TWI574704B - Manufacturing apparatus of medical embolization microspheres - Google Patents
Manufacturing apparatus of medical embolization microspheres Download PDFInfo
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Description
本發明係一種醫療用栓塞微球製程設備，尤指一種快速製成特定粒徑之醫療用栓塞微球，並可降低栓塞微球之製備成本者。 The invention relates to a medical embedding microsphere processing device, in particular to a medical embedding microsphere which is quickly made into a specific particle size, and can reduce the preparation cost of the embedding microsphere.
按，據查，每年約有五十萬人被新診斷罹患肝癌，其中，肝癌為男性之中第五常見之癌症，而於女性中係第七常見之癌症；而就我國而言，肝病被認為係我國之國病，近年來，肝癌業已躍升為我國國人十大癌症發生率第二名。 According to the survey, about 500,000 people are diagnosed with liver cancer every year. Among them, liver cancer is the fifth most common cancer among men, and the seventh most common cancer among women. For China, liver disease is It is believed that it is the country's disease in China. In recent years, the liver cancer industry has jumped to the second place among the top ten cancers in China.
就肝癌之治療方式而言，習見之治療方法包含：手術切除、酒精注射治療、電頻灼燒法、放射線治療、化學治療及經導管肝動脈栓塞術；合併上述其中至少二以上之治療方法，則可得到更好的治療效果；而約半數肝癌病人適合以化療或栓塞術治療，其優點在於，可減緩腫瘤生長速度、減少腫瘤數目及大小，進而使病人降低腫瘤分期、再獲得肝臟移植或改善肝臟移植後之痊癒能力；由於正常肝臟的血液供應，有約70%至75%係由腸道及脾臟回流的門脈供應，25%至30%則係由肝動脈供應，而肝癌細胞90%至95%的養分是來自肝動脈，故經導管肝動脈栓塞術即係透過阻斷肝動脈血流使癌細胞壞死，藉以達致肝癌治癒之效果。 In terms of the treatment of liver cancer, the treatment methods include: surgical resection, alcohol injection therapy, electric burning, radiation therapy, chemotherapy, and transcatheter hepatic artery embolization; and at least two of the above treatment methods, It can get better therapeutic effect; about half of the patients with liver cancer are suitable for chemotherapy or embolization. The advantage is that it can slow down the tumor growth rate, reduce the number and size of tumors, and then reduce the tumor stage, and then get the liver transplant or Improves the healing ability after liver transplantation; due to the blood supply to normal liver, about 70% to 75% are supplied by the portal vein of the intestine and spleen, and 25% to 30% are supplied by the hepatic artery, while the liver cancer cell 90 From 0.01 to 95% of the nutrients are from the hepatic artery, transcatheter hepatic artery embolization is to block the hepatic artery blood flow to make the cancer cells necrotic, so as to achieve the effect of liver cancer healing.
惟此，常用治療肝癌之栓塞物，諸如：明膠(Gelfoam)、無藥物釋放之栓塞球(Embosphere)、藥物釋放栓塞球(Drug-eluting beads-DC beads)及攜帶放射線同位素Yttrium-90栓塞球；就明膠而言，其價格較為便宜，然而，多數係由醫療 機構所自製，皆無流程化控管，故其粒徑大小、消毒能力及品質，皆存有極大之問題，易導致影響醫療品質；而就無藥物釋放之栓塞球而言，其價格極為昂貴，約0.5ml即要價數千元，而若為藥物釋放栓塞球或攜帶放射線同位素Yttrium-90栓塞球，其價格甚至每0.5ml需數萬至數十萬元，上述各式栓塞球價格高昂之主因在於，其製程及粒徑控制不易，而因醫療用之栓塞球之粒徑所需為250μm至350μm或400μm至500μm，故需耗費諸多精密儀器及控制設備方能達致其粒徑所需，再者，其製備速率極為緩慢，且於栓塞球填充藥物之時間耗時甚長，故將導致提高醫療成本，因此患者需負擔之治療費用亦將隨之增加，進而影響醫療品質之或者之權益。 However, commonly used embolization devices for treating liver cancer, such as: gelatin (Gelfoam), drug-free embolization sphere (Embosphere), drug-releasing beads-DC beads, and radioactive isotope Yttrium-90 embolization ball; In the case of gelatin, the price is cheaper, however, most are medical The self-made by the organization has no process control, so its particle size, disinfection ability and quality have great problems, which may affect the quality of the medical treatment. For the embolization ball without drug release, the price is extremely expensive. About 0.5ml is a price of several thousand dollars, and if the drug releases the embolization ball or carries the radioactive isotope Yttrium-90 embolization ball, the price even needs tens of thousands to hundreds of thousands of yuan per 0.5ml, the main reason for the high price of the above-mentioned various embolization balls Therefore, the process and particle size control are not easy, and the diameter of the medically used embolic ball needs to be 250 μm to 350 μm or 400 μm to 500 μm, so it takes a lot of precision instruments and control equipment to achieve the particle size. Furthermore, the preparation rate is extremely slow, and the time required for the embolization of the ball to fill the drug is very long, which will lead to an increase in the medical cost, so that the treatment cost for the patient will also increase, thereby affecting the quality of the medical product. .
有鑑於此，吾等發明人乃潛心進一步研究栓塞球之製程設備，並著手進行研發，期以一較佳發明以解決上述問題，且在經過不斷試驗及修改後而有本發明之問世。 In view of this, our inventors have devote themselves to further research on the process equipment of the embolic ball, and have begun research and development, with a better invention to solve the above problems, and have been experimentally and modified to have the present invention.
緣是，本發明之目的係為解決習之明膠之製程，其粒徑大小、消毒能力及品質無法有效進行控管，而無藥物釋放之栓塞球、藥物釋放栓塞球及攜帶放射線同位素Yttrium-90栓塞球之製造設備及成本昂貴，製備所耗時甚長，故價格極為高昂，導致提高醫療成本，增加患者需負擔之治療費用，進而影響醫療品質之或者之權益等缺失。 The reason is that the purpose of the present invention is to solve the process of the gelatin, the particle size, the disinfection ability and the quality cannot be effectively controlled, and the drug-free embolization ball, the drug release embolization ball and the radioactive isotope Yttrium-90 The manufacturing equipment and cost of the embolization ball are expensive, and the preparation takes a long time, so the price is extremely high, which leads to an increase in medical costs, an increase in the cost of treatment for the patient, and thus an impairment of the quality of the medical product or the like.
為達致以上目的，吾等發明人提供一種醫療用栓塞微球製程設備，其包含：一噴嘴，其設有一流道及一對應連通該流道之噴口；以及一外部激擾裝置，其組設於該噴嘴，該外部激擾裝置係耦接於一控制裝置，該控制裝置係控制該外部激擾裝置之激擾頻率及激擾振幅者。 In order to achieve the above object, the inventors provide a medical embedding microsphere processing apparatus, comprising: a nozzle provided with a first-class channel and a nozzle corresponding to the flow channel; and an external excitation device, the group thereof The external excitation device is coupled to a control device that controls the excitation frequency and the amplitude of the external disturbance device.
據上所述之醫療用栓塞微球製程設備，其中，該外部激擾裝置為高出力堆疊式壓電片或低出力堆疊式壓電片。 The medical embedding microsphere processing apparatus according to the above, wherein the external excitation device is a high-power stacked piezoelectric sheet or a low-output stacked piezoelectric sheet.
據上所述之醫療用栓塞微球製程設備，更包含一注射裝置，其設有注射通道，所述注射通道係連接於該噴嘴之流道，該注射裝置係控制其進料率者。 According to the medical embedding microsphere processing apparatus described above, an injection device is further provided, which is provided with an injection channel which is connected to the flow path of the nozzle, and the injection device controls the feed rate thereof.
據上所述之醫療用栓塞微球製程設備，其中，該注射裝置係不銹鋼製成者，且該注射通道之壁面係經表面電解處理者。 The medical embedding microsphere processing apparatus according to the above, wherein the injection device is made of stainless steel, and the wall surface of the injection channel is subjected to surface electrolytic treatment.
據上所述之醫療用栓塞微球製程設備，更包含一恆溫裝置，其係連結於該注射裝置及該噴嘴，藉以分別恆定該注射裝置及噴嘴之溫度者。 The medical embedding microsphere processing apparatus according to the above aspect further comprises a thermostatic device coupled to the injection device and the nozzle, whereby the temperature of the injection device and the nozzle are respectively constant.
據上所述之醫療用栓塞微球製程設備，其中，該注射裝置係注射溫感性物質於該流道，該溫感性物質係受溫度而改變其黏度者，且該溫感性物質係受該注射裝置及噴嘴所恆定之溫度而呈液態者。 According to the medical embedding microsphere processing apparatus described above, wherein the injection device injects a temperature sensitive substance in the flow path, the temperature sensitive substance is changed in viscosity by temperature, and the temperature sensitive substance is subjected to the injection. The device and the nozzle are in a liquid state at a constant temperature.
據上所述之醫療用栓塞微球製程設備，更包含一冷卻裝置，其係對應設於該噴口，該冷卻裝置設有一對應該噴口之冷卻通道，該冷卻通道係令由噴口輸出之溫感性物質通過並冷卻凝固者。 According to the medical embedding microsphere processing device, there is further provided a cooling device, which is correspondingly disposed on the spout, and the cooling device is provided with a pair of cooling passages corresponding to the spout, and the cooling passage is for sensing the temperature sensitivity of the spout. The substance passes through and cools the solidified person.
據上所述之醫療用栓塞微球製程設備，其中，該冷卻裝置係藉由輸入液態氮，藉以進行輻射冷卻者。 According to the medical embedding microsphere processing apparatus described above, the cooling device is configured to perform radiation cooling by inputting liquid nitrogen.
據上所述之醫療用栓塞微球製程設備，更包含至少一殺菌單元，其係對應設於該噴口。 The medical embedding microsphere processing device according to the above aspect further comprises at least one sterilization unit, which is correspondingly disposed on the spout.
據上所述之醫療用栓塞微球製程設備，其中，所述殺菌單元為紫外線照射裝置。 The medical embedding microsphere processing apparatus according to the above, wherein the sterilization unit is an ultraviolet irradiation device.
據上所述之醫療用栓塞微球製程設備，更包含一集料裝置，其係對應設於該噴口。 According to the medical embedding microsphere processing device described above, a collecting device is further included, which is correspondingly disposed on the spout.
據上所述之醫療用栓塞微球製程設備，其中，該集料裝置更設有一快拆裝置。 According to the medical embedding microsphere processing device described above, the collecting device is further provided with a quick release device.
據上所述之醫療用栓塞微球製程設備，更包含一監控裝置，其係對 應設於該噴口。 According to the medical embedding microsphere processing device described above, a monitoring device is further included, and the pair is It should be located at the spout.
是由上述說明及設置，顯見本發明主要具有下列數項優點及功效，茲逐一詳述如下： It is obvious from the above description and setting that the present invention has the following several advantages and effects, which are detailed as follows:
1.本發明透過恆溫裝置控制溫感性物質之黏度、注射裝置控制進料率、控制裝置控制外部激擾裝置之激擾頻率及激擾振幅，進而藉以控制控制輸出溫感性物質之粒徑，而輸出之溫感性物質經殺菌單元及冷卻裝置進行消毒及凝固後，即可快速製得特定粒徑之醫療用栓塞微球，查黏度為30cP之溫感性物質，透過本發明一秒約可製成約5000顆之栓塞微球，且僅約2分鐘即可製得2ml之栓塞微球，顯見本發明可確實縮短栓塞微球之製程時間，並有效降低栓塞微球之製備成本，進而減低患者之金錢負擔。 1. The invention controls the viscosity of the temperature sensitive substance through the thermostat device, controls the feed rate of the injection device, controls the excitation frequency and the excitation amplitude of the external disturbance device, and then controls and controls the particle size of the output temperature sensitive substance, and outputs After the temperature sensitive substance is disinfected and solidified by the sterilization unit and the cooling device, the medical embedding microsphere of a specific particle diameter can be quickly obtained, and the temperature sensitive substance having a viscosity of 30 cP can be obtained, and can be made by one second of the present invention. 5,000 embolization microspheres, and only 2 minutes to obtain 2ml of embolization microspheres, it is obvious that the present invention can shorten the processing time of embedding microspheres, and effectively reduce the preparation cost of embedding microspheres, thereby reducing the patient's money burden.
2.本發明於欲製備相同原料且不同粒徑之栓塞微球時，可直接調整外部激擾裝置之激擾頻率及激擾振幅即可，亦可依需求而改變該噴口之長度與孔徑比；若欲製成較大粒徑之栓塞微球，則該外部激擾裝置可為高出力堆疊式壓電片；而若欲製成粒徑較小之栓塞微球，則該外部激擾裝置可為低出力之堆疊式壓電片；藉由上述，即能直接且快速製得相異粒徑之栓塞微球。 2. The invention can directly adjust the excitation frequency and the excitation amplitude of the external excitation device when preparing the embedding microspheres of the same raw material and different particle diameters, and can also change the length and aperture ratio of the nozzle according to requirements. If the plug microspheres of larger particle size are to be formed, the external stimulator device may be a high-power stacked piezoelectric sheet; and if the plug microspheres having a smaller particle size are to be formed, the external stimulator device It can be a low-power stacked piezoelectric sheet; by the above, the plug microspheres of different particle sizes can be directly and quickly produced.
3.本發明於欲製備不同原料之栓塞微球時，可依其黏度對應溫度之變化特性，而改變恆溫裝置控制注射裝置及噴嘴所恆定之溫度，而令其呈液態，藉此，本發明確實可依栓塞微球之原料而予以製備者，故具廣泛之適用性者。 3. The present invention is intended to prepare embedding microspheres of different raw materials, and according to the change characteristics of the viscosity corresponding to the temperature, the constant temperature device is controlled to control the temperature of the injection device and the nozzle to be in a liquid state, whereby the present invention It can be prepared according to the raw materials of the embedding microspheres, so it has wide applicability.
4.本發明之注射裝置係不銹鋼製成，且該注射通道之壁面係經表面電解處理，藉以降低注射通道壁面之表面粗糙度，避免污垢及細菌堆積，除更進一步增進進料率之控管外，更可維護溫感性物質之潔淨度，防止其遭受汙染。 4. The injection device of the invention is made of stainless steel, and the wall surface of the injection channel is subjected to surface electrolysis treatment, thereby reducing the surface roughness of the wall surface of the injection channel and avoiding the accumulation of dirt and bacteria, in addition to further improving the control rate of the feed rate. It can also maintain the cleanliness of temperature sensitive substances and prevent them from being polluted.
5.本發明藉由殺菌單元之設置，藉以對於栓塞微球之製程中進行消毒殺菌，且透過於噴口對應設置監控裝置，以隨時捕捉輸出之溫感性物質之影像，以利於分析其粒徑，藉以有效進行監控及即時製程校正者；此外，本發明透過快拆裝置之設置，以增進收集栓塞微球之速率，使更進一步縮減栓塞微球製成 之工時；藉由上述，顯見本發明確實具有操作便利及即時監控、消毒及殺菌之功效，以提升栓塞微球之製程品質者。 5. The invention adopts the setting of the sterilization unit to sterilize and sterilize the process of embedding the microspheres, and the monitoring device is arranged correspondingly to the nozzle to capture the image of the temperature sensitive substance output at any time, so as to facilitate analysis of the particle size. In addition, the invention is effective for monitoring and immediate process calibration; in addition, the present invention is configured by the quick release device to increase the rate of collecting the plug microspheres, so as to further reduce the embedding microspheres. By the above, it is apparent that the present invention has the advantages of convenient operation and immediate monitoring, disinfection and sterilization to improve the process quality of the embedding microspheres.
1‧‧‧噴嘴 1‧‧‧ nozzle
11‧‧‧流道 11‧‧‧ flow path
12‧‧‧噴口 12‧‧‧ spout
2‧‧‧外部激擾裝置 2‧‧‧External disturbance device
21‧‧‧控制裝置 21‧‧‧Control device
3‧‧‧注射裝置 3‧‧‧Injection device
31‧‧‧注射通道 31‧‧‧Injection channel
4‧‧‧恆溫裝置 4‧‧‧ thermostat
5、5a‧‧‧溫感性物質 5, 5a‧‧‧temperature sensitive substances
51‧‧‧栓塞微球 51‧‧‧ embolization microspheres
6‧‧‧冷卻裝置 6‧‧‧Cooling device
61‧‧‧冷卻通道 61‧‧‧Cooling channel
7a、7b‧‧‧殺菌單元 7a, 7b‧‧‧ sterilizing unit
8‧‧‧集料裝置 8‧‧‧ Collector
81‧‧‧快拆裝置 81‧‧‧Quick release device
9‧‧‧監控裝置 9‧‧‧Monitor
[第1圖]係本發明之結構示意圖。 [Fig. 1] is a schematic view showing the structure of the present invention.
[第2圖]係本發明第一實施例激擾頻率為4000Hz時所形成之液束的實驗圖。 [Fig. 2] Fig. 2 is an experimental diagram of a liquid beam formed when the excitation frequency is 4000 Hz according to the first embodiment of the present invention.
[第3圖]係本發明第一實施例激擾頻率為4000Hz時所製成之栓塞微球的實驗圖。 [Fig. 3] Fig. 3 is an experimental diagram of the embedding microspheres produced by the first embodiment of the present invention at a frequency of 4000 Hz.
[第4圖]係本發明第一實施例激擾頻率為5000Hz時所形成之液束的實驗圖。 [Fig. 4] is an experimental diagram of a liquid beam formed when the excitation frequency is 5000 Hz in the first embodiment of the present invention.
[第5圖]係本發明第一實施例激擾頻率為5000Hz時所製成之栓塞微球的實驗圖。 [Fig. 5] Fig. 5 is an experimental diagram of the embedding microspheres produced by the first embodiment of the present invention when the excitation frequency is 5000 Hz.
[第6圖]係本發明第二實施例所形成之液束的實驗圖。 [Fig. 6] Fig. 6 is an experimental diagram of a liquid beam formed in the second embodiment of the present invention.
[第7圖]係本發明第二實施例所製成之栓塞微球的實驗圖。 [Fig. 7] Fig. 7 is an experimental view of the embedding microspheres produced in the second embodiment of the present invention.
[第8圖]係本發明第三實施例所形成之液束的實驗圖。 [Fig. 8] Fig. 8 is an experimental diagram of a liquid beam formed in the third embodiment of the present invention.
[第9圖]係本發明第三實施例所製成之栓塞微球的實驗圖。 [Fig. 9] is an experimental diagram of the embedding microspheres produced in the third embodiment of the present invention.
關於吾等發明人之技術手段，茲舉數種較佳實施例配合圖式於下文進行詳細說明，俾供 鈞上深入了解並認同本發明。 The invention will be described in detail below with reference to the drawings.
請先參閱第1圖至第5圖所示，其係本發明之第一實施例，本發明係一種醫療用栓塞微球51製程設備，其包含：一噴嘴1，其設有一流道11及一對應連通該流道11之噴口12；一外部激擾裝置2，其組設於該噴嘴1，該外部激擾裝置2係耦接於一控制裝置21，該控制裝置21係控制該外部激擾裝置2之激擾頻率及激擾振幅者，該外部激擾裝置2為高出力堆疊式壓電片或低出力堆疊式壓電片； 一注射裝置3，其設有注射通道31，所述注射通道31係連接於該噴嘴1之流道11，該注射裝置3係控制其進料率者，該注射裝置3係不銹鋼製成者，且該注射通道31之壁面係經表面電解處理者；一恆溫裝置4，其係連結於該注射裝置3及該噴嘴1，藉以分別恆定該注射裝置3及噴嘴1之溫度者，該注射裝置3係注射溫感性物質5於該流道11，該溫感性物質5係受溫度而改變其黏度者，且該溫感性物質5係受該注射裝置3及噴嘴1所恆定之溫度而呈液態者；一冷卻裝置6，其係對應設於該噴口12，該冷卻裝置6設有一對應該噴口12之冷卻通道61，該冷卻通道61係令由噴口12輸出之溫感性物質5通過並冷卻凝固者，該冷卻裝置6係藉由輸入液態氮(N2)，藉以進行輻射冷卻者；並如第1圖所示，該冷卻通道61設有一輸入端62及一輸出端63，且該輸入端62之位置係低於該輸出端63，藉以如箭頭方向所示，於位於較低位置之輸入端62輸入液態氮至冷卻通道61，並由較高位置之輸出端63將液態氮排出，以防止液態氮影響噴口12之溫度，或影響噴口12輸出溫感性物質5；至少一殺菌單元7a、7b，其中，如第1圖所示，殺菌單元7a係對應設於該噴口12及冷卻裝置6之間，藉可明確知悉的，以增加冷卻裝置6與噴口12之距離，藉以更進一步防止冷卻裝置6影響噴口12之溫度及噴口12輸出溫感性物質5；而殺菌單元7b係設於冷卻裝置6底端，所述殺菌單元7a、7b為紫外線照射裝置；一集料裝置8，其係對應設於該噴口12，該集料裝置8設有一快拆裝置81；以及一監控裝置9，其係對應設於該噴口12。 Please refer to FIG. 1 to FIG. 5, which is a first embodiment of the present invention. The present invention is a medical embedding microsphere 51 process apparatus, comprising: a nozzle 1 provided with a first-class road 11 and Corresponding to the spout 12 of the flow channel 11; an external stimulator 2 is disposed in the nozzle 1 , the external stimulator 2 is coupled to a control device 21 , and the control device 21 controls the external stimulator If the disturbance frequency of the disturbance device 2 and the amplitude of the disturbance are 2, the external disturbance device 2 is a high-power stacked piezoelectric sheet or a low-output stacked piezoelectric sheet; An injection device 3 is provided with an injection channel 31 connected to the flow channel 11 of the nozzle 1, the injection device 3 controlling the feed rate thereof, the injection device 3 being made of stainless steel, and The wall surface of the injection channel 31 is subjected to surface electrolysis treatment; a thermostatic device 4 is coupled to the injection device 3 and the nozzle 1 to respectively stabilize the temperature of the injection device 3 and the nozzle 1, and the injection device 3 Injecting the temperature sensitive substance 5 into the flow path 11, the temperature sensitive substance 5 is changed in temperature by the temperature, and the temperature sensitive substance 5 is in a liquid state by the constant temperature of the injection device 3 and the nozzle 1; The cooling device 6 is correspondingly disposed on the spout 12, and the cooling device 6 is provided with a pair of cooling passages 61 corresponding to the spouts 12, and the cooling passages 61 pass the temperature sensitive substance 5 outputted from the spout 12 and cool the solidified person. The cooling device 6 is configured to perform radiation cooling by inputting liquid nitrogen (N2); and as shown in FIG. 1, the cooling passage 61 is provided with an input end 62 and an output end 63, and the position of the input end 62 is Below the output 63, as the direction of the arrow It is shown that the liquid nitrogen is input to the cooling passage 61 at the input 62 at the lower position, and the liquid nitrogen is discharged from the output 63 of the higher position to prevent the liquid nitrogen from affecting the temperature of the spout 12 or affecting the temperature sensitivity of the spout 12 output. Substance 5; at least one sterilizing unit 7a, 7b, wherein, as shown in Fig. 1, the sterilizing unit 7a is correspondingly disposed between the spout 12 and the cooling device 6, and can be clearly known to increase the cooling device 6 and the spout 12 distance, thereby further preventing the cooling device 6 from affecting the temperature of the spout 12 and the spout 12 outputting the temperature sensitive substance 5; and the sterilization unit 7b is disposed at the bottom end of the cooling device 6, the sterilization unit 7a, 7b being an ultraviolet irradiation device; An aggregate device 8 is disposed correspondingly to the spout 12, the aggregate device 8 is provided with a quick release device 81, and a monitoring device 9 is correspondingly disposed at the spout 12.
本發明之操作步驟包含： The operation steps of the present invention include:
(a)如第1圖所示，先將溫感性物質5加熱攪拌震盪均勻混和後置於注射裝置3，以透過注射裝置3控制其進料率，該注射裝置3係採用KDS-200注射幫浦，將溫感性物質5透過注射通道31輸入噴嘴1之流道11中，而於輸送溫感性物 質5之過程中，係透過恆溫裝置4恆定注射裝置3之注射通道31內之溫度，藉以維持溫感性物質5為特定黏度之液體，以利於確實控管進料率；而透過注射裝置3係不銹鋼製成，且該注射通道31之壁面係經表面電解處理，藉以降低注射通道31壁面之表面粗糙度，避免污垢及細菌堆積，除更進一步增進進料率之控管外，亦可維護溫感性物質5之潔淨度，防止其遭受汙染。 (a) As shown in Fig. 1, the temperature sensitive substance 5 is first heated and stirred and uniformly mixed, and then placed in the injection device 3 to control the feed rate thereof through the injection device 3. The injection device 3 is a KDS-200 injection pump. The temperature sensitive substance 5 is introduced into the flow channel 11 of the nozzle 1 through the injection channel 31 to transport the temperature sensitive substance. In the process of mass 5, the temperature in the injection channel 31 of the constant injection device 3 is constant through the thermostat 4, thereby maintaining the temperature sensitive substance 5 as a liquid of a specific viscosity, so as to facilitate the control of the feed rate; and the stainless steel through the injection device 3 The wall surface of the injection channel 31 is subjected to surface electrolytic treatment to reduce the surface roughness of the wall surface of the injection channel 31, thereby avoiding dirt and bacteria accumulation, and in addition to further controlling the feed rate, the temperature sensitive substance can also be maintained. 5 cleanliness to prevent it from being contaminated.
(b)於噴嘴1流道11內之溫感性物質5，亦透過恆溫裝置4恆定噴嘴1之流道11及噴口12之溫度，藉以利於溫感性物質5受震盪而由噴口12輸出者，故透過使用者調整該外部激擾裝置2之激擾頻率及激擾振幅，令溫感性物質5受震盪而由噴口12輸出而呈液滴狀之溫感性物質5a；高出力堆疊式壓電片係適用較大粒徑之生產製程，而低出力之堆疊式壓電片係以較高之激擾頻率進行液束之激發，故適用較小粒徑之生產製程。 (b) The temperature sensitive substance 5 in the flow path 11 of the nozzle 1 also passes through the temperature of the flow path 11 and the discharge port 12 of the constant nozzle 1 of the constant temperature device 4, so that the temperature sensitive substance 5 is oscillated by the nozzle 12, so By adjusting the excitation frequency and the excitation amplitude of the external disturbance device 2, the temperature sensitive substance 5 is oscillated and outputted by the nozzle 12 to form a droplet-shaped temperature sensitive substance 5a; the high force stacked piezoelectric film system It is suitable for the production process with larger particle size, and the stacked piezoelectric film with low output is excited by the liquid beam at a higher excitation frequency, so it is suitable for the production process with smaller particle size.
(c)由噴口12輸出之溫感性物質5a，將經由監控裝置9進行監控，隨時捕捉輸出之溫感性物質5a之影像，以利於使用者即時分析其粒徑，藉以有效進行監控及即時之製程校正者，以提升製程之品質。 (c) The temperature sensitive substance 5a outputted from the spout 12 is monitored by the monitoring device 9 to capture the image of the temperature sensitive substance 5a output at any time, so that the user can analyze the particle size in real time, thereby effectively performing monitoring and immediate processing. Calibrator to improve the quality of the process.
(d)由噴口12輸出之溫感性物質5a，將經所述殺菌單元7a、7b進行紫外線照射，藉以進行消毒殺菌。 (d) The temperature-sensitive substance 5a outputted from the spout 12 is subjected to ultraviolet irradiation by the sterilizing units 7a and 7b to perform sterilization.
(e)溫感性物質5a將通過該冷卻裝置6之冷卻通道61，該冷卻裝置6係以輻射冷卻將溫感性物質5a凝固為固態，以形成栓塞微球51。 (e) The temperature sensitive substance 5a will pass through the cooling passage 61 of the cooling device 6, which solidifies the temperature sensitive substance 5a into a solid state by radiation cooling to form the plug microspheres 51.
(f)再經由另一所述殺菌單元7a、7b進行紫外線照射，藉以對栓塞微球51進行二次消毒殺菌。 (f) Ultraviolet irradiation is performed via another sterilization unit 7a, 7b, whereby the embedding microspheres 51 are subjected to secondary sterilization.
(g)栓塞微球51落入集料裝置8，令使用者可藉以進行收集，並可透過快拆裝置81，以利於使用者更換集料裝置8並分裝栓塞微球51者。 (g) The embedding microspheres 51 fall into the collecting device 8 so that the user can collect them and pass through the quick dismounting device 81 to facilitate the user to replace the collecting device 8 and dispense the embedding microspheres 51.
本實施例係將冷卻通道61之長度L1設置為1000mm，而內徑r為55.9mm，監控裝置9之監控範圍L2為以噴口12為起始點之下方100mm之範圍 內，並使用於85℃時黏度為65cP之溫感性物質5，本實施例之實驗參數如下表1所示，令注射裝置3之進料率為4ml/min，恆溫裝置4恆定注射裝置3及噴嘴1之溫度皆為85℃，噴口12之高度與孔徑比(L/d0)為1，且其高度與孔徑皆為150μm，並將外部激擾裝置2之激擾頻率設為4000Hz，激擾振幅為60Vpp，藉此，由噴口12輸出之溫感性物質5a，其液束概如第2圖所示，而其製得之栓塞微球51a概如第3圖所示，其平均粒徑約為344μm；而若將外部激擾裝置2之激擾頻率調整為5000Hz，溫感性物質5a形成之液束如第4圖所示，而其製得之栓塞微球51b概如第5圖所示，其平均粒徑約為319μm。 In this embodiment, the length L1 of the cooling passage 61 is set to 1000 mm, and the inner diameter r is 55.9 mm, and the monitoring range L2 of the monitoring device 9 is the range of 100 mm below the nozzle 12 as a starting point. Inside, and using the temperature sensitive substance 5 having a viscosity of 65 cP at 85 ° C, the experimental parameters of the present example are as shown in Table 1 below, so that the feeding rate of the injection device 3 is 4 ml / min, the constant temperature device 4 constant injection device 3 and the nozzle The temperature of 1 is 85 ° C, the height of the nozzle 12 and the aperture ratio (L / d0) is 1, and its height and aperture are both 150 μm, and the excitation frequency of the external excitation device 2 is set to 4000 Hz, the excitation amplitude 60Vpp, whereby the temperature sensitive substance 5a outputted from the spout 12 has a liquid beam as shown in Fig. 2, and the embedding microsphere 51a obtained as shown in Fig. 3 has an average particle diameter of about 344 μm; and if the excitation frequency of the external disturbance device 2 is adjusted to 5000 Hz, the liquid beam formed by the temperature sensitive substance 5a is as shown in FIG. 4, and the embedding microsphere 51b obtained as shown in FIG. 5 is as shown in FIG. Its average particle size is about 319 μm.
本發明之第二實施例，其與第一實施例之差別在於，本實施例之溫感性物質5係採用硬脂酸(Stearic acid)，其於70℃時之黏度為9.8cP，本實施例之實驗參數如下表2所示，令注射裝置3之進料率為4ml/min，恆溫裝置4恆定注射裝置3及噴嘴1之溫度皆為70℃，噴口12之高度與孔徑比(L/d0)為0.75，且噴口12之高度為150μm，孔徑為200μm，並將外部激擾裝置2之激擾頻率設為2000Hz，激擾振幅為85Vpp，藉此，由噴口12輸出之溫感性物質5a，其液束概如第6圖所示，而其製得之栓塞微球51c概如第7圖所示，其製得栓塞微球51c之粒徑係介於350μm至400μm之間。 The second embodiment of the present invention differs from the first embodiment in that the temperature sensitive substance 5 of the present embodiment is made of stearic acid and has a viscosity of 9.8 cP at 70 ° C. This embodiment The experimental parameters are as shown in Table 2 below, so that the feeding rate of the injection device 3 is 4 ml/min, the temperature of the constant injection device 3 and the nozzle 1 of the thermostat device 4 are both 70 ° C, and the height of the spout 12 is proportional to the aperture ratio (L/d0). It is 0.75, and the height of the nozzle 12 is 150 μm, the aperture is 200 μm, and the excitation frequency of the external disturbance device 2 is set to 2000 Hz, and the excitation amplitude is 85 Vpp, whereby the temperature sensitive substance 5a output from the nozzle 12 is The liquid beam is as shown in Fig. 6, and the embedding microspheres 51c obtained as shown in Fig. 7 have a particle size of the plug microspheres 51c of between 350 μm and 400 μm.
本發明之第三實施例，其與第二實施例之差別在於，本實施例係所採用之溫感性物質5，係於70℃時黏度為65Cp之試液，本實施例之實驗參數如下表2所示，令注射裝置3之進料率為4ml/min，恆溫裝置4恆定注射裝置3及噴嘴1之溫 度皆為70℃，噴口12之高度與孔徑比(L/d0)為0.75，且噴口12之高度為150μm，孔徑為200μm，並將外部激擾裝置2之激擾頻率設為2000Hz，激擾振幅為85Vpp，藉此，由噴口12輸出之溫感性物質5a，其液束概如第8圖所示，而其製得之栓塞微球51d概如第9圖所示，其製得栓塞微球51d之粒徑係介於410μm至500μm之間。 The third embodiment of the present invention differs from the second embodiment in that the temperature sensitive substance 5 used in the present embodiment is a test solution having a viscosity of 65 Cp at 70 ° C. The experimental parameters of the present embodiment are as shown in Table 2 below. As shown, the feed rate of the injection device 3 is 4 ml/min, and the temperature of the constant temperature device 4 is constant between the injection device 3 and the nozzle 1. The degree is 70 ° C, the height of the nozzle 12 and the aperture ratio (L / d0) is 0.75, and the height of the nozzle 12 is 150 μm, the aperture is 200 μm, and the excitation frequency of the external excitation device 2 is set to 2000 Hz, causing disturbance The amplitude is 85 Vpp, whereby the temperature sensitive substance 5a outputted from the spout 12 has a liquid beam as shown in Fig. 8, and the embedding microsphere 51d obtained as shown in Fig. 9 is obtained. The particle diameter of the ball 51d is between 410 μm and 500 μm.
綜上所述，本發明所揭露之技術手段確能有效解決習知等問題，並達致預期之目的與功效，且申請前未見諸於刊物、未曾公開使用且具長遠進步性，誠屬專利法所稱之發明無誤，爰依法提出申請，懇祈 鈞上惠予詳審並賜准發明專利，至感德馨。 In summary, the technical means disclosed by the present invention can effectively solve the problems of the prior knowledge, achieve the intended purpose and efficacy, and are not found in the publication before publication, have not been publicly used, and have long-term progress, The invention referred to in the Patent Law is correct, and the application is filed according to law, and the company is invited to give a detailed examination and grant a patent for invention.
惟以上所述者，僅為本發明之數種較佳實施例，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書內容所作之等效變化與修飾，皆應仍屬本發明專利涵蓋之範圍內。 The above is only the preferred embodiments of the present invention, and the scope of the present invention is not limited thereto, that is, the equivalent changes and modifications made by the scope of the invention and the contents of the invention are all It should remain within the scope of this invention.
1‧‧‧噴嘴 1‧‧‧ nozzle
11‧‧‧流道 11‧‧‧ flow path
12‧‧‧噴口 12‧‧‧ spout
2‧‧‧外部激擾裝置 2‧‧‧External disturbance device
21‧‧‧控制裝置 21‧‧‧Control device
3‧‧‧注射裝置 3‧‧‧Injection device
31‧‧‧注射通道 31‧‧‧Injection channel
4‧‧‧恆溫裝置 4‧‧‧ thermostat
5、5a‧‧‧溫感性物質 5, 5a‧‧‧temperature sensitive substances
51‧‧‧栓塞微球 51‧‧‧ embolization microspheres
6‧‧‧冷卻裝置 6‧‧‧Cooling device
61‧‧‧冷卻通道 61‧‧‧Cooling channel
7a、7b‧‧‧殺菌單元 7a, 7b‧‧‧ sterilizing unit
8‧‧‧集料裝置 8‧‧‧ Collector
81‧‧‧快拆裝置 81‧‧‧Quick release device
9‧‧‧監控裝置 9‧‧‧Monitor
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| WO2005105906A1 (en) * | 2004-04-22 | 2005-11-10 | Boston Scientific Limited | Embolization |
| TW200613018A (en) * | 2004-10-13 | 2006-05-01 | Hewlett Packard Development Co | Thermal drop generator |
| TW201343184A (en) * | 2012-04-27 | 2013-11-01 | Univ Nat Cheng Kung | Pharmaceutical microsphere for embolization |
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| WO2005105906A1 (en) * | 2004-04-22 | 2005-11-10 | Boston Scientific Limited | Embolization |
| TW200613018A (en) * | 2004-10-13 | 2006-05-01 | Hewlett Packard Development Co | Thermal drop generator |
| TW201343184A (en) * | 2012-04-27 | 2013-11-01 | Univ Nat Cheng Kung | Pharmaceutical microsphere for embolization |
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| TWI631962B (en) * | 2017-05-22 | 2018-08-11 | 王覺寬 | Microspheres granulation device based on spherical shape control |
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