TR202101656A2 - INNOVATION IN THE WORKING PRINCIPLE OF ROTATIONAL HINGED KNEE PROSTHESES - Google Patents

INNOVATION IN THE WORKING PRINCIPLE OF ROTATIONAL HINGED KNEE PROSTHESES

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Publication number
TR202101656A2
TR202101656A2 TR2021/01656A TR202101656A TR202101656A2 TR 202101656 A2 TR202101656 A2 TR 202101656A2 TR 2021/01656 A TR2021/01656 A TR 2021/01656A TR 202101656 A TR202101656 A TR 202101656A TR 202101656 A2 TR202101656 A2 TR 202101656A2
Authority
TR
Turkey
Prior art keywords
polyethylene
femur
tibia
knee
lock
Prior art date
Application number
TR2021/01656A
Other languages
Turkish (tr)
Inventor
Dursunoğlu Hayri̇
Caymaz Zafer
Original Assignee
Hipokrat Tibbi Malzemeler Imalat Ve Pazarlama Anonim Sirketi
Hi̇pokrat Tibbi̇ Malzemeler İmalat Ve Pazarlama Anoni̇m Şi̇rketi̇
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 Hipokrat Tibbi Malzemeler Imalat Ve Pazarlama Anonim Sirketi, Hi̇pokrat Tibbi̇ Malzemeler İmalat Ve Pazarlama Anoni̇m Şi̇rketi̇ filed Critical Hipokrat Tibbi Malzemeler Imalat Ve Pazarlama Anonim Sirketi
Priority to TR2021/01656A priority Critical patent/TR202101656A2/en
Priority to PCT/TR2022/050094 priority patent/WO2022169436A2/en
Publication of TR202101656A2 publication Critical patent/TR202101656A2/en

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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
    • A61F2/38Joints for elbows or knees
    • A61F2/3836Special connection between upper and lower leg, e.g. constrained
    • A61F2/384Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement
    • A61F2/3845Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement allowing only for single rotation
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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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    • A61F2/3836Special connection between upper and lower leg, e.g. constrained
    • A61F2/384Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement
    • A61F2/385Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement also provided with condylar bearing surfaces
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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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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
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    • A61F2002/30357Stepped cylinders, i.e. having discrete diameter changes
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2002/30362Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
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    • A61F2002/30433Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
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    • A61F2002/30474Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using an intermediate sleeve interposed between both prosthetic parts to be coupled
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    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30495Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a locking ring
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    • A61F2002/30884Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity

Abstract

Buluş konusu, diz eklemi tümör ve revizyon cerrahi uygulamalarında kullanılmak üzere dizayn edilen rotasyonlu menteşeli diz protezi ile ilgilidir. Buluş konusu özellikle diz eklemi cerrahi uygulamalarında kullanılan menteşeli diz protezlerinde, femur ve tibia parçalarının birbiriyle bağlantısını sağlayan kilit sistemi ile ilgilidir. Femur ve tibia parçalarının birbirinden ayrılmasını (dislokasyon) önleyen ve tibia medial-lateral (internal-external) rotasyon hareketlerine müsaade eden dislokasyon kilit sistemi geliştirilmesi ile ilgilidir.The subject of the invention relates to a hinged knee prosthesis with rotation designed for use in tumor and revision surgery of the knee joint. The subject of the invention is related to the locking system that connects the femur and tibia parts to each other, especially in hinged knee prostheses used in knee joint surgery applications. It is related to the development of a dislocation locking system that prevents the separation (dislocation) of the femur and tibia parts from each other and allows tibia medial-lateral (internal-external) rotation movements.

Description

TARIFNAME ROTASYONLU MENTESELI DIZ PROTEZLERININ ÇALISMA PRENSIBINDE YENILIK Teknik Alan Bulus konusu, diz eklemi tümör ve revizyon cerrahi uygulamalarinda kullanilmak üzere dizayn edilen rotasyonlu menteseli diz protezi ile ilgilidir. Bulus konusu özellikle diz eklemi cerrahi uygulamalarinda kullanilan menteseli diz protezlerinde, femur ve tibia parçalarinin birbiriyle baglantisini saglayan kilit sistemi ile ilgilidir. Femur ve tibia protezlerinin birbirinden ayrilmasini (dislokasyon) önleyen ve tibia mediaI-lateral (internal-external) rotasyon hareketlerine müsaade eden dislokasyon kilit sistemi gelistirilmesi ile ilgilidir. Önceki Teknik Mevcut teknikte kullanilan menteseli diz protezlerinde femur ve tibia parçalarinin birbiriyle baglantisini saglayan ve medial-Iateral (internal-external) rotasyon hareketlerine müsaade eden cihazlar bulunmaktadir. Fakat mevcut teknikteki bu cihazlarda femur ve tibia parçalarinin çekme basma yönünde (dikey eksende / vertikal aks) birbirinden ayrilmasini önleyen bir kilit mekanizmasi bulunmamaktadir. Kilit mekanizmasi bulunan sistemlerde de mediaI-lateral (internal-external) rotasyon hareketleri yapilamamaktadir. Diger bir ifadeyle; baglanti, rotasyon ve çekme-basma yönünde (dikey eksende / vertikal aks) ayrilmama eylemlerini ayni anda saglayan bir kilit sistemi bulunmamaktadir. Diz protezlerinde kullanilan offset adaptörü femur ve tibia bölgesinde femoral ve tibial komponentlerin kemik yapisinda uygun eksenel sapma ve kaydirma islemlerini saglamak için oldukça önemli bir unsurdur. Fakat mevcut tekniklerde menteseli diz protezlerinde femur ve tibial parçalarinin ayrilmasini engelleyen baglanti mafsalinda kilit sistemi bulunmamasi nedeniyle baglanti mafsali uzun bir yapiya sahip olacak sekilde üretilmektedir. Baglanti mafsalinin uzun olmasi, özellikle menteseli ve/veya mafsalli tümör diz protezlerinde offset adaptörünün baglantisi için gerekli alan birakmamakta ve offset adaptörü kullanimini engellemektedir. Rotasyonlu menteseli diz sistemlerinde karsilasilan en büyük sorunlardan biri, femur ve tibia protezlerinin cerrahi uygulama sonrasinda çekme basma yönünde (dikey eksende / vertikal aks) birbirinden ayrilarak (dislokasyon) diz protezinin kullanilamaz hale gelmesidir. Bu durumun sonucu olarak hasta ikinci kez ameliyat edilmekte ve rotasyon özelligi olmayan sabit menteseli diz protezleri kullanilmaktadir. Mevcut teknikteki menteseli sistemlerde bütün yükleri göbek mili ve polietilen burç karsilamaktadir. Mevcut teknikte kullanilan menteseli diz protezlerinde polietilen burç asinmasina bagli olarak göbek mili ekseninde olusan yalpalama neticesinde protezdeki stabilitenin kaybolmasidir. Diz protezindeki stabilitenin kaybolmasiyla ve sürtünmenin etkisiyle polietilen burç zamanla yok olmaktadir. Bunun neticesinde metal-metal sürtünmesinden kaynaklanan metal debrizi (partikülleri) olusmakta ve bu partiküller kana karismaktadir. Bu gibi durumlarda hasta tekrar ameliyata alinarak hasarli parçalar yenisiyle degistirilmektedir. Hatta bazi durumlarda tüm sistem yenisiyle degistirilebilmektedir. Bu sebeple hasta birden fazla kez ameliyat geçirmekte ve bu durumdan psikolojik ve/veya maddi olarak önemli derecede olumsuz etkilenmektedir. Ayrica menteseli diz protezi uygulanan hastalarda bag ve yumusak doku kayiplari çok fazla oldugundan anatomik eksende dislokasyon riski oldukça fazla olmaktadir. Bu durum hasta sagliginin olumsuz etkilenmesine neden olmaktadir. Bulusun Amaci Bulusun amaci, yeni kilit sistemi ile femur ve tibia protezlerinin cerrahi uygulama sonrasinda çekme basma yönünde (dikey eksende / vertikal aks) birbirinden ayrilmasinin (dislokasyon) önüne geçilmesidir. Bulus ile - Femoral komponent ile polietilen insert ürünlerinin birbiriyle yüzeysel temasi saglanmakta, - Gelen kuvvetlerin ve olusan gerilmelerin tibial inserte aktarilmasi saglanmakta, - Bu sayede polietilen burç asinmasina bagli olarak göbek mili ekseninde olusan yalpalamanin önüne geçilmekte ve protez ömrü uzatilmakta, - Kilitlenme sistemi sayesinde yeterli uzunlukta üretilen baglanti mafsali ile offset adaptörü kullaniminin mafsalli ve menteseli tümör diz protezlerinde de kullanimini saglamak, - Menteseli diz protezi uygulanan hastalarda çok fazla bag ve yumusak doku kayiplari olmasi nedeniyle dikey eksende (vertikal aks) olusabilecek dislokasyon riski engellenmekte, - Hastanin tekrar tekrar ameliyat olmasina olan gereklilik ortadan kaldirilmaktadir. Bulusun yapisal ve karakteristik özellikleri ve tüm avantajlari asagida verilen sekiller ve bu sekillere atif yapilmak suretiyle yazilan detayli açiklama sayesinde daha net olarak anlasilacaktir. Bu nedenle degerlendirmenin de bu sekiller ve detayli açiklama göz önüne alinarak yapilmasi gerekmektedir. Bulusun Ayrintili Açiklamasi Sekillerin Açiklamasi: Sekil - 1 Menteseli revizyon diz sistemin perspektif görünümü Sekil - 2 Menteseli distal femur tümör diz sistemi perspektif görünümü Sekil - 3 Menteseli proksimal tibia tümör diz sistemi perspektif görünümü Sekil - 4 Menteseli total tümör diz sistemi perspektif görünümü Sekil - 5 Menteseli diz protez sisteminin demonte görünümü Sekil - 6 Menteseli diz protez sisteminin demonte görünümü Sekil - 7 Femoral komponent parçalarinin demonte görünümü Sekil - 8 Femoral komponent ve baglanti mafsali demonte görünümü Sekil - 9 Femoral komponent parçalarinin monte görünümü Sekil - 10 Polietilen insert perspektif görünümü Sekil - 11 Polietilen insert ve polietilen kilit alttan demonte görünümü Sekil- 12 Tibial komponent parçalarinin demonte görünümü Sekil - 13 Polietilen insert ve tibial komponent demonte görünümü Sekil - 14 Polietilen insert ile tibial komponentin internal rotasyonun temsili gösterimi Sekil - 15 Internal rotasyonun üstten görünümü Sekil - 16 Polietilen insert ile tibial komponentin external rotasyonun temsili gösterimi Sekil - 17 External rotasyonun üstten görünümü Sekil - 18 Femoral komponent ve tibial komponent demonte görünümü Sekil - 19 Femoral komponent ve tibial komponent yandan monte görünümü Sekil - 20 Femoral komponent ve tibial komponent monte perspektif görünümü Sekil - 21 Polietilen kilit üstten görünümü Sekil - 22 Polietilen kilit perspektif görünümü Sekil - 23 Polietilen kilit monte görünümü Sekil - 24 Polietilen kilit birinci halka kesit (A) detayinin görünümü Sekil- 25 Tirnakli pim kilitlenme görünümü Sekil- 26 Tirnakli pim ikinci halka kesit (B) detayinin görünümü Sekil - 27 Baglanti kulaklari kilitlenme görünümü Sekil - 28 Baglanti kulaklari monte görünümü Referans Numaralari: 1. Femoral Komponent 1.1. Komponent Deligi 1.2. Kondil Yüzeyi 2. Polietilen Burç 2.1. Polietilen Burç Deligi 3. Baglanti Mafsali 3.1. Setuskur Deligi 3.2. Fatura Bölgesi 3.3. Göbek Mili Deligi 3.4. Yuvarlatilmis Uç Kisim 3.5. Baglanti Kulaklari 4. Göbek Mili 4.1. Göbek Mili Yuvasi . Göbek Mili Setuskuru 6. Polietilen Insert 6.1. Kilit Yuvasi 6.2. Polietilen Insert Yuvasi 6.3. Baglanti Mafsal Yuvasi 6.4. Yuvarlanma Yüzeyi 7. Polietilen Kilit 8. Tibial Komponent 8.1. Tüp Deligi 8.2. Tirnakli Pim 9. Polietilen Tüp . Femoral Stem 11. Tibial Stem 12. Offset Adaptör 13. Offset Adaptör Setuskuru 14. Offset Adaptör Yuvasi A: Birinci Halka Kesiti B: Ikinci Halka Kesiti Bulusa konu olan dislokasyon kilit sistemi, tibia ve femur kemikleri için kullanilan menteseli tümör diz ve menteseli revizyon diz sisteminde kullanilmak üzere Sekil- 1, Sekil-2, Sekil-3 ve Sekil-4' te gösterilmektedir. Sekil - 5 ve Sekil - 6' da diz ekleminin kemik yapisini olusturan üst kisimda bulunan femoral stem (10) ve alt kisimda bulunan tibial stem (11) için diz protez kilit sistemi demonte hali gösterilmektedir. Kilitli diz sisteminin femur bölgesini olusturan parçalarin montaji Sekil - 7 ve Sekil - 8' de gösterilmektedir. Femur bölgesini olusturmak üzere femoral komponent (1) üzerinde her iki yanda ve iç kisimda açilan komponent deliklerine (1.1), komponent delikleri (1.1) ile ayni ölçüye sahip polietilen burçlar (2) yerlestirilmektedir. Polietilen burçlar (2) üzerinde polietilen burç delikleri (2.1) açilmaktadir. Komponent deliklerine (1.1) yerlestirilen polietilen burç deliklerine (2.1) sahip polietilen burçlar (2) Sekil - 7' de görülen komponent delikleri (1.1) arasinda bulunan mesafeye silindirik yapiya sahip baglanti mafsali (3) konumlanmaktadir. Silindirik yapiya sahip baglanti mafsalinin (3) üst kisminda bulunan yuvarlak forma sahip göbek mili deligi (3.3) komponent delikleri (1.1) üzerine yerlestirilmis polietilen burçlar (2) arasinda bulunan mesafeye yuvarlak kismi yan olacak sekilde oturtulmaktadir. (Sekil - 8) Baglanti mafsali (3) üzerinde bulunan göbek mili deligi (3.3) ile polietilen burç (2) üzerinde bulunan polietilen burç delikleri (2.1) ile karsilikli getirilerek yerlestirilmektedir. Sekil - 7' de görülen göbek mili (4), komponent delikleri (1.1) ve komponent delikleri (1.1) ile karsilikli bulunan göbek mili delikleri (3.3) arasindan geçerek yerlestirilmektedir. Göbek mili (4) üzerinde bulunan göbek mili yuvasi (4.1) ile baglanti mafsali (3) üzerinde bulunan setuskur deligi (3.1) birbirleri ile karsilikli getirilmektedir. Göbek mili setuskuru (5) sayesinde femoral komponente (1) yerlestirilen ve karsilikli bulunan setuskur deligi (3.1) ve göbek mili yuvasina (4.1) yerlestirilerek baglanti mafsali (3) femoral komponente (1) sabitlenmektedir. Böylece sistemin femur bölgesi tamamlanmis olmaktadir. (Sekil - 9) Dislokasyon kilit sisteminin tibia bölgesini olusturan parçalar Sekil- 11, Sekil- 12 ve Sekil - 13' te ayrintili bir sekilde gösterilmektedir. Tibia bölgesini olusturan parçalardan biri olan polietilen insert (6) üst görünümü Sekil - 10' da gösterilmektedir. Tibia bölgesini olusturmak üzere polietilen insert (6) üzerinde açilan yuvarlak forma sahip baglanti mafsal yuvasi (6.3) içerisinde kilit yuvasi (6.1) olusturulmaktadir. Baglanti mafsal yuvasi (6.3) içerisinde olusturulmus yuvarlak forma sahip kilit yuvasina (6.1) yarim ay seklinde görülen polietilen kilit (7) parçasi kapanma yönünde esnetilerek yerlestirilmektedir. (Sekil - 21, Sekil- 22) Kapanma yönünde esnetilerek yerlestirilen polietilen kilit (7) parçasi kilit yuvasina (6.1) ulastiginda esneme kuvveti kayboldugundan eski konuma gelmekte ve polietilen insert (6) üzerinde sabit kalmaktadir. (Sekil - 23) Polietilen kilidin (7) kilit yuvasina (6.1) sabitlenmesi Sekil - 24' te yer alan birinci halka kesitinde (A) ayrintili bir sekilde gösterilmektedir. Tibia bölgesini olusturan parçalardan bir digeri olan Sekil - 12'de görülen tibial komponent (8) içerisine tüp deligi (8.1) açilmaktadir. Açilan tüp deligi (8.1) tibial komponentin (8) tam orta kisminda bulunmakta ve içerisine silindirik yapiya sahip polietilen tüp (9) yerlestirilmektedir. Tibial komponent (8) üzerinde sag ve sol kisimda bulunan çikintili yapiya sahip tirnakli pimler (8.2), polietilen insert (6) üzerinde sag ve sol kisimda bulunan fasulye seklindeki polietilen insert yuvalari (6.2) ile karsilikli getirilir ve baski kuvveti uygulamak suretiyle polietilen insert yuvalarina (6.2) oturtulmaktadir. (Sekil - 25) Bu baski kuvveti sayesinde polietilen insert (6) ile tibial komponent (8) kilitlenmesi gerçeklestirilmis olmaktadir. Tirnakli pimlerin (8.2) polietilen insert yuvalari (6.2) ile kilitlenmesi Sekil - 26' da yer alan ikinci halka kesitinde (B) ayrintili bir sekilde gösterilmektedir. Polietilen insert yuvalarina (6.2) ile tirnakli pimlerin (8.2) erkek- disi geçme sistemi sayesinde polietilen insert (6) parçasinin tibial komponent (8) parçasindan ayrilmasi engellenmis olmaktadir. Polietilen insert (6) üzerinde bulunan polietilen insert yuvalarinin (6.2) fasulye seklinde olmasi sayesinde polietilen insert yuvalarina (6.2) oturtulan tirnakli pimlere (8.2) hareket kabiliyeti kazandirilmaktadir. Hareket kabiliyeti sayesinde polietilen insert (6) iç-dis dönme (internal-external rotasyon) hareketi saglamaktadir. (Sekil - 14, Sekil - 15, Sekil - 16, Sekil - 17) Ayri ayri montaji gerçeklestirilen femur ve tibia parçalarinin demonte hali Sekil - 18' de gösterilmektedir. Montaj islemi gerçeklesen femur parçalarindan baglanti mafsali (3), montaj islemi gerçeklestirilen tibia parçalarindan polietilen insert (6) üzerinde bulunan baglanti mafsal yuvasina (6.3) oturtulmaktadir. Baglanti mafsalinin (3) yuvarlatilmis uç kismi (3.4), polietilen insert (6) içerisine yerlestirilen polietilen kilit (7) parçasini açilma yönünde esneterek ilerlemektedir. Baglanti mafsalinin (3) polietilen kilit (7) içerisine ilerlemesi ile polietilen kilit (7) baglanti mafsali (3) üzerinde olusturulan fatura bölgesine (3.2) ulasmaktadir. Fatura bölgesi (3.2), baglanti mafsalinin (3) orta kisminda ve daha küçük yariçapa sahip silindirik bir bölge olup çap düsüsü meydana getirmektedir. Polietilen kilit (7) parçasi üzerindeki açilma kuvveti kaybolacagindan polietilen kilit (7) parçasi tekrar eski konumuna kapanmaktadir. Polietilen kilit (7) parçasinin kapanma eylemi ile birlikte montajli femur ve montajli tibia parçalarinin birbirinden ayrilmasi engellenmektedir. (Sekil - 19) Femur ve tibia parçalarinin kilitleme islemi gerçeklestirildiginde femoral komponentin (1) sag ve sol olacak sekilde alt kisimda bulunan kondil yüzeyleri (1.2) ile polietilen insert (6) üst kisminda yine sag ve sol tarafta bulunan yuvarlanma yüzeyleri (6.4) üst üste getirilerek aralarinda yüzeysel temas saglanmaktadir. Ayri ayri montaji gerçeklestirilen femur ve tibia parçalarinin, femoral stem (10) ve tibial stem (11) ile irtibatlanmasi offset adaptörü (12) ile saglanmaktadir. Femur parçalarinin femoral steme (10) irtibatlanmasi için silindirik yapiya sahip offset adaptörünün (12) alt kismi femoral komponentin (1) üst kisminda bulunan yuvarlak ve konik forma sahip offset adaptör yuvasi (14) içerisine yerlestirilmektedir. Offset adaptörünün (12) üst kismina ise femoral stemin (10) konik alt kismi yerlestirilmekte ve offset adaptör setuskuru (13) sayesinde offset adaptörü (12) femoral komponent (1) ile femoral stemin (10) irtibatlanmasini saglayarak ara eleman görevi görmektedir. Tibia parçalarinin tibial steme (11) irtibatlanmasi ise silindirik yapiya sahip offset adaptörünün (12) üst kismi tibial komponentin (8) alt bölgesinde bulunan yuvarlak ve konik forma sahip offset adaptör yuvasi (14) içerisine tibial komponentin (8) alt kismindan yerlestirilmektedir. Offset adaptörünün (12) alt kismina ise silindirik forma sahip tibial stemin (11) konik üst kismi yerlestirilmekte ve offset adaptörü setuskuru (13) ile offset adaptörü (12) tibial komponent (8) ile tibial stemin (11) irtibatlanmasini saglayarak ara eleman görevi görmektedir. (Sekil - 5) Böylece offset adaptörünün (12) diz protezlerinde kullanilmasi ile femur ve tibia bölgesinde femoral komponent (1) ve tibial komponentlerin (8) kemik yapisinda uygun eksenel sapma ve kaydirma islemleri saglanmaktadir. Diz protezine gelen her türlü kuvvet ve olusan gerilmelerin polietilen insert (6) parçasina aktarilmasi saglanmaktadir. (Sekil - 20) Gelen kuvvetlerin ve olusan basinçlarin polietilen insert (6) parçasina aktarilmasi ile polietilen burç (2) asinmasina bagli olarak göbek mili (4) ekseninde olusan yalpalamanin önüne geçilmekte ve protez ömrü uzatilmaktadir. Femur ve tibia parçalarinin kilitlenmesi alternatif uygulamada baglanti mafsali (3) üzerine eklenen baglanti kulaklari (3.5) ile yapilmaktadir. Polietilen insert (6) üzerinde açilan yuvarlak forma sahip baglanti mafsal yuvasi (6.3) içerisinde kilit yuvasi (6.1) olusturulmaktadir. Baglanti mafsali (3), baglanti mafsal yuvasi (6.3) içerisinde olusturulmus yuvarlak forma sahip kilit yuvasina (6.1) ilerlemektedir. Kilitleme islemi baglanti kulaklarina (3.5) uygun pozisyon referansi saglayan kilit yuvasi (6.1) ile saglanmaktadir. Baglanti mafsalinin (3) baglanti mafsal yuvasi (6.3) içerisinde ilerlemesi ile baglanti mafsali (3) üzerinde yer alan baglanti kulaklari (3.5), kilit yuvasina (6.1) ulasmaktadir. Baglanti kulaklarinin (3.5) kilit yuvasina (6.1) ulasmasi ile kilitleme islemi gerçeklesmektedir. TR TR TR DESCRIPTION INNOVATION IN THE WORKING PRINCIPLE OF ROTATIONAL HINGED KNEE PROSTHESES Technical Field The subject of the invention is about the rotating hinged knee prosthesis designed to be used in knee joint tumor and revision surgery applications. The subject of the invention is related to the locking system that ensures the connection of the femur and tibia parts with each other, especially in hinged knee prostheses used in knee joint surgery applications. It is related to the development of a dislocation lock system that prevents the femur and tibia prostheses from being separated from each other (dislocation) and allows tibia medial-lateral (internal-external) rotation movements. Prior Art Hinged knee prostheses used in the current technique contain devices that connect the femur and tibia parts to each other and allow medial-Iateral (internal-external) rotation movements. However, these devices in the current technique do not have a locking mechanism that prevents the femur and tibia parts from being separated from each other in the tension-compression direction (vertical axis / vertical axis). In systems with a locking mechanism, medial-lateral (internal-external) rotation movements cannot be performed. In other words; There is no locking system that simultaneously provides the actions of connection, rotation and non-separation in the tension-compression direction (on the vertical axis / vertical axis). The offset adapter used in knee prostheses is a very important element to ensure appropriate axial deviation and shifting processes in the bone structure of the femoral and tibial components in the femur and tibia region. However, in current techniques, since there is no locking system in the connection joint that prevents the separation of the femur and tibial parts in hinged knee prostheses, the connection joint is produced to have a long structure. The long connection joint does not leave the necessary space for the connection of the offset adapter, especially in hinged and/or articulated tumor knee prostheses, and prevents the use of the offset adapter. One of the biggest problems encountered in rotational hinged knee systems is that the femur and tibia prostheses separate from each other (dislocation) in the tension-compression direction (vertical axis / vertical axis) after surgical application, making the knee prosthesis unusable. As a result of this situation, the patient is operated on for the second time and fixed hinged knee prostheses without rotation feature are used. In the hinged systems of the current technique, all loads are carried by the hub shaft and polyethylene bushing. In the hinged knee prostheses used in the current technique, the stability of the prosthesis is lost as a result of wobble in the hub shaft axis due to polyethylene bushing wear. The polyethylene bushing disappears over time due to the loss of stability in the knee prosthesis and the effect of friction. As a result, metal debris (particles) resulting from metal-metal friction are formed and these particles mix with the blood. In such cases, the patient is taken into surgery again and the damaged parts are replaced with new ones. In some cases, the entire system can even be replaced with a new one. For this reason, the patient undergoes surgery more than once and is significantly negatively affected psychologically and/or financially. In addition, the risk of dislocation in the anatomical axis is quite high in patients undergoing hinged knee prosthesis, as there is a lot of connective and soft tissue loss. This situation causes negative effects on patient health. Purpose of the Invention The purpose of the invention is to prevent the femur and tibia prostheses from being separated from each other (dislocation) in the tension-compression direction (vertical axis / vertical axis) after surgical application, with the new locking system. With the invention, - Superficial contact of the femoral component and polyethylene insert products is ensured with each other, - Incoming forces and resulting stresses are transferred to the tibial insert, - In this way, the wobble in the hub shaft axis due to polyethylene bushing wear is prevented and the life of the prosthesis is extended, - Thanks to the locking system, sufficient Ensuring the use of the offset adapter with the long connection joint produced in hinged and hinged tumor knee prostheses, - The risk of dislocation that may occur in the vertical axis due to the excessive ligament and soft tissue losses in patients undergoing hinged knee prosthesis is prevented, - The patient has to undergo repeated surgery. The necessity is eliminated. The structural and characteristic features and all the advantages of the invention will be understood more clearly thanks to the figures given below and the detailed explanation written by referring to these figures. For this reason, the evaluation should be made taking these figures and detailed explanation into consideration. Detailed Description of the Invention Explanation of the Drawings: Figure - 1 Perspective view of the hinged revision knee system Figure - 2 Perspective view of the hinged distal femur tumor knee system Figure - 3 Perspective view of the hinged proximal tibia tumor knee system Figure - 4 Perspective view of the hinged total tumor knee system Figure - 5 Disassembled view of the hinged knee prosthesis system Figure - 6 Disassembled view of the hinged knee prosthesis system Figure - 7 Disassembled view of the femoral component parts Figure - 8 Disassembled view of the femoral component and connection joint Figure - 9 Assembled view of the femoral component parts Figure - 10 Perspective view of the polyethylene insert Figure - 11 Disassembled view of polyethylene insert and polyethylene lock from below Figure - 12 Disassembled view of tibial component parts Figure - 13 Disassembled view of polyethylene insert and tibial component Figure - 14 Representative representation of internal rotation of the tibial component with polyethylene insert Figure - 15 Top view of internal rotation Figure - 16 Polyethylene Representative representation of external rotation of the tibial component with insert Figure - 17 Top view of external rotation Figure - 18 Disassembled view of the femoral component and tibial component Figure - 19 Side mounted view of the femoral component and tibial component Figure - 20 Perspective view of the femoral component and tibial component mounted Figure - 21 Top view of the polyethylene lock Figure - 22 Perspective view of the polyethylene lock Figure - 23 Mounted view of the polyethylene lock Figure - 24 View of the first ring section (A) detail of the polyethylene lock Figure - 25 View of the claw pin locking section Figure - 26 View of the claw pin second ring section (B) detail view Figure - 27 Connection ears locking view Figure - 28 Connection ears assembled view Reference Numbers: 1. Femoral Component 1.1. Component Hole 1.2. Condyle Surface 2. Polyethylene Bushing 2.1. Polyethylene Bushing Hole 3. Connection Joint 3.1. Set Screw Hole 3.2. Invoice Region 3.3. Hub Shaft Bore 3.4. Rounded End Part 3.5. Connection Ears 4. Hub Shaft 4.1. Hub Shaft Housing . Hub Shaft Set Screwdriver 6. Polyethylene Insert 6.1. Lock Slot 6.2. Polyethylene Insert Slot 6.3. Connection Joint Seat 6.4. Rolling Surface 7. Polyethylene Lock 8. Tibial Component 8.1. Tube Hole 8.2. Tab Pin 9. Polyethylene Tube. Femoral Stem 11. Tibial Stem 12. Offset Adapter 13. Offset Adapter Set Screwdriver 14. Offset Adapter Slot A: First Ring Section B: Second Ring Section The dislocation lock system that is the subject of the invention is used for the hinged tumor knee and hinged revision knee used for tibia and femur bones. It is shown in Figure-1, Figure-2, Figure-3 and Figure-4 to be used in the system. Figure - 5 and Figure - 6 show the disassembled state of the knee prosthesis locking system for the femoral stem (10) in the upper part, which forms the bone structure of the knee joint, and the tibial stem (11) in the lower part. The assembly of the parts forming the femur region of the locked knee system is shown in Figure - 7 and Figure - 8. Polyethylene bushings (2) with the same size as the component holes (1.1) are placed in the component holes (1.1) opened on both sides and inside of the femoral component (1) to form the femur region. Polyethylene bushing holes (2.1) are opened on the polyethylene bushings (2). The polyethylene bushings (2) with polyethylene bushing holes (2.1) placed in the component holes (1.1) and the connection joint (3) with a cylindrical structure is positioned in the distance between the component holes (1.1) shown in Figure - 7. The round shaped hub shaft hole (3.3) located on the upper part of the cylindrical connecting joint (3) is placed on the distance between the polyethylene bushings (2) placed on the component holes (1.1), with the round part sideways. (Figure - 8) It is placed by aligning the hub shaft hole (3.3) on the connection joint (3) with the polyethylene bushing holes (2.1) on the polyethylene bushing (2). The hub shaft (4) seen in Figure - 7 is placed by passing between the component holes (1.1) and the hub shaft holes (3.3) located opposite each other. The hub shaft slot (4.1) on the hub shaft (4) and the set screw hole (3.1) on the connection joint (3) are aligned with each other. Thanks to the hub shaft set screw (5), the connecting joint (3) is fixed to the femoral component (1) by placing the corresponding set screw hole (3.1) in the femoral component (1) and the hub shaft slot (4.1). Thus, the femur region of the system is completed. (Figure - 9) The parts forming the tibia region of the dislocation lock system are shown in detail in Figure-11, Figure-12 and Figure-13. The top view of the polyethylene insert (6), which is one of the parts forming the tibia region, is shown in Figure - 10. A lock slot (6.1) is formed within the round-shaped connection joint slot (6.3) opened on the polyethylene insert (6) to form the tibia region. The polyethylene lock (7) piece, seen in the shape of a half-moon, is placed in the round-shaped lock slot (6.1) formed within the connection joint slot (6.3) by stretching it in the closing direction. (Figure - 21, Figure- 22) When the polyethylene lock (7) part, which is placed by stretching in the closing direction, reaches the lock slot (6.1), it returns to its previous position as the stretching force disappears and remains fixed on the polyethylene insert (6). (Figure - 23) The fixing of the polyethylene lock (7) to the lock slot (6.1) is shown in detail in the first ring section (A) in Figure - 24. A tube hole (8.1) is opened into the tibial component (8) shown in Figure 12, which is another of the parts that make up the tibia region. The opened tube hole (8.1) is located in the middle part of the tibial component (8) and a cylindrical polyethylene tube (9) is placed inside. The clawed pins (8.2) with a protruding structure located on the right and left sides of the tibial component (8) are brought together with the bean-shaped polyethylene insert slots (6.2) located on the right and left sides on the polyethylene insert (6) and by applying pressure force, they are placed in the polyethylene insert slots. (6.2) is fitted. (Figure - 25) Thanks to this pressure force, the polyethylene insert (6) and the tibial component (8) are locked. The locking of the claw pins (8.2) with the polyethylene insert slots (6.2) is shown in detail in the second ring section (B) in Figure 26. Thanks to the male-female connection system of the polyethylene insert slots (6.2) and the clawed pins (8.2), the polyethylene insert (6) part is prevented from separating from the tibial component (8). Thanks to the bean-shaped shape of the polyethylene insert slots (6.2) on the polyethylene insert (6), the claw pins (8.2) placed on the polyethylene insert slots (6.2) are given mobility. Thanks to its mobility, the polyethylene insert (6) provides internal-external rotation movement. (Figure - 14, Figure - 15, Figure - 16, Figure - 17) The disassembled state of the femur and tibia parts, which were assembled separately, is shown in Figure - 18. The connection joint (3), one of the assembled femur parts, is placed in the connection joint slot (6.3) on the polyethylene insert (6) one of the assembled tibia parts. The rounded end part (3.4) of the connection joint (3) advances by stretching the polyethylene lock (7) part placed inside the polyethylene insert (6) in the opening direction. As the connection joint (3) advances into the polyethylene lock (7), the polyethylene lock (7) reaches the invoice area (3.2) created on the connection joint (3). The bill region (3.2) is a cylindrical region with a smaller radius in the middle part of the connection joint (3) and creates a diameter decrease. Since the opening force on the polyethylene lock (7) part will disappear, the polyethylene lock (7) part closes again to its previous position. With the closing action of the polyethylene lock (7) part, the assembled femur and assembled tibia parts are prevented from separating from each other. (Figure - 19) When the locking process of the femur and tibia parts is performed, the condyle surfaces (1.2) located on the lower part of the femoral component (1), right and left, and the rolling surfaces (6.4) located on the right and left sides on the upper part of the polyethylene insert (6). They are placed on top of each other to ensure superficial contact between them. The connection of the femur and tibia parts, which are assembled separately, to the femoral stem (10) and tibial stem (11) is provided by the offset adapter (12). In order to connect the femur parts to the femoral stem (10), the lower part of the cylindrical offset adapter (12) is placed into the round and conical shaped offset adapter slot (14) located on the upper part of the femoral component (1). The conical lower part of the femoral stem (10) is placed on the upper part of the offset adapter (12), and thanks to the offset adapter set screw (13), the offset adapter (12) serves as an intermediate element by connecting the femoral component (1) and the femoral stem (10). For the connection of the tibia parts to the tibial stem (11), the upper part of the cylindrical offset adapter (12) is placed into the round and conical shaped offset adapter slot (14) located in the lower region of the tibial component (8) from the lower part of the tibial component (8). The conical upper part of the tibial stem (11), which has a cylindrical form, is placed at the bottom of the offset adapter (12), and the offset adapter sets screw (13) and the offset adapter (12) serves as an intermediate element by connecting the tibial component (8) and the tibial stem (11). . (Figure - 5) Thus, by using the offset adapter (12) in knee prostheses, appropriate axial deviation and shifting processes are provided in the bone structure of the femoral component (1) and tibial components (8) in the femur and tibia region. All kinds of forces and resulting stresses on the knee prosthesis are transferred to the polyethylene insert (6) piece. (Figure - 20) By transferring the incoming forces and the resulting pressures to the polyethylene insert (6) part, the wobble that occurs in the hub shaft (4) axis due to the wear of the polyethylene bushing (2) is prevented and the life of the prosthesis is extended. In the alternative application, the locking of the femur and tibia parts is done with the connection ears (3.5) added to the connection joint (3). A lock slot (6.1) is formed within the round-shaped connection joint slot (6.3) opened on the polyethylene insert (6). The connection joint (3) advances into the round-shaped lock slot (6.1) created within the connection joint slot (6.3). The locking process is provided by the lock slot (6.1) which provides a suitable position reference to the connection ears (3.5). As the connection joint (3) advances within the connection joint slot (6.3), the connection ears (3.5) located on the connection joint (3) reach the lock housing (6.1). The locking process takes place when the connection ears (3.5) reach the lock slot (6.1).TR TR TR

TR2021/01656A 2021-02-03 2021-02-03 INNOVATION IN THE WORKING PRINCIPLE OF ROTATIONAL HINGED KNEE PROSTHESES TR202101656A2 (en)

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PCT/TR2022/050094 WO2022169436A2 (en) 2021-02-03 2022-02-02 Innovation in the working principle of rotating hinged knee prostheses

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Publication number Priority date Publication date Assignee Title
US6773461B2 (en) * 2001-01-29 2004-08-10 Zimmer Technology, Inc. Constrained prosthetic knee with rotating bearing
US6485519B2 (en) * 2001-01-29 2002-11-26 Bristol-Myers Squibb Company Constrained prosthetic knee with rotating bearing
US8157869B2 (en) * 2007-01-10 2012-04-17 Biomet Manufacturing Corp. Knee joint prosthesis system and method for implantation
CN109009578A (en) * 2018-08-21 2018-12-18 北京市春立正达医疗器械股份有限公司 Knee hinge joint prosthese

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