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

• US 8,097,926 B2
• Filed: 03/12/2010
• Issued: 01/17/2012
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Arora, William J., De Graff, Bassel
• Primary Examiner(s): Lee, Calvin
• Application Number:
  US12/723,475
• Publication Number:
  US 20110034912A1
• Time in Patent Office: 676 Days
• Field of Search: 257/48, 257/419, 257E21521-E21531, 438/11, 438/53
• US Class Current: 257/419
• 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 to deliver ablative therapy to a tissue, the apparatus comprising:

a stretchable substrate;

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

a facility to deliver ablative therapy; and

an array of sensors generating data indicative of an electrical conduction of said tissue;

an output facility comprising a display; and

a processing facility in electronic communication with said circuitry and said output facility, said processing facility for receiving said data indicative of the electrical conduction of said tissue and configured to;

generate a map of conductive pathways in said tissue based on the data indicative of the electrical conduction of said tissue, and

cause said output facility to display said map.

2. The apparatus of claim 1, wherein the output facility further comprises a user interface configured to accept a command from an operator to activate said facility to deliver ablative therapy, and wherein said processing facility is further configured to activate said facility to deliver ablative therapy based on the command.

3. The apparatus of claim 1, wherein said processing facility is further configured to determine areas of tissue having an abnormal property.

4. The apparatus of claim 3, wherein said tissue is cardiac tissue and said abnormal property comprises an arrhythmic region of said cardiac tissue.

5. The apparatus of claim 1, wherein said processing facility is further configured to suggest an area of said tissue on which to deliver ablative therapy.

6. The apparatus of claim 5, wherein suggestion is based, in part, on said data indicative of electrical conduction of said tissue.

7. The apparatus of claim 5, wherein suggestion is based, in part, on said areas of tissue having an abnormal property.

8. The apparatus of claim 7, wherein said display provides said suggestion to an operator.

9. The apparatus of claim 7, further comprising a user interface communicatively coupled to the processing facility, wherein said user interface comprises a facility to select an area on said tissue in which to deliver said ablative therapy.

10. The apparatus of claim 9, wherein said facility to select an area on said tissue in which to deliver said ablative therapy is a graphical depiction of a suggested area in which to deliver ablative therapy.

11. The apparatus of claim 1, wherein said substrate is inflatable.

12. The apparatus of claim 1, wherein circuitry is encapsulated with a thin polymer layer.

13. The apparatus of claim 1, wherein circuitry is stretchable up to 300%.

14. The apparatus of claim 1, wherein said facility to deliver ablative therapy comprises devices located discretely from one another.

15. The apparatus of claim 14, wherein said circuitry comprises stretchable electrical interconnects.

16. The apparatus of claim 15, wherein said stretchable interconnects electrically connect said discretely located devices of said facility to deliver ablative therapy.

17. The apparatus of claim 15, wherein said stretchable interconnects are arranged boustrophedonicially to define rungs between said sensing devices, said rungs being substantially parallel with one another, and a plurality of said rungs having substantially the same length and displacement therebetween, wherein the ratio of said length of said plurality of said rungs and said displacement between said plurality of said rungs is at least 10:

1.

18. The apparatus of claim 14, wherein said discretely located devices of said facility to deliver ablative therapy are configured to be in an active array.

19. The apparatus of claim 14, wherein said discretely located devices of said facility to deliver ablative therapy are configured to cryo-ablate said tissue.

20. The apparatus of claim 1, wherein said array of sensors is configured to be an array of active electronic devices.

21. The apparatus of claim 1, wherein said apparatus further comprises a multiplexer.

22. The apparatus of claim 21, wherein said substrate is a balloon coupled with a catheter guide wire, and said multiplexer is located at the base of at least one of said guide wire and said balloon.

23. The apparatus of claim 1, wherein said discretely located devices of said facility to deliver ablative therapy are configured to emit electromagnetic radiation.

24. The apparatus of claim 1, wherein said processing facility is within said circuitry.