Endovascular navigation system and method

• US 9,119,551 B2
• Filed: 11/08/2011
• Issued: 09/01/2015
• Est. Priority Date: 11/08/2010
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Vasonova, Inc. (Teleflex Incorporated)
• Inventors: Qi, Wenkang, Hill, Bradley
• Primary Examiner(s): EVOY, NICHOLAS LANE
• Application Number:
  US13/292,010
• Publication Number:
  US 20120136242A1
• Time in Patent Office: 1,393 Days
• Field of Search: None
• US Class Current: 1/1
• 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

An endovascular navigation and positioning system including a transducer on a distal end of an endovascular instrument, a control system connected to the transducer, the control system being configured to generate and receive at least one acoustic signal using the transducer, a pre-processor containing computer-readable instructions for manipulating the acoustic signal input to extract information related to desired parameters, a processor configured to evaluate the parameters to generate an output related to guidance of the instrument, and an output device for displaying an indication of the output generated by the processor. The processor may evaluate the information using artificial intelligence including inference rules related to navigation state, comparisons to information in a database, and probabilities, among others. The system may use an electrical signal as a confirmation input. Further disclosed is a method of navigating and positioning an endovascular device in a vasculature.

Claims

1. A positioning or navigation system, comprising:

an acoustic transducer mounted on a distal end of an endovascular instrument;

a control system in communication with the acoustic transducer, the control system being configured to generate and receive an acoustic signal using the acoustic transducer;

a pre-processor configured to receive the acoustic signal as an acoustic input, and configured to extract one or more acoustic features from the acoustic input;

a processor configured to receive the one or more extracted acoustic features from the pre-processor, and to;

retrieve a first set of predefined membership functions corresponding to a first positional or navigational state of the endovascular instrument;

retrieve a second set of predefined membership functions corresponding to a second positional or navigational state of the endovascular instrument, wherein the second set of predefined membership functions is different from the first set of predefined membership functions, and wherein the second positional or navigational state is different from the first second or navigational state;

input each of the extracted acoustic features into a corresponding membership function in the first set of predefined membership functions to determine a first contribution value for each extracted acoustic feature;

sum the first contribution values for the extracted acoustic features to generate a first score for the first positional or navigational state, wherein the first score indicates a likelihood that the endovascular instrument is in the first positional or navigational state;

input each of the extracted acoustic features into a corresponding membership function in the second set of predefined membership functions to determine a second contribution value for each extracted acoustic feature;

sum the second contribution values for the extracted acoustic features to generate a second score for the second positional or navigational state, wherein the second score indicates a likelihood that the endovascular instrument is in the second positional or navigational state;

compare the first score to the second score to determine whether the endovascular instrument is in the first positional or navigational state or the second positional or navigational state; and

generate positional or navigational guidance information for the endovascular instrument based on the determined first or second positional or navigational state; and

an output device configured to display an indication of the positional or navigational guidance information generated by the processor.

2. The positioning system of claim 1, further comprising a sensing electrode mounted on the endovascular instrument, the sensing electrode in communication with the control system,

wherein the control system is further configured to receive an electrical signal from the sensing electrode,

wherein the pre-processor is further configured to extract one or more electrical features from the electrical signal;

and

wherein the processor is further configured to;

input each of the one or more electrical features into a corresponding membership function in the first set of predefined membership functions, and

input each of the one or more electrical features into a corresponding membership function in the second set of predefined membership functions.

3. The positioning system of claim 1, wherein the acoustic signal comprises a non-imaging ultrasound signal.

4. The positioning system of claim 2, wherein the electrical signal comprises an ECG signal.

5. The positioning system of claim 2, wherein the electrical signal comprises an EMG signal.

6. The positioning system of claim 2, wherein the electrical signal comprises an EEG signal.

7. The positioning system of claim 1, wherein the processor is further configured to execute artificial intelligence programming.

8. The positioning system of claim 2, wherein the processor is further configured to execute artificial intelligence programming.

9. The positioning system of claim 1, wherein the processor is further configured to evaluate the one or more extracted acoustic features based on inference rules, an expert system, a neural network, or logic.

10. The positioning system of claim 2, wherein the processor is further configured to evaluate the one or more extracted electrical features based on inference rules, an expert system, a neural network, or logic.

11. The positioning system of claim 1, wherein the processor is further configured to evaluate whether a power level of the acoustic signal is below a threshold.

12. The positioning system of claim 2, wherein the processor is further configured to evaluate whether a power level of the electrical signal is below a threshold.

13. The positioning system of claim 1, wherein the processor is further configured to evaluate whether an antegrade flow in a blood vessel is greater than a retrograde flow in the blood vessel.

14. The positioning system of claim 1, wherein the processor is further configured to evaluate whether a retrograde flow in a blood vessel is greater than an antegrade flow in the blood vessel.

15. The positioning system of claim 1, wherein the processor is further configured to evaluate whether a low frequency signal is greater than a high frequency signal in both an antegrade flow in a blood vessel and a retrograde flow in the blood vessel.

16. The positioning system of claim 2, wherein the control system is further configured to synchronize the acoustic signal and the electrical signal.

17. The positioning system of claim 2, wherein the processor is further configured to evaluate a P-wave in the received electrical signal.

18. The positioning system of claim 17, wherein the processor is configured to evaluate the P-wave in the received electrical signal by providing an output when the P-wave in the received electrical signal is elevated above a reference P-wave.

19. The positioning system of claim 17, wherein the processor is configured to evaluate the P-wave in the received electrical signal by providing an output when the P-wave in the received electrical signal is at or below a reference P-wave.

20. The positioning system of claim 17, wherein the processor is configured to evaluate the P-wave in the received electrical signal by providing an output when the P-wave in the received electrical signal is biphasic.

21. The positioning system of claim 1, wherein the first positional or navigational state of the endovascular instrument is that the endovascular instrument is moving in a desired direction, and the second positional or navigational state of the endovascular instrument is that the endovascular instrument is positioned in a desired location.

22. The positioning system of claim 1, wherein the first positional or navigational state of the endovascular instrument is that the endovascular instrument is moving in an undesired direction, and the second positional or navigational state of the endovascular instrument is that the endovascular instrument is positioned in a desired location.

23. The positioning system of claim 1, wherein the indication of the positional guidance information when the endovascular instrument is in the first positional or navigational state is different from the indication of the positional guidance information when the endovascular instrument is in the second positional or navigational state.

24. The positioning system of claim 2, wherein the one or more electrical features correspond to a pre-selected portion of a regular electrical wave produced by a heart.

25. The positioning system of claim 24, wherein the electrical wave is an electrocardiogram, and the pre-selected portion is an RS amplitude.

26. The positioning system of claim 24, wherein the electrical wave is an electrocardiogram, and the pre-selected portion is an electrocardiogram segment.

27. The positioning system of claim 24, wherein the electrical wave is an electrocardiogram, and the pre-selected portion is an electrocardiogram interval.

28. The positioning system of claim 2, wherein the one or more electrical features correspond to a pre-selected portion of an irregular electrical wave produced by a heart.

29. The positioning system of claim 28, wherein the one or more electrical features correspond to a pre-selected portion of an electrical wave produced by a body having arrhythmia.

30. The positioning system of claim 4, wherein the one or more acoustic features corresponds to a ratio of a retrograde power of flow in a blood vessel to an antegrade power of the flow in the blood vessel during a single ECG cycle.

31. The positioning system of claim 1, wherein the one or more acoustic features corresponds to a ratio of a low frequency flow power to a high frequency flow power.

32. The positioning system of claim 1, wherein the one or more acoustic features are extracted during a portion of a heartbeat.

33. The positioning system of claim 32, wherein the one or more acoustic features are extracted during retrograde flow produced by atrial contraction.

34. The positioning system of claim 32, wherein the one or more acoustic features are extracted during antegrade flow during systole.

35. The positioning system of claim 32, wherein the one or more acoustic features are extracted during retrograde flow at the end of systole.

36. The positioning system of claim 32, wherein the one or more acoustic features are extracted during antegrade flow during diastole.

37. The positioning system of claim 2, wherein the one or more electrical features are extracted from a portion of an QRS complex.

38. The positioning system of claim 2, wherein the one or more electrical features comprise a ratio of a magnitude of a P-wave measured by the sensing electrode and a magnitude of a P-wave measured by an external electrode.

39. The positioning system of claim 2, wherein the one or more electrical features comprise an indication of presence of a biphasic P-wave.

40. The positioning system of claim 1, wherein the processor is further configured to multiply the extracted one or more acoustic features, the first set of predefined membership functions, or the second set of predefined membership functions by one or more weights.

41. The positioning system of claim 40, wherein the at least one of the one or more weights is lowered if the acoustic signal is weak, and the at least one of the one or more weights is increased in the acoustic signal is strong.

44. The positioning system of claim 1, wherein the processor is configured to compare the first score to the second score to determine whether the endovascular instrument is in the first positional or navigational state or the second positional or navigational state by:

determining that the first score is greater than the second score; and

determining, based on the determination that the first score is greater than the second score, that the endovascular instrument is in the first positional or navigational state.

45. The positioning system of claim 1, wherein the processor is configured to compare the first score to the second score to determine whether the endovascular instrument is in the first positional or navigational state or the second positional or navigational state by:

determining that the second score is greater than the first score; and

determining, based on the determination that the second score is greater than the first score, that the endovascular instrument is in the second positional or navigational state.

46. The positioning system of claim 1, wherein the first positional or navigational state of the endovascular instrument is that the endovascular instrument is moving in a desired direction, and the second positional or navigational state of the endovascular instrument is that the endovascular instrument is moving in an undesired direction.

42. A positioning or navigation system, comprising:

an acoustic transducer mounted on a distal end of an endovascular instrument;

a sensing electrode mounted on the endovascular instrument;

a control system in communication with the acoustic transducer and the sensing electrode, the control system being configured to generate and receive an acoustic signal using the acoustic transducer, and the control system being further configured to receive an electrical signal from the sensing electrode;

a pre-processor configured to receive the acoustic signal as an acoustic input and the electrical signal as an electrical input, and configured to extract one or more acoustic features from the acoustic input and to extract one or more electrical features from the electrical input;

a processor configured to receive the one or more extracted acoustic and electrical features from the pre-processor, and to;

retrieve a first set of predefined membership functions corresponding to a first positional or navigational state of the endovascular instrument;

retrieve a second set of predefined membership functions corresponding to a second positional or navigational state of the endovascular instrument, wherein the second set of predefined membership functions is different from the first set of predefined membership functions, and wherein the second positional or navigational state is different from the first second or navigational state;

input each of the extracted acoustic and electrical features into a corresponding membership function in the first set of predefined membership functions to determine a first contribution value for each extracted acoustic and electrical feature;

sum the first contribution values for the extracted acoustic and electrical features to generate a first score for the first positional or navigational state, wherein the first score indicates a likelihood that the endovascular instrument is in the first positional or navigational state;

input each of the extracted acoustic and electrical features into a corresponding membership function in the second set of predefined membership functions to determine a second contribution value for each extracted acoustic and electrical feature;

sum the second contribution values for the extracted acoustic and electrical features to generate a second score for the second positional or navigational state, wherein the second score indicates a likelihood that the endovascular instrument is in the second positional or navigational state;

compare the first score to the second score to determine first score to the second score the endovascular instrument is in the first positional or navigational state or the second positional or navigational state; and

generate positional or navigational guidance information for the endovascular instrument based on the determined first or second positional or navigational state; and

an output device configured to display an indication of the positional or navigational guidance information generated by the processor.

43. A positioning or navigation system, comprising:

a sensing electrode mounted on an endovascular instrument;

a control system in communication with the sensing electrode, the control system being configured to receive an electrical signal from the sensing electrode;

a pre-processor configured to receive the electrical signal as an electrical input, and configured to extract one or more electrical features from the electrical input;

a processor configured to receive the one or more extracted electrical features from the pre-processor, and to;

retrieve a first set of predefined membership functions corresponding to a first positional or navigational state of the endovascular instrument;

retrieve a second set of predefined membership functions corresponding to a second positional or navigational state of the endovascular instrument, wherein the second set of predefined membership functions is different from the first set of predefined membership functions, and wherein the second positional or navigational state is different from the first second or navigational state;

input each of the extracted electrical features into a corresponding membership function in the first set of predefined membership functions to determine a first contribution value for each extracted electrical feature;

sum the first contribution values for the extracted electrical features to generate a first score for the first positional or navigational state, wherein the first score indicates a likelihood that the endovascular instrument is in the first positional or navigational state;

input each of the extracted electrical features into a corresponding membership function in the second set of predefined membership functions to determine a second contribution value for each extracted electrical feature;

sum the second contribution values for the extracted electrical features to generate a second score for the second positional or navigational state, wherein the second score indicates a likelihood that the endovascular instrument is in the second positional or navigational state;

compare the first score to the second score to determine whether the endovascular instrument is in the first positional or navigational state or the second positional or navigational state; and

generate positional or navigational guidance information for the endovascular instrument based on the determined first or second positional or navigational state; and

an output device configured to display an indication of the positional or navigational guidance information generated by the processor.