System for placement of a catheter including a signal-generating stylet

• US 9,526,440 B2
• Filed: 06/19/2014
• Issued: 12/27/2016
• 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: Burnside, Eddie K., Messerly, Shayne
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US14/309,511
• Publication Number:
  US 20140303492A1
• Time in Patent Office: 922 Days
• Field of Search: 600407-480
• 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 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• 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 5/0833 Measuring rate of oxygen consumption
• 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 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4263 using sensors not mounted on the probe, e.g. mounted on an external reference frame
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61B 8/4472 Wireless probes
• 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 unit for temporary placement on the patient'"'"'s chest, and an ultrasound probe. The tip location sensor senses a field produced by 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 to enable guidance of the catheter tip to a desired position with respect to a node of the patient'"'"'s heart. The stylet includes an electromagnetic coil that can be operably connected to the sensor unit and/or console through a sterile barrier without compromising the barrier. The stylet can also be wirelessly connected to the sensor unit and/or console.

Claims

1. A system for placing a catheter in a patient'"'"'s vasculature, comprising:

a console including a display;

an ultrasound probe for ultrasonically imaging a portion of the patient'"'"'s vasculature for depiction as an ultrasound image on the display, the ultrasound probe configured to communicate imaging information to the console;

a stylet removably positionable in a lumen of the catheter, the stylet including a radiating element capable of producing an electromagnetic field;

a stylet control module connected to the stylet, the stylet control module configured to control operation of the radiating element, wherein the stylet control module includes a timer circuit configured to send electrical pulses at a pulse signal frequency to the radiating element; and

an external sensor configured to detect the electromagnetic field of the radiating element, the electromagnetic field providing electromagnetic field information for determining a position of the catheter with respect to the external sensor during advancement of the catheter in the patient'"'"'s vasculature, the external sensor configured to communicate the electromagnetic field information to the console for depiction on the display with the ultrasound image, wherein at least one of the console and the external sensor includes a circuit configured to synchronize the at least one of the console and the external sensor with the pulse signal frequency.

2. The system according to claim 1, wherein the stylet is positioned within a sterile field, wherein the external sensor is positioned outside of the sterile field, and wherein the external sensor includes a second connector that operably connects to a first connector of the stylet through a sterile barrier without compromising the sterile barrier.

3. The system according to claim 2, wherein the sterile barrier comprises a physical barrier, and one of the first and second connectors includes a piercing component that pierces the physical barrier.

4. The system according to claim 2, wherein the radiating element of the stylet includes an electromagnetic coil that is substantially co-terminal with a distal tip of the catheter when the stylet is positioned in the lumen of the catheter, wherein the sterile barrier is a drape, and wherein the first connector includes a piercing component that pierces the drape.

5. The system according to claim 4, wherein the piercing component includes a first electrical contact that physically engages a second electrical contact of the second connector to electrically interconnect the first and second connectors.

6. The system according to claim 1, wherein the stylet control module is capable of wirelessly transmitting at least one characteristic of the electromagnetic field produced by the radiating element.

7. The system according to claim 6, wherein the at least one characteristic is wirelessly transmitted between the stylet control module and the console.

8. The system according to claim 7, wherein the at least one characteristic that is wirelessly transmitted is transmitted using one of visible, infrared, and RF radiation.

9. The system according to claim 6, wherein the circuit is a phase locking circuit for synchronizing the pulse signal frequency of the electromagnetic field produced by the radiating element with at least one of the console and the external sensor.

10. The system according to claim 1, wherein the stylet control module includes pulse circuitry and the timer circuit is part of the pulse circuitry.

11. The system according to claim 10, wherein the console includes the timer circuit, and the timer circuit is configured to synchronize the console with the pulse signal frequency, and wherein the stylet control module includes a transmitter, wherein the console includes a console receiver, and wherein the transmitter is designed to receive data from the timer circuit relating to the pulse signal frequency of the electrical pulse signal and to transmit the data to the console receiver.

12. The system according to claim 11, wherein the transmitter and console receiver are configured to communicate via infrared or radiofrequency wavelengths.

13. The system according to claim 10, wherein the timer circuit is adjustable to permit adjustment and selection of the pulse signal frequency of the electrical pulse signal.

14. The system according to claim 10, wherein the timer circuit automatically selects one of a plurality of possible frequencies of the electrical pulse signal as the pulse signal frequency, and wherein the console is configured to successively scan the plurality of possible frequencies and perform frequency identification functions to identify the the pulse signal frequency selected by the timer circuit.

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

visualizing a portion of the vasculature using an ultrasound probe for generating an ultrasound image of the portion of the vasculature for display on a console;

inserting a stylet into a catheter, the stylet including a stylet radiating element configured to produce an electromagnetic field, the stylet coupled to a stylet control module including a timer circuit;

introducing the catheter into the vasculature;

positioning a sensor on the patient, the sensor configured to detect the electromagnetic field of the radiating element and to determine a position of the stylet radiating element with respect to the sensor via electromagnetic field information provided by the electromagnetic field;

advancing the catheter and the stylet radiating element through the vasculature;

sending an electrical pulse signal from the stylet control module to the stylet radiating element at a pulse signal frequency;

detecting the stylet radiating element with respect to the sensor;

synchronizing the pulse signal frequency with at least one of the console and the sensor;

determining a position of the catheter with respect to the sensor during the advancing by determining the position of the stylet radiating element with respect to the sensor; and

displaying, on the console, the ultrasound image and a representation of the position of the catheter.

16. The method according to claim 15, wherein the stylet includes a first connector, and wherein the sensor includes a second connector, the method further comprising:

placing a sterile barrier over the sensor; and

connecting the first and second connectors through the sterile barrier.

17. The method according to claim 16, wherein the sterile barrier includes a drape, wherein one of the first and second connectors includes a piercing component, the connecting step comprising penetrating the drape with the piercing component without compromising the sterile barrier.

18. The method according to claim 16, wherein the connecting comprises electrically connecting the sensor to the stylet radiating element.

19. The method according to claim 15, further comprising transmitting data relating to the pulse signal frequency of the electrical pulse signal from the stylet control module to the console via infrared or radiofrequency wavelengths.

20. The method according to claim 19, wherein synchronizing the pulse signal frequency with at least one of the console and the sensor includes synchronizing the pulse signal frequency with the console.