CATHETER BALLOON METHODS AND APPARATUS EMPLOYING SENSING ELEMENTS

• US 20130150693A1
• Filed: 08/06/2012
• Published: 06/13/2013
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Bassel de Graff
• Inventors: De Graff, Bassel, Dowling, Kevin, Ghaffari, Roozbeh, Liu, Cliff, D'Angelo, Robert, Klinker, Lauren, Lee, Stephen P., Hsu, Yung-Yu
• Granted Patent: US 9,545,216 B2
• Time in Patent Office: Days
• US Class Current: 600/373
• 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 plurality of sensing elements disposed on the flexible substrate;

wherein 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.

6. The apparatus of claim 1 or 2, further comprising:

a shaft coupled to the inflatable body;

a flex board disposed over or inside the shaft;

a plurality of wires connected to the flex board to provide and/or obtain electrical signals to the flex board; and

an intermediate bus electrically coupled to a flex board and to the plurality sensors,

wherein the plurality of sensing elements comprise at least one of a pressure sensor or an impedance sensor.

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

8. The apparatus of claim 1 or 2, wherein the sensing elements are disposed in a longitudinal direction along portions of the inflatable body that experience minimal strain when the inflatable body is in a deflated state.

9. The apparatus of claim 1 or 2, wherein the coupling bus is an annular bus, and wherein the annular bus is disposed as a ring substantially about a circumference of the inflatable body.

10. The apparatus of claim 1 or 2, wherein the coupling bus is a serpentine bus, and wherein the serpentine bus comprises a plurality of serpentine structures.

11. The apparatus of claim 1 or 2, wherein one or more of the sensing elements of the plurality of sensing elements comprises contact sensors

12. The apparatus of claim 1 or 2, wherein the plurality of sensing elements are disposed about an equator of the inflatable body.

13. The apparatus of claim 1 or 2, wherein the plurality of sensing elements are disposed proximate to a distal portion of the inflatable body.

14. The apparatus of claim 1 or 2, wherein the plurality of sensing elements are disposed in helical pattern about the inflatable body.

15. The apparatus of claim 1 or 2, 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.

16. The apparatus of claim 15, wherein the at least one encapsulation layer comprises a polymer.

17. The apparatus of claim 1 or 2, 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.

18. The apparatus of claim 1 or 2, wherein the inflatable body is disposed near a distal end of a catheter.

19. The apparatus of claim 1 or 2, wherein the inflatable body is a balloon.

20. The apparatus of claim 19, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, barrel-shaped.

21. The apparatus of claim 1 or 2, wherein the coupling bus has a T-configuration or an annular ring structure.

22. The apparatus of claim 1 or 2, further comprising an encapsulation material disposed over substantially a portion of the plurality of sensing elements.

23. The apparatus of claim 22, wherein the encapsulation material comprises polyurethane.

24. The apparatus of claim 1 or 2, wherein the sensing elements are formed from a conductive material.

25. The apparatus of claim 1 or 2, wherein the coupling bus is formed from a conductive material.

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

a flexible substrate forming an inflatable body;

a coupling bus disposed about a region of the inflatable body;

a plurality of sensing elements disposed on the flexible substrate,

wherein the plurality of sensing elements are coupled to the coupling bus, and

wherein the plurality of sensing elements are disposed about a portion of a circumference of the inflatable body such that the sensor elements are disposed at areas of minimal curvature of the inflatable body in a deflated state.

3. The apparatus of claim 2, wherein the coupling bus is a serpentine bus, and wherein the serpentine bus electrically couples the plurality of sensing elements.

4. The apparatus of claim 2, further comprising an encapsulation material disposed over substantially a portion of the coupling bus.

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

26. A method of fabricating an apparatus for medical diagnosis and/or treatment, the method comprising:

providing a coupling bus that is coupled to a plurality of sensing elements;

disposing the coupling bus about a region of an inflatable body; and

disposing the plurality of sensing elements about a portion of a circumference of the inflatable body such that the sensor elements are disposed at areas of minimal curvature of the inflatable body.

27. The method of claim 26, further comprising extracting the coupling bus and the plurality of sensing elements from a carrier substrate prior to disposing the coupling bus about the region of the inflatable body.

28. The method of claim 26, wherein the disposing the coupling bus about the region of the inflatable body comprises applying the coupling bus using a dissolvable tape backing.

29. The method of claim 26, wherein the coupling bus is disposed near a distal region of the inflatable body and the plurality of sensing elements are disposed closer to a mid-portion of the inflatable body.

30. 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; and

a plurality of sensing elements that are coupled to the coupling bus, wherein;

one or more sensing elements of the plurality of sensing elements comprises contact sensors,

the coupling bus is disposed near a distal end of the inflatable substrate, and

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; 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.

31. The method of claim 30, wherein the measurement provides an indication of a disease state of the portion of the tissue.

32. The method of claim 30, 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.

33. An apparatus for displaying a representation of measurements of a plurality of sensing elements disposed about at least a portion of a circumference of an inflatable body during a medical diagnosis and/or treatment of a tissue, the apparatus comprising:

a display;

a memory storing machine-readable instructions; and

one or more processor units to execute the machine-readable instructions,

wherein execution of the machine-readable instructions causes the display to display the representation of the measurements, and

wherein the representation comprises (i) a plurality of first indicators, each first indicator corresponding to a sensing element of the plurality of sensing elements that measures a signal below a threshold value, and (ii) a plurality of second indicators, each second indicator corresponding to a sensing element of the plurality of sensing elements that measures a signal above the threshold value.

34. The apparatus of claim 33, wherein the measurement below the threshold value indicates that the corresponding sensing element of the plurality of sensing elements is not in contact with the tissue.

35. The apparatus of claim 33, wherein the measurement above the threshold value indicates that at least a portion of the corresponding sensing element of the plurality of sensing elements is in contact with the tissue.

36. An apparatus for displaying a representation of measurements of a plurality of sensing elements disposed about at least a portion of a circumference of an inflatable body during a medical diagnosis and/or treatment of a tissue, the apparatus comprising:

a display;

a memory storing machine-readable instructions; and

one or more processor units to execute the machine-readable instructions,

wherein execution of the machine-readable instructions causes the display to display the representation of the measurements,

wherein the representation comprises (i) a plurality of first spatial representations, each first spatial representation corresponding to a sensing element of the plurality of sensing elements that is disposed at a first latitude of the inflatable body, and (ii) a plurality of second spatial representations, each second spatial representation corresponding to a sensing element of the plurality of sensing elements that is disposed at a second latitude of the inflatable body that is different from the first latitude.

37. The apparatus of claim 36, wherein each of the first spatial representations or each of the second spatial representations displays a first indication if the corresponding sensing element measures a signal above a threshold value.

38. The apparatus of claim 36, wherein each of the first spatial representations or each of the second spatial representations displays a second indication if the corresponding sensing element measures a signal below a threshold value.

39. A stretchable electronic system comprising:

a flexible annular interconnect; and

a first plurality of electrodes coupled to the flexible annular interconnect.

40. The stretchable electronic system of claim 39, wherein the flexible annular interconnect has a first radius and wherein each electrode in the first plurality of electrodes is coupled to the flexible annular interconnect via at least one flexible connector extending from the annular interconnect such that the first plurality of electrodes are positioned at a second radius distinct from the first radius.

41. The stretchable electronic system of claim 39 or 40, wherein the flexible annular interconnect is formed from a conductive material.

42. The stretchable electronic system of claim 40, wherein the second radius is greater than the first radius.

43. The stretchable electronic system of claim 40, further comprising a second plurality of electrodes coupled to the flexible annular interconnect, each electrode in the second plurality of electrodes coupled to the flexible annular interconnect via the at least one flexible connector extending from the annular interconnect such that the second plurality of electrodes are positioned at a third radius, distinct from the first and second radii.

44. The stretchable electronic system of claim 43, wherein the third radius is greater than the second radius.

45. The stretchable electronic system of claim 39, further comprising a flexible substrate forming an inflatable body, the flexible annular interconnect and the first plurality of electrodes coupled to a peripheral portion of the flexible substrate.

46. The stretchable electronic system of claim 45, wherein the inflatable body is disposed near a distal end of a catheter.

47. The stretchable electronic system of claim 45, further comprising an intermediate layer disposed between the flexible annular interconnect.

48. The stretchable electronic system of claim 45, wherein the inflatable body is a balloon.

49. The stretchable electronic system of claim 48, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, barrel-shaped.

50. The stretchable electronic system of claim 39, wherein the flexible annular interconnect comprises at least one intermediate bus for electronically connecting each electrode with an electrical source.

51. The stretchable electronic system of claim 39, wherein the flexible annular interconnect has a serpentine morphology.

52. The stretchable electronic system of claim 39, further comprising a flexible substrate forming an inflatable body coupled to the flexible annular interconnect.

53. The stretchable electronic system of claim 39, wherein the flexible annular interconnect has a T-configuration or an annular ring structure.

54. The stretchable electronic system of claim 39, wherein the flexible annular interconnect has a T-configuration or an annular ring structure.

55. The stretchable electronic system of claim 39, further comprising an encapsulation material disposed over at least a portion of the flexible annular interconnect.

56. The stretchable electronic system of claim 53, wherein the encapsulation material comprises a polyurethane.

57. A system for mapping contact with a surface, the system comprising:

an inflatable body;

a plurality of electrodes coupled to the inflatable body;

an electronic display electrically coupled to the plurality of electrodes, the electronic display providing a visual representation of the spatial location of the plurality of electrodes on the inflatable body, the electronic display changing a visual attribute of an electrode in the plurality of electrodes in response to a change in an electrical signal produced by the electrode, and the change in the electrical signal identifying a contact condition of the electrode with respect to the surface.

58. The system of claim 57, wherein the visual attribute is a binary representation

59. The system of claim 57, wherein the visual attribute is a quantitative representation.

60. A stretchable electronic system comprising:

a flexible interconnect; and

a plurality of impedance based electrode pairs coupled to the flexible interconnect, wherein the electrode pairs measures impedance between two electrodes of the electrode pair.

61. A method of manufacturing a contact mapping balloon catheter, the method comprising:

identifying regions of maximum curvature on the balloon of the balloon catheter when the balloon is in a deflated state; and

coupling a plurality of electrodes to the balloon such that the plurality of electrodes are positioned outside of the regions of maximum curvature.