Endovascular navigation system and method

• US 10,335,240 B2
• Filed: 11/29/2015
• Issued: 07/02/2019
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Grunwald, Sorin, Hill, Bradley
• Primary Examiner(s): Turchen, Rochelle D
• Application Number:
  US14/953,391
• Publication Number:
  US 20160151118A1
• Time in Patent Office: 1,311 Days
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• 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 8/42 Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/5207 : involving processing of raw data to produce diagnostic data, e.g. for generating an image reconstruction G06T11/00

Abstract

The endovascular navigation system includes an elongate flexible member configured to access the venous vasculature of a patient, a sensor disposed at a distal end of the elongate flexible member and configured to sense a physiological characteristic of the venous vasculature, a processor and an output device. The processor is configured to receive and process the physiological characteristic of the venous vasculature, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature. The output device is configured to display a visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature, where the visual indication is different from the physiological characteristic of the venous vasculature of the patient.

Claims

1. An endovascular navigation system, comprising:

an elongate flexible member configured to access the venous vasculature of a patient;

a sensor disposed at a distal end of the elongate flexible member and configured to sense a physiological signal of the venous vasculature of the patient;

a processor configured to;

receive the physiological signal of the venous vasculature of the patient provided by the sensor;

process the physiological signal to determine one or more physiological characteristics of the venous vasculature of the patient;

track a position of the distal end of the elongate flexible member within the venous vasculature of the patient over time; and

determine, based on the one or more physiological characteristics of the venous vasculature of the patient, that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient;

a display output device configured to simultaneously display;

a graphical representation of a path between tracked positions of the distal end of the elongate flexible member within the venous vasculature of the patient over time;

a first visual indication of the position of the distal end of the elongate flexible member in real time;

at least part of the physiological signal provided by the sensor over time; and

a second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient only when it is determined that the position of the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, wherein the second visual indication is different from the physiological characteristic of the venous vasculature of the patient, and the graphical representation is different from the at least part of the physiological signal and the second visual indication; and

an audible output device configured to output an audible indication of the position of the distal end of the elongate flexible member.

2. The system of claim 1, wherein the predetermined structure within the venous vasculature of the patient is the superior vena cava of the patient.

3. The system of claim 2, wherein the predetermined structure within the venous vasculature of the patient is the lower one-third of the superior vena cava of the patient.

4. The system of claim 1, wherein the processor is configured to determine that the position of the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient by determining that the physiological characteristic of the venous vasculature of the patient satisfies a threshold associated with the predetermined structure within the venous vasculature of the patient.

5. The system of claim 1, wherein the processor is configured to determine that the position of the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient by comparing the physiological characteristic of the venous vasculature of the patient with a pattern associated with the predetermined structure within the venous vasculature of the patient.

6. The system of claim 5, wherein the processor is further configured to receive one or more patterns associated with the predetermined structure within the venous vasculature of the patient.

7. The system of claim 5, wherein the pattern associated with the predetermined structure within the venous vasculature of the patient is a blood flow pattern associated with the predetermined structure within the venous vasculature of the patient.

8. The system of claim 1, wherein the second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient is a blue indicator.

9. The system of claim 1, wherein the display output device is configured to display at least part of the physiological signal provided by the sensor in real-time.

10. The system of claim 1, wherein the processor is further configured to dynamically calibrate settings of the endovascular navigation system for the patient based on the processing of the physiological signal of the venous vasculature of the patient.

11. The system of claim 1, wherein:

the processor is further configured to determine, based on the one or more physiological characteristics of the venous vasculature of the patient, that the distal end of the elongate flexible member is against a wall of the venous vasculature of the patient; and

the display output device is further configured to display, in response to the determination that the distal end of the elongate flexible member is against the wall of the venous vasculature of the patient, another visual indication that the distal end of the elongate flexible member is against the wall of the venous vasculature of the patient and to stop display of the second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient.

12. The system of claim 1, wherein:

the processor is further configured to determine, based on the one or more physiological characteristics of the venous vasculature of the patient, that the distal end of the elongate flexible member is moving towards the predetermined structure within the venous vasculature of the patient; and

the display output device is further configured to display, in response to the determination that the distal end of the elongate flexible member is moving towards the predetermined structure within the venous vasculature of the patient, another visual indication that the distal end of the elongate flexible member is moving towards the predetermined structure within the venous vasculature of the patient and to stop display of the second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient.

13. The system of claim 1, wherein:

the processor is further configured to determine, based on the one or more physiological characteristics of the venous vasculature of the patient, that the distal end of the elongate flexible member is moving away from the predetermined structure within the venous vasculature of the patient; and

the display output device is further configured to display, in response to the determination that the distal end of the elongate flexible member is moving away from the predetermined structure within the venous vasculature of the patient, another visual indication that the distal end of the elongate flexible member is moving away from the predetermined structure within the venous vasculature of the patient and to stop display of the second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient.

14. The system of claim 1, wherein the sensor is configured to detach from the elongate flexible member while the elongate flexible member remains in the venous vasculature of a patient.

15. The system of claim 1, wherein the physiological signal of the venous vasculature of the patient comprises an in vivo non-image based ultrasound signal of the venous vasculature of the patient.

16. The system of claim 15, wherein the one or more physiological characteristics of the venous vasculature of the patient are selected from a group consisting of a blood flow direction, a blood flow velocity, a blood flow signature pattern, a pressure signature pattern, A-mode information, and a preferential non-random direction of flow.

17. The system of claim 1, wherein the processor is configured to receive the physiological signal of the venous vasculature of the patient from the sensor via a wireless connection.

18. The system of claim 1, wherein the elongate flexible member is a catheter, a guide wire, or a stylet.

20. The system of claim 1, wherein the processor is further configured to process the physiological signal to remove noise from and rescale the physiological signal before display of the physiological signal by the display output device.

21. The system of claim 1, wherein:

the processor is further configured to determine, based on the one or more physiological characteristics of the venous vasculature of the patient, that the distal end of the elongate flexible member is outside of the predetermined structure within the venous vasculature of the patient; and

the display output device is further configured to stop display of the second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient while displaying the at least part of the physiological signal provided by the sensor over time.

22. The system of claim 1, wherein the display output device is configured to display the graphical representation of the path between positions of the distal end of the elongate flexible member within the venous vasculature of the patient over time by displaying an entirety of the path of the distal end of the elongate flexible member from an insertion point to the predetermined structure.

23. The system of claim 1, wherein the display output device is configured to display the graphical representation of the path between positions of the distal end of the elongate flexible member within the venous vasculature of the patient over time by simultaneously displaying an image showing the expected vessel travel path of the distal end of the elongate flexible member from an insertion point to the predetermined structure.

24. The system of claim 23, wherein the display output device is configured to display the graphical representation of the path between positions of the distal end of the elongate flexible member within the venous vasculature of the patient over time by simultaneously displaying an image showing the vascular tree of the patient.

19. An endovascular navigation method, comprising:

receiving a physiological signal of a venous vasculature of a patient provided from a sensor on a distal end of an elongate flexible member within the venous vasculature of the patient;

processing the physiological signal to determine one or more physiological characteristics of the venous vasculature of the patient;

tracking a position of the distal end of the elongate flexible member within the venous vasculature of the patient over time;

determining, based on the one or more physiological characteristics of the venous vasculature of the patient, that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient;

simultaneously displaying;

a graphical representation of a path between tracked positions of the distal end of the elongate flexible member within the venous vasculature of the patient over time;

a first visual indication of the position of the distal end of the elongate flexible member in real time;

at least part of the physiological signal provided by the sensor over time; and

only when it is determined that the position of the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient, a second visual indication that the distal end of the elongate flexible member is within the predetermined structure within the venous vasculature of the patient,

wherein the second visual indication is different from the physiological characteristic of the venous vasculature of the patient, and the graphical representation is different from the at least part of the physiological signal and the second visual indication; and

outputting an audible indication of the position of the distal end of the elongate flexible member.