# US 11,432,740 B2 · Introducer sheath localization and visualization

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- Number: US 11,432,740 B2
- Document ID: US11432740B2
- Status: Granted
- Kind: B2
- Application number: 16/448,728
- Filed: 2019-06-21
- Published: 2020-01-02
- Granted: 2022-09-06
- Earliest claimed: 2018-06-28
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Eitan Oren; Oded Sudarsky; Adar Shlain; Stavit Cohen
- Web page: https://patentgrep.com/patent/US11432740B2

## CPC

- A61B 5/062: {using magnetic field}
- A61B 5/063: {using impedance measurements}
- A61B 5/068: {using impedance sensors}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 34/25: {User interfaces for surgical systems}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2017/00053: {Mapping}
- A61B 2017/00243: {cardiac}
- A61B 2018/00577: {Ablation}
- A61B 2018/00678: {upper}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2053: {Tracking an applied voltage gradient}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Aspects of the present disclosure are directed to the localization of an introducer sheath relative to an intravascular catheter. Further embodiments of the present disclosure are directed to the visualization of the introducer sheath on a graphical user interface of a navigation system.

## Claims

### Claim 1

A system for visualizing an introducer sheath location within the body, the system comprising:
controller circuitry configured and arranged to
receive electrical signals from one or more electrodes on an electrophysiology catheter indicative of a position and orientation of a distal end of the catheter and a position of an introducer sheath relative to the catheter,
determine the position and orientation of the distal end of the catheter and the position of the introducer sheath relative to the catheter, and
generate an image for a display that visualizes states indicative of the relative locations of the catheter and the introducer sheath including a first visualization state where the visual indicator of the introducer sheath is proximal a proximal-most electrode of the plurality of electrodes, a second visualization state where the visual indicator of the introducer sheath is disposed over at least one of the plurality of electrodes of the catheter, and a third visualization state where the visual indicator covers each of the one or more electrodes on the catheter.

### Claim 2 (depends on 1)

The system of claim 1, wherein the controller circuitry is further configured and arranged to determine the position of the introducer sheath relative to the catheter by
determining a baseline impedance of the one or more electrodes outside of an introducer sheath,
monitoring the impedance of the electrodes during an operation,
determining whether the impedance of the one or more electrodes exceeds the baseline impedance, and
generating the image for the display including the introducer sheath in one of the three visualization states based on the determined impedance of the one or more electrodes relative to the baseline impedance.

### Claim 3 (depends on 2)

The system of claim 2, wherein the controller circuitry is further configured and arranged to generate the image for the display including the introducer sheath in the third visualization state when the impedance of all the monitored electrodes exceeds the baseline impedance.

### Claim 4 (depends on 2)

The system of claim 2, wherein the controller circuitry is further configured and arranged to generate the image for the display including the introducer sheath in the second visualization state when the impedance of at least one of the monitored electrodes exceeds the baseline impedance.

### Claim 5 (depends on 2)

The system of claim 2, wherein the controller circuitry is further configured and arranged to generate the image for the display including the introducer sheath in the first visualization state when the impedance of all the monitored electrodes is below the baseline impedance.

### Claim 6 (depends on 2)

The system of claim 2, wherein the controller circuitry is further configured and arranged to vary the generated image visualizing the introducer sheath depending on the type of the catheter.

### Claim 7 (depends on 1)

The system of claim 1, wherein the one or more electrodes are configured and arranged to facilitate electrophysiology mapping, catheter localization using an impedance-based navigation system, or catheter localization using a magnetic field based navigation system.

### Claim 8 (depends on 2)

The system of claim 2, wherein the controller circuitry is further configured and arranged to verify introducer sheath position relative to the catheter using geometric and temporal rules, including:
the electrodes determined to be out of the sheath are contiguous and include the distal most electrode on the catheter and the electrodes determined to be in the sheath are contiguous and include the proximal most electrode on the catheter, and
during relative movement between the catheter and the introducer sheath, the electrode impedance readings cross the impedance threshold sequentially based on relative position along a length of the catheter.

### Claim 9 (depends on 1)

The system of claim 1, wherein the generated image for the display is overlaid on a real-time fluoroscopic image, three-dimensional model, or a static fluoroscopic image.

### Claim 10

A system for detecting and visualizing a location of an introducer sheath comprising:
an introducer sheath configured and arranged to navigate a patient vasculature;
a catheter including one or more electrodes, the catheter configured and arranged to be delivered to a target region within the vasculature via a lumen within the introducer sheath;
controller circuitry communicatively coupled to the one or more electrodes and configured and arranged to
determine a position of the catheter within the patient based on electrical signals received from the one or more electrodes on the catheter,
determine an approximate position of the introducer sheath based on the electrical signals received from the one or more electrodes on the catheter, and
generate an image for a display that visualizes the relative locations of the catheter and the introducer sheath; and
the display, communicatively coupled to the controller circuitry, is configured and arranged to display the generated image to a clinician to assist in diagnostic and therapeutic intravascular procedures.

### Claim 11 (depends on 10)

The system of claim 10, wherein the controller circuitry is further configured and arranged to determine the position of the introducer sheath relative to the catheter by determining a baseline impedance of the one or more electrodes outside of an introducer sheath and monitoring the impedance of the electrodes during an operation, when the impedance of one or more of the electrodes exceeds a threshold, the one or more electrodes are determined to be in contact with an inner wall of the catheter sheath.

### Claim 12 (depends on 11)

The system of claim 11, wherein the controller circuitry is further configured and arranged to generate an image visualizing the catheter enclosed within the introducer sheath when the impedance of all the monitored electrodes exceeds the threshold.

### Claim 13 (depends on 11)

The system of claim 11, wherein the controller circuitry is further configured and arranged to generate an image visualizing the catheter partially enclosed within the introducer sheath when the impedance of at least one of the monitored electrodes exceeds the threshold.

### Claim 14 (depends on 11)

The system of claim 11, wherein the controller circuitry is further configured and arranged to visualize a distal end of the introducer sheath extending past the electrodes on the catheter in response to sensing electrical signals indicative of sheath contact.

### Claim 15 (depends on 11)

The system of claim 11, wherein the controller circuitry is further configured and arranged to generate an image visualizing an end effector of the catheter extending out of a distal end of the introducer sheath when the impedance of the one or more monitored electrodes are below the threshold.