JP2006122689A - アナライトの検出および治療用物質の管理のための装置 - Google Patents
アナライトの検出および治療用物質の管理のための装置 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
- 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
- A61B5/14532—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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- 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
Abstract
【解決手段】サンプリング針(12)と、サンプリング針に含まれ、体液中の対象となるアナライトを検出するセンサ(14)と、センサからの信号を受け取って処理する分析手段(16)と、分析手段からの信号を受け取り注射アクチュエータに信号を送る制御装置と、注射アクチュエータに応答して対象となる薬を必要量だけ投与する注射器とを含む患者の体に直接薬を投与する装置。
【選択図】図1
Description
本発明の実施形態を使用して、患者の血液中のグルコースの濃度を測定することができる。第2図に示されたものに類似の装置の実施形態を使用して、患者は、針12の尖った端を、自分の体の都合のよい位置に挿入する。血液は、毛管現象または他の流体力学的な力によって針12に流れ込み、グルコースセンサ14と接触する。その後、針12を引き抜くことができる。センサ14は、グルコースと検出媒体との相互作用を光学的に測定するセンサとすることができる。たとえば、センサは、膜の細孔内に固定されたグルコースオキシダーゼおよびカタラーゼからなるものとすることができる。グルコースを含む溶液の存在下では、グルコースが酸化され、それに対応する量の酸素が消耗される。酸素の消耗は、米国特許第5043286号に記載されているように、ルミネセンス性の物質の使用を介して測定できる。したがって、酸素の消耗は、患者の血液中のグルコースの濃度に対応する。好ましい実施形態では、センサ14は、光ファイバまたは他の光学コンジット60の端に置くことができる範囲まで微細化される。
1gの燻蒸(fumed)シリカ(Sigma Chemical、セントルイス)を遠心分離チューブに加え、8.0gの無菌水を加える。2.0gの3−アミノプロピルトリエトキシシラン((AP)TES)(Sigma、ミズーリ州セントルイス)をチューブに加え、シリカのすべてが解けるまでよく攪拌する。1mlの6N HCl(Anachemia、ニューヨーク州Rouses Point)を加え、攪拌する。この反応混合物を70℃水浴で1時間加熱し、溶液を攪拌する。遠心分離と上澄みの注ぎ出しを3回行い、毎回注ぎ出しの後に40mlの無菌水を加え、溶液を攪拌する。
4.7mgのカタラーゼ(ウシ肝臓、Sigma、ミズーリ州セントルイス)を、0.75mlのPESK 7.5(100mMのNaCl、50mMのリン酸ナトリウムと、1mMのEDTAと、0.05%のKathon CG抗菌物質(Rohm and Haas、ペンシルベニア州フィラデルフィア)溶液との、pH7.5の溶液)に加える。12.5mgの1,2,4,5−無水ベンゼンテトラカルボン酸(PMA)(Aldrich、ウィスコンシン州ミルウォーキー)を、1mlのPESK 7.5に加える。攪拌によってPMAを懸濁させる。50μLのPMA溶液を酵素溶液に加え、攪拌し、室温で1時間回転する。0.75mlのアミノ化されたシリカの溶液(25mg/mlのシリカ)を加える。遠心分離と上澄みの注ぎ出しを3回行い、毎回1mlの50mM 2[N−モルフォリノ]メタンスルホン酸(MES)(Sigma、ミズーリ州セントルイス)、pH5.5を加え、攪拌する。1.5mgの1−エチル−3−(3−ジメチルアミノプロピル)カルボジイミドHCl(EDC)(Pierce、イリノイ州ロックフォード)を加え、1時間回転する。遠心分離と上澄みの注ぎ出しを2回行い、毎回1mlの無菌水を加え、無菌水の最初の追加の後に溶液を攪拌する。
25mgのグルコースオキシダーゼ(aspergillus niger, Boehringer Mannheim、インディアナ州インディアナポリス)を計量し、2.5mlのPESK 7.5に加える。2.5mgの1,2,4,5−無水ベンゼンテトラカルボン酸(PMA)(Aldrich、ウィスコンシン州ミルウォーキー)をグルコースオキシダーゼ溶液に加える。溶液を攪拌し、室温で1時間回転する。5mlのアミノ化されたシリカの溶液(25mg/mlのシリカ)を加える。遠心分離と上澄みの注ぎ出しを3回行い、毎回4mlの50mM MES、pH5.5を加え、注ぎ出しの後で溶液を攪拌する。5mgのEDCを加え、1時間回転する。遠心分離と上澄みの注ぎ出しを3回行い、注ぎ出しのそれぞれの後に4mlのPESK 7.5を加え、溶液を攪拌するが、最後の注ぎ出しの後は無菌水を追加する。
センサ表面に固定された酵素を保持するための、F133樹脂と称する樹脂マトリクスを、下記の重量の各成分を化合させることによって作る。
Joncryl 537・・・・・・・・・・・・・65.04mg
(Johnson Wax、ウィスコンシン州 Racine)
NH4OH、10%水溶液・・・・・・・・・・・・・・8.91mg
2−エトキシエタノール(Aldrich、・・・・・・20.94mg
ウィスコンシン州ミルウォーキー)
フタル酸ジブチル・・・・・・・・・・・・・・・・・・・7.13mg
(Fluka、ニューヨーク州Rokonkoma)
Surfynol 104H(Air Products、・・・・・・・・・ 2.50mg
ペンシルベニア州Allentown)
Surfynol 695(Air Products)・・・・・・・・・・・5.0mg
Acrysol 275(Rohm and Haas、・・・・・・・・・30.6mg
ペンシルベニア州フィラデルフィア)
80mgの液体樹脂と、15mgの固定されたカタラーゼと、134mgの固定されたグルコースオキシダーゼと、0.085Mのtrehalose(Sigma、ミズーリ州セントルイス)を含む347mgの水とを化合させる。三つの成分の活性のある混合は、混汞器(WIG−L−BUG, Crescent Dental Co.、イリノイ州Lyons)を使用して3分間激しくゆすることによって行われる。この樹脂と他の適した代替物は、国際特許公告第WO95/22057号に開示されている。本明細書に記載の方法では、粒子を樹脂マトリクス(「ペイント」とも称する)に混合し、酵素活性を持続させるために水性であるという長所を有する。また、液体の、容易な分与と製造しやすさももたらされる。1μリットルのペイントを、直径0.6μmの細孔を有するポリカーボネート膜(Poretics、カリフォルニア州Livermore)に与える。滴は、膜の表面に広がって、細孔を濡らす。その後、表面をティシュペーパーで拭き、細孔内のペイントだけを残す。その後、ペイントを細孔内で乾燥させ、グルコースオキシダーゼおよびカタラーゼを保持するための水に不溶性のマトリクスを形成する。
100mgの白金テトラペンタフルオロフェニルポルフィン(Pt(TFPP))(Porphyrin Products、ユタ州Logan)を25mlのシリコーンポリマー貯蔵液に溶かすことによって、酸素に敏感な色素の溶液を用意する。シリコーンポリマー貯蔵液は、100mlのテトラヒドロフランに10gのジメチルシロキサン−ビスフェノールA−ポリカーボネートブロック共重合体(GE、ニューヨーク州Waterford)を溶かすことによって作られる。1μlの色素溶液を、直径0.4μmの細孔を有するポリカーボネート膜104(Poretics、カリフォルニア州Livermore)に与える。溶液を乾かす。第6図からわかるように、酸素に敏感な色素102を含む膜104は、250μm光ファイバケーブル60の端に巻き付けられる。膜104は、小さいOリング106によってケーブルに固定される。ペイントマトリクス内に酵素を含む第二の膜108が、酸素に敏感な色素を含む膜104の上に配置される。膜108も、小さいOリング(図示せず)によって固定される。
第3図に示された実施形態に類似する、本発明の追加の実施形態では、針12が、患者の体の都合のよい部分に挿入される。血液または他の体液が、毛管現象および/または他の流体力学的な力によって針12に流れ込み、光学的に透明なハウジング40によって囲まれた室を充たす。その後、針12を患者の体から引き抜くことができ、針とハウジングアセンブリを、光学分析器具(図示せず)の中またはこれに隣接して配置することができる。このような器具は、血液または他の体液によって充たされた透明のハウジング40を通るように可視、赤外または他の光のビームを向けることによって、グルコースまたは対象となる別のアナライトの濃度を測定する。本実施形態と共に使用できる分析技法の説明は、米国特許第5209231号(偏光測定を介するグルコース濃度の測定)、米国特許第5383452号(固有ルミネセンス偏光の検出を介するグルコース濃度の測定)および米国特許第4882492号(反射または伝播された近赤外光の減法相関分光学を介するグルコース濃度の測定)に記載されている。追加の分析手段は、当業者には明白であり、また、本開示を読むことから明白になる。
本発明のもう一つの実施形態では、第4図に示されたものに類似の装置を使用する。この実施形態では、センサ14が、血液中のグルコースの濃度を検出する針の内部に取り付けられた電気化学センサである。このようなセンサの一例が、本明細書と同一の日付に出願された同時係属の米国特許出願(代理人整理番号5843.US.01)に記載されている。
本発明のもう一つの任意選択の実施形態は、血中グルコース濃度を測定し、インシュリンまたは他の治療用物質を必要量だけ自動的に注射するのに使用される。第2図または第4図に示されたものに類似の装置の実施形態を使用して、患者は、針12を自分の体の都合のよい部分に挿入する。血液は、毛管現象および/または他の流体力学的な力によって針12に流れ込み、センサ14に達する。この実施形態では、針12は、体に挿入されたままになる。センサ14は、針の内部に取り付けられた電気化学センサまたは光学センサであり、第5図に示されるように、血中のグルコースの濃度を検出し、この濃度を表す信号を、分析手段16を介して制御装置20に送る。制御装置20は、ユーザ制御52または記憶されたアルゴリズム54もしくはその両方を介して患者によって指示された通りに動作するが、インシュリンの必要量を示す信号を注射アクチュエータ56に送る。アクチュエータ56は、注射装置18に、サンプリング針12を介してインシュリンを必要量だけ注射させる。注射の間、バルブ(図示せず)によって通気孔38を閉じて、インシュリンが確実に患者に注入されるようにすることができる。
Claims (8)
- (a)サンプリング針と、
(b)体液中の対象となるアナライトを検出する、サンプリング針に含まれるセンサと、
(c)センサからの信号を受け取って、処理する分析手段と、分析手段から信号を受け取り、注射アクチュエータに信号を送るための制御装置と、
注射アクチュエータに応答して対象となる薬を必要量だけ投与するための注射器と
を含む患者の体に直接に薬を投与するための装置。 - 制御装置が、注射される薬の必要量を決定するためのユーザ入力を含む請求の範囲第1項に記載の装置。
- 制御装置が、注射される薬の必要量を決定するための分析方法を含む請求の範囲第1項に記載の装置。
- 分析方法が、アルゴリズムである請求の範囲第3項に記載の装置。
- (a)注射アクチュエータに信号を送るための制御装置と、
(b)針を含み、注射アクチュエータに応答して薬を必要量だけ投与するための注射器と
を含む患者の体に直接に薬を投与するための装置。 - 制御装置が、注射される薬の必要量を決定するためのユーザ入力を含む請求の範囲第5項に記載の装置。
- 制御装置が、注射される薬の必要量を決定するための分析方法を含む請求の範囲第5項に記載の装置。
- (a)注射アクチュエータに信号を送るための制御装置と、注射アクチュエータに応答して薬を必要量だけ投与するための針を備えた注射器とを含む薬投与装置を提供するステップと、
(b)注射器を患者に刺すステップと、
(c)注射アクチュエータに応答して薬を必要量だけ投与するステップと
を含む患者の体に直接に薬を投与する方法。
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US57488095A | 1995-12-19 | 1995-12-19 |
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JP09522809A Division JP2000504239A (ja) | 1995-12-19 | 1996-11-26 | アナライトの検出および治療用物質の管理のための装置 |
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JP2006122689A true JP2006122689A (ja) | 2006-05-18 |
JP3993210B2 JP3993210B2 (ja) | 2007-10-17 |
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JP09522809A Pending JP2000504239A (ja) | 1995-12-19 | 1996-11-26 | アナライトの検出および治療用物質の管理のための装置 |
JP2005324355A Expired - Fee Related JP3993210B2 (ja) | 1995-12-19 | 2005-11-09 | アナライトの検出および治療用物質の管理のための装置 |
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JP09522809A Pending JP2000504239A (ja) | 1995-12-19 | 1996-11-26 | アナライトの検出および治療用物質の管理のための装置 |
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US (2) | US6032059A (ja) |
EP (2) | EP1522255B1 (ja) |
JP (2) | JP2000504239A (ja) |
AT (2) | ATE287660T1 (ja) |
CA (1) | CA2240405C (ja) |
DE (2) | DE69634265T2 (ja) |
ES (1) | ES2236759T3 (ja) |
WO (1) | WO1997022291A1 (ja) |
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JP2011507556A (ja) * | 2006-12-22 | 2011-03-10 | メディンゴ・リミテッド | 生体内電気化学的分析対象物感知を伴った液体供給 |
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US6032059A (en) | 2000-02-29 |
DE69634265D1 (de) | 2005-03-03 |
US6014577A (en) | 2000-01-11 |
DE69634265T2 (de) | 2006-04-27 |
CA2240405A1 (en) | 1997-06-26 |
EP0868144B1 (en) | 2005-01-26 |
DE69637553D1 (de) | 2008-07-10 |
CA2240405C (en) | 2005-07-26 |
EP1522255A1 (en) | 2005-04-13 |
EP0868144A1 (en) | 1998-10-07 |
EP1522255B1 (en) | 2008-05-28 |
JP2000504239A (ja) | 2000-04-11 |
ES2236759T3 (es) | 2005-07-16 |
ATE287660T1 (de) | 2005-02-15 |
JP3993210B2 (ja) | 2007-10-17 |
WO1997022291A1 (en) | 1997-06-26 |
ATE396644T1 (de) | 2008-06-15 |
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