TWI803665B - indwelling needle assembly - Google Patents

indwelling needle assembly Download PDF

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TWI803665B
TWI803665B TW108125452A TW108125452A TWI803665B TW I803665 B TWI803665 B TW I803665B TW 108125452 A TW108125452 A TW 108125452A TW 108125452 A TW108125452 A TW 108125452A TW I803665 B TWI803665 B TW I803665B
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Taiwan
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outer needle
notch
base
hollow cylindrical
diameter portion
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TW108125452A
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Chinese (zh)
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TW202010531A (en
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河內一成
中川大輔
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日商托普股份有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

本發明提供一種能夠將滯留於外針基座內之血液短時間內即完全排出之留置針組裝體。 此留置針組裝體(1)具備:外針(2);外針基座(3);中空圓筒構件(4);止血閥(44),其具有開閉自如之切縫(45)且內嵌於中空圓筒構件(4);及連接構件(5),在中空圓筒構件(4)朝前端方向被壓動時,其基端部被插入至止血閥(44)之切縫(45)內。外針基座(3)具備:小徑部(34)、較小徑部(34)於前端側延伸之大徑部(33)。中空圓筒構件(4)其基端側具有第1切缺部(41),其外周面具有將前端部(42)與第1切缺部(41)連接之通氣溝部(43),可自基端位置朝前端位置前進;連接構件(5)之突起部(53)之第2切缺部(54)開口於與第1切缺部(41)不同之方向。 The invention provides an indwelling needle assembly capable of completely discharging the blood retained in the outer needle base in a short time. This indwelling needle assembly (1) has: an outer needle (2); an outer needle base (3); a hollow cylindrical member (4); a hemostatic valve (44), which has a slit (45) that can be opened and closed freely and an inner Embedded in the hollow cylindrical member (4); and the connecting member (5), when the hollow cylindrical member (4) is pressed toward the front end, its base end is inserted into the slit (45) of the hemostatic valve (44) )Inside. The outer needle base (3) has: a small diameter portion (34), a large diameter portion (33) extending from the front end side of the small diameter portion (34). The base end side of the hollow cylindrical member (4) has a first notch (41), and its outer peripheral surface has an air channel (43) connecting the front end (42) and the first notch (41), which can be automatically The base end position advances toward the front end position; the second notch (54) of the protrusion (53) of the connecting member (5) opens in a direction different from that of the first notch (41).

Description

留置針組裝體indwelling needle assembly

本發明有關一種留置針組裝體。The invention relates to an indwelling needle assembly.

先前,已有一種留置針組裝體為人所知(例如,參見專利文獻1),此留置針組裝體具備:外針基座,其將外針以前端部支持,並於基端部具有可連接誘導件端子之誘導件圓錐部;通氣性止血閥,其配設於該外針基座之內部;及連接構件,其將該止血閥開閉。Previously, an indwelling needle assembly has been known (for example, refer to Patent Document 1). The conical part of the inducer connected to the terminal of the inducer; the breathable hemostatic valve arranged inside the outer needle base; and the connecting member used to open and close the hemostatic valve.

於上述留置針組裝體中,上述止血閥係由中空有底筒狀體構成,於該有底筒狀體之底部具備開閉自如之切縫。另一方面,上述連接構件係由與上述外針基座之內部的前端部一體形成之中空有底筒狀體所構成。上述連接構件朝向上述止血閥之切縫形成為漸細狀,藉由被插入上述切縫而將上述止血閥開啟。In the above-mentioned indwelling needle assembly, the above-mentioned hemostatic valve is composed of a hollow bottomed cylindrical body, and a slit that can be opened and closed freely is provided at the bottom of the bottomed cylindrical body. On the other hand, the connecting member is formed of a hollow bottomed cylindrical body integrally formed with the inner front end portion of the outer needle base. The slit of the connecting member toward the hemostatic valve is tapered, and the hemostatic valve is opened by being inserted into the slit.

上述留置針組裝體係將內針自基端部經由上述止血閥之內部插入上述外針之內部,於使該內針之銳利的前端部自該外針之前端部突出的狀態下,穿刺入靜脈之血管。此時,上述內針具有於上述止血閥與上述連接構件之間開口於上述外針基座內之開口部,其若穿刺入血管,則自該開口部血液流出至上述外針基座之內部。因此,上述外針基座係由透明或半透明之材料構成,藉由視認自上述開口部流出之血液,可確認上述內針穿刺入血管。In the aforementioned indwelling needle assembly system, the inner needle is inserted from the base end through the inside of the hemostatic valve into the outer needle, and the sharp front end of the inner needle protrudes from the front end of the outer needle to puncture the vein. blood vessels. At this time, the inner needle has an opening between the hemostatic valve and the connecting member that opens into the outer needle base, and when it is pierced into a blood vessel, blood flows out from the opening to the inside of the outer needle base. . Therefore, the outer needle base is made of a transparent or translucent material, and the penetration of the inner needle into the blood vessel can be confirmed by visually recognizing the blood flowing out from the opening.

上述內針若穿刺入血管,則使上述外針沿該內針前進,而穿刺入血管。而後,藉由於上述外針穿刺入血管之狀態下拔去上述內針,則該外針將以穿刺入血管之狀態被留置。When the inner needle punctures the blood vessel, the outer needle is advanced along the inner needle to puncture the blood vessel. Then, by pulling out the above-mentioned inner needle in the state of the above-mentioned outer needle piercing the blood vessel, the outer needle will be left in the state of piercing the blood vessel.

根據上述留置針組裝體,在上述外針穿刺入血管之狀態下,若輸液裝置等之前端所設的誘導件端子被插入基端部,則上述止血閥由該誘導件端子壓動,藉此,上述連接構件被插入該止血閥之切縫,而使該止血閥開啟。其結果為,自上述輸液裝置供給之藥液等經由上述外針被送入血管內。According to the above-mentioned indwelling needle assembly, when the inducer terminal provided at the front end of the transfusion device or the like is inserted into the base end while the outer needle is pierced into the blood vessel, the hemostatic valve is pressed by the inducer terminal, thereby , the connecting member is inserted into the slit of the hemostatic valve to open the hemostatic valve. As a result, the liquid medicine or the like supplied from the infusion device is sent into the blood vessel through the outer needle.

然而,流出至上述外針基座之內部的血液若原狀滯留,將會有成為細菌之繁殖源或血栓源之問題。However, if the blood flowing out to the inside of the outer needle base remains as it is, there will be a problem of becoming a breeding source of bacteria or a source of thrombus.

為了解決上述問題,業界曾提案一種將上述連接構件配置於上述止血閥之基端部側,使上述連接構件由上述誘導件端子朝前端部側壓動而被插入上述切縫,而另一方面在該連接構件之前端部之側面具有切缺部之留置針組裝體(例如,參見專利文獻2)。In order to solve the above problems, the industry has proposed a method of disposing the above-mentioned connecting member on the base end side of the above-mentioned hemostatic valve, so that the above-mentioned connecting member is pressed toward the front end side by the above-mentioned inducer terminal and inserted into the above-mentioned slit. An indwelling needle assembly having a notch on the side of the front end of the connecting member (for example, see Patent Document 2).

根據上述專利文獻2所記載之留置針組裝體,藉由使自上述輸液裝置供給之藥液等從上述連接構件前端部之側面所設的切缺部流出,而可將滯留於上述外針基座之內部的血液洗流並流入至血管。 [先前技術文獻] [專利文獻]According to the indwelling needle assembly described in the above-mentioned Patent Document 2, the liquid medicine etc. supplied from the above-mentioned infusion device can flow out from the cutout part provided on the side surface of the front end part of the above-mentioned connecting member, so that the blood stagnant in the base of the outer needle can be released. The blood inside the seat washes and flows into the blood vessels. [Prior Art Literature] [Patent Document]

[專利文獻1]日本特表2016-506855號公報 [專利文獻2]日本特許第5651597號公報[Patent Document 1] Japanese National Publication No. 2016-506855 [Patent Document 2] Japanese Patent No. 5651597

[發明解決之課題][Problems to be solved by the invention]

然而,根據上述專利文獻2所記載之留置針組裝體,藥液係從突出於止血閥之切縫的前端側之連接構件前端部的側面所設之切缺部流出,因此於外針基座之內部,滯留於距該連接構件前端部之該切缺部遠方的區域之血液的排出會耗費時間,或是排出有不完全之情事,是為其不便之處。However, according to the indwelling needle assembly described in the above-mentioned Patent Document 2, the liquid medicine flows out from the notch provided on the side of the front end of the connecting member protruding from the front end side of the slit of the hemostasis valve, so the liquid medicine flows out from the side of the front end of the connecting member protruding from the front end of the slit of the hemostatic valve. Inside, the discharge of the blood stagnated in the area far from the notch at the front end of the connecting member takes time, or the discharge is incomplete, which is inconvenient.

本發明之目的在於消除此等不便,而提供一種能夠在短時間完全排出滯留於外針基座之內部的血液之留置針組裝體。 [用以解決課題之手段]The purpose of the present invention is to eliminate these inconveniences and provide an indwelling needle assembly capable of completely draining the blood stagnated inside the outer needle base in a short time. [Means to solve the problem]

為了達成上述目的,本發明之留置針組裝體,其特徵在於具備:外針,其由中空筒狀體構成,於穿刺入血管之狀態下被留置;外針基座,其由中空筒狀體構成,以前端部支持該外針,且於基端部具有可連接誘導件端子之誘導件圓錐部;中空圓筒構件,其配置於該外針基座的內部之基端側;止血閥,其具有於與該外針基座之軸向正交的面上開閉自如之切縫,且內嵌於中空圓筒構件;及連接構件,其配置於該外針基座之內部之前端部,在該中空圓筒構件由該誘導件端子朝前端方向被壓動時被插入至該止血閥之切縫,而連通該切縫之前後;且該外針基座具備:較該誘導件圓錐部更位於前端側之小徑部、及較該小徑部於前端側延伸之大徑部;該中空圓筒構件於其基端側具有第1切缺部,外周面具有將前端部與該第1切缺部連接而使氣體通過並且另一方面抑制液體通過之通氣溝部,該中空圓筒構件可自其外周面與該小徑部抵接之基端位置朝向該第1切缺部之至少一部分配置於該大徑部之前端位置前進;該連接構件具備至少1個第2切缺部,並具備用以插入該止血閥的切縫之突起部,該第2切缺部在與第1切缺部不同之方向開口。In order to achieve the above object, the indwelling needle assembly of the present invention is characterized in that it has: an outer needle, which is composed of a hollow cylindrical body, and is indwelled in a state of being punctured into a blood vessel; an outer needle base, which is composed of a hollow cylindrical body The outer needle is supported by the front end, and the inducer conical portion is provided at the base end to be connected to the inducer terminal; the hollow cylindrical member is disposed on the base end side inside the outer needle base; the hemostatic valve, It has a slit that can be opened and closed freely on the surface perpendicular to the axial direction of the outer needle base, and is embedded in a hollow cylindrical member; and a connecting member, which is arranged at the front end of the outer needle base, When the hollow cylindrical member is pressed toward the front end by the inducer terminal, it is inserted into the slit of the hemostatic valve, and communicates with the front and rear of the slit; and the outer needle base has: a conical portion compared with the inducer A small diameter portion located on the front end side, and a large diameter portion extending from the small diameter portion to the front end side; the hollow cylindrical member has a first notch on its base end side, and the outer peripheral surface has a front end portion and the first cutout portion. 1. The cutout part is connected to allow the passage of gas and prevent the passage of liquid on the other hand. The hollow cylindrical member can be directed toward at least the first cutout part from the base end position where its outer peripheral surface abuts the small-diameter part. A part is disposed at the front end of the large-diameter portion; the connecting member has at least one second notch, and has a protrusion for inserting into the slit of the hemostatic valve, and the second notch is in contact with the first The notches open in different directions.

本發明之留置針組裝體中,上述中空圓筒構件位於上述基端位置之狀態下,與上述先前之留置針組裝體相同,自基端部插入內針,將該內針經由上述止血閥插入上述外針之內部,而將該內針之銳利之前端部穿刺入靜脈之血管。而後,使血液自上述內針之開口部流出至上述外針基座之內部。此時,上述外針基座之內部雖存有空氣,但本發明之留置針組裝體由於上述中空圓筒構件之外周面形成有上述通氣溝部,因而該空氣乃經由該通氣溝部排氣至上述第1切缺部。上述通氣溝部使氣體通過,並且另一方面可抑制液體通過,因此上述血液實質上無法通過通氣溝部,而上述外針基座的內部由上述血液圓滑地充滿。In the indwelling needle assembly of the present invention, in the state where the hollow cylindrical member is located at the base end position, the inner needle is inserted from the base end, and the inner needle is inserted through the hemostatic valve as in the above-mentioned indwelling needle assembly. The inside of the above-mentioned outer needle, and the sharp front end of the inner needle is pierced into the blood vessel of the vein. Then, make the blood flow out from the opening of the inner needle to the inside of the outer needle base. At this time, although there is air inside the outer needle base, the indwelling needle assembly of the present invention has the above-mentioned air channel part formed on the outer peripheral surface of the above-mentioned hollow cylindrical member, so the air is exhausted to the above-mentioned air channel part through the air channel part. 1st missing part. The air channel part allows gas to pass through, and on the other hand, prevents liquid from passing through, so the blood cannot pass through the air channel part substantially, and the inside of the outer needle base is smoothly filled with the blood.

若上述內針穿刺入血管,藉由使上述外針沿該內針前進而穿刺入血管後拔去上述內針,可使該外針以穿刺入血管之狀態留置。If the inner needle is pierced into the blood vessel, the outer needle can be left in the state of piercing the blood vessel by advancing the outer needle along the inner needle to penetrate the blood vessel and then pulling out the inner needle.

其次,在上述外針穿刺入血管之狀態下,若設於輸液裝置等之前端的誘導件端子被插入上述留置針組裝體之基端部,則上述中空圓筒構件由該誘導件端子壓動,藉此自上述基端位置前進至上述前端位置。如此,上述連接構件之突起部被插入上述止血閥之切縫而使該止血閥開啟,並使該切縫之前後連通。其結果為,自上述輸液裝置供給之藥液等通過上述中空圓筒構件之內部及上述連接構件之第2切缺部,而經由上述外針被送入血管內。Next, when the inducer terminal provided on the front end of the infusion device etc. is inserted into the base end of the indwelling needle assembly in the state where the outer needle is pierced into the blood vessel, the hollow cylindrical member is pressed by the inducer terminal, Thereby, it advances from the said base end position to the said front end position. In this way, the protruding portion of the connecting member is inserted into the slit of the hemostatic valve to open the hemostatic valve and communicate the front and back of the slit. As a result, the medical solution or the like supplied from the infusion device passes through the inside of the hollow cylindrical member and the second notch of the connecting member, and is sent into the blood vessel through the outer needle.

此時,本發明之留置針組裝體中,上述中空圓筒構件位於上述基端位置,上述第1切缺部之至少一部分配置於上述大徑部,同時該中空圓筒構件之外周面與該外針基座之內周面之間具有間隙。因此,上述藥液等之一部分自上述中空圓筒構件之第1切缺部經由該中空圓筒構件之外周面與該外針基座之內周面間之間隙流出至該外針基座內,並將充滿該外針基座內部之血液自上述連接構件之第2切缺部壓送流至上述外針。At this time, in the indwelling needle assembly of the present invention, the hollow cylindrical member is located at the base end position, at least a part of the first notched portion is arranged at the large diameter portion, and the outer peripheral surface of the hollow cylindrical member is in contact with the base end. There are gaps between the inner peripheral surfaces of the outer needle bases. Therefore, a part of the above-mentioned liquid medicine etc. flows out into the outer needle base from the first notch of the hollow cylindrical member through the gap between the outer peripheral surface of the hollow cylindrical member and the inner peripheral surface of the outer needle base. , and the blood filled inside the outer needle base is pressure-fed to the above-mentioned outer needle from the second notch of the connecting member.

因之,根據本發明之留置針組裝體,滯留於上述外針基座之內部之血液可在短時間內即完全排出,且可自上述第2切缺部經由上述外針回送到血管內。又,本發明之留置針組裝體中,由於上述第2切缺部開口於與上述第1切缺部不同之方向,因此為了使自該第1切缺部流出至上述外針基座內之上述藥液等流入該第2切缺部,其乃沿該外針基座之內周面迴旋流動,故可將滯留於上述外針基座之內部之血液進一步在短時間內完全排出。Therefore, according to the indwelling needle assembly of the present invention, the blood stagnated inside the outer needle base can be completely discharged in a short time, and can be returned to the blood vessel from the second notch through the outer needle. Also, in the indwelling needle assembly of the present invention, since the second notch opens in a direction different from that of the first notch, in order to allow the fluid flowing from the first notch into the outer needle base The above-mentioned liquid medicine and the like flow into the second notch, which flows in a swirl along the inner peripheral surface of the outer needle base, so the blood stagnated in the inner of the outer needle base can be further discharged completely in a short time.

於本發明之留置針組裝體中,較佳的是上述第2切缺部相對上述第1切缺部,在成直角之方向開口。若是如此,自上述第1切缺部流出至上述外針基座內之上述藥液等為了流入該第2切缺部而沿該外針基座之內周面迴旋流動時,自該第1切缺部流出且流入該第2切缺部為止之該藥液等之流動長度變得相等。因此,可將滯流於上述外針基座之內部之血液有效率地排出。In the indwelling needle assembly of the present invention, it is preferable that the second notch opens in a direction perpendicular to the first notch. If so, when the above-mentioned liquid medicine etc. flowing out from the above-mentioned first notch into the above-mentioned outer needle base flows into the second notch and swirls along the inner peripheral surface of the outer needle base, it will flow from the first notch. The flow lengths of the liquid medicine etc. from the notch outflow to the second notch are equal. Therefore, the stagnant blood inside the outer needle base can be efficiently discharged.

又,於本發明之留置針組裝體中,上述連接構件可與上述外針基座一體形成,但較佳的是與上述外針基座為另外個體。Also, in the indwelling needle assembly of the present invention, the connecting member may be integrally formed with the outer needle base, but it is preferably a separate body from the outer needle base.

上述止血閥之切縫,雖期望能形成於由中空有底筒狀體所構成之該止血閥的底面之中央,但因加工精度之故有自中央偏離形成之情形時,會有上述連接構件難以插入該切縫的情況。然而,於本發明之留置針組裝體中,上述連接構件與上述外針基座為另外個體之情況下,可相對於該外針基座之軸以任意之角度傾斜。因此,上述連接構件傾斜而指向上述止血閥之切縫時,可將該連接構件插入該切縫,在該切縫自該止血閥之底面之中央偏離形成的情況下也可因應。Although the slit of the above-mentioned hemostatic valve is expected to be formed in the center of the bottom surface of the hemostatic valve composed of a hollow cylindrical body with a bottom, if the slit is deviated from the center due to processing accuracy, the above-mentioned connecting member will be present. It is difficult to insert the slit. However, in the indwelling needle assembly of the present invention, when the above-mentioned connecting member and the above-mentioned outer needle base are separate bodies, they can be inclined at any angle with respect to the axis of the outer needle base. Therefore, when the above-mentioned connection member is tilted to point to the slit of the hemostatic valve, the connection member can be inserted into the slit, and it can also be accommodated when the slit is deviated from the center of the bottom surface of the hemostatic valve.

以下,參照附圖針對本發明之實施方式進一步詳細說明Hereinafter, the embodiments of the present invention will be described in detail with reference to the accompanying drawings.

如第1A圖所示,本實施方式之留置針組裝體1具備:由中空筒狀體所構成之外針2、以前端部支持外針2之外針基座3、配設於外針基座3內之基端側之中空圓筒構件4、及於外針基座3之內部之的端部配設於外針2與中空圓筒構件4之間之連接構件5。As shown in Figure 1A, the indwelling needle assembly 1 of this embodiment includes: an outer needle 2 made of a hollow cylindrical body, an outer needle base 3 supporting the outer needle 2 with a front end, and an outer needle base 3 arranged on the outer needle base. The base end side hollow cylindrical member 4 inside the base 3 and the connecting member 5 arranged between the outer needle 2 and the hollow cylindrical member 4 at the end inside the outer needle base 3 .

外針基座3為由透明或半透明之樹脂所構成之中空筒狀體,具備:形成於前端部之支持外針2之小徑支持部31、自支持部31往向基端部逐漸擴徑之擴徑部32、連接於擴徑部32之基端側之大徑部33、連接於大徑部33之基端側之小徑部34、及連接小徑部34之基端側且自小徑部34往向基端部逐漸擴徑之誘導件圓錐部35。外針基座3換言之具備較誘導件圓錐部35位於前端側之小徑部34、及較小徑部34於前端側延伸之大徑部33。The outer needle base 3 is a hollow cylindrical body made of transparent or translucent resin, and has: a small-diameter support portion 31 formed at the front end to support the outer needle 2, and gradually expands from the support portion 31 toward the base end. The enlarged diameter portion 32 of the diameter, the large diameter portion 33 connected to the base end side of the enlarged diameter portion 32, the small diameter portion 34 connected to the base end side of the large diameter portion 33, and the base end side connected to the small diameter portion 34 and The conical portion 35 of the inducer gradually expands in diameter from the small diameter portion 34 toward the base end portion. In other words, the outer needle base 3 has a small-diameter portion 34 located on the front end side relative to the inducer conical portion 35 , and a large-diameter portion 33 extending from the small-diameter portion 34 on the front end side.

中空圓筒構件4於基端側具有例如一對之第1切缺部41、41,第1切缺部41、41相對中空圓筒構件4之軸對稱地設置。又,中空圓筒構件4其前端部42與第1切缺部41之間之外周面上,具有將前端部42與第1切缺部41連接之複數個通氣溝部43。通氣溝部43例如具有100〜200 μm之寬,形成可令空氣等之氣體通過而另一方面可抑制血液等液體通過之構成。The hollow cylindrical member 4 has, for example, a pair of first cutouts 41 , 41 on the base end side, and the first cutouts 41 , 41 are provided symmetrically with respect to the axis of the hollow cylindrical member 4 . Furthermore, the hollow cylindrical member 4 has a plurality of air grooves 43 connecting the front end 42 and the first notch 41 on the outer peripheral surface between the front end 42 and the first notch 41 . The vent groove portion 43 has a width of, for example, 100 to 200 μm, and is configured to allow gas such as air to pass through while suppressing the passage of liquid such as blood.

又,中空圓筒構件4可自前端部42之外周面全面與小徑部34抵接之基端位置,朝較該基端位置為前端側之第1切缺部41之至少一部分配置於大徑部33之前端位置前進,前端部42中內嵌有由中空有底筒狀體構成之止血閥44。止血閥44由軟質樹脂構成,在與外針基座3之軸向正交之面即底面具有開閉自如之切縫45。又,止血閥44可為圓盤狀或實心圓柱狀。Furthermore, the hollow cylindrical member 4 can be arranged at least a part of the first notched portion 41 on the front end side from the base end position where the outer peripheral surface of the front end portion 42 abuts the small diameter portion 34 on the large side. The front end position of the diameter portion 33 advances, and a hemostasis valve 44 made of a hollow cylindrical body with a bottom is embedded in the front end portion 42 . The hemostatic valve 44 is made of soft resin, and has a slit 45 that can be opened and closed freely on the surface perpendicular to the axial direction of the outer needle base 3 , that is, the bottom surface. Also, the hemostatic valve 44 can be in the shape of a disc or a solid cylinder.

如第1B圖所示,連接構件5由硬質樹脂構成,具有遊嵌於外針基座3之內部的擴徑部32之圓錐狀嵌合部51、及連接於嵌合部51之後端側且插入切縫45之插入部52。插入部52較嵌合部51為小徑,形成為往向後端部逐漸縮徑。嵌合部51具備自其前端部朝基端側沿軸形成且開口於嵌合部51之側面之第1U字溝部53,插入部52具備自其前端部朝基端側沿軸形成且開口於相對軸與第1U字溝部53對稱側之第2U字溝部54。第1U字溝部53與第2U字溝部54於嵌合部51與插入部52之邊界經由連通孔55連通。又,插入部52於相對軸與第2U字溝部54之開口部對稱之側具備平坦部56。 As shown in FIG. 1B, the connecting member 5 is made of hard resin, has a conical fitting portion 51 that is loosely fitted in the enlarged diameter portion 32 inside the outer needle base 3, and is connected to the rear end side of the fitting portion 51. Insert the insertion portion 52 of the slit 45 . The insertion portion 52 has a smaller diameter than the fitting portion 51, and is formed to gradually decrease in diameter toward the rear end. The fitting part 51 has a first U-shaped groove part 53 formed along the axis from its front end toward the base end side and opened on the side surface of the fitting part 51. The second U-shaped groove portion 54 on the side symmetrical to the first U-shaped groove portion 53 . The first U-shaped groove portion 53 communicates with the second U-shaped groove portion 54 at the boundary between the fitting portion 51 and the insertion portion 52 through the communication hole 55 . Also, the insertion portion 52 includes a flat portion 56 on a side symmetrical to the opening of the second U-shaped groove portion 54 with respect to the axis.

連接構件5中,藉由第1U字溝部53及第2U字溝部54形成第2切缺部,第1U字溝部53與第2U字溝部54分別開口於與第1切缺部41不同之方向,例如開口於與一對第1切缺部41之連結線正交之方向。 In the connection member 5, the second notch is formed by the first U-shaped groove 53 and the second U-shaped groove 54, and the first U-shaped groove 53 and the second U-shaped groove 54 open in directions different from the first notch 41, respectively. For example, the opening is in a direction perpendicular to the connecting line of the pair of first notches 41 .

其次,針對本實施方式之留置針組裝體1之作動進行說明。 Next, the operation of the indwelling needle assembly 1 of this embodiment will be described.

使用留置針組裝體1時,首先如第1圖所示,於中空圓筒構件4位於其前端部42之外周面全面與小徑部34抵接之基端位置的狀態下,將圖未示之內針自誘導件圓錐部35之基端部插入止血閥44之切縫45。於中空圓筒構件4位於基端狀態之狀態下,連接構件5之爪部53、53並未插入止血閥44之切縫45。 When using the indwelling needle assembly 1, first, as shown in FIG. 1, the hollow cylindrical member 4 is located at the base end position where the outer peripheral surface of the front end portion 42 is in full contact with the small diameter portion 34. The inner needle is inserted into the slit 45 of the hemostatic valve 44 from the base end of the conical portion 35 of the inducer. When the hollow cylindrical member 4 is located at the base end state, the claws 53 , 53 of the connecting member 5 are not inserted into the slit 45 of the hemostatic valve 44 .

於是,已插入止血閥44之切縫45之上述內針,乃經由連接構件5之第2切缺部(第2U字溝部54及第1U字溝部53)被插入外針2之內部,而該內針之銳利的前端部乃以自外針2之前端部突出的狀態穿刺入靜脈之血管。上述內針具有在止血閥44與連接構件5之間開口於外針基座3之大徑部33的開口部,若穿刺入血管,則血液自該開口部 流出(回流)至大徑部33之內部。 Then, the above-mentioned inner needle that has been inserted into the slit 45 of the hemostatic valve 44 is inserted into the inside of the outer needle 2 through the second notch portion (the second U-shaped groove portion 54 and the first U-shaped groove portion 53) of the connecting member 5, and the The sharp front end of the inner needle protrudes from the front end of the outer needle 2 to puncture the blood vessel of the vein. The above-mentioned inner needle has an opening opened to the large-diameter portion 33 of the outer needle base 3 between the hemostasis valve 44 and the connecting member 5. If the needle is punctured into a blood vessel, blood will pass through the opening. It flows out (returns) to the inside of the large-diameter portion 33 .

此時,大徑部33之內部雖存在空氣,然該空氣經由形成於中空圓筒構件4之外周面的通氣溝部43自前端部42排氣至第1切缺部41,而大徑部33之內部由上述血液圓滑地充滿。又,通氣溝部43可令空氣等之氣體通過,但另一方面可抑制血液等液體之通過,因此上述血液雖有侵入通氣溝部43之情事但實質上無法通過通氣溝部43。 At this time, although there is air inside the large-diameter portion 33, the air is exhausted from the front end portion 42 to the first notch portion 41 through the air channel portion 43 formed on the outer peripheral surface of the hollow cylindrical member 4, and the large-diameter portion 33 The interior is smoothly filled with the aforementioned blood. Also, the vent groove part 43 allows gas such as air to pass through, but on the other hand, it can inhibit the passage of liquid such as blood.

又,此時由於外針基座3係由透明或半透明之樹脂構成,自外部可透視大徑部33之內部,藉由視認大徑部33之內部的血液,可確認上述內針穿刺入血管。 Also, at this time, since the outer needle base 3 is made of transparent or translucent resin, the inside of the large-diameter portion 33 can be seen through from the outside, and the blood inside the large-diameter portion 33 can be seen through to confirm the penetration of the above-mentioned inner needle. Blood vessel.

其次,若上述內針穿刺入血管,則使外針2沿該內針前進,而穿刺入血管。而後,於外針2穿刺入血管之狀態下藉由拔出上述內針,可於將外針2以穿刺入血管之狀態留置。 Next, when the inner needle punctures the blood vessel, the outer needle 2 is advanced along the inner needle to puncture the blood vessel. Then, by pulling out the above-mentioned inner needle in the state where the outer needle 2 is pierced into the blood vessel, the outer needle 2 can be left in the state where the outer needle 2 is pierced into the blood vessel.

其次,於留置針組裝體1中,如第3圖所示,將輸液裝置等之前端所設之誘導件端子6插入誘導件圓錐部35。如是,則中空圓筒構件4由誘導件端子6朝前端側壓動,而朝前端位置前進,使得第1切缺部41之至少一部分配置於大徑部33。又,與此同時,連接構件5之插入部52插入止血閥44之切縫45而令止血閥44開啟。其結果為,藉由連接構件5之插入部52使得切縫45之前後連通,而自上述輸液裝置所供給之藥液等乃自止血閥44、第2U字溝部54及第1U字溝部53經由外針2被送入血管內。 Next, in the indwelling needle assembly 1 , as shown in FIG. 3 , the inducer terminal 6 provided at the front end of the infusion set or the like is inserted into the inducer conical portion 35 . If so, the hollow cylindrical member 4 is pushed toward the front end side by the inducer terminal 6 and advances toward the front end position, so that at least a part of the first notched portion 41 is disposed on the large diameter portion 33 . Also, at the same time, the insertion portion 52 of the connecting member 5 is inserted into the slit 45 of the hemostatic valve 44 to open the hemostatic valve 44 . As a result, the insertion portion 52 of the connection member 5 makes the slit 45 communicate front and rear, and the liquid medicine supplied from the above-mentioned infusion device passes through the hemostatic valve 44, the second U-shaped groove portion 54, and the first U-shaped groove portion 53. The outer needle 2 is sent into the blood vessel.

此時,如第4圖所示,上述藥液等之主流S1係自中空圓筒構件4經由連接構件5之第2U字溝部54及第1U字溝部53流入外針2之內部,但因中空圓筒構件4具有第1切缺部41,而於上述前端位置,前端部42之外周面與外針基座3之大徑部33之內周面之間存有間隙。因此,上述藥液之一部分乃自第1切缺部41通過前端部42之外周面與外針基座3之大徑部33之內周面間的間隙流入大徑部33,而形成支流S2 。藉此,即便是血液侵入通氣溝部43之情形,該血液可藉由上述藥液等之支流S2 朝大徑部33方向被洗流。而且,上述藥液等之支流S2 等流入第2U字溝部54而與主流S1 合流。再者,支流S2 之一部分乃形成沿相對軸在與第2U字溝部54對稱之側形成的平坦部56流動之支流S3 ,支流S3 流入第1U字溝部53而與主流S1 合流。At this time, as shown in FIG. 4, the main flow S1 of the above-mentioned liquid medicine etc. flows into the inside of the outer needle 2 from the hollow cylindrical member 4 through the second U-shaped groove portion 54 and the first U-shaped groove portion 53 of the connecting member 5. The hollow cylindrical member 4 has a first notch 41 , and at the front end position, there is a gap between the outer peripheral surface of the front end portion 42 and the inner peripheral surface of the large diameter portion 33 of the outer needle base 3 . Therefore, part of the above-mentioned liquid medicine flows into the large-diameter portion 33 from the first notch portion 41 through the gap between the outer peripheral surface of the front end portion 42 and the inner peripheral surface of the large-diameter portion 33 of the outer needle base 3 to form a branch flow S 2 . Thereby, even if blood invades the vent groove portion 43, the blood can be washed toward the large diameter portion 33 by the branch flow S2 of the above-mentioned medical solution or the like. Then, the tributary flow S2 and the like of the chemical solution and the like flow into the second U-shaped groove portion 54 and merge with the main flow S1 . Furthermore, a part of the branch S2 forms a branch S3 flowing along the flat portion 56 formed on the side symmetrical to the second U-shaped groove 54 relative to the axis, and the branch S3 flows into the first U-shaped groove 53 and merges with the main flow S1 .

其結果為,充滿大徑部33之血液可藉由上述藥液等之支流S2 、S3 自第2U字溝部54及第1U字溝部53流入外針2之內部,可將該血液短時間內即完全自外針基座3之內部排出。As a result, the blood filling the large-diameter portion 33 can flow into the outer needle 2 from the second U-shaped groove portion 54 and the first U-shaped groove portion 53 through the tributaries S 2 and S 3 of the above-mentioned medicinal liquid, and the blood can be absorbed in a short time. The inside is completely discharged from the inside of the outer needle base 3 .

此時,第2U字溝部54及第1U字溝部53相對於一對第1切缺部41、41之連結線例如開口於正交方向,因此自第1切缺部41流出之上述藥液等之支流S2 乃自中空圓筒構件4之前端部42之周圍沿著外針基座3之大徑部33的內周面一面迴旋一面流入第2U字溝部54,而且上述藥液等之支流S3 乃自中空圓筒構件4之前端部42之周圍沿著外針基座3之大徑部33的內周面一面迴旋一面自平坦部56流入第1U字溝部53,因此可將上述血液自外針基座3之內部有效率地排出。At this time, the second U-shaped groove portion 54 and the first U-shaped groove portion 53 are opened in a direction perpendicular to the connecting line of the pair of first notch portions 41, 41, for example, so that the above-mentioned liquid medicine etc. flowing out of the first notch portion 41 The tributary S2 flows into the second U-shaped groove 54 from around the front end 42 of the hollow cylindrical member 4 along the inner peripheral surface of the large-diameter portion 33 of the outer needle base 3, and the tributaries of the above-mentioned liquid medicine etc. S3 flows from the flat part 56 into the first U-shaped groove part 53 from the periphery of the front end part 42 of the hollow cylindrical member 4 along the inner peripheral surface of the large-diameter part 33 of the outer needle base 3, so that the above-mentioned blood can be drawn Efficiently discharge from the inside of the outer needle base 3 .

又,止血閥44之切縫45因加工精度之故有自止血閥44之中央(軸)偏離形成之情形。然而,本實施方式之留置針組裝體1中,如第1圖所示,連接構件5之嵌合部51相對於外針基座3之擴徑部32係遊嵌,嵌合部51之外周面與擴徑部32之內周面之間具有間隙。Also, the slit 45 of the hemostatic valve 44 may deviate from the center (axis) of the hemostatic valve 44 due to machining accuracy. However, in the indwelling needle assembly 1 of the present embodiment, as shown in FIG. 1 , the fitting portion 51 of the connecting member 5 is loosely fitted with the enlarged diameter portion 32 of the outer needle base 3 , and the outer periphery of the fitting portion 51 There is a gap between the surface and the inner peripheral surface of the enlarged diameter portion 32 .

因此,連接構件5相對於外針基座3之軸可以任意角度傾斜,當切縫45自止血閥44之中央偏離形成時,相對外針基座3之軸傾斜之爪部53、53指向切縫45時,可將爪部53、53插入切縫45。Therefore, the connecting member 5 can be inclined at any angle with respect to the axis of the outer needle base 3. When the slit 45 is deviated from the center of the hemostatic valve 44, the claws 53, 53 inclined relative to the axis of the outer needle base 3 point to the slit. When the slit 45 is made, the claws 53 , 53 can be inserted into the slit 45 .

又,止血閥44之切縫45之加工精度優異之情形下,如第4圖所示,作為連接構件5之插入部52於外針基座3之前端部可與外針基座3之擴徑部32一體形成。於第4圖所示之連接構件5中,插入部52係往向後端部逐漸縮徑形成,於側面具有一對第2切缺部57。Also, when the processing accuracy of the slit 45 of the hemostatic valve 44 is excellent, as shown in FIG. The diameter portion 32 is integrally formed. In the connecting member 5 shown in FIG. 4 , the insertion portion 52 is gradually reduced in diameter toward the rear end, and has a pair of second notched portions 57 on the side.

另,於本實施方式中,藉由將外針基座3以透明或半透明之樹脂構成,而可視認大徑部33之內部之血液而確認上述內針穿刺入血管。然而,外針基座3若是具有可自外部確認大徑部33之內部之血液的構成,則也可由不透明之樹脂構成。In addition, in this embodiment, since the outer needle base 3 is made of transparent or translucent resin, the blood inside the large-diameter portion 33 can be seen and confirmed that the above-mentioned inner needle has penetrated into the blood vessel. However, the outer needle base 3 may be made of opaque resin as long as the blood inside the large-diameter portion 33 can be confirmed from the outside.

1:留置針組裝體 2:外針 3:外針基座 4:中空圓筒構件 5:連接構件 6:誘導件端子 33:大徑部 34:小徑部 35:誘導件圓錐部 41:第1切缺部 43:通氣溝部 44:止血閥 45:切縫 53、54、57:第2切缺部1: Indwelling needle assembly 2: outer needle 3: Outer needle base 4: Hollow cylindrical member 5: Connecting components 6: Inducer terminal 33: Large diameter part 34: Small diameter department 35: The cone part of the inducer 41: The first notch 43: Ventilation groove 44: Hemostasis valve 45: Slit 53, 54, 57: the second notch

第1A圖為顯示本發明留置針組裝體之一個構成例的立體圖,第1B圖為第1A圖的部分放大立體圖。 第2圖為第1圖的II-II線剖視圖。 第3圖為顯示第1圖所示之本發明留置針組裝體之作動的說明用剖視圖。 第4圖為顯示第3圖所示狀態之藥液之流動的說明用立體圖。 第5圖為顯示本發明留置針組裝體之其他構成例的說明用剖視圖。Fig. 1A is a perspective view showing a configuration example of the indwelling needle assembly of the present invention, and Fig. 1B is a partially enlarged perspective view of Fig. 1A. Fig. 2 is a sectional view taken along line II-II in Fig. 1 . Fig. 3 is an explanatory sectional view showing the operation of the indwelling needle assembly of the present invention shown in Fig. 1 . Fig. 4 is an explanatory perspective view showing the flow of the liquid medicine in the state shown in Fig. 3 . Fig. 5 is an explanatory sectional view showing another configuration example of the indwelling needle assembly of the present invention.

1:留置針組裝體 1: Indwelling needle assembly

2:外針 2: outer needle

3:外針基座 3: Outer needle base

4:中空圓筒構件 4: Hollow cylindrical member

5:連接構件 5: Connecting components

31:支持部 31: Support Department

32:擴徑部 32: Expanding part

33:大徑部 33: Large diameter part

34:小徑部 34: Small diameter department

35:誘導件圓錐部 35: The cone part of the inducer

41:第1切缺部 41: The first notch

42:前端部 42: front end

43:通氣溝部 43: Ventilation groove

44:止血閥 44: Hemostasis valve

45:切縫 45: Slit

51:嵌合部 51: Fitting part

52:插入部 52: Insertion part

53:第2切缺部 53: The second notch

54:第2切缺部 54: The second notch

55:連通孔 55: Connecting hole

56:平坦部 56: flat part

Claims (3)

一種留置針組裝體,其特徵在於具備: 外針,其由中空筒狀體構成,於穿刺入血管之狀態下被留置; 外針基座,其由中空筒狀體構成,以前端部支持該外針,且於基端部具有可連接誘導件端子之誘導件圓錐部; 中空圓筒構件,其配置於該外針基座的內部之基端側; 止血閥,其具有於與該外針基座之軸向正交的面上開閉自如之切縫,且內嵌於中空圓筒構件;及 連接構件,其配置於該外針基座之內部之前端部,在該中空圓筒構件由該誘導件端子朝前端方向被壓動時可插入至該止血閥之切縫,而連通該切縫之前後;且 該外針基座具備:較該誘導件圓錐部更位於前端側之小徑部、及較該小徑部於前端側延伸之大徑部; 該中空圓筒構件於其基端側具有第1切缺部,外周面具有將前端部與該第1切缺部連接而使氣體通過並且另一方面抑制液體通過之通氣溝部,該中空圓筒構件可自其外周面與該小徑部抵接之基端位置朝向該第1切缺部之至少一部分配置於該大徑部之前端位置前進; 該連接構件具備至少1個第2切缺部,並具備用以插入該止血閥的切縫之突起部,該第2切缺部開口於與第1切缺部不同之方向。An indwelling needle assembly is characterized in that it has: The outer needle, which is composed of a hollow cylindrical body, is left in the state of puncturing into the blood vessel; An outer needle base, which is composed of a hollow cylindrical body, supports the outer needle with the front end, and has a conical part of the inducer at the base end that can be connected to the terminal of the inducer; a hollow cylindrical member disposed on the base end side inside the outer needle base; A hemostatic valve, which has a slit that can be opened and closed freely on a surface perpendicular to the axial direction of the outer needle base, and is embedded in a hollow cylindrical member; and A connecting member, which is arranged at the front end of the outer needle base, can be inserted into the slit of the hemostatic valve when the hollow cylindrical member is pressed toward the front end by the inducer terminal, and communicates with the slit before and after; and The outer needle base has: a small diameter portion located on the front end side compared with the conical portion of the inducer, and a large diameter portion extending on the front end side compared with the small diameter portion; The hollow cylindrical member has a first notch at its proximal end, and its outer peripheral surface has an air channel that connects the front end to the first notch to allow gas to pass through while suppressing the passage of liquid. The component can advance from the base end position where the outer peripheral surface abuts the small diameter portion toward the front end position where at least a part of the first notch is disposed on the large diameter portion; The connecting member has at least one second notch, and has a protrusion for inserting into the slit of the hemostatic valve, and the second notch opens in a direction different from that of the first notch. 如申請專利範圍第1項之留置針組裝體,其中上述第2切缺部相對上述第1切缺部,在成直角之方向開口。The indwelling needle assembly as claimed in item 1 of the scope of the patent application, wherein the above-mentioned second notch is opened in a direction at right angles to the above-mentioned first notch. 如申請專利範圍第1項之留置針組裝體,其中上述連接構件與上述外針基座為另外個體。The indwelling needle assembly as claimed in item 1 of the scope of the patent application, wherein the above-mentioned connecting member and the above-mentioned outer needle base are separate entities.
TW108125452A 2018-07-25 2019-07-18 indwelling needle assembly TWI803665B (en)

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JP2018139238A JP7091593B2 (en) 2018-07-25 2018-07-25 Indwelling needle assembly
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TWI803665B true TWI803665B (en) 2023-06-01

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Publication number Priority date Publication date Assignee Title
JP6889820B2 (en) * 2017-07-21 2021-06-18 株式会社トップ Indwelling needle assembly
TWI751624B (en) * 2020-07-24 2022-01-01 瑟鎂科技股份有限公司 Sutureless vascular connector

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012517327A (en) * 2009-02-11 2012-08-02 ベクトン・ディキンソン・アンド・カンパニー System and method for providing a flow control valve for a medical device
JP2015080707A (en) * 2013-10-24 2015-04-27 株式会社トップ Indwelling needle
WO2015141366A1 (en) * 2014-03-20 2015-09-24 テルモ株式会社 Catheter assembly

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9750928B2 (en) * 2013-02-13 2017-09-05 Becton, Dickinson And Company Blood control IV catheter with stationary septum activator
JP6889820B2 (en) * 2017-07-21 2021-06-18 株式会社トップ Indwelling needle assembly

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012517327A (en) * 2009-02-11 2012-08-02 ベクトン・ディキンソン・アンド・カンパニー System and method for providing a flow control valve for a medical device
JP2015080707A (en) * 2013-10-24 2015-04-27 株式会社トップ Indwelling needle
WO2015141366A1 (en) * 2014-03-20 2015-09-24 テルモ株式会社 Catheter assembly

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