US7045141B2 — Allograft bone composition having a gelatin binder

Claim 1

Independent Claim 114 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of allograft osteoinductive bone material which is at least partially demineralized in a carrier forming a composition, the bone material ranging from about 20% to about 65% of the weight of the composition and the carrier comprising a gelatin component dissolved in an aqueous solution containing a hydrogel, said composition being lyophilized to achieve a crosslinking of the gelatin to obtain a structural stability which is maintained after application to said bone defect site, said gelatin comoonent ranting from about 10% to about 50% by weight of the composition after lyophilization.

Claim 2

Dependent Claim 114 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of allograft osteoinductive bone material which is at least partially demineralized in a carrier forming a composition, the bone material ranging from about 20% to about 65% of the weight of the composition and the carrier comprising a gelatin component dissolved in an aqueous solution containing a hydrogel, said composition being lyophilized to achieve a crosslinking of the gelatin to obtain a structural stability which is maintained after application to said bone defect site, said gelatin comoonent ranting from about 10% to about 50% by weight of the composition after lyophilization.

Claim 3

Dependent Claim 27 words

A sterile bone repair composition as claimed in claim 1 wherein said mixture includes bone morphogenic protein in excess of the amount naturally occurring in allogeneic bone.

Claim 4

Dependent Claim 24 words

A sterile bone repair composition as claimed in claim 1 wherein said osteoinductive bone material is demineralized with a calcium content below about 1%.

Claim 5

Dependent Claim 27 words

A malleable bone composition as claimed in claim 1 wherein said gelatin carrier includes a phosphate buffered saline with a pH ranging from 7.0 to about 7.4.

Claim 6

Dependent Claim 26 words

A malleable bone composition as claimed in claim 1 wherein said bone material is partially mineralized with a calcium content between about 4% to about 8%.

Claim 7

Dependent Claim 28 words

A sterile bone repair composition as claimed in claim 1 wherein said aqueous solution comprises at least one ofa group consisting of water, saline and phosphate buffered saline.

Claim 8

Dependent Claim 34 words

A sterile bone repair composition as claimed in claim 1 wherein said hydrogel is selected from the group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC).

Claim 9

Dependent Claim 25 words

A sterile bone repair composition as claimed in claim 1 wherein said allograft aqueous solution has a pH ranging from about 7.0 to about 7.4.

Claim 10

Dependent Claim 26 words

A sterile bone repair composition as claimed in claim 1 wherein said bone material includes bone particles ranging from 100 microns to 850 microns in size.

Claim 11

Dependent Claim 36 words

A sterile bone repair composition as claimed in claim 1 wherein said bone material contains growth factors transforming growth factor (TGF-beta), platelet derived growth factor (PDGF), osteopontin, fibroblast growth factor (FGF) and insulin-like growth factor (IGF-1).

Claim 12

Dependent Claim 149 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of allogeneic osteoinductive bone material which is partially demineralized and has a residual calcium content ranging from about 4.0% to about 8.0% in an aqueous gelatin carrier, said aqueous gelatin carrier contains a gelatin component and a hydrogel component, said hydrogel component comprising at least one of a group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC) which is lyophilized to remove the water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained alter application to said bone repair site, with said bone material ranging from about 30% to about 60% of the weight of the composition and said gelatin component ranging from about 30% to about 60% by weight of the composition.

Claim 13

Dependent Claim 149 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of allogeneic osteoinductive bone material which is partially demineralized and has a residual calcium content ranging from about 4.0% to about 8.0% in an aqueous gelatin carrier, said aqueous gelatin carrier contains a gelatin component and a hydrogel component, said hydrogel component comprising at least one of a group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC) which is lyophilized to remove the water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained alter application to said bone repair site, with said bone material ranging from about 30% to about 60% of the weight of the composition and said gelatin component ranging from about 30% to about 60% by weight of the composition.

Claim 14

Dependent Claim 28 words

A sterile bone repair composition as claimed in claim 11 wherein said aqueous gelatin contains a phosphate buffered saline with a pH ranging from 7.0 to about 7.4.

Claim 15

Dependent Claim 33 words

A sterile bone repair composition as claimed in claim 12 wherein phosphate in said phosphate buffered saline includes at least two phosphate ions HPO 4 −2 and H 2 PO 4 −1 .

Claim 16

Dependent Claim 33 words

A sterile bone repair composition as claimed in claim 11 including antimicrobial and/or antibiotics erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin, gentamycm and vitamins.

Claim 17

Dependent Claim 27 words

A sterile bone repair composition as claimed in claim 11 wherein said composition includes bone morphogenic proteins in excess of the amount naturally occurring in allogeneic bone.

Claim 18

Dependent Claim 21 words

A sterile bone repair composition as claimed in claim 11 wherein said composition has a pH ranging from 6.8 to 7.4.

Claim 19

Dependent Claim 36 words

A sterile bone repair composition as claimed in claim 11 wherein said bone material contains growth factors transforming growth factor (TGF-beta), platelet derived growth factor (PDGF), osteopontin, fibroblast growth factor (FGF) and insulin-like growth factor (IGF-1).

Claim 20

Dependent Claim 128 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising new bone growth inducing partially demineralized lyophilized allograft bone material having a particle size ranging from about 100 to about 850 microns mixed in an aqueous gelatin carrier, containing a hydrogel component ranging from 5% to 10% by weight to form a composition which is lyophilized to remove water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone defect site with said bone material ranging from about 30% to about 50% of the weight of the composition of the structure and the crosslinked gelatin ranging from 30% to 60% by weight of the composition of the structure.

Claim 21

Dependent Claim 128 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site comprising new bone growth inducing partially demineralized lyophilized allograft bone material having a particle size ranging from about 100 to about 850 microns mixed in an aqueous gelatin carrier, containing a hydrogel component ranging from 5% to 10% by weight to form a composition which is lyophilized to remove water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone defect site with said bone material ranging from about 30% to about 50% of the weight of the composition of the structure and the crosslinked gelatin ranging from 30% to 60% by weight of the composition of the structure.

Claim 22

Dependent Claim 36 words

A sterile bone repair composition as claimed in claim 18 wherein said hydrogel component comprises at least one ofa group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC).

Claim 23

Dependent Claim 167 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of partially demineralized lyophilized allograft bone material with a calcium content greater than 4% and less than 8% dry weight and a particle size ranging from about 100 to about 850 microns mixed in an aqueous gelatin carrier having a hydrogel component comprising a glycosaminoglycan ranging from about 5.0% to about 15.0% by weight of the composition and having a molecular weight of at least 700,000 Daltons, said mixture being lyophilized to remove water content with the water content after lyophilization ranging from about 0.1% to about 1.0% leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone repair site with said bone material ranging from about 30% to about 50% of the weight of the composition and the crosslinked gelatin ranging from 30% to 60% by weight of the composition.

Claim 24

Dependent Claim 167 words

A sterile bone repair composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of partially demineralized lyophilized allograft bone material with a calcium content greater than 4% and less than 8% dry weight and a particle size ranging from about 100 to about 850 microns mixed in an aqueous gelatin carrier having a hydrogel component comprising a glycosaminoglycan ranging from about 5.0% to about 15.0% by weight of the composition and having a molecular weight of at least 700,000 Daltons, said mixture being lyophilized to remove water content with the water content after lyophilization ranging from about 0.1% to about 1.0% leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone repair site with said bone material ranging from about 30% to about 50% of the weight of the composition and the crosslinked gelatin ranging from 30% to 60% by weight of the composition.

Claim 25

Dependent Claim 19 words

A sterile bone repair composition as claimed in claim 20 wherein said glycosaminoglycan is sodium hyaluronate and its derivatives.

Claim 26

Dependent Claim 20 words

A sterile bone repair composition as claimed in claim 20 wherein said aqueous gelatin carrier includes a phosphate buffered saline.

Claim 27

Dependent Claim 31 words

An osteoimplant as claimed in claim 20 wherein said glycosaminoglycan is selected from a group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC).

Claim 28

Dependent Claim 110 words

An osteoimplant for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized allograft osteoinductive bone material mixed in a phosphate buffered aqueous gelatin carrier which is lyophilized to remove water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone repair site, said bone material ranging from about 30% to about 60% of the weight of the structure and the crosslinked gelatin ranging from 30% to 60% by weight of the structure with the water content of said structure ranging from about 0.1% to about 1.0%.

Claim 29

Dependent Claim 110 words

An osteoimplant for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized allograft osteoinductive bone material mixed in a phosphate buffered aqueous gelatin carrier which is lyophilized to remove water content leaving a crosslinked gelatin bone structure having a structural stability which is maintained after application to said bone repair site, said bone material ranging from about 30% to about 60% of the weight of the structure and the crosslinked gelatin ranging from 30% to 60% by weight of the structure with the water content of said structure ranging from about 0.1% to about 1.0%.

Claim 30

Dependent Claim 24 words

A method as claimed in claim 24 wherein said osteoinductive bone material is powdered bone ranging from about 100 microns to about 850 microns.

Claim 31

Dependent Claim 27 words

A method as claimed in claim 24 wherein said osteoinductive bone material is powdered bone with a residual calcium content ranging from about 4% to about 8%.

Claim 32

Dependent Claim 30 words

A method as claimed in claim 24 wherein said osteoinductive bone material is powdered bone which has been deniineralized to have a residual calcium content which is less than 1%.

Claim 33

Dependent Claim 16 words

A method as claimed in claim 24 wherein said osteoinductive bone material includes mineralized bone chips.

Claim 34

Independent Claim 86 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution; b. mixing osteoinductive bone material in an aqueous solution and gelatin mixture to obtain a formulation; c. shaping said formulation into a specific shape; and d. subjecting said shaped formulation to lyophilization at a negative temperature to remove at least 90% of water from said aqueous gelatin osteoinductive bone mixture crosslinking said gelatin and osteoinductive bone material contained therein to form a solid structure.

Claim 35

Independent Claim 86 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution; b. mixing osteoinductive bone material in an aqueous solution and gelatin mixture to obtain a formulation; c. shaping said formulation into a specific shape; and d. subjecting said shaped formulation to lyophilization at a negative temperature to remove at least 90% of water from said aqueous gelatin osteoinductive bone mixture crosslinking said gelatin and osteoinductive bone material contained therein to form a solid structure.

Claim 36

Dependent Claim 26 words

A method as claimed in claim 29 wherein said aqueous solution comprises at least one of a group consisting of phosphate buffered saline, saline and water.

Claim 37

Dependent Claim 21 words

A method as claimed in claim 29 wherein said aqueous solution includes a hydrogel component of less than 10% by weight.

Claim 38

Dependent Claim 34 words

A method as claimed in claim 31 wherein said hydrogel component comprises at least one of a group consisting of sodium hyaluronate and its derivatives, chitosan, sodium alginate, dextran, carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC).

Claim 39

Dependent Claim 21 words

A method as claimed in claim 29 wherein said aqueous solution has a pH ranging from about 7.0 to about 7.4.

Claim 40

Independent Claim 133 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution; b. mixing from about 20% to about 50% by weight osteoinductive bone material in an aqueous gelatin and hydrogel mixture to obtain a bone repair formulation, said hydrogel being less than 10% by weight of said formulation; c. shaping said bone repair formulation into a specific shape for; and d. lyophilizing said shaped bone repair formulation below 0° C. for a period of time sufficient to leave from 0.01 to 0.8% water in said aqueous gelatin osteoinductive bone formulation and crosslink said gelatin with said osteoinductive bone material contained therein to form a solid structure with said gelatin ranging from about 30% to about 60% fo the weight of the structure.

Claim 41

Independent Claim 133 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution; b. mixing from about 20% to about 50% by weight osteoinductive bone material in an aqueous gelatin and hydrogel mixture to obtain a bone repair formulation, said hydrogel being less than 10% by weight of said formulation; c. shaping said bone repair formulation into a specific shape for; and d. lyophilizing said shaped bone repair formulation below 0° C. for a period of time sufficient to leave from 0.01 to 0.8% water in said aqueous gelatin osteoinductive bone formulation and crosslink said gelatin with said osteoinductive bone material contained therein to form a solid structure with said gelatin ranging from about 30% to about 60% fo the weight of the structure.

Claim 42

Dependent Claim 26 words

A method as claimed in claim 34 wherein said aqueous solution comprises at least one of a group consisting of phosphate buffered saline, saline and water.

Claim 43

Dependent Claim 18 words

A method as claimed in claim 34 wherein said lyophilization is at −40° C. for about 4 hours.

Claim 44

Independent Claim 110 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution containing a glycosaminoglycan; b. mixing osteoinductive demineralized bone material having a size ranging from 100 microns to 2 mm and 30% to 60% by weight in said aqueous gelatin solution to obtain a formulation; c. shaping said formulation into a specific shape; and d. subjecting said shaped formulation to lyophilization at a temperature of at least −40° C. to remove at least 92% of water from said aqueous gelatin osteoinductive bone mixture crosslinking said gelatin, glycosaminoglycan and osteoinductive demineralized bone material contained therein to form a solid structure.

Claim 45

Independent Claim 110 words

A method of constructing a crosslinked osteoinductive bone repair construct comprising the steps of: a. dissolving a gelatin in an aqueous solution containing a glycosaminoglycan; b. mixing osteoinductive demineralized bone material having a size ranging from 100 microns to 2 mm and 30% to 60% by weight in said aqueous gelatin solution to obtain a formulation; c. shaping said formulation into a specific shape; and d. subjecting said shaped formulation to lyophilization at a temperature of at least −40° C. to remove at least 92% of water from said aqueous gelatin osteoinductive bone mixture crosslinking said gelatin, glycosaminoglycan and osteoinductive demineralized bone material contained therein to form a solid structure.

Claim 46

Dependent Claim 51 words

A method as claimed in claim 37 wherein said lyophilization of step d, is conducted for at least 4 hours after which the temperature is raised to about +35° C. for 20 to 28 hours with the formulation at the higher temperature being placed under a vacuum of about 350 mTorr.

Claim 47

Dependent Claim 24 words

A method as claimed in claim 37 wherein about 0.1 to about 8% of the original water is left in the formulization after lyophilization.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2009-05-15	2009-11-14	2010-05-16	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2013-05-15	2013-11-14	2014-05-16	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2017-05-15	2017-11-14	2018-05-16	$7700.00	Window Closed / Lapsed

Allograft bone composition having a gelatin binder

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