CATHETER BALLOON EMPLOYING FORCE SENSING ELEMENTS

• US 20140012160A1
• Filed: 03/15/2013
• Published: 01/09/2014
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, Hsu, Yung-Yu
• Granted Patent: US 9,757,050 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• 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 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• 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 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/10187 : Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/10188 : Inflation or deflation data displays
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

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 force sensing elements disposed on the flexible substrate. The plurality of force sensing elements are disposed about the inflatable body such that the force 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; and

a plurality of force sensing elements disposed on the flexible substrate;

each force sensing element of the plurality of force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components,

wherein a measure of an electrical property of at least one of the conductive components provides an indication of a force applied to the inflatable body.

6. The apparatus of claim 1 or 2, further comprising a shaft coupled to the inflatable body, wherein the shaft comprises a cryoablation device, a laser ablation device, a high intensity ultrasound or a RF device.

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

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

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

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

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

14. The apparatus of claim 13, wherein the balloon is cylindrical, onion-shaped, cone-shaped, dog-bone-shaped, barrel-shaped.

16. The apparatus of claim 1 or 2, wherein the force applied to the inflatable body causes a degree of compression of the elastic dielectric component between the two conductive components, and wherein the measure of the electrical property of the at least one of the conductive components changes based on the degree of compression of the elastic dielectric component, thereby providing an indication of the force applied to the inflatable body.

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

18. The apparatus of claim 1 or 2, wherein, for at least one force sensing element of the plurality of force sensing elements, one of the two conductive components is larger than another of the two conductive components.

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

a flexible substrate forming an inflatable body; and

a coupling bus disposed on the flexible substrate about a portion of a circumference of the inflatable body, each force sensing element of the plurality of force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components,

wherein each of the plurality of force sensing elements is coupled to the coupling bus, and

wherein a measure of an electrical property of at least one of the conductive components provides an indication of a force applied to the inflatable body.

3. The apparatus of claim 2, wherein the coupling bus is a serpentine bus, and wherein the serpentine bus electrically couples at least one conductive component of each of the plurality of force 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.

7. The apparatus of claim 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.

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

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

19. 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 force sensing elements, each force sensing element of the plurality of force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components;

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

disposing the plurality of force sensing elements about a portion of a circumference of the inflatable body.

20. The method of claim 19, further comprising extracting the coupling bus and the plurality of force sensing elements from a carrier substrate prior to disposing the coupling bus about the region of the inflatable body.

21. The method of claim 19, wherein each of the plurality of force sensing elements comprises a respective first conductive component and a respective second conductive component, and wherein the disposing the coupling bus about the region of the inflatable body comprises:

applying the respective first conductive component of each of the plurality of force sensing elements to a portion of flexible substrate bus; and

disposing the respective second conductive component substantially parallel to the respective first conductive component of each of the plurality of force sensing elements.

22. 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 force sensing elements that are coupled to the coupling bus, each force sensing element of the plurality of force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components; and

recording an electrical measurement of at least one force sensing element of the plurality of force sensing elements, wherein the measurement provides an indication of a force applied to the inflatable body.

23. The method of claim 22, wherein the measurement provides an indication of a contact state of the portion of the tissue with the at least one force sensing element of the plurality of force sensing elements.

24. An apparatus for displaying a representation of measurements of a plurality of force 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 processor-executable instructions; and

one or more processor units to execute the processor-executable instructions,

wherein execution of the processor-executable instructions causes the display to display a plurality of representations of the measurements, and

wherein each representation of the plurality of representations corresponds to a force sensing element of the plurality of force sensing elements, each force sensing element of the plurality of force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components.

25. The apparatus of claim 24, wherein the representation comprises (i) a plurality of first indicators, each first indicator corresponding to a force sensing element of the plurality of force sensing elements that measures a force below a threshold value, and (ii) a plurality of second indicators, each second indicator corresponding to a force sensing element of the plurality of force sensing elements that measures a force above the threshold value.

26. The apparatus of claim 24, wherein the measurement below the threshold value indicates that the corresponding force sensing element of the plurality of force sensing elements is not in contact with the tissue.

27. The apparatus of claim 24, wherein the measurement above the threshold value indicates that at least a portion of the corresponding force sensing element of the plurality of force sensing elements is in contact with the tissue.

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

an inflatable body;

a plurality of force sensing elements coupled to the inflatable body, each force sensing elements comprising;

two conductive components, disposed substantially parallel to each other; and

an elastic dielectric component disposed between the two conductive components;

an electronic display electrically coupled to the plurality of force sensing elements, the electronic display providing a visual representation of the spatial location of each of the plurality of force sensing elements on the inflatable body, wherein;

the electronic display changes a visual attribute of the visual representation of a respective force sensing element in response to a change in an electrical measurement of the respective force sensing element; and

the change in the electrical measurement identifies a contact condition of the respective force sensing element with respect to the surface.

29. The system of claim 28, wherein the visual attribute is a binary representation

30. The system of claim 28, wherein the visual attribute is a quantitative representation.