Systems, Methods, and Devices Having Stretchable Integrated Circuitry for Sensing and Delivering Therapy

• US 20140303452A1
• Filed: 11/29/2013
• Published: 10/09/2014
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh
• Granted Patent: US 9,119,533 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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 5/683 : Means for maintaining contact with the body A61B5/6802 takes precedence
• 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 5/743 : Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• 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 medical diagnosis and/or treatment, the apparatus comprising:

a flexible substrate;

an expandable assembly coupled to the flexible substrate, the expandable assembly being operable to adjust the flexible substrate from an undeployed configuration to a deployed configuration; and

stretchable circuitry disposed on the flexible substrate, the stretchable circuitry being configured to remain functional upon conforming to a surface of a tissue.

2. The apparatus as recited in claim 1, wherein the flexible substrate is substantially flat.

3. The apparatus as recited in claim 2, wherein the flexible substrate is a sheet.

4. The apparatus as recited in claim 3, wherein the sheet is shaped as a polygon.

5. The apparatus as recited in claim 4, wherein the polygon has four sides.

6. The apparatus as recited in claim 4, wherein the expandable assembly comprises a plurality of supports, each support being coupled to a corner of the polygon.

7. The apparatus as recited in claim 6, wherein each of the plurality of supports extends from a center of the polygon to the respective corner of the polygon.

8. The apparatus as recited in claim 3, wherein the sheet is foldable such that the sheet is folded when the flexible substrate is in the undeployed configuration and the sheet is unfolded when the flexible substrate is in the deployed configuration.

9. The apparatus as recited in claim 1, wherein the flexible substrate is composed of a polymer.

10. The apparatus as recited in claim 1, wherein the expandable assembly is composed of nitinol.

11. The apparatus as recited in claim 1, wherein the stretchable circuitry comprises a plurality of electrodes.

12. The apparatus as recited in claim 11, wherein at least one of the plurality of electrodes is configured as a recording electrode.

13. The apparatus as recited in claim 11, wherein at least one of the plurality of electrodes is configured as a stimulating electrode.

14. The apparatus as recited in claim 11, wherein the stretchable circuitry further comprises at least one sensor.

15. The apparatus as recited in claim 14, wherein the at least one sensor comprises at least one of a contact sensor, a pressure sensor, an impedance sensor, and a temperature sensor.

16. The apparatus as recited in claim 11, wherein the stretchable circuitry further comprises a first plurality of sensors configured to sense a first tissue parameter and a second plurality of sensors configured to sense a second tissue parameter that is different than the first tissue parameter.

17. The apparatus as recited in claim 11, wherein the stretchable circuitry further comprises a plurality of stretchable interconnects to electrically interconnect at least some of the plurality of electrodes.

18. The apparatus as recited in claim 1, wherein the stretchable circuitry has an active electrical circuit density of at least 16 active electrical circuits per cm2.

19. The apparatus as recited in claim 18, wherein the stretchable circuitry has an active electrical circuit density ranging from about 48 active electrical circuits per cm2 to about 512 active electrical circuits per cm2.

20. The apparatus as recited in claim 18, wherein the active electrical circuits include at least one of electrodes and sensors.

21. The apparatus as recited in claim 1, wherein the stretchable circuitry comprises a plurality of sensors.

22. The apparatus as recited in claim 21, wherein the plurality of sensors comprises at least one of a contact sensor, a pressure sensor, an impedance sensor, and a temperature sensor.

23. The apparatus as recited in claim 1, wherein the flexible substrate is composed of a bioadsorbable material.

24. The apparatus as recited in claim 23, wherein the bioadsorbable material is silk.

25. The apparatus as recited in claim 1, further comprising a catheter having a catheter shaft extending from a proximal end to a distal end, the expandable assembly being coupled to the distal end of the catheter shaft.

26. The apparatus as recited in claim 25, wherein the catheter includes a sheath coupled to the distal end of the catheter shaft and wherein the expandable assembly is operable to retract the flexible substrate into the sheath when the flexible substrate is in the undeployed configuration.

27. The apparatus as recited in claim 1, wherein the stretchable circuitry comprises a facility to deliver ablative therapy.

28. The apparatus as recited in claim 25, wherein the facility to deliver ablative therapy comprises at least one of a cryoablation device, a laser ablation device, a high intensity ultrasound device, a microwave device, and a radiofrequency device.