US6123731A
Expired / Lapsed
US
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Osteoimplant and method for its manufacture
Assignee: Warsaw Orthopedic Inc
•
Filing: 1998-02-06
•
Granted: 2000-09-26
•
Expires: 2018-02-06
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 04:03
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; A61L; A61L27/00; A61L27/36; A61L27/3604; A61L27/3608; A61L27/3641; A61L27/3645; A61L27/365; A61L27/3683; A61L27/3695; A61F2/2875; A61F2/3094; A61F2/44; A61F2/442; 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: 76
Claim 1
Independent Claim
81 words
An osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by exposing the bone-derived elements to a chemical crosslinking agent, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 2
Dependent Claim
81 words
An osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by exposing the bone-derived elements to a chemical crosslinking agent, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 3
Dependent Claim
75 words
An osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by application of energy, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 4
Dependent Claim
75 words
An osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by application of energy, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 5
Dependent Claim
74 words
A osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by dehydrothermal treatment, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 6
Dependent Claim
74 words
A osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their surface-exposed collagen, wherein the chemical linkages are formed by dehydrothermal treatment, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 7
Dependent Claim
74 words
A osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other though chemical linkages between their surface-exposed collagen wherein the chemical linkages are formed by enzymatic treatment, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 8
Dependent Claim
74 words
A osteoimplant which comprises a solid aggregate of bone-derived elements, adjacent bone-derived elements being bonded to each other though chemical linkages between their surface-exposed collagen wherein the chemical linkages are formed by enzymatic treatment, wherein the bone-derived elements are sheets obtained by longitudinally slicing the diaphyseal region of whole cortical bone, and wherein at least one of the sheets possesses a fully or partially demineralized outer surface and a nondemineralized or partially demineralized core.
Claim 9
Dependent Claim
39 words
The osteoimplant of claim 1 wherein the chemical crosslinking agent is selected from the group consisting of monoaldehydes, dialdehydes, polyepoxy compounds, polyvalent metallic oxides, organic tannins, phenolic oxides derived from plants, hydrazide, dicyclohexyl carbodiimide, hexamethylene diisocyanate, sugars and enzymes.
Claim 10
Dependent Claim
28 words
The osteoimplant of claim 1 wherein the bone-derived elements are exposed to the chemical crosslinking agent by placing the bone-derived elements in a solution of chemical crosslinking agent.
Claim 11
Dependent Claim
28 words
The osteoimplant of claim 1 wherein the bone-derived elements are exposed to the chemical crosslinking agent by exposing the bone-derived elements to vapors of the chemical crosslinking agent.
Claim 12
Dependent Claim
14 words
The osteoimplant of claim 1 wherein the chemical crosslinking agent is a polyepoxy compound.
Claim 13
Dependent Claim
15 words
The osteoimplant of claim 1 wherein the chemical crosslinking agent is a monoaldehyde or dialdehyde.
Claim 14
Dependent Claim
12 words
The osteoimplant of claim 1 wherein the chemical crosslinking agent is formalin.
Claim 15
Dependent Claim
15 words
The osteoimplant of claim 1 wherein the chemical crosslinking agent is polyethylene glycol diglycidyl ether.
Claim 16
Dependent Claim
12 words
The osteoimplant of claim 1 wherein the bone-derived elements are superficially demineralized.
Claim 17
Dependent Claim
12 words
The osteoimplant of claim 1 further comprising at least one other component.
Claim 18
Dependent Claim
54 words
The osteoimplant of claim 13 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 19
Dependent Claim
24 words
The osteoimplant of claim 1 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 10 to about 200 MPa.
Claim 20
Dependent Claim
24 words
The osteoimplant of claim 1 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 20 to about 200 MPa.
Claim 21
Dependent Claim
13 words
The osteoimplant of claim 1 wherein each sheet is approximately 1.5 mm thick.
Claim 22
Dependent Claim
24 words
The osteoimplant of claim 1 wherein the sheets are assembled into a layered structure prior to exposing the sheets to a chemical crosslinking agent.
Claim 23
Dependent Claim
15 words
The osteoimplant of claim 1 wherein at least one of the sheets is fully demineralized.
Claim 24
Dependent Claim
18 words
The osteoimplant of claim 1 wherein at least one of the sheets is coated with demineralized bone powder.
Claim 25
Dependent Claim
17 words
The osteoimplant of claim 18 possessing a total thickness of from about 2 to about 20 mm.
Claim 26
Dependent Claim
13 words
The osteoimplant of claim 1 configured and dimensioned as a square or rectangle.
Claim 27
Dependent Claim
11 words
The osteoimplant of claim 1 configured and dimensioned as a cylinder.
Claim 28
Dependent Claim
22 words
The osteoimplant of claim 1 wherein the solid aggregate of bone-derived elements possesses a network of pores, perforations, apertures, channels, or spaces.
Claim 29
Dependent Claim
26 words
The osteoimplant of claim 24 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
Claim 30
Dependent Claim
10 words
The osteoimplant of claim 2 wherein the energy is heat.
Claim 31
Dependent Claim
11 words
The osteoimplant of claim 2 wherein the energy is radiant energy.
Claim 32
Dependent Claim
14 words
The osteoimplant of claim 2 wherein the energy is ultraviolet light or microwave energy.
Claim 33
Dependent Claim
13 words
The osteoimplant of claim 2 wherein the application of energy comprises dye-mediated photo-oxidation.
Claim 34
Dependent Claim
12 words
The osteoimplant of claim 2 wherein the bone-derived elements are superficially demineralized.
Claim 35
Dependent Claim
12 words
The osteoimplant of claim 2 further comprising at least one other component.
Claim 36
Dependent Claim
54 words
The osteoimplant of claim 31 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 37
Dependent Claim
24 words
The osteoimplant of claim 2 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 10 to about 200 MPa.
Claim 38
Dependent Claim
24 words
The osteoimplant of claim 2 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 20 to about 200 MPa.
Claim 39
Dependent Claim
13 words
The osteoimplant of claim 2 wherein each sheet is approximately 1.5 mm thick.
Claim 40
Dependent Claim
21 words
The osteoimplant of claim 2 wherein the sheets are assembled into a layered structure prior to applying energy to the sheets.
Claim 41
Dependent Claim
15 words
The osteoimplant of claim 2 wherein at least one of the sheets is fully demineralized.
Claim 42
Dependent Claim
18 words
The osteoimplant of claim 2 wherein at least one of the sheets is coated with demineralized bone powder.
Claim 43
Dependent Claim
17 words
The osteoimplant of claim 36 possessing a total thickness of from about 2 to about 20 mm.
Claim 44
Dependent Claim
13 words
The osteoimplant of claim 2 configured and dimensioned as a square or rectangle.
Claim 45
Dependent Claim
11 words
The osteoimplant of claim 2 configured and dimensioned as a cylinder.
Claim 46
Dependent Claim
22 words
The osteoimplant of claim 2 wherein the solid aggregate of bone-derived elements possesses a network of pores, perforations, apertures, channels, or spaces.
Claim 47
Dependent Claim
26 words
The osteoimplant of claim 42 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
Claim 48
Dependent Claim
12 words
The osteoimplant of claim 3 wherein the bone-derived elements are superficially demineralized.
Claim 49
Dependent Claim
12 words
The osteoimplant of claim 3 further comprising at least one other component.
Claim 50
Dependent Claim
54 words
The osteoimplant of claim 3 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 51
Dependent Claim
24 words
The osteoimplant of claim 3 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 10 to about 200 MPa.
Claim 52
Dependent Claim
24 words
The osteoimplant of claim 3 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 20 to about 200 MPa.
Claim 53
Dependent Claim
13 words
The osteoimplant of claim 3 wherein each sheet is approximately 1.5 mm thick.
Claim 54
Dependent Claim
22 words
The osteoimplant of claim 3 wherein the sheets are assembled into a layered structure prior to subjecting the sheets to dehydrothermal treatment.
Claim 55
Dependent Claim
15 words
The osteoimplant of claim 3 wherein at least one of the sheets is fully demineralized.
Claim 56
Dependent Claim
18 words
The osteoimplant of claim 3 wherein at least one of the sheets is coated with demineralized bone powder.
Claim 57
Dependent Claim
17 words
The osteoimplant of claim 50 possessing a total thickness of from about 2 to about 20 mm.
Claim 58
Dependent Claim
13 words
The osteoimplant of claim 3 configured and dimensioned as a square or rectangle.
Claim 59
Dependent Claim
11 words
The osteoimplant of claim 3 configured and dimensioned as a cylinder.
Claim 60
Dependent Claim
22 words
The osteoimplant of claim 3 wherein the solid aggregate of bone-derived elements possesses a network of pores, perforations, apertures, channels, or spaces.
Claim 61
Dependent Claim
26 words
The osteoimplant of claim 56 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
Claim 62
Dependent Claim
12 words
The osteoimplant of claim 4 wherein the enzymatic treatment comprises tissue transglutaminase.
Claim 63
Dependent Claim
12 words
The osteoimplant of claim 4 wherein the bone-derived elements are superficially demineralized.
Claim 64
Dependent Claim
12 words
The osteoimplant of claim 4 further comprising at least one other component.
Claim 65
Dependent Claim
54 words
The osteoimplant of claim 60 wherein the component is selected from the group consisting of reinforcing particles, reinforcing fibers, fillers, bone-growth inducing substances, growth factors, filly 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 66
Dependent Claim
24 words
The osteoimplant of claim 4 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 10 to about 200 MPa.
Claim 67
Dependent Claim
24 words
The osteoimplant of claim 4 wherein the solid aggregate of bone-derived elements possesses a compression strength of from about 20 to about 200 MPa.
Claim 68
Dependent Claim
13 words
The osteoimplant of claim 4 wherein each sheet is approximately 1.5 mm thick.
Claim 69
Dependent Claim
22 words
The osteoimplant of claim 4 wherein the sheets are assembled into a layered structure prior to subjecting the sheets to enzymatic treatment.
Claim 70
Dependent Claim
15 words
The osteoimplant of claim 4 wherein at least one of the sheets is fully demineralized.
Claim 71
Dependent Claim
18 words
The osteoimplant of claim 4 wherein at least one of the sheets is coated with demineralized bone powder.
Claim 72
Dependent Claim
17 words
The osteoimplant of claim 65 possessing a total thickness of from about 2 to about 20 mm.
Claim 73
Dependent Claim
13 words
The osteoimplant of claim 4 configured and dimensioned as a square or rectangle.
Claim 74
Dependent Claim
11 words
The osteoimplant of claim 4 configured and dimensioned as a cylinder.
Claim 75
Dependent Claim
22 words
The osteoimplant of claim 4 wherein the solid aggregate of bone-derived elements possesses a network of pores, perforations, apertures, channels, or spaces.
Claim 76
Dependent Claim
26 words
The osteoimplant of claim 71 wherein the pores, perforations, apertures, channels or spaces have incorporated therein one or more bone growth inducing or bone healing substances.
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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) | 2003-09-26 | 2004-03-27 | 2004-09-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-09-26 | 2008-03-27 | 2008-09-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-09-26 | 2012-03-27 | 2012-09-26 | $7700.00 | Window Closed / Lapsed |