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

• US 8,781,555 B2
• Filed: 03/02/2010
• Issued: 07/15/2014
• 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): Le, Long V.
• Assistant Examiner(s): LARYEA, LAWRENCE N
• Application Number:
  US12/715,556
• Publication Number:
  US 20100204569A1
• Time in Patent Office: 1,596 Days
• Field of Search: 600/407, 600/509, 600/424, 600/443, 600528-529, 600/409, 600/447, 600/428, 600/587, 600/121, 604/523, 604/194, 604/585, 604/264, 604/95.01, 606/129, 128845-849, 128/852, 607/5
• US Class Current: 600/424
• 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 locator for locating a portion of a stylet within a body of a patient, comprising:

a stylet that is positionable in a lumen of a catheter including a first connector disposed at a proximal end thereof;

a radiating element included with the stylet, the radiating element capable of producing an electromagnetic field; and

an external sensor unit positionable on a chest portion of the patient capable of detecting the electromagnetic field of the radiating element after the stylet is adapted to be positioned at least partially within the body of the patient, the external sensor unit includes a second connector, the first and second connectors are operably connectable such that the external sensor is operably connected to the radiating element through a physical barrier that provides at least a portion of a sterile barrier interposed therebetween without compromising the sterile barrier, and one of the first and second connectors includes a piercing component that pierces the physical barrier.

2. The locator as defined in claim 1, wherein the piercing component includes a first electrical contact that physically engages a second electrical contact of the other connector to electrically interconnect the first and second connectors.

3. The locator as defined in claim 2, further comprising a control module for controlling operation of the radiating element.

4. The locator as defined in claim 3, wherein the control module is capable of wirelessly transmitting at least one characteristic of the electromagnetic field produced by the radiating element.

5. The locator as defined in claim 4, wherein the at least one characteristic is transmitted between the control module and a component of a system for assisting in placement of the stylet.

6. The locator as defined in claim 4, further comprising a phase locking circuit for synchronizing a frequency of the electromagnetic field produced by the radiating element.

7. The locator as defined in claim 4, wherein the characteristic that is wirelessly transmitted is transmitted using one of visible, infrared, and RF radiation.

8. The locator as defined in claim 1, wherein the radiating element includes a first connector and the sensor unit includes a second connector, and one of the first and second connectors are configured to penetrate and operably connect to the other of the first and second connector after the sterile barrier is created without compromising the sterile barrier.

9. The locator as defined in claim 8, wherein one of the first and second connectors includes a piercing component to create a passage through a physical barrier creating a portion of the sterile field when the first and second connectors are mated, and wherein the first and second connectors interconnect when mated to enclose the passage and preserve the sterility of the sterile barrier.

10. A method for establishing a connection between a radiating element included with an implantable stylet and an external sensor unit through a sterile barrier, the method comprising:

positioning a stylet in a lumen of a catheter including a first connector disposed at a proximal end thereof having a radiating element included with the stylet, the radiating element capable of producing an electromagnetic field;

positioning the sensor unit on a patient capable of detecting the electromagnetic field of the radiating element after the stylet is adapted to be positioned at least partially within the body of the patient, the external sensor unit includes a second connector;

placing the sterile barrier over the sensor unit; and

operably connecting the first and second connectors such that the radiating element is operably connected to the sensor unit by penetrating a physical barrier that provides at least a portion of the sterile barrier with a piercing component of one of the first and second connectors without compromising the sterile barrier.

11. The method for establishing a connection as defined in claim 10, wherein the sterile barrier is a drape.

12. The method for establishing a connection as defined in claim 11, wherein operably connecting the radiating element further comprises:

penetrating the sterile barrier with the piercing element, the piercing element being electrically connected to the radiating element.

13. The method for establishing a connection as defined in claim 10, wherein operably connecting the radiating element to the sensor unit further comprises:

operably connecting the radiating element located in a sterile field to the sensor unit located outside of the sterile field.

14. The method for establishing a connection as defined in claim 13, wherein the radiating element is removably included with the stylet, and wherein the method further comprises:

physically connecting a tether connector operably connected to the radiating element with a connector of the sensor unit, the sterile barrier being interposed therebetween before the physical connection.

15. The method for establishing a connection as defined in claim 10, further comprising:

inserting the stylet including the radiating element in the body of the patient; and

monitoring a field produced by the radiating element.

16. The method for establishing a connection as defined in claim 10, further comprising creating a passage through a physical barrier that creates a portion of the sterile barrier with a connector of one of the radiating element and the sensor unit after the sterile barrier is placed over the sensor unit.

17. A locator for locating a portion of a medical device within a body of a patient, comprising:

a stylet that is positionable in a lumen of a catheter including a first connector disposed at a proximal end thereof;

a radiating element included with the stylet, the radiating element capable of producing an electromagnetic field, 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; and

an external sensor unit positionable on a chest portion of the patient capable of detecting the electromagnetic field of the radiating element after the stylet is adapted to be positioned at least partially within the body of the patient, the external sensor unit includes a second connector, the first and second connectors are operably connectable such that the external sensor is operably connected to the radiating element through a drape that provides at least a portion of a sterile barrier interposed therebetween without compromising the sterile barrier, the first connector includes a piercing component that pierces the drape, the piercing component including an electrical contact.

18. The locator as defined in claim 17, wherein the electrical contact physically engages a second electrical contact of the second connector to electrically interconnect the first and second connectors.

19. The locator as defined in claim 17, further comprising a control module for controlling operation of the radiating element.

20. The locator as defined in claim 19, wherein the control module is capable of wirelessly transmitting at least one characteristic of the electromagnetic field produced by the radiating element.

21. The locator as defined in claim 20, further comprising a phase locking circuit for synchronizing a frequency of the electromagnetic field produced by the radiating element.