TW202124865A - Solenoid valve, delivery device having a solenoid valve and delivery device having a solenoid valve and a disassembly-prevention safety catch - Google Patents
Solenoid valve, delivery device having a solenoid valve and delivery device having a solenoid valve and a disassembly-prevention safety catch Download PDFInfo
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Description
本發明係關於一種電磁閥控制之投遞器,經由該電磁閥對氣體壓力之精確控制,而使該投遞器能精確和輕易達成無針投遞藥物、生物性物質或保養品組合物至患者皮下之功效。The present invention relates to a delivery device controlled by a solenoid valve, through which the solenoid valve accurately controls the gas pressure, so that the delivery device can accurately and easily deliver a needle-free drug, biological substance or skin care composition to the patient's subcutaneous effect.
隨著醫學美容(cosmetology)技術之進展以及各式醫療技術之演進,已發展出各式各樣之美容及美妝產品組合物、抗老化產品等,但能將該等產品安全遞送至目標物(如患者之皮膚)之方法甚為有限。一般坊間商業上可購得之電動按摩器具,其僅是將該等美容及美妝產品組合物、抗老化產品或具醫療效果之藥物,以按摩之方式塗抹在患部上之皮膚,然後期待皮膚能自行吸收;然而其所得到之效果卻極其有限,也往往浪費該等昂貴之美容及美妝產品組合物、抗老化產品或具醫療效果之藥物。雖然後來亦有開發出一些霧化器產品,其號稱能將欲遞送之美容及美妝產品組合物霧化,而增加皮膚吸收之效果,但其僅是簡單之將欲遞送之物霧化,其效果亦無法被接受。With the advancement of cosmetology technology and the evolution of various medical technologies, various beauty and cosmetic product compositions, anti-aging products, etc. have been developed, but these products can be safely delivered to the target (Such as the patient's skin) methods are very limited. Generally, the electric massage appliances available in the market are just to apply the beauty and makeup product composition, anti-aging product or medicine with medical effect to the skin of the affected area by massage, and then expect the skin It can be absorbed by itself; however, its effects are extremely limited, and these expensive beauty and cosmetic product compositions, anti-aging products or medicines with medical effects are often wasted. Although some nebulizer products were later developed, which claim to be able to atomize the beauty and makeup product composition to be delivered, and increase the effect of skin absorption, but it is only a simple atomization of the substance to be delivered. The effect is also unacceptable.
雖然市面上亦有提供基因槍裝置,可用來遞送生物性物質,但其缺點為噪音太大,且其震波所產生之高速高壓氣體很容易殺死細胞,不容易控制其強度,因此有其危險性,不適合用於遞送藥物、生物性物質或保養品組合物至患者皮下。Although there is also a gene gun device on the market that can be used to deliver biological substances, its disadvantage is that the noise is too large, and the high-speed and high-pressure gas generated by the shock wave can easily kill the cells, and it is not easy to control the strength, so it is dangerous It is not suitable for delivering drugs, biological substances or skin care products to the patient's skin.
有鑑於此,本發明之目的係在提供一種新穎之電磁閥,及由該電磁閥控制之投遞器,以構造簡單使體積及壓損較小之新穎電磁閥控制氣體開關,而輕易達成無針投遞藥物或保養品至患者皮下之功效;且本發明之電磁閥控制之投遞器,操縱簡單、安全、節省成本、無需麻藥,即可投遞藥品或保養品至患者皮下。In view of this, the purpose of the present invention is to provide a novel solenoid valve, and a delivery device controlled by the solenoid valve, which has a simple structure and a novel solenoid valve with small volume and pressure loss to control the gas switch, so as to easily achieve no needle The effect of delivering medicines or skin care products to the patient's skin; and the solenoid valve controlled delivery device of the present invention is simple, safe, cost-saving, and can deliver medicines or skin care products to the patient's skin without anesthetics.
本發明提供一種電磁閥,及具有該電磁閥之可遞送化妝品組合物、生物性物質(DNA或RNA或蛋白質等)及藥物之投遞器,其包括: 一噴嘴、一送料機構、一蓄壓艙及一啟動元件,或進一步包括一防拆保險;該噴嘴後上方係與該送料機構連接,及其後端係與該蓄壓艙連接;該送料機構之下方係分別與該噴嘴及該蓄壓艙連接;該蓄壓艙前端係分別與該送料機構及該噴嘴連接;該電磁閥前端係與該蓄壓艙連接;及該防拆保險係設置於該蓄壓艙下方之一握把結構,以提供該握把結構上之該啟動元件之保險功能。The present invention provides a solenoid valve, and a delivery device with the solenoid valve capable of delivering cosmetic compositions, biological substances (DNA or RNA or protein, etc.) and drugs, which includes: A nozzle, a feeding mechanism, a pressure accumulating chamber and a starting element, or further including a tamper-proof safety; the upper rear of the nozzle is connected with the feeding mechanism, and the rear end thereof is connected with the pressure accumulating chamber; the feeding mechanism The lower part is connected with the nozzle and the pressure accumulator respectively; the front end of the pressure accumulator is connected with the feeding mechanism and the nozzle respectively; the front end of the solenoid valve is connected with the pressure accumulator; and the anti-dismantling safety is arranged in A grip structure under the pressure accumulating chamber provides the safety function of the activation element on the grip structure.
其中該構造簡單和壓損較小之新穎電磁閥機構包括:一電磁開關、一閥本體、一閥蓋、一閥軸、一復位彈簧、一第一橡膠環、一第二橡膠環及一第三橡膠環;該閥本體與閥蓋沿軸心固鎖相連,並於閥本體與閥蓋相連處設置第一橡膠環以確保不使氣體洩漏,閥本體沿軸心線設置一軸孔提供復位彈簧及閥軸作動之空間;閥軸上設置一第二橡膠環及一第三橡膠環,第二橡膠環為防止閥門處氣體洩漏,第三橡膠環使得軸孔可分隔前腔及後腔之壓力;其後腔底部設置之復位彈簧將閥軸推向閥門以關閉出氣。The novel solenoid valve mechanism with simple structure and low pressure loss includes: a solenoid switch, a valve body, a valve cover, a valve shaft, a return spring, a first rubber ring, a second rubber ring, and a first rubber ring. Three rubber rings; the valve body and the bonnet are fixedly connected along the axis, and a first rubber ring is arranged at the connection between the valve body and the bonnet to ensure that no gas leaks. The valve body is provided with a shaft hole along the axis to provide a return spring And the space where the valve shaft is actuated; a second rubber ring and a third rubber ring are arranged on the valve shaft. The second rubber ring prevents gas leakage at the valve, and the third rubber ring allows the shaft hole to separate the pressure of the front cavity and the rear cavity. ; The return spring at the bottom of the back cavity pushes the valve shaft to the valve to close the air outlet.
該電磁閥結構具一流體入口、閥門、第一流道、第二流道及排氣孔,該流體入口與該前腔及第一流道連通,第二流道與後腔連通,排氣孔與大氣連通;電磁開關與該閥本體固鎖相連,該電磁閥開關受控於電磁開關,電磁開關關閉時,使一第一流道和一第二流道連通,故使前腔及後腔氣體壓力平衡,因後腔較前腔多一復位彈簧之彈簧力,使閥軸抵住閥門,電磁閥關閉;電磁開關開啟時,使第二流道和排氣孔連通,後腔之壓力與大氣連通,使得後腔氣體壓力卸除,當前腔壓力大於復位彈簧之彈簧力時電磁閥開啟;該電磁閥利用該電磁開關,形成該閥軸之一前腔和一後腔間之一壓力差,設計上該壓力差需大於該復位彈簧之設計彈簧力量,而促使該閥軸移動,以執行該閥門開關之動作。The solenoid valve structure has a fluid inlet, a valve, a first flow channel, a second flow channel, and an exhaust hole. The fluid inlet communicates with the front cavity and the first flow channel, the second flow channel communicates with the rear cavity, and the exhaust hole communicates with the front cavity and the first flow channel. The atmosphere is connected; the solenoid switch is connected to the valve body with a fixed lock. The solenoid valve switch is controlled by the solenoid switch. When the solenoid switch is closed, a first flow channel and a second flow channel are connected, so that the gas pressure in the front and rear chambers Balance, because the back cavity has one more spring force of the return spring than the front cavity, the valve shaft is pressed against the valve and the solenoid valve is closed; when the solenoid switch is turned on, the second flow path is connected to the exhaust hole, and the pressure in the back cavity is connected to the atmosphere , So that the gas pressure in the rear chamber is relieved, and the solenoid valve opens when the front chamber pressure is greater than the spring force of the return spring; the solenoid valve uses the solenoid switch to form a pressure difference between a front chamber and a rear chamber of the valve shaft. The pressure difference needs to be greater than the design spring force of the return spring, so as to prompt the valve shaft to move to perform the valve switching action.
該電磁閥內部流體路徑設計上避免過多轉折,使流體形成流暢之流體路徑,可減少流體經流電磁閥之壓力損失,簡易機構設計僅需少量部件,使得本發明之電磁閥可使用於各種應用,如本發明之投遞器或可攜式基因槍等。此外,該流暢之流體路徑,無轉角設計,使得本發明之閥門較傳統之閥門容易清理,因此可避免欲被遞送之化妝品組合物、生物性物質及藥物之間之交互汙染。The internal fluid path of the solenoid valve is designed to avoid too many turns, so that the fluid forms a smooth fluid path, which can reduce the pressure loss of the fluid flowing through the solenoid valve. The simple mechanism design requires only a small number of components, so that the solenoid valve of the present invention can be used in various applications , Such as the delivery device or portable gene gun of the present invention. In addition, the smooth fluid path and no-corner design make the valve of the present invention easier to clean than traditional valves, thus avoiding cross-contamination between cosmetic compositions, biological substances, and drugs to be delivered.
此外,該電磁閥氣體流量係由該流體路徑上之有效斷面面積與閥門開口尺寸控制,有效斷面面積即電磁閥內部流體路徑之最小斷面面積,其中該供氣系統可為氮氣供氣系統或氦氣供氣系統。In addition, the gas flow rate of the solenoid valve is controlled by the effective cross-sectional area of the fluid path and the valve opening size. The effective cross-sectional area is the minimum cross-sectional area of the fluid path inside the solenoid valve. The gas supply system can be nitrogen gas supply. System or helium gas supply system.
該蓄壓艙係經由該電磁閥控制,當該閥門開啟時則被供應一氣體至該蓄壓艙中直至該氣體建立一壓力,該壓力再將由該送料機構釋出之該化妝品組合物、該生物性物質或該藥物加速,而使該生物性物質或該藥物經由該噴嘴送達一目標物;其中該壓力係等同於該電磁閥之流體出口之壓力(即閥門開啟時,閥門處之壓力);其中該氣體為一氮氣或一氦氣。The pressure accumulating chamber is controlled by the solenoid valve. When the valve is opened, a gas is supplied to the pressure accumulating chamber until the gas builds up a pressure, which will then release the cosmetic composition and the The biological substance or the drug is accelerated, so that the biological substance or the drug is delivered to a target through the nozzle; wherein the pressure is equal to the pressure at the fluid outlet of the solenoid valve (that is, the pressure at the valve when the valve is opened) ; Wherein the gas is a nitrogen or a helium.
本發明投遞器所遞送之該生物性物質係選自於一核酸物質、一蛋白質、一病毒顆粒、一肉毒桿菌及其組合所組成之群組,而該藥物係為一經皮吸收之藥物。﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽;該化妝品組合物係選自於醇類、酯類、複合多醣體、堅果油及維生素及其組合所組成之群組。The biological substance delivered by the delivery device of the present invention is selected from the group consisting of a nucleic acid substance, a protein, a viral particle, a botulinum bacterium, and a combination thereof, and the drug is a transdermal drug. ﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽﷽; The cosmetic composition is selected from the group consisting of alcohols, esters, complex polysaccharides, nut oils, vitamins and combinations thereof.
為進一步闡明本發明,茲以下列實施例並配合圖式,以詳細說明本發明之構成內容及其所達成之功效。In order to further clarify the present invention, the following embodiments and drawings are used to illustrate the composition of the present invention and its effects in detail.
實施例一Example one
如第1圖所示,其繪示本發明一較佳實施例之一種投遞器100之本體結構部分。該投遞器100至少包括一噴嘴(nozzle)101、一送料機構102、一蓄壓艙103、一握把結構104、一啟動元件105、一防拆保險106、一後端接頭107及一電磁閥108。該後端接頭107經電磁閥108連接一氣體來源(如一高壓氣瓶),經由電磁閥108控制並提供一氣體(如氮氣或氦氣)流入(如箭頭所示之方向)蓄壓艙103,隨後該氣體於蓄壓艙103之空間內,建立一較高之預定壓力後,藉由該壓力將由送料機構102所釋出之化妝品組合物、 生物性物質(DNA或RNA或蛋白質等)或藥物加速,最後經由噴嘴101遞送至目標物材料為堅固耐用之。蓄壓艙103所使用之材料為堅固耐用之輕質金屬,如鋁合金、鋁鎂合金等。送料機構102及噴嘴101所使用之材料則為生物相容性金屬,如不鏽鋼及其合金、鈷合金和鈦合金等。上述遞送機制之作動,係經由握把結構104上之啟動元件105所啟動,而握把結構104上之防拆保險106則賦予保險之功能,防止誤觸啟動元件105所產生之不必要之遞送。As shown in FIG. 1, it shows the main body structure part of a
本發明較佳實施例中所遞送之化妝品組合物、生物性物質或藥物可使用不含攜帶顆粒之液體溶液或含攜帶顆粒之液體溶液,並利用一適當之壓力將液體溶液均勻加速至所需之速度,而減少對目標物(如皮膚細胞)之損害。The cosmetic composition, biological substance or medicine delivered in the preferred embodiment of the present invention can use a liquid solution without particles or a liquid solution containing particles, and use an appropriate pressure to uniformly accelerate the liquid solution to the desired level. Speed, and reduce the damage to the target (such as skin cells).
本發明投遞器中之送料機構102,可設計成可定時和定量釋出欲被遞送之液體溶液,使得本發明投遞器能更準確遞送一定劑量之液體溶液至目標物。The
實施例二 本發明之電磁閥工作原理
如第2圖所示,本發明為構造簡單和壓損較小之電磁閥200,由一電磁開關205來驅動,電磁開關205關閉時使第一流道201a及第二流道201b連通,使得閥軸204之前腔204a中之壓力與閥軸204之後腔204b氣體壓力相等,因此閥軸204前後腔之氣體壓力平衡,所以閥軸204靜止不動,而使閥門210關閉。當電磁開關205開啟時使第二流道201b及排氣孔201c連通,此時閥軸204之後腔204b中之壓力通過第二流道201b由排氣孔201c卸壓,使得閥軸204之前腔204a中之氣體壓力大於閥軸204之後腔204b中之氣體壓力,因此閥軸204利用此壓力差向後運動,最後電磁閥200中之閥門210被打開,所以氣體流通,即氣體源中之氣體流入第1圖中之蓄壓艙103。As shown in Figure 2, the present invention is a
當電磁開關205關閉時,使第一流道201a與第二流道201b連通,此時閥軸204之後腔204b之壓力與閥軸204之前腔204a之壓力相等,但復位彈簧203之彈簧力和閥軸204之後腔204b之壓力大於閥軸204之前腔204a之壓力,故將閥軸204推向前,進而關閉閥門210,因此氣體斷流,即氣體無法流入第1圖中之蓄壓艙103。When the
由以上之說明可知,本發明之電磁閥優於一般之電磁閥之特點包括:
1. 流暢式流體路徑設計,可避免流體經過電磁閥時之壓力損失。
2. 簡易式機構設計,使得電磁閥組成料件較少且組裝簡便,更有利於配合不同產品之客製化生產,如本發明之投遞器。
3. 電磁開關205之功能為氣流引導,故需選擇符合功能需求之電磁開關搭配使用。From the above description, it can be seen that the solenoid valve of the present invention is superior to ordinary solenoid valves in terms of features including:
1. Smooth fluid path design can avoid pressure loss when fluid passes through the solenoid valve.
2. The simple mechanism design makes the solenoid valve less material and easy to assemble, which is more conducive to the customized production of different products, such as the delivery device of the present invention.
3. The function of the
如第10 圖所示,符合功能需求之電磁開關1000機構包括:一開關主體1001、一線圈1002、一動鐵芯1003、一復位彈簧1004、一第一氣密環1008、一第二氣密環1009、一第三氣密環1010及一第四氣密環1011;該電磁開關本體沿軸心線設置一軸孔提供復位彈簧1004、動鐵芯1003作動之空間;動鐵芯1003上設置一第一氣密環1008、一第二氣密環1009、一第三氣密環1010及一第四氣密環1011,為確保不使氣體洩漏。當線圈1002通電時產生電磁力,使動鐵芯1003克服彈簧力,因此第二流道1006與排氣孔1007連通;當線圈1002斷電時電磁力消失,動鐵芯1003在彈簧力的作用下復位,因此第一流道1005與第二流道1006連通。As shown in Figure 10, the
實施例3Example 3
如第3圖所示,本發明之防拆保險300包括一公端301和一母端302,公端301和母端302利用緊配合條件,使得兩者被緊密結合,此外於公端處可另外鎖上一螺絲,避免公端301和母端302彼此脫離。於公端301和母端302間設置一卡楯303(如O型扣環)。結合後之防拆保險300,有一可移動之距離D,當於公端301處往下推時,其移動距離D至一定位,此時卡楯303會卡住啟動元件105(第1圖),使啟動元件105無法被按壓;當於公端301處往上推時,其移動距離D至一定位,此時卡楯303會離開啟動元件105(第1圖),使啟動元件105可被按壓。As shown in Figure 3, the
防拆保險300之公端301和母端302之銜接處G,其表面有一經設計之齒紋,以增加兩端結合之摩擦力。若欲強行使用工具分離公端301和母端302,該齒紋隨即會被破壞,無法再將兩端結合,而由此達成本發明防拆保險300之防拆功能。The joint G of the
其他電磁閥樣品穩定流量與壓差測量
表1 受測電磁閥
測量穩定流量 使用工具:浮子式流量計、氮氣、氣體調壓閥及氣管。Measure steady flow Tools used: float flowmeter, nitrogen, gas pressure regulator and gas pipe.
測量方法說明: 安裝方式如第8圖所示,在氮氣瓶上安裝氣體調壓閥,並連接氣管至浮子式流量計,在流量計另一端接上氣管並連接受測之電磁閥,完成測量前安裝作業。 開啟氮氣瓶,觸發受測電磁閥,並將氣體調壓閥出氣端壓力設定在15 psi,觀察流量計之浮子穩定於哪一刻度。Measurement method description: The installation method is shown in Figure 8. Install a gas pressure regulator on the nitrogen cylinder and connect the gas pipe to the float flowmeter. Connect the gas pipe to the other end of the flowmeter and connect the solenoid valve under test to complete the installation before measurement. Turn on the nitrogen cylinder, trigger the solenoid valve to be tested, and set the pressure at the outlet end of the gas pressure regulator to 15 psi, and observe which scale the float of the flowmeter is stable.
水位高度差測試 使用工具:氮氣、氣體調壓閥、氣管、連通管及捲尺(用於記錄水位高度)。Water level difference test Tools used: nitrogen, gas pressure regulator, trachea, connecting pipe and tape measure (used to record the water level).
測量方法說明: 安裝方式如第9圖所示,安裝完成後,開啟氮氣氣瓶、觸發受測電磁閥,逐漸將氣體調壓閥出氣端壓力調至 5 psi,記錄兩端水位高度差。Measurement method description: The installation method is shown in Figure 9. After the installation is completed, open the nitrogen gas cylinder, trigger the solenoid valve under test, and gradually adjust the pressure at the outlet end of the gas pressure regulator to 5 psi, and record the water level difference between the two ends.
測試結果:
表2 穩定流量量測數據
結論 經測試,發現比較本發明之電磁閥在流量方面有最佳表現;且水位高度差量測數據中得知壓力損失在受測電磁閥中為最小。in conclusion After testing, it is found that the solenoid valve of the present invention has the best performance in terms of flow; and the water level difference measurement data shows that the pressure loss is the smallest among the solenoid valves tested.
投遞器施打膜聯蛋白 A2 (Anx A2) The delivery device administers Annexin A2 (Anx A2)
表4 實驗組別
表5 膜聯蛋白A2施打結果
第4圖顯示投遞器在20至100 psi之壓力條件下,皆可以將膜聯蛋白A2 投遞至真皮層,其投遞深度並不受壓力條件改變之影響,其中於 50、60 或 70 psi 之投遞壓力條件下, 其呈現之投遞效果最佳,80 psi 之壓力條件則膜聯蛋白 A2 之表現量減少 (表5)。Figure 4 shows that the delivery device can deliver Annexin A2 to the dermis under pressure conditions of 20 to 100 psi, and its delivery depth is not affected by changes in pressure conditions, among which delivery is at 50, 60 or 70 psi Under pressure conditions, it exhibits the best delivery effect. Under pressure conditions of 80 psi, the expression of Annexin A2 decreases (Table 5).
投遞器隨著壓力條件之改變 (20至100 psi之間),皆能將藥物(膜聯蛋白A2)投遞至真皮層,尤其是50至70 psi之間之效果最佳,故最佳為以選擇壓力條件50至70 psi之間進行藥物遞送。With the change of pressure conditions (between 20 and 100 psi), the delivery device can deliver the drug (Annexin A2) to the dermis. Especially the effect between 50 and 70 psi is the best, so the best is Select pressure conditions between 50 and 70 psi for drug delivery.
投遞器 施打 pCMV - ß-galactosidase DNA Post-administration is pCMV - ß -galactosidase DNA
測試方法:
(1) 以ddH2
O配製金粒包覆1 µg pCMV-ß-galactosidase vector溶液。
(2) 將C57BL/6小鼠小鼠秤重並固定,於鼠蹊部以針筒施打水合氯醛(chloral hydrate) 5%,劑量為0.2 ml/20g。
(3) 將老鼠腹部進行剃毛,透過投遞器對小鼠於50 psi壓力下施打20 µl pCMV-ß-galactosidase vector溶液和金粒包覆pCMV-ß-galactosidase vector 溶液。
(4) 於48小時後,將老鼠進行犧牲,並取下老鼠腹部皮膚進行石蠟切片。Test method: (1) Prepare 1 µg pCMV-ß-galactosidase vector solution coated with gold particles with ddH 2 O. (2) C57BL/6 mice were weighed and fixed, and
測試結果: 第5圖顯示(A) 400 倍視野之切片結果。(B) 200 倍視野之切片結果。藍色部位則是經過染色後其代表β-半乳糖苷酶(ß-galactosidase)基因表現之區域。Test Results: Figure 5 shows (A) the sectioning result of 400x field of view. (B) Section result of 200 times field of view. The blue part is the area that represents the expression of the β-galactosidase gene after staining.
該結果顯示基因投遞於48小時之後,ß-galactosidase基因表現於真皮層與表皮層之間,證明本發明之投遞器進行基因投遞,其最深深度可以達到真皮層。因此,此結果亦顯示本發明之投遞器應用於基因治療或DNA疫苗接種方面,亦可以有效產生反應。This result showed that the ß-galactosidase gene was expressed between the dermis layer and the
投遞器施打Delivery 人類生長激素Human growth hormone
測試方法:
(1) 以生理食鹽水配製40 µg/10 µl之生長激素溶液。
(2) 將C57BL/6小鼠小鼠秤重並固定,於鼠蹊部以針筒施打水合氯醛(chloral hydrate) 5%,劑量為0.2 ml/20g。
(3) 將老鼠腹部進行剃毛,透過本發明之投遞器對小鼠於60 psi壓力下施打200 µl人類生長激素(100 µl之劑量設定條件,施打2次),或透過傳統注射器進行注射。
(4) 於第 2、4、8 小時後,對老鼠進行抽血。
(5) 透過ELISA kits分析其第2、4、8小時之血液中生長激素變化水平。Test Methods:
(1) Prepare 40 µg/10 µl growth hormone solution with normal saline.
(2) C57BL/6 mice were weighed and fixed, and
測試結果: 第6圖顯示無論是透過本發明之投遞器或傳統式注射器施打生長激素,皆可以促使血液中之生長激素濃度水平上升許多;但也顯示於傳統式注射器的注射條件下,其血液中生長激素之濃度水平於第2小時即上升起來,濃度略高於本發明之投遞器投遞組別。即使如此,在第 4、8 小時之結果卻顯示本發明之投遞器投遞組別之血液生長激素濃度明顯高於傳統式注射器之組別,甚至隨著時間之增加,差距越來越大。因此,本發明之投遞器之遞送效果,基本上係優於傳統式注射器。Test Results: Figure 6 shows that whether it is administered through the delivery device of the present invention or a traditional syringe, the growth hormone concentration level in the blood can increase a lot; but it also shows that the growth hormone in the blood grows under the injection conditions of the traditional syringe The concentration level of hormones rises in the second hour, and the concentration is slightly higher than that of the delivery group of the present invention. Even so, the results at the 4th and 8th hours show that the blood growth hormone concentration of the delivery group of the present invention is significantly higher than that of the traditional syringe group, and even with the increase of time, the gap is getting bigger and bigger. Therefore, the delivery effect of the delivery device of the present invention is basically better than that of a traditional syringe.
Luciferase 蛋白 ( 螢光素酶蛋白) 投遞結構破壞性測試 Luciferase protein ( luciferase protein ) delivery structure destructive test
測試方法: (1) 將2.4 ng/μl luciferase蛋白溶液透過含有1 mg/ml BSA之1x裂解緩衝溶液 (lysis buffer) 稀釋成濃度0.01 ng/μl。 (2) 100μl luciferase 蛋白溶液透過本發明之投遞器分別以40至80 psi 投遞至50mL 離心管中。而控制組則是未經過本發明之投遞器投遞之稀釋luciferase蛋白溶液。 (3) 每個組別各取50μl與50μl BGLAR進行均勻混合,並進一步測量其冷光值。 (4) 破壞百分率計算公式,其公式如下: 破壞百分率(%)=(控制組(control) 之 RLU 值-基因槍施打回收液體之 RLU 值)/ 控制組(control) 之 RLU 值×100%。Test Methods: (1) Dilute the 2.4 ng/μl luciferase protein solution through 1x lysis buffer containing 1 mg/ml BSA to a concentration of 0.01 ng/μl. (2) 100μl of luciferase protein solution is delivered into a 50mL centrifuge tube at 40 to 80 psi through the delivery device of the present invention. The control group is a diluted luciferase protein solution that has not been delivered by the delivery device of the present invention. (3) Take 50μl and 50μl BGLAR from each group and mix them evenly, and then measure the luminescence value. (4) The formula for calculating the percentage of damage is as follows: Damage percentage (%) = (RLU value of the control group-RLU value of the liquid recovered from the gene gun) / RLU value of the control group × 100%.
測試結果:
表 6
表6顯示luciferase活性之破壞率於40 psi至80 psi時,隨著壓力之增加,對投遞物質之破壞率也隨之增加,但於80 psi時之破壞率仍僅為 1.55%。故根據本發明之投遞器於壓力範圍40至80 psi下進行操作,對投遞物質之破壞性係不大。Table 6 shows that when the destruction rate of luciferase activity is between 40 psi and 80 psi, as the pressure increases, the destruction rate of the delivered substance also increases, but the destruction rate at 80 psi is still only 1.55%. Therefore, the delivery device according to the present invention operates under a pressure range of 40 to 80 psi, which is not very destructive to the delivered substance.
LuciferaseLuciferase 蛋白投遞後之半衰期測試Half-life test after protein delivery
測試方法:
(1) 以 ddH2
O 配製金粒包覆 1 µg pGL3-Luciferase vector 溶液,以及 1、3、10 μg pGL3-Luciferase vector溶液。
(2) 將 C57BL/6小鼠秤重並固定,於鼠蹊部以針筒施打水合氯醛 (chloral hydrate) 5%,劑量為 0.2 ml/20g。
(3) 將老鼠腹部進行剃毛,透過本發明之投遞器對C57BL/6小鼠於 60 psi (Naked DNA) 壓力下施打20 µl pGL3-basic vector溶液和金粒包覆 pGL3-Luciferase vector溶液,以及各濃度之pGL3-Luciferase vector 溶液。
(4) 於24、48、72、96、120、144、168 小時的時候,對老鼠進行抽血,並分離出血清。
(5) 以 BGLAR 試劑組(BGLAR kits) 分析血液中 Luciferase 的表現量。Test method: (1) Prepare gold particles coated with 1 µg pGL3-Luciferase vector solution and 1, 3, 10 µg pGL3-Luciferase vector solution with ddH 2 O. (2) C57BL/6 mice were weighed and fixed, and
測試結果: 第7圖顯示透過本發明之投遞器投遞金粒包覆基因或裸露基因入老鼠體內後,金粒包覆方式投遞或裸露方式投遞之luciferase基因於24小時內即達到最高表現量。金粒包覆之投遞方式下,此時其表現量高於裸露基因投遞方式之組別。但換成時間依賴性之模式下進行觀察,結果卻顯示裸露基因方式之投遞下,其活性卻比金粒包覆投遞方式之活性高,甚至於168小時仍具有活性。因此,此結果顯示出以本發明之投遞器投遞 DNA 疫苗,裸露投遞方式比金粒包覆投遞方式之半衰期長。Test Results: Figure 7 shows that after the gold particle-coated gene or naked gene is delivered into the mouse through the delivery device of the present invention, the luciferase gene delivered in the gold-coated or naked manner reaches the highest expression level within 24 hours. Under the delivery method coated with gold particles, the expression level at this time is higher than that of the group of naked gene delivery methods. However, it was observed in a time-dependent mode, and the results showed that the activity of the naked gene delivery method was higher than that of the gold particle coated delivery method, and it was still active even for 168 hours. Therefore, this result shows that the half-life of the naked delivery method of the DNA vaccine delivered by the delivery device of the present invention is longer than that of the gold particle coated delivery method.
綜上所述之實施例,僅是本發明之較佳實施例,並非對本發明做任何形式上之限制,任何所屬技術領域中具有通常知識者,若在不脫離本發明所提技術方案之範圍內,利用本發明所揭示技術內容所作出局部更動或修飾之等效實施例,並且未脫離本發明之技術方案內容,均仍屬於本發明技術方案之範圍內。In summary, the above-mentioned embodiments are only preferred embodiments of the present invention, and do not limit the present invention in any form. Anyone who has common knowledge in the relevant technical field does not deviate from the scope of the technical solutions proposed by the present invention. Within the scope of the technical solution of the present invention, the equivalent embodiments made by using the technical content disclosed in the present invention to make partial changes or modifications without departing from the technical solution content of the present invention.
100 投遞器
101 噴嘴
102 送料機構
103 蓄壓艙
104 握把結構
105 啟動元件
106 防拆保險
107 後端接頭
108 電磁閥
200 電磁閥
201 閥本體
201a 第一流道
201b 第二流道
201c 排氣孔
202 閥蓋
203 復位彈簧
204 閥軸
204a 前腔
204b 後腔
205 電磁開關
206 第一橡膠環
207 第二橡膠環
208 第三橡膠環
209 流體入口
210 閥門
211 軸心線
300 防拆保險
301 公端
302 母端
303 卡楯
401氣體鋼瓶
402 受測電磁閥
403 氣流方向
404 連通管
405 氣體調壓閥
406 浮子式流量計
1000 電磁開關
1001 開關主體
1002 線圈
1003 動鐵芯
1004 復位彈簧
1005 第一流道
1006 第二流道
1007 排氣孔
1008 第一氣密環
1009 第二氣密環
1010 第三氣密環
1011 第四氣密環
D 可移動之距離
G 銜接處100
第1圖係本發明一較佳實施例之投遞器本體結構剖面示意圖。 第2圖係本發明一較佳實施例之電磁閥剖面示意圖,圖(A)為電磁閥關閉狀態-第一流道位置剖面、(B)為電磁閥關閉狀態-第二流道位置剖面,圖(C) 為電磁閥開啟狀態-第一流道位置剖面、圖(D) 為電磁閥開啟狀態-第二流道位置剖面。 第3圖係本發明一較佳實施例之防拆保險示意圖。 第4圖係繪示以本發明之投遞器遞送膜聯蛋白 A2至老鼠皮膚組織後,進行組織免疫染色,並以光學顯微鏡觀察之結果(視野倍率為 400X)。 第5圖係繪示以本發明之投遞器遞送pCMV- ß -galactosidase DNA至老鼠皮膚組織後,進行組織免疫染色,並以光學顯微鏡觀察之結果(A 之視野倍率為400X,B之視野倍率為400X)。 第6圖係繪示以本發明之投遞器遞送人類生長激素至老鼠體內之測試結果;其中CTL:控制組,I.D.:皮下注射,Bio-Jet:投遞器。 第7圖係繪示以本發明之投遞器遞送Lucferase蛋白至老鼠體內之半衰期測試結果。 第8圖係繪示電磁閥樣品穩定流量測量之安裝方式。 第9圖係繪示電磁閥樣品壓差測量之安裝方式。 第10圖係繪示本發明電磁開關作動之示意圖;圖(A):電磁開關關閉示意圖,圖(B):電磁開關關閉示意圖,圖(C):電磁開關開啟示意圖;圖(D)電磁開關開啟示意圖。Figure 1 is a schematic cross-sectional view of the main body structure of the delivery device according to a preferred embodiment of the present invention. Figure 2 is a schematic cross-sectional view of a solenoid valve according to a preferred embodiment of the present invention. Figure (A) is a closed state of the solenoid valve-a cross section of the first flow passage position, and (B) is a closed state of the solenoid valve-a cross section of the second flow passage position. (C) is the open state of the solenoid valve-the first flow passage position section, and Figure (D) is the open state of the solenoid valve-the second flow passage position section. Figure 3 is a schematic diagram of a tamper-evident insurance according to a preferred embodiment of the present invention. Figure 4 shows the results of tissue immunostaining after the delivery of Annexin A2 to mouse skin tissues using the delivery device of the present invention and observation with an optical microscope (field of view magnification 400X). Figure 5 shows the results of tissue immunostaining after delivery of pCMV-ß-galactosidase DNA to mouse skin tissue by the delivery device of the present invention, and observation with an optical microscope (the visual field of A is 400X, and the visual magnification of B is 400X). Figure 6 shows the test results of delivering human growth hormone to mice with the delivery device of the present invention; where CTL: control group, I.D.: subcutaneous injection, Bio-Jet: delivery device. Figure 7 shows the half-life test results of the delivery of Lucferase protein into mice by the delivery device of the present invention. Figure 8 shows the installation method for stable flow measurement of solenoid valve samples. Figure 9 shows the installation method of the solenoid valve sample pressure difference measurement. Figure 10 is a schematic diagram showing the actuation of the electromagnetic switch of the present invention; Figure (A): a schematic diagram of the electromagnetic switch closed; Figure (B): a schematic diagram of the electromagnetic switch closed; Figure (C): a schematic diagram of the electromagnetic switch open; Figure (D) the electromagnetic switch Open the schematic.
100 投遞器
101 噴嘴
102 送料機構
103 蓄壓艙
104 握把結構
105 啟動元件
106 防拆保險
107 後端接頭
108 電磁閥100
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