JPH07275227A - 経皮センサ挿入セット - Google Patents
経皮センサ挿入セットInfo
- Publication number
- JPH07275227A JPH07275227A JP7055585A JP5558595A JPH07275227A JP H07275227 A JPH07275227 A JP H07275227A JP 7055585 A JP7055585 A JP 7055585A JP 5558595 A JP5558595 A JP 5558595A JP H07275227 A JPH07275227 A JP H07275227A
- Authority
- JP
- Japan
- Prior art keywords
- sensor
- patient
- needle
- percutaneous
- distal portion
- 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
Links
Classifications
-
- 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
- A61B5/1486—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 enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—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 enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- 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
- A61B5/6849—Needles in combination with a needle set
-
- 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
- A61M25/02—Holding devices, e.g. on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0206—Holding devices, e.g. on the body where the catheter is secured by using devices worn by the patient, e.g. belts or harnesses
Abstract
態で患者のセンサを迅速且つ容易に設置するのに適した
センサ挿入セットを提供する。 【構成】 挿入セット10は、患者の皮膚36の上に取
り付ける取付用ベース34を貫通して延びる挿入針14
を有する。可撓性薄膜センサは、取付用ベース34で支
持され且つモニタ32に電気的に接続される導電性コン
タクト30を形成する近位部28と、取付用ベース34
から突出し、センサ電極18を備えた遠位部16とを有
する。センサ12の近位部28及び遠位部16は直線的
にオフセットされ、取付用ベース4を患者の皮膚36上
に押し付けたときに、挿入針14を用いた経皮的なセン
サの設置のために、遠位部16は挿入針14の内部に嵌
合される。次いで、挿入針14は引き抜かれ、センサ電
極18が患者の血液等と接触した状態で、所定の挿入位
置にセンサ遠位部16を残す。
Description
患者の身体内の所定の箇所におくための装置及び方法に
関する。より詳しくは、本発明は、例えば周期的な血中
ぶどう糖の読み取りを得るのに用いられる種類の可撓性
薄膜センサの迅速且つ容易な経皮的設置のための改良さ
れた且つ比較的単純な挿入セットに関する。
び/又は定量する医学上の適用例を含む、ある範囲の適
用例のために、種々の電気化学センサが開発されてき
た。一つの例として、糖尿病患者の血中ぶどう糖濃度の
指標を得るのに用いられるぶどう糖センサが開発され
た。このような読み取りは、患者へのインシュリンの定
期的な投与を典型的に包含する治療上の規制をモニタ及
び/又は調整するのに特に有益である。これに関し、血
中ぶどう糖の読み取りは、米国特許第 4,562,751号、同
特許第 4,678,408号、同特許第 4,685,903号で一般的に
説明されているような外部式の半自動薬剤注入ポンプあ
るいは米国特許第 4,573,994号で一般的に述べられてい
るような自動薬剤注入ポンプに関連して特に有益であ
る。
細胞外の液体と直接接触する状態でのセンサ電極の皮下
設置のために、比較的小さな且つ可撓性の電気化学セン
サが開発された。ここに、このようなセンサは、長い期
間にわたって周期的な読み取りを得るのに用いることが
できる。一つの形態では、可撓性経皮センサが薄膜マス
ク法によって作られ、ここでは、細長いセンサは、ポリ
イミドシートあるいはこれに類した材料からなる可撓性
絶縁層間に包囲された薄膜導電要素を有する。このよう
な薄膜センサは、典型的には、患者の血液等に直接接触
した状態での経皮的な設置のために遠位端に設けられた
露出した電極と、適当なモニタ機器と都合のよい電気的
な接続のための外部に位置する近位端に設けられた露出
した導電性コンタクトとを有する。このような薄膜セン
サは、患者をモニタする適用例では、重大な約束を持っ
ているが、不幸にも、センサ電極を患者の血液あるいは
他の細胞外の液体と直接接触した状態で経皮的に設置す
るのが困難であった。
あるいは他の細胞外の液体と直接接触した状態で患者に
センサを迅速且つ容易に設置するのに適したセンサ挿入
セットおよび関連した薄膜センサに関する。
気化学センサのような可撓性センサを患者の身体の所定
の箇所におくための皮下挿入セットが提供される。この
挿入セットは、患者の皮膚に着座した取り付けを行うよ
うになった取付用ベースを貫通するスロット付きの挿入
針を有する。可撓性薄膜センサは、取付用ベースによっ
て支持された近位部と、取付用ベースから突出し且つセ
ンサ電極を有する遠位部とを有する。センサの近位部お
よび遠位部は直線的にオフセットつまり非整列され、取
付用ベースを患者の皮膚に押し付けると、経皮的な設置
のために遠位部がスロット付き挿入針内に嵌合される。
挿入はりを取付用ベースから引き抜いて、患者内の位
置、例えば、皮下、血管内、筋肉内あるいは静脈内の箇
所にセンサ遠位部を残すことができる。センサ近位部の
導電性コンタクトは、適当なモニタ機器に電気的に接続
可能であり、この結果、適当な血中の化学的な読み取り
を得ることができる。
位部は、一般的に、平行にオフセットした関係で形成さ
れ、それらの間を傾斜して延びる短い移行部を備えてい
る。取付ベースを患者の皮膚の上に着座させたときに、
近位部は、患者の皮膚とほぼ平行に配置される状態の取
付ベースに取り付けられる。スロット付き挿入針内のほ
ぼ同軸な位置にセンサ遠位部を受入れるために、センサ
の移行部は傾斜して折り曲げられている。センサが挿入
針から横方向に分離するのを防止するために、硬化した
エポキシのビードのような保持部材が、センサ遠位部に
支持されていてもよい。
設置した上で、挿入針を患者の皮膚に突き刺すと、可撓
性センサの遠位部は、経皮的に配置される。次いで、挿
入針を患者および取付ベースから引き抜くことができ
る。このような引き抜きの間、挿入針はセンサ遠位部の
上をスライドし、これによりセンサ遠位部を所定の箇所
に残す。
は、センサ遠位部に設けられ且つそこから患者の外側の
外部位置まで延びる一本のチューブからなっていてもよ
い。このチューブは、小さなボアの内腔を形成し、この
内腔を、その後に、患者に薬剤を導入し、或いは、その
他に、周期的なセンサ較正作用のために、所定のセンサ
較正液をセンサ電極の近くに導入するのに用いてもよ
い。本発明の他の特徴および利点は、本発明の原理を例
示のために示す添付図面と共に次の詳細な説明から明ら
かになろう。
符号10で全体的に示す改良されたセンサ挿入セット
は、可撓性センサ12の患者の身体の所定の箇所での経
皮的な設置のために用意される。挿入セット10は、露
出した一以上のセンサ電極18を有するセンサ遠位部1
6の迅速且つ容易な経皮的設置のために、堅い中空の挿
入針14を有する。それゆえ、挿入針14は、センサ電
極18を上記所定の箇所に残すために引き抜き可能であ
る。
に、患者の状態を表す血液の特定のパラメータをモニタ
するのに用いられる種類の可撓性薄膜電気化学センサの
正確な設置を容易にするように設計されている。挿入セ
ット10は、患者の不快感および外傷を最小にする方法
で、センサを皮下に或いは患者の身体の所定の他の箇所
に設置するように設計されている。一つの好ましい適用
例では、センサ12は、血中ぶどう糖濃度をモニタする
ように設計されていてもよく、また、糖尿病患者にイン
シュリンを投与する米国特許第 4,562,751号、同第 4,6
78,408号、同第4,685,903号、同第 4,573,994号に開示
のような外部の或いは移植可能な種類の自動化された或
いは半自動化された薬剤注入ポンプと共に使用されても
よい。
電気化学センサ12は、いわゆる薄膜マスク法によっ
て、ポリアミドフィルムあるいはシートのような所定の
絶縁材料からなる上、下の層22、24の間に埋め込ま
れ又は包囲された細長い薄膜導体20を有するように構
成されている。センサを経皮的に設置したときに、患者
の血液と直接接触できるように、センサ電極18は遠位
部16の先端で上層22を介して露出されている。遠位
部16は、傾斜して延びる又はオフセットした移行部2
6によって、近位部28に連結されている。近位部28
の端は、導電性コンタクトパッド30で終わっており、
パッド30は、上側絶縁層22を介して露出されてい
る。この分野では既知のように、また、図1に概略的に
示すように、これらコンタクトパッド30は、センサ電
極18から送出された信号に応じて患者の状態をモニタ
する適当なモニタ32に、電気的に接続できるようにな
っている。この一般的な種類の可撓性薄膜センサの詳し
い説明は、本願(Docket番号 34279) と同時に出願し
た、同時継続している発明の名称「薄膜センサ組立方
法」の米国出願(MiniMed 社 Docket 番号MT-0222)で行
われており、これを本願に援用する。
上に設置できるようになった取付用ベース34によって
支持されている。図示のように、取付用ベース34は、
適当な感圧粘着剤40で被覆された下側面を有する細長
い且つほぼ矩形の可撓性発泡パッド38を有する(図
1)。挿入セット10を使用する準備が整うまで、粘着
層40を覆い且つ保護するために、通常、引きはがし紙
片42が設けられている。
サ12の近位部28は、可撓性パッド38と、その上の
支持プレート44との間に挟まれており、支持プレート
44は、可撓性パッド38に形成された直立するレール
46間に都合良く位置決めされている。近位センサ部2
8は、可撓性パッド38に形成されたキー孔スロット4
8内で下方に傾斜して折り曲げられた移行部26に連結
された最前端を有する。すなわち、図5に示すように、
キー孔スロット48は、円形孔の一側から半径方向に突
出する狭い且つ比較的まっすぐなスリットを有する。可
撓性センサ12の移行部26は、上記スリット内に下方
に傾斜して折り曲がり、その後、上記円形孔で横方向に
延びている。その一方で、移行部26は、遠位センサ部
16に連結されている。キー孔スロット48は、パッド
38を通って、約45度の角度で、傾斜して延びるよう
に示されているが、90度までの他の傾斜向きを用い得
ることは勿論である。
れた円形の針用ポート50を通って、更に、可撓性取付
パッド38のキー孔スロット48の円形孔を通って、滑
り嵌めで受け入れられるようになっている。図1、図2
に示すように、挿入針14は、尖った先端52と、先端
52から針の一側に沿ってその後端のハブ56の位置あ
るいはハブ56の近くまで長手方向に延びる開放した狭
いスロット54を有する。挿入針14は、支持プレート
44および取付用ベース34のキー孔スロット48に嵌
挿され、針のスロット54は、キー孔スロット48のま
っすぐなスリット部分に横方向に対面している。この構
成では、図4、図6に示すように、センサ遠位部16と
近位部28との間の移行部26が、針のスロット54を
通って横方向に突出し、センサの遠位部16は、挿入針
14内で同軸に整列されているが、センサの近位部28
に対して直線的に整列しておらず、オフセットされてい
る。
患者の身体の所定の箇所でのセンサ遠位部16の経皮的
な設置を迅速且つ容易にする。より詳しくは、パッド3
8から引きはがし片42(図1)を取り除き、このと
き、取付用ベース34を患者の皮膚に押し付けて固定す
ることができる。この工程中、挿入針14を患者の皮膚
36(図6)に突き通して、その中でセンサ遠位端16
を適当な経皮的な配置箇所まで支持する。挿入針14か
らのセンサ遠位部16のふとした横方向の分離を防止す
るために、エポキシ等からなる硬化したビードのような
保持部材58をセンサの遠位部16の長さ方向に沿った
一以上の位置に設置してもよい。これに関し、センサ1
2の厚みと結合した保持部材58は、針のスロット54
の幅よりも大きな寸法を形成し、これにより、針のスロ
ット54を通るセンサ12の横向きの分離を防止でき
る。
て、センサが経皮的に設置されると、挿入針14を患者
から引き抜くことができる。この引き抜き工程中、図7
に示すように、挿入針14は、センサ遠位部16の上を
スライドし、センサの電極18を所定の挿入箇所に残
す。センサの近位部28の導電性コンタクトパッド30
はモニタ32に適当に連結され、その結果、センサ12
は、糖尿病患者の血中ぶどう糖の読み取りのような血液
の化学的性質の読み取りのために、長時間にわたって使
用することができる。
実施例を示す。ここに、変形された保持部材158は、
センサ12に付着された一本の可撓性チューブの形で設
けられている。このチューブ158は、移行部26およ
び近位部28に沿って可撓性センサ12の輪郭に従うよ
うにして、挿入針14を介して患者の身体の外部の箇所
まで延びている。チューブ158は、所望のとき、患者
への薬剤投与のための都合のよい経皮的な内腔を提供す
る。その代わりに、チューブ158は、センサ電極18
の直前の箇所で、患者に、所定の較正液(calibration f
luid) を投与することのできる通路を形成する。これに
関して、センサ電極18を、周期的なぶどう糖濃度の読
み取りを得ることができるように設計すると、正確な血
中ぶどう糖の読み取りを確実にするために、これら電極
18の時々の再較正が必要となり、或いは、望ましい。
て、可撓性薄膜電気化学センサを患者の所定の位置に迅
速且つ簡単に設置するとができる比較的単純な装置を提
供する。スロット付きの挿入針によって、比較的狭いゲ
ージの針を使用することができ、これにより、患者の外
傷および関連する不快感を最小にする。
更あるいは改良は、当業者には明らかであろう。したが
って、特許請求の範囲で述べるようなことを除いて、上
記の説明および添付の図面によって本発明を限定する意
図はない。
入セットを示す斜視図。
示す拡大部分分解斜視図。
断面図。
の滑り嵌め組立体を示す拡大部分斜視図。
断面図。
断面図。
視図。
立られた挿入針おおびセンサを示す平面図。
Claims (15)
- 【請求項1】 患者の皮膚に取り付けるようになった取
付用ベースと、 該取付用ベースによって支持される近位部と、前記取付
用ベースから突出し且つ少なくとも1つのセンサ電極を
有する遠位部とを有し、前記近位部と前記遠位部とが互
いに関して非整列である可撓性センサと、 前記取付用ベースによってそこから突出するように支持
され、その中に前記センサの前記遠位部を受け入れる中
空挿入針とを有し、 前記挿入針が、前記取付用ベースおよび前記センサの前
記遠位部からの前記針のスライド引き抜きを許容するた
めに、その一側に沿って長手方向に延びるスロットを有
する、ことからなる経皮センサ挿入セット。 - 【請求項2】 前記センサが、更に、前記近位部と前記
遠位部とを横方向にオフセットした関係で相互連結する
移行部を有し、前記遠位部が前記針の中に受け入れられ
たときに、前記移行部は前記針のスロットを通って延び
る、請求項1の経皮センサ挿入セット。 - 【請求項3】 更に、前記センサ遠位部が前記針のスロ
ットを通って横方向に変位するのを防止するために、前
記センサ遠位部に設けられた保持部材を有する、請求項
1の経皮挿入センサ。 - 【請求項4】 前記保持部材が、硬化したエポキシのビ
ーズからなる、請求項3の経皮挿入センサ。 - 【請求項5】 前記保持部材が、前記センサ遠位部に連
結され且つセンサ遠位部を経皮的に配置したときに、セ
ンサ遠位部から患者の外側の位置まで延びる一本のチュ
ーブからなり、該チューブが、前記センサ電極に及びそ
れに近い位置から液を選択的に送るための経皮的な液体
流路を形成する、請求項3の経皮センサ挿入セット。 - 【請求項6】 前記センサが、可撓性薄膜センサであ
る、請求項1の経皮センサ挿入セット。 - 【請求項7】 前記センサが、電気化学センサである、
請求項1の経皮センサ挿入セット。 - 【請求項8】 前記センサが、ぶどう糖センサである、
請求項1の経皮センサ挿入セット。 - 【請求項9】 前記取付用ベース及び前記センサ遠位部
から前記挿入針を手で引き抜くのを容易にするために、
前記挿入針が、尖った先端と、そこに設けられたハブを
備えた後端とを有する、請求項1の経皮センサ挿入セッ
ト。 - 【請求項10】 前記挿入針が、該針の中に前記センサ
遠位部を滑り嵌めで受け入れるために前記センサ遠位部
とほぼ同軸に整列した状態で前記取付用ベースに形成さ
れた開放ポートを通って延び、前記取付用ベースが患者
の皮膚の上に設置されると、患者の皮膚を突き通して、
前記センサ遠位部を患者の挿入位置まで支持するよう
に、前記挿入針が位置決めされ、該挿入針は、患者の皮
膚および前記取付用ベースから摺動可能に引き抜いて、
前記センサ遠位端を前記挿入位置に残すことができる、
請求項1の経皮センサ挿入セット。 - 【請求項11】 前記センサ近位部が、少なくとも1つ
の露出した伝導性コンタクトを有する、請求項1の経皮
センサ挿入セット。 - 【請求項12】 前記取付用ベースが、これを前記患者
の皮膚に取り外し可能に付着させるための手段を有す
る、請求項1の経皮センサ挿入セット。 - 【請求項13】 前記取付用ベースが、前記センサ遠位
部に対して角張った関係で前記センサ近位部を支持して
いる、請求項1の経皮センサ挿入セット。 - 【請求項14】 前記取付用ベースが、前記患者の皮膚
の上に設置されるようになっており且つ前記センサ近位
部を支持するパッドを有し、前記センサ移行部が、前記
パッドに形成されたポートを通って延びるために、前記
センサ近位部に対して折り曲がった関係である、請求項
1の経皮センサ挿入セット。 - 【請求項15】 前記パッドに形成された前記ポート
が、ほぼ円形の孔から半径方向に延びる比較的まっすぐ
のスリットを形成するほぼキー孔の形状を有し、前記セ
ンサ移行部が、前記円形の孔の中の位置で、前記近位部
から前記まっすぐのスリットを通って前記遠位部まで延
びるように折り曲げられている、請求項14の経皮セン
サ挿入セット。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/213,101 US5390671A (en) | 1994-03-15 | 1994-03-15 | Transcutaneous sensor insertion set |
US08/213101 | 1994-03-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH07275227A true JPH07275227A (ja) | 1995-10-24 |
JP3571100B2 JP3571100B2 (ja) | 2004-09-29 |
Family
ID=22793730
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP05558595A Expired - Lifetime JP3571100B2 (ja) | 1994-03-15 | 1995-03-15 | 経皮センサ挿入セット |
Country Status (5)
Country | Link |
---|---|
US (1) | US5390671A (ja) |
EP (1) | EP0678308B1 (ja) |
JP (1) | JP3571100B2 (ja) |
CA (1) | CA2143172C (ja) |
DE (1) | DE69517085T2 (ja) |
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Also Published As
Publication number | Publication date |
---|---|
JP3571100B2 (ja) | 2004-09-29 |
EP0678308B1 (en) | 2000-05-24 |
CA2143172A1 (en) | 1995-09-16 |
US5390671A (en) | 1995-02-21 |
DE69517085D1 (de) | 2000-06-29 |
DE69517085T2 (de) | 2000-11-02 |
EP0678308A1 (en) | 1995-10-25 |
CA2143172C (en) | 2005-07-26 |
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