Devices and methods for endovascular electrography

• US 10,349,857 B2
• Filed: 09/15/2016
• Issued: 07/16/2019
• 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:
  US15/266,977
• Publication Number:
  US 20170000367A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• 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 5/065 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 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 2039/1022 additionally providing electrical connection
• 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 25/0097 characterised by the hub connectors A61M39/10
• 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: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A method for positioning an endovascular device in or near the heart using electrocardiogram (ECG) signals. The method includes receiving an endovascular ECG signal including a plurality of waveforms, processing the endovascular ECG signal to calculate a P-wave amplitude and a spectral power for each predetermined time period, determining a maximum P-wave amplitude and an associated maximum spectral power, associating the maximum P-wave amplitude and the maximum spectral power with a predetermined location in or near the heart, calculating a location based on a ratio of the P-wave amplitude to the maximum P-wave amplitude and a ratio of the spectral power to the maximum spectral power, and displaying the location to a user.

Claims

1. A computer-based method for positioning an endovascular device in or near a heart using electrocardiogram (ECG) signals, comprising:

receiving an endovascular ECG signal, associated with the endovascular device, including a plurality of waveforms, each waveform having at least a P-wave component;

processing the endovascular ECG signal, over a plurality of predetermined time periods, to calculate a P-wave amplitude and a spectral power for each predetermined time period;

determining a maximum P-wave amplitude from a plurality of P-wave amplitudes resulting from processing the endovascular ECG signal over the plurality of predetermined time periods, and an associated maximum spectral power from a plurality of spectral powers resulting from processing the endovascular ECG signal over the plurality of predetermined time periods;

associating the maximum P-wave amplitude and the maximum spectral power with a predetermined location in or near the heart;

calculating a location of the endovascular device, for each predetermined time period, based on a ratio of the P-wave amplitude to the maximum P-wave amplitude and a ratio of the spectral power to the maximum spectral power; and

displaying the location of the endovascular device to a user for each predetermined time period.

2. The computer-based method according to claim 1, wherein the P-wave amplitude for each predetermined time period is a peak-to-peak value, and the maximum P-wave amplitude is a peak-to-peak value.

3. The computer-based method according to claim 2, wherein processing the endovascular ECG signal includes determining a polarity for each P-wave amplitude, for each predetermined time period, and calculating the location of the endovascular device is also based on the P-wave polarity for each predetermined time period.

4. The computer-based method according to claim 3, wherein the predetermined location is a caval-atrial junction.

5. The computer-based method according to claim 4, wherein the location of the endovascular device is an upper portion of a superior vena cava if the ratio of the P-wave amplitude to the maximum P-wave amplitude is less than 0.4, the ratio of the spectral power to the maximum spectral power is less than 0.4, and the P-wave polarity is unipolar.

6. The computer-based method according to claim 5, wherein the location of the endovascular device is a lower third of the superior vena cava if the ratio of the P-wave amplitude to the maximum P-wave amplitude is between 0.4 and 0.6, the ratio of the spectral power to the maximum spectral power is between 0.4 and 0.6, and the P-wave polarity is unipolar.

7. The computer-based method according to claim 6, further comprising:

calculating an R-wave amplitude for each predetermined time period when processing the endovascular ECG signal, wherein the location of the endovascular device is the caval-atrial junction if the ratio of the P-wave amplitude to the maximum P-wave amplitude is greater than 0.9, the ratio of the spectral power to the maximum spectral power is greater than 0.9, and the P-wave amplitude is greater than the R-wave amplitude.

8. The computer-based method according to claim 7, wherein the location of the endovascular device is a right atrium if the ratio of the spectral power to the maximum spectral power is between 0.6 and 0.9, and the P-wave polarity is bipolar.

9. The computer-based method according to claim 8, wherein the location of the endovascular device is an upper third of an inferior vena cava if the ratio of the P-wave amplitude to the maximum P-wave amplitude is between 0.4 and 0.6, the ratio of the spectral power to the maximum spectral power is between 0.4 and 0.6, and the P-wave polarity is unipolar with reversed polarity.

10. The computer-based method according to claim 4, wherein the endovascular device is a central venous catheter coupled to an adapter that includes an electrode in contact with a saline solution column exposed to a tip of the catheter, and the endovascular ECG signal is based on an electrical signal measured by the electrode.

11. The computer-based method according to claim 10, further comprising:

simultaneously receiving a skin ECG signal with the endovascular ECG signal, associated with a skin ECG lead, including a plurality of waveforms, each waveform having at least a P-wave component;

processing the skin ECG signal, over the plurality of predetermined time periods, to calculate a skin P-wave amplitude and a skin spectral power for each predetermined time period;

determining a maximum skin P-wave amplitude from a plurality of skin P-wave amplitudes resulting from processing the skin ECG signal over the plurality of predetermined time periods, and an associated maximum skin spectral power from a plurality of skin spectral powers resulting from processing the skin ECG signal over the plurality of predetermined time periods;

associating the maximum skin P-wave amplitude and the maximum skin spectral power with the predetermined location in or near the heart; and

calculating the location of the endovascular device, for each predetermined time period, based on a ratio of the skin P-wave amplitude to the maximum skin P-wave amplitude and a ratio of the skin spectral power to the maximum skin spectral power.

12. The computer-based method according to claim 11, wherein the location of the endovascular device is an upper portion of a superior vena cava if the ratio of the skin P-wave amplitude to the maximum skin P-wave amplitude is between 0.9 and 1.2, the ratio of the skin spectral power to the maximum skin spectral power is between 0.9 and 1.2, and the P wave polarity is unipolar.

13. The computer-based method according to claim 12, wherein the location of the endovascular device is a lower third of the superior vena cava if the ratio of the skin P-wave amplitude to the maximum skin P-wave amplitude is between 1.5 and 2.0, the ratio of the skin spectral power to the maximum skin spectral power is between 1.5 and 2.0, and the P-wave polarity is unipolar.

14. The computer-based method according to claim 13, further comprising:

calculating an R-wave amplitude for each predetermined time period when processing the skin ECG signal, wherein the location of the endovascular device is the caval-atrial junction if the ratio of the skin P-wave amplitude to the maximum skin P-wave amplitude is greater than 2.5, the ratio of the skin spectral power to the maximum skin spectral power is greater than 2.59, and the skin P-wave amplitude is greater than the skin R-wave amplitude.

15. The computer-based method according to claim 14, wherein the location of the endovascular device is a right atrium if the ratio of the skin spectral power to the maximum skin spectral power is between 2.0 and 2.5, and a skin P-wave polarity determined for each skin P-wave amplitude for each predetermined time period is bipolar.

16. The computer-based method according to claim 15, wherein the location of the endovascular device is an upper third of an inferior vena cava if the ratio of the skin P-wave amplitude to the maximum skin P-wave amplitude is between 0.9 and 1.2, the ratio of the skin spectral power to the maximum skin spectral power is between 0.9 and 1.2, and the P-wave polarity is unipolar with reversed polarity.