Measurement system

Abstract

Measurements are performed on biological subjects by using microstructures to penetrate the functional barriers of the target. [Solution] A system for performing measurements on a biological object, comprising: at least one substrate 511 including a plurality of plate microstructures 512.1, 512.2 configured to penetrate the stratum corneum of the object; at least one sensor operably connected to at least one microstructure and configured to measure a response signal from at least one microstructure; and one or more electronic processing devices configured to perform at least one of the following: determine the measured response signal, provide an output based on the measured response signal, perform an analysis using at least part of the measured response signal, and store data indicating at least part of the measured response signal.

Claims

1. A system for performing measurements on living organisms, a) A substrate comprising at least one set of microstructures configured to penetrate the stratum corneum of the biological object, wherein at least some of the microstructures include an insulating layer extending around the proximal end of the microstructure, the insulating layer covers half the length of the microstructure, and the leading edge of the microstructure is non-insulating, b) At least one sensor operably connected to at least one microstructure and configured to measure a response signal from the at least one microstructure, c) i) Determine the measured response signal, ii) (1) Providing an output based on the measured response signal, (2) At least partial analysis using the measured response signals, and (3) Storage of data that shows at least a portion of the measured response signal Perform at least one of the following: One or more electronic processing devices configured as follows: A system that includes this.

2. The system includes a signal generator operably connected to at least one microstructure for applying a stimulus signal, The one or more processing devices described above are: a) Control of the signal generator for performing the measurement, and b) Control of the signal generator according to the measured response signal. The system according to claim 1, configured to perform at least one of the following.

3. The system according to claim 2, wherein the response signal and stimulus signal include electrical signals, and the substrate includes electrical connections that enable the electrical signals to be applied to or received from each microstructure.

4. 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. The one or more processing devices described above are: a) To enable at least one measurement to be performed, and b) Controlling which microstructures are used to measure the response signal or apply the stimulus. The system according to any one of claims 1 to 3, configured to control the switch for at least one of the following:

5. The aforementioned response signal is a) Fluid level, b) visualization; c) Mapping, d) mechanical properties; e) force; f) Pressure, g) muscle exercise; h) Blood pulse wave, i) Presence, absence, level, or concentration of the analyte, j) blood oxygen saturation; k) Tissue inflammation state, l) Bioimpedance, m) Biocapacitance, n) Bioconductance, and a) Electrical signals in the body A system according to any one of claims 1 to 4, wherein at least one of the following is represented.

6. The system according to any one of claims 1 to 5, wherein the microstructure is at least partially tapered and has a substantially rounded rectangular cross-sectional shape.

7. The microstructure is applied to the target skin, a) At least some of the microstructures are i) Penetrating the stratum corneum, ii) It enters the living epidermis but not the dermis, and iii) Enters the dermis It is at least one of the following: b) At least some of the microstructures are i) (1) Less than 2500 μm, (2) Less than 1000 μm, (3) Less than 750 μm, (4) Less than 450 μm, (5) Less than 300 μm, (6) Less than 250 μm, (7) 250 μm, (8) 150 μm, (9) More than 100 μm, (10) More than 50 μm, (11) More than 10 μm At least one of the lengths, ii) (1) Less than 2500 μm, (2) Less than 1000 μm, (3) Less than 750 μm, (4) Less than 450 μm, (5) Less than 300 μm, (6) Less than 250 μm, (7) The scale of the length, (8) Larger than the above length, (9) Larger than the above length, (10) Same as the above length, (11) 250 μm, (12) 150 μm, and (13) More than 50 μm The largest width of at least one of them, and iii) (1) Smaller than the above width, (2) A width considerably smaller than the above width, (3) A scale smaller than the aforementioned length, (4) Less than 300 μm, (5) Less than 200 μm, (6) Less than 50 μm, (7) 25 μm, and (8) More than 10 μm at least one of the maximum thicknesses The system according to any one of claims 1 to 6, comprising at least one of the following.

8. At least some of the microstructures include electrodes, At least one electrode, a) Extending over the length of the distal portion of the microstructure, b) Extending over the length of a portion of the microstructure spaced apart from the tip, c) Arranged in close proximity to the distal end of the microstructure, d) Arranged in close proximity to the tip of the microstructure, e) Extending over at least 25% of the length of the microstructure, f) Extending over less than 50% of the length of the microstructure, g) Extending over 60 μm of the microstructure, h) configured to be positioned within the living epidermis of the subject when in use, i) i) Less than 200,000 μm², ii) 22,500 μm², and iii) At least 2,000 μm² Having a surface area that is at least one of the following The system according to any one of claims 1 to 7, wherein at least one of the above is the system according to claim 1 to 7.

9. At least some of the aforementioned microstructures are provided in a group, a) Response signals are measured between microstructures within the group, and b) Stimuli are applied between microstructures within the group. The system according to any one of claims 1 to 8, wherein at least one of the above is included.

10. The one or more microstructures interact with one or more target analytes such that the response signal depends on the presence, absence, level, or concentration of the target analyte. The system according to any one of claims 1 to 9, wherein selectively, the analyte interacts with a coating on the microstructure to alter the electrical or optical properties of the coating, thereby enabling the detection of the analyte.

11. At least some of the aforementioned microstructures are at least partially covered with a coating, Selectively, a) At least some microstructures are not covered, b) At least some of the microstructures are porous and have an internal coating, c) At least some microstructures are partially covered, d) Different microstructures have different coatings. e) Different parts of the microstructure include different coatings, f) At least some microstructures include multiple coatings, g) At least some of the microstructures are coated with a selectively soluble coating. The system according to any one of claims 1 to 10, wherein at least one of the above is the system according to claim 1 to 10.

12. The system includes an actuator configured to apply force to the substrate for at least one of penetrating and piercing the stratum corneum, a) The actuator is i) Electromagnetic actuator, ii) Vibration motor, iii) Piezoelectric actuator, and iv) Mechanical Actuator It is at least one of the following: b) The actuator is i) biasing force; ii) Vibration force, and iii) A single continuous force The system according to any one of claims 1 to 11, configured to add at least one of the following.

13. The one or more electronic processing devices described above are: a) Analyze the measured response signals to determine at least one index that at least partially indicates the physiological status associated with the subject. b) Analyzing the measured response signals to determine at least one metric, using the at least one metric to determine at least one index, the at least one index at least partially indicating the physiological status associated with the subject, fitting the at least one metric to at least one computational model to determine the index, the at least one computational model embodying the relationship between health status and the at least one metric, and obtained by applying machine learning to a reference metric derived from subject data measured for one or more reference subjects, and c) i) Presence, absence, or degree of a medical condition, ii) Prognosis related to medical condition, iii) Presence, absence, level, or concentration of biomarkers iv) Presence, absence, level, or concentration of the analyte, v) Fluid level in the subject, vi) Blood oxygenation, and vii) Bioelectric activity Determine the physiological status that exhibits at least one of the following: The system according to any one of claims 1 to 12, wherein at least one of the above is present.

14. The system includes a monitoring device and a patch comprising the substrate and the microstructure. a) The monitoring device is i) Inductively connected to the patch, ii) To be attached to the patch, iii) The patch is brought into contact when the reading is to be performed. at least one of the following, b) The monitoring device is i) Have the measurement performed. ii) Analyze the measured values ​​at least partially. iii) Controlling the stimulus applied to at least one microstructure, iv) To generate output, v) To provide an output that shows the aforementioned indicator, vi) To provide recommendations based on the aforementioned indicators, and vii) Make an action be performed Configured to perform at least one of the following The system according to any one of claims 1 to 13, wherein at least one of the above is the system according to claim 1 to 13.

15. The aforementioned system, a) A wearable monitor device that performs the measurement, b) i) Receive the target data derived from the measured response signal, ii) Analyze the target data to generate at least one index, the at least one index at least partially indicating the physiological status related to the target, Processing system and The system according to any one of claims 1 to 14, including the system described in any one of claims 1 to 14.

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