Systems and methods for catheter tip placement using ECG

• US 10,188,831 B2
• Filed: 08/09/2016
• Issued: 01/29/2019
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Bel Holding BV, Veldhoeve Holding B.V.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Elberse, Lambertus Wilhelmus Johannes, Veldhuijzen, Franciscus Ludovicus Maria Johannes
• Primary Examiner(s): Levicky, William J
• Application Number:
  US15/232,251
• Publication Number:
  US 20160346512A1
• Time in Patent Office: 903 Days
• CPC Class Codes: A61B 2505/05 Surgical care
• 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 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/0133 Tip steering devices

Abstract

A system and method for catheter placement using ECG is provided. In certain embodiments, the system and method can generate a patient specific window for tracking a characteristic of an ECG waveform, such as the amplitude of a P-wave. The patient specific window can be utilized in a system and method for assisting in the placement of a catheter within a patient.

Claims

1. A method comprising the steps of:

acquiring a plurality of surface ECG signals from at least one surface ECG electrode and a plurality of intravascular ECG signals from an intravascular ECG electrode, the intravascular ECG electrode configured to be coaxially surrounded by a peripherally inserted catheter, the at least one surface ECG electrode and the intravascular ECG electrode configured to be connected to a central processing unit (CPU);

generating an averaged surface ECG signal from the plurality of surface ECG signals and an averaged intravascular ECG signal from the plurality of intravascular ECG signals;

determining a first fiducial point by identifying a first extremum within the averaged surface ECG signal;

establishing a first ECG search window between a first predetermined value and a second predetermined value, both the first predetermined value and the second predetermined value being offset from the first fiducial point;

determining a second fiducial point by identifying a second extremum within the first ECG search window;

establishing a second ECG search window by identifying a first local extremum on a first side of the second fiducial point and a second local extremum on a second side of the second fiducial point;

applying the second ECG search window to the averaged intravascular ECG signal to generate an intravascular ECG search window;

moving the intravascular ECG electrode from a first location to a second location; and

displaying on a display in communication with the CPU, a graphical instruction to a user to advance or retract the intravascular ECG electrode, the graphical instruction to the user to advance or retract the intravascular ECG electrode is in response to the user moving the intravascular ECG electrode from the first location to the second location.

2. The method of claim 1, wherein the averaged intravascular ECG signal is measured over at least five heartbeats.

3. The method of claim 1, wherein the first predetermined value is at least 40 ms prior to the first fiducial point;

and the second predetermined value is at least 220 ms prior to the first fiducial point.

4. The method of claim 1, wherein the averaged surface ECG signal is measured over at least five heartbeats.

5. The method of claim 1, wherein the at least one surface ECG electrode is at least two surface ECG electrodes.

6. The method of claim 5, wherein at least two surface ECG electrodes is at least three surface ECG electrodes.

7. A method comprising the steps of:

acquiring a plurality of surface ECG signals from at least one surface ECG electrode and a plurality of intravascular ECG signals from an intravascular ECG electrode, the intravascular ECG electrode configured to be coaxially surrounded by a catheter tip, the at least one surface ECG electrode and the intravascular ECG electrode being connected to a central processing unit (CPU);

generating an averaged surface ECG signal from the plurality of surface ECG signals and an averaged intravascular ECG signal from the plurality of intravascular ECG signals;

determining a first fiducial point by identifying a first extremum, the first extremum identified within the averaged surface ECG signal;

establishing a first ECG search window between a first predetermined value and a second predetermined value, both the first predetermined value and the second predetermined value being offset from the first fiducial point;

determining a second fiducial point by identifying a second extremum, the second extremum identified within the first ECG search window;

establishing a second ECG search window between a first local extremum on a first side of the second fiducial point and a second local extremum on a second side of the second fiducial point so that the second ECG search window is narrower than the first ECG search window;

applying the second ECG search window to the averaged intravascular ECG signal to generate an intravascular ECG search window;

moving the intravascular ECG electrode from a first location to a second location;

displaying, on a display in communication with the CPU, a graphical instruction to a user to advance or retract the intravascular ECG electrode, the graphical instruction to the user to advance or retract the intravascular ECG electrode is in response to the user moving the intravascular ECG electrode from the first location to the second location.

8. The method of claim 7, wherein the averaged intravascular ECG signal is measured over a plurality of at least five heartbeats.

9. The method of claim 7, wherein generating the intravascular ECG search window comprises identifying a fifth extremum, the fifth extremum identified within the averaged intravascular ECG signal.

10. The method of claim 7, wherein the intravascular ECG signal within the intravascular ECG search window is a P-wave.

12. The method of claim 7, further comprising the step of generating a moving averaged intravascular ECG signal.

13. The method of claim 12, further comprising the steps of:

determining a first amplitude based on a third extremum, the third extremum identified within the moving averaged intravascular ECG signal with the intravascular electrode at the first position, and

determining a second amplitude based on a fourth extremum, the fourth extremum identified within the moving averaged intravascular ECG signal with the intravascular electrode at the second position.

14. The method of claim 13, wherein:

when the second amplitude is greater than the first amplitude, the graphical instruction to the user to advance the intravascular ECG electrode is displayed.

15. The method of claim 14, wherein the first amplitude and the second amplitude are determined from the moving averaged intravascular ECG signal.

16. The method of claim 13, wherein:

when the second amplitude is less than the first amplitude, the graphical instruction to retract the intravascular ECG catheter is displayed.

11. A method comprising the steps of:

acquiring a plurality of surface ECG signals from at least one surface ECG electrode and a plurality of intravascular ECG signals from an intravascular ECG electrode, the at least one surface ECG electrode and the intravascular ECG electrode being connected to a central processing unit (CPU);

generating an averaged surface ECG signal from the plurality of surface ECG signals and an averaged intravascular ECG signal from the plurality of intravascular ECG signals, both the averaged surface ECG signal and the averaged intravascular ECG signal measured over at least 5 heartbeats;

determining a first fiducial point by identifying a first extremum within the averaged surface ECG signal and the averaged intravascular ECG signal;

establishing a first ECG search window between a first predetermined value and a second predetermined value, the first predetermined value and the second predetermined value being offset from the first fiducial point;

determining a second fiducial point by identifying a second extremum within the first ECG search window;

establishing a second ECG search window between a first local extremum on a first side of the second fiducial point and a second local extremum on a second side of the second fiducial point;

applying the second ECG search window to the averaged intravascular ECG signal to generate an intravascular ECG search window;

moving the intravascular ECG electrode from a first location to a second location;

displaying, on a display in communication with the CPU, a graphical instruction to a user to advance or retract the intravascular ECG electrode such that the intravascular ECG electrode is placed at the lower one-third of the superior vena cava (SVC), the graphical instruction is in response to the user moving the intravascular ECG electrode from the first location to the second location.