TWI737457B - Syringe - Google Patents
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- TWI737457B TWI737457B TW109128239A TW109128239A TWI737457B TW I737457 B TWI737457 B TW I737457B TW 109128239 A TW109128239 A TW 109128239A TW 109128239 A TW109128239 A TW 109128239A TW I737457 B TWI737457 B TW I737457B
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Abstract
Description
本發明係關於一種注射裝置,更具體地,係關於一種用於遞送微球及/或顆粒藥物的注射裝置,施加外力於注射推桿時,注射筒內產生紊流以擾動微球及/或顆粒藥物,可避免聚集及沉降。 The present invention relates to an injection device, and more specifically, to an injection device for delivering microspheres and/or granular drugs. When an external force is applied to the injection plunger, turbulence is generated in the syringe to disturb the microspheres and/or Granular drugs can avoid aggregation and sedimentation.
選擇性體內放射治療(selective internal radiation therapy,SIRT)是一種透過體內定點輻射治療來治療癌細胞與腫瘤的方法。使用SIRT的病患,絕大多數都有腫瘤無法經手術切除的問題存在,尤其是肝細胞癌或肝轉移的特定患者。 Selective internal radiation therapy (SIRT) is a method to treat cancer cells and tumors through targeted radiation therapy in the body. Most patients who use SIRT have the problem that their tumors cannot be surgically removed, especially those with hepatocellular carcinoma or liver metastases.
傳統的放射治療係以外部放射源照射人體,放射線穿透人體皮膚、脂肪等屏障後進入體內,可破壞或消除體內癌細胞與腫瘤。然而,放射線經過人體遮蔽後能量會大幅衰減,通常經計算而必須施加更大的輻射計量,惟過量的輻射計量同時也將導致鄰近的正常細胞遭受破壞,此問題往往導致病患存活率下降。為了克服此問題,SIRT因而衍生,其係自傳統化學栓塞術(chemoembolization)發想、衍生,直接將放射性微球透過血液傳遞到腫瘤內部 的小血管,後受尺寸大小限制而卡在腫瘤內部的小血管中,藉此直接於該位點釋放出高劑量放射能。 Traditional radiotherapy irradiates the human body with external radiation sources. The radiation penetrates the human skin, fat and other barriers and enters the body, which can destroy or eliminate cancer cells and tumors in the body. However, the energy of radiation will be greatly attenuated after being shielded by the human body. Generally, a larger radiation measurement must be applied by calculation. However, excessive radiation measurement will also cause damage to neighboring normal cells. This problem often leads to a decline in patient survival. In order to overcome this problem, SIRT was derived from the idea and derivation of traditional chemical embolization (chemoembolization), which directly transmits radioactive microspheres into the tumor through the blood. The small blood vessels are restricted by their size and get stuck in the small blood vessels inside the tumor, thereby directly releasing high-dose radioactivity at the site.
SIRT這樣使用微球注射至血液中以直接照射的方式在臨床上有明確的優勢:第一,微球注射至動脈後,利用腫瘤血管增生的特性,將放射性微球傳遞至目標器官腫瘤進行放射治療;第二,隨著放射性微球停留時間增加,微球中的放射性物質逐漸衰減,最終微球失去放射性而成為無害的物質殘留於體內;第三,可透過血管擴張等藥物,進一步控制動脈的血流流量,讓放射性微球優先進入腫瘤,而相對減低對其他器官正常組織的傷害。 In SIRT, the use of microspheres injected into the blood to directly irradiate has clear clinical advantages: First, after microspheres are injected into the arteries, they use the characteristics of tumor vascular proliferation to deliver radioactive microspheres to the target organ tumor for radiation. Treatment; second, as the residence time of the radioactive microspheres increases, the radioactive substances in the microspheres gradually attenuate, and eventually the microspheres lose their radioactivity and become harmless substances remaining in the body; third, drugs such as vasodilators can be used to further control the arteries The high blood flow allows the radioactive microspheres to enter the tumor preferentially, and the damage to the normal tissues of other organs is relatively reduced.
但是,SIRT仍有諸多潛藏的傷害風險及待改善之處。 However, SIRT still has many potential harm risks and needs to be improved.
其一,市面上的放射性微球有玻璃及樹脂兩種材質,其中,樹脂微球的放射計量則遠不如玻璃微球,為了達到效果必須注射更多數量的樹脂微球,數量眾多的樹脂微球容易彼此聚集、相互推擠,而導致樹脂微球殘留於注射筒及導引管中,致使操作困難、或注射入體內的放射計量不足。另一方面,雖然玻璃微球放射計量較高,但玻璃微球比重相當大,在抽取瓶、注射筒及輸液管路中極容易沉降,同樣容易使得放射性微球堆積殘留於抽取瓶內、阻塞或殘留於注射筒及導引管中,如圖1A及圖1B所示。 First, the radioactive microspheres on the market are made of glass and resin. Among them, the radiation measurement of resin microspheres is far inferior to that of glass microspheres. In order to achieve the effect, a larger number of resin microspheres must be injected. The balls tend to gather and push against each other, resulting in the resin microspheres remaining in the syringe and the guide tube, making the operation difficult or the amount of radiation injected into the body insufficient. On the other hand, although glass microspheres have a relatively high radiometric measurement, the specific gravity of glass microspheres is quite large, and they are very easy to settle in the extraction bottle, syringe and infusion line. It is also easy to cause the accumulation of radioactive microspheres to remain in the extraction bottle and block. Or remain in the syringe and guide tube, as shown in Figure 1A and Figure 1B.
其二,為了避免放射性微球殘留於注射筒及導引管中,目前臨床上可進行SIRT的注射組件必須搭配外加的幫浦加壓系統才能將放射性微球強制注射入動脈。然而,根據2015年美國緊急醫療研究機構所提出最需急迫應對的十大醫療科技危害中,即有動/靜脈注射管路混亂(例如幫浦加壓系統的管路)造成藥品及輸液給予錯誤的危害。由於治療處所管線複雜,例如加護病房或手術病人可能同時會有多達12條的注射管路,若SIRT注射組件必須搭配外加的幫浦加 壓系統,勢必增加諸如注射管路連結到錯誤的輸液幫浦或頻段、注射管路連結到錯誤的輸液容器或投藥管線等等的風險。 Second, in order to prevent radioactive microspheres from remaining in the syringe and guide tube, the current clinically available SIRT injection components must be combined with an external pump pressure system to force the radioactive microspheres into the artery. However, according to the 2015 U.S. Emergency Medical Research Agency, among the top ten medical technology hazards that need urgent response, there is confusion in the arterial/venous injection pipeline (such as the pipeline of the pump pressurization system), which causes the wrong medicine and infusion to be given. The harm. Due to the complexity of the pipeline in the treatment area, for example, the intensive care unit or the surgical patient may have up to 12 injection lines at the same time. If the SIRT injection component must be combined with an additional pump The pressure system will inevitably increase the risk of connecting the injection line to the wrong infusion pump or frequency band, and the injection line to the wrong infusion container or dosing line.
因此,如何於進行SIRT的注射過程時,避免放射性微球彼此聚集、沉降,而致放射性微球殘留於注射筒及導引管中,同時降低使用額外的管路,以減少注射管路混亂的問題係SIRT所面臨的重要課題。 Therefore, during the SIRT injection process, how to prevent the radioactive microspheres from agglomerating and sedimenting each other, resulting in the radioactive microspheres remaining in the syringe and the guide tube, and reducing the use of additional tubing to reduce the confusion of the injection tubing The problem is an important issue facing SIRT.
有鑑於此,本發明提供一種注射裝置,包括: In view of this, the present invention provides an injection device including:
包括頂開口及底開口之容置筒,係用以容納待注射物;以及 A containing tube including a top opening and a bottom opening is used to contain the object to be injected; and
推桿部件,係以氣密地可往復推拉的方式自該底開口插設於該容置筒中,該推桿部件包括: The push rod component is inserted into the accommodating cylinder from the bottom opening in an airtight manner that can be pushed back and forth, and the push rod component includes:
推桿,其前端具有開孔; The push rod has an opening at the front end;
螺旋件,係具有螺旋軸與設於該螺旋軸其中一端之抵接部,該螺旋軸之另一端插入至該推桿之開孔,使該螺旋軸部分容置於該開孔內,另一部分則突出該開孔; The screw is provided with a screw shaft and an abutment portion provided at one end of the screw shaft, the other end of the screw shaft is inserted into the opening of the push rod, so that the screw shaft is partially contained in the opening, and the other part Then highlight the opening;
彈簧,係具有分別連接該推桿之前端以及該螺旋件之抵接部的兩端;以及 The spring has two ends respectively connected to the front end of the push rod and the abutting part of the spiral member; and
至少一組攪拌葉片組件,係設於該螺旋件之抵接部,該攪拌葉片組件具有至少兩葉片,且各該葉片具有凹槽及通孔, At least one set of mixing blade assembly is arranged on the abutting part of the spiral element, the mixing blade assembly has at least two blades, and each of the blades has a groove and a through hole,
其中,當施力使該推桿沿該容置筒之軸向移動時,帶動該螺旋軸自該開孔旋出或旋入而令該彈簧變形,且該螺旋件驅動該攪拌葉片組件轉動,以攪拌該待注射物。 Wherein, when a force is applied to move the push rod along the axial direction of the accommodating cylinder, the screw shaft is driven to rotate out or screw in from the opening to deform the spring, and the screw drives the stirring blade assembly to rotate, To stir the to be injected.
於一具體實施態樣中,當不再施力於推桿時,該變形之彈簧驅動該螺旋軸自該開孔旋入或旋出並驅動該攪拌葉片組件轉動,以攪拌該待注射物,同時,該推桿移動至原位置。 In a specific embodiment, when no force is applied to the push rod, the deformed spring drives the screw shaft to rotate in or out of the opening and drives the stirring blade assembly to rotate to stir the object to be injected, At the same time, the push rod moves to the original position.
於一具體實施態樣中,該推桿之開孔之內壁上具有內螺紋,且該螺旋軸之側壁上具有與該內螺紋相配的外螺紋,當該螺旋軸於該開孔內滑移時,因相配的該內螺紋與該外螺紋使該螺旋軸旋轉。 In a specific embodiment, the inner wall of the opening of the push rod has an internal thread, and the side wall of the screw shaft has an external thread that matches the internal thread. When the screw shaft slides in the opening At this time, the screw shaft rotates due to the matching internal thread and the external thread.
於一具體實施態樣中,該螺旋軸與該推桿之開孔之間以旋轉結構相結合。 In a specific embodiment, the screw shaft and the opening of the push rod are combined with a rotating structure.
於一具體實施態樣中,該旋轉結構為密封防水軸承。 In a specific implementation aspect, the rotating structure is a sealed waterproof bearing.
於一具體實施態樣中,該推桿部件復包括底盤,係設於該推桿之前端,使該彈簧之兩端分別連接該底盤以及該螺旋件之抵接部。 In a specific embodiment, the push rod component further includes a chassis, which is arranged at the front end of the push rod, so that the two ends of the spring are respectively connected to the chassis and the abutment portion of the spiral member.
於一具體實施態樣中,該底盤具有供該螺旋軸穿設其中之中央通孔,且該底盤之中央通孔之內壁上具有與該螺旋軸之側壁上之外螺紋相配的內螺紋。 In a specific embodiment, the chassis has a central through hole for the screw shaft to pass through, and the inner wall of the central through hole of the chassis has an internal thread that matches the external thread on the side wall of the spiral shaft.
於一具體實施態樣中,該推桿部件復包括頂錐盤,係設於該螺旋件之抵接部上。 In a specific embodiment, the push rod component further includes a top cone disc, which is arranged on the abutting portion of the spiral element.
於一具體實施態樣中,當未施力於該推桿時,該容置筒之頂開口至該頂錐盤之間的距離小於該容置筒之頂開口至底開口之間的距離的四分之一。 In a specific embodiment, when no force is applied to the push rod, the distance between the top opening of the accommodating cylinder and the top cone is less than the distance between the top opening and the bottom opening of the accommodating cylinder A quarter.
於一具體實施態樣中,以該葉片之總長度為基準,該葉片之凹槽係設於自該葉尖為起點之總長度四分之一的範圍內。 In a specific embodiment, based on the total length of the blade, the groove of the blade is set within a quarter of the total length starting from the tip of the blade.
於一具體實施態樣中,以該葉片之總長度為基準,該葉片之通孔係位於自該葉尖為起點之總長度四分之三的範圍外。 In a specific embodiment, based on the total length of the blade, the through hole of the blade is located outside the range of three-quarters of the total length starting from the tip of the blade.
於一具體實施態樣中,該通孔之孔徑係50μm至200μm。 In a specific embodiment, the aperture of the through hole is 50 μm to 200 μm.
於一具體實施態樣中,該葉片之水平面與該螺旋軸之徑向之間的夾角為30至45度。 In a specific embodiment, the angle between the horizontal plane of the blade and the radial direction of the spiral shaft is 30 to 45 degrees.
於一具體實施態樣中,該推桿部件包括兩組攪拌葉片組件,且於另一具體實施態樣中,該兩組攪拌葉片組件組構成以相反旋轉方向的方式與該螺旋件相接。 In one embodiment, the push rod component includes two sets of stirring blade assemblies, and in another embodiment, the two sets of stirring blade assemblies are formed to be connected to the spiral member in opposite rotation directions.
於一具體實施態樣中,該攪拌葉片組件具有三葉片。 In a specific embodiment, the stirring blade assembly has three blades.
於一具體實施態樣中,該容置筒之外壁具有螺旋狀凸起,該螺旋狀凸起作用為加強注射操作時前端手指支撐,以達到穩定注射的目的。 In a specific implementation aspect, the outer wall of the accommodating cylinder has a spiral protrusion, and the spiral protrusion functions to strengthen the front end finger support during the injection operation, so as to achieve the purpose of stable injection.
於一具體實施態樣中,該底盤與該推桿之前端之連接處設有底盤墊片。 In a specific implementation aspect, a chassis gasket is provided at the connection between the chassis and the front end of the push rod.
於一具體實施態樣中,該注射裝置復包括頂嘴,係與該頂開口連接。 In a specific embodiment, the injection device further includes a top nozzle connected to the top opening.
於一具體實施態樣中,該注射裝置復包括頂開口塞具,係套設於該容置筒之頂開口中,且該頂開口塞具具有開口,以供該頂嘴與該頂開口塞具連接。 In a specific embodiment, the injection device further includes a top opening stopper, which is sleeved in the top opening of the accommodating cylinder, and the top opening stopper has an opening for the ejector and the top opening stopper connect.
於一具體實施態樣中,該容置筒復包括側開口,係連接注射管線,使注射用液體經該注射管線注入該容置筒。 In a specific implementation aspect, the accommodating cylinder includes a side opening, which is connected to an injection line, so that the injection liquid is injected into the accommodating cylinder through the injection line.
於一具體實施態樣中,該容置筒復包括側開口塞具,係設於該容置筒之側開口中,以密封該側開口。 In a specific implementation aspect, the accommodating cylinder further includes a side opening plug, which is arranged in the side opening of the accommodating cylinder to seal the side opening.
如於一具體實施態樣中,該待注射物係裝載微球及/或顆粒藥物。 As in a specific embodiment, the substance to be injected is loaded with microspheres and/or granular drugs.
於一具體實施態樣中,該注射裝置係由包括矽橡膠、聚乙烯、丙烯酸樹脂、聚氨酯、聚丙烯、聚甲基丙烯酸甲酯、聚乙二醇、聚甲基丙烯酸羥乙酯、聚乙交酯、聚乳酸、殼聚醣、透明質酸及水凝膠的至少一種材質所製成。 In a specific embodiment, the injection device is composed of silicone rubber, polyethylene, acrylic resin, polyurethane, polypropylene, polymethyl methacrylate, polyethylene glycol, polyhydroxyethyl methacrylate, polyethylene Made of at least one material of lactide, polylactic acid, chitosan, hyaluronic acid and hydrogel.
於一具體實施態樣中,該容置筒之內壁以及該攪拌葉片組件之表面塗佈有疏水性高分子膜,且於另一具體實施態樣中,該疏水性高分子膜係聚二甲基矽氧烷(PDMS)或聚四氟乙烯(PTFE)。 In a specific embodiment, the inner wall of the accommodating cylinder and the surface of the stirring blade assembly are coated with a hydrophobic polymer film, and in another embodiment, the hydrophobic polymer film is polymerized Methylsiloxane (PDMS) or polytetrafluoroethylene (PTFE).
本發明的注射裝置係具有特殊結構的推桿部件,其中,當施力使推桿沿容置筒之軸向移動時,推桿部件中的螺旋件通過螺旋軸自推桿的開孔旋出或旋入,該旋出或旋入的旋轉運動驅動攪拌葉片組件轉動,使待注射物被攪拌葉片組件攪拌。另一方面,由於螺旋軸的移動,使得彈簧產生壓縮或拉伸的變形,因此當不再施力於推桿時,變形之彈簧會驅動推螺旋件再次自推桿的開孔旋出或旋入且驅動攪拌葉片組件轉動,同時使推桿移動至原位置。 The injection device of the present invention is a push rod component with a special structure, wherein, when a force is applied to move the push rod along the axial direction of the accommodating cylinder, the screw in the push rod component is screwed out from the opening of the push rod through the screw shaft Or screw in, the rotating motion of the screw out or screw in drives the stirring blade assembly to rotate, so that the to-be-injected material is stirred by the stirring blade assembly. On the other hand, due to the movement of the screw shaft, the spring is deformed by compression or tension. Therefore, when no force is applied to the push rod, the deformed spring will drive the push screw to unscrew or rotate from the opening of the push rod again. Into and drive the mixing blade assembly to rotate, and at the same time move the push rod to the original position.
其次,本發明的注射裝置中,攪拌葉片組件的葉片上具有特殊的結構,如凹槽及通孔,該結構令攪拌葉片組件轉動時可使周圍流體產生不規則紊流,藉此避免微球及/或顆粒藥物聚集、沉降、提高分散。 Secondly, in the injection device of the present invention, the blade of the mixing blade assembly has special structures, such as grooves and through holes, which can cause irregular turbulence in the surrounding fluid when the mixing blade assembly rotates, thereby avoiding microspheres. And/or granular medicine aggregates, settles, and improves dispersion.
因此,施力於本發明的注射裝置的推桿部件時,容置筒內之微球及/或顆粒藥物可經攪拌葉片組件所產生的紊流擾動而分散,並經由容置筒之頂開口被推出,操作簡便且不需要外加幫浦加壓系統。 Therefore, when a force is applied to the push rod component of the injection device of the present invention, the microspheres and/or granular medicine in the container can be dispersed by the turbulence generated by the stirring blade assembly, and pass through the top opening of the container. It is pushed out, easy to operate and does not require an external pump pressure system.
1:習知用於SIRT之注射組件 1: Conventional injection components used for SIRT
10:容置筒 10: Containment tube
11:頂開口 11: Top opening
12:底開口 12: bottom opening
13:側開口 13: side opening
130:側開口塞具 130: Side opening plug
22:推桿 22: putter
220:開孔 220: open hole
23:底盤 23: Chassis
24:螺旋件 24: Spiral
241:螺旋軸 241: Spiral shaft
242:抵接部 242: contact part
26:彈簧 26: Spring
28:攪拌葉片組件 28: Mixing blade assembly
29:頂錐盤 29: Top cone
30:頂嘴 30: talk back
301:頂開口塞具 301: Top opening plug
40:螺旋軸 40: Spiral shaft
41,41’,41”:葉片 41,41’,41”: Blade
410,410’,410”:凹槽 410,410’,410”: groove
411,411’,411”:通孔 411,411’,411”: Through hole
412:葉尖 412: Leaf Tip
h,h’,t,t’:距離 h,h’,t,t’: distance
L:總長度 L: total length
圖1A係習知用於SIRT之注射組件之外觀結構示意圖;圖1B係剖面結構示意圖。 Fig. 1A is a schematic diagram of the appearance and structure of a conventional injection assembly used for SIRT; Fig. 1B is a schematic diagram of the cross-sectional structure.
圖2A及圖2B係本發明注射裝置之具體實施例之剖面結構示意圖,其中,圖2A係未施力於推桿時之剖面結構示意圖,而圖2B係施力於推桿時之剖面結構示意圖。 2A and 2B are schematic cross-sectional structure diagrams of specific embodiments of the injection device of the present invention, wherein FIG. 2A is a schematic cross-sectional structure diagram when no force is applied to the push rod, and FIG. 2B is a schematic cross-sectional structure diagram when force is applied to the push rod .
圖3係本發明注射裝置之具體實施例之剖面結構分解示意圖。 Fig. 3 is an exploded schematic view of a cross-sectional structure of a specific embodiment of the injection device of the present invention.
圖4A至圖4D係本發明注射裝置之攪拌葉片組件具體實施例之頂視示意圖;圖4E及圖4F係攪拌葉片組件實施態樣之側視示意圖。 4A to 4D are schematic top views of specific embodiments of the stirring blade assembly of the injection device of the present invention; FIGS. 4E and 4F are schematic side views of the implementation of the stirring blade assembly.
以下藉由特定的具體實施例說明本發明之實施方式,熟悉此技藝之人士可由本說明書所揭示之內容輕易地瞭解本發明之其他優點及功效。 The following specific examples illustrate the implementation of the present invention. Those familiar with the art can easily understand the other advantages and effects of the present invention from the contents disclosed in this specification.
須知,本說明書所附圖式所繪示之結構、比例、大小等,均僅用以配合說明書所揭示之內容,以供熟悉此技藝之人士之瞭解與閱讀,並非用以限定本發明可實施之限定條件,故不具技術上之實質意義,任何結構之修飾、比例關係之改變或大小之調整,在不影響本發明所能產生之功效及所能達成之目的下,均應仍落在本發明所揭示之技術內容得能涵蓋之範圍內。 It should be noted that the structure, ratio, size, etc. shown in the drawings in this manual are only used to match the content disclosed in the manual for the understanding and reading of those who are familiar with the art, and are not intended to limit the implementation of the present invention. Therefore, it does not have any technical significance. Any structural modification, proportional relationship change or size adjustment should still fall within the original The technical content disclosed by the invention can be covered.
併同參閱圖2A及圖3,係本發明注射裝置之具體實施例之結構示意圖。 Also refer to Fig. 2A and Fig. 3, which are the structural schematic diagrams of the specific embodiment of the injection device of the present invention.
本實施例中,注射裝置包括容置筒10以及推桿部件。所述容置筒10包括頂開口11、側開口13及底開口12。雖然本實施例中所述容置筒10包括有側開口13,但於其他實施例中,亦可不設置側開口13。本實施例中,所述頂開口11係待注射物之推出口,頂開口11用以連接頂嘴30,且為了緊密連接、避免氣體或液體自縫隙中滲入或洩漏,可進一步設置頂開口塞具301於所述容置筒10之頂開口11中,所述頂開口塞具301具有開孔,其可供頂嘴30插入而與所述容置筒10連通,藉以提升頂開口11與頂嘴30之間的連接密著性。
In this embodiment, the injection device includes a
本實施例中,所述側開口13可設置側開口塞具130,以密封所述側開口13,避免氣體或液體洩漏或自外部滲入。或者,於其他實施例中,所述側開
口13可連接注射管線,使注射用液體經注射管線注入該容置筒10。例如,以所述側開口塞具130密封所述側開口13以執行第一次注射,若注射完畢後所述容置筒10內仍有殘留物,可通過移除所述側開口塞具130,而連接注射管線,通過導入注射液體以沖提所述容置筒10內之殘留物,並使後述之推桿部件於所述容置筒10內往復移動,使殘留物懸浮、分散於注射液體中,再進行第二次注射。
In this embodiment, the
所述底開口12係用以通入所述推桿部件,令所述推桿部件設於該容置筒10中,使得所述推桿部件與所述容置筒10之間以氣密地可往復推拉的方式相結合。
The
所述容置筒10之內部空間係裝載待注射物,於本實施例中,所述待注射物係微球及/或顆粒藥物,當所述推桿部件沿所述容置筒10之軸向進行推進運動時,微球及/或顆粒藥物經由頂開口11被推出至頂嘴30,而頂嘴30復可接置導引管等注射管線以連接至體內,如此,微球及/或顆粒藥物經頂開口11、頂嘴30、導引管而傳遞體內。
The internal space of the
所述容置筒之外壁還可具有螺旋狀凸起,所述凸起可作為注射操作時手指之支撐部位,以利穩定注射。 The outer wall of the accommodating cylinder may also have spiral protrusions, and the protrusions can be used as supporting parts of the fingers during injection operation to facilitate stable injection.
本實施例中,推桿部件包括推桿22、螺旋件24、彈簧26以及至少一組攪拌葉片組件28。推桿部件還可包括底盤23及頂錐盤29。
In this embodiment, the push rod component includes a
所述推桿22之前端具有開孔220,而所述螺旋件24具有螺旋軸241與設於螺旋軸241其中一端之抵接部242,螺旋軸241之另一端則插入至推桿22之開孔220,使得螺旋軸241之一部分容置於該開孔220內,另一部分則突出該開孔220。所述彈簧26之兩端分別連接推桿22之前端以及螺旋件24之抵接部242。所述攪拌葉片組件28,係設於螺旋件24之抵接部242。
The front end of the
所述開孔220之內壁上具有內螺紋,且螺旋軸241之側壁上亦具有與所述內螺紋相配的外螺紋。因此,當螺旋軸241於開孔220內滑移時,因相配該
內螺紋與外螺紋使得螺旋軸於移動的同時進行旋轉,即旋出或旋入。當施力使推桿22移動時,螺旋軸241自開孔220旋出或旋入,驅動所述攪拌葉片組件28轉動,使該待注射物被攪拌。具體地,如圖2B所示,當施力使推桿22沿容置筒10之軸向推進時,螺旋軸241自開孔220旋出,螺旋軸241之端部與開孔220底部之間的距離t變長,由距離t變為距離t’。
The inner wall of the
所述彈簧26圍繞螺旋軸241。彈簧26之作用在於提供反饋動力來源,也可避免攪拌葉片組件28在推桿部件滑移過程中卡死無法作用的問題。如圖2A所示,當未施力於推桿22時,所述彈簧26未經壓縮。當施加外力於推桿22時,螺旋軸241自開孔220旋出或旋入,螺旋軸241外露於開孔220的長度(即推桿22前端至螺旋件24之抵接部242的距離)發生變化,因而使彈簧26壓縮或拉伸變形,當不再施力於推桿22時,變形之彈簧26驅動推桿22移動,螺旋軸241同時再次自開孔220旋入或旋出並驅動攪拌葉片組件28轉動。具體地,如圖2B變為圖2A,變形之彈簧26驅動推桿22移動,螺旋軸241自開孔220旋入,螺旋軸241之端部與開孔220底部之間的距離t’變短,由距離t’變為距離t。另外,彈簧26亦能避免因過度的旋轉使螺旋件24損壞。
The
所述螺旋軸241與推桿22之開孔220之間可以旋轉結構相結合,所述旋轉結構例如為密封防水軸承。
The
推桿部件還可包括設於推桿22之前端之底盤23,使彈簧26之兩端分別連接底盤23以及螺旋件24之抵接部242。所述底盤23具有中央通孔,因而螺旋軸241可穿過中央通孔而插入推桿22之開孔220。所述底盤23之中央通孔之內壁上亦可具有與螺旋軸241之側壁上之外螺紋相配的內螺紋。另外,底盤23與推桿22之前端之連接處還可設置底盤墊片。
The push rod component may further include a
推桿部件還可包括設於螺旋件24之抵接部242上之頂錐盤29。
The push rod component may further include a
本實施例中,如圖2A未施力於推桿時,所述容置筒10之頂開口11至該推桿部件之頂錐盤29之間的距離h小於該容置筒10之頂開口11至底開口12之間的距離的四分之一,以避免攪拌葉片組件28卡在所述容置筒10之開口而無法作用,導致螺旋軸241損壞。
In this embodiment, when no force is applied to the push rod as shown in FIG. 2A, the distance h between the
如圖2B施力使推桿22沿容置筒10之軸向推進時,整個推桿部件連同推桿22和螺旋件24向容置筒10內推進,同時,螺旋軸241還自推桿22之開孔220旋出,因此,設於螺旋件24之抵接部242上之頂錐盤29朝頂開口11靠近,容置筒10之頂開口11至該推桿部件之頂錐盤29之間的距離h變短,由距離h變為距離h’,使待注射物自頂開口11被推出。
When force is applied to push the
以下進一步對攪拌葉片組件28詳細說明。
The
本實施例中,攪拌葉片組件28與螺旋件24之抵接部242相接。具體地,所述攪拌葉片組件24套設於所述螺旋件24之抵接部242。當所述螺旋軸241自開孔220旋入或旋出時,所述螺旋件24的旋轉運動驅動該攪拌葉片組件28一起轉動。本發明通過攪拌葉片組件28之旋轉所引起之紊流來擾動容置筒10內之微球或顆粒藥物,避免微球或顆粒藥物因比重大而沉降或者團聚、結塊等。
In this embodiment, the stirring
如圖4A所示,所述葉片41與螺旋軸40相接。具體地,所述攪拌葉片組件28具有至少兩葉片,例如可具有兩葉片、三葉片、四葉片、五葉片等,如圖4A所示,其係所述攪拌葉片組件28具有三葉片之具體實施例。
As shown in FIG. 4A, the
於其他實施例中,可進一步對所述攪拌葉片組件28之各該葉片進行設計。如圖4B及圖4E所示,葉片41具有凹槽410,410’,所述凹槽410,410’可設於靠近葉片41之尾端,例如可設於以葉片41之葉尖412為起點之總長度L四分之一的範圍內。該凹槽410,410’可為鋸齒凹槽結構,且可具有複數個。當葉片41旋轉時,凹槽410,410’使葉片41所產生之紊流更不規則,剪切力增大,可破壞微球或顆粒藥物因團聚所形成的塊狀物,提高分散性。
In other embodiments, each blade of the
於其他實施例中,如圖4C及圖4E所示,可於葉片41上設置通孔411,411’,通孔411,411’可於葉片41旋轉時提供圓弧、軸向、徑向之湍流力及渦流和漩渦,避免微球或顆粒藥物殘留於容置筒10之壁面或底部,同時可提供微球或顆粒藥物之流動通道。具體地,通孔411,411’可位於各葉片41之前端,例如可設於以葉片41之葉尖412為起點之總長度L四分之三的範圍外。通孔411,411’之孔徑可為50μm至200μm,例如50、60、70、80、90、100、110、120、130、140、150、160、170、180、190或200μm,但不限於此。凹槽410,410’與通孔411,411’還可同時設置於葉片41上,以增進分散的效果。
In other embodiments, as shown in FIGS. 4C and 4E, the
所述攪拌葉片組件28之葉片還可以傾斜的方式設置,提供更佳的剪切力,具體地,葉片之水平面與螺旋軸40之徑向之間的夾角為30至45度,例如30、35、40或45度角,但不限於此。如圖4F所示,葉片41’之水平面與螺旋軸G之徑向之間的夾角為45度。
The blades of the
所述攪拌葉片組件28可為一組、兩組、三組等,可通過設置不同節距來改變泵唧率及推力的組合。如圖4D及圖4E所示,其示出了兩組攪拌葉片組件28的實施例,兩組攪拌葉片組件28皆套設於螺旋件24之螺旋軸40上而與螺旋軸40相接,上攪拌葉片組件28具有三葉片41’,且下攪拌葉片組件28亦具有三葉片41”,且葉片41’,41”皆具有凹槽410’,410”與通孔411’,411”。
The
設置兩組攪拌葉片組件以上時,至少一攪拌葉片組件因螺旋軸之旋轉而轉動,而其他攪拌葉片組件可選擇被螺旋軸驅動或不被螺旋軸驅動。不被螺旋軸驅動之攪拌葉片組件可被其他攪拌葉片組件所引起之液流所驅動。具體而言,設置兩組攪拌葉片組件時,上攪拌葉片組件被配置為因螺旋軸驅動而旋轉,下攪拌葉片組件則被配置為因上攪拌葉片組件所引起之液流驅動而旋轉,下攪拌葉片組件的旋轉方向與上攪拌葉片組件的旋轉方向相反。 When more than two sets of stirring blade assemblies are provided, at least one stirring blade assembly rotates due to the rotation of the screw shaft, and the other stirring blade assemblies can be driven by the screw shaft or not driven by the screw shaft. The mixing blade assembly that is not driven by the screw shaft can be driven by the liquid flow caused by other mixing blade assemblies. Specifically, when two sets of stirring blade assemblies are provided, the upper stirring blade assembly is configured to rotate due to the drive of the screw shaft, and the lower stirring blade assembly is configured to rotate due to the liquid flow driven by the upper stirring blade assembly, and the lower stirring blade assembly The direction of rotation of the blade assembly is opposite to the direction of rotation of the upper mixing blade assembly.
本發明的注射裝置可由包括矽橡膠、聚乙烯、丙烯酸樹脂、聚氨酯、聚丙烯或聚甲基丙烯酸甲酯等不可降解之材料所製成,或者,亦可由聚乙交酯(PGA)、聚乳酸、殼聚醣、透明質酸及水凝膠的至少一種材料所製成。於其他實施例中,本發明的注射裝置可由包括聚甲基丙烯酸羥乙酯、聚乙二醇、殼聚醣、透明質酸的至少一種材料所製成。 The injection device of the present invention can be made of non-degradable materials including silicone rubber, polyethylene, acrylic resin, polyurethane, polypropylene or polymethyl methacrylate, or it can also be made of polyglycolide (PGA), polylactic acid , Chitosan, hyaluronic acid and at least one material of hydrogel. In other embodiments, the injection device of the present invention may be made of at least one material including polyhydroxyethyl methacrylate, polyethylene glycol, chitosan, and hyaluronic acid.
本實施例中,所述容置筒10之內壁以及攪拌葉片組件28之表面可塗佈有疏水性高分子膜,以避免微球或顆粒藥物之沾黏,亦減少因微球或顆粒藥物之碰撞而產生之塑膠微粒,避免該塑膠微粒一併被注入人體而造成危害。疏水性高分子膜例如為聚二甲基矽氧烷(PDMS)或聚四氟乙烯(PTFE)。
In this embodiment, the inner wall of the
由上述可知,本發明的注射裝置係具有特殊結構的推桿部件,當施力使推桿沿容置筒之軸向移動時,推桿部件中的螺旋件通過螺旋軸自推桿的開孔旋出或旋入,該旋出或旋入的旋轉運動驅動攪拌葉片組件轉動,使待注射物被攪拌葉片組件攪拌。另一方面,由於螺旋軸的移動,使得彈簧產生壓縮或拉伸的變形,因此當不再施力於推桿時,變形之彈簧會驅動推螺旋件再次自推桿的開孔旋出或旋入且驅動攪拌葉片組件轉動,同時使推桿移動至原位置。本發明注射裝置的攪拌葉片組件具有特殊的結構,葉片上具有凹槽及通孔,故攪拌葉片組件轉動時可使周圍流體產生不規則紊流,藉此避免微球及/或顆粒藥物聚集、沉降、提高分散。 It can be seen from the above that the injection device of the present invention is a push rod component with a special structure. When a force is applied to move the push rod along the axial direction of the accommodating cylinder, the screw in the push rod component passes through the screw shaft from the opening of the push rod. Rotating out or screwing in, the rotating motion of the screwing out or screwing in drives the stirring blade assembly to rotate, so that the to-be-injected material is stirred by the stirring blade assembly. On the other hand, due to the movement of the screw shaft, the spring is deformed by compression or tension. Therefore, when no force is applied to the push rod, the deformed spring will drive the push screw to unscrew or rotate from the opening of the push rod again. Enter and drive the mixing blade assembly to rotate, and at the same time move the push rod to the original position. The stirring blade assembly of the injection device of the present invention has a special structure, and the blades are provided with grooves and through holes. Therefore, when the stirring blade assembly rotates, the surrounding fluid can produce irregular turbulence, thereby avoiding the accumulation of microspheres and/or granular drugs. Settling and improving dispersion.
因此,施力於本發明的注射裝置的推桿部件時,容置筒內之微球及/或顆粒藥物可經攪拌葉片組件所產生的紊流擾動而分散,並經由容置筒之頂開口被推出,操作簡便且不需要外加幫浦加壓系統。 Therefore, when a force is applied to the push rod component of the injection device of the present invention, the microspheres and/or granular medicine in the container can be dispersed by the turbulence generated by the stirring blade assembly, and pass through the top opening of the container. It is pushed out, easy to operate and does not require an external pump pressure system.
應當理解地,在本發明所揭示之技術內容得能涵蓋之範圍內,各技術特徵(例如具體實施態樣及實施例所揭示者)可以自由地相互組合以形成新的或更佳的技術方案,為簡潔起見,在此不贅述。且本發明所揭示之由端值所構 成之數值範圍中,只要數值落於上下兩端值之間,即應包含在本發明所揭示的範圍內,且其與端點或其他數值所形成之次範圍亦應理所當然地包含在本發明所揭示的範圍內。 It should be understood that, within the scope of the technical content disclosed in the present invention, various technical features (such as those disclosed in specific implementations and embodiments) can be freely combined with each other to form new or better technical solutions , For the sake of brevity, I won’t repeat it here. And what the present invention discloses is constructed by the end value As long as the value falls between the upper and lower ends of the numerical value range, it shall be included in the scope disclosed in the present invention, and the sub-range formed by it and the end points or other numerical values shall naturally be included in the present invention. Within the scope of the disclosure.
10:容置筒 10: Containment tube
130:側開口塞具 130: Side opening plug
22:推桿 22: putter
220:開孔 220: open hole
23:底盤 23: Chassis
24:螺旋件 24: Spiral
26:彈簧 26: Spring
28:攪拌葉片組件 28: Mixing blade assembly
29:頂錐盤 29: Top cone
30:頂嘴 30: talk back
301:頂開口塞具 301: Top opening plug
h:距離 h: distance
t:距離 t: distance
Claims (20)
Priority Applications (1)
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TW109128239A TWI737457B (en) | 2020-08-19 | 2020-08-19 | Syringe |
Applications Claiming Priority (1)
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TW109128239A TWI737457B (en) | 2020-08-19 | 2020-08-19 | Syringe |
Publications (2)
Publication Number | Publication Date |
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TWI737457B true TWI737457B (en) | 2021-08-21 |
TW202208007A TW202208007A (en) | 2022-03-01 |
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TW109128239A TWI737457B (en) | 2020-08-19 | 2020-08-19 | Syringe |
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TW (1) | TWI737457B (en) |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TW202019492A (en) * | 2018-11-21 | 2020-06-01 | 白金科技股份有限公司 | Radioactive microsphere, preparation method thereof and radioactive filler composition |
US10710007B2 (en) * | 2012-06-25 | 2020-07-14 | Grayl Inc. | Filtration container assemblies and methods |
US10737075B2 (en) * | 2016-02-08 | 2020-08-11 | Orbusneich Medical Pte. Ltd. | Drug eluting balloon |
-
2020
- 2020-08-19 TW TW109128239A patent/TWI737457B/en active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10710007B2 (en) * | 2012-06-25 | 2020-07-14 | Grayl Inc. | Filtration container assemblies and methods |
US10737075B2 (en) * | 2016-02-08 | 2020-08-11 | Orbusneich Medical Pte. Ltd. | Drug eluting balloon |
TW202019492A (en) * | 2018-11-21 | 2020-06-01 | 白金科技股份有限公司 | Radioactive microsphere, preparation method thereof and radioactive filler composition |
Also Published As
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TW202208007A (en) | 2022-03-01 |
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