201121510 六、發明說明： 【發明所屬之技術領域】 本發明係關於一種人體植入物及其製造方法，詳言之， 係關於一種人工牙根植體及其製造方法。 【先前技術】 人體植入物包括人工牙根植體、骨釘等物植入人體内， 以人工牙根植體為例說明。人工牙根約分為植體 (Fixture)、支台（Abutment)、及假牙冠（Prosthetic cr〇wn)三 部分，在植入植體部分後，經測試確認骨穩固狀態已足以 負載日常生活所需之應力’即可接上支台與假牙冠，恢復 牙齒應有之功能並兼顧美觀性。 一般而言，鈦金屬植體表面處理技術可利用電漿熔射 (Plasma spray)、高溫燒結多孔塗層（P〇r〇us coating)、機械 加工或0Μ"砂酸钱處理（Sandblasting etching)能夠產生微米 級的粗糙表面。 電漿熔射HA表面處理的植體’在長期研究顯示，有表 面剝落及被骨吸收而導致失敗率過高之現象，在市場上逐 漸受質疑。電漿熔射純鈦塗層’此法缺點為無法確定電激 熔射過程中鈦粉會完全熔融，未熔融顆粒將可能剝落而停 留在鄰近淋巴結的疑慮，造成嚴重異物反應。 南溫燒結多孔塗層’此法是將純鈦小球與黏結劑現合後 製成類似膠狀液體直接黏附在欽合金基材上，在高真介傲 向溫（12 5 0 C至13 0 0 C )長時間（1〜3小時）下進行燒結，此多 孔塗層將可提供骨内長（bone ingrowth)固定方式。但是在 144991.doc 201121510 進行真空高溫燒結時，造成鈦合金之延性（dUetility)、物 性（t〇ughness)、抗疲勞強度的嚴重降低；此多孔結構除提 供骨組織生長外’·細菌也可能在孔洞内生長引起感染，同 時此人工牙根如手術失敗不易進行二次手術。201121510 VI. Description of the Invention: [Technical Field] The present invention relates to a human implant and a method of manufacturing the same, and more particularly to an artificial root implant and a method of manufacturing the same. [Prior Art] Human implants include artificial root implants, bone nails, etc., implanted in the human body, and artificial root implants are taken as an example. Artificial roots are divided into three parts: the implant, the Abutment, and the prosthetic cr〇wn. After the implant is implanted, the bone stability is tested to be sufficient for daily life. The stress can be connected to the abutment and the false crown to restore the function of the teeth and aesthetics. In general, titanium implant surface treatment technology can use plasma spray, high temperature sintered porous coating (P〇r〇us coating), mechanical processing or 0Μ"Sandblasting etching Produces a rough surface of micron order. In the long-term studies, plasma-sprayed HA surface-treated implants have been repeatedly questioned in the market due to surface peeling and bone absorption resulting in a high failure rate. Plasma sprayed pure titanium coating' The disadvantage of this method is that it is impossible to determine that the titanium powder will be completely melted during the electric spray, and the unmelted particles may peel off and remain in the adjacent lymph nodes, causing serious foreign matter reaction. South temperature sintered porous coating 'This method is to make the pure titanium pellets and the binders are made into a similar gel-like liquid and directly adhere to the Qin alloy substrate, in the high Zhenshen proud temperature (12 5 0 C to 13 0 0 C ) Sintering is carried out for a long time (1 to 3 hours), and the porous coating will provide a bone ingrowth fixation. However, when vacuum high temperature sintering is carried out at 144991.doc 201121510, the ductility (dUetility), physical properties (t〇ughness) and fatigue strength of the titanium alloy are severely reduced; in addition to providing bone tissue growth, the porous structure may also be The growth in the cavity causes infection, and the artificial root is difficult to perform a second operation if the operation fails.
嗔砂及酸㈣理’藉由同時提供㈣級與次㈣級粗繞 表面’提供骨細胞貼附與生長’在骨整合階段增加與骨接 觸面積。“前市面植體主要表面處理方法，其優點在製 程成本低，缺點在以酸財式製備次微米級㈣表面時， 酸韻殘液如何在次微米級粗i结構中，完整且確效的去 除，也面臨廢液處理環保議題。 以傳統喷砂及㈣處理之㈣牙材表面，無法成親水狀 態，需浸置於低能量化學液體中，才能呈現植牙體之親水 用上具相當 性。此方式在植牙體儲存’及醫師診療過程使 不便性。 參考美國專利公開第20060161256號，其揭示一種且有 • &感染及具生物相容性欽覆層植體及其製作方法，其所採 用之製程，乃採用有機金屬二氧化鈦前驅物，若要獲致與 基材間高附著力，須加溫至.500ta上如此會導致 人工牙根鈦合金基材機械性質之降低。 ，國專利第咖055號，其揭示一種人工牙根之改 良結構，其頸部具有極細雙螺紋，能增加與骨頭的接觸面 積执具有緊密穩固之功效，且於上端頸部係利用高拋光面 的^十，除具有極佳之抗菌功效，可避免增加感染的機會 成月吸收。然而，其僅揭示採用高抛光面的設計，並 [s] 14499 丨.doc 201121510 未有抗菌成分之導入。 因此，有必要提供一種創新且具進步性的人體植入物及 其製造方法，以解決上述問題。 【發明内容】 本發明提供一種人體植入物，包括：一底材、一第一層 金屬膜及一第二層氧化鈦鍍膜。該底材具有一表面。該第 一層金屬膜形成於該表面。該第二層氧化鈦鑛膜形成於該 第一層金屬膜上’部分第二層氧化鈦鍍膜具有奈米銀微粒 或奈米銅微粒。 本發明另^供一種人體植入物之製造方法’包括以下步 驟：（a)表面處理該人體植入物之一底材之一表面；（b)形 成一第一層金屬膜於該表面；及（c)形成一第二層氧化鈦鍍 膜於該第一層金屬膜上，部分第二層氧化鈦鍍膜具有奈米 銀微粒或奈米銅微粒。 本發明之人體植入物及其製造方法，該第二層氧化鈦鍍 膜具有高骨整合性，利於該人體植入物與細胞貼附，且該 第二層氧化鈦鍍膜經UV光照射，可產生親水性，有助於 該人體植入物植於骨頭時，組織液及骨母細胞非常容易進 入人體植入物之該第二層氧化鈦鍍膜表面之微米及奈米結 構上，有助於植入初期細胞之貼附功能。另外，奈米銀微 粒或奈米銅微粒具有極佳之抗菌功效，可避免人體植入物 植入初期因外來細菌造成感染的機會，因發炎而造成骨吸 收，甚至造成植入之失敗。本發明之人體植入物及其製造 方法可提高植入成功率。 [S] I4499l.doc 201121510 【實施方式】 參考圖1，其顯示本發明實施例人工牙根植體之立體示 意圖。參考圖2，其顯示本發明實施例人工牙根植體之螺 牙部分之各層結構示意圖。參考圖3，其顯示本發明實施 例人工牙根植體之上端頸部分之各層結構示意圖。以下利 用圖1至3說明本發明人體植入物及其製造方法。在本發明 實施例中，以人工牙根植體說明本發明之人體植入物，本 發明之人體植入物不限於人工牙根植體。 配合參考圖1及圖2，在本實施例中，本發明人工牙根植 體10包括一螺牙部分11及一上端頸部分丨2。該螺牙部分11 包括：一底材111、一第一層金屬膜112及一第二層氧化鈦 鍍膜113。該底材in具有一表面。該第一層金屬膜112形 成於該表面。該第二層氧化鈦鍍膜1丨3形成於該第一層金 屬膜112上。 。亥螺牙部分1 1之該底材1 1 1係為一金屬底材，該金屬底 材之粗度範圍為Ra 1_3 μηι。在本實施例中，係以噴砂或微 米尺寸粗化加工’表面處理該螺牙部分丨丨之金屬底材u j 之該表面。較佳地，該金屬底材之粗度範圍為Ra 15_2.5 μιη ° 在本實施例中，以真空蒸鍍或濺鍍方法，形成該第一層 金屬膜112於該螺牙部分丨丨之該金屬底材ηι之表面，該第 一層金屬膜112為鉻、鈦、鈒、錕、或酷金屬。因該第一 層金屬膜112與該金屬底材U1之親和力較強，可作為該金 屬底材111與該第二層氧化鈦鍍膜u 3之接合層，以加強第 144991.doc 201121510 二層氧化鈦鍍膜113之附著力。 在本實施例中，以真空蒸鍍或濺鍍方法，形成該第二層 氧化鈦鍍膜113於該螺牙部分u之該第一層金屬膜112上。 忒第一層氧化鈦鍍膜】丨3具有奈米結構，且係採用真空製 程藉由原子沉積過程中，利用能量控制所產生，故無殘留 化學物質之疑慮。且本發明之該第二層氧化鈦鍍膜丨13並 非利用習知濕式製程所採用酸蝕及鹼蝕方法，該習知濕式 製私在產生奈米孔洞之同時，所使用之化學酸、鹼物質， 很難保證能完整去除。 該第二層氧化鈦鍍膜丨13具有高骨整合性。較佳地該 第一層氧化鈦鍍膜113具有銳鈦礦-氧化鈦（Anatase_Ti〇2 (101))或金紅石-氧化鈦（RutUeTi〇2(11〇))相結構，該第二 層氧化鈦鍍膜113再經UV光（或太陽光）照射後，可產生親 水性，其水滴接觸角會低於5度。該親水性有助於該人工 牙根植體植於齒槽骨時’組織液及骨母細胞非常容易進入 人工牙根植體10之該第二層氧化鈦鍍膜U3表面之微米及 奈米結構上，有助於植入初期細胞之貼附功能。 由於該親水性係採用物理反應原理，非採用化學反應或 塗藥方式’該第二層氧化鈦鍍膜U3本身具高強度機械性 質’因此在植入齒槽骨過程中，不會因如化學塗藥方式其 附著植體強度不足，造成塗層剝離之問題。 配合參考圖1及圖3 ’本發明人工牙根植體1〇之上端頸部 分12包括：一底材121、一第一層金屬膜122及一第二層氧 化鈦鍍膜123。該底材121具有一表面。該第一層金屬膜 144991.doc 201121510 122形成於該表面。該第二層氧化鈦鍍膜ι23形成於該第一 層金屬膜122上。 在本實施例中，係以拋光加工，表面處理該上端頸部分 12之金屬底材121之該表面，使該金屬底材ι21之粗度範圍 為Ra 0.05-0.5 μχη。較佳地，該金屬底材之粗度範圍為Ra 0.05-0.2 μπι。 在本實施例中，以真空蒸鍍或濺鍍方法，形成該第—層 金屬膜122於該上端頸部分12之該金屬底材121之表面，該 第一層金屬膜122為鉻、鈦、釩、鈮、或锆金屬。因該第 一層金屬膜122與該金屬底材m之親和力較強，可作為該 金屬底材121與該第二層氧化鈦鍍膜123之接合層，以加強 第二層氧化鈦鍍膜123之附著力。 在本實施例中’以共蒸鍍、共濺鍍或離子植入方法，將 奈米銀微粒或奈米銅微粒125均勻摻雜於該第二層氧化鈦 鑛膜123内’形成該第二層氧化鈦鍍膜123於該上端頸部分 12之該第一層金屬膜122上。該上端頸部分之第二層氧化 鈦鍍膜之厚度為50-1000 nm。 a亥上頸部分12之第一層氧化欽錄膜123包括奈米銀微 粒或奈米銅微粒12 5，奈米銀微粒或奈米銅微粒12 5之大小 範圍為1-100 nm。較佳地’該上端頸部分12之奈米銀微粒 或奈米銅微粒125之大小範圍為1-50 nm。最佳地，該上端 頸部分12之奈米銀微粒或奈米銅微粒125之大小範圍為卜 20 nm 〇 該上端頸部分12之奈米銀微粒或奈米銅微粒125與第二 144991.doc 201121510 層氧化鈦鍍膜123之體積比範圍為〇〗·1〇%。較佳地，該上 端頸部分12之奈米銀微粒或奈米銅微粒ι25與第二層氧化 鈦鍍膜123之體積比範圍為〇_2_8%。最佳地，該上端頸部 分12之奈米銀微粒或奈米鋼微粒125與第二層氧化鈦鍍膜 123之體積比範圍為0.3-3%。 於人工牙根植體ίο之上端頸部分12，因該上端頸部位12 係與軟組織牙齦接觸，其表面具有第二層氧化鈦鍍膜 123，且具有奈米銀微粒或奈米銅微粒丨25，係為一層具高 生物相谷性及抗菌性之鍍層，該鍍層即使在不具uv光照 射下，亦有極佳之抗菌功效，可避免人工牙根植體植入初 期因外來細菌造成感染的機會，因發炎而造成骨吸收，甚 至造成植牙之失敗。 因此，本發明人體植入物及其製造方法，可應用在醫療 用人工牙根植體及其他人體或動物骨植入物，可有效提昇 植入成功率。 惟上述實施例僅為說明本發明之原理及其功效，而非限 制本心明。因此，習於此技術之人士對上述實施例進行修 改及變化仍不脫本發明之精神。本發明之權利範圍應如後 述之申请專利範圍所列。 【圖式簡單說明】 圖1顯示本發明實施例人工牙根植體之立體示意圖； 圖2顯示本發明實施例人工牙根植體之螺牙部分之各層 結構示意圖；及 圖3顯示本發明實施例人工牙根植體之上端頸部分之各 144991.doc 201121510 層結構示意圖。 【主要元件符號說明】 ίο 本發明人工牙根植體 11 螺牙部分 12 上端頸部分 111 螺牙部分之底材 112 螺牙部分之第一層金屬膜 113 螺牙部分之第二層氧化鈦鍍膜 121 上端頸部分之底材 122 上端頸部分之第一層金屬膜 123 上端頸部分之第二層氧化鈦鍍膜 125 奈米銀微粒或奈米銅微粒The shale and acid (four) rationale provide increased bone contact area during the osseointegration phase by providing both (four) and sub (four) grades of rough-wound surface 'providing bone cell attachment and growth'. “The main surface treatment method of the pre-market implants has the advantages of low process cost, and the disadvantage is that when the sub-micron (four) surface is prepared by acid and acid, how the acid residue is in the sub-micron coarse i structure, complete and effective Removal, it also faces the environmental issues of waste liquid treatment. With traditional sandblasting and (4) treatment, the surface of the tooth material cannot be made into a hydrophilic state, and it needs to be immersed in a low-energy chemical liquid in order to present the hydrophilicity of the implant body. This method is inconvenient in the storage of the implant and the medical treatment of the physician. Referring to U.S. Patent Publication No. 20060161256, it discloses an & infective and biocompatible intertwined implant and a method for making the same, The process used is the use of organometallic titanium dioxide precursors, in order to obtain high adhesion to the substrate, it must be heated to .500ta, which will lead to the reduction of the mechanical properties of the artificial titanium root titanium alloy substrate. No. 055, which discloses an improved structure of artificial roots, which has a very fine double thread on the neck, which can increase the contact area with the bone and has a tight and stable effect, and is at the upper end. The neck system utilizes a high-polished surface, in addition to having excellent antibacterial properties, it can avoid the chance of increasing infection and monthly absorption. However, it only reveals the design with high polished surface, and [s] 14499 丨.doc 201121510 There is no introduction of antibacterial ingredients. Therefore, it is necessary to provide an innovative and progressive human implant and a manufacturing method thereof to solve the above problems. SUMMARY OF THE INVENTION The present invention provides a human implant comprising: a bottom a first metal film and a second titanium oxide film. The substrate has a surface. The first metal film is formed on the surface. The second titanium oxide film is formed on the first metal layer. The portion of the second layer of titanium oxide coating on the film has nano silver particles or nano copper particles. The invention further provides a method for manufacturing a human implant comprising the following steps: (a) surface treating the human implant a surface of one of the substrates; (b) forming a first metal film on the surface; and (c) forming a second layer of titanium oxide on the first metal film, and a portion of the second titanium oxide film having Nano silver particles Or nano copper particles. The human implant of the present invention and the method of manufacturing the same, the second layer of titanium oxide coating has high osseointegration, which facilitates attachment of the human implant to cells, and the second layer of titanium oxide coating Irradiation by UV light can produce hydrophilicity, which helps the tissue fluid and osteoblasts to easily enter the micron and nanostructure of the second titanium oxide coating surface of the human implant when the human implant is implanted on the bone. It helps to implant the initial cell attachment function. In addition, nano silver particles or nano copper particles have excellent antibacterial effect, which can avoid the chance of infection caused by foreign bacteria in the initial stage of implantation of human implants. Inflammation causes bone resorption, and even causes failure of implantation. The human implant of the present invention and the method of manufacturing the same can improve the implantation success rate. [S] I4499l.doc 201121510 [Embodiment] Referring to Figure 1, the present invention is shown Example A schematic view of an artificial dental root implant. Referring to Fig. 2, there is shown a schematic view showing the structure of each layer of the screw portion of the artificial root implant of the embodiment of the present invention. Referring to Figure 3, there is shown a schematic view of the various layers of the upper neck portion of the artificial root implant of the embodiment of the present invention. The human implant of the present invention and a method of manufacturing the same will be described below with reference to Figs. In the embodiment of the present invention, the human implant of the present invention is described by an artificial dental implant, and the human implant of the present invention is not limited to the artificial root implant. Referring to Figures 1 and 2, in the present embodiment, the artificial root implant 10 of the present invention includes a threaded portion 11 and an upper neck portion 丨2. The thread portion 11 includes a substrate 111, a first metal film 112, and a second titanium oxide film 113. The substrate in has a surface. The first metal film 112 is formed on the surface. The second layer of titanium oxide plating film 1?3 is formed on the first layer metal film 112. . The substrate 1 1 1 of the Hailuo tooth portion 1 1 is a metal substrate having a thickness ranging from Ra 1_3 μηι. In the present embodiment, the surface of the metal substrate u j of the thread portion is surface-treated by sand blasting or micron size roughening. Preferably, the thickness of the metal substrate is Ra 15_2.5 μηη °. In this embodiment, the first metal film 112 is formed on the screw portion by vacuum evaporation or sputtering. The surface of the metal substrate ηι, the first metal film 112 is chromium, titanium, tantalum, niobium, or a cool metal. Because the affinity of the first metal film 112 and the metal substrate U1 is strong, it can serve as a bonding layer between the metal substrate 111 and the second titanium oxide coating u 3 to strengthen the second layer oxidation of the 144991.doc 201121510 The adhesion of the titanium coating 113. In the present embodiment, the second layer of titanium oxide plating film 113 is formed on the first layer metal film 112 of the thread portion u by vacuum evaporation or sputtering.忒The first layer of titanium oxide coating] 丨3 has a nanostructure, and is vacuum-processed by atomic deposition, using energy control, so there is no doubt about residual chemical. Moreover, the second layer of titanium oxide coating film 13 of the present invention does not utilize the acid etching and alkali etching method used in the conventional wet process, and the conventional chemical method uses the chemical acid, Alkali substances, it is difficult to guarantee complete removal. The second layer of titanium oxide coated crucible 13 has high osteointegration. Preferably, the first layer of titanium oxide coating 113 has an anatase-titanium oxide (Anatase_Ti〇2 (101)) or rutile-titanium oxide (RutUeTi〇2 (11〇)) phase structure, the second layer of titanium oxide After the coating 113 is irradiated with UV light (or sunlight), hydrophilicity is generated, and the contact angle of the water droplets is less than 5 degrees. The hydrophilicity helps the artificial root implant to be implanted in the alveolar bone. The tissue fluid and the osteoblast are very easy to enter the micron and nanostructure of the surface of the second layer of the titanium oxide coating U3 of the artificial root implant 10, Helps to attach the initial cell attachment function. Since the hydrophilicity adopts the principle of physical reaction, the chemical reaction or the application method is not used. The second layer of titanium oxide coating U3 itself has high-strength mechanical properties. Therefore, in the process of implanting the alveolar bone, it is not caused by, for example, chemical coating. The method of drug attachment is insufficient in strength, causing the problem of peeling off the coating. Referring to Figures 1 and 3, the upper end of the artificial root implant 1 of the present invention comprises a substrate 121, a first metal film 122 and a second titanium oxide film 123. The substrate 121 has a surface. The first layer of metal film 144991.doc 201121510 122 is formed on the surface. The second titanium oxide plating film ι23 is formed on the first metal film 122. In the present embodiment, the surface of the metal substrate 121 of the upper end neck portion 12 is surface-treated by a polishing process so that the thickness of the metal substrate ι 21 ranges from Ra 0.05 to 0.5 μχη. Preferably, the metal substrate has a thickness ranging from Ra 0.05 to 0.2 μm. In this embodiment, the first layer metal film 122 is formed on the surface of the metal substrate 121 of the upper end neck portion 12 by vacuum evaporation or sputtering, and the first metal film 122 is made of chromium or titanium. Vanadium, bismuth, or zirconium metal. Since the first metal film 122 has a strong affinity with the metal substrate m, it can serve as a bonding layer between the metal substrate 121 and the second titanium oxide film 123 to enhance the adhesion of the second titanium oxide film 123. force. In the present embodiment, 'nano-silver particles or nano-copper particles 125 are uniformly doped in the second-layer titanium oxide ore film 123 by co-evaporation, co-sputtering or ion implantation to form the second A layer of titanium oxide coating 123 is on the first layer of metal film 122 of the upper end neck portion 12. The second layer of titanium oxide coating on the upper neck portion has a thickness of 50-1000 nm. The first layer of the oxidation film 123 of the upper neck portion 12 includes nano silver particles or nano copper particles 12 5 , and the size of the nano silver particles or the nano copper particles 12 5 ranges from 1 to 100 nm. Preferably, the nano silver particles or the nano copper particles 125 of the upper end neck portion 12 have a size ranging from 1 to 50 nm. Preferably, the size of the nano silver particles or the nano copper particles 125 of the upper neck portion 12 is in the range of 20 nm, the nano silver particles or the nano copper particles 125 of the upper neck portion 12 and the second 144991.doc The volume ratio of the 201121510 layer of titanium oxide coating 123 is 〇··1〇%. Preferably, the volume ratio of the nano silver particles or the nano copper particles ι25 of the upper neck portion 12 to the second titanium oxide coating film 123 is in the range of 〇_2_8%. Most preferably, the volume ratio of the upper end neck portion to 12 nano silver particles or nano steel particles 125 to the second layer titanium oxide film 123 is in the range of 0.3 to 3%. The upper end neck portion 12 of the artificial root implant ίο is in contact with the soft tissue gingiva, and has a second titanium oxide coating 123 on the surface thereof, and has nano silver particles or nano copper particles 丨25, It is a layer with high bio-grain and anti-bacterial coating. This coating has excellent antibacterial effect even without UV light, which can avoid the chance of infection caused by foreign bacteria in the early stage of artificial root implant. Bone resorption due to inflammation, and even the failure of implants. Therefore, the human implant of the present invention and the method for manufacturing the same can be applied to medical artificial root implants and other human or animal bone implants, which can effectively improve the implantation success rate. However, the above-described embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to be limiting. Therefore, those skilled in the art can make modifications and changes to the above embodiments without departing from the spirit of the invention. The scope of the invention should be as set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing the artificial root implant of the embodiment of the present invention; FIG. 2 is a schematic view showing the structure of each layer of the screw portion of the artificial root implant of the embodiment of the present invention; and FIG. 3 is a view showing the artificial embodiment of the present invention. The 144991.doc 201121510 layer structure diagram of the upper neck portion of the root implant. [Main component symbol description] ίο Artificial dental implant 11 of the present invention The threaded portion 12 The upper neck portion 111 The substrate of the thread portion 112 The first layer of the metal film 113 of the thread portion The second layer of the titanium oxide film 121 of the thread portion The upper layer neck portion of the substrate 122, the upper layer of the first portion of the metal film 123, the upper portion of the neck portion of the second layer of titanium oxide coating 125 nano silver particles or nano copper particles
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