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

• US 8,536,667 B2
• Filed: 12/23/2011
• Issued: 09/17/2013
• 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:
  US13/336,518
• Publication Number:
  US 20120226130A1
• Time in Patent Office: 634 Days
• Field of Search: 438/11, 438/53, 257/48, 257/419, 257E21521-E21531
• 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 for detecting and measuring aspects of a tissue of a subject'"'"'s body, comprising:

a. a stretchable substrate;

b. stretchable circuitry disposed on said stretchable substrate, said stretchable circuitry comprising;

(i) a first array of sensing devices comprising contact sensors to generate data indicating that one or more sensors of said first array of sensing devices is in contact with said tissue and to generate data indicative of an area of said contact;

(ii) a second array of sensing devices to detect data indicative of a parameter of said tissue; and

(iii) a plurality of stretchable interconnects to electrically interconnect at least some of the sensing devices of the first array of sensing devices or at least some of the sensing devices of the second array of sensing devices; and

c. a processing facility in electronic communication with said stretchable circuitry, wherein the processing facility receives data indicative of said area of said contact and activates one or more sensing devices of said second array of sensing devices that correspond to said area of said contact.

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

3. The apparatus of claim 1, wherein said stretchable substrate is a sheet.

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

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

6. The apparatus of claim 1, wherein said stretchable circuitry comprises stretchable electrical interconnects.

7. The apparatus of claim 6, wherein said stretchable interconnects electrically connect said sensing devices.

8. The apparatus of claim 7, 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.

9. The apparatus of claim 1, wherein said sensing devices are located discretely from one another.

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

11. The apparatus of claim 1, wherein said stretchable substrate is a balloon coupled with a catheter guide wire, and said multiplexer is located at the base of said guide wire.

12. The apparatus of claim 1, wherein said sensing devices in said first array of sensing devices comprise temperature sensors.

13. The apparatus of claim 1, wherein said sensing devices in said first array of sensing devices comprise contact sensors.

14. The apparatus of claim 1, wherein said sensing devices in said first array of sensing devices comprise pressure sensors.

15. The apparatus of claim 1, wherein said sensing devices in said first array of sensing devices comprise sensors generating data relating to electrical conductance of said tissue.

16. The apparatus of claim 1, wherein said sensing devices in said first array of sensing devices comprises ultrasound receivers.

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

18. The apparatus of claim 1, wherein said processing facility is separate from said stretchable circuitry.

19. The apparatus of claim 1, wherein said stretchable circuitry further comprises a therapeutic facility.

20. The apparatus of claim 19, wherein said therapeutic facility is configured to ablate said tissue.

21. The apparatus of claim 20, wherein said therapeutic facility is configured to emit electromagnetic radiation to ablate said tissue.

22. The apparatus of claim 20, wherein said therapeutic facility comprises an element to emit microwave energy.

23. The apparatus of claim 20, wherein said therapeutic facility comprises an element to emit thermal energy.

24. The apparatus of claim 20, wherein said therapeutic facility comprises an element to emit a laser.

25. The apparatus of claim 20, wherein said therapeutic facility comprises an ultrasound emitter.

26. The apparatus of claim 1, wherein said apparatus further comprises an output facility in electronic communication with said processing facility, said processing facility configured to (i) use said data indicative of a parameter of said tissue and said visual data to generate output data, and (ii) cause said output facility to display said output data.

27. The apparatus of claim 1, wherein said output data is a map related to said tissue.

28. The apparatus of claim 27, wherein said map comprises a map of electrical activity of said tissue.

29. The apparatus of claim 1, wherein said tissue is a pulmonary vein.

30. The apparatus of claim 1, wherein said tissue is a septal wall of a heart.

31. The apparatus of claim 1, wherein said tissue is an atrial surface of a heart.

32. The apparatus of claim 1, wherein said tissue is a ventricular surface of a heart.

33. The apparatus of claim 1, wherein said plurality of stretchable interconnects electrically interconnect at least some of the sensing devices of the first array of sensing devices with at least some of the sensing devices of the second array of sensing devices.

34. An apparatus for delivery of a therapeutic agent to tissue in a subject'"'"'s body, the apparatus comprising:

a stretchable substrate;

a stretchable circuit positioned at least in part on said stretchable substrate, the stretchable circuitry comprising;

a first plurality of electrodes coupled to the stretchable substrate, the first plurality of electrodes configured to deliver the therapeutic agent;

a second plurality of contact sensors coupled to the stretchable substrate, the second plurality of contact sensors configured to generate data indicative of contact of a portion of the apparatus with the tissue, and

a plurality of stretchable interconnects to electrically interconnect at least some of the electrodes of the first plurality of electrodes or at least some of the contact sensors of the second plurality of contact sensors; and

at least one processing device coupled to the first plurality of electrodes configured to deliver the therapeutic agent and the second plurality of contact sensors, the processing device configured to activate one or more electrode in the first plurality of electrodes in response to receipt of a signal from one or more contact sensors of the plurality of contact sensors indicative of contact of the portion of the apparatus with the tissue.

35. The apparatus of claim 34, wherein the first plurality of electrodes includes electrodes configured to transmit electromagnetic radiation for ablation of the tissue.

36. The apparatus of claim 34, wherein the first plurality of electrodes includes electrodes configured to release a chemical compound.

37. The apparatus of claim 34, wherein said plurality of stretchable interconnects electrically interconnect at least some of the electrodes of the first plurality of electrodes with at least some of the contact sensors of the second plurality of contact sensors.