Tissue fixation devices and methods of fixing tissue

• US 7,846,180 B2
• Filed: 10/02/2003
• Issued: 12/07/2010
• Est. Priority Date: 06/22/1999
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Cerier, Jeffrey C.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/677,633
• Publication Number:
  US 20040133238A1
• Time in Patent Office: 2,623 Days
• Field of Search: 606/139, 606142-144, 606/148, 606/151, 606153-158, 606/213, 606/216, 606219-221, 606/228, 606/232, 227/67, 227/68, 24/901, 24/93, 24/94, 241/02.FC, 241/147, 242/98, D24/145
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2915 : arcuate shaped guiding means
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2917 : with flexible part
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires

Abstract

A tissue fixation device may include a suture, a first securing element connected to a first portion of the suture, and a second securing element connected to a second portion of the suture. The first and second securing elements are each rotatable from a first position during deployment of the tissue fixation device that is suitable for each securing element to pass through a respective hole formed in tissue to a second position when the tissue fixation device is deployed that inhibits each securing element from passing through the respective hole formed in the tissue. An exemplary method of fixing tissue may include creating two holes in the tissue and deploying a tissue fixation device having a suture connecting two securing elements by advancing each securing element through a respective hole in the tissue and causing each securing element to rotate to a position that inhibits the securing element from passing through the respective hole.

Claims

1. A tissue fixation device comprising:

a suture;

a first bioimplantable pledget having at least one through hole formed therein having a minimum diameter greater than a maximum diameter of the suture, a first portion of the suture passing through the at least one through hole in the first pledget and a second portion of the suture configured to inhibit the second portion from passing through the at least one through hole in the first pledget;

a second bioimplantable pledget having at least one through hole formed therein, the first pledget being spaced apart from the second pledget to receive tissue therebetween when the tissue fixation device is deployed;

a first bioimplantable securing element connected to a portion of the suture, the first securing element being rotatable from

a first orientation in which the securing element is oriented at least substantially parallel to the at least one through hole formed in the first pledget and the second pledget, to

a second orientation in which the securing element is oriented at least substantially perpendicular to the at least one through hole in the second pledget,

wherein the suture, the first and second pledgets, and the first securing element are effective to fix adjacent layers of living tissue.

2. The tissue fixation device of claim 1, further comprising a second suture and a second bioimplantable securing element connected to a portion of the second suture.

3. The tissue fixation device of claim 2, wherein a first portion of the second suture passes through a second through hole in the first pledget and a second portion of the suture is configured to inhibit the second portion of the suture from passing through the second through hole in the first pledget.

4. The tissue fixation device of claim 3, wherein the second securing element is rotatable from

a first position in which the second securing element is oriented at least substantially parallel to the second through hole in the first pledget and a second through hole in the second pledget to

a second position in which the securing element is oriented at least substantially perpendicular to the second through hole in the second pledget.

5. The tissue fixation device of claim 2, wherein said second suture comprises a material suitable for suturing human or animal tissue in vivo, and

said second securing element comprises biocompatible material.

6. The tissue fixation device of claim 1, wherein said suture comprises a material suitable for suturing human or animal tissue in vivo, and

said securing element comprises biocompatible material.

7. A tissue fixation device comprising:

a suture suitable for in vivo placement in a human body;

a first biocompatible securing element connected to a first portion of the suture;

a second biocompatible securing element connected to a second portion of the suture, each said first and second securing elements being rotatable from a first position during deployment of the tissue fixation device that is suitable for each securing element to pass through a respective hole formed in human or animal tissue to a second position substantially perpendicular to the first position when the tissue fixation device is deployed that inhibits each securing element from passing through the respective hole formed in said tissue;

a deployment instrument having first and second tubes configured to deliver the first and second securing elements in the first position through the tubes and through the respective hole formed in said tissue;

a first pledget having a plurality of through holes formed therein, the suture passing through the through holes in the first pledget; and

a second pledget having a plurality of through holes formed therein, the suture passing through the through holes in the second pledget, the second pledget being spaced apart from the first pledget when the tissue fixation device is deployed.

8. The tissue fixation device of claim 7, wherein the first and second securing elements are spaced apart from a third portion of the suture when the tissue fixation device is deployed, the human or animal tissue being fixed between the securing elements and the third portion during deployment.

9. The tissue fixation device of claim 8, wherein a portion of the suture is coupled to another portion of the suture.

10. The tissue fixation device of claim 9, wherein the portions are coupled by knotting.

11. The tissue fixation device of claim 9, wherein the portions are coupled by welding.

12. The tissue fixation device of claim 9, wherein the first portion of the suture passes through openings in the first securing element.

13. The tissue fixation device of claim 12, wherein the second portion of the suture passes through openings in the second securing element.

14. The tissue fixation device of claim 7, wherein the suture passes through the through holes as to enable the first pledget to be positioned between the first and second securing elements and the tissue when the tissue fixation device is deployed.

15. The tissue fixation device of claim 7, wherein the suture has two ends, and both ends are disposed on the same side of the first pledget.

16. The tissue fixation device of claim 7, wherein the first securing element and the second securing element are oriented at least substantially parallel to the holes in the tissue in the first position.

17. The tissue fixation device of claim 7, wherein the first securing element and the second securing element are oriented at least substantially perpendicular to the holes in the tissue in the second position.

18. The tissue fixation device of claim 7, wherein the first securing element and the second securing element are each generally cylindrical in shape.

19. The tissue fixation device of claim 7, wherein each said first securing element and second securing element includes a sharp tip.

20. The tissue fixation device of claim 7, wherein each said first securing element and second securing element have an elongated shape such that the long axis of the securing element is larger than the diameter of the respective hole.

21. The tissue fixation device of claim 7, wherein the suture is endless.

22. The tissue fixation device of claim 7, wherein the suture forms a closed loop.

23. A tissue fixation device comprising:

a suture;

a first bioimplantable pledget having a plurality of through holes formed therein, the suture passing through the through holes in the first pledget;

a second bioimplantable pledget having a plurality of through holes formed therein, the first pledget being spaced apart from the second pledget to receive tissue therebetween when the tissue fixation device is deployed;

a first bioimplantable securing element having a sharp tip and a proximal end configured for removable attachment to an instrument, the first securing element being coupled to the suture; and

a second bioimplantable securing element having a sharp tip and a proximal end configured for removable attachment to an instrument, the second securing element being coupled to the suture,

wherein the suture, the first and second pledgets, and the first and second securing elements are effective to fix adjacent layers of living tissue.

24. The tissue fixation device of claim 23, wherein said suture comprises a material suitable for suturing human or animal tissue in vivo, and

said first and second securing elements comprise biocompatible material.