JP2005505360A - 積層接着性光学センサ - Google Patents

積層接着性光学センサ Download PDF

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JP2005505360A
JP2005505360A JP2003534894A JP2003534894A JP2005505360A JP 2005505360 A JP2005505360 A JP 2005505360A JP 2003534894 A JP2003534894 A JP 2003534894A JP 2003534894 A JP2003534894 A JP 2003534894A JP 2005505360 A JP2005505360 A JP 2005505360A
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cover layer
disposed
emitter
detector
sensor
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マイケル パトリック オネイル，
ポウル ディー． マンハイマー，
ロドニー チン，
アドナン マーチャント，
ジョセフ コークレイ，
ドン ハンヌラ，
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ネルコアー ピューリタン ベネット インコーポレイテッド
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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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/68335—Means for maintaining contact with the body using adhesives including release sheets or liners
    • 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
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A61B5/6819—Nose
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips
    • 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
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/684—Indicating the position of the sensor on the body
    • A61B5/6841—Indicating the position of the sensor on the body by using templates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/14—Coupling media or elements to improve sensor contact with skin or tissue
    • A61B2562/146—Coupling media or elements to improve sensor contact with skin or tissue for optical coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • 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
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A61B5/02427—Details of sensor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3144—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths for oxymetry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Abstract

カバー層、カバーの第１の側面上に配置するエミッタ、カバーの第１の側面上に配置するディテクタ、および、カバーの同じ第１の側面上に配置する複数の積層独立接着層を有する光学センサ。ここで、最上部を露出した接着層が、患者の肌に取り付けられる。このように、組織位置の位置チェックを実行するセンサが取り除かれる場合、接着層の１つも取り除かれ、かつ、処分される、患者の肌に再取り付けするために、フレッシュな接着表面を下に露出する。接着層の独立ピースは、製品の使用年数を拡張するために連続して利用され得る。
【選択図】図１

Description

【技術分野】
【０００１】
（関連出願の相互参照）
本願は、２００１年１０月１２日に出願された米国仮特許出願第６０／３２８，９２４号の優先権を主張する。この出願の教示を、本明細書において参照として援用する。
【背景技術】
【０００２】
本発明は、光学センサに関し、特に、パルスオキシメータセンサに関する。
【０００３】
多くのタイプの光学センサが、患者の生理学的特徴を計測するために利用される。通常、光学センサは、患者の組織の一部分を介して散乱し、かつ、検出される放射光を提供する。酸素飽和率、パルス率、組織ビリルビリン等のような様々な患者の特徴は、このような光を解析することから決定され得る。
【０００４】
パルス酸素計測は、通常、動脈血のヘモグロビンの血中酸素飽和率、組織を供給する各血液脈動の容積、および、各患者の鼓動に対応する血液脈動の速度等の（これらに限定されない）、様々な血流の特徴を計測するために利用される。これらの特徴の計測は、非侵入性センサの利用によって達成された。非侵入性センサは、血液が組織に潅流する、患者の組織の一部分を介して光を散乱させ、このような組織の光の吸収を光電子的に感知する。吸収された光の量は、計測される血液の構成物質の量を計算するために利用される。
【０００５】
組織を介して散乱した光は、血液中に存在する血液構成物質量の代表的な量で、吸収された１つ以上の波長を有するように選択される。組織を介して散乱した伝達される光の量は、組織の血液構成物質の量および関連した光の吸収量を変化させることによって、変動する。このようなセンサは、血中酸素飽和率を計測する公知の技術に従って、通常光源およびフォトディテクタとともに提供される。光源は、血中酸素レベルを計測するために、少なくとも２つの異なる波長の光を発生させることに適応する。フォトディテクタは、これらの波長の両方を感知する。
【０００６】
公知の非侵入性センサは、指、耳、または頭皮のような身体の一部分に対して安全であるデバイスを備える。動物およびヒトでは、これらの身体の部分の組織は、血液により潅流され、これらの組織表面は、センサに対して容易にアクセス可能である。
【０００７】
あるタイプの光学センサが、センサ上の接着層によって実現される、接着性取り付け具によって患者の外部の組織に付加される。患者をモニタリングする間に、組織の位置のサイトチェックを実行するために、サンサを除去する必要はない。この除去は、通常、接着層に損傷を与える。さらに、接着タイプのセンサは、多くの場合、使い捨てタイプのセンサにより利用される。使い捨てタイプのセンサでは、光エミッタおよびディテクタは、相対的に固定されたエミッタおよびディテクタの分離を維持する硬い光学マウントの特権（ｂｅｎｅｆｉｔ）なく、支持体上にマウントされる。
【発明の開示】
【発明が解決しようとする課題】
【０００８】
従って、接着性タイプ光学センサの機能を改良する必要がある。
【課題を解決するための手段】
【０００９】
（発明の要旨）
本発明は、カバー層、カバーの第１の側面に配置されるエミッタ、カバーの第１の側面に配置されるディテクタ、および、カバーの同じ第１の側面に配置される複数の積層方独立接着層を有する光学センサを提供する。ここで、最上部の露出した接着層は、患者の肌に取り付けられる。従って、センサが組織の位置のサイトチェックを実行するために除去される場合、接着層の１つが除去かつ破棄され得、患者の肌への再取り付けのために下のフレッシュな接着性表面を露出する。接着層の独立ピースは、製品の寿命を拡張するために連続して利用され得る。
【００１０】
本発明のある局面は、エミッタおよびディテクタを囲むおおよそ環状の接着層を利用することにつながり、従って、エミッタとディテクタとの間にいくらかの接着剤が存在することを避け、光学分路を最小化する。光学分路は、計測精度に不利な影響を与えるものとして知られている。
【００１１】
本発明の別の局面は、光学的に透明なＰＶＣ材料のようなソフトまたは従順な材料から作られる光学レンズを利用し、組織壊死を最小化することにつながる。
【００１２】
本発明の別の局面は、半剛体光学マウント構造の利用につながる。半剛体光学マウント構造により、定位置にエミッタおよびディテクタを保持して、相対的に固定された電子光学機器（エミッタおよびディテクタ）の間の分離を維持し、さらに、センサが付加された場合に、最小量のトルクおよびねじれが生じることを可能にする。相対的に固定された分離を維持することによって、半剛体光学マウントは、検出された電子光学信号のアーティファクトを誘導する運動を低減する。この電子光学信号は、計測精度に不利に干渉を与え得る。本発明の本質および利点のさらなる理解のために、添付の図面に関連する以下の説明に対する参照がなされるべきである。
【発明を実施するための最良の形態】
【００１３】
図１は、本発明の実施形態によるセンサ１００の分解図である。センサは、センサートップ１またはカバー層を含み、センサートップ１またはカバー層は、センサが患者の肌に取り付けられる場合に、周囲の環境にさらされる。ある実施形態では、カバー層１は、通常のＰＶＣ発砲から製造される。もしくは、カバー層１は、ウレタン発砲材料、特にオープンセル通気性ウレタン発砲から製造される。このウレタン発砲は、例えば、ＣｏｎｎｅｃｔｉｃｕｔのＲｏｇｅｒｓ ｃｏｒｐｏｒａｔｉｏｎより市販のウレタンのＰＯＲＯＮ（登録商標）類である。好ましくは金属化されたプラスチック膜を含むマスク層２が、カバー層１の接着するように取り付けられる。好ましい実施形態では、金属化されたマスク層２は、カバー層１に取り付けるために合成接着層によりアルミニウム処理されたポリプロピレン膜である。金属化されたマスク層２は、フォトディテクタ７と干渉することを妨げ、２次的な光を最小化または拒絶するように配置される。本明細書中で用いられるように、２次的な光は、エミッタ１１以外のソースから発生する全ての光を含み、周辺または手術用光源を含むソースから発生した可能性のある光の全てを含む。エミッタ１１は、患者の肌に所定の波長の光を導くように構成される。患者の肌に導かれた光は、患者の組織を介して散乱し、体内に存在する血液構成物質の量を表す量の血液によって吸収される１つ以上の波長となるように選択される。フォトディテクタ７はまた、マスク層２の上に配置され、エミッタ１１に隣接して、患者の組織を介して拡散した光の量を検出する。患者の組織を介して拡散した光の量は、組織内の血液構成成分の量および関連する光の吸収の変化に応じて変動する。
【００１４】
血液酸素レベルを計測するために、エミッタは、血中酸素飽和率を計測する公知の技術に従って、少なくとも２つの波長の光を発生させることに適応する。血中酸素飽和率に適応する場合、センサは、大人の患者に対してのみ利用可能であるわけではなく、新生児および小児患者に利用することにも適応する。新生児および小児用途への適応は、患者のジオメトリおよび肌の特徴とより適合するサイズおよび／または接着材料の調整を含み得る。さらに、センサは、選択的に異なる波長のエミッタを利用し得、従って、低血中酸素飽和率でより正確な読み取りをもたらすエミッタとディテクタとの組み合わせを利用し得、これは、いくつかの患者の場合である。低酸素飽和率の範囲に対して最適化される光源は、本明細書の出願人に譲渡された「Ｐｕｌｓｅ Ｏｘｉｍｅｔｅｒ ａｎｄ Ｓｅｎｓｏｒ Ｏｐｔｉｍｉｚｅｄ ｆｏｒ Ｌｏｗ Ｓａｔｕｒａｔｉｏｎ」と称する米国特許第５，７８２，２３７号に記載される。この明細書は、その全体を本明細書中で参照として援用される。
【００１５】
ファラデー遮蔽体５は、フォトディテクタ７の前面に配置され、外部電界の効果を低減する。外部電界は、フォトディテクタからの電気信号に不利になるような影響を与え得る。半剛体光学マウント構造６は、マスク層２の上に配置され、固定されたエミッタ１１とディテクタ７との間の分離を維持する態様で、エミッタ１１およびディテクタ７を囲み、かつ、保持して、さらに、センサが患者に付加された場合、ある最小量の屈曲およびねじれが生じることを可能にする。半剛体光学マウントが定位置にない場合、多くの場合、トルクがエミッタ１１とディテクタ７との間の方向の変化を生じさせ得、これは、較正および運動誘発アーティファクトの変化を介してセンサにより得られる計測の精度と干渉し得る。ある実施形態では、半剛体光学マウント６が、黒のポリプロピレン材料から製造される。光学マウントの黒色はまた、エミッタとディテクタとの間の光学分路の可能性を低減し、これはまた、計測の不正確さをもたらし得る。ウィンドウまたはレンズ４は、適切な接着剤を利用してディテクタおよびエミッタに１つずつ取り付けられるか、または、結合され（例えば、紫外線硬化接着工程）、エミッタ１１から組織へ放射し、組織から収集去れ、かつ、ディテクタ７に導かれる光を結合することを手伝う。ある実施形態では、レンズ４は、光学減衰を最小化する光学的に透明なプラスチック材料から作られる。別の実施形態では、レンズ４は、透明なＰＶＣ、ウレタン、または室温加硫（ＲＴＶ）材料等の従順な材料から作られる。レンズに従順な材料を選択する選択肢は、センサが患者に適応された場合に、肌の壊死の可能性を妨げることを要望することによって推進される。好ましくは、従順な材料が、Ｓｈｏｒｅ Ａ デュロメータスケールで６０より小さい硬さを有する。もしくは、このレンズに加えて、エミッタおよび／またはディテクタ構成はまた、光学拡散器を含み得る。光学拡散器を利用することの利点は、センサが組織異質性に対する感度がより低くなることであり、従って、より均一かつより正確な結果を提供する。
【００１６】
マスク層３は、マスク層３より下の部分に接着するように接続される。マスク層３は、マスク層３よりも下に配置される光学マウント６を介してフィットし、かつ、この光学マウント６を取り囲む開口部を内部に有する。マスク３は、接着層のスタックを後で取り付けるために、実質的に平らなプラットフォームとして機能する。ある実施形態では、マスク層は、ＰＯＲＯＮ（登録商標）類等のセルラーウレタン発砲から形成され、圧力感知接着剤を利用してカバー層１に取り付けられる。最後に、接着層８、９および１０のスタックは、マスク層３の上に配置される。最下位の接着層９が、アクリルトランスファー接着剤を利用してマスク層３に取り付けられる。ある実施形態では、３つの接着層のスタックが、マスク層３の上に配置され、他の複数の積層型接着層がまた、本発明の実施形態の範囲内となる。
【００１７】
ある実施形態では、接着層は、エミッタ１１とフォトディテクタ７との間に接着層が存在しないように、リング形状であり、これにより、フォトエミッタとフォトディテクタとの間の光学分路を最小化する。光学分路は、計測の不正確さをもたらすものとして知られる。接着層またはリングは、患者の組織に取り付けるために、一側面上のアクリルの接着剤を有するポリエチレン膜から製造され得る。あるいは、接着層またはリングは、両側面接着層を有していてもよく、この場合、接着層は、リリース層（例えばリリースペーパー）によって他方から分離される。積層型または扇形に広がるアレイに構成された非接着性タブ部分（例えば、８ａ）を含み、臨床医が以下の層をさらすために用いられた接着層を容易に接着かつ除去することが可能となる。タブ部分は、非接着性の色のついたタブ（例えば、緑、黄、赤、ラベンダー、オレンジ）であってもよく、接着リングを容易に除去することが可能になる。もしくは、別のリリース層（示されない）が、接着層のスタックの上に配置され、まさに第１の接着層を覆う一方で、このリリース層は、ストレージ中にある。
【００１８】
ある実施形態では、接着リングは、反射光を最小化するように黒であり、光学ベースの計測の精度に影響を与えるものとして知られている。ある実施形態では、接着リングは、熱安定であり、それにより、リング間の接着性は、熱にさらされた結果、損なわれない。さらに、接着リングは、リングの背面に、例えば、低分子量のシリコンオイル等の剥離剤を含み得、隣接するリングが別のリングと固着することを最小化するか、または、防ぐ。ある側面にアクリルの圧力感知接着剤を有する連続０．００１インチの厚さのポリエチレン膜を含む、様々な別のリング構成が利用され得る。連続膜は、ポリエステル、ポリイミドまたはテフロン（登録商標）等のほかの材料から作られ得、特定の強度、剥離力および温度安定性の要件を達成する。この膜の表面に利用される接着剤は、アクリル、合成ゴム、天然ゴム（例えば、ラテックス）または他の毒性のない接着剤であり得る。このリングは、キャリア膜としてある側面に剥離剤を有するペーパーを含み得る。このことは、各リリース線上に、「接着層＃１」のようなユーザ情報をプリントすることを可能にし、または、黒のインクが付けられ得、光学分路を制御する。
【００１９】
もしくは、接着リングは、リング形状である必要はなく、光学分路を最小化するためにエミッタとディテクタとの間の黒いストリップを有する、連続接着性表面であってもよい。
【００２０】
接着層の予め取り付けられたスタックは、使い捨て接着型センサという拡張された用途を可能にする。センサに対する所望の特性は、周期的に（例えば、１２時間ごとに１回）センサの位置をチェックする能力であり、何日かの間連続して使用することができる能力を維持することである。患者の肌に接着するように取り付けられた従来の使い捨てセンサでは、接着性の劣化およびセンサ取り付け位置の下の組織のかさぶた（ｓｌｏｕｇｈｉｎｇ）性質により、センサの位置を変える複数のサイクルは不可能であった。この機能不全の再取り付けは、完全なセンサの再配置を必要とした。これは、患者モニタリング手続きのコスト全体を増大させる。しかし、予め取り付けられた接着リングのスタックの利用により、位置チェックを実行するセンサが取り除かれた場合、接着層の１つもまた取り除かれ得、フレッシュな接着性表面を下にさらす。従って、連続的に利用される接着層の幾つかの独立したピースを有することは、製品の耐用年数を拡張し、患者モニタリング手続きのコスト全体を低減する。
【００２１】
図２は、組み立てられたセンサ１００の透視図である。この図（図２）は、最上部接着層８と、フォトエミッタ１１およびフォトディテクタ７を覆うレンズ４とを示す。さらに、図２は、センサ１００に取り付けられたケーブル１４を示す。タブポーション１ａおよび１ｂ（図１に示される）は、ケーブル１４のまわりを包み、安定した態様でケーブルおよびセンサを保持する。ケーブル１４は、トレースまたはワイヤ（示されない）を介してフォトエミッタ１１およびディテクタ７を取り付ける。
【００２２】
図３は、図２の実施形態の上面図である。図３もまた、最上部接着層８と、フォトエミッタ１１およびフォトディテクタ７を覆うレンズ４を示す。さらに、図２は、センサ１００に取り付けられたケーブル１４を示す。図４は、図３の「Ａ−Ａ」の断面図を示す。図４は、カバー層１、最上部接着層８およびレンズ４を示し、これは、フォトエミッタ１１およびフォトディテクタ７の上に配置される。図４から理解されるように、センサ１００は、実質的に平坦であるが、レンズ４は、センサの平面から外側に突出する。従って、取り付けられる際に、このレンズは、患者の組織位置（例えば、額）を押し、緩やかに肌を押すことによって、光結合および光学浸透深度を向上させる。レンズは、センサ平面から外側に突出しているので、隣接する接着層は、必然的に、患者の組織の位置からオフセットしているかまたは離れている平面上に横たわり、それにより、使用中に肌へレンズを「引っ張る」。このことは、センサと組織との間の良好な光学コンタクトを保証し、光分路の潜在的な寄与を低減する。
【００２３】
図５は、ヒンジリッドを有する本発明のセンサ２００の別の実施形態の透視図である。センサ２００は、接着側面を有するリング形状層２０２を含み、この接着側面は、モニタリングの間に患者に取り付けられるように構成される。センサ２００はまた、ヒンジリッド２０４を含み、ヒンジリッド２０４は、上述のようにフォトエミッタおよびフォトディテクタ（示されない）を含む必要な電子光学機器を保持する。ヒンジリッド２０４は、ヒンジ接続２０８によってリング形状の接着層２０２に結合され、ヒンジ接続２０８は、患者からセンサを取り除く必要なく、センサ位置のリフティングおよびチェックを可能にする。ケーブル２１０は、センサの適切な動作のために、フォトディテクタおよびフォトエミッタに接続されるリードおよびワイヤを提供する。クラスプ２０６は、患者のモニタリングに効果的な位置にヒンジリッド２０４を固定する。クラスプ２０６はまた、センサ位置をチェックするために、ヒンジリッド２０４を臨床医がリフティングすることによって利用される。ある実施形態では、クラスプ２０６は、リング形状層２０２を接着するように係合する。別の実施形態では、クラスプ２０６は、機械的クラスプタイプの接続を介して、リング形状の層と係合する。リング形状層２０２はまた、上述の積層接着構成を組み込み、患者にセンサの取り外しおよび再取り付けの繰り返しを可能にする。
【００２４】
図６は、位置チェック中に患者に位置付けられた図５のセンサを示す図である。この図（図６）から理解されるように、リング形状層２０２は、患者に接着するように取り付けられる一方、フォトエミッタ２１２およびフォトディテクタ２１４を含むヒンジリッド２０４は、センサ位置の下の組織の位置をチェックすることを可能にするように、患者の額からリフティングされる。ケーブル２１０は、センサの適切な動作のために、フォトディテクタおよびフォトエミッタに接続されたリードおよびワイヤを提供する。
【００２５】
本発明の複数の積層接着層の実施形態およびヒンジリッドの実施形態はまた、任意の使い捨てセンサ、特に使い捨てオキシメータセンサの動作を改良するために利用される。これらの使い捨てセンサは、組織からディテクタへの光の反射に基づくセンサ（組織の同じ側に配置されるエミッタとディテクタにより上述された）、および、透過型センサ含む。ここで、エミッタおよびディテクタは、調査される組織位置の反対側に配置される。複数の積層接着層の実施形態またはヒンジリッドの実施形態を組み込み得るセンサの例は、様々な組織位置（Ｄ−２０、Ｄ−２５、Ｎ−２５、Ｉ−２０、Ｒ−１５のような指の先端、脚、鼻、および額の位置を含む）で利用する接着性の再利用可能なセンサ、ならびに、本願の出願人によって製造されているＡ、Ｎ、Ｉ、およびＰシリーズのセンサを含む。
【００２６】
さらに、本発明の複数の積層接着層の実施形態およびヒンジリッドの実施形態は、大人の患者に対してのみ利用可能であるのではなく、肌の荒れ（ｔｅａｒｉｎｇ）の発生を最小化するソフトゲル接着剤を利用することがときどき好ましくなるような患者に対しても利用可能である。このような患者は、老人、小児または新生児の患者を含む。光学センサのソフトゲルの含有は、本明細書中においてその全体を参照として援用する、本明細書の出願人に譲渡された「Ｇｅｌ Ｐａｄ Ｏｐｔｉｃａｌ Ｓｅｎｓｏｒ」と称する米国特許第５，８３０，１３６号に記載される。ソフトゲル接着剤の別の実施形態は、単一の接着層（積層されない）のみを含む。なぜなら、いくつかのゲル材料は、接着特性をリフレッシュする水または溶剤により洗浄され得るからである。このように、ゲル接着剤の複数の層の利用は、各患者に複数のセンサを設置することを必要とし得るが、これに限定されない。
【００２７】
当業者に理解されるように、本発明は、本発明の本質的な特徴から逸脱することなく、他の特定の形式で実現され得る。例えば、使い捨てセンサは、額または鼻センサであってもよいし、センサは、大人、小児、または新生児の患者に利用するように構成されてもよいし、センサは、積層型の態様で構成された接着層のいくつかの可能な構成を利用してもよい。これらの他の実施形態は、添付の特許請求の範囲で規定される本発明の範囲内に含まれることが意図される。
【図面の簡単な説明】
【００２８】
【図１】図１は、本発明の実施形態によるセンサ１００の分解図である。
【図２】図２は、本発明の実施形態によるセンサの透視図である。
【図３】図３は、図２の実施形態の上面図である。
【図４】図４は、図３の「Ａ−Ａ」の断面図である。
【図５】図５は、ヒンジ式リッドを有する本発明のセンサの別の実施形態の透視図である。
【図６】図６は、サイトチェック中の患者に位置付けられた図５のセンサを示す図である。

Claims (31)

  1. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層と
    を含む、センサ。
  2. 前記接着層のそれぞれは、前記エミッタおよび前記ディテクタを囲むリング形状層であり、接着剤が該エミッタとディテクタとの間に存在しない、請求項１に記載のセンサ。
  3. 前記エミッタの上に配置する第１のレンズと、前記ディテクタの上に配置する第２のレンズとをさらに含み、該第１および第２のレンズは、光学的に透明かつ従順な材料から作られる、請求項１に記載のセンサ。
  4. 前記従順な材料は、ＰＶＣ、ウレタン、ＲＴＶ、およびその組み合わせからなる材料の群から選択される光学的に透明な材料である、請求項３に記載のセンサ。
  5. 前記従順な材料は、光学的に透明であり、およそ６０より短いＳｈｏｒｅ Ａのデュロメータ硬さを有する、請求項３に記載のセンサ。
  6. 前記センサは、実質的に平坦な表面を含み、前記エミッタおよびディテクタは、該実施時的に平面な表面から外側へ突出している、請求項１に記載のセンサ。
  7. 前記センサは、患者の額の極率に適合するように構成された湾曲した表面を有し、前記エミッタおよび前記ディテクタは、該湾曲した表面から外側に突出している、請求項１に記載のセンサ。
  8. 前記湾曲した表面は、新生児または小児患者の額の湾曲に適合するように構成される、請求項７に記載のセンサ。
  9. 前記カバー層上に配置する実質的に堅い光学マウントをさらに含み、該光学マウントは、第１および第２の開口部を有する、該第１および第２の開口部は、前記エミッタおよび前記ディテクタのそれぞれを囲む、請求項１に記載のセンサ。
  10. 前記カバー層と前記ディテクタとの間に配置する光学的に透明な層をさらに含む、請求項１に記載のセンサ。
  11. 前記センサは、オキシメータセンサである、請求項１に記載のセンサ。
  12. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、センサ。
  13. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該エミッタの上に配置する第１のレンズと、
    該ディテクタの上に配置する第２のレンズであって、該第１のおよび第２のレンズは、従順な材料から作られる、レンズと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層と
    を含む、センサ。
  14. 前記ソフト材料は、ＰＶＣ、ウレタン、ＲＴＶ、およびその組み合わせからなる材料の群から選択される光学的に透明な材料である、請求項１３に記載のセンサ。
  15. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該センサは、実質的に平坦な表面を含み、該エミッタおよび該ディテクタは、該実質的に平坦な表面から外側に突出している、複数の積層独立接着層と
    を含む、センサ。
  16. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層と
    を含む、センサ。
  17. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層と、
    該カバー層と該ディテクタとの間に配置する光学的に透明な層と
    を含む、センサ。
  18. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、センサ。
  19. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該エミッタの上に配置する第１のレンズと、
    該ディテクタの上に配置する第１のレンズであって、該第１および該第２のレンズは、従順な材料から作られ、該ソフト材料は、光学的に透明なＰＶＣである、第２のレンズと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、センサ。
  20. 前記センサは、オキシメータセンサである、請求項９〜１５のいずれか１つの記載のセンサ。
  21. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層と
    を含む、オキシメータセンサ。
  22. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、オキシメータセンサ。
  23. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、オキシメータセンサ。
  24. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該エミッタの上に配置する第１のレンズと、
    該ディテクタの上に配置する第１のレンズであって、該第１および該第２のレンズは、従順な材料から作られ、該ソフト材料は、光学的に透明なＰＶＣである、第２のレンズと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置する複数の積層独立接着層であって、該接着層のそれぞれは、該エミッタおよび該ディテクタを囲むリング形状の層であり、該エミッタと該ディテクタとの間に接着剤が存在しない、複数の積層独立接着層と
    を含む、オキシメータセンサ。
  25. おおよそ環状のベースであって、患者のある組織位置に取り付けるように構成される、ベースと、
    端部が該ベースの近接した端部にヒンジ接続されたリッドと、
    該リッドの第１の側面の上に配置するエミッタと、
    該リッドの該第１の側面の上に配置するディテクタと、
    該リッドの離れた端部に接続されるクラスプであって、該ベースの遠い端部と係合するように構成される、クラスプと
    を含む、センサ。
  26. 患者のある組織位置に取り付けるために、前記おおよそ環状のベースの第１の側面の上に配置する接着層をさらに含む、請求項２５に記載のセンサ。
  27. 患者のある組織位置に取り付けるために、前記おおよそ環状のベースの第１の側面の上に配置する複数の積層独立接着層をさらに含む、請求項２５に記載のセンサ。
  28. 前記センサは、第１のモードおよび第２のモードで動作するように構成され、
    該第１のモードにおいて、前記クラスプは前記ベースと係合し、前記リッドおよび前記ベースは一緒に実質的に平坦なセンサを形成し、
    該第２のモードにおいて、該クラスプは、該ベースから係合が解除され、該リッドは、前記組織位置からリフティングされる、請求項２５に記載のセンサ。
  29. 前記センサは、オキシメータセンサである、請求項２５に記載のセンサ。
  30. カバー層と、
    該カバー層の第１の側面の上に配置するエミッタと、
    該カバー層の該第１の側面の上に配置するディテクタと、
    該カバー層の上に配置される実質的に硬い光学マウントであって、該光学マウントは、第１および第２の開口部を有し、該第１および第２の開口部は、該エミッタおよび該ディテクタをそれぞれ囲む、光学マウントと、
    該カバー層の該第１の側面の上に配置するソフトゲル接着層であって、該ゲル接着層は、該エミッタおよび該ディテクタを囲むリング形状層であり、該エミッタと該ディテクタとの間にゲルが存在しない、ソフトゲル接着層と
    を含む、オキシメータセンサ。
  31. 前記ゲル接着層は、２つ以上の別個の層からなる、請求項３０に記載のセンサ。
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US8433383B2 (en) 2013-04-30
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US20030109775A1 (en) 2003-06-12
US20140135600A1 (en) 2014-05-15
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US6748254B2 (en) 2004-06-08
WO2003031961A3 (en) 2003-12-04
WO2003031961A2 (en) 2003-04-17
JP2010155159A (ja) 2010-07-15
US20040199063A1 (en) 2004-10-07
US9351685B2 (en) 2016-05-31
US7113815B2 (en) 2006-09-26
EP2294973A2 (en) 2011-03-16
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US20060276700A1 (en) 2006-12-07
JP5410357B2 (ja) 2014-02-05

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