Apparatus for use with needle insertion guidance system

• US 10,238,418 B2
• Filed: 06/30/2015
• Issued: 03/26/2019
• 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: Cox, Jeremy B., Jho, Jiaye Z., Golden, Robert N.
• Primary Examiner(s): Hoffa, Angela M
• Application Number:
  US14/788,305
• Publication Number:
  US 20150297114A1
• Time in Patent Office: 1,365 Days
• Field of Search: None
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• 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 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 5/063 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 5/283 Invasive
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• 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 8/4254 : using sensors mounted on the probe
• CPC Class Codes: A61B 8/4444 : related to the probe
• CPC Class Codes: A61B 8/461 : Displaying means of special interest
• 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 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 : Magnetic means; Magnetic markers

Abstract

An integrated catheter placement system and method for placing a catheter in a patient body. The system may include a system console having a display, a tip location sensor operably connected to the system console and placed onto a body of a patient. The tip location sensor may be designed to sense a magnetic field of a first medical device. The system may also include an ECG tip confirmation component operably connected to the system console via the tip location sensor, and an ultrasound probe operably connected to the system console, the ultrasound probe including one or more magnetic sensors designed to sense a magnetic field of a second medical device different from the first medical device. The system may further include a processor associated with the console designed to utilize data relating to the magnetic field of the second medical device to determine a position and/or orientation thereof.

Claims

1. An integrated catheter placement system, comprising:

a first medical device producing a first magnetic field;

a second medical device producing a second magnetic field;

a system console, including a display;

a tip location sensor operably connected to the system console and adapted to be placed onto a body of a patient, the tip location sensor designed to sense the first magnetic field;

an electrocardiogram (ECG) tip confirmation component operably connected to the system console via the tip location sensor, the ECG tip confirmation component including;

an ECG sensor assembly coupled to the first medical device; and

a reference electrode and a ground electrode adapted to be placed onto the body of the patient;

an ultrasound probe operably connected to the system console, the ultrasound probe including one or more magnetic sensors designed to sense the second magnetic field; and

a processor associated with the console designed to utilize data relating to the sensed second magnetic field to determine a position and/or orientation of the second medical device relative to the one or more magnetic sensors,

wherein the display is designed to show;

an image taken by the ultrasound probe and a depiction of the second medical device positioned and/or oriented with respect to the image based on the determined position and/or orientation of the second medical device relative to the one or more magnetic sensors,

a position of the first medical device relative to the tip location sensor based on the sensed first magnetic field, and

waveform information related to an ECG signal detected by the ECG sensor assembly to indicate a proximity of the ECG sensor assembly to a heart node of the patient.

2. The system according to claim 1, wherein the first medical device comprises a stylet removably positionable within a lumen of a catheter, and wherein the first magnetic field is produced by a magnetic assembly.

3. The system according to claim 2, wherein the magnetic assembly includes a plurality of magnetic elements positioned proximate a distal end of the stylet, and wherein the stylet is designed for positioning in the lumen of the catheter such that the plurality of magnetic elements are substantially proximate a distal tip of the catheter.

4. The system according to claim 3, wherein the plurality of magnetic elements comprise a plurality of permanent magnets.

5. The system according to claim 1, wherein the first medical device comprises a stylet including:

a magnetic assembly;

the ECG sensor assembly including an electrically conductive core wire; and

a first connector in operable communication with the core wire of the ECG sensor assembly, the first connector including a pin contact in operable communication with the core wire, the pin contact disposed in a channel defined in the first connector.

6. The system according to claim 5, further comprising a second connector included with the tip location sensor, the second connector connecting to the first connector to enable the ECG signals detected by the ECG sensor assembly to be communicated to the tip location sensor.

7. The system according to claim 6, wherein the first and second connectors are physically connected via a perforation defined in a drape interposed between the stylet and the tip location sensor, the physical connection of the first and second connectors producing the perforation in the drape and confining the perforation so as to prevent a compromise of a sterile field of the patient.

8. The system according to claim 1, wherein the second medical device is a magnetized needle.

9. The system according to claim 1, wherein the second medical device is a needle, and wherein the second magnetic field is produced by a magnetic element coupled to the needle.

10. The system according to claim 9, wherein the magnetic element is a permanent magnet.

11. The system according to claim 1, wherein the one or more magnetic sensors comprises a plurality of magnetic sensors embedded within a housing of the ultrasound probe.

12. The system according to claim 11, wherein each of the plurality of magnetic sensors is designed to detect the second magnetic field in three spatial dimensions.

13. The system according to claim 12, wherein each of the plurality of magnetic sensors includes orthogonal sensor coils.

14. The system according to claim 11, wherein the plurality of magnetic sensors are designed to continuously detect the second magnetic field, and wherein the system is designed to continuously update a depiction of the second medical device on the display, such that the position and orientation of the second medical device relative to an image produced by the ultrasound probe is continuously updated upon simultaneous movements of the ultrasound probe and the second medical device.

15. The system according to claim 1, wherein 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.

16. The system according to claim 1, wherein the display is designed to show the image taken by the ultrasound probe and the depiction of the second medical device in a first mode, wherein the display is designed to show the position of the first medical device relative to the tip location sensor in a second mode, wherein the display is designed to show the waveform information related to the ECG signal in a third mode, and wherein a desired mode to be shown by the display is selected without a user reaching out of a sterile field of the patient.

17. The system according to claim 16, wherein the waveform information related to the ECG signal in the third mode is a current ECG trace of the heart node of the patient.

18. The system according to claim 16, wherein the display in the second mode is designed to show a first icon to indicate a first proximity of the first medical device to the tip location sensor and a second icon to indicate a depth of the first medical device with respect to the tip location sensor.