Methods and devices for trauma welding

• US 10,368,924 B2
• Filed: 07/21/2017
• Issued: 08/06/2019
• 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:
  US15/656,425
• Publication Number:
  US 20170333094A1
• Time in Patent Office: 746 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 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 fracture repair device comprising:

a plate having at least one hole, the hole having a bonding surface comprised of a polymeric material, wherein the plate is positionable on the surface of a bone;

a fastener configured to secure the plate to the bone, the fastener comprised of a shaft and a head, the shaft configured to pass through the hole in the plate and secure the fastener to the bone, wherein the head is configured to be coupled to the plate, the fastener head having a bonding surface comprised of polymeric material, wherein the bonding surface of the fastener head is configured to be positioned against the bonding surface of the plate hole and coupled to the bonding surface of the plate hole by application of energy, the coupling occurring at a coupling location between bonding surface of the fastener head and the bonding surface of the plate hole;

an effector configured to apply the energy; and

at least one sensor associated with the effector and operative to indicate at least one of pressure applied to and position of at least one of the fastener and the bonding surface of the plate hole during the application of energy,

wherein after the energy is applied, the fastener shaft is free of any thermal modification from the applied energy.

2. The device of claim 1 wherein the head of the fastener is at least one of (i) threaded and configured for insertion into a threaded hole in the plate and (ii) unthreaded and configured for insertion into and unthreaded hole in the plate.

3. The device of claim 1 wherein the plate and the fastener are biodegradable.

4. The device of claim 1 wherein the applied energy by which the bonding surface of the fastener is coupled to the bonding surface of the plate hole is at least one of resistive heating, radiofrequency, ultrasound, microwave, laser, electromagnetic, electro shockwave, and plasma.

5. The device of claim 1 wherein the polymeric material of the bonding surface of the plate hole and the polymeric material of the bonding surface of the fastener head are comprised of PEEK.

6. The device of claim 1 wherein the sensor associated with the effector and operative to indicate position is at least one of a linear variable displacement transducer (LVDT) and a hall-effect sensor.

7. The device of claim 1 wherein at least one of the plate, fastener, and effector is configured to pass through at least one of a fixed cannula and an expandable cannula.

8. The device of claim 1 wherein the at least one sensor associated with the effector is configured to be operative to indicate a change in shape of the fastener during the application of energy, whereby the application of energy is changed based on a change in shape of the fastener indicated by the sensor.

9. The device of claim 1 wherein the at least one sensor associated with the effector is configured to be operative to communicate feedback to vary, start, and stop the application of energy.

10. The device of claim 1 wherein the effector is configured to be controlled with a robotic mechanism.

11. The device of claim 1 wherein the fastener comprises a metallic core enclosed by a polymeric material.