US6437018B1 — Malleable paste with high molecular weight buffer…

Claim 1

Independent Claim 138 words

A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteoinductive and osteoconductive bone powder with a particle size ranging from about 100 to about 850 microns in an aqueous carrier solution, the bone powder ranging from about 25 to about 35% of the weight of the composition, the carrier comprising a hydrogel component of sodium hyaluronate in a phosphate buffered aqueous solution, said hydrogel component having a high molecular weight ranging from over six hundred thousand to three million Daltons with a stable viscosity at a temperature range from about 22° to about 37° C. and ranging from about 0.75% to about 5.0% by weight of the aqueous carrier solution, said composition having a pH ranging from about 6.8 to about 7.4.

Claim 2

Dependent Claim 138 words

A sterile formable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteoinductive and osteoconductive bone powder with a particle size ranging from about 100 to about 850 microns in an aqueous carrier solution, the bone powder ranging from about 25 to about 35% of the weight of the composition, the carrier comprising a hydrogel component of sodium hyaluronate in a phosphate buffered aqueous solution, said hydrogel component having a high molecular weight ranging from over six hundred thousand to three million Daltons with a stable viscosity at a temperature range from about 22° to about 37° C. and ranging from about 0.75% to about 5.0% by weight of the aqueous carrier solution, said composition having a pH ranging from about 6.8 to about 7.4.

Claim 3

Dependent Claim 27 words

A sterile formable bone 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 27 words

A sterile formable bone composition as claimed in claim 1 wherein said phosphate includes two phosphate ions HPO 4 −2 and H 2 PO 4 −1 .

Claim 5

Dependent Claim 21 words

A sterile formable bone composition as claimed in claim 1 wherein said composition has an isotonic state of about 300 mOsmol/Kg.

Claim 6

Dependent Claim 19 words

A sterile formable bone composition as claimed in claim 1 wherein said bone powder contains cortical allograft bone powder.

Claim 7

Dependent Claim 18 words

A sterile formable bone composition as claimed in claim 1 wherein said bone powder contains corticalcancellous bone powder.

Claim 8

Dependent Claim 22 words

A sterile formable bone composition as claimed in claim 1 wherein the aqueous carrier solution includes an ionic salt based phosphate buffer.

Claim 9

Dependent Claim 130 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in sodium hyaluronate with an ionic salt based phosphate buffer carrier causing the composition to have a pH ranging between about 6.8 and about 7.4, the sodium hyaluronate component having a molecular weight of at least six hundred and sixty thousand Daltons and a stable viscosity ranging from 6,000 to about 275,000 cps at a temperature range of 22° to 37° C., the bone content of the carrier ranging in weight from about 20% to less than 50% total weight of the composition.

Claim 10

Dependent Claim 130 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in sodium hyaluronate with an ionic salt based phosphate buffer carrier causing the composition to have a pH ranging between about 6.8 and about 7.4, the sodium hyaluronate component having a molecular weight of at least six hundred and sixty thousand Daltons and a stable viscosity ranging from 6,000 to about 275,000 cps at a temperature range of 22° to 37° C., the bone content of the carrier ranging in weight from about 20% to less than 50% total weight of the composition.

Claim 11

Dependent Claim 23 words

A sterile formable bone putty composition as claimed in claim 8 wherein said saline phosphate buffer carrier includes a sodium based phosphate compound.

Claim 12

Dependent Claim 28 words

A sterile formable bone putty composition as claimed in claim 8 wherein said phosphate includes two phosphate ions HPO 4 −2 and H 2 PO 4 −1 .

Claim 13

Dependent Claim 22 words

A sterile formable bone putty composition as claimed in claim 8 wherein said composition has an isotonic state of about 300 mOsmol/Kg.

Claim 14

Dependent Claim 18 words

A sterile formable bone putty composition as claimed in claim 8 wherein said sodium hyaluronate has been irradiated.

Claim 15

Dependent Claim 36 words

A sterile formable bone putty composition as claimed in claim 8 including antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin, gentamycin and vitamins.

Claim 16

Dependent Claim 28 words

A sterile formable bone putty composition as claimed in claim 8 wherein said mixture includes bone morphogenic proteins in excess of the amount naturally occurring in allogeneic bone.

Claim 17

Dependent Claim 108 words

A formable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in a high molecular weight sodium hyaluronate and saline phosphate buffer carrier, the bone demineralized content of the composition ranging from about 30% to about 35% by weight and the high molecular weight sodium hyaluronate component being sterile and constituting a percentage of the carrier not in excess of 5% of the weight of the carrier and has a molecular weight greater than 600,000 Daltons.

Claim 18

Dependent Claim 108 words

A formable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in a high molecular weight sodium hyaluronate and saline phosphate buffer carrier, the bone demineralized content of the composition ranging from about 30% to about 35% by weight and the high molecular weight sodium hyaluronate component being sterile and constituting a percentage of the carrier not in excess of 5% of the weight of the carrier and has a molecular weight greater than 600,000 Daltons.

Claim 19

Dependent Claim 126 words

A sterile formable bone gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 800 microns in a high molecular weight sodium hyaluronate having a molecular weight of at least about six hundred and sixty thousand Daltons in saline phosphate buffer carrier with the sodium hyaluronate component comprising about 75% to about 2.5% of the carrier weight and having a viscosity of about 1,800 to 13,000 cps, the bone powder content of the composition ranging from about 25% to about 30% with said composition having an osmolality ranging from about 280 to about 340 mOsmol/Kg.

Claim 20

Dependent Claim 126 words

A sterile formable bone gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 800 microns in a high molecular weight sodium hyaluronate having a molecular weight of at least about six hundred and sixty thousand Daltons in saline phosphate buffer carrier with the sodium hyaluronate component comprising about 75% to about 2.5% of the carrier weight and having a viscosity of about 1,800 to 13,000 cps, the bone powder content of the composition ranging from about 25% to about 30% with said composition having an osmolality ranging from about 280 to about 340 mOsmol/Kg.

Claim 21

Dependent Claim 28 words

A sterile formable bone gel composition as claimed in claim 16 wherein said composition includes bone morphogenic proteins in excess of the amount naturally occurring in allogeneic bone.

Claim 22

Dependent Claim 28 words

A sterile formable bone gel composition as claimed in claim 16 wherein said phosphate includes two phosphate ions HPO 4 −2 and H 2 PO 4 −1 .

Claim 23

Dependent Claim 20 words

A sterile formable bone gel composition as claimed in claim 16 wherein said bone powder contains cortical allograft bone powder.

Claim 24

Dependent Claim 20 words

A sterile formable bone gel composition as claimed in claim 16 wherein said bone powder contains corticalcancellous allograft bone powder.

Claim 25

Dependent Claim 98 words

A sterile formable bone putty 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in a hydrogel ionic salt based phosphate buffer carrier, the hydrogel component comprising sodium hyaluronate and its derivatives and ranging from about 2.0% to about 5.0% by weight of the carrier and having a molecular weight of at least 600,000 Daltons, said composition having a pH ranging from 6.8 to 7.4.

Claim 26

Dependent Claim 98 words

A sterile formable bone putty 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 710 microns in a hydrogel ionic salt based phosphate buffer carrier, the hydrogel component comprising sodium hyaluronate and its derivatives and ranging from about 2.0% to about 5.0% by weight of the carrier and having a molecular weight of at least 600,000 Daltons, said composition having a pH ranging from 6.8 to 7.4.

Claim 27

Dependent Claim 104 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder in a high molecular weight hydrogel in saline phosphate buffer solution carrier, said hydrogel comprising an acid mucopolysaccharide having a molecular weight of at least 700,000 Daltons, the bone amount content of the composition ranging from about 30% to about 38% by weight and the high molecular weight hydrogel ranging from about 2.0%to about 5.0% by weight of the carrier, said composition having an osmolality ranging from 280-340 mOsmol/Kg.

Claim 28

Dependent Claim 104 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder in a high molecular weight hydrogel in saline phosphate buffer solution carrier, said hydrogel comprising an acid mucopolysaccharide having a molecular weight of at least 700,000 Daltons, the bone amount content of the composition ranging from about 30% to about 38% by weight and the high molecular weight hydrogel ranging from about 2.0%to about 5.0% by weight of the carrier, said composition having an osmolality ranging from 280-340 mOsmol/Kg.

Claim 29

Dependent Claim 108 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder in a high molecular weight hydrogel and saline phosphate buffer solution carrier, said hydrogel comprising an acid mucopolysaccharide having a molecular weight of at least 600,000 Daltons, the bone amount content of the composition ranging from about 30% to about 35% by weight and the high molecular weight hydrogel ranging from about 2.0% to about 4.0% by weight of the carrier, said composition having a pH ranging from about 7.2 to about 7.4.

Claim 30

Dependent Claim 108 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder in a high molecular weight hydrogel and saline phosphate buffer solution carrier, said hydrogel comprising an acid mucopolysaccharide having a molecular weight of at least 600,000 Daltons, the bone amount content of the composition ranging from about 30% to about 35% by weight and the high molecular weight hydrogel ranging from about 2.0% to about 4.0% by weight of the carrier, said composition having a pH ranging from about 7.2 to about 7.4.

Claim 31

Dependent Claim 110 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized human allograft bone powder carrier in a high molecular weight hydrogel and saline phosphate buffer solution carrier, said hydrogel comprising an sodium hyaluronate having a molecular weight of at least 3,000,000 Daltons, the bone amount content of the composition ranging from about 30% to about 38% by weight and the high molecular weight hydrogel ranging from about 0.25% to about 1.5% by weight of the carrier, said composition having a pH ranging from about 6.8 to about 7.4.

Claim 32

Dependent Claim 110 words

A sterile formable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized human allograft bone powder carrier in a high molecular weight hydrogel and saline phosphate buffer solution carrier, said hydrogel comprising an sodium hyaluronate having a molecular weight of at least 3,000,000 Daltons, the bone amount content of the composition ranging from about 30% to about 38% by weight and the high molecular weight hydrogel ranging from about 0.25% to about 1.5% by weight of the carrier, said composition having a pH ranging from about 6.8 to about 7.4.

Claim 33

Dependent Claim 35 words

A sterile formable bone putty composition as claimed in claim 24 wherein said carrier has a stable viscosity ranging from 120,000 to 275,000 cps at a temperature range from about 22° to about 37° C.

Claim 34

Dependent Claim 26 words

A sterile formable bone composition as claimed in claim 1 including an additive of living cells such as chondrocytes, bone marrow cells and mesenchymal stem cells.

Claim 35

Dependent Claim 19 words

A sterile formable bone composition as claimed in claim 1 including an additive of at least one growth factor.

Claim 36

Dependent Claim 18 words

A sterile formable bone composition as claimed in claim 1 wherein said bone powder contains cancerous bone powder.

Claim 37

Dependent Claim 27 words

A sterile formable bone putty composition as claimed in claim 23 including an additive of living cells such as chondrocytes, bone marrow cells and mesenchymal stem cells.

Claim 38

Dependent Claim 20 words

A sterile formable bone putty composition as claimed in claim 23 including an additive of at least one growth factor.

Claim 39

Dependent Claim 18 words

A sterile formable bone composition as claimed in claim 23 wherein said bone powder contains cancellous bone powder.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2005-08-19	2006-02-18	2006-08-20	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2009-08-19	2010-02-18	2010-08-20	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2013-08-19	2014-02-18	2014-08-20	$7700.00	Window Closed / Lapsed

Malleable paste with high molecular weight buffered carrier for filling bone defects

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