Cardiac catheter employing conformal electronics for mapping

• US 9,545,285 B2
• Filed: 10/05/2012
• Issued: 01/17/2017
• Est. Priority Date: 10/05/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Elolampi, Brian, Ghaffari, Roozbeh, Lee, Stephen P.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/646,613
• Publication Number:
  US 20130274562A1
• Time in Patent Office: 1,565 Days
• 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 18/20 using laser
• 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 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0237 with a thermoelectric element in the probe for cooling purposes
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes 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 5/02055 : Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 : by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 : Determining heart rate variability
• CPC Class Codes: A61B 5/036 : by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/053 : Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 : invasively, e.g. using a catheter
• 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 5/1473 : invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/259 : using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/339 : Displays specially adapted therefor
• CPC Class Codes: A61B 5/361 : Detecting fibrillation
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor

Abstract

An apparatus for medical diagnosis and/or treatment is provided. The apparatus includes a flexible substrate, an intermediate bus disposed on the flexible substrate, and a plurality of sensing elements disposed on the flexible substrate and coupled to the intermediate bus. The plurality of sensing elements and intermediate bus are disposed on the flexible substrate such that the sensing elements are disposed at areas of minimal strain of the flexible substrate.

Claims

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

a flexible substrate disposed on a catheter;

a plurality of sensing elements disposed in a close-packed array;

a first intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a first quadrant of the flexible substrate;

a second intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a second quadrant of the flexible substrate, opposite the first quadrant;

a third intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a third quadrant of the flexible substrate; and

a fourth intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a fourth quadrant of the flexible substrate, opposite the third quadrant.

2. The apparatus of claim 1, wherein the sensing elements are disposed at areas of minimum bending and/or flexing of the flexible substrate.

3. The apparatus of claim 1, wherein a measurement of the plurality of sensing elements provides a measure of an amount of contact between the flexible substrate and a surface.

4. The apparatus of claim 3, wherein the surface is a portion of a tissue, and a measurement from the plurality of sensing elements provides an indication of an arrhythmia condition of the tissue.

5. The apparatus of claim 3, wherein the surface is a portion of a tissue, and a measurement from the plurality of sensing elements provides an indication of an atrial fibrillation or a ventricular fibrillation of the tissue.

6. The apparatus of claim 1, wherein the flexible substrate forms an inflatable body, and a portion of the first intermediate bus, the second intermediate bus, the third intermediate bus, and/or the fourth intermediate bus is disposed about a distal region of the inflatable body.

7. The apparatus of claim 6, wherein a measurement of the plurality of sensing elements provides a measure of an amount of contact between the inflatable body and a tissue.

8. The apparatus of claim 7, wherein the measurement of the plurality of sensing elements provides a mapping of the tissue.

9. The apparatus of claim 7, wherein the measurement of the plurality of sensing elements provides a spatial mapping and/or a temporal mapping of an arrhythmia.

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

a flexible substrate forming an inflatable body and being disposed on a catheter;

a plurality of sensing elements disposed on the flexible substrate proximate to a distal region of the inflatable body in an array;

a first intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a first quadrant of the inflatable body;

a second intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a second quadrant of the inflatable body, opposite the first quadrant;

a third intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a third quadrant of the inflatable body; and

a fourth intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a fourth quadrant of the inflatable body, opposite the third quadrant, wherein the third quadrant is oriented at substantially a 90°

angle relative to the first quadrant, and a portion of the first intermediate bus, the second intermediate bus, the third intermediate bus, and/or the fourth intermediate bus is disposed about the distal region of the inflatable body.

11. The apparatus of claim 10, wherein the first intermediate bus, the second intermediate bus, the third intermediate bus, and the fourth intermediate bus are electrically conductive.

12. The apparatus of claim 11, wherein portions of the first intermediate bus, the second intermediate bus, the third intermediate bus, and the fourth intermediate bus are formed from a non-conductive material.

13. The apparatus of claim 10, further comprising at least one coupling structure disposed about the distal region of the inflatable body, wherein a portion of the first intermediate bus, the second intermediate bus, the third intermediate bus, and/or the fourth intermediate bus is coupled to a portion of the at least one coupling bus.

14. The apparatus of claim 13, wherein the coupling structure is a non-conductive structure.

15. The apparatus of claim 10, wherein the plurality of sensing elements are disposed in the array at an area of minimum curvature of the inflatable body proximate to the distal region of the inflatable body.

16. The apparatus of claim 10, wherein the first intermediate bus, the second intermediate bus, the third intermediate bus, and the fourth intermediate bus electronically connects the plurality of sensing elements with an electrical source.

17. The apparatus of claim 10, wherein the plurality of sensing elements are disposed in the array in the first, second, third, and fourth quadrants of the distal region of the inflatable body.

18. The apparatus of claim 10, wherein the first intermediate bus, the second intermediate bus, the third intermediate bus, and the fourth intermediate bus are collections of serpentine buses, and wherein the serpentine buses electrically couple to the plurality of sensing elements.

19. The apparatus of claim 10, further comprising an encapsulation material disposed over substantially a portion of the first intermediate bus, the second intermediate bus, the third intermediate bus, and/or the fourth intermediate bus and/or the plurality of sensing elements.

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

21. The apparatus of claim 10, wherein the plurality of sensing elements comprise at least one of a pressure sensor and/or at least one impedance sensor.

22. The apparatus of claim 10, wherein one or more of the sensing elements of the plurality of sensing elements comprises contact sensors.

23. The apparatus of claim 10, further comprising an encapsulation layer disposed over the plurality of sensing elements, wherein the encapsulation layer positions the sensing elements at a neutral mechanical plane.

24. The apparatus of claim 23, wherein the encapsulation layer comprises a polymer.

25. The apparatus of claim 10, wherein the inflatable body is disposed near a distal end of the catheter.

26. The apparatus of claim 25, wherein the catheter comprises a cryoablation device, a laser ablation device, a high intensity ultrasound, and/or a RF device.

27. The apparatus of claim 10, wherein the inflatable body is a balloon.

28. The apparatus of claim 27, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, barrel-shaped.

29. The apparatus of claim 10, wherein the sensing elements are formed from a conductive material.

30. The apparatus of claim 10, wherein the first intermediate bus, the second intermediate bus, the third intermediate bus, and the fourth intermediate bus are formed from a conductive material.

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

an inflatable body having a distal portion and being disposed on a catheter;

a plurality of sensing elements disposed on the inflatable body proximate to the distal portion;

a first intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a first quadrant of the inflatable body;

a second intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a second quadrant of the inflatable body, opposite the first quadrant;

a third intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a third quadrant of the inflatable body;

a fourth intermediate bus coupled to one or more sensing elements of the plurality of sensing elements disposed in a fourth quadrant of the inflatable body, opposite the third quadrant; and

an electronic display electrically coupled to the plurality of sensing elements, the electronic display providing a visual representation of the spatial orientation of the plurality of sensing elements on the inflatable body, the electronic display changing a visual attribute of an electrode in the plurality of sensing elements 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, wherein the third quadrant is oriented at substantially a 90°

angle relative to the first quadrant, and a portion of the first intermediate bus, the second intermediate bus, the third intermediate bus, and/or the fourth intermediate bus is disposed about the distal portion of the inflatable body.

32. The apparatus of claim 31, wherein the visual attribute is a binary representation.

33. The apparatus of claim 31, wherein the visual attribute is a quantitative representation.

34. An apparatus for readout of one or more multiplexed signals, the apparatus comprising:

a flexible substrate forming an inflatable body and being disposed on a catheter;

a plurality of active electrical circuits disposed on the flexible substrate, the plurality of active electrical circuits configured to transmit one or more multiplexed signals to at least one signal processor, at least one active electrical circuit of the plurality of active electrical circuits comprising;

at least one electrode; and

at least one source-follower amplifier coupled to the at least one electrode;

wherein the plurality of active electrical circuits are disposed in a distributed arrangement on the substrate such that the apparatus is conformable to a contour of a surface to be measured;

a first conductive intermediate bus coupled to one or more active electrical circuits of the plurality of active electrical circuits disposed in a first quadrant of the inflatable body;

a second conductive intermediate bus coupled to one or more active electrical circuits of the plurality of active electrical circuits disposed in a second quadrant of the inflatable body, opposite the first quadrant;

a third conductive intermediate bus coupled to one or more active electrical circuits of the plurality of active electrical circuits disposed in a third quadrant of the inflatable body; and

a fourth conductive intermediate bus coupled to one or more active electrical circuits of the plurality of active electrical circuits disposed in a fourth quadrant of the inflatable body, opposite the third quadrant, wherein the third quadrant is oriented at substantially a 90°

angle relative to the first quadrant.

35. The apparatus of claim 34, wherein the plurality of active electrical circuits are disposed at areas of minimal curvature of the inflatable body in the distributed arrangement.

36. The apparatus of claim 34, wherein each active electrical circuit of the plurality of active electrical circuits is coupled to at least one adjacent active electrical circuit of the plurality of active electrical circuits via at least one conductive flexible interconnection.

37. The apparatus of claim 34, wherein each active electrical circuit of the plurality of active electrical includes at least one sensing element.

38. The apparatus of claim 37, wherein the plurality of active electrical circuits is configured to transmit one or more multiplexed signals to the at least one signal processor via the first conductive intermediate bus, the second conductive intermediate bus, the third conductive intermediate bus, and/or the fourth conductive intermediate bus.

39. The apparatus of claim 34, wherein the at least one active electrical circuit of the plurality of active electrical circuits further comprises at least one pass-through switch, and wherein the at least one source-follower amplifier is coupled to the at least one pass-through switch.

40. The apparatus of claim 34, wherein each of the active electrical circuit of the plurality of active electrical circuits comprises:

at least one electrode;

at least one source-follower amplifier coupled to the at least one electrode; and

at least one pass-through switch coupled to the at least one source-follower amplifier.

41. The apparatus of claim 40, wherein the at least one source-follower amplifier is an input transistor having a drain coupled to ground, and wherein the pass-through switch is a pass-through transistor coupled to the input transistor.

42. The apparatus of claim 41, wherein a source of the input transistor is coupled to a drain of the pass-through transistor.

43. The apparatus of claim 42, wherein a source of the pass-through transistor is coupled to the drain of that respective pass-through transistor, and wherein the respective at least one electrode of each active electrical circuit is coupled to a gate of the respective input transistor.

44. The apparatus of claim 42, wherein the input transistor is a NMOS transistor.

45. The apparatus of claim 42, wherein the pass-through transistor is a NMOS transistor.

46. The apparatus of claim 42, wherein the plurality of active electrical circuits are read in a row-column arrangement, and wherein each row-column element of the row-column arrangement corresponds to at least one active electrical circuit of the plurality of active electrical circuits.

47. The apparatus of claim 46, wherein the source of the pass-through transistor of each respective active electrical circuits is coupled to a column output of each respective row-column element.

48. The apparatus of claim 47, wherein all columns of the row-column arrangement are read substantially simultaneously, and wherein a single row of the row-column arrangement is active when the columns of the row-column arrangement are read.

49. The apparatus of claim 47, wherein the source of the pass-through transistor of at least two active electrical circuits are coupled to the column output of each respective row-column element.

50. The apparatus of claim 47, wherein each row input of the row-column arrangement is coupled to a gate of a pass-through transistor of each active electrical circuit of the plurality of active electrical circuits.

51. The apparatus of claim 47, wherein the voltage at the gate of the input transistor determines the voltage at the source of the input transistor.