Catheter balloon having stretchable integrated circuitry and sensor array

• US 9,655,560 B2
• Filed: 03/15/2013
• Issued: 05/23/2017
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Callsen, Gilman, Ghaffari, Roozbeh, Arora, William J., Schlatka, Benjamin
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US13/844,635
• Publication Number:
  US 20130225965A1
• Time in Patent Office: 1,530 Days
• Field of Search: 60410301, 600381, 600361, 623 111
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• 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 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02014 Determining aneurysm
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A system, device and method are presented for utilizing stretchable active integrated circuits with inflatable bodies. The invention allows for such operative features to come into direct contact with body structures, such as the inner wall of a lumen. Such direct contact increases accuracy of measurement and delivery of therapy.

Claims

1. A device, comprising:

an inflatable and expandable body having a stretchable surface with soft or elastic properties enabling the inflatable and expandable body to expand without tearing or breaking; and

a stretchable electronic circuit embedded in or affixed to the stretchable surface of the inflatable and expandable body, the stretchable electronic circuit including a plurality of components that accommodate expanding of the inflatable and expandable body and remain functional when the inflatable and expandable body is expanded, the plurality of components comprising;

a plurality of electrodes arranged as discrete device islands on the stretchable surface of the inflatable and expandable body; and

a plurality of stretchable interconnects embedded in or affixed to the stretchable surface of the inflatable and expandable body to electrically interconnect at least two electrodes of the plurality of electrodes,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first electrode and to a second electrode of the plurality of electrodes to directly electrically interconnect the first electrode to the second electrode, and wherein the plurality of components includes a plurality of CMOS integrated circuits arranged as discrete device islands among the plurality of electrodes around the inflatable and expandable body.

2. The device of claim 1, wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to an electrode of the plurality of electrodes and to a CMOS integrated circuit of the plurality of CMOS integrated circuits to directly electrically interconnect the electrode to the CMOS integrated circuit.

3. The device of claim 1, wherein the stretchable electronic circuit is operable when the inflatable and expandable body is inflated and the stretchable surface is stretched.

4. The device of claim 1, wherein the plurality of components further comprises at least one discrete operative device.

5. The device of claim 4, wherein the at least one discrete operative device comprises an amplifier.

6. The device of claim 4, wherein the at least one discrete operative device comprises a semiconductor structure.

7. The device of claim 4, wherein the at least one discrete operative device comprises at least one photo detector.

8. The device of claim 1, further comprising a processor, wherein at least one of the plurality of components is in electronic communication with the processor, the processor receiving data generated by the at least one of the plurality of components, the processor being programmed to analyze the data.

9. The device of claim 1, wherein at least one of the plurality of components comprises a sensor.

10. The device of claim 9, wherein the sensor detects temperature data.

11. The device of claim 10, further comprising a processor, wherein at least one of the plurality of components is in electronic communication with the processor, the processor receiving data generated by the at least one of the plurality of components, the processor being programmed to generate a spatial temperature map of an arterial lumen.

12. The device of claim 9, wherein the sensor is a capacitance sensor.

13. The device of claim 9, wherein the sensor detects an initial contact diameter of an arterial lumen.

14. The device of claim 13, further comprising a processor, wherein at least one of the plurality of components is in electronic communication with the processor, the processor receiving data generated by the at least one of the plurality of components, the processor being programmed to generate a tactile image map of an arterial lumen.

15. The device of claim 9, wherein the sensor detects data related to electrical conductivity.

16. The device of claim 9, wherein the plurality of components comprises at least one contact sensor and at least one temperature sensor, wherein the at least one contact sensor measures a force of contact with an arterial lumen, and wherein the at least one temperature sensor detects temperature data.

17. The device of claim 16, wherein the at least one contact sensor measures the force of contact with the arterial lumen while the at least one temperature sensor detects the temperature data.

18. The device of claim 9, wherein the sensor comprises a thermocouple.

19. The device of claim 1, wherein the plurality of components comprises at least one radiation sensor.

20. The device of claim 1, wherein the plurality of components comprises at least one actuator.

21. The device of claim 1, wherein the device comprises a feedback capability to detect a contact between a portion of the device and an arterial lumen.

22. The device of claim 1, wherein the inflatable and expandable body is made of a polymer.

23. The device of claim 1, wherein at least one of the plurality of components comprises at least one temperature sensor, and wherein the at least one temperature sensor performs multiple temperature measurements.

24. A device, comprising:

an inflatable and expandable body having a stretchable surface with soft or elastic properties enabling the inflatable and expandable body to expand without tearing or breaking; and

a stretchable electronic circuit embedded in or affixed to the stretchable surface of the inflatable and expandable body, the stretchable electronic circuit including a plurality of components that accommodate expanding of the inflatable and expandable body and remain functional when the inflatable and expandable body is expanded, the plurality of components comprising;

a plurality of temperature sensors arranged as discrete device islands on the stretchable surface of the inflatable and expandable body; and

a plurality of stretchable interconnects embedded in or affixed to the stretchable surface of the inflatable and expandable body to electrically interconnect at least two of the plurality of temperature sensors,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first temperature sensor and to a second temperature sensor of the plurality of temperature sensors to directly electrically interconnect the first temperature sensor to the second temperature sensor, and wherein the plurality of components includes a plurality of CMOS integrated circuits arranged as discrete device islands among the plurality of temperature sensors around the inflatable and expandable body.

25. The device of claim 24, wherein the plurality of components further comprises at least one contact sensor, wherein the at least one contact sensor measures a force of contact with an arterial lumen while the plurality of temperature sensors detect temperature data.

26. The device of claim 24, wherein the plurality of temperature sensors comprise at least one thermocouple.

27. The device of claim 24, wherein the plurality of components further comprises at least one radiation sensor.

28. The device of claim 24, wherein the device comprises a feedback capability to detect a contact between a portion of the device and an arterial lumen.

29. A device, comprising:

an inflatable and expandable body having a stretchable surface with soft or elastic properties enabling the inflatable and expandable body to expand without tearing or breaking; and

a stretchable electronic circuit embedded in or affixed to the stretchable surface of the inflatable and expandable body, the stretchable electronic circuit including a plurality of components that accommodate expanding of the inflatable and expandable body and remain functional when the inflatable and expandable body is expanded, the plurality of components comprising;

at least one temperature sensor arranged as a discrete device island on the stretchable surface of the inflatable and expandable body;

at least one radiation sensor arranged as a discrete device island on the stretchable surface of the inflatable and expandable body; and

a plurality of stretchable interconnects embedded in or affixed to the stretchable surface of the inflatable and expandable body to electrically interconnect the plurality of components,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to the at least one temperature sensor and to the at least one radiation sensor to directly electrically interconnect the at least one temperature sensor to the at least one radiation sensor, and wherein the plurality of components includes a plurality of CMOS integrated circuits arranged as discrete device islands among the at least one temperature sensor and the at least one radiation sensor around the inflatable and expandable body.

30. The device of claim 29, wherein the plurality of components further comprises at least one contact sensor, wherein the at least one contact sensor measures a force of contact with an arterial lumen while the plurality of temperature sensors detect temperature data.

31. A catheter apparatus, comprising:

an inflatable and expandable body having a stretchable surface with soft or elastic properties enabling the stretchable surface to be expanded without tearing or breaking; and

stretchable electronic circuitry embedded in or disposed on the stretchable surface of the inflatable and expandable body, the stretchable electronic circuitry comprising a plurality of components, wherein the plurality of components include at least one of;

a plurality of electrodes arranged as discrete device islands on the stretchable surface of the inflatable and expandable body;

a plurality of temperature sensors arranged as discrete device islands on the stretchable surface of the inflatable and expandable body; and

a plurality of stretchable interconnects embedded in or affixed to the stretchable surface of the inflatable and expandable body to electrically interconnect at least one of the plurality of components,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first electrode and to a second electrode, a temperature sensor, or a combination thereof to directly electrically interconnect the first electrode to a second electrode, a temperature sensor, or a combination thereof, wherein at least one of the plurality of stretchable interconnects is configured to conform to the stretchable surface of the inflatable and expandable body when the stretchable surface of the inflatable and expandable body is relaxed, and wherein the plurality of components includes a plurality of CMOS integrated circuits arranged as discrete device islands around the inflatable and expandable body.