JPWO2020069564A5

JPWO2020069564A5 -

Info

Publication number: JPWO2020069564A5
Application number: JP2021543546A
Authority: JP
Publication date: 2022-10-11
Anticipated expiration: 2039-10-01

Claims

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.

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 .

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 .

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

5. The substrate of any one of claims 1-4 , wherein the substrate comprises electrical connections that allow electrical signals to be applied to and/or received from each microstructure. The system described in paragraph.

The system includes one or more switches for selectively connecting at least one of the at least one sensor and at least one signal generator to one or more of the microstructures; 6. A device as claimed in any preceding claim , wherein one or more processing devices are configured to control the switch and the signal generator to enable at least one measurement to be performed . system.

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.

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.

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

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 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

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:

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.

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.

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.