Electronics for detection of a condition of tissue

• US 9,579,040 B2
• Filed: 09/04/2012
• Issued: 02/28/2017
• Est. Priority Date: 09/01/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Rafferty, Conor, Carbeck, Jeffrey D., Dickson, Alexander, Dowling, Kevin, Hsu, Yung-Yu, Kacyvenski, Isaiah, Schlatka, Benjamin, Wei, Henry
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US13/603,290
• Publication Number:
  US 20130245388A1
• Time in Patent Office: 1,638 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/442 Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/68335 : including release sheets or liners
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 8/4416 : related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions

Abstract

Apparatus are provided for monitoring a condition of a tissue based on a measurement of an electrical property of the tissue. In an example, the electrical property of the tissue is performed using an apparatus disposed above the tissue, where the apparatus includes at least two conductive structures, each having a non-linear configuration, where the at least two conductive structures are disposed substantially parallel to each other. In another example, the electrical property of the tissue is performed using an apparatus disposed above the tissue, where the apparatus includes at least one inductor structure.

Claims

1. An apparatus disposed on tissue for monitoring a condition of the tissue, the apparatus comprising:

a first plurality of conductive structures, each of the conductive structures in the first plurality of conductive structures having a non-linear configuration that facilitates flexibility of the first plurality of conductive structures to flexing, stretching, or torsion of the tissue to which the apparatus is disposed upon, thereby aiding in maintaining the first plurality of conductive structures in contact with the tissue;

a second plurality of conductive structures, each of the conductive structures in the second plurality of conductive structures having a non-linear configuration that facilitates flexibility of the second plurality of conductive structures to flexing, stretching, or torsion of the tissue to which the apparatus is disposed upon, thereby aiding in maintaining the second plurality of conductive structures in contact with the tissue, each of the conductive structures in the second plurality of conductive structures being disposed substantially parallel to each of the conductive structures in the first plurality of conductive structures in an alternating and interdigitated configuration;

a first brace structure disposed substantially perpendicular to each of the conductive structures in the first plurality of conductive structures, the first brace structure being electrically coupled to each of the conductive structures in the first plurality of conductive structures;

a second brace structure disposed substantially perpendicular to each of the conductive structures in the second plurality of conductive structures, the second brace structure being electrically coupled to each of the conductive structures in the second plurality of conductive structures, wherein the first brace structure and the second brace structure aid in maintaining a substantially uniform separation between each of the conductive structures in the first plurality of conductive structures and each of the immediately adjacent conductive structures in the second plurality of conductive structures; and

a non-conducting spacer structure having a first end and a second end, the first end of the non-conducting spacer structure being physically coupled to the first brace structure and the second end of the non-conducting spacer structure being physically coupled to the second brace structure such that the non-conducting spacer structure aids in (i) maintaining a substantially uniform separation between the first brace structure and the second brace structure and (ii) maintaining a substantially uniform form factor of the apparatus during deformation of the apparatus,

wherein a capacitive based measurement performed by applying a potential across one of the conductive structures in the first plurality of conductive structures and a directly adjacent one of the conductive structures in the second plurality of conductive structures provides an indication of the condition of the tissue.

2. The apparatus of claim 1, wherein the condition of the tissue is a hydration state of the tissue, a volume of sweat lost, a mechanical property of the tissue, or a disease state of the tissue.

3. The apparatus of claim 1, wherein each of the conductive structures in the first plurality of conductive structures and each of the conductive structures in the second plurality of conductive structures has a zig-zag configuration, a serpentine configuration, or a rippled configuration.

4. The apparatus of claim 1, wherein the first brace structure and the second brace structure are both formed from a conductive material, and wherein the first brace structure electrically links the first plurality of conductive structures to an external circuit, and wherein the second brace structure electrically links the second plurality of conductive structures to the external circuit.

5. The apparatus of claim 1, wherein the non-conducting spacer structure is disposed substantially parallel to a principal direction of the first plurality of conductive structures and the second plurality of conductive structures.

6. The apparatus of claim 1, wherein the first brace structure is in electrical communication with a first electrical contact of the apparatus and the second brace structure is in electrical communication with a second electrical contact of the apparatus, and wherein the first electrical contact and the second electrical contact are in electrical communication with at least one of a power source, a wireless receiver, a wireless transmitter, a wireless transceiver, and a temperature sensor.

7. The apparatus of claim 1, further comprising a plurality of cross-link structures disposed between directly adjacent conductive structures, each cross-link structure of the plurality of cross-link structures being formed from a dielectric material.

8. The apparatus of claim 1, further comprising an encapsulation layer disposed over at least a portion of the first plurality of conductive structures and the second plurality of conductive structures.

9. The apparatus of claim 8, wherein portions of the encapsulation layer comprise an adhesive, and wherein the adhesive is configured to attach the portions of the encapsulation layer to the tissue.

10. The apparatus of claim 8, further comprising a plurality of cross-link structures disposed between directly adjacent conductive structures, each cross-link structure of the plurality of cross-link structures being formed from the same material as the encapsulation layer.

11. The apparatus of claim 8, wherein the encapsulation layer is a polymer.

12. The apparatus of claim 11, wherein the polymer is a polyimide.

13. The apparatus of claim 1, further comprising a backing layer in physical communication with at least a portion of the first plurality of conductive structures and the second plurality of conductive structures, wherein the backing layer is a polymer.

14. The apparatus of claim 1, further comprising an ultrasound apparatus, and wherein the ultrasound apparatus provides a measure of a condition of the tissue.

15. The apparatus of claim 14, wherein the ultrasound apparatus comprises:

an ultrasound generator configured to be disposed proximate to a first portion of the tissue of interest, wherein the ultrasound generator comprises a piezoelectric crystal, wherein the ultrasound generator directs ultrasound waves at a portion of the tissue; and

an ultrasound receiver configured to be disposed proximate to a second portion of the tissue of interest that is different from the first portion,

wherein the ultrasound receiver provides a measure of ultrasound waves arriving at the second portion of the tissue, and

wherein the measure of ultrasound waves arriving at the second portion of the tissue provides an indication of the condition of the tissue.

16. The apparatus of claim 1, further comprising at least one of the following:

a battery, a transmitter, a transceiver, a memory, a radio-frequency identification (RFID) chip, a processing unit, an analog sensing block, a UVA sensor, a UVB sensor, and a temperature sensor.

17. A method for monitoring a condition of a tissue, the method comprising:

receiving data indicative of the measurement, wherein the measurement is performed using at least one the apparatus of claim 1; and

analyzing the received data using at least one processor unit, the analysis providing the indication of the condition of the tissue.

18. The method of claim 17, wherein the analyzing the received data comprises applying an effective circuit model to the data, and wherein a value of a parameter of the model provides the indication of the condition of the tissue.

19. The method of claim 17, wherein the analyzing the received data comprises comparing the data to a calibration standard, and wherein the comparing provides the indication of the condition of the tissue.

20. The method of claim 19, wherein the calibration standard comprises a correlation between values of capacitive-based measurement and the indication of the condition of the tissue.

44. The apparatus of claim 1, further comprising a second non-conducting spacer structure having a first end and a second end, the first end of the second non-conducting spacer structure being physically coupled to the first brace structure and the second end of the second non-conducting spacer structure being physically coupled to the second brace structure.

45. The apparatus of claim 1, wherein the first plurality of conductive structures includes semiconductor material and the second plurality of conductive structures includes semiconductor material.

46. The apparatus of claim 8, wherein the encapsulation layer includes polyurethane.

21. An apparatus for monitoring a condition of a tissue, the apparatus comprising:

at least two conductive structures configured to be disposed above the tissue and running substantially parallel to each other along substantially an entire length of the at least two conductive structures, wherein each of the at least two conductive structures has a non-linear configuration, and where the at least two conductive structures are arranged in a curved configuration that facilitates flexibility of the apparatus to flexing, stretching or torsion of the tissue to thereby maintain the apparatus in contact with the tissue, wherein each of the at least two conductive structures maintains a separation of neighboring conductive structures of the at least two conductive structures to a substantially uniform value of distance;

at least two contact structures, each being in electrical communication with at least one of the at least two parallel conductive structures;

at least two non-conductive spacer structures, each of the at least two non-conductive spacer structures non-conductively coupling at least one of the at least two conductive structures to one of the at least two contact structures; and

wherein a capacitive-based measurement performed by applying a potential across one of the at least two conductive structures and a directly adjacent one of the at least two conductive structures provides a measure of the condition of the tissue.

22. The apparatus of claim 21, wherein the condition of the tissue is a hydration state of the tissue, a volume of sweat lost, a mechanical property of the tissue, or a disease state of the tissue.

23. The apparatus of claim 21, wherein each of the plurality of conductive structures has a zig-zag configuration, a serpentine configuration, or a rippled configuration.

24. The apparatus of claim 21, wherein each of the at least two contact structures electrically links the at least two conductive structures to an external circuit.

25. The apparatus of claim 21, wherein each of the at least two contact structures is in electrical communication with at least one of a power source, a wireless receiver, a wireless transmitter, a wireless transceiver, and a temperature sensor.

26. The apparatus of claim 21, further comprising an encapsulation layer disposed over at least a portion of the at least two conductive structures.

27. The apparatus of claim 26, wherein portions of the encapsulation layer comprise an adhesive, and wherein the adhesive is configured to attach the portions of the encapsulation layer to the tissue.

28. The apparatus of claim 27, wherein the encapsulation layer is a polymer.

29. The apparatus of claim 28, wherein the polymer is a polyimide.

30. The apparatus of claim 21, further comprising at least one cross-link structure coupled at each end thereof to a portion of each of the least two conductive structures.

31. The apparatus of claim 30, wherein each of the at least one cross-link structure is disposed substantially perpendicularly to the portion of the at least two substantially parallel conductive structures.

32. The apparatus of claim 21, further comprising a plurality of cross-link structures disposed between the at least two conductive structures, each cross-link structure of the plurality of cross-link structures being formed from a dielectric material.

33. The apparatus of claim 32, further comprising a plurality of cross-link structures disposed between neighboring conductive structures, each cross-link structure of the plurality of cross-link structures being formed from the same material as the encapsulation layer.

34. The apparatus of claim 33, wherein the encapsulation layer is a polymer.

35. The apparatus of claim 34, wherein the polymer is a polyimide.

36. The apparatus of claim 21, further comprising a backing layer in physical communication with at least a portion of the at least two conductive structures, wherein the backing layer is a polymer.

37. The apparatus of claim 21, further comprising an ultrasound apparatus, and wherein the ultrasound apparatus provides a measure of a condition of the tissue.

38. The apparatus of claim 37, wherein the ultrasound apparatus comprises:

an ultrasound generator configured to be disposed proximate to a first portion of the tissue of interest, wherein the ultrasound generator comprises a piezoelectric crystal, wherein the ultrasound generator directs ultrasound waves at a portion of the tissue; and

an ultrasound receiver configured to be disposed proximate to a second portion of the tissue of interest that is different from the first portion,

wherein the ultrasound receiver provides a measure of ultrasound waves arriving at the second portion of the tissue, and

wherein the measure of ultrasound waves arriving at the second portion of the tissue provides an indication of the condition of the tissue.

39. The apparatus of claim 21, further comprising at least one of the following:

a battery, a transmitter, a transceiver, a memory, a radio-frequency identification (RFID) chip, a processing unit, an analog sensing block, a UVA sensor, a UVB sensor, and a temperature sensor.

40. A method for monitoring a condition of a tissue, the method comprising:

receiving data indicative of the capacitive-based measurement, wherein the capacitive-based measurement is performed using the apparatus of claim 21; and

analyzing the received data using at least one processor unit, the analysis providing an the indication of the condition of the tissue.

41. The method of claim 40, wherein the analyzing the received data comprises applying an effective circuit model to the data, and wherein a value of a parameter of the model provides the indication of the condition of the tissue.

42. The method of claim 40, wherein the analyzing the received data comprises comparing the data to a calibration standard, and wherein the comparing provides the indication of the condition of the tissue.

43. The method of claim 42, wherein the calibration standard comprises a correlation between values of capacitive-based measurement and the indication of the condition of the tissue.

47. The apparatus of claim 21, wherein the at least two conductive structures includes semiconductor material.

48. The apparatus of claim 27, wherein the encapsulation layer includes polyurethane.