APPARATUS AND METHOD FOR CATHETER NAVIGATION AND TIP LOCATION

• US 20110196248A1
• Filed: 02/02/2011
• Published: 08/11/2011
• Est. Priority Date: 06/12/2009
• Status: Active Grant

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Grunwald, Sorin
• Granted Patent: US 9,125,578 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• 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 5/063 using impedance measurements
• CPC Class Codes: A61B 5/068 using impedance sensors
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/347 Detecting the frequency distribution of signals
• 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 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: H01R 13/6205 : Two-part coupling devices held in engagement by a magnet

Abstract

Devices and methods for obtaining and using endovascular electrograms in a number of clinical applications and settings are disclosed. In one embodiment, methods are disclosed for triggering analysis of an endovascular ECG waveform based on the detection of a peak in a skin-based ECG waveform in order to determine a location of an indwelling medical device, such as a catheter. In another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analysis of the energy profile of a detected P-wave. In yet other embodiments, magnetic connecting devices for establishing an operable connection through a sterile field are disclosed.

Claims

1. A method for locating an indwelling medical device within a body of a patient, the method comprising:

detecting a first peak in a first ECG waveform;

triggering analysis of a second ECG waveform when the first peak is detected;

detecting a second peak in the second ECG waveform; and

determining a position of a portion of the indwelling medical device based on a characteristic of the second peak.

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

iteratively detecting the second peak, wherein determining a position further comprises determining the position of the portion of the indwelling medical device based on a change of the characteristic as the second peak is iteratively detected.

3. The method for locating as defined in claim 1, wherein the first ECG waveform is acquired via a skin-placed first electrode, wherein the second ECG waveform is acquired via a second electrode operably connected with a conductive path to a location within the body, wherein the indwelling device includes a catheter, and wherein the portion of the indwelling device includes a distal tip of the catheter.

4. The method for locating as defined in claim 1, wherein triggering analysis of the second ECG waveform further comprises:

triggering analysis via the second electrode, the second electrode being disposed endovascularly within the body.

5. The method for locating as defined in claim 1, wherein detecting the first peak and detecting the second peak further comprise:

detecting a first peak in a first ECG waveform acquired via a skin-placed first electrode, the first peak including an R-wave peak; and

detecting a second peak in the second ECG waveform, the second peak including a P-wave peak.

6. The method for locating as defined in claim 1, further comprising:

simultaneously depicting the first and second ECG waveforms on a first portion of a display.

7. The method for locating as defined in claim 1, further comprising:

simultaneously depicting a current view of the first and second ECG waveforms on a first portion of a display; and

depicting a past view of the first and second ECG waveforms on a second portion of the display.

8. The method for locating as defined in claim 7, further comprising:

depicting a location icon representing a position within the body of the portion of the indwelling medical device on a portion of the display; and

updating depiction of the location icon according to iteratively determining the position of the portion of the indwelling medical device.

9. The method for locating as defined in claim 8, wherein depicting the location icon further comprises:

depicting the location icon atop a representative image of a heart of the patient.

10. The method for locating as defined in claim 1, further comprising:

depicting at least one of the first and second ECG waveforms on a display of a mobile phone or handheld device via wireless transfer.

11. The method for locating as defined in claim 1, wherein triggering the analysis of the second ECG waveform is executed automatically by a processor of a catheter location apparatus.

12. The method for locating as defined in claim 1, wherein detecting an R-wave peak as the first peak in the first ECG waveform is performed when a P-wave peak is absent in the first ECG waveform due to arrhythmia but at least a portion of a P-wave segment is present in the second ECG waveform.

13. A method for locating an indwelling medical device within a body of a patient, the method comprising:

detecting a P-wave of an ECG waveform via an electrode associated with the medical device, the electrode sensing an endovascular ECG signal via a conductive path into the body of the patient;

calculating at least one of an amount of positive amplitude of the P-wave and an amount of negative amplitude of the P-wave; and

determining a position of a portion of the indwelling medical device based on the calculated amount of at least one of the positive amplitude and the negative amplitude of the P-wave.

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

depicting the determined position of the portion of the indwelling medical device on a display.

15. The method for locating as defined in claim 13, further comprising:

depicting the detected P-wave of the ECG signal on a display.

16. The method for locating as defined in claim 13, wherein the amount of positive amplitude includes an amount of P-wave amplitude above a baseline of the ECG waveform and wherein the amount of negative amplitude includes an amount of P-wave negative amplitude below the baseline of the ECG waveform.

17. The method for locating as defined in claim 13, wherein detecting the P-wave, calculating at least one of the amounts, and determining the position are iteratively performed to determine a change in the amount of at least one of the positive amplitude and negative amplitude of the P-wave over time.

18. The method for locating as defined in claim 17, wherein determining the position of the portion of the indwelling medical device further includes:

determining the portion of the indwelling medical device to be above and moving toward a sinoatrial node of a heart of the patient when the amplitude of the P-wave is positive and is increasing in positive amplitude.

19. The method for locating as defined in claim 18, wherein determining the position of the portion of the indwelling medical device further includes:

determining the portion of the indwelling medical device to be below and moving away from the sinoatrial node when the amplitude of the P-wave is negative and is increasing in negative amplitude.

20. The method for locating as defined in claim 13, wherein at least one of detecting the P-wave, calculating at least one of the amounts, and determining the position is at least partially controlled or monitored by a mobile phone or handheld device.

21. A connecting device for electrically connecting a first conductive component in a sterile field to a second conductive component outside of the sterile field, comprising:

a body including an electrically conductive surface, the body including a magnetic element such that the electrically conductive surface is magnetic,

wherein the second conductive component is electrically connected to the connecting device and wherein the first conductive component is electrically connected to the connecting device by placing a magnetically attractable connector of the first conductive component on the electrically conductive surface without manually touching the electrically conductive surface such that the connector is magnetically secured to the electrically conductive surface.

22. A connecting device for electrically connecting a first conductive component in a sterile field to a second conductive component outside of the sterile field, comprising:

a body including a cup-shaped receptacle, an electrically conductive surface being included within the receptacle; and

a magnetic element disposed proximate the cup-shaped receptacle,

wherein the second conductive component is electrically connected to the connecting device and wherein the first conductive component is electrically connected to the connecting device by inserting an end of a connector of the first conductive component into the cup-shaped receptacle of the connecting device without manually touching the connecting device surface such that the connector is magnetically secured to the electrically conductive surface within the cup-shaped receptacle.

23. The connecting device as defined in claim 22, wherein the connector of the first conductive component is disposed at an end of a stiff elongate body.

24. The connecting device as defined in claim 22, wherein the first conductive component includes an ECG lead and wherein the second conductive component includes a tether to an ECG system.

25. A method for locating an indwelling medical device within a body of a patient encountering arrhythmia, the method comprising:

detecting at least a portion of a P-wave of an ECG waveform via an electrode associated with the medical device, the electrode sensing an endovascular ECG signal via a conductive path into the body of the patient;

calculating at least one of an amount of positive amplitude of the P-wave portion, an amount of negative amplitude of the P-wave portion, and an amount of electrical energy of the P-wave portion; and

determining a position of a portion of the indwelling medical device based on the calculated amount of at least one of the positive amplitude and the negative amplitude of the P-wave portion.

26. The method for locating as defined in claim 25, wherein calculating the at least one of the amount of positive amplitude of the P-wave portion and the amount of negative amplitude of the P-wave portion further comprises:

detecting a frequency of the at least one of the amount of positive amplitude of the P-wave portion and the amount of negative amplitude of the P-wave portion.

27. A method for locating an indwelling medical device within a body of a patient, the method comprising:

detecting a skin ECG waveform via a skin-placed electrode;

detecting an endovascular ECG waveform via an electrode associated with the medical device, the electrode sensing an endovascular ECG signal via a conductive path into the body of the patient;

displaying a current view of the skin ECG waveform and the endovascular ECG waveform in a first window; and

displaying a past view of the skin ECG waveform and the endovascular ECG waveform in a second window.

28. The method for locating as defined in claim 27, wherein the skin ECG waveform and the endovascular waveform are displayed in a time-synchronized manner, and wherein the first and second windows are included on a single user interface.

29. The method for locating as defined in claim 27, wherein the electrode sensing the endovascular ECG signal is included with the medical device within a vasculature of the patient.