201004600 九、發明說明： 【發明所屬之技術領域】 特別是指-種骨釘的 本發明是有關於一種製造方法 製造方法® 【先前技術】201004600 IX. Description of the invention: [Technical field to which the invention pertains] In particular, the present invention relates to a manufacturing method. Manufacturing method® [Prior Art]
^骨科手術中使用的植人物（―般稱為骨釘）型態相 泛，參閱圖1 ’即為一種骨釘的型態，其具有—頭部11、 一自該頭部11延伸出之桿身部12，其製造方法多是利【用^ 械切削出如圖1所示般外型概呈一錐狀的頭部11，且詨-部11上具有一用於供手術器械接合以驅動該頭部 身部12轉動的凹槽lu，該料部12是呈_圓桿狀且Z 具有同樣由機械切削加工所形成的螺紋121，而頭部I】 凹槽111的製作方式H制鑽孔的方式在該頭部u ^ 鑽出一内孔，接著再利用沖壓的方式製出—六角凹槽 總結上述，運用此種傳統方式製作出的習知骨釘，其 骨釘頭部11外形由切削加工方式製造而成，該頭部u之凹 槽ill因先前經過鑽孔的加工步驟，故頭部u内凹槽^ 底面有明顯在鑽孔過程中留下之尖銳特徵。 目前骨釘於植入患者之骨頭内的方式，是由醫療人員 手持手術H械並將其套人該骨釘之頭部U或***於 該骨釘頭部11之凹槽111以旋轉施力，此時’該骨釘之結 構本身需有足夠強度以抵抗植入時的扭力；在植入患者體 内後，沿著骨釘縱軸要承受垂直於縱轴之反覆應力，而骨 釘在承受疲勞應力時，臨床上常見之問題為該骨釘之頭部 5 201004600 ::二桿身部12交接之幾何不連續處容易斷裂，而斷裂後該 二#12及不易取出’徒增加醫師困擾並影響病人術後治 療結果。 此外，習知骨釘之頭部u經過鑽孔後，會在該凹槽 111底端形成明顯的尖銳特徵，而造成該頭部u的實體體 積較少㈤槽m較深），並直接影響其結構強度，使其抗疲 勞強度降低，同樣會增加骨釘容易在其頭部u與桿身部η 之接合處產生疲勞破壞的機率。^ The image of the implanted person ("commonly called bone nail" type used in orthopedic surgery, see Figure 1 ' is a type of bone nail, which has a head 11 extending from the head 11 The shaft portion 12 is manufactured by a method of cutting a head portion 11 having a tapered shape as shown in FIG. 1 and having a head portion 11 for engaging a surgical instrument. a groove lu for driving the rotation of the head portion 12, the material portion 12 is in the shape of a round rod and Z has a thread 121 which is also formed by mechanical cutting, and the head portion I] is formed by the groove 111 The way of drilling is to drill an inner hole in the head u ^, and then to make a hexagonal groove by means of stamping. The above-mentioned conventional nails are manufactured by using the conventional method, and the nail head 11 is The shape is manufactured by cutting, and the groove ill of the head u is subjected to the processing step of the previous drilling, so that the bottom surface of the groove u in the head u has sharp features which are left in the drilling process. At present, the nail is implanted into the bone of the patient by the medical personnel holding the surgical H-arm and inserting the head U of the nail or the groove 111 of the nail head 11 to rotate the force. At this time, the structure of the nail itself needs to have sufficient strength to resist the torsion during implantation; after implantation in the patient, the longitudinal axis along the longitudinal axis of the nail is subjected to the repetitive stress perpendicular to the longitudinal axis, and the nail is When suffering from fatigue stress, the common problem in the clinic is that the head of the nail is 5 201004600: the geometric discontinuity of the intersection of the two shafts 12 is easy to break, and after the fracture, the second #12 is not easy to take out. And affect the patient's postoperative treatment results. In addition, after the hole u of the conventional nail is drilled, a sharp sharp feature is formed at the bottom end of the groove 111, and the physical volume of the head u is less (5) the groove m is deeper, and directly affects Its structural strength reduces its fatigue strength, which also increases the probability that the nail will easily cause fatigue damage at the joint between the head u and the shaft η.
【發明内容】 因此’本發明之目的，即在提供一種藉由锻造來達到 較佳之機械性質的骨釘製造方法。 於是，本發明之骨針之製造方法，依序包含一備製步 驟、一鍛造步驟，及一加工步驟。 該備製步驟係先製出一塊狀金屬以供使用。 該鍛造步驟係對該塊狀金屬進行擠壓並成型出一初胚 ，該初胚包括一具有鍛流線之頭部，及一自該頭部延伸出 之桿身部。 ❹ 該加工步驟是對該初胚之頭部及桿身部進行加工處理 本發明之功效在於，利用該鍛造步驟中強迫使該塊狀 金屬塑性變形，使該金屬材料在變形後能夠具有連續之晶 粒流向（即鍛流線），因而可改善晶粒組織，使材質細密化、 均質化’並獲得優良的抗疲勞性、韌性及耐衝擊性等機械 性質。 6 201004600 【實施方式】 有關本發明之前述及其他技術内容、特點與功效，在 以下配合參考圖式之二個較佳實施例的詳細說明中，將可 清楚的呈現。 在本發明被詳細描述之前，要注意的是，在以下的說 明中’類似的元件是以相同的編號來表示。 參閱圖2、3,並配合參閱圖4,本發明骨釘之製造方 ❹ 法之第較佳實施例，包含一備製步驟2、一鍛造步驟3、 —加工步驟4、一表面處理步驟5，及一清洗步驟6。 首先進行該備製步驟2，是製出一圓柱形之金屬塊體以 供後續製程使用’在本實施例中，是採用生醫用鈦合金（鈦 6鋁4釩，Ti_6A1_4v)以作為該塊狀金屬之材料但也可為 其他種類之金屬或等效材質，例如生醫用純鈦、不鏽鋼， 或是鈷-鉻-鉬合金等，並不侷限於本實施例所揭露之特定 材質。 • #著進行該鍛造步驟3,係利用三模三沖之鍛造機具以 對該塊狀金屬進行沖壓，以使該塊狀金屬產生塑性變形並 成型出一初胚。該初胚具有一頭部3卜及-自該頭部31延 伸=之杯身部32 ’該頭部31具有-可供骨科手術器械接合 之八角形凹槽311，使醫療人員可利用該手術器械來驅動該 頭部轉動，進而連動該該桿身部32植人患者之骨頭内 ’在此要注意的是’該凹槽311是藉由锻頭（heading)之方式 以在該頭部31上形成該凹槽3U，且該凹槽311之形狀可 因不同型態之沖頭而改變，例如本實施例是採用六角形沖 7 201004600 頭以製出六角形凹槽3U，但也可採用四角形、梅花形等形 狀的沖頭以製出相對應形狀之凹槽311，以供不同型態之骨 科手術器械使用。 ~ ^ 此外，在本實施例中，僅是以三模三沖之鍛造機具作 為成形設備，但也可為其他種類之鍛造機具，端視實際實 施時的需求而定，並不應侷限於本實施例之說明。 值得注意的是，在本實施例中的該鍛造步驟3中，所 有用於執行沖Μ之鍛造機具在業界中已為相當習知的設備 ’以及利用模具來沖壓成型出所需要的形狀之專門技術， 應為所屬技術領域中具有通常知識者所熟知的，在此即不 對鍛造機具及模具的詳細構造與工作原理進行贅述。 接著進行該加工步驟4,是對該初胚之頭部31及桿^ 部32進行加工處理，例如決定該桿身部32或頭部31是今 /月或八有螺紋、#身部32之底端為鈍態或尖銳等態樣，名 本實施例中是在該桿身冑32上加工出螺紋321，並成型办 工出如圖4所示般之特定型態的頭部Μ，以配合一骨相 100使用。 要注意的是，骨科手術中所使用的骨釘型態相當多， 但所屬技術領域中具有通常知識者，應能視該骨釘是要應 用於患者之特定㈣，或是搭配特定骨科植人物使用，以 應用上述之製造方法來製出所需要的骨釘，例如，於加工 步驟4中，僅在該桿身部32之局部表面上加工出螺紋321 等。 參閱圖5，即為配合-脊椎橋正器之固定座綱使用的 201004600 骨釘。 接著進行一表面處理步驟5,該表面處理步驟5是對該 成品之表面進行表面處理以改變其特性。例如常見的霧化 處理：使用喷砂製程使骨釘成品之表面霧化，而成品進行 霧化處理的功效在於，當在手術中使用該骨釘成品時，霧 化之表面特性才不會大量反射出因手術燈照明所產生的刺 眼反光，反光會導致手術人員於手術過程中操作的不便性 增加，因此霧化之表面不會有令臨床人員感到刺眼的反光 現象產生。或例如對成品進行發色處理，進而使成品表面 產生顏色，不同顏色之成品也易於讓使用人員分辨。簡士 之’進行表面處理的方式有相當多，必需視所選用之骨釘 用途來決定最適合之表面處理方式，以改變醫療器材金屬 成品的表面特性，而此技術應為所屬技術領域中具有通常 知識者所了解的，在此即不贅述。 最後進行該清洗步驟6 ’是利用酸、驗清洗液交互地對 加工後之成品進行清洗，以將製造時之油污洗淨，之後再 利用RO純水將清洗液清洗乾淨後烘乾，清洗烘乾後之成品 表面乾淨無菌，以達手術用醫療器材使用上的要求。 參閱圖6,為本發明骨釘之製造方法的第二較佳實施例 ，該第二較佳實施例大致上是與該第—較佳實施例相同， 相同之處不再贅言’其中不相同之處在於：在該加工步驟4 中’是對該桿身部32進行表面研磨以使其具有平滑之表面 〇 藉由上述結合鍛造之製程，本發明骨釘之製造方法， 9 201004600 確實較以往的骨釘製造方式，具有下列優點： 1. 優良的抗疲勞性、韌性及耐衝擊性等機械性質： 藉由鍛造之製造方式，使該骨釘在鍛壓過程中 是藉由鍛造機具強迫該材料塑性變形，使材料有連 續之晶粒流向，因而可改善晶粒組織，使材質細密 化、均質化，並獲得較佳之機械性質，進而使其結 構強度以及臨床耐用性更佳。 2. 改善習知骨釘之頭部31與桿身部32之接合處容易 斷裂之問題： 參 由於該骨釘頭部31之凹槽311同樣是在該鍛造 步驟3中直接藉由該鍛造機具之沖壓所形成，不是 如習知般需要先在該頭部上進行鑽孔，才能進行凹 槽311沖壓作業，因此，本發明之骨釘的頭部31不 僅不會受到鑽孔時對該頭部31結構強度的破壞也 不會如習知般在經過鑽孔後，會使凹槽311底端形 成明顯的尖銳特徵，也就是說，本發明之凹槽3U 的深度較淺，故該頭部31與該桿身部32接合之部© 分即會有較大的實體體積，進而相對增加骨釘之頭 部31的強度，降低骨釘可能於該頭部31與桿身部 32之連接處斷裂的機率。 3·製程簡化並減少廢料： 本發明利用鍛造之方式製造該骨釘，由於該初 胚的淨外形已趨近於最終產品的外形，相較於習知 的製作方式，即能夠有效減少後續加工的繁瑣程序 10 201004600 ，又因切削加工會產生廢料，然鍛造製程能有效減 少廢料的產生’以降低成本，提升利潤。 4.成品骨釘臨床實用性高： 本發明之骨釘除了結構強度高之外，更可藉由 該表面處理步驟5而使得骨釘成品之表面具有特殊 表面特性，如霧化、發色的效果，增加醫療手術人 員於手術過程中的便利性。 歸納上述，本發明之骨釘之製造方法，利用該鍛造步 驟3中對該塊狀金屬進行鍛造，以形成該骨釘之頭部31， 使骨釘成品具有優良的抗疲勞性、韌性及耐衝擊性等機械 性質’且該頭部31之凹槽311同樣是藉由鍛造所製出，有 效地改善習知骨釘之頭部31與桿身部32之接合處容易斷 裂之問題，且利用鍛造為成型方式能夠有效簡化製程並減 少廢料，有利於降低成本以提升整體利潤，故確實能達到 本發明之目的。 “惟以上所述者，僅為本發明之二個較佳實施例而已， 當不能以此限定本發明實施之範圍，即大凡依本發明申請 專利範圍及發明說明内容所作之簡單的等效變化與修飾， 皆仍屬本發明專利涵蓋之範圍内。 【圖式簡單說明】 圖1是一剖視圖，說明習知骨釘的結構； 圖2是一流程示意圖，說明本發明骨釘之製造方法之 第一較佳實施例； 圖3是一剖視圖，說明該第—較佳實施例所製出之骨 11 201004600 釘成品， 圖4是一使用狀態示意圖，约B0外贫 . 啤說明該第一較佳實施例所 製出之骨釘成品與一骨板之配合情形； 圖5是一使用狀態示意圖，說明該第—較佳實施例所 製出之骨釘成品與一脊椎矯正器之固定座的配合情形；及 圖6是一使用狀態示意圖，說明本發明骨釘之製造方 法之第二較佳實施例所製出之骨釘成品。SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a method of manufacturing a bone nail by forging to achieve better mechanical properties. Thus, the method of manufacturing a bone needle of the present invention comprises, in order, a preparation step, a forging step, and a processing step. The preparation step is to first produce a piece of metal for use. The forging step extrudes the block metal and forms an initial embryo comprising a head having a forging line and a shaft portion extending from the head. ❹ The processing step is to process the head and the shaft portion of the primordial object. The invention has the effect of forcibly deforming the block metal by the forging step, so that the metal material can have continuous after deformation. The grain flow direction (ie, the forging line) can improve the grain structure, make the material finer and homogenized, and obtain excellent mechanical properties such as fatigue resistance, toughness and impact resistance. The present invention and other technical contents, features and advantages of the present invention will be apparent from the following detailed description of the preferred embodiments of the accompanying drawings. Before the present invention is described in detail, it is noted that in the following description, similar elements are denoted by the same reference numerals. Referring to Figures 2 and 3, and with reference to Figure 4, a preferred embodiment of the method for manufacturing a bone nail of the present invention comprises a preparation step 2, a forging step 3, a processing step 4, and a surface treatment step 5. And a cleaning step 6. First, the preparation step 2 is performed to produce a cylindrical metal block for use in a subsequent process. In the present embodiment, a biomedical titanium alloy (titanium 6 aluminum 4 vanadium, Ti_6A1_4v) is used as the block. The material of the metal may be other kinds of metals or equivalent materials, such as biomedical pure titanium, stainless steel, or cobalt-chromium-molybdenum alloy, etc., and is not limited to the specific materials disclosed in the embodiment. • The forging step 3 is performed by using a three-mode three-punch forging implement to press the block metal to plastically deform the block metal and form an initial embryo. The primordial has a head 3 and a cup portion 32 extending from the head 31. The head 31 has an octagonal groove 311 for the orthopaedic surgical instrument to be engaged, so that medical personnel can use the operation. The instrument drives the head to rotate, thereby interlocking the bone portion 32 into the bone of the implanted patient. 'It should be noted here that the groove 311 is in the heading manner by the heading 31. The groove 3U is formed thereon, and the shape of the groove 311 can be changed by different types of punches. For example, in this embodiment, a hexagonal punch 7 201004600 head is used to make a hexagonal groove 3U, but it can also be used. A punch of a quadrangular shape, a plum shape or the like is formed to form a correspondingly shaped groove 311 for use in different types of orthopedic surgical instruments. In addition, in the present embodiment, only the three-mode three-punch forging implement is used as the forming apparatus, but other types of forging implements may be used, depending on the actual implementation requirements, and should not be limited to this. Description of the embodiments. It should be noted that in the forging step 3 in this embodiment, all the forging implements for performing the punching have been well-known equipment in the industry' and the expertise for stamping and forming the required shape by using a mold. It should be well known to those of ordinary skill in the art, and the detailed construction and working principle of the forging implement and the mold are not described herein. Next, the processing step 4 is performed by processing the head 31 and the rod portion 32 of the blast, for example, determining that the shaft portion 32 or the head portion 31 is a thread of the present month or eight, and the body portion 32 is The bottom end is a passive or sharp isomorphous shape. In this embodiment, a thread 321 is machined on the shaft 胄 32, and a specific type of head Μ is formed as shown in FIG. Used in conjunction with a bone phase 100. It should be noted that there are quite a few types of bone nails used in orthopedic surgery, but those with ordinary knowledge in the technical field should be able to see whether the nail is to be applied to a patient (IV) or to a specific orthopedic person. In order to produce the desired nail by applying the above-described manufacturing method, for example, in the processing step 4, the thread 321 or the like is machined only on the partial surface of the shaft portion 32. Referring to Figure 5, the 201004600 bone nail used in conjunction with the fixed seat of the spinal bridge. Next, a surface treatment step 5 is performed, which is to surface-treat the surface of the finished product to change its characteristics. For example, the common atomization treatment: the surface of the finished nail is atomized by using a sand blasting process, and the effect of the atomization treatment of the finished product is that when the finished nail is used in surgery, the surface characteristics of the atomization are not large. Reflecting the glare of the surgical light, the reflection will cause the operator to increase the inconvenience of the operation during the operation, so the surface of the atomization will not have the glare of the clinical staff. Or, for example, the finished product is subjected to a color treatment to produce a color on the surface of the finished product, and the finished product of different colors is also easy for the user to distinguish. There are quite a few ways for Jade's surface treatment. It is necessary to determine the most suitable surface treatment method depending on the nail application used to change the surface characteristics of the metal finished product of medical equipment. This technology should have the usual knowledge in the technical field. What the person knows is not repeated here. Finally, the cleaning step 6' is to use the acid and the cleaning liquid to alternately clean the processed product to wash the oil during the manufacturing process, and then clean the cleaning liquid with RO pure water, then dry and clean. The surface of the finished product is clean and sterile to meet the requirements for the use of surgical medical equipment. Referring to FIG. 6, a second preferred embodiment of the method for manufacturing a bone nail according to the present invention is substantially the same as the first preferred embodiment, and the similarities are no longer ambiguous. In the processing step 4, 'the surface of the shaft portion 32 is surface-ground to have a smooth surface, and the method for manufacturing the bone nail of the present invention by using the above-described combined forging process, 9 201004600 is indeed more conventional than The method of manufacturing the bone nail has the following advantages: 1. Excellent mechanical properties such as fatigue resistance, toughness and impact resistance: by forging manufacturing, the bone nail is forced by the forging machine during the forging process. The plastic deformation causes the material to have a continuous grain flow direction, thereby improving the grain structure, making the material finer and homogenized, and obtaining better mechanical properties, thereby further improving the structural strength and clinical durability. 2. Improving the problem that the joint between the head 31 of the conventional nail and the shaft portion 32 is easily broken: the groove 311 of the nail head 31 is also directly used in the forging step 3 by the forging implement The punching is formed, and it is not necessary to perform drilling on the head as before, so that the punching operation of the groove 311 can be performed. Therefore, the head 31 of the nail of the present invention is not only subjected to the drilling of the head. The structural strength of the portion 31 is not destroyed as is conventionally formed, and the bottom end of the groove 311 is formed into a sharp sharp feature, that is, the depth of the groove 3U of the present invention is shallow, so the head The portion of the portion 31 that is joined to the shaft portion 32 has a large physical volume, thereby relatively increasing the strength of the head portion 31 of the nail, and reducing the connection of the nail to the shaft portion 32 of the head portion 31. The probability of breaking. 3. Process simplification and reduction of waste: The invention manufactures the bone nail by means of forging. Since the net shape of the initial embryo has approached the shape of the final product, the subsequent processing can be effectively reduced compared with the conventional production method. The cumbersome procedure 10 201004600, because of the processing will produce waste, but the forging process can effectively reduce the production of waste 'to reduce costs and increase profits. 4. High clinical applicability of the finished bone nail: In addition to the high structural strength, the bone nail of the invention can further make the surface of the finished nail nail surface have special surface characteristics, such as atomization and color development, by the surface treatment step 5. The effect is to increase the convenience of medical operators during the operation. In summary, the method for manufacturing a bone nail of the present invention utilizes the forging step 3 to forge the block metal to form the head 31 of the bone nail, so that the finished nail product has excellent fatigue resistance, toughness and resistance. The mechanical property of the impact and the like, and the groove 311 of the head 31 is also produced by forging, effectively improving the problem that the joint between the head 31 of the conventional nail and the shaft portion 32 is easily broken, and utilizing Forging is a molding method which can effectively simplify the process and reduce waste, and is advantageous in reducing costs and improving overall profit, so that the object of the present invention can be achieved. The above is only the two preferred embodiments of the present invention, and the scope of the present invention is not limited thereto, that is, the simple equivalent changes made according to the scope of the present invention and the description of the invention. And the modifications are still within the scope of the present invention. [Schematic Description] FIG. 1 is a cross-sectional view showing the structure of a conventional bone nail; FIG. 2 is a schematic flow chart showing the manufacturing method of the bone nail of the present invention. FIG. 3 is a cross-sectional view showing the finished product of the bone 11 201004600 produced by the first preferred embodiment, and FIG. 4 is a schematic view of the state of use, about B0 is poor. The beer indicates the first comparison. FIG. 5 is a schematic view showing the state of use of the bone nail product and the fixed seat of a spinal orthosis according to the first embodiment of the present invention; FIG. FIG. 6 is a schematic view showing the state of use of the bone nail product produced by the second preferred embodiment of the method for manufacturing the bone nail of the present invention.
12 201004600 【主要元件符號說明】 2…… •…備製步驟 4 ......... ••加工步驟 3…… •…鍛造步驟 5 ......... ’·表面處理步驟 31 ··.·· …·頭部 6 ......... •清洗步驟 311… …·凹槽 100…… ••骨板 32·.··· •…桿身部 200…… ••脊椎矯正器之 321… …·螺紋 固定座 1312 201004600 [Explanation of main component symbols] 2... •...Preparation step 4 ......... •Processing step 3... •...Forging step 5 ......... '·Surface Processing step 31 ·······Head 6 ......... • Washing step 311... ... recess 100... ••Bone plate 32·.···•... shaft portion 200 ...... •• 321 of the spine aligner... Threaded mount 13