Stylets for use with apparatus for intravascular placement of a catheter

• US 9,636,031 B2
• Filed: 09/29/2010
• Issued: 05/02/2017
• 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.
• Primary Examiner(s): Lee, Erica
• Application Number:
  US12/893,916
• Publication Number:
  US 20110015533A1
• Time in Patent Office: 2,407 Days
• Field of Search: 600509, 600585
• 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 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
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers

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. Stylets and catheters including various multiple bipolar and monopolar electrode configurations are also disclosed.

Claims

1. A catheter placement system configured for positioning a catheter within a vasculature of a patient, comprising:

a console having a display;

a plurality of electrodes located at a distal end of the catheter, of each the plurality of electrodes configured for sensing separate ECG signals of the patient, and the plurality of electrodes being operably connected to the console; and

a processor included with the console, the processor;

(i) performing a differential comparison of a plurality of ECG signals sensed by a subset of the plurality of electrodes with a baseline ECG signal sensed by a baseline electrode of the plurality of electrodes to determine resultant ECG signals and a position of the distal end of the catheter based on at least one of the resultant ECG signals;

(ii) identifying an amplitude of a P-wave from each of the resultant ECG signals; and

(iii) generating an output for the display that plots the amplitudes of the P-wave from the resultant ECG signals according to a position of each of the plurality of electrodes on the catheter.

2. The catheter placement system as defined in claim 1, wherein the processor implements an algorithm for performing the differential comparison that provides the resultant ECG signals, the resultant ECG signals providing information relating to the position of the distal end of the catheter with respect to a node of the patient'"'"'s heart producing the plurality of ECG signals.

3. The catheter placement system as defined in claim 2, wherein the resultant ECG signals include only differences between the plurality of ECG signals and the baseline ECG signal.

4. The catheter placement system as defined in claim 3, wherein the resultant ECG signals differences in amplitude of at least one of a P-wave and a QRS complex between each of the plurality of ECG signals and the baseline ECG signal.

5. The catheter placement system as defined in claim 1, wherein the plurality of electrodes is disposed on a stylet removably positionable within a lumen of the catheter and further includes a plurality of distal electrodes of a first polarity disposed proximate a distal end of the stylet, a counterpart electrode of a second polarity, and a ground electrode.

6. The catheter placement system as defined in claim 5, wherein the plurality of distal electrodes and the counterpart electrode cooperate to define a plurality of bipolar electrodes.

7. The catheter placement system as defined in claim 6, wherein six bipolar electrodes are included on the stylet, including six distal electrodes of a positive polarity and a proximally disposed counterpart electrode of a negative polarity.

8. The catheter placement system as defined in claim 5, wherein the stylet further includes at least one magnetic element for enabling tracking of the stylet by an external sensor.

9. The catheter placement system as defined in claim 1, wherein the plurality of electrodes include monopolar electrodes that are disposed on a stylet removably positionable within a lumen of the catheter, and wherein the catheter includes at least one conductive feature to enable transfer of ECG signals through the catheter to at least one of the electrodes.

10. The catheter placement system as defined in claim 1, wherein the plurality of electrodes are operably connected to the console via a wirelessly transmitting dongle.

11. The catheter placement system as defined in claim 1, wherein the plurality of electrodes are positioned in a known relation to the distal end of the catheter in which each electrode is differently spaced from the distal end of the catheter.

12. The catheter placement system as defined in claim 1, wherein the plurality of electrodes are configured for insertion into the vasculature of the patient, and the differential comparison between each of subset of the plurality of ECG signals and the baseline ECG signal comprises differences in amplitude.