JPH11309124A - 針入深さを検知するためのセンサ付きシャフトによる針入度試験の装置および方法 - Google Patents

針入深さを検知するためのセンサ付きシャフトによる針入度試験の装置および方法

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Publication number
JPH11309124A
JPH11309124A JP11082487A JP8248799A JPH11309124A JP H11309124 A JPH11309124 A JP H11309124A JP 11082487 A JP11082487 A JP 11082487A JP 8248799 A JP8248799 A JP 8248799A JP H11309124 A JPH11309124 A JP H11309124A
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JP
Japan
Prior art keywords
shaft
impedance
needle
penetration
depth
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP11082487A
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English (en)
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JPH11309124A5 (ja
JP4406706B2 (ja
Inventor
Paul Lum
ポール・ラム
Jr Hewlett E Melton
ヒューレット・イー・メルトン・ジュニア
Tad Decatur Simons
タッド・デカタウアー・サイモンス
Michael Greenstein
ミカエル・グリーンステイン
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HP Inc
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Hewlett Packard Co
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Publication of JPH11309124A publication Critical patent/JPH11309124A/ja
Publication of JPH11309124A5 publication Critical patent/JPH11309124A5/ja
Application granted granted Critical
Publication of JP4406706B2 publication Critical patent/JP4406706B2/ja
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/150137—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by vibration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150167—Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15121—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising piezos
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15125—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising a vacuum or compressed fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
    • A61B5/15128—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • 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
    • A61M5/46—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 having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00738—Depth, e.g. depth of ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00755—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth

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  • Health & Medical Sciences (AREA)
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  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measurement Of Length, Angles, Or The Like Using Electric Or Magnetic Means (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

(57)【要約】 【課題】 患者の組織中へ入れる針のような、長い構造
物をある物体に挿入する際、その浸入（針入）深さを適
正なものにすること。 【解決手段】 物体表面の下の深さによって変化するイ
ンピーダンスを有する前記物体中への針入用シャフト１
０２を備えた装置において、針入先端１０３を有するシ
ャフト本体と、前記先端１０３に近接した第１および第
２の電導性端末とから成り、電導性端末の間の物体の材
料のインピーダンス変化を検知して針入深さについての
情報をもたらすようにしたシャフト１０２を含んで成る
装置。

Description

【発明の詳細な説明】
【０００１】
【発明の属する技術分野】本願発明は、シャフトによる
物体の針入技術に関し、より詳細には、皮下注射針の針
入深さを測定するための装置と方法に関する。
【０００２】
【従来の技術】患者の組織中へ入れる針のような、長い
構造物をある物体に挿入する際、しばしば、その浸入
（針入）がどれほど深いかを知る必要がある。
【０００３】
【発明が解決しようとする課題】所望の結果を得るのに
必要な深さを越えて針入することは、努力の空費となる
ばかりか、患者を過度に苦しめることになる。それ以上
の針入が物体に不必要な損傷を生じかねず且つ予定の針
入深さに到達したら針入を停止させるのが望ましい故、
深さの情報は、しばしば、短時間で必要となる。例え
ば、血液成分の分析と定量化は、患者の身体の状態をよ
りよく理解するための重要な診断ツールであり、しかも
血液試料は、針又はランセット（刃針）によって傷を負
わせて採取しなければならない。必要以上の深さに針又
はランセットを挿入すれば、皮膚組織に過度の痛みと外
傷を生ずる。頻繁に採血しなければならない糖尿病患者
のような患者の場合、過度の痛みと組織の外傷はどれ
も、採血日課に応じる意欲をくじくものである。
【０００４】皮膚は、２つの層、即ち上皮と真皮から成
っている。動脈および静脈の導管床（ｖａｓｃｕｌａｒ
ｂｅｄｓ）に接続された毛管構造は、垂直に立ち上が
って、真皮に配置する。Ｍｅｉｓｓｎｅｒの小体（ｃｏ
ｒｐｕｓｃｌｅｓ）のような神経センサおよび神経の自
由端末も真皮にある。皮下組織の層は、真皮の下にあ
る。補給動脈および静脈の毛管は、その組織床の横にあ
る。導管床内で混ぜ合わされたそれらの関連センサと共
に、求心性と遠心性の神経線維が差し込まれた脂肪質組
織もある。これらの組織層の深さは、個体によって異な
る。現在市販されている皮膚穿刺用の針又はランセット
は、ランセット穿刺操作の実験データに基づいて針入深
さを予め設定している。従って、上述の針又はランセッ
トが使われる時は何時でも最適の針入深さに達するとい
う確証はない。不十分な深さに起因した採血の失敗を避
けるため、患者は、しばしば、過度針入され、このこと
が不必要な痛みを生ずるのである。
【０００５】必要とされるものは、過不足の針入の無い
最適深さまでの挿入に使用できるところの採血用針又は
ランセットである。同様に、過不足の針入をせずに物体
中に長いシャフトを挿入するその他の針入用途において
も必要性は存在するのである。
【０００６】
【課題を解決するための手段】本願発明においては、物
体中への細長い構造体の針入の深さは、細長い構造体が
針入された材料のインピーダンスをその細長い構造体の
先端で検知するところのインピーダンスセンサで測定さ
れる。
【０００７】１つの様相において、本願発明は、物体表
面の下の深さに応じて変化するインピーダンスを示すと
ころの物体中への針入用シャフトを有する装置を提供す
る。当該装置は、針入用先端とその先端近くに２つの電
導性端末を有するシャフト本体を含むシャフトを包含す
る。２つの電導性端末は先端近くにあって、その電導性
端末間で検知される物体の材料のインピーダンスの変化
により、所望の針入深さが到達されたかどうかについて
の情報が提供されるようにしたものである。
【０００８】本願発明のシャフトは、比較的浅い上部層
に比してより深い皮膚組織層の間の電気的インピーダン
スを利用している故、本発明は、特に、皮膚に穴を開け
て患者から血液を採取することに適用できる。インピー
ダンスは、例えば、皮膚組織の層を刺し通す金属性針に
よってモニタすることができる。針が、最初に、皮膚の
外部上皮と真皮中に針入する時は、初期の高インピーダ
ンスが見られる。その針が脂肪層へ近付くにつれ、イン
ピーダンスの逓減が観測される。
【０００９】本願発明のシャフトを含む、当該装置を使
えば、針入深さによって変化する電気的インピーダンス
を示す物体中への最適針入を達成することができる。針
を皮膚に挿入して患者から血液を採取する場合では、こ
のことは、過剰針入の外傷と痛みを最小にできるだけで
はなく、不十分な針入のために失敗に終わる血液採取の
フラストレーションと痛みを避けることができるのであ
る。不快および組織損傷についての前述の減少によっ
て、例えば、採血日課に対する患者の応諾を著しく好転
させることができる。
【００１０】
【発明の実施の形態】１様相において、本願発明は、シ
ャフトを身体中に挿入する時の針入深さを検知するため
の技術を提供するものである。本明細書で用いられる
時、用語”シャフト”は、対象物に針入する先端を持っ
た一般的には細長い本体を有する物体を指す。用途によ
っては、シャフト本体は、固いか又は幾分柔軟性があっ
てもよい。好ましくは、その先端は、針入を容易にする
ため比較的尖った尖端か又は斜角をつけた刃を有する。
その尖端は、予め存在している孔に通さなくてもシャフ
トを身体中に押し付けることができるよう十分尖ってい
る。シャフト本体は、円形もしくは非円形の断面（例え
ば、矩形断面）をもっているものでよい。一例として、
皮下挿入に適する針大のシャフトを以下の実施例で説明
する。理解すべきは、非医療用シャフトを含む、その他
の非皮下用シャフトも本願発明に従って作製且つ使用す
ることができるということである。
【００１１】針類およびランセット類 図１は、本願発明による皮膚針入用シャフトを駆動する
装置の実施例である。図１において、装置１００は、シ
ャフト１０２の先端１０３の周りに組織のインピーダン
スを検知するための電導性端末部をもつシャフト１０２
（例えば、針又はランセット）を包含する。その端末部
に電気的に接続された（インピーダンスを検知する電気
回路を含む）インピーダンスセンサ１０４によって電気
的インピーダンスが検知される。例えば、材料又は回路
における２点間の電気的インピーダンスを検知する電気
機器類および回路類は、当分野で周知である。電気制御
式ドライバ１０６は、針入の”基板”（ｓｕｂｓｔｒａ
ｔｅ）と呼ぶことができるところの、患者の皮膚および
その下の組織に針入できるようシャフト１０２を駆動す
る。ドライバ１０６は、プロセッサ１０８によって制御
され、そのプロセッサは、インピーダンスセンサ１０４
が所望の針入が到達され終わったことを示すインピーダ
ンス変化を検知するとドライバを停止させる。
【００１２】図解のため、図２は、本願発明において、
例えば、装置１００のシャフト１０２として使用できる
皮下用針１１０の一部分の実施例を示す。図２は、皮下
針１１０の軸に沿った断面図であり、図３は、皮下針１
１０の断面である。皮下針１１０は、組織中へ針入でき
るよう遠位の方の端部１１５に尖端１１４を有する堅い
シャフト本体１１２を含む。シャフト本体１１２は、堅
い、非電導性の（例えば、ポリイミドのような、高分子
の）管１１６を有し、その管１１６の軸の所は中央内穴
１１８（ｃｅｎｔｒａｌ ｌｕｍｅｎ）となっている。
管１１６の近似軸に配置された電導性（例えば、金属タ
ングステン）導線１２０は、尖端１１４から基部の方に
伸びている。タングステン線１２０は、遠位の方の端部
１１５に近接した電導性末端１２３を有する。本明細書
に用いられる時、用語”遠位の方の”（ｄｉｓｔａｌ）
は、針が物体に針入しようとしている時の物体（例え
ば、患者の皮膚）に向かう方向を指示し、用語”基部の
方の”（ｐｒｏｘｉｍａｌ）は、”遠位の方の”それの
逆方向、従って、物体から遠ざかる方向に該当する。電
導性コーティング１２２（例えば、クロム／金めっきコ
ーティング）が非電導性導管１１６の外表面に付けら
れ、尖端１１４が電導性端部１２５となっている。好ま
しくは、銀エポキシのような、電導性の接着剤１２４
（図２参照）を用いて、電導性導線１２０の遠位の方の
端部を皮下針１１０の遠位の方の端部１１５に接着す
る。
【００１３】更に、もし望まれるなら、内穴中を伝わる
ことがある流体を捕集できるようチャンバー即ち容器を
内穴１１８に接続してもよい。このチャンバー即ち容器
は、非電導性バッグ、注入器、内穴に接続されたその他
の導管、およびその類であってよい。
【００１４】前述の皮下針は、例えば、ポリイミドの導
管を電気めっきして、電導性コーティングをそのポリイ
ミド管上に付け、そして、例えば、タングステン線をそ
のポリイミド管に挿入し且つその線の端末を皮下針の遠
位の方の端部に銀エポキシを使って貼り付けることによ
って作製することができる。この遠位の方の端部は、電
導性材料が全て配置された後で尖らしてよい。電導線１
２０の基部の方の端部と電導性コーティング１２２の基
部の方の端部は、皮下針１１０の針入深さを検知するた
めの、装置１００、又はその他の類似機器のインピーダ
ンスセンサに接続することができる。電導性コーティン
グを作るのに適したその他の材料には、例えば、銀、ニ
ッケル、白金、チタン、およびタングステンがある。電
導線を作るのに適した材料としては、例えば、銀、ニッ
ケル、白金、チタン、金、アルミニウム、およびタング
ステンがある。
【００１５】図４に示すような、別の実施例では、中空
の非電導性針１２６の内穴１２７を電導性材料１３０で
充填し且つ非電導性針上を金属コーティング１３２で被
覆することにより、一体構造の（ｓｏｌｉｄ）針組立１
２６を作ることができる。得られる細長い構造体を修正
して尖った先端を作り出すことができる。あるいは、非
伝導性材料を堅い金属線上に被覆して、その後、電導性
金属の外被覆を非伝導性材料で被覆して一体構造の針を
形成してもよい。そのような針は、シャフト断面を示し
ているところの、図４に示されたそれと類似の構造を有
することになろう。
【００１６】針入用の針シャフトを更に堅くするため
に、遠位の方の端部に通じる導体を有する針を、付加剛
性を付与する材料で更に被覆してよい。金属類又は合金
類のような、多くの堅い材料が当分野で周知である。前
述の付加剛性を付与するのに適した材料例は、窒化チタ
ンである。
【００１７】図５は、本願発明の皮下針の別の実施例を
示す。図５の皮下針１３４では、内穴１３８をもった内
側電導管１３６は、軸から更に離れている電導性コーテ
ィング１４２から内側電導管１３６を電気的に絶縁する
非電導性材料１４０のコーティングが施されている。こ
の皮下針１３４は、例えば、鉄針を非電導性材料で被覆
し、次いで、その非伝導性材料の上に金属コーティング
を溶射（スパッタリング）し、その後、電気めっきして
外側電導性コーティング１４２を形成することによって
作ることができる。
【００１８】図６（側面図）および図７（正面図）は、
更に別の実施例を示すもので、この場合、患者の皮膚中
への挿入に適したシャフトは、シャフト先端を囲んでい
る組織のインピーダンスを検知するための導体を含んで
いる。シャフト１４４は、矩形断面をもち（図７の正面
図参照）、中央部分１４６は、２つの導体１４８Ａ，１
４８Ｂの間にサンドイッチ状に挟まれたシャフト１４４
に沿って長手方向に伸びる堅い非伝導性材料から作られ
ている。その中央部分は、皮膚に切り込めるよう尖った
エッジ１５０に至る尖った先端１４８を有している。皮
膚の創傷を切るためのランセットとして前述のシャフト
を用いて、血液を採取することができる。
【００１９】シャフトの駆動機構 本願発明の（針類、ランセット類、刃類を含む）シャフ
トを駆動するのに多様なドライバを用いることができ
る。当該ドライバは、所望の深さが達成された時にその
ドライバを、好ましくは、自動的に、停止できるように
電気的に制御できるものである。この方法で、最小量の
痛みと外傷サイズを課すだけで患者から血液を引き出す
操作のような、最小の針入を使って所望の結果が達成さ
れるように針入深さを最適化することができる。ドライ
バに使える機構の例としては、気送式（ｐｎｅｍａｔｉ
ｃ）、電磁式（ｅｌｅｃｔｒｏｍｅｃｈａｎｉｃａ
ｌ）、および圧電式（ｐｉｅｚｏｅｌｅｃｔｒｉｃ）機
構がある。
【００２０】図８は、ねじ式機構を使ってシャフトを連
続的に駆動するためのドライバを備えた装置を示す。図
８の実施例では、シャフト１５０は、ねじ付きロッド１
５６と噛み合うところの、スリーブ１５４に固定的に連
結されたベース１５２に貼り付けられる。スリーブ１５
４のねじは、ねじ付きロッド１５６の回転によってねじ
付きロッド１５６の軸方向に沿ってスリーブ１５４が動
かされるように、ねじ付きロッド１５６と噛み合わされ
る。それ故、ねじ付きロッド１５６のある方向の回転
（例えば、時計方向の回転）を御するモータ１５８は、
シャフト１５０の遠位方向における前進運動を制御す
る。モータ１５８を停止すれば、シャフト１５０の前方
への前進が止まる。モータ１５８を被針入対象物に対し
て固定位置に保持し且つそのモータを制御することによ
り、シャフト１５０の針入深さが制御されるのである。
更に、間欠的に、順次に前進するようにモータ１５８を
駆動することもできる。望まれるなら、シャフト１５０
を前進および後退させるために前方および後方の両運動
を与えるべく、２方向に回転するようモータ１５８を操
作してもよい。
【００２１】図９は、連続的に前進するようシャフトを
駆動できる別の実施例を図解したものである。この実施
例では、シャフト１５０（例えば、針）がベース１６０
に貼り付けられる。ベース１６０（および従ってシャフ
ト１５０）は、ベース１６０と側面で噛み合っているロ
ーター１６２Ａによって前方方向、即ち、遠位方向に動
くよう駆動され、その結果、ローター１６２Ａを回転さ
せることで、ベース１６０とシャフト１５０を遠位方向
に移動させることになる。そのローター１６２Ａは、モ
ータ１６４で駆動される。別のローター１６２Ｂは、ロ
ーター１６２Ａのそれの反対側で支持するようにベース
１６０と噛み合っている。ローター１６２Ａ又はロータ
ー１６２Ｂの何れかは、アイドラ（空転）ローターであ
ってよい。ローター１６２Ａとローター１６２Ｂは、ギ
ヤによって又は摩擦力でベース１６０と噛み合っていて
よい。
【００２２】図１０は、シャフトを身体中に挿入するの
に往復動作を利用した、本願発明のシャフト−針入装置
の実施例を示す。シャフト１５０は、連接アーム１６８
Ａ，１６８Ｂで起動されるリンク１６６に付ける。連接
アーム１６８Ａおよび１６８Ｂは、相互に枢軸で旋回で
きるように（ｐｉｖｏｔａｂｌｙ）接続される。連接ア
ーム１６８Ｂは、ローター１７０の中心から外れた位置
に枢軸で旋回できるように接続され、このローターがま
た、モータ１７２で駆動される。このように、ローター
１７０の回転が、連接アーム１６８Ａ，１６８Ｂの前後
往復運動となり、それがシャフト１５０に伝達されるの
である。加えて、シャフト１５０を遠位方向に前進させ
るために、システム全体を遠位方向に一様に前進させて
もよい。
【００２３】図１１は、例えば、リンク１６６として、
使用できるばね機構の実施例を示す。ベース１５２に支
持されたシャフト１５０は、１次スプリングコイル１７
６Ａと２次スプリングコイル１７６Ｂとから成るところ
の、ばね機構で保持される。１次スプリングコイル１７
６Ａと２次スプリングコイル１７６Ｂは、それぞれ、ス
プリングコイルとベース１５２の一部を収容しているハ
ウジング１８０の出張り（ｌｅｄｇｅ）１７８によって
１端が保持される。端末のディスク１７７は、スプリン
グコイル１７６Ａ，１７６Ｂの基部の方の端部に配置さ
れ且つスプリングコイル１７６Ａ，１７６Ｂの軸を通し
て伸びる硬質ロッドによってベース１５２に貼り付けら
れる。（部分的に図示された）ハンマー１８１を使っ
て、端末ディスク１７７を押し込むことができ、これが
シャフト１５０を前記硬質ロッドによって前方へ駆動す
る。押し込みの後、スプリング１７６Ａおよびスプリン
グ１７６Ｂがそのシャフトを後方へ移動させることがで
きる。スプリング１７６Ａ，１７６Ｂの１つはオプショ
ンであって、代替例はそれらの中の１つだけを使うこと
になる。
【００２４】図１２は、往復運動を起こさせて針入用シ
ャフトを駆動するための圧電式ドライバ１８２の１実施
例を示す。前述の実施例におけるように、シャフト１５
０をベース１５２に貼り付け、そのベースを圧電振動子
１８４に取付ける。電気的に付勢されると、圧電振動子
１８４が振動して、ベース１５２とシャフト１５０を前
後運動で移動させる。この振動ドライバ系全体を前進さ
せることも可能である。圧電振動子の作製および使用技
術は、当分野で周知であり、本願開示に基づくシャフト
を駆動させるのに容易に適用できる。
【００２５】図１３は、シャフトを駆動させるための往
復運動を起こさせる流体メカニズムを示す。ここでは、
シャフト１５０は、ピストンハウジング１８８における
（チャンバー１８７Ａ、チャンバー１８７Ｂおよびピス
トン１８６で占められる容積を含む図示された）チャン
バー内で滑動可能なピストン１８６に付けられる。ピス
トン１８６に対して遠位にある遠位流体導管１９０によ
って流体がチャンバー１８７Ｂに入ってピストンを基部
の方へ、即ち、遠位方向とは反対の方向に、駆動させる
ことができる。同時に、好ましくは、ピストン１８６に
対して基部の方にある基部流体導管口１９２によって流
体が漏出して、チャンバー１８７Ａに過剰な圧力を生ず
ることなくピストンの移動を助長することができる。逆
に、遠位流体導管１９０が流体を漏出させる一方、基部
流体導管１９２によって流体がチャンバー１８７Ａに入
って、ピストンを遠位の方へ駆動することができる。多
路弁１９６（例えば、三路弁）に接続された共通の流体
入口導管１９４によって、流体を基部流体導管１９２に
入れたり又は遠位流体導管１９０に入れることができ
る。あるいは、ピストンに対して基部の方および遠位の
方のチャンバー１８７に流体を導く一方、同時に、チャ
ンバーの反対側で流体を追い出せば、往復運動を生ずる
ことになる。時間中、遠位方向でのシャフト１５０の段
階的な前進を得るため、遠位流体導管１９０よりも多量
の流体を基部流体導管１９２に入れることができる。自
由選択で、チャンバー１８７Ａおよび１８７Ｂの１つ又
は両方を周囲圧力に対して閉じた状態に保持して、その
機構の構造に過剰なストレスをかけないようにしてもよ
い。あるいは、図１３に示した全機構を、往復運動させ
ながら、前進させてもよい。シャフト１５０の段階的移
動を御するためにチャンバー１８７へ入れる流体として
は、気体又は液体を用いることができる。
【００２６】本願発明はまた、のこぎり作用（ｓａｗｉ
ｎｇ ａｃｔｉｏｎ）でシャフトが前進する用途も見出
すことができる。前述の装置の一例は、外側管と内側管
によって血液を導くことができるよう細長い構造を有し
ている。これらの管は、相互に、同心で、１つが他の上
で自由に滑動できるようそれらの間が低摩擦で密に近接
した状態で結合されているものである。それらの管の遠
位の方の端部は、それぞれ、円形の尖った切刃を有して
いる。管は、長手方向に往復運動をするよう駆動され、
そのため、外側管の尖ったリング状の端部が内側管の端
部より遠位となったり、内側管の尖ったリング状の端部
が外側管の端部より遠位となったりを交互に繰り返すこ
とになる。この方法で、細長の構造体が２つの管による
のこぎり作用で組織に針入することができる。
【００２７】本願発明のシャフト（例えば、針、ランセ
ット、等）を御すための駆動機構は、流体材料の適切な
深さがいったん検知されてしまうと、それより深くシャ
フトが針入するのを阻止するところの帰還電子回路で制
御することができる。典型的には、そのような制御系
は、図１に示したプロセッサに配置されることになろ
う。前述の制御系に対する制御アルゴリズムを、図１４
で示したような典型的流れ図で説明する。このアルゴリ
ズムでは、いったん起動されると、ドライバは、シャフ
トを一時に１ステップ移動させて、測定されたインピー
ダンスによってシャフトが目標領域（例えば、皮膚に針
入する針による毛管床の血液）に達したことが表示され
るか、もしくは予め定められた針入深さが到達されるま
で、増分距離を前進させ、その点で、ドライバは、制御
回路系によって停止されることになる。シャフトが適切
な深さに達したかどうかは、インピーダンスの変化の大
きさ又はインピーダンスそのものの大きさによって決め
ることができる。インピーダンス値又は飛越し（ｊｕｍ
ｐ）値の選択は、熟練した当業者が実行し得るものであ
る。シャフトが針入しつつある対象物の外部にプロセッ
サを設けて、シャフトの動きを制御すると共に、所望の
深さが達成されたかどうかを決めるべく、インピーダン
ス情報を収集・処理できるようにしてよい。情報を処理
し、ドライバを制御するための電気装置類と電気回路
類、並びに電気的インピーダンスを検知するためのそれ
らは、当分野で周知である。前述の電気装置類と電気回
路類は、コンピュータ類又はマイクロプロセッサ類を含
むこともあり得る。
【００２８】本願の装置を最適状態で使用するには、好
ましくは、針入深さによるインピーダンスの変化を実験
的に定める。数回のサンプリング後、インピーダンス変
化に関連して挿入深さを設定できるように装置を調整し
て、その個人についての特定の選択（例えば、針入深さ
とサンプル容積）に適合させるようにしてよい。別法
は、個々の患者に特有のインピーダンスデータ対深さを
得、そして、複数の血液サンプルからデータを採った
後、得られるデータを使って、将来の血液サンプルに向
く針入深さを設定することになろう。
【００２９】本願発明の望ましい実施例を詳細に記述且
つ説明したが、理解すべきは、熟練した当業者は、発明
の範囲内で諸修正を行い得るということである。例え
ば、本願発明は、広範囲の医用又は非医用領域、例え
ば、水、ガス、石油、等に関わる地表の掘削などに適用
できることは言うまでもない。
【００３０】＜１＞ 物体表面の下の深さによって変化
するインピーダンスを有する前記物体中への針入用シャ
フトを備えた装置において、（ｉ） 針入先端を有する
シャフト本体と、（ｉｉ）前記先端に近接した第１およ
び第２の電導性端末と、から成り、電導性端末の間の物
体の材料のインピーダンス変化を検知して針入深さにつ
いての情報をもたらすようにしたシャフトを含んで成る
装置。
【００３１】＜２＞ 前記先端の周りの第１および第２
の電導性端末間のインピーダンスを検知できるようにイ
ンピーダンス変化検知用の第１および第２の電導性端末
に電気的に接続されたインピーダンスセンサを包含す
る、前記＜１＞に記載の装置。
【００３２】＜３＞ 第１電導性端末からインピーダン
スセンサに導く第１の導体と第２電導性端末からインピ
ーダンスセンサに導く第２の導体とを包含し、前記シャ
フトが前記の第１導体と第２導体間に介在する電気的絶
縁体を含む、前記＜２＞に記載の装置。
【００３３】＜４＞ 第１導体がシャフトの一方の側に
あり且つ第２導体がシャフトの第２の側にあり、前記第
１および第２導体が相互に電気的に接触しないようにし
た、前記＜３＞に記載の装置。
【００３４】＜５＞ 先端からシャフトを通して流体を
導くために先端から伸びるチャンネルをシャフト中に包
含する、前記＜１＞に記載の装置。
【００３５】＜６＞ 前記シャフトが中心線を有し且つ
第２導体が前記中心線に近接していて、前記シャフトが
前記第１導体と前記第２導体との間に介在する電気的絶
縁体を含む、前記＜５＞に記載の装置。
【００３６】＜７＞ 前記電気的絶縁体が管であり、前
記第１導体が、絶縁体管と、前記絶縁管内部に伸びる前
記第２導体とを取囲む電導性層であり、且つインピーダ
ンスセンサが前記先端から離れて配置される、前記＜６
＞に記載の装置。
【００３７】＜８＞ 前記シャフト本体が、金属管と、
前記金属管上に被覆された電気絶縁層および電気絶縁層
上に被覆された導体層とから成り、金属コーティングが
第１電導性端末からセンサに繋がり且つ金属管が第２電
導性端末からセンサに繋がり、且つインピーダンスセン
サは、シャフトが物体に針入した時に前記物体の外部に
配される、前記＜５＞に記載の装置。
【００３８】＜９＞ 前記シャフトに接続されていて、
そこからの流体を受けるべく前記チャンネルと流体連絡
している容器を包含する、前記＜５＞に記載の装置。
【００３９】＜１０＞ 前記シャフト本体は、患者の皮
膚に針入するための皮下注射針の大きさを有する、前記
＜２＞に記載の装置。
【００４０】＜１１＞ 逐次段階（ｉｎｃｒｅｍｅｎｔ
ａｌ ｓｔｅｐｓ）で身体中にシャフトを押し込むため
の機械的ドライバを包含する、前記＜２＞に記載の装
置。
【００４１】＜１２＞ 動物対象物の表面下の深さに応
じて変化するインピーダンスを有する動物対象物中への
針入用シャフトを備えた装置において、（ａ） 針入用
の尖った先端を有していて、皮下注射針のような大きさ
のシャフトと、 （ｂ） 前記シャフトに接続されてい
て、電導性端末間の対象物の材料のインピーダンス変化
を検知して針入の深さに関する情報を与えられるように
前記の尖った先端に近接した第１および第２の電導性端
末と、前記のインピーダンスの変化を検知するための電
気回路類と、電気回路類に電導性端末を接続するべく前
記シャフトに沿って伸びる第１および第２の導体と、前
記第１導体と前記第２導体との間に介在する電気的絶縁
体とを包含するインピーダンスセンサと、（ｃ） 前記
のインピーダンス変化によって駆動作用が影響を受ける
ことを特徴とする、シャフトを逐次駆動させるための機
械的ドライバと、を含んで成る装置。
【００４２】＜１３＞ 対象物にシャフトを押し込む方
法において、（ａ） 対象物に針入させるべくシャフト
を駆動させるステップと、（ｂ） 針入中、所望の深さ
が到達されたかどうかを決めるためにシャフトの尖端に
近接した対象物の材料のインピーダンスを検知し且つそ
の検知されたインピーダンスに基づいて駆動作用を修正
するステップと、を設けて成る方法。
【００４３】＜１４＞ ドライバを使って前記シャフト
を逐次駆動するステップを包含する、前記＜１３＞に記
載の方法。
【００４４】＜１５＞ 身体中に針入できるよう前記シ
ャフトを往復運動で駆動するステップを包含する、前記
＜１４＞に記載の方法。
【００４５】＜１６＞ 所望の針入深さが検知された時
に駆動作用を停止させるステップを包含する、前記＜１
３＞に記載の方法。
【００４６】＜１７＞ シャフトがその内部にチャンネ
ルを有し、更に、流体を身体からシャフトを通して流し
て流体を採取できるようにするステップを包含する、前
記＜１３＞に記載の方法。
【００４７】＜１８＞ 動物の皮膚を通して針大のシャ
フトを挿入する方法において、（ａ） 動物中にその皮
膚を通して針入できるよう針大のシャフトを駆動するス
テップと、（ｂ） 所望の針入深さが到達されたかどう
かを決めるために電気的に検知するステップと、（ｃ）
所望の深さが到達された時に針大のシャフトの前進を
停止させるステップと、 を設けて成る方法。
【００４８】＜１９＞ 前記針大のシャフトを駆動する
ために電気的ドライバを用いるステップと所望の深さが
到達された時にその電気的ドライバを電気的に停止させ
るステップとを包含する、前記＜１８＞に記載の方法。
【００４９】＜２０＞ 対象物の表面下の深さに応じて
変化するインピーダンスを有する対象物中への針入用シ
ャフトを備えた装置の作製方法において、（ａ） 針入
用シャフトに先端を設けるステップと、（ｂ） 前記シ
ャフトの先端に近接して第１および第２の電導性端末を
配置し、第１および第２の電導性端末間の対象物の材料
のインピーダンス変化を検知して針入の深さに関する情
報を与えられるようにするステップと、（ｃ） 前記の
インピーダンスの変化を検知するための電気回路類に第
１および第２の電導性端末を接続するステップと、を設
けて成る方法。
【００５０】
【発明の効果】本願発明による装置は、物体表面の下の
深さによって変化するインピーダンスを有する前記物体
中への針入用シャフトを備えた装置において、（ｉ）
針入先端を有するシャフト本体と、（ｉｉ）前記先端に
近接した第１および第２の電導性端末と、から成り、電
導性端末の間の物体の材料のインピーダンス変化を検知
して針入深さについての情報をもたらすようにしたシャ
フトを含んで成る装置である。本願発明による、この装
置よれば、患者の組織中へ入れる針のような、長い構造
物をある物体に挿入する際、その浸入（針入）深さを適
正なものにすることができる。
【図面の簡単な説明】
【図１】本願発明の装置の実施例を示す。
【図２】本願発明のシャフトの実施例を示す。
【図３】本願発明のシャフトの実施例を示す。
【図４】本願発明のシャフトの別の実施例を示す。
【図５】本願発明のシャフトの更に別の実施例を示す。
【図６】本願発明のランセットの実施例を示す。
【図７】本願発明のランセットの実施例を示す。
【図８】本願発明によるシャフトを駆動するためのドラ
イバの実施例を包含する装置を示す。
【図９】本願発明によるシャフトを駆動するためのドラ
イバの実施例を包含する装置を示す。
【図１０】シャフトを駆動するためのドライバの実施例
を包含する装置を示す。
【図１１】シャフトを駆動するためのドライバの実施例
の一部分を包含する装置を示す。
【図１２】シャフトを駆動するための圧電式ドライバの
一部分を包含する装置を示す。
【図１３】シャフトを駆動するための流体駆動式ドライ
バの一部分を包含する装置を示す。
【図１４】本願発明によるシャフトの駆動用ドライバを
制御するためのアルゴリズムに関する流れ図を示す。
【符号の説明】
１００ 装置 １０２ シャフト １０３ 先端 １０４ インピーダンスセンサ １０６ 電気制御式ドライバ １０８ プロセッサ １１０ 皮下用針 １１２ シャフト本体 １１４ 先端 １１５ 先端 １１６ 管 １１８ 中央内孔 １２０ 導線 １２２ コーティング １２３ 電導性末端 １２４ 接着剤 １２５ 電導性端部 １２６ 針組立 １３０ 電導性材料 １３２ コーティング １３４ 皮下針 １３６ 内側電導管 １３８ 内穴 １４２ 外側電導性コーティング １４４ シャフト １４６ 中央部分 １４８Ａ 導体 １４８Ｂ 導体 １５０ シャフト １５２ ベース １５６ ねじ付きロッド １５８ モータ １６０ ベース １６２Ａ ロータ １６２Ｂ ロータ １６４ モータ １６６ リンク １６８Ａ 連結アーム １６８Ｂ 連結アーム １７０ ロータ １７２ モータ １７６Ａ １次スプリングコイル １７６Ｂ ２次スプリングコイル １７７ ディスク １７８ 出っ張り １８０ ハウジング １８２ ドライバ １８４ 圧電振動子 １８６ ピストン １８７Ａ チャンバ １８７Ｂ チャンバ １８８ ピストンハウジング １９０ 遠位流体導管 １９２ 基部流体導管 １９４ 流体入口導管 １９６ 多路弁
───────────────────────────────────────────────────── フロントページの続き (72)発明者 ヒューレット・イー・メルトン・ジュニア アメリカ合衆国 カルフォルニア州，サニ ーベイル，ロイヤル・アン・ドライヴ 1138 (72)発明者 タッド・デカタウアー・サイモンス アメリカ合衆国 カルフォルニア州，パ ロ・アルト，ウォルター・ヘイス・ドライ ヴ 155 (72)発明者 ミカエル・グリーンステイン アメリカ合衆国 カルフォルニア州，ロ ス・アルトス，コヴィングトン・ロード 860

Claims (1)

    【特許請求の範囲】
  1. 【請求項１】 物体表面の下の深さによって変化するイ
    ンピーダンスを有する前記物体中への針入用シャフトを
    備えた装置において、 （ｉ） 針入先端を有するシャフト本体と、 （ｉｉ）前記先端に近接した第１および第２の電導性端
    末と、 から成り、電導性端末の間の物体の材料のインピーダン
    ス変化を検知して針入深さについての情報をもたらすよ
    うにしたシャフトを含んで成る装置。
JP08248799A 1998-03-30 1999-03-25 皮膚針入装置 Expired - Fee Related JP4406706B2 (ja)

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US09/050,853 US6391005B1 (en) 1998-03-30 1998-03-30 Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US09/050-853 1998-03-30

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JPH11309124A true JPH11309124A (ja) 1999-11-09
JPH11309124A5 JPH11309124A5 (ja) 2006-05-25
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JP2021142213A (ja) * 2020-03-13 2021-09-24 朝日インテック株式会社 穿刺針、針カテーテル、及び、カテーテルシステム

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US8439872B2 (en) 2013-05-14
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US6391005B1 (en) 2002-05-21
DE19914485A1 (de) 1999-11-18
US7780631B2 (en) 2010-08-24
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US20100228194A1 (en) 2010-09-09
GB2335990A (en) 1999-10-06

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