US4844854A
Expired / Lapsed
US
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Process for making a surgical device using two-phase compositions
Assignee: United States Surgical Corp
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Filing: 1987-11-05
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Granted: 1989-07-04
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Expires: 2007-11-05
Abstract
Abstract An absorbable, annealed surgical device made from a multi-phase, polymeric composition derived from lactide and glycolide is disclosed. Preferably, the composition has two phases, both phases are continuous, the first phase has about 0 - about 25% m glycolide moieties, the overall composition has up to 45% m glycolide moieties, and the first phase constitutes at least 50% (and preferably not more than about 95%) by weight of the composition. The device has a high distortion temperature, good resistance to hot-wet creep, but yet loses tensile strength in vivo guickly. The composition per se is injection-moldable, can be annealed, and is not brittle.
Inventors
- 👤 Donald S. Kaplan
- 👤 Matthew E. Hermes
- 👤 Ross R. Muth
- 👤 John J. Kennedy
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 19:34
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/04; A61L31/041; A61L31/12; A61L31/125; A61L31/129
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
156 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer in a first phase; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases; (c) recovering the final polymer from the final polymerization stage; (d) forming a surgical device from the final polymer; and (e) annealing the surgical device wherein lactide moieties comprise at least 50% by weight of the annealed surgical device; (f) the quantities of monomers being chosen so that (i) one phase of the final polymer has from about 0 -about 25% m glycolide moieties and about 75 - about 100% m lactide moieties and (ii) the final polymer overall has up to 45% m glycolide moieties.
Claim 2
Dependent Claim
156 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer in a first phase; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases; (c) recovering the final polymer from the final polymerization stage; (d) forming a surgical device from the final polymer; and (e) annealing the surgical device wherein lactide moieties comprise at least 50% by weight of the annealed surgical device; (f) the quantities of monomers being chosen so that (i) one phase of the final polymer has from about 0 -about 25% m glycolide moieties and about 75 - about 100% m lactide moieties and (ii) the final polymer overall has up to 45% m glycolide moieties.
Claim 3
Dependent Claim
22 words
The process of claim 1 wherein annealing is carried out at from 80° to 130° C. for from 10 to 120 minutes.
Claim 4
Dependent Claim
18 words
The process of claim 1 wherein annealing is carried out at about 90° C. for about 90 minutes.
Claim 5
Dependent Claim
103 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer in a first phase; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases and a predominant amount of lactide; (c) recovering the final polymer; (d) forming a surgical device by injection molding the final polymer at a temperature below the melting point of the glycolide-rich phase.
Claim 6
Dependent Claim
103 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer in a first phase; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases and a predominant amount of lactide; (c) recovering the final polymer; (d) forming a surgical device by injection molding the final polymer at a temperature below the melting point of the glycolide-rich phase.
Claim 7
Dependent Claim
21 words
The process according to claim 4 wherein annealing is carried out at from 80°-130° C. for from 10 to 120 minutes.
Claim 8
Dependent Claim
15 words
The process according to claim 4 wherein the first polymer is composed of lactide moieties.
Claim 9
Dependent Claim
27 words
The process according to claim 4 wherein one phase of the final polymer has from about 0-about 25% m glycolide moieties and about 75-about 100% lactide moieties.
Claim 10
Dependent Claim
16 words
The process according to claim 4 wherein the surgical device is a surgical clip or staple.
Claim 11
Dependent Claim
91 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases and a predominant amount of lactide; (c) recovering the polymer; (d) forming a surgical device from the final polymer; and (e) annealing the surgical device.
Claim 12
Dependent Claim
91 words
A process for making a surgical device, comprising the steps: (a) polymerizing a first monomer mixture containing a predominant amount of lactide until the polymerization is substantially complete, thereby forming a first polymer; (b) adding to the first polymer a second monomer mixture containing glycolide and polymerizing the second monomer mixture in the presence of the first polymer, thereby forming a final polymer having two phases and a predominant amount of lactide; (c) recovering the polymer; (d) forming a surgical device from the final polymer; and (e) annealing the surgical device.
Claim 13
Dependent Claim
21 words
The process according to claim 9 wherein annealing is carried out at from 80°-130° C. for from 10 to 120 minutes.
Claim 14
Dependent Claim
15 words
The process according to claim 9 wherein the first polymer is composed of lactide moieties.
Claim 15
Dependent Claim
27 words
The process according to claim 9 wherein one phase of the final polymer has from about 0-about 25% m glycolide moieties and about 75-about 100% lactide moieties.
Claim 16
Dependent Claim
15 words
The process according to claim 9 wherein the surgical device is a clip or staple.
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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) | 1992-07-03 | 1993-01-02 | 1993-07-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-07-03 | 1997-01-02 | 1997-07-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-07-03 | 2001-01-02 | 2001-07-04 | $7700.00 | Window Closed / Lapsed |