Apparatus and method for catheter navigation using endovascular energy mapping

• US 10,271,762 B2
• Filed: 11/30/2016
• Issued: 04/30/2019
• 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): Marlen, Tammie K
• Application Number:
  US15/365,872
• Publication Number:
  US 20170079552A1
• Time in Patent Office: 881 Days
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2034/2053 Tracking an applied voltage gradient
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/063 using impedance measurements
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• 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 5/349 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 5/7203 for noise prevention, reduction or removal
• 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 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 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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: A61M 25/09 Guide wires

Abstract

Devices and methods obtain and use endovascular electrograms (or electrocardiograms/ECGs) in a number of clinical applications and settings. In one embodiment, a method for locating an indwelling medical device within a vasculature of a patient includes identifying an endovascular ECG waveform complex from an endovascular ECG signal associated with the indwelling medical device, then calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof. A position of the medical device within the vasculature is then determined by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex.

Claims

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

identifying with indicators of a graphical user interface on a display screen of a portable device an endovascular ECG waveform complex from an endovascular ECG signal associated with endovascular electrodes of the indwelling medical device;

determining an energy of the endovascular ECG waveform complex;

calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof by applying data-processing algorithms of a computer module of the portable device; and

determining a position of the indwelling medical device within the vasculature by observation of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex in the graphical user interface by a user of the portable device.

2. The method for locating according to claim 1, wherein the method is at least partially performed with an ECG signal monitoring system including the display screen for depicting the endovascular ECG waveform complex, and wherein determining the position includes observing information relating to the absolute value of the energy of the endovascular ECG waveform complex as depicted on the display.

3. The method for locating according to claim 1, wherein the endovascular ECG waveform complex includes both positive energy values and negative energy values, and wherein identifying the endovascular ECG waveform complex includes identifying two successive peaks of an R-wave with the indicators of the graphical user interface.

4. The method for locating according to claim 1, wherein the endovascular ECG signal is detected by the endovascular electrodes, which are disposed proximate to a distal tip of the indwelling medical device.

5. The method for locating according to claim 4, wherein the indwelling medical device is a catheter.

6. The method for locating according to claim 1, wherein the predetermined segment of the endovascular ECG waveform complex includes an entirety of the endovascular ECG waveform complex corresponding to a complete single heartbeat of the patient.

7. The method for locating according to claim 1, wherein calculating the absolute value of the energy further comprises:

discretely sampling a number of portions of the endovascular ECG waveform complex;

calculating with the data-processing algorithms squares of amplitudes of the endovascular ECG waveform complex at each of the number of discretely sampled portions of the endovascular ECG waveform complex over the predetermined segment;

summing with the data-processing algorithms the squares of the amplitudes; and

dividing with the data-processing algorithms the summed squares of the amplitudes by the number of discretely sampled portions of the endovascular ECG waveform complex.

8. The method for locating according to claim 1, wherein identifying the endovascular ECG waveform complex further comprises identifying with the indicators of the graphical user interface an R-peak, a P-wave segment, and a P-peak of the endovascular ECG waveform complex on the display screen.

9. The method for locating according to claim 1, wherein the method is iteratively executed for successively detected endovascular ECG waveform complexes as the indwelling medical device is advanced within the vasculature.

10. The method for locating according to claim 1, further comprising:

identifying with the indicators of the graphical user interface a skin ECG waveform complex from a skin ECG signal sensed by an electrode on the patient; and

determining an energy of the skin ECG waveform complex;

calculating an absolute value of the energy of the skin ECG waveform complex over a predetermined segment time synchronized with the predetermined segment of the endovascular ECG waveform complex by applying the data-processing algorithms,

wherein determining the position of the indwelling medical device includes determining by the user from the graphical user interface the position of the indwelling medical device based on a ratio of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex to the absolute value of the energy of the predetermined segment of the skin ECG waveform complex.

11. A method for locating an indwelling catheter within a vasculature of a patient, comprising:

identifying with indicators of a graphical user interface on a display screen of a portable device an endovascular ECG waveform complex from an endovascular ECG signal associated with endovascular electrodes of the indwelling catheter and a skin ECG waveform complex from a skin ECG signal;

determining an energy of the endovascular ECG waveform complex and an energy of the skin ECG waveform complex;

calculating an absolute value of the energy of the endovascular ECG waveform complex over a predetermined segment thereof and an absolute value of the energy of the skin ECG waveform complex over a predetermined segment thereof by applying data-processing algorithms of a computer module of the portable device, the predetermined segments corresponding in time with one another; and

determining a position of the indwelling catheter within the vasculature from the graphical user interface by a user of the portable device using at least one of the absolute values of the energy of the predetermined segment of the endovascular ECG waveform complex or the energy of the predetermined segment of the skin ECG waveform complex.

12. The method for locating according to claim 11, wherein determining the position further comprises determining the position of the indwelling catheter based on a ratio of the absolute value of the energy of the predetermined segment of the endovascular ECG waveform complex to the absolute value of the energy of the predetermined segment of the skin ECG waveform complex.

13. The method for locating according to claim 11, wherein the method is iteratively executed for successively detected waveform complexes as the indwelling catheter is advanced within the vasculature.