# US 8,771,721 B2 · Flexible bone composite

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- Number: US 8,771,721 B2
- Document ID: US8771721B2
- Status: Granted
- Kind: B2
- Application number: 13/838,629
- Filed: 2013-03-15
- Published: 2013-08-15
- Granted: 2014-07-08
- Earliest claimed: 2004-06-10
- Assignees: DePuy Synthes Products, Inc.
- Applicants: Depuy Synthes Products, LLC
- Inventors: Sean Kerr; James W. Dwyer
- Web page: https://patentgrep.com/patent/US8771721B2

## CPC

- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61F 2/28: Bones
- A61L 24/0089: {containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084}
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61P 19/00: Drugs for skeletal disorders
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- 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 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30064: {Coating or prosthesis-covering structure made of biodegradable material}
- A61F 2002/30113: {circular}
- A61F 2002/30153: {rectangular}
- A61F 2002/30293: {Cylindrical body made by spirally rolling up a sheet or a strip around itself}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30769: {madreporic}
- A61F 2002/30785: {parallel}
- A61F 2002/30971: {Laminates, i.e. layered products}
- A61F 2210/0004: bioabsorbable
- A61F 2230/0006: circular
- A61F 2230/0019: rectangular
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates in general to implantable flexible bone composites, and method for preparing the same. The flexible bone composite includes at least one polymeric layer and at least one calcium-containing layer. The polymeric layer can be a polymeric layer including a synthetic polymer. The calcium-containing layer can include a calcium compound such as β-Ca3(PO4)2. The flexible bone composites of the invention are useful as bone void fillers and have improved handling characteristics.

## Claims

### Claim 1

A multilayer flexible bone composite comprising:
a first polymeric layer comprising a flexible polymer and having a first side and a second side;
a first calcium-containing layer comprising granules of a calcium compound affixed to the first side of the first polymeric layer, wherein a majority of the external surface of the granules of the first calcium-containing layer is not covered with polymer; and
a second calcium-containing layer comprising granules of a calcium compound affixed to the second side of the first polymeric layer.

### Claim 2 (depends on 1)

The multilayer flexible bone composite of claim 1, further including a second polymeric layer comprising a flexible polymer, wherein the second calcium-containing layer is disposed between the first polymeric layer and the second polymeric layer.

### Claim 3 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the second polymeric layer has a first side and a second side and wherein the granules of the second calcium-containing layer are affixed to the first side of the second polymeric layer.

### Claim 4 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer is substantially free of calcium compounds.

### Claim 5 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer comprises a resorbable polymer.

### Claim 6 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer comprises a synthetic polymer.

### Claim 7 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the flexible polymer of the first polymeric layer and/or the second polymeric layer comprises repeat units selected from the group consisting of L-lactic acid, D-lactic acid, L-lactide, D-lactide, D,L-lactide, glycolide, a lactone, a lactam, ε-caprolactone, trimethylene carbonate, a cyclic carbonate, a cyclic ether, para-dioxanone, beta-hydroxybutyric acid, beta-hydroxypropionic acid, beta-hydroxyvaleric acid, and combinations thereof.

### Claim 8 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the flexible polymer of the first polymeric layer and/or the second polymeric layer has a glass transition temperature between about 30 degrees C. and about 100 degrees C.

### Claim 9 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer has a thickness ranging from about 0.01 mm to about 1.0 mm.

### Claim 10 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer includes one or more perforations.

### Claim 11 (depends on 2)

The multilayer flexible bone composite of claim 2, wherein the first polymeric layer and/or the second polymeric layer includes one or more cuts or slits.

### Claim 12 (depends on 11)

The multilayer flexible bone composite of claim 11, wherein the one or more cuts or slits has a length ranging from about 0.5 mm to about 10 mm.

### Claim 13 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein first calcium-containing layer and/or the second calcium-containing layer is substantially free of polymer.

### Claim 14 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein the calcium compound of the first calcium-containing layer and/or the second calcium-containing layer are selected from the group consisting of CaHPO4.nH2O, α-Ca3(PO4)2, α-bar-Ca3(PO4)2, β-Ca3(PO4)2, Ca5(PO4)3OH, Ca10(PO4)6(OH)2, Ca4O(PO4)2, CaP4 O11, Ca2P2O7, Ca(H2PO4)2.nH2O, Ca8H2(PO4)6 nH2O, and combinations thereof, where n is a number ranging from 0 to 5.

### Claim 15 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein the calcium compound of the first calcium-containing layer and the second calcium-containing layer is β-Ca3(PO4)2.

### Claim 16 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein the calcium compound of the first calcium-containing layer and/or the second calcium-containing layer is substantially free of hydroxyapatite.

### Claim 17 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein the granules of the first calcium-containing layer and/or the second calcium-containing layer have a mean diameter of about 0.05 mm to about 10 mm.

### Claim 18 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein each granules of the first calcium-containing layer and/or the second calcium-containing layer has a surface area of about 0.1 m2/g to about 100 m2/g.

### Claim 19 (depends on 1)

The multilayer flexible bone composite of claim 1, further comprising bone marrow cells in an interior of the multilayer flexible bone composite prior to implantation.

### Claim 20 (depends on 1)

The multilayer flexible bone composite of claim 1, wherein the multilayer flexible bone composite is soaked in aspirated bone marrow.