Methods and devices for trauma welding

• US 7,967,820 B2
• Filed: 05/03/2006
• Issued: 06/28/2011
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Beyers, Justin E., Cremens, Matthew J., Bonutti, Peter M.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Bates; David W
• Application Number:
  US11/416,618
• Publication Number:
  US 20070270833A1
• Time in Patent Office: 1,882 Days
• Field of Search: 606/60, 606/62, 606/63, 606/64, 623/23.15, 623/23.28, 623/23.23, 623/23.44, 403/269, 403/270, 228/1.1
• US Class Current: 606/64
• 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 method for stabilizing a bone having a cortex and a medullary canal, the method comprising:

positioning an elongate rod in the medullary canal of the bone, the elongate rod having a bonding region including polymeric material;

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;

positioning a fastener, the fastener having polymeric material at a leading portion, in the passageway of the cortex such that at least the leading portion of the fastener is in contact with the bonding region of the elongate rod, the bonding region generally aligned with the passageway of the cortex; and

bonding the polymeric material of the fastener at the leading portion of the fastener to the polymeric material of the bonding region of the elongate rod, using ultrasonic energy, while the fastener is positioned in the passageway of the cortex, the bonding occurring at a bonding location,

wherein the bonding location is free of any through holes.

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

3. The method of claim 1 wherein the bonding region includes an indentation in the elongate rod.

4. The method of claim 1 wherein the bonding region includes a channel being an extension of the passageway.

5. The method of claim 1 wherein bonding the fastener includes bonding the fastener to the cortex of the bone whereby the fastener resists movement between the bone and elongate rod.

7. The method of claim 1 further including contouring a trailing end of the fastener after bonding the fastener.

13. The method of claim 1 wherein the bonding region on the elongate rod is created prior to positioning the elongate rod in the medullary canal of the bone.

14. The method of claim 1 wherein the ultrasonic energy is applied by an end effector and the end effector contacts a trailing portion of the fastener remotely located from the leading portion of the fastener.

15. The method of claim 14 wherein the bonding region on the elongate rod is created prior to positioning the elongate rod in the medullary canal of the bone.

16. The method of claim 15 wherein at least one of the fastener and elongate rod comprises a metallic core enclosed by a polymeric material.

28. The method of claim 1, wherein a sensor is associated with a device for applying ultrasonic energy, the sensor operative to indicate a pressure applied to the fastener during the application of ultrasonic energy.

29. The method of claim 1, 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.

30. The method of claim 1, wherein a sensor is associated with an ultrasonic device operative to generate energy used for bonding the fastener, 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.

31. The method of claim 1, wherein a sensor is associated with an ultrasonic device operative to generate energy used for bonding, the sensor operative to communicate feedback to the ultrasonic device, whereby the ultrasonic device may vary, start, and stop application of ultrasonic energy.

32. The method of claim 1, wherein a shape of the fastener changes during the application of ultrasonic energy.

33. The method of claim 1, wherein a shape of the trailing end of the fastener changes during the application of ultrasonic energy.

34. The method of claim 1, wherein the fastener is free of a trailing head or cap after application of ultrasonic energy.

35. The method of claim 1, wherein at least one of the elongate rod and fastener includes metal, and a polymeric material proximate a bonding region.

36. The method of claim 1, wherein the ultrasonic energy is provided by an ultrasonic device having an end effector, and 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.

37. The method 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.

38. The method of claim 1, wherein the bonding region of the elongate rod is free of through holes.

39. The method of claim 33 wherein the feedback system controls the drive voltage to maintain a constant power of ultrasonic energy.

6. A method for stabilizing a bone, the method comprising:

positioning an elongate rod in the medullary canal of the 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;

positioning a fastener in the passageway of the cortex such that at least a leading portion of the fastener is in contact with a bonding region of the elongate rod, the bonding region generally aligned with the passageway of the cortex; and

bonding the leading portion of the fastener to the bonding region of the elongate rod while the fastener is positioned in the passageway of the cortex,

wherein the elongate rod and fastener include thermoplastic material and wherein ultrasonic energy is used to bond the fastener to the bonding region of the elongate rod,

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 bonding the fastener includes bonding the fastener to the elongate rod and to two cortex areas of the bone.

8. A method for stabilizing a bone, the method comprising:

positioning an elongate member in the medullary canal of the bone, the elongate member having a bonding region including thermoplastic material;

positioning a reinforcing member including thermoplastic material on a cortical surface of the bone such that the cortex of the bone is positioned between the elongate member and reinforcing member;

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

positioning a fastener having a leading portion including thermoplastic material in the passageway,. such that at least the leading portion of the fastener is in contact with the bonding region of the elongate member, the bonding region generally aligned with the passageway; and

bonding the leading portion of the fastener to the bonding region of the elongate member by applying ultrasonic energy to the fastener at a distance away from the leading portion of the fastener, while the fastener is positioned in the passageway,

wherein the leading portion of the fastener is positioned in an indentation in the elongate member and wherein the indentation extends only partially into the elongate member.

9. The method of claim 8 wherein the thermoplastic material is PEEK.

10. The method of claim 9 wherein ultrasonic energy is used to bond the fastener to the bonding region of the elongate member.

11. The method of claim 10 wherein bonding the fastener includes bonding the fastener to the reinforcing member whereby the fastener resists relative movement of the elongate member and reinforcing member with the cortex of the bone therebetween.

12. The method of claim 11 further including contouring a trailing end of the fastener after bonding the fastener.

17. A method for stabilizing a long bone, the method comprising:

positioning an elongate rod including thermoplastic material in the medullary canal of the long bone;

positioning a fastener having thermoplastic material at a leading portion through the bone such that at least the leading portion of the fastener is in contact with the elongate rod, and at least a trailing portion of the fastener extends through a cortical surface of the long bone to a position exterior of the bone;

positioning an end effector in contact with the trailing portion of the fastener exterior of the bone;

applying ultrasonic energy with the end effector to the trailing portion of the fastener to cause thermal bonding of thermoplastic material of the leading portion of the fastener to the thermoplastic material of the elongate rod, with the ultrasonic energy; and

changing the shape of the fastener during bonding of the fastener

wherein the ultrasonic energy is generated by an ultrasonic energy generating system with a drive voltage and wherein the ultrasonic energy generating system includes a feedback system to monitor and control the drive voltage.

18. The method of claim 17 wherein at least one of the fastener and elongate rod comprises a metallic core enclosed by a polymeric material.

19. The method of claim 17 wherein the leading portion of the fastener is positioned in an indentation in the elongate rod and wherein the indentation extends only partially into the elongate rod.

20. The method of claim 17, wherein a shape of the fastener changes during the application of ultrasonic energy.

21. The method of claim 17, wherein a sensor is associated with a device for applying ultrasonic energy, the sensor operative to indicate a change in shape of the fastener during the application of ultrasonic energy, whereby application of ultrasonic energy is changed based on a change in shape of the fastener indicated by the sensor.

22. The method of claim 17, wherein a shape of the trailing end of the fastener changes during application of ultrasonic energy.

23. The method of claim 17, wherein the fastener is free of a trailing head or cap after application of ultrasonic energy.

24. The method of claim 17, wherein a sensor is associated with an ultrasonic device operative to generate ultrasonic energy for bonding, the sensor operative to communicate feedback to the ultrasonic device, whereby the ultrasonic device may vary, start, and stop application of ultrasonic energy.

25. The method of claim 17, wherein one of the end effector and the trailing portion of the fastener is provided with a recess, and the other is provided with an extension shaped to mate with said recess.

26. The method of claim 17, wherein a leading portion of the fastener includes a shape selected from the group consisting of:

prong, Morse taper, wedge, and angled taper.

27. The method of claim 17, wherein the elongate rod is free of through holes.