US6037519A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Ceramic fusion implants and compositions
Assignee: Warsaw Orthopedic Inc
•
Filing: 1997-10-20
•
Granted: 2000-03-14
•
Expires: 2017-10-20
Abstract
Abstract Bone graft substitute compositions are provided for promoting new bone growth and arthrodesis. The compositions include a carrier for controlled delivery of osteoinductive factors. In one embodiment, the carriers include a biphasic calcium phosphate ceramic having between about 2-40% hydroxyapatite and about 98-60% tricalcium phosphate by volume, and a calcium/phosphorous ratio of between about 1.50 to about 1.60. The invention also includes osteoinductive compositions including the carriers and an effective amount of a bone morphogenetic protein dispersed within the ceramic. The composition has a weight ratio of protein to ceramic of no more than about 1:200. In a specific embodiment, the weight ratio of protein to ceramic is between about 1:200 and about 1:2000. Spinal implants (10) are also provided which include a body (11) having a wall (12) sized for engagement within a space (S) between adjacent vertebrae (V) to maintain the space (S) and a confining matrix (13) for confining new bone growth to the body (11). The matrix (13) includes a biphasic calcium phosphate ceramic which degrades at a rate to provide calcium and phosphate for the new bone growth without reduced density of bone adjacent the space and an effective amount of a substantially pure osteogenic factor bound to the ceramic.
Inventors
- 👤 William F. McKay
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 23:43
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/40; A61L27/42; A61L27/425; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2/30; A61F2/44; A61F2/4455; A61F2/446; A61F2/4465; A61F2/447; A61L27/02; A61L27/12; A61L27/50; A61L27/54; A61L31/00; A61L31/02; A61L31/026; A61L31/12; A61L31/121; A61L31/123; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/68; A61B17/70; A61B17/7062; A61F2/4405; A61F2/442; A61F2002/2817; A61F2002/2835; A61F2002/30001; A61F2002/30108; A61F2002/3011; A61F2002/30112; A61F2002/30113; A61F2002/30133; A61F2002/30138; A61F2002/30153; A61F2002/30199; A61F2002/30224; A61F2002/30261; A61F2002/30621; A61F2002/30622; A61F2002/30667; A61F2002/30677; A61F2002/448; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61F2230/0015; A61F2230/0017; A61F2230/0019; A61F2230/0063; A61F2230/0069; A61F2230/0082; A61F2310/00; A61F2310/00005; A61F2310/00179; A61F2310/00293; A61L2430/00; A61L2430/38; Y; Y10; Y10S; Y10S606/00; Y10S606/907; Y10S606/912
Claims Analysis
Total Claims: 54
Claim 1
Independent Claim
90 words
A spinal implant, comprising: a body having an outer wall of a height sufficient for engagement within a space between adjacent vertebrae to maintain the space, a superior bone engaging surface, an inferior bone engaging surface, a confining matrix between said surfaces for confining new bone growth to said matrix, said confining matrix having pores and including a biphasic calcium phosphate ceramic having between about 2-40% hydroxyapatite and between about 98-60% tricalcium phosphate by volume; and a therapeutically effective amount of a bone growth inductive factor entrapped within said matrix.
Claim 2
Dependent Claim
90 words
A spinal implant, comprising: a body having an outer wall of a height sufficient for engagement within a space between adjacent vertebrae to maintain the space, a superior bone engaging surface, an inferior bone engaging surface, a confining matrix between said surfaces for confining new bone growth to said matrix, said confining matrix having pores and including a biphasic calcium phosphate ceramic having between about 2-40% hydroxyapatite and between about 98-60% tricalcium phosphate by volume; and a therapeutically effective amount of a bone growth inductive factor entrapped within said matrix.
Claim 3
Dependent Claim
20 words
The spinal implant of claim 1, wherein said ceramic has a calcium/phosphorous ratio of between about 1.50 to about 1.60.
Claim 4
Dependent Claim
16 words
The spinal implant of claim 2, wherein said ceramic has a calcium/phosphorous ratio of about 1.51.
Claim 5
Dependent Claim
17 words
The spinal implant of claim 1, wherein said bone growth inductive factor is a bone morphogenetic protein.
Claim 6
Dependent Claim
32 words
The spinal implant of claim 4, wherein said bone morphogenetic protein is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12 and BMP-13.
Claim 7
Dependent Claim
23 words
The spinal implant of claim 5, wherein said bone morphogenetic protein is a heterodimer of at least two BMPs selected from said group.
Claim 8
Dependent Claim
15 words
The spinal implant of claim 6, wherein said heterodimer is a BMP-2 and BMP-7 heterodimer.
Claim 9
Dependent Claim
16 words
The spinal implant of claim 4, wherein said bone morphogenetic protein is a bovine extracted BMP.
Claim 10
Dependent Claim
21 words
The spinal implant of claim 1, wherein said implant has a kidney-shaped cross-section to conform to the shape of vertebral endplates.
Claim 11
Dependent Claim
11 words
The spinal implant of claim 1, wherein said body is rectangular-shaped.
Claim 12
Dependent Claim
26 words
The spinal implant of claim 1, wherein said implant has a weight ratio of bone growth inductive factor to ceramic of no more than about 1:200.
Claim 13
Dependent Claim
27 words
The spinal implant of claim 11, wherein said implant has a weight ratio of bone growth inductive factor to ceramic of between about 1:200 and about 1:2000.
Claim 14
Dependent Claim
23 words
The spinal implant of claim 12, wherein said implant has a weight ratio of bone growth inductive factor to ceramic of about 1:1250.
Claim 15
Dependent Claim
24 words
The spinal implant of claim 1, wherein said biphasic calcium phosphate ceramic has a pore size from about 200 microns to about 600 microns.
Claim 16
Dependent Claim
21 words
The spinal implant of claim 1, wherein said biphasic calcium phosphate ceramic has a porosity between about 60% to about 80%.
Claim 17
Dependent Claim
12 words
The spinal implant of claim 15, wherein said porosity of about 70%.
Claim 18
Dependent Claim
24 words
The spinal implant of claim 1, wherein said biphasic calcium phosphate ceramic includes between about 2-20% hydroxyapatite and about 80-98% tricalcium phosphate by volume.
Claim 19
Dependent Claim
22 words
The spinal implant of claim 17, wherein said biphasic calcium phosphate ceramic includes between about 5-20% hydroxyapatite and about 80-95% tricalcium phosphate.
Claim 20
Dependent Claim
21 words
The spinal implant of claim 18 wherein said biphasic calcium phosphate ceramic includes about 20% hydroxyapatite and about 80% tricalcium phosphate.
Claim 21
Dependent Claim
46 words
An osteoinductive composition comprising: a biphasic calcium phosphate ceramic carrier including between about 2-40% hydroxyapatite and about 98-60% tricalcium phosphate by volume; and a therapeutically effective amount of a bone growth inductive factor dispersed within said carrier for controlled formation of new bone within said carrier.
Claim 22
Dependent Claim
46 words
An osteoinductive composition comprising: a biphasic calcium phosphate ceramic carrier including between about 2-40% hydroxyapatite and about 98-60% tricalcium phosphate by volume; and a therapeutically effective amount of a bone growth inductive factor dispersed within said carrier for controlled formation of new bone within said carrier.
Claim 23
Dependent Claim
21 words
The osteoinductive composition of claim 20, wherein said ceramic carrier includes between 2-20% hydroxyapatite and between 80-98% tricalcium phosphate by volume.
Claim 24
Dependent Claim
20 words
The osteoinductive composition of claim 21, wherein said ceramic carrier includes between 5-20% hydroxyapatite and 80-95% tricalcium phosphate by volume.
Claim 25
Dependent Claim
19 words
The osteoinductive composition of claim 22, wherein said ceramic carrier includes 20% hydroxyapatite and 80% tricalcium phosphate by volume.
Claim 26
Dependent Claim
21 words
The osteoinductive composition of claim 20, wherein said ceramic carrier has a calcium/phosphorous ratio of between about 1.50 to about 1.60.
Claim 27
Dependent Claim
17 words
The osteoinductive composition of claim 24, wherein said ceramic carrier has a calcium/phosphorous ratio of about 1.51.
Claim 28
Dependent Claim
17 words
The osteoinductive composition of claim 20, wherein said bone growth inductive factor is a bone morphogenetic protein.
Claim 29
Dependent Claim
32 words
The osteoinductive composition of claim 26, wherein said bone morphogenetic protein is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12 and BMP-13.
Claim 30
Dependent Claim
23 words
The osteoinductive composition of claim 27, wherein said bone morphogenetic protein is a heterodimer of at least two BMPs selected from said group.
Claim 31
Dependent Claim
16 words
The osteoinductive composition of claim 26, wherein said bone morphogenetic protein is a recombinant human BMP.
Claim 32
Dependent Claim
16 words
The osteoinductive composition of claim 26, wherein said bone morphogenetic protein is a bovine extracted BMP.
Claim 33
Dependent Claim
25 words
The osteoinductive composition of claim 20, wherein said composition has a ratio of bone growth inductive factor to ceramic of no more than about 1:200.
Claim 34
Dependent Claim
23 words
The osteoinductive composition of claim 31, wherein said composition has a ratio of factor to ceramic of between about 1:200 to about 1:2000.
Claim 35
Dependent Claim
19 words
The osteoinductive composition of claim 32, wherein said composition has a ratio of factor to ceramic of about 1:1250.
Claim 36
Dependent Claim
22 words
The osteoinductive composition of claim 20, wherein said ceramic carrier is a body having a porosity between about 60% to about 80%.
Claim 37
Dependent Claim
12 words
The osteoinductive composition of claim 34, wherein said porosity is about 70%.
Claim 38
Dependent Claim
25 words
The osteoinductive composition of claim 20, wherein said ceramic carrier is a body having a pore size from about 200 microns to about 600 microns.
Claim 39
Dependent Claim
14 words
The osteoinductive composition of claim 20, wherein said ceramic carrier is in granular form.
Claim 40
Dependent Claim
41 words
A carrier for controlled delivery of a bone growth inductive factor, comprising a porous biphasic calcium phosphate ceramic having between about 2-40% hydroxyapatite and about 98-60% tricalcium phosphate, said ceramic having a calcium/phosphorous ratio of between about 1.50 to about 1.60.
Claim 41
Dependent Claim
41 words
A carrier for controlled delivery of a bone growth inductive factor, comprising a porous biphasic calcium phosphate ceramic having between about 2-40% hydroxyapatite and about 98-60% tricalcium phosphate, said ceramic having a calcium/phosphorous ratio of between about 1.50 to about 1.60.
Claim 42
Dependent Claim
15 words
The carrier of claim 38, wherein said ceramic has a calcium/phosphorous ratio of about 1.51.
Claim 43
Dependent Claim
24 words
The carrier of claim 38, wherein said ceramic is in the form of a body having a porosity between about 60% to about 80%.
Claim 44
Dependent Claim
11 words
The carrier of claim 40, wherein said porosity is about 70%.
Claim 45
Dependent Claim
20 words
The carrier of claim 38, wherein said ceramic has a pore size from about 200 microns to about 600 microns.
Claim 46
Dependent Claim
20 words
The carrier of claim 38, wherein said ceramic includes between about 2-20% hydroxyapatite and about 80-98% tricalcium phosphate by volume.
Claim 47
Dependent Claim
20 words
The carrier of claim 43, wherein said ceramic includes between about 5-20% hydroxyapatite and about 80-95% tricalcium phosphate by volume.
Claim 48
Dependent Claim
19 words
The carrier of claim 44, wherein said ceramic includes about 20% hydroxyapatite and about 80% tricalcium phosphate by volume.
Claim 49
Dependent Claim
51 words
An implant, comprising: a porous ceramic body defining a confining matrix for confining new bone growth within said body; and a therapeutically effective amount of a bone growth inductive factor entrapped within said matrix at a weight ratio of bone growth inductive factor to ceramic of no more than about 1:200.
Claim 50
Dependent Claim
51 words
An implant, comprising: a porous ceramic body defining a confining matrix for confining new bone growth within said body; and a therapeutically effective amount of a bone growth inductive factor entrapped within said matrix at a weight ratio of bone growth inductive factor to ceramic of no more than about 1:200.
Claim 51
Dependent Claim
15 words
The spinal implant of claim 46, wherein said weight ratio is between 1:200 and 1:2000.
Claim 52
Dependent Claim
12 words
The implant of claim 47, wherein said weight ratio is about 1:1250.
Claim 53
Dependent Claim
14 words
The implant of claim 46, wherein said ceramic is a biphasic calcium phosphate ceramic.
Claim 54
Dependent Claim
16 words
The implant of claim 46, wherein said bone growth inductive factor is a bone morphogenetic protein.
References Cited (Backward Citations)
US4097935A
Cited
US4294753A
Cited
US4596574A
Cited
US5108922A
Cited
US5366875A
Cited
US5187076A
Cited
US5013649A
Cited
US5116738A
Cited
US5106748A
Cited
US4820305A
Cited
US4878915A
Cited
US4877864A
Cited
US5015247A
Cited
US5026373A
Cited
US4961740A
Cited
US4961740B1
Cited
US5147402A
Cited
US5192327A
Cited
WO1993000432A1
Cited
US5306303A
Cited
US5769897A
Cited
US5464440A
Cited
EP0616814A1
Cited
WO1994026892A1
Cited
WO1994026893A1
Cited
US5756457A
Cited
WO1996040014A1
Cited
US5702449A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-03-14 | 2003-09-13 | 2004-03-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-03-14 | 2007-09-13 | 2008-03-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-03-14 | 2011-09-13 | 2012-03-14 | $7700.00 | Window Closed / Lapsed |