US6189537B1
Expired / Lapsed
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Process for producing osteoinductive bone, and osteoinductive bone produced thereby
Assignee: Lifenet Health
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Filing: 1996-09-06
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Granted: 2001-02-20
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Expires: 2016-09-06
Abstract
Abstract The invention produces osteoinductive bone using a controlled-flow apparatus. The apparatus allows for the controlled extraction of undesirable constituents from a body tissue. The invention provides for the demineralization of ground bone particles or pieces of cancellous or cortical bone which permits the controlled and reproducible demineralization of bone to produce bone which is maximally osteoinductive. It has been demonstrated that ground cadaveric bone which is demineralized to a residual calcium level approximating 2% by dry weight of bone is optimally osteoinductive as assayed using in vivo and in vitro assays of osteoinductivity. The controlled-flow apparatus includes one or more solution containers which supply solutions to be pumped into one or more vessels filled with tissue samples to be extracted. Solvent outflowing from the vessels can be monitored for pH, calcium ion concentration or conductivity as a basis for determining when extraction is complete. Using the invention, a linear relationship has been shown to exist between eluent pH and percent residual calcium in the bone being demineralized. Thus, the invention permits the reproducible demineralization of bone which is optimally osteoinductive. The invention also corrects the percent residual calcium in bone which is overly demineralized, returning it to a state of being optimally osteoinductive.
Inventors
- 👤 Lloyd Wolfinbarger, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 21:56
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2/30; A61F2/46; A61F2/4644; A61L27/3604; A61L27/3608; A61L27/3641; A61L27/3645; A61L27/365; B; B01; B01D; B01D11/00; B01D11/02; B01D11/0215; B01D11/0253; B01D11/0257; A61F2/3094; A61L2430/00; A61L2430/02; A61L2430/40; Y; Y10; Y10S; Y10S623/00; Y10S623/901; Y10S623/92; Y10S623/923
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
39 words
A process for producing osteoinductive bone, comprising the step of: contacting bone with an acid solvent under conditions effective to demineralize said bone to contain 1.8 wt % to 2.5 wt % residual calcium, wherein osteoinductive bone is produced.
Claim 2
Dependent Claim
39 words
A process for producing osteoinductive bone, comprising the step of: contacting bone with an acid solvent under conditions effective to demineralize said bone to contain 1.8 wt % to 2.5 wt % residual calcium, wherein osteoinductive bone is produced.
Claim 3
Dependent Claim
25 words
The process of claim 1 , wherein said step of contacting comprises: contacting said bone with a continuous flow of one or more acidic solvents.
Claim 4
Dependent Claim
29 words
The process of claim 1 , wherein said step of contacting with acidic solvent is carried out for a time of from about 80 min. to about 200 min.
Claim 5
Dependent Claim
70 words
A process for producing osteoinductive bone demineralized to contain 1.8 wt % to 2.5 wt % residual calcium comprising the step of: contacting said bone with a flow of detergent solvent to produce bone substantially free from bone marrow elements; contacting said bone with a flow of acidic solvent under conditions effective to demineralize bone to contain 1.8 wt % to 2.5 wt % residual calcium, to produce osteoinductive bone.
Claim 6
Dependent Claim
70 words
A process for producing osteoinductive bone demineralized to contain 1.8 wt % to 2.5 wt % residual calcium comprising the step of: contacting said bone with a flow of detergent solvent to produce bone substantially free from bone marrow elements; contacting said bone with a flow of acidic solvent under conditions effective to demineralize bone to contain 1.8 wt % to 2.5 wt % residual calcium, to produce osteoinductive bone.
Claim 7
Dependent Claim
15 words
The process of claim 4 , further comprising the step of: dehydrating said osteoinductive bone.
Claim 8
Dependent Claim
22 words
The process of claim 5 , wherein said dehydrating step comprises: contacting said osteoinductive bone with a flow of a dehydrating solvent.
Claim 9
Dependent Claim
15 words
The process of claim 6 , wherein said dehydrating solvent comprises: one or more alcohols.
Claim 10
Dependent Claim
51 words
The process of claim 4 , further comprising: periodically sampling pH of an eluent acidic solvent during said step of contacting said bone with a flow of acidic solvent until a pH of from about 0.8 to about 1.5 has been reached; washing said bone with water to produce osteoinductive bone.
Claim 11
Dependent Claim
97 words
A process for producing osteoinductive bone, comprising: contacting bone in a container, said container, comprising having an inlet and an outlet, with a flow of acid solvent wherein said acid solvent flows into said container through said inlet and eluent acid solvent exits said container through said outlet; periodically sampling pH of eluent acid solvent exiting container through said outlet, during said step of contacting until eluent acid solvent reaches a pH of from 0.8 to 1.5 to produce demineralized bone; and washing said demineralized bone with water to produce osteoinductive bone, wherein osteoinductive bone is produced.
Claim 12
Dependent Claim
97 words
A process for producing osteoinductive bone, comprising: contacting bone in a container, said container, comprising having an inlet and an outlet, with a flow of acid solvent wherein said acid solvent flows into said container through said inlet and eluent acid solvent exits said container through said outlet; periodically sampling pH of eluent acid solvent exiting container through said outlet, during said step of contacting until eluent acid solvent reaches a pH of from 0.8 to 1.5 to produce demineralized bone; and washing said demineralized bone with water to produce osteoinductive bone, wherein osteoinductive bone is produced.
Claim 13
Dependent Claim
38 words
The process of claim 9 , wherein said bone comprises one or more members selected from the group consisting of: ground bone; cortical or cancellous bone strips; cortical or cancellous bone cubes; and cortical or cancellous bone chips.
Claim 14
Dependent Claim
27 words
The process of claim 9 , wherein said step of contacting is carried out until said eluent acid solvent reaches a pH of from 0.9 to 1.2.
Claim 15
Dependent Claim
17 words
Osteoinductive bone produced by the process as claimed in any one of claims 9 or 11 .
Claim 16
Dependent Claim
31 words
The process of claim 9 , further comprising; prior to said step of contacting, subjecting said bone to a flow of detergent solution to remove bone marrow elements from said bone.
Claim 17
Independent Claim
74 words
A method for producing osteoinductive bone from demineralized bone having less than 2.0 wt % residual calcium, comprising: suspending said demineralized bone in calcium phosphate at a pH of from 1.5 to 3.5 to produce a suspension; incubating said suspension to form an incubated suspension; adjusting pH of said incubated suspension to from 5.5 to 8.5 to produce adjusted suspension; and washing said adjusted suspension to produce osteoinductive bone, wherein osteoinductive bone is produced.
Claim 18
Independent Claim
74 words
A method for producing osteoinductive bone from demineralized bone having less than 2.0 wt % residual calcium, comprising: suspending said demineralized bone in calcium phosphate at a pH of from 1.5 to 3.5 to produce a suspension; incubating said suspension to form an incubated suspension; adjusting pH of said incubated suspension to from 5.5 to 8.5 to produce adjusted suspension; and washing said adjusted suspension to produce osteoinductive bone, wherein osteoinductive bone is produced.
Claim 19
Dependent Claim
19 words
The method of claim 14 , wherein said suspension is incubated for from about 2.5 to about 15 minutes.
Claim 20
Dependent Claim
27 words
Osteoinductive bone suitable for use in humans, comprising: bone demineralized to an extent that bone produced contains approximately 2.0 wt % to 2.2 wt % residual calcium.
Claim 21
Dependent Claim
27 words
Osteoinductive bone suitable for use in humans, comprising: bone demineralized to an extent that bone produced contains approximately 2.0 wt % to 2.2 wt % residual calcium.
Claim 22
Dependent Claim
25 words
The process of any one of claims 1 , 9 , 14 , or 16 , wherein said osteoinductive bone comprises human or animal bone.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-02-20 | 2004-08-21 | 2005-02-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-02-20 | 2008-08-21 | 2009-02-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-02-20 | 2012-08-21 | 2013-02-20 | $7700.00 | Window Closed / Lapsed |