US6214368B1
Expired / Lapsed
US
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Bone substitution material and a method of its manufacture
Assignee: Etex Corp
•
Filing: 1996-05-20
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Granted: 2001-04-10
•
Expires: 2016-05-20
Abstract
Abstract The present invention provides a novel process for converting a standard inert amorphous calcium phosphate precipitate into highly reactive amorphous solids. The amorphous solids can be used to react with other calcium phosphate solids to form a poorly-crystalline synthetic hydroxyapatite that provides both bioactivity and structural integrity. This novel amorphous material can be reacted with other calcium phosphates at or below 37° C. to form a bone-like material consisting of poorly crystalline hydroxyapatite.
Inventors
- 👤 Dosuk D. Lee
- 👤 Christian Rey
- 👤 Maria Aiolova
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:39
CPC Classifications
C; C04; C04B; C04B28/00; C04B28/34; C04B28/344; C01; C01B; C01B25/00; C01B25/16; C01B25/26; C01B25/32; A; A61; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2/30; A61F2/30756; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2009; A61L; A61L24/00; A61L24/02; A61L27/00; A61L27/02; A61L27/12; A61L27/36; A61L27/38; A61L27/40; A61L27/42; A61L27/425; C01B25/321; C01B25/325; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30762; A61F2/46; A61F2/4644; A61F2002/4648; A61F2210/00; A61F2210/0004; A61F2310/00; A61F2310/00005; A61F2310/00179; A61F2310/00293; A61L2400/00; A61L2400/06; A61L2430/00; A61L2430/02; C04B2111/00; C04B2111/00474; C04B2111/00836; Y; Y10; Y10S; Y10S977/00; Y10S977/70; Y10S977/773; Y10S977/775; Y10S977/776; Y10S977/778; Y10S977/779; Y10S977/832; Y10S977/833; Y10S977/84; Y10S977/895; Y10S977/896; Y10S977/90; Y10S977/902; Y10S977/904; Y10S977/915; Y10S977/926
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
101 words
A formable paste, suitable for use as a bone substitution material, comprising: a powder comprising a first calcium phosphate material having at least 90% amorphous character and an acidic second calcium phosphate material, the powder having a calcium to phosphorous molar ratio in the range of about 1.2 to 1.68; and a fluid in an amount to provide a formable or injectable consistency, said paste remaining injectable or formable for a time greater than about 60 minutes at about 22° C. and hardenable within about 30 minutes at about 37° C., said paste suitable for use as a bone substitute material.
Claim 2
Dependent Claim
101 words
A formable paste, suitable for use as a bone substitution material, comprising: a powder comprising a first calcium phosphate material having at least 90% amorphous character and an acidic second calcium phosphate material, the powder having a calcium to phosphorous molar ratio in the range of about 1.2 to 1.68; and a fluid in an amount to provide a formable or injectable consistency, said paste remaining injectable or formable for a time greater than about 60 minutes at about 22° C. and hardenable within about 30 minutes at about 37° C., said paste suitable for use as a bone substitute material.
Claim 3
Dependent Claim
25 words
The past of claim 1 , wherein the mixture is injectable and formable at about 4° C. for a time up to about 12 hours.
Claim 4
Dependent Claim
27 words
The past of claim 1 , wherein said paste converts into a poorly crystalline hydroxyapatite having the X-ray diffraction pattern of naturally occurring bone within five hours.
Claim 5
Dependent Claim
28 words
The paste of claim 1 , wherein said paste converts into a poorly crystalline hydroxyapatite having the X-ray diffraction pattern of naturally occurring bone within seventy five minutes.
Claim 6
Dependent Claim
21 words
The paste of claim 1 , wherein the paste is hardenable within about 10 to 30 minutes at about 37° C.
Claim 7
Dependent Claim
23 words
The paste of claim 1 , wherein the material comprises a promoter selected to convert the calcium phosphate into a hydroxyapatitic calcium phosphate.
Claim 8
Dependent Claim
29 words
The paste of claim 1 , wherein the fluid is selected from the group consisting of water, a physiologically acceptable pH-buffered solution, saline solution, serum and tissue culture medium.
Claim 9
Dependent Claim
20 words
The paste of claim 1 , wherein the mixture comprises a second calcium phosphate powder which is amorphous or microcrystalline.
Claim 10
Dependent Claim
35 words
The paste of claim 1 , wherein the second calcium phosphate powders selected from the group consisting of dicalcium phosphate dihydrate, calcium metaphosphate, heptacalcium phosphate, poorly crystalline hydroxyapatite, calcium pyrophosphates, octacalcium phosphate, and tricalcium phosphates.
Claim 11
Dependent Claim
13 words
The paste of claim 1 or 8 , further comprising additional calcium sources.
Claim 12
Dependent Claim
13 words
The paste of claim 1 or 8 , further comprising additional phosphate sources.
Claim 13
Independent Claim
108 words
A method of promoting bone growth, comprising: providing a paste, said paste comprising a calcium phosphate powder, said powder comprising a first calcium phosphate material having at least 90% amorphous character and an acidic second calcium phoshate material the powder having a calcium to phosphorous molar ratio in the range of about 1.2 to 1.68, and a fluid in an amount which provides a formable or injectable consistency, said paste remaining injectable or formable for a time greater than about 60 minutes at about 22° C.; applying the paste to a site requiring bone growth: and allowing the paste to harden at the site within about 30 minutes.
Claim 14
Independent Claim
108 words
A method of promoting bone growth, comprising: providing a paste, said paste comprising a calcium phosphate powder, said powder comprising a first calcium phosphate material having at least 90% amorphous character and an acidic second calcium phoshate material the powder having a calcium to phosphorous molar ratio in the range of about 1.2 to 1.68, and a fluid in an amount which provides a formable or injectable consistency, said paste remaining injectable or formable for a time greater than about 60 minutes at about 22° C.; applying the paste to a site requiring bone growth: and allowing the paste to harden at the site within about 30 minutes.
Claim 15
Dependent Claim
23 words
The method of claim 12 , further comprising: addition of a bone regenerative protein or an antibiotic to the mixture prior to application.
Claim 16
Dependent Claim
29 words
The method of claim 12 , wherein the fluid is selected from the group consisting of water, a physiologically acceptable pH-buffered solution, saline solution, serum and tissue culture medium.
Claim 17
Independent Claim
18 words
The method of claims 12 , wherein the paste is formed into the use shape outside the body.
Claim 18
Dependent Claim
28 words
The method paste of claim 12 , wherein said paste converts into a poorly crystalline hydroxyapatite having the X-ray diffraction pattern of naturally occurring bone within five hours.
Claim 19
Dependent Claim
28 words
The method of claim 12 , wherein said paste converts into a poorly crystalline hydroxyapatite having the X-ray diffraction pattern of naturally occurring bone within seventy five minutes.
Claim 20
Dependent Claim
21 words
The method of claim 12 , wherein the paste is hardenable within about 10 to 30 minutes at about 37° C.
Claim 21
Dependent Claim
35 words
The method of claim 12 , wherein the second calcium phosphate is selected from the group consisting of dicalcium phosphate dihydrate, calcium metaphosphate, heptacalcium phosphate, poorly crystalline hydroxyapatite, calcium pyrophosphates, octacalcium phosphate, and tricalcium phosphates.
Claim 22
Dependent Claim
24 words
The paste of claim 1 , wherein the second calcium phosphate material is an acidic calcium phosphate having a pH between 5 and 7.
Claim 23
Dependent Claim
24 words
The method of claim 12 , wherein the second calcium phosphate material is an acidic calcium phosphate having a pH between 5 and 7.
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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) | 2004-04-09 | 2004-10-09 | 2005-04-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-04-09 | 2008-10-09 | 2009-04-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-04-09 | 2012-10-09 | 2013-04-10 | $7700.00 | Window Closed / Lapsed |