Systems, methods, and devices having stretchable integrated circuitry for sensing and delivering therapy

• US 10,186,546 B2
• Filed: 04/27/2017
• Issued: 01/22/2019
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: De Graff, Bassel, Ghaffari, Roozbeh, Arora, William J.
• Primary Examiner(s): Lee, Calvin
• Application Number:
  US15/498,941
• Publication Number:
  US 20180076336A1
• Time in Patent Office: 635 Days
• Field of Search: 438455-457, 257291, 257773-786
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• 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 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/6821 : Eye
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6847 : mounted on an invasive device
• CPC Class Codes: A61B 5/6869 : Heart
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61N 7/022 : intracavitary
• CPC Class Codes: H01L 27/14618 : Containers
• CPC Class Codes: H01L 27/14632 : Wafer-level processed structures
• CPC Class Codes: H01L 27/14645 : Colour imagers
• CPC Class Codes: H01L 27/14687 : Wafer level processing
• CPC Class Codes: H01L 27/14692 : Thin film technologies, e.g. amorphous, poly, micro- or nanocrystalline silicon
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/1433 : Application-specific integrated circuit [ASIC]
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/19042 : being an inductor
• CPC Class Codes: H01L 2924/19043 : being a resistor
• CPC Class Codes: H01L 2924/30105 : Capacitance

Abstract

System, devices and methods are presented that integrate stretchable or flexible circuitry, including arrays of active devices for enhanced sensing, diagnostic, and therapeutic capabilities. The invention enables conformal sensing contact with tissues of interest, such as the inner wall of a lumen, a the brain, or the surface of the heart. Such direct, conformal contact increases accuracy of measurement and delivery of therapy. Further, the invention enables the incorporation of both sensing and therapeutic devices on the same substrate allowing for faster treatment of diseased tissue and fewer devices to perform the same procedure.

Claims

1. An apparatus for detecting and measuring aspects of a tissue of a body of a subject, comprising:

expandable substrate;

stretchable circuitry disposed on said substrate and configured to remain functional upon conforming to a surface of said tissue, said circuitry comprising;

sensing devices configured to detect data indicative of a parameter of said tissue upon said circuitry being in conformal contact with said tissue, and

an array of imaging devices configured to generate visual data;

a processing facility in electronic communication with said circuitry and configured to receive said data indicative of said parameter of said tissue and said visual data; and

an output facility in electronic communication with said processing facility,

wherein said processing facility is configured to (i) use said data indicative of said parameter of said tissue and said visual data to generate output data, and (ii) cause said output facility to display said output data.

2. The apparatus of claim 1, wherein the sensing devices include a thermistor, a thermocouple, a silicon band gap temperature sensor, a thin-film resistance temperature sensor, a photodetector, a piezoelectric sensor, an ultrasonic sensor, or an ion sensitive field effect transistor, or combinations thereof.

3. The apparatus of claim 1, wherein the processing facility is configured to activate the circuitry to commence with detecting the data indicative of the parameter in response to one or more pressure measurements from one or more of the sensing devices satisfying a threshold value.

4. The apparatus of claim 1, wherein the parameter is a thermal parameter, an optical parameter, an electrochemical parameter, a biochemical parameter, an electrical parameter, or a mechanical parameter.

5. The apparatus of claim 1, wherein the circuitry further comprises a receiver circuit and a transmitter circuit which are configured to receive and transmit signals, respectively, in a wireless mode.

6. The apparatus of claim 1, wherein the circuitry further comprises an inductive coupling transceiver comprising an inductor-based receiver and transmitter coil.

7. The apparatus of claim 1, wherein the sensing devices include a plurality of contact sensors arranged in an array on the expandable substrate.

8. The apparatus of claim 1, wherein the circuitry further comprises one or more light sources configured to illuminate the tissue, and the array of imaging devices are configured to generate the visual data based on light generated by the one or more light sources reflected from the tissue.

9. The apparatus of claim 8, wherein the one or more light sources are one or more LEDs.

10. The apparatus of claim 1, wherein the expandable substrate includes a conformal sheet that is adapted to wrap conformally on a portion of the tissue of the body of the subject.

11. The apparatus of claim 10, wherein at least one of the sensing devices comprises electrodes configured to receive electrocardiography signals, and the expandable substrate and the stretchable circuitry form an ECG monitor.

12. The apparatus of claim 1, wherein the sensing devices include one or more contact sensors that generate data indicating contact with the tissue.

13. The apparatus of claim 12, wherein the data indicating contact indicates an area of the contact.

14. The apparatus of claim 1, wherein the circuitry further comprises one or more elements configured to effect a desired therapy.

15. The apparatus of claim 14, wherein the one or more elements are configured to deliver coolant, the apparatus further comprising a catheter delivery system configured to provide the coolant to the one or more elements.

16. The apparatus of claim 14, wherein the one or more elements comprises one or more LEDs arranged in an array, and the one or more LEDs are configured to deliver photo therapy to photoactive neurons in the tissue.

17. The apparatus of claim 14, wherein the one or more elements comprise one or more electrodes configured to deliver ablative therapy.

18. The apparatus of claim 14, wherein the one or more elements comprise heat or light-emitting electronics configured to activate a drug-delivery polymer.

19. The apparatus of claim 18, wherein the light-emitting electronics comprise LEDs configured to cause a de-polymerization reaction within the drug-delivery polymer for releasing one or more drugs.