JP5603915B2 - Infusion needle and missing needle detection system - Google Patents

Infusion needle and missing needle detection system Download PDF

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JP5603915B2
JP5603915B2 JP2012222137A JP2012222137A JP5603915B2 JP 5603915 B2 JP5603915 B2 JP 5603915B2 JP 2012222137 A JP2012222137 A JP 2012222137A JP 2012222137 A JP2012222137 A JP 2012222137A JP 5603915 B2 JP5603915 B2 JP 5603915B2
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needle
infusion
needle tube
tube
pressure
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JP2014073230A (en
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善温 時光
敏昭 千葉
真人 藤原
悟 堀岡
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Nikkiso Co Ltd
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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
    • A61M5/329—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 characterised by features of the needle shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02152—Measuring pressure in heart or blood vessels by means inserted into the body specially adapted for venous pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
    • 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
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • 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
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3297—Needles arranged coaxially
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A61M2039/082—Multi-lumen tubes

Description

本発明は、患者の血管に穿刺して、薬液等を通す輸液針、および針抜け検知システムに関する。   The present invention relates to an infusion needle that punctures a blood vessel of a patient and allows a drug solution or the like to pass through, and a needle drop detection system.

患者の血管内に薬液を注入する方法としては、カテーテルや留置針を血管内に留置して、先端から薬液を注入する方法が用いられている。例えば、がん治療の一種として抗がん剤を用いた化学療法では、カテーテルや留置針を静脈の血管内に留置して、抗がん剤（あるいは抗がん剤を希釈した薬液）を血管内に投与（注入）している。   As a method for injecting a drug solution into a patient's blood vessel, a method in which a catheter or an indwelling needle is placed in the blood vessel and the drug solution is injected from the tip is used. For example, in chemotherapy using an anticancer drug as a type of cancer treatment, a catheter or an indwelling needle is placed in a vein, and the anticancer drug (or a drug solution diluted with the anticancer drug) is placed in the blood vessel. It is administered (injected).

しかしながら、抗がん剤等の薬液には、がん細胞のみならず正常な細胞に損傷を与えるものがある。このような薬液を投与する際に、誤って留置針等が血管外に外れると、血管外の体組織に薬液が漏出し、この状態を放置しておくと、薬液が漏出した部分の細胞に損傷を与える虞があった。そこで、留置針が血管外へ外れたことを検知する種々の方法が提案されている。例えば、留置針の先端からノイズ音を発生させ、留置針を穿刺した皮膚の近傍に貼り付けられた受信部によってノイズ音の有無を検知して、留置針が血管外へ外れたことを判断する構成が提案されている（例えば、特許文献１参照）。また、留置針の先端付近に磁性部を設け、留置針を穿刺した皮膚の近傍に貼り付けられた磁気センサーによって磁性部の磁束密度の変化を検知して、留置針が血管外へ外れたことを判断する構成が提案されている（例えば、特許文献２参照）。   However, some chemical solutions such as anticancer drugs damage not only cancer cells but also normal cells. When such a drug solution is administered, if the indwelling needle or the like is mistakenly removed from the blood vessel, the drug solution leaks into the body tissue outside the blood vessel. There was a risk of damage. Therefore, various methods for detecting that the indwelling needle has moved out of the blood vessel have been proposed. For example, a noise sound is generated from the tip of the indwelling needle, and the presence or absence of the noise sound is detected by a receiving unit attached in the vicinity of the skin punctured with the indwelling needle to determine that the indwelling needle has come out of the blood vessel. A configuration has been proposed (see, for example, Patent Document 1). In addition, a magnetic part was provided near the tip of the indwelling needle, and a change in the magnetic flux density of the magnetic part was detected by a magnetic sensor attached near the skin where the indwelling needle was punctured. The structure which judges this is proposed (for example, refer patent document 2).

特開２０１１−２００４２９号公報JP 2011-200909 A 特開２０１１−２００４３０号公報JP 2011-200430 A

ところで、上記した特許文献１または特許文献２に記載の構成では、留置針のほかノイズ発生器とノイズ受信器、磁気発生器と磁気センサー等が必要になるため、構成が複雑になっていた。また、血管に薬液を注入する際に、留置針を穿刺した後でノイズ受信器等を皮膚に貼り付ける必要があり、作業が複雑になっていた。さらに、受信部等の貼り付け位置がずれると、正確にノイズ音等を受信できず、留置針が血管外へ外れたことを検知できない虞があった。   By the way, in the configuration described in Patent Document 1 or Patent Document 2 described above, since a noise generator and a noise receiver, a magnetic generator and a magnetic sensor, and the like are required in addition to the indwelling needle, the configuration is complicated. In addition, when injecting a drug solution into a blood vessel, it is necessary to stick a noise receiver or the like to the skin after puncturing the indwelling needle, which complicates the work. Furthermore, if the attaching position of the receiving unit or the like is shifted, noise sound or the like cannot be received accurately, and it may not be possible to detect that the indwelling needle has come out of the blood vessel.

本発明は、上記した事情に鑑みてなされたものであり、その目的は、簡単な構成で針先が血管外へ外れたことを確実に検知できる輸液針、および針抜け検知システムを提供しようとするものである。   The present invention has been made in view of the circumstances described above, and an object of the present invention is to provide an infusion needle and a needle omission detection system that can reliably detect that the needle tip has come out of the blood vessel with a simple configuration. To do.

本発明は、上記目的を達成するために提案されたものであり、請求項１に記載のものは、先端部分が開口した管状の針管部を備え、
該針管部は、外針管内に内針管を挿通した二重管構造で構成され、外針管の内周面と内針管の外周面との間には周面側空間を形成し、内針管内には針芯側空間を形成し、
前記周面側空間または針芯側空間のいずれか一方を液が通過可能な針管流路とし、他方を該針管流路とは液密に区画され、前記先端部分の圧力を針管部の基端側へ伝達する空気を内在可能な圧力伝達空間としたことを特徴とする輸液針である。 The present invention has been proposed in order to achieve the above object, and the one according to claim 1 includes a tubular needle tube portion having an open front end portion.
The needle tube portion has a double tube structure in which the inner needle tube is inserted into the outer needle tube, and a circumferential surface side space is formed between the inner peripheral surface of the outer needle tube and the outer peripheral surface of the inner needle tube. The needle core side space is formed in
Either one of the space on the peripheral surface side or the space on the needle core side is used as a needle tube channel through which liquid can pass, and the other is partitioned liquid-tightly from the needle tube channel. An infusion needle characterized by having a pressure transmission space in which air transmitted to the end side can be contained.

請求項２に記載のものは、前記内針管の先端に開放口を設けることで前記針芯側空間の先端部分を開放し、
前記外針管の外周面に開放口を設けることで前記周面側空間の先端部分を開放したことを特徴とする請求項１に記載の輸液針である。 The thing of Claim 2 opens the front-end | tip part of the said needle core side space by providing an open port in the front-end | tip of the said inner needle tube,
2. The infusion needle according to claim 1 , wherein a distal end portion of the circumferential surface side space is opened by providing an opening on an outer circumferential surface of the outer needle tube .

請求項３に記載のものは、請求項１または請求項２に記載の輸液針と、
該輸液針の圧力伝達空間に接続され、前記空気により伝達された前記圧力を検知可能な圧力検知手段と、を備えたことを特徴とする針抜け検知システムである。 What is described in claim 3 is an infusion needle according to claim 1 or claim 2,
A needle omission detection system comprising pressure detection means connected to a pressure transmission space of the infusion needle and capable of detecting the pressure transmitted by the air .

請求項４に記載のものは、前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、
前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に輸液を停止する輸液停止手段と、を備えたことを特徴とする請求項３に記載の針抜け検知システムである。 According to a fourth aspect of the present invention, there is provided an infusion needle position determining means for determining whether or not the distal end portion of the needle tube portion is positioned in a blood vessel based on information on the pressure detected by the pressure detecting means,
The needle according to claim 3, further comprising: an infusion stop unit that stops the infusion when the infusion needle position determining unit determines that the distal end portion of the needle tube part is not located in the blood vessel. It is a missing detection system.

請求項５に記載のものは、前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、
前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に報知する報知手段と、
を備えたことを特徴とする請求項３または請求項４に記載の針抜け検知システムである。 According to a fifth aspect of the present invention, the infusion needle position determination means for determining whether or not the tip portion of the needle tube portion is located in the blood vessel based on the information on the pressure detected by the pressure detection means,
Informing means for informing when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in the blood vessel,
The needle omission detection system according to claim 3 or 4, wherein the needle omission detection system is provided.

請求項６に記載のものは、前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に信号を送信する信号送信手段と、
該信号送信手段から送られてきた信号を受信する信号受信手段と、を備え、
該信号受信手段が受信した信号に基づいて前記報知手段が報知することを特徴とする請求項５に記載の針抜け検知システムである。 According to a sixth aspect of the present invention, there is provided a signal transmitting means for transmitting a signal when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in the blood vessel,
Signal receiving means for receiving a signal sent from the signal transmitting means,
The needle dropout detection system according to claim 5, wherein the notification unit notifies based on a signal received by the signal reception unit.

本発明によれば、以下のような優れた効果を奏する。
請求項１に記載の発明によれば、先端部分が開口した管状の針管部を備え、該針管部は、外針管内に内針管を挿通した二重管構造で構成され、外針管の内周面と内針管の外周面との間には周面側空間を形成し、内針管内には針芯側空間を形成し、前記周面側空間または針芯側空間のいずれか一方を液が通過可能な針管流路とし、他方を該針管流路とは液密に区画され、前記先端部分の圧力を針管部の基端側へ伝達する空気を内在可能な圧力伝達空間としたので、空気が伝達した針管部の先端部分周辺の圧力の変化を検知することで、輸液針が血管から外れたことを確実に検知できる。また、輸液針ユニットの外に別途受信部等の構成を設ける必要がなく、構成を簡単にすることができる。これにより、製造コストの低減を図ることができる。また、前記針管部は、外針管内に内針管を挿通した二重管構造で構成され、外針管の内周面と内針管の外周面との間には周面側空間を形成し、内針管内には針芯側空間を形成し、前記周面側空間または針芯側空間のいずれか一方を前記針管流路とし、他方を前記圧力伝達空間としたので、針管流路と圧力伝達空間とが形成された針管部を簡単な構造で実現することができる。 According to the present invention, the following excellent effects can be obtained.
According to the first aspect of the present invention, a tubular needle tube portion having an open front end portion is provided, and the needle tube portion has a double tube structure in which the inner needle tube is inserted into the outer needle tube, and the inner periphery of the outer needle tube. A peripheral surface side space is formed between the surface and the outer peripheral surface of the inner needle tube, a needle core side space is formed in the inner needle tube, and liquid is placed in either the peripheral surface side space or the needle core side space. Since the needle tube channel that can be passed , the other is liquid-tightly divided from the needle tube channel, and the pressure transmission space that can contain the air that transmits the pressure of the distal end portion to the proximal end side of the needle tube portion, By detecting a change in pressure around the distal end portion of the needle tube portion to which air has been transmitted, it is possible to reliably detect that the infusion needle has detached from the blood vessel. Further, it is not necessary to separately provide a configuration such as a receiving unit outside the infusion needle unit, and the configuration can be simplified. Thereby, the manufacturing cost can be reduced. Further, the needle tube portion has a double tube structure in which the inner needle tube is inserted into the outer needle tube, and a peripheral surface side space is formed between the inner peripheral surface of the outer needle tube and the outer peripheral surface of the inner needle tube. A needle core side space is formed in the needle tube, and either the peripheral surface side space or the needle core side space is used as the needle tube flow channel, and the other is used as the pressure transmission space. It is possible to realize the needle tube portion formed with a simple structure.

請求項２に記載の発明によれば、前記内針管の先端に開放口を設けることで前記針芯側空間の先端部分を開放し、前記外針管の外周面に開放口を設けることで前記周面側空間の先端部分を開放したので、針芯側空間の開放口と周面側空間の開放口とを離間させることができる。これにより、針管部の先端部分の外方の圧力を検知する際に、針管流路から流出する液の圧力の影響を受け難く、針管部の先端部分の外方の圧力を安定して検出し易くなる。 According to the second aspect of the present invention, the distal end portion of the needle core side space is opened by providing an open port at the distal end of the inner needle tube, and the open port is provided on the outer peripheral surface of the outer needle tube. Since the front end portion of the surface side space is opened, the opening of the needle core side space and the opening of the circumferential surface side space can be separated. As a result, when detecting the pressure outside the tip of the needle tube, the pressure outside the tip of the needle tube is stably detected without being affected by the pressure of the liquid flowing out of the needle tube channel. It becomes easy.

請求項３に記載の発明によれば、請求項１または請求項２に記載の輸液針と、該輸液針の圧力伝達空間に接続され、前記空気により伝達された前記圧力を検知可能な圧力検知手段と、を備えて針抜け検知システムを構成したので、輸液針が血管から外れたことを確実に検知できる。 According to the third aspect of the present invention, the infusion needle according to the first or second aspect and the pressure detection that is connected to the pressure transmission space of the infusion needle and can detect the pressure transmitted by the air. And the needle dropout detection system is configured to reliably detect that the infusion needle is detached from the blood vessel.

請求項４に記載の発明によれば、前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に輸液を停止する輸液停止手段と、を備えたので、輸液針が血管から外れた場合には迅速に輸液を停止することができる。   According to the fourth aspect of the present invention, the infusion needle position determining means for determining whether or not the distal end portion of the needle tube portion is positioned in the blood vessel based on the information on the pressure detected by the pressure detecting means. An infusion stop means for stopping the infusion when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in the blood vessel, so that the infusion needle is removed from the blood vessel. Can stop the infusion quickly.

請求項５に記載の発明によれば、前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、前記針管部の先端部分が血管内に位置しないと判定された場合に報知する報知手段と、を備えて針抜け検知システムを構成したので、輸液針が血管から外れたことを一層容易に検知できる。   According to the fifth aspect of the present invention, the infusion needle position determining means for determining whether or not the distal end portion of the needle tube portion is located in the blood vessel based on the information on the pressure detected by the pressure detecting means. And an informing means for informing when it is determined that the distal end portion of the needle tube portion is not located in the blood vessel, so that the needle dropout detecting system is configured, so that it is easier to detect that the infusion needle has detached from the blood vessel. it can.

請求項６に記載の発明によれば、前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に信号を送信する信号送信手段と、該信号送信手段から送られてきた信号を受信する信号受信手段と、を備えて針抜け検知システムを構成し、信号受信手段が受信した信号に基づいて前記報知手段が報知するので、輸液針を穿刺した患者から離れた場所、例えばナースステーション等に報知手段を設置でき、患者から離れた場所にいたとしても輸液針が血管から外れたことを検知できる。   According to the invention described in claim 6, when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in the blood vessel, the signal transmitting means transmits the signal, and the signal transmitting means And a signal receiving means for receiving a signal sent from the device, and constitutes a needle drop detection system, and the notification means notifies on the basis of the signal received by the signal receiving means, so that the patient who has punctured the infusion needle An informing means can be installed at a remote location, such as a nurse station, and it can be detected that the infusion needle has detached from the blood vessel even if the notification means is away from the patient.

輸液針の外観図である。It is an external view of an infusion needle. 輸液針の断面図である。It is sectional drawing of an infusion needle. 輸液針の要部の部分断面図であり、（ａ）は穿刺部の部分断面図、（ｂ）は針基部の部分断面図である。It is a fragmentary sectional view of the principal part of an infusion needle, (a) is a fragmentary sectional view of a puncture part, and (b) is a fragmentary sectional view of a needle base. 輸液針の先端部分が血管内に留置された状態の針抜け検知システムを説明する模式図である。It is a mimetic diagram explaining a needle omission detection system in the state where the tip part of an infusion needle was detained in a blood vessel. 外周面で周面側空間を開放した針管部の説明図である。It is explanatory drawing of the needle tube part which open | released the surrounding surface side space by the outer peripheral surface.

以下、本発明を実施するための形態を図面に基づいて説明する。
輸液針１は、図１および図２に示すように、先端部分が開口した管状の針管部３と、該針管部３よりも太い針基部４とを備えて構成されている。針管部３は、先端に穿刺部３ａが形成された細長い金属管で構成され、内側に薬液や血液などの液が通過可能な針管流路と、該針管流路とは液密に区画されて連通不能な圧力伝達空間とを形成している。具体的に説明すると、外針管５の内部に内針管６を挿通して二重管構造で構成されており、外針管５と内針管６とを同心軸上に配置し、内針管６の基端部を外針管５の基端よりも針基部４の内側へ延ばしている。また、図３に示すように、外針管５の内周面と内針管６の外周面との間には、圧力伝達空間として機能する円筒状の周面側空間８を形成し、内針管６内には針管流路として機能する針芯側空間９を内針管６の全長に亘って形成するとともに当該針芯側空間９の穿刺部３ａ側を開放し、周面側空間８および針芯側空間９を針管部３の軸方向に沿って延在させている。 Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings.
As shown in FIGS. 1 and 2, the infusion needle 1 is configured to include a tubular needle tube portion 3 having an open front end portion and a needle base portion 4 that is thicker than the needle tube portion 3. The needle tube portion 3 is formed of an elongated metal tube having a puncture portion 3a formed at the tip thereof, and a needle tube channel through which a liquid such as a drug solution or blood can pass, and the needle tube channel are liquid-tightly partitioned. And a pressure transmission space incapable of communication. More specifically, the inner needle tube 6 is inserted into the outer needle tube 5 to form a double tube structure, and the outer needle tube 5 and the inner needle tube 6 are arranged on a concentric axis. The end portion extends from the proximal end of the outer needle tube 5 to the inside of the needle base portion 4. As shown in FIG. 3, a cylindrical peripheral surface side space 8 that functions as a pressure transmission space is formed between the inner peripheral surface of the outer needle tube 5 and the outer peripheral surface of the inner needle tube 6. A needle core side space 9 functioning as a needle tube flow path is formed in the inside over the entire length of the inner needle tube 6, and the puncture portion 3a side of the needle core side space 9 is opened, and the peripheral surface side space 8 and the needle core side are opened. The space 9 extends along the axial direction of the needle tube portion 3.

さらに、図３（ｂ）に示すように、外針管５の基端部側の外周面には連通開口５ａを開設し、針基部４内に形成される空間の一部と周面側空間８とを連通開口５ａを介して連通するように構成されている。そして、周面側空間８の穿刺部３ａ側（図３（ａ）中、左側）を開放し、周面側空間８内には圧力伝達媒体（本実施形態では空気）１０を内在させ、穿刺部３ａの外方の圧力が圧力伝達媒体１１を介して針管部３の基端側（針基部４側）へ伝達され得るように構成されている。なお、針管部３の先端部分を血管内に挿入した状態で、血液が周面側空間８内に穿刺部３ａ側から流入する虞がある場合には、周面側空間８の穿刺部３ａ側の開放部を可撓性のあるフィルター（図示せず）で覆う等して、血液の周面側空間８内への流入を阻止して血液が図４に示す後述の圧力計１２（本発明における圧力検知手段に相当）に到達しないようにするとともに、穿刺部３ａの外方の圧力が圧力伝達媒体１１に伝達されるように構成することが好ましい。   Further, as shown in FIG. 3 (b), a communication opening 5 a is formed in the outer peripheral surface on the proximal end side of the outer needle tube 5, and a part of the space formed in the needle base 4 and the peripheral surface side space 8 are formed. Are communicated with each other through the communication opening 5a. Then, the puncture portion 3a side (left side in FIG. 3A) of the circumferential surface side space 8 is opened, and a pressure transmission medium (air in this embodiment) 10 is contained in the circumferential surface side space 8 to puncture. The pressure outside the portion 3 a can be transmitted to the proximal end side (the needle base portion 4 side) of the needle tube portion 3 through the pressure transmission medium 11. If there is a risk that blood may flow into the peripheral surface side space 8 from the puncture portion 3a side with the distal end portion of the needle tube portion 3 inserted into the blood vessel, the peripheral surface side space 8 in the puncture portion 3a side 4 is covered with a flexible filter (not shown) to prevent blood from flowing into the peripheral surface side space 8, and the blood is shown in FIG. It is preferable that the pressure transmission medium 11 is configured to transmit the pressure outside the puncture portion 3a.

針基部４は、針管部３と同軸上に位置する基部本体１３と、該基部本体１３から分岐した分岐部１４とを一体成型して構成された略ｙ字状のプラスチック製部材であり、針管部３の基端側に接続されている。そして、針基部４内には、針芯側空間（針管流路）９を後述のチューブ１６（図１および図４参照）へ連通させるチューブ接続空間１７と、周面側空間（圧力伝達空間）８を後述の制御部１８（本発明における圧力検知手段、輸液針位置判定手段に相当）へ連通（接続）させる伝達側連通空間１９とを形成している。   The needle base 4 is a substantially y-shaped plastic member formed by integrally molding a base main body 13 coaxially with the needle tube 3 and a branching portion 14 branched from the base main body 13. It is connected to the base end side of the part 3. In the needle base portion 4, a tube connection space 17 for communicating a needle core side space (needle tube flow path) 9 with a tube 16 (see FIGS. 1 and 4) described later, and a circumferential surface side space (pressure transmission space). 8 is formed with a transmission side communication space 19 that communicates (connects) 8 to a control unit 18 (corresponding to pressure detecting means and infusion needle position determining means in the present invention) described later.

基部本体１３は、針管部３と同軸上に位置する円筒状を呈しており、針管部３側に位置する先端部１３ａを、当該基部本体１３の基端部１３ｂ（図２中、右側部）よりも縮径している。また、先端部１３ａ内の中心軸上には外針管５の基端部を液密状態で挿入し、針管部３の基端部を針管部３内の挿入空間に形成された段差部に突き当てて、周面側空間８のうち針管部３内に位置する端部を閉塞している。さらに、基部本体１３の基端部１３ｂの中心軸上には、内針管６のうち外針管５から突出した基端部を液密状態で挿入している。そして、基部本体１３の基端部１３ｂのうち内針管６の挿入端を挟んで針管部３とは反対側（図３（ｂ）中、基端部１３ｂの右側）には、円筒状のチューブ接続空間１７を形成し、該チューブ接続空間１７を輸液針１の基端の外方（図３（ｂ）中、右側方）に向けて開放するとともに、針芯側空間９のうち針基部４内に位置する基端側へ連通させている。なお、チューブ接続空間１７は、開放口側に向けて次第に拡径したテーパとなっており、輸液針１に接続されるチューブ１６の先端に設けられたルアー（図示せず）を嵌めて接続するルアーテーパ構造を構成している。また、基部本体１３の外周のうちチューブ接続空間１７の開放口側に位置する箇所には、チューブ１６の端部に装着されるロックリング１６ａが螺合可能なおねじ部２０を形成している。そして、チューブ１６の端部をチューブ接続空間１７に嵌め込んでロックリング１６ａをおねじ部２０へ螺合すると、チューブ１６と基部本体１３とが液密状態で密着して、チューブ１６の内部空間と針芯側空間９とが連通するように構成されている。   The base body 13 has a cylindrical shape that is positioned coaxially with the needle tube portion 3, and a distal end portion 13 a that is positioned on the needle tube portion 3 side is connected to a base end portion 13 b of the base body 13 (right side portion in FIG. 2). The diameter is smaller than that. Further, the proximal end portion of the outer needle tube 5 is inserted in a liquid-tight state on the central axis in the distal end portion 13 a, and the proximal end portion of the needle tube portion 3 is pushed into a step portion formed in the insertion space in the needle tube portion 3. The end part located in the needle tube part 3 in the peripheral surface side space 8 is closed. Furthermore, a base end portion protruding from the outer needle tube 5 of the inner needle tube 6 is inserted in a liquid-tight state on the central axis of the base end portion 13 b of the base body 13. A cylindrical tube is disposed on the side opposite to the needle tube portion 3 (on the right side of the base end portion 13b in FIG. 3B) across the insertion end of the inner needle tube 6 in the base end portion 13b of the base body 13. A connection space 17 is formed, the tube connection space 17 is opened toward the outside of the proximal end of the infusion needle 1 (on the right side in FIG. 3B), and the needle base portion 4 in the needle core side space 9 is opened. It communicates with the proximal side located inside. The tube connection space 17 has a taper that gradually increases in diameter toward the opening, and a luer (not shown) provided at the tip of the tube 16 connected to the infusion needle 1 is fitted and connected. A luer taper structure is formed. In addition, a male screw portion 20 to which a lock ring 16 a attached to the end portion of the tube 16 can be screwed is formed at a position located on the open port side of the tube connection space 17 in the outer periphery of the base main body 13. Then, when the end portion of the tube 16 is fitted into the tube connection space 17 and the lock ring 16a is screwed into the male screw portion 20, the tube 16 and the base body 13 are in close contact with each other in a liquid-tight state, and the internal space of the tube 16 is reached. And the needle core side space 9 are configured to communicate with each other.

分岐部１４は、基部本体１３の先端部１３ａの側面から分岐して基部本体１３の基端部１３ｂの側方へ向かって突出した円筒形状を呈しており、当該分岐部１４の内部には伝達側連通空間１９を分岐部１４の軸方向に沿って形成している。また、該伝達側連通空間１９のうち分岐部１４の突出端側に位置する部分を外方へ開放し、基部本体１３側の端部開口を外針管５の連通開口５ａに接続し、伝達側連通空間１９と周面側空間８とを連通開口５ａを介して連通している。さらに、伝達側連通空間１９の内部には圧力伝達媒体（本実施形態では空気）２２を内在させ、周面側空間８内の圧力伝達媒体１１から伝達される圧力を、伝達側連通空間１９内の圧力伝達媒体２２を通じて分岐部１４の外方へ伝達できるように構成されている。   The branch portion 14 has a cylindrical shape that branches from the side surface of the distal end portion 13 a of the base body 13 and protrudes toward the side of the base end portion 13 b of the base body 13, and is transmitted to the inside of the branch portion 14. The side communication space 19 is formed along the axial direction of the branch portion 14. Further, a portion of the transmission side communication space 19 located on the protruding end side of the branching portion 14 is opened outward, and an end opening on the base body 13 side is connected to the communication opening 5a of the outer needle tube 5, and the transmission side The communication space 19 and the circumferential surface side space 8 communicate with each other through the communication opening 5a. Further, a pressure transmission medium (air in the present embodiment) 22 is provided inside the transmission side communication space 19, and the pressure transmitted from the pressure transmission medium 11 in the circumferential surface side space 8 is transmitted in the transmission side communication space 19. The pressure transmission medium 22 can be transmitted to the outside of the branch portion 14.

次に、針抜け検知システムについて、前述の輸液針１を用いて薬液を血液内に注入する場合を例に説明する。本実施形態の針抜け検知システム２５は、図４に示すように、上記した輸液針１、チューブ１６、薬液バッグ２６、クランプ２７（本発明における輸液停止手段に相当）、圧力計１２、制御部１８、圧力伝達チューブ２８、圧力モニター２９、および報知ランプ３０（本発明における報知手段に相当）を備え、穿刺部３ａの外方の圧力が周面側空間８内および伝達側連通空間１９内の圧力伝達媒体１１，２２により伝達されて制御部１８に伝達されることを特徴としている。薬液バッグ２６は、抗がん剤等の薬液が貯留される容器である。チューブ１６は、可撓性を有し、一端が輸液針１の分岐部１４に接続されると共に、他端が薬液バッグ２６に接続されている。これにより、薬液バッグ２６内の薬液を、チューブ１６および針芯側空間９を介して血管３２内に導入することができる。また、チューブ１６の途中には点滴筒３１が設けられており、薬液の流れを目視で確認することができる。さらに、点滴筒３１の下流側には、クランプ２７が設けられている。クランプ２７は、手動あるいは制御部１８からの信号により、チューブ１６を圧迫して薬液の流量を調節したり、薬液の流れを停止させたりすることができる。   Next, the needle drop detection system will be described by taking as an example a case where a liquid medicine is injected into the blood using the above-described infusion needle 1. As shown in FIG. 4, the needle drop detection system 25 of the present embodiment includes the above-described infusion needle 1, tube 16, chemical solution bag 26, clamp 27 (corresponding to the infusion stop means in the present invention), pressure gauge 12, and control unit. 18, a pressure transmission tube 28, a pressure monitor 29, and a notification lamp 30 (corresponding to notification means in the present invention), and the pressure outside the puncture portion 3 a is within the circumferential surface side space 8 and the transmission side communication space 19 It is transmitted by the pressure transmission media 11 and 22 and transmitted to the control unit 18. The drug solution bag 26 is a container for storing a drug solution such as an anticancer drug. The tube 16 has flexibility, one end is connected to the branch portion 14 of the infusion needle 1 and the other end is connected to the drug solution bag 26. Thereby, the chemical solution in the chemical solution bag 26 can be introduced into the blood vessel 32 through the tube 16 and the needle core side space 9. In addition, a drip tube 31 is provided in the middle of the tube 16 so that the flow of the chemical solution can be visually confirmed. Further, a clamp 27 is provided on the downstream side of the drip tube 31. The clamp 27 can adjust the flow rate of the chemical solution by pressing the tube 16 manually or by a signal from the control unit 18 or can stop the flow of the chemical solution.

圧力計１２は、圧力伝達媒体（本実施形態では空気）３３が内在する圧力伝達チューブ２８を用いて輸液針１の分岐部１９を接続し、圧力伝達媒体１１，２２，３３により穿刺部３ａの外方から伝達してきた圧力を測定するものである。また、制御部１８は、圧力計１２で測定された測定された圧力値を取得できる機能を備え、クランプ２７、圧力モニター２９、および報知ランプ３０の駆動を制御する制御手段としても機能する。さらに、制御部１８は、当該制御部１８が測定した圧力の情報に基づいて、穿刺部３ａが血管３２内に位置するか否かを判定し、穿刺部３ａが血管３２内に位置していない場合に発信機３５（本発明における信号送信手段に相当）へ駆動信号を送信するように構成されている。この駆動信号は、発信機３５によって発信（送信）され、輸液針１から離れた場所、例えばナースステーション等に設置された受信機３６（本発明における信号受信手段に相当）によって受信される。そして、受信機３６と同じ場所に設置された報知ランプ３０は、この駆動信号に応じて、点灯して警報する。なお、駆動信号は、発信機３５と受信機３６をケーブル等で接続して電気信号等を送受信するようにしてもよいし、発信機３５と受信機３６をケーブル等で接続せずに、電波を送受信するようにしてもよい（すなわち、駆動信号の送受信は有線でも無線でもよい）。さらに、制御部１８は、穿刺部３ａが血管３２内に位置していない場合にクランプ２７を制御して、薬液が輸液針１側へ流れないようにチューブ１６の流れを停止させる。圧力モニター２９は、制御部１８からの信号を受信し、制御部１８によって測定された圧力の情報を一定の時間間隔（例えば、０．１秒間隔）で表示する。   The pressure gauge 12 connects the branch portion 19 of the infusion needle 1 using a pressure transmission tube 28 containing a pressure transmission medium (air in this embodiment) 33, and the pressure transmission medium 11, 22, 33 connects the puncture portion 3 a. The pressure transmitted from the outside is measured. Further, the control unit 18 has a function of acquiring the measured pressure value measured by the pressure gauge 12 and also functions as a control unit that controls driving of the clamp 27, the pressure monitor 29, and the notification lamp 30. Further, the control unit 18 determines whether or not the puncture unit 3a is located in the blood vessel 32 based on the pressure information measured by the control unit 18, and the puncture unit 3a is not located in the blood vessel 32. In this case, the driving signal is transmitted to the transmitter 35 (corresponding to the signal transmitting means in the present invention). This drive signal is transmitted (transmitted) by the transmitter 35 and is received by a receiver 36 (corresponding to the signal receiving means in the present invention) installed in a place away from the infusion needle 1, for example, a nurse station. And the notification lamp 30 installed in the same place as the receiver 36 lights up and warns according to this drive signal. The driving signal may be transmitted and received by connecting the transmitter 35 and the receiver 36 with a cable or the like, or the transmitter 35 and the receiver 36 may not be connected with a cable or the like. May be transmitted / received (that is, transmission / reception of the drive signal may be wired or wireless). Furthermore, the control part 18 controls the clamp 27, when the puncture part 3a is not located in the blood vessel 32, and stops the flow of the tube 16 so that a chemical | medical solution may not flow to the infusion needle 1 side. The pressure monitor 29 receives a signal from the control unit 18 and displays information on the pressure measured by the control unit 18 at a constant time interval (for example, every 0.1 second).

次に、上記した針抜け検知システム２５による薬液の注入、および輸液針１の針先位置の検知（特に、針抜け検知）について説明する。まず、輸液針１を患者の血管３２内に穿刺する。なお、他端が薬液バッグ２６に接続されたチューブ１６の一端を基部本体１３に予め接続すると共に、チューブ１６内および針芯側空間９内の空気を排除しておく。そして、血管３２内への薬液の注入を開始すると共に、輸液針１を通じて伝達される圧力の測定を開始する。   Next, the injection of the chemical solution and the detection of the needle tip position of the infusion needle 1 (particularly, the needle drop detection) will be described by the needle drop detection system 25 described above. First, the infusion needle 1 is punctured into the blood vessel 32 of the patient. One end of the tube 16 whose other end is connected to the chemical solution bag 26 is connected in advance to the base body 13 and air in the tube 16 and the needle core side space 9 is excluded. Then, the injection of the chemical solution into the blood vessel 32 is started, and the measurement of the pressure transmitted through the infusion needle 1 is started.

ここで、穿刺部３ａが血管３２内に留置されている場合には、血管３２内の圧力が制御部１８で測定される。しかしながら、穿刺部３ａが血管３２外に外れ、血管３２以外の体組織（例えば、皮下組織）３８内に位置している場合には、血管３２内の圧力とは異なる体組織３８内の圧力が検出され、穿刺部３ａが体外に完全に外れてしまった場合には、大気圧が検出される。このように、穿刺部３ａの位置に応じて、制御部１８で検出される圧力が異なる（変化する）ため、穿刺部３ａが血管３２内に位置し、薬液が正常に注入されているか否かを判断することができる。すなわち、輸液針１を通じて伝達される圧力を監視し、この圧力の変化により輸液針１の針抜けを検知することができる。   Here, when the puncture unit 3 a is placed in the blood vessel 32, the pressure in the blood vessel 32 is measured by the control unit 18. However, when the puncture portion 3 a is detached from the blood vessel 32 and is located in a body tissue (for example, subcutaneous tissue) 38 other than the blood vessel 32, the pressure in the body tissue 38 is different from the pressure in the blood vessel 32. When it is detected and the puncture part 3a has completely detached from the body, atmospheric pressure is detected. Thus, since the pressure detected by the control unit 18 varies (changes) depending on the position of the puncture unit 3a, it is determined whether the puncture unit 3a is located in the blood vessel 32 and the drug solution is normally injected. Can be judged. That is, the pressure transmitted through the infusion needle 1 can be monitored, and the needle dropout of the infusion needle 1 can be detected by this change in pressure.

そして、輸液針１（穿刺部３ａ）を血管３２内に留置し、薬液を注入している状態で、制御部１８により測定される圧力が血液内の圧力から変化したならば、穿刺部３ａが血管３２内に位置していないと制御部１８が判定し、例えばナースステーション等に設置された報知ランプ３０を駆動して周囲に報知する。同時に、クランプ２７を制御して、薬液が輸液針１側へ流れないようにチューブ１６の流れを停止させる。また、制御部１８により検出された圧力は、圧力モニター２９に表示されているため、この圧力モニター２９の表示を確認することで、穿刺部３ａの外方の圧力が変化したことを容易に認識することができる。これにより、穿刺部３ａが血管３２内に位置していないと容易に判定することができる。なお、本発明は、圧力の絶対値により針抜けを判定する場合に限らず、脈動のパターンの変化により針抜けを判定してもよい。   If the pressure measured by the control unit 18 changes from the pressure in the blood while the infusion needle 1 (puncture unit 3a) is placed in the blood vessel 32 and the medicinal solution is injected, the puncture unit 3a The control part 18 determines that it is not located in the blood vessel 32, for example, drives the notification lamp 30 installed in a nurse station or the like to notify the surroundings. At the same time, the clamp 27 is controlled to stop the flow of the tube 16 so that the drug solution does not flow to the infusion needle 1 side. Further, since the pressure detected by the control unit 18 is displayed on the pressure monitor 29, it is easy to recognize that the pressure outside the puncture unit 3a has changed by checking the display on the pressure monitor 29. can do. Thereby, it can be easily determined that the puncture unit 3 a is not located in the blood vessel 32. Note that the present invention is not limited to the case where the needle omission is determined based on the absolute value of the pressure, and the needle occlusion may be determined based on a change in the pulsation pattern.

このように、輸液針１は、穿刺部３ａの外方の圧力を圧力伝達媒体（空気）１１，２２，３３により制御部１８へ伝達可能としたので、圧力伝達媒体１１，２２，３３が伝達した穿刺部３ａ周辺の圧力の変化を検知することで、輸液針１が血管３２から外れたことを確実に検知できる。また、輸液針１の外に別途受信部等の構成を設ける必要がなく、構成を簡単にすることができる。これにより、製造コストの低減を図ることができる。さらに、針管部３は、外針管５内に内針管６を挿通した二重管構造で構成され、外針管５の内周面と内針管６の外周面との間には、圧力伝達空間として機能する周面側空間８を形成し、内針管６内には針管流路として機能する針芯側空間９を形成したので、針管流路と圧力伝達空間とが形成された針管部３を簡単な構造で実現することができる。   Thus, since the infusion needle 1 can transmit the pressure outside the puncture unit 3a to the control unit 18 by the pressure transmission media (air) 11, 22, 33, the pressure transmission media 11, 22, 33 transmit the pressure. By detecting the change in pressure around the puncture portion 3a, it is possible to reliably detect that the infusion needle 1 has been detached from the blood vessel 32. Further, it is not necessary to separately provide a configuration such as a receiving unit outside the infusion needle 1, and the configuration can be simplified. Thereby, the manufacturing cost can be reduced. Further, the needle tube portion 3 is configured by a double tube structure in which the inner needle tube 6 is inserted into the outer needle tube 5, and a pressure transmission space is provided between the inner peripheral surface of the outer needle tube 5 and the outer peripheral surface of the inner needle tube 6. Since the function peripheral surface side space 8 is formed, and the needle core side space 9 functioning as a needle tube flow path is formed in the inner needle tube 6, the needle tube portion 3 in which the needle tube flow path and the pressure transmission space are formed can be easily formed. It can be realized with a simple structure.

また、針抜け検知システム２５は、針管部３の先端部分の外方から圧力伝達媒体１１，２２，３３により伝達された圧力の情報を表示する圧力モニター２９を備えたので、針管部３の先端部分の外方における圧力の変化を容易に認識することができる。これにより、輸液針１が血管３２から外れたことを容易に検知できる。さらに、輸液針１から伝達された圧力の情報に基づいて、穿刺部３ａが血管３２内に位置するか否かを判定する制御部１８と、穿刺部３ａが血管３２内に位置していない場合に報知する報知ランプ３０と、を備えたので、輸液針１が血管３２から外れたことを一層容易に検知できる。加えて、制御部１８が血管３２内に位置していないと判定した場合に信号を送信する発信機３５と、発信機３５から送られてきた信号を受信する受信機３６と、を備え、受信機３６が受信した信号に基づいて報知ランプ３０が報知するので、輸液針１を穿刺した患者から離れた場所、例えばナースステーション等に報知ランプ３０を設置でき、患者から離れた場所にいたとしても輸液針１が血管３２から外れたことを検知できる。さらに、穿刺部３ａが血管３２内に位置していないと制御部１８が判定すると、クランプ２７が制御部１８により制御されて輸液を停止するので、輸液針１が血管から外れた場合には迅速に輸液を停止することができる。   Further, the needle dropout detection system 25 includes the pressure monitor 29 that displays information on the pressure transmitted from the outside of the distal end portion of the needle tube portion 3 by the pressure transmission mediums 11, 22, 33. A change in pressure outside the part can be easily recognized. Thereby, it can be easily detected that the infusion needle 1 is detached from the blood vessel 32. Furthermore, based on the pressure information transmitted from the infusion needle 1, the control unit 18 that determines whether or not the puncture unit 3 a is located in the blood vessel 32, and the puncture unit 3 a is not located in the blood vessel 32 Since the notification lamp 30 for notifying the user is provided, it is possible to more easily detect that the infusion needle 1 is detached from the blood vessel 32. In addition, the control unit 18 includes a transmitter 35 that transmits a signal when it is determined that the control unit 18 is not located in the blood vessel 32, and a receiver 36 that receives a signal transmitted from the transmitter 35. Since the notification lamp 30 notifies on the basis of the signal received by the machine 36, even if the notification lamp 30 can be installed in a place away from the patient who has punctured the infusion needle 1, for example, a nurse station, etc. It can be detected that the infusion needle 1 is detached from the blood vessel 32. Furthermore, when the control unit 18 determines that the puncture unit 3a is not located in the blood vessel 32, the clamp 27 is controlled by the control unit 18 to stop the infusion. Infusion can be stopped.

ところで、上記実施形態では、クランプ２７を用いてチューブ１６の流れを制御したが、これには限られない。例えば、輸液ポンプ等を用いて、薬液バッグ２６から輸液針１側に薬液を送るようにしてもよい。この場合において、穿刺部３ａが血管３２内に位置していない場合には、制御部１８が輸液ポンプ等を制御（停止）して、チューブ１６内の薬液の流れを停止させる。また、上記実施形態では、薬液バッグ２６からの薬液を血管に注入する例を示したが、これには限られない。例えば、輸血バッグからの血液を血管に注入する際にも、本発明の輸液針を用いることができる。   By the way, in the said embodiment, although the flow of the tube 16 was controlled using the clamp 27, it is not restricted to this. For example, you may make it send a chemical | medical solution from the chemical | medical solution bag 26 to the infusion needle 1 side using an infusion pump. In this case, when the puncture unit 3 a is not located in the blood vessel 32, the control unit 18 controls (stops) the infusion pump or the like to stop the flow of the drug solution in the tube 16. Moreover, although the example which inject | pours the chemical | medical solution from the chemical | medical solution bag 26 to the blood vessel was shown in the said embodiment, it is not restricted to this. For example, the infusion needle of the present invention can also be used when injecting blood from a transfusion bag into a blood vessel.

また、上記実施形態の輸液針１では、針管部３を細長い金属管で構成したが、これには限られない。例えば、穿刺部が形成されておらず、針管部が可撓性を有する樹脂等で構成されたカテーテルまたは留置針を、本発明の輸液針として使用することもできる。さらに、上記実施形態では、周面側空間８を圧力伝達空間とし、針芯側空間９を針管流路としたが、これには限定されず、周面側空間を針管流路とし、針芯側空間を圧力伝達空間としてもよい。また、外針管５内と内針管６とを同心軸上に配置する場合を説明したが、本発明はこれに限定されるものではなく、例えば、内針管６を外針管５の内周面に当接するように配置してもよいし、内周面に一体成形してもよい。そして、外針管５内に内針管６を挿通した二重管構造で針管部３を構成したが、本発明はこれに限定されない。要は、内部に針管流路と圧力伝達空間とが形成されれば、針管部の構造は問わない。例えば、単一の管部材の内側に仕切壁が軸方向に沿って配置されて管部材の内部を二分し、一方の空間を針管流路とし、他方の空間を圧力伝達空間としてもよい。   Moreover, in the infusion needle 1 of the said embodiment, although the needle tube part 3 was comprised with the elongate metal tube, it is not restricted to this. For example, a catheter or an indwelling needle in which a puncture portion is not formed and a needle tube portion is made of a flexible resin or the like can be used as the infusion needle of the present invention. Furthermore, in the said embodiment, although the surrounding surface side space 8 was made into the pressure transmission space and the needle core side space 9 was made into the needle tube flow path, it is not limited to this, The surrounding surface side space is made into the needle tube flow path, and a needle core The side space may be a pressure transmission space. Moreover, although the case where the inside of the outer needle tube 5 and the inner needle tube 6 are disposed on the concentric axis has been described, the present invention is not limited to this. For example, the inner needle tube 6 is disposed on the inner peripheral surface of the outer needle tube 5. You may arrange | position so that it may contact | abut and may integrally mold to an internal peripheral surface. And although the needle tube part 3 was comprised by the double tube structure which penetrated the inner needle tube 6 in the outer needle tube 5, this invention is not limited to this. In short, the structure of the needle tube portion is not limited as long as the needle tube flow path and the pressure transmission space are formed inside. For example, a partition wall may be arranged along the axial direction inside a single tube member, and the inside of the tube member may be divided into two, one space may be used as a needle tube flow path, and the other space may be used as a pressure transmission space.

また、上記実施形態では、針管部３の先端で圧力伝達空間（周面側空間８）を開放したが、本発明はこれに限定されない。要は、針管部３の先端部分の外方の圧力を圧力伝達空間内の圧力伝達媒体に伝えることができれば、圧力伝達空間の開放箇所はどこでもよい。例えば、図５に示すように、針管部３′の外周面で圧力伝達空間（周面側空間８′）を開放してもよい。このようにすれば、針管流路（針芯側空間９′）の開放口４０と圧力伝達空間（周面側空間８′）の開放口４１とを離間させることができる。これにより、針管部３′の先端部分の外方の圧力を検知する際に、針管流路から流出する液の圧力の影響を受け難く、針管部３′の先端部分の外方の圧力を安定して検出し易い。   Moreover, in the said embodiment, although the pressure transmission space (circumferential surface side space 8) was open | released at the front-end | tip of the needle tube part 3, this invention is not limited to this. In short, as long as the pressure outside the tip portion of the needle tube portion 3 can be transmitted to the pressure transmission medium in the pressure transmission space, the pressure transmission space may be opened anywhere. For example, as shown in FIG. 5, the pressure transmission space (circumferential surface side space 8 ′) may be opened on the outer peripheral surface of the needle tube portion 3 ′. In this way, the opening 40 of the needle tube channel (needle core side space 9 ') and the opening 41 of the pressure transmission space (circumferential surface side space 8') can be separated. As a result, when detecting the pressure outside the tip portion of the needle tube portion 3 ′, the pressure outside the tip portion of the needle tube portion 3 ′ is stabilized without being affected by the pressure of the liquid flowing out from the needle tube flow path. And easy to detect.

ところで、上記実施形態では、圧力伝達媒体として空気を採用したが、本発明はこれに限定されない。要は、針管部の先端部分の外方の圧力を伝達可能な材料であれば、どのようなものでもよく、輸液を受ける患者に悪影響を及ぼさなければ、空気以外の気体や液体を圧力伝達媒体として採用してもよい。また、上記各実施形態では、報知手段として報知ランプを用いたが、本発明はこれに限定されない。例えば、警報音を鳴らす警報機等を用いてもよい。さらに、上記各実施形態では、針抜け検知システム２５に圧力モニター２９と報知ランプ３０との両方を備えたが、少なくともいずれか一方を備えた構成であってもよい。また、本発明における輸液針を患者にテープで固定し易くするために、輸液針の側部から平板状の突出片（所謂「羽根」）を突設してもよい。   By the way, in the said embodiment, although air was employ | adopted as a pressure transmission medium, this invention is not limited to this. In short, any material can be used as long as it can transmit the pressure outside the tip of the needle tube, and any gas or liquid other than air can be used as a pressure transmission medium as long as it does not adversely affect the patient receiving the infusion. May be adopted. Moreover, in each said embodiment, although the alerting | reporting lamp was used as an alerting | reporting means, this invention is not limited to this. For example, an alarm device that sounds an alarm sound may be used. Further, in each of the above embodiments, the needle drop detection system 25 includes both the pressure monitor 29 and the notification lamp 30, but a configuration including at least one of them may be employed. Moreover, in order to make it easy to fix the infusion needle in the present invention to the patient with a tape, a flat protrusion (a so-called “blade”) may be projected from the side of the infusion needle.

そして、前記した実施の形態は全ての点で例示であって制限的なものではないと考えられるべきである。本発明は、上記した説明に限らず特許請求の範囲によって示され、特許請求の範囲と均等の意味及び範囲内での全ての変更が含まれるものである。   The above-described embodiment should be considered as illustrative in all points and not restrictive. The present invention is not limited to the above description, but is defined by the scope of the claims, and includes all modifications within the scope and meaning equivalent to the scope of the claims.

１ 輸液針
３，３′ 針管部
３ａ 穿刺部
４ 針基部
５ 外針管
５ａ 連通開口
６ 内針管
８，８′ 周面側空間
９，９′ 針芯側空間
１１ 周面側空間内の圧力伝達媒体
１２ 圧力計
１３ 基部本体
１３ａ 先端部
１３ｂ 基端部
１４ 分岐部
１６ チューブ
１６ａ ロックリング
１７ チューブ接続空間
１８ 制御部
１９ 伝達側連通空間
２０ おねじ部
２２ 伝達側連通空間内の圧力伝達媒体
２５ 針抜け検知システム
２６ 薬液バッグ
２７ クランプ
２８ 圧力伝達チューブ
２９ 圧力モニター
３０ 報知ランプ
３１ 点滴筒
３２ 血管
３３ 圧力伝達チューブ内の圧力伝達媒体
３５ 発信機
３６ 受信機
３８ 体組織
４０ 針芯側空間の開放口
４１ 周面側空間の開放口 DESCRIPTION OF SYMBOLS 1 Infusion needle 3, 3 'Needle pipe part 3a Puncture part 4 Needle base part 5 Outer needle pipe 5a Communication opening 6 Inner needle pipe 8, 8' Peripheral surface side space 9, 9 'Needle core side space 11 Pressure transmission medium in peripheral surface side space 12 Pressure gauge 13 Base body 13a Tip portion 13b Base end portion 14 Branch portion 16 Tube 16a Lock ring 17 Tube connection space 18 Control portion 19 Transmission side communication space 20 Male thread portion 22 Pressure transmission medium 25 in the transmission side communication space Needle removal Detection system 26 Chemical solution bag 27 Clamp 28 Pressure transmission tube 29 Pressure monitor 30 Notification lamp 31 Drip tube 32 Blood vessel 33 Pressure transmission medium 35 in the pressure transmission tube Transmitter 36 Receiver 38 Body tissue 40 Opening opening 41 in the needle core side space Opening space on the surface side

Claims (6)

先端部分が開口した管状の針管部を備え、
該針管部は、外針管内に内針管を挿通した二重管構造で構成され、外針管の内周面と内針管の外周面との間には周面側空間を形成し、内針管内には針芯側空間を形成し、
前記周面側空間または針芯側空間のいずれか一方を液が通過可能な針管流路とし、他方を該針管流路とは液密に区画され、前記先端部分の圧力を針管部の基端側へ伝達する空気を内在可能な圧力伝達空間としたことを特徴とする輸液針。 Provided with a tubular needle tube with an open tip,
The needle tube portion has a double tube structure in which the inner needle tube is inserted into the outer needle tube, and a circumferential surface side space is formed between the inner peripheral surface of the outer needle tube and the outer peripheral surface of the inner needle tube. The needle core side space is formed in
Either one of the space on the peripheral surface side or the space on the needle core side is used as a needle tube channel through which liquid can pass, and the other is partitioned liquid-tightly from the needle tube channel. An infusion needle characterized by having a pressure transmission space in which air transmitted to the end side can be contained. 前記内針管の先端に開放口を設けることで前記針芯側空間の先端部分を開放し、
前記外針管の外周面に開放口を設けることで前記周面側空間の先端部分を開放したことを特徴とする請求項１に記載の輸液針。 Opening the tip portion of the needle core side space by providing an opening at the tip of the inner needle tube,
2. The infusion needle according to claim 1 , wherein a distal end portion of the circumferential surface side space is opened by providing an opening in the outer circumferential surface of the outer needle tube . 請求項１または請求項２に記載の輸液針と、
該輸液針の圧力伝達空間に接続され、前記空気により伝達された前記圧力を検知可能な圧力検知手段と、を備えたことを特徴とする針抜け検知システム。 An infusion needle according to claim 1 or claim 2;
A needle omission detection system comprising: pressure detection means connected to a pressure transmission space of the infusion needle and capable of detecting the pressure transmitted by the air . 前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、
前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に輸液を停止する輸液停止手段と、を備えたことを特徴とする請求項３に記載の針抜け検知システム。 An infusion needle position determining means for determining whether or not a tip portion of the needle tube portion is located in a blood vessel based on information on the pressure detected by the pressure detecting means;
The needle according to claim 3, further comprising: an infusion stop unit that stops the infusion when the infusion needle position determining unit determines that the distal end portion of the needle tube part is not located in the blood vessel. Missing detection system. 前記圧力検知手段により検知された圧力の情報に基づいて、前記針管部の先端部分が血管内に位置するか否かを判定する輸液針位置判定手段と、
前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に報知する報知手段と、
を備えたことを特徴とする請求項３または請求項４に記載の針抜け検知システム。 An infusion needle position determining means for determining whether or not a tip portion of the needle tube portion is located in a blood vessel based on information on the pressure detected by the pressure detecting means;
Informing means for informing when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in the blood vessel,
The needle omission detection system according to claim 3 or 4, further comprising: 前記針管部の先端部分が血管内に位置していないと前記輸液針位置判定手段が判定した場合に信号を送信する信号送信手段と、
該信号送信手段から送られてきた信号を受信する信号受信手段と、を備え、
該信号受信手段が受信した信号に基づいて前記報知手段が報知することを特徴とする請求項５に記載の針抜け検知システム。 A signal transmitting means for transmitting a signal when the infusion needle position determining means determines that the distal end portion of the needle tube portion is not located in a blood vessel;
Signal receiving means for receiving a signal sent from the signal transmitting means,
6. The needle dropout detection system according to claim 5, wherein the notifying means notifies based on a signal received by the signal receiving means.
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