CA2419326A1 - Method of making an orthopaedic implant having a porous metal surface - Google Patents

Method of making an orthopaedic implant having a porous metal surface Download PDF

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Publication number
CA2419326A1
CA2419326A1 CA002419326A CA2419326A CA2419326A1 CA 2419326 A1 CA2419326 A1 CA 2419326A1 CA 002419326 A CA002419326 A CA 002419326A CA 2419326 A CA2419326 A CA 2419326A CA 2419326 A1 CA2419326 A1 CA 2419326A1
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CA
Canada
Prior art keywords
sheet
pad
porous metal
film
polyaryletherketone
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
CA002419326A
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French (fr)
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CA2419326C (en
Inventor
Michael Hawkins
Steven James Charlebois
Jerry W. Howard
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Zimmer Inc
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Zimmer Inc
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Publication date
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Publication of CA2419326A1 publication Critical patent/CA2419326A1/en
Application granted granted Critical
Publication of CA2419326C publication Critical patent/CA2419326C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907—Nets or sleeves applied to surface of prostheses or in cement
    • A—HUMAN NECESSITIES
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    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • B29C45/14467—Joining articles or parts of a single article
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/681—Component parts, details or accessories; Auxiliary operations
    • B29C70/683—Pretreatment of the preformed part, e.g. insert
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/88—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts characterised primarily by possessing specific properties, e.g. electrically conductive or locally reinforced
    • B29C70/882—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts characterised primarily by possessing specific properties, e.g. electrically conductive or locally reinforced partly or totally electrically conductive, e.g. for EMI shielding
    • B29C70/885—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts characterised primarily by possessing specific properties, e.g. electrically conductive or locally reinforced partly or totally electrically conductive, e.g. for EMI shielding with incorporated metallic wires, nets, films or plates
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/3662—Femoral shafts
    • A61F2/3676—Distal or diaphyseal parts of shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30929—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having at least two superposed coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30967—Diffusion bonding
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30968—Sintering
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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    • A61F2002/30971—Laminates, i.e. layered products
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
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    • A—HUMAN NECESSITIES
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C45/14811—Multilayered articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901—Method of manufacturing prosthetic device

Abstract

An orthopaedic implant having a porous metal surface in a preferred embodiment, the implant comprises three layers including a biocompatible metal core of desired shape, a polymer intermediary layer, and a surface layer comprising a porous biocompatible metal, shaped appropriately to act as the surface of an orthopaedic implant is provided. The core and the pad are placed in an injection molding device wherein a polymer intermediary layer is injection molded between the pad and the metal core, thereby bonding the pad to the metal core.

Claims (14)

1. A method for impregnating a porous metal pad with a polymer, wherein the method comprises:
(a) providing a first sheet of biocompatible metal, a first sheet of heat-resistant releasable plastic film, a sheet of semi-crystalline polymer film, a porous metal pad, a second sheet of heat-resistant releasable plastic film, and a second of sheet of biocompatible metal;
(b) creating an abutting arrangement of the sheets and pad such that the biocompatible metal sheets form the outer most layers of the arrangement, and the porous metal pad abuts the polyaryletherketone film; and (c) placing the arrangement into a press for sufficient time and under sufficient temperature and pressure to allow the semi-crystalline polymer film to interpose itself within the porous metal sheet, to form an impregnated porous metal pad.
2. The method of Claim 1, wherein the biocompatible metal sheets comprise commercially pure titanium.
3. The method of Claim 1, wherein the semi-crystalline polymer film is selected from the group consisting of polyetheretherketone, polyaryletherketone, and polyphenylene-sulfide.
4. The method of Claim 1, wherein the heat resistant releasable plastic film is a polyimide film.
5. A method of forming an orthopaedic implant having a porous metal surface, the method comprising:

(a) providing a first sheet of biocompatible metal, a first sheet of heat resistant releasable plastic film, a sheet of semi-crystalline polymer film, a porous metal pad, a second sheet of heat resistant releasable plastic film, and a second sheet of biocompatible metal;

(b) arranging the of sheets and the pad, such that the same are each adjacent to at least one other sheet or pad, and that the biocompatible metal sheets form the outermost layers of the arrangement, and the porous metal pad abuts the polyaryletherketone film sheet;

(c) placing the layered arrangement into a press for a sufficient time and under sufficient temperature and pressure to allow the polyaryletherketone film to interpose itself into the porous metal pad, thus forming an impregnated porous metal pad;

(d) placing the impregnated pad into a molding device;

(e) molding a polymer implant body adjacent to the polymer impregnated inner surface or the pad, such that it is bonded to the surface of the implant body;
6. The method of Claim 5, wherein the biocompatible metal is titanium.
7. The method of Claim 5, wherein the semi-crystalline polymer film is selected from the group consisting of polyetheretherketone, polyaryletherketone and polyphenylenesulfide.
8. The method of Claim 5, wherein the heat resistant releasable polymer film is a polyimide film.
9. A method of forming an orthopaedic implant having a core, a polymeric intermediary layer, and a porous metal surface, the method comprising:

(a) providing a substantially solid core;

(b) providing a porous metal pad having a desired size and a desired shape suitable for bonding to the core;

(c) providing a first sheet of biocompatible metal, a first sheet of heat resistant releasable plastic film, a sheet of semi-crystalline polymer film, a second sheet of heat resistant releasable plastic film, and a second sheet of biocompatible metal;

(d) providing an abutting layered arrangement of the sheets and the porous metal pad such that the biocompatible metal sheets form the outermost layer of the arrangement such that the porous metal sheet abuts the polyaryletherketone film sheet;

(e) placing the layered arrangement into a press for sufficient time and under suffident temperature and pressure to allow the semi-crystalline polymer film to interpose itself into the porous metal pad; thus forming an impregnated porous metal pad;

(f) placing the arrangement and the core into an injection molding device; and (g) injection molding a polymer intermediate layer around the core and between the core and the polymer impregnated inner surface of the pad.
10. The method of Claim 9, wherein the metal core comprises a cobalt-chromium, molybdenum alloy.
11. The method of Claim 9, wherein the biocompatible metal sheet is commercially pure titanium.
12. The method of Claim 9, wherein the heat resistant releasable plastic film is a polyimide film.
13. The method of Claim 9, wherein the polymer intermediate layer is selected from the group consisting of polyaryletherketone, polyetheretherketone and polyphenylenesulfide.
14. The method of Claim 9, wherein the semi-crystalline polymer is selected from the group consisting of polyaryletherketone, polyetheretherketone and polyphenylenesulfide.
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US20030155686A1 (en) 2003-08-21
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JP4271960B2 (en) 2009-06-03
AU2003200571A1 (en) 2003-09-04
HK1061345A1 (en) 2004-09-17
ES2262947T3 (en) 2006-12-01
JP2003319955A (en) 2003-11-11
CA2419326C (en) 2010-08-10
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EP1354570A1 (en) 2003-10-22
US6740186B2 (en) 2004-05-25

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