Balloon catheter with force sensor

Patent metadata

Field	Value
Publication number	US-12369975-B2
Application number	US-202016863815-A
Country	US
Kind code	B2
Filing date	Apr 30, 2020
Priority date	Sep 12, 2019
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

In one embodiment, a system includes a balloon catheter configured to be inserted into a body-part of a living subject, the balloon catheter comprising an insertion tube having a distal tip, a force sensor connected to the distal tip, and an inflatable balloon including a proximal portion connected to the force sensor so that the force sensor is disposed between the distal tip of the insertion tube and the inflatable balloon, and multiple electrodes disposed around an outer surface of the balloon, and configured, when the balloon is inflated, to contact tissue at respective locations in the body-part, wherein the force sensor is configured to output at least one force signal indicative of a magnitude and a direction of a force applied by the balloon on the tissue when the balloon is inflated.

First claim

What is claimed is:

1. A system comprising a balloon catheter configured to be inserted into a body-part of a living subject, the balloon catheter comprising:
an insertion tube comprising a distal tip;
a force sensor disposed distal to the distal tip, the force sensor comprising a spring member comprising:
at least one distal arm extending to a distal end of the force sensor along a longitudinal axis;
at least one distal coupling protrusion disposed at the distal end of the force sensor and extending away from the at least one distal arm in a first circumferential direction about the longitudinal axis;
at least one proximal arm extending to a proximal end of the force sensor along the longitudinal axis and away from the at least one distal arm;
at least one proximal coupling protrusion disposed at the proximal end of the force sensor extending away from the at least one proximal arm in a second, opposite circumferential direction relative to the at least one distal coupling protrusion and about the longitudinal axis such that the at least one distal coupling protrusion and the proximal coupling protrusion have an opposite circumferential orientation relative to one another; and
a first helicoid ramp and a second helicoid ramp separated by a through-gap between the first and second helicoid ramps, the first and second helicoid ramps each comprising:
a first section that extends along the spring member at a helix angle; and
a second section extending from the first section that curves, relative to the helix angle, towards the at least one distal coupling protrusion and onto the at least one distal arm,

the first and second helicoid ramps joining at a distal end of the second sections;

an inflatable balloon including:
a proximal portion connected to the force sensor via the distal coupling protrusion so that the force sensor is disposed between the distal tip of the insertion tube and the inflatable balloon; and
multiple electrodes disposed around an outer surface of the inflatable balloon, and configured, when the inflatable balloon is inflated, to contact tissue at respective locations in the body-part; and

a coupler attached to the distal tip of the insertion tube and to the force sensor via the at least one proximal coupling protrusion,
the force sensor being configured to output at least one force signal indicative of a magnitude and a direction of a force applied by the inflatable balloon on the tissue when the inflatable balloon is inflated.

2. The system according to claim 1 , further comprising:
a display; and
processing circuitry configured to:
compute the magnitude and the direction of the force responsively to the at least one force signal; and
render to the display a representation of a force vector and a representation of the inflatable balloon, responsively to the at least one force signal.

3. The system according to claim 2 , wherein:
the balloon catheter further comprises at least one position sensor configured to output at least one position signal indicative of a position of the distal tip;
the processing circuitry is configured to:
compute the position of the distal tip responsively to the at least one position signal; and
render to the display the representation of the force vector responsively to the computed magnitude and direction, and the representation of the inflatable balloon responsively to the computed position and the at least one force signal.

4. The system according to claim 2 , wherein the processing circuitry is configured to:
receive a plurality of contact signals from the multiple electrodes;
in response to the plurality of contact signals, assess a respective quality of contact of each of the multiple electrodes with the tissue; and
render to the display the representation of the inflatable balloon, while modifying a visual feature of one of the multiple electrodes responsively to the respective quality of contact of the multiple electrodes with the tissue at the respective locations.

5. The system according to claim 2 , wherein the processing circuitry is further configured to:
compute a location of the distal tip responsive to receiving at least one location signal from at least one location sensing coil;
receive a plurality of contact signals from the multiple electrodes; and
determine a respective quality of contact of each of the multiple electrodes with the tissue based at least in part on the plurality of contact signals and the at least one force signal.

6. The system according to claim 5 , wherein the processing circuitry is further configured to:
render to the display the representation of the inflatable balloon and the representation of the force vector responsive to the computed magnitude and direction, while modifying a visual feature of at least one of the multiple electrodes based at least in part on the respective quality of contact of the multiple electrodes with the tissue at the respective locations and the at least one force signal.

7. The system according to claim 2 , wherein:
the balloon catheter further comprises at least one impedance-based position sensor configured to output at least one position signal indicative of a position of the distal tip; and
the processing circuitry is further configured to:
compute the position of the distal tip responsively to the at least one position signal;
receive a plurality of contact signals from the multiple electrodes;
in response to the plurality of contact signals and the at least one force signal, assess a respective quality of contact of each of the multiple electrodes with the tissue;
render to the display the representation of the inflatable balloon responsive to the computed magnitude and direction and the computed position; and
render to the display the representation of the force vector responsively to the computed magnitude and direction, while modifying a visual feature of at least one of the multiple electrodes based at least in part on the respective quality of contact of the multiple electrodes with the tissue at the respective locations and the at least one force signal.

8. The system according to claim 7 , wherein the processing circuitry is further configured to render to the display the representation of the force vector and the representation of the balloon catheter with an image of the body-part, the image of the body-part being taken from an anatomical scan.

9. The system according to claim 1 , wherein each of the multiple electrodes is a flexible electrode formed from a polyamide substrate with a gold covering thereon.

10. The system according to claim 1 , the coupler comprising at least one notch, the at least one proximal coupling protrusion mating with the at least one notch.

11. The system according to claim 1 , wherein the coupler is a first coupler, and the system comprises a second coupler attached to the inflatable balloon and comprising at least one notch, the at least one distal coupling protrusion mating with the at least one notch of the second coupler.

12. The system according to claim 1 , wherein the first and second helicoid ramps extend in a spiral direction along the longitudinal axis towards the at least one proximal coupling protrusion.

13. The system according to claim 1 , further comprising a flex circuit comprising two location sensing coils.

14. The system according to claim 1 , wherein the multiple electrodes comprise at least one ablation electrode mounted on the inflatable balloon and at least one temperature sensor mounted on the inflatable balloon.

15. The system according to claim 14 , wherein the at least one abla

Assignees

• Biosense Webster Israel Ltd

Inventors

• Govari Assaf
• Beeckler Christopher Thomas
• Keyes Joseph Thomas
• Herrera Kevin Justin

Classifications

• A61M25/10

  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 title

• A61B2218/002

  Irrigation · CPC title

• A61B2018/1467

  using more than two electrodes on a single probe · CPC title

• A61B2018/00875

  Resistance or impedance · CPC title

• A61B2018/00797

  measured by multiple temperature sensors · CPC title