201130459 六、發明說明： 【發明所屬之技術領域】 本發明係隸屬於人工植入物之領域，特別係斜對 椎間盤之植入結構加以改良之發明。 【先前技術】 按，脊椎（Vertebra)亦有人稱之為脊柱（Spine)，其主 要係用以支撐人體直立的主幹，就結構上作分類，其由上 而下總共包括了七個頸椎（Cervicai vertebrae)、十二個 胸椎（Thoracic vertebrae)、五個腰椎（Lumbar vertebrae)、薦骨（sacrum)及尾骨（c〇ccyx)，其具有支撐 身體、保護脊髓之功能，在各節之間又以椎間盤 Untei^vertebral disc)作緩衝，該椎間盤提供了脊椎避震 及可供彎曲的功能。 在許多臨床病例中可以瞭解到，脊椎本身受損及發生 病變的機會相當高’故而在國内外已發展出了多種不同型 式的脊椎内固定器’當脊椎因跌傷或其他因素發生傷害 時’可藉由外科手術將脊椎内固定器植入人體的脊椎側， 而可提供患者適切的支撐作用，雖然患者在加裝了固定器 後雖無法如同一般健康的人般蹦蹦跳跳，但已解決了早期 脊椎受傷後即必須長期臥床的問題，該類脊椎内固定器確 為外科醫學上的一大進步，對患者而言亦是一大福音。但 對於一些椎間盤退化或受損的患者而言，脊椎固定器並無 法完全解決患者之問題，因為一般腰椎間的椎間盤病變屬 於脊椎病變中較常見的一種，其椎間盤被壓扁時，會使得 201130459 椎管（Spinal canal)變窄而壓迫神經，習知之脊椎固定器 的安裝雖然提供了患者脊椎的一份支撐力量，但其手術後 的剛性固定構造反而破壞人體脊椎整體的活動性，往往未 能完全解決患者的痛苦與不便。 近年來，人工椎間盤（Artificial Disc)已經開始進行 臨床使用，用以治療椎間盤退化性疾病（Degenerative Disc Disease)。目前市面上可見的人工椎間盤有遇水可凝 固的（Hydraulic)型式、彈性的（Elastic)型式、液動的 (Hydrostatic)型式與磨耗的（Wear)型式等。此類的人工椎 間盤不僅可以達到重建塌陷椎間盤高度的治療目的，同時 也可以使受治療區椎間盤的活動度不致於減少。 有關習知技術則請參閱第一圖所示，一種傳統人工椎 間盤之組成包括一上盤、一下盤及一核體，該核體之頂部 及底部分別具有一球狀凸起部，用以分別接觸於上盤底部 的凹槽及下盤頂部的凹槽。上盤的頂部表面及下盤的底部 分別設有齒狀物，使其嵌入鄰近之椎骨内，以增加人工椎 間盤的穩定度。由於習用該核體的頂部及底部與上盤的底 部及下盤的頂部分別為近球面關節的接觸形式，因此具有 可屈曲、伸展、側彎及扭轉的運動模式，但是於該核體的 頂部與該上盤的底部之間，以及該核體的底部與該下盤的 頂部之間無任何限制的機構設計，因此無法有效的限制該 上盤及該下盤過度的作屈曲及側彎的脊椎運動模式，且該 上盤的底部與該核體的頂部之間，以及該下盤的頂部及該 核體的底部之間無任何擋止結構，該上、下盤與該核體之 間容易因過大的脊椎運動或磨耗變薄而導致彼此脫位。 201130459 另外，亦有US7465317號美國專利，以及台灣第 577318號專利案所揭露之人工椎間盤結構等前案，不論上 述那一習用創作，其在植入人體脊椎之間時，因為受限於 單一的結構型態，必須由人體的前方植入，然而此種方式 不僅安全性低且難度高，因此如何設計出結構精巧，符合 安全植入需求之人工椎間盤，便成為本案發明人思及之方 向。 有鑑於此，本發明人乃針對前述習用創作問題深入探 討，並藉由多年從事相關產業之研發與製造經驗，積極尋 求解決之道，經過長期努力之研究與發展，終於成功的開 發出本發明『人工脊椎植入物』，以改善習用創作之問題。 【發明内容】 本發明之主要目的，在於解決上述的問題而提供一種 人工脊椎植入物之改良，其係令人工椎間盤的組成能有利 於安全性高的植入手術的進行，同時本發明之人工脊椎植 入物結構的設計，亦能使人工椎間盤的受力作動更能達到 穩定順暢且具彈性緩衝之效能者。 本發明之一主要特徵為提供一種人工脊椎植入物，包 括：一上定位部，包括一定位板體；一下定位部，包括一 定位板體，其與該上定位部之定位板體平行對稱；及一彈 性部，包括二對向彎折成型之彈性件，其位於該上定位部 與該下定位部之間且各該彈性件之二端係分別固定於該二 定位板體。 本發明之另一主要特徵為提供一種人工脊椎植入 物，包括：一上定位部，包括一定位板體，該定位板體外 201130459 表面凸設複數個錐尖體；一下定位部，包括一定位板體， 其與該上定位部之定位板體平行對稱且其外表面凸設複數 個錐尖體；及至少一彈性部，在該二定位板體之間，各該 彈性部包括二彈性件，各彈性件之相對上下二腳位呈θ夾 角，二夾角θ係相對設置，且在該夾角θ處具有一樞轴， 再利用該腳位之末端結合、固設於該等定位板體之内表面 處，進而利用該上及下定位部之錐尖體裝刺進裝設部位内 層作為固定之手段。 ® 藉此，利用二個或二個以上之植入物組成人工椎間盤之 結構設計，令人工椎間盤能以安全性的手法植入脊椎與脊 椎之間，再透過上及下定位部及彈性部之樞軸部位產生減 緩、吸收震動之彈性力，令其受力作動更為穩定、順暢。 有關本發明所採用之技術、手段及其功效，茲舉一較 佳實施例並配合圖式詳細說明於後，相信本發明上述之目 的、構造及特徵，當可由之得一深入而具體的暸解。 【實施方式】 φ 請先參閱圖2〜圖5所示，其顯示根據本發明第一實 施例的人工脊椎植入物（1 )，其係概呈框架彈性體狀，且 其材質為欽合金，其包括一上定位部（1 0A)，一下定位 部（1 0 B )，及一彈性部（3 0 A )，其中： 該上、下定位部（10A，10B)，係各包括一定位 板體（1 1 )且呈對稱平行狀，於各該定位板體（1 1 ) 外表面凸設有複數個錐尖體（1 2 )。 該彈性部（3 0 A )，係由二對向彎折之彈性件（3 1 A、3 1 B)所組成，各該彈性件（3 1 A、3 1 B)係 201130459 屬鈦合金線材彎折構造，且其係經由捲繞彎折成型 角的彈性構造，而且二炎角θ係相對設置的。各 2) =、3 1 Β)之上下二侧為相對稱之腳位 ⑴），於各該彈性件（31Α、3 1Β)之中段 形成-樞軸（3 3 )。而該彈性件（3 稱之腳位（32)係與另4性件（31^之1；；= 對稱之腳位（3 2)對向結合，且該等腳位（3 係固定於二該定位板體（1 1)内表面，而令該上、下-= 〇Α’1〇Β)及彈性部(…)結合成-體 請再參閱圖4及圖5所示，本發明以該二植人物 構成人工推間盤時，係令該二植入物（工）由人體後方二 Ζ依序植人—㈣椎體之間，如此不僅能在進行植入手術 ’避開主要神經組織’且能夠提供均衡而穩定的脊椎支撐 效果’即本發明能透過該彈性部（3 0Α)吸收上下及扭 轉之作用力者。 η。如圖6所不，有關該彈性部（3 〇 Α )亦係可設計為 早4折成型有-夾角0為銳角的彈性件（3 1 Β)，戍者 如圖7所示，有關該彈性部（3 〇Α)亦係可設計為二圈 形彈簧，而藉以吸收上下及扭轉之作用力者。 一清參閱圖8〜圖1 2 ’係本發明第二實施例，其與第 一實施例之差異在於彈性部（3 〇 Β)之彈性件（3丄C、 3 1 D )構化’即第二實施例之彈性部（3 〇 b)係由複 數個分離且平行的彈性件（3 1 C、3 ! D )所對向組成。 各該彈f生件（3 1 C、3 1D)係中段位置捲繞一圈後形 201130459 成樞轴（3 3 )’使其上、下二端橫設有相對且具有夹角 θ為銳角之腳位（3 2)構造，而各該彈性件（3 1 C、 f 1D)之夾角θ係相對設置。於各該腳位（3 2)末端 f折、、，。σ & ( 3 2 1 )，再利用各該結合段（3 2丄）與 該士下疋位σΡ ( 1 0 A、1 〇 B )之定位板體（1 1 ) 内表面固定結合。 如此，如圖1]、圖, _ 依序植入二節脊椎體之=:全同：二/八物(1) •^间杈供女全的植入手術，以及提 供均衡而穩定的支擇效果。 士杳再者，請參閱圖1 3、圖1 4，係本發明第三實施例， 本實施例的彈性部（3 〇 c)之彈性件（3工e、3⑴ 分別由一彈性板材所一體彎折捲繞而成，其包括各側具 目對:腳位（32)’其二相對腳位（32)的失角β 角”及位於該二相對腳位（3 2 )間之捲繞形㈣ )’ m腳位（3 2)間係延伸接設一結合段 (3 2 1 )。㈣位於上下端之結合段（ 下定位部⑴a、10b)之定位板體（⑴表上 固定結合。 j 卸 再者’請參閱圖丄5、圖工6，係本發明第四實施例， ^，例的彈性部（3〇D)在結構設計上係因應當人工 植入物尺寸較大時，則該彈性部（3〇D)亦可由複數组 (至少2組）分離且平行之彈性部（3 〇 C)所組成，藉 定位部（1〇A、1〇B)之二該定位板‘ ::複數組彈性部（3。c)，以期增加人工 含椎植人物（1 )整體結構㈣，及增進其❹效能者 201130459 據此，由於本發明之植入物之彈性部係由二側呈對稱 之彈性線材或單一彈性板材所組成，且其係組設於該二定 位部之間，因此該植入物能吸收及承受大幅度的震動力 量，而當本發明藉由植入二對稱之該植入物以作為人工椎 間盤時，則該人工脊椎植入物能平衡及穩定的承受脊椎支 撐壓力者。 綜上所述，本發明在同類產品中實有其極佳之進步性 ，同時遍查國内外關於此類結構之技術資料、文獻中亦未 發現有相同的構造，是以，本發明實已具備發明專利要件 ，爰依法提出申請。上述實施例，僅用以舉例說明本發明 ，據以在不離本發明精神之範圍，熟習此項技藝者憑之而 作之各種變形、修飾與應用，均應包括於本發明之範疇者 【圖式簡單說明】 圖1 .係習知專利案之立體分解圖。 圖2:係本發明第一實施例之側視圖。 圖3 :係本發明第一實施例之前視圖。 圖4 :係本發明第一實施例植入二節脊椎骨間之側視示 意圖。 圖5 :係本發明第一實施例植入二節脊椎骨間之前視示 意圖。 圖6 :其係顯示該彈性部為單一彎折成型之彈性件。 圖7 :其係顯示該彈性部為一圈形彈簣元件。 201130459 圖8 :係本發明第二實施例之立體外觀圖。 圖9 :係本發明第二實施例之側視圖。 圖10:係本發明第二實施例之前視圖。 圖1 1 .係本發明第二實施例植入二郎脊椎骨間之前視示 意圖。 圖12:係本發明第二實施例植入二節脊椎骨間之側視示 意圖。 圖13:係本發明第三實施例之側視圖。 鲁 圖1 4 :係本發明第三實施例之χ-χ剖面圖。 圖15:係本發明第四實施例之側視圖。 圖1 6 :係本發明第四實施例之γ-γ剖面圖。 【主要元件符號說明】 植入物：（1 ) 上定位部：（1 〇 A ) 下定位部：（1 〇 B ) φ 定位板體：（11) 錐尖體：（1 2 ) 彈性部：（3 〇 a) 彈性部：（3 〇 B ) 彈性部：（3 〇 C) 彈性部：（3 〇 D ) 彈性件（3 1 A、3 1 B) 彈性件（3 1 C、3 1D) 彈性件（3 1 E、3 1 F) 201130459 腳位：（3 2 ) 結合段：（3 2 1 ) 極轴·（ 3 3 )201130459 VI. Description of the Invention: TECHNICAL FIELD OF THE INVENTION The present invention is in the field of artificial implants, and in particular, an invention for improving the implant structure of the intervertebral disc. [Prior Art] According to the Vertebra, there is also a spine (Spine), which is mainly used to support the body's upright trunk. It is classified in terms of structure. It consists of a total of seven cervical vertebrae from top to bottom (Cervicai). Vertebrae), twelve thoracic vertebrae, five lumbar vertebrae, sacrum and caudal bone (c〇ccyx), which support the body and protect the spinal cord, between the sections The intervertebral disc Untei^vertebral disc) is used for cushioning, and the intervertebral disc provides the function of spinal suspension and bending. In many clinical cases, it can be known that the spine itself is damaged and the chance of developing lesions is quite high. Therefore, many different types of spinal internal fixators have been developed at home and abroad. 'When the spine is injured by falls or other factors' The spinal internal fixator can be implanted into the spine side of the human body by surgery, and the patient can be provided with appropriate support. Although the patient cannot jump like a normal person after installing the fixer, the problem has been solved. The problem of having to stay in bed for a long time after an early spinal injury is a major advancement in surgical medicine and a great boon for the patient. However, for some patients with degeneration or damage of the intervertebral disc, the spinal fixator can not completely solve the problem of the patient, because the intervertebral disc lesion of the lumbar intervertebral disc is a common type of spinal lesion, and when the intervertebral disc is flattened, it will make 201130459 The spinal canal narrows and compresses the nerve. Although the installation of the conventional spinal fixator provides a supporting force for the patient's spine, the rigid fixed structure after the operation actually destroys the activity of the human spine as a whole, often failing. Completely solve the pain and inconvenience of the patient. In recent years, artificial discs have begun clinical use to treat Degenerative Disc Disease. The artificial intervertebral discs currently available on the market are available in a water-resistant type, an elastic type, an Elastic type, a Hydrostatic type, and a worn type. Such artificial intervertebral discs can not only achieve the therapeutic purpose of reconstructing the height of the collapsed intervertebral disc, but also can reduce the activity of the intervertebral disc in the treated area. For the prior art, please refer to the first figure. The composition of a conventional artificial intervertebral disc includes an upper disc, a lower disc and a core body. The top and bottom of the core body respectively have a spherical convex portion for respectively Contact the groove at the bottom of the upper plate and the groove at the top of the lower plate. The top surface of the upper disc and the bottom of the lower disc are respectively provided with teeth to be embedded in the adjacent vertebrae to increase the stability of the artificial intervertebral disc. Since the top and bottom of the core body and the top of the upper plate and the top of the lower plate are respectively in contact with the near spherical joint, there is a motion mode of buckling, stretching, side bending and twisting, but at the top of the core body. There is no restriction mechanism between the bottom of the upper plate and the bottom of the core body and the top of the lower plate, so that the upper plate and the lower plate cannot be effectively restrained from excessive buckling and side bending. a spinal motion mode, and between the bottom of the upper disc and the top of the core, and between the top of the lower disc and the bottom of the core without any stop structure, between the upper and lower discs and the core It is easy to dislocate each other due to excessive spine movement or thinning of wear. 201130459 In addition, there are also US7465317 US patents, as well as the artificial disc structure disclosed in Taiwan No. 577318 patent, regardless of the above-mentioned practical creation, when it is implanted between the human spine, because it is limited to a single The structure type must be implanted in front of the human body. However, this method is not only safe and difficult, so how to design an artificial intervertebral disc with delicate structure and meeting the requirements of safe implantation has become the direction of the inventor of this case. In view of this, the present inventors have intensively discussed the above-mentioned conventional creation problems, and actively pursued solutions through years of experience in research and development and manufacturing of related industries. After long-term efforts in research and development, the present invention has finally succeeded in developing the present invention. "Artificial Spine Implants" to improve the problem of custom creation. SUMMARY OF THE INVENTION The main object of the present invention is to solve the above problems and provide an improvement of an artificial spinal implant, which is capable of facilitating the implantation of a high-safety implant, and the present invention The design of the artificial spinal implant structure can also make the force of the artificial intervertebral disc more stable and smooth and flexible. A main feature of the present invention is to provide an artificial spinal implant, comprising: an upper positioning portion, comprising a positioning plate body; and a lower positioning portion comprising a positioning plate body parallel to the positioning plate body of the upper positioning portion And an elastic portion, comprising two oppositely bent elastic members, located between the upper positioning portion and the lower positioning portion, and the two ends of each of the elastic members are respectively fixed to the two positioning plate bodies. Another main feature of the present invention is to provide an artificial spinal implant, comprising: an upper positioning portion, comprising a positioning plate body, the surface of the positioning plate outside the 201130459 surface is provided with a plurality of cone-shaped tips; the lower positioning portion includes a positioning a plate body, which is parallel to the positioning plate body of the upper positioning portion and has a plurality of tapered tip bodies protruding from the outer surface thereof; and at least one elastic portion, wherein the elastic portion includes two elastic members between the two positioning plate bodies The upper and lower legs of each elastic member are at an angle θ, and the two angles θ are oppositely disposed, and have a pivot at the angle θ, and then the end of the foot is combined and fixed on the positioning plate body. At the inner surface, the inner layer of the mounting portion is used as a means for fixing by the cone-shaped body of the upper and lower positioning portions. ® By using two or more implants to form the structure of the artificial intervertebral disc, the intervertebral disc can be implanted between the spine and the spine in a safe manner, and then through the upper and lower positioning portions and the elastic portion. The pivot part generates an elastic force that slows down and absorbs vibration, making it more stable and smooth. The above-mentioned objects, structures and features of the present invention will be described in detail with reference to the preferred embodiments of the present invention. . [Embodiment] φ Please refer to FIG. 2 to FIG. 5, which shows an artificial spinal implant (1) according to a first embodiment of the present invention, which is generally in the form of a frame elastic body, and is made of a plastic alloy. The utility model comprises an upper positioning portion (10A), a lower positioning portion (10B), and an elastic portion (30A), wherein: the upper and lower positioning portions (10A, 10B) each comprise a positioning The plate body (1 1 ) is symmetrically parallel, and a plurality of cone-shaped tip bodies (1 2 ) are protruded from the outer surface of each of the positioning plate bodies (1 1 ). The elastic portion (30A) is composed of two oppositely bent elastic members (3 1 A, 3 1 B), and each of the elastic members (3 1 A, 3 1 B) is a titanium alloy wire of 201130459 The bent structure is formed by winding an elastic structure of a bending forming angle, and the diurnal angle θ is relatively disposed. Each of the 2) =, 3 1 Β) upper and lower sides is a symmetrical relative position (1)), and a pivot (3 3 ) is formed in each of the elastic members (31Α, 3 1Β). The elastic member (3) is said to be in the opposite direction to the other four members (31^1;; = symmetrical feet (3 2), and the three positions are fixed in two The inner surface of the positioning plate body (11), and the upper and lower portions of the upper and lower portions are combined with the elastic portion (...). Referring to FIG. 4 and FIG. 5, the present invention When the two implanted characters constitute the artificial pusher disc, the two implants (workers) are implanted sequentially from the rear of the human body—(4) between the vertebral bodies, so that not only can the implant be performed to avoid the main nerve The tissue 'is capable of providing a balanced and stable spinal support effect', that is, the present invention can absorb the forces of up and down and torsion through the elastic portion (30°). η. As shown in Fig. 6, the elastic portion (3 〇Α) It can also be designed to be formed by an elastic member (3 1 Β) with an acute angle of 0. The latter is also shown in Figure 7. The elastic part (3 〇Α) can also be designed as a two-ring shape. a spring, which absorbs the forces of up and down and twisting. See Figure 8 to Figure 1 2 for a second embodiment of the present invention, which differs from the first embodiment in the elastic portion (3). The elastic member (3丄C, 3 1 D ) of the Β), that is, the elastic portion (3 〇b) of the second embodiment is composed of a plurality of separate and parallel elastic members (3 1 C, 3 ! D ) The composition of the opposite direction. Each of the bullets (3 1 C, 3 1D) is wound in a middle position and the shape is 201130459. The pivot (3 3 )' is placed on the upper and lower ends to be opposite and has a clamp. The angle θ is an acute angle (3 2) structure, and the angle θ of each of the elastic members (3 1 C, f 1D) is oppositely disposed. At each end of the foot (32), f is folded, and σ & ( 3 2 1 ), and then the combined surface (3 2 丄) is fixedly coupled with the inner surface of the positioning plate body (1 1 ) of the lower 疋 Ρ Ρ ( 1 0 A, 1 〇 B ). As shown in Figure 1], Figure, _ sequentially implanted two vertebral bodies =: Identical: two / eight things (1) • ^ between the female implant surgery, and provide a balanced and stable selection effect Further, referring to FIG. 13 and FIG. 14 , in the third embodiment of the present invention, the elastic members (3 e c) of the elastic portion (3 〇 c) of the present embodiment are respectively made of an elastic plate material. The whole body is bent and wound, which includes the opposite sides: the foot position (3 2) 'the two opposite angles (32) of the angle of deviation β angle" and the winding shape between the two opposite feet (3 2) (4)) 'm feet (3 2) between the extensions and a combination Section (3 2 1 ). (4) Positioning plate body at the upper and lower end joint sections (lower positioning parts (1)a, 10b) ((1) fixed joint on the table. j Unloader's please refer to Figure 5, Figure 6 According to the fourth embodiment of the present invention, the elastic portion (3〇D) of the example is structurally designed because the size of the artificial implant should be large, and the elastic portion (3〇D) can also be composed of multiple arrays (at least 2 groups). Separate and parallel elastic parts (3 〇 C), by the positioning part (1〇A, 1〇B) two of the positioning plate ' :: complex array elastic part (3. c), in order to increase the artificial structure of the artificially implanted person (1) (4), and to improve the performance of the cockroach 201130459 Accordingly, since the elastic portion of the implant of the present invention is symmetrical elastic wire or single elastic plate on both sides The composition is assembled between the two positioning portions, so that the implant can absorb and withstand a large amount of vibration force, and the present invention is used as an artificial intervertebral disc by implanting the two symmetric implants. At this time, the artificial spinal implant can balance and stably withstand the pressure of the spinal support. In summary, the present invention has excellent progress in similar products, and at the same time, the technical materials of such structures at home and abroad are not investigated, and the same structure is not found in the literature. Have the invention patent requirements, and apply in accordance with the law. The above embodiments are intended to be illustrative of the present invention, and various modifications, adaptations and applications may be made by those skilled in the art without departing from the scope of the invention. Brief description of the formula] Figure 1. A perspective exploded view of a conventional patent case. Figure 2 is a side view of a first embodiment of the present invention. Figure 3 is a front elevational view of a first embodiment of the present invention. Figure 4 is a side elevational view of the first embodiment of the present invention implanted between two vertebrae. Fig. 5 is a front view of the first embodiment of the present invention implanted between two vertebrae. Figure 6: It shows that the elastic portion is a single bent and formed elastic member. Figure 7: It shows that the elastic portion is a loop-shaped magazine element. 201130459 Figure 8 is a perspective view of a second embodiment of the present invention. Figure 9 is a side view of a second embodiment of the present invention. Figure 10 is a front elevational view of a second embodiment of the present invention. Fig. 11 is a front view of the second embodiment of the present invention implanted between the Erlang vertebrae. Figure 12 is a side elevational view of the second embodiment of the present invention implanted between two vertebrae. Figure 13 is a side view showing a third embodiment of the present invention. Lutu Figure 14 is a cross-sectional view of the χ-χ of the third embodiment of the present invention. Figure 15 is a side view showing a fourth embodiment of the present invention. Figure 16 is a cross-sectional view of γ-γ of the fourth embodiment of the present invention. [Main component symbol description] Implant: (1) Upper positioning part: (1 〇A) Lower positioning part: (1 〇B) φ Positioning plate body: (11) Cone tip body: (1 2 ) Elastic part: (3 〇a) Elastic part: (3 〇B) Elastic part: (3 〇C) Elastic part: (3 〇D) Elastic part (3 1 A, 3 1 B) Elastic part (3 1 C, 3 1D) Elastic parts (3 1 E, 3 1 F) 201130459 Pin position: (3 2 ) Bonding section: (3 2 1 ) Polar axis · ( 3 3 )