201034642 六、發明說明： 【發明所屬之技術領域】 本發明是一種骨骼植入物成形方法，該骨骼植 入物係屬於生物體植入或固定用物體，用以植入於 生物骨骼之植入物。本發明的骨骼植入物成形方法 特別指一種於骨骼植入物之植入部形成粗糙加工處 理面之表面粗糙部的骨骼植入物成形方法。 Ο 【先前技術】 隨著科技的日益發達，醫學技術也隨之蓬勃進 * 展’縱使病患在原有生物體損壞後，亦可藉由一種 人造件的置換技術取代原有生物體的機能，實為病 患之一大福音，惟，先前的技術中所使用的植入物 往往因設計不周全’如圖六所示，顯示了一種目前 ❹習用的骨骼植入物一，該骨骼植入物係在螺牙部加 工之後才作壓花加工或紋路切割等處理步驟，螺牙 部往往受到後續的壓花加工或紋路切割等處理的愿 迫而導致螺牙部的螺紋遭破壞，使螺紋不平整，此 螺牙遭破壞的植入物在植入時會造成骨絡組織的破 壞；如圖七所示，顯示了一種目前習用的骨骼植入 物二’上方具有與其他人造件連結的連接端9〇,下 方則為略呈圓柱形的植入部80係用以植入骨骼内固 定，等待骨頭生長完成時，骨骼植入物埋入骨骼内， 3 201034642 該植入部80係僅以喷砂及酸蝕作為表面處理之加工， 而在骨骼植入物上造成粗糙的表面狀態，藉此以達到 骨整合效果，但該骨骼植入物外形若僅經過喷砂及酸 蝕過程，只能呈細微粗糙效果，該粗糙效果以肉暾觀 之，仍是一種平順表面，無明顯凸紋或凹紋的粗糙效 果，然，較平滑的植入部80表面或粗糙度太小使植 入後之牢固性無法確實達到理想之要求，使骨頭生 長完成時，植入物與骨骼仍無法緊密結合而鬆脫。 〇 【發明内容】 緣是，本發明係針對以上問題加以研究，經長 時間之設計與開發，進而完成本案「骨骼植入物成 形方法」，除了進行螺牙部成形加工步驟以形成鎖固 旋入骨骼所需螺牙部外，另具有表面塑性加工步驟 使骨骼植入物之外表面具有粗糙加工處理面，且在 〇 該表面塑性加工步驟之後進行螺牙部成形加工步 驟，其目的在使螺牙部的成形能保持完整不變形的 狀態，可使得骨骼植入物經塑性加工處理後變得更 緊實，不致因後續的加工步驟而損壞螺牙部的形 狀，同時，表面塑性加工步驟所形成粗糙加工處理 面的各種凹紋則可以使骨細胞生長到凹紋缺口裡， 使骨骼植入物與骨組織的結合更為穩固，組織可以 生長進入該凹紋缺口中，而形成銷鍵，以便能夠阻 4 201034642 •止該植入元件在該組織中的旋轉，該表面塑性加工 步驟所形成粗糙加工處自面成形出4有明顯的複數 凸紋或凹紋的表面粗糙部之植入物，該等凸紋或凹 紋排列於植入部之外表面，與骨骼有較為多角度與 更多面的接觸，可有效提升手術後與增長的骨骼結 合的速度，並避免長期使用骨骼植入物時發生沉骨 效應（植入物與骨骼形成鬆弛的情況），並可減低手 術後植入物表面外露之情形，提高植入物在骨骼中 之穩定性。 即’本發明之目的在於提供一種容易旋入骨 骼，且與骨骼有更多面的接觸以增加更多結合面積 之月路植入物。該骨絡植入物具有一植入部，該植 入部包含具有粗糙加工處理面之表面粗糙部及一螺 牙部，提供一種增加儲存骨血範圍，更加強其表面 強度’使骨絡植入物較能順利進入骨絡内，並可加強 抵抗尚扭力所造成的破壞程度，同時與骨骼有較為 多面積的接觸，由表面塑性加工步驟所形成粗糙加 工處理面的各種凹紋則可以使骨細胞生長到凹紋缺 口裡，使骨骼植入物與骨組織的結合更為穩固，組 織可以生長進入該凹紋缺口中，而形成銷鍵，以便 能夠阻止該植入元件在該組織中的旋轉，可有效提 升手術後與增長的骨絡結合的速度，藉此以達到更 佳之骨整合效果。 5 201034642 【實施方式】 明之功效完全〜責解審查委員及習於此技術人士’對本發 結構、組成、功L 圖示及圖號’就本發明之 組成功效特徵’詳細說明如下： 本發明之骨絡植入物1成形方法包含一表面 加工步驟及一螺牙部 塑性201034642 VI. Description of the Invention: [Technical Field] The present invention is a bone implant forming method, which belongs to an object for implantation or fixation of an organism, and is implanted in a biological bone implant. Things. The bone implant forming method of the present invention particularly refers to a bone implant forming method for forming a rough surface of a rough processing surface at an implant portion of a bone implant. Ο 【Prior Art】 With the development of science and technology, medical technology has also flourished. Even after the patient is damaged by the original organism, the function of the original organism can be replaced by a replacement technology of artificial parts. It is a great gospel for patients. However, the implants used in previous techniques are often incompletely designed. As shown in Figure 6, a bone implant is currently used. After the processing of the thread, the processing steps such as embossing or grain cutting are performed, and the thread portion is often subjected to subsequent embossing or grain cutting, and the thread of the thread is broken, so that the thread is broken. Unevenness, the damaged implant can cause damage to the bone tissue when implanted; as shown in Figure 7, it shows that a currently used bone implant II' has a connection with other artificial parts. The connecting end 9〇, the lower cylindrical implant 80 is used for implanting the bone fixation, and the bone implant is buried in the bone when the bone growth is completed. 3 201034642 The implant 80 is only Spray And acid etching as a surface treatment, and causing a rough surface state on the bone implant, thereby achieving the osseointegration effect, but the bone implant shape can only be subjected to sand blasting and acid etching process. Fine rough effect, the rough effect is still a smooth surface without the obvious rough or concave rough effect. However, the smoother surface of the implant 80 or the roughness is too small for the implant. The firmness does not really meet the ideal requirements, so that when the bone grows, the implant and the bone still cannot be tightly coupled and loosened. 〇 [Summary of the Invention] The present invention is directed to the above problems, and after a long period of design and development, the "bone implant forming method" of the present invention is completed, except that the thread forming process is performed to form a locking screw. In addition to the screw portion required for the bone, the surface plastic processing step has a rough processing surface on the outer surface of the bone implant, and the thread forming process step is performed after the surface plastic working step, the purpose of which is to make The formation of the thread can maintain a complete and non-deformed state, which can make the bone implant become more compact after plastic processing, without damaging the shape of the screw due to subsequent processing steps, and at the same time, the surface plastic processing step The various concave lines formed on the rough processed surface can grow the bone cells into the concave notch, so that the binding of the bone implant and the bone tissue is more stable, and the tissue can grow into the concave notch to form a pin. In order to be able to resist 4 201034642 • The rotation of the implant element in the tissue, the rough processing of the surface plastic working step Forming an implant having 4 surface reliefs having a plurality of complex ridges or indentations, the ridges or indentations are arranged on the outer surface of the implant portion, and have more angles and more faces with the bone Contact can effectively increase the speed of binding to growing bone after surgery, and avoid the sinking effect (implantation and bone formation relaxation) when using bone implants for a long time, and reduce the surface exposure of the implant after surgery In this case, the stability of the implant in the bone is improved. That is, the object of the present invention is to provide a lunar implant that is easily screwed into the bone and has more face contact with the bone to increase more bonding area. The bone graft has an implant portion comprising a surface roughened portion having a rough processed surface and a screw portion, which provides an increase in the storage bone blood range and strengthens the surface strength of the bone implant. The material can smoothly enter the bone network, and can strengthen the resistance caused by the resistance to the torsion, and at the same time, the bone has a relatively large area of contact, and the various concave lines formed by the surface plastic processing step can make the bone The cells grow into the indentation gap, making the bone implant and bone tissue more stable, and the tissue can grow into the indentation gap to form a pin to prevent rotation of the implant element in the tissue. It can effectively improve the speed of the combination with the growing bone after surgery, in order to achieve better osseointegration effect. 5 201034642 [Embodiment] The function of the present invention is completely explained to the reviewing committee and the person skilled in the art 'the structure, composition, diagram and figure of the present invention' are described below as follows: The osseous implant 1 forming method comprises a surface processing step and a plasticity of a screw portion
植入於生物骨丄係用於成形1 有兩端之柱狀體如圖—所干，呈一具 形成該骨雜人物1之她加工處理面⑴= 如m係魏凸紋或贼制㈣骨絡植入 兮嫂Η植入部10外表面，而成一表面粗糙部11， 二牙部η成形加工步驟係於該植人部1G外表面成 、，而成一螺牙部12 ,該表面粗糙部u之粗糙 =工處理面111為該螺牙部12之螺牙所分割。上述之 月絡植入物1成形方法，該表面塑性加工步驟先於 該螺牙部成形加工步驟。 本發明之第一實施例如圖一、圖二所示，係用以 植入於生物骨骼之骨骼植入物1，其具有植入部10， 上方為連接端20，該植入部10外表面具有表面粗糙 部11及一螺牙部12，該表面粗糙部11之粗糙加工 處理面111係複數凹紋或凸紋排列於植入部1〇形成該 表面粗糙部11，其中該表面粗糙部11與該螺牙部 12互相交錯，使該粗綠加工處理面Hi為該螺牙部 6 201034642 12所分割，·該粗糙加工處理面1U係由植入部〗〇之 上部外表面往下延伸匯集形成一略呈錐狀、圓球狀 或螺旋狀之端緣即植入端13，而於螺牙部12的成形 過程中，係使形成螺旋溝槽之寬度小於其螺牙之螺 距，因而粗糙加工處理面ηι為該螺牙部12分割成 螺旋狀造形’亦即該螺牙部12所形成螺旋溝槽與下一 螺圈的螺旋溝槽之間具有一距離，該距離係使該粗 糙加工處理面111亦呈螺旋狀排列於植入部1〇之外 表面（如圖一所示）；第一實施例之粗糙加工處理 面放大示意圖如圖二所示，該表面粗糙加工所形成 粗糙表面之凹紋溝槽112深度小於該螺牙部12所 形成溝槽121之深度，該粗糖加工處理面m係具 凹紋溝槽112的塑性加工紋所形成之粗糙表面，而 其中具有格狀或網狀塑性加工紋者如圖三（3)所 示，具有上下縱向排列栅狀之塑性加工紋者如圖三 (b)所不，具有環繞植入部1〇之外表面周緣橫向之塑 性加工紋者如圖三所示，而具有橫向與縱向交 錯排列環繞植入部1 〇之外表面周緣之塑性加工紋者 如圖二（d)所示，圖三（a)、圖三（b)、圖三（c)、圖 三（d)之塑性加工紋係環繞排列之明顯的複數凸紋 或凹紋所形成之粗繞表面，該凸紋或凹紋係肉眼便 能直接觀察之加工紋。 在月絡植入物1的成形過程中，包含一表面塑性 加工步驟及一螺牙部成形加工步驟，該表面塑性加 7Implanted in the biological bone system for forming 1 columnar body with two ends as shown in the figure, which is a processing surface (1) of the formation of the bone character 1 (= m system Wei embossing or thief system (4) The osseointegration is implanted into the outer surface of the implant portion 10 to form a surface roughness portion 11. The second tooth portion η forming process is formed on the outer surface of the implanted portion 1G to form a threaded portion 12, which is rough. Roughness of the portion u = the working surface 111 is divided by the thread of the thread portion 12. In the above-described method of forming the collateral implant 1, the surface plastic working step precedes the step of forming the screw portion. A first embodiment of the present invention, as shown in FIG. 1 and FIG. 2, is a bone implant 1 for implanting a biological skeleton, which has an implant portion 10 and a connection end 20 on the upper surface of the implant portion 10. The surface roughness portion 11 and the screw portion 12 are formed, and the rough processing surface 111 of the surface roughness portion 11 is formed by the plurality of concave or convex lines arranged on the implant portion 1 to form the surface roughness portion 11, wherein the surface roughness portion 11 is formed. The screw-shaped portion 12 is interlaced with each other, and the rough green processed surface Hi is divided into the screw portion 6 201034642 12. The rough processed surface 1U is extended from the upper surface of the upper portion of the implant portion. Forming a slightly tapered, spherical or spiral end edge, that is, the implant end 13, and during the forming process of the threaded portion 12, the width of the formed spiral groove is smaller than the pitch of the screw, and thus rough The processing surface ηι is divided into a spiral shape by the screw portion 12, that is, a distance between the spiral groove formed by the screw portion 12 and the spiral groove of the next spiral ring, the distance is such that the rough processing The processing surface 111 is also spirally arranged on the outer surface of the implant portion 1 As shown in FIG. 1 , an enlarged schematic view of the rough processing surface of the first embodiment is shown in FIG. 2 , and the depth of the concave groove 112 formed by the surface roughening process is smaller than the groove 121 formed by the screw portion 12 . The depth of the rough sugar processing surface m is a rough surface formed by the plastic working grain of the concave groove 112, and the lattice-like or reticulated plastic processing grain has a vertical or vertical arrangement as shown in FIG. 3(3). The plastic-grained grain of the grid is as shown in Figure 3(b). The plastic-worked grain with the lateral periphery of the surface surrounding the implant 1〇 is shown in Figure 3, and has a lateral and longitudinal staggered arrangement around the implant. 1 The plastic working grain on the outer surface of the outer surface is shown in Figure 2 (d), and the plastic working lines of Figure 3 (a), Figure 3 (b), Figure 3 (c), and Figure 3 (d) are arranged in a circle. The apparently thick embossed surface formed by a plurality of ridges or indentations which can be directly observed by the naked eye. During the forming process of the collateral implant 1, a surface plastic processing step and a thread forming process step are included, and the surface plasticity is added.
〇 的在使螺牙部12的成形能保持完整不變形的狀 態’不致因後續的加工步驟而損S螺牙部12的形 狀，同時該表面粗糙部U與該螺牙部12互相交 201034642 二步：係於一胚料外表面形成粗糙加工處理面 ?中該粗糙加工處理面⑴係具凹紋溝槽112 所形成之粗經表面，且該粗糙加卫處理面m係塑 挫加處理面’即滾軋加工、擠製加工、抽拉加工、 锻造加工、壓花加工、壓印加工·齒加工所成形 曰·輪表φ上述塑性加1亦包括在高於材料再結 晶溫度以上的溫度進行的熱加工（或稱熱作），或低 於材料再結晶溫度以下的溫度進行的冷加工(或稱 冷作）；該螺牙部成形加卫步驟係使該粗链加工處 理面U1為一螺牙所分割而形成螺牙部12;在表 面塑性加工步驟之後才進行螺牙部加工步驟，其目 錯，使該表面粗糙部11之粗糙加工處理面U1為 該螺牙部12所分割’其巾該表面㈣加工所形成 粗糙表面之凹紋溝槽112深度小於該螺牙部12所 形成螺旋溝槽之深度。 於第一實施例如圖一所示，骨骼植入物丨之連接 端20係具有一開口或定位孔，可供連接人造件、另 一連接件或連接工具（可為手動或電動工具）進行 灰入作業，而第_一實施例如圖四所示，即骨絡植入物 1之連接端20以定位柱形式表現；第三實施例如圖 8 201034642 五所示，即骨骼植入物丨之植入部1〇末端具有缺口 14以順利旋入於骨骼内。 上述骨骼植入物1之較佳實施例（圖一、圖二、 圖二（a)、圖三（b)、圖三（c)、圖三（d)、圖四、圖 五）係一體成形件，且所使用之胚料係生物相容性 之材料製成，該生物相容性之材料尤其以鈦金屬或 鈦合金材料為佳’該骨骼植入物1可應用的領域為 人造植牙或一人工骨釘。但實際的應用領域不以此 為限，凡可應用在生物體中之植入物，皆屬於本發 明所涵蓋之範圍。 綜上所述，本發明之成形方法，使螺牙部的成形 能保持完整不變形的狀態，可使得骨骼植入物塑性 加工處理後變得更緊實，不致因後續的加工步驟而 損壞螺牙部的形狀，同時，塑性加工步驟所形成粗 糙加工處理面的各種凹紋則可以使骨細胞生長到 凹紋缺口裡’使骨胳植入物與骨組織的結合更為穩 固’組織可以生長進入該凹紋缺口中，而形成銷 鍵’以便能夠阻止該植入元件在該組織中的旋轉， 該塑性加工步驟所形成粗糙加工處理面成形出具 有明顯的複數凸紋或凹紋的表面粗糙部之植入 物，該等凸紋或凹紋排列於植入部之外表面，與骨 骼有較為多角度與更多面的接觸，可有效提升手術 後與增長的骨骼結合的速度，並避免長期使用骨骼 201034642 植入物時發生沉骨效應（植入物與骨骼形成鬆弛的 情況），減低手術後植入物表面外露之情形。 【圖式簡單說明】 圖一係本發明第一實施例。 圖二係粗糙加工處理面放大示意圖。 圖三(a)、圖三(b)、圖三(c)、圖三(d)係本發明第一實施例 粗糙加工處理面在螺牙加工後各種凸紋或凹紋示 〇 意圖。 圖四係本發明第二實施例。 圖五係本發明第三實施例。 圖六係習知之骨骼植入物一。 圖七係習知之骨骼植入物二。 201034642 【主要元件符號說明】 1骨骼植入物 10植入部 11表面粗糙部 111粗糙加工處理面 112凹紋溝槽 12螺牙部 121螺牙部所形成螺旋溝槽 Ο 13植入端 14植入端缺口 20連接端 80植入部 90連接端The state in which the shaping of the thread portion 12 is maintained intact and not deformed 'does not damage the shape of the screw portion 12 due to the subsequent processing steps, and the surface roughness portion U and the thread portion 12 intersect each other 201034642 Step: forming a rough processing surface on the outer surface of a blank material, wherein the rough processing surface (1) is a rough surface formed by the concave groove 112, and the roughening treatment surface m is a plastic processing surface 'The rolling process, the extrusion process, the drawing process, the forging process, the embossing process, the embossing process, the tooth forming process, the wheel table φ, the plastic addition 1 is also included at a temperature higher than the material recrystallization temperature. Performing hot working (or hot work), or cold working (or cold work) at a temperature lower than the recrystallization temperature of the material; the screw forming and curing step is such that the thick chain processing surface U1 is one The thread is divided to form the thread portion 12; the thread processing step is performed after the surface plastic working step, and the rough processing surface U1 of the surface rough portion 11 is divided by the screw portion 12 The surface of the towel (4) is shaped The depth of the concave groove 112 of the roughened surface is smaller than the depth of the spiral groove formed by the threaded portion 12. In the first embodiment, as shown in FIG. 1, the connecting end 20 of the bone implant has an opening or a positioning hole for connecting the artificial member, another connecting member or a connecting tool (which can be a manual or electric tool). The operation is performed, and the first embodiment is as shown in FIG. 4, that is, the connecting end 20 of the osseous implant 1 is represented by a positioning post; the third embodiment is shown in FIG. 8 201034642, that is, the implant of the bone implant The end of the entrance has a notch 14 for smooth screwing into the bone. The preferred embodiment of the above-mentioned bone implant 1 (Fig. 1, Fig. 2, Fig. 2(a), Fig. 3(b), Fig. 3(c), Fig. 3(d), Fig. 4, Fig. 5) a molded part, and the blank used is made of a biocompatible material, and the biocompatible material is particularly preferably a titanium metal or a titanium alloy material. The field of application of the bone implant 1 is artificial planting. A tooth or an artificial bone nail. However, the actual application field is not limited thereto, and any implant that can be applied to an organism is within the scope of the present invention. In summary, the forming method of the present invention enables the forming of the thread to maintain a complete and non-deformed state, which can make the bone implant become more compact after plastic processing, and does not damage the snail due to subsequent processing steps. The shape of the tooth, at the same time, the various concave lines on the rough surface of the plastic processing step can make the bone cells grow into the concave notch, which makes the binding of the bone implant and the bone tissue more stable. Entering the indentation gap to form a pin key to prevent rotation of the implant component in the tissue, the plastic working step forming the roughened surface to form a surface roughness having a significant plurality of ridges or indentations Implants, the ridges or indentations are arranged on the outer surface of the implant, and have more angles and more contact with the bone, which can effectively improve the speed of bonding with the growing bone after surgery and avoid The long-term use of the bone 201034642 implant has a sinking effect (in the case of implant and bone formation relaxation), reducing the exposure of the implant surface after surgery. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a first embodiment of the present invention. Figure 2 is an enlarged schematic view of the rough processing surface. Fig. 3 (a), Fig. 3 (b), Fig. 3 (c), and Fig. 3 (d) are the first embodiment of the present invention. The rough processed surface is intended to be various embossing or concave after the thread processing. Figure 4 is a second embodiment of the present invention. Figure 5 is a third embodiment of the present invention. Figure 6 is a conventional bone implant. Figure 7 is a conventional bone implant II. 201034642 [Major component symbol description] 1 bone implant 10 implant portion 11 surface roughness portion 111 rough processing surface 112 concave groove 12 screw portion 121 screw groove formed by the screw portion 13 implant end 14 plant Inlet notch 20 connection end 80 implant portion 90 connection end
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