Systems and methods for guidance and placement of an intravascular device

• US 9,839,372 B2
• Filed: 02/06/2015
• Issued: 12/12/2017
• Est. Priority Date: 02/06/2014
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Bukhman, Vladislav, Misener, Anthony K., Vassylyev, Valeriy, Urry, Robin S., Tanner, Brian S.
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US14/615,932
• Publication Number:
  US 20150216446A1
• Time in Patent Office: 1,040 Days
• Field of Search: 600407-480
• 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 5/062 using magnetic field
• 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 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules

Abstract

A guidance and placement system and associated methods for assisting a clinician in the placement of a catheter or other medical device within the vasculature of a patient is disclosed. In one embodiment, a method for guiding a medical device to a desired location within a vasculature of a patient is also disclosed and comprises detecting an intravascular ECG signal of the patient and identifying a P-wave of a waveform of the intravascular ECG signal, wherein the P-wave varies according to proximity of the medical device to the desired location. The method further comprises determining whether the identified P-wave is elevated, determining a deflection value of the identified P-wave when the identified P-wave is elevated, and reporting information relating to a location of the medical device within the patient'"'"'s vasculature at least partially according to the determined deflection value of the elevated P-wave.

Claims

1. A method for guiding a medical device to a desired location within a vasculature of a patient, the method comprising:

detecting an intravascular ECG signal of the patient;

identifying a P-wave of a waveform of the intravascular ECG signal, the P-wave varying according to proximity of the medical device to the desired location;

determining whether the identified P-wave is elevated;

determining a deflection value of the identified P-wave when the identified P-wave is elevated; and

reporting information relating to a location of the medical device within the vasculature of the patient at least partially according to the determined deflection value of the elevated P-wave.

2. The method for guiding as defined in claim 1, further comprising:

detecting an external ECG signal of the patient;

identifying an external P-wave of a waveform of the external ECG signal; and

using the identified external P-wave in identifying the P-wave of the intravascular ECG signal.

3. The method for guiding as defined in claim 2, wherein identifying the external P-wave further includes:

identifying a QRS complex of the waveform of the external ECG signal;

identifying a T-wave of the waveform of the external ECG signal; and

determining a RR interval between successive waveforms of the external ECG signal.

4. The method for guiding as defined in claim 3, wherein the external ECG signal is detected by a pair of external electrodes placed on a skin of the patient.

5. The method for guiding as defined in claim 1, wherein the intravascular ECG signal is detected by a sensor component included with a stylet removably received within the medical device.

6. The method for guiding as defined in claim 1, wherein identifying a P-wave, determining whether the identified P-wave is elevated, and determining the deflection value are executed by a processor of a system operably connected with the medical device.

7. The method for guiding as defined in claim 6, wherein identifying a P-wave, determining whether the identified P-wave is elevated, and determining the deflection value are executed iteratively by the processor.

8. The method for guiding as defined in claim 1, wherein the medical device includes a catheter and wherein the desired location is proximate a lower portion of a superior vena cava of a heart of the patient.

9. The method for guiding as defined in claim 1, wherein reporting information relating to the location of the medical device includes reporting one of a plurality of zones, each zone relating to a proximity of the medical device to a signal-emitting node of a heart of the patient.

10. The method for guiding as defined in claim 1, wherein reporting information relating to a location of the medical device includes outputting the information to at least one of an audio device and a display device.

11. The method for guiding as defined in claim 1, wherein reporting information relating to a location of the medical device includes outputting graphical information to a display device of a placement system for the medical device.

12. The method for guiding as defined in claim 11, wherein the graphical information includes a plurality of icons that correspond to a proximity of the medical device to a signal-emitting node of a heart of the patient.

13. A method for guiding a medical device to a desired location within a vasculature of a patient, the method comprising:

detecting an intravascular ECG signal of a signal-emitting portion of a heart of the patient by an intravascular ECG sensor component included with the medical device; and

determining whether a P-wave of a waveform of the intravascular ECG signal is elevated based on a plurality of predetermined thresholds, the P-wave varying according to a distance of the intravascular ECG sensor component from the signal-emitting portion of the heart, the predetermined thresholds relating to at least one of the following;

(a) an amplitude of the P-wave of the intravascular ECG signal within a predetermined range;

(b) a slope of the P-wave of the intravascular ECG signal within a predetermined range; and

(c) a noise component of the intravascular ECG signal within a predetermined range.

14. The method for guiding as defined in claim 13, further comprising:

determining a deflection value of the P-wave when the P-wave is elevated; and

reporting information relating to a location of the medical device within the vasculature of the patient at least partially according to the determined deflection value of the P-wave.

15. The method for guiding as defined in claim 13, wherein detecting the intravascular ECG signal, determining whether the P-wave is elevated, and determining the deflection value are performed iteratively.

16. A system for guiding a medical device to a desired location within a vasculature of a patient, comprising:

at least an intravascular ECG sensor for detecting an intravascular ECG signal of the patient;

a processor that receives the intravascular ECG signal, the processor;

identifying a P-wave of a waveform of the intravascular ECG signal, the P-wave varying according to proximity of the medical device to the desired location;

determining whether the identified P-wave is elevated;

determining a deflection value of the identified P-wave when the identified P-wave is elevated; and

reporting information relating to a location of the medical device within the vasculature of the patient at least partially according to the determined deflection value of the elevated P-wave; and

an output device that reports the information relating to the location of the medical device.

17. The system for guiding as defined in claim 16, wherein the processor determining whether the identified P-wave is elevated further includes at least one of:

determining whether at least one of a frequency and an amplitude of the identified P-waves falls within a predetermined range; and

determining whether a noise component of the intravascular ECG signal falls within a predetermined range.

18. The system for guiding as defined in claim 16, wherein the output device includes a display of the system.

19. The system for guiding as defined in claim 18, wherein the processor executes a decision tree, the decision tree determining when to report the information relating to the location of the medical device.

20. The system as defined in claim 19, wherein the system further includes at least one of a magnet tracking modality and an ultrasound imaging modality.

21. In a guidance system including a medical device for insertion into a vasculature of a patient, an external ECG sensor component, and an intravascular ECG sensor component included with the medical device, a method for guiding the medical device, the method comprising:

(a) identifying a P-wave from a waveform of an intravascular ECG signal from the intravascular ECG sensor component after insertion of the medical device into the vasculature;

(b) determining whether at least one of a frequency and an amplitude of the identified P-wave falls within a predetermined range;

(c) determining whether a noise component of the intravascular ECG signal falls within a predetermined range; and

(d) determining whether the identified P-wave is at an elevated state based upon the determinations of stages (b) and (c).

22. The method for guiding as defined in claim 21, further comprising:

(e) determining a deflection value for the identified P-wave when the identified P-wave is at an elevated state as determined in stage (d).

23. The method for guiding as defined in claim 22, further comprising:

(f) depicting a position of the medical device based on the deflection value as determined in stage (e).

24. The method for guiding as defined in claim 23, wherein a processor of the system executes a decision tree, the decision tree determining an aspect of depicting the position of the medical device.

25. The method for guiding as defined in claim 24, wherein the decision tree iteratively queries a data set of a plurality of zone reports until at least 50 zone reports are acquired.

26. The method for guiding as defined in claim 24, wherein the processor depicts the position of the medical device when at least three of five zone reports from the data set are identical.

27. The method for guiding as defined in claim 21, further comprising:

identifying an external P-wave of a waveform of an external ECG signal from the external ECG sensor component; and

using the identified external P-wave to identify the P-wave of the intravascular ECG signal in stage (a).

28. A method for guiding a catheter to a desired location within a vasculature of a patient, the method comprising:

inserting a distal portion of the catheter into the vasculature via an insertion site on a limb of the patient;

detecting a baseline ECG signal of the patient via an ECG sensor included with the catheter, the baseline ECG signal being detected when the distal portion of the catheter is disposed between the insertion site and a junction point of the limb with the patient'"'"'s torso ;

attempting to identify a baseline P-wave of a waveform of the baseline ECG signal;

identifying an intravascular P-wave of a waveform of an intravascular ECG signal, the intravascular ECG signal being detected when the distal portion of the catheter is disposed at a location distal to the junction point of the limb, the intravascular P-wave varying according to proximity of the catheter to the desired location;

determining whether the identified intravascular P-wave is elevated;

determining a deflection value of the identified intravascular P-wave when the identified intravascular P-wave is elevated; and

reporting information relating to a location of the catheter within the vasculature of the patient at least partially according to the determined deflection value of the elevated identified intravascular P-wave.

29. The method for guiding as defined in claim 28, wherein identifying the intravascular P-wave is at least partially is executed using information relating to the identification of the baseline P-wave.