SE515572C2 - Implantat, sätt att framställa det och användning av det - Google Patents

Implantat, sätt att framställa det och användning av det

Info

Publication number
SE515572C2
SE515572C2 SE9803078A SE9803078A SE515572C2 SE 515572 C2 SE515572 C2 SE 515572C2 SE 9803078 A SE9803078 A SE 9803078A SE 9803078 A SE9803078 A SE 9803078A SE 515572 C2 SE515572 C2 SE 515572C2
Authority
SE
Sweden
Prior art keywords
tissue
kit
compatible
implant
implant according
Prior art date
Application number
SE9803078A
Other languages
English (en)
Other versions
SE9803078D0 (sv
SE9803078L (sv
Inventor
Lars Bruce
Ingrid Bruce
Original Assignee
Lanka Ltd
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
Application filed by Lanka Ltd filed Critical Lanka Ltd
Priority to SE9803078A priority Critical patent/SE515572C2/sv
Publication of SE9803078D0 publication Critical patent/SE9803078D0/sv
Priority to DE69926766T priority patent/DE69926766T2/de
Priority to CNB998107662A priority patent/CN1230134C/zh
Priority to CA002343366A priority patent/CA2343366C/en
Priority to BR9913579-5A priority patent/BR9913579A/pt
Priority to US09/786,755 priority patent/US6565606B1/en
Priority to AU60165/99A priority patent/AU743913B2/en
Priority to DK99968616T priority patent/DK1112046T3/da
Priority to MXPA01002558A priority patent/MXPA01002558A/es
Priority to PCT/SE1999/001576 priority patent/WO2000013615A1/en
Priority to EP99968616A priority patent/EP1112046B1/en
Priority to ES99968616T priority patent/ES2249062T3/es
Priority to JP2000568426A priority patent/JP4201986B2/ja
Priority to AT99968616T priority patent/ATE301978T1/de
Priority to KR1020017003042A priority patent/KR100639471B1/ko
Priority to ZA200102000A priority patent/ZA200102000B/en
Publication of SE9803078L publication Critical patent/SE9803078L/sv
Priority to NO20011178A priority patent/NO320714B1/no
Publication of SE515572C2 publication Critical patent/SE515572C2/sv

Links

Classifications

    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • 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
    • A61F2/28—Bones
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • 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
    • A61L27/14—Macromolecular materials
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3616—Blood, e.g. platelet-rich plasma
    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
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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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • A—HUMAN NECESSITIES
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    • 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
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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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    • 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
    • A61F2/28—Bones
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30588—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with solid particles
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30975—Designing or manufacturing processes made of two halves
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A61F2002/3445—Acetabular cups having a number of shells different from two
    • A61F2002/3448—Multiple cups made of three or more concentric shells fitted or nested into one another
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4681—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by applying mechanical shocks, e.g. by hammering
    • A61F2002/4683—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by applying mechanical shocks, e.g. by hammering by applying ultrasonic vibrations
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • 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
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys

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Description

30 35 SITS 5ï?2ä3ï?§; ;ïi:_.:a: 2 benägenhet att tillväxa ökar ju kortare avståndet mellan kornen är.
Uppfinningen tar lärdom från de redan kända tekni- kerna enligt ovan och av nämnda försök. Den till grund för uppfinningen liggande insikten år således att mate- rialkornen måste sammanhållas och helst sammanpackas och att kroppseget biologiskt material, vävnad, samt näring skall finnas i materialet eller skall ha möjlighet att penetrera detta.
Man skulle kunna säga att kroppshålrummet i US-A- 5 015 256 utgör formen i sättet enligt US-A-5 217 496 och innehåller naturlig näringslösning för celltillväxt, näm- ligen kroppsegen kroppsvätska, såsom blod.
I US-4 755 184 beskrivs ett implantat i form av en korv, vars hölje består av en porös slang tillknuten vid ändarna. Höljet är hårt packat.
Enligt uppfinningen innefattar implantatet en sats av en blandning av porösa korn/granuler av vävnadsvänligt slag och av sönderdelat vävnadskompatibelt biologiskt material, företrädesvis egen kroppsvävnad och företrädes- vis egen kroppsvävnad från implanteringsstället, vilken sats är innesluten i en säck eller svepning av ett väv- nadskompatibelt, flexibelt ark, folie, väv eller dylikt med öppningar/perforeringar/maskor som är genomträngliga för vävnadstillväxt inifrån säcken/svepningen till omgiv- ningen och utifrån in i säcken. Satsen skall vara väl sammanhållen och helst sammanpackad i säcken/svepningen.
Sistnämnda bör vara tillsluten, t ex igensydd så att inga korn/granulat kan vandra ut från säcken/svepningen.
Säcken/svepningen kan t ex bestå av gasbinda.
Den företrädesvis genomförda packningen av satsen i säcken/svepningen utföres till en packningsgrad som er- fordras för ändamålet som implantatet skall fylla. Är ändamålet med implantatet att det skall bära kroppsdelar eller hålla ett avstånd mellan kroppsdelar, såsom rygg- kotor, skall packningsraden vara större, dvs kunna ha bärande och avståndshållande funktion, än om det är lO 15 20 25 30 35 515 5Z?w: 3 frågan om att fylla ut en grop i kroppen, t ex för plast- kirurgiskt ändamål och annat om det är frågan om bentill- växtstimulerande medel för reumatiker.
Sammanpackningen av satsen i säcken/svepningen kan med fördel ske genom vibrering. Denna ger den ytterligare fördelen att också god blandning av satsens komponenter erhålles liksom att näring intränger i kornens/granuler- nas porer, vilket är av fördel. Vibrering kan ske vid en viss högre frekvens för blandning och en annan, lägre frekvens för sammanpackning. För vibrering kan t ex ultraljud användas.
Näring kan tillföras satsen in vitro, t ex nedsänk- ning av säcken med satsen i en konventionell näringslös- ning eller blod/plasma och vibrering av säcken, genom vars väggöppningar näringen får tillgång till satsen för àstadkommande av vävnadstillväxt. Näring kan emellertid också tillföras satsen in vivo, på implanteringsstället, som då innehåller kroppsegna vätskor som kan penetrera säcken.
Alltefter användningsändamàlet för implantatet kan implantatet sys, spikas o dyl fast på implantatstället i/på kroppen vilket kan vara nödvändigt när implantatet fyller ut en grop i kroppen och risk föreligger för dislokalisering. Om däremot implantatet kan förväntas kilas fast, t ex mellan ryggradskotor, behöver inget speciellt fastsättningsmedel användas.
Implantatet formas vid sammanpackningen till en form som väl fyller ut gropen, utrymmet eller avståndet där det skall insättas. Det är väsentligt att så sker, efter- som annars (avstånd mellan kroppsvävnad och säck) risk finns för att ingen fastväxning av implantatet sker eller för att bindväv bildas mellan säck och kroppsvävnad.
Det torde ha framgått att formen av implantatet enligt uppfinningen kan vara godtycklig, såsom platt skiva, remsa, cylinder, stav, etc.
Formningen kan utföras under tillhjälptagande av någon/några ytterligare, vävnadskompatibla komponenter i 10 15 20 25 30 35 4 satsen som gör att satsen är knådbar och behäller formen som knådningen givit åt säcken/svepningen. En lämplig sådan komponent är härdbar tvåkomponentsfibrin, som är tillgänglig på marknaden.
Säcken/svepningen kan när det så anses lämpligt bestå av ett resorberbart material. Exempel på ett sådant är SURGICEL (TM) fràn ETHICON LTD.
Som material för de vävnadsvänliga kornen/granulerna kan väljas enligt uppfinningen först och främst titan, men också andra, för fackmannen för ändamålet redan kända material är lämpade, såsom biokeramer, bioglas, hydroxi- apatit, polymerer, dextran, etc. Porösa korn/granuler som inte av naturen är porösa, t ex titan, erhålles genom på känt sätt, t ex genom att en smälta av materialet genom- blåses med gas eller vätska.
Kornen/granulerna har en väsentligen jämn storleks- fördelning, företrädesvis plastiska och oregelbundna.
Detta för att, när det gäller låsning och kompaktering genom vibration, ingen skiktning i olika partikelstor- lekar skall uppkomma i kroppshålrummet och ty åtföljande risk för ojämn och därmed försämrad vävnadstillväxt. Med väsentligen jämn storleksfördelning avses att korn/gra- nuldiametern kan variera med i 50%, företrädesvis i 25% eller därunder. Kornens/granulernas absoluta storlek kan variera inom relativt vida gränser, varvid kornen/gra- nulstorlek under 5 mm betraktas som mest lämpliga. Den undre gränsen kan vara svår att fastställa, och mycket små kornpartiklar torde kunna användas i kombination med en biokompatibel vätska som bilder de små partiklarna (dammet). Normalt används dock korn/granuler med stor- lekar över 0,1 mm. Företrädesvis kan den övre gränsen ligga vid ca 2 mm och den undre gränsen vid 0,5 mm. All- mänt kan sägas att korn/granulstorleken väljes med hänsyn till det utrymme som efter avslutad operation skall vara packat med korn/granuler, dvs större korn/granuler kan väljas för större kroppshålrum än för små. Uttrycken 10 l5 20 25 30 35 . u.. 515 5721:22: 4ï:=::;. 5 ”korn/granuler”, ”oregelbundna” och ”diameter” omfattar andra former än (ungefärligen) sfäriska).
Enligt uppfinningen kan blandningen av satskompo- nenterna för àstadkommande av ovannämnda sats utföras före införande av satserna i säcken eller före svepningen av satserna. Härvid gäller att en sats näringsmedel till- sätts blandningen. Alternativt och fortfarande enligt uppfinningen kan blandningen utföras efter införande i säcken eller efter svepningen av satserna.
Vid exempelvis ryggradsoperation för ersättning av utslitna mellankotsskivor mellan ryggkotor används ofta implantat som inskruvas mellan kotorna. Dessa implantat är stela och kan innehålla benfragment, se US-A-4 501 269 och US-A-5 489 308. Dylika benfragment föreligger emel- lertid inte alltid i tillräcklig mängd och det är implan- taten som har den bärande funktionen och kan förorsaka smärta. Dylika implantat är vidare komplicerade och dyra i framställning.
Uppfinningen råder här bot och förslår ett implantat av ovan ätergiven typ för stabilisering av ryggraden.
I fig 1 visas två formstabila ringcylindriska säckar l med ett innehåll enligt ovan och insatta mellan tvä kotor K. Säckarna 1 är väl fyllda med satsen (korn/gra- nulmaterialet är av titan), som har vibrerats för god blandning och sammanpackning, så att kotdistansen kan hållas korrekt. funktionen. Säckarna består av ovan utpekade, exemplifie- Ben bildas snabbt och övertar den bärande rande resorberbara materialet. Fig la är en sektion a-a.
I fig 2 visas ett implantat 2 enligt uppfinningen insatt i en höftbensskàl S för fixering av ett höftbens- implantat 3 i höftbensskàlen, vilket höftbensimplantat 3 består av en konventionell plastskàl 4 med titanbelägg- ning 5 och vilar på, med presspassning, en efter höft- bensskålen formad tunn säck 1 med ovan beskriven sats, där kornen/granulerna består av titan. Säcken l består också av utpekade, exemplifierande resorberbara material i form av en väv. .n f; I ytterligare en utföringsform av uppfinningen är den inre kammaren i ett ryggradsimplantat av den typ som beskrivs t ex i US-A-5 015 247 och US-A-4 501 269 fylld med ett implantat enligt uppfinningen.

Claims (8)

10 15 20 25 30 35 5-2--~-'::: *Itt ti; 2.. k.. .. v. n.. . - -~ f "ï° PATENTKRAV
1. Implantat (protes), innefattande en sats av en blandning av poröst korn/granulformigt material av väv- nadsvänligt slag och sönderdelat vävnadskompatibelt bio- logiskt material, helst eget kroppsmaterial, (t ex ben- mjöl), k ä n n e t e c k n a t därav, att satsen inne- håller ytterligare en vävnadskompatibel komponent som medger knådning av satsen och att satsen är innesluten i en säck eller svepning av flexibelt vävnadskompatibelt material och med porer/öppningar/maskor/perforeringar eller dylikt med en storlek som medger ut- och inväxt av vävnad av det biologiska materialet.
2. Implantat enligt kravet 1, k ä n n e t e c k - n a t därav, att det flexibla materialet är en av resor- berbar väv, t ex av regenererad cellulosa eller polymer.
3. Implantat enligt kravet 1 eller 2, k ä n n e - t e c k n a t därav, att det korn/granulformiga materia- let består av titan eller polymer eller dextran.
4. Implantat enligt något av kraven 1-3, k ä n - n e t e c k n a t därav, att satsen innehåller näring/- näringslösning av sådant slag som befrämjar tillväxt av det vävnadskompatibla biologiska materialet i satsen.
5. Implantat enligt något av kraven 1-4, k ä n - n e t e c k n a t därav, att satsen innehåller vidare en vävnadskompatibel härdbar komponent och härdare härför.
6. Implantat enligt något av kraven 1-5, k ä n - n e t e c k n a t därav, att storleken av kornen/granu- lerna är mellan 0,1 och 5 mm, företrädesvis 0,5-2 mm.
7. Implantat enligt något av kraven 1-6, k ä n - n e t e c k n a t därav, att satskomponenterna är sammanpackade i säcken/svepningen.
8. Implantat enligt något av kraven 1-7, k ä n - n e t e c k n a t därav, att satsen innehåller blod.
SE9803078A 1998-09-09 1998-09-09 Implantat, sätt att framställa det och användning av det SE515572C2 (sv)

Priority Applications (17)

Application Number Priority Date Filing Date Title
SE9803078A SE515572C2 (sv) 1998-09-09 1998-09-09 Implantat, sätt att framställa det och användning av det
ZA200102000A ZA200102000B (en) 1998-09-09 1999-09-09 Implant, method of making the same and use of the same.
MXPA01002558A MXPA01002558A (es) 1998-09-09 1999-09-09 Implante, metodo para elaborar el mismo y uso del mismo.
EP99968616A EP1112046B1 (en) 1998-09-09 1999-09-09 Malleable implant
CA002343366A CA2343366C (en) 1998-09-09 1999-09-09 Implant, method of making the same and use of the same
BR9913579-5A BR9913579A (pt) 1998-09-09 1999-09-09 Implante, método de fabricação do mesmo e uso do mesmo
US09/786,755 US6565606B1 (en) 1998-09-09 1999-09-09 Implant, method of making the same and use the same
AU60165/99A AU743913B2 (en) 1998-09-09 1999-09-09 Implant, method of making the same and use of the same
DK99968616T DK1112046T3 (da) 1998-09-09 1999-09-09 Formbart implantat
DE69926766T DE69926766T2 (de) 1998-09-09 1999-09-09 Formbares implantat
PCT/SE1999/001576 WO2000013615A1 (en) 1998-09-09 1999-09-09 Implant, method of making the same and use of the same
CNB998107662A CN1230134C (zh) 1998-09-09 1999-09-09 植入物以及它的制造方法与应用
ES99968616T ES2249062T3 (es) 1998-09-09 1999-09-09 Implante maleable.
JP2000568426A JP4201986B2 (ja) 1998-09-09 1999-09-09 インプラント、その製造方法及びその使用方法
AT99968616T ATE301978T1 (de) 1998-09-09 1999-09-09 Formbares implantat
KR1020017003042A KR100639471B1 (ko) 1998-09-09 1999-09-09 이식체, 이의 제조 방법 및 용도
NO20011178A NO320714B1 (no) 1998-09-09 2001-03-08 Implantat.

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US7056577B1 (en) 1999-04-28 2006-06-06 Tigran Technologies Ab Body for providing ingrowth and growth of bone tissue and/or connective tissue and method of making such a body

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AU6016599A (en) 2000-03-27
CN1230134C (zh) 2005-12-07
JP4201986B2 (ja) 2008-12-24
MXPA01002558A (es) 2003-03-10
KR20010079779A (ko) 2001-08-22
KR100639471B1 (ko) 2006-10-27
BR9913579A (pt) 2001-05-22
EP1112046B1 (en) 2005-08-17
SE9803078D0 (sv) 1998-09-09
ES2249062T3 (es) 2006-03-16
AU743913B2 (en) 2002-02-07
SE9803078L (sv) 2000-03-10
DE69926766T2 (de) 2006-06-08
NO20011178D0 (no) 2001-03-08
EP1112046A1 (en) 2001-07-04
CA2343366A1 (en) 2000-03-16
US6565606B1 (en) 2003-05-20
ATE301978T1 (de) 2005-09-15
WO2000013615A1 (en) 2000-03-16
CN1316891A (zh) 2001-10-10
DK1112046T3 (da) 2005-12-19
NO20011178L (no) 2001-03-08
DE69926766D1 (de) 2005-09-22
NO320714B1 (no) 2006-01-23
CA2343366C (en) 2008-05-13
ZA200102000B (en) 2001-09-12
JP2002524137A (ja) 2002-08-06

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