Surgical devices assembled using heat bondable materials

• US 6,203,565 B1
• Filed: 07/27/1999
• Issued: 03/20/2001
• Est. Priority Date: 06/28/1990
• Status: Expired due to Fees

• Current Assignee: P TECH, LLC
• Original Assignee: Mark V. Brillhart, Peter M. Bonutti
• Inventors: Bonutti, Peter M., Brillhart, Mark V.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/362,279
• Time in Patent Office: 602 Days
• Field of Search: 606/232, 606/220, 606/228, 606/215
• US Class Current: 606/232
• 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 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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 2017/0619 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
• CPC Class Codes: A61B 2017/867 with integral locking or clamping means
• CPC Class Codes: A61F 2/30734 Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
• CPC Class Codes: A61F 2/367 Proximal or metaphyseal parts of shafts trochanteric devices connected to said proximal parts A61F2/30739
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: B29C 65/602 using hollow rivets B29C65/607 takes precedence
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73791 biodegradable
• CPC Class Codes: B29C 66/8322 Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2067/046 : PLA, i.e. polylactic acid or polylactide

Abstract

Surgical devices such as implants or suture fastenings are assembled from a plurality of discrete components, one of which components includes a heat bondable plastic material for bonding the components together. At least two components are bonded to each other by the applying heat to the heat bondable plastic material of one component. The heat bondable plastic material is preferably a polymeric or composite material suitable for surgical applications and implantation in humans, and may be a biodegradable material. A laser may be used as the heat source. The present invention is advantageously embodied in heat bonded fastenings for sutures or K-wires, in which a variety of different suture anchors are usable, including expandable distal suture anchors. Other embodiments include a metal bone plate which is held to bone by a metal bone screw and a nut of bondable material bonded to the plate to secure the connection; a piece of bondable material bonded to a metal prosthesis to custom fit the prosthesis; and a surgical implant custom formed by bonding together a plurality of discrete elements one or more of which is bondable.

Claims

1. A method comprising the steps of moving an anchor connected with a suture into engagement with a first segment of body tissue, said step of moving an anchor connected with a suture into engagement with a first segment of body tissue includes embedding the anchor in the first segment of body tissue with the suture connected with the anchor and extending from the first segment of body tissue and expanding the anchor while the anchor is disposed in the body tissue, moving at least the suture through a second segment of body tissue, thereafter, moving a retainer along the suture toward the second segment of body tissue, pressing the first and second segments of body tissue together, said step of pressing the first and second segments of the body tissue together includes tensioning the suture, transmitting force from the suture through the anchor to the first segment of body tissue, transmitting force from retainer to the second segment of body tissue while maintaining the portion of the suture between the anchor and the retainer straight under the influence of tension in the suture, gripping the suture with the retainer by plastically deforming the retainer while continuing to press the first and second segments of the body tissue together, thereafter, transmitting force between the suture anchor and retainer to continue to press the first and second segments of body tissues together while maintaining the portion of the suture between the anchor and the retainer straight under the influence of tension in the suture.

2. A method as set forth in claim 1 wherein said step of embedding the anchor in the first segment of the body tissue includes changing the orientation of at least a portion of the anchor relative to the body tissue.

3. A method as set forth in claim 1 wherein said step of embedding the anchor in the body tissue includes moving the anchor into the body tissue and increasing the extent of the anchor in a direction transverse to a longitudinal axis of the suture while the anchor is in the body tissue.

4. A method as set forth in claim 1 wherein said step of moving at least the suture through a second segment of body tissue includes moving the anchor and a portion of the suture through the second segment of body tissue.

5. A method as set forth in claim 1 wherein said step of gripping the suture with the retainer includes connecting the retainer with the suture without significant deformation of the suture.

6. A method as set forth in claim 1 wherein said step of gripping the suture with the retainer includes bonding the retainer to the suture.

7. A method as set forth in claim 1 wherein said step of gripping the suture with the retainer includes heating the retainer and bonding the material of the retainer to the suture.

8. A method as set forth in claim 1 wherein a first end portion of the suture is connected with the anchor, said step of gripping the suture with the retainer includes inserting a second end portion of the suture through an opening in the retainer and moving at least a portion of a side surface of the opening in the retainer into engagement with an outer side surface of the suture.

9. A method as set forth in claim 1 wherein said step of plastically deforming the retainer includes heating at least a portion of material forming the retainer into a transition temperature range of the material of the retainer.

10. A method as set forth in claim 1 wherein the retainer has polymer chains oriented in a direction extending along a longitudinal axis of a portion of the suture, the polymer chains being contracted to cause material of the retainer to grip the suture.

11. A method comprising the steps of moving an anchor into a bone through an opening in a surface on the bone with a suture connected to the anchor, moving a suture retainer along the suture toward the bone, tensioning the suture, retaining the anchor against movement relative to the bone under the influence of force transmitted between the anchor and the bone while tensioning the suture, and securing the suture retainer against movement relative to the suture while tensioning the suture and retaining the anchor against movement relative to the bone under the influence of force transmitted to the anchor through the suture by transmitting force between the anchor and the bone, said step of securing the suture retainer against movement relative to the suture includes gripping the suture with the suture retainer by deforming the suture retainer while continuing to tension the suture.

12. A method as set forth in claim 11 further including the step of pressing body tissue against the surface on the bone under the influence of force transmitted to the body tissue from the suture retainer.

13. A method as set forth in claim 11 wherein said step of moving the anchor through an opening in a surface on the bone is performed with the anchor in a first orientation relative to the bone, said step of retaining the anchor against movement relative to the bone includes changing the orientation of the anchor from the first orientation to a second orientation relative to the bone.

14. A method as set forth in claim 11 wherein said step of retaining the anchor against movement relative to the bone includes transmitting force from the anchor to soft cancellous bone tissue.

15. A method comprising the steps of moving an anchor into a bone through an opening in a surface on the bone with a suture connected to the anchor, moving a suture retainer along the suture toward the bone, tensioning the suture, retaining the anchor against movement relative to the bone under the influence of force transmitted between the anchor and the bone while tensioning the suture, said step of retaining the anchor against movement relative to the bone includes expanding the anchor after performing said step of moving the anchor through an opening in a surface on the bone, and securing the suture retainer against movement relative to the suture while tensioning the suture and retaining the anchor against movement relative to the bone under the influence of force transmitted to the anchor through the suture by transmitting force between the anchor and the bone.

16. A method as set forth in claim 15 further including the step of pressing body tissue against the surface on the bone under the influence of force transmitted to the body tissue from the suture retainer.

17. A method as set forth in claim 15 wherein said step of securing the suture retainer against movement relative to the suture includes gripping the suture with the suture retainer by deforming the suture retainer while continuing to tension the suture.

18. A method as set forth in claim 15 wherein said step of moving the anchor through an opening in a surface on the bone is performed with the anchor in a first orientation relative to the bone, said step of retaining the anchor against movement relative to the bone includes changing the orientation of the anchor from the first orientation to a second orientation relative to the bone.

19. A method as set forth in claim 15 wherein said step of retaining the anchor against movement relative to the bone includes transmitting force from the anchor to soft cancellous bone tissue.

20. A method as set forth in claim 15 wherein said step of securing the suture retainer against movement relative to the suture includes heating at least a portion of material forming the suture retainer into a transition temperature range of the material of the suture retainer.

21. A method as set forth in claim 15 wherein the suture retainer has polymer chains oriented in direction extending along a longitudinal axis of a portion of the suture, the polymer chains being contracted to cause material of the suture retainer to grip the suture.

22. A method of connecting body tissue with bone, said method comprising the steps of moving an anchor through the body tissue into the bone with a suture connected to the anchor, moving a suture retainer along the suture toward the body tissue and bone, tensioning the suture, retaining the anchor against movement relative to the bone under the influence of force transmitted between the anchor and bone while tensioning the suture, said step of retaining the anchor against movement relative to the bone includes embedding the anchor in the bone with the suture connected to the anchor and extending through the body tissue, said step of embedding the anchor in the bone includes expanding the anchor while the anchor is in the bone, transmitting force from the suture retainer to the body tissue to press the body tissue against the bone while performing said steps of tensioning the suture and retaining the anchor against movement relative to the bone, and securing the suture retainer against movement relative to the suture while tensioning the suture and retaining the anchor against movement relative to the bone.

23. A method as set forth in claim 22 wherein said step of securing the suture retainer against movement relative to the suture includes heating at least a portion of material forming the suture retainer into a transition temperature range of the material of the suture retainer.

24. A method as set forth in claim 22 wherein the suture retainer has polymer chains oriented in a direction extending along a longitudinal axis of a portion of the suture, the polymer chains being contracted to cause material of the suture retainer to grip the suture.

25. A method as set forth in claim 22 wherein said step of moving the anchor through the body tissue into the bone includes moving the anchor into the bone along a first path of movement, said step of moving the suture retainer along the suture toward the body tissue and bone includes moving the suture retainer along the first path of movement.

26. A method as set forth in claim 22 wherein said step of embedding the anchor in the bone includes changing the orientation of at least a portion of the anchor relative to the bone.

27. A method as set forth in claim 22 wherein said step of embedding the anchor in the bone includes moving the anchor into the bone and increasing the extent of the anchor in a direction transverse to a longitudinal central axis of the suture while the anchor is in the bone.

28. A method as set forth in claim 22 wherein said step of securing the suture retainer against movement relative to the suture includes connecting the suture retainer with the suture without significant deformation of the suture.

29. A method as set forth in claim 22 wherein said step of securing the suture retainer against movement relative to the suture includes bonding the suture retainer to the suture.

30. A method as set forth in claim 22 wherein said step of securing the suture retainer against movement relative to the suture includes heating the suture retainer and bonding material of the suture retainer to the suture.

31. A method as set forth in claim 22 wherein said step of securing the suture retainer against movement relative to the suture includes gripping the suture with the suture retainer by deforming the suture retainer while continuing to tension the suture.

32. A method comprising the steps of connecting a suture which is formed separately from an anchor with the anchor, moving the anchor connected with the suture into engagement with a first segment of body tissue, moving at least the suture through a second segment of body tissue, thereafter, moving a retainer along the suture toward the second segment of body tissue, moving at least one of the first and second segments of body tissue relative to the other segment of body tissue while performing said step of moving a retainer along the suture toward the second segment of body tissue, pressing the first and second segments of body tissue together, said step of pressing the first and second segments of the body tissue together includes tensioning the suture, transmitting force from the suture through the anchor to the first segment of body tissue, transmitting force from a retainer to the second segment of body tissue while maintaining tension in the suture, gripping the suture with the retainer by plastically deforming the retainer while continuing to press the first and second segments of the body tissue together and while maintaining tension in the suture, and, thereafter, transmitting force between the suture anchor and retainer to continue to press the first and second segments of body tissue together while maintaining tension in the suture.

33. A method as set forth in claim 32 wherein said step of moving an anchor into the first segment of body tissue includes moving the anchor into the body tissue in a first direction relative to the body tissue, said step of moving the retainer along the suture toward the second segment of body tissue includes sliding the retainer along the suture in the first direction relative to the body tissue.

34. A method as set forth in claim 32 wherein said step of moving an anchor connected with a suture into a first segment of body tissue includes embedding the anchor in the first segment of body tissue with the suture connected with the anchor and extending from the first segment of body tissue.

35. A method as set forth in claim 32 wherein said step of moving the anchor connected with the suture into engagement with a first segment of body tissue includes expanding the anchor while the anchor is disposed in the body tissue.

36. A method as set forth in claim 32 wherein said step of moving the anchor connected with the suture into engagement with a first segment of body tissue includes changing the orientation of at least a portion of the anchor relative to the body tissue while the anchor is in engagement with the body tissue.

37. A method as set forth in claim 32 wherein said step of moving the anchor connected with the suture into engagement with a first segment of body tissue includes moving the anchor into the body tissue and increasing the extent of the anchor in a direction transverse to a longitudinal axis of the suture while the anchor is in the body tissue.

38. A method as set forth in claim 32 wherein said step of moving at least the suture through a second segment of body tissue includes moving the anchor and a portion of the suture through the second segment of body tissue.

39. A method as set forth in claim 32 wherein said step of gripping the suture with the retainer includes connecting the retainer with the suture without significant deformation of the suture.

40. A method as set forth in claim 32 wherein said step of gripping the suture with the retainer includes bonding the retainer to the suture.

41. A method as set forth in claim 32 wherein said step of gripping the suture with the retainer includes heating the retainer and bonding the material of the retainer to the suture.

42. A method as set forth in claim 32 wherein a first end portion of the suture is connected with the anchor, said step of gripping the suture with the retainer includes inserting a second end portion of the suture through an opening in the retainer and moving at least a portion of a side surface of the opening in the retainer into engagement with an outer side surface of the suture.

43. A method as set forth in claim 32 wherein said step of plastically deforming the retainer includes heating at least a portion of material forming the retainer into a transition temperature range of the material of the retainer.

44. A method as set forth in claim 32 wherein the retainer has polymer chains oriented in a direction extending along a longitudinal axis of a portion of the suture, the polymer chains being contracted to cause material of the retainer to grip the suture.

45. A method of connecting body tissue with bone, said method comprising the steps of connecting a suture which is formed separately from an anchor with the anchor, moving the anchor into the bone with the suture connected to the anchor, moving a suture retainer along the suture toward the body tissue and bone, tensioning the suture while moving the suture retainer along the suture toward the body tissue and bone, retaining the anchor against movement relative to the bone under the influence of force transmitted between the anchor and bone while tensioning the suture, transmitting force from the suture retainer to the body tissue to press the body tissue against the bone while performing said steps of tensioning the suture and retaining the anchor against movement relative to the bone, and securing the suture retainer against movement relative to the suture while tensioning the suture and retaining the anchor against movement relative to the bone.

46. A method as set forth in claim 45 wherein said step of moving the anchor into the bone includes moving the anchor into the bone along a first path of movement, said step of moving the suture retainer along the suture toward the body tissue and bone includes moving the suture retainer along the first path of movement.

47. A method as set forth in claim 45 wherein said step of retaining the anchor against movement relative to the bone includes embedding the anchor in the bone with the suture connected to the anchor and extending through the body tissue.

48. A method as set forth in claim 45 wherein said step of retaining the anchor against movement relative to the bone includes expanding the anchor while the anchor is in the bone.

49. A method as set forth in claim 45 wherein said step of retaining the anchor against movement relative to the bone includes changing the orientation of at least a portion of the anchor relative to the bone.

50. A method as set forth in claim 45 wherein said step of retaining the anchor against movement relative to the bone includes moving the anchor into the bone and increasing the extent of the anchor in a direction transverse to a longitudinal central axis of the suture while the anchor is in the bone.

51. A method as set forth in claim 45 wherein said step of securing the suture retainer against movement relative to the suture includes connecting the suture retainer with the suture without significant deformation of the suture while continuing to tension the suture.

52. A method as set forth in claim 45 wherein said step of securing the suture retainer against movement relative to the suture includes bonding the suture retainer to the suture while continuing to tension the suture.

53. A method as set forth in claim 45 wherein said step of securing the suture retainer against movement relative to the suture includes heating the suture retainer and bonding material of the suture retainer to the suture while continuing to tension the suture.

54. A method as set forth in claim 45 wherein said step of securing the suture retainer against movement relative to the suture includes gripping the suture with the suture retainer by deforming the suture retainer while continuing to tension the suture.

55. A method as set forth in claim 45 wherein said step of securing the suture retainer against movement relative to the suture includes heating at least a portion of material forming the suture retainer into a transition temperature range of the material of the suture retainer.

56. A method as set forth in claim 45 wherein the suture retainer has polymer chains oriented in a direction extending along a longitudinal axis of a portion of the suture, the polymer chains being contracted to cause material of the suture retainer to grip the suture.

57. A method comprising the steps of providing a flexible force transmitting member which is biodegradable and is formed by a plurality of interconnected strands which are at least partially formed of polylactide, positioning the flexible force transmitting member relative to body tissue, tensioning the flexible force transmitting member to transmit force from the strands of polylactide to the body tissue, and maintaining tension in the flexible force transmitting member by securing a biodegradable retainer which is at least partially formed of polylactide to the flexible force transmitting member, said step of securing a biodegradable retainer to the flexible force transmitting member includes bonding material of the retainer to the strands of polylactide, said step of bonding material of the retainer to the strands of polylactide includes heating at least a portion of the material of the retainer into a transition temperature range of the material of the retainer.

58. A method as set forth in claim 57 wherein first and second portions of the flexible force transmitting member extend through the retainer in a side-by-side relationship.

59. A method as set forth in claim 57 further including the step of inserting one end of the strands of polylactide through an opening in the retainer, said step of bonding material of the retainer to the strands of polylactide includes pressing material of the retainer which at least partially defines the opening in the retainer against the strands of polylactide.

60. A method as set forth in claim 57 wherein said step of bonding material of the retainer to the strands of polylactide includes gripping a first portion of the strands of polylactide with the retainer and gripping a second portion of the strands of polylactide with the retainer.

61. A method as set forth in claim 57 further including the step of pressing the strands of polylactide against the body tissue under the influence of tension in the flexible force transmitting member.

62. A method as set forth in claim 57 wherein the retainer has polymer chains oriented in a direction extending along a longitudinal axis of a portion of the force transmitting member, the polymer chains being contracted to cause the material of the retainer to grip the force transmitting member.

63. A method comprising the steps of providing a flexible force transmitting member which is at least partially formed of a plurality of strands of a biodegradable material, positioning the force transmitting member relative to body tissue with a longitudinal extending central portion of the strands of biodegradable material extending at least part way around the body tissue, providing a retainer formed of biodegradable material, tensioning the strands of biodegradable material to apply force against the body tissue with the central portion of the strands of biodegradable material, and maintaining the tension in the strands of biodegradable material by gripping a first portion of the strands of biodegradable material with the retainer at a location adjacent to a first end of the central portion of the strands of biodegradable material and by gripping a second portion of the strands of biodegradable material with the retainer at a location adjacent to a second end of the central portion of the strands of biodegradable material, the first and second portions of the strands of biodegradable material extend through the retainer in a side-by-side relationship.

64. A method as set forth in claim 63 wherein said steps of gripping a first portion of the strands of biodegradable material with the retainer and gripping a second portion of the strands of biodegradable material with the retainer includes heating material of the retainer into a transition temperature range of the material of the retainer and plastically deforming the heated material of the retainer.

65. A method as set forth in claim 63 wherein said step of gripping the second portion of the strands of biodegradable material with the retainer includes bonding material of the retainer to the second portion of the strands of biodegradable material.

66. A method as set forth in claim 63 further including the step of inserting one end of the strands of biodegradable material through an opening in the retainer, said step of gripping a second portion of the strands of biodegradable material with the retainer includes pressing material of the retainer which at least partially defines the opening in the retainer against the strands of biodegradable material.

67. A method as set forth in claim 63 wherein said steps of gripping a first portion of the strands of biodegradable material with the retainer and gripping a second portion of the strands of biodegradable material with the retainer includes contracting polymer chains which extend along the strands of biodegradable material.

68. A method comprising the steps of providing a flexible force transmitting member which is at least partially formed of a plurality of strands of a biodegradable material, positioning the force transmitting member relative to body tissue with a longitudinal extending central portion of the strands of biodegradable material extending at least part way around the body tissue, providing a retainer formed of biodegradable material, tensioning the strands of biodegradable material to apply force against the body tissue with the central portion of the strands of biodegradable material, and maintaining the tension in the strands of biodegradable material by gripping a first portion of the strands of biodegradable material with the retainer at a location adjacent to a first end of the central portion of the strands of biodegradable material and by gripping a second portion of the strands of biodegradable material with the retainer at a location adjacent to a second end of the central portion of the strands of biodegradable material, said steps of gripping a first portion of the strands of biodegradable material with the retainer and gripping a second portion of the strands of biodegradable material with the retainer includes heating material of the retainer into a transition temperature range of the material of the retainer and plastically deforming the heated material of the retainer.

69. A method as set forth in claim 68 wherein said steps of gripping a first portion of the strands of biodegradable material with the retainer and gripping the second portion of the strands of biodegradable material with the retainer includes bonding material of the retainer to the second portion of the strands of biodegradable material.

70. A method as set forth in claim 68 further including the step of inserting one end of the strands of biodegradable material through an opening in the retainer, said step of gripping a first portion of the strands of biodegradable material with the retainer and gripping a second portion of the strands of biodegradable material with the retainer includes pressing material of the retainer which at least partially defines the opening in the retainer against the second portion of the strands of biodegradable material.

71. A method as set forth in claim 68 wherein said steps of gripping a first portion of the strands of biodegradable material with the retainer and gripping a second portion of the strands of biodegradable material with the retainer includes contracting polymer chains which extend along the strands of biodegradable material.

72. A method as set forth in claim 68 wherein said step of plastically deforming heated material of the retainer includes pressing heated material of the retainer against one of the first and second portions of the strands of biodegradable material.

73. A method as set forth in claim 72 wherein said step of heating material of the retainer into the transition temperature range includes heating material of the retainer disposed adjacent to the one of the first and second portions of the strands of biodegradable material.