Apparatus and methods relating to intravascular positioning of distal end of catheter

• US 10,159,531 B2
• Filed: 09/08/2015
• Issued: 12/25/2018
• Est. Priority Date: 04/05/2012
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Misener, Anthony K., Morgan, Paul D., McLaughlin, William R., Kassab, Ghassan S., Combs, William, Svendsen, Mark, Markowitz, H. Toby
• Primary Examiner(s): Henson, Devin
• Application Number:
  US14/848,331
• Publication Number:
  US 20160067449A1
• Time in Patent Office: 1,204 Days
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• 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 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/063 using impedance measurements
• CPC Class Codes: A61B 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet. In another embodiment, techniques for identifying and locating obstructions in the vessel in which a device is disposed are disclosed.

Claims

1. A placement system for placing a medical device within a body of a patient, comprising:

a stylet including a magnetic assembly configured to produce at least a magnetic field;

a stylet advancement assembly designed to selectively advance a distal end of the stylet a predetermined distance past a distal tip of the medical device;

a sensor placed in proximity to the patient and configured to detect the magnetic field of the magnetic assembly when the medical device is disposed within a vessel of the patient, wherein detection by the sensor of the magnetic field is indicative of a relative location of a portion of the medical device within the vessel of the patient; and

at least a first electrode and a second electrode configured to generate an electric field, the placement system configured to obtain a plurality of field measurements of the electric field when the medical device is disposed in the vessel of the patient, the field measurements indicative of at least one location of a portion of the medical device within the vessel of the patient,

wherein the field measurements are indicative to a user when an obstruction is encountered within the vessel by the medical device, the placement system enabling the user to observe the relative location of the portion of the medical device via detection of the magnetic field of the magnetic assembly by the sensor when the obstruction is encountered.

2. The placement system as defined in claim 1, wherein the medical device is a catheter assembly defining at least one lumen and wherein the sensor is placed on a chest of the patient during placement of the catheter into the vessel.

3. The placement system as defined in claim 2, wherein the magnetic assembly includes a plurality of permanent magnets.

4. The placement system as defined in claim 3, wherein the magnetic assembly included on the stylet is removably disposed within the at least one lumen of the catheter assembly.

5. The placement system as defined in claim 4, wherein the first electrode and the second electrode further include an excitation/detection electrode included on the stylet, an excitation electrode configured for placement on a skin surface of the patient, and a detection electrode configured for placement on the skin surface of the patient.

6. The placement system as defined in claim 5, wherein the stylet, the excitation electrode, and the detection electrode are operably connected to the sensor, and wherein the excitation electrode and the detection electrode are disposed on a lower left portion of an abdomen of the body of the patient.

7. The placement system as defined in claim 1, wherein the placement system is further configured to detect ECG signals from a heart node of the patient to assist a clinician in placing a distal end of the medical device in a desired location within the vessel.

8. The placement system as defined in claim 1, wherein the placement system further includes an ultrasound probe and is capable of ultrasonically imaging a portion of the vessel of the patient.

9. The placement system as defined in claim 1, further including a display that is configured to depict information relating to the plurality of field measurements and information relating to the relative location of the portion of the medical device via detection of the magnetic field of the magnetic assembly.

10. The placement system as defined in claim 9, wherein the information relating to the plurality of field measurements includes a conductance curve and wherein the information relating to the relative location of the portion of the medical device includes an image of the sensor superimposed with the relative location of the portion of the medical device.

11. The placement system as defined in claim 1, wherein the information relating to the plurality of field measurements includes a graphical representation of a relative cross-sectional area of the vessel in which the medical device is disposed.

12. The placement system as defined in claim 1, wherein the stylet advancement assembly includes a housing including a connector designed to connect to a proximal end of the medical device.

13. The placement system as defined in claim 12, wherein the stylet advancement assembly further includes a slider disposed in the housing, the slider coupled to the stylet via a stylet retainer, the slider designed to translate from a retracted position to an extended position within the housing.

14. The placement system as defined in claim 13, wherein the distal end of the stylet is in the medical device in the slider retracted position, and wherein the distal end of the stylet is distal of the distal tip of the medical device in the extended position.

15. The placement system as defined in claim 13, wherein the stylet retainer comprises a pierceable septum.