Wire fasteners for use in minimally invasive surgery and means and methods for handling those fasteners

• US 6,162,233 A
• Filed: 08/06/1999
• Issued: 12/19/2000
• Est. Priority Date: 02/23/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Cardiovascular Technologies, LLC
• Inventors: Williamson, Warren P. IV, Ward, Thomas J., Spence, Paul A., Keller, George A., Robinson, Cecil R.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/369,196
• Time in Patent Office: 501 Days
• Field of Search: 606/142, 606/151, 606/139, 606/157, 606/158, 606/143, 606/106, 606/161, 606/219, 606/220, 606/232, 227/902, 227/175.1-181, 128/898
• US Class Current: 606/142
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07242 achieving different staple heights during the same shot, e.g. using an anvil anvil having different heights or staples of different sizes
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61F 2/2409 : Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation

Abstract

Wire fasteners having legs with lengths that can be one hundred times the width of the fastener are used to secure items, such as prosthesis valves to a patient during minimally invasive surgery. The fasteners are manipulated into position and then are immobilized by the legs thereof for tensioning, cutting and forming in situ. The fasteners are manipulated, tensioned and formed from the leg end of the fasteners. Tools for initially placing the fasteners and for immobilizing, tensioning, cutting and bending the fastener legs are disclosed. Once the fasteners are initially placed, the prosthesis is placed on the long legs of the placed fasteners and is guided into position on the legs. Once the prosthesis is in position, the legs of the fasteners are immobilized, tensioned, cut and bent into staple-like shapes to secure the prosthesis to the patient. A method for carrying out the procedure using the long fastener is also disclosed. Using the teaching of the present disclosure, a surgeon can customize a fastener to the particular surgery or even to the particular portion of surgery being performed during the surgery.

Claims

1. A fastener for use in surgery comprising:

a body having a base and a formable leg extending from said base, said leg being formable at least in a portion thereof located adjacent to said base, said formable portion having a terminus spaced from said base;

said body having a width dimension;

said leg having a pointed end which is driven through a supporting structure, an unformed length dimension measured from said base to said terminus, and a formed length dimension of said formable portion measured from said base to a bent end of said formable leg formed by cutting said formable leg and bending said formable leg over adjacent to said terminus;

the unformed length being greater than the formed length.

2. A fastener for use in surgery comprising:

a body having a base and a formable leg extending from said base;

said body having a width dimension;

said leg having a pointed end which is driven through a supporting structure, an unformed length dimension measured from said base to said pointed end, and a formed length dimension measured between said base and an end formed on said formable leg by cutting said formable leg and bending said formable leg into a retaining shape;

the unformed length being greater than the formed length.

3. A fastener for use in surgery comprising:

a body having a base and a formable leg extending from said base, said leg having a pointed end which is driven through a supporting structure and a length measured from said base to said pointed end, said length being indeterminate and said formable leg being formable from said base to said pointed end.

4. The fastener defined in claim 3 wherein said base has a width dimension and the length dimension of said leg is more than five times said width dimension.

5. A wire fastener for use in minimally invasive surgery comprising:

a U-shaped body having a base and two formable legs extending from said base;

said body having a width dimension measured from one leg to the other;

each leg having a pointed end which is driven through a supporting structure and an unformed length dimension measured from said base to the pointed end thereof;

the length dimension of each leg being greater than said width dimension by a factor of five or more and a formed length dimension which is less than the unformed length dimension.

7. The fastener defined in claim 5, wherein the length dimension of said leg is greater than said width dimension by a factor of ten or more.

8. The fastener defined in claim 5, wherein the length dimension of said leg is greater than said width dimension by a factor of one hundred or more.

6. A fastener for use in minimally invasive surgery comprising:

a body having a base and a formable leg extending from said base;

said body having a width dimension;

said leg having a pointed end which is driven through a supporting structure, an unformed length dimension measured from said base to said pointed end, and a formed length dimension measured from said base to a bent end of said formable leg formed by cutting said formable leg and bending said formable leg into a retaining shape;

the unformed length being greater than the formed length.

9. The fastener defined in claim 6 where the unformed length is long enough to locate the pointed end of said leg outside a patient when said base is in place inside the patient.

10. The fastener defined in claim 6 further including means for cutting the leg and for bending the cut leg so the end of said cut leg form a retaining feature, said means engaging the leg.

11. The fastener defined in claim 9 wherein said means engages the leg on one side of the tissue with the base of said fastener being located on another side of the tissue whereby the tissue is located between said leg end and the base of said fastener.

12. The fastener defined in claim 6 wherein said leg is J-shaped adjacent to said base.

13. The fastener defined in claim 6 wherein said pointed end includes a needle tip swaged on said pointed end.

14. The fastener defined in claim 6 wherein said fastener includes two legs.

15. The fastener defined in claim 6 in which the base of said fastener includes an arcuate perimeter.

16. The fastener defined in claim 6 wherein the width is the longest dimension of the base of said fastener.

17. The fastener defined in claim 6 in which said fastener is formed of composite materials.

18. The fastener defined in claim 6 in which said leg is one material and said base is a different material.

19. The fastener defined in claim 18 in which said one material includes suture material.

20. The fastener defined in claim 19 in which said base is hollow.

21. A method of placing a fastener in a patient during surgery comprising:

providing a fastener for use in surgery having a body having a base and a formable leg extending from said base, said leg having a pointed end and a length measured from said base;

locating the fastener inside a patient on one side of a tissue being operated on;

driving a pointed end of the fastener through the tissue;

grasping the leg after the leg has penetrated the tissue;

tensioning the leg and moving the base of the fastener against the tissue;

immobilizing the leg on the other side of the tissue;

engaging the end of the immobilized leg; and

bending the leg to force the end into a retaining shape to define a formed length, and having the unformed length greater than the formed length.

22. The method defined in claim 21 in which the step of immobilizing the leg is performed by grasping the leg on the side of the tissue opposite that of the base of the fastener whereby the tissue is located between the base of the fastener and any means used to immobilize the leg.

23. The method defined in claim 22 further including a step of cutting the leg.

24. A method of placing a fastener in a patient during surgery comprising:

providing a fastener for use in surgery having a body having a base and a formable leg extending from said base, said leg having a point on one end thereof and an unformed length measured from said base;

locating the fastener inside a patient on one side of a tissue being operated on;

driving a pointed end of the fastener through the tissue;

engaging the fastener only at the leg after the leg has penetrated the tissue;

tensioning the engaged leg and moving the fastener until the base of the fastener moves against the tissue;

engaging the end of the immobilized leg; and

bending the leg to force the end back into a retaining shape to define a bent length, the bent length being less than the unformed length.

25. A method of placing a fastener in a patient during surgery comprising:

providing a fastener for use in surgery having a body having a base and a formable leg extending from said base, said leg having a point on one end thereof and an unformed length measured from said base;

locating the fastener inside a patient on one side of a tissue being operated on;

driving a pointed end of the fastener through the tissue;

using only the leg of the fastener, moving the fastener into position and forming the fastener with said forming including cutting the leg and bending the leg into a retaining shape to define a formed length with the formed length being less than the unformed length.

26. A method of placing a fastener in a patient during minimally invasive surgery comprising:

providing a fastener having a body with a formable portion and having a base and a formable leg extending from said base;

said body having a width dimension;

said leg having a pointed end;

locating the fastener inside a patient on one side of a tissue being operated on;

driving the pointed end through the tissue;

grasping the leg after the leg has penetrated the tissue;

tensioning the leg and moving the base of the fastener against the tissue;

immobilizing the leg on the other side of the tissue;

cutting the leg to form the end;

bending the leg to force the end back over towards the base of the fastener so the bent leg has a bent length measured from the base which is less than the unformed length.

27. The method defined in claim 26 including placing a pledget on the fastener adjacent to the base.

28. The method defined in claim 26 including placing a prosthesis on the fastener from the pointed end and moving the prosthesis on the fastener leg into position adjacent the tissue.

29. The method defined in claim 26 including grasping the tissue prior to driving the pointed end through the tissue.

30. The method defined in claim 26 including placing a plurality of fasteners.

31. The method defined in claim 30 including a step of organizing the fasteners.

32. The method defined in claim 26 including a step of rotating the fastener while the fastener is penetrating the tissue.

33. A tool for use in placing a fastener during surgery comprising:

a body;

a handle on one end of the body of said tool;

a track on the body of the tool for slidably holding said fastener on the body of said tool;

means for forcing the fastener along the body of the tool toward tissue being penetrated;

means for guiding the pointed end of said fastener through a patient'"'"'s tissue;

means for grasping the pointed end after the pointed end have exited the tissue; and

means for drawing the base of the fastener against the tissue.

34. The tool defined in claim 33 in which said means for drawing the base of the fastener against the tissue also draws the fastener leg out of the patient.

35. The tool defined in claim 34 further including means for supporting the leg after it has been drawn through the tissue.

36. The tool defined in claim 35 further including means for covering the point on the fastener leg after the leg has been drawn through the tissue.

37. In combination with a fastener for use in surgery which comprises:

a body having a base and a leg extending from said base, said leg having a pointed end and a length measured from said base, said length being indeterminate, a tool comprising;

a body;

a handle on one end of the body of said tool;

a track on the body of the tool for slidably holding said fastener on the body of said tool;

means for forcing the fastener along the body of the tool toward tissue being penetrated;

means for guiding the pointed end of said fastener through a patient'"'"'s tissue;

means for grasping the pointed end after the pointed end have exited the tissue; and

means for drawing the base of the fastener against the tissue.

38. In combination with a fastener for use in minimally invasive surgery which comprises:

a body having a base and a leg extending from said base;

said body having a width dimension;

said leg having a pointed end, an unformed length dimension measured from said base to said pointed end, and a formed length dimension measured between said base and an end, with the end located between the pointed end and said base and being defined by cutting the leg; and

the unformed length being greater than the formed length, said tool comprising;

a body;

a handle on one end of the body of said tool;

a track on the body of the tool for slidably holding said fastener on said body;

means for forcing the fastener along the body of the tool toward tissue being penetrated;

means for guiding the pointed end of said fastener through a patient'"'"'s tissue;

means for grasping the pointed end after the pointed end have exited the tissue; and

means for drawing the fastener leg out of the patient.

39. The tool defined in claim 38 wherein said track is disposable and is releasably held on the body of said tool.

40. The tool defined in claim 38 further including means for rotating the fastener as it is penetrating the tissue.

41. The tool defined in claim 39 further including a lever on the tool body and a rod connected to said lever and extending toward the handle of the tool body, and means on said lever for releasably grasping the fastener adjacent to the pointed end thereof.

42. The tool defined in claim 38 further including a fastener driver mechanism on the end of the body of the tool, said fastener driver mechanism including a one-way pawl and a spring.

43. The tool defined in claim 38 further including means for grasping tissue, said means for grasping tissue including a first jaw and a second jaw, each jaw being mounted on one end of a jaw actuating rod which extends toward said handle.

44. The tool defined in claim 38 further including a point protector on the fastener.

45. The tool defined in claim 38 further including an operating mechanism on the handle.