JP5963047B2 - Needle assembly - Google Patents

Needle assembly Download PDF

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JP5963047B2
JP5963047B2 JP2012155473A JP2012155473A JP5963047B2 JP 5963047 B2 JP5963047 B2 JP 5963047B2 JP 2012155473 A JP2012155473 A JP 2012155473A JP 2012155473 A JP2012155473 A JP 2012155473A JP 5963047 B2 JP5963047 B2 JP 5963047B2
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protective cover
use state
cannula
axial groove
tip
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JP2014014598A (en
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佳邦 内田
佳邦 内田
伸晃 稲毛
伸晃 稲毛
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Nipro Corp
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Nipro Corp
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Priority to PCT/JP2013/068346 priority patent/WO2014010503A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths

Description

本発明は針組立体に関し、詳しくは保護カバーを前進させてカヌラの先端を囲繞する使用前状態および保護カバーを後退させて上記カヌラの先端を露出させる使用状態にすることが可能な針組立体に関する。   The present invention relates to a needle assembly, and in particular, a needle assembly that can be put into a pre-use state in which a protective cover is advanced to surround the tip of the cannula and a use state in which the protective cover is retracted to expose the tip of the cannula. About.

従来、カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する保護カバーと、上記ハブに設けられるとともに上記保護カバーを先端より出没可能に収納する筒状部と、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段とを備えた針組立体が知られている（特許文献１）。
この特許文献１の針組立体には、上記筒状部または保護カバーにそれぞれ係合突起および上記係合突起の移動を規制するガイド手段が設けられており、これら係合突起およびガイド手段によって、上記保護カバーが上記筒状部より前方に突出して上記カヌラの先端を囲繞する使用前状態と、筒状部の内部に後退して上記カヌラの先端を露出させる使用状態と、再び筒状部より前方に突出してカヌラの先端を囲繞するとともに再び後退しないように固定される使用後状態とに移動させるようになっている。 Conventionally, a hub that holds the cannula, a protective cover that moves forward and backward with respect to the hub and surrounds the tip of the cannula, a cylindrical part that is provided on the hub and accommodates the protective cover so that it can protrude and retract from the tip, There is known a needle assembly that includes a biasing means that is elastically mounted between the hub and the protective cover and biases the protective cover forward (Patent Document 1).
In the needle assembly of Patent Document 1, an engagement protrusion and a guide means for restricting the movement of the engagement protrusion are provided on the cylindrical portion or the protective cover, respectively. With the engagement protrusion and the guide means, The pre-use state in which the protective cover protrudes forward from the cylindrical part and surrounds the tip of the cannula, the use state in which the tip of the cannula is exposed by retreating inside the cylindrical part, and again from the cylindrical part It protrudes forward and surrounds the tip of the cannula and is moved to a post-use state that is fixed so as not to retreat.

国際公開２００９−１５４１３１号公報International Publication No. 2009-154131

しかしながら、上記特許文献１の針組立体の場合、保護カバーが使用前状態から使用状態へと後退する際、係合突起がガイド手段によってガイドされ、上記保護カバー全体が回転しながら後退するようになっていた。
その結果、カヌラを患者に穿刺する際、保護カバーは患者の皮膚に接触しながら上記使用前状態から使用状態へと後退するが、保護カバーがハブに対して相対的に回転してしまうことから、回転トルクが加わり、穿刺しづらいという問題点があった。
このような問題に鑑み、使用前状態から使用状態とする際に回転トルクが加わらず容易に穿刺することが可能な針組立体を提供するものである。
However, in the case of the needle assembly of Patent Document 1, when the protective cover is retracted from the pre-use state to the used state, the engaging protrusion is guided by the guide means so that the entire protective cover is retracted while rotating. It was.
As a result, when the cannula is punctured into the patient, the protective cover retracts from the pre-use state to the use state while contacting the patient's skin, but the protective cover rotates relative to the hub. However, there was a problem that rotation torque was applied and it was difficult to puncture.
In view of such problems, it is an object of the present invention to provide a needle assembly that can be punctured easily without applying rotational torque when changing from a pre-use state to a use state.

すなわち請求項１の発明にかかる針組立体は、カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する保護カバーと、上記ハブに設けられるとともに上記保護カバーを先端より出没可能に収納する筒状部と、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記筒状部または保護カバーのいずれか一方に設けられた係合突起と、いずれか他方に設けられて上記係合突起の移動を規制するガイド手段とを備え、
上記係合突起およびガイド手段により、上記保護カバーが上記筒状部より前方に突出して上記カヌラの先端を囲繞する使用前状態と、筒状部の内部に後退して上記カヌラの先端を露出させる使用状態と、再び筒状部より前方に突出してカヌラの先端を囲繞するとともに再び後退しないように固定される使用後状態とに移動させる針組立体において、
上記係合突起を上記筒状部と保護カバーとのいずれか一方に設けるとともに、上記ガイド手段を上記いずれか他方に設け、
上記ガイド手段を、上記カヌラの軸方向に延びる軸方向溝と、上記軸方向溝の一端部側に形成した段差状部とから構成し、
上記段差状部を、上記軸方向溝よりも深く形成し、カヌラの軸方向に対して斜め方向に他端部側に向かって延びる斜め方向溝と、上記軸方向溝と上記斜め方向溝との段差により形成したガイド面とから構成し、
上記使用前状態において、上記係合突起は上記軸方向溝の他端部側に位置し、
上記使用前状態から使用状態とする際には、上記係合突起が上記軸方向溝にガイドされ、これにより上記保護カバーが回転せずに一端部側に後退し、
上記使用状態から使用後状態とする際には、上記係合突起が上記ガイド面にガイドされ、これにより上記保護カバーが回転しながら他端部側に前進するようにしたことを特徴としている。
That is, the needle assembly according to the invention of claim 1 includes a hub for holding the cannula, a protective cover that moves forward and backward with respect to the hub to surround the tip of the cannula, and is provided on the hub and has the protective cover at the tip. Provided in either one of the cylindrical part or the protective cover, a cylindrical part that can be retracted more and more, an urging means that is elastically mounted between the hub and the protective cover and urges the protective cover forward An engagement protrusion provided on the other side, and a guide means provided on one of the other sides to restrict movement of the engagement protrusion,
The pre-use state in which the protective cover protrudes forward from the cylindrical portion and surrounds the tip of the cannula by the engaging protrusion and the guide means, and the tip of the cannula is exposed by retreating to the inside of the cylindrical portion. In the needle assembly that moves between the use state and the post-use state that protrudes forward from the cylindrical portion again, surrounds the tip of the cannula and is fixed so as not to retreat,
The engaging protrusion is provided on one of the cylindrical portion and the protective cover, and the guide means is provided on the other of the above,
The guide means comprises an axial groove extending in the axial direction of the cannula, and a stepped portion formed on one end side of the axial groove,
The step-shaped portion is formed deeper than the axial groove, and includes an oblique groove extending obliquely with respect to the axial direction of the cannula toward the other end side, and the axial groove and the oblique groove. It consists of a guide surface formed by steps,
In the pre-use state, the engaging protrusion is located on the other end side of the axial groove,
When changing from the pre-use state to the use state, the engagement protrusion is guided by the axial groove, whereby the protective cover does not rotate and retracts to one end side,
When changing from the use state to the post-use state, the engagement protrusion is guided by the guide surface, whereby the protective cover moves forward to the other end side while rotating .

上記発明によれば、上記係合突起とガイド手段とによって、上記保護カバーが使用前状態から使用状態へと後退する際に回転しないことから、回転トルクが生じず容易に穿刺することが可能となる。
一方、上記係合突起とガイド手段とによって、保護カバーは回転しながら使用状態から使用後状態へと前進するため、使用後状態において保護カバーからカヌラが再度露出しないようにすることができる。 According to the invention, the engagement protrusion and the guide means do not rotate when the protective cover is retracted from the pre-use state to the use state, so that it is possible to easily puncture without generating rotational torque. Become.
On the other hand, because the protective cover is rotated from the use state to the post-use state by the engagement protrusion and the guide means, the cannula can be prevented from being exposed again from the protective cover in the post-use state.

（ａ）は本実施例にかかる針組立体の使用前状態を示す断面図を、（ｂ）は当該使用前状態における係合突起とガイド手段との関係を示している。(A) is sectional drawing which shows the state before use of the needle | hook assembly concerning a present Example, (b) has shown the relationship between the engagement protrusion and guide means in the said state before use. （ａ）は針組立体の使用状態を示す断面図を、（ｂ）は当該使用状態における係合突起とガイド手段との関係を示している。(A) is sectional drawing which shows the use condition of a needle | hook assembly, (b) has shown the relationship between the engagement protrusion and guide means in the said use condition. （ａ）は針組立体の使用状態と使用後状態との間の状態を示す断面図を、（ｂ）は当該状態における係合突起とガイド手段との関係を示している。(A) is sectional drawing which shows the state between the use state of a needle | hook assembly, and the state after use, (b) has shown the relationship between the engagement protrusion and guide means in the said state. （ａ）は針組立体の使用後状態を示す断面図を、（ｂ）は当該使用後状態における係合突起とガイド手段との関係を示している。(A) is sectional drawing which shows the state after use of a needle | hook assembly, (b) has shown the relationship between the engagement protrusion and guide means in the said state after use.

以下、図示実施例について説明すると、図１〜図４は図示しないシリンジの先端に接続された針組立体１を、以下に説明する各状態ごとに示したものであって、この針組立体１を用いることでカヌラ２の露出による誤穿刺事故を防止することが可能となっている。
針組立体１は、カヌラ２を保持するハブ３と、ハブ３に対して進退動して上記カヌラ２の先端を囲繞する保護カバー４と、上記ハブ３に設けられるとともに上記保護カバー４を先端より出没可能に収納する筒状部５と、上記ハブ３と保護カバー４との間に弾装されて保護カバー４を前方に付勢する付勢手段としてのばね部６とを備えている。
そして本実施例の針組立体１は、図１に示す前進した保護カバー４によりカヌラ２が囲繞された使用前状態と、図２に示す保護カバー４が後退してカヌラ２が突出した使用状態と、図４に示す、上記使用状態から図３の状態を介して再び保護カバー４によりカヌラ２を囲繞した使用後状態とに変化可能となっている。 1 to 4 show the needle assembly 1 connected to the tip of a syringe (not shown) for each state described below. By using this, it is possible to prevent accidental puncture accidents due to exposure of the canula 2.
The needle assembly 1 includes a hub 3 that holds the cannula 2, a protective cover 4 that moves forward and backward with respect to the hub 3 to surround the tip of the cannula 2, and is provided on the hub 3 and has the protective cover 4 at the tip. A cylindrical portion 5 that is housed in a more retractable manner, and a spring portion 6 that is elastically mounted between the hub 3 and the protective cover 4 and biases the protective cover 4 forward.
The needle assembly 1 according to the present embodiment is in a pre-use state in which the cannula 2 is surrounded by the advanced protective cover 4 shown in FIG. 1 and a use state in which the protective cover 4 shown in FIG. 4 can be changed from the use state shown in FIG. 4 to a post-use state in which the cannula 2 is surrounded by the protective cover 4 again through the state shown in FIG.

上記ハブ３は筒状を有すると共に、その基部には上記シリンジの接続される接続部３ａが形成され、先端には上記カヌラ２を保持する保持部３ｂが形成され、上記接続部３ａの外周には上記ばね部６の一端が弾接するばね受け部３ｃが設けられている。
上記カヌラ２は上記保持部３ｂによって筒状部５の先端よりも前方に突出しており、また図１、図４に示すように上記保護カバー４が使用前状態または使用後状態に位置すると、当該保護カバー４によってカヌラ２の先端が囲繞されるようになっている。
上記ばね受け部３ｃは有底筒状に形成され、その底部には上記ばね部６の後端が弾接し、その外周面には上記筒状部５が固定されるようになっている。 The hub 3 has a cylindrical shape, and a connecting portion 3a to which the syringe is connected is formed at a base portion, a holding portion 3b that holds the cannula 2 is formed at a distal end, and an outer periphery of the connecting portion 3a is formed. Is provided with a spring receiving portion 3c with which one end of the spring portion 6 is elastically contacted.
The cannula 2 protrudes forward from the tip of the cylindrical part 5 by the holding part 3b, and when the protective cover 4 is positioned in the pre-use state or the post-use state as shown in FIGS. The tip of the cannula 2 is surrounded by the protective cover 4.
The spring receiving portion 3c is formed in a bottomed cylindrical shape, the rear end of the spring portion 6 is elastically contacted to the bottom portion, and the cylindrical portion 5 is fixed to the outer peripheral surface thereof.

上記保護カバー４およびばね部６は弾性を有する樹脂によって一体成形され、その中央を上記ハブ３およびカヌラ２が貫通するように形成されている。
保護カバー４はハブ３より出没可能に設けられたカバー部１１と、該カバー部１１の後方に設けられた大径の係合部１２とから構成され、カバー部１１と係合部１２との境界には段差が形成されている。
また、上記係合部１２の側面には対向する位置に２つの貫通孔１２ａが形成されており、該貫通孔１２ａの内部には変形部１３を介して係合突起１４が設けられている。
この係合突起１４は通常上記係合部１２の外周面より外方に突出ており、係合突起１４が外周側から押圧されると、上記変形部１３が変形してカヌラ２側に移動し、押圧力が解除されるともとの位置に復帰するようになっている。
上記ばね部６は上記係合部１２の後端に直列に連結され、上記ハブ３のばね受け部３ｃとの間に弾装されることにより、上記保護カバー４を前方に付勢するようになっている。 The protective cover 4 and the spring portion 6 are integrally formed of an elastic resin, and are formed so that the hub 3 and the canula 2 pass through the center thereof.
The protective cover 4 includes a cover portion 11 provided so as to be able to protrude and retract from the hub 3, and a large-diameter engaging portion 12 provided behind the cover portion 11. A step is formed at the boundary.
Further, two through holes 12 a are formed on the side surfaces of the engaging portion 12 at opposing positions, and an engaging protrusion 14 is provided inside the through hole 12 a via a deforming portion 13.
The engaging protrusion 14 normally protrudes outward from the outer peripheral surface of the engaging portion 12. When the engaging protrusion 14 is pressed from the outer peripheral side, the deforming portion 13 is deformed and moves to the cannula 2 side. When the pressing force is released, it returns to its original position.
The spring portion 6 is connected in series with the rear end of the engagement portion 12 and is elastically mounted between the spring receiving portion 3c of the hub 3 so as to urge the protective cover 4 forward. It has become.

上記筒状部５は、筒状の筒状体５ａおよびその先端に設けられたキャップ体５ｂとから構成され、その内周面には上記保護カバー４の係合突起１４をガイドするためのガイド手段２１が形成されている。
上記筒状体５ａの先端には上記保護カバー４のカバー部１１と略同径の開口部５ｃが形成されており、図１に示す使用前状態において、上記カバー部１１と係合部１２との段差が当該開口部５ｃに当接し、保護カバー４の前進を阻止するようになっている。 The tubular portion 5 is composed of a tubular tubular body 5a and a cap body 5b provided at the tip thereof, and a guide for guiding the engaging protrusion 14 of the protective cover 4 on the inner peripheral surface thereof. Means 21 are formed.
An opening 5c having substantially the same diameter as that of the cover 11 of the protective cover 4 is formed at the tip of the cylindrical body 5a. In the state before use shown in FIG. Are in contact with the opening 5c to prevent the protective cover 4 from moving forward.

上記ガイド手段２１は、上記係合突起１４と同様、対向する位置に２箇所形成されており、筒状部５の軸方向に形成した軸方向溝２１ａと、当該軸方向溝２１ａに対してカヌラ２の基部側に面するように設けられた傾斜面２１ｂとを有している。
上記軸方向溝２１ａは、筒状部５の先端から後方に向けて形成された溝となっており、図１（ｂ）に示す使用前状態において、上記保護カバー４の係合突起１４は当該軸方向溝２１ａの先端部に位置するようになっている。
また上記軸方向溝２１ａは上記係合突起１４の幅と略同じ幅となっており、このため係合突起１４が軸方向溝２１ａを移動する間、係合突起１４は筒状部５に対して直交する方向に移動できず、これにより保護カバー４の回転を阻止するようになっている。
上記傾斜面２１ｂは上記軸方向溝２１ａの後端部に形成されており、具体的には軸方向溝２１ａの後方に当該軸方向溝２１ａよりも深い溝を形成したことにより形成した段差形状となっている。つまり上記段差状部は、上記軸方向溝２１ａよりも深く形成され、カヌラ２の軸方向に対して斜め方向に延びる斜め方向溝と、上記軸方向溝２１ａと上記斜め方向溝との段差により形成したガイド面とから構成されており、かつ当該傾斜面２１ｂは軸方向溝２１ａの軸方向後方に面するように形成されている。
また上記傾斜面２１ｂは、上記軸方向溝２１ａの後端部から図１（ｂ）に示すように斜め前方に向けて傾斜しており、この傾斜面２１ｂにおける前方側の端部には、図４に示す使用後状態において上記保護カバー４の係合突起１４を収容する貫通孔２２が形成されている。
The guide means 21 is formed at two opposing positions in the same manner as the engagement protrusion 14, and an axial groove 21a formed in the axial direction of the cylindrical portion 5 and a cannula with respect to the axial groove 21a. 2 and an inclined surface 21b provided so as to face the base side.
The axial groove 21a is a groove formed from the tip of the cylindrical portion 5 toward the rear, and in the pre-use state shown in FIG. It is located at the tip of the axial groove 21a.
Further, the axial groove 21a has substantially the same width as the engagement protrusion 14, so that the engagement protrusion 14 moves relative to the tubular portion 5 while the engagement protrusion 14 moves in the axial groove 21a. Therefore, the protective cover 4 is prevented from rotating.
The inclined surface 21b is formed at the rear end of the axial groove 21a. Specifically, the inclined surface 21b has a step shape formed by forming a groove deeper than the axial groove 21a behind the axial groove 21a. It has become. That is, the stepped portion is formed deeper than the axial groove 21a, and is formed by an oblique groove extending obliquely with respect to the axial direction of the cannula 2, and a step between the axial groove 21a and the oblique groove. The inclined surface 21b is formed so as to face the axially rearward side of the axial groove 21a .
Further, the inclined surface 21b is inclined obliquely forward from the rear end portion of the axial groove 21a as shown in FIG. 1B, and the front end portion of the inclined surface 21b is illustrated in FIG. In the state after use shown in FIG. 4, a through hole 22 for receiving the engaging protrusion 14 of the protective cover 4 is formed.

以下、上記構成を有する針組立体１の取り扱いについて説明する。
まず、針組立体１のハブ３における接続部３ａを図示しないシリンジの先端に装着して、針組立体１を図１に示す使用前状態とする。
その際、保護カバー４はばね部６の付勢力によって前方に付勢され、係合部１２が筒状部５の開口部５ｃに後方から当接することで、保護カバー４が筒状部５より前方に突出してカヌラ２を囲繞するようになっている。
一方、保護カバー４の係合突起１４は図１（ｂ）に示すように上記ガイド手段２１における軸方向溝２１ａの前方に位置しており、また係合突起１４は軸方向溝２１ａによって直交方向への移動が阻止され、保護カバー４が筒状部５に対して回転しないようになっている。 Hereinafter, the handling of the needle assembly 1 having the above configuration will be described.
First, the connecting portion 3a of the hub 3 of the needle assembly 1 is attached to the tip of a syringe (not shown), and the needle assembly 1 is brought into a pre-use state shown in FIG.
At that time, the protective cover 4 is urged forward by the urging force of the spring portion 6, and the engaging portion 12 comes into contact with the opening portion 5 c of the cylindrical portion 5 from the rear, so that the protective cover 4 is more than the cylindrical portion 5. It protrudes forward and surrounds the cannula 2.
On the other hand, the engaging protrusion 14 of the protective cover 4 is located in front of the axial groove 21a in the guide means 21 as shown in FIG. 1B, and the engaging protrusion 14 is orthogonally crossed by the axial groove 21a. Therefore, the protective cover 4 is prevented from rotating with respect to the cylindrical portion 5.

次に、図１の状態から使用者が針組立体１を患者の皮膚に対して略垂直方向に押し当てると、患者の皮膚に接触した保護カバー４はばね部６の付勢力に抗して後退し、カヌラ２が相対的に突出して患者に穿刺され、図２に示す使用状態となる。
ここで、保護カバー４が使用前状態から後退を開始すると、保護カバー４に設けた係合突起１４が上記ガイド手段２１の軸方向溝２１ａに沿って軸方向に後退し、その間上記保護カバー４は筒状部５に対して回転せずに後退する。
保護カバー４がさらに後退すると、係合突起１４は上記軸方向溝２１ａの後端に形成された傾斜面２１ｂを超えてさらに軸方向に後退し、最終的には図２に示すように保護カバー４が完全に筒状部５に収容され、係合突起１４は筒状部５の後方に位置することとなる。
その間、上記係合突起１４は上記ガイド手段２１によって直交方向にガイドされないため、保護カバー４は回転せずに後退する。その結果、穿刺時に回転トルクが生じることなく、容易に穿刺することが可能となっている。 Next, when the user presses the needle assembly 1 against the patient's skin from the state shown in FIG. 1, the protective cover 4 that contacts the patient's skin resists the biasing force of the spring portion 6. The patient moves backward, the canula 2 relatively protrudes and is punctured by the patient, and the use state shown in FIG. 2 is obtained.
Here, when the protective cover 4 starts to retreat from the pre-use state, the engaging protrusion 14 provided on the protective cover 4 retreats in the axial direction along the axial groove 21a of the guide means 21, while the protective cover 4 is in the meantime. Retreats without rotating relative to the tubular part 5.
When the protective cover 4 is further retracted, the engaging protrusion 14 is further retracted in the axial direction beyond the inclined surface 21b formed at the rear end of the axial groove 21a, and finally, as shown in FIG. 4 is completely accommodated in the cylindrical portion 5, and the engaging projection 14 is located behind the cylindrical portion 5.
Meanwhile, since the engaging protrusion 14 is not guided in the orthogonal direction by the guide means 21, the protective cover 4 moves backward without rotating. As a result, it is possible to puncture easily without generating rotational torque during puncturing.

そして、針組立体１が使用状態となってカヌラ２が患者に穿刺されると、使用者はシリンジを操作して薬剤等の投与を行い、その後、使用者はシリンジごと針組立体１を後退させて患者から除去し、図３の状態となる。
筒状部５が患者から離隔すると、保護カバー４はばね部６の付勢力によって患者に接触した状態を維持したまま上記筒状部５に対して相対的に前進し、これに伴って保護カバー４の係合突起１４が前進する。
すると、図３（ｂ）に示すように、当該係合突起１４は上記軸方向溝２１ａの後端部に形成された傾斜面２１ｂに当接する。この際、上記係合突起１４は、上記傾斜面２１ｂのガイド面に当接する箇所が該傾斜面２１ｂのガイド面と平行な面に形成されており、この面が傾斜面２１ｂのガイド面に当接するようになっている。
ここで、上記傾斜面２１ｂは上記軸方向溝２１ａの後端部に形成されて軸方向後方に面して形成されているため、上記係合突起１４は傾斜面２１ｂを乗り越えることはできず、係合突起１４が上記軸方向溝２１ａの内部に移動して図１の使用前状態に復帰することはない。
このときも保護カバー４は患者の皮膚と接触しているが、保護カバー４は上記ばね部６の付勢力だけで皮膚に接触しているだけであり、また上記使用状態から図３に示す係合突起１４が傾斜面２１ｂに当接するまでは、保護カバー４は略直線的に回転せずに移動するため、保護カバー４の回転による回転トルクは生じず、容易に後退可能となっている。
When the needle assembly 1 is in use and the cannula 2 is punctured by the patient, the user operates the syringe to administer a medicine and the like, and then the user retracts the needle assembly 1 together with the syringe. And removed from the patient, resulting in the state of FIG.
When the tubular portion 5 is separated from the patient, the protective cover 4 moves forward relative to the tubular portion 5 while maintaining the state of being in contact with the patient by the biasing force of the spring portion 6. The four engaging protrusions 14 move forward.
Then, as shown in FIG. 3B, the engaging protrusion 14 comes into contact with an inclined surface 21b formed at the rear end portion of the axial groove 21a. At this time, the engaging protrusion 14 is formed at a position where it abuts against the guide surface of the inclined surface 21b in a plane parallel to the guide surface of the inclined surface 21b, and this surface contacts the guide surface of the inclined surface 21b. It comes to touch.
Here, since the inclined surface 21b is formed at the rear end portion of the axial groove 21a and faces rearward in the axial direction, the engagement protrusion 14 cannot get over the inclined surface 21b. The engagement protrusion 14 does not move into the axial groove 21a and return to the pre-use state of FIG.
At this time, the protective cover 4 is in contact with the patient's skin, but the protective cover 4 is only in contact with the skin only by the urging force of the spring portion 6, and the relationship shown in FIG. Until the mating protrusion 14 abuts against the inclined surface 21b, the protective cover 4 moves without rotating in a substantially linear fashion, so that no rotational torque is generated by the rotation of the protective cover 4, and the protective cover 4 can be easily retracted.

そして、図３の状態からさらに保護カバー４が前進すると、係合突起１４は保護カバー４の前進に併せて上記傾斜面２１ｂに沿って斜め前方に移動し、これにより保護カバー４は筒状部５に対して回転しながら前進して、図４の使用後状態となる。
その際、上記係合突起１４が傾斜面２１ｂの端部に形成された上記貫通孔２２に差し掛かると、保護カバー４の変形部１３が元の形状に復帰して、係合突起１４が貫通孔２２の内部に突出して嵌合する。
その結果、その後保護カバー４に前方からの付勢力が作用しても、上記保護カバー４の後退を阻止することができ、カヌラ２の再露出が阻止され、針組立体１の再利用や誤穿刺事故を防止することができる。 When the protective cover 4 further advances from the state of FIG. 3, the engaging protrusion 14 moves obliquely forward along the inclined surface 21b as the protective cover 4 moves forward, so that the protective cover 4 becomes a cylindrical part. 4 advances to the state after use as shown in FIG.
At that time, when the engaging protrusion 14 reaches the through hole 22 formed at the end of the inclined surface 21b, the deformed portion 13 of the protective cover 4 returns to its original shape, and the engaging protrusion 14 penetrates. It protrudes and fits into the hole 22.
As a result, even if an urging force from the front acts on the protective cover 4 thereafter, the protective cover 4 can be prevented from moving backward, the re-exposure of the cannula 2 is prevented, and the needle assembly 1 can be reused or misused. A puncture accident can be prevented.

上記実施例にかかる針組立体１によれば、保護カバー４が使用前状態および使用後状態においてカヌラ２を囲繞するため、使用者への誤穿刺を防止することが可能となっている。
特に、図１の使用前状態から図２の使用状態となる際、つまりカヌラ２を患者に穿刺する際には、上記保護カバー４の係合突起１４はガイド手段２１によって軸方向に移動するため、保護カバー４を回転させずに後退させることができる。
このように、カヌラ２を穿刺する際に保護カバー４が回転しないことから、穿刺時に回転トルクが生じることなく、容易に穿刺することが可能となっている。
ここで、本実施例に係る針組立体１と、上記特許文献１に記載された穿刺時に回転トルクが生じてしまう針組立体とについて、実際に穿刺時における上記回転トルクの測定を行った。
測定には上記保護カバー４の先端にトルクゲージを装着し、上記筒状部５をカヌラ２の軸方向に移動させて、保護カバー４が後退しながら回転することによる回転トルクを複数回ずつ測定した。
その結果、本実施例に係る針組立体１は、保護カバー４が後退する際に回転しないため回転トルクは０であったが、上記特許文献１に記載された構成を有する針組立体の場合、平均して１４．５ｇの回転トルクが測定された。
なお、上記実施例とは逆に、上記係合突起１４を筒状部５の内周面に形成し、上記ガイド手段２１を保護カバー４の外周面に形成してもよく、その際、上記保護カバー４のガイド手段においては、上記傾斜面２１ｂが前方に面して形成され、係合突起１４は保護カバー４が前進して傾斜面２１ｂに前方から当接することによりガイドされることとなる。 According to the needle assembly 1 according to the above embodiment, since the protective cover 4 surrounds the cannula 2 in the pre-use state and the post-use state, it is possible to prevent erroneous puncture to the user.
In particular, when the state before use of FIG. 1 is changed to the state of use of FIG. 2, that is, when the cannula 2 is punctured into a patient, the engaging protrusion 14 of the protective cover 4 is moved in the axial direction by the guide means 21. The protective cover 4 can be retracted without rotating.
Thus, since the protective cover 4 does not rotate when puncturing the cannula 2, it is possible to puncture easily without generating rotational torque during puncturing.
Here, with respect to the needle assembly 1 according to the present example and the needle assembly described in Patent Document 1 that generates rotational torque during puncturing, the rotational torque during actual puncturing was measured.
For the measurement, a torque gauge is attached to the tip of the protective cover 4, the cylindrical part 5 is moved in the axial direction of the cannula 2, and the rotational torque caused by rotating the protective cover 4 while retreating is measured several times. did.
As a result, the needle assembly 1 according to the present example did not rotate when the protective cover 4 was retracted, so the rotational torque was 0. However, in the case of the needle assembly having the configuration described in Patent Document 1 above On average, a rotational torque of 14.5 g was measured.
Contrary to the above embodiment, the engaging projections 14 may be formed on the inner peripheral surface of the cylindrical portion 5, and the guide means 21 may be formed on the outer peripheral surface of the protective cover 4. In the guide means of the protective cover 4, the inclined surface 21b is formed so as to face forward, and the engaging projection 14 is guided by the protective cover 4 moving forward and coming into contact with the inclined surface 21b from the front. .

１ 針組立体 ２ カヌラ
３ ハブ ４ 保護カバー
５ 筒状部 ６ ばね部
１４ 係合突起 ２１ ガイド手段
２１ａ 軸方向溝 ２１ｂ 傾斜面 DESCRIPTION OF SYMBOLS 1 Needle assembly 2 Kanura 3 Hub 4 Protective cover 5 Cylindrical part 6 Spring part 14 Engagement protrusion 21 Guide means 21a Axial groove 21b Inclined surface

Claims (4)

カヌラを保持するハブと、ハブに対して進退動して上記カヌラの先端を囲繞する保護カバーと、上記ハブに設けられるとともに上記保護カバーを先端より出没可能に収納する筒状部と、上記ハブと保護カバーとの間に弾装されて保護カバーを前方に付勢する付勢手段と、上記筒状部または保護カバーのいずれか一方に設けられた係合突起と、いずれか他方に設けられて上記係合突起の移動を規制するガイド手段とを備え、
上記係合突起およびガイド手段により、上記保護カバーが上記筒状部より前方に突出して上記カヌラの先端を囲繞する使用前状態と、筒状部の内部に後退して上記カヌラの先端を露出させる使用状態と、再び筒状部より前方に突出してカヌラの先端を囲繞するとともに再び後退しないように固定される使用後状態とに移動させる針組立体において、
上記係合突起を上記筒状部と保護カバーとのいずれか一方に設けるとともに、上記ガイド手段を上記いずれか他方に設け、
上記ガイド手段を、上記カヌラの軸方向に延びる軸方向溝と、上記軸方向溝の一端部側に形成した段差状部とから構成し、
上記段差状部を、上記軸方向溝よりも深く形成し、カヌラの軸方向に対して斜め方向に他端部側に向かって延びる斜め方向溝と、上記軸方向溝と上記斜め方向溝との段差により形成したガイド面とから構成し、
上記使用前状態において、上記係合突起は上記軸方向溝の他端部側に位置し、
上記使用前状態から使用状態とする際には、上記係合突起が上記軸方向溝にガイドされ、これにより上記保護カバーが回転せずに一端部側に後退し、
上記使用状態から使用後状態とする際には、上記係合突起が上記ガイド面にガイドされ、これにより上記保護カバーが回転しながら他端部側に前進するようにしたことを特徴とする針組立体。 A hub for holding the cannula, a protective cover that moves forward and backward with respect to the hub and surrounds the tip of the cannula, a cylindrical part that is provided on the hub and accommodates the protective cover so that it can protrude and retract from the tip, and the hub Urging means that is elastically mounted between the protective cover and the protective cover forward, an engagement protrusion provided on either the cylindrical portion or the protective cover, and provided on either one And a guide means for restricting the movement of the engagement protrusion,
The pre-use state in which the protective cover protrudes forward from the cylindrical portion and surrounds the tip of the cannula by the engaging protrusion and the guide means, and the tip of the cannula is exposed by retreating to the inside of the cylindrical portion. In the needle assembly that moves between the use state and the post-use state that protrudes forward from the cylindrical portion again, surrounds the tip of the cannula and is fixed so as not to retreat,
The engaging protrusion is provided on one of the cylindrical portion and the protective cover, and the guide means is provided on the other of the above,
The guide means comprises an axial groove extending in the axial direction of the cannula, and a stepped portion formed on one end side of the axial groove,
The step-shaped portion is formed deeper than the axial groove, and includes an oblique groove extending obliquely with respect to the axial direction of the cannula toward the other end side, and the axial groove and the oblique groove. It consists of a guide surface formed by steps,
In the pre-use state, the engaging protrusion is located on the other end side of the axial groove,
When changing from the pre-use state to the use state, the engagement protrusion is guided by the axial groove, whereby the protective cover does not rotate and retracts to one end side,
When changing from the use state to the post-use state, the engagement protrusion is guided by the guide surface, whereby the protection cover rotates and moves forward to the other end side. Assembly. 上記係合突起を保護カバーの外周面に設け、
上記段差状部は、上記ガイド手段を、筒状部の内周面に軸方向に形成した軸方向溝と、当該軸方向溝に対してカヌラの基部側に設けた上記段差状部とから構成し、
上記段差状部を、上記軸方向溝よりも深く形成し、カヌラの軸方向に対して斜め方向にカヌラの先端部側に向かって延びる斜め方向溝と、上記軸方向溝と上記斜め方向溝との段差により形成したガイド面とから構成し、
上記使用前状態において、上記保護カバーの係合突起は上記軸方向溝の先端部に位置し、
当該使用前状態から使用状態とする際には、上記係合突起が上記軸方向溝にガイドされ、これにより上記保護カバーが回転せずにカヌラの基部側に後退し、
上記使用状態から使用後状態とする際には、上記係合突起が後方から上記ガイド面に当接するとともに当該ガイド面にガイドされて斜め前方に移動し、これにより上記保護カバーが回転しながら前進することを特徴とする請求項１に記載の針組立体。 The engagement protrusion is provided on the outer peripheral surface of the protective cover,
The stepped portion comprises the guide means comprising an axial groove formed in the axial direction on the inner peripheral surface of the tubular portion, and the stepped portion provided on the base side of the cannula with respect to the axial groove. And
The stepped portion is formed deeper than the axial groove, and extends obliquely toward the tip of the cannula in an oblique direction with respect to the axial direction of the cannula, the axial groove and the oblique groove, And a guide surface formed by the steps of
In the pre-use state, the engagement protrusion of the protective cover is located at the tip of the axial groove,
When changing from the pre-use state to the use state, the engagement protrusion is guided by the axial groove , whereby the protective cover does not rotate and retracts toward the base of the cannula,
When changing from the use state to the post-use state, the engagement protrusion comes into contact with the guide surface from behind and is guided by the guide surface to move obliquely forward, whereby the protective cover moves forward while rotating. The needle assembly according to claim 1. 上記係合突起は、上記ガイド面に当接する箇所が、該ガイド面と平行な面に形成されていることを特徴とする請求項１又は請求項２に記載の針組立体。The needle assembly according to claim 1 or 2, wherein the engagement protrusion is formed on a surface parallel to the guide surface at a position where the engagement protrusion abuts the guide surface. 上記筒状部は、上記ハブに設けられた筒状体と、該筒状体の先端に設けられたキャップ体とから構成されており、筒状体の先端部またはキャップ体のいずれかに上記段差状部が設けられていることを特徴とする請求項１ないし請求項３のいずれかに記載の針組立体。The cylindrical portion is composed of a cylindrical body provided on the hub and a cap body provided at the tip of the cylindrical body, and the cylindrical portion is provided on either the tip of the cylindrical body or the cap body. The needle assembly according to any one of claims 1 to 3, wherein a stepped portion is provided.
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CN104548282B (en) * 2015-01-12 2018-07-20 江苏磐宇科技有限公司 A kind of assemble method of anti-needle thorn protective device
US11529473B2 (en) 2015-11-03 2022-12-20 Dali Medical Devices Ltd. Safety needles and methods of use thereof
EP3370808A4 (en) * 2015-11-03 2019-05-01 Dali Medical Devices Ltd. Safety needles and methods of use thereof
KR101661580B1 (en) * 2016-04-11 2016-09-30 김정규 Safety assembly combined with syringe and safety syringe comprising the same
US10792438B2 (en) * 2016-12-13 2020-10-06 Becton, Dickinson And Company Safety needle devices
CN110548198B (en) 2018-06-01 2022-07-15 天津华鸿科技股份有限公司 Disposable syringe needle
CN115268562B (en) * 2022-06-22 2024-03-22 贵州电网有限责任公司 Quick adjusting device for protection device

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CA1315166C (en) * 1988-10-05 1993-03-30 John S. Parry Injection devices
DE60112440T2 (en) * 2000-05-31 2006-04-20 Novo Nordisk A/S DISPOSABLE 2-POINT INJECTION NEEDLE
JP4603262B2 (en) * 2001-11-30 2010-12-22 ノボ・ノルデイスク・エー／エス Safe needle structure
EP2298394A4 (en) * 2008-06-20 2017-11-22 Nipro Corporation Needle assembly
CA2733932C (en) * 2008-08-15 2017-04-11 Becton, Dickinson And Company Safety pen needle assembly

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