METHODS AND DEVICES FOR INTRACORPOREAL BONDING OF IMPLANTS WITH THERMAL ENERGY

• US 20080039845A1
• Filed: 02/06/2007
• Published: 02/14/2008
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter, Beyers, Justin, Cremens, Matthew
• Granted Patent: US 9,421,005 B2
• Time in Patent Office: Days
• US Class Current: 606/62
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1128 of nerves
• CPC Class Codes: A61B 17/1146 of tendons
• CPC Class Codes: A61B 17/1721 for applying pins along or parallel to the axis of the femoral neck
• CPC Class Codes: A61B 17/1742 for the hip
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7058 Plates mounted on top of bone anchor heads or shoulders
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/725 with locking pins or screws of special form
• 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 17/8033 having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
• CPC Class Codes: A61B 17/8038 the additional component being inserted in the screw head
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/844 with expandable anchors or anchors having movable parts
• CPC Class Codes: A61B 17/861 : specially shaped for gripping driver
• CPC Class Codes: A61B 17/866 : Material or manufacture
• CPC Class Codes: A61B 17/8685 : comprising multiple separate parts
• CPC Class Codes: A61B 17/88 : Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8863 : Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2017/00004 : (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00022 : Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00504 : Tissue welding
• CPC Class Codes: A61B 2017/00955 : thermoplastic
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0432 : the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0437 : the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 : with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/045 : snug fit within the anchor
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/8655 : with special features for locking in the bone
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/32 : for the hip
• CPC Class Codes: A61F 2/3603 : implanted without ablation of the whole natural femoral head endoprosthetic cartilage A61F2/30756
• CPC Class Codes: A61F 2/38 : for elbows or knees
• CPC Class Codes: A61F 2/3804 : for elbows
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/40 : for shoulders
• CPC Class Codes: A61F 2/4081 : Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/4202 : for ankles
• CPC Class Codes: A61F 2/4455 : for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4465 : having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/468 : Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3068 : the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/30973 : Two joined adjacent layers having complementary interlocking protrusions and recesses
• CPC Class Codes: A61F 2002/3401 : with radial apertures, e.g. radial bores for receiving fixation screws
• CPC Class Codes: A61F 2002/3403 : Polar aperture
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/828 : Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0068 : the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: G06F 21/1077 : Recurrent authorisation
• CPC Class Codes: G06F 2221/2137 : Time limited access, e.g. to a computer or data

Abstract

The present invention provides a method for stabilizing a fractured bone. The method includes positioning an elongate rod in the medullary canal of the fractured bone and forming a passageway through the cortex of the bone. The passageway extends from the exterior surface of the bone to the medullary canal of the bone. The method also includes creating a bonding region on the elongate rod. The bonding region is generally aligned with the passageway of the cortex. Furthermore, the method includes positioning a fastener in the passageway of the cortex and on the bonding region of the elongate rod and thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway of the cortex.

Claims

1. A method for stabilizing a fractured bone, the method comprising:

positioning an elongate rod in the medullary canal of the fractured bone;

forming a passageway through the cortex of the bone, the passageway extending from the exterior surface of the bone to the medullary canal of the bone;

creating a bonding region on the elongate rod, the bonding region generally aligned with the passageway of the cortex;

positioning a fastener in the passageway of the cortex and on the bonding region of the elongate rod; and

thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway of the cortex.

2. The method of claim 1 wherein the elongate rod and fastener include thermoplastic material.

3. The method of claim 2 wherein ultrasonic energy is used to thermally bond the fastener to the bonding region of the elongate rod.

4. The method of claim 3 wherein the bonding region includes a roughened surface on the elongate rod.

5. The method of claim 3 wherein the bonding region includes an indentation in the elongate rod.

6. The method of claim 3 wherein the bonding region includes a channel being an extension of the passageway.

7. The method of claim 3 wherein thermally bonding the fastener includes thermally bonding the fastener to the cortex of the bone whereby the fastener resists movement between the bone and elongate rod.

8. The method of claim 1 wherein forming a passageway and creating a bonding region includes drilling a hole completely through the bone and elongate rod, wherein positioning the fastener includes positioning the fastener in the drilled hole, and wherein thermally bonding the fastener includes bonding the fastener to the elongate rod and to two cortex areas of the bone.

9. The method of claim 1 further including contouring a proximal end of the fastener after thermally bonding the fastener.

10. A method for stabilizing a fractured bone, the method comprising:

positioning an elongate plate on the exterior surface of the fractured bone;

forming a passageway extending through the elongate plate and into the bone;

positioning a fastener in the passageway;

thermally bonding the fastener to the bone while the fastener is positioned in the passageway.

11. The method of claim 10 wherein the elongate plate and fastener include thermoplastic material.

12. The method of claim 11 wherein ultrasonic energy is used to thermally bond the fastener to the bone.

13. The method of claim 12 wherein thermally bonding the fastener includes thermally bonding the fastener to the elongate plate whereby the fastener resists relative movement between the bone and elongate plate.

14. The method of claim 13 further including contouring a proximal end of the fastener after thermally bonding the fastener.

15. A method for stabilizing a fractured bone, the method comprising:

positioning an elongate rod in the medullary canal of the fractured bone;

positioning an elongate plate on the exterior surface of the bone such that the cortex of the bone is positioned between the elongate rod and plate;

forming a passageway through the elongate plate and the cortex of the bone, the passageway extending from the exterior surface of the elongate plate to the medullary canal of the bone;

creating a bonding region on the elongate rod, the bonding region generally aligned with the passageway;

positioning a fastener in the passageway and on the bonding region of the elongate rod; and

thermally bonding the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway.

16. The method of claim 15 wherein the elongate rod, elongate plate, and fastener include thermoplastic material.

17. The method of claim 16 wherein the thermoplastic material is PEEK.

18. The method of claim 17 wherein ultrasonic energy is used to thermally bond the fastener to the bonding region of the elongate rod.

19. The method of claim 18 wherein thermally bonding the fastener includes thermally bonding the fastener to the elongate plate whereby the fastener resists relative movement of the elongate rod and plate with the cortex of the bone therebetween.

20. The method of claim 19 further including contouring a proximal end of the fastener after thermally bonding the fastener.

21. A weldable fastener assembly for attachment of a first tissue or implant material to a second tissue comprising:

an anchor having a longitudinal axis, a distal end and a proximal end, wherein the distal end is configured for insertion into the second tissue and the proximal end defines a bore that extends at least partially along the longitudinal axis of the anchor;

a fastener cap having a lid and a post, wherein at least a portion of the post is dimensioned to fit within the anchor bore, and wherein the fastener cap defines a channel extending at least partially through the post and lid; and

wherein at least one of the anchor or cap can be welded when an energy source is disposed inside the channel of the fastener cap.

22. The weldable fastener assembly of claim 21, wherein the anchor comprises a helical thread disposed on an outer surface of the distal end of the anchor, wherein the thread is configured for engaging with the second tissue.

23. The weldable fastener assembly of claim 22, wherein the helical thread disposed on the outer surface of the distal end of the anchor is a self-tapping thread.

24. The weldable fastener assembly of claim 21, wherein the distal end of the anchor is substantially conical.

25. The weldable fastener assembly of claim 21, wherein the anchor is configured to be disposed within a tissue bore having a first diameter and the fastener cap lid is larger than the tissue bore.

26. The weldable fastener assembly of claim 21, further comprising one or more projections on the fastener cap post and one or more corresponding receptacles in the anchor bore, wherein engagement of the fastener cap post projections with the anchor bore receptacles increases the force required to separate the anchor and fastener cap.

27. The weldable fastener assembly of claim 21, wherein the anchor is comprised of hydrophilic material.

28. The weldable fastener assembly of claim 21, wherein the anchor and fastener cap are substantially free of energy directors.

29. The weldable fastener assembly of claim 21, further comprising a welding instrument having a horn that contacts the fastener cap lid and an elongated extension configured to fit within the fastener cap channel.

30. The weldable fastener assembly of claim 29, wherein the elongated extension is configured to expose the energy source to the fastener cap along the entire length of the channel.

31. The weldable fastener assembly of claim 29, wherein the elongated extension is configured to expose energy to a distal end of the fastener cap post disposed within the anchor bore.

32. The weldable fastener assembly of claim 21, wherein at least one of the anchor and fastener cap is made of PEEK.

33. A weldable fastener assembly for attachment of a first tissue or implant material to a second tissue comprising:

an anchor having a longitudinal axis, a distal end and a proximal end, wherein the distal end is configured for insertion into the second tissue and the proximal end defines a bore that extends at least partially along the longitudinal axis of the anchor, and wherein a first helical thread is disposed on the interior surface of the anchor bore;

a fastener cap having a lid and a post, wherein at least a portion of the post has a second helical thread dimensioned to engage with the first helical thread on the anchor; and

wherein at least one of the anchor or cap can be welded when an energy source is disposed inside the channel of the fastener cap.

34. The weldable fastener assembly of claim 33, wherein the fastener cap defines a channel extending at least partially through the post and lid for receiving the energy source.

35. The weldable fastener assembly of claim 33, wherein the anchor comprises a third helical thread disposed on an outer surface of the distal end of the anchor, wherein the third thread is configured for engaging with the second tissue.

36. The weldable fastener assembly of claim 33, wherein the anchor is substantially cylindrical.

37. The weldable fastener assembly of claim 33, wherein the anchor is comprised of hydrophilic material.

38. The weldable fastener of claim 34, further comprising a welding instrument having an elongated extension configured to fit within the fastener cap channel and expose the energy source to the fastener cap along its length.

39. The weldable fastener of claim 33, wherein the anchor comprises an inner core made of first material that is thermoplastic and weldable, and wherein the anchor further comprises an outer layer comprised of a second material.

40. The weldable fastener of claim 39, wherein the outer layer of the anchor comprises metallic material.

41. The weldable fastener of claim 39, wherein the outer layer of the anchor comprises a second, weldable thermoplastic material having a higher welding temperature than the material of the inner core.

42. A weldable bone plate assembly comprising:

an intramedullary rod;

a bone plate comprising a thermoplastic, weldable material;

a fastener having a lid and a post, wherein at least a portion of the post is dimensioned to be disposed through the plate and extend into at least a portion of the intramedullary rod, and wherein the fastener lid and post define a channel extending at least partially therethrough; and

wherein at the fastener can be welded to at least one of the intramedullary rod and bone plate when an energy source is disposed inside the channel of the fastener.

43. The bone plate assembly of claim 42, wherein the intramedullary rod is comprised of a thermoplastic, weldable material.

44. The bone plate assembly of claim 42, wherein the bone plate is comprised of a thermoplastic, weldable material.

45. The bone plate assembly of claim 44, wherein the bone plate is substantially free of pre-formed, threaded holes.

46. A weldable fastener assembly for attachment of a first tissue or implant material to a second tissue comprising:

an anchor having a longitudinal axis, a distal end and a proximal end, wherein the distal end is configured for insertion into the second tissue and the proximal end defines a proximal tip extending away from the distal end of the anchor;

a fastener cap having a lid and a post, wherein the distal end of the post defines a receptacle that is configured to receive the proximal tip of the anchor, and wherein the fastener cap further defines a channel extending at least partially through the post and lid; and

wherein at least one of the anchor or cap can be welded when an energy source is disposed inside the channel of the fastener cap.

47. The weldable fastener assembly of claim 46, wherein the proximal tip extends along the longitudinal axis of the anchor.

51. The weldable fastener assembly of claim 46, wherein the anchor further comprises a helical thread disposed on an outer surface of the distal end of the anchor, wherein the thread is configured for engaging with the second tissue.

52. The weldable fastener assembly of claim 46, wherein the fastener cap is comprised of hydrophilic material.

53. The weldable fastener assembly of claim 46, wherein at least one of the anchor and fastener cap is made of PEEK.

48. The weldable fastener assembly of claim 48, wherein the anchor comprises a plurality of proximal tips.

49. The weldable fastener assembly of claim 48, wherein at least two of the plurality of proximal tips are parallel to each other.

50. The weldable fastener assembly of claim 48, wherein the assembly further comprises a plurality or fastener caps corresponding in number to the number of proximal tips.

54. A method for stabilizing fractured bone, the method comprising:

providing a sheet of weldable, thermoplastic material;

wrapping the sheet of material around a portion of a fractured bone so that at least a first portion of the sheet overlaps with a second portion of the sheet;

exposing the overlapping first and second portions of the sheet disposed around the fractured bone to an energy source;

welding at least a portion of the overlapping first and second portions of the sheet to stabilize the fractured bone.

55. The method of claim 54, further comprising the step of exposing the sheet to the energy source for a sufficient time to cause the sheet to shrink and apply compressive force to the fractured bone.

56. The method of claim 54, wherein the weldable sheet is a mesh material that permits passage of body fluid.

57. The method of claim 54, wherein the weldable sheet comprises two or more layers of laminated materials, wherein at least one layer is an impermeable membrane.

58. A method for stabilizing a damaged tissue, the method comprising:

providing a sheet of weldable, thermoplastic material;

wrapping the sheet of material around a portion of the damaged tissue so that at least a first portion of the sheet overlaps with a second portion of the sheet to form a tube-like structure;

exposing the overlapping first and second portions of the sheet disposed around the tissue to an energy source;

welding at least a portion of the overlapping first and second portions of the sheet to stabilize the tissue.

59. The method of claim 58, wherein the damaged tissue is a blood vessel, and wherein the method further comprises the step of using a balloon in the vessel to increase structural rigidity of the vessel during welding of the sheet of material.

60. The method of claim 58, wherein the sheet of weldable, thermoplastic material comprises at least one impermeable layer.