JP2009539438A - 経皮センサのための挿入器 - Google Patents
経皮センサのための挿入器 Download PDFInfo
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- 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
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- A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
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Abstract
【選択図】図22
Description
本発明は、例えばグルコース・センサのような患者の血液中の成分を登録することができる経皮センサのための挿入器に関する。挿入器は、患者の皮下に配置されるべきセンサ部分を含む、挿入前及び挿入中にセンサハウジングに接続されている挿入針を有する針ユニットを備える。
米国特許公開公報第2002/0077599A1号(特許文献1)は、薄型の(low-profile)、傾斜した注入セットのための挿入器に関連する。その挿入器は、挿入器ハウジングであって、底壁と、底壁に実質的に平行な方向において後退した位置と拡張された位置との間で移動するために挿入器ハウジングへとスライド可能なように接続された固定器具と、を有する挿入器ハウジングを備える。挿入器はまた、挿入器ハウジングの外面へと接続された基盤部材を備える。固定器具は、センサハウジングを解放可能なように受け入れるよう、構成されている。使用時、固定器具30は前方へ移動し、針27及びセンサ26を適切な角度で皮膚に突き刺し、適切な距離で皮下層に入れる。そして解放ボタン66を押下することにより、挿入器アセンブリ10からセンサハウジング28を解放することができる。その後、取り付けパッド80が皮膚に固定され、針27が取り外され、そしてセンサ26を定位置に残す。この文献は、どちらかといえば複雑な構造に関するものであり、その複雑さにより、上部及び下部の2つのハウジング部分を使用することが余儀なくされる。それらの部分は、任意の適正な材料により構築することができるのであり、ネジ(図5の23)、連結タブ、接着剤、ヒートステーキング(heat-staking)、又はそれらの組み合わせ、又は他の、周知であるような任意の留め付け手段を介して、一緒に固定することが可能である。
本発明の目的は、ユーザにとって使用中の取り扱いや使用後の処分が容易で安全であるような、経皮センサのための、単純で、高価ではない挿入器を提供することである。
−ハウジングの内側表面には運搬ボディの移動を確実にするためのガイド手段が備えられている。
−センサハウジングは皮下に配置されるべきセンサを備えている。
−針ハブは、皮膚に突き刺すための針を備えている。
−センサハウジングと針ハブとは、解放可能なようにお互い留め付けられ、そしてお互い留め付けられている時、針はセンサに近接している。ある実施形態において、針は少なくとも部分的にはセンサを囲んで配置されている。
−運搬ボディの外側表面には、運搬ボディのハウジングに対する、後退した位置と前進した位置との間における移動を確実にするためのガイド手段が備えられている。
−運搬ボディは解放手段に接続されており、解放手段が操作される時、運搬ボディとセンサハウジングと針ハブとは、バネユニットにより、前進した位置へと追いやられる。ユーザがその装置を皮膚に対して押し当てる時に、針とセンサの一部とが、皮下に配置されるであろう。
−針ハブと運搬ボディとには、解放不可能な、相互ロック手段が備えられている。
−ハウジング(1)の内側表面には、運搬ボディ(4)の移動をガイドするためのガイド手段(9a,9b,9c)が備えられている。
−センサハウジング(3)は、皮下に配置されるべきセンサ部分(5)を備えている。
−針ハブ(2)は、皮膚に突き刺すための挿入針(6)を備えている。
−センサハウジング(3)と針ハブ(2)とは、解放可能なようにお互い接続され、そしてお互い接続されている時、挿入針(6)はセンサ部分(5)に近接している。
−運搬ボディ(4)の外側表面には、ハウジング(1)に対する後退した位置と前進した位置との間における移動をガイドするようなガイド手段(9e,9d,9f)が備えられている。
−バネユニット(13)は解放手段(7)に接続されており、解放手段(7)が作動される時、センサハウジング(3)と針ハブ(2)と運搬ボディ(4)とは、バネユニットにより、前進した位置へと追いやられる。そこにおいて、針(6)とセンサ部分(5)とを皮下に配置することが可能であり、針ハブ(2)と運搬ボディ(4)とには、解放不可能な相互ロック手段が備えられている。
−ハウジング(1)における下部ベースは、突き出た部分(10)を有して形成されており、その突き出た部分(10)は、挿入の間ユーザに対して正しい挿入角度を指示するような、挿入針(6)の長手方向に傾斜している。
本発明における好ましい実施形態が示されるような添付図面を参照しつつ、本発明は、以下で更に詳細に説明される。
(1)ハンドルの低い側における突起部23が、ハウジング1の低い部分の内側にある、隆起した部分24を通過するまで、又は
(2)ガイド手段9d上の突き出た部分30が、ハウジング1のL字型断面ガイド手段9bの端部か、又は開口部を通過するまで、
引っ張ることにより、針ユニット2,4は後退した位置へと運ばれる(図10参照)。その後、ユーザは上向きに曲がった部分10を皮膚に対して配置し、針ユニット2,4を解放する。
Claims (18)
- ハウジング(1)と、センサハウジング(3)と、針ハブ(2)と、バネユニット(13)と、運搬ボディ(4)と、を備えた経皮センサのための挿入器であって、
−前記ハウジング(1)の内側表面には前記運搬ボディ(4)の移動をガイドするためのガイド手段(9a,9b,9c)が備えられており、
−前記センサハウジング(3)は皮下に配置されるべきセンサ部分(5)を備えており、
−前記針ハブ(2)は皮膚に突き刺すための挿入針(6)を備えており、
−前記センサハウジング(3)と前記針ハブ(2)とは、解放可能なようにお互い接続されており、それらが接続されているとき、前記挿入針(6)は前記センサ部分(5)に近接しており、
−前記運搬ボディ(4)の外側表面には、後退した位置と前進した位置との間においての前記ハウジング(1)に対する移動をガイドするようなガイド手段(9e,9d,9f)が備えられており、そして、
−前記バネユニット(13)は解放手段(7)に接続されており、該解放手段(7)が作動するとき、前記センサハウジング(3)と前記針ハブ(2)と前記運搬ボディ(4)とは前記バネユニットによって前進した位置へと追いやられ、該前進した位置において前記針(6)とセンサ部分(5)とを皮下に配置することが可能であって、
前記針ハブ(2)と前記運搬ボディ(4)とには解放不可能な相互ロック手段が備えられており、
前記挿入針(6)は、皮下に配置される前記センサ部分(5)の部分を少なくとも部分的に取り囲んでいることを特徴とする、
挿入器。 - 前記針ハブ(2)と前記運搬ボディ(4)とは単一ユニットとして作成されることを特徴とする、請求項1に記載の挿入器。
- 前記針ハブ(2)は開口部(15)を備え、そして前記運搬ボディ(4)には前記針ハブ(2)内の該開口部(15)に対応する突起部(16)が備えられていることを特徴とする、請求項1に記載の挿入器。
- 挿入後の、前記針ハブ(2)と前記運搬ボディ(4)とを備えた針ユニット(2,4)を、後退した位置に配置することが可能であることを特徴とする、請求項1乃至3のいずれか1つに記載の挿入器。
- 前記ハウジング(1)の下部ベースは突き出た部分(10)を有して形成されていることを特徴とする、請求項1乃至4のいずれか1つに記載の挿入器。
- 前記突き出た部分(10)は、前記挿入針(6)における長手方向に傾斜を形成していることを特徴とする、請求項5に記載の挿入器。
- ストッパー(12,12a)を備えることを特徴とする、請求項1乃至6のいずれか1つに記載の挿入器。
- 前記ストッパー(12a)は、フランジ(9f)のためのトラック(19)の少なくとも一方の端部からなることを特徴とする、請求項7に記載の挿入器。
- 前記ハウジング(1)は、挿入器に対する運搬用包装の少なくとも一部を形成することを特徴とする、請求項1に記載の挿入器。
- 前記ハウジング(1)にはハードトップ(20)が備えられていることを特徴とする、請求項1に記載の挿入器。
- 前記バネユニット(13)は第1の位置(p1)において前記ハウジング(1)に、そして第2の位置(p2)において前記運搬ボディ(4)又は前記針ハブ(2)に、留め付けられており、前記バネユニット(13)がバイアスされていないとき、該第1の位置は、該第2の位置よりも前記ハウジング(1)の前端部に接近した状態におかれることを特徴とする、請求項1に記載の挿入器。
- 前記バネユニット(13)は弾力性のあるOリングであることを特徴とする、請求項1に記載の挿入器。
- 前記バネユニット(13)は第1の位置において前記ハウジング1に留め付けられており、そして第2の位置において前記運搬ボディ(4)又は前記針ハブ(2)に固定されており、前記バネユニット(13)がバイアスされていないとき、該第1の位置は、該第2の位置よりも前記ハウジング(1)の後端部に接近した状態におかれることを特徴とする、請求項1に記載の挿入器。
- 前記バネユニット(13)は、前記ハウジング(1)の後端部と前記針ユニット(2,4)との間に配置された平らなバネであることを特徴とする、請求項1に記載の挿入器。
- 前記バネユニット(13)は、前記針ユニット(2,4)の各々の側に位置する2つの出っ張ったカーブからなる形状を有し、そしてバイアスされていない状態においては、
各々のカーブは一端(13b)において前記針ユニット(2,4)に固定され、もう一方の端(13a)においては、前記針ユニット(2,4)への固定部の後ろでハウジング(1)に固定されていることを特徴とする、請求項14に記載の挿入器。 - 請求項1乃至15に記載された挿入器の使用方法であって、挿入されたセンサは患者の血液中のグルコースを登録することが可能であることを特徴とする、方法。
- セットハウジング(1)と、センサハウジング(3)と、針ハブ(2)と、バネユニット(13)と、運搬ボディ(4)と、を備えた経皮センサのための挿入器であって、
−前記ハウジング(1)の内側表面には前記運搬ボディ(4)の移動をガイドするためのガイド手段(9a,9b,9c)が備えられており、
−前記センサハウジング(3)は皮下に配置されるべきセンサ部分(5)を備えており、
−前記針ハブ(2)は皮膚に突き刺すための挿入針(6)を備えており、
−前記センサハウジング(3)と前記針ハブ(2)とは、解放可能なようにお互い接続されており、それらが接続されているとき、前記挿入針(6)は前記センサ部分(5)に近接しており、
−前記運搬ボディ(4)の外側表面には、後退した位置と前進した位置との間においての前記ハウジング(1)に対する移動をガイドするようなガイド手段(9e,9d,9f)が備えられており、
−前記バネユニット(13)は解放手段(7)に接続されており、該解放手段(7)が作動するとき、前記センサハウジング(3)と前記針ハブ(2)と前記運搬ボディ(4)とは前記バネユニットによって前進した位置へと追いやられ、該前進した位置において前記針(6)とセンサ部分(5)とを皮下に配置することが可能であって、
前記針ハブ(2)と前記運搬ボディ(4)とには解放不可能な相互ロック手段が備えられており、
−前記ハウジング(1)の下部ベースは突き出た部分(10)を有して形成されており、該突き出た部分(10)は、前記挿入針(6)における長手方向に、挿入中のユーザに対して正しい挿入角度を指示するような傾斜を形成していることを特徴とする、挿入器。 - 前記突き出た部分(10)の一部は、前記挿入針(6)がそれに沿って移動することができるようなラインの上方に位置し、前記突き出た部分(10)の一部は、該ラインを越えたところに位置することを特徴とする、請求項17に記載の挿入器。
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JP2015509011A (ja) * | 2011-12-11 | 2015-03-26 | アボット ダイアベティス ケア インコーポレイテッドAbbott Diabetes Care Inc. | 検体センサ装置、接続部および方法 |
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JPWO2014045448A1 (ja) * | 2012-09-24 | 2016-08-18 | テルモ株式会社 | センサ挿入装置 |
JP2020099723A (ja) * | 2015-11-11 | 2020-07-02 | メドトロニック ミニメド インコーポレイテッド | コネクタシステム |
JP7142660B2 (ja) | 2015-11-11 | 2022-09-27 | メドトロニック ミニメド インコーポレイテッド | コネクタシステム |
WO2019155688A1 (ja) * | 2018-02-07 | 2019-08-15 | テルモ株式会社 | 留置装置及びベース部材 |
JPWO2019155688A1 (ja) * | 2018-02-07 | 2021-01-28 | テルモ株式会社 | 留置装置及びベース部材 |
JP7117333B2 (ja) | 2018-02-07 | 2022-08-12 | テルモ株式会社 | 留置装置及びベース部材 |
Also Published As
Publication number | Publication date |
---|---|
AU2007256561B2 (en) | 2012-07-19 |
KR20090026760A (ko) | 2009-03-13 |
AU2007256561A1 (en) | 2007-12-13 |
US8439838B2 (en) | 2013-05-14 |
IL195429A0 (en) | 2009-08-03 |
EP2023818A2 (en) | 2009-02-18 |
US20100022863A1 (en) | 2010-01-28 |
CA2653631A1 (en) | 2007-12-13 |
MX2008015245A (es) | 2008-12-15 |
WO2007140783A2 (en) | 2007-12-13 |
WO2007140783A3 (en) | 2008-07-03 |
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