Endovascular navigation system and method

• US 10,368,830 B2
• Filed: 07/29/2015
• Issued: 08/06/2019
• Est. Priority Date: 11/08/2010
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Qi, Wenkang, Hill, Bradley
• Primary Examiner(s): Rozanski, Michael T
• Application Number:
  US14/811,923
• Publication Number:
  US 20150327837A1
• Time in Patent Office: 1,469 Days
• Field of Search: 600424
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/465 adapted to display user selection data, e.g. icons or menus
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 2230/00 Measuring parameters of the user
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

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

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.

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

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

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

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

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

7. 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.

8. 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.

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

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