 1, wherein the fastener driver is configured to impart a momentum to the fastener sufficient to drive the fastener through the first soft tissue or prosthesis and into the second soft tissue.

5. The surgical device of claim 4, wherein the fastener driver is configured to transfer hydraulic force to the fastener to impart the momentum.

6. The surgical device of claim 5, wherein saline is provided for hydraulic propulsion.

7. The surgical device of claim 1, wherein the anchoring filaments of the fastener are configured to resist proximal movement of the fastener when the fastener is driven through the first soft tissue or prosthesis and into the second soft tissue.

8. The surgical device of claim 1, wherein the fastener driver includes a plurality of flanges configured to contact a distal face of the proximal head to limit the depth to which the fastener is driven by the fastener driver.

9. The surgical device of claim 8, wherein the flanges are radially expandable from each other to release the proximal head of the fastener.

10. The surgical device of claim 1, wherein the filament is a suture attached to the fastener.

11. A surgical device, comprising:

a fastener including a proximal end, a proximal head having a locking mechanism, an elongated body having a corresponding locking mechanism configured to interlock with the locking mechanism, and a distal tip;

a filament secured to the fastener and extending proximally from a proximal end of the elongated body; and

a fastener driver coupled to a single device body and configured to distally drive the fastener with sufficient impulse through a first unsupported soft tissue or prosthesis and into a second unsupported soft tissue such that the fastener anchors within the second unsupported soft tissue; and

a retraction mechanism coupled to the single device body and configured to proximally reel the filament after the fastener has been driven by the fastener driver of the single device body such that the second unsupported soft tissue is drawn towards the first unsupported soft tissue or prosthesis, the retraction mechanism being configured to apply a sufficient retraction force utilizing the proximal head to the fastener to bring the elongated body into the proximal head thereby engaging the locking mechanism of the proximal head to the corresponding locking mechanism of the elongated body and bringing a proximal surface of the second unsupported soft tissue in direct apposition to a distal surface of the first unsupported soft tissue or prosthesis.

12. The device of claim 11, wherein the filament is a braided filament.

13. The surgical device of claim 11, wherein the distance to which the fastener is driven is limited by a predetermined amount of slack in the filament prior to the driving, the distance being limited by the tautening of the filament.

14. The device of claim 11, wherein the fastener includes proximally extending anchoring filaments configured to anchor the fastener into the second tissue.

15. The surgical device of claim 11, the fastener driver being configured to impart a momentum to the fastener sufficient to drive the fastener through the first soft tissue and into the second soft tissue when the second soft tissue is unsupported.

16. The surgical device of claim 11, wherein the fastener driver is configured to drive the fastener at a predetermined distance and velocity based on a determined distance between the first tissue or prosthesis and the second tissue.

17. The surgical device of claim 16, wherein the fastener driver is adjustable to drive the fastener at different distances and velocities based on the determined distances between the first tissue or prosthesis and the second tissue.

18. The surgical device of claim 11, wherein the fastener driver is configured to drive the fastener using a hydraulic propulsion.

19. The surgical device of claim 18, wherein saline is provided for the hydraulic propulsion.

20. The surgical device of claim 11, wherein the retraction mechanism comprises a capstan configured to proximally reel the filament after the fastener has been driven by the fastener driver.

21. The surgical device of claim 20, wherein the proximal reeling of the filament causes a corresponding proximal movement of the second tissue when the fastener is anchored in the second tissue.

22. The surgical device of claim 11 wherein the fastener is molded to the filament.

23. The surgical device of claim 22, wherein the fastener is coextruded with the filament.

24. The surgical device of claim 23, wherein the filament is a braided filament.

25. The surgical device of claim 11, wherein the fastener includes a plurality of molded radially disposed anchoring filaments.

26. The surgical device of claim 11, wherein the retraction mechanism comprises a capstan configured to proximally reel the filament after the fastener has been driven by the fastener driver such that the second tissue is drawn to the first tissue or prosthesis.

27. The surgical device of claim 11, wherein the fastener further includes:

a proximal threaded portion;

wherein the proximal head is internally threaded and configured to mate with the threaded portion of the fastener.

28. The surgical device of claim 27, wherein the retraction mechanism comprises a capstan configured to proximally reel the filament after the fastener has been driven by the fastener driver such that the second tissue is drawn towards the first tissue or prosthesis.

29. The surgical device of claim 28, wherein the proximal head is coupled to the threaded portion of the fastener such that any remaining gap between the second tissue and the first tissue or prosthesis is closed.