# US 10,441,683 B2 · Method for restoring bone using shapeable bone graft substitute and instruments for delivery thereof

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- Number: US 10,441,683 B2
- Document ID: US10441683B2
- Status: Granted
- Kind: B2
- Application number: 15/710,071
- Filed: 2017-09-20
- Published: 2018-01-11
- Granted: 2019-10-15
- Earliest claimed: 2004-06-23
- Assignees: Orthovita, Inc.
- Applicants: Orthovita, Inc.
- Inventors: Charanpreet S. Bagga; Theodore D. Clineff; Erik M. Erbe; Michael W. Paris; Gina M. Nagvajara; Antony Koblish
- Web page: https://patentgrep.com/patent/US10441683B2

## CPC

- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- 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 17/7095: {the filler comprising unlinked macroscopic particles}
- A61B 17/8822: {characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum}
- A61F 2/28: Bones
- A61L 27/20: Polysaccharides
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- 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 2/3094: {Designing or manufacturing processes}
- A61F 2/34: Acetabular cups
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- 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)}
- 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 2002/2882: {Malar or zygomatic implants}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30151: {rhomboidal or parallelogram-shaped}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30235: {tubular, e.g. sleeves}
- A61F 2002/30245: {Partial spheres}
- A61F 2002/30261: {parallelepipedal}
- 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 2002/30736: {Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect}
- A61F 2002/30838: {Microstructures}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0085: hardenable in situ, e.g. epoxy resins
- A61F 2230/0017: Angular shapes
- A61F 2230/0069: cylindrical
- A61F 2230/0071: spherical
- A61F 2230/0082: parallelepipedal
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2400/16: Materials with shape-memory or superelastic properties
- 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)
- 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)

## Abstract

Disclosed is directed to a method for restoring bone in an animal comprising: accessing a site to be restored; loading a syringe body with a flowable bone graft material; mating the syringe body with a delivery tube; positioning the delivery tube at the site to be restored; using a syringe piston to advance the said material into the delivery tube; using the syringe piston or a plunger that mates with the delivery tube after removal of the syringe body to deliver the bone graft to the site at a force of less than 50 lbs. extrusion force; wherein said material is at least 75% porous with a mineral to polymer ratio of 80:20.

## Claims

### Claim 1

A method for restoring bone in an animal comprising:
accessing a site to be restored;
loading a syringe body with a flowable bone graft material;
imbibing the flowable bone graft material with bone marrow aspirate, blood or saline with application of positive pressure for a sufficient period of time to form a homogeneous injectable mass;
mating the syringe body with a delivery tube;
positioning the delivery tube at the site to be restored;
using a syringe piston to advance the said material into the delivery tube;
using the syringe piston or a plunger that mates with the delivery tube after removal of the syringe body to deliver the homogeneous injectable mass to the site at a force of less than 50 lbs. extrusion force;
wherein the flowable bone graft material is at least 75% porous,
wherein the flowable bone graft material comprises a dry bone graft material having a homogeneous mixture comprising collagen in the amount of about 15% to about 30% by weight and a calcium phosphate,
wherein a ratio of the collagen and the calcium phosphate is same throughout the homogeneous mixture, and
wherein the dry bone graft material has macro-porosity, meso-porosity, and microporosity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the extrusion force is between about 20 lbs to about 25 lbs.

### Claim 3 (depends on 1)

The method of claim 1, wherein the syringe body and delivery tube are threadingly engaged.

### Claim 4 (depends on 1)

The method of claim 1, wherein said flowable bone graft material is 80% porous.

### Claim 5 (depends on 1)

The method of claim 1, wherein said flowable bone graft material is 90% porous.