Apparatus and display methods relating to intravascular placement of a catheter

• US 9,549,685 B2
• Filed: 09/26/2014
• Issued: 01/24/2017
• Est. Priority Date: 11/26/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Cox, Jeremy B., Crook, Christian W.
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/498,887
• Publication Number:
  US 20150018701A1
• Time in Patent Office: 851 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/378 using ultrasound
• 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 46/00 Surgical drapes
• 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 5/283 Invasive
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient'"'"'s vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient'"'"'s chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient'"'"'s heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Claims

1. A method for displaying ECG signal data of a node of a patient, comprising:

detecting the ECG signal data with an ECG sensor component at least partially disposed in the patient, the ECG sensor component having a processor and being included in a catheter placement system;

sampling the ECG signal data;

identifying a first ECG waveform and a second ECG waveform from the sampled ECG signal data by the processor of the ECG sensor component;

defining at least one parameter of a display window of the catheter placement system; and

displaying the first ECG waveform and the second ECG waveform in the display window according to the at least one parameter of the display window, wherein displaying the first ECG waveform and the second ECG waveform includes;

displaying (i) a first horizontal line that traces a peak of a P-wave portion of the first ECG waveform having a first amplitude; and

(ii) a second horizontal line that traces a peak of a P-wave portion of the second ECG waveform having a second amplitude, the second amplitude being different than the first amplitude.

2. The method for displaying according to claim 1, wherein displaying the first ECG waveform further comprises:

combining, by the processor, the first ECG waveform with at least one previous ECG waveform when permitted by the at least one parameter of the display window; and

displaying the first ECG waveform with the at least one previous ECG waveform in the display window when permitted by the at least one parameter of the display window.

3. The method for displaying according to claim 1, wherein defining the at least one parameter further comprises defining the at least one parameter of the display window according to at least one of a user-defined control and an autonomous control.

4. The method for displaying according to claim 1, wherein the display window is included on a visual display of a console of the catheter placement system.

5. The method for displaying according to claim 1, wherein defining the at least one parameter further comprises defining a number of ECG waveforms to be included in the display window.

6. The method for displaying according to claim 1, wherein defining the at least one parameter further comprises defining an amount of time each ECG waveform is to be shown in the display window.

7. A method for displaying an ECG waveform of a node of a patient, comprising:

detecting ECG signal data with an ECG sensor component at least partially disposed in the patient, the ECG sensor component having a processor and being included in a catheter placement system;

sampling the ECG signal data;

identifying a first ECG waveform and a second ECG waveform from the sampled ECG signal data by the processor of the ECG sensor component;

identifying a characteristic of the first ECG waveform and a characteristic of the second ECG waveform by the processor of the ECG sensor component; and

displaying the first ECG waveform and the second ECG waveform in a display window of the catheter placement system, wherein displaying the first ECG waveform and the second ECG waveform includes;

displaying (i) a first horizontal line that traces a peak of the characteristic of the first ECG waveform having a first amplitude and;

(ii) a second horizontal line that traces a peak of the characteristic of the second ECG waveform having a second amplitude, the second amplitude being different than the first amplitude.

8. The method for displaying according to claim 7, wherein identifying the P-wave portion of the first ECG waveform and the P-wave portion of the second ECG waveform includes comparing a portion of the first ECG waveform and a portion of the second ECG waveform with a known P-wave template.

9. The method for displaying according to claim 7, further comprising:

identifying a QRS complex of the first ECG waveform with the catheter placement system;

determining a ratio between a magnitude of the P-wave portion of the first ECG waveform and a magnitude of the QRS complex of the first ECG waveform; and

displaying the first ECG waveform with data relating to the ratio.

10. The method for displaying according to claim 7, further comprising freezing the ECG waveform on the display window of the catheter placement system in response to user input.

11. The method for displaying according to claim 7, further comprising storing data relating to the first ECG waveform in a storage location.

12. The method for displaying according to claim 7, wherein the method is looped to display successive ECG waveforms.

13. The method for displaying according to claim 7, further comprising producing audible or visual output in response to a characteristic of the first ECG waveform.