CA2363262A1 - Bioabsorbable, biocompatible polymers for tissue engineering - Google Patents

Bioabsorbable, biocompatible polymers for tissue engineering Download PDF

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Publication number
CA2363262A1
CA2363262A1 CA 2363262 CA2363262A CA2363262A1 CA 2363262 A1 CA2363262 A1 CA 2363262A1 CA 2363262 CA2363262 CA 2363262 CA 2363262 A CA2363262 A CA 2363262A CA 2363262 A1 CA2363262 A1 CA 2363262A1
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Prior art keywords
tissue
polymer
strength
composition
stress
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CA 2363262
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French (fr)
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CA2363262C (en
Inventor
Simon F. Williams
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Tepha Inc
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Individual
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20—Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2525—Coating or impregnation functions biologically [e.g., insect repellent, antiseptic, insecticide, bactericide, etc.]

Abstract

Bioabsorbable biocompatible polymers which provide a good match between their properties and those of certain tissue structures are provided. The bioabsorbable biocompatible polymers can be prepared with tensile strengths, elongation to breaks, and/or tensile modulus (Young's modulus) values of the tissues of the cardiovascular, gastrointestinal, kidney and genitourinary, musculoskeletal, and nervous systems, as well as those of the oral, dental, periodontal, and skin tissues.
Methods for processing the bioabsorbable biocompatible polymers into tissues engineering devices are also provided.

Claims (44)

1. A composition or device for use in tissue engineering comprising a bioabsorbable biocompatible polymer comprising polyhydroxyalkanoate, wherein the polymer has one or more mechanical properties selected from the group consisting of stress, strain, stress-strain, stress-strain hysteresis, stress-strain relaxation, viscoelasticity, contraction stress, resting stress, Young's modulus, tensile strength, durability, yield point, failure strength, toughness, ductility, softness, hardness, creep, elastic deformation, wear resistance, shear failure, roughness, compressive strength, load capacity, modulus of elasticity, ultimate compressive strength, yield strength, stress-strain relationship, scratch resistance, abrasion resistance, flexural modulus, shear modulus, contact angle, surface tension, adhesive strength, surface free energy, bending strength, shear strength, bonding strength, bending strength, bending stiffness, compressive modulus, bending modulus, fracture toughness, elongation, fiber strength, fiber modulus, fiber elongation, thermal expansion coefficient, fracture toughness, static and dynamic elasticity, longitudinal stretch, stress, and strain, radial stretch, stress and strain, circumferential stretch, stress and strain, ultimate elongation, viscosity, expansion, static and kinetic coefficients of friction, plasticity, axial tension, shock absorbance, bearing strength, formability, rigidity, stress rupture, bend radius, impact strength, and fatigue strength, equivalent to the same properties of a differentiated tissue or tissue structure, wherein the polymer comprises polyhydroxyalkanoate.
2. The composition of claim 1 wherein the polymer degrades in vivo in less than one year.
3. The composition of claim 1 wherein the polymer has an extension to break of over 25%.
4. The composition of claim 3 wherein the polymer is in the form of a fiber and the extension to break is over 45%.
5. The composition of claim 1 wherein the polymer has a tensile strength less than 10,000 psi.
6. The polymer of claim 5 wherein the polymer is in the form of a fiber and the tensile strength is less than 50,000 psi.
7. The composition of claim 1 wherein the polymer has a Youngs modulus of less than 100,000 psi.
8. The polymer of claim 7 wherein the polymer is in the form of a fiber and the Youngs modulus is less than 200,000 psi.
9. The composition of claim 1 wherein the polymer has a melting temperature less than 190 ÀC.
10. The composition of claim 1 wherein the polymer has a glass transition temperature less than 20 ÀC.
11. The composition of claim 1 wherein the polymer has two or more properties selected from the group consisting of extension to break over 25%, tensile strength less than 10,000 psi, Youngs modulus less than 100,000 psi, glass transition less than 20 ÀC, and melting temperature less than 190 ÀC.
12. The composition of claim 1 wherein the tissue is selected from the group consisting of cardiovascular, gastrointestinal, kidney, genitourinary, musculoskeletal, nervous, oral, breast, periodontal, and skin.
13. The composition of claim 1 wherein the mechanical property is selected from the group consisting of tensile strength, Youngs modulus, elongation to break, hardness, compressive strength, burst strength, toughness, and impact strength.
14. The composition of claim 1 wherein the tissue is cartilage and the polymer has a tensile strength of 435 psi ~25%.
15. The composition of claim 1 wherein the tissue is skin and the polymer has a tensile strength of 1,100 psi~25%.
16. The composition of claim 1 wherein the tissue is tendon and the polymer has a tensile strength of 7,700 psi~25%.
17. The composition of claim 1 wherein the tissue is aorta and the polymer has a tensile strength of 160 psi~25%.
18. The composition of claim 1 wherein the tissue is cardiac muscle and the polymer has a tensile strength of 16 psi~25%.
19. The composition of claim 1 wherein the tissue is bone and a polymer has a tensile strength of 10,000 psi~25%.
20. The composition of claim 1 wherein the tissue is enamel and the polymer has a tensile strength of 1,600 psi~25%.
21. The composition of claim 1 wherein the tissue is skin and the polymer has an ultimate elongation of 78%~25%.
22. The composition of claim 1 wherein the tissue is tendon and the polymer has an ultimate elongation of 10%~25%.
23. The composition of claim 1 wherein the tissue is cartilage and polymer has an ultimate elongation of 30%~25%.
24. The composition of claim 1 wherein the tissue is heart and the polymer has an ultimate elongation of 10-15%~25%.
25. The composition of claim 1 wherein the tissue is aorta and the polymer has an ultimate elongation in the transverse and longitudinal directions of 77-81%~25%.
26. The composition of claim 1 wherein the tissue is skin and the polymer has a Youngs modulus of 2,000-18,000 psi~25%.
27. A device comprising a bioabsorbable biocompatible polymer with one of more mechanical properties equivalent to a specific tissue or tissue structure, wherein the device is selected from the group consisting of a tissue engineering scaffold, guided tissue repair material, wound dressing, drug delivery vehicle, anti-adhesion material, cell encapsulation material, coating, implant, stent, orthopaedic device, prosthetic, adhesive, diagnostic, sutures, surgical meshes, staples, meniscus repair and regeneration devices, screws (interference screws and meniscal screws), bone plates and plating systems, cardiovascular patches, pericardial patches, slings, pins, anti-adhesion barriers, articular cartilage repair devices, nerve guides, tendon and ligament repair devices, atrial septal defect patches, bulking and filling agents, vein valves, bone marrow scaffolds, bone graft scaffolds, skin substitutes, dural substitutes, ocular implants, spinal fusion cages, and muscular implants (cardiac and skelatal).
28. The device of claim 27 wherein the device is a tissue engineering scaffold or matrix.
29. The device of claim 28 wherein the polymer degrades in vivo in less than two years.
30. The device of claim 28 wherein the tissue engineering scaffold which has different properties in different regions.
31. The device of claim 28 wherein the scaffold or matrix is flexible.
32. The device of claim 28 wherein the tissue is heart valve or blood vessel.
33. The device of claim 28 wherein the tissue engineering scaffold or matrix is for tissue engineering of musculoskeletal tissue.
34. The device of claim 28 wherein the tissue is selected from the group consisting of cartilage, tendon, ligament, and bone.
35. The device of claim 28 wherein the tissue engineering scaffold or matrix is for tissue engineering of genitourinary tissue.
36. The device of claim 28 wherein the tissue forms a structure selected from the group consisting of bladder, ureter, and urethra.
37. The device of claim 28 for tissue engineering of gingiva.
38. The device of claim 28 seeded with cells for implantation.
39. The device of claim 28 further comprising materials selected from the group consisting of other polymers, compounds, additives, biologically active substances, growth factors, cell attachment factors, and drugs.
40. A method for producing a bioabsorbable biocompatible polymer composition comprising:
selecting a tissue structure and measuring one or more mechanical properties selected from the group consisting of stress, strain, stress-strain, stress-strain hysteresis, stress-strain relaxation, viscoelasticity, contraction stress, resting stress, Young's modulus, tensile strength, durability, yield point, failure strength, toughness, ductility, softness, hardness, creep, elastic deformation, wear resistance, shear failure, roughness, compressive strength, load capacity, modulus of elasticity, ultimate compressive strength, yield strength, stress-strain relationship, scratch resistance, abrasion resistance, flexural modulus, shear modulus, contact angle, surface tension, adhesive strength, surface free energy, bending strength, shear strength, bonding strength, bending strength, bending stiffness, compressive modulus, bending modulus, fracture toughness, elongation, fiber strength, fiber modulus, fiber elongation, thermal expansion coefficient, fracture toughness, static and dynamic elasticity, longitudinal stretch, stress, and strain, radial stretch, stress and strain, circumferential stretch, stress and strain, ultimate elongation, viscosity, expansion, static and kinetic coefficients of friction, plasticity, axial tension, shock absorbance, bearing strength, formability, rigidity, stress rupture, bend radius, impact strength, and fatigue strength, equivalent to the same properties of a differentiated tissue or tissue structure, and selecting from a combination of monomers that can be polymerized to make a polymer, one or more monomers which when linked in a polymeric form, have the mechanical property or properties of the tissue or tissue structure.
41. The method of claim 40 wherein the tissue structure is selected from the group consisting of cardiovascular structures including heart valves and blood vessels, gastrointestinal structures, kidney, genitourinary structures including bladder, ureter, and urethra, musculoskeletal structures including bone, cartilage, tendon, and ligament, nervous system structures, oral tissues, periodontal tissues, and skin tissue.
42. The method of claim 40 wherein the monomers are selected from hydroxy acids.
43. The method of claim 40 wherein the polymer is selected from the group consisting of polyester, poly(orthoester), polyanhydride, polyphosphazene, polyesteramide, polypeptide, polyamide, polydihydropyran, and polycyanoacrylate.
44. The method of claim 40 wherein the polymercontains one or more linkages selected from the group consisting of ester, amide, urethane, carbonate, iminocarbonate, oxalate, oxamate, orthoester, anhydride, phosphazene, glycoside, and ether linkages.
CA 2363262 1999-03-04 2000-03-03 Bioabsorbable, biocompatible polymers for tissue engineering Expired - Lifetime CA2363262C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12282799P 1999-03-04 1999-03-04
US60/122,827 1999-03-04
PCT/US2000/005676 WO2000051662A1 (en) 1999-03-04 2000-03-03 Bioabsorbable, biocompatible polymers for tissue engineering

Publications (2)

Publication Number Publication Date
CA2363262A1 true CA2363262A1 (en) 2000-09-08
CA2363262C CA2363262C (en) 2010-09-28

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US (2) US6514515B1 (en)
EP (1) EP1159015A1 (en)
JP (1) JP4554084B2 (en)
AU (1) AU3722800A (en)
CA (1) CA2363262C (en)
WO (1) WO2000051662A1 (en)

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