TWI817854B - Microneedles molding set and method for manufacturing microneedle patches using the same - Google Patents
Microneedles molding set and method for manufacturing microneedle patches using the same Download PDFInfo
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- TWI817854B TWI817854B TW111145738A TW111145738A TWI817854B TW I817854 B TWI817854 B TW I817854B TW 111145738 A TW111145738 A TW 111145738A TW 111145738 A TW111145738 A TW 111145738A TW I817854 B TWI817854 B TW I817854B
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- 238000004519 manufacturing process Methods 0.000 title claims description 34
- 238000000034 method Methods 0.000 title claims description 23
- 238000000465 moulding Methods 0.000 title abstract description 21
- 239000000243 solution Substances 0.000 claims description 27
- 238000002347 injection Methods 0.000 claims description 24
- 239000007924 injection Substances 0.000 claims description 24
- 238000000605 extraction Methods 0.000 claims description 12
- 230000010412 perfusion Effects 0.000 claims description 10
- 238000001802 infusion Methods 0.000 claims description 2
- 238000005516 engineering process Methods 0.000 description 26
- 238000000520 microinjection Methods 0.000 description 12
- 238000010586 diagram Methods 0.000 description 11
- 238000013461 design Methods 0.000 description 8
- 238000010146 3D printing Methods 0.000 description 6
- 238000005086 pumping Methods 0.000 description 6
- 239000002861 polymer material Substances 0.000 description 5
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 238000007711 solidification Methods 0.000 description 2
- 230000008023 solidification Effects 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 238000007605 air drying Methods 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 230000037317 transdermal delivery Effects 0.000 description 1
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Abstract
Description
本揭露係有關於一種微針模具組，特別是一種可用於微射出成型技術製作微針貼片的微針模具組。本揭露還涉及此使用此微針模具組製造微針貼片的方法。 The present disclosure relates to a microneedle mold set, particularly a microneedle mold set that can be used to produce microneedle patches using microinjection molding technology. The present disclosure also relates to a method of manufacturing a microneedle patch using the microneedle mold set.
微針貼片已成為新一代經皮傳送藥物或活性物質的有效方式，藉由微針能以有效且幾近無痛的方式，將藥物或活性物質穩定傳輸至皮下組織或血液中。目前量產製造微針貼片的方式，包括離心方式或是鼓風拉伸風乾法製作方式。離心方式在製作時微針貼片時，需將微針配方溶液以離心方式引入細小的微針模孔內，且離心時間至少需要30分鐘以上，並不適合用於量產製程；而鼓風拉伸風乾法受限於此方法的製造特性，微針不僅無法依照設計的長度生產，且因微針乾燥固化成型後的切斷及拉伸斷裂過程，會不可控地生產出針體形狀呈現不規則狀且微針長度不一的產品，導致微針貼片無法穩定傳輸藥物。 Microneedle patches have become a new generation of effective means of transdermal delivery of drugs or active substances. Microneedles can stably transport drugs or active substances into subcutaneous tissue or blood in an effective and almost painless manner. The current mass production methods for manufacturing microneedle patches include centrifugal method or air-blast stretching and air-drying method. When using the centrifugal method to make microneedle patches, the microneedle formula solution needs to be introduced into the tiny microneedle mold holes in a centrifugal method, and the centrifugation time needs to be at least 30 minutes, which is not suitable for mass production processes; while air blast pulling The air-expanded drying method is limited by the manufacturing characteristics of this method. Not only can microneedles not be produced according to the designed length, but also due to the cutting and tensile breaking process after drying and solidification of microneedles, the shape of the needle body will be uncontrollably produced and the shape will be different. Products with regular shapes and different microneedle lengths make the microneedle patch unable to deliver drugs stably.
進一步考量傳統微針在使用時，微針的長短、大小、分佈等特性，並無法針對不同使用者的皮膚表面特性或皮下血管分佈情況來進行特定設計，因此，本揭露發明人於先前專利申請案中(TWI698263)已揭露一種微針元件的製造方法與微針模具的製造方法，其係利用干涉掃描技術來取得使用者 皮膚組織之直向剖面資料及橫向剖面資料，並根據所獲得的資料來取得皮膚模型，藉此來建立微針模板，使微針能更精確地被設計及生產出來。 Further consideration is given to the characteristics of the length, size, distribution and other characteristics of the microneedles when using traditional microneedles, which cannot be specifically designed according to the skin surface characteristics or subcutaneous blood vessel distribution of different users. Therefore, the inventor of the present disclosure has proposed in a previous patent application The case (TWI698263) has disclosed a method for manufacturing microneedle components and a method for manufacturing microneedle molds, which uses interference scanning technology to obtain user information. The vertical section data and transverse section data of the skin tissue are obtained, and the skin model is obtained based on the obtained data to establish a microneedle template so that the microneedle can be designed and produced more accurately.
一般製作微針模板可以選用適合的母模材料以及加工工法來製作，例如：先前技術(TWI725900)曾在一基板上以雷射方法加工複數個微米或奈米孔穴，以獲得一母模；以該母模為模板，再以一矽膠材料進行翻模，以獲得具微針結構之模板。又例如：先前技術(CN103568160A)採用微機電技術或者在基材上製作微針陣列的母模結構，並在母模上澆注第一類聚合物材料，待固化成型後脫模，得到微針陣列的母模結構相反結構的微針陣列模具，再將第二類聚合物材料加入到微針陣列模具的上表面，透過加熱使第二類聚合物材料軟化，再斷絕熱源，以機械壓力把軟化的第二類聚合物材料壓入所述微針陣列模具上的微孔內，待冷卻、脫模後，待到聚合物材料微針陣列貼片。 Generally, microneedle templates can be made by selecting suitable master mold materials and processing methods. For example, the previous technology (TWI725900) used laser processing to process a plurality of micron or nano holes on a substrate to obtain a master mold; The master mold is used as a template, and a silicone material is used to flip the mold over to obtain a template with a microneedle structure. Another example: the previous technology (CN103568160A) uses micro-electromechanical technology or makes a master mold structure of a microneedle array on a substrate, and pours the first type of polymer material on the master mold. After solidification and molding, it is demoulded to obtain a microneedle array. Create a microneedle array mold with the opposite structure of the master mold, and then add the second type of polymer material to the upper surface of the microneedle array mold, soften the second type of polymer material through heating, then cut off the heat source, and use mechanical pressure to soften the The second type of polymer material is pressed into the micropores on the microneedle array mold, and after cooling and demoulding, the polymer material microneedle array is patched.
先前技術製作微針貼片大多涉及母模再翻模，不僅需要較多工序，所獲得的微針貼片也容易因翻模而失真。再者，如先前所述，在灌注微針配方溶液時，大多採用離心方式來進行，又或者利用上述機械壓力方式，將軟化的微針配方壓入微針陣列模具上的微孔內。離心方式因耗時較長，較不適用於量產製程，而以機械壓力方法灌模所獲得的微針貼片則容易因灌模時模具微孔內殘存氣體，而導致微針長短不一，良率不佳。 The production of microneedle patches using the previous technology mostly involves re-molding the master mold, which not only requires more processes, but also results in microneedle patches that are easily distorted due to the re-molding. Furthermore, as mentioned previously, when infusing the microneedle formula solution, most methods are centrifuged, or the softened microneedle formula is pressed into the micropores on the microneedle array mold using the above-mentioned mechanical pressure method. The centrifugal method takes a long time and is less suitable for mass production processes. Microneedle patches obtained by filling molds with mechanical pressure are prone to residual gas in the micropores of the mold during molding, resulting in uneven microneedle lengths. , poor yield.
有鑑於上述微針貼片製作過程的種種缺失，本揭露發明人利用干涉掃描技術來取得使用者皮膚組織之直向剖面資料及橫向剖面資料，並根據所獲得的資料來取得皮膚模型，藉此來建立三維微針模板資料，再以3D列印技術製作出更精確符合皮膚模型的三維微針模板。再者，本揭露發明人進一步將 微射出技術應用於微針配方溶液灌注，再搭配微針模具組的設計，得以更快速、更方便、良率更好的方式來製作微針貼片，並可應用於大量生產製程。 In view of the various shortcomings in the above-mentioned microneedle patch production process, the inventor of the present disclosure uses interference scanning technology to obtain vertical and horizontal cross-sectional data of the user's skin tissue, and obtains a skin model based on the obtained data. To create three-dimensional microneedle template data, and then use 3D printing technology to produce a more accurate three-dimensional microneedle template that fits the skin model. Furthermore, the inventor of the present disclosure further Micro-injection technology is applied to the infusion of microneedle formula solutions, and coupled with the design of microneedle mold sets, microneedle patches can be produced in a faster, more convenient and yield-producing manner, and can be applied to mass production processes.
本揭露提供一種微針模具組，至少包括保壓上蓋、二向連接頭、通道、微針模板、橡膠墊圈、保壓下蓋以及鎖固裝置。保壓上蓋具有內部空間及外部表面，內部空間具有頂部表面、側表面及向下開口。二向連接頭設置於保壓上蓋之外部表面。通道由頂部表面貫通保壓上蓋，以使內部空間與外部表面之二向連接頭連通。微針模板具有上表面、下表面及側表面。上表面具有複數個微針模孔，各個微針模孔開口設有澆口，各個澆口之間以流道連接，流道及澆口用以引導溶液進入微針模孔內。橡膠墊圈套設於微針模板之側表面。鎖固裝置用以將組裝後之微針模具組之保壓上蓋及保壓下蓋密合鎖固。其中，微針模具組裝時將微針模板套設橡膠墊圈後，再以保壓上蓋之內部空間將其覆蓋並容置，使微針模板之上表面與內部空間之頂部表面緊密貼合，且橡膠墊圈與內部空間之側表面緊密貼合，微針模板之下表面不凸出內部空間之向下開口。接著再以保壓下蓋覆蓋內部空間之向下開口，並以鎖固裝置將保壓上蓋與保壓下蓋相互鎖固，使兩者密合。 The present disclosure provides a microneedle mold set, which at least includes a pressure-maintaining upper cover, a two-way connector, a channel, a microneedle template, a rubber gasket, a pressure-maintaining lower cover, and a locking device. The pressure-maintaining upper cover has an internal space and an external surface, and the internal space has a top surface, a side surface and a downward opening. The two-way connector is arranged on the outer surface of the pressure-maintaining upper cover. The channel runs through the pressure-maintaining upper cover from the top surface to connect the two-way connector between the internal space and the external surface. The microneedle template has an upper surface, a lower surface and a side surface. The upper surface has a plurality of microneedle mold holes. Each microneedle mold hole opening is provided with a gate. The gates are connected by flow channels. The flow channels and gates are used to guide the solution into the microneedle mold holes. The rubber gasket is set on the side surface of the microneedle template. The locking device is used to tightly lock the pressure-maintaining upper cover and pressure-maintaining lower cover of the assembled microneedle mold set. Among them, when assembling the microneedle mold, the microneedle template is covered with a rubber gasket, and then the internal space of the pressure-maintaining upper cover is used to cover and accommodate it, so that the upper surface of the microneedle template closely fits the top surface of the internal space, and The rubber gasket is in close contact with the side surface of the internal space, and the lower surface of the microneedle template does not protrude from the downward opening of the internal space. Then, the pressure-maintaining lower cover is used to cover the downward opening of the internal space, and a locking device is used to lock the pressure-maintaining upper cover and the pressure-maintaining lower cover to each other so that the two are tightly sealed.
在本揭露之一實施例中，各個微針模孔之形狀可以是倒圓錐體、倒三角錐體、倒四角錐體中之任一種或其組合。 In one embodiment of the present disclosure, the shape of each microneedle mold hole may be any one of an inverted cone, an inverted triangular pyramid, an inverted quadrangular pyramid, or a combination thereof.
在本揭露之一實施例中，各個微針模孔之形狀可以是倒圓錐體、倒三角錐體、倒四角錐體中之任一種或其組合，且該微針模孔開口孔徑或邊長不大於1mm。 In one embodiment of the present disclosure, the shape of each microneedle mold hole can be any one of an inverted cone, an inverted triangular pyramid, an inverted quadrangular pyramid, or a combination thereof, and the opening aperture or side length of the microneedle mold hole Not larger than 1mm.
在本揭露之一實施例中，各個微針模孔之深度可以是相同深度或不相同深度。 In an embodiment of the present disclosure, the depths of the microneedle mold holes may be the same depth or different depths.
在本揭露之一實施例中，各個微針模孔深度不大於2mm。 In one embodiment of the present disclosure, the depth of each microneedle mold hole is no greater than 2 mm.
在本揭露之一實施例中，各個微針模孔之間距可以是相同間距或不相同間距。 In an embodiment of the present disclosure, the spacing between microneedle mold holes may be the same spacing or different spacings.
在本揭露之一實施例中，流道可以是H型流道或S型流道之任一種或其組合。 In an embodiment of the present disclosure, the flow channel may be any one of an H-shaped flow channel or an S-shaped flow channel or a combination thereof.
在本揭露之一實施例中，流道截面可以是矩形、圓弧形、圓形或梯形。 In an embodiment of the present disclosure, the cross section of the flow channel may be rectangular, arc-shaped, circular or trapezoidal.
本揭露進一步提出一種微針貼片之製造方法，至少包括以下步驟：提供一如上述任一實施例之微針模具組；將一注射裝置以注射管路連接至微針模具組之二向連接頭之一開口；再將一抽氣裝置以抽氣管路連接至微針模具組之二向連接頭之另一開口；啟動注射裝置，以一灌注流速將一體積之微針貼片配方溶液灌注進入微針模具組內，直到灌注結束後關閉注射裝置；啟動該抽氣裝置對微針模具組進行抽氣，使微針模具組內部空間之微針模孔內的殘存氣體排除；待微針貼片配方溶液固化後進行脫模，完成後即可得一微針貼片。 The present disclosure further proposes a method for manufacturing a microneedle patch, which at least includes the following steps: providing a microneedle mold set as in any of the above embodiments; connecting an injection device with an injection pipeline to the two-way connection of the microneedle mold set One opening of the head; then connect an air extraction device with an air extraction pipeline to the other opening of the two-way connector of the microneedle mold set; start the injection device and inject a volume of microneedle patch formula solution at a perfusion flow rate Enter the microneedle mold set and close the injection device after the perfusion is completed; start the air extraction device to evacuate the microneedle mold set so that the residual gas in the microneedle mold holes in the internal space of the microneedle mold set is eliminated; wait until the microneedle After the patch formula solution is solidified, it is demoulded. After completion, a microneedle patch can be obtained.
10:微針模具組 10: Microneedle mold set
100:保壓上蓋 100: Pressure-maintaining upper cover
101:內部空間 101:Internal space
1011:頂部表面 1011: Top surface
1012:通道 1012:Channel
1013:向下開口 1013:Open downward
1014:內部空間側表面 1014: Internal space side surface
102:外部表面 102:External surface
103:二向連接頭 103: Two-way connector
200:微針模板 200: Microneedle template
201:微針模板之上表面 201: Upper surface of microneedle template
2011:微針模孔 2011: Microneedle mold hole
2012:S型流道 2012:S-type flow channel
2013:澆口 2013: Gate
2014:H型流道 2014:H-type flow channel
202:微針模板之側表面 202: Side surface of microneedle template
203:微針模板之下表面 203: Lower surface of microneedle template
300:橡膠墊圈 300:Rubber gasket
400:保壓下蓋 400: pressure maintaining lower cover
500:鎖固裝置 500: Locking device
S5a~S5f:步驟流程 S5a~S5f: step process
第1圖為本揭露之一實施例之微針模具組結構圖。 Figure 1 is a structural diagram of a microneedle mold set according to an embodiment of the present disclosure.
第2A圖為本揭露之一實施例之微針模具組之保壓上蓋結構圖。 Figure 2A is a structural diagram of the pressure-maintaining upper cover of the microneedle mold set according to an embodiment of the present disclosure.
第2B圖為本揭露之一實施例之微針模具組之保壓上蓋剖面圖。 Figure 2B is a cross-sectional view of the pressure-maintaining upper cover of the microneedle mold set according to one embodiment of the present disclosure.
第3A圖至第3C圖為本揭露之一實施例之微針模板結構示意圖。 Figures 3A to 3C are schematic structural diagrams of a microneedle template according to an embodiment of the present disclosure.
第4A圖為本揭露之一實施例之微針模孔形狀的第一示意圖。 Figure 4A is a first schematic diagram of the shape of the microneedle mold hole according to an embodiment of the present disclosure.
第4B圖為本揭露之一實施例之微針模孔形狀的第二示意圖。 Figure 4B is a second schematic diagram of the shape of the microneedle mold hole according to an embodiment of the present disclosure.
第4C圖為本揭露之一實施例之微針模孔形狀的第三示意圖。 Figure 4C is a third schematic diagram of the shape of the microneedle mold hole according to an embodiment of the present disclosure.
第5圖為本揭露之一實施例之微針貼片之製造方法流程圖。 Figure 5 is a flow chart of a manufacturing method of a microneedle patch according to an embodiment of the present disclosure.
以下將參照相關圖式，說明本揭露之微針模具組及使用該微針模具組製造微針貼片的方法之實施例，為了清楚與方便圖式說明之故，圖式中的各部件在尺寸與比例上可能會被誇大或縮小地呈現。在以下描述及/或申請專利範圍中，當提及元件「連接」或「耦合」至另一元件時，其可直接連接或耦合至該另一元件或可存在介入元件；而當提及元件「直接連接」或「直接耦合」至另一元件時，不存在介入元件，用於描述元件或層之間之關係之其他字詞應以相同方式解釋。為使便於理解，下述實施例中之相同元件係以相同之符號標示來說明。 The following will describe embodiments of the microneedle mold set of the present disclosure and the method of manufacturing microneedle patches using the microneedle mold set with reference to the relevant drawings. For the sake of clarity and convenience in the illustration of the drawings, each component in the drawings is Size and proportions may be exaggerated or reduced. In the following description and/or patent claims, when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may be present; and when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may be present; When a component is "directly connected" or "directly coupled" to another component, there are no intervening components present, and other words used to describe the relationship between components or layers should be interpreted in a like manner. To facilitate understanding, the same components in the following embodiments are labeled with the same symbols for description.
請參閱第1圖，其係為本揭露之一實施例之一種微針模具組結構圖之結構示意圖。如圖所示，在本實施例中，微針模具組10至少包括保壓上蓋100、微針模板200、橡膠墊圈300、保壓下蓋400以及鎖固裝置500。保壓上蓋100具有二向連接頭103，設置於保壓上蓋100之外部表面102。
Please refer to Figure 1, which is a schematic structural diagram of a microneedle mold set according to an embodiment of the present disclosure. As shown in the figure, in this embodiment, the microneedle mold set 10 at least includes a pressure-maintaining
請參閱第2A圖及第2B圖，其係為本揭露之一實施例中所述微針模具組10之保壓上蓋100的結構圖及其剖面圖。在本實施例中，該保壓上蓋100具有內部空間101及外部表面102，內部空間101具有頂部表面1011、側表面1014及向下開口1013。二向連接頭103設置於保壓上蓋100之外部表面102。通
道1012由頂部表面1011貫通保壓上蓋100，以使內部空間101與外部表面102之二向連接頭103連通。
Please refer to Figures 2A and 2B, which are structural views and cross-sectional views of the pressure-maintaining
請參閱第3A圖至第3C圖，其係為本揭露之一實施例之微針模板200結構示意圖。如第3A圖所示，在本實施例中所示之微針模板200具有上表面201、下表面203及側表面202。其中，在一實施例中，如第3B圖所示，上表面201具有複數個微針模孔2011，各微針模孔2011開口設有澆口2013，各澆口之間以S型流道2012連接，S型流道2012及澆口2013用以引導溶液進入微針模孔2011。在另一實施例中，如第3C圖所示，各澆口2013之間是以H型流道2014連接，H型流道2014及澆口2013用以引導溶液進入微針模孔2011。
Please refer to Figures 3A to 3C, which are schematic structural diagrams of the
進一步說明，本揭露之一實施例之一種微針模具組10至少包括保壓上蓋100、二向連接頭103、通道1012、微針模板200、橡膠墊圈300、保壓下蓋400以及鎖固裝置500。保壓上蓋100其具有內部空間101及外部表面102。內部空間具有頂部表面1011、側表面1014及向下開口1013。二向連接頭103設置於保壓上蓋100之外部表面102。通道1012由頂部表面1011貫通保壓上蓋100，以使內部空間101與外部表面102之二向連接頭103連通。微針模板200具有上表面201、下表面203及側表面202。其中，上表面201具有複數個微針模孔2011，各微針模孔2011開口設有澆口2013，各澆口之間以S型流道2012(如第3B圖所示)或H型流道2014(如第3C圖所示)連接，S型流道或H型流道及澆口用以引導溶液進入微針模孔內。橡膠墊圈300套設於微針模板200之側表面202。鎖固裝置500用以將組裝後之微針模具組10之保壓上蓋100及保壓下蓋400密合鎖固。其中，微針模具組10組裝時，將微針模板200套設橡膠墊圈300後，再以保壓上蓋100之內部空間101將其覆蓋並容置，使微針模板200之上表面201與內部
空間101之頂部表面1011緊密貼合，且橡膠墊圈300與內部空間101之側表面1014緊密貼合。其中，微針模板200之下表面203不凸出內部空間101之向下開口1013。然後，再以保壓下蓋400覆蓋該內部空間101之向下開口1013，並以鎖固裝置500將保壓上蓋100與保壓下蓋400相互鎖固，使兩者密合。
To further explain, a microneedle mold set 10 according to an embodiment of the present disclosure at least includes a pressure-maintaining
在本揭露之一實施例中，發明人利用先前揭露之微針模板之製造方法，先利用干涉掃描技術來取得使用者皮膚組織之直向剖面資料及橫向剖面資料，並根據所獲得的資料來取得皮膚模型，藉此來建立三維微針模板資料，再以3D列印技術製作出更精確符合皮膚模型的三維微針模板。因此，在一實施例中所述微針模孔2011在微針模板200上表面201的排列位置、形狀、大小以及微針深度等，皆可依據上述模型來設計。
In one embodiment of the present disclosure, the inventor uses the previously disclosed manufacturing method of microneedle templates, first uses interference scanning technology to obtain vertical and horizontal cross-sectional data of the user's skin tissue, and based on the obtained data, Obtain the skin model to create three-dimensional microneedle template data, and then use 3D printing technology to produce a three-dimensional microneedle template that more accurately matches the skin model. Therefore, in one embodiment, the arrangement position, shape, size, and microneedle depth of the
請參閱第4A圖~第4C圖，其為本揭露之一實施例之微針模孔形狀的第一示意圖、第二示意圖及第三示意圖。如第4A圖所示，各個微針模孔2011的形狀可以是如第4A圖所示之倒圓錐體。如第4B圖所示，各個微針模孔2011的形狀可以是如第4B圖所示之倒三角錐體。如第4B圖所示，各個微針模孔2011的形狀可以是如第4C圖所示之倒四角錐體。在另一實施例中，各個微針模孔2011的形狀可以是倒圓錐體、倒三角錐體、倒四角錐體中之任一種或其組合，且微針模孔2011開口孔徑或邊長不大於1mm。
Please refer to Figures 4A to 4C, which are the first schematic diagram, the second schematic diagram and the third schematic diagram of the shape of the microneedle mold hole according to an embodiment of the present disclosure. As shown in Figure 4A, the shape of each
在另一實施例中，上述各個微針模孔之深度可以是相同深度或不相同深度；在一實施例中，上述各微針模孔深度不大於2mm。例如：在一實施例中，所述各微針模孔深度係依據皮膚模型的資料來設計，該微針模孔深度係介於250um~1.8mm之間、介於300um~1.6mm之間、介於310um~1.4 mm之間、介於320um~1.2mm之間、介於330um~1.0mm之間、介於335um~800um之間。 In another embodiment, the depths of each of the microneedle mold holes may be the same depth or different depths; in one embodiment, the depth of each of the microneedle mold holes is not greater than 2 mm. For example: in one embodiment, the depth of each microneedle mold hole is designed based on the data of the skin model, and the depth of the microneedle mold hole is between 250um~1.8mm, between 300um~1.6mm, Between 310um~1.4 mm, between 320um~1.2mm, between 330um~1.0mm, between 335um~800um.
在一實施例中，所述微針模板200上表面201的各個微針模孔2011之間的間距可以是相同間距或是不相同間距。例如，各個微針模孔之排列可以是矩陣式或非矩陣式的排列方式，也可以是依照皮膚模型來進行微針模孔的排列，以避開皮下血管。
In one embodiment, the spacing between the
本揭露之一種微針模具組10利用微射出成型技術來設計微針模具組10，使其可應用微射出成型技術來快速量產高良率之微針貼片，同時也可以藉由獲取皮膚模型並合併3D列印技術，來客製化微針貼片產品。因此，本揭露在微針模板200的設計上，在各個微針模孔2011的開口設有澆口2013，各澆口2013再經由流道連接起來，流道的設計可以依據各微針模孔的位置來設計，例如：在一實施例中，上述流道是如第3B圖所示之S型流道2012；而在另一實施例中，上述流道則是如第3C圖所示之H型流道2014。此外，為配合皮膚模型所安排的微針模孔2011的位置，上述流道也可以是S型流道2012及H型流道2014相互搭配應用，也可以是非特定形狀的流道。本技術領域之通常知識者應可在不悖離本揭露之設計概念下進行均等修飾。
The microneedle mold set 10 disclosed in this disclosure uses microinjection molding technology to design the microneedle mold set 10 so that it can use microinjection molding technology to quickly mass-produce microneedle patches with high yield, and at the same time, it can also obtain skin models. And incorporate 3D printing technology to customize microneedle patch products. Therefore, in the design of the
此外，考量微針配方溶液可能因配方不同而有不同之黏度，在使用微射出成型技術灌注時，微針配方溶液在流道流動可能會受到阻力，因此，本揭露之一實施例中，其中，微針模板200上的流道之截面形狀，可以設計成矩形、圓弧形、圓形或梯形，以減少微針配方溶液在流道流動時的阻力。
In addition, considering that the microneedle formula solution may have different viscosities due to different formulas, when infused using micro-injection molding technology, the microneedle formula solution may encounter resistance in the flow channel. Therefore, in one embodiment of the present disclosure, where The cross-sectional shape of the flow channel on the
請參閱第5圖，其係為本揭露之一實施例之一種微針貼片之製造方法流程圖。如圖所示，本實施例之微針貼片之製造方法，至少包括以下步驟： Please refer to Figure 5, which is a flow chart of a manufacturing method of a microneedle patch according to one embodiment of the present disclosure. As shown in the figure, the manufacturing method of the microneedle patch of this embodiment includes at least the following steps:
步驟S5a：提供上述任一實施例之微針模具組。本揭露之一種微針貼片之製造方法係利用微射出成型技術來製作微針貼片，因此所使用之微針模具組，係為上述任一實施例之任一種微針模具組，其整合微針模板模型設計及3D列印鑄模技術來製作微針模板，再將微針模板搭配保壓上蓋及保壓下蓋等元件，組成適用於以微射出成型技術製作微針貼片之微針模具組。 Step S5a: Provide the microneedle mold set of any of the above embodiments. The manufacturing method of the microneedle patch disclosed in the present disclosure uses micro-injection molding technology to manufacture the microneedle patch. Therefore, the microneedle mold set used is any of the microneedle mold sets of any of the above embodiments, and its integration Microneedle template model design and 3D printing molding technology are used to produce the microneedle template, and then the microneedle template is combined with components such as a pressure-maintaining upper cover and a pressure-maintaining lower cover to form a microneedle suitable for making microneedle patches using micro-injection molding technology. Mold set.
步驟S5b：將注射裝置以注射管路連接至微針模具組之二向連接頭之開口。在一實施例中，注射裝置為微量注射幫浦，可設定灌注溶液的流速及單位時間內灌注的溶液體積。 Step S5b: Connect the injection device to the opening of the two-way connector of the microneedle mold set using the injection pipeline. In one embodiment, the injection device is a microinjection pump, which can set the flow rate of the perfusion solution and the volume of the perfusion solution per unit time.
步驟S5c：將抽氣裝置以抽氣管路連接至微針模具組之二向連接頭之另一開口。 Step S5c: Connect the air extraction device with the air extraction pipeline to the other opening of the two-way connector of the microneedle mold set.
步驟S5d：啟動注射裝置，以一灌注流速將一體積之微針貼片配方溶液灌注進入微針模具組內，直到灌注結束後關閉注射裝置。本領域之通常知識者應能理解，由於微針貼片配方溶液會因其組成分的不同而具有不同的配方溶液黏度，因此，所使用之灌注流速主要是透過注射幫浦來調整，依配方溶液黏度及微針模板的設計來調整灌注流速區間。例如：在一實施例中，所使用的灌注流速區間為0.5ml/min~2.0ml/min。應了解，當注射幫浦啟動後，開始對微針模具組進行灌注一體積之微針貼片配方溶液時，會對微針模具組內部空間施予壓力，即如微注射成型技術，將配方溶液以上述壓力進行灌模，有助於加速灌注成型速度。 Step S5d: Start the injection device, pour a volume of the microneedle patch formula solution into the microneedle mold set at a perfusion flow rate, and close the injection device after the perfusion is completed. Those with ordinary knowledge in the field should be able to understand that since the microneedle patch formula solution will have different viscosity of the formula solution due to different components, the perfusion flow rate used is mainly adjusted through the injection pump, depending on the formula. The solution viscosity and the design of the microneedle template are used to adjust the perfusion flow rate range. For example: in one embodiment, the perfusion flow rate range used is 0.5ml/min~2.0ml/min. It should be understood that when the injection pump is started and a volume of microneedle patch formula solution is poured into the microneedle mold set, pressure will be exerted on the internal space of the microneedle mold set. That is, like micro-injection molding technology, the formula will be The solution is poured into the mold at the above pressure, which helps to speed up the injection molding speed.
步驟S5e：啟動抽氣裝置對微針模具組進行抽氣，使微針模具組內部空間之微針模孔內的殘存氣體排除。一般而言，當微針配方溶液黏度較高時，其溶液流動性較差，較不易完整灌注微針模孔，常會發生有氣體殘存在微針模孔內，因此，本揭露之製造方法利用抽氣裝置，對已完成灌注之微針模具組進行抽氣，使殘存於微針模孔內之氣體得以排除。 Step S5e: Start the air extraction device to evacuate the microneedle mold set so that the residual gas in the microneedle mold holes in the internal space of the microneedle mold set is eliminated. Generally speaking, when the viscosity of the microneedle formula solution is high, the fluidity of the solution is poor, and it is difficult to completely fill the microneedle mold holes. Gas will often remain in the microneedle mold holes. Therefore, the manufacturing method of the present disclosure uses pumping. The air device evacuates the filled microneedle mold set so that the gas remaining in the microneedle mold holes can be eliminated.
步驟S5f：待微針貼片配方溶液固化後進行脫模，完成後即可得微針貼片。 Step S5f: After the microneedle patch formula solution is solidified, demoulding is performed. After completion, the microneedle patch can be obtained.
上述抽氣及注射步驟亦可先進行抽氣，待微針模具組內部空間殘存氣體排除後，再開始進行注射步驟，同樣可以避免灌注時，微針模孔內殘存氣體的發生。應注意，上述抽氣或注射步驟係分開進行，且抽氣管路及注射管路各分別具有氣密閥門，當抽氣步驟進行時，先打開抽氣管路閥門並關閉注射管路閥門再進行抽氣，待抽氣完成則關閉抽氣管路閥門再打開注射管路閥門開始進行注射步驟；反之亦然。再者，本技術領域之通常知識者應能理解，上述閥門亦可設置在二向連接頭內，只要能使抽氣管路及注射管路之間維持互不相通的氣密狀態，避免相互影響即可達成相同的效果，在此並不用以侷限本發明之範疇。 The above air extraction and injection steps can also be performed by air extraction first, and then the injection step can be started after the residual gas in the internal space of the microneedle mold set is eliminated. This can also avoid the occurrence of residual gas in the microneedle mold hole during filling. It should be noted that the above-mentioned pumping or injection steps are performed separately, and the pumping pipeline and the injection pipeline each have air-tight valves. When the pumping step is carried out, first open the pumping pipeline valve and close the injection pipeline valve before pumping. After the exhaustion is completed, close the exhaust line valve and then open the injection line valve to start the injection step; vice versa. Furthermore, those of ordinary skill in the art should understand that the above-mentioned valve can also be provided in the two-way connector, as long as the air-tight state between the exhaust pipeline and the injection pipeline can be maintained to avoid mutual influence. The same effect can be achieved, and this is not intended to limit the scope of the present invention.
當然，本實施例僅用於舉例說明而非限制本揭露的範圍，根據本實施例的微針貼片之製造方法而進行的等效修改或變更仍應包含在本揭露的專利範圍內。 Of course, this embodiment is only for illustration and does not limit the scope of the present disclosure. Equivalent modifications or changes based on the manufacturing method of the microneedle patch of this embodiment should still be included in the patent scope of the present disclosure.
值得一提的是，現有的微針貼片之製造方法，大多使用離心方式來進行灌模，除了製程上涉及較為耗時的離心過程外，其操作上更需要較有 經驗者來施行，因此，不論在生產效率、製程簡化、生產成本上，根據本揭露實施例的微針貼片製造方法均具有明顯優勢。 It is worth mentioning that the existing manufacturing methods of microneedle patches mostly use centrifugal methods for mold filling. In addition to the time-consuming centrifugal process involved in the manufacturing process, the operation also requires more skill. Therefore, the microneedle patch manufacturing method according to the embodiment of the present disclosure has obvious advantages in terms of production efficiency, process simplification, and production cost.
再者，本揭露得搭配發明人先前之建模技術及3D列印鑄模技術，於一實施例中所生產之微針貼片，可依照客戶皮膚模型或使用上之需求，多樣性地客製化生產因應多種皮膚表面結構特徵的微針貼片，更具量產有靈活性。 Furthermore, this disclosure can be combined with the inventor's previous modeling technology and 3D printing molding technology. In one embodiment, the microneedle patch produced can be diversified and customized according to the customer's skin model or usage needs. Chemically produce microneedle patches that respond to a variety of skin surface structural characteristics, making mass production more flexible.
儘管本揭露描述的方法的步驟以特定順序示出和描述，但是每個方法的操作順序可以改變，也可以相反的順序執行某些步驟，或者某些步驟也與其他步驟同時執行。在另一個實施例中，不同步驟可以間歇和/或交替的方式實施。 Although the steps of the methods described in this disclosure are shown and described in a specific order, the order of operations of each method may be changed, some steps may be performed in reverse order, or some steps may be performed concurrently with other steps. In another embodiment, the different steps may be performed in an intermittent and/or alternating manner.
綜上所述，本揭露搭配皮膚建模技術、3D列印鑄模技術來製作可用於微射出成型製作方法的微針模具組，並進一步利用微射出成型技術來製作微針貼片。相對於現有的微針貼片的製造方法，本揭露可明顯有效縮短生產微針貼片的時間。再者，利用注射裝置施以壓力進行微射出成型時，藉由微針模板上澆口及流道的設計，能讓微針配方溶液更有效地流入微針模孔內，再搭配灌注完成後的抽氣步驟，得以讓微針模孔內殘存的氣體排除，提高微針的完整性及良率。依照本揭露的實施例之微針模具組及使用其製造微針貼片的製造方法，不論在生產效率、製程簡化上，均具有明顯優勢。 To sum up, this disclosure uses skin modeling technology and 3D printing casting technology to produce a microneedle mold set that can be used in micro-injection molding manufacturing methods, and further uses micro-injection molding technology to produce microneedle patches. Compared with the existing manufacturing methods of microneedle patches, the present disclosure can significantly effectively shorten the time for producing microneedle patches. Furthermore, when using the injection device to apply pressure for micro-injection molding, the design of the gate and flow channel on the microneedle template can allow the microneedle formula solution to flow into the microneedle mold hole more effectively. The air extraction step allows the remaining gas in the microneedle mold holes to be eliminated, improving the integrity and yield of the microneedle. The microneedle mold set and the manufacturing method using the same to manufacture microneedle patches according to the embodiments of the present disclosure have obvious advantages in terms of production efficiency and process simplification.
可見本揭露在突破先前之技術下，確實已達到所欲增進之功效，且也非熟悉該項技藝者所易於思及，其所具之進步性、實用性，顯已符合專利之申請要件，爰依法提出專利申請，懇請 貴局核准本件發明專利申請案，以勵創作，實感德便。 It can be seen that this disclosure has indeed achieved the desired improvement effect by breaking through the previous technology, and it is not easily imagined by those familiar with the technology. Its progress and practicality clearly meet the requirements for patent application. I have filed a patent application in accordance with the law, and I sincerely request your office to approve this application for an invention patent to encourage creation and I feel it is very convenient.
以上所述僅為舉例性，而非為限制性者。其它任何未脫離本揭露之精神與範疇，而對其進行之等效修改或變更，均應該包含於後附之申請專利範圍中。 The above is only illustrative and not restrictive. Any other equivalent modifications or changes that do not depart from the spirit and scope of this disclosure should be included in the appended patent application scope.
10:微針模具組 10: Microneedle mold set
100:保壓上蓋 100: Pressure-maintaining upper cover
101:內部空間 101:Internal space
102:外部表面 102:External surface
103:二向連接頭 103: Two-way connector
200:微針模板 200: Microneedle template
300:橡膠墊圈 300:Rubber gasket
400:保壓下蓋 400: pressure maintaining lower cover
500:鎖固裝置 500: Locking device
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6611707B1 (en) * | 1999-06-04 | 2003-08-26 | Georgia Tech Research Corporation | Microneedle drug delivery device |
| WO2008157592A1 (en) * | 2007-06-20 | 2008-12-24 | 3M Innovative Properties Company | Ultrasonic injection molding on a web |
| CN101072668B (en) * | 2004-12-07 | 2011-08-31 | 3M创新有限公司 | Method of molding a microneedle |
| CN103301092A (en) * | 2012-03-06 | 2013-09-18 | 中国科学院理化技术研究所 | Polymer micro-needle array chip and preparation method and application thereof |
-
2022
- 2022-11-29 TW TW111145738A patent/TWI817854B/en active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6611707B1 (en) * | 1999-06-04 | 2003-08-26 | Georgia Tech Research Corporation | Microneedle drug delivery device |
| CN101072668B (en) * | 2004-12-07 | 2011-08-31 | 3M创新有限公司 | Method of molding a microneedle |
| WO2008157592A1 (en) * | 2007-06-20 | 2008-12-24 | 3M Innovative Properties Company | Ultrasonic injection molding on a web |
| CN103301092A (en) * | 2012-03-06 | 2013-09-18 | 中国科学院理化技术研究所 | Polymer micro-needle array chip and preparation method and application thereof |
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