System and method for ankle arthroplasty

• US 9,204,971 B2
• Filed: 09/07/2011
• Issued: 12/08/2015
• Est. Priority Date: 06/27/2003
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Memometal Technologies SA (Stryker Corporation)
• Inventors: Rydell, Mark A., McGarvey, Scott, Felt, Jeffrey C.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/226,839
• Publication Number:
  US 20110320005A1
• Time in Patent Office: 1,553 Days
• Field of Search: 623/21.18, 623/18.11, 623/13.12, 623/16.11, 623/21.17, 623/22.11
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/562 Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain
• 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 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4225 for feet, e.g. toes
• CPC Class Codes: A61F 2/4606 of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30148 lozenge- or diamond-shaped
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/3071 : Identification means; Administration of patients
• CPC Class Codes: A61F 2002/30754 : Implants for interposition between two natural articular surfaces
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/30881 : Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/4205 : Tibial components
• CPC Class Codes: A61F 2002/4207 : Talar components
• CPC Class Codes: A61F 2002/4215 : Lateral row of tarsal bones
• CPC Class Codes: A61F 2002/4233 : for metatarso-phalangeal joints, i.e. MTP joints
• CPC Class Codes: A61F 2002/4622 : having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2250/0085 : Identification means; Administration of patients
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

A monolithic interpositional arthroplasty implant for use in repairing gyngylmus joints such as the joints of the ankle. The implant is a monolithic tibiotalar implant having a first major surface shaped to be positioned against a tibia. The tibia is allowed to articulate across the first major surface. A second major surface is shaped to be positioned against the talus.

Claims

1. A monolithic tibiotalar implant for use in arthroplasty repair of ginglymus joints, comprising:

a first major surface of the monolithic implant curved for positioning against a tibia and configured to allow the tibia to articulate across the first major surface;

a second major surface of the monolithic implant curved for positioning against a talus; and

a protrusion proximate to the implant'"'"'s anterior side sized to engage the neck of the talus, wherein the first and second major surfaces curve only in an anterior-posterior direction, and wherein the first major surface is curved differently than the second major surface such that the first major surface is adapted to be congruent with the tibia and the second major surface is adapted to be congruent with the talus, and wherein the monolithic implant is comprised of a polymeric biomaterial that includes both hard and soft segments to provide at least one of desirable wear resistance, congruency, and cushioning properties.

2. The implant according to claim 1 wherein the monolithic tibiotalar implant has one or more external structures adapted to improve retention of the implant within the joint site.

3. The implant according to claim 2 wherein the protrusion is located on the implant'"'"'s anterior side.

4. The implant according to claim 1 wherein the implant is comprised of a biomaterial.

5. The implant according to claim 4 wherein the biomaterial is a polyurethane.

6. The implant according to claim 5 wherein the polyurethane is biocompatible with respect to cytotoxicity, sensitization, genotoxicity, chronic toxicity, and carcinogenicity.

7. The implant according to claim 5 wherein the polyurethane has a Shore hardness of at least about 60 D or less.

8. A method of repairing a tibiotalar joint, comprising the steps of providing and implanting an implant according to claim 1, the implant being inserted through an incision anterior to the tibiotalar joint.

9. The implant according to claim 1 inserted into a ginglymus joint, the ginglymus joint being a tibiotalar joint, the monolithic implant'"'"'s first major surface positioned against the tibia, its second major surface positioned against the talus, and the protrusion proximate the implant'"'"'s anterior side is engaged with a neck of the talus.

10. The implant according to claim 1, wherein the implant is made of polyurethane having hard and soft segments.

11. The implant according to claim 10, wherein the hard segments are made of oligourethane units formed from diisocyanate and chain extender, and wherein the soft segments are made of polyol units.

12. A monolithic device for implantation into an ankle joint space within the body of a mammal, the device comprising:

a monolithic structure fabricated from a biocompatible, biodurable material that is configured to be inserted into the joint compartment, the monolithic structure including first and second major surfaces, the first major surface curved for positioning against a tibia, such that the tibia can articulate across the first major surface, and the second major surface curved for positioning against a talus, wherein the monolithic device is substantially free of anchoring portions that need to be attached to the bone, cartilage, ligaments or other tissue, wherein the first and second major surfaces curve only in an anterior-posterior direction, and wherein the first major surface is curved differently than the second major surface such that the first major surface is adapted to be congruent with the tibia and the second major surface is adapted to be congruent with the talus, and wherein the monolithic implant is comprised of a polymeric biomaterial that includes both hard and soft segments to provide at least one of desirable wear resistance, congruency, and cushioning properties.

13. The device according to claim 12 wherein stability of the device within the joint space is provided by the congruency of the device to the talus.

14. The device according to claim 12, wherein the monolithic structure is made of polyurethane having hard and soft segments.

15. The device according to claim 14, wherein the hard segments are made of oligourethane units formed from diisocyanate and chain extender, and the soft segments are made of polyol units.

16. A monolithic interpositional tibiotalar implant for use in repairing joints of the ankle, comprising:

a first major surface curved for positioning against a tibia and curved to allow the tibia to articulate across the first major surface; and

a second major surface curved for positioning against a talus, wherein the implant has a protrusion proximate its anterior side configured to engage the neck of a talus to improve fixation to the talus,

wherein the monolithic implant is comprised of a polymeric biomaterial that includes both hard and soft segments to provide at least one of desirable wear resistance, congruency, and cushioning properties, and

wherein the first and second major surfaces curve only in an anterior-posterior direction.

17. The implant according to claim 16, wherein the hard segments are made of oligourethane units formed from diisocyanate and chain extender, and wherein the soft segments are made of polyol units.