Apparatus and method for catheter navigation and tip location

• US 10,231,643 B2
• Filed: 09/04/2015
• Issued: 03/19/2019
• 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:
  US14/846,496
• Publication Number:
  US 20150374261A1
• Time in Patent Office: 1,292 Days
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• 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 5/063 using impedance measurements
• CPC Class Codes: A61B 5/068 using impedance sensors
• 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: A61B 5/726 using Wavelet transforms
• 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 25/0102 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: H01R 13/6205 Two-part coupling devices held in engagement by a magnet

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

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

detecting a P-wave of an ECG waveform via an electrode associated with the indwelling medical device, the electrode sensing an endovascular ECG signal via a conductive path into the body of the patient;

calculating at least one of an amount of positive amplitude of the P-wave and an amount of negative amplitude of the P-wave; and

determining a position of a portion of the indwelling medical device based on the calculated amount of at least one of the positive amplitude and the negative amplitude of the P-wave, wherein the portion of the indwelling medical device is determined to be above and moving toward a sinoatrial node of a heart of the patient when the calculated amount of amplitude of the P-wave is positive and is increasing in positive amplitude,

wherein detecting the P-wave, calculating at least one of the amounts of positive amplitude and negative amplitude, and determining the position are iteratively performed to determine a change in the amount of at least one of the positive amplitude and negative amplitude of the P-wave over time.

2. The method for locating according to claim 1, further comprising depicting the determined position of the portion of the indwelling medical device on a display.

3. The method for locating according to claim 1, further comprising depicting the detected P-wave of the ECG signal on a display.

4. The method for locating according to claim 1, wherein the amount of positive amplitude includes an amount of P-wave amplitude above a baseline of the ECG waveform and wherein the amount of negative amplitude includes an amount of P-wave amplitude below the baseline of the ECG waveform.

5. The method for locating according to claim 1, wherein determining the position of the portion of the indwelling medical device further includes determining the portion of the indwelling medical device to be below and moving away from the sinoatrial node when the amplitude of the P-wave is negative and is increasing in negative amplitude.

6. The method for locating according to claim 1, wherein at least one of detecting the P-wave, calculating at least one of the amounts, and determining the position is at least partially controlled or monitored by a mobile phone or handheld device.