TWI682795B - The use picosecond lasers of color marking processing method at surface of the needle head - Google Patents
The use picosecond lasers of color marking processing method at surface of the needle head Download PDFInfo
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Abstract
本發明係有關針頭表面顏色標示之加工方法,係包括以下步驟:步驟一:皮秒雷射顏色標示;步驟二:切斷器切斷;步驟三:超音波酸洗去氧化皮膜;步驟四:針頭電解鈍化處理;步驟五:清洗與烘乾;步驟六:針頭與針座膠合組裝;步驟七:真空封裝與光學檢測;步驟八:滅菌處理;主要利用皮秒雷射於針頭表面上進行顏色的標示,於所述針頭的表面顏色上,分別給予不同的3種顏色標記,且3段不同顏色的中間給予2段針頭原色;藉此提供低溫加工、內應力小、表面平滑、潔淨度高、無鐵水鏽產生、抗蝕性強及排斥性低之針頭皮秒雷射表面顏色加工方法。 The invention relates to a processing method for color marking on the surface of a needle, which includes the following steps: step 1: picosecond laser color marking; step 2: cutting by a cutter; step 3: ultrasonic pickling to remove oxide film; step four: Electrolytic passivation treatment of needles; Step 5: Washing and drying; Step 6: Glue assembly of needle and needle base; Step 7: Vacuum packaging and optical inspection; Step 8: Sterilization; Mainly use picosecond laser to color the surface of the needle Mark on the surface color of the needle, respectively, and give three different color marks, and the middle of the three different colors give two segments of the primary color of the needle; thereby providing low temperature processing, low internal stress, smooth surface, high cleanliness 1. The color processing method of the laser surface of the needle skin without iron rust, strong corrosion resistance and low repulsion.
Description
本發明屬於侵入式醫療器械之一,尤指一種針對針頭表面進行皮秒雷射之顏色標示的加工方法。 The invention belongs to one of the invasive medical instruments, in particular to a processing method for marking the color of the picosecond laser on the surface of the needle.
近年來隨着微加工方式與微精密技術的進步,使得一般性醫療器械的品質大大的被提升,而加工技術也趨於簡單化,一般的針頭多為光滑的表面,沒有任何之刻度,所以操作者在進行時,很難準確的預測到針頭的所在位置與進入體組織的深度,尤其在侵入特殊的組織部位,更加易於破壞到周邊的組織部位,例如醫美治療所常進行之眼眶部位之相關醫療行為,最易造成操作者的失誤,導致臨床上的醫療糾紛發生,或是導致病人日後生活上的不便,也讓臨床之操作者內心變得在操作過程的困難與不適,而無法達到有效的醫療行為與治療效果。 In recent years, with the advancement of micro-machining methods and micro-precision technology, the quality of general medical devices has been greatly improved, and the processing technology has also tended to be simplified. The general needles are mostly smooth surfaces without any scale, so During the operation, it is difficult for the operator to accurately predict the position of the needle and the depth of entry into the body tissue, especially when invading a special tissue site, it is easier to destroy the surrounding tissue site, such as the orbital site commonly used in medical and aesthetic treatment The related medical behaviors are most likely to cause operator errors, lead to clinical medical disputes, or cause inconvenience in the patient's life in the future, but also make the clinical operator's heart become difficult and uncomfortable in the operation process. To achieve effective medical behavior and treatment effect.
因此,吾人運用本發明技術與產品,將可解決醫護人員習用之不方便性與避免臨床所易造成之缺失,再則藉由此發明技術與產品,可提供符合醫護人員所需之表面顏色之預警示針頭。 Therefore, we use the technology and products of the present invention to solve the inconvenience of medical personnel and avoid the clinically-prone defects, and then by inventing the technology and products, we can provide the surface color that meets the needs of medical personnel Early warning needle.
為了解決注射裝置在侵入體組織,不安全之深度與位置之缺點,吾人利用皮秒雷射之表面顏色加工技術,於針頭表面給予不同顏色的 安全警示加工技術;此針頭的表面上標示有不同的顏色,不同的顏色可透過人眼直接辨視侵入的深度,所以此加工後的針頭,將可給予醫護人員或是操作者預先提示或警示的功能,方便讓操作者與醫護人員準確與衡量所進入體組織部位的深度與位置。 In order to solve the shortcomings of the insecure depth and position of the injection device in invading body tissue, we used the surface color processing technology of the picosecond laser to give different colors on the surface of the needle Safety warning processing technology; the surface of the needle is marked with different colors, and the different colors can directly identify the depth of intrusion through the human eye, so the processed needle will be given to medical staff or operators for advance reminders or warnings The function is convenient for the operator and the medical staff to accurately and measure the depth and position of the body tissue part entered.
本發明之針頭可運用於各種液態藥物的輸入與檢測用之體液抽出,舉例當進行面部或口腔內部位的液態藥物輸入時,針管進入體組織深度,可依據針頭表面的顏色,進行判斷進入體組織的深度與位置,讓操作者輕鬆操作到所需要之位置,並給予注射液態藥物,從而達到準確的醫療效果與避免破壞到其他體組織。 The needle of the present invention can be applied to the input of various liquid medicines and the extraction of body fluids for detection. For example, when the liquid medicine is input to the face or the inside of the mouth, the depth of the needle tube entering the body tissue can be determined according to the color of the surface of the needle The depth and position of the tissue allows the operator to easily operate to the desired position, and gives the injection of liquid medicine, so as to achieve accurate medical results and avoid damage to other body tissues.
依上述所要解決的問題,此發明的目的乃提供了一種微型與精密的皮秒雷射的表面顏色加工方式,改良注射裝置表面沒有標示與可辨識深度的加工方法;此技術所生產之產品,將期待給予醫療人員克服出錯之心理障礙;再則為了達到此目的,本發明的加工步驟,係含:步驟一:皮秒雷射顏色標示;步驟二:切斷器切斷;步驟三:超音波酸洗去氧化皮膜;步驟四:針頭表面處理;步驟五:清洗與烘乾;步驟六:針頭與針座膠合組裝;步驟七:真空封裝與光學檢測;步驟八:滅菌處理;此發明之關鍵在利用皮秒雷射於針頭表面上進行顏色的標示,且由針尖端後退3mm的位置為開始點的第1標記位置,共給予3個小段,每小段的長度為2.5mm,再則前段顏色與後段顏色之間距離2.5mm,屬於無加工位置,其顏色為針頭原色;依發明所述針頭的表面顏色分別給予不同的3種顏色標記,且3段不同顏色的中間給予2段針頭原色;舉例第1段為綠色,代表安全區;第2段為黃色,代表警示區;第3段為紅色,代表危險區,如第2圖所示為此發明之 注射裝置的針頭表面顏色示意圖面;注射裝置乃包含針筒、活塞、推柱、針座、針頭與護套,如第3圖所示為注射裝置的示意圖;注射器之成品應用於各種液態藥物的輸入與人體檢測使用之體液抽出等。 Based on the above-mentioned problems to be solved, the purpose of this invention is to provide a miniature and precise picosecond laser surface color processing method, to improve the processing method of the surface of the injection device without marking and recognizable depth; the products produced by this technology, It will be expected to give medical staff to overcome the psychological barriers to errors; then to achieve this goal, the processing steps of the present invention include: Step 1: picosecond laser color marking; Step 2: cut off by the cutter; Step 3: super Sonic acid pickling to remove the oxide film; Step four: surface treatment of the needle; Step five: cleaning and drying; Step six: glue assembly of the needle and the needle base; Step seven: vacuum packaging and optical inspection; Step eight: sterilization treatment; this invention The key is to use the picosecond laser to mark the color on the surface of the needle, and the position of 3mm from the tip of the needle is the first mark position of the starting point. A total of 3 small segments are given, the length of each small segment is 2.5mm, and then the front segment The distance between the color and the rear color is 2.5mm, which belongs to the non-processing position, and the color is the primary color of the needle; according to the invention, the surface color of the needle is given different 3 color marks, and the middle of the 3 different colors is given 2 primary colors of the needle ; For example, the first paragraph is green, representing the safety zone; the second paragraph is yellow, representing the warning zone; the third paragraph is red, representing the danger zone, as shown in Figure 2 for this invention Schematic diagram of the color of the surface of the needle of the injection device; the injection device includes a syringe, piston, push pin, needle seat, needle and sheath, as shown in Figure 3 is a schematic diagram of the injection device; the finished product of the syringe is used for various liquid drugs Body fluid extraction used for input and human detection.
本發明乃屬於侵入性之醫療器械與加工行為,其注射裝置之功能在於液態藥物的輸入或檢測時可抽出體液,透過人眼之視覺可精確的觀察與辨識到針頭,所在深度與位置,並可避免破壞到易於受傷之體組織,讓醫療人員或操作人員的可避免失誤的發生,提供臨床上具安全性與可靠度之器材;再則表面有預警示之顏色針頭,將易於辨識與判斷針頭所在體組織深度與位置。 The present invention is an invasive medical device and processing behavior. The function of the injection device is to draw out body fluids during the input or detection of liquid drugs. The needle can be accurately observed and recognized through the vision of the human eye. It can avoid damage to the body tissue that is easy to be injured, so that medical staff or operators can avoid mistakes, and provide clinically safe and reliable equipment; in addition, the color needles with warning signs on the surface will be easy to identify and judge The depth and position of the body tissue where the needle is located.
本發明之皮秒雷射之表面顏色加工技術,係以皮秒雷射表面上色技術,其加工技術屬於低溫加工之特性,其技術乃可得到品質優良、內應力小、表面平滑、高潔淨度、高抗蝕性及低排斥性之針頭表面顏色加工方法;而吾人之發明流程,乃採用易於取得之不銹鋼原材料(如SUS304系列或SUS316系列),再則皮秒雷射為低溫加工之技術,其可製造出品質優良、價格低、內應力小、表面平滑、有明顯的鈍化邊、富鉻化層多、高淨潔性、抗蝕性強、且低排斥性之針頭表面顏色加工技術,亦符合發明專利之創新性、新穎性、進步性與可應用性所需之,足見其加工增益處。 The surface color processing technology of the picosecond laser of the present invention is based on the picosecond laser surface coloring technology. The processing technology belongs to the characteristics of low temperature processing. The technology can obtain excellent quality, small internal stress, smooth surface and high cleanliness. The method of processing the surface color of the needle with high degree of corrosion resistance, high corrosion resistance and low repulsion; our invention process uses easily available stainless steel raw materials (such as SUS304 series or SUS316 series), and then the picosecond laser is a low temperature processing technology , It can produce needle surface color processing technology with excellent quality, low price, low internal stress, smooth surface, obvious passivation edges, many chromium-rich layers, high cleanliness, strong corrosion resistance, and low repulsion. It meets the needs of innovation, novelty, progress and applicability of invention patents, which shows its processing gains.
S101‧‧‧利用皮秒雷射於一針頭表面上進行顏色的標示 S101‧‧‧Use picosecond laser to mark the color on the surface of a needle
S102‧‧‧利用切斷器切斷該針頭 S102‧‧‧Cut the needle with a cutter
S103‧‧‧利用超音波酸洗該針頭的表面,以去除該針頭表面上的氧化皮膜 S103‧‧‧Using ultrasound to pickle the surface of the needle to remove the oxide film on the surface of the needle
S104‧‧‧針對該針頭進行一表面處理 S104‧‧‧ Perform a surface treatment on the needle
S105‧‧‧清洗與烘乾該針頭 S105‧‧‧Clean and dry the needle
S106‧‧‧將該針頭與一針座相互膠合組裝成一注射裝置 S106‧‧‧The needle and a needle base are glued together to form an injection device
S107‧‧‧將該注射裝置進行真空封裝,且針對該針頭進行一光學檢測 S107‧‧‧ Vacuum package the injection device and perform an optical inspection on the needle
S108‧‧‧針對該針頭進行一滅菌處理 S108‧‧‧ Perform a sterilization treatment on the needle
第一圖:係為發明之加工方法流程方塊圖;第二圖:係為發明之顏色位置;第三圖:係為發明之注射裝置之結構示意圖; 第四圖:係為本發明技術之經皮秒雷射完成之針頭表面顏色之樣品示意圖。 The first picture: a block diagram of the invention's processing method; the second picture: the color position of the invention; the third picture: a schematic structural diagram of the injection device of the invention; The fourth picture is a sample diagram of the surface color of the needle completed by the picosecond laser of the technology of the present invention.
為利貴審查員瞭解此發明特徵、內容、優點及所能達成之功效,茲請配合此發明之圖式第1至4圖,進行相關之實施例與表達形式上之詳細說明,同時前述說明如下,並請於文中使用之圖式輔佐參閱;吾人之內文與圖示,其主旨僅為示意及輔助說明書之用,未必為本發明實施後之真實比例與精準配置,故不應就所附之流程與配置關係侷限本發明於實際實施上的專利範圍,符合先前所敘說明。 In order to facilitate your examiner to understand the features, content, advantages and achievable effects of this invention, please refer to Figures 1 to 4 of the drawings of this invention for detailed descriptions of related embodiments and expressions. , And please refer to the diagrams used in the text for assistance; my main text and illustrations are for the purpose of illustration and auxiliary instructions only, and may not be the true scale and precise configuration after the implementation of the present invention, so they should not be attached The relationship between the process and the configuration limits the patent scope of the present invention in actual implementation, and is in accordance with the descriptions previously described.
請參閱第1圖所示,為本發明之加工流程方塊圖;此發明之針頭表面顏色之加工法為最適化之實施例,此係包含之步驟:步驟一:利用皮秒雷射於一針頭表面上進行顏色的標示(S101);步驟二:利用切斷器切斷該針頭(S102);步驟三:利用超音波酸洗該針頭的表面,以去除該針頭表面上的氧化皮膜(S103);步驟四:針對該針頭進行一表面處理(S104);步驟五:清洗與烘乾該針頭(S105);步驟六:將該針頭與一針座相互膠合組裝成一注射裝置(S106);步驟七:將該注射裝置進行真空封裝,且針對該針頭進行一光學檢測(S107);步驟八:針對該針頭進行一滅菌處理(S108)。 Please refer to the first figure, which is a block diagram of the processing flow of the present invention; the processing method of the surface color of the needle of this invention is the most optimized embodiment, which includes the steps: Step 1: use a picosecond laser on a needle Mark the color on the surface (S101); Step 2: Cut the needle with a cutter (S102); Step 3: Pickle the surface of the needle with ultrasound to remove the oxide film on the surface of the needle (S103) ; Step 4: Perform a surface treatment on the needle (S104); Step 5: Wash and dry the needle (S105); Step 6: Glue the needle and a needle base to assemble an injection device (S106); Step 7 : Vacuum packaging the injection device and performing an optical inspection on the needle (S107); Step 8: Performing a sterilization process on the needle (S108).
前述之針頭1,侵入性之針頭可分為停留針與非停留針2大種;常見的針頭材料,乃經退火狀態之304系列之不銹鋼,但並不以此限制本發明,其亦可為316系列之不銹鋼與其他任何可作為針頭之材料,都屬於本發明的保護範圍;本發明所採用之材料,係以退火狀態之304系列之不銹鋼,其內部表面已完成表面研磨處理,而外表面則需經過無心研磨與拋光處理,符合國際ASTM材料標準,但並不以此限制本發明,凡是任何符合其
特性之各種材料,都屬本發明的保護範圍。
The
其中,步驟一之皮秒雷射表面顏色加工方法,此步驟係利用三維電腦繪圖(3D CAD)軟體繪製出該針頭表面3種顏色位置與尺寸之圖面;輸入皮秒雷射加工機之電腦撰寫加工路徑程式,且將路徑程式進行模擬其顏色位置之再確認,修改路徑程式的檔頭和檔尾部份,最後將設定相關彩色標示的加工條件,進行顏色標示的加工步驟。所述皮秒雷射表面顏色之加工參數的設定範圍與項目如下:(1).顏色深度h(μm),10μm±10μm,(2).速度s(mm/sec),25mm/s-125mm/s,(3).光斑大小Φ(μm),0.025mm-0.03mm,(4).光學焦距f(mm),20mm-30mm,(5).加工功率W(W),7W-19W自動調整,(6).脈沖頻率Hz(kHz),400kHz-715kHz,(7).脈衝能量w(μ)10μ-40μ,(8).脈寬B(ns),3ns-80ns,(9).3種顏色的皮秒雷射之波長λ/(nm)分別為,綠色755nm,黃色532nm-755nm與紅色532nm,(10).材料表面溫度T(℃),200℃-350℃,該針頭之管內通入恆溫液體,保持材料之加工溫度。 Among them, the first step is the picosecond laser surface color processing method, this step is to use three-dimensional computer graphics (3D CAD) software to draw the surface of the needle surface 3 color positions and dimensions; enter the picosecond laser processing machine computer Write the processing path program, and then confirm the color position of the path program, modify the file header and file end of the path program, and finally set the processing conditions of the relevant color labeling and perform the color labeling processing steps. The setting range and items of the processing parameters of the picosecond laser surface color are as follows: (1). Color depth h (μm), 10 μm ± 10 μm, (2). Speed s (mm/sec), 25mm/s-125mm /s, (3). Spot size Φ (μm), 0.025mm-0.03mm, (4). Optical focal length f (mm), 20mm-30mm, (5). Processing power W (W), 7W-19W automatic Adjustment, (6). Pulse frequency Hz (kHz), 400kHz-715kHz, (7). Pulse energy w (μ) 10μ-40μ, (8). Pulse width B (ns), 3ns-80ns, (9). The wavelengths λ/(nm) of the picosecond lasers of the three colors are: green 755nm, yellow 532nm-755nm and red 532nm, (10). Material surface temperature T (℃), 200℃-350℃, the needle Constant temperature liquid is introduced into the tube to maintain the processing temperature of the material.
步驟二乃是於皮秒雷射加工夾頭與雷射頭之前方位置(右側位置)加上切斷器,當皮秒雷射加工完該針頭表面顏色後,再利用此切斷器切斷該針頭。 The second step is to add a cutter to the position (right position) in front of the picosecond laser processing chuck and the laser head. After the picosecond laser processing the surface color of the needle, use this cutter to cut The needle.
步驟三之超音波去氧化皮膜,亦先說明為何採用此技術之原因;主因乃經皮秒雷射後,針頭表面加工表面易沾染細屑,所以吾人採用可產生高振動頻率之超音波壓強,清潔針頭之表面;超音波潔淨的過程,針頭會隨著音波做相同頻率的振動,而液體也會連續產生負壓現象,此時液體將產生拉裂之空化作用與衝擊波作用;清潔槽內的清洗液,在接受超音波振動能量後,將會產生類似正負交變的衝擊波,此過程可得到空化之 液體氣泡群,其氣泡群將侵入針頭的表面,而此氣泡會有反覆的收縮與膨脹現象,並將藏在細縫或深孔的細屑或污物清洗乾淨。本發明藉由此方式,並搭配酸洗液去除因皮秒雷射加工後,所產生之細屑或污物等。其中,步驟三之超音波去氧化皮膜之化學配方,乃為5%稀硫酸與95%去離子水混合,其操作控制溫度為25℃-30℃之間,時間控制為10-15分鐘;最後用去離子水沖洗數次與烘乾;本發明無需除油污之過程,乃因皮秒雷射加工後,表面不會產生油污之問題,所以吾人只針對去氧化皮膜部份進行加工。 The ultrasonic deoxidizing film in step 3 also explains the reason why this technology is adopted. The main reason is that after the skin laser is processed, the surface of the needle surface is prone to be contaminated with fine debris. Therefore, we use ultrasonic pressure that can generate high vibration frequencies. Clean the surface of the needle; in the process of ultrasonic cleaning, the needle will vibrate at the same frequency as the sound wave, and the liquid will also continuously produce negative pressure, at this time the liquid will produce cavitation and shock wave effects of cracking; clean the tank After receiving ultrasonic vibration energy, the cleaning fluid will generate shock waves similar to positive and negative alternating, which can be cavitation Liquid bubble group, the bubble group will invade the surface of the needle, and this bubble will repeatedly shrink and expand, and clean the fine chips or dirt hidden in the slits or deep holes. In this way, the invention is combined with pickling liquid to remove fine chips or dirt generated by picosecond laser processing. Among them, the chemical formula of the ultrasonic deoxidizing film in step 3 is a mixture of 5% dilute sulfuric acid and 95% deionized water. Its operating control temperature is between 25℃-30℃, and the time control is 10-15 minutes; finally It is rinsed several times with deionized water and dried; the present invention does not require the process of degreasing, because the problem of oil pollution does not occur on the surface after laser processing in picoseconds, so we only process the deoxidized film part.
步驟四之針頭表面處理,亦用哈氏槽同時進行拋光與鈍化處理,將針頭接於陽極,而還原金屬接於陰極,前述兩者置於電解液中,通入直流電源,而哈氏槽底部之攪拌器起動,利於加工過程之電解液的均勻性和溫度的掌控;電解拋光處理的作用,乃是利用反電鍍原理與電場集中效應之方式,產生溶解作用並達成針頭表面平坦化、光澤化(鏡面級光澤,表面可達Ra=0.15-0.55μm)、提昇抗腐蝕能力與體組織相容之加工技術;本發明技術最重要的部份,乃是將針頭之表面層的鐵原子移除,保留表面層之鉻原子,使針頭之表面充滿鉻原子(因鉻原子易為人體組織所接受,不易產生排斥性)。其中,步驟四之針頭表面處理,其電解拋光液加入去離子水的液體總含量為150ml,其化學配方為:(1)、磷酸溶液之濃度為10%;(2)、硫酸溶液之濃度為40%;(3)、三氧化鉻溶液之濃度為5%;(4)、去離子水與其他添加劑(如乙二醇)之濃度為45%;且該電解液溫度控制為80-100℃,電壓控制12V±5V,時間控制為1-2小時。上述所揭示之化學配方於實做過程,亦可依據情況不同給予調整,當電解拋光液的配方不同時,其濃度也會有所變化,此時黏度亦會有所改變;如為了提升針頭的表面品質,添加劑將 是一個重要的控制因子,本實施例的添加劑係為乙二醇,但不以此限制本發明,其亦可為可達到該目的之任何添加劑,都屬本發明的保護範圍。本發明之針頭表面處理的鈍化過程,乃將皮秒雷射加工後的直角邊給予鈍化成圓弧邊,防止針頭進入體組織時破壞血管內壁層;至於前述提針頭的鈍化液含加入去離子水的液體總含量為100ml;鈍化液的化學配方及用量包括:(1)、重鉻酸鉀溶液之濃度為20%;(2)、氫氧化鈉溶液之濃度為4%;(3)、去離子水溶液76%;且控制其(酸鹼值)PH值至6-7,而操作時間控制在30-55分鐘。 The surface treatment of the needle in step 4 is also performed with the Hastelloy tank for simultaneous polishing and passivation treatment. The needle is connected to the anode, and the reduced metal is connected to the cathode. The foregoing two are placed in the electrolyte and passed through a DC power source. The stirrer at the bottom is started, which is conducive to the control of the electrolyte uniformity and temperature during the process; the role of electrolytic polishing is to use the principle of reverse electroplating and the concentrated effect of the electric field to produce a dissolving effect and achieve flatness and gloss on the surface of the needle (Mirror-level gloss, surface can reach Ra=0.15-0.55μm), processing technology to improve corrosion resistance and body tissue compatibility; the most important part of the technology of the present invention is to move the iron atoms in the surface layer of the needle In addition, the chromium atoms in the surface layer are retained, so that the surface of the needle is filled with chromium atoms (because chromium atoms are easily accepted by human tissues, it is not easy to produce repulsion). Among them, in the surface treatment of the needle in step 4, the total content of the electrolytic polishing solution added with deionized water is 150ml, and its chemical formula is: (1), the concentration of phosphoric acid solution is 10%; (2), the concentration of sulfuric acid solution is 40%; (3), the concentration of chromium trioxide solution is 5%; (4), the concentration of deionized water and other additives (such as ethylene glycol) is 45%; and the temperature of the electrolyte is controlled to 80-100℃ , Voltage control 12V±5V, time control is 1-2 hours. The chemical formula disclosed above can be adjusted according to the actual situation. When the formula of the electrolytic polishing solution is different, the concentration will change, and the viscosity will also change at this time; for example, to improve the needle Surface quality, additives will It is an important control factor. The additive in this embodiment is ethylene glycol, but it does not limit the invention in this way, and it can also be any additive that can achieve this purpose, which falls within the protection scope of the invention. The passivation process of the surface treatment of the needle of the present invention is to passivate the right-angled edge after the picosecond laser processing into a rounded edge to prevent the damage of the inner wall layer of the blood vessel when the needle enters the body tissue; The total liquid content of ionized water is 100ml; the chemical formula and dosage of the passivation liquid include: (1), the concentration of potassium dichromate solution is 20%; (2), the concentration of sodium hydroxide solution is 4%; (3) , 76% deionized aqueous solution; and control its (acid value) PH value to 6-7, and the operating time is controlled at 30-55 minutes.
步驟五之清洗烘乾,亦係去離子水沖洗數次及使用吹風機烘乾;本發明執行之目的,乃係為去除因執行步驟三與步驟四所殘留之表面化學物質,並方便後續執行滅菌之步驟,讓滅菌劑以得到完全滅菌與避免於微生物細胞的再接觸,進而得到消毒或滅菌的效果。 The cleaning and drying in step 5 is also rinsed with deionized water several times and dried with a hair dryer; the purpose of the implementation of the present invention is to remove the surface chemical substances remaining in steps 3 and 4 and facilitate subsequent sterilization In this step, let the sterilization agent be completely sterilized and avoid re-contact with the microbial cells, so as to obtain the effect of sterilization or sterilization.
步驟六之針頭與針座膠合組裝,其注射針頭乃置放於針座內,完成固定後於接合處貫入接著劑,再給予烘乾完成,其成品如第2圖所示。 The needle of step 6 is glued and assembled with the needle base. The injection needle is placed in the needle base. After the fixation is completed, the adhesive is penetrated at the joint and then dried. The finished product is shown in Figure 2.
步驟七之光學檢測與真空封裝;亦將注射裝置放入塑膠保護殼中,並於塑膠保護殼上貼上防護貼紙;塑膠保護殼為PE材質,防護貼紙則為防水低透氣度的紙材,兩者都適用於環氧乙烷E.O.滅菌處理之材料;光學檢測的目的是在量測針頭經皮秒雷射加工後,針對針頭表面顏色位置與長度測量是否符合所設計之方式。 Step 7: Optical inspection and vacuum packaging; also put the injection device into the plastic protective shell, and affix a protective sticker on the plastic protective shell; the plastic protective shell is made of PE material, and the protective sticker is made of waterproof and low-permeability paper. Both are suitable for materials with ethylene oxide EO sterilization treatment; the purpose of optical inspection is to measure whether the color position and length of the needle surface conform to the designed method after the needle is processed by picosecond laser.
步驟八之針頭滅菌處理;滅菌處理乃是消滅所有微生物,也包含細菌繁殖體、芽孢、病毒及黴菌,而達到完全無菌狀態。本發明係用 環氧乙烷E.O.滅菌,其廣泛應用於醫療器材或半成品之殺菌與消毒,其使用溫度如60℃,曝氣時間8小時,E.O.滅菌處理可存放期限為六個月內;滅菌前,凡需使用之侵入式醫療器材在滅菌前都須先徹底清洗乾淨,並且進行初步的分類,浸泡於「維持溶液」內,等待滅菌處理。前述之針頭,經由前述各步驟即完成針頭表面顏色標示之加工方法,如第4圖所示。相較於習知技術,本發明之加工過程在於以容易取得之材料、加工技術及設備,經一連串習知的加工流程與方法,完成之注射裝置;本發明之針頭加工過程屬於低溫加工方式,且無殘留內應力之問題,而且以皮秒雷射在針頭表面標示顏色,再則利用超音波酸洗液處理表面殘留物,最後加進行針頭的表面處理,如拋光、切割邊的鈍化與觸發表面富鉻化;此針頭適合人體之短暫性侵入與亦或停留於體組織表面(一般為3天-4天)。 Needle sterilization in step 8; sterilization is to eliminate all microorganisms, including bacterial propagules, spores, viruses and molds, and achieve complete sterility. The invention is used Ethylene oxide EO sterilization is widely used in the sterilization and disinfection of medical equipment or semi-finished products. Its use temperature is 60℃, aeration time is 8 hours, and the storage period of EO sterilization can be stored within six months. The invasive medical equipment used must be thoroughly cleaned before sterilization, and preliminary classification, soaked in "maintenance solution", waiting for sterilization treatment. The aforementioned needle is processed through the aforementioned steps to complete the color marking of the needle surface, as shown in Figure 4. Compared with the conventional technology, the processing procedure of the present invention is an injection device completed by a series of conventional processing procedures and methods with readily available materials, processing techniques and equipment; the needle processing procedure of the present invention belongs to a low-temperature processing method, There is no problem of residual internal stress, and the color of the needle surface is marked with a picosecond laser, then the surface residue is treated with ultrasonic pickling solution, and finally the surface treatment of the needle is added, such as polishing, passivation and triggering of the cutting edge The surface is chromium-rich; this needle is suitable for the transient intrusion of the human body and also stays on the surface of the body tissue (generally 3 days to 4 days).
同時為求其穩定品質、合理之價格,表面平滑、潔淨度高、抗蝕性佳、低排斥性,並可提升使用之壽命,而提出該專利之特別具有之新穎性、進步性及創新性之特異點;同時也可突破目前針頭表面顏色標示之加工方法,足見其增益之處。 At the same time, in order to seek its stable quality, reasonable price, smooth surface, high cleanliness, good corrosion resistance, low rejection, and can improve the service life, the patent is particularly novel, progressive and innovative. The unique point; at the same time, it can also break through the current processing method of the color marking on the surface of the needle, which shows its gain.
綜觀上述所知,本發明已突破先前之製造技術的困難面,且確實達到所欲增進之功效,再則此為非熟悉之已知技術者,所易思及之加工過程;所以,本發明申請前都未曾公開或發表,其所具有之新穎性、進步性、創新性,顯已符合國內、外之發明專利的申請要件,爰依法提出發明申請,懇請貴局核准本件發明專利申請案,以勵發明,至感德便。 In view of the above knowledge, the present invention has broken through the difficulties of the previous manufacturing technology and has indeed achieved the desired improvement. Then this is the processing process that is unfamiliar to the known technology and easy to think of; therefore, the present invention It has not been published or published before the application, and its novelty, progress, and innovation have clearly met the requirements of domestic and foreign invention patent applications. You have filed an application for invention according to law and urge your office to approve this application for an invention patent. To inspire invention, to feel virtuous.
依前所述之實施例僅係為說明本發明之技術思想及特點,其目的在使熟習此項技藝之人士能夠瞭解本發明之內容並據此實施,當不能 以此限定本發明之專利範圍,即大凡依本發明所揭示之精神所作之均等變化或修飾,仍應涵蓋在本發明之專利範圍內。 The foregoing embodiments are only for explaining the technical ideas and features of the present invention, and its purpose is to enable those skilled in the art to understand the contents of the present invention and implement it accordingly. In this way, the patent scope of the present invention is defined, that is, any equal changes or modifications made according to the spirit disclosed by the present invention should still be covered by the patent scope of the present invention.
S101‧‧‧利用皮秒雷射於一針頭表面上進行顏色的標示 S101‧‧‧Use picosecond laser to mark the color on the surface of a needle
S102‧‧‧利用切斷器切斷該針頭 S102‧‧‧Cut the needle with a cutter
S103‧‧‧利用超音波酸洗該針頭的表面,以去除該針頭表面上的氧化皮膜 S103‧‧‧Using ultrasound to pickle the surface of the needle to remove the oxide film on the surface of the needle
S104‧‧‧針對該針頭進行一表面處理 S104‧‧‧ Perform a surface treatment on the needle
S105‧‧‧清洗與烘乾該針頭 S105‧‧‧Clean and dry the needle
S106‧‧‧將該針頭與一針座相互膠合組裝成一注射裝置 S106‧‧‧The needle and a needle base are glued together to form an injection device
S107‧‧‧將該注射裝置進行真空封裝,且針對該針頭進行一光學檢測 S107‧‧‧ Vacuum package the injection device and perform an optical inspection on the needle
S108‧‧‧針對該針頭進行一滅菌處理 S108‧‧‧ Perform a sterilization treatment on the needle
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CN2584200Y (en) * | 2002-01-14 | 2003-11-05 | 胡振满 | Disposable dispensing needle |
TW201132373A (en) * | 2010-03-23 | 2011-10-01 | Biomate Medical Devices Technology Co Ltd | Acupuncture needle processing and packing device and method thereof |
TW201215380A (en) * | 2010-10-04 | 2012-04-16 | Sheng-Yao Lin | Vascular stent manufacturing method |
WO2014162613A1 (en) * | 2013-04-05 | 2014-10-09 | テルモ株式会社 | Medical member |
WO2016094620A1 (en) * | 2014-12-11 | 2016-06-16 | Facet Technologies, Llc | Needle with multi-bevel tip geometry |
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CN2584200Y (en) * | 2002-01-14 | 2003-11-05 | 胡振满 | Disposable dispensing needle |
TW201132373A (en) * | 2010-03-23 | 2011-10-01 | Biomate Medical Devices Technology Co Ltd | Acupuncture needle processing and packing device and method thereof |
TW201215380A (en) * | 2010-10-04 | 2012-04-16 | Sheng-Yao Lin | Vascular stent manufacturing method |
WO2014162613A1 (en) * | 2013-04-05 | 2014-10-09 | テルモ株式会社 | Medical member |
WO2016094620A1 (en) * | 2014-12-11 | 2016-06-16 | Facet Technologies, Llc | Needle with multi-bevel tip geometry |
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