Surgical helical fastener with applicator

• US 20020013605A1
• Filed: 10/01/2001
• Published: 01/31/2002
• Est. Priority Date: 08/05/1994
• Status: Active Grant

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Sherwood Services AG
• Inventors: Lunsford, John, Bolduc, Lee, Kramer, Thomas A., McCoy, Tim, Hodges, Brian A.
• Granted Patent: US 6,562,051 B1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: Y10S 227/901 Surgical clip appliers
• CPC Class Codes: Y10S 227/902 Surgical clips or staples
• CPC Class Codes: Y10S 606/91 Polymer
• CPC Class Codes: Y10S 606/916 Tool for installing or removing orthopedic fastener
• CPC Class Codes: Y10T 24/4695 Wire curved or bent

Abstract

A helical fastener having a high retentive surface area is provided and has a first end for enhancing penetration into tissue and a second end comprising a coil sectioning a diameter of the fastener for receiving longitudinal and rotational forces. The helical fasteners are attached to body tissue by a fastener applicator having a proximal portion comprising a handle and an actuator and an elongate distal portion for housing a plurality of fasteners. A transferring action of the actuator provides longitudinal and rotational movement of the fasteners out of the distal portion and into body tissue.

Claims

1. A fastener for ligating tissue or attaching an implantable device, the fastener comprising:

a continuous helical coil having a distal end and a proximal end;

a first helical coil section at said distal end;

tissue piercing means on said first coil; and

means for inserting said continuous helical coil so that said continuous helical coil penetrates tissue to ligate the tissue to position and attach the implantable device.

2. The fastener of claim 1, wherein said tissue piercing means is a point formed at a terminal end of said first helical coil section.

3. The fastener of claim 2, wherein said point of said first helical coil section and an adjacent coil section define a gap, said gap adapted to determine depth of penetration and pitch of the fastener in tissue and retentive strength of the fastener to tissue.

4. The fastener of claim 1, wherein said continuous helical coil has a uniform pitch between coils.

5. The fastener of claim 1, wherein said continuous helical coil has a pitch between coils that can be varied by an applicator.

6. The fastener of claim 1, wherein said continuous helical coil has a pitch sufficient to entrap tissue between coils.

7. The fastener of claim 1, wherein said continuous helical coil has a pitch that can be increased as said fastener is inserted into the tissue.

8. The fastener of claim 1, wherein said continuous helical coil has a pitch of 0.050 inches.

9. The fastener of claim 1, wherein said continuous helical coil has a pitch range from 0 to a maximum of 3.0 times a diameter of said helical coil.

10. The fastener of claim 1, wherein said means for inserting said continuous helical coil is a T-bar at said proximal end.

11. The fastener of claim 10, wherein a rotational force and a longitudinal force is applied to said T-bar by an applicator that rotates and delivers said continuous helical coil into tissue.

12. The fastener of claim 1, wherein said continuous helical coil is sized to fit within a cannula having a diameter of at least 1 mm.

13. The fastener of claim 1, wherein at least a portion of said continuous helical coil is coated with a biocompatible lubricious material for facilitating delivery of the fastener into tissue.

14. The fastener of claim 1, wherein said continuous helical coil is made from absorbable material.

15. The fastener of claim 1, wherein said continuous helical coil is made from a metallic material selected from the group of materials consisting essentially of titanium, titanium alloys, stainless steel and nickel chrome alloys.

16. The fastener of claim 1, wherein said continuous helical coil is made from a polymeric material selected from the group of materials consisting essentially of plastics, liquid crystal polymers, HDPE, polyglycolic acid, and polyglycolid hydroxgacetic acid.

17. The fastener of claim 1, wherein said continuous helical coil is longitudinally collapsible and expandable.

18. The fastener of claim 1, further comprising one or more barbs projecting in reverse direction and positioned proximate to said tissue piercing means.

19. A fastener for ligating tissue or for attaching an implantable device, the fastener comprising:

a continuous helical coil having a distal end and a proximal end;

a point on said distal end for piercing the tissue;

a first helical coil section adjacent said distal end and having a gap between said point and said first helical coil section; and

a T-bar section at said proximal end for engagement with an applicator for inserting said helical coil through the tissue to position and attach the implantable device.

20. The fastener of claim 19, wherein said gap is adapted to determine depth of penetration and pitch of the fastener in tissue and retentive strength of the fastener to tissue.

21. The fastener of claim 19, wherein said continuous helical coil has a uniform pitch between coils.

22. The fastener of claim 19, wherein said continuous helical coil has a pitch between coils that can be varied by the applicator.

23. The fastener of claim 19, wherein said continuous helical coil has a pitch that can be increased as the fastener is inserted into the tissue.

24. The fastener of claim 19, wherein said continuous helical coil is made from absorbable material.

25. The fastener of claim 19, wherein said continuous helical coil is made from a metallic material selected from the group of materials consisting essentially of titanium, titanium alloys, stainless steel and nickel chrome alloys.

26. The fastener of claim 19, wherein said continuous helical coil is made from a polymeric material selected from the group of materials consisting essentially of plastics, liquid crystal polymers, HDPE, polyglycolic acid and polyglycolid hydroxgacetic acid.

27. The fastener of claim 19, wherein said continuous helical coil is longitudinally collapsible and expandable.

28. The fastener of claim 19, further comprising one or more barbs projecting in reverse direction and positioned proximate to said point.

29. A fastener for ligating tissue or for attaching an implantable device, the fastener comprising:

a continuous double helical coil having a distal end and a proximal end;

said distal end terminating with dual points each for piercing the tissue;

dual first helical coil sections adjacent said distal end each being associated with one of said dual points and each defining a gap therebetween; and

a connecting bar at said proximal end for engagement with an applicator for inserting said double helical coil through the tissue to position and attach the implantable device.

30. The fastener of claim 29, wherein said gap is adapted to determine depth of penetration and pitch of the fastener in tissue and retentive strength of the fastener to tissue.

31. The fastener of claim 29, wherein said continuous double helical coil has uniform pitch between coils.

32. The fastener of claim 29, wherein said continuous double helical coil has a pitch between coils that can be varied by the applicator.

33. The fastener of claim 29 wherein said continuous double helical has a pitch that can be increased as the fastener is inserted into the tissue.

34. The fastener of claim 29, where said continuous double helical coil is made from absorbable material.

35. The fastener of claim 29, wherein said continuous double helical coil is mad e from a metallic material selected from the group of materials consisting essentially of titanium, titanium alloys, stainless steel and nickel chrome alloys.

36. The fastener of claim 29, wherein said continuous double helical coil is made from a polymeric material selected from the group of materials consisting essentially of plastics, liquid crystal polymers, HDPE, polyglycolic acid and polyglycolid hydroxgacetic acid.

37. The fastener of claim 29, wherein said continuous double helical coil is longitudinally collapsible and expandable.

38. The fastener of claim 29, further comprising a pivot post extending from said connecting bar and toward said distal end, said pivot post having a pointed terminal end.

39. The fastener of claim 29, further comprising one or more barbs projecting in reverse direction and positioned proximate to said dual points.

40. An applicator for attaching fasteners to body tissue comprising:

a distal portion having an elongate outer tube, a connecting end and a terminal end;

a proximal portion having a handle and an actuator, said proximal portion attached to said connecting end of said distal portion;

a rotator contained in said outer tube;

said rotator adapted to receive a plurality of fasteners and adapted to cooperate with said actuator; and

means for threading and ejecting the fasteners out of said terminal end.

41. The applicator of claim 40, further comprising:

a lock/clip indicator adapted to engage said plurality of fasteners; and

a load spring adapted to apply longitudinal forces against said lock/clip indicator and to bias said plurality of fasteners toward said terminal end.

42. The applicator of claim 41, wherein said lock/clip indicator is configured to prevent actuation of said actuator upon discharge of said plurality of fasteners from the applicator.

43. The applicator of claim 40, wherein a groove extends longitudinally along substantially the length of said rotator, said groove adapted to receive coils of said plurality of fasteners.

44. The applicator of claim 40, wherein said rotator has a cross-sectional profile approximating a D-shape and is adapted to receive coils of said plurality of fasteners.

45. The applicator of claim 40, wherein said threading and ejecting means is a thread form contained in an interior of said terminal end adapted to engage said plurality of fasteners.

46. The applicator of claim 45, wherein said thread form is an interlock spring fixedly retained in said interior of said terminal end.

47. The applicator of claim 40, wherein said threading and ejecting means a nose piece attached to said terminal end, said nose piece having structure projecting perpendicularly toward a longitudinal axis of said outer tube and adapted to engage said plurality of fasteners.

48. The applicator of claim 40, wherein said distal portion and said proximal position are releasably secured together.

49. The applicator of claim 48, wherein said distal portion is disposable and said proximal portion is reusable.

50. The applicator of claim 40, wherein said actuator includes:

a lever having a first end and a second end, said lever pivotally attached about a midpoint to said handle;

said first end of said lever adapted to be gripped by hand;

a lead screw rotatably attached to an interior of said handle;

a nut driver, said second end of said lever pivotally attached to said nut driver, said nut driver adapted to travel along said lead screw, thereby turning said lead screw; and

said lead screw attached to said rotator so that as the lever is depressed by hand the nut driver will travel along the lead screw toward said rotator thereby turning said rotator in the process.

51. The applicator of claim 50, wherein said lead screw is a high helix lead screw.

52. The applicator of claim 50, wherein said lever has a midsection extension.

53. The applicator of claim 52, further comprising gear teeth formed within said interior of said handle.

54. The applicator of claim 53, further comprising a spring loaded pawl pivotally attached to said midsection extension and adapted to engage said gear teeth.

55. The applicator of claim 40, wherein said actuator includes:

a lever having a first end, a midsection, and a second end, said first end pivotally attached to said handle, said midsection adapted to be gripped by hand;

a lead screw rotatably attached to an interior of said handle;

a nut driver, said second end pivotally attached to said nut driver, said nut driver adapted to travel along said lead screw, thereby turning said lead screw; and

means for said lead screw to releasably engage said rotator so that as the lever is depressed by hand, the nut driver will travel along the lead screw toward said rotator thereby turning said rotator in the process and so that when the lever is returned to its undepressed position, the lead screw will rotate in the reverse direction and independently of the rotator which remains stationary.

56. The applicator of claim 55, wherein said lead screw is a high helix lead screw.

57. The applicator of claim 55, wherein said releasable engagement means is a ratchet mechanism.

58. The applicator of claim 55, wherein said lever has a mid-section extension, formed in said mid-section extension are a plurality of teeth.

59. The application of claim 58, further comprising a latch pawl cooperating with said teeth to prohibit said lever from backstroking until it has been completely depressed.