200402314 (1) 玖、發明說明 【發明所屬之技術領域】 本發明係關於一種噴射注射器，其係用以將液體藥物 刺穿待治療人士之皮膚，此噴射注射器包含一用以充壓及 容置藥物之外殻，此外殻由一封閉周緣壁及一底壁所界 定，該底壁具有一面向外殻內部空間的內表面及一相對的 外表面，底壁具有至少一通道延伸於該內表面與外表面之 間，且當使用該注射器時，該藥物會通過該通道，且該藥 物會自外殻排出並且轉變成可刺穿該人士皮膚之薄狀噴射 流。本發明亦關於一種操作此一注射器之方法。 本發明亦關於一種製造此一噴射注射器之方法，該噴 射注射器可將液體藥物刺穿待治療人士之皮膚，此噴射注 射器包含一用以充壓及容置藥物之外殻，此外殼由一封閉 周緣壁及一具有至少一通道之底壁所界定。 【先前技術】 目前用以注射一液體藥物之無針式噴射注射器係可產 生一噴射流，該噴射流係藉由本身具有的力量來刺穿待治 療人士之皮膚。這些注射器通常包括一高壓外殻，此外殼 具有一個或更多個開口作爲噴射流之出口。該一個或多個 開口係相當狹窄，通常約爲幾十分之一毫米。某些開口在 合理性及重製性上係極難譬如藉由射出模塑塑膠材料來製 造成具有相近的公差裕度。此外，亦難以將開口製造成具 有可使噴射流可連貫及精確束縮以達到最佳皮膚刺穿效果 (2) (2)200402314 之外形及流暢性。 國際專利申請WO 0 1 /05 45 4號係關於一種無針式注 射筒，其包含一具有互套元件之注射器，該互套元件中之 內部元件具有數個小槽道形成在其周緣表面，俾將一自充 壓室道出之藥物經由該數個槽道而傳導至一病患之皮膚， 使得複數個藥物流可以刺穿皮膚。每一槽道之孔口係與皮 膚相接觸，且藥物流係直接注射至皮膚中，亦即，在其之 間未具有任何間隙。該藥物流之細度係由槽道之尺寸所決 定，且槽道之截面積具有極小的尺寸。若尺寸太小，則在 槽道中之流動阻力將會過高而降低藥物的流量，如此將危 害到原本欲達到之注射效果。 【發明內容】 本發明之一目的係要提供一種噴射注射器，其具有可 產生一可調整細度且同時具有精確流量之噴射流的能力， 以達到一所需要的注射效果。 本發明之另一目的係要提供一種能夠便宜、可靠且容 易地製造一噴射注射器之方法。 本發明之又一目的係要提供一種噴射注射器，其具有 一出口，該出口在注射期間不會受到人們皮膚的污染。 本發明這些及其他目的可以藉由一種在本說明書之前 序中所提到之噴射注射器來達成，其特徵在於該通道包括 一流動束縮限制件，俾在自該外殼排出之藥物中形成一高 壓’其中一主體係連接至該通道，該主體係朝向遠離該通 -5- (3) (3)200402314 道之方向而呈漸細狀，且終結在一尖端，且其中該主體亘 有一周緣表面，其可收納所排出之藥物且將其導向該尖 端，以產生一自該尖端湧出之連續噴射流。 一種用以製造依照本發明且在前序之第二段落中所陳 述之噴射注射器的方法，其特徵爲以下之步驟： (i) 提供一模具以射出模塑成型該封閉周緣壁及底壁以 及在該底壁中之一穿孔； (ii) 機器力13工處理該模具形成該底壁之內表面及/或該 底壁之細孔的部分，使得在模具之壁體中形成凹部，例如 藉由銑磨、切削、刻溝、電花加工或蝕刻等方法； (iii) 注塡該模具以在該內表面及/或細孔之壁體上形 成突起； (iv) 提供一模具以射出模塑成型一插入件，該插入件 具有一大致呈錐狀之主體而可被收納在該細孔中，且具有 一大致符合該細孔之壁體之周緣表面； (v) 增添於或取代步驟（ii)，機器加工該模具用以形成 該周緣表面之壁體的部分，使得在模具之壁體中形成凹 部，例如藉由銑磨、切削、刻溝、電花加工或蝕刻等方法； (vi) 注塡該模具以在該周緣表面上形成突起；及 (Vi i)藉由將插入件插入至外殼中而將該大致呈錐狀之 主體定位在該細孔中，且以其尖端先置入，使得該突起接 觸一對置表面或壁體，藉此在該細孔壁體與大致呈錐狀之 主體之周緣表面之間形成一大致呈環圈狀間隙之通道。 在用以製造依照本發明且在前序之第二段落中所陳述 -6- (4) (4)200402314 之噴射注射器的另一種方法中，其特徵爲以下之步驟： (i) 提供一模具以射出模塑成型該封閉周緣壁及底壁以 及在該底壁中之一穿孔； (ii) 注塡該模具； (iii) 機器力D工處理所形成之細孔的壁體，使得在該壁 體形成凹溝，例如藉由銑磨、切削、刻溝或飩刻等方法， 該凹溝係自該底壁之內表面延伸至其外表面； (iv) 提供一模具以射出模塑成型一插入件，該插入件 具有一大致呈錐狀之主體而可被收納在該細孔中，且具有 一大致符合該細孔之壁體之周緣表面； (v) 增添於或取代步驟（iii)，機器加工該周緣表面，使 得當依照步驟（v i)而將插入件定位在該細孔中時，該凹溝 係自該底壁之內表面延伸至其外表面； (vi) 藉由將插入件插入至外殼中而將該大致呈錐狀之 主體定位在該細孔中，且以其尖端先置入，使得該錐狀主 體之周緣表面與該細孔之壁體相接觸，藉此在該細孔與該 主體之間形成複數個呈管狀流動路徑之通道。 本發明之進一步特徵係陳述於申請專利範圍附屬項 中 〇 【實施方式】 本發明之較佳實施例將參考後附圖式來加以說明θ 本發明係關於一種藉由產生或形成一藥物噴射流以傳 遞一液體藥物或刺穿待治療人士之噴射注射器，該噴射流 (5) 200402314 具有一精確的細度，且可迫入至該人士的皮膚而進入其體 內。 現請參照圖1 -3，依照本發明之一噴射注射器通常包 含一用以容納一待施配藥物2之外殻或貯槽1，其中該藥 物係以習於此技術者所熟知的方式所充壓’例如藉由一活 塞裝置（未圖示）。外殼1係由一封閉周緣壁3、一未圖示 之頂部（非本發明之部分）及一底壁4所界定。底壁4具有 一面向外殼1內部空間之內表面5及一相對的外表面6。 一通道7(參考圖4)係設置在底壁4中，其係分別延伸於 該內表面5及外表面6之間，且當使用該注射器時，藥物 2便會由外殼1排出。最好，通道7係一介於穿孔或細孔 8 (參考圖5 )與一插置在細孔8內部之插入件9之間的間 隙。在圖示實施例中，一單一細孔係對正置中於該外殼1 之對稱軸1 1，且該細孔8具有一沿遠離該外殻1方向收 歛之截錐狀外形，且係由一壁體1 2所界定。該插入件9 具有一大致呈錐狀之主體10，且係配置成可插入至外殻 中，使得該大致呈錐狀之主體1 0之一部分1 3可被收納在 細孔8中，其中該部分1 3之周緣表面3 9係大致相符於壁 體1 2。主體1 〇係沿遠離通道7之方向而呈漸細狀，並且 終止於一距該底壁4 一段距離而外在外殼外面之尖點或尖 端1 4，且定位在該對稱軸1 1。較佳地’該尖端係呈尖 狀，然而其邊緣亦可略呈截錐狀，以釋放液體。由於通道 7及主體皆具有大致呈錐狀之外表面’因此通道之寬 度便可藉由在這些部位之間進行軸向位移或定位而很輕易 -8- (6) (6)200402314 地加以調整。 在細孔壁體1 2與大致呈錐狀之主體1 〇之部分1 3之 間的通道或間隙7係用作爲一流動束縮限制，俾當使用該 噴射注射器時，可在自外殼1排出之藥物中產生一高壓。 大致呈錐狀之主體的其餘部分1 5，亦即，在其部分1 3對 置於該細孔壁體1 2與其尖端1 4之間的部分’係具有一周 緣表面40 ’其可收納或補捉自通道7流出之藥物，並且 將其導向尖端1 4以產生或形成一連貫、薄的噴射流自該 尖端湧出。在包括該主體1 〇之尖端1 4的至少一區域中係 具有一凹曲周緣表面或凹曲周緣線（當觀看通過軸線之截 面時）’且較佳地，該主體部分1 5介於底壁4之外表面6 與尖端1 4之間的所有部分都呈凹曲狀，參考圖4。此一 造型槪要地描示所排出之藥物的流動情況。在該通道7中 經加至之藥物流或分流16係藉由所謂的Co anda效應而沿 著該部分15之周緣表面40且貼著該表面而流動（-s)。當 接近該尖端1 4時，分流便在到達尖端1 4之前匯合或聚合 而產生一大致均質的流體17抵達至尖端14，並且形成一 連貫、薄的噴射流1 8由該尖端1 4湧出。該噴射流之細部 與流動束縮限制有關，亦即該流體（-s) 1 6之壓力。凹曲表 面或曲線之曲率亦可略有不同。爲了具有一連貫的流體， 最好該表面係設計成可以在朝向尖端之收歛流體之間具有 一遞減的角度，且最好在該尖端可以具有一幾乎平行或實 質平行的流動，例如藉由使表面接近尖端的切線大致重 合。截面之收歛凹曲線可譬如爲一圓形之弧段，但最好該 (7) (7)200402314 曲率係朝向尖端而改變，若將曲線之曲率改變成如一橢圓 形、拋物線或雙曲線或介於這些形狀之間的弧段，便可使 曲率係朝向尖端而改變。較佳地，該弧段係相對於對稱軸 1 1而呈鏡像關係，且更佳地，其亦可配置成能夠具有一 朝向尖端而遞減之曲率，且最佳地，其係設置成可在尖端 處具有上述實質平行線。 現請參照圖1 ’ 一定位元件1 9係自該底壁4突伸而 出，且較佳地並未強制性地終止於超出或位在該大致呈錐 狀之主體10之尖端14的高度。超出尖端之位置可在尖端 與目標部位之間保持一距離，例如使流體在撞擊該目標之 前便形成流體，而在該尖端之位置或在尖端後面之位置則 係可使該尖端碰觸該目標表面，例如用以作爲一短針，以 截取目標組織及降低對液體噴射流的刺穿需求。定位元件 1 9係當注射藥物時用以放置在待治療人士之皮膚上。如 此圖式所示，噴射注射器之封閉周緣壁3、底壁4及定位 元件1 9係以樹脂藉由射出成型模塑所製成之單件製品， 且較佳由聚碳酸酯所製成。相較於在用以傳遞藥物之技藝 中使用較小的貫孔而言，在底壁4中較大的細孔8係較容 易製成具有精確的公差裕度。 如上所述，插入件9包含一大致呈錐狀之主體1 0， 當注射器組裝完成時’其基部係大致定位在該底壁4之內 表面5，如圖4所示。然而，且最佳地，插入件9亦包含 一頭部主體21 ’如圖1及2所示’其係配置成可插入至 外殼1而接近該底壁4，並且連接至大致呈錐狀之主體200402314 (1) 发明. Description of the invention [Technical field to which the invention belongs] The present invention relates to a jet injector, which is used to pierce the liquid medicine with the skin of the person to be treated. A shell of a drug, the shell being defined by a closed peripheral wall and a bottom wall, the bottom wall having an inner surface facing the inner space of the shell and an opposite outer surface, the bottom wall having at least one channel extending on the inner surface And the outer surface, and when the syringe is used, the drug will pass through the channel, and the drug will be discharged from the housing and transformed into a thin jet that can penetrate the person's skin. The invention also relates to a method of operating such a syringe. The invention also relates to a method for manufacturing the injection syringe, which can pierce the liquid medicine through the skin of the person to be treated. The injection syringe includes a shell for filling and containing the medicine, and the shell is closed by a Defined by a peripheral wall and a bottom wall having at least one channel. [Prior art] The current needleless jet injector for injecting a liquid medicine can generate a jet stream which pierces the skin of the person to be treated by its own force. These syringes usually include a high pressure housing having one or more openings as outlets for the jet stream. The one or more openings are quite narrow, usually about a few tenths of a millimeter. Some openings are extremely difficult in terms of rationality and reproducibility, such as by injection molding of a plastic material to have similar tolerance margins. In addition, it is difficult to manufacture the openings with the shape and smoothness that allows the jet stream to be coherent and accurately constricted to achieve the best skin piercing effect. (2) (2) 200402314 International patent application WO 0 1/05 45 No. 4 relates to a needle-less syringe, which includes a syringe with an inter- sleeve element, and the inner element in the inter- sleeve element has several small channels formed on its peripheral surface. (2) Conducting a medicine discharged from the compression chamber to the skin of a patient through the plurality of channels, so that a plurality of medicine flows can pierce the skin. The orifice of each channel is in contact with the skin, and the drug stream is injected directly into the skin, that is, without any gap between them. The fineness of the drug flow is determined by the size of the channel, and the cross-sectional area of the channel has a very small size. If the size is too small, the flow resistance in the channel will be too high and the drug flow will be reduced, which will endanger the intended injection effect. SUMMARY OF THE INVENTION An object of the present invention is to provide a jet injector which has the ability to generate a jet stream with adjustable fineness and precise flow rate at the same time, so as to achieve a desired injection effect. Another object of the present invention is to provide a method capable of manufacturing a jet syringe inexpensively, reliably, and easily. Yet another object of the present invention is to provide a jet injector having an outlet which is not contaminated by human skin during injection. These and other objects of the present invention can be achieved by an injection syringe mentioned in the preamble of this specification, characterized in that the channel includes a flow beam contraction restricting member to form a high pressure in the drug discharged from the casing. 'One of the main systems is connected to the channel, and the main system tapers away from the Tong-5- (3) (3) 200402314 path, and ends at a tip, where the main body has a peripheral edge The surface, which can receive the discharged medication and direct it to the tip to produce a continuous jet stream emerging from the tip. A method for manufacturing a jet injector according to the present invention and stated in the second paragraph of the preamble, characterized by the following steps: (i) providing a mold for injection molding the closed peripheral wall and the bottom wall, and One of the bottom walls is perforated; (ii) a portion of the mold that forms the inner surface of the bottom wall and / or the pores of the bottom wall is processed by a machine force, so that a recess is formed in the wall of the mold, such as by By milling, cutting, grooving, electroforming, or etching; (iii) injecting the mold to form protrusions on the inner surface and / or the wall of the fine hole; (iv) providing a mold to eject the mold An insert is molded, the insert has a substantially conical body that can be received in the fine hole, and has a peripheral surface that substantially matches the wall of the fine hole; (v) added to or replaced by a step (Ii) machining the part of the mold used to form the wall of the peripheral surface so that a recess is formed in the wall of the mold, for example, by milling, cutting, grooving, electrical processing or etching; vi) inject the mold to the peripheral surface Forming a protrusion; and (Vi i) positioning the generally tapered body in the thin hole by inserting an insert into the housing, and inserting the tip first so that the protrusion contacts a pair of facing surfaces or A wall body, thereby forming a channel having a substantially annular gap between the pore wall body and the peripheral surface of the substantially conical body. In another method for manufacturing a jet injector according to the present invention and stated in the second paragraph of the preamble, (6) (4) (4) 200402314, it is characterized by the following steps: (i) providing a mold The closed peripheral wall and the bottom wall and a perforation in the bottom wall are formed by injection molding; (ii) the mold is injected; (iii) the wall of the fine hole formed by the mechanical force is processed so that the The wall body forms a groove, for example, by milling, cutting, grooving or engraving, the groove extends from the inner surface to the outer surface of the bottom wall; (iv) providing a mold for injection molding An insert having a substantially conical body that can be received in the fine hole, and a peripheral surface of a wall body substantially matching the fine hole; (v) adding to or replacing step (iii) ), The peripheral surface is machined so that when the insert is positioned in the fine hole according to step (vi), the groove extends from the inner surface to the outer surface of the bottom wall; (vi) by placing The insert is inserted into the housing to position the generally conical body in the thin hole, First into its tip, so that the peripheral surface of the main body of the tapered contact with the wall of the pores, thereby forming a plurality of tubular flow paths between the channels and pores of the body. Further features of the present invention are stated in the appendix to the scope of patent application. [Embodiment] The preferred embodiment of the present invention will be described with reference to the following drawings. The present invention relates to a method for generating or forming a drug jet To deliver a liquid medicine or pierce the injection syringe of the person to be treated, the jet (5) 200402314 has a precise fineness and can be forced into the person's skin and into its body. Referring now to FIGS. 1-3, a spray injector according to the present invention generally includes a housing or reservoir 1 for containing a drug 2 to be dispensed, wherein the drug is filled in a manner well known to those skilled in the art. Pressing, for example, by a piston device (not shown). The outer shell 1 is defined by a closed peripheral wall 3, a top (not part of the invention) and a bottom wall 4 (not shown). The bottom wall 4 has an inner surface 5 facing the inner space of the casing 1 and an opposite outer surface 6. A channel 7 (refer to FIG. 4) is provided in the bottom wall 4 and extends between the inner surface 5 and the outer surface 6, respectively. When the syringe is used, the medicine 2 is discharged from the casing 1. Preferably, the channel 7 is a gap between the perforation or fine hole 8 (refer to FIG. 5) and an insert 9 inserted inside the fine hole 8. In the illustrated embodiment, a single pore is aligned in the symmetry axis 11 of the casing 1, and the pore 8 has a truncated cone shape that converges in a direction away from the casing 1. A wall is defined by 12. The insert 9 has a main body 10 having a generally tapered shape, and is configured to be insertable into a housing, so that a part 13 of the main body 10 having a substantially tapered shape can be received in the fine hole 8, wherein The peripheral surface 3 9 of the part 13 is substantially consistent with the wall 12. The main body 10 is tapered in a direction away from the channel 7, and ends at a point or tip 14 outside the housing at a distance from the bottom wall 4, and is positioned on the axis of symmetry 11. Preferably, the tip is pointed, but the edge may be slightly truncated to release liquid. Since the channel 7 and the main body have a generally tapered outer surface, the width of the channel can be easily adjusted by axial displacement or positioning between these parts. -8- (6) (6) 200402314 . The passage or gap 7 between the pore wall 12 and the part 13 of the substantially conical body 10 is used as a flow constriction restriction. When using the injection syringe, it can be discharged from the casing 1 A high pressure is generated in the drug. The remaining part 15 of the generally conical body, that is, the part between the part 13 and the fine-walled part 12 and the tip 14 thereof, has a peripheral surface 40, which can receive or The drug flowing out of the channel 7 is made up and directed to the tip 14 to produce or form a continuous, thin jet stream from the tip. A concave peripheral surface or a concave peripheral line (when viewed through a cross-section of the axis) is provided in at least one region including the tip 14 of the main body 10, and preferably, the main body portion 15 is between the bottom All parts between the outer surface 6 of the wall 4 and the tip 14 are concavely curved, referring to FIG. 4. This shape describes the flow of the discharged drug. The added drug flow or shunt 16 in the channel 7 flows (-s) along and against the peripheral surface 40 of the portion 15 by the so-called Co anda effect. As the tip 14 is approached, the splits converge or converge before reaching the tip 14 to produce a substantially homogeneous fluid 17 arriving at the tip 14 and forming a continuous, thin jet 18 flowing out of the tip 14. The detail of the jet is related to the restriction of the flow beam, that is, the pressure of the fluid (-s) 16. The curvature of the concave surface or curve may also be slightly different. In order to have a coherent fluid, it is preferred that the surface be designed to have a decreasing angle between convergent fluids towards the tip, and it is preferred that the tip may have an almost parallel or substantially parallel flow, such as by using The tangent of the surface near the tip is approximately coincident. The convergent concave curve of the cross section can be, for example, a circular arc segment, but it is best that the curvature of (7) (7) 200402314 is changed toward the tip. If the curvature of the curve is changed to an ellipse, parabola or hyperbola The arc between these shapes can change the curvature towards the tip. Preferably, the arc segment is in a mirror-image relationship with respect to the axis of symmetry 11, and more preferably, it can also be configured to have a decreasing curvature toward the tip, and most preferably, it is arranged to be The tip has the aforementioned substantially parallel line. Referring now to FIG. 1 ′, a positioning element 19 projects from the bottom wall 4, and preferably does not terminate compulsorily beyond the height of the tip 14 of the substantially conical body 10. . A position beyond the tip can maintain a distance between the tip and the target, for example, the fluid can form fluid before it hits the target, and the position of the tip or behind the tip can cause the tip to touch the target The surface is used, for example, as a short needle to intercept target tissue and reduce the need for puncture by a liquid jet. The positioning element 19 is used to place on the skin of a person to be treated when a medicine is injected. As shown in the figure, the closed peripheral wall 3, the bottom wall 4 and the positioning element 19 of the injection syringe are single-piece products made of resin by injection molding, and preferably made of polycarbonate. Compared to the use of smaller through holes in the technique for drug delivery, the larger pores 8 in the bottom wall 4 are easier to make with precise tolerance margins. As described above, the insert 9 includes a main body 10 having a generally tapered shape. When the syringe is assembled, its base is positioned approximately on the inner surface 5 of the bottom wall 4, as shown in FIG. However, and most preferably, the insert 9 also includes a head body 21 'as shown in Figs. 1 and 2', which is configured to be insertable into the housing 1 near the bottom wall 4, and is connected to a generally tapered main body
-10- (8) 200402314 1 0。較佳地，頭部主體2 1及大致呈錐狀之主體1 0係藉由 射出成型模塑樹脂而製成之單件式構件，適當的材料爲聚 碳酸酯塑膠。頭部主體2 1具有一配合該封閉周緣壁3之 內表面23的周緣表面22、一具有配合該底壁4之內表面 5形狀的底部表面24以及複數個形成在頭部主體2 1中且 直接或間接地連接（下文將說明）該外殼1與細孔8之凹槽 25，該凹槽25沿著周緣表面22、底部表面24而延伸， 且終止於細孔區域中之內表面5。 請參考圖3，該通道7係數個形成在該大致呈錐狀之 主體10之上方部分13中之凹溝26，且其延伸於主體10 之下方部分1 5及該凹槽25之末端之間，藉此使該外殼1 之內部空間與下方部分1 5相連通，且最終與該噴射流形 成尖端14相連通。在另一選擇方式或額外方式中，數個 凹溝係形成在細孔壁體1 2中而自其內表面5延伸至其外 表面6，此在圖式中未示出。在剛才所述之情況中，一鍵 裝置（未示出，但爲習於此技者所熟知）係配置成可將凹槽 25之出口對準於凹溝26之入口。每一凹槽25具有一大 於該凹溝26之表面積，該凹槽25可使經充壓之藥物自外 殼1的內部空間通往相關之凹溝26的內部空間中。 在本發明之另一實施例中，該通道7係設計成大致相 同於一環圈狀間隙，以取代複數個凹溝。依照此一實施 例’數個間隔裝置係設置在該插入件9與底壁4之間及/ 或插入件9與細孔壁體1 2之間，藉此在該大致呈錐狀之 主體之周緣表面3 9與細孔壁體1 2之間形成一環圈狀間 1D->1 -11 - (9) (9)200402314 隙。 現請參考圖5及6，其中分別顯示垂直於該對稱軸之 細孔的截面以及沿該對稱軸1 1之截面，該間隔裝置係由 該大致呈錐狀之主體1 0之上方部分1 3之周緣表面3 9所 突出之突起27，並且與細孔8之壁體丨2相銜接。該突起 27之數量至少爲三個，且當安裝該插入件9時，其係自 底壁4之內表面5延伸至外表面6。當呈針狀時，該突起 2 7較佳爲成對配置，如圖6所示。在另一選擇方式或額 外方式中，該突起可設置在該細孔8之壁體1 2上或者係 自該細孔壁體1 2上突伸而出，而與該上方部分1 3之周緣 表面3 9相銜接（參考圖9)。該突起2 7可以爲浮凸、針 體、立柱、肋體、脊部等等，並且與其所突伸出之表面/ 壁體一體成型。圖7描示間隔裝置爲設置在頭部主體21 之底部表面24與底壁4之內表面5之間的突起。在此一 實施例中，亦可以達到如同在細孔壁體1 2與大致呈錐狀 之主體1 〇之周緣表面3 9之間之環圈狀間隙所可達到的限 制效果。圖8以放大比例描示該突起2 7係自該底壁.4之 內表面5突伸而出，而圖9係以相似的比例描示該突起 27自頭部主體21之底部表面24突伸而出。圖10描示另 一選擇方式，其中該突起27係與插入件9之頭部主體21 一體成型。該突起亦可以具有類似於針對圖8及9所述之 構造。 圖Π槪要描示本發明又另一實施例。該錐狀主體 1 〇，尤其係其上方部分丨3以及細孔8係製造成具有較粗 4 ^ -12- (10) (10)200402314 略的公差裕度，因而在大致呈錐狀之主體10之上方部分 1 3之周緣表面3 9與細孔8之周圍壁體1 2之間係產生間 隙。這些間隙2 8係共同形成一通道7 ’以將藥物自該外 殼1傳遞至該插入件9之噴射流形成部分1 5。 現請參照圖1 2及1 3，其中描示具有可撓性壁體之實 施例，其中該可撓性壁體構成一流動束縮限制通道，其中 該限制量係與該外殻1中之壓力有關。 在上述描示及討論的實施例中，插入件9係一連續且 均質的主體。然而，依照圖1 2所示之實施例，該插入件 9係一由一可撓彈性薄壁殻29所界定之中空主體。插入 件9之頭部主體2 1具有一直徑小於外殼1之內徑，且在 其間構成一環狀槽道3 0。較佳地，頭部主體2 1之底部表 面2 4相對於該對稱軸1 1係形成一角度，該角度係比底壁 4之內表面5與對稱軸之間的角度還要陡銳，因而形成一 自外殼1流動至細孔8的流動路徑。當在外殼中之藥物被 充壓時，其便會流入至介於頭部主體2 1與底壁4之間的 空間中，造成該大致呈錐狀之主體1 0之壁體沿著箭頭3! 之方向而向內撓曲，且該尖端1 4區域係作爲一樞軸，使 得在錐狀主體1 0與該細孔壁體1 2之間暫時形成一間隙 3 2，而使藥物可在其間流動。 圖1 3顯示本發明另一實施例，其係與可撓性壁體配 合作動。在此一實施例與前述實施例之間的主要差異點在 於，該底壁4之一中央孔口係設計成類似一截錐漏斗或料 斗的形狀，以取代具有收歛細孔的板體。一形成如同〜截 -13- (11) (11)200402314 錐漏斗狀且自該外殼1朝外收歛之可撓彈性壁3 3係憑靠 於底壁4且終止於一底部表面34，而構成一與該大致呈 錐狀之主體1 〇相接觸之尖端邊緣。該可撓彈性壁3 3與底 壁4 一體成型，且在其上方部分形成有複數個平頭凹溝或 凹部3 6。如上述實施例所述，除了圖1 2所示者以外，一 具有或未具有頭部主體21之連續插入件9係被定位在該 壁體3 3內部。當充壓時，在外殼1中之藥物便流入至該 凹溝3 6中，而造成可撓彈性壁3 3沿著箭頭3 7之方向向 外撓曲，且在底壁4與可撓彈性壁3 3之間的接合處爲一 樞軸。因此，該可撓彈性壁3 3之下方部分將會與大致呈 錐狀之主體1 〇分離，而在其間暫時形成一可使藥物於其 間流動之通道7。 本發明亦關於用以製造上述噴射注射器（除了圖11及 1 2之實施例以外）之方法。 一種用以製造譬如圖5至1 0所描示之噴射注射器的 方法包括以下之步驟。 (i) 製造一模具（未圖示）以射出模塑成型該封閉周緣壁 3及底壁4以及在該底壁中之一穿孔8。製造此一用以生 產所指定物件之模具乃係習於此技者所熟知的，因此在此 不再贅述。 (ii) 機器力卩工處理該模具形成該底壁4之內表面5及/ 或該底壁之細孔8的部分，使得在模具之壁體中形成凹 部，例如藉由銑磨、切削、刻溝、電花加工或鈾刻等方 法。藉由此加工便可形成具有精確公差裕度的極小（及較-10- (8) 200402314 1 0. Preferably, the head main body 21 and the generally tapered main body 10 are single-piece members made by injection molding of a molding resin, and a suitable material is polycarbonate plastic. The head body 21 has a peripheral surface 22 that matches the inner surface 23 of the closed peripheral wall 3, a bottom surface 24 that has a shape that matches the inner surface 5 of the bottom wall 4, and a plurality of formed in the head body 21, and The housing 1 is directly or indirectly connected (explained below) with the groove 25 of the fine hole 8, which extends along the peripheral surface 22 and the bottom surface 24 and terminates in the inner surface 5 in the fine hole area. Referring to FIG. 3, the channel 7 has a plurality of grooves 26 formed in the upper portion 13 of the substantially conical body 10, and extends between the lower portion 15 of the body 10 and the end of the groove 25. Therefore, the internal space of the casing 1 is communicated with the lower portion 15 and finally communicated with the jet flow forming tip 14. In another alternative or additional manner, a plurality of grooves are formed in the pore wall 12 and extend from its inner surface 5 to its outer surface 6, which is not shown in the drawings. In the case just described, a one-button device (not shown, but well known to those skilled in the art) is configured to align the exit of the recess 25 with the entrance of the recess 26. Each groove 25 has a larger surface area than the groove 26, and the groove 25 allows the filled medicine to pass from the internal space of the casing 1 to the internal space of the associated groove 26. In another embodiment of the present invention, the channel 7 is designed to be substantially the same as a ring-shaped gap to replace a plurality of grooves. According to this embodiment, a plurality of spacers are provided between the insert 9 and the bottom wall 4 and / or between the insert 9 and the fine-walled wall 12 to thereby form a substantially conical body. A ring-shaped space 1D-> 1 -11-(9) (9) 200402314 gap is formed between the peripheral surface 39 and the pore wall body 12. Please refer to FIGS. 5 and 6, which respectively show the cross section of the pores perpendicular to the axis of symmetry and the cross section along the axis of symmetry 11. The spacer device is composed of the upper part 10 of the substantially conical body 10. The protrusion 27 protruding from the peripheral surface 39 is connected with the wall body 2 of the fine hole 8. The number of the protrusions 27 is at least three, and when the insert member 9 is installed, it extends from the inner surface 5 to the outer surface 6 of the bottom wall 4. When in the shape of a needle, the protrusions 27 are preferably arranged in pairs, as shown in FIG. 6. In another alternative or additional manner, the protrusion may be provided on the wall body 12 of the fine hole 8 or may protrude from the wall body 12 of the fine hole, and protrude from the peripheral edge of the upper portion 13 The surfaces 39 are connected (refer to FIG. 9). The protrusions 27 can be embossed, needles, posts, ribs, ridges, etc., and are integrally formed with the surface / wall body from which they protrude. FIG. 7 illustrates the spacer as a protrusion provided between the bottom surface 24 of the head body 21 and the inner surface 5 of the bottom wall 4. In this embodiment, it is also possible to achieve the limiting effect as a ring-shaped gap between the pore wall body 12 and the peripheral surface 39 of the substantially conical body 10. FIG. 8 depicts the protrusion 27 from the bottom wall 5 at an enlarged scale, and FIG. 9 depicts the protrusion 27 from the bottom surface 24 of the head body 21 at a similar scale. Reach out. FIG. 10 illustrates another option, in which the protrusion 27 is formed integrally with the head body 21 of the insert 9. The protrusion may also have a structure similar to that described with reference to Figs. Figure Π 槪 is a diagram illustrating yet another embodiment of the present invention. The tapered body 10, especially the upper part 3 and the fine hole 8 are manufactured to have a thicker tolerance of 4 ^ -12- (10) (10) 200402314, so the body is generally tapered. A gap is created between the peripheral surface 39 of the upper part 13 of 10 and the peripheral wall 12 of the fine hole 8. These gaps 28 and 8 together form a channel 7 'to transfer the medicine from the housing 1 to the jet-forming portion 15 of the insert 9. Please refer to FIGS. 12 and 13, which illustrate an embodiment with a flexible wall, wherein the flexible wall forms a flow constriction limiting channel, and the limiting amount is equal to that in the housing 1. Stress related. In the embodiment described and discussed above, the insert 9 is a continuous and homogeneous body. However, according to the embodiment shown in FIG. 12, the insert 9 is a hollow body defined by a flexible and elastic thin-walled shell 29. The head body 21 of the insert member 9 has a diameter smaller than the inner diameter of the housing 1, and an annular groove 30 is formed therebetween. Preferably, the bottom surface 2 4 of the head body 2 1 forms an angle with respect to the axis of symmetry 11, which is steeper than the angle between the inner surface 5 of the bottom wall 4 and the axis of symmetry, so A flow path is formed from the casing 1 to the pores 8. When the medicine in the shell is filled, it will flow into the space between the head body 21 and the bottom wall 4, causing the wall of the roughly conical body 10 along the arrow 3 ! And flex inwardly, and the area of the tip 14 serves as a pivot, so that a gap 3 2 is temporarily formed between the tapered body 10 and the pore wall 12, so that the drug can Flow in between. Fig. 13 shows another embodiment of the present invention, which cooperates with a flexible wall. The main difference between this embodiment and the previous embodiment lies in that a central opening of the bottom wall 4 is designed like a truncated cone funnel or hopper to replace a plate with converging pores. A flexible elastic wall 3, which is formed like a truncated -13- (11) (11) 200402314 cone and converges outward from the casing 1, is formed by resting on the bottom wall 4 and terminating on a bottom surface 34. A tip edge that contacts the generally conical body 10. The flexible elastic wall 3 3 is integrally formed with the bottom wall 4, and a plurality of flat-headed grooves or recesses 36 are formed in an upper portion thereof. As described in the above embodiment, in addition to those shown in Fig. 12, a continuous insert 9 with or without a head body 21 is positioned inside the wall body 33. When filling, the medicine in the casing 1 flows into the groove 36, causing the flexible elastic wall 33 to flex outward in the direction of the arrow 37, and the bottom wall 4 and the flexible elasticity The joint between the walls 33 is a pivot. Therefore, the lower part of the flexible elastic wall 33 will be separated from the substantially conical body 10, and a channel 7 can be temporarily formed in which the medicine can flow. The present invention also relates to a method for manufacturing the above-mentioned injection syringe (in addition to the embodiments of Figs. 11 and 12). A method for manufacturing a jet injector such as that shown in Figs. 5 to 10 includes the following steps. (i) A mold (not shown) is manufactured for injection molding the closed peripheral wall 3 and the bottom wall 4 and a perforation 8 in one of the bottom walls. The manufacturing of the mold for producing the designated object is well known to those skilled in the art, so it will not be repeated here. (ii) The part of the mold that forms the inner surface 5 of the bottom wall 4 and / or the pores 8 of the bottom wall is machine-processed by the machine force so that a recess is formed in the wall of the mold, for example, by milling, cutting, Grooving, electrical processing or uranium engraving. With this processing, extremely small (and
iD -14- (12) 200402314 大）的凹部。 (III) 注塡該模具以在該內表面5及/或細孔8之壁體 12上形成突起27。 (IV) 製造一模具（未圖示）以射出模塑成型一插入件 9 ’ S插入件9具有一大致呈錐狀之主體1 〇而可被收納在 該細孔8中’且具有一大致符合該細孔之壁體1 2之周緣 表面3 9 ;參考步驟（丨）。 (v)增添於或取代步驟（ii)，機器加工該模具用以形成 言亥周Uf表面3 9之壁體的部分，使得在模具之壁體中形成 凹邰’例如藉由銑;磨、切削、刻溝、電花加工或触刻等方 法。 (vi) 注塡該模具以在該周緣表面39上形成突起27。 (vii) 將如此模塑之外殻〗（及一體成型之定位元件19) 與插入件9自其模具中取出，且藉由將插入件9插入至外 殼中而將該大致呈錐狀之主體1 0放置在該細孔8中，且 以其尖端14先置入，使得該突起27接觸一對置表面或壁 體（5，12，24，3 9)，藉此在該細孔8與主體10之間形成 一大致呈環圈狀間隙之通道7。 此外，一種用以製造依照圖1 - 3所描示之噴射注射器 白勺方法係包括以下步驟。 (i) 依照先前方法之步驟（i)製造一模具。 (ii) 注塡該模具。 (Hi)機器力日工處理所形成之細孔8的壁體12 ’使得在 該壁體中形成凹溝2 6，例如藉由i先磨、切削、刻溝或倉虫 -15- less (13) (13)200402314 刻等方法，該凹溝係自該底壁之一內表面延伸至其外表 面。 Ον)依照先前方法之步驟（iv)來製造一模具。 (V)添加於或取代步驟（iii)，機器加工處理該周緣表面 39 ’俾當依照步驟（vi)來將插入件9定位至該細孔8中 時，可使凹溝26自底壁4之內表面5延伸至其外表面 6 ° (v〇藉由將插入件9插入至外殻1中而將該大致呈錐 狀之主體1 0定位在該細孔8中，且以其尖端1 4先置入， 使得該大致呈錐狀之主體〗〇之周緣表面3 9接觸該細孔8 之壁體1 2，而在該細孔與主體之間形成一大致呈複數個 管狀流動路徑之通道7。每一流動路徑因此由一凹溝2 6 及細孔壁體1 2之一對置表面積或該周緣表面3 9所界定。 習於此技者應可瞭解，依照圖1 3之實施例係以類似 於上述有關該凹溝26(步驟v)之方法所製成。 圖1 2之噴射注射器的插入件9較佳由吹製模塑成型 方法所製成。一相關的氣體引入□(未圖示）係設置在殼29 之上方（水平）壁體中。在將插入件自模具中移出之後，該 氣體引入口便能以習知的適當方式加以氣密密封。 【圖式簡單說明】 圖1係依照本發明之一實施例之噴射注射器的斷面縱 向剖面圖； 圖2係一配置成可插入至圖1之噴射注射器之外殼中 ：i > -16- (14) (14)200402314 之插入件的立體視圖； 圖3係沿著剖面線A · A所取之截面視圖； 圖4係圖1及2所示實施例之插入件之一部分與周圍 壁體部分的放大視圖，其中描示一排出藥物流，其中爲說 明起見，在追些部分之間的間隙係誇大顯示； 圖5係一類似於圖3之視圖，且描示本發明之第二實 施例； 圖6係圖5之實施例的斷面縱向截面圖； 圖7係一類似於圖1之視圖，其中描示本發明之第三 實施例； 圖8係依照圖7之實施例之壁體部分的部分放大視圖； 圖9係類似於圖3之視圖’其中描示本發明之第四實 施例； 圖1 0係本發明第五實施例之插入件之一部分的放大 詳細視圖； 圖11係類似於圖3之視圖，其中槪要描示本發明之 第六實施例； 圖12係類似於圖丨之視圖’其中描示本發明之第七 實施例； 圖13係類似於圖2之視圖，其中描示本發明之第八 實施例。 [元件符號對照表] 1外殼 ID J/ -17- (15)200402314 2藥物 3封閉周緣壁 4 底壁 5 內表面 6 外表面 7通道 8細孔iD -14- (12) 200402314 large) recess. (III) Inject the mold to form protrusions 27 on the inner surface 5 and / or the wall 12 of the fine hole 8. (IV) Manufacture a mold (not shown) for injection molding an insert 9 ′ The insert 9 has a substantially tapered body 10 and can be housed in the fine hole 8 ′ and has an approximate The peripheral surface 3 9 of the wall body 12 corresponding to the pores is referred to in step (丨). (v) Adding to or replacing step (ii), machining the mold to form a part of the wall of the Uf surface 39, so that a recess is formed in the wall of the mold, for example, by milling; grinding, Cutting, grooving, electroforming or touch engraving. (vi) Inject the mold to form a protrusion 27 on the peripheral surface 39. (vii) Take out the thus molded casing (and the integrally-shaped positioning element 19) and the insert 9 from its mold, and insert the insert 9 into the casing to form the substantially conical body 10 is placed in the fine hole 8 and is inserted with its tip 14 first, so that the protrusion 27 contacts a pair of facing surfaces or walls (5, 12, 24, 39), whereby the fine hole 8 and A passage 7 is formed between the main bodies 10 with a substantially annular gap. In addition, a method for manufacturing the injection syringe described in FIGS. 1-3 includes the following steps. (i) Make a mold according to step (i) of the previous method. (ii) Inject the mold. (Hi) The wall body 12 ′ of the pores 8 formed by the mechanical force day-work process makes grooves 2 6 formed in the wall body, for example, by grinding, cutting, grooving, or siloing -15- less ( 13) (13) 200402314 and other methods, the groove extends from an inner surface to an outer surface of the bottom wall. Ον) Manufacture a mold according to step (iv) of the previous method. (V) is added or replaced in step (iii), and the peripheral surface 39 is machined; when the insert 9 is positioned in the fine hole 8 according to step (vi), the groove 26 can be raised from the bottom wall 4 The inner surface 5 extends to its outer surface 6 ° (v. The substantially conical body 10 is positioned in the fine hole 8 by inserting the insert 9 into the housing 1, and with its tip 1 4 Put it in first, so that the peripheral surface 39 of the generally conical body 0 contacts the wall 12 of the fine hole 8 and a roughly tubular flow path is formed between the fine hole and the body. Channel 7. Each flow path is therefore defined by an opposing surface area of one of the grooves 26 and the pore wall 12 or the peripheral surface 39. Those skilled in the art should understand that the implementation according to FIG. 13 The example is made in a manner similar to the above-mentioned groove 26 (step v). The insert 9 of the injection syringe of Fig. 12 is preferably made by a blow molding method. A related gas introduction □ (Not shown) is provided in the (horizontal) wall above the shell 29. After the insert is removed from the mold, the gas inlet It is hermetically sealed in a known and appropriate manner. [Brief description of the drawings] FIG. 1 is a longitudinal sectional view of a spray injector according to an embodiment of the present invention; FIG. 2 is a spray configured to be insertable into FIG. In the housing of the syringe: i > -16- (14) (14) 200402314 perspective view of the insert; Figure 3 is a cross-sectional view taken along section line A · A; Figure 4 is shown in Figures 1 and 2 An enlarged view of a part of the insert and the surrounding wall part of the embodiment, which depicts a discharged drug flow, in which the gap between these parts is exaggerated for illustration; FIG. 5 is a view similar to FIG. 3 Fig. 6 is a longitudinal sectional view of the embodiment of Fig. 5; Fig. 7 is a view similar to Fig. 1 showing a third embodiment of the present invention Figure 8 is a partially enlarged view of a wall portion according to the embodiment of Figure 7; Figure 9 is a view similar to Figure 3 'in which a fourth embodiment of the invention is depicted; Figure 10 is a fifth embodiment of the invention A detailed enlarged view of a part of the insert; FIG. 11 is similar to FIG. 3 A view in which a sixth embodiment of the present invention is to be described; FIG. 12 is a view similar to FIG. 1 ′ in which a seventh embodiment of the present invention is shown; FIG. 13 is a view similar to FIG. 2 in which the present invention is shown The eighth embodiment of the invention. [Element symbol comparison table] 1 Case ID J / -17- (15) 200402314 2 Drug 3 Closed peripheral wall 4 Bottom wall 5 Inner surface 6 Outer surface 7 Channel 8 Fine hole
9插入件 1 〇錐狀主體 1 1對稱軸 1 2細孔壁體 1 3錐狀主體之部分 14尖端 1 5部分 16分流9 Insert 1 〇Conical body 1 1 Symmetry axis 1 2 Fine-pore wall 1 3 Part of conical body 14 Tip 1 5 Part 16 Shunt
1 7均質流 1 8噴射流 1 9定位元件 20基部 21頭部主體 2 2 周緣表面 23內表面 2 4底部表面 25凹槽1 7 homogeneous flow 1 8 jet flow 1 9 positioning element 20 base 21 head body 2 2 peripheral surface 23 inner surface 2 4 bottom surface 25 groove
4' Ϋΐ- 10 JO -18- (16) (16)200402314 26凹溝 27突起 28間隙 29殼體 3 0環圈狀槽道 3 1箭頭（方向） 32間隙 3 3可撓彈性壁 3 4底部表面 36 凹口 3 7箭頭（方向） 3 9 周緣表面 4 0 周緣表面4 'Ϋΐ- 10 JO -18- (16) (16) 200 402 314 26 groove 27 protrusion 28 gap 29 housing 3 0 ring-shaped channel 3 1 arrow (direction) 32 gap 3 3 flexible elastic wall 3 4 bottom Surface 36 Notch 3 7 Arrow (direction) 3 9 Peripheral surface 4 0 Peripheral surface
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