Apparatus and method for catheter navigation and tip location

• US 9,125,578 B2
• Filed: 02/02/2011
• Issued: 09/08/2015
• 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
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/019,939
• Publication Number:
  US 20110196248A1
• Time in Patent Office: 1,679 Days
• Field of Search: 600/517, 600/521, 600/523
• US Class Current: 1/1
• 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 obtain and use endovascular electrograms in a number of clinical applications and settings. In one embodiment, methods for triggering analysis of an endovascular ECG waveform are 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 are used for establishing an operable connection through a sterile field.

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, the second peak including a peak of a P-wave; and

determining a position of a portion of the indwelling medical device based on a characteristic of the second peak, including determining the portion of the indwelling medical device to be above and moving toward a sino-atrial node of a heart of the patient when an amplitude of the P-wave is positive and is increasing in positive amplitude.

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 3, 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 the first ECG waveform is acquired via a skin-placed first electrode and the first peak includes an R-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 third portion of the display; and

updating depicting 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 the first peak in the first ECG waveform is an R-wave peak and a P-wave peak is absent in the first ECG waveform due to arrhythmia.

13. The method for locating as defined in claim 1, wherein the first ECG waveform is acquired using a first external, skin-placed electrode, wherein the second ECG waveform is acquired using a second electrode on the indwelling medical device, and wherein the method further comprises displaying a real-time view of the first ECG waveform and a real-time view of the second ECG waveform in a first window.

14. The method for locating as defined in claim 13, wherein the first ECG waveform and the second ECG waveform are displayed in a time-synchronized manner.

15. The method for locating as defined in claim 13, wherein the first ECG waveform is acquired via measurement between the first external, skin-placed electrode and a second external, skin-placed electrode, and wherein the second ECG waveform is acquired via measurement between the second electrode on the indwelling medical device and one of the first external, skin-placed electrode or the second external, skin placed electrode.

16. The method for locating as defined in claim 13, further comprising displaying a past, frozen view of the first ECG waveform and a past, frozen view of the second ECG waveform in a second window.

17. The method for locating as defined in claim 16, wherein the first window and the second window are included side by side on a single user interface.

18. The method for locating as defined in claim 1, wherein the first ECG waveform is acquired using a first external, skin-placed electrode and wherein the second ECG waveform is acquired using a second electrode on the indwelling medical device, the method further comprising:

displaying a real-time view of the first ECG waveform and a real-time view of the second ECG waveform in a first window; and

displaying a frozen reference ECG waveform related to the first ECG waveform and a frozen reference ECG waveform related to the second ECG waveform in a second window.

19. The method for locating as defined in claim 18, wherein the first window and the second window are included on a single user interface and display simultaneously.

20. The method for locating as defined in claim 18, wherein the displaying a frozen reference ECG waveform related to the first ECG waveform and a frozen reference ECG waveform related to the second ECG waveform in the second window comprises displaying a past, frozen view of the first ECG waveform and a past, frozen view of the second ECG waveform in the second window.

21. The method for locating as defined in claim 18, wherein the first ECG waveform is acquired via measurement between the first external, skin-placed electrode and a second external, skin-placed electrode, and wherein the second ECG waveform is acquired via measurement between the second electrode on the indwelling medical device and one of the first external, skin-placed electrode or the second external, skin placed electrode.

22. The method for locating as defined in claim 1, wherein the analysis of the second ECG waveform includes running a decision support algorithm.

23. The method for locating as defined in claim 1, wherein the analysis of the second ECG waveform includes a computational analysis of the characteristic of the second peak.

24. 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, the second peak including a peak of a P-wave; and

determining a position of a portion of the indwelling medical device based on a characteristic of the second peak, including determining the portion of the indwelling medical device to be above and moving away from a sino-atrial node of a heart of a patient when an amplitude of the P-wave is negative and is increasing in negative amplitude.

25. The method for locating as defined in claim 24, wherein the first ECG waveform is acquired using a first external, skin-placed electrode and wherein the second ECG waveform is acquired using a second electrode on the indwelling medical device, the method further comprising:

displaying a real-time view of the first ECG waveform and a real-time view of the second ECG waveform in a first window; and

displaying a frozen reference ECG waveform related to the first ECG waveform and a frozen reference ECG waveform related to the second ECG waveform in a second window.

26. The method for locating as defined in claim 25, wherein the first window and the second window are included on a single user interface and display simultaneously.

27. The method for locating as defined in claim 25, wherein displaying a frozen reference ECG waveform related to the first ECG waveform and a frozen reference ECG waveform related to the second ECG waveform in the second window comprises displaying a past, frozen view of the first ECG waveform and a past, frozen view of the second ECG waveform in the second window.

28. The method for locating as defined in claim 25, wherein the first ECG waveform is acquired via measurement between the first external, skin-placed electrode and a second external, skin-placed electrode, and wherein the second ECG waveform is acquired via measurement between the second electrode on the indwelling medical device and one of the first external, skin-placed electrode or the second external, skin placed electrode.