Apparatus for use with needle insertion guidance system

• US 10,342,575 B2
• Filed: 10/03/2016
• Issued: 07/09/2019
• 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., Burnside, Eddie K.
• Primary Examiner(s): Hoffa, Angela M
• Application Number:
  US15/284,355
• Publication Number:
  US 20170020561A1
• Time in Patent Office: 1,009 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

A guidance system for assisting with the insertion of a needle into a patient body is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. The needle can include a donut-shaped magnet disposed about the needle cannula, or a removable stylet with a magnetic element and a strain gauge for detection of the needle distal tip.

Claims

1. A guidance system, comprising:

a needle configured for insertion into a patient, wherein the needle is magnetized to produce a magnetic field;

an ultrasound imaging probe configured to ultrasonically image an image area including an internal portion of the patient, the ultrasound imaging probe including one or more sensors configured to sense the magnetic field;

a processor configured to use data relating to the magnetic field sensed by the one or more sensors to determine a position of the needle in three spatial dimensions relative to the ultrasound imaging probe; and

a display configured to depict an image of the internal portion of the patient produced by the ultrasound imaging probe and a depiction representative of the needle with respect to the image of the internal portion of the patient based on the position determined by the processor, wherein an approach to the internal portion of the patient is depicted when the needle is outside of the image area.

2. The guidance system according to claim 1, wherein the needle further comprises a strain gauge for detecting a bending of the needle.

3. The guidance system according to claim 2, wherein the strain gauge is included on a stylet configured for insertion into a lumen of the needle.

4. The guidance system according to claim 1, wherein the one or more sensors comprises an annular sensor disposed on an external portion of the ultrasound imaging probe proximate a head portion of the ultrasound imaging probe.

5. The guidance system according to claim 1, wherein the one or more sensors include orthogonal sensor coils to enable the processor to determine a pitch and a yaw attitude of the needle.

6. The guidance system according to claim 1, wherein the one or more sensors comprise a plurality of magnetic sensors embedded within a housing of the ultrasound imaging probe.

7. The guidance system according to claim 6, wherein each of the plurality of magnetic sensors is configured for detection of the magnetic field in three spatial dimensions.

8. The guidance system according to claim 7, wherein each of the plurality of magnetic sensors includes orthogonal sensor coils.

9. The guidance system according to claim 6, wherein the plurality of magnetic sensors are configured to continuously detect the magnetic field, and wherein the guidance system is configured to continuously update the image of the image area, such that the position of the needle with respect to the image area is continuously updated.