Catheter balloon methods and apparatus employing sensing elements

• US 9,545,216 B2
• Filed: 08/06/2012
• Issued: 01/17/2017
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: D'Angelo, Robert, de Graff, Bassel, Dowling, Kevin, Ghaffari, Roozbeh, Klinker, Lauren, Lee, Stephen P., Liu, Cliff, Hsu, Yung-Yu
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/568,022
• Publication Number:
  US 20130150693A1
• Time in Patent Office: 1,625 Days
• Field of Search: 600372-377, 600380-381, 600/393, 600/460, 600/481, 600508-509, 604/96.01, 604/97.01, 604/99.01, 604/103.1, 606 20- 52
• US Class Current: 1/1
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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 2017/00526 Methods of manufacturing
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/222 : Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/02158 : provided with two or more sensor elements
• CPC Class Codes: A61B 5/026 : Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/036 : by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0538 : invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/6858 : with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 : intracavitary
• CPC Class Codes: Y10T 156/1089 : of discrete laminae to single face of additional lamina
• CPC Class Codes: Y10T 29/49002 : Electrical device making

Abstract

An apparatus for medical diagnosis and/or treatment is provides. The apparatus includes a flexible substrate forming an inflatable body and a plurality of sensing elements disposed on the flexible substrate. The plurality of sensing elements are disposed about the inflatable body such that the sensing elements are disposed at areas of minimal curvature of the inflatable body in a deflated state.

Claims

1. An apparatus for medical diagnosis and/or treatment, the apparatus comprising:

a flexible substrate forming an inflatable body;

a coupling bus disposed along a latitude of and offset from the equator of the inflatable body;

a plurality of sensing elements disposed along at least one latitude of the inflatable body offset from the coupling bus, each sensing element comprising a pair of electrodes;

a plurality of stretchable interconnects, each stretchable interconnect electrically connecting a separate electrode of a separate sensing element of the plurality of sensing elements to the coupling bus; and

an intermediate bus disposed longitudinally about the inflatable body, the intermediate bus electrically connecting the coupling bus to a flexible printed circuit board.

2. The apparatus of claim 1, wherein the coupling bus comprises a plurality of serpentine interconnects, each coupling bus serpentine interconnect being electrically connected to a separate stretchable interconnect of the plurality of stretchable interconnects.

3. The apparatus of claim 1, further comprising an encapsulation material disposed over substantially a portion of the coupling bus.

4. The apparatus of claim 3, wherein the encapsulation material comprises polyurethane.

5. The apparatus of claim 2, further comprising:

a shaft coupled to the inflatable body,

wherein the flexible printed circuit board is disposed on the shaft, the intermediate bus comprises a plurality of serpentine interconnects, each intermediate bus serpentine interconnect being electrically connected to a separate coupling bus serpentine interconnect, and the plurality of sensing elements comprise at least one of a pressure sensor or an impedance sensor.

6. The apparatus of claim 5, wherein the shaft comprises a cryoablation device, a laser ablation device, a high intensity ultrasound or a RF device.

7. The apparatus of claim 1, wherein the sensing elements are disposed along portions of the inflatable body that experience minimal strain when the inflatable body is in a deflated state.

8. The apparatus of claim 1, wherein one or more of the sensing elements of the plurality of sensing elements comprises contact sensors.

9. The apparatus of claim 1, wherein each sensing element of the plurality of sensing elements is arranged on the flexible substrate in one of two annular rings.

10. The apparatus of claim 9, wherein sensing elements of the first annular ring are staggered on the inflatable body relative to sensing elements of the second annular ring.

11. The apparatus of claim 1, wherein the plurality of sensing elements are disposed in a helical pattern about the inflatable body.

12. The apparatus of claim 1, further comprising at least one encapsulation layer disposed over the plurality of sensing elements, wherein the encapsulation layer positions the sensing elements at a neutral mechanical plane.

13. The apparatus of claim 12, wherein the at least one encapsulation layer comprises a polymer.

14. The apparatus of claim 1, further comprising at least one intermediate layer disposed between the plurality of sensing elements and the inflatable body, wherein the at least one intermediate layer positions the sensing elements at a neutral mechanical plane.

15. The apparatus of claim 1, wherein the inflatable body is disposed near a distal end of a catheter.

16. The apparatus of claim 1, wherein the inflatable body is a balloon.

17. The apparatus of claim 16, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, or barrel-shaped.

18. The apparatus of claim 1, wherein the coupling bus has a T-configuration.

19. The apparatus of claim 1, further comprising an encapsulation material disposed over substantially a portion of the plurality of sensing elements.

20. The apparatus of claim 19, wherein the encapsulation material comprises polyurethane.

21. The apparatus of claim 1, wherein the sensing elements are formed from a conductive material.

22. The apparatus of claim 1, wherein the coupling bus is formed from a conductive material.

23. A method of performing a medical diagnosis and/or treatment on a tissue, the method comprising:

disposing in proximity to the tissue an apparatus comprising;

a flexible substrate forming an inflatable body;

a coupling bus disposed along a latitude of and offset from the equator of the inflatable body;

a plurality of sensing elements disposed along at least one latitude of the inflatable body offset from the coupling bus, each sensing element comprising a pair of electrodes;

a plurality of stretchable interconnects, each stretchable interconnect electrically connecting a separate electrode of a separate sensing element of the plurality of sensing elements to the coupling bus; and

an intermediate bus disposed longitudinally about the inflatable body, the intermediate bus electrically connecting the coupling bus to a flexible printed circuit board; and

recording a measurement of at least one sensing element of the plurality of sensing elements, wherein the measurement provides an indication of a state of a portion of the tissue.

24. The method of claim 23, wherein the measurement provides an indication of a disease state of the portion of the tissue.

25. The method of claim 23, wherein the measurement provides an indication of a contact state of the portion of the tissue with the at least one sensing element of the plurality of sensing elements.

26. An apparatus for medical diagnosis and/or treatment, the apparatus comprising:

a shaft;

a flexible substrate forming an inflatable body disposed at a distal end of the shaft, a longitudinal axis of the inflatable body being aligned with the shaft;

a coupling bus disposed along a latitude of the inflatable body;

sensing elements disposed on the flexible substrate and electrically connected to the coupling bus, at least one of the sensing elements being arranged on the flexible substrate in a first one of two annular rings, and all remaining of the sensing elements on the flexible substrate being arranged in a second one of the two annular rings; and

an intermediate bus disposed longitudinally about the inflatable body, the intermediate bus electrically connecting the coupling bus to a flexible printed circuit board,

wherein at least one of the sensing elements located within the first one or the second one of the two annular rings is positioned on the flexible substrate to interface with an ostium of a lumen within which the apparatus is inserted, with the inflatable body in an inflated state.

27. The apparatus of claim 26, wherein each sensing element of a first of the two annular rings is about 7.5 mm from the distal pole of the inflatable body, and each sensing element of a second of the two annular rings is about 10 mm from the distal pole of the inflatable body.

28. The apparatus of claim 27, wherein the coupling bus forms an annular ring about 12 mm from the distal pole of the inflatable body.

29. The apparatus of claim 26, wherein the sensing elements of the first annular ring are staggered relative to the sensing elements of the second annular ring.

30. The apparatus of claim 26, further comprising:

a plurality of wires connected to the flexible printed circuit board to provide and/or obtain electrical signals to the flexible printed circuit board,

wherein the intermediate bus is electrically coupled to the flexible printed circuit board and to the sensing elements through the coupling bus, the sensing elements comprise at least one of a pressure sensor or an impedance sensor and are individually electrically connected to the flexible printed circuit board through the coupling bus and the intermediate bus, and the flexible printed circuit board is disposed over or inside the shaft.

31. The apparatus of claim 30, wherein the shaft comprises a cryoablation device, a laser ablation device, a high intensity ultrasound or a RF device.

32. The apparatus of claim 26, wherein the coupling bus is formed as an annular ring having a radius of about 12 mm from the distal pole of the inflatable body.

33. The apparatus of claim 32, wherein the coupling bus is a serpentine bus, and wherein the serpentine bus comprises a plurality of stretchable serpentine interconnects.

34. The apparatus of claim 26, wherein one or more of the sensing elements comprise contact sensors.

35. The apparatus of claim 26, wherein the coupling bus is disposed about an equator of the inflatable body.

36. The apparatus of claim 26, wherein the sensing elements are disposed in a helical pattern about the inflatable body relative to the longitudinal axis.

37. The apparatus of claim 26, wherein each sensing element includes a pair of electrodes, the apparatus further comprising:

a plurality of stretchable interconnects, each stretchable interconnect electrically connecting a separate electrode of a separate sensing element of the sensing elements to the coupling bus.

38. The apparatus of claim 37, wherein the coupling bus comprises a plurality of serpentine interconnects, each coupling bus serpentine interconnect being electrically connected to a separate stretchable interconnect.

39. The apparatus of claim 26, further comprising at least one encapsulation layer disposed over the sensing elements, wherein the encapsulation layer positions the sensing elements at a neutral mechanical plane.

40. The apparatus of claim 26, further comprising at least one intermediate layer disposed between the sensing elements and the inflatable body, wherein the at least one intermediate layer positions the sensing elements at a neutral mechanical plane.

41. The apparatus of claim 26, wherein the inflatable body is a balloon.

42. The apparatus of claim 41, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, barrel-shaped.

43. The apparatus of claim 26, further comprising an encapsulation material disposed over substantially a portion of the sensing elements.

44. The apparatus of claim 43, wherein the encapsulation material comprises polyurethane.

45. The apparatus of claim 26, wherein the sensing elements are formed from a conductive material.