System and method for tracking and determining characteristics of inflatable medical instruments using fiber-optical realshape data

Patent metadata

Field	Value
Publication number	US-11039890-B2
Application number	US-201615736854-A
Country	US
Kind code	B2
Filing date	Jun 8, 2016
Priority date	Jun 24, 2015
Publication date	Jun 22, 2021
Grant date	Jun 22, 2021

Abstract

A system and method for tracking and determining characteristics of an inflatable medical instrument that is configured for interventional deployment. The system includes a guidewire that is positioned within a lumen of the inflatable medical instrument. The guidewire includes an optical fiber for a FORS system. The FORS system is configured to measure a shape of the guidewire during the interventional deployment of the inflatable medical instrument. A shape analysis module is configured to analyze the FORS data from the FORS system and determine characteristics of the inflatable medical instrument, including the diameter of the inflatable instrument, the pressurization of the instrument, whether the instrument has ruptured and the position of the inflatable instrument during an interventional procedure.

First claim

The invention claimed is:

1. A medical system, comprising:
an inflatable medical instrument configured for interventional deployment, the inflatable medical instrument including a lumen running longitudinally through a central portion of an inflatable structure of the inflatable medical instrument;
a guidewire positioned within the lumen and configured to guide the inflatable medical instrument during the interventional deployment;
an optical shape sensing system comprising an optical fiber integrated in the guidewire, the optical fiber being configured to provide shape sensing data indicating a curvature of the guidewire during the interventional deployment; and
at least one processor and a non-transitory memory for storing instructions that, when executed by the at least one processor, cause the at least one processor to determine inflation and pressurization characteristics of the inflatable structure based on the shape sensing data indicating the curvature of the guidewire within the inflatable structure.

2. The system as recited in claim 1 , wherein the instructions cause the at least one processor to further determine at least one of a node distance, axial strain, or three-dimensional shape of the inflatable medical instrument.

3. The system as recited in claim 1 , wherein the memory further includes a lookup table or model, wherein the instructions further cause the at least one processor to perform calibration of the inflatable medical instrument using the lookup table or model.

4. The system as recited in claim 1 , wherein the instructions further cause the at least one processor to detect when the inflatable medical instrument has ruptured, and to produce a signal when a rupture is detected.

5. The system as recited in claim 1 , wherein the instructions further cause the at least one processor to generate a graphical model of the inflatable medical instrument based on the determined characteristics, and to update the graphical model based on data from an imaging modality or due to a user input.

6. The medical system as recited in claim 1 , wherein the optical fiber is integrated within a wall of the lumen.

7. The medical system as recited in claim 1 , wherein determining the characteristics of the inflatable medical instrument comprises determining whether the inflatable medical instrument is pressurized or unpressurized when inflated.

8. The medical system as recited in claim 7 , wherein determining the characteristics of the inflatable medical instrument comprises determining a diameter of the inflatable medical instrument during inflation and deflation.

9. The medical system as recited in claim 1 , wherein the instructions further cause the at least one processor to determine changes in a linear distance between points at opposite sides of the inflatable medical instrument based on the shape sensing data, and to determine the characteristics of the inflatable structure using the determined changes.

10. The system as recited in claim 1 , wherein the curvature of the guidewire is substantially linear when the inflatable structure of the medical instrument is uninflated and unpressurized,
wherein the curvature of the guidewire is deformed when the inflatable structure of the medical instrument is inflated and unpressurized, and
wherein the curvature of the guidewire is substantially linear when the inflatable structure of the medical instrument is inflated and pressurized.

11. A medical system for tracking and determining characteristics of an inflatable medical instrument configured for interventional deployment, the system comprising:
an inflatable medical instrument configured for interventional deployment, and comprising an inflatable structure;
a guidewire positioned within a lumen running longitudinally through a central portion of the inflatable structure of the inflatable medical instrument for guiding the inflatable medical instrument during the interventional deployment, wherein the guidewire exhibits deformations responsive to inflation and pressurization of the inflatable structure of the inflatable medical instrument;
an optical shape sensing system comprising an optical fiber integrated in the guidewire for measuring a shape of the guidewire during the interventional deployment of the inflatable medical instrument; and
a workstation including:
one or more processors, and
a non-transitory memory for storing instructions that, when executed by the one or more processors, cause the one or more processors to determine characteristics of the inflatable medical instrument based on a curvature of the guidewire within the inflatable structure indicated by sensing data from the optical shape sensing system.

12. The system as recited in claim 11 , wherein the instructions cause the one or more processors to determine the characteristics of the inflatable medical instrument by computing shape parameters for the inflatable medical instrument.

13. The system as recited in claim 11 , wherein the memory includes a lookup table or model for calibration of the inflatable medical instrument.

14. The system as recited in claim 11 , wherein the instructions further cause the one or more processors to generate a graphical model based on the determined characteristics, and to update the graphical model based on data from an imaging modality or due to a user input.

15. The system as recited in claim 11 , wherein the determined characteristics of the inflatable medical instrument comprise a diameter of the inflatable medical instrument, a pressure of the inflatable medical instrument and/or a total number of inflation cycles for the inflatable medical instrument.

16. A method for tracking and determining characteristics of an inflatable medical instrument configured for interventional deployment, the method comprising:
positioning a guidewire within a lumen running longitudinally through a central portion of an inflatable structure of the inflatable medical instrument, the guidewire including an optical fiber for performing optical shape sensing of the guidewire;
guiding the inflatable medical instrument during the interventional deployment using the guidewire;
determining a curvature of the guidewire during the interventional deployment of the inflatable medical instrument using the optical fiber; and
determining inflation and pressurization characteristics of the inflatable structure based on the determined curvature of the guidewire within the inflatable structure.

17. The method as recited in claim 16 , wherein the characteristics of the inflatable medical instrument comprise diameter of the inflatable medical instrument.

18. A device comprising:
an inflatable medical instrument including an inflatable structure and a lumen running longitudinally through a central portion of the inflatable structure;
a guidewire positioned in the lumen for guiding the inflatable medical instrument during interventional deployment, the guidewire including an optical fiber; and
at least one processor and a non-transitory memory for storing instructions that, when executed by the at least one processor, cause the at least one processor to detect from shape sensing data from the optical fiber a shape of the optical fiber, the shape of the optical fiber indicating a curvature of the guidewire within the inflatable structure, and to determine whether the inflatable medical instrument is pressurized after inflation based on the curvature of the guidewire.

19. The device of claim 18 , wherein the instructions further cause the at least one proc

Assignees

• Koninklijke Philips Nv

Inventors

• Cole Gregory
• Thienphrapa Paul
• Flexman Molly Lara
• Noonan David Paul
• Kahya Neriman Nicoletta

Classifications

• A61B5/6853 Primary

  with a balloon · CPC title

• A61B2090/0809

  Indication of cracks or breakages · CPC title

• A61B2090/3614

  using optical fibre · CPC title

• A61B2090/0803

  Counting the number of times an instrument is used · CPC title

• A61B2034/2065

  Tracking using image or pattern recognition · CPC title