Methods for utilizing vibratory energy to weld, stake and/or remove implants

• US 8,496,657 B2
• Filed: 08/29/2008
• Issued: 07/30/2013
• 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:
  US12/202,210
• Publication Number:
  US 20090024161A1
• Time in Patent Office: 1,796 Days
• Field of Search: 606 62- 68, 606/86.B, 606280-331, 606/99
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• 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 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• 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 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 17/8802 Equipment for handling bone cement or other fluid fillers
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• 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 2017/044 : with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/1107 : for blood vessels
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 8/429 : characterised by determining or monitoring the contact between the transducer and the tissue
• CPC Class Codes: A61F 2/0811 : Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/30 : Joints
• CPC Class Codes: A61F 2/30721 : Accessories
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3094 : Designing or manufacturing processes
• CPC Class Codes: A61F 2/32 : for the hip
• CPC Class Codes: A61F 2/34 : Acetabular cups
• CPC Class Codes: A61F 2/36 : Femoral heads ; Femoral endoprostheses
• 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 2/44 : for the spine, e.g. vertebrae, spinal discs
• 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 2/46 : Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2/468 : Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/067 : modular
• 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 2002/30067 : Coating or prosthesis-covering structure made of thermoplastic material
• 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 2002/30576 : with extending fixation tabs
• 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 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• 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 2220/0008 : Fixation appliances for connecting prostheses to the body
• 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: A61F 2310/00952 : Coating, pre-coating or prosthesis-covering structure made of bone cement, e.g. pre-applied PMMA cement mantle
• CPC Class Codes: A61N 2007/0013 : Fracture healing
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Vibratory energy is applied using a horn applied to the fastener, and tuned to generate vibratory motion proximate the horn, or at a point distal to the horn, for example at a point along the fastener body, or at the end of the fastener. Melted or softened material of the fastener bonds to a contacting surface, which may be body tissue or another implant. The contacting surface may also include bondable material, softenable or meltable through vibratory energy derived from contact with the fastener. To improve a bond, particularly where dissimilar materials are to be bonded, one or more contacting surfaces is provided with a roughened or porous surface, or a surface including one or more cavities or projections into or onto which softened or melted bondable material may form, bonding once the bondable material has cooled.

Claims

1. A method for stabilizing an object implanted within the body, the object coated over at least a portion of its exterior surface with a polymer material, the method comprising:

inserting an elongate fastener, having a proximal fastener end and a distal fastener end, through body tissue to contact the coated object with the distal fastener end;

contacting the proximal fastener end with a vibratory horn, the horn connected to a source of vibratory energy, the horn operative to transfer vibratory energy to the fastener,

wherein contact between the horn and the proximal fastener end is sufficiently firm to prevent generation of sufficient heat to substantially soften the proximal fastener end as a result of vibration between the proximal fastener end and the horn, and

wherein vibratory energy is transmitted through the fastener to cause vibration at the distal end of the fastener sufficient to produce heat between the distal fastener end and the coated object, the produced heat sufficient to soften the polymer material of the coated object, thereby bonding the fastener to the coated object after vibratory energy is discontinued and the polymer material cools and hardens;

wherein a connection is formed between the elongated fastener and the coated object.

2. The method of claim 1, wherein the vibratory energy includes ultrasonic energy.

3. The method of claim 1, wherein the polymer coating of the coated object is selected from the group consisting of:

thermoplastic, acrylic, poly carbonate (LEXAN), polystyrene, polysulfone (ULDALL), acrylics polycarbonate, ABS, styrene, acetyl (DELRIN), nylon, polyester, polyethylene, polyether ether ketone, poly propylene, polyvinylchloride (PVC), Caprolactam, polylactic acid (PLA), polyglycolic acid (PGA), copolymers of PGA and PLA, polyethylene glycol (PEG)-copolymer, D,L-lactide-co-glycolide polyester, polyaryl ether ketone, polyetheretherketone (PEEK).

4. The method of claim 1, wherein the amount of heat required to soften the polymer material is substantially confinable, due to the thermal properties of the coating and the fastener, to an area of contact between the coated object and the distal fastener end, thereby protecting living body tissue near the contact between the distal fastener end and the coated object from substantial thermal tissue necrosis.

5. The method of claim 1, wherein at least a portion of the distal fastener end includes polymer material, and wherein the polymer material of the distal fastener end softens during transmission of vibratory energy.

6. The method of claim 5, wherein the polymer material of the distal fastener end is the same material as the object coating, and wherein the polymer material of the distal fastener end and the coating mix when softened, thereby welding the distal fastener to the object.

7. The method of claim 1, wherein the coated object includes an intramedullary rod.

8. The method of claim 7, wherein the intramedullary rod has a core portion that includes a metallic material.

9. The method of claim 1, wherein the polymer material includes a thermoplastic material.

10. The method of claim 1, wherein the polymer material includes PMMA.

11. The method of claim 1, wherein the coating includes a therapeutic agent.

12. The method of claim 7, wherein the intramedullary rod has a threaded end.

13. The method of claim 1, wherein the fastener has a core that includes a metallic material.

14. A method of fastening one or more objects within the body, the method comprising:

passing a first end of a fastener configured to extend to at least one space in or adjacent at least one object, at least one object or the first end of the fastener including a polymer material;

positioning the fastener with respect to at least one space;

contacting the fastener with a vibratory horn; and

applying vibratory energy to the vibratory horn, operative to cause the vibratory horn to transfer vibration to the first end, producing heat thereby softening and expanding the first end,

wherein at least the first end expands to a dimension at least as large as a portion of at least one space,

wherein at least a portion of the fastener is secured relative to at least one space.

15. The method of claim 14, whereby the first end includes a polymer material selected from the group consisting of:

thermoplastic, acrylic, poly carbonate (LEXAN), polystyrene, polysulfone (ULDALL), acrylics polycarbonate, ABS, styrene, acetyl (DELRIN), nylon, polyester, polyethylene, polyether ether ketone, poly propylene, polyvinylchloride (PVC), Caprolactam, polylactic acid (PLA), polyglycolic acid (PGA), copolymers of PGA and PLA, polyethylene glycol (PEG)-copolymer, D,L-lactide-co-glycolide polyester, polyaryl ether ketone, polyetheretherketone (PEEK).

16. The method of claim 14, wherein at least a portion of the fastener is secured within the body with a threadable connection.

17. The method of claim 14, wherein the vibratory horn has a curved shape, and wherein the first end is caused to form a complementary curved shape upon application of vibratory energy.

18. The method of claim 14, wherein the vibratory energy includes ultrasonic energy.

19. The method of claim 14, wherein the object includes an intramedullary rod.

20. The method of claim 14, wherein the fastener and at least one object include a polymer material.