Catheter balloon methods and apparatus employing sensing elements

• US 9,622,680 B2
• Filed: 05/29/2015
• Issued: 04/18/2017
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA), Trusted Positioning Inc. (TDK Corporation)
• Original Assignee: MC10, Inc.
• Inventors: Ghaffari, Roozbeh, D'Angelo, Robert, De Graff, Bassel, Dowling, Kevin, Hsu, Yung-Yu, Klinker, Lauren E., Lee, Stephen P., Liu, Cliff
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Antiskay, Brian M
• Application Number:
  US14/726,136
• Publication Number:
  US 20150320472A1
• Time in Patent Office: 690 Days
• Field of Search: 600372-374, 600377, 600381, 600485, 600488, 600508-509, 604 9503, 604 9601, 604508-509, 606 20- 23, 606 25- 26
• 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. A cryoablation apparatus comprising:

a flexible substrate forming an inflatable cryoballoon;

one or more delivery channels coupled to the inflatable cryoballoon for delivering a cryoablation fluid to the inflatable cryoballoon;

a plurality of sensing elements disposed on the inflatable cryoballoon for sensing tissue targeted for ablation, the plurality of sensing elements including a plurality of impedance sensing elements;

a coupling bus disposed along a latitude of the inflatable cryoballoon and electrically coupled to the plurality of sensing elements; and

an intermediate bus disposed longitudinally along the inflatable cryoballoon and electrically coupling the coupling bus to a measurement collection circuit for collecting measurements from the plurality of sensing elements.

2. The apparatus of claim 1, wherein the plurality of sensing elements includes at least one pressure sensing element and at least one temperature sensing element.

3. The apparatus of claim 1, wherein the plurality of sensing elements includes at least one pressure sensing element.

4. The apparatus of claim 1, wherein the plurality of sensing elements includes at least one temperature sensing element.

5. The apparatus of claim 1, wherein the cryoablation fluid is alcohol or nitrous oxide.

6. The apparatus of claim 1, wherein the flexible substrate includes one or more microchannels coupled to at least one delivery channel for delivering the cryoablation fluid throughout the inflatable cryoballoon.

7. The apparatus of claim 6, wherein at least one of the microchannels has a diameter of 10 to 100 μ

m.

8. The apparatus of claim 6, the apparatus further comprising:

a shaft coupled to the inflatable cryoballoon including a first channel and a second channel, the first channel being in fluid communication with the inflatable cryoballoon to inflate the inflatable cryoballoon and the second channel being in fluid communication with the plurality of microchannels to deliver the cryoablation fluid to the plurality of microchannels.

9. The apparatus of claim 1, wherein the plurality of impedance sensing elements includes a plurality of electrode pairs arranged in a circumferential orientation around the inflatable cryoballoon, each electrode pair of the plurality of electrode pairs being configured to measure an impedance between the electrode pair.

10. The apparatus of claim 9, wherein the impedance indicates whether the inflatable cryoballoon is in conformal contact with a surface of the tissue at the electrode pair on the inflatable cryoballoon.

11. The apparatus of claim 9, wherein the circumferential orientation of the plurality of sensing elements corresponds to a circumferential area of contact with a coronary vessel around the inflatable cryoballoon, with the inflatable cryoballoon in an inflated state.

12. The apparatus of claim 1, wherein the plurality of sensing elements is disposed in a circumferential orientation along at least one portion of the inflatable cryoballoon that experiences minimum strain when the inflatable cryoballoon is in a deflated state.

13. The apparatus of claim 1, wherein the plurality of sensing elements is configured to generate contact data representative of contact between the plurality of sensing elements and the tissue.

14. The apparatus of claim 6, further comprising:

an electronic circuit embedded in or affixed to the flexible substrate, the electronic circuit including the plurality of sensing elements.

15. The apparatus of claim 14, further comprising:

a plurality of micro-valves operatively connected to the electronic circuit and fluidically connected to the one or more microchannels to selectively deliver the cryoablation fluid to selected portions of the inflatable cryoballoon.

16. The apparatus of claim 1, wherein the plurality of impedance sensing elements includes a plurality of bipole electrodes configured to measure impedance differences.

17. The apparatus of claim 16, wherein each bipole electrode of the plurality of bipole electrodes is configured to inject current into a surface on which the bipole electrode is placed and measure a voltage across the bipole electrode and another bipole electrode of the plurality of bipole electrodes.

18. The apparatus of claim 1, wherein one or more sensing elements of the plurality of sensing elements include one or more active components, one or more passive components, or a combination thereof.

19. The apparatus of claim 18, wherein the one or more active components include one or more amplifiers.

20. The apparatus of claim 1, wherein the plurality of sensing elements include electrical impedance tomography (EIT) contact sensors.

21. The apparatus of claim 1, wherein the plurality of sensing elements includes one or more lateral strain sensors, one or more temperature sensors, one or more intracardiac electrogram (EGM) sensors, one or more light-emitting diodes (LEDs), one or more multiplexors, one or more recording electrodes, one or more contact sensors, or a combination thereof.