JP2022172220A - 軟質検体センサ - Google Patents
軟質検体センサ Download PDFInfo
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- JP2022172220A JP2022172220A JP2022134207A JP2022134207A JP2022172220A JP 2022172220 A JP2022172220 A JP 2022172220A JP 2022134207 A JP2022134207 A JP 2022134207A JP 2022134207 A JP2022134207 A JP 2022134207A JP 2022172220 A JP2022172220 A JP 2022172220A
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- analyte sensor
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Abstract
Description
出願データシートに明記されているありとあらゆる優先権の主張、またはその補正は、37 CFR 1.57の下で参照により本明細書に組み込まれている。本出願は、2017年1月19日に出願した米国仮出願第62/448,295号の利益を主張するものである。前述の出願は、全体が参照により本明細書に組み込まれ、これにより明示的に本明細書の一部をなす。
本明細書で説明されている様々な実施形態の理解を円滑にするために、多数の術語が以下で定義されている。
グルコース+O2→グルコン酸塩H2O2
という化学反応によって例示される。
生体内連続検体感知技術は、膜内でのセンサのコーティングを成功させグルコース濃度測定を円滑にするために最小剛性に基づき決定される剛性(たとえば、ヤング率、曲げ弾性率、および/または座屈力によって定義される剛性)を有する生体内センサに依存し得る。
図1は、いくつかの例示的な実装形態による、例示的なシステム100を示している。システム100は、センサ電子機器112と連続検体センサ110とを備える連続検体センサシステム101を具備する。システム100は、薬剤送達ポンプ102およびグルコースメーター104などの、他のデバイスおよび/またはセンサを備え得る。連続検体センサ110は、センサ電子機器112に物理的に接続されてよく、連続検体センサ110と一体である(たとえば、解放不可能に取り付けられる)か、または連続検体センサ110に解放可能に取り付け可能であるものとしてよい。センサ電子機器112、薬剤送達ポンプ102、および/またはグルコースメーター104は、表示デバイス114、116、118、および/または120などの、1つまたは複数のデバイスと結合されるものとしてよい。
センサ実施形態1:生体内で使用するように構成されている連続検体センサであって、細長芯と、細長芯上に配設されている作用電極と、作用電極の少なくとも一部を覆う膜であって、膜は酵素層を含み、連続検体センサの一部はセンサ電子機器ハウジングから延在し、0.25ニュートン(N)未満の座屈力を有するように構成されている、膜とを備える連続検体センサ。
100 システム
101 連続検体センサシステム
102 薬剤送達ポンプ
104 グルコースメーター
110 連続検体センサ
110' センサ帯状物
112 センサ電子機器
114、116、118、120 表示デバイス
114 比較的小型のキーフォブに似た表示デバイス
116 比較的大型のハンドヘルド型表示デバイス
118 携帯電話
120 コンピュータ
205 特定用途向け集積回路(ASIC)
210 ポテンショスタット
211 第1の入力ポート
214 プロセッサモジュール
216 プログラムメモリ
218 メモリ
220 データ記憶メモリ
222 ユーザインターフェース
224 ボタン
226 液晶ディスプレイ(LCD)
228 振動器
230 音響変換器(たとえば、スピーカー)
232 遠隔計測モジュール
234 電池
236 レギュレータ
237 第2の入力ポート
238 通信ポート
239 出力ポート
300 ハウジング
302 底面
304 開口部
406 ネットワーク
490 クラウドベースの検体プロセッサ
502 細長導電体
504 第2の層
506 窓
508 膜
510 細長芯
512 第1の層
514 第3の層
602 電極ドメイン
604 干渉ドメイン
606 酵素ドメイン
608 抵抗ドメイン
610 実質的に平面状の導電性層
612 層
700 センサ
702 細長芯
704 作用電極
706 参照または対向電極
708、710 導電性経路
800 力
900 力
1000 導電性トレース
1002 断面形状
1102 フィラメント押出成形機
1108 冷媒
1104、1106 トレース押出成形機
1110 細長芯構造
1200 導電性トレース
1300 溝
1400 スキージ
1402 液体導体
1502 繊維加熱器
1504 ラミネートダイ
1510 細長導電性芯構造
1600 導電性リボントレース
1700 誘導加熱器
1702 位置決めガイド
1704 ローラー
1710 細長導電性芯構造
1800 トレース
1802 電極
1900 細長絶縁体
1901 繊維束
1902 細長非導電性芯構造
2000 導電性トレース
2100 パターン形成絶縁層
2101 細長導電性芯構造
2102 窓
2300 絶縁層
2301 軟質細長導電体
2302 電極層
2302 コーティング
2303 窓
2304 第1の側
2306 第2の側
2400 近位端
2402 切欠
2500 コーティング
2501 束
2504 絶縁層
2503 窓
2504 同軸絶縁層
2600 切欠
2702 ステンシル
2704、2706 開口部
2710 電極
2712 トレース
2800 層
2802 絶縁層
2802' 絶縁材料
2804 トレース層
2806 第2の電極層
2808 第1の電極層
2808' トレース材料(たとえば、銀)
2810 絶縁層
2810' シート
2811 窓
2820 外縁
2822 断面プロファイル
2900 端部分
2904 縁部分
2906 切欠
2909 窓
3000 シート
3100 ローラー
3102 切断装置
3202 実質的に平坦な縁
3206 丸い側壁
3208 実質的に楕円形の断面プロファイル
3302 絶縁層
3303 絶縁層
3305 対向電極
3306 第2の電極層
3308 層
3310 絶縁層
3311 窓
3400 丸い側壁
3402 実質的に楕円形の断面プロファイル
3420 トレース層
3500、3600 グラフ
3602 第1の曲線
3604 曲線
3606 曲線
3608 曲線
3610 曲線
3700、3702 層
3700 親水性層
3706 一部
3706 濡れている部分
3708 濡れていない部分
3710 水和界面
3800 非導電性(たとえば、ポリマー)芯
3802 導電性トレース
3804 部分
3900 縁
4000 膜流体
4002 電場または磁場
4200 場
4400 磁場発生コンポーネント
4402 基材
4404、4406 磁場発生コンポーネント
4408、4410 磁場
4410' 対向磁場
4411 回転するプラットフォーム
4412 方向
4500 電場発生コンポーネント
4502 基材
4504 電場発生器
4505 電場発生器
4506 電場
4508 電源
4510 導電性トレース
4520 機構
4600 均等目盛りのグラフ
4602、4604、4606、4608 疲労特性曲線
4700 対数目盛りのグラフ
Claims (39)
- 生体内で使用するように構成されている連続検体センサであって、
細長芯と、
前記細長芯上に配設されている作用電極と、
前記作用電極の少なくとも一部を覆う膜であって、前記膜は酵素層を含み、前記連続検体センサの一部はセンサ電子機器ハウジングから延在し、0.25ニュートン(N)未満の座屈力を有するように構成されている、膜と
を備える連続検体センサ。 - 前記細長芯は、147GPa未満のヤング率を有する細長導電性芯を備える、請求項1に記載の連続検体センサ。
- 前記細長導電性芯の少なくとも一部を覆う導電性材料の層をさらに含む、請求項2に記載の連続検体センサ。
- 前記細長導電性芯は、銅、金、マグネシウム、銀、スズ、チタン、チタン合金、および亜鉛からなる群から選択される少なくとも1つの材料を含む、請求項3に記載の連続検体センサ。
- 前記導電性材料は、白金、白金イリジウム、金、パラジウム、イリジウム、これらの合金、黒鉛、炭素、および導電性ポリマーからなる群から選択される導電性材料を含む、請求項4に記載の連続検体センサ。
- 前記導電性材料の前記層の少なくとも一部を覆う絶縁材料の層をさらに含み、前記作用電極は、一部は、前記導電性材料の前記層の電極部分を露出する絶縁材料の前記層内の窓によって形成される、請求項3に記載の連続検体センサ。
- 絶縁材料の前記層の少なくとも一部を覆う追加の導電性層をさらに含み、前記追加の導電性層は参照電極を含む、請求項6に記載の連続検体センサ。
- 前記細長芯は、細長ポリマー芯を含み、前記細長芯の一部は、1 1/2GPa未満の曲げ弾性率を有する、請求項1から7のいずれか一項に記載の連続検体センサ。
- 前記細長ポリマー芯の長さに沿って延びる少なくとも1つの導電性トレースをさらに含み、前記導電性トレースの一部は前記作用電極を含む、請求項8に記載の連続検体センサ。
- 前記細長ポリマー芯は、細長楕円形ポリマー芯を含み、少なくとも1つの導電性トレースは、前記細長楕円形ポリマー芯に沿って延びる、請求項8に記載の連続検体センサ。
- 前記作用電極は、前記少なくとも1つの導電性トレースの一部を含む、請求項10に記載の連続検体センサ。
- 前記細長芯は、細長繊維芯を含む、請求項1から11のいずれか一項に記載の連続検体センサ。
- 前記細長芯は、
前記細長繊維芯を実質的に囲む細長絶縁体と、
前記細長絶縁体に沿って延びる少なくとも1つの導電性トレースとをさらに含む、請求項12に記載の連続検体センサ。 - 前記細長繊維芯は、1つまたは複数のケブラー繊維を含む、請求項12に記載の連続検体センサ。
- 前記細長芯は、前記1つまたは複数のケブラー繊維上の導電性コーティングをさらに含み、前記導電性コーティングを有する前記1つまたは複数のケブラー繊維の一部は、前記作用電極を形成する、請求項14に記載の連続検体センサ。
- 請求項1から15のいずれか一項に記載の連続検体センサと、前記連続検体センサからのセンサ信号を処理するように構成されているセンサ電子機器とを備える連続検体センサシステムであって、前記センサ電子機器は、前記センサ電子機器ハウジング内に配設され、前記センサ電子機器ハウジングは、患者の皮膚の外側に取り付けられるように構成される連続検体センサシステム。
- 前記細長芯の一部は、0.02N未満の座屈力を有する、請求項1から15のいずれか一項に記載の連続検体センサ。
- 前記細長芯の一部は、0.1kPaから300kPaの間の曲げ弾性率を有する、請求項17に記載の連続検体センサ。
- 生体内で使用するように構成されている連続検体センサであって、
作用電極を備える細長導電体であって、前記細長導電体は複数の実質的に平面状の層を含み、連続検体センサシステムのハウジングから延在するように構成されている前記複数の実質的に平面状の層の一部が全体として0.25ニュートン(N)未満の座屈力を有する、細長導電体と、
前記作用電極の少なくとも一部を覆う膜であって、前記膜は酵素層を含む、膜と
を備える連続検体センサ。 - 前記複数の実質的に平面状の層は、
絶縁ポリマー層と、
前記絶縁ポリマー層の第1の側に配設されている第1の電極層と、
前記絶縁ポリマー層の対向する第2の側に配設されている第2の電極層であって、前記作用電極は、前記第1の電極層の一部を含み、前記第2の電極層は、参照電極を含む、第2の電極層と
を含む、請求項19に記載の連続検体センサ。 - 前記第1の電極層上に形成された追加の絶縁ポリマー層をさらに含み、前記追加の絶縁ポリマー層は、前記作用電極を画定する窓を備える、請求項20に記載の連続検体センサ。
- 前記膜は、前記追加の絶縁ポリマー層内の前記窓内の前記第1の電極層上に配設され、前記追加の絶縁ポリマー層には、前記窓の外の前記膜が実質的にない、請求項21に記載の連続検体センサ。
- 前記複数の実質的に平面状の層は、断面において、実質的に楕円形の外面を備える、請求項21に記載の連続検体センサ。
- 前記絶縁ポリマー層は、第1および第2の絶縁ポリマー層を含み、前記複数の実質的に平面状の層は、前記第1の絶縁ポリマー層と前記第2の絶縁ポリマー層との間に配設される対向電極層をさらに含む、請求項21に記載の連続検体センサ。
- 前記複数の実質的に平面状の層は、前記第1の電極層と前記絶縁ポリマー層との間に配設される導電性トレース層をさらに含む、請求項20に記載の連続検体センサ。
- 前記複数の実質的に平面状の層は、前記導電性トレース層上に形成された追加の絶縁ポリマー層をさらに含み、前記追加の絶縁ポリマー層は、前記作用電極を画定する窓を備える、請求項25に記載の連続検体センサ。
- 前記細長導電体の追加の部分には、前記膜が実質的にない、請求項19から26のいずれか一項に記載の連続検体センサ。
- 生体内で使用するように構成されている連続検体センサであって、
作用電極を備える細長導電体であって、前記細長導電体は生体外の自立細長導電体および生体内の非自立細長導電体であるように構成される、細長導電体と、
前記作用電極の少なくとも一部を覆う膜であって、前記膜は酵素層を含む、膜とを備える連続検体センサ。 - 前記細長導電体は、前記細長導電体の少なくとも一部と患者の組織との間の接触に応答して前記自立細長導電体から前記非自立細長導電体に変わるように構成される、請求項28に記載の連続検体センサ。
- 前記細長導電体は、華氏78度から100度の間の遷移温度で前記自立細長導電体から前記非自立細長導電体に変わるように構成される、請求項28または29に記載の連続検体センサ。
- 前記細長導電体は、前記細長導電体の少なくとも一部による患者組織からの体液の吸収に応答して前記自立細長導電体から前記非自立細長導電体に変わるように構成される、請求項28から30のいずれか一項に記載の連続検体センサ。
- 前記細長導電体は、患者組織からの体液と前記細長導電体の少なくとも一部との間の化学反応に応答して前記自立細長導電体から前記非自立細長導電体に変わるように構成される、請求項28から31のいずれか一項に記載の連続検体センサ。
- 前記細長導電体は、前記連続検体センサに対するセンサ電子機器によって生成される電磁場に応答して前記自立細長導電体から前記非自立細長導電体に変わるように構成される、請求項28から32のいずれか一項に記載の連続検体センサ。
- 前記細長導電体は、細長導電性芯を含む、請求項28から33のいずれか一項に記載の連続検体センサ。
- 前記細長導電体は、細長ポリマー芯を含む、請求項28から34のいずれか一項に記載の連続検体センサ。
- 前記細長導電体は、複数の実質的に平面状の層を含む、請求項28から35のいずれか一項に記載の連続検体センサ。
- 請求項28から36のいずれか一項に記載の連続検体センサと、前記連続検体センサからのセンサ信号を処理するように構成されているセンサ電子機器とを備える連続検体センサシステムであって、前記センサ電子機器は、患者の皮膚の外側に取り付けられるように構成されているハウジング内に配設される、連続検体センサシステム。
- 生体内では、前記細長導電体は、0.01N未満の座屈力を有する、請求項37に記載の連続検体センサ。
- 前記非自立細長導電体は、重力下の重量と、重力下で前記重量未満である座屈力とを有する、請求項28から38のいずれか一項に記載の連続検体センサ。
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