TW299228B - - Google Patents

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Publication number
TW299228B
TW299228B TW084103163A TW84103163A TW299228B TW 299228 B TW299228 B TW 299228B TW 084103163 A TW084103163 A TW 084103163A TW 84103163 A TW84103163 A TW 84103163A TW 299228 B TW299228 B TW 299228B
Authority
TW
Taiwan
Prior art keywords
prosthesis
screw
patent application
humerus
protrusion
Prior art date
Application number
TW084103163A
Other languages
English (en)
Original Assignee
Kirschner Medical Corp
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 Kirschner Medical Corp filed Critical Kirschner Medical Corp
Application granted granted Critical
Publication of TW299228B publication Critical patent/TW299228B/zh

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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
    • A61F2/40Joints for shoulders
    • A61F2/4014Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/40Joints for shoulders
    • A61F2/4059Humeral shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30723Plugs or restrictors for sealing a cement-receiving space
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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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    • A61F2002/30331Connections 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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    • A61F2002/30329Connections 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
    • A61F2002/30332Conically- or frustoconically-shaped protrusion and recess
    • A61F2002/30339Double cones, i.e. connecting element having two conical connections, one at each of its opposite ends
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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
    • A61F2002/30405Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The 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
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
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Description

A7 B7 經濟部中央標準局員工消費合作社印製 五、發明説明(/ ) Ijg背晷 jpg筋圃 本發明係有關於模組式肱骨假體,此假體可用以替換全 肩關節,也可用於人肱骨重建。 IS-此枋越夕銳明 肱骨假體是此技藝已知的*用κ替代人肩關節。此等假 體~般包括配置於肱骨稈内的延長的莖部份,及假體肱骨 頭,此假體肱骨頭用Μ替代天然的肱骨頭,配置於肩窩内 °最近為人接受的治療三及四部份肱骨顗裂開骨折(各骨 片的血液供應已受損害的情形)的方法,是進行半闞節成 形術.,用假體替代肱骨頭。經驗顯示,與非手術治療相比 ’半關節成形術的结果相當不錯。這是因為肱骨頭骨折部 份的血液供應常受損害且常有骨壊死發生的闞係。 發給Dines等的美國專利4, 865,605號揭示此種前此技 藝的模組化肩假體。此假體包括具平面支持表面的延長的 莖部份,其一端支持一半球形肱骨頭。支持表面及肱骨頭 之一包括一莖,另一包括一孔。莖及孔都圼錐形,Μ便將 頭固定於捍上。發給Dale等的美國專利4,191,670號也揭 示類似的構造。 D i n e s等及D a U等的假體的頭及莖都是模組化的,就是 說都製成不同的大小,但都有統一大小的錐形莖及孔。因 之可選擇合適大小的延長莖部份,且各不同大小的頭,在 装於肱骨桿上時,可裝於選擇的延長莖部份上。此構造可 讓外科醫生在裝此假體時,藉了在手術内評估不同大小的 肱骨頭’準確地使軟組織的張力獲得平衡。如果必須修改 -4- 本紙張尺度適用中國國家標準(CNS ) A4規格(210Χ 297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝· 訂 經濟部中央梯準局負工消費合作社印製 A7 B7 五、發明説明(>) 3目+的大小,也可不需移除延長的莖部份即可完成修改。 Dines等及Dale等所揭示的此種装置使用於全肩關節替換 時是有效的,因為此情形下肱骨桿是健康的,目的只在插 入假體替代健康肱骨桿與肩之間的關節,但用於治療眩骨 桿骨折並不理想。 與上面掲示的假體相反,也有人設計出專用於肱骨桿骨 祈的肱骨釕或棒。肱骨釘或棒一般是圓柱形的,係用以插 入骨祈的眩骨爾内管内。一旦插入後,訂或棒即需固定於 原處,例如用穿過釘及骨的交叉螺絲釘固定,或M固定於 上端的螺絲帽固定。使用訂時,肱骨頭及肱骨外科頸以下 2-3公分的胺骨桿部份必須是未受損傷的。是以在肱骨頭 發生骨折或肱骨頭一帶有骨折時,肱骨訂是沒有用的。此 外’前此技藝用Μ治療需修補骨折的肱骨頭的肱骨頭骨折 也不理想。在有些情形下,骨折片的血液循環尚佳,骨折 片可能會活’只需修補肱骨頭即可。但為使用前述的 Dines及Dale的肩假體,必須去掉肱骨頭,而用插於關節 窩或肩窩内的假體眩骨將之取代。是以並無法用以修補胺 骨頭。 因之’琨在霈要製造一種不僅可替代全肩關節且可用从 修補肱骨桿骨折的模組式假體。也就是說,此装置應可用 以分別或同時治療肱骨桿及供骨頭骨折。此種假體應能在 治療肱骨桿骨祈(肱骨頭尚健康)時可保留夭然的肱骨頭。 此假體應能提供外科翳生試圖修補骨折的肱骨頭的彈性選 擇*只在修補不成功時才於將來行半或全關節成形術。此 外’此假體應能有效地治療肱骨桿中間骨折,此假體的構 本紙張尺度適用中國國家標隼(CNS ) A4規格(210乂297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 經濟部中央標隼局員工消費合作社印製 A7 B7五、發明説明(3〇 造可跨越病人長骨或維形骨的骨折,並能適當地装於肱骨 桿的髄内腔内。 龙發明概沭 本發明係關於裝於病人肱骨内的模組式肱骨假體。本發 明可使用於(1)桿骨折,(2)肱骨頭骨折,(3)出現桿骨 折及肱骨頭骨折時,(4)半關節成形術,及(5)全瞄節成 形術。在頭骨折時,可用假體替代天然頭,或,如果骨折 片尚是活的,此等骨折片可於骨折帽上重建。一般是替代 肱骨頭,但本發明給予外科輅生另一選擇。如有必要,將 來可將骨折帽取下用假體頭替代。 該體包括近端肱骨部份,此部份有瘪莖段及配置於遠 莖段上端的平台。平台係K一角度裝配於遠莖段上。平台 上配置有錐形突出。此假體包括一骨折帽 > 骨折帽的週邊 璧及端璧在骨折帽内構成錐形開口。開口的形狀與錐形突 出一般相同。骨折帽係以摩擦錐形鎖方式將突出置於開口 内配置於近端肱骨部份上,必要時還可再取下。此假體藉 重組骨折帽附近的天然肱骨頭骨片、並將重組的骨片固定 於骨折帽使天然肱骨頭重建。 在另一具體實施例中,此假體包括其内有錐形開口的肱 骨頭,其開口與錐形突出的形狀一般相同。此肱骨頭可配 置於錐形突出上以替代病人天然的肱骨頭,必要時還可取 下。此假體肱骨頭可與骨折帽互相替換。 在另一具體實施例中,本發明關於裝於病人肱骨内的模 組式肱骨假體,包括有上端及下端的近端眩骨部份。此假 體還包括有上端及下端的遠端莖延長部。此延長部配置於 (請先閲讀背面之注意事項再填寫本頁) 裝. 訂 -6 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) 經濟部中央標準局員工消費合作社印製 A7 B7五、發明説明() 近端肱骨部份的下端。 在另一具體實施例中•此假體包括鎖定機構*將莖延長 部鎖於近端肱骨部份。 在另一具體實施例中,本發明關於將模組式肱骨假體装 於病人體内κ修補肱骨頭骨折的方法。此假體包括近端肱 骨部份及骨折帽。肱骨頭的骨片組合並固定於骨折帽上。 骨折帽係配置於近端肱骨部份。此假體係以將肱骨部份插 入病人肱骨桿内,使再建的肱骨頭以裝於病人關節窩内的 方式裝入病人體内。 圖式:篛沭 圖.1為本發明用於骨折及關節替代的模組式肱骨假體的 側視平面圖,包括近端肱骨部份、骨折帽、遠端莖延長部 及鎖定機構,此鎖定機構係用Κ將遠端莖延長部鎖於近端 肱骨部份。 圖la示模組式肱骨假體,其骨折帽與圖1所示者略有變 化。 圖2-8示各種鎖定機構的側視平面圖。 圖9為配置於人肱骨內的本發明假體側面平面圖。 較住旦賭g脓例詳沭 如圖1所示,係根據本發明模組式肱骨假體。圖1所示 為分解情彤之假體,包括近端肱骨部份10·遠端莖延長部 20,骨折帽40及肱骨頭50。組合起來後,莖延長部20會鎖 住於近端肱骨部份10上,其鎖的方式容後述。骨折帽40及 肱骨頭50可Μ互換,二者都是以可移除的方式配置於近端 肱骨部份10的上端。使用時|骨折帽40或肱骨頭50之一配 (请先閱讀背面之注意事項再填寫本莧) 裝. 訂 -7- 本紙張尺度適用中國國家標準(CNS ) Α4規格(210 X297公釐) 29Q228 A7 B7 經濟部中央標隼局員工消費合作社印製 五、發明説明() 置於近端肱骨部份10上。Μ延長部20,骨折帽40及肱骨頭 5 0都是模組化的,就是說,它們製成的大小不同,但其形 狀及裝於近端肱骨部份10的一端的大小是相同的,這樣, 任何莖延長部20、骨折帽40或肱骨頭50都可配置於近端肱 骨部份10上。 近端肱骨部份10包括縱向延長的圓柱狀違端莖段11,其 上端或近端配置平台12。平台12較佳是Μ與圓筒狀的遠端 莖段11的縱軸成30-60度角配置。此角度一般等於肱骨頭 軸與肱骨内髓管(即近端肱骨或肱骨桿内的空管)所成的角 度。在假體装於病人身上時,平台12的作用在防止内饈管 内的.裝置下沉,並能將解剖學上的荷載分佈於近端肱骨上 。錐形圓柱16以平台12的上表面作中心向上伸出。較佳是 圓柱16的高為δ毫米,平均直徑為19毫米。圓柱16的外週 表面向下M2.5角成賴射錐形。 前、後及中支桿13由莖段11近端或上端向外伸出,用以 支持平台12。側翼14也由莖段11上端向外伸出。支桿13及 翼14可共同構成由此伸出的鏠線孔,例如經翼14配置的孔 14a 。在接於骨或软組織時,此鏠線孔用以穿過鏠線。莖 段11也可包括縱向延伸的槽或粘固劑溝15,供莖固定於肱 骨管上。近端肱骨部份10的遠莖段11,除了平台12上表面 及錐形圓柱16外,可作多孔塗覆K便骨生長。此種塗覆 ΐδ於圖1中遠莖段η上端示出。違莖段η之長度,由其最 上端平台12下表面算起,可達33-125毫米,其直徑為 6.3- 19.1毫米。於下端,遠莖段11包括柱狀延長部或突 出32,其上作成外螺絲。突出32較佳是約13毫米長,直徑 (請先閲讀背面之注意Ϋ項再填寫本頁) 本紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) 經濟部中央標隼扃負工消費合作社印製 Α7 Β7 五、發明説明() 8毫米,係於莖段11上Μ切或輥壓製成。外螺絲所形成的 孔内可壓進小圓柱狀聚乙烯塞(圖上未示出)。 假體1堪包括遠端莖延長部20。莖延長部20下端可Μ是 圓形的,而其上端製成凹陷34。凹陷3 4有内螺紋*例如, 係由標準的或螺旋鎖内螺絲製成。二者都係用切或滾壓製 造。 螺紋凹陷34之螺紋部份與螺紋突出32的長度及直徑大致 相同*並具有相對應的螺距。螺紋凹陷34與螺紋突出32共 同形成鎖定機構,用Μ將莖延長部20藉突出32旋於凹陷 34内Κ固鎖於近端肱骨部份。附於突出32螺絲内的聚乙烯 塞有.在莖延長部20及近端肱骨部份10將形成壓配合的作用 0 莖延長部20係製成各種大小,有不同長度,如必需時堪 製成不同直徑。但所有莖延長部的形狀及凹陷34量度都是 一樣的。瑄樣,莖延長部20是模組化的,任一莖延長部 20都可固定於近端肱骨部份10上。例如,具不同長度但具 相同鎖部份的莖延長部之製造,如圖2及8所示,示其各 種鎖定機構,此假體的模組方面併入本發明的各種鎖定機 構。此外,近端肱骨部份10也可製成不同大小,例如,用 不同長度的遠莖段11製成。 因之*藉了選擇合適量度的莖延長部20,並藉鎖定機構 將之固定於選擇的近端肱骨部份上,可使假體1適合個別 病人。例如,肱骨桿較長的且有桿中間骨折的病人,可選 擇較長的莖延長部20,Κ便假體延伸過骨折點。對於肱骨 桿特別尖细的病人,可將莖延長部20變细,Μ使假體延伸 -9- 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐) (請先閲讀背面之注意事項再填寫本頁) 裝. .1Τ 經濟部中央標準局員工消費合作社印製 A7 B7五、發明説明() 過骨折處,同時在内Μ管維持良好配合。變细的情形可例 見於圃8。 假體1也包括骨折帽40·在重建天然的肱骨頭時*可將 頭骨片固定於此帽内然後插入病人肩窩。骨折帽40為帽形 ,具一般為錐形的外週邊璧41及形成錐形開口 43的端璧 42。螺絲孔45配置於端璧42。固定螺絲47可通過螺絲孔 45由内側配置,並旋入骨片以固定於骨折帽。突起部份 44伸至外週璧41週邊附近。錐形開口 43與近端肱骨部份 10之錐形圓柱16之形狀及量度一般相同。骨折帽40可藉將 錐形圓柱16配置於錐形開口 43内而配置且固定於近端肱骨 部份J0上,俾與平行設置在平台12上表面之突出部份44配 合而形成磨擦錐形鎖。磨擦錐形鎖的強度足以將骨折帽 40固定於近端肱骨部份10上,有效地排除骨折帽40在遇到 —般力量時由近端肱骨部份10移開的可能。但在施以縱向 力時,骨折帽40又可從近端肱骨部份10移開,即便在遠端 莖段11配置於肱骨桿時亦然。骨折帽40配置於錐形圓柱 1 6上時,中間有一間隙,此間隙係由突起部份44及平台 1 2上表面間構成,Μ確保錐形鎖在二組件之間接觸。 像違端莖延長部20—樣,骨折帽40係Μ近端肱骨部份模 组化的。骨折帽4 0可製成各種大小,例如*有不同的直徑 及長度,但其维形開口直徑卻是一致的。這樣,任何骨折 帽40可固鎖於近端肱骨部份10上。骨折帽的長度可在8毫 米至16毫米之範圍内,直徑範圍為22毫米至35毫米。 骨折帽40的端璧可以是平的,如圖1所示。或如圖1 a所 示,骨折帽40’可包括端璧42',為圓頂形,於不同角度 (請先閲讀背面之注意事項再填寫本頁) 裝. 訂 本紙張尺度適用中國國家標隼(CNS ) A4規格(210X297公釐〉 A7 B7 經濟部中央標隼局J工消費合作社印製 五、發明説明() 配置螺絲孔45'。在二具體實施例中,骨折帽40及40 ’的 形狀及大小,都可使病人装假體1後在^折帽與窩間留有 空隙。此空隙之大小一般與病人天然肱骨頭一樣,如下所 述,足K使肱骨頭骨片組合後用螺絲47固定於骨折帽上, 適合肩窩。這樣*骨折帽40可用於重建病人的天然肱骨頭 Ο 假體1也包括基本上為半球形的肱骨頭50。頭50包括上 關節面52,其形狀直接適合於肩窩,或適合於相配的肩窩 假體。面52較佳是高度磨光的。面52的球形半徑被設計成 可配合解剖學上的肱骨量度,或可滿足預先決定的與肩窩 假體名間的關係。肱骨頭5 0係用於必要時代替病人天然的 肱骨顗,例如,在肱骨頭嚴重傷害時。雖則假體1包括肱 骨頭50及骨折帽40此等組件是可互換的,在給病人裝假體 時只能選擇其一使用。 肱骨頭50也包括錐形開口 54,其形狀及量度對應於维形 圓柱16,可形成如前述骨折帽40樣的鎖。此錐形鎖使肱骨 頭50固定於近端肱骨部份1〇上,可有效防止在装於病人身 上時因遭遇一般的力量而移動。但施以縱向力時•頭50可 從近端肱骨部份10移除,縱令遠端莖段11配置於肱骨桿時 亦然。 像骨折帽40 —樣,眩骨頭50是模組化的*就是說,係製 成各種大小的,但其錐彤開口 54是一樣大的* Μ使任何肱 骨頭50Μ可取下的方式装於近端肱骨部份10上。肱骨帽 5 0製成球形半徑為19毫米至32毫米,直徑為36至64毫米。 如圖2所示,模組式肱骨假體包括如圖1所示的另一種 (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 -11- 本紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) 經濟部中央標準局員工消費合作社印聚 Α7 Β7 五、發明説明() 鎖定機構構形。假體100包括有圓柱狀違端莖段111的近 端肱骨部份11 〇 。雖則未曾示出,遠端莖段111可包括如 圖1所示的槽15的槽。内螺絲的凹陷134之構造類似如圖 1所示的凹陷34,係形成於莖111的下端。遠端莖段120 包括外螺絲的延長部或突出132 ,其構造類似如圖1所示 的突出32的構造。延長部132與凹陷134共同形成纟貞定機 構,將遠端莖延長部120鎖於莖段111上’其方式如前圖 1所示。此外,各種不同長度的莖延長部120 ’但圖2所 示延長部132之大小都一樣,也是本發明組合化的明顯處 。延長部120的長度自6毫米至216毫米。 圖3-8示根據本發明的假體及包括的各種鎖定機構’此 鎖定機構將遠端莖延長部鎖於近端肱骨部份上。鎖定機構 的變化包括對應的近端肱骨部份的遠端莖段及遠端莖延長 部的構造差異。只Μ基本上構造相同編號也與圖1及2相 同的各部份說明每一具體實施例中不同的近端肱骨部份及 遠端莖延長部。此外,雖未示出,骨折帽及肱骨頭的構造 也相同。 圖3示包括各種鎖定機構的模組式肱骨假體。假體200 包括有圓柱狀莖段211及槽215的近端肱骨部份210 。莖 段211包括其下端形成的螺絲凹陷234 。凹陷234之製造 方式如圖1凹陷34。 遠端莖延長部220包括其上所製成的莖段開口 222 ,此 開口係製於其下端。凹陷234之製造於圖1所示凹陷34相 同0 遘端莖延長部220包括於其中形成的莖段開口 222 ,此 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 經濟部中央標準局員工消費合作社印製 A7 B7五、發明説明() 開口由近端向下延伸。莖段開口 222之直徑幾等於遠端莖 段211之直徑,例如為9.5毫米。遠端莖延長部220也包 括於其中製成的並由開口 222向下延伸至莖延長部220下 端的螺絲開口 224 。螺絲開口 224之半徑與莖段222開口 相似,例如為6毫米,其長度為20毫米。於下端,螺絲開 口 224的直徑加大成頭開口 226 ,有上圓錐部份226a及下 圓錐部份226b。上部份226a的平均直徑可為7毫米,下部 份226b直徑為8毫米。 鎖螺絲232包括頭232a,圓柱延伸部份232b及螺絲紋部 份232c。頭232a之形狀及量度幾與頭開口 226相同。圓柱 延伸郄份232 b之長度及直徑幾與螺絲開口 22 4相同。螺絲 紋部份232c之長度與直徑幾等於凹陷234之長度*而部份 232c有對應的螺距。因之,鎖螺絲232之總長度一般等於 顗開口 226 ,螺絲開口 224及凹陷234的總長度。 遠端莖延長部220可以將圓柱莖段221插入莖段開口 2 2 2的方法鎖於近端肱骨部份2 1 0上。莖段2 11之下部於 螺絲開口 2 2 4的上端置於莖延長部的上内面。鎖螺絲2 3 2 經鎖開口 2 2 4配置,且旋入螺絲紋凹陷2 3 4内,以使遠端 莖延長部220鎖於近端肱骨部份210上,K頭232a置於頭 開口 226内。遠端莖延長部220也是模組化的,開口 222 的直徑及開口 224的長度與直徑都是一樣的。逭端莖延長 部220的總長度可藉改變開口 222的長度而改變。或者, 遠端莖延長部220的長度可藉改變螺絲開口 224的長度而 改變,鎖螺絲232的圓柱延伸部232b的長度也做對應的改 變。頭2 3 2 a及螺絲紋部份2 3 2 c的大小部是一律的。 本紙張尺度適用中國國家標準(CNS ) A4規格(210 X 297公釐) 經濟部中央標準局員工消費合作社印製 A7 B7 五、發明説明() 圖4不圖3所不的鎖定機構的另一構形。假體300實質 上與第二具髏實施例的假體200相同,包括近端肱骨部份 310 ,而此部份又包括圓柱狀莖段311及螺絲凹陷334 。 遠端莖延長部320包括遠端莖開口 322及螺絲開口 324 。 但螺絲開口 3 22的頭開口 3 26為圓頂形,延伸至遠端莖延 長部320的底。鎖螺絲332包括螺絲頭332a ,圓柱狀延伸 部332b及螺絲紋部份332c。螺絲頭332a包括形狀及大小都 對應於頭開口 326的圓頂部份及多邊頭部份。 遠端莖延長部320係藉鎖螺絲332 K圖3所示方式鎖於 莖段311上。螺绦頭332a的圓頂部份装於頭開口 326内, K螺絲頭332a的多逢部份從外部配置於遠端莖32〇上。此 一構形提供單一形末端的又一優點。 圖5示包括另一變化的鎖定機構的棋組式肱骨假體。假 體400包括有圓柱狀遠端莖段411的近端肱骨部份410 , 遠莖段411之外面構成縱向槽415 。莖段411下端形成維 形凹陷436 。凹陷436之長度可為13毫米,上端直徑為 8.4毫米,下端直徑為9.5毫米。 模組化遠端莖延長部420包括錐形突出438 ,由其上端 伸出。錐形突出438的形狀對應於錐形凹陷436 。遠端莖 延長部420可藉將突出438插於凹陷436内>乂鎖於近端肱 骨部份410上,由是形成錐形鎖以摩擦装配方式將各組件 固定一起。此摩擦椎形鎖強到足以使遠端莖延長部420鎖 住於近端肱骨部份410上,有效地排除在装於病人體内時 一般力量可使其移動。但莖延長部420可K縱向力從近端 肱骨部份410取下。 -14- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X29*7公釐) (請先閱讀背面之注意事項再填寫本頁) 裝· 訂 經濟部中央標隼局員工消費合作社印裝 A7 B7 五、發明説明() 圖6示圖5所示的鎖定機構的另一構形。假體500包括 有圓柱狀遠端莖段511的近端肱骨部份510 ,上有縱向槽 515 。莖段511包括錐形下端或突出538 ,其長度可為 13毫米,上直徑9.5毫米,下直徑δ.4毫米。模組化的遠 端莖延長部520包括錐形凹陷536 ,其形狀及量度對應於 錐形遠端538 。凹陷536包括縱向狹長切口 536a,此切口 始自上端終於凹陷536下内面。將錐形遠端538插入錐形 凹陷536内即可將遠端莖延長部520可鎖於近端肱骨部份 510上,從而形成錐形鎖以摩擦配適方式將各組件固定一 起。在錐形遠端538插入時,縱向狹長切口 536a使錐形凹 陷稍為張開。 圖7示圖3及圖5所示包括有鎖定機構組合的模組式肱 骨假體。假體600包括有圓柱形遠端莖段611的近端肱骨 部份610 ,其上有縱向槽615 。莖段611包括其下端的錐 形突出638 ,其構造與圖5所示突出438相似。突出638 包括螺絲凹陷634 ,其構造如圖3所示凹陷234相似。模 組化違端莖延長部620包括錐形凹陷636 ,其構造與圖5 所示凹陷436相似,其形狀及量度對應於錐形突出638 。 遠端莖延長部620也包括縱螺絲開口 624 ,由錐形凹陷 636向下延伸,及頭開口 626 ,由開口 624向下延伸。螺 絲開口 624及頭開口 626之構造與圖3所示螺絲開口 224 及頭開口 226相似。 鎖螺絲632構造與.圖3所示鎖螺絲232相似,包括螺絲 顗6 3 2 a,圓柱狀延伸部6 3 2 b及螺絲部份6 3 2 c。螺絲頭 632a之形狀與量度幾與頭開口 626之形狀與量度相同,而 -15- 本紙張尺度適用中國國家標準(CNS ) Α4规格(210'〆297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝. ,ιτ 經濟部中央樣準局員工消費合作社印製 A7 -__B7 五、發明説明() 圖柱狀延伸部632b之長度與直徑幾與螺絲開口 β24相同。 螺絲部份632c之形狀與量度幾等於蟋絲凹陷634之形狀與 最度’ m部份632c有對應的螺距。因之,鎖螺絲632的缌 長度一般等於頭開口 626 ,螺絲開口 624及螺絲凹陷634 之總長度。 將錐形突出638插入錐形凹陷β36内可使遠端莖延長部 6 20鎖於近端肢骨部份6 1 0上,由是提供以摩擦装配將各 組件固定一起的錐形鎖,其方式與圖5所示錐形鎖相同。 另將鎖螺絲632經螺絲孔624插人並旋於螺絲凹陷63 4内 進一步固定遠端莖延長部6 20於近端肱骨部份610上,以 φ 頭632a位於頭626内。瑄樣,假體600提供二種方式將遠 端莖延長部固定於近端肱骨部份上。 圖8示包括另一鎖定機構變化的模組式肱骨假體。假體 700包括有於其内形成螺絲凹陷734的近端肱骨部份。假 髖7 00邐包括模組化的遠端莖延長部7 2〇 ,其上有延伸自 上端的對懕的螺絲突出732 。突出732可旋於絲凹陷734 内Μ使莖延長部7 20固定於近端肱骨部份710上。莖延長 部720也包括孔742 ,經此孔可用交叉嫘絲固定假體於肱 骨内。 圖8示各種不同長度的莖延長部720 ,在有些情形下, 此類莖延長部製成可向下向内的錐形。製成錐形的延長部 7 20包括第一圓柱部份720 a,具有第一直徑並構成延長郜 720的上端,第二直徑部份720b有較第一直徑小的第二直 徑*構成延長部720的下端,第一及第二部份之間還有第 三錐形部份720c。但每一遠端莖延長部720包括螺絲突出 ______-16-_ 本紙張又度適用中國國家揉準(CNS ) A4規格(210X29?公釐) (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 A7 B7 經濟部中央標準局員工消費合作社印製 五、發明説明() 732 ,有一致的長度和直徑。因之,任何遠端莖延長部 720可Μ旋轉螺絲突出732至螺絲凹陷734内的方法固定 於近端肱费部份710上。特定莖延長部的選擇基於病人内 越管的大小及内饈管是否向内成錐形。 圖9顯示使用本發明假體修補骨折的肱骨。特定地說, 圈9示四部分的骨折。骨折的四部份是:1)肱骨桿60,為 最大的骨片,2)肱骨頭骨片65,已置於骨折帽40,3)較大 的粗隆骨片75,及4)較小的粗隆骨片(未示出)。如所示情 形*骨折係Μ圖8的假體700修補,但也可用圖卜8所示 任何假體。遠端莖延長部720係根據病人的肱骨桿長度選 擇,.也根據内髓管是否圼錐形,Μ選擇所需的錐形莖延長 部。所選的遠端莖延長部鎖於近端肱骨部份。如有必^, 可以遒可取下的方式插入肱骨桿試用不同大小的莖延長部 7 2 0 ,直到選對大小及錐形合適的莖延長部。所選骨折帽 40是適合病人的。 肱骨頭65的骨片已在骨折帽40附近重組,可藉經螺絲孔 將固定螺絲47 (未於圖9示出)插入骨片固定於骨折帽。這 樣天然肱骨頭係在骨折帽40内重建。然後將重建的肱骨頭 及骨折帽經上述錐形鎖固定於近端肱骨部份7 1 0 。假體 7 〇 0係插入肱骨桿6 0内,如有必要並用横向螺絲7 0固定於 胺骨桿上。#折骨片經鏠線孔714a固定於假體700上。然 後將重建的天然肱骨頭插入病人肩窩完成植人。如有必要 ,可使用另外的肩窩假體。 或者’如果天然肱骨頭是健康的,在近端肱骨部份710 及莖延長部720插入肱骨桿60後再插入骨折帽。 -17- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁) 装. 訂 Α7 Β7 五、發明説明() 如果肱贵頭骨折嚴重到不能重建*肱骨頭已不能活,或 關節炎時軟骨已退化的情形,可用合適大小的肱骨頭50替 代骨折帽40。肱骨頭50可插入肩窩或肩窩假體内。此外, 如果使用骨折帽40重建肱骨頭已證明不成功,可將骨折帽 40及重建的骨除去,用肱骨頭50替代。 根據本發明上述假體•可用以修補不同大小不同形狀的 肱骨桿,以及重建肱骨頭。如果最终證明肱骨頭重建不成 功•本發明允許Μ後用人工肱骨頭替代重建的肱骨頭。如 果一開始即決定肱骨頭已受傷到不能重建,此假體可與肱 骨頭假體組合。 本潑明假體所有零件都可用已知的可植入級材料,如 TI6A14V或CoOMo,製造。近端肱骨部份及肱骨頭可Μ鑲 造,而莖延長部可Μ鋪造也可用精煉的棒材製造。肱骨頭 也可用陶瓷材料,如氧化鋁或氧化锆,製造。 (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 經濟部中央標準局員工消費合作社印製 本紙張尺度適用中國國家標準(CNS ) Α4規格(210X 297公釐)

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  1. 經濟部中央標準局負工消費合作社印製 29922¾ 韶 C8 D8 六、申請專利範圍 1. 一種模組式肱骨假體,用於植於病人肱骨内,此肱骨包 括天然的肱骨桿及天然的肱骨頭,該假體包括: 近端肱骨部份*包括遠端莖段及配置於該遠端莖段上 端的平台,該平台Μ—角度配置於該遠端莖段,該近端 肱骨部份包括配置於該平台上的錐形突出;及 骨折帽,該骨折帽有週邊壁及端壁於該骨折帽内形成 錐形開口,該錐形開口與該錐形突出一般有相同形狀, Κ突出裝於該開口内產生摩擦錐形鎖,可使該骨折帽以 還可再取下的方式配置於該近端肱骨部份上*其中, 藉在該骨折帽内重組天然肱骨頭的骨片,並固定重組 的骨片於該骨折帽上,該假體可使骨折的天然肱骨頭重 建。 2. 根據申請專利範圍第1項之假體,該骨折帽的該端壁配 置有多個穿透該端壁的螺絲孔,該假體還包括多個固定 螺絲,將該固定螺絲通過螺絲孔插入骨片内即可將重組 的骨片固定於該骨折帽上。 3. 根據申請專利範圃第1項之假體,另包括有錐形開口的 肱骨頭假體,該骨頭假體的錐形開口與該錐形突出具有 大致相同形狀,該肱骨頭假體可藉將該突出装入該肱骨 、 頭假體之該開口内形成摩擦錐形鎖Μ遨可再取下的方式 配置於該近端肱骨部份上,其中該肱骨頭假體與該骨折 帽可互換配置於該近端肱骨部份上。 4. 根據申請專利範圍第1項之假體,另包括遠端莖延長部 *該莖延長部聯於該遠端莖段之下端*其中該遠端莖段 及該莖延長部包括模組化組件,Μ便近端肱骨部份與不 -19- 本紙張尺度適用中國國家揉準(CNS ) Α4说格(210X297公釐) (請先聞讀背面之注意事項再填寫本瓦) 袈- 訂 申請專利範圍 同大小的遠端莖延長部聯到一起。 5 ·根據申請專利範圍第4項之假體,另包括用以將該遠端 莖延長部鎖於該近端肱骨部份的鎖工具。 6. 根撺申請專利範圍第5項之假體,其中該模組化組件係 該鎖工具。 7. 根撺申請專利範圍第1項之假體,其中該假體的一部份 外表面是作孔塗覆的。 8. 根據申請專利範圍第1項之假體*其中該端壁實質上是 平的而該週邊壁一般是圓柱形。 9· 根據申請專利範圍第1項之假體*其中該端壁實質上是 圓頂形,而該週邊壁一般是圓柱形。 10. —種將模組式肱骨假體植於病人體内Μ修補肱骨頭骨折 的方法,此假體包括近端肱骨部份及配置於近端肱骨部 份上端的骨折帽,該方法包括的步驟有: 組合並固定骨片於骨折帽上Μ重建病人肱骨頭骨片; 將骨折帽配置於近端肱骨部份上;及 藉將近端肱骨部份插入病人供骨桿給病人装上假髖, 並將重建的肱骨頭装入肩窩。 經濟部中央標準局員工消費合作社印製 (請先閲讀背面之注意事項再填寫本頁) 11. 一榑棋組式陈骨假體,用从植入病人眩骨内,該假體包 括: 有上端及下端的近端肱骨部份;及 有上端及下端的遠端莖延長部,該延長部如、還可取下 的方式配置於該近端肱骨部份的下端。 12. 根據申請專利範圍第11項之假體,其包括用以將該遠端 莖延長部鎖於該近端肱骨部份的鎖工具。 ___-20-__ ^紙張尺度適用中國國家標準(CNS ) Α4規格(210X297公釐) ' ------- ABCD 經濟部中央標準局貞工消费合作社印製 六、申請專利範圍 13. 根據申請專利範圍第12項之假體,該鎖工具包括: 一由該近端肱骨部份之該下端之一及該莖延長部之該 上端延伸出之突出;及 由該近端肱骨部份之該另一下端及該莖延長部之該上 端所形成之凹陷,該凹陷之形狀對應於該突出*該突出 装於該凹陷內。 14. 根據申請專利範圍第13項之假體,該突出及該凹陷有對 應的錐形。 15. 根據申請專利範圍第13項之假體,該突出及該凹陷有對 應的螺絲,該突出旋於該凹陷內。 16. 根據申請專利範圍第12項之假體,該鎖工具包括於該近 端肱骨部份内形成的螺絲凹陷及於該遠端莖延長部上形 成的螺絲突出。 17. 根據申請專利範圍第12項之假體,其中該近端肱骨部份 之該下端包括於其內形成的螺絲凹陷,及 該鎖工具包括延伸經該遠端莖延長部的鎖螺絲,且有 一配置於該螺絲凹陷内的車過螺絲的端。 18. 根據申請專利範圍第17項之假體,其中該遠端延長部包 括: 於其内形成的且由該延長部上端向下延伸的第一開口 ,該第一開口之直徑至少等於該近端肱骨部份下端之直 徑;及 於其内形成的且由第一開口延伸至該莖延長部之第二 開口,該第二開口之至少一部份之直徑實質上等於鎖螺 絲之直徑*且其中 -21- 本紙張尺度逋用中國國家揉準(CNS ) A4洗格(210X297公釐) (請先Η讀背面之注意事項再填寫本頁) .策· 訂 A8 B8 C8 D8 經濟部中央標準局貞工消费合作社印製 六、申請專利範圍 1 1 1 該 遠 端 莖 延 長 部 係 Μ該 近 端 肱 骨 部 份 之 下 端 藉 該 第 一 1 1 1 開 □ 及 延 伸 過 該 第 一 與第 二 開 口 的 鎖 螺 絲 配 置 於 該 近 端 1 肱 骨 部 份 上 0 請 先 1 1 19 . 根 據 甲 請 專 利 範 圍 第 18項 之 假 體 其 中 該 第 二 開 □ 包 括 閲 讀 1 1 於 其 下 端 形 成 的 較 大 直徑 部 份 且 該 鎖 螺 絲 包 括 適 合 裝 背 面 1 I 之 1 於 該 較 大 直 徑 部 份 的 頭。 注 意 1 | 20 . 根 據 甲 請 專 利 範 圍 第 18項 之 假 體 其 中 該 第 二 開 □ 包 括 事 項 1 I 再 1 於 其 下 端 形 成 的 較 大 直徑 部 份 且 該 鎖 螺 絲 包 括 —' 頭 9 此 頭 適 合 裝 於 該 較 大 直徑 部 份 的 第 — 部 份 及 向 外 延 伸 至 寫 本 頁 衣 1 該 較 大 直 徑 部 份 的 第 二部 份 〇 1 21 . 根 據 申 請 專 利 範 圍 第 11項 之 假 體 另 包 括 1 1 由 該 近 端 肱 骨 部 份 之該 下 端 及 該 遠 端 莖 延 長 部 之 該 上 1 1 端 之 —* 延 伸 出 之 錐 形 突出 ♦ 1 訂 於 該 近 端 肱 骨 部 份 之另 —A 該 下 端 及 該 遠 端 莖 延 長 部 之 1 1 該 上 端 形 成 的 錐 形 凹 陷, 該 AjV 錐 形 凹 陷 之 形 狀 對 應 於 該 錐 1 1 形 突 出 而 該 錐 形 突 出係 裝 於 該 錐 形 凹 陷 内 形 成 摩 擦 維 1 | 形 鎖 1 X 於 該 近 端 肱 骨 部 份 形成 的 螺 絲 凹 陷 及 I 延 伸 過 該 遠 端 莖 延 長部 的 鎖 螺 絲 此 鎖 螺 絲 有 配 罝 於 1 1 該 螺 絲 凹 陷 的 螺 絲 端 0 1 I 22. 根 據 串 請 專 利 範 圍 第 21項 之 假 體 其 中 該 突 出 由 該 近 肱 1 1 骨 部 份 延 伸 而 該 维 形凹 陷 係 於 該 遠 莖 延 長 部 形 成 該 1 I 螺 絲 凹 陷 係 於 該 维 形 突出 形 成 0 1 1 23 . 根 據 申 請 專 利 範 圍 第 11項 之 假 體 該 遠 端 莖 延 長 部 包 括 1 I 有 第 一 直 徑 的 第 圓 柱狀 部 份 形 成 該 遠 端 莖 延 長 部 之 上 1 1 I -22 - 1 1 1 本纸張尺度逍用中國國家揉準(CNS ) A4規格(210X297公釐) A8 B8 C8 D8 六、申請專利範圍 端,邐有較第一直徑為小的第二直徑的第二圓柱狀部份 ,配置於該遠端莖延長部之下端,及第三維形部份配置 於該第一及第二部份之間。 24.根據申請專利範圍第11項之假體,該遠端莖延長部包括 配置其上的穿通的孔,該假體堪包括横向螺絲,該交横 向螺絲穿通並配置於該孔以固定該假體於肱骨上。 (請先閏讀背面之注意事項再填寫本頁) 裝· 訂 經濟部中央標準局貝工消費合作社印製 -23- 本紙浪尺度適用中國國家標準(CNS ) Μ規格(210X297公釐)
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