CA2460026A1 - Porous ceramic composite bone grafts - Google Patents

Porous ceramic composite bone grafts Download PDF

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Publication number
CA2460026A1
CA2460026A1 CA002460026A CA2460026A CA2460026A1 CA 2460026 A1 CA2460026 A1 CA 2460026A1 CA 002460026 A CA002460026 A CA 002460026A CA 2460026 A CA2460026 A CA 2460026A CA 2460026 A1 CA2460026 A1 CA 2460026A1
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implant
biodegradable polymer
equal
porous
less
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CA002460026A
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French (fr)
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CA2460026C (en
Inventor
Timothy J.N.. Smith
Jason Hendry
Sydney M. Pugh
Reginald Smith
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Warsaw Orthopedic Inc
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Individual
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    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/425—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • 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
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249967—Inorganic matrix in void-containing component
    • 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
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249978—Voids specified as micro
    • 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
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249978—Voids specified as micro
    • Y10T428/249979—Specified thickness of void-containing component [absolute or relative] or numerical cell dimension
    • 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
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249981—Plural void-containing components
    • 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
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249987—With nonvoid component of specified composition

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Composite Materials (AREA)
  • Inorganic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Dental Preparations (AREA)

Abstract

The invention relates to porous ceramic composites incorporating biodegradable polymers for use as a bone substitute in the fields of orthopaedics and dentistry or as a scaffold for tissue engineering applications. The porous ceramic composite implant for connective tissue replacement comprises a porous ceramic matrix having a biodegradable polymer provided on internal and external surfaces of the ceramic matrix. The biodegradable polymer allows for the passage and/or delivery of a variety of agents throughout the porous ceramic matrix and improves mechanical properties of the implant in vivo.

Claims (53)

1. A porous ceramic composite implant, said implant comprising;
- a sintered matrix body of a calcium phosphate-based compound, said body possessing an open interconnected porous structure with internal and external surfaces; and - a biodegradable polymer coating provided throughout said sintered matrix body on said external and internal surfaces of said open interconnected porous structure, wherein said polymer coating still allows for the passage and/or delivery of agents and/or cells throughout said open interconnected porous structure and also improves the mechanical properties of said implant.
2. The implant of claim 1, wherein said biodegradable polymer coating is provided as a continuous coating.
3. The implant of claim 9, wherein said biodegradable polymer coating is provided as a discontinuous coating.
4. The implant of any one of claims 1 to 3, wherein said biodegradable polymer coating is porous.
5. The implant of claim 2, 3 or 4, wherein said biodegradable polymer coating further comprises discrete particles of a ceramic.
6. The implant of any one of claims 1 to 5, wherein said biodegradable polymer coating is selected from the group consisting of photosensitive polymers, polycaprolactone, polyanhydrides, poly (ortho esters), poly (amino acids), pseudo-poly (amino acids), polyethylene glycol, polyesters and mixtures thereof.
7. The implant of claim 6, wherein said photosensitive polymers are selected from the group consisting of polyhydroxybutyrate, polyhydroxyvalerate and copolymers thereof.
8. The implant of claim 6, wherein said polyester is selected from the group consisting of poly(lactic acid) and poly(glycolic acid).
9. The implant of any one of claims 1 to 8, wherein said polymer coating has a thickness of up to about 250 microns.
10. The implant of claim 9, wherein said biodegradable polymer coating has a pharmaceutical agent incorporated therein.
11. The implant of claim 10, wherein said pharmaceutical agent is an agent selected from the group consisting of epidermal growth factor, fibroblast growth factor, platelet derived growth factor, transforming growth factor, antimicrobials, antibiotics, parathyroid hormone, leukemia inhibitory factor, insulin-like growth factor, bone morphogenetic proteins, osteogenin, sodium fluoride, estrogens, calcitonin, biphosphonates, calcium carbonate, prostaglandins, vitamin K and mixtures thereof.
12. The implant of claim 9, wherein said sintered matrix body is loaded with a population of cells selected from the group consisting of cartilage cells, tendon cells, bone cells, ligament cells, organ cells, musculotendinous cells and mixtures thereof.
13. The implant of claim 1, wherein said calcium-phosphate based compound is selected from the group consisting of hydroxyapatite, carbonated apatite, Skelite.TM,, fluroapatite, alpha-tricalcium phosphate, beta-tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate and mixtures thereof.
14. The implant of claim 13, wherein said calcium-phosphate based compound is Skelite TM which is a compound of calcium, oxygen and phosphorous, wherein a portion of at least one of calcium, oxygen and phosphorous is substituted with an element having an ionic radius of approximately 0.1 to 0.6.ANG..
15. The implant of claim 14, wherein said compound has the formula:
(Ca)~(P1-x-y-z B x C y D z)O i}2 wherein B, C and D are selected from those elements having an ionic radius of approximately 0.1 to 0.4.ANG.:
x is greater than or equal to zero but less than 1;
y is greater than or equal to zero but less than 1;
z is greater than or equal to zero but less than 1;
x + y + z is greater than zero but less than 1;
i is greater than or equal to 2 but less than or equal to 4; and j is equal 4-.delta., where .delta. is greater than or equal to zero but less than or ~ equal to 1.
16. The implant of claim 4, wherein said biodegradable polymer coating has a substantially high degree of porosity.
17. The implant of claim 16, wherein said biodegradable polymer coating has a porosity of about 50 to about 200 microns.
18. The implant of claim 1, wherein said porous structure has a porosity of about 200 to about 600 microns.
19. The implant of claim 5, wherein said particles are up to about 5C
microns.
20. The implant of claim 1, wherein said sintered matrix body has a gradient porosity wherein outermost regions are most dense and poros ty increases towards the center of the matrix body.
21. The implant of claim 1 or 20, wherein said sintered matrix body has hollow ligaments.
22. The implant of claim 21, wherein said hollow ligaments are filled with a biodegradable polymer.
23. The implant of claim 22, wherein said biodegradable polymer is selected from the group consisting of photosensitive polymers, polycaprolactone, polyanhydrides, poly (ortho esters), posy (amino acids), pseudo-poly (amino acids), polyethylene glycol, polyesters and mixtures thereof.
24. The implant of claim 22 or 23, wherein said biodegradable polymer is porous.
25. A method of malting a coated porous ceramic composite implant for connective tissue replacement, said method comprising;
(i) impregnating an organic reticulated foam structure with a slurry of calcium-phosphate compound;
(ii) drying the impregnated foam structure to form a slurry coated foam structure;
(iii) pyrolyzing the slurry coated foam structure formed in (II) and sintering to provide a sintered porous matrix body possessing an open interconnected porous structure with internal and external surfaces; and (iv) applying a coating of a biodegradable polymer to said exterior and interior surfaces of said porous ceramic implant.
26. The method of claim 25, wherein said slurry is formed by mixing a calcium phosphate compound with water and a dispersing agent.
27. The method of claim 26, wherein said dispersing agent is selected from the group consisting of sodium polyacrylate, ammonium polyacrylate, sodium citrate, sodium tartrate, sodium carbonate, sodium silicate, tetrasodium pyrophosphate and mixtures thereof.
28. The method of claim 26, wherein said slurry comprises about 1 to about 3.5% by volume dispersing agent
29. The method of claim 28, wherein said slurry is milled to contain solid particle sizes of up to about 50 microns prior to impregnation of said foam structure.
30. The method of claim 26, wherein one or more additives is added to said slurry.
31. The method of claim 30, wherein said additive is selected from the group consisting of binder, wetting agent, anti-foaming agent and mixtures thereof.
32. The method of claim 31, wherein said slurry comprises about less than 10% by volume binder.
33. The method of claim 31, wherein said slurry comprises less than about 2% by volume wetting agent.
34. The method of claim 31, wherein said slurry comprises less than about 2% by volume anti-foaming agent.
35. The method of claim 25, wherein step (i) is repeated until a desired thickness of up to about 100 microns is achieved.
36. The method of claim 25, wherein said slurry has a solid content of milled particles of up to about 30% by volume.
37. The method of claim 25, wherein after step (i) any excess slurry is removed by vacuum.
38. The method of claim 25, wherein step (ii) is conducted at a temperature of up to about 90°C.
39. The method of claim 38, wherein step (iii) heating is conducted at a temperature of up to about 200°C and sintering is conducted at a temperature of up to about 1300°C.
40. The method of claim 25, wherein after step (111) and prior to step (iv) a thermally decomposable material is provided within interstices of said porous matrix body and a slip casting process is used to coat selected surfaces of said body followed by thermal processing to provide a solid ceramic coating on said body.
41. The method of claim 26, wherein said calcium-phosphate based compound is selected from the group consisting of hydroxyapatite, carbonated apatite, Skelite TM, fluroapatite, alpha-tricalcium phosphate, beta-tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate and mixtures thereof.
42. The implant of claim 13, wherein said calcium-phosphate based compound is Skelite TM which is a compound of calcium, oxygen and phosphorous, wherein a portion of at least one of calcium, oxygen and phosphorous is substituted with an element having an ionic radius of approximately 0.1 to 0.6.ANG.
43. The method of claim 42, wherein said compound has the formula:
(CA)1{(P1-x-y-z B x C y D z)O j}2 wherein B, C and D are selected from those elements having an ionic radius of approximately 0.1 to 0.4.ANG.;
x is greater than or equal to zero but less than 1:
y is greater than or equal to zero but less than 1;
z is greater than or equal to zero but less than 1;
x + y + z is greater than zero but less than 1;
i is greater than or equal to 2 but less than or equal to 4; and j is equal 4-.delta., where .delta. is greater than or equal to zero but less than or equal to 1.
44. The method of claim 25, wherein step (i) is conducted using centripetal force to provide gradient porosity.
45. The method of claim 25, wherein said biodegradable polymer coating is provided as a continuous coating.
46. The method of claim 25, wherein said biodegradable polymer coating is provided as a discontinuous coating.
47. The method of claim 45 or 46, wherein said biodegradable polymer coating is porous.
48. The method of claim 25, 45, 46 or 47, wherein said biodegradable polymer coating is provided as a polymer composite containing particles of porous ceramic matrix.
49. The method of claim 48, wherein said polymer is selected from the group consisting of photosensitive polymers, polycaprolactone, polyanhydrides, poly (ortho esters), poly (amino acids), pseudo-poly (3mina acids), polyethylene glycol, polyesters and mixtures thereof.
50. The method of claim 49, wherein said photosensitive polymers are selected from polyhydroxybutyrate, polyhydroxyvalerate and copolymers thereof.
51. The method of claim 49, wherein said polyester is selected from poly(lactic acid) and poly(glycolic acid).
52. The method of claim 25, wherein said sintered matrix body has ~ollow ligaments that are filled with a biodegradable polymer.
53. The method of claim 25, 45, 46, 47 or 52, wherein said polymer has a pharmaceutical agent incorporated therein.

particulate debris, during standard orthopaedic fixation practice. The porous bone substitute is a porous ceramic composite.
In accordance with the present invention, is a composite bone substitute comprising a porous osteoinductive ceramic matrix and a biodegradable polymer.
In a preferred embodiment, the biodegradable polymer is provided as a coating on the ceramic matrix. The osteoinductive porous ceramic matrix possesses optimum pore size, pore size distribution, porosity, and pore connectivity to promote the rapid in-growth of bony tissue.
In aspects of the invention, the porous matrix has a porosity of about 200 to about 600 microns.

According to an aspect of the present invention there is provided a porous ceramic composite implant, said implant comprising;

- a porous ceramic matrix having a biodegradable polymer provided on internal and external surfaces of said ceramic matrix, wherein said biodegradable polymer allows for the passage and/or delivery of a variety of agents throughout said porous ceramic matrix and improves mechanical properties of said implant.

According to another aspect of the present invention is a porous ceramic composite comprising:
- an isolated bioresorbable biomaterial compound comprising calcium, oxygen and phosphorous, wherein a portion of at least one of said elements is substituted with an element having an ionic radius of approximately 0.1 to 0.6 ~~
and a biodegradable polymer.

According to a further aspect of the present invention is a porous ceramic composite comprising;
- a biomaterial compound having the formula:
(Ca)r{(P1-x=y-z B x C y D z)O j}2 wherein B, C and D are selected from those elements having an ionic radius of approximately 0:1 to 0.4.ANG.;
x is greater than or equal to zero but less than 1;
y is greater than or equal to zero but less than 1;
z is greater than or equal to zero but less than 1;
x + y + z is greater that, zero but less than 1;
i is greater than or equal to 2 but less than or equal to 4;
j is equal 4-.delta., where .delta. is greater than or equal to zero but less than or equal to 1;
and - a biodegradable polymer.

According to a further aspect of the present invention, the biodegradable polymer coating is porous in order that the underlying osteoinductive ceramic matrix is exposed to the physiological environment and positively influence bone cell behaviour.

According to another aspect of the present invention, the polymer has a substantially high degree of porosity, in aspects the porosity is about 50 to about 200 microns.

According to a further aspect of the present invention, the biodegradable polymer itself is a composite material containing small quantities of the osteoinductive ceramic material such that cells in contact with the implant surface will be stimulated to initiate the bone repair process.

According to a further aspect of the present invention, the pores of the osteoinductive ceramic matrix are filled with a porous network of a biodegradable.
polymer of a composition the same as, or different, than the polymer coating.

According to a further aspect of the present invention, the porous network may be formed with a variety of polymers including photosensitive polymers.
The photosensitive polymer is present during in vivo or in vitro cell seeding, proliferation and differentiation phases of tissue formation. The
CA2460026A 2001-09-24 2002-09-24 Porous ceramic composite bone grafts Expired - Fee Related CA2460026C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US32406801P 2001-09-24 2001-09-24
US60/324,068 2001-09-24
PCT/CA2002/001450 WO2003026714A1 (en) 2001-09-24 2002-09-24 Porous ceramic composite bone grafts

Publications (2)

Publication Number Publication Date
CA2460026A1 true CA2460026A1 (en) 2003-04-03
CA2460026C CA2460026C (en) 2011-06-28

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Country Status (8)

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US (1) US7875342B2 (en)
EP (1) EP1429817B8 (en)
JP (1) JP4691322B2 (en)
AT (1) ATE359836T1 (en)
AU (1) AU2002325762B2 (en)
CA (1) CA2460026C (en)
DE (1) DE60219646T2 (en)
WO (1) WO2003026714A1 (en)

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CN103520779A (en) * 2012-07-02 2014-01-22 李亚屏 Porous composite biological material containing multiple active ions and preparation method thereof

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