JP2013543407A - 組織集積センサー - Google Patents
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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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- A61B5/1468—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 chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—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 chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
- A61B5/14735—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 chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter comprising an immobilised reagent
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- A61B5/1495—Calibrating or testing of in-vivo probes
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- 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
- A61B5/6802—Sensor mounted on worn items
- A61B5/681—Wristwatch-type devices
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- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7271—Specific aspects of physiological measurement analysis
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Abstract
Description
本出願は、2010年10月6日に出願された米国仮出願第61/390,252号の利益を主張し、その開示は全体として参照により本明細書に援用される。
利用なし。
用語「組織集積」とは、生体組織内に組み込まれた場合、組織の血管(例えば、毛細血管)との近接近の状態である材料(例えば、足場)を意味する。「近接近」とは、組織内に埋め込まれた材料(足場)内の任意点から最も近い血管までの平均距離が、天然の(元の)組織における任意点から最も近い血管までの平均距離よりも大きく、100ミクロン未満であることを意味する。
本明細書には、対象に埋め込むためのセンサー(又は検知媒体)が記載されている。センサーは、組織集積足場と少なくとも1つの検知部分で作られている。
本明細書に記載されているセンサーは、典型的には、組織集積足場(マトリックスとも称される)材料を含む。好ましくは、本発明の組織集積足場は、該足場が組織集積及び/又は脈管化を促進するような材料及び/又は微小構築物を用いて構築されてもよい。例えば、多孔性足場は、組織生体材料固着を提供し、細孔全体での内部成長を促進する。得られる組織増殖の「通路(hallway)」又は「チャネル」のパターンは、経時的に持続し、宿主細胞集積を促進する多量の空間充填塊である。本明細書に記載されている生体材料の細孔の全て又はその大部分は、好ましくは相互連結(同時連続)されている。生体材料の同時連続の細孔構造は、インプラントにおける細胞の空間充填内部成長を促進し、順に異物反応を制限し、センサーとして作用するインプラントの能力の長期(1週間を超えて、最大数年)の維持をもたらす。組織集積足場を提供する代替構造体には、非無作為形状又は無作為形状で配置されてもよいファイバー(例えば、直径1〜10ミクロン又はそれを超える、例えば5、6、7、8、9、10ミクロン又はそれを超える)が含まれる。また、組織集積足場(任意の形態で)は、多光子重合技術によって形成され得る。Kaehrら.(2008)Proc.Nat’l.Acad.Sci.USA 105(26):8850−8854;Nielson et al.(2009)Small 1:120−125;Kasprzak,Doctoral Dissertation,Georgia Institute of Technology,2009年5月。
本明細書に記載されている組織集積足場は、典型的には、1以上の分析物を検出する検知部分と組み合わせられる(又は検知部分で作られる)。
組織集積足場と分析物検知部分との組み合わせは、移植可能な検知媒体、検知媒体、組織集積センサー、組織集積バイオセンサー、組織集積検知媒体又はそれらの変形体と呼ばれてもよい。
本発明の別の局面は、哺乳動物生体内での半連続、連続及び/又は長期の使用のための組織集積バイオセンサーシステムである。本明細書に記載されているバイオセンサーシステムは、組織集積バイオセンサー(以下に記載されている)を含む。他のコンポーネントには、以下の1以上が含まれる:受信装置、照明器、検出器、シグナル受信機、シグナル送信機、シグナル処理コンポーネント、エネルギー貯蔵コンポーネント、データ記憶コンポーネント、データ送信機、データ表示、データ処理コンポーネント及びそれらの組み合わせが挙げられる。これらの他のコンポーネントの1以上は、センサーシグナルを検出するためのセンサー全体に存在する装着型パッチ内に組み込まれてもよく、又は携帯用若しくは他のデバイス内に組み込まれてもよく、それは、移植されたセンサー全体で周期的に保持され、測定を行う。図18参照。
本発明の別の局面は、組織集積センサーを作成するための方法である。組織集積センサーを創作するための方法は、対象の分析物に応答して、測定可能なシグナル(単数又は複数)を生成するように十分に、検知部分の統合を維持する方法で検知部分と組織集積足場を組み合わせるプロセスを含む。
以下は、本明細書に記載されている組織集積センサーを作製するための1つの提案された方法を説明する。この方法は、足場材料として非架橋PMMA鋳型マイクロスフェアとpHEMAの使用を伴う。PMMAマイクロスフェア鋳型は、ふるいにかけられたPMMAスフェア(36μm、5%未満のCV)を用い、テフロン(登録商標)スペーサーによる2つのガラススライド間に鋳型ビーズを配置することにより調製された。焼結プロセスは、ビーズを密接にパッキングするために、少なくとも10分間(1回以上で)超音波処理することを含む。超音波処理後、ビーズが融合するのに十分な時間、十分な温度に鋳型を加熱する(例えば、約177℃に24時間加熱する)。
以下は、本明細書に記載されている組織集積センサーを作製するための1つの方法を説明する。この方法は、足場材料として非架橋PMMA鋳型マイクロスフェアとpHEMAの使用を伴う。PMMAマイクロスフェア鋳型は、ふるいにかけられたPMMAスフェア(36μm、5%未満のCV)を用い、テフロン(登録商標)スペーサーによる2つのガラススライド間に鋳型ビーズを配置することにより調製された。焼結プロセスは、(ビーズを密接にパッキングするために)少なくとも10分間超音波処理し、次に、鋳型を177℃に24時間加熱することを含む(これらの条件は異なるオーブンについて変更し、またビーズの異なるバッチについて変更してもよい)。
以下は、本明細書に記載されている組織集積センサーを作製するための1つの提案された方法を説明する。この方法は、足場材料として非架橋PMMA鋳型マイクロスフェアとpHEMAの使用を伴う。PMMAマイクロスフェア鋳型は、ふるいにかけられたPMMAスフェア(36μm、5%未満のCV)を用い、テフロン(登録商標)スペーサーによる2つのガラススライド間に鋳型ビーズを配置することにより調製される。焼結プロセスは、(ビーズを密接にパッキングするために)少なくとも10分間超音波処理し、次に、鋳型を177℃に24時間加熱することを含む(これらの条件は異なるオーブンについて変更し、またビーズの異なるバッチについて変更してもよい)。
直径300〜500μm、長さ5mmのロッド内の組織集積センサーは、19〜23ゲージの挿入針、トロカール、修飾された生検デバイス又は皮膚下に移植するように操作された他のデバイスに置かれる。センサーは、挿入前に場合により脱水され又は圧搾され、より小さな挿入針の使用を可能にする。
センサーからのデータは、回収され、加工され、スマートフォン、他の携帯型デバイス、コンピュータスクリーン又は他の視覚化フォーマット上に、例えば、Medtronicから利用可能な市販のデータ表示デバイスを用いて表示させる。生データは、分析濃度に変換され、又は分析濃度(例えば、高さ、低さ、範囲内)の何らかの非定量的な表示に変換される。時間内若しくは傾向内における任意の所定点の値(経時的なグラフ)又はある期間の要約統計量が与えられる。データの質の表示を場合により与える。
Claims (15)
- 分析物を検出するための組織集積センサーであって、該センサーは、以下:
組織集積足場;及び
1以上の検知部分であって、該分析物の存在下で検出可能なシグナルを生成する検知部分
を含み;そして
さらに、対象とする組織に設置された場合、前記センサーが該分析物を検出する組織集積センサー。 - 足場が1以上の検知部分からなる、請求項1に記載のセンサー。
- 足場がポリマーを含む、請求項1に記載のセンサー。
- ポリマーがハイドロゲルを含む、請求項1〜3のいずれか1項に記載のセンサー。
- 検知部分が足場内に埋め込まれている、請求項1〜4のいずれか1項に記載のセンサー。
- 検知部分が足場の外部に付着している、請求項1〜4のいずれか1項に記載のセンサー。
- 検知部分の外部に被覆をさらに含む、請求項1〜6のいずれか1項に記載のセンサー。
- 足場は多孔性であり、さらに該足場の細孔の少なくとも2つが相互接続されている、請求項1〜7のいずれか1項に記載のセンサー。
- 検知部分がマイクロスフェア又はナノスフェアを含む、請求項1〜8のいずれか1項に記載のセンサー。
- センサーが多層を含む、請求項1〜9のいずれか1項に記載のセンサー。
- センサーが1以上のファイバーを含む、請求項1〜10のいずれか1項に記載のセンサー。
- 1以上の較正部分をさらに含む、請求項1〜11のいずれか1項に記載のセンサー。
- 請求項1〜12のいずれか1項に記載の組織集積センサー;及び
検知部分によって生じたシグナルを発生または測定するモジュール
を含む、分析物を検出するためのシステム。 - 検出器、シグナル受信機、シグナル送信機、シグナル処理コンポーネント、エネルギー貯蔵コンポーネント、データ記憶コンポーネント、データ送信機、データ表示デバイス、データ処理コンポーネント及びそれらの組み合わせからなる群から選択されるコンポーネントをさらに含む、請求項13に記載のシステム。
- 請求項1〜12のいずれか1項に記載のセンサーを組織に組み込み、分析物の存在を検出することを含む、対象とする組織における分析物を検出するための方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US39025210P | 2010-10-06 | 2010-10-06 | |
US61/390,252 | 2010-10-06 | ||
PCT/US2011/055157 WO2012048150A1 (en) | 2010-10-06 | 2011-10-06 | Tissue-integrating sensors |
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JP2015205520A Division JP2016047252A (ja) | 2010-10-06 | 2015-10-19 | 組織集積センサー |
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JP2013543407A true JP2013543407A (ja) | 2013-12-05 |
JP5827999B2 JP5827999B2 (ja) | 2015-12-02 |
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JP2013532954A Active JP5827999B2 (ja) | 2010-10-06 | 2011-10-06 | 組織集積センサー |
JP2015205520A Pending JP2016047252A (ja) | 2010-10-06 | 2015-10-19 | 組織集積センサー |
JP2018247880A Pending JP2019088807A (ja) | 2010-10-06 | 2018-12-28 | 組織集積センサー |
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JP2018247880A Pending JP2019088807A (ja) | 2010-10-06 | 2018-12-28 | 組織集積センサー |
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US (4) | US10463287B2 (ja) |
EP (1) | EP2624744A4 (ja) |
JP (3) | JP5827999B2 (ja) |
KR (1) | KR101690535B1 (ja) |
CN (3) | CN103260501B (ja) |
AU (4) | AU2011311889C1 (ja) |
BR (1) | BR112013008154A2 (ja) |
CA (3) | CA2813041C (ja) |
WO (1) | WO2012048150A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2016519655A (ja) * | 2013-03-14 | 2016-07-07 | プロフサ,インコーポレイテッド | 酸素センサ |
JP2017523863A (ja) * | 2014-08-11 | 2017-08-24 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | 連続検体センサー |
Families Citing this family (35)
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JP5694920B2 (ja) * | 2008-05-14 | 2015-04-01 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | クリーナブルインターフェースおよびストレイトラインアタッチメントを備える分離可能な注入セット |
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