DK165727B - Middel til at fastgoere en ledprotese - Google Patents
Middel til at fastgoere en ledprotese Download PDFInfo
- Publication number
- DK165727B DK165727B DK585588A DK585588A DK165727B DK 165727 B DK165727 B DK 165727B DK 585588 A DK585588 A DK 585588A DK 585588 A DK585588 A DK 585588A DK 165727 B DK165727 B DK 165727B
- Authority
- DK
- Denmark
- Prior art keywords
- grains
- prosthesis
- bone
- cavity
- trunk
- Prior art date
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Classifications
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/02—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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A61F2/36—Femoral heads ; Femoral endoprostheses
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- 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
- 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
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4607—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of hip femoral endoprostheses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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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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- A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
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- A61F2/02—Prostheses implantable into the body
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
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- A—HUMAN NECESSITIES
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- A61F2310/00203—Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
-
- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2310/00179—Ceramics or ceramic-like structures
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2310/00329—Glasses, e.g. bioglass
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- 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
- A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA
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- 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
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
- A61F2310/00616—Coating made of titanium oxide or hydroxides
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- 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
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
-
- 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
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/908—Bone
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Adhesives Or Adhesive Processes (AREA)
- Protection Of Pipes Against Damage, Friction, And Corrosion (AREA)
- Road Signs Or Road Markings (AREA)
- Cable Accessories (AREA)
- Graft Or Block Polymers (AREA)
- Emergency Protection Circuit Devices (AREA)
- Buffer Packaging (AREA)
- Burglar Alarm Systems (AREA)
- Non-Disconnectible Joints And Screw-Threaded Joints (AREA)
- Joining Of Building Structures In Genera (AREA)
- Steroid Compounds (AREA)
- Saccharide Compounds (AREA)
- Led Devices (AREA)
- Circuit Arrangement For Electric Light Sources In General (AREA)
Description
DK 165727 B
5 i Nærværende opfindelse vedrører et middel til at fastgøre en ledprotese, hvis stamme er forsynet med en friktionsoverflade.
En sædvanlig fiksering af en ledprotese sker ved at cementere den til knoglevævet, det vil sige fylde et mellemrum mellem ledprotesen og knoglevæggen med knoglecement. Problemet med utilfredsstillende, langvarig fastgørelse af ce-10 menterede proteser har resulteret i, at der nu mere sjældent gøres brug af cement til at fastgøre proteser. I denne forbindelse er det vigtigt, at formen på protesestammen, som indsættes i hulrummet, der er udsparet i knoglen, svarer godt til hulrummets form, og at afstanden, der skal ud-15 fyldes mellem knoglevæggen og protesestammens overflade, er så kort som muligt, for at knoglevæv kan dannes og inden for en rimelig tid vokse til på protesen fra alle sider for at forankre den til knoglevæggen. Den mindste afstand, der skal udfyldes, er naturligvis en fysisk kontakt mellem pro-20 tesens overflade og knoglevæggen, men ved en ledprotese i en knogle er det meget usandsynligt, at en sådan kontakt kan oprettes undtagen i punkter, hvilket ikke er tilstrækkeligt. Det er vanskeligt at kombinere den cementfrie metode, som består i at etablere en sådan fysisk kontakt og gi-25 ver god langtidsfiksering men en dårlig fiksering på kort sigt med metoden med anvendelse af knoglecement, som giver god fiksering på kort sigt men dårlig langvarig fiksering, eftersom knoglecementen isolerer proteseoverfladen fra knoglevæggen.
30
Fra DE offentliggørelsesskrift nr. 2 305 441 kendes et implantat, der fastgøres ved en spændemekanisme. Denne mekanisme omfatter en samling af kugler, som er anbragt i hulrummet mellem det udhulede knoglevæv og det delvist hule 35 skaft på implantatet. Det hule skaft indeholder nogle cylindriske legemer, der af en skrue øverst i skaftet presses
DK 165727B
2 sammen og i anlæg mod en tværstift i bunden af skaftet. Ved denne sammenpresning af legemerne udvides skaftet, hvorved den nævnte samling af kugler kommer i spænd mellem knoglevævet og ydersiden af implantatets hule skaft, så implanta-5 tet forankres i knoglen.
For at frembringe den indbyrdes sammenlåsning af de sfæriske kugler kræves der en række foranstaltninger i form af en tværstift i bunden af skaftet, cylindriske legemer i det 10 hule skaft samt en skrue foroven i skaftet, hvorfor det kendte implantat er ret kompliceret i sin opbygning.
Det er derfor formålet med opfindelsen at angive et middel, der på langt enklere og dermed billigere måde kan forankre 15 et implantat, såsom en ledpro.tese, i en knogle på en sikker og varigt stabil måde.
Dette opnås ved et middel til at fastgøre en ledprotese, hvis stamme er forsynet med en friktionsoverflade, hvilket 20 middel ifølge opfindelsen er særegent ved at bestå af en i det væsentlige homogen blanding af et biologisk, kompatibelt, kornformigt materiale, i hvilket kornene har en i det væsentlige ens partikelstørrelsesfordeling og er i det væsentlige irregulære og plastiske.
25
Efter at operationen er fuldført, skal disse korn pakkes tæt og låses i forhold til hinanden og i forhold til knoglevævet og protesestammen. Den indbyrdes låsning af kornene ifølge opfindelsen kræver intet tryk, eftersom kornene er 30 uregelmæssige (og plastiske) og kiles ind mellem hverandre, det vil sige er selvlåsende. Ved at bruge korn som forankringsmasse, kan der tillades større tolerancer mellem protesestammen og knoglevævet sammenlignet med sædvanlig operation uden anvendelse af cement, hvorved problemerne i 35 sammenhæng med anvendelse af knoglecement samtidig elimine res. Nærværende opfindelse frembyder således en løsning på 3
Ulv Ibb/Z/ IS
! problemet at opnå god fiksering på kort sigt såvel som god langvarig fiksering.
I praksis kan fikseringen af protesen opnås på forskellige 5 måder.
Fortrinsvis udføres fikseringen på følgende måde.
Et hulrum udspares i knoglen, i hvilken protesen skal fast-10 gøres. Korn af biologisk, kompatibelt materiale anbringes i hulrummet for at danne et underlag, hvorpå protesen trykkes ned i kornunderlaget, indtil hovedsagelig hele protesestammen er omgivet af kornene. En indretning til at holde på kornene anbringes omkring protesestammen, og protesen fik-15 seres endeligt eventuelt ved slag med et værktøj.
Blandingen af korn indføres mere bestemt i hulrummet, så blandingen i det væsentlige fylder hulrummet som et underlag af korn. Kornunderlaget skal i det væsentlige nå op til 20 operationsfladen. Den fjerneste ende af protesestammen indsættes derfor i underlaget, og kornene underkastes ved en slagkraft på protesen vibrationer af en sådan frekvens, at kornene fluidiseres. Medens kornene er fluidiserede, drives stammen ned i underlaget i det væsentlige til dens beregne-25 de, endelige stilling. Kornene i underlaget underkastes derefter vibrationer af en sådan anden frekvens, at der tilvejebringes pakning, det vil sige en sammenlåsning og sammenpakning af kornene i forhold til hinanden og af kornene i forhold til protesestammen og knoglevævet.
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Efter dette trin med sammenlåsning og sammenpakning kan protesen efter valg fikseres endeligt ved slag, der udøves i dens længderetning.
35 Alternativt kan kornblandingen lægges ind i hulrummet efter, at protesestammen, som her er konisk tilspidset, er
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4 sat ind i hulrummet. I dette tilfælde sættes protesestammen først ind i hulrummet, så der forbliver et mellemrum mellem hulrummets afgrænsende vægge, som består af knoglevæv, og protesestammens udvendige friktionsflade. Komblandingen 5 fyldes derefter ind i dette mellemrum i det væsentlige op til operationsfladen. Sammentrykningstrinnet udføres derefter ved at slå en eller flere gange på stammens hoved. På denne måde vil kornene blive kilet sammen, det vil sige pakket sammen i mellemrummet, og derved medføre sammenpak-10 ning og sammenlåsning.
Som tidligere nævnt anvendes for protesefiksering med midlet ifølge opfindelsen proteser, hvis stamme har en udvendig friktionsflade, som, efter at operationen er fuldført, 15 er tilpasset til at sikre mekanisk låsning mellem protesestaramen og kornene. Den udvendige friktionsflade er udformet med uregelmæssigheder og en ujævnhed, som kan være af i det væsentlige samme størrelse som kornene uden dog nødvendigvis at være af samme størrelse. Formen på den udvendige 20 friktions flade er ikke kritisk, så længe kornene kan gribe ind i uregelmæssigheder på den. Tilsvarende sammenlåsning mellem kornene og knoglevævet opnås også, eftersom knoglevævet vil have ujævnheder, som stammer fra udsparingen, og i hvilke kornene kan gribe ind.
25
Indgrebet mellem stammens yderflade og kornene, mellem de forskellige korn og mellem kornene og knoglevævet forbedres, hvis stammen efter vibrationstrinnet efter valg til sidst udsættes for et eller flere fikseringsslag. På denne 30 måde vil kornene, der ligger op mod knoglevævet, trænge dybt ind i knoglevævet og i indgreb med stammens yderflade, hvis de ikke har gjort det tidligere under trinet med låsning og sammentrykning.
35 For at gøre det lettere at drive protesen ned i kornunderlaget er den fjerneste ende af protesestammen passende til- 5
ulv A bo/Z/ D
spidset, og protesestammen smalner konisk til mod sin fjerneste ende.
Kornene, som bruges ved midlet ifølge opfindelsen, skal 5 tilfredsstille visse krav for at give tilfredsstillende resultat af den kirurgiske operation. Kornene skal således bestå af biologisk, kompatibelt materiale. Et eksempel på sådanne materialer er primært titan (som efter oxydering i luften har et udvendigt lag af titandioxyd). Andre egnede 10 materialer er tantal, niobium og legeringer deraf, for eksempel titanlegeringer. Såkaldte biokeramiske stoffer, som for eksempel A1203, bioglas og hydroksyapatit, kan også bruges. Korn af andre materialer, som er overfladebelagte med lag af biologisk, kompatibelt materiale, fortrinsvis 15 titan, kan naturligvis også bruges. Endvidere kan kornmassen bestå helt eller delvist af korn af legemes-endogent materiale, som for eksempel malet knoglevæv.
Som nævnt ovenfor er kornblandingen, der fyldes i hulrum-20 met, en i det væsentlige homogen blanding. Kornene skal have en i det væsentlige ensformet partikelstørrelsesfordeling, så der ved sammenlåsningen og sammenpakningen ved vibration ikke sker en lagdeling i forskellige partikelstørrelser i hulrummet med en efterfølgende risiko for ure-25 gelmæssig og forringet vækst af knoglevæv. Udtrykket "i det væsentlige ensformet partikelstørrelsesfordeling" som anvendt her betyder, at partikeldiameteren kan variere med ± 50% fortrinsvis ± 25% eller mindre. Den absolutte kornstørrelse kan variere inden for ret vide rammer, hvorved en 30 partikelstørrelse mindre end omkring 5 mm betragtes som op timal. Den nederste grænse kan være vanskelig at sætte. Meget små kornpartikler kan være anvendelige i forbindelse med en biologisk, kompatibel væske, der binder de små kornpartikler (det fine). Normalt anvendes imidlertid kornpar-35 tikler af størrelsen over 0,1 mm. Fortrinsvis kan den øverste grænse være omkring 2 mm og den nedre grænse omkring
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6 0,5 mm. Generelt sagt vælges partikelstørrelsen under hensyn til det mellemrum, som skal pakkes med korn, efter at operationen er udført, hvorfor grovere partikler normalt vælges til hofteledsoperationer, medens mindre partikel-5 størrelse anvendes for eksempel ved fingerledsoperationer.
For at frembringe total sammenlåsning, det vil sige låsning af knoglevæv til korn, kom til korn, kom til protesestamme, skal komene endvidere være irregulære og plastiske, 10 det vil sige være i stand til at ændre deres form, når de underkastes en udvendig kraft og bibeholder den nye form, når den udvendige kraft er ophørt med at virke. Skønt det er muligt at anvende massive korn, fortrækkes korn, der har en vis, fortrinsvis høj porøsitet. Porøse korn opnås på 15 kendt måde ved at blæse gas eller væske gennem en smelte af granuleret materiale. Efter valg kan kornene fyldes eller belægges med antibiotika og/eller vækststimulerende tilsætningsmidler.
20 I den ovenfor beskrevne, foretrukne udformning fluidiseres kornene i kornunderlaget for at muliggøre, at protesestammen kan drives ned i kornunderlaget i det udsparede hulrum. Fluidiseringen udføres i to trin; det første med en høj frekvens, som muliggør, at protesestammen kan drives ned i 25 kornunderlaget, fordi kornene i underlaget, der er fyldt i hulrummet, opfører sig som en væske. Dette første fluidise-ringstrin følges af fluidisering ved en lavere frekvens, som giver plads for kornene i underlaget mellem hinanden, så de kiles sammen i forhold til hinanden og derved medfø-30 rer sammenpakning og sammenlåsning. Passende frekvenser for vibrationerne, der kræves til fluidiseringen, sammenpakning og -låsning, kan let afprøves i hvert særlige tilfælde af hvem som helst med almindeligt kendskab til fagområdet og afhænger af faktorer, såsom korntype og protesetype. Gode 35 resultater er blevet opnået ved anvendelse af en pneumatisk drevet, oscillerende knoglesav af sædvanlig type og her
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7 forsynet med gribemidler i tilfælde med titanpulver med en partikelstørrelse på mellem 1 og 1,5 mm.
Kornmassen fikseres i hulrummet ved at anbringe en krave 5 eller ring af knoglecement eller plast omkring protesestammen over det tilbageværende, sammenpakkede, sammenlåste underlag af korn. Alternativt kan knoglecement eller en lignende hurtigt hærdende væske hældes over kornene.
10 Protesen (protesestammen) kan være af kendt type, for så vidt den har en udvendig, for eksempel grov eller ujævn friktionsoverflade. Stammen kan passende bestå af et biologisk, kompatibelt, vækstfremmende materiale eller have et overfladelag af et sådant materiale, som således danner den 15 udvendige friktionsflade.
Midlet ifølge opfindelsen skal forklares nærmere i det følgende under henvisning til tegningen, hvor der er vist en hofteledsprotese, som er fastgjort ved hjælp af midlet 20 ifølge nærværende opfindelse.
Mellemrummet mellem et knoglevæv 1 og ydervæggen 2 på den koniske stamme på en hofteledsprotese fyldes med irregulære korn 3 af rent titan med en størrelse på omkring 1 mm. Kor-25 nene 3 er porøse og er fremkommet ved at blæse gas gennem en smelte af det granulerede materiale. Kornene pakkes og sammenkiles i forhold til hinanden. Mekanisk sammenlåsning frembringes mellem stammens ydervæg 2 og kornene, der ligger der imod, såvel som mellem knoglevævet 1 og kornene, 30 der støder op dertil. En "bundprop" 4, som fordelagtigvis består af et stykke af patientens egen hofteledskugle, som tidligere er fjernet ved den kirurgiske operation, danner en nederste begrænsning af hulrummet og griber ind med det omgivende knoglevæv med en flange. Denne bundprop 4 er ført 35 ned gennem hulrummet og kan tjene som anlæg for kornene 3 mod de kræfter, der hidrører fra neddrivning/nedhamring,
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8 som forklaret i det følgende. Et dække 5 af knoglecement danner en øverste afgrænsning af hulrummet. På tegningen er tykkelsen af kornlaget overdrevet for klarheds skyld.
5 Den ovennævnte sammenpakning,· sammenlåsning og sammenkiling og dermed fastgørelse af protesen afstedkommes på følgende måde.
Efter at kirurgen på sædvanlig måde har udsparet den del af 10 femur, i hvilken protesestammen skal implanteres, og anbragt bundproppen 4, fyldes det resulterende hulrum med kornene 3, som er steriliserede, eventuelt ved autoklavebehandling, op til et niveau lidt under åbningen i den udsparede knogle. Protesestammen indsættes derefter i det såle-15 des dannede underlag af korn 3 og drives så langt ind i det, at der kun står nogle få mm tilbage mellem kraven 7 og knoglens åbning. Til at drive protesestammen ind i kornunderlaget anvendes et vibrereværktøj med indstillelig frekvens, som virker på protesestammens hoved 6 og tilpasses 20 til ved en passende vibrationsfrekvens at løsne kornunderlaget og således tillade stammen at trænge ind i underlaget. Hvis stammens indtrængning i underlaget bliver for langsom på grund af underlagets kompakthed, forøger kirurgen vibrationsfrekvensen. Når der er nået en stilling for 25 protesestammen, som beskrevet ovenfor, underkastes kornene en sådan behandling, at de sætter sig på en måde, så de er sammenpakkede og -låst til hinanden. Dette gøres fortrinsvis ved at ved hjælp af vibreringsværktøjet at udsætte protesestammen for en progressivt aftagende vibrationsfrekvens 30 ved slaget på protesestammen eller på anden måde.
Knoglecement pålægges nu i en ring omkring stammen under kraven 7, hvorpå stammen drives helt ned i kornunderlaget ved at slå med en hammer. Denne forholdsregel forbedrer de 35 førnævnte sammenlåsnings-, kilings- og indtrængningsvirkninger. Knoglecementen i ringen kan nu hærde og danne dæk-
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9 ket 5.
Det har vist sig, at den indledende vibrering af stammen mest fordelagtig kan være en reciprokerende bevægelse langs 5 en tilnærmelsesvis vandret, cirkelformet bue. Denne vibrering bringer kornene 3 i hulrummet for protesestammen til at flyde, og gør det muligt hurtigt at drive stammen ned i underlaget.
10 Skønt opfindelsen er beskrevet med henvisning til hofteledsproteser, er det klart for enhver, der er kendt med fagområdet, at midlet og fremgangsmåden ifølge opfindelsen også kan anvendes ved andre typer proteser.
Claims (6)
1. Middel til at fastgøre ledproteser hvis stammer (2) er forsynet med en friktionsoverflade, kendetegnet 5 ved, at midlet består af en i det væsentlige homogen blanding af et biologisk, kompatibelt, kornformigt materiale, i hvilket kornene (3) har en i det væsentlige ensformet partikelstørrelsesfordeling og er i det væsentlige irregulære og plastiske. 10
2. Middel ifølge krav 1, kendetegnet ved, at partiklernes størrelse er højst 5 mm, fortrinsvis mellem 0,5 og 2 mm.
3. Middel ifølge krav 1 og 2, kendetegnet ved, at kornene (3) kan fluidiseres, når de udsættes for vibrationer med en højere frekvens, og kan låses med hinanden, når de udsættes for vibrationer en lavere frekvens.
4. Middel ifølge et hvilket som helst af kravene 1-3, kendetegnet ved, at det biologisk, kompatible materiale er titan, titanoxyd, tantal, niobium og legeringer deraf eller et biokeramisk materiale.
5. Middel ifølge et hvilket som helst af kravene 1-3, kendetegnet ved, at blandingen består af legems-endogent materiale, som for eksempel malet knogle, efter valg i kombination med et materiale ifølge krav 4.
6. Middel ifølge krav 1, kendetegnet ved, at kornene (3) er i det væsentlige porøse.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE8701313A SE462638B (sv) | 1987-03-30 | 1987-03-30 | Anordning foer fixering av en laangstraeckt protesdel |
SE8701313 | 1987-03-30 | ||
SE8800157 | 1988-03-30 | ||
PCT/SE1988/000157 WO1988007355A1 (en) | 1987-03-30 | 1988-03-30 | Method and means for fixing a joint prosthesis |
Publications (4)
Publication Number | Publication Date |
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DK585588D0 DK585588D0 (da) | 1988-10-20 |
DK585588A DK585588A (da) | 1988-11-25 |
DK165727B true DK165727B (da) | 1993-01-11 |
DK165727C DK165727C (da) | 1993-06-07 |
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DK585588A DK165727C (da) | 1987-03-30 | 1988-10-20 | Middel til at fastgoere en ledprotese |
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US (1) | US5015256A (da) |
EP (2) | EP0353241B1 (da) |
JP (1) | JP2561337B2 (da) |
KR (1) | KR970007085B1 (da) |
CN (1) | CN1024751C (da) |
AT (2) | ATE84407T1 (da) |
AU (1) | AU611900B2 (da) |
BR (1) | BR8807441A (da) |
CA (1) | CA1327099C (da) |
DE (2) | DE3888214T2 (da) |
DK (1) | DK165727C (da) |
ES (1) | ES2006874A6 (da) |
FI (1) | FI93168C (da) |
MX (1) | MX171297B (da) |
NO (1) | NO169043C (da) |
SE (1) | SE462638B (da) |
WO (1) | WO1988007355A1 (da) |
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FR2681235B1 (fr) * | 1991-09-13 | 1993-11-12 | Itac Var Implant | Materiel d'osteosynthese a face de contact osseux recouverte par un revetement de surface. |
GB9202248D0 (en) * | 1992-02-03 | 1992-03-18 | Howmedica | Prosthesis for attachement without bone cement and method of attaching |
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AU713540B2 (en) * | 1994-10-25 | 1999-12-02 | Osteonics Corp. | Interlocking structural elements and method for bone repair, augmentation and replacement |
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SE515572C2 (sv) * | 1998-09-09 | 2001-09-03 | Lanka Ltd | Implantat, sätt att framställa det och användning av det |
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ES2298675T3 (es) * | 1999-10-22 | 2008-05-16 | Archus Orthopedics Inc. | Dispositivos de artroplastia facetaria. |
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US9707024B2 (en) | 2004-03-09 | 2017-07-18 | Skeletal Kinetics, Llc | Use of vibration in composite fixation |
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-
1987
- 1987-03-30 SE SE8701313A patent/SE462638B/sv not_active IP Right Cessation
-
1988
- 1988-03-29 ES ES8800963A patent/ES2006874A6/es not_active Expired
- 1988-03-30 DE DE3888214T patent/DE3888214T2/de not_active Expired - Fee Related
- 1988-03-30 WO PCT/SE1988/000157 patent/WO1988007355A1/en active IP Right Grant
- 1988-03-30 CA CA000562905A patent/CA1327099C/en not_active Expired - Fee Related
- 1988-03-30 CN CN88102795A patent/CN1024751C/zh not_active Expired - Fee Related
- 1988-03-30 JP JP63503109A patent/JP2561337B2/ja not_active Expired - Fee Related
- 1988-03-30 AT AT88903431T patent/ATE84407T1/de not_active IP Right Cessation
- 1988-03-30 DE DE8888903431T patent/DE3877570T2/de not_active Expired - Fee Related
- 1988-03-30 AU AU15712/88A patent/AU611900B2/en not_active Ceased
- 1988-03-30 MX MX010956A patent/MX171297B/es unknown
- 1988-03-30 EP EP88903431A patent/EP0353241B1/en not_active Expired - Lifetime
- 1988-03-30 US US07/411,511 patent/US5015256A/en not_active Expired - Lifetime
- 1988-03-30 BR BR888807441A patent/BR8807441A/pt not_active IP Right Cessation
- 1988-03-30 EP EP92201551A patent/EP0501595B1/en not_active Expired - Lifetime
- 1988-03-30 KR KR1019880701595A patent/KR970007085B1/ko not_active IP Right Cessation
- 1988-10-20 DK DK585588A patent/DK165727C/da not_active IP Right Cessation
- 1988-11-29 NO NO885325A patent/NO169043C/no unknown
-
1989
- 1989-09-29 FI FI894623A patent/FI93168C/fi not_active IP Right Cessation
-
1992
- 1992-06-01 AT AT92201551T patent/ATE101998T1/de not_active IP Right Cessation
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