Integrated system for intravascular placement of a catheter

• US 9,681,823 B2
• Filed: 05/11/2012
• Issued: 06/20/2017
• 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: Stats, Jason R., Messerly, Shayne, Bown, Matthew W., Lemon, Ryan R., Cox, Jeremy B., Misener, Anthony K., Burnside, Eddie K., Crook, Christian W., Breiter, Catherine C., Orome, Amir, Christian, Kelly J.
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US13/469,932
• Publication Number:
  US 20120220854A1
• Time in Patent Office: 1,866 Days
• Field of Search: 600407, 600509, 600424, 600443, 600529, 600528, 600409, 600447, 600428, 600587, 604523, 604194, 604585, 604264
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/372 Details of monitor hardware
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters
• 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 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/467 characterised by special input means
• 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 intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, 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.

Claims

1. A catheter placement system for positioning a catheter in a vasculature of a patient using at least two different modalities, comprising:

a console, including a display;

a stylet removably positionable within a lumen of the catheter, the stylet including;

a magnetic assembly configured to produce a magnetic field;

an electrocardiogram (ECG) sensor assembly for detecting ECG signals of a node of a heart of the patient; and

a first connector in communication with the ECG sensor assembly;

a tip location sensor positionable on a chest of the patient, the tip location sensor configured to detect the magnetic field of the magnetic assembly when the catheter is disposed within the vasculature of the patient, the magnetic field providing magnetic field information for locating the magnetic assembly relative to the tip location sensor, the tip location sensor configured to communicate the magnetic field information to the console;

a second connector included with one of the tip location sensor and the console, the second connector configured to connect to the first connector of the stylet to enable the ECG signals detected by the ECG sensor assembly to be communicated to at least one of the tip location sensor and the console; and

an external electrode configured to be placed on an external portion of the patient, the external electrode coupled to the second connector,

wherein the console is configured to receive the magnetic field information and at least one aspect of the ECG signal detected by the ECG sensor assembly, the at least one aspect of the ECG signal indicative of proximity of the ECG sensor assembly to the node, and configured to show a graphical representation of the magnetic assembly and the at least one aspect of the ECG signal, including an ECG waveform, on the display.

2. The system as defined in claim 1, wherein the console display enables a clinician to ascertain when a distal tip of the catheter is positioned at a predetermined location with respect to the node of the heart.

3. The system as defined in claim 1, wherein the second connector is included with the tip location sensor, and wherein the first and second connectors are physically connected via a perforation defined in a drape interposed between the stylet and the tip location sensor positioned on the chest of the patient, the physical connection of the first and second connectors producing the perforation in the drape and confining the perforation so as to prevent a compromise of a sterile field of the patient.

4. The system as defined in claim 3, wherein the ECG sensor assembly includes an electrically conductive core wire of the stylet, the core wire in operable communication with the first connector.

5. The system as defined in claim 4, wherein the core wire includes a distally tapered portion, the core wire extending to a distal end of the stylet.

6. The system as defined in claim 4, wherein the first connector includes a pin contact in operable communication with the core wire, the pin contact disposed in a channel defined in the first connector.

7. The system as defined in claim 6, wherein the second connector is a fin connector included with the tip location sensor, the first connector being slidably attachable to the second connector such that the pin contact of the first connector is placed in operable communication with a contact of the second connector to enable ECG signals to pass from the ECG sensor assembly to the tip location sensor.

8. The system as defined in claim 7, wherein the fin connector is selectively removable from the tip location sensor.

9. The system as defined in claim 8, wherein the tip location sensor includes a channel that slidably receives a barrel portion of the fin connector such that at least one electrical contact of the tip location sensor is placed in operable communication with at least one electrical contact of the fin connector.

10. The system as defined in claim 1, wherein the magnetic assembly includes a plurality of magnetic elements positioned proximate a distal end of the stylet, the stylet disposed in the lumen of the catheter such that the plurality of magnetic elements are substantially proximate a distal tip of the catheter.

11. The system as defined in claim 1, further comprising an ultrasound probe operably connected to the console for ultrasonically imaging a portion of the vasculature prior to introduction of the catheter into the vasculature for depiction on the display.

12. The system as defined in claim 11, wherein the display in a first mode depicts aspects relating to ultrasonically imaging by the ultrasound probe, wherein the display in a second mode depicts aspects relating to detection by the tip location sensor of the magnetic field of the magnetic assembly, wherein the display in a third mode depicts aspects relating to detection by the ECG sensor assembly, and wherein the mode depicted by the display is selected without requiring a clinician to reach out of a sterile field of the patient.

13. The system as defined in claim 12, wherein the display in the third mode displays a current ECG trace of the heart node of the patient.

14. The system as defined in claim 12, wherein the display in the second mode depicts a first icon to indicate a first proximity of the magnetic assembly to the tip location sensor and a second icon to indicate a second proximity of the magnetic assembly to the tip location sensor.

15. The system as defined in claim 1, wherein the stylet and the second connector are disposable after a single use.