# US 9,433,707 B2 · Bone graft material containment structures

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- Number: US 9,433,707 B2
- Document ID: US9433707B2
- Status: Granted
- Kind: B2
- Application number: 12/712,949
- Filed: 2010-02-25
- Published: 2010-08-26
- Granted: 2016-09-06
- Earliest claimed: 2009-02-25
- Assignees: Orthovita, Inc.
- Applicants: Greg Alan Swords; Daniel Bruce Spagnoli
- Inventors: Greg Alan Swords; Daniel Bruce Spagnoli
- Web page: https://patentgrep.com/patent/US9433707B2

## CPC

- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)}
- 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)}
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/365: {Bones}
- A61L 27/38: {containing added animal cells (organs or tissue containing native cells A61L27/36)}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61F 2/30724: {Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity}
- 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 2002/2817: {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 2002/30576: {with extending fixation tabs}
- A61F 2002/30915: {made of a stack of bonded perforated sheets, grids or wire meshes}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2310/00011: Metals or alloys
- A61L 2300/414: Growth factors
- A61L 2300/64: Animal cells
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- 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)

## Abstract

The present invention provides biocompatible, non-resorbable porous containment structures for containment of bone graft material at a desired location for stimulation of bone growth. The porous containment structures have interconnected pores sized to allow fibrovascular integration with surrounding tissue and conduction of vascular tissue through the structure into the bone graft material.

## Claims

### Claim 1

A method of facilitating growth of bone at a desired location comprising:
shaping, by bending, a biocompatible, non-resorbable porous material comprising a porous matrix of interconnected pores into a shaped porous material for placement into the desired location, the shaped porous material comprising a base portion, a side portion, and a top portion, the side portion sharing a first shaped edge with the base portion to define an interior region of the shaped porous material, the top portion being hingedly attached to a second shaped edge of the side portion such that the top portion forms open and closed positions with the side portion, the top portion providing an opening into the interior region in the open position;
placing a bone graft material inside the interior region of the shaped porous material;
placing the top portion in the closed position by bending the top portion relative to the side portion at the second shaped edge to cover the placed bone graft material;
stably fixing the shaped porous material containing the bone graft material to structures adjacent to the desired location; and
permitting bone to grow in the desired location.

### Claim 2 (depends on 1)

The method of claim 1, wherein after fixing the shaped porous material containing the bone graft material to structures adjacent to the desired location, soft tissues are closed over the shaped porous material.

### Claim 3 (depends on 1)

The method of claim 1, further comprising permitting blood vessels to infiltrate into the shaped porous material.

### Claim 4 (depends on 1)

The method of claim 1, wherein the porous material is formed by sintering particles of polymer or metal into the desired shape.

### Claim 5 (depends on 1)

The method of claim 1, wherein the porous material further comprises a metal mesh, a metal wire, or multiple layers of metal mesh or metal wire sintered together.

### Claim 6 (depends on 1)

The method of claim 1, wherein the bone graft material is bone, a synthetic material, a growth factor, a cell, or a combination thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the bone is autologous bone, autologous bone particulate, allogenic bone, human cadaver bone, xenograft bone, animal bone, or bone chips.

### Claim 8 (depends on 6)

The method of claim 6, wherein the synthetic material is hydroxyapatite, calcium phosphate, ceramics, bioactive glass, calcium sulfate, or a polymer-based bone graft substitute.

### Claim 9 (depends on 6)

The method of claim 6, wherein the growth factor is bone morphogenic protein (BMP), a BMP mimetic, recombinant human bone morphogenic protein 2 (rhBMP-2), platelet-rich plasma (PRP), transforming growth factor-beta (TGF-beta), platelet-derived growth factor (PDGF), recombinant human platelet derived growth factor (rhPDGF), insulin-like growth factor, fibroblast growth factor, a xenographic bone protein, a growth differentiation factor, calcitonin, or a calcitonin mimetic.

### Claim 10 (depends on 6)

The method of claim 6, wherein the cell is a stem cell, a bone marrow cell, a mesenchymal stem cell, or a combination thereof.

### Claim 11 (depends on 1)

The method of claim 1, wherein the porous matrix contains pores of average diameter of 40 to about 1000 microns, about 100 to about 800 microns, about 100 to about 500 microns, about 50 to about 500 microns, about 60 to about 400 microns, about 200 to about 400 microns, or about 100 to about 200 microns.

### Claim 12 (depends on 1)

The method of claim 1, wherein the porous material has a pore volume from about 20% to about 60%, or from about 40% to about 50%.

### Claim 13 (depends on 1)

The method of claim 1, wherein the porous material has a thickness of about 0.1 to about 2.0 mm, about 0.1 to about 1.0 mm, about 0.1 to about 0.9 mm, about 0.1 to about 0.8 mm, about 0.2 to about 0.4 mm, about 0.2 to about 0.3 mm, or about 0.25 mm.

### Claim 14 (depends on 1)

The method of claim 1, wherein the pores are omnidirectional.

### Claim 15 (depends on 1)

The method of claim 1, wherein the pores are multidimensional.

### Claim 16 (depends on 1)

The method of claim 1, wherein the porous material is sintered polyethylene, the pores are in the range of about 40 to about 1000 microns in average diameter, the pore volume is about 20% to about 60%, and the porous material is about 0.1 to about 3.0 mm in thickness.

### Claim 17 (depends on 1)

The method of claim 1, wherein the shaped porous material includes opposing side portions, and wherein the shaped porous material is placed in a trough-like manner between the bone graft material and the desired location to contain the bone graft material.

### Claim 18 (depends on 1)

The method of claim 1, further comprising inserting a bone plate through the porous material and the structures adjacent to the desired location, the structures being bone.

### Claim 19 (depends on 18)

The method of claim 18, wherein the bone plate includes openings therethrough.

### Claim 20 (depends on 1)

The method of claim 1, wherein the shaped porous material has a cylindrical-like shape.

### Claim 21 (depends on 1)

The method of claim 1, wherein the shaped porous material is box-shaped.