JP7312346B2 - lancing device - Google Patents

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JP7312346B2
JP7312346B2 JP2021185318A JP2021185318A JP7312346B2 JP 7312346 B2 JP7312346 B2 JP 7312346B2 JP 2021185318 A JP2021185318 A JP 2021185318A JP 2021185318 A JP2021185318 A JP 2021185318A JP 7312346 B2 JP7312346 B2 JP 7312346B2
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needle
vibration detection
vibration
contact
internal cavity
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JP2023072716A (en
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洋 川平
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OBLIGATO 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body

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  • Media Introduction/Drainage Providing Device (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

本発明は、血管に穿刺するための穿刺装置に関する。 The present invention relates to a puncture device for puncturing a blood vessel.

日本において、中心静脈穿刺は、初期臨床研修医にとって必須の基本手技とされている（新医師臨床研修制度における指導ガイドライン 厚生労働省 ２００５年）。 In Japan, central venous puncture is regarded as an essential basic procedure for initial clinical trainees (instruction guideline for new doctor clinical training system, Ministry of Health, Labor and Welfare, 2005).

中心静脈穿刺は、「超音波ガイド下」が推奨されており、超音波画像により血管の位置・方向・深さなどを確認しながら穿刺針を進め、動脈に触れないように穿刺針を進め、静脈に穿刺することが行われている（特許文献１～３）。 For central venous puncture, "ultrasonic guidance" is recommended, and the puncture needle is advanced while confirming the position, direction, depth, etc. of the blood vessel using ultrasonic images, and the puncture needle is advanced so as not to touch the artery, and the vein is punctured (Patent Documents 1 to 3).

特許第５５３１２３９号公報Japanese Patent No. 5531239 特許第６８２８３８９号公報Japanese Patent No. 6828389 特開２０２１－１９９５５JP 2021-19955

本発明の目的は、簡易に静脈かどうかを確認することができる穿刺装置を提供することにある。 SUMMARY OF THE INVENTION An object of the present invention is to provide a puncture device that can easily confirm whether or not there is a vein.

本発明者は、超音波（エコー）ガイド下での穿刺の際に、超音波発生部と穿刺装置とを別々の手で持つ必要あるところ、超音波での確認と穿刺とを両手で行う必要があり手技が煩雑であるという課題を認識した。本発明者は、動脈と静脈との間で振動の違いがあることに着目し、穿刺に当たって、針部に加わる振動状態を把握し、針部が接する部分が動脈と静脈の違いを識別し、静脈であることを確認してから静脈に穿刺する方策がより安全な穿刺を実施できることを見出し、本発明に係る穿刺装置を発明するに至った。 The inventor of the present invention has recognized the problem that, when puncturing under ultrasound (echo) guidance, it is necessary to hold an ultrasound generator and a puncture device with separate hands, but confirmation with ultrasound and puncturing must be performed with both hands, which makes the procedure complicated. The present inventor focused on the fact that there is a difference in vibration between an artery and a vein, and discovered that safer puncture can be performed by grasping the vibration state applied to the needle during puncture, distinguishing whether the portion in contact with the needle is an artery or a vein, confirming that the portion is a vein, and then puncturing the vein, thereby inventing the puncture device according to the present invention.

本発明の穿刺装置は、
血管内に穿刺し得る針部と、
前記針部の振動を検知する振動検知部と、を含む。 The puncture device of the present invention is
a needle portion that can be punctured into a blood vessel;
a vibration detection section that detects vibration of the needle section.

本発明において、
前記針部は、筒状であって、内部空洞があるものとすることができる。 In the present invention,
The needle may be tubular and have an internal cavity.

本発明において、
血管内に針部を穿刺し、前記針部の内部空洞を通じて、前記血管内に挿入物を挿入するためのものであることができる。 In the present invention,
It can be for puncturing a needle into a blood vessel and inserting an insert into the blood vessel through an internal cavity of the needle.

本発明において、
前記振動検知部は、脈動を検知し得るものであることができる。 In the present invention,
The vibration detector can detect pulsation.

本発明において、
前記振動検知部が検知した振動状態により動脈の脈動か、静脈の脈動かを判断するための判断部を含むことができる。 In the present invention,
A judging section may be included for judging an arterial pulsation or a venous pulsation based on the vibration state detected by the vibration detection section.

本発明において、
前記針部の端に当接部が設けられ、
把持部を含み、
前記当接部と前記把持部との間に振動検知部が設けられ、
前記振動検知部は、前記当接部を通じて前記針部の伸長方向に作用する力を受け、前記針部の振動を検知するものであることができる。 In the present invention,
A contact portion is provided at the end of the needle portion,
including a grip,
A vibration detection section is provided between the contact section and the grip section,
The vibration detection section may detect vibration of the needle section by receiving a force acting in an extension direction of the needle section through the contact section.

本発明に係る穿刺装置は、人の血管のみならず、人以外の動物の血管の穿刺にも適用可能である。 The puncture device according to the present invention can be applied not only to puncture blood vessels of humans but also to puncture blood vessels of animals other than humans.

本発明の穿刺装置は、動脈と静脈とは脈動や脈圧が異なるため、動脈か静脈かを知ることができる。安全な手技を実現することができる。また、振動で脈管を識別し、穿刺の簡便化を図ることができる。特に、頚部や鎖骨周囲から穿刺する中心静脈穿刺において有用で、エコーでまず血管走行（解剖）の概略を認知した後に、穿刺装置を片手で操作し、振動で動脈、静脈かどうかを識別することができるものである。
また、教育デバイスとしても使用することができ、ラーニングカーブの短縮化を図ることができる。動脈穿刺を減少させ、医療安全を担保することができる腕から挿入する中心静脈カテーテル（PICC(Peripherally Inserted Central Venous Catheter)）に適用可能である。 With the puncture device of the present invention, arteries and veins have different pulsations and pulse pressures, so it is possible to determine whether the puncture is arteries or veins. A safe procedure can be realized. In addition, the vibration can be used to identify the vessel, thereby simplifying the puncture. In particular, it is useful for central venous puncture, in which puncture is performed from the neck or around the clavicle. After first recognizing the outline of the running blood vessel (anatomy) with echo, the puncture device can be operated with one hand, and vibration can be used to distinguish between arteries and veins.
It can also be used as an educational device, shortening the learning curve. It is applicable to PICC (Peripherally Inserted Central Venous Catheter) inserted from the arm, which can reduce arterial puncture and ensure medical safety.

実施の形態に係る穿刺装置を模式的に示す図である。1 is a diagram schematically showing a puncture device according to an embodiment; FIG. 実施の形態に係る穿刺装置を模式的に示す図である。1 is a diagram schematically showing a puncture device according to an embodiment; FIG. 実施の形態に係る穿刺装置の使用例を模式的に示す図である。FIG. 4 is a diagram schematically showing a usage example of the puncture device according to the embodiment; 実施の形態に係る穿刺装置の機能図である。1 is a functional diagram of a puncture device according to an embodiment; FIG.

実施の形態に係る穿刺装置１０は、図１に示すように、血管内に穿刺する針部１２を有する。針部１２は、筒状であっても、棒状であってもよい。針部１２が筒状で内部空洞１２ａがある場合には、針部１２の内部空洞１２ａを通じて、血管内に挿入物を挿入することができる。 A puncture device 10 according to an embodiment has a needle portion 12 for puncturing into a blood vessel, as shown in FIG. The needle portion 12 may be cylindrical or rod-shaped. If the needle portion 12 is cylindrical and has an internal cavity 12a, an insert can be inserted into the blood vessel through the internal cavity 12a of the needle portion 12. As shown in FIG.

振動検知部１４は、脈動を検知し得るものとすることができる。振動検知部１４は、針部１２に加わる振動を検知することができるものであれば特に限定されず、たとえば、変位センサ、加速度センサ、圧力センサ、圧電素子などにより構成することができる。振動検知部１４は、たとえば、３ｍｍ以上、好ましくは３～１０ｍｍ、より好ましくは５～７ｍｍの振幅を検知するものであることができる。振動検知部１４は、一つであっても、複数であってもよい。 The vibration detection unit 14 can detect pulsation. Vibration detection section 14 is not particularly limited as long as it can detect vibration applied to needle section 12. For example, vibration detection section 14 can be configured by a displacement sensor, an acceleration sensor, a pressure sensor, a piezoelectric element, or the like. The vibration detection unit 14 can detect an amplitude of, for example, 3 mm or more, preferably 3 to 10 mm, and more preferably 5 to 7 mm. The number of vibration detection units 14 may be one or plural.

穿刺装置１０自体を把持するための把持部１６を設けることができる。把持部１６は、手で持つことができる公知の柄とすることができる。針部１２に内部空洞１２ａがある場合には、把持部１６を筒状とし、把持部１６の内部空洞１６ａの径と針部１２の内部空洞１２ａの径と同じとし、把持部１６の内部空洞１６ａと針部１２の内部空洞１２ａとが連続する態様とすることができる。 A gripper 16 may be provided for gripping the lancing device 10 itself. The grip portion 16 can be a known handle that can be held by hand. When the needle portion 12 has the internal cavity 12a, the grip portion 16 may be cylindrical, the diameter of the internal cavity 16a of the grip portion 16 may be the same as the diameter of the internal cavity 12a of the needle portion 12, and the internal cavity 16a of the grip portion 16 and the internal cavity 12a of the needle portion 12 may be continuous.

穿刺装置１０を挿入物の挿入を支援する支援装置として用いる場合には、針部１２および把持部１６を筒状に設けることができる。この場合に、把持部１６の針部１２側とは逆側の端部から挿入物を入れて、針部１２の先端から挿入物を出すことができるように、把持部１６の伸長方向に伸びる内部空洞１６ａと、針部１２の伸長方向に伸びる内部空洞１２ａとを、直線上に設けることができる。これにより、図２に示すように、穿刺装置１０の針部１２を血管内に刺した後、カテーテル３０などを穿刺装置１０内の内部空洞を通じて血管に誘導することができる。 When the puncture device 10 is used as a support device for assisting insertion of an insert, the needle portion 12 and the grip portion 16 can be provided in a cylindrical shape. In this case, an internal cavity 16a extending in the extending direction of the gripping part 16 and an internal cavity 12a extending in the extending direction of the needle part 12 can be provided on a straight line so that the insert can be inserted from the end of the gripping part 16 opposite to the needle part 12 side and the insert can be taken out from the tip of the needle part 12. As a result, as shown in FIG. 2, after the needle portion 12 of the puncture device 10 is pierced into the blood vessel, the catheter 30 or the like can be guided through the inner cavity of the puncture device 10 into the blood vessel.

図３に示すように、穿刺装置１０は、針部１２の把持部１６側の端に当接部１８を設け、当接部１８と把持部１６との間に振動検知部１４を設けることができる。振動検知部１４は、当接部１８を通じて針部１２の伸長方向に作用する力を受け、針部１２の振動を検知することができる。当接部１８は、針部１２の端に設けられたフランジにより構成してもよい。当接部１８は、突起であってもよい。当接部１８と把持部１６との間に、振動検知部１４を一つまたは複数設けることができ、複数設ける場合には、振動検知部１４を周状に設けることができる。 As shown in FIG. 3 , the lancing device 10 can be provided with a contact portion 18 at the grip portion 16 side end of the needle portion 12 and a vibration detection portion 14 between the contact portion 18 and the grip portion 16 . Vibration detection section 14 receives a force acting in the extension direction of needle section 12 through contact section 18 , and can detect vibration of needle section 12 . The contact portion 18 may be configured by a flange provided at the end of the needle portion 12 . The contact portion 18 may be a protrusion. One or a plurality of vibration detectors 14 can be provided between the contact portion 18 and the grip portion 16. When a plurality of vibration detectors 14 are provided, the vibration detectors 14 can be provided circumferentially.

穿刺装置１０は、図４に示すように、振動検知部１４が検知した振動状態により動脈５０の脈動か、静脈４０の脈動かを判断するための判定部２０を含むことができる。具体的には、振動検知部１４が検知した振動に基づき、脈動数を推定し、その脈動数から針部１２の先端が受けた振動が動脈５０によるものかまたは静脈４０によるものかを判定することができる。判定部２０は、ＣＰＵ，ＲＯＭおよびＲＡＭにより構成される処理装置により実現することができる。 As shown in FIG. 4 , the puncture device 10 can include a determination unit 20 for determining whether the artery 50 pulsates or the vein 40 pulsates based on the vibration state detected by the vibration detection unit 14 . Specifically, the number of pulsations is estimated based on the vibration detected by the vibration detection unit 14, and it can be determined from the number of pulsations whether the vibration received by the tip of the needle unit 12 is due to the artery 50 or the vein 40. The determination unit 20 can be realized by a processing device composed of a CPU, a ROM and a RAM.

穿刺装置１０は、表示部２２を含むことができる。表示部２２は、振動センサーが検知した数値や、脈動数、針部１２が受けた振動が動脈５０によるものか静脈４０によるものかの情報を表示することができる。表示部２２は、液晶表示装置などの公知の表示装置を適用することができる。 Lancing device 10 may include display 22 . The display unit 22 can display the numerical value detected by the vibration sensor, the number of pulsations, and information as to whether the vibration received by the needle unit 12 is due to the artery 50 or the vein 40 . A known display device such as a liquid crystal display device can be applied to the display unit 22 .

穿刺装置１０は、針部１２および把持部１６に内部空洞がある場合には、カテーテル３０などのイントロデューサーとして適用することができる。 Puncture device 10 can be applied as an introducer such as catheter 30 when needle portion 12 and grip portion 16 have internal cavities.

穿刺装置１０は、試験穿刺や本穿刺などにも適用することができる。 The puncture device 10 can also be applied to test puncture, main puncture, and the like.

本実施の形態によれば、動脈と静脈との間で振動の違いがあることに着目し、穿刺に当たって、針部１２に加わる振動状態を把握し、針部１２が接する部分が動脈と静脈の違いを識別し、静脈であることを確認してから静脈に穿刺する方策がより安全な穿刺を実施できる。 According to the present embodiment, focusing on the fact that there is a difference in vibration between an artery and a vein, a safer puncture can be performed by grasping the vibration state applied to the needle part 12 during puncture, identifying the difference between the artery and the vein in the part with which the needle part 12 contacts, and puncturing the vein after confirming that it is a vein.

本実施の形態は、本発明の範囲内において種々の変形が可能である。 Various modifications of the present embodiment are possible within the scope of the present invention.

１０ 穿刺装置
１２ 針部
１２ａ 内部空洞
１４ 振動検知部
１６ 把持部
１６ａ 内部空洞
１８ 当接部
２０ 判定部
２２ 表示部
３０ カテーテル
４０ 静脈
５０ 動脈 10 Puncture device 12 Needle 12a Internal cavity 14 Vibration detector 16 Grasping part 16a Internal cavity 18 Contact part 20 Determination part 22 Display part 30 Catheter 40 Vein 50 Artery

Claims (6)

血管内に穿刺され得る針部と、
前記針部の振動を検知する振動検知部と、
把持部とを含み、
前記振動検知部は、前記針部に接触しており、
前記針部は、筒状であり、かつ、前記針部の伸長方向に貫通する内部空洞を有し、
前記把持部は、筒状であり、かつ、前記把持部の伸長方向に貫通する内部空洞を有し、
前記針部の内部空洞と、前記把持部の内部空洞は、直線上に設けられており、
前記把持部の前記針部側とは逆側の端部において、前記把持部の内部空洞は開放されている、穿刺装置。 a needle that can be punctured into a blood vessel;
a vibration detection unit that detects vibration of the needle;
a gripping portion;
The vibration detection unit is in contact with the needle,
the needle portion is cylindrical and has an internal cavity penetrating in the extending direction of the needle portion;
The gripping portion is cylindrical and has an internal cavity penetrating in the extending direction of the gripping portion,
the inner cavity of the needle part and the inner cavity of the grip part are provided on a straight line,
The puncture device , wherein an internal cavity of the gripping portion is open at an end portion of the gripping portion opposite to the needle portion side. 血管内に穿刺され得る針部と、
前記針部の振動を検知する振動検知部と、
把持部と、
前記針部の把持部側の端に設けられた当接部とを含み、
前記振動検知部は、前記当接部に接触しており、
前記針部は、筒状であり、かつ、前記針部の伸長方向に貫通する内部空洞を有し、
前記把持部は、筒状であり、かつ、前記把持部の伸長方向に貫通する内部空洞を有し、
前記針部の内部空洞と、前記把持部の内部空洞は、直線上に設けられており、
前記把持部の前記針部側とは逆側の端部において、前記把持部の内部空洞は開放されている、穿刺装置。 a needle that can be punctured into a blood vessel;
a vibration detection unit that detects vibration of the needle;
a gripping portion;
a contact portion provided at the end of the needle portion on the side of the grip portion ,
The vibration detection portion is in contact with the contact portion,
the needle portion is cylindrical and has an internal cavity penetrating in the extending direction of the needle portion;
The gripping portion is cylindrical and has an internal cavity penetrating in the extending direction of the gripping portion,
the inner cavity of the needle part and the inner cavity of the grip part are provided on a straight line,
The puncture device , wherein an internal cavity of the gripping portion is open at an end portion of the gripping portion opposite to the needle portion side. 請求項１または２において、
前記把持部の針部側とは逆側の端部からカテーテルを入れて、前記針部の先端から前記カテーテルを血管内に導くためのものである、穿刺装置。 In claim 1 or 2,
A puncture device for inserting a catheter from the end of the grip portion opposite to the needle portion and guiding the catheter into a blood vessel from the tip of the needle portion. 請求項１または２において、
前記振動検知部は、脈動を検知し得るものである穿刺装置。 In claim 1 or 2 ,
The lancing device, wherein the vibration detection unit is capable of detecting pulsation. 請求項１または２において、
前記振動検知部が検知した振動状態により動脈の脈動か、静脈の脈動かを判断するための判断部を含む穿刺装置。 In claim 1 or 2 ,
A puncture device comprising a judgment unit for judging whether it is an arterial pulsation or a venous pulsation based on the vibration state detected by the vibration detection unit. 請求項１または２において、
前記針部の端に当接部が設けられ、
前記当接部と前記把持部との間に振動検知部が設けられ、
前記振動検知部は、前記当接部を通じて前記針部の伸長方向に作用する力を受け、前記針部の振動を検知し、
前記当接部は、針部の端から側方に向かって伸びるフランジにより構成され、
前記振動検知部は、複数設けられ、前記針が伸びる方向の延長線上の周りに配置されている、穿刺装置。

In claim 1 or 2 ,
A contact portion is provided at the end of the needle portion,
A vibration detection section is provided between the contact section and the grip section,
the vibration detection unit receives a force acting in the extension direction of the needle through the contact portion and detects vibration of the needle;
the contact portion is configured by a flange extending laterally from the end of the needle portion,
The puncture device, wherein a plurality of the vibration detection units are provided and arranged around an extension line in a direction in which the needle extends .
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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015510830A (en) 2012-03-18 2015-04-13 トラウマテック ソリューションズ ベー．フェー． Devices and methods for intravascular access and treatment
US20200139086A1 (en) 2017-05-31 2020-05-07 Fondazione Istituto Italiano Di Tecnologia Hand-held device for inserting a needle into a non-homogeneous material

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62183772A (en) * 1986-02-10 1987-08-12 福留　武朗 Vessel puncturing instrument

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015510830A (en) 2012-03-18 2015-04-13 トラウマテック ソリューションズ ベー．フェー． Devices and methods for intravascular access and treatment
US20200139086A1 (en) 2017-05-31 2020-05-07 Fondazione Istituto Italiano Di Tecnologia Hand-held device for inserting a needle into a non-homogeneous material

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