US5324307A
Expired / Lapsed
US
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Polymeric surgical staple
Assignee: Covidien AG
•
Filing: 1991-11-27
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Granted: 1994-06-28
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Expires: 2011-11-27
Abstract
Abstract A one piece surgical repair device consists essentially of a polymeric wire. The polymeric wire is comprised of an oriented, semicrystalline polymer. The surgical repair device can be a staple and is capable of permanent flexural deformation at ambient temperature.
Inventors
- 👤 Peter K. Jarrett
- 👤 Donald J. Casey
- 👤 Louis Rosati
- 👤 James W. Dwyer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 17:25
CPC Classifications
A; A61; A61L; A61L31/00; A61B; A61B17/00; A61B17/064; A61L31/04; A61L31/041; A61L31/06; A61L31/12; A61L31/125; A61L31/129; A61L31/14; A61L31/148; A61B17/0644; A61B17/56; A61B17/58; A61B17/68; A61B17/72; A61B17/80; A61B17/84; A61B17/86; A61B2017/00004
Claims Analysis
Total Claims: 52
Claim 1
Independent Claim
50 words
An article of manufacture comprising a one piece surgical repair device consisting essentially of a polymeric wire comprised of an oriented, semicrystalline polymer and having a Young's modulus of greater than about 600,000 psi, wherein the one piece surgical repair device is capable of permanent flexural deformation at ambient temperature.
Claim 2
Dependent Claim
50 words
An article of manufacture comprising a one piece surgical repair device consisting essentially of a polymeric wire comprised of an oriented, semicrystalline polymer and having a Young's modulus of greater than about 600,000 psi, wherein the one piece surgical repair device is capable of permanent flexural deformation at ambient temperature.
Claim 3
Dependent Claim
18 words
The article of claim 1 wherein the polymeric wire has a diameter of about 0.005 to 0.050 inches.
Claim 4
Dependent Claim
14 words
The article of claim 2 wherein the diameter is about 0.010 to 0.025 inches.
Claim 5
Dependent Claim
15 words
The article of claim 1 wherein the Young's modulus is greater than about 800,000 psi.
Claim 6
Dependent Claim
17 words
The article of claim 4 wherein the oriented polymer is from about 20 to 70 percent crystalline.
Claim 7
Dependent Claim
16 words
The article of claim 5 wherein said oriented polymer is up to about 60 percent crystalline.
Claim 8
Dependent Claim
16 words
The article of claim 1 wherein said oriented, semicrystalline polymer is a homopolymer of polylactic acid.
Claim 9
Dependent Claim
16 words
The article of claim 1 wherein said oriented, semicrystalline polymer is a homopolymer of polyglycolic acid.
Claim 10
Dependent Claim
19 words
The article of claim 1 wherein said oriented, semicrystalline polymer is a multi-phase polymer derived from lactide and glycolide.
Claim 11
Dependent Claim
14 words
The article of claim 1 wherein said oriented, semicrystalline polymer is a block copolymer.
Claim 12
Dependent Claim
14 words
The article of claim 10 wherein the block copolymer comprises lactic acid ester linkages.
Claim 13
Dependent Claim
23 words
The article of claim 1 wherein said block copolymer comprises linkages prepared from monomers selected from the group consisting of ε-caprolactone and 1,3-dioxan-2-one.
Claim 14
Dependent Claim
20 words
The article of claim 12 wherein the lactic acid ester linkages comprise about 95 mole percent of said block copolymer.
Claim 15
Dependent Claim
13 words
The article of claim 13 wherein the remaining linkages are prepared from 1,3-dioxan-2-one.
Claim 16
Dependent Claim
13 words
The article of claim 12 wherein the remaining linkages are prepared from ε-caprolactone.
Claim 17
Dependent Claim
24 words
The article in any one of claims 2, 3 or 5-5 to 17 inclusive wherein the one piece surgical repair device is a staple.
Claim 18
Dependent Claim
26 words
The article in any one of claims 2, 3 or 5-15 inclusive wherein the one piece surgical repair device is a cerclage wire or Kirschner wire.
Claim 19
Dependent Claim
42 words
The article in any one of claims 10 to 15 wherein at least one of the continuous phases has an in vivo glass transition temperature of more than about 37° C. and comprises more than about 50 mole percent of the copolymer.
Claim 20
Dependent Claim
65 words
An article of manufacture comprising a one piece surgical staple consisting essentially of a polymeric wire comprised of an oriented, semicrystalline block copolymer having at least one continuous phase, and comprising more than about 50 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε-caprolactone, wherein the one piece surgical staple is capable of permanent flexural deformation at ambient temperature.
Claim 21
Dependent Claim
65 words
An article of manufacture comprising a one piece surgical staple consisting essentially of a polymeric wire comprised of an oriented, semicrystalline block copolymer having at least one continuous phase, and comprising more than about 50 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε-caprolactone, wherein the one piece surgical staple is capable of permanent flexural deformation at ambient temperature.
Claim 22
Dependent Claim
65 words
An article of manufacture comprising a one piece, sterile surgical repair device manufactured from a polymeric wire comprising an extrusile, biocompatible polymer having at least one continuous phases, at least one of the continuous phases having an in vivo glass transition temperature of more than about 37° C., wherein the one piece, sterile surgical repair device is capable of permanent flexural deformation at ambient temperature.
Claim 23
Dependent Claim
65 words
An article of manufacture comprising a one piece, sterile surgical repair device manufactured from a polymeric wire comprising an extrusile, biocompatible polymer having at least one continuous phases, at least one of the continuous phases having an in vivo glass transition temperature of more than about 37° C., wherein the one piece, sterile surgical repair device is capable of permanent flexural deformation at ambient temperature.
Claim 24
Dependent Claim
18 words
The article of claim 20 wherein the polymeric wire has a diameter of about 0.005 to 0.50 inches.
Claim 25
Dependent Claim
14 words
The article of claim 21 wherein the diameter is about 0.010 to 0.025 inches.
Claim 26
Dependent Claim
22 words
The article of claim 20, 21 or 22 wherein the polymeric wire has a Young's modulus of greater than about 600,000 psi.
Claim 27
Dependent Claim
15 words
The article of claim 23 wherein the Young's modulus is greater than about 800,000 psi.
Claim 28
Dependent Claim
13 words
The article of claim 20 wherein the extrusile, biocompatible polymer is a copolymer.
Claim 29
Dependent Claim
12 words
The article of claim 25 wherein the copolymer is a block copolymer.
Claim 30
Dependent Claim
39 words
The article of claim 25, or 26 wherein at least one of the continuous phases has an in vivo glass transition temperature of more than about 37° C. and comprises more than about 50 mole percent of the copolymer.
Claim 31
Dependent Claim
19 words
The article of claim 20 wherein the extrusile, biocompatible polymer is a multi-phase polymer derived from two different monomers.
Claim 32
Dependent Claim
39 words
The article in any one of the claims 20 to 22 or 25 to 28 wherein the one piece surgical repair device is a staple and the polymeric wire has a Young's modulus of greater than about 600,000 psi.
Claim 33
Dependent Claim
28 words
The article in any one of claims 20 to 22 or 25 to 28 wherein the one piece surgical repair device is a cerclage wire or Kirschner wire.
Claim 34
Dependent Claim
78 words
A one piece, sterile surgical staple useful in mammalian tissue, the staple comprising an extruded polymeric wire consisting essentially of an oriented, semicrystalline bioabsorbable polymer, or blend of at least two polymers wherein at least one polymer is a semicrystalline polymer, the oriented, semicrystalline bioabsorbable polymer or blend comprising a continuous phase having a glass transition temperature of greater than the in-vivo temperature of the mammalian tissue, wherein said staple is capable of permanent deformation in body fluids.
Claim 35
Dependent Claim
78 words
A one piece, sterile surgical staple useful in mammalian tissue, the staple comprising an extruded polymeric wire consisting essentially of an oriented, semicrystalline bioabsorbable polymer, or blend of at least two polymers wherein at least one polymer is a semicrystalline polymer, the oriented, semicrystalline bioabsorbable polymer or blend comprising a continuous phase having a glass transition temperature of greater than the in-vivo temperature of the mammalian tissue, wherein said staple is capable of permanent deformation in body fluids.
Claim 36
Dependent Claim
98 words
An article of manufacture comprising an irradiation sterilized, surgical staple manufactured from an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable polymer having at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37° C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young's modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.
Claim 37
Dependent Claim
98 words
An article of manufacture comprising an irradiation sterilized, surgical staple manufactured from an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable polymer having at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37° C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young's modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.
Claim 38
Dependent Claim
14 words
The article of claim 32 wherein said irradiation sterilized, surgical staple is one piece.
Claim 39
Dependent Claim
15 words
The article of claim 33 wherein the bioabsorbable polymer is a homopolymer of polylactic acid.
Claim 40
Dependent Claim
21 words
The article of claim 32 wherein the extruded and drawn polymeric wire has a diameter of about 0.010 to 0.025 inches.
Claim 41
Dependent Claim
15 words
The article of claim 33 wherein the bioabsorbable polymer is a homopolymer of polyglycolic acid.
Claim 42
Dependent Claim
12 words
The article of claim 32 wherein the bioabsorbable polymer is a copolymer.
Claim 43
Dependent Claim
20 words
The article of claim 37 wherein the copolymer comprises more than about 50 mole percent of glycolic acid ester linkages.
Claim 44
Dependent Claim
34 words
The article of claim 38 wherein said irradiation sterilized, surgical staple maintains about 100 percent after 7 days and greater than about 70 percent after 21 days in vivo of its initial opening strength.
Claim 45
Dependent Claim
13 words
The article of claim 37 wherein the copolymer comprises lactic acid ester linkages.
Claim 46
Dependent Claim
23 words
The article of claim 40 wherein the block copolymer comprises linkages prepared from monomers selected from the group consisting of ε-caprolactone and 1,3-dioxan-2-one.
Claim 47
Dependent Claim
25 words
The article of claim 40 wherein the copolymer is a block copolymer and comprises more than about 50 mole percent of lactic acid ester linkages.
Claim 48
Dependent Claim
13 words
The article of claim 42 wherein the remaining linkages are prepared from 1,3-dioxan-2-one.
Claim 49
Dependent Claim
121 words
An article of manufacture comprising an irradiation sterilized, surgical staple consisting essentially of an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable block copolymer having at least about 80 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε-caprolactone, and comprising at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37° C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young's modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.
Claim 50
Dependent Claim
121 words
An article of manufacture comprising an irradiation sterilized, surgical staple consisting essentially of an extruded and drawn polymeric wire having a diameter of about 0.005 to 0.050 inches, the polymeric wire comprising a bioabsorbable block copolymer having at least about 80 mole percent of lactic acid ester linkages and the remaining linkages are prepared from ε-caprolactone, and comprising at least one continuous phases, the at least one continuous phase having an in vivo glass transition temperature of more than about 37° C., wherein the irradiation sterilized, surgical staple is capable of permanent flexural deformation, has a Young's modulus of greater than about 800,000 psi, and maintains at least about 50 percent of its initial opening strength after 21 days in vivo.
Claim 51
Dependent Claim
22 words
The article of claim 43 or 44 wherein the lactic acid ester linkages comprise about 95 mole percent of the block copolymer.
Claim 52
Dependent Claim
36 words
The article as in any one of claims 40 to 44 wherein said irradiation sterilized, surgical staple maintains greater than about 110 percent of its initial opening strength from about 7 to 21 days in vivo.
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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) | 1997-06-27 | 1997-12-27 | 1998-06-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-06-27 | 2001-12-27 | 2002-06-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-06-27 | 2005-12-27 | 2006-06-28 | $7700.00 | Window Closed / Lapsed |