US6206883B1
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US
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Bioabsorbable materials and medical devices made therefrom
Assignee: Howmedica Osteonics Corp
•
Filing: 1999-03-05
•
Granted: 2001-03-27
•
Expires: 2019-03-05
Abstract
Abstract A bioabsorbable material such as a terpolymer of poly-(L-lactide/D-lactide/glycolide). The material may consist of 85 molar percent L-lactide, 5 molar percent D-lactide, and 10 molar percent glycolide. The material may have a heat of fusion of about 15-25 J/G, tensile strength retention at 26 weeks of incubation of at least about 50%, and tensile strength retention at 52 weeks of incubation of at most about 25%. The material may be used in implantable devices such as bone fixation devices.
Inventors
- 👤 Deger C. Tunc
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 06:08
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/68; A61B17/80; A61L; A61L31/00; A61L31/04; A61L31/06; Y; Y10; Y10S; Y10S606/00; Y10S606/907; Y10S606/91
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
15 words
An implantable medical device comprising a terpolymer having repeating units of L-lactide, D-lactide and glycolide.
Claim 2
Dependent Claim
15 words
An implantable medical device comprising a terpolymer having repeating units of L-lactide, D-lactide and glycolide.
Claim 3
Dependent Claim
29 words
The medical device of claim 1 wherein the device is selected from the group consisting of a bone plate, bone screw, mesh, suture anchor, tack, pin or intramedullary rod.
Claim 4
Dependent Claim
11 words
The medical device of claim 2 consisting essentially of unreinforced poly-(L-lactide/D-lactide/glycolide).
Claim 5
Dependent Claim
11 words
The medical device of claim 3 consisting essentially of reinforced poly-(L-lactide/D-lactide/glycolide).
Claim 6
Dependent Claim
17 words
The medical device as set forth in claim 1 comprising at least about 2 molar percent D-lactide.
Claim 7
Dependent Claim
17 words
The medical device as set forth in claim 5 comprising at least about 4 molar percent D-lactide.
Claim 8
Dependent Claim
18 words
The medical device as set forth in claim 6 comprising about 2 to about 10 molar percent D-lactide.
Claim 9
Dependent Claim
26 words
The medical device as set forth in claim 7 comprising about 80-90 molar percent L-lactide, about 2-10 molar percent D-lactide, and about 5″15 molar percent glycolide.
Claim 10
Dependent Claim
25 words
The medical device as set forth in claim 8 comprising about 83-87 molar percent L-lactide, about 3-7 percent D-lactide, and about 8-12 molar percent glycolide.
Claim 11
Dependent Claim
25 words
The medical device as set forth in claim 9 consisting essentially of 85 molar percent L-lactide, 5 molar percent D-lactide, and 10 molar percent glycolide.
Claim 12
Dependent Claim
57 words
The medical device as set forth in claim 1 further comprising about 0.1-5 molar percent of a polymer formed from alpha-hydroxy-alpha-ethylbutyric acid; alpha-hydroxy-beta-methylvaleric acid; alpha-hydroxyacetic acid; alpha-hydroxybutyric acid; alpha-hydroxycaproic acid; alpha-hydroxydecanoic acid; alpha-hydroxyheptanoic acid; alpha-hydroxyisobutyric acid; alpha-hydroxyisocaproic acid; alpha-hydroxyisovaleric acid; alpha-hydroxymyristic acid; alpha-hydroxyoctanoic acid; alpha-hydroxystearic acid; alpha-hydroxyvaleric acid; beta-butyrolactone; beta-propiolactide; gamma-butyrolactone; pivalolactone; or tetramethylglycolide; or combinations thereof.
Claim 13
Dependent Claim
44 words
The medical device as set forth in claims 1 made by the process comprising: a) combining L-lactic acid monomer, glycolic acid monomer and at least about 2 molar percent D-lactic acid monomer to form a mixture; and b) polymerizing substantially all of the mixture.
Claim 14
Dependent Claim
18 words
The process of clam 12 wherein the polymerization is performed is performed in the presence of a catalyst.
Claim 15
Dependent Claim
18 words
The process of clam 12 wherein the polymerization is performed is performed in the presence of a catalyst.
Claim 16
Dependent Claim
16 words
The process of claim 13 wherein the polymerization is performed for between 24 and 72 hours.
Claim 17
Dependent Claim
34 words
The medical device as set forth in claim 1 wherein the polymer has a heat of fusion of about 0.4-10 J/G, tensile strength retention at 52 weeks at incubation of a most about 25%.
Claim 18
Dependent Claim
53 words
The medical device as set forth in claim 1 wherein the polymer has a tensile strength at 0 weeks of incubation in buffered saline at 37° C. of about 65-101 MPa, tensile strength at 26 weeks of incubation of about 50-75 MPa, and tensile strength at 52 weeks of incubation of 0 MPa.
Claim 19
Dependent Claim
15 words
The polymeric material of claim 16 having a heat of fusion of about 0.4-10 J/G.
Claim 20
Dependent Claim
15 words
The polymeric material of claim 17 having a heat of fusion of about 0.5-5 J/G.
Claim 21
Dependent Claim
19 words
The polymeric material of claim 18 formed from a resin having a heat of fusion of about 15-25 J/G.
Claim 22
Dependent Claim
19 words
The polymeric material of claim 19 formed from a resin having a heat of fusion of about 18-21 J/G.
Claim 23
Dependent Claim
47 words
The polymeric material of claim 20 having tensile strength at 0 weeks of incubation in buffered saline at 37° C. of about 74-92 MPa, tensile strength at 26 weeks of incubation of about 56-69 MPa, and tensile strength at 52 weeks of incubation of about 0 MPa.
Claim 24
Dependent Claim
60 words
The medical device as set forth in claim 1 wherein the polymer has a bending strength of at least 120 MPa at 0 weeks incubation in buffered saline at 37° C., at least 110 at 4 weeks incubation, at least 110 at 8 weeks incubation, at least 70 at 12 weeks incubation and at least 45 at 26 weeks incubation.
Claim 25
Dependent Claim
22 words
The medical device as set forth in claim 1 wherein the polymer has an inherent viscosity between about 4.0 and 7.5 dl/g.
Claim 26
Dependent Claim
23 words
The medical device as set forth in claim 23 wherein the polymer has an inherent viscosity of between about 6.0 and 6.5 dl/g.
Claim 27
Dependent Claim
26 words
An implantable medical device comprising a polymer having repeating units depicted by the formula: where the molar percentages of the repeating units are: 80≦n≦90 2≦p≦10 5≦q≦15.
Claim 28
Dependent Claim
26 words
An implantable medical device comprising a polymer having repeating units depicted by the formula: where the molar percentages of the repeating units are: 80≦n≦90 2≦p≦10 5≦q≦15.
Claim 29
Dependent Claim
60 words
The medical devices as set forth in claim 25 wherein the polymer further comprises about 0.1-5 molar percent of a polymer formed from alpha-hydroxy-alpha-ethylbutyric acid; alpha-hydroxy-beta-methylvaleric acid; alpha-hydroxyacetic acid; alpha-hydroxybutyric acid; alpha-hydroxycaproic acid; alpha-hydroxydecanoic acid; alpha-hydroxyheptanoic acid; alpha-hydroxyisobutyric acid; alpha-hydroxyisocaproic acid; alpha-hydroxyisovaleric acid; alpha-hydroxymyristic acid; alpha-hydroxyoctanoic acid; alpha-hydroxystearic acid; alpha-hydroxyvaleric acid; beta-butyrolactone; beta-propiolactide; gamma-butyrolactone; pivalolactone; or tetramethylglycolide; or combinations thereof.
Claim 30
Dependent Claim
17 words
The medical device as set forth in claim 25 comprising at least about 4 molar percent D-lactide.
Claim 31
Dependent Claim
25 words
The medical device as set forth in claim 25 comprising about 83-87 molar percent L-lactide, about 3-7 percent D-lactide, and about 8-12 molar percent glycolide.
Claim 32
Dependent Claim
25 words
The medical device as set forth in claim 28 consisting essentially of 85 molar percent L-lactide, 5 molar percent D-lactide, and 10 molar percent glycolide.
Claim 33
Dependent Claim
54 words
The medical device as set forth in claim 25 wherein the polymer has a tensile strength of at 0 weeks of incubation in buffered saline at 37° C. of about 65-101 MPa, tensile strength at 26 weeks of incubation of about 50-75 MPa and tensile strength at 52 weeks of incubation at 0 MPa.
Claim 34
Dependent Claim
57 words
The medical device as set forth in claim 25 wherein the polymer has a bending strength of at least 120 MPa at 0 weeks incubation in buffered saline at 37° C., at least 110 at 4 weeks, at least 110 at 8 weeks, at least 70 at 12 weeks and at least 45 at 26 weeks incubation.
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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) | 2004-03-26 | 2004-09-25 | 2005-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-03-26 | 2008-09-25 | 2009-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-03-26 | 2012-09-25 | 2013-03-27 | $7700.00 | Window Closed / Lapsed |