Methods and devices for intracorporeal bonding of implants with thermal energy

• US 9,421,005 B2
• Filed: 02/06/2007
• Issued: 08/23/2016
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Cremens, Matthew J., Beyers, Justin E.
• Primary Examiner(s): Merene, Jan Christopher
• Assistant Examiner(s): COTRONEO, STEVEN J
• Application Number:
  US11/671,556
• Publication Number:
  US 20080039845A1
• Time in Patent Office: 3,486 Days
• Field of Search: 606 62- 68, 606/86.B, 606280-331
• US Class Current: 1/1
• 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 bone, the method comprising:

positioning a plate on the exterior surface of the bone;

positioning a fastener in a passageway extending at least partially through the plate and to the bone;

applying ultrasonic energy to thermally bond the fastener to the plate while at least a portion of the fastener is positioned in the passageway,

wherein at least a portion of the fastener includes a thermoplastic material and the ultrasonic energy is generated by an ultrasonic energy generating system having a feedback system configured to

determine at least one of a pressure and impedance of an end effector coupled to the energy generating system; and

adjust a drive voltage of the ultrasonic energy generating system.

2. The method of claim 1 wherein at least a portion of the fastener or plate includes thermoplastic material.

3. The method of claim 1 further including contouring the proximal end of the fastener after thermally bonding the fastener to the plate.

4. The method of claim 1, wherein at least one of the fastener and plate includes a metal at least partially enclosed by a polymer.

5. The method of claim 1 wherein the thermoplastic material is PEEK.

6. The method of claim 1 wherein the thermoplastic material is a resorbable polymer.

7. The method of claim 1 wherein the fastener has a head and a shaft and wherein the ultrasonic energy is applied by an end effector and the end effector contacts the head.

8. The method of claim 7 wherein one of the end effector and the head of the fastener is provided with a recess and the other is provided with an extension shaped to mate with the recess.

9. A weldable plate system comprising:

an embeddable implant configured to be embedded in at least a portion of a body;

a plate configured to be positioned with respect to a portion of a body;

a fastener configured to be at least partially passable through the plate and extend to at least a portion of the embeddable implant; and

an ultrasonic energy generating system having a feedback system configured to

determine at least one of a pressure and impedance of an end effector coupled to the energy generating system; and

adjust a drive voltage of the ultrasonic energy generating system;

wherein the fastener is configured to be welded to at least the embeddable implant with ultrasonic energy from an energy source.

10. The system of claim 9, wherein at least a portion of the embeddable implant or plate includes a polymer.

11. The system of claim 9, wherein at least a portion of the embeddable implant or plate includes a metal.

12. The system of claim 11, wherein at least the embeddable implant or plate is substantially free of pre-formed holes.

13. The system of claim 9 wherein the fastener is configured to be bonded to the plate with ultrasonic energy.

14. The system of claim 13, wherein a proximal end of the fastener is configured to be contoured after bonding to the embeddable implant and plate.

15. The system of claim 9 wherein the feedback system adjusts the drive voltage during welding.

42. The method of claim 14 wherein the thermoplastic material is PEEK.

16. A method for fixation of a bone, the method comprising:

positioning a plate on or adjacent a cortical surface of the bone, the plate including at least one fastener hole;

forming a passageway through the cortical surface and extending through the at least one fastener hole and into the bone;

positioning a fastener in the passageway, the fastener having a thermoplastic material;

applying ultrasonic energy, from an ultrasonic energy generating system having a feedback system configured to;

determine at least one of a pressure and impedance of an end effector coupled to the energy generating system; and

adjust a drive voltage of the ultrasonic energy generating system, to thermally bond the fastener to the plate while the fastener is positioned in the passageway,

wherein at least a portion of the fastener includes a thermoplastic material.

17. The method of claim 16, wherein the plate is a modular plate including first and second plate portions.

18. The method of claim 17, wherein the first and second plate portions are connected prior to positioning on the cortical surface.

19. The method of claim 17, wherein the first and second plate portions are ultrasonically welded together.

20. The method of claim 16, wherein at least a portion of the fastener or plate includes a polymer.

21. The method of claim 16, wherein the fastener has a head at the proximal end and a shaft free of threads.

22. The method of claim 21, wherein the head of the fastener has a smooth surface free of threads.

23. The method of claim 21 wherein the shaft is substantially smooth.

24. The method of claim 21 wherein the ultrasonic energy is applied by an end effector contacting only the head of the fastener.

25. The method of claim 24 wherein one of the end effector and the head of the fastener is provided with a recess and the other is provided with an extension shaped to mate with the recess.

26. The method of claim 16, wherein at least the fastener or plate comprises a metal at least partially enclosed by a polymer.

27. The method of claim 16, further comprising contouring the proximal end of the fastener after thermally bonding the fastener to the bone.

28. The method of claim 16 wherein the feedback system adjusts the drive voltage while bonding.

29. The method of claim 28 wherein the thermoplastic material is PEEK.

30. The method of claim 28 wherein the thermoplastic material is a resorbable polymer.

31. A method for fixation of a bone, the method comprising:

positioning a plate on a cortical surface of the bone, the plate including at least one fastener hole;

forming a passageway through the cortical surface and extending through the at least one fastener hole and into the bone;

positioning a fastener in the passageway; and

applying ultrasonic energy to the fastener to thermally bond the fastener to the plate while the fastener is positioned in the passageway,

wherein at least a portion of the fastener or plate includes thermoplastic material and the ultrasonic energy generated by an ultrasonic energy generating system having a feedback system configured to

determine at least one of a pressure and impedance of an end effector coupled to the energy generating system; and

adjust a drive voltage of the ultrasonic energy generating system.

32. The method of claim 31, wherein the fastener and plate include thermoplastic material.

33. The method of claim 32, wherein a head of the fastener is ultrasonically welded to the plate.

34. The method of claim 33, wherein the shaft of the fastener free of threads.

35. The method of claim 34 wherein the shaft is substantially smooth.

36. The method of claim 33, wherein at least a portion of the fastener or plate includes a metal at least partially enclosed by a polymer.

37. The method of claim 33 wherein the ultrasonic energy is applied by an end effector contacting only the head of the fastener.

38. The method of claim 37 wherein one of the end effector and the head of the fastener is provided with a recess and the other is provided with an extension shaped to mate with the recess.

39. The method of claim 32, further comprising contouring a proximal end of the fastener after thermally bonding the fastener to the plate.

40. The method of claim 39 wherein the fastener hole intersects an edge portion of the plate.

41. The method of claim 31 wherein the feedback system increases the drive voltage.

43. The method of claim 41 wherein the thermoplastic material is a resorbable polymer.