IP Library Granted Patent US 9,125,578
Granted Patent B2
US 9,125,578 · App. 13/019,939 · Granted Sep 8, 2015

Apparatus and method for catheter navigation and tip location

Inventor: Sorin Grunwald (Bucarest, RO)
Assignee: Bard Access Systems, Inc.
A61B5/0452A61B5/042A61B5/04017A61B5/06A61B5/7203A61B5/726A61B2019/5246A61M25/0026A61M25/0102A61M25/0147A61M25/0194A61M2025/09116
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Quick Facts
Patent No.
US 9,125,578
App. No.
13/019,939
Granted
Sep 8, 2015
Kind
B2
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 (44)

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.

Continuity (6)
Continuation In Part 12854083 · Aug 10, 2010
Continuation In Part 12815331 · Jun 14, 2010
Provisional Application 61282397 · Feb 2, 2010
Provisional Application 61272025 · Aug 10, 2009
Provisional Application 61213474 · Jun 12, 2009
Related Publication 20110196248A1 · Aug 11, 2011