JP2022508574A - 流体レベルの判定 - Google Patents
流体レベルの判定 Download PDFInfo
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- JP2022508574A JP2022508574A JP2021543546A JP2021543546A JP2022508574A JP 2022508574 A JP2022508574 A JP 2022508574A JP 2021543546 A JP2021543546 A JP 2021543546A JP 2021543546 A JP2021543546 A JP 2021543546A JP 2022508574 A JP2022508574 A JP 2022508574A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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Abstract
Description
別段の定めがない限り、本明細書で使用される全ての技術用語および科学用語は、本発明が属する技術の当業者によって一般に理解されるのと同じ意味を有する。本明細書に記載されるものと類似または等価の任意の方法および材料を本発明の実践または試験に使用することができるが、好ましい方法および材料が記載される。本発明の目的のために、次の用語が以下に定義される。
次に、生体対象に対して流体レベルの測定を行うためのシステムの例を、図1を参照して説明する。
材料は、例えば製造中に微細構造体を含浸することによって微細構造体自体の中に含有されることができ、または被覆中に提供されることもできる。例えば、ポリマー材料を使用して製造される成形パッチの場合、材料が構造体全体に分散されるように材料がポリマー材料と一緒にモールドに導入されることができる。この例では、ポリマーは、硬化プロセスの間に構造体内に細孔が形成されるように設けられることができる。
使用時には、アクチュエータハウジング335は、パッチが開口部335.2を通して少なくとも部分的に突出した状態で、ハウジング335のベース335.1が対象の皮膚に当接するように配置される。一例ではこれは、操作者にアクチュエータハウジングを保持させることによって達成される。しかし、これは必須ではなく、加えておよび/または代わりにアクチュエータハウジングが上述のようにモニタデバイスに統合され、および/またはその一部を形成することもできる。
この例では、微細構造体は、本体512.1と先端512.2とを有するプレートであり、微細構造体512の角質層への貫通を容易にするためにテーパ状である。この例では、電極プレート517が微細構造体の両側に提供され、これらは一つの接続部513を介してコネクタ515に連結されて、センサ321および/または信号生成器323にさらに接続される。これにより、信号を電極プレートからまとめて測定し、または電極プレートにまとめて印加することが可能になる。しかし、これは必須ではなく、独立した接続部が提供されて各電極が独立して駆動または検知されることを可能にすることもできることが理解されよう。加えて、各電極517は、各面が複数の電極を含むように複数の独立したセグメント517.1、517.2、517.3、517.4に細分されることもできる。
この例では、キャリアウェーハ891が提供され、フォトポリマー層892でスピン被覆される。フォトポリマー層892はUV照射に選択的に曝露され、架橋されて構造領域892.1が作られ、これらが本例では基材を形成する。第二フォトポリマー層893が第一層891の上にスピン被覆され、UV照射に曝露され、架橋されて第二構造領域893.1を形成し、これらが本例では基材から延びる微細構造体を形成する。キャリアウェーハおよび非架橋ポリマーを除去して、図8Dに示す微細構造体が作られる。
次に、微細構造体を含む基材を製造するためのプロセスの例をより詳細に説明する。
最後に、ウェーハは、15mW/cm2のパワーを送達する紫外線源1907を40秒間使用してフラッド曝露される(図19J)。ウェーハをAZ726現像液に一晩浸すことにより構造体が剥離され(図19K)、ウェーハを120℃の熱ショックに15秒間曝露した。構造体が裏返されたモールドから除去され、窒素ガスを用いて乾燥される(図19L)。
次に、保水の測定における微細構造体の使用の例を説明する。
ヒトにおける微細構造体パッチの忍容性および機能性を評価するための研究を行っている。
一例では、上述のシステムは、イオン濃度および/または保水測定などの流体測定が行われることを可能にする。構造体の長さは、標的組織内の特定の層を標的とすることができるように、製造中に制御することができる。一例ではこれは、表皮および/または真皮ISFの流体レベルを標的とするために行われる。
Claims (53)
- 生体対象に対して流体レベルの測定を行うためのシステムであって、
a)前記対象の角質層を突破するように構成された複数の微細構造体を含み、少なくともいくつかの微細構造体は電極を含む、少なくとも一つの基材と、
b)前記少なくとも一つの微細構造体に電気刺激信号を印加するために少なくとも一つの微細構造体に動作可能に接続された信号生成器と、
c)少なくとも一つの微細構造体に動作可能に接続され、少なくとも一つの微細構造体からの電気応答信号を測定するように構成された少なくとも一つのセンサと、
d)
i)測定された応答信号を判定し、前記応答信号は、少なくとも部分的にバイオインピーダンスを示し、
ii)前記対象中の流体レベルを少なくとも部分的に示す少なくとも一つの指標を判定するために、前記測定された応答信号を少なくとも部分的に使用して分析を行う
ように構成された一つ以上の電子処理デバイスと
を備えるシステム。 - 前記微細構造体の少なくともいくつかは、対に設けられ、前記システムは、
a)前記対内の微細構造体の間での応答信号の測定、および
b)前記対内の微細構造体の間での刺激の印加
のうちの少なくとも一つをするように構成される、請求項1に記載のシステム。 - 微細構造体の各対は、
a)対向する実質的に平面状の電極を有する離間されたプレート微細構造体、および
b)離間された実質的に平行なプレート微細構造体
のうちの少なくとも一つを含む、請求項2に記載のシステム。 - a)少なくともいくつかの微細構造体の対は角度がオフセットされる、
b)少なくともいくつかの微細構造体の対は直交して設けられる、
c)隣接する微細構造体の対は直交して設けられる、
d)微細構造体の対は列に設けられ、一つの列の前記微細構造体の対は他の列の微細構造体の対に対して角度がオフセットされる、
e)微細構造体の対は列に設けられ、一つの列の前記微細構造体の対は他の列の微細構造体の対に対して直交して設けられる
のうちの少なくとも一つである、請求項2または請求項3に記載のシステム。 - a)各対内の前記微細構造体間の間隔は、
i)0.25mm未満、
ii)約0.1mm、および
iii)10μm超
のうちの少なくとも一つであり、
b)微細構造体の群間の間隔は、
i)1mm未満、
ii)約0.5mm、および
iii)0.2mm超
のうちの少なくとも一つである、
請求項2~4のいずれか一項に記載の電極装備。 - 前記微細構造体の少なくともいくつかはプレートである、請求項1~5のいずれか一項に記載のシステム。
- 前記プレート微細構造体は、少なくとも部分的にテーパ状であり、実質的に角丸長方形の断面形状を有する、請求項6に記載のシステム。
- 前記微細構造体の少なくともいくつかは、
a)
i)300未満μm、
ii)約150μm、
ii)100μm超、および
iv)50μm超
のうちの少なくとも一つの長さ、
b)
i)前記長さと類似の規模、
ii)前記長さより大きい、
iii)前記長さと約同じ、
iv)300μm未満、
v)約150μm、および
vi)50μm超
のうちの少なくとも一つである最大の幅、ならびに
c)
i)前記幅より小さい、
ii)前記幅よりかなり小さい、
iii)前記長さより小さい規模、
iv)50μm未満、
v)約25μm、
vi)10μm超
のうちの少なくとも一つである厚さ
のうちの少なくとも一つを有する、請求項1~7のいずれか一項に記載のシステム。 - 前記微細構造体の少なくともいくつかは、
a)
i)前記微細構造体の長さの50%未満、
ii)前記微細構造体の長さの少なくとも10%、および
iii)前記微細構造体の長さの約30%
のうちの少なくとも一つの長さ、ならびに
b)
i)少なくとも0.1μm、
ii)5μm未満、および
iii)約1μm
のうちの少なくとも一つの鋭さ
のうちの少なくとも一つである先端を有する、請求項1~8のいずれか一項に記載のシステム。 - 前記微細構造体の少なくともいくつかは、
a)貫通の深さを制御するために角質層に当接するように構成されたショルダ、および
b)ショルダから先端まで延び、前記対象内の前記先端の位置を制御するように構成されるシャフト
のうちの少なくとも一つを含む、請求項1~9のいずれか一項に記載のシステム。 - 前記微細構造体は、
a)5000/cm2未満、
b)100/cm2超、および
c)約600/cm2
のうちの少なくとも一つの密度を有する、請求項1~10のいずれか一項に記載のシステム。 - 前記微細構造体は、
a)1mm未満、
b)約0.5mm、
c)約0.2mm、
d)約0.1mm、および
e)10μm超
のうちの少なくとも一つの間隔を有する、請求項1~11のいずれか一項に記載のシステム。 - 前記基材は、電気信号がそれぞれの微細構造体に印加されることおよび/またはそれぞれの微細構造体から受信されることを可能にする電気接続部を含む、請求項1~12のいずれか一項に記載のシステム。
- 前記システムは、前記少なくとも一つのセンサおよび少なくとも一つの信号生成器のうちの少なくとも一つを前記微細構造体の一つ以上に選択的に接続するための一つ以上のスイッチを含む、請求項1~13のいずれか一項に記載のシステム。
- 前記一つ以上の処理デバイスは、少なくとも一つの測定が行われることを可能にするために前記スイッチおよび前記信号生成器を制御するように構成される、請求項14に記載のシステム。
- a)前記基材上に配置され、一つ以上の微細構造体電極に動作可能に連結された基材コイルと、
b)励起および受信コイルに印加される駆動信号の変更が応答信号として働くように前記基材コイルに近接して配置された前記励起および受信コイルと
を含む、請求項1~15のいずれか一項に記載のシステム。 - 前記電極は、前記微細構造体の表面上に被覆を含む、請求項1~16のいずれか一項に記載のシステム。
- 前記微細構造体は、
a)伝導性コア材料、ならびに
b)伝導性コア材料、および電気信号がポートから放出されることまたは前記ポートによって受信されることを可能にする前記ポートを含む電気絶縁層
のうちの少なくとも一つを含む、請求項1~17のいずれか一項に記載のシステム。 - 前記微細構造体は、
a)前記微細構造体の表面の一部、
b)前記微細構造体の近位端、
c)前記微細構造体の長さの少なくとも半分、
d)前記微細構造体の近位端の約90μm、および
e)前記微細構造体の先端部分の少なくとも一部
のうちの少なくとも一つにわたって延びる絶縁層を含む、請求項1~18のいずれか一項に記載のシステム。 - 少なくとも一つの電極は、
a)200,000μm2未満、
b)約22,500μm2、
c)少なくとも2,000μm2
のうちの少なくとも一つの表面積を有する、請求項1~19のいずれか一項に記載のシステム。 - 少なくとも一つの電極が、
a)前記微細構造体の遠位部分の長さにわたって延びる、
b)先端から離間された前記微細構造体の一部分の長さにわたって延びる、
c)前記微細構造体の遠位端に近接して配置される、
d)前記微細構造体の先端に近接して配置される、
e)前記微細構造体の長さの少なくとも25%にわたって延びる、
f)前記微細構造体の長さの50%未満にわたって延びる、
g)前記微細構造体の約60μmにわたって延びる、および
h)使用時に前記対象の生きた表皮内に配置されるように構成される
のうちの少なくとも一つである、請求項1~20のいずれか一項に記載のシステム。 - 前記基材および前記微細構造体のうちの少なくとも一つは、
a)金属、
b)ポリマー、および
c)シリコン
のうちの少なくとも一つを含む、請求項1~21のいずれか一項に記載のシステム。 - 前記微細構造体は、前記基材を前記対象に固着するために使用されるアンカ微細構造体を含む、請求項1~22のいずれか一項に記載のシステム。
- 前記アンカ微細構造体は、
a)アンカリング構造体を含む、
b)他の微細構造体より長い長さを有する、および
c)真皮に入る
のうちの少なくとも一つである、請求項23に記載のシステム。 - 前記微細構造体は、
a)バイオファウリングを低減する材料、
b)少なくとも一つの物質を前記微細構造体に引き付ける材料、および
c)少なくとも一つの物質を前記微細構造体から反発する材料
のうちの少なくとも一つを含む材料を含む、請求項1~24のいずれか一項に記載のシステム。 - 前記微細構造体の少なくともいくつかは、被覆で被覆される、請求項1~25のいずれか一項に記載のシステム。
- 前記被覆は、
a)
i)親水性を高めるため、
ii)疎水性を高めるため、および
iii)バイオファウリングを最小化するため
のうちの少なくとも一つのために表面特性を改質する、
b)少なくとも一つの物質を前記微細構造体に引き付ける、
c)少なくとも一つの物質を前記微細構造体から反発する、
d)少なくとも一つの物質を前記微細構造体から排除するためのバリアとして働く、ならびに
e)
i)ポリエチレン、
ii)ポリエチレングリコール、
iii)ポリエチレンオキシド、
iv)双性イオン、
v)ペプチド、
vi)ヒドロゲル、および
vii)自己組織化単分子膜
のうちの少なくとも一つを含む
のうちの少なくとも一つである、請求項26に記載のシステム。 - 前記システムは、前記微細構造体に前記角質層を貫通させるために前記基材に力を加えるように構成されたアクチュエータを含む、請求項1~27のいずれか一項に記載のシステム。
- 前記アクチュエータは、
a)電磁アクチュエータ、
b)電気アクチュエータ、
c)圧電アクチュエータ、および
d)機械アクチュエータ
のうちの少なくとも一つである、請求項28に記載のシステム。 - 前記アクチュエータは、
a)振動力、および
b)連続力
のうちの少なくとも一つを加えるように構成される、請求項28または29に記載のシステム。 - 前記振動力は、
a)少なくとも10Hz、
b)約100~200Hz、および
c)1kHz未満
のうちの少なくとも一つの周波数で加えられる、請求項30に記載のシステム。 - 前記力は、
a)
i)1N超、
ii)10N未満、および
iii)約2.5~5N
のうちの少なくとも一つの連続力、ならびに
b)
i)少なくとも1mN、
ii)約200mN、および
iii)1000mN未満
のうちの少なくとも一つの振動力
のうちの少なくとも一つを含む、請求項30または請求項31に記載のシステム。 - 前記アクチュエータは、
a)少なくとも10μm、
b)300μm未満、および
c)約50μm~100μm
のうちの少なくとも一つである前記微細構造体の動きを引き起こすように構成される、請求項28~32のいずれか一項に記載のシステム。 - 前記一つ以上の電子処理デバイスは、前記アクチュエータを制御する、請求項28~33のいずれか一項に記載のシステム。
- 前記少なくとも一つのセンサと、前記信号生成器と、少なくとも一つの電子処理デバイスとを含むハウジングを含む、請求項1~34のいずれか一項に記載のシステム。
- 前記ハウジングは、前記基材に選択的に連結する、請求項35に記載のシステム。
- 前記ハウジングは、
a)電磁連結、
b)機械連結、
c)接着連結、および
d)磁気連結
のうちの少なくとも一つを用いて前記基材に連結する、請求項36に記載のシステム。 - 前記ハウジングおよび前記基材のうちの少なくとも一つは、
a)前記対象に固定される、
b)アンカ微細構造体を使用して前記対象に固定される、
c)接着パッチを使用して前記対象に固定される、および
d)ストラップを使用して前記対象に固定される
のうちの少なくとも一つである、請求項35~37のいずれか一項に記載のシステム。 - 前記ハウジングは、前記微細構造体と信号を通信するために前記基材上の基材コネクタに動作可能に接続するハウジングコネクタを含む、請求項35~38のいずれか一項に記載のシステム。
- 前記システムは、ある期間にわたって反復測定を行うように構成され、前記微細構造体は、前記期間中前記対象内にとどまるように構成される、請求項1~39のいずれか一項に記載のシステム。
- 前記期間は、
a)少なくとも一分、
b)少なくとも一時間、
c)少なくとも一日、および
d)少なくとも一週間
のうちの少なくとも一つである、請求項40に記載のシステム。 - 前記システムは、
a)実質的に連続的に、
b)毎秒、
c)毎分、
d)5~10分毎、および
e)毎時
のうちの少なくとも一つである頻度で反復測定を行うように構成される、請求項1~41のいずれか一項に記載のシステム。 - 前記システムは、
a)前記測定された応答信号から導出された対象データ、および
b)測定された応答信号
のうちの少なくとも一つを伝送する伝送機を含む、請求項1~42のいずれか一項に記載のシステム。 - 前記システムは、
a)前記測定を行い、
b)
i)前記指標を示す出力を提供する、および
ii)前記指標に基づく推奨を提供する
のうちの少なくとも一つを行う
ように構成されるモニタデバイスを含む、請求項1~43のいずれか一項に記載のシステム。 - 前記システムは、モニタデバイス、および前記基材と前記微細構造体とを含むパッチを含む、請求項1~44のいずれか一項に記載のシステム。
- 前記モニタデバイスは、
a)前記パッチに誘導連結される、
b)前記パッチに取り付けられる、
c)読み取りが行われるべきときに前記パッチと接触させられる
のうちの少なくとも一つである、請求項45に記載のシステム。 - 前記モニタデバイスは、
a)測定を行わせること、
b)測定値を少なくとも部分的に分析すること、
c)少なくとも一つの微細構造体に印加される刺激を制御すること、
d)出力を生成すること、
e)前記指標を示す出力を提供すること、
f)前記指標に基づく推奨を提供すること、および
g)アクションを行わせること
のうちの少なくとも一つをするように構成される、請求項45または請求項46に記載のシステム。 - 前記システムは、
a)前記測定を行うウェアラブルモニタデバイスと、
b)
i)前記測定された応答信号から導出された対象データを受信し、
ii)前記対象データを分析して少なくとも一つの指標を生成し、前記少なくとも一つの指標は前記対象に関連する生理学的ステータスを少なくとも部分的に示す、
処理システムと
を含む、請求項1~47のいずれか一項に記載のシステム。 - 前記システムは、
a)前記ウェアラブルモニタデバイスから測定データを受信し、
b)前記測定データを使用して対象データを生成し、
c)前記対象データを前記処理システムに転送し、
d)前記処理システムから指標を受信し、
e)前記指標の表現を表示する
クライアントデバイスを含む、請求項48に記載のシステム。 - 前記システムは少なくとも部分的にウェアラブルである、請求項1~49のいずれか一項に記載のシステム。
- 前記システムは、
a)間質液レベル、
b)間質液レベルの変化、
c)間質液中のイオン濃度、
d)間質液中のイオン濃度の変化、
e)イオン濃度、
f)イオン濃度の変化、
g)体内総水分量、
h)細胞内液レベル、
i)細胞外液レベル、
j)血漿水分レベル、
k)流体量、および
l)保水レベル
のうちの少なくとも一つを示す指標を判定するために、生きた表皮においてインピーダンス測定を行うように構成される、請求項1~50のいずれか一項に記載のシステム。 - 前記指標は前記対象の保水を示す、請求項1~51のいずれか一項に記載のシステム。
- 生体対象に対して流体レベルの測定を行うための方法であって、
a)前記対象の角質層を突破するために複数の微細構造体を含む少なくとも一つの基材を使用するステップであって、少なくともいくつかの微細構造体は電極を含む、ステップと、
b)少なくとも一つの微細構造体に電気刺激信号を印加するために前記少なくとも一つの微細構造体に動作可能に接続された信号生成器を使用するステップと、
c)少なくとも一つの微細構造体に動作可能に接続された少なくとも一つのセンサを使用するステップであって、前記少なくとも一つのセンサは、少なくとも一つの微細構造体からの電気応答信号を測定するように構成される、ステップと、
d)一つ以上の電子処理デバイスにおいて、
i)測定された応答信号を判定するステップであって、前記応答信号は、少なくとも部分的にバイオインピーダンスを示す、ステップと、
ii)前記対象中の流体レベルを少なくとも部分的に示す少なくとも一つの指標を判定するために、前記測定された応答信号を少なくとも部分的に使用して分析を行うステップと
を含む方法。
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