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

• US 10,105,121 B2
• Filed: 11/30/2016
• Issued: 10/23/2018
• 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: Burnside, Eddie K., Messerly, Shayne
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US15/365,734
• Publication Number:
  US 20170079615A1
• Time in Patent Office: 692 Days
• Field of Search: 600437-469
• 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

A positioning system includes a console, an ultrasound probe, a stylet, a stylet control module, and an external sensor. The console includes a display. The ultrasound probe is designed to communicate imaging information to the console. The stylet includes a radiating element capable of producing an electromagnetic field, the electromagnetic field providing electromagnetic field information. The stylet control module includes a timer circuit designed to send electrical pulses at a pulse signal frequency to the radiating element. The external sensor is designed to detect the electromagnetic field and to determine a position of the radiating element with respect to the external sensor as the stylet is advanced in a vasculature of a patient, the external sensor designed to communicate the electromagnetic field information to the console. The system may include a circuit configured to synchronize at least one of the console and the external sensor with the pulse signal frequency.

Claims

1. A positioning system, comprising:

a console including a display;

an ultrasound probe designed to communicate ultrasound imaging information to the console;

a stylet including a radiating element capable of producing an electromagnetic field, the electromagnetic field providing electromagnetic field information;

a stylet control module including a timer circuit designed to send electrical pulses at a pulse signal frequency to the radiating element; and

an external sensor designed to detect the electromagnetic field and to determine a position of the radiating element with respect to the external sensor as the stylet is advanced in a vasculature of a patient, the external sensor designed to communicate the electromagnetic field information to the console;

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 positioning system according to claim 1, wherein the console utilizes the ultrasound imaging information and the electromagnetic field information to present images and depictions on the display.

3. The positioning system according to claim 2, wherein the stylet is positioned in a catheter such that the radiating element is adjacent a distal end of the catheter, and wherein the catheter is advanced in the vasculature of the patient together with the stylet.

4. The positioning system according to claim 3, 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.

5. The positioning system according to claim 4, 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.

6. The positioning system according to claim 4, 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 a lumen of the catheter, wherein the sterile barrier is a drape, and wherein the first connector includes a piercing component that pierces the drape.

7. The positioning system according to claim 6, 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.

8. The positioning 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.

9. The positioning system according to claim 8, wherein the at least one characteristic is wirelessly transmitted between the stylet control module and the console.

10. The positioning system according to claim 9, wherein the at least one characteristic that is wirelessly transmitted is transmitted using one of visible, infrared, and RF radiation.

11. The positioning system according to claim 8, wherein the circuit is a phase locking circuit for synchronizing the pulse signal frequency of the electromagnetic field produced by the radiating element with the at least one of the console and the external sensor.

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

13. The positioning system according to claim 12, wherein the console includes the circuit, and the 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 an electrical pulse signal and to transmit the data to the console receiver.

14. The positioning system according to claim 13, wherein the transmitter and the console receiver are configured to communicate via infrared or radiofrequency wavelengths.

15. The positioning system according to claim 12, wherein the timer circuit is adjustable to permit adjustment and selection of the pulse signal frequency of the electrical pulse signal.

16. The positioning system according to claim 12, 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 pulse signal frequency selected by the timer circuit.