# US 10,864,081 B2 · Wedge osteotomy device and method of use

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- Number: US 10,864,081 B2
- Document ID: US10864081B2
- Status: Granted
- Kind: B2
- Application number: 14/513,300
- Filed: 2014-10-14
- Published: 2015-01-29
- Granted: 2020-12-15
- Earliest claimed: 2012-10-19
- Assignees: Tyber Medical LLC
- Applicants: Tyber Medical LLC
- Inventors: Jeffrey Tyber; Christopher Faresich
- Web page: https://patentgrep.com/patent/US10864081B2

## CPC

- A61F 2/28: Bones
- A61B 17/70: Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B 17/7059: {Cortical plates (A61B17/7007, A61B17/7058 take precedence)}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61B 17/8052: {immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded}
- A61B 17/8095: {Wedge osteotomy devices}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 17/863: {with thread interrupted or changing its form along shank, other than constant taper}
- A61B 17/865: {Packages or dispensers for bone screws or threaded wires}
- A61B 90/94: coded with symbols, e.g. text
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/42: for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F 2/44: for the spine, e.g. vertebrae or spinal discs
- 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)}
- A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine}
- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61F 2/4603: {for insertion or extraction of endoprosthetic joints or of accessories thereof}
- A61F 2/4611: {of spinal prostheses}
- A61L 27/025: {Other specific inorganic materials not covered by A61L27/04 - A61L27/12}
- A61L 27/04: Metals or alloys
- A61L 27/306: {Other specific inorganic materials not covered by A61L27/303 - A61L27/32}
- A61B 17/8645: {Headless screws, e.g. ligament interference screws}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- 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]}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/30011: {differing in porosity}
- A61F 2002/30028: {differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30171: {rosette- or star-shaped}
- A61F 2002/30266: {wedge-shaped parallelepipeds}
- A61F 2002/30281: {wedge-shaped}
- A61F 2002/30321: {differing in roughness}
- A61F 2002/30326: {differing in height or in length}
- A61F 2002/30355: {Cylinder of elliptical or oval basis}
- A61F 2002/30471: {connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type}
- A61F 2002/30507: {using a threaded locking member, e.g. a locking screw or a set screw}
- A61F 2002/30515: {using a locking wedge or block}
- A61F 2002/30523: {by means of meshing gear teeth}
- A61F 2002/30538: {for adjusting angular orientation}
- A61F 2002/30578: {having apertures, e.g. for receiving fixation screws}
- A61F 2002/30593: {hollow}
- A61F 2002/3071: {Identification means; Administration of patients}
- A61F 2002/30733: {Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property}
- A61F 2002/30774: {internally-threaded}
- A61F 2002/30808: {parallel}
- A61F 2002/3082: {Grooves}
- A61F 2002/30836: {knurled}
- A61F 2002/3084: {Nanostructures}
- A61F 2002/30843: {Pyramidally-shaped}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2002/4627: {with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument}
- A61F 2310/00407: Coating made of titanium or of Ti-based alloys
- A61F 2310/00461: Coating made of nickel or Ni-based alloys
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

An orthopedic implant system includes a wedge implant. The implant includes a body having an upper surface extending generally in a first plane. The upper surface has a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong. Portions of the upper surface extend between adjacent longitudinal grooves and transverse grooves form individual peaks. A lower surface extends generally in a second plane, parallel to the first plane. The lower surface has a third plurality of longitudinal grooves and a fourth plurality of transverse grooves extending therealong. Portions of the lower surface extend between adjacent longitudinal grooves and transverse grooves form individual peaks.

## Claims

### Claim 1

An osteotomy implant comprising:
a first bone-engaging surface having a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong such that portions of the first bone-engaging surface extend between adjacent longitudinal grooves and transverse grooves to form a first set of individual peaks;
a second bone-engaging surface having a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong such that portions of the second bone-engaging surface extend between adjacent longitudinal grooves and transverse grooves to form a second set of individual peaks; and
a side surface extending between the first bone engaging surface and the second bone engaging surface,
wherein each of the first set of individual peaks and the second set of individual peaks includes an osteoconductive coating and
wherein the side surface is free from the osteoconductive coating,
wherein the first bone-engaging surface and the second bone-engaging surface form a tapered wedge shape, wherein a first end of the first bone-engaging surface is disposed a first distance from a first end of the second bone-engaging surface, forming a first side wall having a first height, and wherein a second end of the first bone-engaging surface is disposed a second distance from a second end of the second bone-engaging surface, less than the first distance, forming a second side wall having a second height, less than the first height, and
wherein the individual peaks in the first and second sets of individual peaks are tapered such that each of the individual peaks slopes toward the first side wall.

### Claim 2 (depends on 1)

The osteotomy implant according to claim 1, further comprising a core disposed between the first bone-engaging surface and the second bone-engaging surface, the core being constructed from a radiolucent material.

### Claim 3 (depends on 1)

The osteotomy implant according to claim 1, wherein the osteoconductive coating has a thickness of less than 800 microns.

### Claim 4 (depends on 1)

The osteotomy implant according to claim 1, wherein the osteoconductive coating has a thickness of between 5 microns and 800 microns.

### Claim 5 (depends on 1)

The osteotomy implant according to claim 1, wherein the osteoconductive coating is sufficiently thin such that the first bone-engaging surface and the second bone-engaging surface are transparent to imaging.

### Claim 6 (depends on 1)

The osteotomy implant according to claim 1, wherein the osteoconductive coating is sufficiently thick such that the first bone-engaging surface and the second bone-engaging surface are visible to imaging.

### Claim 7 (depends on 1)

The osteotomy implant according to claim 1, wherein the osteoconductive coating comprises a titanium plasma spray.

### Claim 8 (depends on 1)

An osteotomy wedge system comprising:
a. the osteotomy implant according to claim 1;
b. a fixation plate having first and second holes formed therein, a length between the first and second holes being greater than a length between the first bone-engaging surface and the second bone-engaging surface of the implant; and
c. a plurality of bone fixation screws adapted to secure the fixation plate to bone on either side of the implant.

### Claim 9 (depends on 8)

The osteotomy wedge system according to claim 8, wherein a core of the implant has a threaded opening extending between the first bone-engaging surface and the second bone-engaging surface and wherein the fixation plate has a third hole between the first hole and the second hole such that, when the fixation plate is secured to bone, the third hole is axially aligned with the threaded opening.

### Claim 10 (depends on 9)

The osteotomy wedge system according to claim 9, further comprising an insertion instrument releasably couplable to the threaded opening, the insertion instrument being releasably insertable through the third hole.

### Claim 11 (depends on 10)

The osteotomy wedge system according to claim 10, further comprising a fixation screw sized to be insertable through the third hole and into the threaded opening such that the fixation screw secures the fixation plate to the osteotomy implant.

### Claim 12

An osteotomy implant system comprising:
a tapered wedge shaped core constructed from a radiolucent material, the core having a central plane extending therethrough;
a first bone-engaging surface extending at a first acute angle relative to the central plane on a first side of the core, the first bone-engaging surface having a first side facing portion having a first plurality of individual peaks formed therein;
a second bone-engaging surface disposed on an opposing, second side of the core, the second bone-engaging surface having a second side facing portion having a second plurality of individual peaks formed therein, the second bone-engaging surface extending at a second acute angle relative to the central plane such that the first and second bone-engaging surfaces form a tapered shape; and
a side surface extending along the core between the first bone-engaging surface and the second bone-engaging surface, the side surface comprising a lateral portion having an opening formed therein such that the opening is configured to engage an insertion tool, a medial portion disposed distal from the lateral portion, an anterior portion extending between the lateral portion and the medial portion, and a posterior portion disposed distal from the anterior portion,
wherein each of the first and second side facing portions along the anterior and posterior portions includes an osteoconductive coating,
wherein the side surface between the first and second bone-facing surfaces is free from the osteoconductive coating, and
wherein the first and second pluralities of individual peaks are tapered such that each of the individual peaks slopes toward the lateral portion.

### Claim 13 (depends on 12)

The osteotomy implant system according to claim 12, wherein the core has a Young's modulus of between 0.5 GPa and 18 GPa.

### Claim 14 (depends on 12)

The osteotomy implant system according to claim 12, wherein the osteoconductive coating is sufficiently thin to be undetected by imaging.

### Claim 15 (depends on 12)

The osteotomy implant system according to claim 12, further comprising a fixation plate having a first opening and a second opening spaced from the first opening farther than a distance between the first bone engaging surface and the second bone engaging surface.

### Claim 16 (depends on 15)

The osteotomy implant system according to claim 15, wherein the core comprises a peripheral portion having a threaded aperture formed therein.

### Claim 17 (depends on 16)

The osteotomy implant system according to claim 16, wherein the fixation plate further has a third opening located between the first opening and the second opening such that, when the fixation plate is secured over the core, the third opening is aligned with the threaded aperture.

### Claim 18 (depends on 1)

A method of inserting an osteotomy implant to stabilize and reposition a bone, the method comprising the steps of:
a. making a cut in only a single bone at an osteotomy site; and
b. inserting the osteotomy implant according to claim 1 into the cut.

### Claim 19 (depends on 18)

The method according to claim 18, further comprising the step of, after step b., applying a fixation plate over the implant and securing the fixation plate to bone on either side of the implant.

### Claim 20 (depends on 19)

The method according to claim 19, further comprising the step of inserting a fixation screw through the fixation plate and into the implant.

### Claim 21 (depends on 19)

The method according to claim 19, further comprising the step of, between step a. and step b., inserting a wedge tool into the cut.

### Claim 22 (depends on 19)

The method according to claim 19, wherein the step of making the cut comprises a partial osteotomy.

### Claim 23

An implant for metatarsal/cuneiform arthrodesis, the implant comprising:
a first bone-engaging surface having a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong such that portions of the first bone-engaging surface extend between adjacent longitudinal grooves and transverse grooves to form a first set of individual peaks;
a second bone-engaging surface having a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong such that portions of the second bone-engaging surface extend between adjacent longitudinal grooves and transverse grooves to form a second set of individual peaks; and
a side surface extending between the first bone-engaging surface and the second bone-engaging surface, the side surface comprising a lateral side wall having an aperture formed therein,
wherein each of the first set of individual peaks and the second set of individual peaks includes an osteoconductive coating,
wherein the side surface is free from the osteoconductive coating, and
wherein the individual peaks in the first and second sets of individual peaks are tapered such that each of the individual peaks slopes toward the first side wall.
