WO1998012994A1 - Orthopedic device - Google Patents

Orthopedic device

Info

Publication number
WO1998012994A1
WO1998012994A1 PCT/SE1997/001597 SE9701597W WO9812994A1 WO 1998012994 A1 WO1998012994 A1 WO 1998012994A1 SE 9701597 W SE9701597 W SE 9701597W WO 9812994 A1 WO9812994 A1 WO 9812994A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
subelement
body
subelements
characterized
mould
Prior art date
Application number
PCT/SE1997/001597
Other languages
French (fr)
Inventor
Ingvar Eriksson
Anders Wykman
Leif Zackrisson
Original Assignee
Ingvar Eriksson
Anders Wykman
Leif Zackrisson
Priority date (The priority date 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 date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/006Pressing and sintering powders, granules or fibres
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/04Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts comprising reinforcements only, e.g. self-reinforcing plastics
    • B29C70/28Shaping operations therefor
    • B29C70/30Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core
    • B29C70/34Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core and shaping or impregnating by compression, i.e. combined with compressing after the lay-up operation
    • B29C70/345Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core and shaping or impregnating by compression, i.e. combined with compressing after the lay-up operation using matched moulds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/04Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts comprising reinforcements only, e.g. self-reinforcing plastics
    • B29C70/28Shaping operations therefor
    • B29C70/40Shaping or impregnating by compression not applied
    • B29C70/42Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles
    • B29C70/46Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs
    • B29C70/48Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs and impregnating the reinforcements in the closed mould, e.g. resin transfer moulding [RTM], e.g. by vacuum
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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
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    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/367Proximal or metaphyseal parts of shafts
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/3676Distal or diaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004The prosthesis made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30009The prosthesis made from materials having different values of a given property at different locations within the same prosthesis differing in fibre orientations
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    • A61F2/00Filters 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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    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004The prosthesis made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30018The prosthesis made from materials having different values of a given property at different locations within the same prosthesis differing in bending or flexure capacity
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30065Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
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    • A61F2002/30291Three-dimensional shapes spirally-coiled, i.e. having a 2-D spiral cross-section
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    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4631Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor the prosthesis being specially adapted for being cemented
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0071Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0091Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0028Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in fibre orientations
    • AHUMAN NECESSITIES
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    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00395Coating or prosthesis-covering structure made of metals or of alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00395Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407Coating made of titanium or of Ti-based alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00574Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
    • A61F2310/0058Coating made of diamond or of diamond-like carbon DLC
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00592Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2791/00Shaping characteristics in general
    • B29C2791/001Shaping in several steps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7532Artificial members, protheses

Abstract

The present invention relates to load-carrying prosthetic devices for human implantation which are manufactured of a biocompatible fiber-reinforced matrix, e.g. polymer matrix. Furthermore, the present invention relates to processes for manufacturing such a prosthetic device. The prosthetic device is characterized in that the body is made as a solid unit, composed of a plurality of separately manufactured subelements and that the subelements of the body comprise fibers in a polymer matrix, the fibers in each subelement being independently oriented in relation to the fibers in other subelements to provide each subelement with a predetermined strength characteristic.

Description

Orthopedic device

The present mvention relates to load-beanng prosthetic devices for human lmplanta- tion which are manufactured of a biocompatible fiber-reinforced matrix, e.g a polymer matrix. Furthermore the present invention relates to processes for manufacturing such a prosthetic device.

For vaπous medical leasons, a large number of treatments are carried out where the body's natural jomts are replaced by artificial joints, for example in hip joint operations Load-bearing implants, such as hip joint implants of which routine medical use is made, are manufactured of metal alloys. The great difference in elastic properties between these metal implants and the surrounding bone creates problems, howevei. The bone tissue has a substantially lower modulus of elasticity th.an the metal alloys used for the implant This results in an undesirable distribution of stresses in the bone in which the implant is fixed A particular problem is the portions with too little stress, which inhibits bone growth and gradually weakens the bone This can eventually result m the implant loosening from its site By manufacturing the implant in fibei -reinforced composite material, the elastic properties of which are moie compatible with the bone, it is possible to increase the life of the artificial joint

US-A-5 141 521 describes such a prosthetic device and a method for manufacturing the same. The prosthetic device is essentially constructed about two shell halves which are made by winding individual fibers on a geometrically adapted form The shell halves are then joined together and filled with foam or liquid material which forms a core With this device it can. however, be difficult to achieve the required strength m the prosthesis. Furthermore, problems .arise with ιnterl.amιnar shear stresses since there are no fibers for taking up shear stresses directed transversely to the center axis of the neck Another known method of manufacturing orthopedic implants involves stacking fiber layers on each other to form blocks The blocks are then machined to obtain the final geometry of the desired implant

A known .further development of this technology is .an orthopetic implant which is formed of preimpregnated laminae or layers which are stacked on top of each other m accordance with the curved geometry of the desired implant Adjacent lammae have substantially the same geometry and dependent fiber orientations smce the laminae must be arranged in parallel planes The disadvantage of this concept is the difficulty of producmg complex geometries, and therefore subsequent working is necessar>' During machining the fibers are damaged and the strength is reduced Furthermore, lamination is a time-consuming process An additional problem with this type of laminated composite is low interlaminar strength This problem is particularly pronounced in the neck portion of the prosthesis where high interlaminai shear stresses occur

One purpose of the present invention is to achieve a fiber-remforced orthopedic device which does not require any subsequent woik or which only requires a small amount of finishing

Another purpose of the present invention is to achieve a fiber-remforced orthopedic device which can be manufactured with more complicated and exact geometries

An additional purpose of the present mvention is to achieve a fiber-remforced ortho- pedic device which does not have those problems with interlaminar shear stresses which occur in the known technology

This purpose is achieved by an orthopedic load-absorbing device for implantation, said device comprising a body which is manufactured of a biocompatible fiber- reinforced polymer mateπal and which mcludes a posterior side, an anterior side, a lateral side and a medial side, with a proximal portion intended to be included m a joint and a distal portion intended to be fixed in a bone, a center axis extending through the body between the outer ends of the proximal portion and the distal portion, characterized in

- that the body is made as a solid unit, composed of a plurality of separately manu- factured subelements, and

- that the subelements of the body comprise fibers in a polymer matrix, said fibers in each subelement being independently oriented relative to the fibers in other subelements to give each subelement a predetermined strength property.

Furthermore, a first process is achieved for manufacture of an orthopedic load- absorbing device, which is characterized by the steps of

- manufacturing a subelement in a first mould made for the respective subelement. by arranging a fiber material with the selected fiber orientation and preimpregnated with polymer material, in the mould and applying heat and pressure over the mould to achieve a certain shape retention in the subelement, .and

- arranging the subelements in a second mould with a mould cavity corresponding to the geometry of the body and causing these to be finally bonded to each other by applying heat and pressure over the second mould.

Furthermore, a second process is achieved for manufactunng an orthopedic load- absorbing device, characterized by the steps of

- manufacturing a subelement in a first mould made for the respective subelement, by arranging fibers treated with adhesive means, with selected fiber orientation in the mould, .and applying heat and pressure over the mould to achieve a certain shape retention of the subelement,

- arranging the subelements in a second mould with a cavity corresponding to the geometry of the body and cohering these by applying heat and pressure over the mould, thereby achieving a certain cohesion between the subelements. .and

- arranging the assembled subelements in a third mould and causing these to be finally bonded to each other by preferably adding polymer matrix in accordance with Resin Transfer Molding. Furthermore, a third process is achieved for manufacturing an orthopedic load- absorbing which is characterized by the steps of

- manufacturing a subelement by cutting it out of a block of fiber material preimp- regnated with polymer material, said block having a fiber orientation selected for the subelement, and

- arranging the subelements in a second mould and causing these to be finally bonded to each other by applying heat and pressure over the second mould or by gluing the subelements together.

Further developments of the device .and processes are included in the characteristics disclosed in the subclaims.

Additional advantages beyond those already mentioned are achieved with the invention, i.a. more rapid and more simple production.

Additional advantages and characteristics will be evident from the following description.

The present invention will now be described as an example with reference to the accompanying drawings, in which:

Figure 1 is a front view of a hip implant; Figure 2 is a side view of the hip implant in Figure 1 ; Figure 3 shows the hip implant in the same view as in Figure 1 implanted in the body; Figure 4 is a longitudinal section through the hip implant in Figure 1 ; Figure 5 shows a section along the line A-A in Figure 2; Figure 6 shows a section along the line B-B in Figure 4; Figure 7 shows a section corresponding to the section in Figure 5 through an alternative embodiment of the hip implant; Figure 8 shows a step in the manufacture of the device according to one embodiment of a first and a second process; Figure 9 shows an additional step in the manufactuie of the device according to one embodiment of the first and the second process, and

Figure 10 shows injection of polymer matπx m a mould by resin transfer moldmg accordmg to a first embodiment of the second process

With reference to Figs 1 and 2, a hip jomt implant 1, according to a preferred embodiment of the mvention, compπses essentially a curved elongated body 2 which has a center axis 3 The body is provided with an essentially spheπcal head 4 which is disposed on a neck portion 7 which is joined to a curved shoulder portion 8 which in turn is joined to a somewhat conically shaped shank portion 9 Furthei- more. the body is delimited by a proximal portion or jomt connecting portion 5 and a distal portion or anchoring portion 6, opposing lateral and medial surfaces 1 ϋ and 11, respectively, and opposmg posteπor and anterior surfaces 12 and 13, respectively The proximal portion 5 compπses essentially the neck portion 7 and is mtended to be included m a ball and socket jomt, which the head arranged on the neck portion is designed to be pivotally received in a socket in the pelvis The distal poi- tion comprises essentially the shoulder portion 8 and the shank portion 9 and is intended to be anchored m the femur

Fig 3 shows how the implant is arranged in the hip For implantation in human tissue it is suitable that the prosthesis be coated with a metallic titanium layer by ions puttering accordmg to known technology This metal layer is in turn covered with hydroxy apatite, also accordmg to known technology By virtue of the comcal shape of the shank portion, the body is thereafter pressed securely agamst the inner walls of the bone accordmg to what is known as macrofixation When the prosthesis has been fixed m the bone, the bone tissue grows mto the surface with hydroxy apante whereby so-called microfixation takes place The natural socket in the pelvis is replaced by another implant in the form of a socket 15. m which the head 4 is received The socket 15 is of standard type and is manufactured of a matenal. e g lathed UHMWPE (Ultia High Molecular Weight PolyEthvlene) or ceramic matenal such as A1203. suitable for implantation and for pι\otal cooperation with the head 4 The socket is fixed by usmg a so-called bone cement, polymethylmethacrylate (PMMA), for example, which is polymeπzed dunng the incision itself dunng the hip joint operation

Fig 3 shows how a resultant force 16 acts on the hip joint implant When the hip jomt implant is loaded, the force 16 acts on the head 4, and this force is transmitted via the neck 7, the shoulder portion 8 and finally the shank portion 9 to the natural bone 14 of the femur A cross-section through the implant, due to the load 16 is subjected to a bendmg moment, transverse forces, an axially directed compressive force and to some extent torsional forces

Fig 4 shows hoλλ the prosthesis is essentially constructed of a number of subelements 17-20 and 22-23, which compnse fibers in a matrix material A subelement is characterized by extending in all dimensions by virtue of the fact that fibers are arranged m a plurality of layers or bundles which is comparable to known technology where the body is built up of layers or laminae Furthermore, the fiber onenta- tion in a subelement is independent of the fiber orientations of the other subelements in contrast to laminated bodies where the fibers are oriented in parallel planes Furthermoie, the subelements .are geometncally diffenng in shape in ordei to form together the total geometry of the body, in contrast to laminated bodies where adjacent layers or la mae have substantially the same geometry The fibers in the subelements can be arranged to achieve a predetermined strength property in each of the subelements A predetermined strength property is a strength property characteristic for the subelement, for example that the fibers are onented so that the subelement takes up forces m certain directions better than m other directions or that the subelement takes up forces m all directions substantially equally well Suitably the fibers aie onented in each subelement so that essentially optical strength is obtained foi the body in its intended application

In the application in question, the subelements 18and 20 will pnmaπly be subjected to forces the longitudinal direction of the elements Therefore, in this example. it is suitable that the fibers 24, which is only shown very schematically, in the subelements 18 and 20, defining opposite lateral and medial surfaces 10 and 11, respectively, are oriented in the longitudinal direction of the body. In this manner a good load-bearing capacity is obtained as regards those stresses generated by bending moment .and the compressive force acting in the direction of the center axis.

Furthermore, the fibers 25 in this example, which are only shown very schematically, in the subelement 19, which is arranged in the central portion of the body, oriented in planes substantially parallel to the opposite posterior and anterior sides and at an angle of approximately ±45° relative to the center axis. In this manner good load- bearing capacity is obtained with regard to the shear stresses caused by transverse forces. The fiber orientations of the subelements 18. 19 and 20 are of great importance in the proximal portion or the neck portion of the body, where the largest stresses on the body occur.

Other subelements 20 and 23, disposed essentially around the shoulder portion of the body, have fibers which are oriented in the longitudinal direction of the body as are the fibers in the elements 18 and 20.

Fig. 5 shows how the fibers 25 in the subelement 19 are arranged in layers, while the fibers 24 in the subelements 18 and 20 are shown in section perpendicular to the longitudinal direction when they are arranged in bundles in the longitudinal direction of the body.

Fig. 6 shows a section through the joint head and the neck portion. In this example, the head consists of a subelement 17 in a fiber-reinforced polymer material and which is integrated with the body. The joint head is manufactured in accordance with a process which is described in more detail below but which essentially involves rolling up a semi-elliptical fiber mat 21 in a number of layers about an axis and thereafter arranging the head thus formed on the neck portion 7. The fibers in the joint head are in this example oriented in the longitudinal direction of the body. The head 4 can also be a separate element of another matenal, for example ceramic or metallic, arranged on the neck portion of the body.

Fig 7 shows a section corresponding to the section A-A in Figure 2 through an alternative embodiment of the prosthesis. The embodiment described above has subelements stacked on each other, with subelements 1 '-9' in Fig. 7 shown alternately arranged in a "bundle". There are, of course, a number of vaπants of the described embodiment and further conceivable embodiments, which fall within the scope of protecnon of the invention.

The m.anufacture of the previously descnbed implant can suitably be earned out according to a first or a second process Regardless of which process is used, there is determined initially, depending on the type of desired implant, the charactenstics of the subelements which should make up the body In a hip implant of the pre- viously described type, it is considered at present suitable to divide the body mto the previously described subelements 17-20 and 22-23 Furthermore, with regard to the forces which such an implant is subjected to, it is suitable to use the previously descnbed fiber onentations of the subelements. For other implants another division and construction of the subelements can be more suitable and different fiber oπen- tations can be selected

Furthermore, a mould is manufactured for each subelement which is to be included in the body. Moreover, at least one mould is manufactured with a mould cavity for the enure body, i.e. the assembled subelements

In one embodiment of the first process, when manufacturing the subelements. one starts with a fiber material preimpregnated with polymer matenal, such as prepreg or tape The impregnation material thus forms the polymer matrix m the implant. In a first step in manufacturing, the fiber matenal is arranged with a selected onenta- tion for the respective subelement. Fig. 8 shows how a bundle of fibers 27 has been placed in a mould half 26. which is shown partially in section and which has a mould cavity intended for the subelement 20. The fiber bundle can be achieved by rolling or folding a fiber material, in the form of a fiber mat with parallel fibers, into a bundle of suitable thickness. The fibers extend in the longitudinal direction of the rolled up mat, i.e. along the mould cavity. In order to achieve subelements with varying cross-sectional areas, thicknesses .and geometries, while keeping the fiber density essentially constant, it is suggested that the fiber mat have the shape of a trapezoid or a rhombus. When a fiber mat in the shape of a ttapezoid is rolled up or folded perpendicular to its respective parallel sides, fiber bundles of varying cross-section area can be achieved, thus providing good fiber-filling in the entire mould cavity. It is also possible, to achieve a selected degree of fiber-filling, to place more than one fiber bundle in each mould In this embodiment all of the subelements 18, 20, 22 and 23 have essentially parallel fibers, and therefore this method is preferable for arranging the fibers with the selec- ted fiber direction in the moulds for these subelements.

The subelement 19 is manufactured in a somewhat different manner. The starting fiber material for this subelement is, for example, in the form of preimpregnated woven material in which the fibers are angle-oriented ±45°. Sheets are stamped out of the fiber material in accordance with the geometry of the subelement and are stacked in layers m the mould cavity. The stamping out is effected in such a way that the fibers in the body are oriented approximately ±45u in relation to the center axis and in planes parallel with the opposing posterior and anterior surfaces.

In a second step, when the fiber material has been placed in the mould cavity, heat and pressure are applied to the mould cavity for prepolymerization, and the polymer material achieves a certain shape retention in the subelement.

In a third step, the subelements thus manufactured are put together in a mould which has a mould cavity corresponding to the total geometry of the body. Fig. 9 shows a section throueh such a mould 29 which compnses two mould halves 30 and 31. and the body is shown in a section through the shoulder portion. Furthermore, it is shown how the separately manufactured subelements 18, 19, 20, 22 and 23 are placed on top of each other in the mould cavity.

In a fourth step, heat and pressure .are applied to the mould to cure or consolidate depending on whether the impregnation material is a thermosetting plastic or a thermoplastic.

In the second process for manufacturing the above described hip joint implant, according to one embodiment, the starting fiber material is not preimpregnated.

Instead, the fiber material is treated with an adhesive material which can be in the form of a suitable polymer material. The first three steps in the two processes are essentially the same, the difference being that in the first process the fiber material is impregnated and in the second process the fiber material is not impregnated.

In the first step of the second process, the fiber material treated with the adhesive material is ananged with a fiber orientation selected for the respective subelement in the same manner as was described above for the respective subelements.

In the second step of the second process, when the fiber material has been placed in the mould cavity, heat and pressure are applied to the cavity, and the adhesive material achieves a certain shape retention in the subelement.

As in the first process, the subelement 19 is manufactured in a somewhat different manner. The starting fiber material in the second process for manufacturing this subelement is, for example, in the form of a woven hose, m which the fibers are angle-oriented ±45° relative to the longitudinal direction of the hose blank. The fiber material is cut in suitable lengths from the hose bl.ank and extends along essentiall the entire mould cavity when stacked therein. Furthermore, the fiber material is arranged in such a manner in the mould cavity that the longitudinal direction of the hose blank coincides with the longitudinal direction of the mould cavity and so that the fiber matenal in the subelement, when it is arranged in the body, is essentially onented in a plane parallel to the opposite postenor and antenor surfaces In ordei to further fix the cut hose pieces to each other it is suitable to sew them together with fiber thread

In the third step of the second process, the subelements thus manufactured are put together m a second mould cavity corresponding to the total geometry of the body and pressure and heat are applied to the mould to provide a body with a certain shape retention

In the fourth step of the second process, the body is placed in a mould which is arranged to provide the polymer matrix of the body and which has a mould cavity corresponding to the geometry of the finished body Fig 10 shows, from abo\ e. a secnon through the mould 34, compnsmg a mould chamber or cavity 35, an inlet 32 and an outlet 33 After the body has been placed in the mould, polymer matnx is added or injected by mould injection or by resm transfer moulding (RTM) with the polymei matrix being introduced through the inlet 32 and air and surplus polvmei gomg out through the outlet 33

In a fifth step m the second process, the matnx is finally cured, preferably at elevated temperature

A third, though less preferred, process compnses cutting out the respective subelement from a block of fiber-reinforced polymer matenal with the selected fiber oπen- tation or in another mannei working the respective subelements from such a block In this third piocess, however, it is not possible m a simple manner to arrange the fibeis curved in the longitudmal direction of the body However, it is possible to see to it in a simple way that the fibers in the loaded neck portion have the desired fibei onentaπon by suitable cutting of the subelement from the block If the polymei matenal is a thermo setting plastic, the subelements are thereafter glued togethei If the polymer material is a thermoplastic, in addition to gluing the subelements together, it is possible to continue manufacture in accordance with the first process.

It should be understood that the subelements of a body can be manufactured by combining the above described processes.

The pivot head 4 is manufactured in this example of an elongated essentially semi- elliptical fiber mat. Beginning at the minor axis, the mat is rolled up along the major axis about a shaft or a roll with dimensions coπesponding to the neck portion of the body. By suitably selecting the dimensions of the fiber mat, it is wound in several layers about the shaft and forms an essentially spherical head. After the fiber mat has been wrapped up on the shaft, it is given a certain shape retention in the same manner as was described for the subelements. The pivot head 4 is then removed from the shaft or roll and slipped onto the neck portion of the body. If the fiber mat is not impregnated, the pivot head in this example is mounted on the neck before the polymer matrix is introduced. If prepreg is used, the pivot head can be arranged on the body after being manufactured separately and thereafter be consolidated further together. It is also possible to roll or wind up the fiber mat directly on the neck portion of the body. A number of variants of the above described methods of arranging the pivot head on the bodv are possible, all lying within the scope of protection of the invention. In order to improve the surface properties of the pivot head in the slide surface against the socket, the surface can be coated with a metal layer, e.g. DLC (Diamond Like Coating) in accordance with known technology.

The pivot head can also be a metallic, highly polished or ceramic pivot head, made as a separate unit according to known technology. In this case, the pivot head can be arranged on the neck portion of the body in accordance with what is commonly known as a modular process, the pivot head being forced or "slipped" with good fit on the neck portion. Due to the good fit and the fact that the muscles act to contract over the joint, the pivot head is securely mounted on the neck portion of the body. Biocompatible polymers which are used as matrix material m the present invention can essentially be refeπed to the groups thermosettmg and thermoplastics A particularly prefeπed matrix material within each respective group can, for example, be called epoxy plastics of medical quality and polyether etherketone (PEEK). Biocompatible fibers which can be used in the present invention are e.g. carbon-based, glass-based and polymer-based fibers of different types These are well known foi their strength-increasing reinforcing properties. Suitably, fiber materials are used in the form of roving, mats, woven textiles, yarn or the like. Depending on the process of manufacture, the fiber material is of non-preimpregnated or preimpregnated type Suitably, the fibei material for the second process has been pretreated with adhesive matenal

If roving is used as a fiber matenal. it can be placed directly in the required amount m the mould for a subelement

In the prefened embodiment of the second process, a fiber net is slipped over the assembled subelements before injection of a polymer matnx. thus giving additional strength to the body. This can also be advantageous in the other processes in ordei to further improve the properties of the body

Other fiber onentations than those described above can also be achieved m the subelements For example, it can be advantageous to arrange the fibers crosswise in layers in the subelements. Prostheses which aie subjected to other load conditions can be made simply by adapting the selection of fiber orientations in the subelements and dividing the body into subelements for expected loads

It is also conceivable to aπange other components, e.g a core of homogeneous biocompatible matenal If the body can completely enclose other components, a greatei selection of materials is available Other types of joints than hip joints can, of course, be manufactured with advantage according to the above described device or the above described processes. Examples of such joints can be elbow joints, knee joints and shoulder jomts. For shoulder joint prostheses, for example, the distal portion is fixed to the humerus and the proximal portion is articulated in the shoulder. Furthermore, the proximal portion is not only limited for inclusion in ball and socket joints but can also be included in other types of joints, such as are present in knee joints and elbows.

In a further embodiment, the proximal portion can be anchored in another bone in the body, e.g. as splicing elements for fractured bones.

The invention is not limited to that described above or shown in the drawings but can be changed within the scope of the accompanying claims.

Claims

Claims
1. Orthopedic load-bearing device ( 1 ) for implantation, said device comprising a body (2) which is manufactured of a biocompatible fiber-reinforced polymer material and which includes a posterior side (12), an antenor side (13), a lateral side (10) and a medial side (11), with a proximal portion (5) intended to be included in a joint and a distal portion (6) intended to be fixed in a bone, a center axis (3) extending through the body between the outer ends of the proximal portion and the distal por- tion, characterized m
- that the body is made as a solid unit, composed of a plurality of separately manufactured subelements (18-20, 22, 23), and
- that the subelements of the body comprise fibers in a polymer matrix, said fibers in each subelement being independently oriented relative to the fibers in other sub- elements to give each subelement a predetermined strength property.
2. Device according to Claim 1, characterized in
- that at least one subelement (18, 20) in the proximal portion of the body has its fibers (24) oriented essentially parallel to the center axis and/or in planes substanti- ally parallel to the sides of said at least one subelement which face the lateral or medial side.
3. Device according to one of the preceding claims, characterized in
- that at least one single subelement (19) has fibers (25) oriented at an angle, pre- ferably with alternating orientations of approximately ±45°, relative to the center axis and oriented in planes substantially parallel to the anterior and posterior sides, and
- that said single subelement is arranged centrally in the proximal portion of the body.
4. Device accordmg to one of the preceding claims, characterized in
- that the device is a hip joint prosthesis which comprises a curved elongated body (2) and an essentially spherically shaped pivot head (4) which is arranged on a neck portion (7) of the body, which is joined to a curved shoulder portion (8) which in turn is joined to a shank portion (9).
5. Device according to one of the preceding claims, characterized in
- that the lateral side and the medial side are defined by subelements (18, 20) in which the fibers are oriented substantially parallel to the center axis, and - that subelements (22, 23) are arranged in the shoulder portion of the body , said subelements having fibers oriented substantially parallel to the center axis.
6. Device according to one of the preceding claims, characterized in
- that the body comprises a fiber net surrounding the subelements.
7. Device according to one of Claims 4-6, characterized in
- that the pivot head is formed of a rolled up semi-elliptical fiber mat in a polymer matrix.
8. Device according to one of Claims 4-6, characterized in
- that the pivot head is a separately manufactured component of metal or ceramic material.
9. Device according to one of the preceding claims, characterized in - that the subelements are manufactured of fiber material preimpregnated with polymer material, such as prepreg.
10. Device according to one of the preceding claims, characterized in
- that the polymer material is a thermosetting plastic or a thermoplastic, preferabl epoxy of medical quality or polyether etherketone. and
- that the fiber material is carbon-based, glass-based or polymer-based fibers.
11. Process for manufacturing an orthopedic load-bearing device according to one of Claims 1-10, characterized by the steps of
- manufacturing a subelement in a first mould made for the respective subelement, by arranging a fiber material with the selected fiber orientation and preimpregnated with polymer material, in the mould and applying heat and pressure over the mould to achieve a certain shape retention in the subelement, and
- aπanging the subelements in a second mould with a mould cavity corresponding to the geometry of the body and causing these to be fmally bonded to each other by applying heat and pressure over the second mould.
12. Process for manufacturing an orthopedic load-bearing device according to one of Claims 1-10, characterized by the steps of
- manufacturing a subelement in a first mould made for the respective subelement, by arranging fibers treated with adhesive means, with selected fiber orientation in the mould, and applying heat and pressure over the mould to achieve a certain shape retention of the subelement,
- aπanging the subelements in a second mould with a cavity coπesponding to the geometry of the body and cohering these by applying heat and pressure over the mould, thereby achieving a certain cohesion between the subelements, and - aπanging the assembled subelements in a third mould and causing these to be finally bonded to each other by preferably adding polymer matrix in accordance with Resin Transfer Molding.
13. Process for manufacturing an orthopedic load-bearing device according to one of Claims 1-10, characterized by the steps of
- manufacturing a subelement by cutting it out of a block of fiber material preimpregnated with polymer material, said block having a fiber orientation selected for the subelement, and
- aπanging the subelements in a second mould and causing these to be finally bonded to each other by applying heat and pressure over the second mould or by gluing the subelements together. 14 Process accoiding to Claims 11, 12 or 13, characterized by
- onenting, in at least one subelement, the fibers so that they are arranged, m the proximal portion of the body, essentially parallel to the center axis and or m planes substantially parallel to the sides of said at least one subelement which face the lateral or medial side
15 Process accordmg to Claims 11, 12, 13 or 14, characterized by
- arranging the fibers in at least one smgle subelement so that they are onented in the body at an angle, preferably altematmgly onented approximately ±45°. relative to the center axis and oriented in planes substantially parallel to the antenor and posteπoi sides, and
- aπanging said single subelement centrally in the proximal portion of the body
16 Process according to one of Claims 11-15, characterized in
- that a fiber net is slipped over the assembled subelements
17 Process accoidmg to one of Claims 1 1-16, characterized by
- rolling up a semi-elliptical fiber mat along its major axis on a cylindncal element or directly on the pioximal portion to form an essentially sphencal pivot head, and
- aπanging the pivot head on the proximal portion of the body
18 Process accordmg to one of Claims 11-16. characterized by
- arranging a pivot head of metallic or ceramic matenal on the proximal portion of the body
PCT/SE1997/001597 1996-09-27 1997-09-23 Orthopedic device WO1998012994A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
SE9603540-7 1996-09-27
SE9603540 1996-09-27

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