JPWO2020069564A5 - - Google Patents
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- JPWO2020069564A5 JPWO2020069564A5 JP2021543546A JP2021543546A JPWO2020069564A5 JP WO2020069564 A5 JPWO2020069564 A5 JP WO2020069564A5 JP 2021543546 A JP2021543546 A JP 2021543546A JP 2021543546 A JP2021543546 A JP 2021543546A JP WO2020069564 A5 JPWO2020069564 A5 JP WO2020069564A5
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- 239000000758 substrate Substances 0.000 claims 10
- 230000004044 response Effects 0.000 claims 8
- 210000003722 extracellular fluid Anatomy 0.000 claims 5
- 239000000126 substance Substances 0.000 claims 5
- 150000002500 ions Chemical class 0.000 claims 4
- 239000000463 material Substances 0.000 claims 4
- 238000005259 measurement Methods 0.000 claims 4
- 239000012530 fluid Substances 0.000 claims 3
- 230000005284 excitation Effects 0.000 claims 2
- 238000012806 monitoring device Methods 0.000 claims 2
- 210000000434 stratum corneum Anatomy 0.000 claims 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- 239000004698 Polyethylene Substances 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 239000000853 adhesive Substances 0.000 claims 1
- 230000001070 adhesive effect Effects 0.000 claims 1
- 230000004888 barrier function Effects 0.000 claims 1
- 210000000476 body water Anatomy 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 210000002615 epidermis Anatomy 0.000 claims 1
- 239000000017 hydrogel Substances 0.000 claims 1
- 210000002977 intracellular fluid Anatomy 0.000 claims 1
- 239000010410 layer Substances 0.000 claims 1
- 230000004048 modification Effects 0.000 claims 1
- 238000012986 modification Methods 0.000 claims 1
- 230000035515 penetration Effects 0.000 claims 1
- -1 polyethylene Polymers 0.000 claims 1
- 229920000573 polyethylene Polymers 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 239000002094 self assembled monolayer Substances 0.000 claims 1
- 239000013545 self-assembled monolayer Substances 0.000 claims 1
- 230000000638 stimulation Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Claims (15)
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対に設けられ、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を含む、少なくとも一つの基材と、
b)前記対内の微細構造体の間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の対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の対に動作可能に接続され、前記対内の微細構造体の間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。 A system for performing fluid level measurements on a living subject, comprising:
a) comprising a plurality of microstructures configured to penetrate the stratum corneum of said subject, at least some of the microstructures being provided in pairs and spaced apart having opposing substantially planar electrodes; at least one substrate comprising a plate microstructure ;
b) a signal generator operably connected to at least one pair of microstructures for applying electrical stimulation signals between microstructures in said pair;
c) at least one sensor operably connected to at least one pair of microstructures and configured to measure electrical response signals between microstructures in said pair;
d)
i) determining a measured response signal, said response signal being at least partially indicative of bioimpedance;
ii) one or more configured to perform an analysis at least partially using the measured response signal to determine at least one indicator at least partially indicative of fluid level in the subject; and an electronic processing device.
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1に記載のシステム。 a) at least some of the pairs of microstructures are angularly offset;
b) at least some pairs of microstructures are provided orthogonally;
c) pairs of adjacent microstructures are provided orthogonally;
d) pairs of microstructures are provided in rows, said pairs of microstructures in one row being angularly offset with respect to pairs of microstructures in another row;
e) pairs of microstructures are arranged in rows, and at least one of said pairs of microstructures in one row are arranged orthogonal to pairs of microstructures in another row; The system of claim 1 .
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)微細構造体の対間の間隔は、
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1又は2に記載の電極装備。 a) the spacing between said microstructures within each pair is:
i) less than 0.25 mm;
ii) about 0.1 mm, and iii) greater than 10 μm;
b) the spacing between pairs of microstructures is
i) less than 1 mm;
ii) about 0.5 mm, and iii) greater than 0.2 mm.
3. Electrode arrangement according to claim 1 or 2 .
a)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、
b)
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を有する、
c)
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を有する、
d)
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を有する、
e)
i)
(1)前記微細構造体の長さの50%未満、
(2)前記微細構造体の長さの少なくとも10%、および
(3)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
ii)
(1)少なくとも0.1μm、
(2)5μm未満、および
(3)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、
f)
i)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
ii)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
iii)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、ならびに
g)
i)5000/cm 2 未満、
ii)100/cm 2 超、および
iii)約600/cm 2
のうちの少なくとも一つの密度を有する、
のうちの少なくとも一つである、請求項1~3のいずれか一項に記載のシステム。 At least some of the microstructures are
a) is at least partially tapered and has a substantially rounded rectangular cross-sectional shape;
b)
i) less than 300 μm;
ii) about 150 μm;
ii) having a length of at least one of greater than 100 μm, and iv) greater than 50 μm;
c )
i) a scale similar to said length;
ii) greater than said length;
iii) about the same as said length;
iv) less than 300 μm,
v) about 150 μm, and vi) having a maximum width that is at least one of greater than 50 μm.
d )
i) less than said width;
ii) significantly smaller than said width;
iii) a scale smaller than said length;
iv) less than 50 μm,
v) about 25 μm;
vi) having a thickness that is at least one of greater than 10 μm;
e)
i)
(1) less than 50% of the length of the microstructure;
(2) at least 10% of the length of said microstructure, and
(3) about 30% of the length of the microstructure
and the length of at least one of
ii)
(1) at least 0.1 μm;
(2) less than 5 μm, and
(3) about 1 μm
sharpness of at least one of
having a tip that is at least one of
f)
i) an anchor microstructure used to affix said substrate to said object;
ii) a shoulder configured to abut the stratum corneum to control the depth of penetration; and
iii) a shaft extending from a shoulder to a tip and configured to control the position of said tip within said object;
and at least one of
g)
i) less than 5000/ cm2 ,
ii) greater than 100/cm2 , and
iii) about 600/ cm2
has a density of at least one of
The system according to any one of claims 1 to 3 , wherein at least one of
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1~6のいずれか一項に記載のシステム。 a) a substrate coil disposed on the substrate and operably coupled to one or more microstructure electrodes;
b) said excitation and receiving coils positioned in close proximity to said substrate coil such that a modification of the drive signal applied to said excitation and receiving coils acts as a response signal; The system described in paragraph.
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1~7のいずれか一項に記載のシステム。 The microstructure is
a) part of the surface of the microstructure;
b) the proximal end of said microstructure;
c) at least half the length of said microstructures;
8. An insulating layer extending over at least one of d) about 90 μm of a proximal end of said microstructure, and e) at least a portion of a distal portion of said microstructure. The system described in paragraph.
a)
i)200,000μm2未満、
ii)約22,500μm2、
iii)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、
b)前記微細構造体の遠位部分の長さにわたって延びる、
c)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、
d)前記微細構造体の遠位端に近接して配置される、
e)前記微細構造体の先端に近接して配置される、
f)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、
g)前記微細構造体の長さの50%未満にわたって延びる、
h)前記微細構造体の約60μmにわたって延びる、および
i)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1~8のいずれか一項に記載のシステム。 at least one electrode
a)
i) less than 200,000 μm2;
ii ) about 22,500 μm 2 ;
iii ) at least 2,000 μm 2
having a surface area of at least one of
b) extending the length of the distal portion of the microstructure;
c) extending the length of a portion of the microstructure spaced from the tip;
d) positioned proximate to a distal end of said microstructure;
e) positioned proximate to the tip of the microstructure;
f) extends over at least 25% of the length of the microstructure;
g) extends over less than 50% of the length of the microstructure;
h) extends over about 60 μm of said microstructures, and
i) configured to be placed within the living epidermis of said subject when in use;
The system according to any one of claims 1 to 8 , wherein at least one of
i)バイオファウリングを低減する材料、
ii)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
iii)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、
b)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、
のうちの少なくとも一つであり、前記被覆は、
i)
(1)親水性を高めるため、
(2)疎水性を高めるため、および
(3)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、
ii)少なくとも一つの物質を前記微細構造体に引き付ける、
iii)少なくとも一つの物質を前記微細構造体から反発する、
iv)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
v)
(1)ポリエチレン、
(2)ポリエチレングリコール、
(3)ポリエチレンオキシド、
(4)双性イオン、
(5)ペプチド、
(6)ヒドロゲル、および
(7)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1~9のいずれか一項に記載のシステム。 a) the microstructure,
i ) materials that reduce biofouling,
ii ) a material that attracts at least one substance to said microstructures; and
iii ) a material comprising at least one of a material that repels at least one substance from said microstructure;
b) at least some of said microstructures are coated with a coating;
at least one of
i)
(1) to increase hydrophilicity,
(2) to increase hydrophobicity, and
(3) to minimize biofouling
modifying surface properties for at least one of
ii) attracting at least one substance to said microstructure;
iii) repels at least one substance from said microstructure;
iv) act as a barrier to exclude at least one substance from said microstructure;
v)
(1) polyethylene,
(2) polyethylene glycol,
(3) polyethylene oxide,
(4) zwitterion,
(5) peptides;
(6) hydrogels, and
(7) Self-assembled monolayer
contains at least one of
A system according to any preceding claim, wherein at least one of
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1~10のいずれか一項に記載のシステム。 a housing that includes the at least one sensor, the signal generator, and the at least one electronic processing device, the housing selectively coupling to the substrate and one of the housing and the substrate; at least one
a) fixed to said object;
b) anchored to said object using an anchor microstructure;
c) secured to said subject using an adhesive patch, and
d) secured to said subject using a strap
The system according to any one of claims 1 to 10 , wherein at least one of
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、請求項1~11のいずれか一項に記載のシステム。 The system includes a monitoring device and a patch including the substrate and the microstructure, the monitoring device comprising:
a) making said measurements,
b)
i) providing an output indicative of said indicator; and
ii) provide recommendations based on said metrics
do at least one of
A system according to any one of claims 1 to 11 , configured to:
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12に記載のシステム。 The monitor device is
a) inductively coupled to said patch,
b) attached to said patch;
13. The system of claim 12 , wherein at least one of c) is brought into contact with the patch when a reading is to be taken.
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、および
ii)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と、
c)
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1~13のいずれか一項に記載のシステム。 The system includes:
a) a wearable monitor device for performing said measurements;
b)
i) data of interest derived from said measured response signal, and
ii) the measured response signal
a transmitter that transmits at least one of
c)
i) receiving data of interest derived from the measured response signal;
ii) analyzing said subject data to generate at least one indicator, said at least one indicator at least partially indicative of a physiological status associated with said subject;
A system according to any one of claims 1 to 13 , comprising a processing system.
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1~14のいずれか一項に記載のシステム。 The system includes:
a) interstitial fluid level,
b) changes in interstitial fluid levels;
c) the concentration of ions in the interstitial fluid;
d) changes in ion concentration in the interstitial fluid;
e) ion concentration,
f) changes in ion concentration;
g) total body water content,
h) intracellular fluid level,
i) extracellular fluid level,
j) plasma water level;
k) fluid volume; System as described.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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AU2018903709 | 2018-10-02 | ||
AU2018903709A AU2018903709A0 (en) | 2018-10-02 | Measurement System | |
PCT/AU2019/051059 WO2020069564A1 (en) | 2018-10-02 | 2019-10-01 | A system for determining fluid level in a biological subject |
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JP2022508574A JP2022508574A (en) | 2022-01-19 |
JPWO2020069564A5 true JPWO2020069564A5 (en) | 2022-10-11 |
JP7379505B2 JP7379505B2 (en) | 2023-11-14 |
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US (2) | US12048558B2 (en) |
EP (2) | EP3860451A4 (en) |
JP (2) | JP7379505B2 (en) |
AU (4) | AU2019352634C1 (en) |
CA (2) | CA3114763A1 (en) |
WO (2) | WO2020069564A1 (en) |
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