US6294041B1
Expired / Lapsed
US
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Method for an osteoimplant manufacture
Assignee: Warsaw Orthopedic Inc
•
Filing: 1999-04-22
•
Granted: 2001-09-25
•
Expires: 2019-04-22
Abstract
Abstract The invention relates to an osteoimplant fabricated from a solid aggregate of bone derived elements possessing chemical linkages between their adjacent surface-exposed collagen. Also described are various other components which can be incorporated into the bone implant material such as bone-growth inducing substances; and a method of manufacture.
Inventors
- 👤 Todd M. Boyce
- 👤 Albert Manrique
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:30
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/46; A61F2/4644; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/68; A61B17/70; A61B17/7062; A61F2/28; A61F2/2875; A61F2/44; A61F2/442; A61L; A61L27/00; A61L27/36; A61L27/3604; A61L27/3608; A61L27/3641; A61L27/3645; A61L27/365; A61L27/3683; A61L27/3695; A61F2/3094; A61F2/4455; A61F2002/2817; A61F2002/2825; A61F2002/2835; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30057; A61F2002/30059; A61F2002/30108; A61F2002/3011; A61F2002/30112; A61F2002/30113; A61F2002/30125; A61F2002/30138; A61F2002/30153; A61F2002/30154; A61F2002/30199; A61F2002/30224; A61F2002/30225; A61F2002/30261; A61F2002/30316; A61F2002/30329; A61F2002/30448; A61F2002/30535; A61F2002/30593; A61F2002/30599; A61F2002/30667; A61F2002/30677; A61F2/30942; A61F2002/30957; A61F2002/4649; A61F2220/00; A61F2220/0025; A61F2220/005; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61F2230/0008; A61F2230/0017; A61F2230/0019; A61F2230/0021; A61F2230/0063; A61F2230/0069; A61F2230/0082; A61F2250/00; A61F2250/0058; A61F2250/006; A61F2250/0063; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2430/00; A61L2430/02
Claims Analysis
Total Claims: 56
Claim 1
Independent Claim
74 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein chemical linkages are formed by irradiating the bone-derived elements in a gaseous environment to provide oxygen ions which thereafter react with surface-exposed collagen of adjacent bone-derived elements forming chemical linkages therebetween.
Claim 2
Independent Claim
74 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein chemical linkages are formed by irradiating the bone-derived elements in a gaseous environment to provide oxygen ions which thereafter react with surface-exposed collagen of adjacent bone-derived elements forming chemical linkages therebetween.
Claim 3
Independent Claim
49 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein linkages are formed by dye-mediated photo-oxidation.
Claim 4
Independent Claim
49 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein linkages are formed by dye-mediated photo-oxidation.
Claim 5
Independent Claim
73 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein chemical linkages are formed by treating the bone-derived elements with an enzyme which catalyzes formation of chemical linkages between amino acid-functional groups of the surface-exposed collagen of adjacent bone-derived elements.
Claim 6
Independent Claim
73 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein chemical linkages are formed by treating the bone-derived elements with an enzyme which catalyzes formation of chemical linkages between amino acid-functional groups of the surface-exposed collagen of adjacent bone-derived elements.
Claim 7
Dependent Claim
12 words
The method of claim 1 wherein the enzyme is a tissue transglutaminase.
Claim 8
Independent Claim
62 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein the bone-derived elements are provided with mechanically interengaging features selected from the group consisting of tongue-and-groove and mortise-and-tenon features.
Claim 9
Independent Claim
62 words
A method for the manufacture of an osteoimplant which comprises: a) providing a quantity of bone-derived elements initially presenting surface-exposed collagen; and, b) forming chemical linkages between the surface-exposed collagen of adjacent bone-derived elements to bond said elements into a solid aggregate, wherein the bone-derived elements are provided with mechanically interengaging features selected from the group consisting of tongue-and-groove and mortise-and-tenon features.
Claim 10
Dependent Claim
23 words
The method of claim 1 wherein the bone-derived elements are substantially completely demineralized particles, strips or sheets of allogenic and/or xenogenic cortical bone.
Claim 11
Dependent Claim
10 words
The method of claim 1 carried out in a mold.
Claim 12
Dependent Claim
26 words
The method of claim 7 wherein the shaping surfaces of the mold are such as to provide an osteoimplant configured as a bone or section thereof.
Claim 13
Dependent Claim
46 words
The method of claim 7 wherein the shaping surfaces of the mold are such as to provide an osteoimplant configured as an intervertebral insert, a long bone, a cranial bone, a bone of the pelvis, or a bone of the hand or foot or section thereof.
Claim 14
Dependent Claim
20 words
The method of claim 1 wherein the osteoimplant possesses a compression strength of from about 10 to about 200 Mpa.
Claim 15
Dependent Claim
19 words
The method of claim 1 wherein the bone-derived elements are partially demineralized particles, strips or sheets of cortical bone.
Claim 16
Dependent Claim
14 words
The method of claim 1 wherein the bone-derived elements comprise sheets of cortical bone.
Claim 17
Dependent Claim
18 words
The method of claim 12 wherein at least one of the sheets is coated with demineralized bone powder.
Claim 18
Dependent Claim
27 words
The method of claim 12 wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 19
Dependent Claim
15 words
The method of claim 12 wherein at least one of the sheets is fully demineralized.
Claim 20
Dependent Claim
13 words
The method of claim 12 wherein each sheet is approximately 1.5 mm thick.
Claim 21
Dependent Claim
29 words
The method of claim 12 wherein the sheets are assembled into a layered structure prior to forming the chemical linkages between the surface-exposed collagen of the adjacent bone-derived elements.
Claim 22
Dependent Claim
32 words
The method of claim 1 wherein the bone-derived elements are combined with at least one other component prior to forming the chemical linkages between the surface-exposed collagen of the adjacent bone-derived elements.
Claim 23
Dependent Claim
54 words
The method of claim 18 wherein the component is selected from the group consisting of reinforcing particles, reinforcing fibers, fillers, bone-growth inducing substances, growth factors, fully mineralized bone, adhesives, plasticizers, flexibilizing agents, cellular material, genetic material, calcification-controlling agents, hydration facilitating agents, biostatic agents, biocidal agents, polymers, inorganic compounds, substances imparting radiopacity and metallic meshes.
Claim 24
Dependent Claim
15 words
The method of claim 1 wherein the osteoimplant possesses pores, perforations, apertures, channels, or spheres.
Claim 25
Dependent Claim
26 words
The method of claim 20 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
Claim 26
Dependent Claim
19 words
The method of claim 1 wherein the osteoimplant possesses a thickness of from about 2 to about 20 mm.
Claim 27
Dependent Claim
23 words
The method of claim 1 wherein the bone-derived elements comprise a mixture of fully demineralized fibers and partially demineralized fibers of cortical bone.
Claim 28
Dependent Claim
15 words
The method of claim 23 which further comprises forming the fibers into a cylindrical shape.
Claim 29
Dependent Claim
17 words
The method of claim 1 which further comprises incorporating at least one mechanical fastener to the osteoimplant.
Claim 30
Dependent Claim
20 words
The method of claim 25 wherein the mechanical fastener is selected from the group consisting of pins, screws, and dowels.
Claim 31
Dependent Claim
15 words
The method of claim 1 wherein the bone-derived elements are provided with mechanically interengaging features.
Claim 32
Dependent Claim
14 words
The method of claim 27 wherein the bone-derived elements comprise sheets of cortical bone.
Claim 33
Dependent Claim
15 words
The method of claim 1 wherein the solid aggregate is cut to provide the osteoimplant.
Claim 34
Dependent Claim
23 words
The method of claim 2 wherein the bone-derived elements are substantially completely demineralized particles, strips or sheets of allogenic and/or xenogenic cortical bone.
Claim 35
Dependent Claim
16 words
The method of claim 2 wherein the osteoimplant is configured as a bone or section thereof.
Claim 36
Dependent Claim
20 words
The method of claim 2 wherein the osteoimplant possesses a compression strength of from about 10 to about 200 Mpa.
Claim 37
Dependent Claim
19 words
The method of claim 2 wherein the bone-derived elements are partially demineralized particles, strips or sheets of cortical bone.
Claim 38
Dependent Claim
32 words
The method of claim 2 wherein the bone-derived elements are combined with at least one other component prior to forming the chemical linkages between the surface-exposed collagen of the adjacent bone-derived elements.
Claim 39
Dependent Claim
52 words
The method of claim 34 wherein the component is selected from the group consisting of reinforced particles, reinforcing fibers, fillers, bone-growth inducing substances, growth factors, fully mineralized bone, adhesives, plasticizers, flexibilizing agents, cellular material, genetic material, calcification-controlling agents, hydration facilitating agents, biostatic agents, polymers, inorganic compounds, substances imparting radiopacity and metallic meshes.
Claim 40
Dependent Claim
23 words
The method of claim 2 wherein the bone-derived elements comprise a mixture of fully demineralized fibers and partially demineralized fibers of cortical bone.
Claim 41
Dependent Claim
23 words
The method of claim 3 wherein the bone-derived elements are substantially completely demineralized particles, strips or sheets of allogenic and/or xenogenic cortical bone.
Claim 42
Dependent Claim
16 words
The method of claim 3 wherein the osteoimplant is configured as a bone or section thereof.
Claim 43
Dependent Claim
20 words
The method of claim 3 wherein the osteoimplant possesses a compression strength of from about 10 to about 200 Mpa.
Claim 44
Dependent Claim
19 words
The method of claim 3 wherein the bone-derived elements are partially demineralized particles, strips or sheets of cortical bone.
Claim 45
Dependent Claim
32 words
The method of claim 3 wherein the bone-derived elements are combined with at least one other component prior to forming the chemical linkages between the surface-exposed collagen of the adjacent bone-derived elements.
Claim 46
Dependent Claim
52 words
The method of claim 41 wherein the component is selected from the group consisting of reinforced particles, reinforcing fibers, fillers, bone-growth inducing substances, growth factors, fully mineralized bone, adhesives, plasticizers, flexibilizing agents, cellular material, genetic material, calcification-controlling agents, hydration facilitating agents, biostatic agents, polymers, inorganic compounds, substances imparting radiopacity and metallic meshes.
Claim 47
Dependent Claim
23 words
The method of claim 3 wherein the bone-derived elements comprise a mixture of fully demineralized fibers and partially demineralized fibers of cortical bone.
Claim 48
Dependent Claim
23 words
The method of claim 5 wherein the bone-derived elements are substantially completely demineralized particles, strips or sheets of allogenic and/or xenogenic cortical bone.
Claim 49
Dependent Claim
28 words
The method of claim 5 wherein the chemical linkages are formed by dehydrothermal treatment which comprises heating the bone-derived elements to remove water therefrom and removing the water.
Claim 50
Dependent Claim
20 words
The method of claim 5 wherein the osteoimplant possesses a compression strength of from about 10 to about 200 Mpa.
Claim 51
Dependent Claim
19 words
The method of claim 5 wherein the bone-derived elements are partially demineralized particles, strips or sheets of cortical bone.
Claim 52
Dependent Claim
32 words
The method of claim 5 wherein the bone-derived elements are combined with at least one other component prior to forming the chemical linkages between the surface-exposed collagen of the adjacent bone-derived elements.
Claim 53
Dependent Claim
52 words
The method of claim 48 wherein the component is selected from the group consisting of reinforced particles, reinforcing fibers, fillers, bone-growth inducing substances, growth factors, fully mineralized bone, adhesives, plasticizers, flexibilizing agents, cellular material, genetic material, calcification-controlling agents, hydration facilitating agents, biostatic agents, polymers, inorganic compounds, substances imparting radiopacity and metallic meshes.
Claim 54
Dependent Claim
15 words
The method of claim 5 wherein the osteoimplant possesses pores, perforations, apertures, channels, or spaces.
Claim 55
Dependent Claim
26 words
The method of claim 50 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
Claim 56
Dependent Claim
23 words
The method of claim 5 wherein the bone-derived elements comprise a mixture of fully demineralized fibers and partially demineralized fibers of cortical bone.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-09-24 | 2005-03-26 | 2005-09-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-09-24 | 2009-03-26 | 2009-09-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-09-24 | 2013-03-26 | 2013-09-25 | $7700.00 | Window Closed / Lapsed |