CA2442548A1 - High strength bioresorbables containing poly-glycolic acid - Google Patents

High strength bioresorbables containing poly-glycolic acid Download PDF

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Publication number
CA2442548A1
CA2442548A1 CA002442548A CA2442548A CA2442548A1 CA 2442548 A1 CA2442548 A1 CA 2442548A1 CA 002442548 A CA002442548 A CA 002442548A CA 2442548 A CA2442548 A CA 2442548A CA 2442548 A1 CA2442548 A1 CA 2442548A1
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CA
Canada
Prior art keywords
artefact
poly
polymer
fibres
process according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002442548A
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French (fr)
Other versions
CA2442548C (en
Inventor
John Rose
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Smith and Nephew PLC
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Individual
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Publication of CA2442548A1 publication Critical patent/CA2442548A1/en
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Publication of CA2442548C publication Critical patent/CA2442548C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • DTEXTILES; PAPER
    • D02YARNS; MECHANICAL FINISHING OF YARNS OR ROPES; WARPING OR BEAMING
    • D02JFINISHING OR DRESSING OF FILAMENTS, YARNS, THREADS, CORDS, ROPES OR THE LIKE
    • D02J1/00Modifying the structure or properties resulting from a particular structure; Modifying, retaining, or restoring the physical form or cross-sectional shape, e.g. by use of dies or squeeze rollers
    • D02J1/22Stretching or tensioning, shrinking or relaxing, e.g. by use of overfeed and underfeed apparatus, or preventing stretch
    • D02J1/228Stretching in two or more steps, with or without intermediate steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06At least partially resorbable materials
    • A61L17/10At least partially resorbable materials containing macromolecular materials
    • A61L17/12Homopolymers or copolymers of glycolic acid or lactic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/02Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds
    • C08G63/06Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds derived from hydroxycarboxylic acids
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/02Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds
    • C08G63/06Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds derived from hydroxycarboxylic acids
    • C08G63/08Lactones or lactides
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04Polyesters derived from hydroxycarboxylic acids, e.g. lactones

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Materials Engineering (AREA)
  • Textile Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Biological Depolymerization Polymers (AREA)
  • Artificial Filaments (AREA)
  • Polyesters Or Polycarbonates (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)
  • Polyamides (AREA)
  • Reinforced Plastic Materials (AREA)

Abstract

Polymer compositions comprising poly-glycolic acid (PGA) or a functional derivative thereof with a tensile strength of at least 1200 MPa are disclosed.
Processes suitable for manufacturing said compositions are also described, comprising rendering PGA into an amorphous state then drawing to form a highly orientated polymer structure. The polymer compositions can be used to make artefacts, for example sutures, or used in combination with other polymers or non-polymeric substances to produce other artefacts, for example medical devices suitable for implantation into the human body. Processes for the production of said artefacts are also described.

Claims (28)

1. A polymer composition comprising poly-glycolic acid or a functional derivative thereof with a tensile strength of at least 1200MPa
2. A polymer composition of claim 1 formed into orientated fibres
3. A polymer composition of claims 1 to 2 where the fibres have a tensile modulus of at least 22GPa
4. A process for the manufacture of polymer compositions as claimed in claims 1 to 3 comprising increasing polymer chain orientation of a substantially amorphous polymer by drawing at localized points within the mass
5. A process for the manufacture of polymer compositions as claimed in any one of the preceding claims including the steps of forming poly-glycolic acid or a functional derivative thereof into fibres, quenching the fibres then subjecting the quenched fibres to a tension under conditions whereby a defined region of the tensioned fibres is drawn
6. A process according to claim 5 there the fibre-forming method is melt extrusion or solution spinning
7. A process according to claims 5 or 6 wherein the quenched, tensioned fibres are subjected to zone-heating
8. A process according to claims 5 to 7 wherein the quenched, tensioned fibres are subjected to at least two separate drawing steps, each drawing step performed under identical or different conditions
9. An artefact comprising poly-glycolic acid or a functional derivative thereof according to claims 1 to 3 or when produced by the process according to any one of claims 4 to 8
10. An artefact as claimed in claim 9 comprising at least two polymer components
11. An artefact according to claim 10 comprising 10% to 80% by volume poly-glycolic acid or a functional derivative thereof according to claims 1 to 3
12. An artefact of claims 10 or 11 wherein at least one of the polymer components is a co-polymer, or polymer blend
13. An artefact of claims 10 to 12 where at least one of the polymer components is bioresorbable
14. An artefact of claim 13 where the bioresorbable polymer comprises a poly-hydroxy acid, a poly-lactic acid, a poly-caprolactone, a poly-acetal or a poly-anhydride
15. An artefact of any of the preceding claims comprising at least one non-bioresorbable polymer component
16. An artefact of claim 15 where the non-bioresorbable polymer comprises poly-propylene, poly-ethylene, poly-methyl methacrylate or epoxy resin
17. An artefact of any of the preceding claims further containing at least one non-polymeric component
18. An artefact of claim 17 where the non-polymeric component comprises a ceramic, hydroxyapatite or tricalcium phosphate
19. An artefact of claims 17 or 18 where the non-polymeric component comprises a bioactive factor
20. An artefact of claim 19 where the bioactive component comprises a natural or engineered protein, a ribonucleic acid, a deoxyribonucleic acid, a growth factor, a cytokine, an angiogenic factor or an antibody
21. An artefact according to any of the preceding claims in the form of a medical device
22. An artefact of claim 21 where the device is a suture, a scaffold for tissue engineering or implantation, an orthopaedic implant, a complex shaped device or a bone fixation device
23. A process for the manufacture of artefacts according to claims 10 to 22 that further includes the step of compression moulding other polymeric, non-polymeric or blend of polymeric and non-polymeric components in the presence of said fibres
24. A process according to claims 10 to 23 further comprising forming a polymeric component in the presence of said fibres by in situ curing of monomers or other precursors for said polymeric component
25. A process according to claim 24 where the monomers used do not liberate a by-product on polymerization
26. A process according to claims 24 or 25 where at least one of the monomers is a ring-opening monomer that opens to form a poly-hydroxy acid
27. A process according to claims 24 to 26 where at least one monomer is a lactide, a glycolide, a caprolactone, a carbonate or mixtures thereof
28.
CA2442548A 2002-01-31 2003-01-31 High strength bioresorbables containing poly-glycolic acid Expired - Fee Related CA2442548C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0202233.3 2002-01-31
GBGB0202233.3A GB0202233D0 (en) 2002-01-31 2002-01-31 Bioresorbable polymers
PCT/GB2003/000400 WO2003064531A1 (en) 2002-01-31 2003-01-31 High strength bioresorbables containing poly-glycolic acid

Publications (2)

Publication Number Publication Date
CA2442548A1 true CA2442548A1 (en) 2003-08-07
CA2442548C CA2442548C (en) 2012-11-20

Family

ID=9930119

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2442548A Expired - Fee Related CA2442548C (en) 2002-01-31 2003-01-31 High strength bioresorbables containing poly-glycolic acid

Country Status (13)

Country Link
US (1) US7455674B2 (en)
EP (1) EP1470192B1 (en)
JP (1) JP2005516100A (en)
CN (1) CN100345904C (en)
AT (1) ATE439405T1 (en)
AU (1) AU2003239428B2 (en)
CA (1) CA2442548C (en)
DE (1) DE60328753D1 (en)
ES (1) ES2331415T3 (en)
GB (1) GB0202233D0 (en)
IL (1) IL158120A0 (en)
NO (1) NO20034359L (en)
WO (1) WO2003064531A1 (en)

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