Integrated system for intravascular placement of a catheter

• US 9,999,371 B2
• Filed: 10/31/2012
• Issued: 06/19/2018
• 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: Messerly, Shayne, Bown, Matthew W., Burnside, Eddie K., Christian, Kelly J.
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US13/665,420
• Publication Number:
  US 20130060116A1
• Time in Patent Office: 2,057 Days
• Field of Search: 600437-449, 600407, 600509, 600424, 600409, 600428, 600587, 600423, 600420, 600411
• 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. An integrated catheter placement system for placing a catheter in a vasculature of a patient, comprising:

a system console including a tip location mode and an ultrasound mode viewable on a display;

a stylet having a magnetic field associated therewith;

a tip location sensor configured for temporary placement on a portion of a body of the patient, the tip location sensor configured for sensing the magnetic field of the stylet disposed in a lumen of the catheter when a distal portion of the catheter is disposed in the vasculature, the magnetic field providing magnetic field information for locating the stylet relative to the tip location sensor, the tip location sensor configured to communicate the magnetic field information to the system console for displaying an icon indicative of a location of the stylet relative to the tip location sensor on the display in a tip location mode; and

an ultrasound probe for ultrasonically imaging an internal portion of the patient prior to introduction of the catheter into the vasculature, the ultrasound probe configured to communicate imaging information to the system console for viewing on the display as an ultrasound image of the internal portion in the ultrasound mode, the ultrasound probe including user input controls for controlling use of the ultrasound probe in the ultrasound mode and use of the tip location sensor in the tip location mode, wherein the ultrasound image of the internal portion is not displayed in the tip location mode.

2. The system as defined in claim 1, wherein the display is integrated into the console, and wherein the console includes at least one control processor.

3. The system as defined in claim 1, wherein the user input controls are buttons included on the ultrasound probe.

4. The system as defined in claim 1, wherein the user input controls of the ultrasound probe enable toggling of the display between depiction of information relating to the ultrasound mode and information relating to the tip location mode.

5. The system as defined in claim 4, wherein the system console includes a button interface that enables the toggling of the display.

6. The system as defined in claim 1, wherein the magnetic field of the stylet is provided by at least one magnetic element included proximate a distal end of the stylet, the distal end of the stylet being substantially co-terminal with a distal end of the catheter.

7. The system as defined in claim 1, wherein the stylet is removable from the lumen of the catheter after catheter placement is complete.

8. The system as defined in claim 1, wherein the magnetic field of the stylet is produced by a component including one of the following:

a permanent magnet, an electromagnet, and any combination of the foregoing.

9. The system as defined in claim 1, further comprising an electrocardiogram (ECG) tip confirmation component for determining proximity of a distal tip of the catheter to a sino-atrial node of a heart of the patient, the ECG tip confirmation component including:

an ECG sensor assembly included on the stylet for detecting electrical activity of the sino-atrial node; and

at least one external electrode for placement on an external portion of the patient, wherein the ECG sensor assembly and the at least one electrode are operably connected to the system console via the tip location sensor.

10. The system as defined in claim 9, wherein the at least one external electrode comprises a reference electrode and a ground electrode.

11. An integrated catheter placement system for placing a catheter in a vasculature of a patient, comprising:

a console including a tip location mode and an ultrasound mode viewable on a display;

a magnetic assembly associated with the catheter;

a tip location sensor configured to detect a magnetic field of the magnetic assembly, the magnetic field providing magnetic field information for determining a position of the catheter with respect to the tip location sensor during advancement of the catheter in the vasculature, the tip location sensor configured to communicate the magnetic field information to the console for depiction on the display in the tip location mode as an icon indicative of a location of the catheter relative to the tip location sensor; and

an ultrasound probe for ultrasonically imaging a portion of the vasculature, the ultrasound probe configured to communicate imaging information to the console for depiction on the display in the ultrasound mode as an ultrasound image of the portion of the vasculature, the ultrasound probe including user input controls for controlling use of the ultrasound probe in the ultrasound mode and use of the tip location sensor in the tip location mode, wherein the ultrasound image of the portion of the vasculature is only displayed in the ultrasound mode.

12. The system as defined in claim 11, wherein the tip location sensor is positionable on a chest of the patient during catheter placement, and wherein the magnetic assembly is included with a stylet that is removably inserted in a lumen of the catheter, the stylet including at least one magnetic element.

13. The system as defined in claim 12, wherein the at least one magnetic element includes a plurality of ferromagnetic elements.

14. An integrated catheter placement system, comprising:

a system console including a tip location mode and an ultrasound mode viewable on a display;

a stylet having a magnetic field associated therewith;

a tip location sensor positionable onto a body of a patient, the tip location sensor capable of sensing the magnetic field of the stylet disposed in a lumen of a catheter when a distal portion of the catheter is inserted into the body of the patient, the magnetic field providing magnetic field information for determining a location of the distal portion of the catheter relative to the tip location sensor, the tip location sensor configured to communicate the magnetic field information to the system console for viewing on the display in the tip location mode, including as an icon indicative of the location of the distal portion of the catheter relative to the tip location sensor;

an ultrasound probe capable of ultrasonically imaging an internal portion of the patient prior to insertion of the catheter into the body of the patient, the ultrasound probe configured to communicate imaging information to the console for viewing on the display in the ultrasound mode as an ultrasound image of the internal portion, the ultrasound probe including user input controls for controlling use of the ultrasound probe in the ultrasound mode and use of the tip location sensor in the tip location mode, wherein the ultrasound image of the internal portion is not displayed in the tip location mode; and

an electrocardiogram (ECG) tip confirmation component operably connected to the system console via the tip location sensor, the ECG tip confirmation component capable of determining proximity of a distal tip of the catheter to a sino-atrial node of a heart of the patient, the ECG tip confirmation component including an ECG sensor assembly coupled to the stylet, and an external electrode placed onto the body of the patient.

15. A method for placing a catheter within a vasculature of a patient, the method comprising:

ultrasonically imaging a portion of the vasculature in an ultrasound mode of an integrated catheter placement system using an ultrasound probe

depicting the portion of the vasculature as an ultrasound image on a display of a console of the integrated catheter placement system prior to introduction of the catheter into the vasculature of the patient;

introducing the catheter into the vasculature of the patient, the catheter including a magnetic assembly associated therewith, the magnetic assembly producing a magnetic field;

switching from the ultrasound mode to a tip location mode of the integrated catheter placement system, wherein information displayed on the display of the console changes based on whether the integrated catheter placement system is in the ultrasound mode or in the tip location mode and wherein the ultrasound image is not displayed in the tip location mode;

detecting the magnetic field of the magnetic assembly in the tip location mode when the catheter is within the vasculature of the patient, the magnetic field providing magnetic field information for determining a location of the catheter relative to a tip location sensor of the integrated catheter placement system, the tip location sensor configured to communicate the magnetic field information to the console; and

depicting the location of the catheter on the display of the console.

16. The method for placing as defined in claim 15, further comprising, defining a sterile field such that the catheter is introduced into the vasculature of the patient within the sterile field and the display is outside of the sterile field, and controlling the stages of ultrasonically imaging and detecting the magnetic field without reaching out of the sterile field.

17. The method for placing as defined in claim 16, further comprising:

detecting an electrocardiogram (ECG) signal of a heart node of the patient using an ECG sensor assembly associated with the catheter when the catheter is within the vasculature of the patient;

communicating the ECG signal to the console; and

depicting information related to the ECG signal on the display of the console in the tip location mode.

18. The method for placing as defined in claim 17, further comprising controlling the stage of detecting the ECG signal without reaching out of the sterile field of the patient.

19. The method for placing as defined in claim 18, further comprising selectively displaying information in the ultrasound mode and the tip location mode by user input via the ultrasound probe.