# US 10,368,830 B2 · Endovascular navigation system and method

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- Number: US 10,368,830 B2
- Document ID: US10368830B2
- Status: Granted
- Kind: B2
- Application number: 14/811,923
- Filed: 2015-07-29
- Published: 2015-11-19
- Granted: 2019-08-06
- Earliest claimed: 2010-11-08
- Assignees: Arrow International, Inc.
- Applicants: Arrow International, Inc.
- Inventors: Wenkang Qi; Bradley Hill
- Web page: https://patentgrep.com/patent/US10368830B2

## CPC

- A61B 8/06: Measuring blood flow
- A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/283: Invasive
- A61B 5/353: Detecting P-waves
- A61B 5/389: Electromyography [EMG]
- A61B 8/0841: {for locating instruments}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/445: {Details of catheter construction}
- A61B 8/463: {characterised by displaying multiple images or images and diagnostic data on one display}
- A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)}
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 8/465: {adapted to display user selection data, e.g. icons or menus}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0133: {Tip steering devices}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2205/50: with microprocessors or computers
- A61M 2210/12: Blood circulatory system
- A61M 2230/00: Measuring parameters of the user
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- 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

A method of navigating and positioning an endovascular device in a vasculature is disclosed. Initially, a system including an endovascular device and at least one transducer is inserted into the lumen of a patient. An acoustic signal is then transmitted within the lumen. A reflected signal is pre-processed to extract one or more acoustic features. The one or more acoustic features are processed using a computer readable set of rules to produce an output related to guidance of the instrument within a blood vessel or a position of the instrument within the blood vessel.

## Claims

### Claim 1

A method of determining a position of a medical device in vasculature of a patient, the method comprising:
transmitting an ultrasound signal in the vasculature from a distal end of the medical device;
receiving a reflected ultrasound signal;
extracting an ultrasound feature from the reflected ultrasound signal;
receiving an electrical signal from a lead on the medical device;
extracting an ECG feature from the received electrical signal;
calculating a first indicator score by inputting the ultrasound feature and the ECG feature into a first indicator equation;
calculating a second indicator score by inputting the ultrasound feature and the ECG feature into a second indicator equation;
identifying a positional state of the medical device by comparing the first and second indicator scores; and
displaying an indicator on an output device indicating the positional state.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ultrasound feature and the ECG feature infer a distinct position in the vasculature.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first and second indicator equations represent positioning probabilities.

### Claim 4 (depends on 3)

The method of claim 3, wherein the first and second indicator equations correspond to membership functions.

### Claim 5 (depends on 3)

The method of claim 3, wherein calculating the first indicator score includes applying a weighting factor to the ECG and ultrasound features.

### Claim 6 (depends on 1)

The method of claim 1, wherein identifying further comprises selecting the positional state that corresponds to the highest indicator score.

### Claim 7 (depends on 1)

The method of claim 1, wherein calculating the first and second indicator scores further comprises solving preset equations based on a correlation between the ECG and ultrasound features and a probability of a particular position or state of navigation of the medical device.

### Claim 8 (depends on 1)

The method of claim 1, wherein one of the first and second indicator scores relates extracted acoustic features to a direction of movement of the medical device relative to flow in the vasculature.

### Claim 9 (depends on 1)

The method of claim 1, wherein one of the first and second indicator scores relates acoustic features to flow energy in the vasculature.

### Claim 10 (depends on 1)

The method of claim 1, wherein one of the first and second indicator scores relates acoustic features to flow velocity in the vasculature.