Methods and apparatuses for remodeling tissue of or adjacent to a body passage

• US 9,592,386 B2
• Filed: 12/21/2012
• Issued: 03/14/2017
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Mathur, Prabodh, Nassif, Rabih, Lee, Henry H., Dandler, Andres, Espinosa, Joseluis
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/725,885
• Publication Number:
  US 20130165924A1
• Time in Patent Office: 1,544 Days
• Field of Search: 606 41- 50, 606101-105, 29/233.5, 29/354.1
• US Class Current: 1/1
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

Medical devices and methods for making and using the same are disclosed. An example device may include an expandable balloon including an outer surface. At least one flexible circuit may be mounted on the outer surface of the expandable balloon. The at least one flexible circuit may include a first insulating layer, at least one heat sensing device positioned at least partially within the first insulating layer, a conductive layer above the first insulating layer, at least a portion of which is electrically coupled to the heat sensing device, a second insulating layer above the conductive layer, and at least one electrode associated with the conductive layer.

Claims

1. A device, comprising:

(a) an expandable balloon including an outer surface; and

(b) at least one flexible circuit mounted on the outer surface of the expandable balloon, the at least one flexible circuit including;

(i) a first insulating layer, (ii) at least one heat sensing device positioned at least partially within the first insulating layer, (iii) a conductive layer above the first insulating layer, at least a portion of which is electrically coupled to the heat sensing device, (iv) a second insulating layer above the conductive layer, and (v) at least one electrode associated with the conductive layer.

2. The device of claim 1, wherein the at least one electrode is positioned above the second insulating layer and is coupled to the conductive layer through the second insulating layer.

3. The device of claim 1, wherein the heat sensing device comprises a thickness of less than 0.15 mm.

4. The device of claim 1, wherein the at least one electrode is a pair of bipolar electrodes.

5. The device of claim 4, wherein the heat sensing device is positioned between the pair of bipolar electrodes.

6. The device of claim 4, wherein the heat sensing device is positioned relative to the pair of bipolar electrodes such that the heat sensing device is configured to measure a temperature representative of both the bipolar electrodes and a tissue when the device is in contact with the tissue.

7. The device of claim 4, wherein the heat sensing device is electrically coupled to one of the pair of bipolar electrodes.

8. The device of claim 4, wherein the pair of bipolar electrodes comprises a plurality of active electrodes and a plurality of ground electrodes.

9. The device of claim 8, wherein the plurality of active electrodes are arranged along a first longitudinal axis and the plurality of ground electrodes are arranged along a second longitudinal axis that is offset from and approximately parallel to the first longitudinal axis.

10. The device of claim 1, wherein the heat sensing device is positioned relative to the at least one electrode such that the heat sensing device is configured to measure a temperature representative of both the at least one electrode and a tissue when the device is in contact with the tissue.

11. The device of claim 1, the first insulating layer having a base opening;

the heat sensing device being positioned within the base opening and having a first pole and a second pole;

the conductive layer layered on top of the first insulating layer, the conductive layer comprising a first elongate trace connected to the first pole, a second elongate trace connected to the second pole, and a third trace;

the second insulating layer layered on top of the conductive layer, the second insulating layer having a first plurality of openings over the first trace and a second plurality of openings over the third trace;

wherein the at least one electrode includes a first plurality of electrodes layered on top of the second insulating layer and being conductively coupled to the first trace via the first plurality of openings in the second insulating layer; and

a second plurality of electrodes layered on top of the second insulating layer and being conductively coupled to the third trace via the second plurality of openings.

12. The device of claim 11, wherein the first trace comprises a first elongate electrode trace extending in a longitudinal direction.

13. The device of claim 12, wherein the first trace further comprises a first ground pad laterally displaced from the first elongate trace, the ground pad being electronically coupled to the heat sensing device.

14. The device of claim 12, wherein distal portions of each of the first elongate electrode trace and ground pad are connected by a bridge portion.

15. The device of claim 11, wherein the third trace further comprises a second elongate electrode trace substantially parallel to the first elongate electrode trace.

16. The device of claim 11, wherein the first insulating layer and second insulating layer each comprise a flexible polymer.

17. The device of claim 16, wherein the flexible polymer comprises polyimide.