Catheter balloon employing force sensing elements

• US 9,757,050 B2
• Filed: 03/15/2013
• Issued: 09/12/2017
• 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
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/844,767
• Publication Number:
  US 20140012160A1
• Time in Patent Office: 1,642 Days
• Field of Search: 600372-377, 600380-381, 600393, 600460, 600481, 600508-509, 604 9601, 604 9701, 604 9901, 6041031, 606 20- 32
• 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;

first and second conductive components and an elastic dielectric component in a stacked arrangement on the flexible substrate, the first conductive component being stacked between the second conductive component and the flexible substrate, and

the elastic dielectric component being stacked between the first and second conductive components,

wherein a measure of an electrical property of at least one of the first and second 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 a 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 first and second conductive components, and wherein the measure of the electrical property of the at least one of the first and second 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 each force sensing element of the plurality of force sensing elements is 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 first and second conductive components is larger than another of the first and second 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;

a plurality of force sensing element disposed on the flexible substrate, each force sensing element of the plurality of force sensing elements comprising;

first and second conductive components and an elastic dielectric component in a stacked arrangement on the flexible substrate, the first conductive component being stacked between the second conductive component and the flexible substrate, and

the elastic dielectric component being stacked between the first and the second conductive components,

wherein each of the plurality of force sensing elements is coupled to the coupling bus, and a measure of an electrical property of at least one of the first and second 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.