Systems, methods, and devices using stretchable or flexible electronics for medical applications

• US 8,886,334 B2
• Filed: 12/11/2009
• Issued: 11/11/2014
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, de Graff, Bassel, Callsen, Gilman, Arora, William J., Schlatka, Benjamin, Kuznetsov, Eugene
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US12/636,071
• Publication Number:
  US 20100298895A1
• Time in Patent Office: 1,796 Days
• Field of Search: None
• US Class Current: 607/115
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• 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 18/20 using laser
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• 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 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 : for measuring pH
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/24 : Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 : Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6879 : Means for maintaining contact with the body A61B5/6847 takes precedence
• 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: A61B 8/14 : Echo-tomography
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/04 : Electrodes electrosurgical electrodes A61B18/14
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: H01L 27/14609 : Pixel-elements with integrated switching, control, storage or amplification elements scanning details of imagers (circuitry of solid-state image sensors H04N25/00); circuitry of imagers H04N25/70

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 nerve bundle, or the surface of the heart. Such direct, conformal contact increases accuracy of measurement and delivery of therapy.

Claims

1. An apparatus comprising:

a stretchable substrate;

a stretchable circuitry selectively attached to said stretchable substrate, said stretchable circuitry comprising;

an array of recording electrodes receiving signals from a plurality of nerve sources when at least a portion of said array of recording electrodes is in electrical contact with said plurality of nerve sources;

a plurality of amplifiers, each amplifier of said plurality of amplifiers being in electronic communication with a recording electrode of said array of recording electrodes;

at least one stretchable interconnect capable of being made longer or wider without tearing or breaking, said at least one stretchable interconnect disposed between, and in electrical communication with, at least one recording electrode of the array of recording electrodes and at least one amplifier of the plurality of amplifiers, said at least one recording electrode of the array of recording electrodes and said at least one amplifier of the plurality of amplifiers being selectively attached to said stretchable substrate, and at least a portion of said at least one stretchable interconnect being free of said stretchable substrate; and

an array of stimulating electrodes; and

a processing facility in electronic communication with said array of recording electrodes and said array of stimulating electrodes that receives said signals from a plurality of nerve sources from said recording electrodes and is configured to determine a pattern of stimulation signals to be effected by said array of stimulating electrodes.

2. The apparatus of claim 1, wherein said electrical contact comprises physical contact.

3. The apparatus of claim 1, further comprising a multiplexer configured to match said signals from said nerve sources and cause at least one of said plurality of stimulating electrodes to dispatch a corresponding signal to a second plurality of nerves.

4. The apparatus of claim 1, further comprising a user interface to allow an operator to adjust said pattern of stimulation signals.

5. The apparatus of claim 1, wherein said stretchable substrate is an inflatable body.

6. The apparatus of claim 5, wherein said inflatable body is a disk.

7. The apparatus of claim 1, wherein said pattern of stimulation signals is dynamically configurable.

8. The apparatus of claim 1, wherein said processing facility is further configured to generate data related to the electrical conductivity of said nerve sources.

9. The apparatus of claim 8, wherein said processing facility is in electronic communication with an output facility and causes said output facility to generate a map, said map being based on said data related to the electrical conductivity of said nerve sources.

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

11. The apparatus of claim 1, wherein said stretchable circuitry comprises at least one stretchable electrical interconnect, and wherein said stretchable circuitry is stretchable up to 300%.

12. The apparatus of claim 1, wherein said electrodes are located discretely from one another.

13. The apparatus of claim 1, wherein said at least one stretchable interconnect of said stretchable circuitry is a plurality of stretchable electrical interconnects.

14. The apparatus of claim 13, wherein said plurality of stretchable electrical interconnects electrically connect said array of recording electrodes and said plurality of stimulating electrodes.

15. The apparatus of claim 1, wherein said stretchable circuitry comprises temperature sensors.

16. The apparatus of claim 1, wherein said stretchable circuitry comprises contact sensors.

17. The apparatus of claim 1, wherein said stretchable circuitry comprises pressure sensors.

18. The apparatus of claim 1, wherein said stretchable substrate comprises a reservoir in communication with a surface of said stretchable substrate.

19. The apparatus of claim 18, wherein said stretchable circuitry is configured to open valves operable to release a drug contained within said reservoir.

20. The apparatus of claim 19, wherein said stretchable circuitry causes the valves to release said drug in a controlled manner.

21. The apparatus of claim 1, further comprising at least one stretchable interconnect disposed between, and in electrical communication with, at least one stimulating electrode of the array of stimulating electrodes and at least one amplifier of the plurality of amplifiers.

22. An apparatus comprising:

a stretchable substrate;

a stretchable circuitry selectively attached to said stretchable substrate, said stretchable circuitry comprising;

a plurality of dynamically configurable electrodes,

wherein a first set of the plurality of dynamically configurable electrodes is configured as recording electrodes to provide an array of recording electrodes, said recording electrodes receiving signals from a plurality of nerve sources when said array of recording electrodes is in electrical contact with said plurality of nerve sources;

wherein a second set of the plurality of dynamically configurable electrodes is configured as stimulating electrodes to provide an array of stimulating electrodes; and

wherein a dynamically configurable electrode of said plurality of dynamically configurable electrodes can be configured at different times as a recording electrode or as a stimulating electrode;

a plurality of amplifiers, each amplifier of said plurality of amplifiers being in electronic communication with a recording electrode or a sensing electrode; and

at least one stretchable interconnect capable of being made longer or wider without tearing or breaking, said at least one stretchable interconnect disposed between, and in electrical communication with, at least one dynamically configurable electrode of the plurality of dynamically configurable electrodes and at least one amplifier of the plurality of amplifiers, said at least one dynamically configurable electrode of the plurality of dynamically configurable electrodes and said at least one amplifier of the plurality of amplifiers being selectively attached to said stretchable substrate, and at least a portion of said at least one stretchable interconnect being free of said stretchable substrate; and

a processing facility in electronic communication with said plurality of dynamically configurable electrodes that receives said signals from a plurality of nerve sources from said recording electrodes and is configured to determine a pattern of stimulation signals to be effected by said stimulating electrodes.

23. The apparatus of claim 22, wherein said plurality of amplifiers comprises sensing amplifiers and stimulation amplifiers, wherein a dynamically configurable electrode that is configured as a recording electrode is placed in electronic communication with a sensing amplifier of said plurality of amplifiers, and wherein a dynamically configurable electrode that is configured as a stimulating electrode is placed in electronic communication with a stimulation amplifier of said plurality of amplifiers.

24. An apparatus comprising:

a stretchable substrate, said stretchable substrate having a first layer and a second layer, said first layer and said second layer separated by a height;

a stretchable circuitry disposed on said stretchable substrate, said stretchable circuitry comprising;

an array of recording electrodes receiving signals from a plurality of nerve sources when at least a portion of said array of recording electrodes is in electrical contact with said plurality of nerve sources;

a plurality of amplifiers, each amplifier of said plurality of amplifiers being in electronic communication with a recording electrode of said array of recording electrodes;

at least one stretchable interconnect capable of being made longer or wider without tearing or breaking, said at least one stretchable interconnect disposed between, and in electrical communication with, at least one recording electrode of the array of recording electrodes and at least one amplifier of the plurality of amplifiers, said at least one recording electrode of said array of recording electrodes and said at least one amplifier of said plurality of amplifiers being coupled to said first layer, and said at least one stretchable interconnect free to be displaced perpendicular to said second layer; and

an array of stimulating electrodes; and

a processing facility in electronic communication with said array of recording electrodes and said array of stimulating electrodes that receives said signals from a plurality of nerve sources from said recording electrodes and is configured to determine a pattern of stimulation signals to be effected by said array of stimulating electrodes.