Insertion guidance system for needles and medical components

• US 10,231,753 B2
• Filed: 11/30/2016
• Issued: 03/19/2019
• 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: Burnside, Eddie K., Powers, Kelly B., Messerly, Shayne, Jho, Jiaye Z., Hamatake, Bret
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US15/365,752
• Publication Number:
  US 20170079681A1
• Time in Patent Office: 839 Days
• Field of Search: 600437-469, 606130
• 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 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/467 characterised by special input means
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders

Abstract

A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient 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 detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. The system includes a display for depicting the position and/or orientation of the needle together with the image of the target.

Claims

1. A method of guiding a needle, comprising:

preparing the needle for guidance, the needle including a magnetic element producing a magnetic field;

ultrasonically imaging an image area including an internal body portion target using an ultrasound imaging probe, the ultrasound imaging probe including a plurality of magnetic sensors;

generating magnetic field strength data by continuously sensing the magnetic field of the magnetic element via the plurality of magnetic sensors;

determining a position of the needle relative to the magnetic sensors in three spatial dimensions by processing the magnetic field strength data; and

displaying the position of the needle together with an image of the internal body portion target such that an angle of the needle with respect to the internal body portion target is depicted when the needle is outside of the image area.

2. The method according to claim 1, wherein the magnetic element includes a permanent magnet, further comprising attaching the permanent magnet to a proximal portion of the needle.

3. The method according to claim 2, wherein the permanent magnet includes a hole and a shape of the permanent magnet is selected from the group consisting of a square, a pentagon, a triangle, a rectangle, an oval, an octagon, and a pyramid, wherein the attaching comprises inserting a cannula of the needle through the hole.

4. The method according to claim 2, wherein the magnetic element includes a plurality of permanent magnets, the attaching comprising positioning the plurality of permanent magnets in a hub of the needle.

5. The method according to claim 2, wherein the magnetic element includes at least one bar magnet, the attaching comprising disposing the at least one bar magnet orthogonal to a longitudinal axis of a cannula of the needle.

6. The method according to claim 1, further comprising distributing the magnetic sensors in an arcuate fashion within the ultrasound imaging probe.

7. The method according to claim 1, wherein the needle comprises a barcode or an radio frequency identification (RFID) chip, further comprising storing a length of the needle in the barcode or the RFID chip.

8. The method according to claim 1, further comprising determining a length of the needle by the magnetic field strength data.

9. The method according to claim 1, wherein the plurality of magnetic sensors include orthogonal sensor coils.

10. The method according to claim 1, further comprising continuously updating the image area such that the position and an orientation of the needle with respect to the internal body portion target is continuously updated upon simultaneous movements of the probe and the needle.