IP Library Granted Patent US 9,877,665
Granted Patent B2
US 9,877,665 · App. 15/235,376 · Granted Jan 30, 2018

Systems and methods for catheter tip placement using ECG

Inventors: Lambertus Wilhelmus Johannes Elberse (Oss, NL); Franciscus Ludovicus Maria Johannes Veldhuijzen (Liessel, NL)
Assignee: AngioDynamics, Inc.
A61B5/068A61B5/0006A61B5/0402A61B5/042A61B5/044A61B5/04012A61B5/0422A61B5/0452A61B5/04525A61B5/061A61B5/065A61B5/06A61B2505/05A61B2562/0209A61M2025/0166
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Quick Facts
Patent No.
US 9,877,665
App. No.
15/235,376
Granted
Jan 30, 2018
Kind
B2
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. In other embodiments, a tip location algorithm can be used with an anti-thrombogenic catheter and an intravascular electrode assembly for maintaining a high resolution intravascular signal in an ECG based catheter tip placement system.

Claims (37)

1. A method for establishing an ECG search window for a catheter tip placement system, the method comprising:

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

generating a signal averaged ECG signal from the plurality of surface ECG signals;

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

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

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

determining a search window beginning value by identifying a local extremum on a first side of the second fiducial point, and determining a search window ending value by identifying a local extremum on a second side of the second fiducial point; and

establishing a second ECG search window between the search window beginning value and the search window ending value so that the second ECG search window is narrower than the first ECG search window;

acquiring an intravascular ECG signal from an intravascular ECG electrode near the catheter tip, the intravascular ECG electrode being connected to the central processing unit (CPU), the CPU having a signal processing unit;

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

wherein the extremum in the signal averaged surface ECG signal is an extremum of an R-wave; and

displaying signal data on a display, the display communicating with the CPU.

2. The method of claim 1 , wherein the first predetermined value is 40 ms prior to the first fiducial point, and the second predetermined value is 220 ms prior to the first fiducial point.

3. The method of claim 1 , wherein the plurality of ECG signals is measured over up to 15 heartbeats.

4. The method of claim 1 , wherein the local extremum on the first side of the second fiducial point is a first occurrence of a local extremum left of the second fiducial point, and wherein the local extremum on the second side of the second fiducial point is a first occurrence of a local extremum right of the second fiducial point.

5. The method of claim 1 , wherein the step of acquiring a plurality of ECG signals from at least one surface ECG electrode further comprises acquiring a plurality of ECG signals from a plurality of surface ECG electrodes.

6. The method of claim 5 , wherein the plurality of ECG electrodes is three surface ECG electrodes and the ECG signal is a surface signal.

7. The method of claim 6 , wherein the local extremum on the first side of the second fiducial point and the local extremum on the second side of the second fiducial point is determined using an algorithm test.

8. A method for establishing an ECG search window for a catheter tip placement system, the method comprising:

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

generating a signal averaged ECG signal from the plurality of ECG signals;

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

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

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

determining a search window beginning value by identifying a local extremum on a first side of the second fiducial point, and determining a search window ending value by identifying a local extremum on a second side of the second fiducial point; and

establishing a second ECG search window between the search window beginning value and the search window ending value so that the second ECG search window is narrower than the first ECG search window;

acquiring an intravascular ECG signal from an intravascular ECG electrode near the catheter tip, the intravascular ECG electrode being connected to the central processing unit (CPU), the CPU having a signal processing unit;

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

wherein the extremum in the first ECG search window is an extremum of a P-wave; and

displaying signal data on a display, the display communicating with the CPU.

9. The method of claim 8 , wherein the extremum in the signal averaged ECG signal is an extremum of an R-wave.

10. The method of claim 8 , wherein the first predetermined value is 40 ms prior to the first fiducial point, and the second predetermined value is 220 ms prior to the first fiducial point.

11. The method of claim 8 , wherein the plurality of ECG signals is measured up to 15 heartbeats.

12. The method of claim 8 , wherein the local extremum on the first side of the second fiducial point is a first occurrence of a local extremum left of the second fiducial point, and wherein the local extremum on the second side of the second fiducial point is a first occurrence of a local extremum right of the second fiducial point.

13. The method of claim 8 , wherein the step of acquiring a plurality of ECG signals from at least one surface ECG electrode further comprises acquiring a plurality of ECG signals from a plurality of surface ECG electrodes.

14. The method of claim 13 , wherein the plurality of surface ECG electrodes is three surface ECG electrodes and the plurality of ECG signals are surface signals.

15. The method of claim 8 , wherein the local extremum on the first side of the second fiducial point and the local extremum on the second side of the second fiducial point is determined using an algorithm test.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2018
From: ANGIODYNAMICS, INC.; CLINICAL DEVICES B.V.
To: BEL HOLDING B.V.; VELDHOEVE HOLDING B.V.
Reel/Frame 044865/0540 →
SECURITY INTEREST Recorded Nov 8, 2016
From: ANGIODYNAMICS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 040613/0049 →
Continuity (3)
Continuation 14211801 · Mar 14, 2014
Provisional Application 61782913 · Mar 14, 2013
Related Publication 20170035323A1 · Feb 9, 2017