Methods and devices for trauma welding

• US 9,743,963 B2
• Filed: 09/28/2015
• Issued: 08/29/2017
• 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): BATES, DAVID W
• Application Number:
  US14/867,621
• Publication Number:
  US 20160022334A1
• Time in Patent Office: 701 Days
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 for applying suture clamps, clips or locks A61B2017/0488
• 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 bone stabilization system comprising:

an intramedullary rod having a bonding region including polymeric material on the outer surface of the intramedullary rod, wherein the intramedullary rod is positionable within a cavity in a bone; and

a fastener having polymeric material at a leading end surface, wherein the polymeric material at the leading end surface of the fastener is configured to be passed through a channel in the bone, positioned against the bonding region of the intramedullary rod, and coupled to the leading end surface of the fastener to the bonding region of the intramedullary rod using ultrasonic energy, the coupling occurring at a coupling location and wherein the coupling location is free of any through holes.

2. The system of claim 1 wherein the bonding region includes a roughened surface on the intramedullary rod.

3. The system of claim 1 wherein the bonding region includes an indentation in the intramedullary rod.

4. The system of claim 3 wherein the indentation extends only partially into the intramedullary rod.

5. The system of claim 1 wherein the polymeric material of the bonding region includes thermoplastic material.

6. The system of claim 5 wherein the thermoplastic material is PEEK.

7. The system of claim 6 wherein the polymeric material of the fastener includes thermoplastic material.

8. The system of claim 7 wherein the thermoplastic material is PEEK.

9. The system of claim 1 wherein the polymeric material of the fastener includes thermoplastic material.

10. The system of claim 9 wherein the thermoplastic material is PEEK.

11. The system of claim 1 wherein at least one of the fastener or intramedullary rod comprises a metallic core enclosed by a polymeric material.

12. The system of claim 1 wherein the fastener is free of a trailing head or cap.

13. The system of claim 1 wherein a leading portion of the fastener includes a shape selected from the group consisting of:

prong, Morse taper, wedge, and angled taper.

14. The system of claim 1 further comprising an end effector configured to apply the ultrasonic energy.

15. The system of claim 14 wherein a sensor is associated with the end effector, the sensor operative to indicate a pressure applied to the fastener during the application of ultrasonic energy.

16. The system of claim 14 wherein a sensor is positioned proximate the leading portion of the fastener, the sensor operative to indicate a pressure applied to the leading portion of the fastener during the application of ultrasonic energy.

17. The system of claim 14 wherein a sensor is associated with the end effector, the sensor operative to indicate a change in shape of the fastener during the application of ultrasonic energy, whereby the application of ultrasonic energy is changed based on a change in shape of the fastener indicated by the sensor.

18. The system of claim 14 wherein a sensor is associated with the end effector, the sensor operative to communicate feedback to vary, start, and stop application of ultrasonic energy.

19. The system of claim 14 wherein one of the end effector and a trailing portion of the fastener is provided with a recess, and the other end of the end effector is provided with an extension shaped to mate with said recess.