TWM602945U - Processing device for accelerating the dispersion of injection-type fillers by means of pressurization - Google Patents
Processing device for accelerating the dispersion of injection-type fillers by means of pressurization Download PDFInfo
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本創作為一種利用加壓手段以加速注射式填充物分散的處理裝置,包括:一第一容納裝置、一第二容納裝置以及一連接裝置,透過第一接口接合於第一容納裝置的第一注出口,以及第二接口接合於第二容納裝置的第二注出口,使該第一容納裝置與該第二容納裝置彼此相連通。透過交替操作第一容納裝置的第一加壓元件以及第二容納裝置的第二加壓元件,使其進行往復加壓混合的步驟,使該混合物的流速增加並形成剪切應力,從而使注射式填充物中的膠體溶質均勻地溶解於溶劑中,並且使注射式填充物中的該分散質均勻地分散於溶劑中。This creation is a processing device that uses pressurization to accelerate the dispersion of injection-type fillings. It includes: a first containing device, a second containing device, and a connecting device. The first containing device is connected to the first containing device through a first interface. The spout port and the second interface are connected to the second spout port of the second container, so that the first container and the second container communicate with each other. By alternately operating the first pressurizing element of the first containment device and the second pressurizing element of the second containment device to perform the step of reciprocating pressure and mixing, the flow rate of the mixture is increased and shear stress is formed, thereby causing injection The colloidal solute in the type filling is uniformly dissolved in the solvent, and the dispersoid in the injection type filling is uniformly dispersed in the solvent.
Description
本創作係關於一種用於加速注射式填充物分散的處理裝置,尤其是一種搭配利用往復式(back-and-forth)加壓手段,用以加速醫學美容的注射式填充物分散的處理裝置。This creation is about a processing device for accelerating the dispersion of injection-type fillings, especially a processing device that uses back-and-forth pressure to accelerate the dispersion of injection-type fillings for medical beauty.
注射式聚(D,L-乳酸)(injectable poly- D,L-lactic acid,PDLLA)是一種新興的刺激膠原蛋白增生的注射式填充物(injectable filler),可以透過注射填充於人體的軟組織,從而達成除皺、修飾輪廓或使組織豐盈等的醫學美容效果。PDLLA填充物包含PDLLA微球體(microsphere)和羥甲基纖維素(CMC)。PDLLA微球體是用於刺激膠原蛋白增生的成分,但是不溶於注射用溶劑(例如:注射用蒸餾水)中。羥甲基纖維素是一種水溶性高分子,溶解在注射用溶劑中可以成為膠體溶液,從而產生增加黏性、提供分散和懸浮作用等的效果,使PDLLA微球體能夠良好的分散並懸浮在注射用溶液中,並且,含有羥甲基纖維素的注射用溶液具有一定的黏度,在注射後可以更好地保留在目標組織中而不會轉移到其他組織。 Injectable poly (D, L- lactic acid) (injectable poly- D, L -lactic acid, PDLLA) is a new stimulation of collagen injectable fillers (injectable filler), may be filled in the soft tissue of the human body through injection, So as to achieve medical beauty effects such as wrinkle removal, contour modification or tissue plumping. The PDLLA filler contains PDLLA microspheres and hydroxymethyl cellulose (CMC). PDLLA microspheres are ingredients used to stimulate collagen proliferation, but they are insoluble in injection solvents (for example, distilled water for injection). Hydroxymethyl cellulose is a water-soluble polymer, which can become a colloidal solution when dissolved in a solvent for injection, which has the effect of increasing viscosity, providing dispersion and suspension, etc., so that PDLLA microspheres can be well dispersed and suspended in injection In addition, the injection solution containing hydroxymethyl cellulose has a certain viscosity, which can be better retained in the target tissue after injection without transferring to other tissues.
PDLLA填充物透過逐漸刺激膠原蛋白增生來達成醫學美容效果,相對於傳統上直接注射玻尿酸或膠原蛋白的方式可以使醫學美容的效果更加自然且持久。然而,在配製成注射用溶液的狀態下,PDLLA微球體由於水解而逐漸分解成乳酸,而羥甲基纖維素水膠(CMC hydrogel)也會逐漸水解。因此,PDLLA填充物在製備完成後需要透過冷凍乾燥保存,在臨用時才使用注射用溶劑加以還原(reconstitution)。PDLLA fillers gradually stimulate the proliferation of collagen to achieve medical cosmetic effects. Compared with the traditional direct injection of hyaluronic acid or collagen, the medical cosmetic effects can be more natural and lasting. However, when formulated as a solution for injection, PDLLA microspheres are gradually decomposed into lactic acid due to hydrolysis, and CMC hydrogel will also be gradually hydrolyzed. Therefore, the PDLLA filling needs to be freeze-dried and stored after the preparation is completed, and the injection solvent is used for reconstitution before use.
在上述還原步驟中,通常是將注射用溶劑添加到裝有冷凍乾燥的PDLLA填充物的樣品瓶中,並密封樣品瓶或轉移到離心管(或微量離心管)中進行混合。傳統上混合的方式分為手搖法(hand-shaking method)和旋渦法(vortex method)。在所需的填充物濃度較低的情況下,例如,以8mL的溶劑還原200mg的PDLLA填充物的情況下,可以使用手搖法進行混合,但是往往需要超過30分鐘才能將其混合均勻。並且,在所需的填充物濃度較高的情況下,例如,以1.4mL的溶劑還原200mg的PDLLA填充物的情況下,較適合使用旋渦法進行混合。即,將裝有填充物和溶劑的樣品瓶或離心管放置在漩渦產生器(vortex generator)的振盪平台上然後下壓,以2700rpm的轉速使液體產生漩渦以輔助混合。然而,在上述濃度較高的情況下,即使透過旋渦法進行混合,需要超過1小時才能將其混合均勻。In the above reduction step, the injection solvent is usually added to a sample bottle containing freeze-dried PDLLA filling, and the sample bottle is sealed or transferred to a centrifuge tube (or microcentrifuge tube) for mixing. The traditional mixing method is divided into hand-shaking method and vortex method. In the case where the required filler concentration is low, for example, in the case of reducing 200 mg of PDLLA filler with 8 mL of solvent, the hand shake method can be used for mixing, but it often takes more than 30 minutes to mix it uniformly. In addition, when the required filler concentration is high, for example, when 200 mg of PDLLA filler is reduced with 1.4 mL of solvent, it is more suitable to use the vortex method for mixing. That is, the sample bottle or centrifuge tube filled with the filler and the solvent is placed on the vortex generator (vortex generator) oscillating platform and then pressed down, and the liquid is vortexed at 2700 rpm to aid mixing. However, in the case of the above-mentioned high concentration, even if the mixing is performed by the vortex method, it takes more than 1 hour to mix it uniformly.
並且,在上述使用手搖法或旋渦法的傳統臨用現配方法中存在的缺點是,即使透過旋渦法對流體產生高於手搖法的剪切力,以加速和提升PDLLA填充物在添加溶劑還原時的分散速度和效果,仍然相當耗時,而且在均勻分散後靜置30分鐘後,仍然會產生溶劑與填充物分層的現象(如圖13所示),使得傳統的臨用現配方法的使用條件更為嚴苛。對於相似的注射式聚(L-乳酸)(injectable PLLA)產品(包含PLLA、CMC和甘露醇),更需要耗時48小時才能均勻分散。Moreover, the disadvantage of the above-mentioned traditional method of using hand-crank method or vortex method is that even if the vortex method produces a higher shear force on the fluid than the hand-crank method, it accelerates and enhances the PDLLA filler. The dispersing speed and effect during solvent reduction are still quite time-consuming, and after being evenly dispersed, after standing for 30 minutes, there will still be the phenomenon of solvent and filler layering (as shown in Figure 13), making the traditional temporary use The conditions of use of the formulation method are more stringent. For similar injectable poly(L-lactic acid) (injectable PLLA) products (including PLLA, CMC and mannitol), it takes 48 hours to evenly disperse.
不能夠均勻分散的注射用填充物溶液,除了會造成目標組織的醫學美容效果不均勻之外,還可能因為填充物的聚集現象而產生丘疹(papule)、小瘤(nodule)等併發症。Filler solutions for injection that cannot be uniformly dispersed will not only cause uneven medical cosmetic effects of the target tissue, but also may cause complications such as papules and nodules due to the aggregation of fillers.
有鑒於上述問題,需要一種利用加壓手段以加速注射式填充物分散的處理裝置,相較於傳統運用旋渦產生器的方法能夠提供更大的剪切力,從而能夠防止注射式填充物聚集,以縮短注射式填充物的分散所需時間,並且能夠提升其分散效果和穩定性。In view of the above problems, there is a need for a processing device that uses pressurization to accelerate the dispersion of injection-type fillings. Compared with the traditional method using vortex generators, it can provide greater shear force, thereby preventing the injection-type filling from gathering. In order to shorten the time required for the dispersion of injection-type fillers, and can improve its dispersion effect and stability.
本創作之主要目的在提供一種利用加壓手段以加速注射式填充物分散的處理裝置,包括:一第一容納裝置,具有一第一容納本體及一第一加壓元件,該第一容納本體具有一第一容納空間及一第一注出口,該第一注出口之口徑小於該第一容納空間之內徑,該第一加壓元件可動地結合於該第一容納本體之第一容納空間中,透過該第一加壓元件之作動以改變該第一容納空間的容積;一第二容納裝置,具有一第二容納本體及一第二加壓元件,該第二容納本體具有一第二容納空間及一第二注出口,該第二注出口之口徑小於該第二容納空間之內徑,該第二加壓元件可動地結合於該第二容納本體之第二容納空間中,透過該第二加壓元件之作動以改變該第二容納空間的容積;以及一連接裝置,具有一第一接口、一第二接口及連通該第一接口及該第二接口的一通道,透過該第一接口接合於該第一容納裝置的第一注出口,以及該第二接口接合於該第二容納裝置的第二注出口,使該第一容納裝置與該第二容納裝置彼此相連通;其中,在該第一容納裝置的第一容納空間裝載有一預定量的溶劑,並在該第二容納裝置的該第二容納空間中裝載有一注射式填充物,該注射式填充物包含可溶於該溶劑的膠體溶質和不溶於該溶劑的分散質,透過交替操作該第一容納裝置的第一加壓元件以及該第二容納裝置的第二加壓元件,使該溶劑受到加壓地進入該第二容納裝置的第二容納空間以使該注射式填充物和該溶劑形成一混合物,並在排除多餘空氣後,使該混合物受到加壓地再由該第二容納空間進入該第一容納裝置的第一容納空間,透過此種往復加壓混合的步驟,使該混合物的流速增加並形成剪切應力,從而使該注射式填充物中的該膠體溶質均勻地溶解於該溶劑中,並且使該注射式填充物中的該分散質均勻地分散於該溶劑中。The main purpose of this creation is to provide a processing device that uses pressurization to accelerate the dispersion of injection-type fillings, including: a first containing device having a first containing body and a first pressing element, the first containing body It has a first accommodating space and a first spout, the diameter of the first spout is smaller than the inner diameter of the first accommodating space, and the first pressing element is movably coupled to the first accommodating space of the first accommodating body The volume of the first accommodating space is changed through the action of the first pressing element; a second accommodating device has a second accommodating body and a second pressing element, and the second accommodating body has a second The accommodating space and a second injection port, the diameter of the second injection port is smaller than the inner diameter of the second accommodating space, the second pressing element is movably combined in the second accommodating space of the second accommodating body, and passes through the The actuation of the second pressurizing element changes the volume of the second accommodating space; and a connecting device having a first interface, a second interface, and a channel connecting the first interface and the second interface, through the first interface An interface is connected to the first spout port of the first container, and the second interface is connected to the second spout port of the second container, so that the first container and the second container communicate with each other; wherein , The first containing space of the first containing device is loaded with a predetermined amount of solvent, and the second containing space of the second containing device is loaded with an injectable filler, the injectable filler containing soluble The colloidal solute of the solvent and the dispersant insoluble in the solvent, by alternately operating the first pressing element of the first containing device and the second pressing element of the second containing device, the solvent is pressurized to enter the first The second accommodating space of the second accommodating device so that the injection-type filling and the solvent form a mixture, and after removing excess air, the mixture is pressurized and then enters the first accommodating device from the second accommodating space In the first containing space, through the step of reciprocating pressure mixing, the flow rate of the mixture is increased and shear stress is formed, so that the colloidal solute in the injection-type filling is uniformly dissolved in the solvent, and the The dispersion in the injection-type filling is uniformly dispersed in the solvent.
較佳地,其中該第一容納裝置為注射器。Preferably, the first containing device is a syringe.
較佳地,其中該第二容納裝置為注射器。Preferably, the second containing device is a syringe.
較佳地,其中該連接裝置係選自三向閥、L型管、V型管其中之一。Preferably, the connecting device is selected from one of three-way valves, L-shaped tubes, and V-shaped tubes.
較佳地,其中該連接裝置的第一接口及第二接口的截面積分別小於第一容納空間及第二容納空間的截面積。Preferably, the cross-sectional areas of the first interface and the second interface of the connecting device are smaller than the cross-sectional areas of the first accommodating space and the second accommodating space, respectively.
較佳地,其中該分散質包含選自由以下所組成的群組中的至少一種:聚(D,L-乳酸)(PDLLA);聚(L-乳酸)(PLLA);聚己內酯(PCL);玻尿酸(HA);羥基磷灰石(HAP);以及膠原蛋白(Collagen)。Preferably, the dispersant comprises at least one selected from the group consisting of: poly(D,L-lactic acid) (PDLLA); poly(L-lactic acid) (PLLA); polycaprolactone (PCL) ); hyaluronic acid (HA); hydroxyapatite (HAP); and collagen (Collagen).
較佳地,其中該膠體溶質包含選自由以下所組成的群組中的至少一種:羧甲基纖維素(CMC);玻尿酸(HA);以及玻尿酸(HA)和磷酸鈣(TCP)的混合物。Preferably, the colloidal solute includes at least one selected from the group consisting of: carboxymethyl cellulose (CMC); hyaluronic acid (HA); and a mixture of hyaluronic acid (HA) and calcium phosphate (TCP).
較佳地,其中該溶劑包含選自由以下所組成的群組中的至少一種:碳酸氫鈉(sodium bicarbonate)水溶液;注射用蒸餾水(sterile water for injection,SWFI);一般生理食鹽水(normal saline);利多卡因(lidocaine,麻醉藥);含腎上腺素的利多卡因(lidocaine with epinephrine,lidocaine + E);以及甘露醇(mannitol)。Preferably, the solvent includes at least one selected from the group consisting of: sodium bicarbonate (sodium bicarbonate) aqueous solution; sterile water for injection (SWFI); normal saline (normal saline) ; Lidocaine (lidocaine, anesthetic); lidocaine with epinephrine (lidocaine + E); and mannitol (mannitol).
較佳地,其中該分散質為多孔性的微球體。Preferably, the dispersion is porous microspheres.
透過使用本創作的處理裝置來分散注射式填充物,即使在均勻分散後靜置30分鐘之後仍維持均勻分散的效果,具有進步的分散穩定性。By using the processing device of this creation to disperse the injection-type filler, the uniform dispersion effect is maintained even after being allowed to stand for 30 minutes after the uniform dispersion, and the dispersion stability is improved.
另外,透過使用本創作的處理裝置來分散的注射式填充物,不論溶劑的分散效果如何,注射式填充物都沒有產生聚集。並且在分散效果最佳的溶劑中的分散效果也優於現有技術,同樣證明本創作在分散注射式填充物方面具有相當顯著的進步功效。In addition, no matter what the dispersing effect of the solvent, the injection-type filling did not aggregate. And the dispersion effect in the solvent with the best dispersion effect is also better than the prior art, which also proves that this creation has a significant improvement effect in dispersing injection-type fillings.
參照圖1~2,本創作提供一種利用加壓手段以加速注射式填充物分散的處理裝置100,包括一第一容納裝置10、一第二容納裝置20及一連接裝置30。1 to 2, the present invention provides a
第一容納裝置10具有一第一容納本體101及一第一加壓元件102,該第一容納本體101具有一第一容納空間1011及一第一注出口1012,該第一注出口1012之口徑小於該第一容納空間1011之內徑,該第一加壓元件102可動地結合於該第一容納本體101之第一容納空間1011中,透過該第一加壓元件102之作動以改變該第一容納空間1011的內部體積。The first containing
第二容納裝置20,具有一第二容納本體201及一第二加壓元件202,該第二容納本體201具有一第二容納空間2011及一第二注出口2012,該第二注出口2012之口徑小於該第二容納空間2011之內徑,該第二加壓元件202可動地結合於該第二容納本體201之第二容納空間2011中,透過該第二加壓元件202之作動以改變該第二容納空間2011的內部體積。The
連接裝置30具有一第一接口301、一第二接口302、一第三接口303,以及連通該第一接口301、該第二接口302及第三接口303的一通道304。透過該第一接口301接合於該第一容納裝置10的第一注出口1012,以及該第二接口302接合於該第二容納裝置20的第二注出口2012,使該第一容納裝置10與該第二容納裝置20彼此相連通。The connecting
在此先簡述在本實施例中連接裝置30的基本作動方式,如下:在該第一容納裝置10的第一容納空間1011裝載一預定量的溶劑40,並在該第二容納裝置20的該第二容納空間2011中裝載一注射式填充物50,該注射式填充物50包含可溶於該溶劑40的膠體溶質52和不溶於該溶劑40的分散質51(如圖5),透過交替操作該第一容納裝置10的第一加壓元件102以及該第二容納裝置20的第二加壓元件202,使該溶劑40受到加壓地進入該第二容納裝置20的第二容納空間2011,使該注射式填充物50和該溶劑40形成一混合物503(如圖4),並在排除多餘空氣後,使該混合物503受到加壓地再由該第二容納空間2011進入該第一容納裝置10的第一容納空間1011,透過此種往復加壓混合的步驟,使該混合物503的流速增加並形成剪切應力,從而使該注射式填充物50中的該膠體溶質52均勻地溶解於該溶劑40中,並且使該注射式填充物50中的該分散質51均勻地分散於該溶劑40中。Here, the basic operation mode of the connecting
連接裝置30的第一接口301及第二接口302的截面積分別小於第一容納空間1011及第二容納空間2011的截面積,使得該較小的截面積可以在後續的步驟中用於對溶劑40或者溶劑40和注射式填充物50組成的混合物503加壓。The cross-sectional areas of the
第一容納裝置10和第二容納裝置20可以是注射器,或是其他具有相似功能的加壓裝置。以本實施例的注射器為例,可以利用其對應的第一加壓元件102及第二加壓元件202(也就是活塞),透過推進或後拉的動作,以調整第一容納空間1011和第二容納空間2011的容積,並且,該些針筒具有分別與連接裝置30的通道匹配的開口,即,以用於分別連接到連接裝置30的通道。The first containing
接著,在第一容納空間1011中加入溶劑40,並在第一容納空間2011中加入注射式填充物50,注射式填充物50包含可溶於溶劑40的膠體溶質52和不溶於溶劑40的分散質51(參照圖6)。Next, the
注射式填充物50可以是注射式聚(D,L-乳酸)(injectable poly-
D,L-lactic acid),其為一種用於刺激膠原蛋白增生的醫學美容產品。
溶劑40可以是例如:碳酸氫鈉(sodium bicarbonate)水溶液、注射用蒸餾水(sterile water for injection,SWFI)、一般生理食鹽水(normal saline)、利多卡因(lidocaine,麻醉藥)、含腎上腺素的利多卡因(lidocaine with epinephrine,lidocaine + E)或甘露醇(mannitol),較佳地為注射用蒸餾水(SWFI)。The
分散質51可以是例如:聚(D,L-乳酸)(poly-
D,L-lactic acid,PDLLA)、聚(L-乳酸)(PLLA)、聚己內酯(PCL)、玻尿酸(HA)、羥基磷灰石(HAP)或膠原蛋白(Collagen),較佳地為聚(D,L-乳酸)(PDLLA)。
The
分散質51可以是一種多孔性的微球體,具有高密度的表面結構和中空的內部結構。The
膠體溶質52可以是例如:羧甲基纖維素(carboxymethyl cellulose ,CMC)、玻尿酸(hyaluronic acid ,HA),或者是玻尿酸(HA)和磷酸鈣(tricalcium phosphate,TCP)的混合物,較佳地為羧甲基纖維素(CMC)。The
然後,在連接步驟S30中,將第一容納裝置10透過連接裝置30與第二容納裝置20連接,使第一容納空間1011、連接裝置30的通道和第一容納空間2011相互連通。Then, in the connecting step S30, the
參照圖2,在一實施例中,連接裝置30可以是三向閥,具有一第一接口301、一第二接口302、一第三接口303,以及連通第一接口301及第二接口302及第三接口303的一通道304,以及用於控制三個接口彼此間連通狀態的閥門30a。較佳地,可以使用相鄰(即,呈現直角的)的第一接口301、第二接口302分別連接到第一容納裝置10和第二容納裝置20,以使往復加壓混合時,分別操作第一容納裝置10和第二容納裝置20的兩隻手的角度為90度,有利於單人操作時的人體工學。2, in one embodiment, the
參照圖3,在另一實施例中,連接裝置31可以替換為具有兩個通道31a、31b的L型管,僅具有兩個夾角為90度的開口,即第一接口311及第二接口312。或者,連接裝置31可以替換為V型管(圖未顯示),較佳地,該V型管的開口可以由兩個具有60度至120度的夾角的分支通道構成,使得往復加壓混合的進行更符合人體工學,更佳地為90度夾角的型態,即L型管。3, in another embodiment, the connecting
如圖4所示,在初步混合時,沿著A方向對第一容納裝置10的第一加壓元件102加壓以減小第一容納空間1011的容積,從而對第一容納空間1011中的溶劑40加壓,以將溶劑40部分或完全地擠壓到第二容納空間2011中,從而使注射式填充物50和溶劑40形成混合物503。As shown in FIG. 4, during the preliminary mixing, the
由於在第一容納空間2011中除了容納有注射式填充物50之外的部分還容納有空氣(如圖2所示,以下稱為第一空氣60),因此,在初步混合之後可以進一步進行空氣排除以將第一空氣60排除。Since the part of the first
進行空氣排除的原因在於,如果在第一容納空間1011、連接裝置30的第一接口301和第二容納空間2011的連通空間中存在有大量空氣,則這些空氣將會在該連通空間中佔據大量空間並且形成氣壓(約為1大氣壓),從而不利於後續的往復加壓混合的進行。The reason for air removal is that if there is a large amount of air in the communication space between the first
如圖6所示,在空氣排除時,將第一容納裝置10與連接裝置30分離,並透過固定第一容納空間1011的容積(即,保持第一容納裝置10的第一加壓元件102位置不變)來阻擋外部空氣進入第一容納空間1011中;並且,沿著C方向對第二容納裝置20的第二加壓元件202加壓以減小第二容納空間2011的容積,從而對第二容納空間2011中的混合物503加壓,以將第一容納空間2011中的第一空氣60經由連接裝置30的第一接口301排出;然後,將第一容納裝置10重新與連接裝置30連接(如圖8所示)。As shown in FIG. 6, when the air is removed, the first
或者,如圖7所示,也可以不將第一容納裝置10與連接裝置30分離,而是將連接裝置30的閥門30a轉換為使第二容納空間2011與外部連通,並且關閉第一容納裝置10和第二容納裝置20之間的連通。由此,同樣地可以在阻擋外部空氣進入第一容納空間1011的同時,沿著C方向加壓以將第二容納空間2011中的第一空氣60自連接裝置30的第三接口303排出,然後再將閥門30a轉回如圖8所示的狀態以重新連接第一容納裝置10。Or, as shown in FIG. 7, the first
最後,在進行往復加壓混合時,首先參照圖8,繼續沿著C方向對第二容納裝置20的第二加壓元件202加壓以減小第二容納空間2011的容積,從而對第二容納空間2011中的混合物503加壓以將混合物部分或完全地擠壓到第一容納空間1011中。然後,參照圖9,再次沿著A方向對第一容納裝置10的第一加壓元件102加壓以減小第一容納空間1011的容積,從而對第一容納空間1011中的混合物503加壓以將混合物部分或完全地擠壓到第一容納空間2011中。其中,透過重複進行往復加壓混合的步驟,使連通的第一容納空間1011和第二容納空間2011中的混合物的流速增加並形成剪切力以防止膠體溶質52或分散質51聚集,從而使注射式填充物50中的膠體溶質52均勻地溶解於溶劑40中,並且使注射式填充物50中的分散質51均勻地分散於溶劑40中。Finally, when performing reciprocating pressure mixing, first, referring to FIG. 8, continue to pressurize the
參照圖5,其為圖5的部分5A的局部放大示意圖。根據本創作一實施例,在進行混合之前,注射式填充物50為團絮狀結構,其包含表層部分(如圖6的邊界B至邊界B’處)和內芯部分(如圖6的邊界B’以內的部分),並且在內芯部分中還包含第二空氣70。在初步混合時,溶劑40浸潤注射式填充物50的表層部分而使注射式填充物50的表層部分澎潤(如邊界B’至邊界B’’處),並且,溶劑40還與內芯部分中的第二空氣70形成氣液界面(如邊界B’處),從而在氣液界面B’中形成氣泡,即,氣液界面B’為該氣泡的表面,第二空氣70和注射式填充物50的內芯部分被包含在該氣泡中;並且,在往復加壓混合步驟S60中,透過對混合物加壓以使混合物的流速增加並形成剪切力來破壞該氣泡,以使溶劑40進入該氣泡中,從而使注射式填充物50的內芯部分中的膠體溶質52均勻地溶解於溶劑40中,並且使注射式填充物50的內芯部分中的分散質51均勻地分散於溶劑40中,從而形成均勻的分散液80。Referring to FIG. 5, which is a partial enlarged schematic view of
由於上述氣泡的氣液界面B’的表面張力會阻止溶劑40與注射式填充物50的均勻混合,所以需要透過破壞上述氣泡的氣液界面B’來加速混合。Since the surface tension of the gas-liquid interface B'of the bubbles prevents the solvent 40 from uniformly mixing with the injection-
較佳地,進行往復加壓混合步驟的總進行時間為30秒以下即可達成使膠體溶質52均勻溶解並使不溶分散質51均勻分散的效果(如圖10所示,其為圖5的部分5A在重複進行往復加壓混合步驟後的局部放大示意圖),相對於現有技術需要花費20分鐘至48小時具有相當顯著的進步功效。Preferably, the total time for the reciprocating pressure mixing step is less than 30 seconds to achieve the uniform dissolution of the
如圖11所示,挑選4種常見的注射用溶劑:注射用蒸餾水(SWFI)、一般生理食鹽水(NS)、利多卡因(lidocaine)、含腎上腺素的利多卡因(lidocaine + E);以及用於對照的2種溶劑:具有強離子強度的碳酸氫鈉(NaHCO 3)水溶液、作為強滲透性脫水劑的甘露醇(mannitol)。使用上述6種溶劑分別以3分鐘的時間浸潤一顆注射式填充物50。在沒有外力攪拌的情況下,SWFI和mannitol由於具有最弱的離子強度而分散效果較好,這是因為較強的離子強度會造成較多的聚集(aggregation)。 As shown in Figure 11, choose 4 common solvents for injection: distilled water for injection (SWFI), normal saline (NS), lidocaine (lidocaine), and lidocaine containing epinephrine (lidocaine + E); And two solvents used for comparison: sodium bicarbonate (NaHCO 3 ) aqueous solution with strong ionic strength, and mannitol as a strong osmotic dehydrating agent. The above 6 kinds of solvents were used to infiltrate one injection-type filling 50 in 3 minutes. In the absence of external stirring, SWFI and mannitol have a better dispersion effect due to the weakest ionic strength. This is because stronger ionic strength will cause more aggregation.
為了進一步驗證本創作的處理裝置的分散效果,使用本創作的處理裝置對200mg注射式填充物和8mL的溶劑的混合物進行分散,結果如圖14和圖15所示。並且,作為對照,使用一般的漩渦產生器對200mg注射式填充物和8mL的溶劑的混合物進行分散,結果如圖12和圖13所示。In order to further verify the dispersion effect of the processing device of this creation, a mixture of 200 mg injection-type filler and 8 mL of solvent was dispersed using the processing device of this creation, and the results are shown in Figures 14 and 15. In addition, as a control, a mixture of 200 mg of injectable filler and 8 mL of solvent was dispersed using a general vortex generator. The results are shown in FIGS. 12 and 13.
參照圖15,可以看出,透過使用本創作的處理裝置來分散注射式填充物,即使在均勻分散後靜置30分鐘之後,在各種溶劑中的注射式填充物仍維持均勻分散而沒有與溶劑分層,相較於此,現有技術在經過旋渦產生器處理後靜置30分鐘之後出現注射式填充物與溶劑分層的現象(如圖12所示),本創作的分散穩定性良好,具有相當顯著的進步功效。Referring to Figure 15, it can be seen that by using the processing device of this creation to disperse the injectable filler, even after being evenly dispersed and allowed to stand for 30 minutes, the injectable filler in various solvents remains uniformly dispersed without being mixed with the solvent. In contrast to this, in the prior art, the injection-type filling and solvent layering occurs after being left for 30 minutes after being processed by the vortex generator (as shown in Figure 12). This creation has good dispersion stability and has Very significant improvement effect.
並且,參照圖15,圖15為透過使用本創作的處理裝置來分散的注射式填充物在均勻分散後拍攝的顯微照片(左圖和右圖分別使用SWFI和NS作為溶劑)。可以看出,不論在分散效果最佳的SWFI溶劑或在分散效果不佳的NS中, 注射式填充物(如圖15中的黑點)都沒有產生聚集,相較於此,現有技術使用旋渦產生器處理的注射式填充物在分散效果不佳的NS溶劑中出現的嚴重的聚集現象(如圖13右圖),且在分散效果最佳的SWFI溶劑的分散效果(如圖13左圖)也不如本創作均勻,同樣證明本創作在分散注射式填充物方面具有相當顯著的進步功效。And, referring to Figure 15, Figure 15 is a photomicrograph taken after uniform dispersion of the injection-type filling dispersed by using the processing device of this creation (the left and right images use SWFI and NS respectively as solvents). It can be seen that no matter in the SWFI solvent with the best dispersion effect or in the NS with poor dispersion effect, the injection-type filler (the black dot in Figure 15) does not produce aggregation. In contrast, the prior art uses vortex The injection-type filler processed by the generator has serious aggregation in the poorly dispersed NS solvent (Figure 13 right), and the dispersion effect of the SWFI solvent with the best dispersion effect (Figure 13 left) It is not as uniform as this creation, and it also proves that this creation has a significant improvement effect in dispersing injectable fillings.
綜上所述,本創作的處理裝置利用加壓手段以加速注射式填充物分散,搭配使用往復(back-and-forth)加壓方法,提供比傳統的手搖或旋渦產生方法更大的剪切力,足以防止注射式填充物中的膠體溶質或分散質的聚集,並且能夠破壞注射式填充物中的空氣所形成的氣泡,從而在短時間內產生良好的分散效果,並且在均勻分散後維持良好的穩定性。To sum up, the processing device of this creation uses pressure to accelerate the dispersion of injection-type fillers, and uses a back-and-forth pressure method to provide a larger shear than traditional hand-cranked or vortex generation methods. The shear force is sufficient to prevent the aggregation of colloidal solutes or dispersoids in the injection-type filling, and can destroy the bubbles formed by the air in the injection-type filling, so as to produce a good dispersion effect in a short time, and after uniform dispersion Maintain good stability.
綜上所述,本創作在同類產品中實有其極佳之進步性,同時遍查國內外關於此類結構之技術資料,文獻中亦未發現有相同的構造存在在先,是以,本創作時已具備新型專利要件,爰依法提出申請。To sum up, this creation has its excellent progress in similar products. At the same time, we have checked the domestic and foreign technical data on this type of structure. The same structure has not been found in the literature. Therefore, this At the time of creation, the new patent requirements were already in place, and Yan filed an application in accordance with the law.
惟,以上所述者,僅係本創作之較佳可行實施例而已,實施例之間若無明顯相斥的情況,其特徵可彼此結合替換應用。並且,舉凡應用本新型說明書及申請專利範圍所為之等效結構變化,理應包含在本創作之專利範圍內。However, the above are only the preferred and feasible embodiments of the present creation. If there is no obvious conflict between the embodiments, the features can be combined with each other and replaced. In addition, any equivalent structural changes made by applying the specification of this model and the scope of patent application should be included in the scope of patent of this creation.
100:處理裝置
10:第一容納裝置
101:第一容納本體
1011:第一容納空間
1012:第一注出口
102:第一加壓元件
20:第二容納裝置
201:第二容納本體
2011:第二容納空間
2012:第二注出口
202:第二加壓元件
2011:第二容納空間
30:連接裝置
30a:閥門
301:第一接口
302:第二接口
303:第三接口
304:通道
31: 連接裝置
311:第一接口
312:第二接口
40:溶劑
5A:部分
50:注射式填充物
51:分散質
52:膠體溶質
503:混合物
60:第一空氣
70:第二空氣
80:分散液
A:方向
B:邊界
B’:邊界、氣液界面
B’’:邊界
C:方向100: processing device
10: The first containment device
101: The first containing body
1011: first accommodation space
1012: The first injection outlet
102: The first pressing element
20: second containment device
201: The second containing body
2011: second accommodation space
2012: Second injection
202: second pressing element
2011: second accommodation space
30: Connect the
圖1為本創作的處理裝置的示意圖; 圖2為連接裝置的一實施例的示意圖; 圖3為連接裝置的另一實施例的示意圖; 圖4為處理裝置進行初步混合步驟的示意圖; 圖5為圖4的初步混合步驟中的氣泡的局部放大圖; 圖6為處理裝置進行空氣排除步驟的一個實施例的示意圖; 圖7為處理裝置進行空氣排除步驟的另一實施例的示意圖; 圖8~9為處理裝置進行往復加壓混合步驟的示意圖; 圖10為圖5的氣泡經過往復加壓混合步驟之後的局部放大圖; 圖11為注射式填充物在各種溶劑中浸潤3分鐘後的分散型態的照片; 圖12為使用旋渦產生器將注射式填充物均勻分散在各種溶劑中之後靜置30分鐘後的分散型態的照片; 圖13為使用旋渦產生器將注射式填充物均勻分散在各種溶劑中的分散型態的顯微照片; 圖14為使用本創作的處理裝置將注射式填充物均勻分散在各種溶劑中之後靜置30分鐘後的分散型態的照片;以及 圖15為使用本創作的處理裝置將注射式填充物均勻分散在各種溶劑中的分散型態的顯微照片。 Figure 1 is a schematic diagram of the processing device created; Fig. 2 is a schematic diagram of an embodiment of a connecting device; Figure 3 is a schematic diagram of another embodiment of a connecting device; Figure 4 is a schematic diagram of a preliminary mixing step performed by the processing device; Figure 5 is a partial enlarged view of bubbles in the preliminary mixing step of Figure 4; Figure 6 is a schematic diagram of an embodiment of the air removal step performed by the processing device; FIG. 7 is a schematic diagram of another embodiment of the air removal step performed by the processing device; Figures 8-9 are schematic diagrams of reciprocating pressure mixing steps performed by the processing device; 10 is a partial enlarged view of the bubbles of FIG. 5 after the reciprocating pressure mixing step; Figure 11 is a photograph of the dispersion state of the injection-type filling after being immersed in various solvents for 3 minutes; Figure 12 is a photograph of the dispersion state after the injection-type filler is uniformly dispersed in various solvents by using a vortex generator and left for 30 minutes; Figure 13 is a photomicrograph of the dispersion state of the injectable filler uniformly dispersed in various solvents using a vortex generator; Figure 14 is a photograph of the dispersion state of the injection-type filling after being evenly dispersed in various solvents using the processing device of this creation; and Figure 15 is a photomicrograph of the dispersion state of the injection-type filler uniformly dispersed in various solvents using the processing device of this creation.
100:處理裝置 100: processing device
10:第一容納裝置 10: The first containment device
101:第一容納本體 101: The first containing body
1011:第一容納空間 1011: first accommodation space
1012:第一注出口 1012: The first injection outlet
102:第一加壓元件 102: The first pressing element
20:第二容納裝置 20: second containment device
201:第二容納本體 201: The second containing body
2011:第二容納空間 2011: second accommodation space
2012:第二注出口 2012: Second injection
202:第二加壓元件 202: second pressing element
2011:第二容納空間 2011: second accommodation space
30:連接裝置 30: Connect the device
30a:閥門 30a: Valve
40:溶劑 40: Solvent
50:注射式填充物 50: Injectable filler
60:第一空氣 60: First Air
A:方向 A: Direction
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