# US 2008/0188945 A1 · Shaped load-bearing osteoimplant and methods of making same

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- Number: US 2008/0188945 A1
- Document ID: US20080188945A1
- Status: Published application
- Kind: A1
- Application number: 10/736,799
- Filed: 2003-12-16
- Published: 2008-08-07
- Earliest claimed: 1999-02-23
- Assignees: Warsaw Orthopedic, Inc.
- Inventors: Todd M. Boyce; Lawrence A. Shimp; Albert Manrique; John W. Winterbottom
- Web page: https://patentgrep.com/patent/US20080188945A1

## CPC

- 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)}
- A61C 8/0012: {characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00)}
- A61C 8/0036: {Tooth replica}
- A61F 2/28: Bones
- A61F 2/32: for the hip
- A61F 2/4644: {Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C)}
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/3641: {characterised by the site of application in the body (materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60)}
- A61L 27/3645: {Connective tissue}
- A61L 27/3683: {subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment}
- A61L 27/3691: {characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation}
- A61L 27/3839: {characterised by the site of application in the body (materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60)}
- A61L 27/3847: {Bones}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61B 17/72: Intramedullary devices, e.g. pins or nails
- A61B 17/742: {having one or more longitudinal elements oriented along or parallel to the axis of the neck}
- 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 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/044: {with a threaded shaft, e.g. screws}
- A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)}
- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping}
- A61F 2/34: Acetabular cups
- A61F 2/36: Femoral heads {; Femoral endoprostheses}
- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61F 2/446: {having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones}
- A61F 2/4611: {of spinal prostheses}
- 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 2002/2825: {Femur}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/2871: {Radius}
- A61F 2002/2892: {Tibia}
- A61F 2002/30004: {the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis}
- A61F 2002/30059: {differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30113: {circular}
- A61F 2002/30125: {elliptical or oval}
- A61F 2002/30143: {hexagonal}
- A61F 2002/30146: {octagonal}
- A61F 2002/30148: {lozenge- or diamond-shaped}
- A61F 2002/30153: {rectangular}
- A61F 2002/30154: {square}
- A61F 2002/30158: {trapezoidal}
- A61F 2002/30225: {Flat cylinders, i.e. discs}
- A61F 2002/30237: {partial tubes}
- A61F 2002/30261: {parallelepipedal}
- A61F 2002/30266: {wedge-shaped parallelepipeds}
- A61F 2002/30433: {using additional screws, bolts, dowels, rivets or washers e.g. connecting screws}
- A61F 2002/30535: {Special structural features of bone or joint prostheses not otherwise provided for}
- A61F 2002/30561: {breakable or frangible}
- A61F 2002/30622: {Implant for fusing a joint or bone material}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30785: {parallel}
- A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2002/30957: {using a positive or a negative model, e.g. moulds}
- A61F 2002/30962: {using stereolithography}
- A61F 2002/30968: {Sintering}
- A61F 2002/3611: {Heads or epiphyseal parts of femur}
- A61F 2002/365: {Connections of heads to necks}
- A61F 2002/3686: {bent}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2230/0006: circular
- A61F 2230/0008: elliptical or oval
- A61F 2230/0017: Angular shapes
- A61F 2230/0019: rectangular
- A61F 2230/0021: square
- A61F 2230/0026: trapezoidal
- A61F 2230/0069: cylindrical
- A61F 2230/0082: parallelepipedal
- A61F 2250/0014: having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F 2250/0058: Additional features; Implant or prostheses properties not otherwise provided for
- A61F 2250/0071: breakable or frangible
- A61F 2310/00011: Metals or alloys
- A61F 2310/00161: Carbon; Graphite
- A61F 2310/00173: Graphite
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00347: Nacre or mother-of-pearl
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- B33Y 80/00: Products made by additive manufacturing
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- 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)
- 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)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## Abstract

A load-bearing osteoimplant which comprises a shaped, coherent aggregate of bone particles.

## Claims

### Claim 1

A load-bearing osteoimplant comprising a shaped coherent mass of bone particles possessing a bulk density of greater than about 0.7 g/cm3.

### Claim 2

A load-bearing osteoimplant comprising a shaped coherent mass of bone particles possessing a wet compressive strength of at least about 3 MPa.

### Claim 3

A method for making a load-bearing osteoimplant which comprises:
a) providing an aggregate containing bone particles and, optionally, one or more optional components selected from the group consisting of binder, filler, plasticizer, wetting agent, surface active agent, biostatic/biocidal agent, bioactive substance, reinforcing material and reinforcing structure; and,
b) shaping the aggregate into a coherent mass in at least one shaping operation to provide a shaped composite having an initial configuration for subsequent shaping into a desired osteoimplant or a final configuration corresponding to that of the osteoimplant.

### Claim 4 (depends on 3)

The method of claim 3 wherein shaping step (b) further comprises an initial shaping of the aggregate into an osteoimplant blank and a subsequent shaping of the osteoimplant blank into a fully shaped osteoimplant.

### Claim 5 (depends on 3)

The method of claim 3 wherein the shaping of the aggregate is accomplished by compressing the aggregate within a mold, optionally at elevated temperature.

### Claim 6 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by molding.

### Claim 7 (depends on 3)

The method of claim 3 wherein the molding is injection molding.

### Claim 8 (depends on 7)

The method of claim 7 wherein the molding is blow molding.

### Claim 9 (depends on 7)

The method of claim 7 wherein the molding is rotational molding.

### Claim 10 (depends on 7)

The method of claim 7 wherein the molding is leach molding.

### Claim 11 (depends on 7)

The method of claim 7 wherein the molding is leavening molding.

### Claim 12 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by casting.

### Claim 13 (depends on 12)

The method of claim 12 wherein the casting is solvent casting.

### Claim 14 (depends on 12)

The method of claim 12 wherein the casting is gel casting.

### Claim 15 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by a CAD/CAM operation.

### Claim 16 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by rolling.

### Claim 17 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by vacuum-forming.

### Claim 18 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by sintering.

### Claim 19 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by melt-forming.

### Claim 20 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by thermoforming.

### Claim 21 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by foam molding.

### Claim 22 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by forging.

### Claim 23 (depends on 3)

The method of claim 3 wherein the aggregate is shaped at least in part by laser fusion of polymer binder therein.

### Claim 24 (depends on 4)

The method of claim 4 wherein subsequent shaping of the blank into the fully shaped osteoimplant includes a machining operation.

### Claim 25 (depends on 15)

The method of claim 15 which further comprises:
a) imaging a patient's implantation site to provide digital information for a three dimensional model of an osteoimplant to be implanted at the site;
b) converting the three dimensional model of the osteoimplant into a CAD file stored in the memory of a computer;
c) machining a blank which is a coherent mass of an aggregate containing bone particles and, optionally, one or more optional components selected from the group consisting of binder, filler, plasticizer, wetting agent, surface active agent, biostatic/biocidal agent, bioactive substance, reinforcing material and reinforcing structure to provide the osteoimplant, the machining being carried out by a machine executing a defined tool path numerically controlled by the computer in which the CAD file is stored.

### Claim 26 (depends on 25)

The method of claim 25 wherein imaging step (a) is carried out by CAT scan, MRI or MUI.

### Claim 27 (depends on 15)

The method of claim 15 which further comprises;
a) imaging a patient's implantation site to provide digital information for a three dimensional model of an osteoimplant to be implanted at the site;
b) converting the three dimensional model of the osteoimplant into a CAD file stored in memory of a computer;
c) forming a mold whose shaping surface conforms to the osteoimplant using the CAD file; and
d) forming the osteoimplant in the mold.

### Claim 28 (depends on 27)

The method of claim 27 wherein imaging step (a) is carried out by CAT scan, MRI or MUI.

### Claim 29

An integral implant insertion instrument and implant comprising an implant insertion instrument portion integrally attached to an implant portion by a weakened, break-away connection such that on insertion of the implant portion at the implantation site, the implant insertion instrument portion is separated from the implant portion by a breaking-away force applied thereto, the implant portion being a load-bearing osteoimplant comprising a shaped, coherent mass of bone particles.

### Claim 30 (depends on 29)

The integral implant insertion instrument and implant of claim 29 in which the load-bearing osteoimplant portion contains at least one additional component selected from the group consisting of binder, filler, plasticizer, wetting agent, surface active agent, biostatic/biocidal agent, bioactive substance, reinforcing material, reinforcing structure or combinations thereof.

### Claim 31 (depends on 30)

The integral implant insertion instrument and implant of claim 30 in which the binder present in the load-bearing osteoimplant is a natural, synthetic or semisynthetic bioresorbable or nonbioresorbable polymer.

### Claim 32 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 12 to about 200 MPa.

### Claim 33 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 15 to about 130 MPa.

### Claim 34 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 17 to about 200 mPa.

### Claim 35 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 20 to about 200 mPa.

### Claim 36 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 31 to about 200 mPa.

### Claim 37 (depends on 1)

The osteoimplant of claim 1 possessing a wet compressive strength of from about 56 to about 200 mPa.

### Claim 38

A load-bearing osteoimplant comprising a shaped, coherent mass of bone particles possessing a bulk density of greater than about 0.7 g/cm3 and a wet compressive strength of at least about 3 MPa, wherein the bone particles comprise a combination of nondemineralized and demineralized bone.

### Claim 39 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 12 to about 200 MPa.

### Claim 40 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 15 to about 130 MPa.

### Claim 41 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 17 to about 200 mPa.

### Claim 42 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 20 to about 200 mPa.

### Claim 43 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 31 to about 200 mPa.

### Claim 44 (depends on 38)

The osteoimplant of claim 38 possessing a wet compressive strength of from about 56 to about 200 mPa.