Integrated systems for intravascular placement of a catheter

• US 10,165,962 B2
• Filed: 05/08/2013
• Issued: 01/01/2019
• 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): HOFFA, ANGELA MARIE
• Application Number:
  US13/890,158
• Publication Number:
  US 20130245434A1
• Time in Patent Office: 2,064 Days
• Field of Search: 600439-451, 600456, 600462, 604523, 604 94, 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 placing a catheter in a vasculature of a patient, comprising:

an ultrasound probe that ultrasonically images an internal portion of the patient in an ultrasound mode prior to introduction of the catheter into the vasculature;

a magnetic assembly included with the catheter and designed to produce a magnetic field;

an electrocardiogram (ECG) tip confirmation component configured to obtain an intravascular ECG signal indicative of 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 operably coupled to the catheter to measure an intravascular ECG signal;

a tip location sensor positionable on 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;

at least one console configured to receive the magnetic field information and the intravascular ECG signal; and

a display configured to simultaneously display

a graphical representation of the magnetic assembly based on the magnetic field information; and

in an ECG tip confirmation mode, successive ECG waveforms based on the data obtained using the ECG tip confirmation component, wherein the successive ECG waveforms change in relation to the proximity of the distal tip of the catheter to the sino-atrial node.

2. The system as defined in claim 1, wherein the ultrasound probe includes user input controls and wherein functionality of both the ultrasound probe and the ECG tip confirmation component is controllable within a sterile field established about a portion of the patient by the user input controls on the ultrasound probe.

3. The system as defined in claim 2, wherein the magnetic assembly includes a stylet disposed in a lumen of the catheter to produce the magnetic field, and wherein the tip location sensor and the ultrasound probe are operably connected to the at least one console.

4. The system as defined in claim 3, wherein the ECG sensor assembly is included with the stylet disposed in the catheter lumen.

5. The system as defined in claim 4, wherein the ECG tip confirmation component further includes at least one electrode placed onto a body of the patient and wherein the at least one electrode and the ECG sensor assembly are operably coupled to the at least one console via the tip location sensor.

6. The system as defined in claim 1, wherein the at least one console comprises a first console and a second console, wherein the ultrasound probe is operably connected to the first console and wherein the ECG sensor assembly is operably connected to the second console, at least one of the first and second consoles including the display.

7. The system as defined in claim 1, further comprising an ECG electrode configured to generate a reference ECG waveform, wherein the reference ECG waveform is configured to be displayed on the display in the ECG tip confirmation mode.

8. A method for placing a catheter within a vasculature of a patient via a catheter placement system including a display, an ultrasound probe with a plurality of buttons thereon to call one or more modes to the display, an electrocardiogram (ECG) sensor assembly, a tip location sensor, a console, and the catheter, wherein the catheter includes a magnetic assembly designed to produce a magnetic field, the method comprising:

ultrasonically imaging with the ultrasound probe a portion of the vasculature for depiction on the display in an ultrasound mode;

introducing the catheter into the vasculature of the patient following the imaging;

detecting, for depiction on the display, a first ECG signal and a successive second ECG signal of a heart node of the patient by the ECG sensor assembly at least partially disposed within the catheter when the catheter is within the vasculature of the patient;

detecting, with the tip location sensor positioned on the patient, 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;

receiving, with the console, the magnetic field information and the first ECG signal and the successive second ECG signal; and

displaying simultaneously on the display;

in a tip location mode, a graphical representation of the magnetic assembly based on the magnetic field information; and

in an ECG tip confirmation mode, a first ECG waveform based on the first ECG signal, and a successive second ECG waveform based on the successive second ECG signal, wherein the first ECG waveform and the successive second ECG waveform are each indicative of different distances between a distal tip of the catheter and the heart node.

9. The method for placing as defined in claim 8, further comprising controlling at least one of the stages of ultrasonically imaging, detecting the first ECG signal, and detecting the magnetic field without reaching out of a sterile field of the patient.

10. The method for placing as defined in claim 8, wherein the plurality of buttons includes a button to call the ultrasound mode to the display, further comprising the step of calling the ultrasound mode to the display.

11. The method for placing as defined in claim 8, wherein the plurality of buttons includes a button to call the tip location mode to the display, further comprising the step of calling the tip location mode to the display.

12. The method for placing as defined in claim 8, wherein the plurality of buttons includes a button to call the ECG tip confirmation mode to the display, further comprising the step of calling the ECG tip confirmation mode to the display.

13. The method for placing as defined in claim 8, wherein the plurality of buttons includes a button to call the ECG tip confirmation mode to the display and a button to call the tip location mode to the display, further comprising the step of calling both the ECG tip confirmation mode and the tip location mode to the display.

14. The method for placing as defined in claim 8, wherein the catheter placement system further comprises an ECG electrode configured to generate a reference ECG waveform, wherein the step of displaying on the display, in the ECG tip confirmation mode, includes displaying the reference ECG waveform.

15. A catheter placement system for inserting a catheter into a vasculature of a patient, comprising:

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

a magnetic assembly configured to produce a magnetic field; and

an electrocardiogram (ECG) sensor assembly configured to detect ECG signals of a node of a heart of the patient;

a tip location sensor positionable on a portion of a body 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 ECG sensor assembly operably connected to the tip location sensor to enable the ECG signals detected by the ECG sensor assembly to be communicated to the tip location sensor; and

a display configured to simultaneously display;

a graphical representation of the magnetic assembly based on the magnetic field information; and

successive ECG waveforms based on the ECG signals detected by the ECG sensor assembly, wherein the successive ECG waveforms change in relation to the proximity of a distal end of the stylet to the node of the heart and the successive ECG waveforms indicate when a target proximity of the distal end of the stylet to the node of the heart has been achieved.

16. The system as defined in claim 15, wherein at least one processor is included in the tip location sensor to process data relating to the ECG signals detected by the ECG sensor assembly and wherein the display is included on a console for displaying the successive ECG waveforms based on the ECG signals detected by the ECG sensor assembly.