US6458375B1 — Malleable paste with allograft bone reinforcement…

Claim 1

Independent Claim 154 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic or osteoconductive bone powder with a particle size ranging from about 250 to about 750 microns and osteogenic bone chips of a larger size ranging from 0.1 to 10 mm in a carrier, the demineralized bone powder ranging from about 15% to about 35% of the weight of the composition and the osteogenic bone chips ranging from 5% to about 20% of the weight of the composition, the carrier being selected from a aqueous sodium based phosphate buffered solution and a hydrogel consisting of a mucopolysaccharide, said mucopolysaccharide having a high molecular weight ranging from seven hundred thousand to three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a pH ranging from about 7.2 to about 7.4.

Claim 2

Dependent Claim 154 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic or osteoconductive bone powder with a particle size ranging from about 250 to about 750 microns and osteogenic bone chips of a larger size ranging from 0.1 to 10 mm in a carrier, the demineralized bone powder ranging from about 15% to about 35% of the weight of the composition and the osteogenic bone chips ranging from 5% to about 20% of the weight of the composition, the carrier being selected from a aqueous sodium based phosphate buffered solution and a hydrogel consisting of a mucopolysaccharide, said mucopolysaccharide having a high molecular weight ranging from seven hundred thousand to three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a pH ranging from about 7.2 to about 7.4.

Claim 3

Dependent Claim 18 words

A sterile malleable bone composition as claimed in claim 1 wherein said composition includes added bone morphogenic proteins.

Claim 4

Dependent Claim 27 words

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

Claim 6

Dependent Claim 20 words

A sterile malleable bone composition as claimed in claim 1 comprising the addition of a calcium salt to the carrier.

Claim 7

Dependent Claim 29 words

A sterile malleable bone composition as claimed in claim 1 wherein the balance of the carrier formulation contains a sodium phosphate buffer and has a pH of about 7.2.

Claim 8

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone powder is cortical allograft bone powder.

Claim 9

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone powder is cortical-cancellous allograft bone powder.

Claim 10

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are cortical allograft bone chips.

Claim 11

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are cortical-cancellous allograft bone chips.

Claim 12

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are mineralized allograft bone chips.

Claim 13

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 1 wherein said bone chips are demineralized allograft bone chips.

Claim 14

Dependent Claim 44 words

A sterile malleable bone composition as claimed in claim 1 wherein antimicrobial and/or antibiotics selected from the group consisting essentially of erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin are added to said composition.

Claim 15

Dependent Claim 16 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel is sodium hyaluronate.

Claim 16

Dependent Claim 15 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel is chitosan.

Claim 17

Dependent Claim 21 words

A sterile malleable bone composition as claimed in claim 1 wherein said composition has a pH ranging from 6.8 to 7.4.

Claim 18

Dependent Claim 21 words

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

Claim 19

Dependent Claim 22 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel has a molecular weight of at least 700,000 Daltons.

Claim 20

Dependent Claim 23 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel has a molecular weight of at least of 1,000,000 Daltons.

Claim 21

Dependent Claim 22 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel consists of the group of sodium hyaluronate and chitosan.

Claim 22

Dependent Claim 21 words

A sterile malleable bone composition as claimed in claim 1 wherein said hydrogel substantially maintains its viscosity from 22-37 degrees C.

Claim 23

Dependent Claim 16 words

A sterile malleable bone composition as claimed in claim 1 wherein said aqueous solution is saline.

Claim 24

Dependent Claim 164 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and cortical bone rods having a length ranging from 1 mm to about 10 mm and a thickness to length ratio ranging of about 1:2 to 1:20, the demineralized bone powder ranging from about 15 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 20% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in saline phosphate buffer solution, said hydrogel having a high molecular weight ranging from about seven hundred thousand to about three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a substantially neutral osmolality.

Claim 25

Dependent Claim 164 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and cortical bone rods having a length ranging from 1 mm to about 10 mm and a thickness to length ratio ranging of about 1:2 to 1:20, the demineralized bone powder ranging from about 15 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 20% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in saline phosphate buffer solution, said hydrogel having a high molecular weight ranging from about seven hundred thousand to about three million Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution, said composition having a substantially neutral osmolality.

Claim 26

Dependent Claim 19 words

A sterile malleable bone composition as claimed in claim 23 wherein said composition mixture includes added bone morphogenic proteins.

Claim 27

Dependent Claim 28 words

A sterile malleable bone composition as claimed in claim 23 wherein said phosphate buffer includes two phosphate ions HPO 4 −2 and H 2 PO 4 −1 .

Claim 28

Dependent Claim 21 words

A sterile malleable bone composition as claimed in claim 23 wherein said composition has an isotonic state of about 300 mOsmol/Kg.

Claim 29

Dependent Claim 22 words

A sterile malleable bone composition as claimed in claim 23 wherein said bone rods are orientated in one direction in said composition.

Claim 30

Dependent Claim 44 words

A sterile malleable bone composition as claimed in claim 23 wherein antimicrobial and/or antibiotics selected from the group consisting essentially of erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin are added to said composition.

Claim 31

Dependent Claim 23 words

A sterile malleable bone composition as claimed in claim 23 wherein said hydrogel has a molecular weight of at least one million Daltons.

Claim 32

Dependent Claim 25 words

A sterile malleable bone composition as claimed in claim 23 wherein said bone rods have a diameter ranging from 0.4 mm to about 2.0 mm.

Claim 33

Dependent Claim 18 words

A sterile malleable bone composition as claimed in claim 23 wherein said cortical bone rods are partially demineralized.

Claim 34

Dependent Claim 25 words

A sterile malleable bone composition as claimed in claim 31 wherein said bone rods have a diameter ranging from 3.0 mm to about 5.00 mm.

Claim 35

Dependent Claim 20 words

A sterile malleable bone composition as claimed in claim 23 wherein said cortical bone rods are fully demineralized and flexible.

Claim 36

Dependent Claim 21 words

A sterile malleable bone composition as claimed in claim 23 wherein said cortical bone rods are randomly orientated in said composition.

Claim 37

Dependent Claim 142 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 750 microns and surface demineralized cortical bone rods having a diameter ranging from 1.0 mm to 5.00 mm with a diameter to length ratio ranging from 1:2 to 1:20, the demineralized bone powder ranging from about 25 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 10% of the weight of the composition, said carrier comprising a high molecular weight hydrogel mucosaccharide in aqueous phosphate buffered solution, said mucosaccharide having a high molecular weight over 700,000 Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution.

Claim 38

Dependent Claim 142 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 750 microns and surface demineralized cortical bone rods having a diameter ranging from 1.0 mm to 5.00 mm with a diameter to length ratio ranging from 1:2 to 1:20, the demineralized bone powder ranging from about 25 to about 30% of the weight of the composition and the cortical bone rods ranging from 5% to about 10% of the weight of the composition, said carrier comprising a high molecular weight hydrogel mucosaccharide in aqueous phosphate buffered solution, said mucosaccharide having a high molecular weight over 700,000 Daltons and ranging from about 2.0% to about 5.0% by weight of the carrier solution.

Claim 39

Dependent Claim 21 words

A sterile malleable bone composition as claimed in claim 35 wherein said cortical bone rods are randomly oriented in said composition.

Claim 40

Dependent Claim 23 words

A sterile malleable bone composition as claimed in claim 35 wherein said cortical bone rods are oriented in one direction in said composition.

Claim 41

Dependent Claim 153 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and mineral cortical bone rods having a diameter ranging from 0.4 to about 2.0 mm and a diameter to length ratio of about 2- to about 6, the demineralized bone powder ranging from about 25 to about 35% of the weight of the composition and the mineralized cortical rods ranging from 5% to about 25% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in a buffered phosphate saline solution, said hydrogel having a high molecular weight of at least 1.0-10 6 Daltons and ranging from about 1.0% to about 5.0% by weight of the carrier solution.

Claim 42

Dependent Claim 153 words

A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a carrier and a mixture of demineralized osteogenic bone powder with a particle size ranging from about 250 to about 1000 microns and mineral cortical bone rods having a diameter ranging from 0.4 to about 2.0 mm and a diameter to length ratio of about 2- to about 6, the demineralized bone powder ranging from about 25 to about 35% of the weight of the composition and the mineralized cortical rods ranging from 5% to about 25% of the weight of the composition, said carrier comprising a hydrogel selected from a group consisting of sodium hyaluronate, chitosan and carboxy-methyl-cellulose in a buffered phosphate saline solution, said hydrogel having a high molecular weight of at least 1.0-10 6 Daltons and ranging from about 1.0% to about 5.0% by weight of the carrier solution.

Claim 43

Dependent Claim 130 words

A sterile malleable 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 750 microns and mineralized cortical allograft bone chips ranging from 1.0 mm to 10.00 mm in size and cortical bone rods in a hyaluronic acid saline phosphate buffer carrier, the hyaluronic acid component ranging from above 2.0% to about 5% of the carrier solution and having a molecular weight of at least 1.0×10 6 Daltons, the total bone content of the bone powder, bone chips and bone rods in the carrier ranging in weight from about 30% to about 50% total weight of the composition.

Claim 44

Dependent Claim 130 words

A sterile malleable 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 750 microns and mineralized cortical allograft bone chips ranging from 1.0 mm to 10.00 mm in size and cortical bone rods in a hyaluronic acid saline phosphate buffer carrier, the hyaluronic acid component ranging from above 2.0% to about 5% of the carrier solution and having a molecular weight of at least 1.0×10 6 Daltons, the total bone content of the bone powder, bone chips and bone rods in the carrier ranging in weight from about 30% to about 50% total weight of the composition.

Claim 45

Dependent Claim 110 words

A sterile malleable 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 750 microns and mineralized bone chips ranging from 0.1 mm-10 mm in a high molecular weight sodium hyaluronate and saline carrier with a phosphate buffer, the bone content of the composition ranging from about 25% to about 45% by weight and the high molecular weight sodium hyaluronate component ranges from about 2% to about 5% of the carrier and has a molecular weight greater than one million Daltons.

Claim 46

Dependent Claim 110 words

A sterile malleable 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 750 microns and mineralized bone chips ranging from 0.1 mm-10 mm in a high molecular weight sodium hyaluronate and saline carrier with a phosphate buffer, the bone content of the composition ranging from about 25% to about 45% by weight and the high molecular weight sodium hyaluronate component ranges from about 2% to about 5% of the carrier and has a molecular weight greater than one million Daltons.

Claim 47

Dependent Claim 117 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone chips ranging from 1-10 mm in size in a carrier solution, said carrier solution comprising a high molecular weight chitosan having a molecular weight over 1.0×10 5 Daltons in an aqueous buffered phosphate with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component ranging from 2 to 5% of the carrier solution and said composition having a substantially neutral osmolality.

Claim 48

Dependent Claim 117 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone chips ranging from 1-10 mm in size in a carrier solution, said carrier solution comprising a high molecular weight chitosan having a molecular weight over 1.0×10 5 Daltons in an aqueous buffered phosphate with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component ranging from 2 to 5% of the carrier solution and said composition having a substantially neutral osmolality.

Claim 49

Dependent Claim 124 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cordical bone rods having a diameter to length ratio ranging from 1:2-1:20 mm in length in a carrier, said carrier comprising a high molecular weight chitosan having a molecular weight over 1.0×10 6 Daltons in a water phosphate buffered solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component ranging from 2 to 5% of the carrier solution and said composition having a substantially neutral osmolality.

Claim 50

Dependent Claim 124 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cordical bone rods having a diameter to length ratio ranging from 1:2-1:20 mm in length in a carrier, said carrier comprising a high molecular weight chitosan having a molecular weight over 1.0×10 6 Daltons in a water phosphate buffered solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component ranging from 2 to 5% of the carrier solution and said composition having a substantially neutral osmolality.

Claim 51

Dependent Claim 17 words

A sterile malleable bone putty as claimed in claim 42 wherein said cortical bone rods are mineralized.

Claim 52

Dependent Claim 18 words

A sterile malleable bone putty as claimed in claim 42 wherein said cortical bone rods are partially demineralized.

Claim 53

Dependent Claim 18 words

A sterile malleable bone putty as claimed in claim 42 wherein said cortical bone rods are fully demineralized.

Claim 54

Dependent Claim 101 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cordical bone rods having a diameter to length ratio ranging from 1:2-1:20 mm in length in a high molecular weight carboxy-methyl-cellulose phosphate buffered water carrier solution with the bone content of the putty composition ranging up to 30% and the carboxy-methyl-cellulose component ranging from 2 to 5% by weight of the carrier solution.

Claim 55

Dependent Claim 101 words

A sterile malleable 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 demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 750 microns and mineralized bone cordical bone rods having a diameter to length ratio ranging from 1:2-1:20 mm in length in a high molecular weight carboxy-methyl-cellulose phosphate buffered water carrier solution with the bone content of the putty composition ranging up to 30% and the carboxy-methyl-cellulose component ranging from 2 to 5% by weight of the carrier solution.

Claim 56

Dependent Claim 17 words

A sterile malleable bone putty as claimed in claim 46 wherein said cortical bone rods are mineralized.

Claim 57

Dependent Claim 18 words

A sterile malleable bone putty as claimed in claim 46 wherein said cortical bone rods are partially demineralized.

Claim 58

Dependent Claim 18 words

A sterile malleable bone putty as claimed in claim 46 wherein said cortical bone rods are fully demineralized.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2005-09-30	2006-04-01	2006-10-01	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2009-09-30	2010-04-01	2010-10-01	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2013-09-30	2014-04-01	2014-10-01	$7700.00	Window Closed / Lapsed

Malleable paste with allograft bone reinforcement for filling bone defects

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