Catheter balloon having stretchable integrated circuitry and sensor array

• US 9,289,132 B2
• Filed: 10/07/2009
• Issued: 03/22/2016
• Est. Priority Date: 10/07/2008
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Callsen, Gilman, Arora, William J., Schlatka, Benjamin
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/575,008
• Publication Number:
  US 20100087782A1
• Time in Patent Office: 2,358 Days
• Field of Search: 604/103.01, 600/381, 600/361, 623/1.11
• US Class Current: 1/1
• 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, the stretchable surface having soft or elastic properties enabling the stretchable surface to be made longer or wider 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 stretching or expanding of the stretchable surface of the inflatable and expandable body and remain functional when the stretchable surface is stretched or expanded, the plurality of components comprising;

a plurality of discrete operative devices arranged as 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 some of the plurality of discrete operative devices,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first discrete operative device and to a second discrete operative device of the plurality of discrete operative devices to directly electrically interconnect the first discrete operative device to the second discrete operative device.

2. The device of claim 1, wherein at least some of the discrete operative devices comprise a CMOS integrated circuit, and at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a CMOS integrated circuit of one discrete operative device and to a CMOS integrated circuit of a discrete operative device adjacent to the one discrete operative device to directly electrically interconnect the adjacent CMOS integrated circuits.

3. The device of claim 1, wherein said stretchable electronic circuit is printable.

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

5. The device of claim 4, wherein said inflatable and expandable body is expanded to stretch up to 500 percent.

6. The device of claim 1, wherein said device further comprises a transceiver receiving data from at least one of the plurality of discrete operative devices.

7. The device of claim 1, wherein at least some of the plurality of stretchable interconnects are configured to be buckled when said inflatable and expandable body is relaxed.

8. The device of claim 1, wherein at least some of the plurality of stretchable interconnects are non-coplanar with said inflatable and expandable body when said inflatable and expandable body is relaxed.

9. The device of claim 1, wherein at least some of the plurality of stretchable interconnects are coplanar with said inflatable and expandable body when said inflatable and expandable body is inflated.

10. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises an amplifier.

11. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises a semiconductor structure.

12. The device of claim 11, wherein said semi-conductor structure is a single crystalline semi-conductor structure.

13. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises a transducer.

14. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises at least one photodetector.

15. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises at least one ultrasound emitter.

16. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises light emitting electronics.

17. The device of claim 16, wherein said light emitting electronics comprise an LED.

18. The device of claim 1, wherein said stretchable electronic circuit comprises light emitting electronics.

19. The device of claim 18, wherein said light emitting electronics comprises an LED.

20. The device of claim 1, further comprising a processor, wherein at least one of the plurality of discrete operative devices is in electronic communication with the processor, said processor receiving data generated by said at least one discrete operative device, said processor being programmed to generate data for an image related to a body lumen.

21. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises a sensor.

22. The device of claim 21, wherein said sensor detects temperature data.

23. The device of claim 22, further comprising a processor, wherein at least one of the plurality of discrete operative devices is in electronic communication with the processor, said processor receiving data generated by said at least one discrete operative device, said processor being programmed to generate a spatial temperature map of a lumen.

24. The device of claim 21, wherein said sensor is a capacitance sensor.

25. The device of claim 21, wherein said sensor detects data related to pressure.

26. The device of claim 25, wherein said sensor is a piezo-electric sensor.

27. The device of claim 25, wherein said sensor detects mechanical properties of a lumen.

28. The device of claim 25, wherein said sensor detects an initial contact diameter of a lumen.

29. The device of claim 25, further comprising a processor, wherein at least one of the plurality of discrete operative devices is in electronic communication with the processor, said processor receiving data generated by said at least one discrete operative device, said processor being programmed to generate a tactile image map of a lumen.

30. The device of claim 21, wherein said sensor detects data related to electrical conductivity.

31. The device of claim 30, wherein said data related to electrical conductivity is the conductivity of plaque inside of a lumen.

32. The device of claim 21, wherein said sensor detects data related to pH.

33. The device of claim 21, wherein said sensor detects data related to enzymatic activity.

34. The device of claim 21, wherein said sensor detects data related to chemical activity.

35. The device of claim 1, wherein at least one of the plurality of discrete operative devices comprises a sensor that continuously generates data.

36. The device of claim 35, wherein said continuously generated data is recorded.

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

38. The device of claim 1, wherein said inflatable and expandable body is a balloon.

39. The device of claim 1, wherein the inflatable and expandable body is fitted with a stent.

40. The device of claim 1, further comprising a drug delivery polymer comprising a drug.

41. The device of claim 40, wherein said stretchable electronic circuit activates said drug delivery polymer.

42. The device of claim 1, wherein at least one of the plurality of discrete operative devices is ultra thin.

43. The device of claim 1, wherein each stretchable interconnect of the plurality of stretchable interconnects is directly attached to each discrete operative device of a pair of discrete operative devices to directly electrically interconnect the pair of discrete operative devices.

44. A balloon catheter apparatus, comprising:

an inflatable and expandable body having a stretchable surface, the stretchable surface having soft or elastic properties enabling the stretchable surface to be made longer or wider 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 discrete operative devices arranged as device islands on the stretchable surface of the inflatable and expandable body, wherein the plurality of discrete operative devices include at least one of;

an integrated circuit;

a physical sensor;

a biological and/or chemical sensor;

an active pixel sensor;

an amplifier;

an analog-to-digital (A/D) converter;

a digital-to-analog (D/A) converter;

an optical collector;

an electro-mechanical transducer;

a piezo-electric actuator;

at least one light emitting diode (LED);

light emitting electronics;

at least one memory device;

a clock; and

active matrix switches; 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 some of the plurality of discrete operative devices, wherein at least some of the plurality of stretchable interconnects are configured to be buckled or non-coplanar with the stretchable surface of the inflatable and expandable body when the stretchable surface of the inflatable and expandable body is relaxed,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first discrete operative device and to a second discrete operative device of the plurality of discrete operative devices to directly electrically interconnect the first discrete operative device to the second discrete operative device.

45. The apparatus of claim 44, wherein at least some of the plurality of stretchable interconnects are configured to be substantially coplanar with the stretchable surface of the inflatable and expandable body when the stretchable surface of the inflatable and expandable body is significantly expanded.

46. The apparatus of claim 44, wherein the plurality of discrete operative devices include:

at least one pressure sensor;

at least one imaging sensor array; and

at least one temperature sensor.

47. The apparatus of claim 46, wherein the plurality of discrete devices are arranged on or in the stretchable surface of the inflatable and expandable body so as to provide distributed mechanical sensing and imaging information regarding a biological tissue, and wherein the apparatus further comprises:

a processor communicatively coupled to at least some of the plurality of discrete devices to facilitate generation of a tactile and visual map of the biological tissue based at least in part on the distributed mechanical sensing and imaging information.

48. The apparatus of claim 47, further comprising a stent fitted around the inflatable and expandable body.

49. A balloon catheter apparatus, comprising:

an inflatable and expandable body having a stretchable surface, the stretchable surface having soft or elastic properties enabling the stretchable surface to be made longer or wider 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 discrete operative devices arranged as device islands on the stretchable surface of the inflatable and expandable body, wherein the plurality of discrete operative devices include a plurality of CMOS integrated circuits; 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 some of the plurality of CMOS integrated circuits,

wherein at least one stretchable interconnect of the plurality of stretchable interconnects is directly attached to a first discrete operative device and to a second discrete operative device of the plurality of discrete operative devices to directly electrically interconnect the first discrete operative device to the second discrete operative device.

50. The apparatus of claim 49, wherein at least some of the plurality of CMOS integrated circuits are disposed on or in the stretchable surface of the inflatable and expandable body as a one-dimensional array.

51. The apparatus of claim 49, wherein at least some of the plurality of CMOS integrated circuits are disposed on or in the stretchable surface of the inflatable and expandable body as a two-dimensional array.