# US 7,608,113 B2 · Demineralized bone implants

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- Number: US 7,608,113 B2
- Document ID: US7608113B2
- Status: Granted
- Kind: B2
- Application number: 10/718,804
- Filed: 2003-11-24
- Published: 2004-06-03
- Granted: 2009-10-27
- Earliest claimed: 2001-02-28
- Assignees: Synthes USA, LLC
- Inventors: Michael L. Boyer, II; David C. Paul; Christopher M. Angelucci
- Web page: https://patentgrep.com/patent/US7608113B2

## 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)}
- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- A61B 17/688: {for reattaching pieces of the skull}
- A61B 17/7059: {Cortical plates (A61B17/7007, A61B17/7058 take precedence)}
- A61B 17/7071: {Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61F 2/28: Bones
- A61F 2/2846: {Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006)}
- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61F 2/44: for the spine, e.g. vertebrae or spinal discs
- A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine}
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/365: {Bones}
- 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}
- A61B 17/68: Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)}
- 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}
- A61B 17/8085: {with pliable or malleable elements or having a mesh-like structure, e.g. small strips (A61B17/8071, A61B17/8076 take precedence)}
- A61B 2017/0647: {having one single leg, e.g. tacks}
- A61F 2/00: Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (dental prostheses A61C13/00; artificial kidneys A61M1/14; artificial hearts A61M60/00)
- A61F 2/08: Muscles; Tendons; Ligaments
- A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)}
- A61F 2/3094: {Designing or manufacturing processes}
- 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 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61F 2002/2807: {Chin implants}
- 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 2002/2839: {Bone plugs or bone graft dowels}
- A61F 2002/30011: {differing in porosity}
- A61F 2002/30014: {differing in elasticity, stiffness or compressibility}
- A61F 2002/30016: {differing in hardness, e.g. Vickers, Shore, Brinell}
- A61F 2002/30057: {made from both cortical and cancellous adjacent parts}
- A61F 2002/30059: {differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts}
- A61F 2002/30075: {swellable, e.g. when wetted}
- A61F 2002/30092: {using shape memory or superelastic materials, e.g. nitinol}
- A61F 2002/30113: {circular}
- A61F 2002/30126: {oval-O-shaped}
- A61F 2002/3013: {figure-"8"- or hourglass-shaped}
- A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped}
- A61F 2002/30143: {hexagonal}
- A61F 2002/30153: {rectangular}
- A61F 2002/30154: {square}
- A61F 2002/30159: {Concave polygonal shapes}
- A61F 2002/30166: {H-shaped or I-shaped}
- A61F 2002/30169: {Pi-shaped}
- A61F 2002/30172: {T-shaped}
- A61F 2002/30233: {Stepped cylinders, i.e. having discrete diameter changes}
- A61F 2002/30235: {tubular, e.g. sleeves}
- A61F 2002/30261: {parallelepipedal}
- A61F 2002/30293: {Cylindrical body made by spirally rolling up a sheet or a strip around itself}
- A61F 2002/30324: {differing in thickness}
- A61F 2002/30387: {Dovetail connection}
- A61F 2002/30433: {using additional screws, bolts, dowels, rivets or washers e.g. connecting screws}
- A61F 2002/30462: {retained or tied with a rope, string, thread, wire or cable}
- A61F 2002/30578: {having apertures, e.g. for receiving fixation screws}
- A61F 2002/30593: {hollow}
- A61F 2002/30594: {slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots}
- A61F 2002/30784: {Plurality of holes}
- A61F 2002/30785: {parallel}
- A61F 2002/30787: {inclined obliquely with respect to each other}
- A61F 2002/30828: {parallel}
- A61F 2002/30841: {Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes}
- A61F 2002/30843: {Pyramidally-shaped}
- A61F 2002/30879: {Ribs}
- A61F 2002/30892: {parallel}
- A61F 2002/30904: {serrated profile, i.e. saw-toothed}
- A61F 2002/30909: {Nets}
- A61F 2002/30914: {Details of the mesh structure, e.g. disposition of the woven warp and weft wires}
- A61F 2002/30973: {Two joined adjacent layers having complementary interlocking protrusions and recesses}
- A61F 2002/4415: {elements of the prosthesis being arranged in a chain like manner}
- A61F 2002/444: {for replacing the nucleus pulposus}
- A61F 2002/4649: {Bone graft or bone dowel harvest sites}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0061: swellable
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0006: circular
- A61F 2230/0008: elliptical or oval
- A61F 2230/001: Figure-8-shaped, e.g. hourglass-shaped
- A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
- A61F 2230/0017: Angular shapes
- A61F 2230/0019: rectangular
- A61F 2230/0021: square
- A61F 2230/0028: Shapes in the form of latin or greek characters
- A61F 2230/0047: Pi-shaped
- A61F 2230/0052: T-shaped
- A61F 2230/0069: cylindrical
- A61F 2230/0082: parallelepipedal
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0019: differing in hardness, e.g. Vickers, Shore, Brinell
- A61F 2250/0023: differing in porosity
- A61F 2250/0029: differing in bending or flexure capacity
- A61F 2250/0036: differing in thickness
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- Y10S 623/919: Bone
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Selectively demineralized bone-derived implants are provided. In one embodiment, a bone sheet for implantation includes a demineralized field surrounding mineralized regions. In another embodiment, a bone defect filler includes a demineralized cancellous bone section in a first geometry. The first geometry is compressible and dryable to a second geometry smaller than the first geometry, and the second geometry is expandable and rehydratable to a third geometry larger than the second geometry.

## Claims

### Claim 1

A method of providing a bone implant comprising:
demineralizing a block of cancellous bone having a first geometry;
wetting the block;
compressing the block from the first geometry to a second geometry smaller than the first geometry;
hardening the block after the block has been compressed to the second geometry; and
re-expanding the block to a third geometry larger than the second geometry.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second geometry is configured and dimensioned as a pellet.

### Claim 3 (depends on 1)

The method of claim 1, wherein the second geometry is configured and dimensioned as a cylinder.

### Claim 4 (depends on 1)

The method of claim 1, wherein the second geometry is configured and dimensioned as a generally flat shape.

### Claim 5 (depends on 1)

The method of claim 1, wherein the second geometry is configured and dimensioned as a donut-like shape.

### Claim 6 (depends on 1)

The method of claim 1, wherein the second geometry is configured and dimensioned as a dumbbell shape.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
exposing the block to a swelling agent.

### Claim 8 (depends on 7)

The method of claim 7, wherein the swelling agent is water.

### Claim 9 (depends on 1)

The method of claim 1, further comprising:
inserting the block into an anatomical space.

### Claim 10 (depends on 1)

The method of claim 1, wherein the hardening step includes drying the block.

### Claim 11 (depends on 1)

The method of claim 1, wherein the re-expanding step includes hydrating the block.

### Claim 12

A method of providing a bone implant comprising:
demineralizing a block of cancellous bone having a first geometry;
wetting the block;
compressing the block from the first geometry to a second geometry smaller than the first geometry;
hardening the block after the block has been compressed to the second geometry; and
inserting the block into a spinal cage.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
re-expanding the block in the spinal cage to a third geometry larger than the second geometry.

### Claim 14 (depends on 13)

The method of claim 13, wherein the third geometry is smaller than the first geometry.

### Claim 15 (depends on 12)

The method of claim 12, wherein the step of wetting the block comprises hydrating the block.

### Claim 16

A method of providing a bone implant comprising:
demineralizing a block of cancellous bone having a first geometry;
softening the block so that the block may be compressed from the first geometry to a second geometry smaller than the first geometry;
permitting the block to harden after the block has been compressed to the second geometry;
inserting the block into a cavity; and
re-expanding the block to a third geometry larger than the second geometry, wherein the third geometry is cylindrical in shape.

### Claim 17 (depends on 16)

The method of claim 16, wherein the step of softening the block comprises applying a swelling agent to the block.

### Claim 18 (depends on 17)

The method of claim 17, wherein the swelling agent is water.

### Claim 19

A method of providing a bone implant comprising:
demineralizing a block of cancellous bone having a first geometry;
softening the block so that the block may be compressed from the first geometry to a second geometry smaller than the first geometry;
permitting the block to harden after the block has been compressed to the second geometry;
inserting the block into a cavity; and
re-expanding the block to a third geometry larger than the second geometry, wherein the cavity is defined by a spinal cage.

### Claim 20 (depends on 19)

The method of claim 19, wherein the spinal cage includes perforations and the third geometry of the expanded block fills at least part of the cavity and at least some of the perforations.

### Claim 21

A method of preparing a bone implant comprising:
demineralizing a block of cancellous bone having a first geometry;
hydrating the block so that the block may be compressed from the first geometry to a second geometry smaller than the first geometry;
dehydrating the block;
inserting the dehydrated block into a hollow cage; and
re-expanding the block to a third geometry larger than the second geometry.

### Claim 22 (depends on 21)

The method of claim 21, wherein the step of dehydrating the block includes hardening the block.

### Claim 23 (depends on 21)

The method of claim 21, wherein the second geometry has a pellet-like shape.

### Claim 24 (depends on 21)

The method of claim 21, wherein the re-expanding step includes wetting the block with a swelling agent.

### Claim 25 (depends on 24)

The method of claim 24, wherein the swelling agent is water.

### Claim 26 (depends on 21)

The method of claim 21, wherein the hollow cage is a spinal cage.

### Claim 27 (depends on 21)

The method of claim 21, wherein the hollow cage has a cylindrical shape defining a cavity therein.

### Claim 28 (depends on 21)

The method of claim 21, wherein the hollow cage includes perforations and the third configuration of the expanded block fills at least some of the perforations.

### Claim 29 (depends on 21)

The method of claim 21, wherein the dehydrating step includes freeze drying the block.

### Claim 30 (depends on 21)

The method of claim 21, wherein the second geometry has a pellet-like shape.