Apparatus and method for endovascular device guiding and positioning using physiological parameters

• US 10,321,890 B2
• Filed: 01/28/2016
• Issued: 06/18/2019
• 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, Sander, Fiona M., Samson, Wilfred J., Hill, Bradley, Cheng, E. Tina
• Primary Examiner(s): Turchen, Rochelle
• Application Number:
  US15/009,745
• Publication Number:
  US 20160143560A1
• Time in Patent Office: 1,237 Days
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• 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 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 : Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/353 : Detecting P-waves
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/369 : Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 7/04 : Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61B 8/02 : Measuring pulse or heart rate
• 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 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• 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 8/461 : Displaying means of special interest
• 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 8/488 : involving Doppler signals
• CPC Class Codes: A61B 8/565 : involving data transmission via a network
• CPC Class Codes: G09B 23/288 : for artificial respiration or heart massage

Abstract

An endovascular navigation system and method are disclosed. The endovascular navigation system includes an elongate flexible member, a endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal, a processor and an output device. The processor is configured to receive the endovascular electrogram signal, to determine a peak amplitude of a P-wave in the endovascular electrogram signal, and to determine that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient. 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 of the patient, where the visual indication is different from the endovascular electrogram signal 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;

an endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal of the venous vasculature of the patient;

a processor configured to;

receive the endovascular electrogram signal of the venous vasculature of the patient provided by the endovascular electrogram lead;

determine a peak amplitude of a P-wave in the endovascular electrogram signal;

determine an amplitude within the QRS complex of the endovascular electrogram signal;

compare the peak amplitude of the P-wave to the amplitude within the QRS complex to determine a P-wave relative amplitude; and

determine, based at least in part on the P-wave relative amplitude, that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient; and

an output device configured to display, in response to the determination 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 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 visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

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 the peak amplitude of the P-wave in the endovascular electrogram signal by:

determining a first peak amplitude of a first P-wave in a first heartbeat of the endovascular electrogram signal; and

determining a second peak amplitude of a second P-wave in a second heartbeat of the endovascular electrogram signal.

5. The system of claim 4, 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 second peak amplitude of the second P-wave is greater than the first peak amplitude of the first P-wave.

6. The system of claim 4, wherein the processor is configured to:

determine the amplitude within the QRS complex of the endovascular electrogram signal by;

determine a first amplitude within a first QRS complex in the first heartbeat of the endovascular electrogram signal; and

determine a second amplitude within a second QRS complex in the second heartbeat of the endovascular electrogram signal; and

compare the peak amplitude of the P-wave to the amplitude within the QRS complex to determine the P-wave relative amplitude by;

compare the first peak amplitude of the first P-wave to the first amplitude within the first QRS complex to determine a first P-wave relative amplitude; and

compare the second peak amplitude of the second P-wave to the second amplitude within the second QRS complex to determine a second P-wave

relative amplitude.

7. The system of claim 6, 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 second P-wave relative amplitude is greater than the first P-wave relative amplitude.

8. The system of claim 4, wherein the processor is further configured to:

determine a first amplitude of a first R-wave in the first heartbeat of the endovascular electrogram signal;

determine a second amplitude of a second R-wave in the second heartbeat of the endovascular electrogram signal;

compare the first peak amplitude of the first P-wave to the first amplitude of the first R-wave to determine a first P-wave relative amplitude; and

compare the second peak amplitude of the second P-wave to the second amplitude of the second R-wave to determine a second P-wave relative amplitude.

9. The system of claim 8, 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 second P-wave relative amplitude is greater than the first P-wave relative amplitude.

10. The system of claim 1, wherein the 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.

11. The system of claim 1, wherein the output device is further configured to display the endovascular electrogram signal of the venous vasculature of the patient while displaying the visual indication.

12. The system of claim 1, wherein the endovascular electrogram lead is integral with the body of the elongate flexible member.

13. The system of claim 1, wherein the endovascular electrogram lead extends from the distal end of the elongate flexible member.

14. The system of claim 1, wherein the endovascular electrogram lead is a first endovascular electrogram lead disposed at the distal end of the elongate flexible member, and the system further comprises:

a second endovascular electrogram lead disposed at the distal end of the elongate flexible member and configured to sense a baseline endovascular electrogram signal of the venous vasculature of the patient.

15. The system of claim 1, further comprising a non-imaging ultrasound transducer disposed at the distal end of the elongate flexible member and configured to sense in vivo non-image based ultrasound information of the venous vasculature of the patient, wherein the processor is further configured to receive and process the in vivo non-image based ultrasound information.

16. The system of claim 15, wherein:

the processor is further configured determine, based on the processing of the in vivo non-image based ultrasound information, that the distal end of the elongate flexible member is against a wall of the venous vasculature of the patient; and

the 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,

the other visual indication is different from the visual indication.

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

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

19. The system of claim 1, wherein the endovascular electrogram lead is in contact with blood in the venous vasculature of the patient.

20. An endovascular navigation method, comprising:

receiving an endovascular electrogram signal of a venous vasculature of a patient provided from an endovascular electrogram lead on a distal end of an elongate flexible member within the venous vasculature of the patient;

processing the endovascular electrogram signal of the venous vasculature of the patient received from the endovascular electrogram lead to;

determine a peak amplitude of a P-wave in the endovascular electrogram signal;

determine an amplitude within the QRS complex of the endovascular electrogram signal; and

compare the peak amplitude of the P-wave to the amplitude within the QRS complex to determine a P-wave relative amplitude; and

determining, based at least in part on the P-wave relative amplitude, that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient; and

displaying, in response to the determination 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 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 visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

21. An endovascular navigation system, comprising:

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

an endovascular electrogram lead disposed at a distal end of the elongate flexible member and configured to sense an endovascular electrogram signal of the venous vasculature of the patient;

a processor configured to;

receive the endovascular electrogram signal of the venous vasculature of the patient provided by the endovascular electrogram lead;

determine a first peak amplitude of a first P-wave and a first amplitude within a first QRS complex in a first heartbeat of the endovascular electrogram signal;

determine a second peak amplitude of a second P-wave and a second amplitude within a second QRS complex in a second heartbeat of the endovascular electrogram signal;

compare the first peak amplitude of the first P-wave to the first amplitude within the first QRS complex to determine a first P-wave relative amplitude;

compare the second peak amplitude of the second P-wave to the second amplitude within the second QRS complex to determine a second P-wave relative amplitude; and

determine, based at least in part on the first P-wave relative amplitude

and the second P-wave relative amplitude, that the position of the distal end of the elongate flexible member is within a predetermined structure within the venous vasculature of the patient; and

an output device configured to display, in response to the determination 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 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 visual indication is different from the endovascular electrogram signal of the venous vasculature of the patient.

22. The system of claim 21, wherein the predetermined structure within the venous vasculature of the patient is the superior vena cava of the patient.

23. The system of claim 21, wherein the predetermined structure within the venous vasculature of the patient is the lower one-third of the superior vena cava of the patient.

24. The system of claim 21, wherein the output device is further configured to display the endovascular electrogram signal of the venous vasculature of the patient while displaying the visual indication.