JP3571100B2 - 経皮センサ挿入セット - Google Patents
経皮センサ挿入セット Download PDFInfo
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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
- A61B5/145—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
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- 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
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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
- A61B5/6846—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
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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
- A61M25/02—Holding devices, e.g. on the body
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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
- A61M25/02—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
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Description
【産業上の利用分野】
この発明は、一般的に、センサを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。
【0002】
【従来の技術】
近年、患者の血中の特定の因子を検出及び/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。
【0003】
【発明が解決しようとする課題】
患者の血液或いは他の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。
【0004】
本発明は、特に、センサ電極が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。
【0005】
【課題を解決するための手段】
本発明によれば、薄膜電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。近位部の長手方向軸線と遠位部の長手方向軸線は互いに同軸上に整合しておらず、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。
【0006】
好ましい形態では、センサ近位部および遠位部は、近位部と遠位部とを相互に連結する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。
【0007】
取付ベースを患者の皮膚の上に押し付けて設置した上で、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。
【0008】
本発明の他の好ましい形態では、保持部材は、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。
【0009】
【実施例】
例示としての図面に示すように、図1に参照符号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16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。
【0010】
本発明の経皮センサ挿入セット10は、特に、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 4,678,408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。
【0011】
図2、図3に最もよく示すように、可撓性電気化学センサ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26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。
【0012】
センサ12は、患者の皮膚36(図6)の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。
【0013】
図4および図5に示すように、可撓性センサ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28は、可撓性パッド38に形成されたキー孔スロット48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。
【0014】
挿入針14は、支持プレート44に形成さ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。
【0015】
使用において、挿入セット10によって、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38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12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。
【0016】
取付用ベース34を患者の皮膚の上に付けて、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。
【0017】
図8および図9は、本発明の他の好ましい実施例を示す。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 fluid) 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。
【0018】
本発明の経皮センサ挿入セットは、かくして、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。
【0019】
本発明の経皮センサ挿入セットの種々の変更あるいは改良は、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。
【図面の簡単な説明】
【図1】本発明の新規な特徴を具体化する経皮センサ挿入セットを示す斜視図。
【図2】図1の経皮センサ挿入セットの部分の組立体を示す拡大部分分解斜視図。
【図3】図1の3−3線にほぼ沿って切断した拡大部分断面図。
【図4】センサ挿入セットの挿入針および可撓性センサの滑り嵌め組立体を示す拡大部分斜視図。
【図5】図4の5−5線にほぼ沿って切断した拡大部分断面図。
【図6】図1の6−6線にほぼ沿って切断した拡大部分断面図。
【図7】可撓性センサからの挿入針の引き抜きを示す斜視図。
【図8】本発明の変形した好ましい態様を具体化した組立られた挿入針おおびセンサを示す平面図。
【図9】図8の9−9線にほぼ沿った拡大断面図。
【符号の説明】
10 挿入セット
12 可撓性センサ
14 挿入針
16 センサ遠位部
18 センサ電極
26 センサ移行部
28 センサ近位部
30 導電性コンタクトバッド
38 可撓性パッド
40 感圧粘着剤
48 キー孔スロット
54 針のスロット
58 保持部材
158 チューブ
Claims (15)
- 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、前記近位部の長手方向軸線と前記遠位部の長手方向軸線が互いに同軸上に整合していない可撓性センサと、
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。 - 前記センサが、更に、前記近位部と前記遠位部とを相互に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。
- 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の経皮挿入センサセット。
- 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の経皮挿入センサセット。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 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。
- 前記取付用ベースが、前記センサ近位部が前記センサ遠位部に対して折れ曲がるように、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。
- 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ように、前記センサ近位部に対して折り曲げられている、請求項1の経皮センサ挿入セット。
- 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 |
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JPH07275227A JPH07275227A (ja) | 1995-10-24 |
JP3571100B2 true JP3571100B2 (ja) | 2004-09-29 |
Family
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Application Number | Title | Priority Date | Filing Date |
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JP05558595A Expired - Lifetime JP3571100B2 (ja) | 1994-03-15 | 1995-03-15 | 経皮センサ挿入セット |
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US (1) | US5390671A (ja) |
EP (1) | EP0678308B1 (ja) |
JP (1) | JP3571100B2 (ja) |
CA (1) | CA2143172C (ja) |
DE (1) | DE69517085T2 (ja) |
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-
1994
- 1994-03-15 US US08/213,101 patent/US5390671A/en not_active Expired - Lifetime
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1995
- 1995-02-14 EP EP95102028A patent/EP0678308B1/en not_active Expired - Lifetime
- 1995-02-14 DE DE69517085T patent/DE69517085T2/de not_active Expired - Lifetime
- 1995-02-22 CA CA002143172A patent/CA2143172C/en not_active Expired - Fee Related
- 1995-03-15 JP JP05558595A patent/JP3571100B2/ja not_active Expired - Lifetime
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DE69517085T2 (de) | 2000-11-02 |
JPH07275227A (ja) | 1995-10-24 |
EP0678308A1 (en) | 1995-10-25 |
EP0678308B1 (en) | 2000-05-24 |
CA2143172A1 (en) | 1995-09-16 |
US5390671A (en) | 1995-02-21 |
DE69517085D1 (de) | 2000-06-29 |
CA2143172C (en) | 2005-07-26 |
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