Devices and methods for securing sutures and ligatures without knots

• US 6,409,743 B1
• Filed: 07/08/1999
• Issued: 06/25/2002
• Est. Priority Date: 07/08/1998
• Status: Expired due to Fees

• Current Assignee: Axya Holdings, Inc. (Tornier Incorporated)
• Original Assignee: Axya Medical, Inc. (Tornier Incorporated)
• Inventors: Fenton, Paul V. Jr.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/349,663
• Time in Patent Office: 1,083 Days
• Field of Search: 606/232, 606/144, 606/138, 292/43, 24/305.R, 24/305.W, 24/305.P, 241/146, 24/17.AP, 24/11, 243/04
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/0488 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 2017/0619 thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it suture cutters A61B17/0467; ultrasonic cutters A61B17/320068; electrically heated instruments A61B18/08

Abstract

A fusible collar for securing sutures without knots and for securing living tissue structures together without sutures is provided. The fusible collar is made of a resilient compressible material and is formed generally in a C-shape which can be compressed into an O-shape, with portions of the collar overlapping around the structures to be secured. Energy is applied to the overlapping portions of the collar to cause localized heating and plastic flow so as to fuse the overlapped portions together. The collar can include one or more energy directors on a contact surface to direct and focus energy to particular regions so as to effect collar-to-suture welding.

The invention further provides a kit for securing elongated structures without knots. The kit includes the fusible collar and a tool for compressing the collar around the elongated structures and fusing the collar to itself and/or the elongated structures. The tool includes generally an energy source; a weld head; and an end effector for supporting the collar during compression; and electronics, switches, and control devices for supplying the weld energy and activating the end effector. Suitable energy sources for welding include thermal, optical, heat, radiofrequency energy, current sources, and preferably ultrasonic energy.

Claims

1. A device for securing one or more elongated members, comprising:

a collar having a C-shape, said collar being disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar extends circumferentially between two end portions, said collar having an innermost surface and an outermost surface, said surfaces extending between said end portions,

said collar being resilient so that after cessation of a deforming force, said collar returns to substantially said C-shape, is made of a flexible, fusible material, and wherein said collar is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable and wherein said overlapping portions of said collar are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar.

2. The device according to claim 1, wherein the elongated members comprise surgical sutures made of a fusible material, wherein the sutures are adapted to fuse to at least one of the collar and to one another in a knotless weld upon application of sufficient energy to the collar.

3. The device according to claim 2, wherein the collar includes one or more energy directors extending from an said innermost surface of the collar into the central region, wherein the energy directors define fusion regions of the sutures and the collar and are adapted to focus energy applied to the collar to the fusion regions so that one or more of the elongated members and collar are fusible together at the fusion regions.

4. The device according to claim 1 wherein the collar includes one or more protrusions extending from said innermost surface of the collar into the central region and said protrusions are adapted to secure the elongated members within the central region.

5. The device according to claim 1, wherein the energy applied to the collar is ultrasonic energy .

6. The device according to claim 1, wherein the energy applied to the collar is selected from the group consisting of thermal energy, optical energy, electrical energy and current sources.

7. The device according to claim 1, wherein the collar is made of a thermoplastic polymeric material.

8. The device according to claim 1 where in the collar includes one or more energy directors located on one or more opposing surfaces of the end portions in the overlap area, wherein the energy directors define fusion regions for the end portions within overlapped area and are adapted to focus energy applied to the collar to the fusion regions so that the end portions are fusible together.

9. A device for securing one or more elongated members, comprising:

a collar disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis,

wherein said collar extends circumferentially between two end portions, said collar having an outermost surface and an innermost surface extending between said end portions,

wherein said collar is made of a flexible, fusible material and is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, wherein said overlapping portions of said collar are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar,

wherein the elongated members comprise surgical sutures made of a fusible material, and

wherein the collar includes one or more energy directors extending from said innermost surface of the collar into the central region,

wherein the energy directors define fusion regions of said surgical sutures and collar and are adapted to focus energy applied to the collar to the fusion regions so that one or more of said surgical sutures and collar are fusible together at the fusion regions in a knotless weld upon application of sufficient energy to the collar.

10. The device according to claim 9 wherein the elongated members comprise a band of material adapted for securing a plurality of anatomical structures together.

11. A device for securing one or more elongated members, comprising:

a collar disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis,

wherein said collar extends circumferentially between two end portions, said collar having an outermost surface and an innermost surface extending between said end portions,

wherein said collar is made of a flexible, fusible material and is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overapping portions are substantially smooth and wherein the amount of overlapping is selectively adustable,

wherein the collar includes one or more energy directors located on one or more opposing surfaces of the overlapping portions,

said energy directors defining fusion regions for the end portions within the overlapped portions and are adapted to focus energy applied to the collar to the fusion regions so that the end portions are fusible together and around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar.

12. The device according to claim 11 wherein the elongated members comprise surgical sutures made of a fusible material, wherein the sutures are adapted to fuse to at least one of the collar and to one another in a knotless weld upon application of sufficient energy to the collar.

13. A kit for securing one or more elongated living tissue structures, the kit comprising:

a collar having a C-shape, said collar being disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar extends circumferentially between two end portions, said collar having an innermost surface and an outermost surface, said surfaces extending between said end portions,

said collar being resilient so that after cessation of a deforming force, said collar returns to substantially said C-shape, is made of a flexible, fusible material, and wherein said collar is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein said overlapping portions of said collar are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar; and

a fusing tool for compressing the collar around the tissue structures so that the tissue structures are securely retained within the central region, and for applying energy to the collar to fuse the overlapped portions together, wherein the fusing tool includes an energy source, a welding head for effecting the fusion, and an end effect for supporting the collar during compression and fusion.

14. The kit according to claim 13 wherein the energy source is an ultrasonic transducer, and the fusing tool further includes a welding horn extending between the ultrasonic transducer and the welding head for transmitting ultrasonic energy from the transducer to the welding head.

15. A kit according to claim 14 wherein the end effector includes one or more jaw members adapted for selective deployment around at least a portion of the collar to form an ultrasonic welding anvil.

16. A kit according to claim 15, wherein the end effector includes a pair of opposed jaws which are moveable with respect to each other.

17. A kit according to claim 15, wherein the end effector includes a pair of jaws which are resiliently biased toward each other.

18. A kit for joining a plurality of surgical sutures together without a knot, the kit comprising:

a collar having a C-shape,

said collar being disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar extends circumferentially between two end portions, said collar having an innermost surface and an outermost surface, said surfaces extending between said end portions,

said collar being resilient so that after cessation of a deforming force, said collar returns to substantially said C-shape, is made of a flexible, fusible material, and wherein said collar is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein the overlapping portions of the collar are adapted to fuse to each other around the central region upon application of sufficient energy to at least one of the overlapping portions of the collar;

a fusing tool for compressing the collar around the surgical sutures so that the surgical sutures are securely retained within the central region, and for applying energy to the collar to fuse the overlapped portions together, wherein the fusing tool includes an energy source, a welding head for effecting the fusion, and an end effector for supporting the collar during compression and fusion.

19. A kit according to claim 18 wherein the energy source is an ultrasonic transducer, and the fusing tool further includes a welding horn extending between the ultrasonic transducer and the welding head for transmitting ultrasonic energy from the transducer to the welding head, and wherein the end effector includes one or more jaw members adapted for selective deployment around at least a portion of the collar to form an ultrasonic welding anvil.

20. A kit according to claim 19, wherein the end effector includes a pair of opposed jaws which are moveable with respect to each other.

21. A kit according to claim 19, wherein the end effector includes a pair of jaws which resiliently biased toward each other.

22. A method for securing one or more elongated members together, comprising the steps of:

providing a collar having a C-shape, said collar being disposed about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar extends circumferentially between two end portions, said collar having an innermost surface and an outermost surface, said surfaces extending between said end portions,

said collar being resilient so that after cessation of a deforming force, said collar returns to substantially said C-shape, is made of a flexible, fusible material, and wherein said collar is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost surface and said outermost surface are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein the overlapping portions of the collar are adapted to fuse to each other around the central region upon application of sufficient energy to at least one of the overlapping portions of the collar;

encircling the elongated members to be joined with the collar;

compressing the collar around the elongated members so that the end portions of the collar overlap one another; and

applying sufficient energy to the overlapping portions of the collar while the collar is compressed so as to fuse the overlapping portions of the collar to each other around the elongated members.

23. The method according to claim 22 wherein one elongated member is compressed by the collar to restrict the flow of fluid through the elongated member.

24. A method for joining a plurality of polymeric surgical sutures together in a knotless weld, comprising the steps of:

a collar disposed about a central recion, the central region extending along a central axis, for containing at least a portion of the polymeric surgical sutures aligned with the central axis, wherein the collar extends circumferentially between two end portions and is made of a flexible, fusible material, and wherein the collar is biasable into a nominally closed position so that the end portions of the collar overlap, and wherein the overlapping portions of the collar are adapted to fuse to each other around the central region upon application of sufficient eniergy to at least one of the overlapping portions of the collar; and

encircling a plurality of surgical sutures to be joined together with the collar;

compressing the collar around the sutures so that the end portions of the collar overlap one another and contact the sutures; and

applying sufficient energy to the overlapped portions of the collar while the collar is compressed around the sutures to fuse the overlapped portions of the collar to each other and portions of the collar to portions of the sutures.

31. The device according to claim 24 wherein the collar assembly includes one or more protrusions extending from said innermost surface of one or both u-shaped elements into the central region when interfit and are adapted to secure the elongated members within the central region.

25. A device for securing one or more elongated members, comprising:

a collar assembly disposable about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar assembly includes two U-shaped cross-sectioned elements, each extending between a first end portion and a second end portion and each having a innermost surface and an outermost surface extending between said end portions, wherein said U-shaped elements are adapted to interfit to extend circumferentially about said central region, with said first end portions mutually adjacent and said second end portions mutually adjacent, being made of a flexible, fusible material, and wherein said collar assembly, when interfit, is deformable into a nominally closed position so that said first end portions of said U-shaped elements overlap, and said second end portions of said U-shaped elements overlap, so that said innermost surfaces and said outermost surfaces are opposite each other forming an overlap area, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein said overlapping end portions of said U-shaped elements are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar assembly.

26. The device according to claim 25, wherein the elongated members comprise surgical sutures made of a fusible material, wherein the sutures are adapted to fuse to at least one to the collar assembly and to one another in a knotless weld upon application of sufficient energy to the collar assembly.

27. The device according to claim 26, wherein one or both U-shaped elements include one or more energy directors extending from said innermost surface of said one or both U-shaped elements into the central region, wherein the energy directors define fusion regions of the sutures and the collar assembly and are adapted to focus energy applied to the collar assembly to the fusion regions so that one or more of the elongated members and collar assembly are fusible together at the fusion regions.

28. The device according to claim 27 wherein the elongated members comprise a band of material adapted for securing a plurality of anatoimical structures together.

29. The device according to claim 25 wherein one or both U-shaped elements include one or more energy directors located on one or more opposing surfaces of the end portions thereof in the overlap area, wherein the energy directors define fusion regions for the end portions within overlap area and are adapted to focus energy applied to the collar assembly to the fusion regions so that the end portions are fusible together.

30. The device according to claim 29 wherein the elongated members comprise surgical sutures made of a fusible material, wherein the sutures are adapted to fuse to at least one of the collar assembly and to one another in a knotless weld upon application of sufficient energy to the collar assembly.

32. The device according to claim 25, wherein the energy applied to the collar assembly is ultrasonic energy.

33. The device according to claim 25, wherein the energy applied to the collar assembly is selected from the group consisting of thermal energy, optical energy, electrical energy and current sources.

34. The device according to claim 25, wherein the collar assembly is made of a thermoplastic polymeric material.

35. A device for securing one or more elongated living tissue structures, comprising:

a collar having a C-shape, said collar being resilient so that after cessation of a deforming force, said collar returns to substantially said C-shape, said collar being disposed about a central region, said central region extending along a central axis for containing at least a portion of said living tissue structures aligned with said central axis, wherein said collar extends circumferentially between two end portions said collar having an innermost surface and an outermost surface extending between said end portions, and is made of a flexible, fusible material, and wherein said collar is deformable into a nominally closed position so that said end portions of said collar overlap so that regions of said innermost and outermost surfaces are opposite each other forming overlapping portions, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein said overlapping portions of said collar are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar.

36. The device according to claim 35, wherein the collar includes one or more energy directors extending from said innermost surface of the collar into the central region, wherein the energy directors define fusion regions of the collar and are adapted to focus energy applied to the collar to the fusion regions.

37. The device according to claim 35 wherein the collar includes one or more protrusions extending from said innermost surface of the collar into the central region and are adapted to secure the living tissue structures within the central region.

38. The device according to claim 35, wherein the energy applied to the collar is ultrasonic energy.

39. The device according to claim 35, wherein the energy applied to the collar is selected from the group consisting of thermal energy, optical energy, electrical energy and current sources.

40. The device according to claim 35, wherein the collar is made of a thermoplastic polymeric material.

41. A device for securing one or more living tissue structures, comprising:

a collar assembly disposable about a central region, said central region extending along a central axis for containing at least a portion of said elongated members aligned with said central axis, wherein said collar assembly includes two U-shaped cross-sectioned elements, each extending between a first end portion and a second end portion and each having an innermost surface and an outermost surface extending between said end portions, wherein said U-shaped elements are adapted to interfit to extend circumferentially about said central region, with said first end portions mutually adjacent and said second end portions mutually adjacent, being made of a flexible, fusible material, and wherein said collar assembly, when interfit deformable into a norninally closed position so that said first end portions of said U-shaped elements overlap, and said second end portions of said U-shaped elements overlap, so that said innermost surfaces and said outermost surfaces are opposite each other forming overlap areas, wherein the surfaces of said overlapping portions are substantially smooth and wherein the amount of overlapping is selectively adjustable, and wherein said overlapping end portions of said U-shaped elements are adapted to fuse to each other around said central region upon application of sufficient energy to at least one of said overlapping portions of said collar assembly.

42. The device according to claim 41, wherein one or both U-shaped elements include one or more energy directors extending from said innermost surfaces of said one or both U-shaped elements into the central region, wherein the energy directors define fusion regions of the collar assembly and are adapted to focus energy applied to the collar assembly to the fusion regions so that the collar assembly are fusible together at the fusion regions.

43. The device according to claim 41 wherein the collar assembly includes one or more protrusions extending from said innermost surface of one or both u-shaped elements into the central region when interfit and are adapted to secure the living tissue structures within the central region.

44. The device according to claim 41, wherein the energy applied to the collar assembly is ultrasonic energy.

45. The device according to claim 41, wherein the energy applied to the collar assembly is selected from the group consisting of thermal energy, optical energy, electrical energy and current sources.

46. The device according to claim 41, wherein the collar assembly is made of a thermoplastic polymeric material.