TR201906795A2 - Ters omuz protezi̇nde yeni̇li̇k - Google Patents

Ters omuz protezi̇nde yeni̇li̇k Download PDF

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TR201906795A2
TR201906795A2 TR2019/06795A TR201906795A TR201906795A2 TR 201906795 A2 TR201906795 A2 TR 201906795A2 TR 2019/06795 A TR2019/06795 A TR 2019/06795A TR 201906795 A TR201906795 A TR 201906795A TR 201906795 A2 TR201906795 A2 TR 201906795A2
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Turkey
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shoulder
prosthesis
proximal
orthopedic
humeral component
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TR2019/06795A
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English (en)
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Keçeci̇ Burçi̇n
Küçük Levent
Dursunoğlu Hayri̇
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Hipokrat Tibbi Malzemeler Imalat Ve Pazarlama Anonim Sirketi
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Priority to TR2019/06795A priority Critical patent/TR201906795A2/tr
Priority to PCT/TR2020/050396 priority patent/WO2020226598A1/en
Publication of TR201906795A2 publication Critical patent/TR201906795A2/tr

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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
    • A61F2/40—Joints for shoulders
    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • 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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    • A61F2/4059—Humeral shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • 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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    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections 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
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • 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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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
    • A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
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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
    • 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
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
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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
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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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    • A61F2/30—Joints
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    • A61F2002/4018—Heads or epiphyseal parts of humerus
    • A61F2002/4022—Heads or epiphyseal parts of humerus having a concave shape, e.g. hemispherical cups
    • 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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    • A61F2002/4037—Connections of heads to necks
    • 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
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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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    • A61F2/4081—Glenoid components, e.g. cups
    • A61F2002/4085—Glenoid components, e.g. cups having a convex shape, e.g. hemispherical heads

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)
  • Prostheses (AREA)

Abstract

Buluş konusu, ortopedik ters omuz ameliyatlarında kullanılan, omzu içe çeviren kas (subscapularis) ile protez arasında bağlantı yaparak omzun içe dönmesini sağlayıp, hastanın günlük hayatında omzunu daha verimli bir şekilde hareket ettirmesini mümkün kılan protez ile ilgilidir. Buluş, humerus proksimalinde herhangi bir nedenle oluşan defektlerin rekonstrüksiyonu için kullanılabilen ortopedik bir üründür.Buluş özellikle, tıbbi medikal sahada omuz döndürücü kaslarının (rotator manşet) yetersizliği, kireçlenme (artrit) ve kompleks omuz kırıkları gibi ileri derecede omuz yapısı bozukluklarında kullanılmak üzere tasarlanan ortopedik bir protez ile ilgilidir.

Description

TARIFNAME TERS omuz PROTEZINDE YENILIK Teknik Alan Bulus konusu, ortopedik ters omuz ameliyatlarinda kullanilan, omzu içe çeviren kas (subscapularis) ile protez arasinda baglanti yaparak omzun içe dönmesini saglayip, hastanin günlük hayatinda omzunu daha verimli bir sekilde hareket ettirmesini mümkün kilan protez ile ilgilidir. Bulus, humerus proksimalinde herhangi bir nedenle olusan defektlerin rekonstrüksiyonu için kullanilabilen ortopedik bir üründür.
Bulus özellikle, tibbi medikal sahada omuz döndürücü kaslarinin (rotator manset) yetersizligi, kireçlenme (artrit) ve kompleks omuz kiriklari gibi ileri derecede omuz yapisi bozukluklarinda kullanilmak üzere tasarlanan ortopedik bir protez ile ilgilidir. Önceki Teknik Ters (reverse) omuz protezleri tamir edilemeyecek derecede rotator manset (omuz döndürücü kaslari) yirtigi ve artrit (kireçlenme), kompleks kiriklar ile birlikte agrili hareket kisitliligi olan hastalara uygulanmaktadir. Ters omuz protezi omuz sorunlarinin cerrahi tedavisinde önemli ve iyi bir seçenek olup, 30 yili askin süredir kullanilmaktadir.
Mevcut teknikte omzu içe çeviren kasin (subscapularis) proteze baglantisini saglayacak bir yapi bulunmamaktadir. Bu durum, kolun içe dönmesinde zafiyete yol açmaktadir. Hastanin günlük hayatindaki pantolon arka cebine uzanma, kadinlarin üst iç çamasirini baglama gibi bazi faaliyetleri yapamamasina neden olmaktadir.
Teknikte bilinen uygulamada, 2014-12306 tescil numarali Türk Patent ve Marka Kurumu dokümaninda, addüksiyon sirasinda humeral insert ile glenoid kemigin alt parçasi arasinda bir uyumsuzluk oldugunu ve bu uygunsuzlugu ortadan kaldirmak amaciyla yeni bir ters omuz protezi gelistirildiginden bahsedilmektedir.
Ayrica, teknigin bilinen bir diger durumunda proksimal humerus protezi kemik içine tamamen gömüldügü için sütür materyallerini göndermede proksimal humeral bilesendeki sütür delikleri yeterli gelmemektedir.
Bulusun Amaci Yukarida belirtilen mevcut teknikte var olan problemleri çözme amaciyla yeni bir ters omuz protezi gelistirilmistir. Gelistirilen bu ters omuz protezinin amaci, tibbi medikal sahada omuz humerus proksimalinde herhangi bir nedenle olusan defektlerin rekonstrüksiyonu için kullanilmasidir.
Bulus, omuzdaki çevirici kaslarin (rotator cufftendonlari) dikis materyali kullanilarak proteze monte edilmesini saglayacak yapiyi içermektedir. Ilgili kasin veya kaslarin tekrar proteze tutturulmasi sayesinde protezden daha yüksek bir fonksiyonel sonuç elde edilmektedir.
Omzu içe çeviren kasin (subscapularis) proteze baglantisinin yapilmasiyla birlikte, kolun içe dönmesinde meydana gelen zafiyet ortadan kalkmaktadir. Böylelikle, hasta günlük hayatindaki pantolon arka cebine uzanma, kadinlarin üst iç çamasirini baglama gibi faaliyetleri yerine getirebilecektir.
Bulusun bir diger amaci, çoklu sütür delikleri içeren bu protezin proksimal kemik kaybi vakalarinda kullanilabilmesidir. Bulusta bahsi geçen, ekstra sütür delikleri sayesinde gerekli görülen konumlardan istenilen miktarda sütür materyalleri gönderilebilmektedir.
Bulusun Detayli Açiklamasi Bu bulusun amacina ulasmak için, herhangi bir nedenle tamir edilemeyecek derecede rotator manset (omuz döndürücü kaslari) yirtigi ve artrit (kireçlenme), kompleks kiriklar ile birlikte agrili hareket kisitliligi olusan defektlerin rekonstrüksiyonunda kullanilmak üzere tasarlanan ortopedik bir protez olan bu ürün ve bilesenleri ekli sekillerle gösterilmistir.
Bu sekillerden; Sekil 1 - Bulus unsuru içeren ters omuz protezinin demontaj görünümü Sekil 2 - Bulus unsuru içeren ters omuz protezinin montaj görünümü Sekil 3 - Proksimal humeral bilesenin yandan kesit görünümü Sekil 4 - Bulusta yer alan proksimal humeral bilesenin alttan görünümü Sekil 5 - Sütür deliklerinin ve kanal çevrelerinin yandan kesit görünümü Sekil 6 - Sütür materyallerinin sütür deliklerinden geçisi Referans Numaralari Kilitli vida Metaglene Glenoid küresi Humeral insert Proksimal humeral bilesen .1 Çevresel sütür deligi .2 Çevresel oluk .3 Delik agzi ve kanal çevresi 6. Humeral stem Bulusumuz ters omuz protezi ile ilgili olup, kilitli vida (1) içeren metaglene (2), glenoid küresi (3), humeral insert (4), proksimal humeral bilesen (5), humeral stem (6) unsurlarindan olusmaktadir. Sekil 1'de bulus unsurlarinin demontaj halde yandan kesit görünümleri verilmektedir. Sekil 2'de ise bulus unsurlarinin temsili uygulamasinin montaj halde yandan kesit görünümleri yer almaktadir.
Metaglene (2); glenosphere ile uyumlu olacak sekilde farkli boyut seçenegine sahip olan, baslangiç fiksasyonu kolaylastirmak amaciyla merkezleyici stem, vida deligi (kilavuz çekilmis delik) ve kanalli mil içeren bir unsurdur. Metaglene (2), protezin glenoid kemigine merkezlenerek yerlestirilmesini saglamaktadir. Maksimum fiksasyon ve stabilite için kilitli vida (1) kullanilmaktadir. Ayrica, 2 tip metaglene mevcuttur ve çimentosuz implante edilebilmektedir.
Glenoid küresinin (3) boyutu, glenoid kemigine sabitlemede kullanilan metaglene (2) boyutuna göre belirlenmektedir. Seçilen boyuttaki glenoid küresi (3) metaglene (2) üzerine yerlestirilir.
Humeral insert (4) üzerinde yer alan çentik, proksimal humeral bilesenin (5) sirt kisminda yer alan markalama çizgisi ile ayni hizada olacak sekilde konumlandirilmaktadir ve humeral insert (4) el yardimi ile serbest olarak proksimal humeral bilesene (5) yerlestirilmektedir.
Konumlandirma sonrasinda proksimal humeral bilesenin (5) üzerine humeral insert (4) çakici ile çakilmaktadir. Sonra, hasta rahat pozisyondayken humeral insert (4) glenoid küresi (3) üzerine yerlestirilmektedir. Kemik çimentosu donmaya devam ederken, omuz yavasça incelenerek, belirlenmis hareket araligi ve eklem stabilitesi kontrol edilmektedir.
Kol distal humerus yönünde çekilirken, çekme sirasinda humeral Insert'in (4) glenoid küresinden (3) ayrilmasi deltoid gerginliginin yetersiz oldugunu göstermektedir. Tüm kontroller yapildiktan sonra eklem bosluklari yikanip, kalintilardan temizlenmektedir.
Bulusumuza ait esas unsur olan proksimal humeral bilesende (5), çevresel sütür delikleri (5.1 ), kemige gömülü olan sütür deliklerinden farkli olarak proksimal alin yüzeye dik olacak sekilde konumlanmis halde bulunmaktadir (Sekil 3, 4, 5). Dikis materyali kullanilarak, çevresel sütür deliklerinden (5.1) omuzdaki çevirici kaslar proteze monte edilmektedir (Sekil 6). Ayrica. sütür materyallerinin rahat geçebilmesi için proksimal yan yüzeylere ve alin yüzeye paralel olacak sekilde açilmis çevresel sütür delikleri (5.1) ile es sayida çevresel oluk (5.2) bulunmaktadir. Sütür materyallerinin hasar görmemesi için çevresel sütür delik (5.1) agizlari ve kanal çevreleri (5.3) yuvarlatilmistir (Sekil 5). Bahsi geçen çevresel sütür delikleri (5.1) sayesinde istenilen miktarda ve gerekli görülen konumlardan sütür materyalleri gönderilebilmektedir (Sekil 6).

Claims (1)

  1. ISTEM LER Bulus, ortopedik ters omuz ameliyatlarinda kullanilan bir protez olup, karakterize edici özelligi; en az bir adet çevresel sütür deligine (5.1) ve en az bir adet çevresel oluga sahip (5.2) proksimal humeral bilesen (5) içermesidir. istem 1'e uygun proksimal humeral bilesen (5) olup, karakterize edici özelligi; çevresel sütür deliklerinin (5.1) proksimal aliri yüzeye dik olacak sekilde bulunmasidir. istem 1'e uygun proksimal humeral bilesen (5) olup, karakterize edici özelligi; çevresel oluklarin (5.2) proksimal yan yüzeylere ve alin yüzeye paralel olacak sekilde açilmasidir. Istem 1'e uygun proksimal humeral bilesen (5) olup, karakterize edici özelligi; çevresel sütür delik (5.1) agizlari ve kanal çevreleri (5.3) yuvarlatilmis olmasidir.
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