Insertion guidance system for needles and medical components

• US 9,554,716 B2
• Filed: 05/27/2011
• Issued: 01/31/2017
• 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:
  US13/118,033
• Publication Number:
  US 20110282188A1
• Time in Patent Office: 2,076 Days
• Field of Search: 600/407, 600/509, 600/424, 600/443, 600/529, 600/528, 600/409, 600/447, 600/428, 600/587, 604/523, 604/194, 604/585, 604/564, 606/129
• US Class Current: 1/1
• 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 guidance system, comprising:

an ultrasound imaging device including a probe for ultrasonically imaging an image area including an internal body portion target;

a needle including a magnetic element attached to a proximal portion thereof;

a plurality of magnetic sensors included with the probe, each of the plurality of magnetic sensors configured to continuously sense a magnetic field of the magnetic element of the needle in order to generate magnetic field strength data;

a processor configured to receive the magnetic field strength data sensed by the magnetic sensors to determine a position of the needle relative to the magnetic sensors in three spatial dimensions; and

a display, wherein the guidance system is configured such that the display can depict the determined position of the needle together with an image of the internal body portion target provided by the ultrasound imaging device with the determined position and the image oriented such that an angle of the needle'"'"'s approach to the internal body portion target is depicted when the needle is outside of the image area.

2. The guidance system as defined in claim 1, wherein the magnetic element includes a permanent magnet that is disposed in a hub of the needle, and wherein no physical connection exists between the magnetic element and the magnetic sensors.

3. The guidance system as defined in claim 1, wherein the magnetic sensors are distributed in an arcuate fashion within the probe.

4. The guidance system as defined in claim 1, wherein the magnetic element includes a permanent magnet defining a hole through which a cannula of the needle is received, and wherein a shape of the permanent magnet defines one of a square, a pentagon, a triangle, a rectangle, an oval, an octagon, and a pyramid.

5. The guidance system as defined in claim 1, wherein the magnetic element includes a plurality of permanent magnets included in a hub of the needle.

6. The guidance system as defined in claim 1, wherein the magnetic element includes at least one bar magnet disposed orthogonal to a longitudinal axis of a cannula of the needle.

7. The guidance system as defined in claim 1, wherein the needle includes a length, and the guidance system is configured such that the length of the needle can be input into the system prior to use.

8. The guidance system as defined in claim 7, wherein the system is configured such that the length of the needle can be stored in a barcode or an RFID chip included with the needle.

9. The guidance system as defined in claim 1, wherein a length of the needle is determined by a magnetic field strength of the magnetic element.

10. A guidance system, comprising:

a needle including a magnetic element attached to a proximal portion thereof;

an ultrasound imaging probe physically independent from the needle for ultrasonically imaging an image area including an internal body portion target;

a plurality of magnetic sensors included with the probe, each of the plurality of magnetic sensors configured to continuously sense a magnetic field of the magnetic element in order to generate magnetic field strength data;

a processor configured to receive the magnetic field strength data sensed by the magnetic sensors to determine a location and orientation of the needle relative to the magnetic sensors; and

a display, wherein the guidance system is configured such that the guidance system can depict an image of the internal body portion target taken by the ultrasound imaging probe and a representation of the needle oriented and located with respect to the image on the display such that an angle of the needle'"'"'s approach to the internal body portion target is depicted when the needle is outside of the image area, the representation expressing the determined position and orientation of the needle relative to the internal body portion target.

11. The guidance system as defined in claim 10, wherein the magnetic element is disposed within a hub of the needle, and the plurality of magnetic sensors are disposed within the probe.

12. A guidance system, comprising:

an ultrasound imaging probe for ultrasonically imaging an image area including an internal body portion target;

a medical device separate from the probe configured for insertion into the internal body portion target, the medical device having a magnetic field associated therewith;

a plurality of magnetic sensors associated with the probe, each of the plurality of magnetic sensors configured to sense the magnetic field of the medical device in order to generate magnetic field strength data;

a processor configured to receive the magnetic field strength data sensed by the magnetic sensors to determine a position and orientation of the medical device relative to the probe; and

a display, wherein the guidance system can be operated such that the display shows an image of the internal body portion target taken by the ultrasound imaging probe and a representation of the medical device the representation expressing the determined position and orientation of the medical device relative to the internal body portion target, and wherein an angle of the medical device'"'"'s approach to the internal body portion target can be depicted when the medical device is outside of the image area.

13. The guidance system as defined in claim 12, wherein the medical device is a needle, and the internal body portion target is a blood vessel.

14. The guidance system as defined in claim 12, wherein the magnetic field is provided by a magnetic element coupled to the medical device.

15. The guidance system as defined in claim 14, wherein the magnetic element is disposed within a hub of the medical device, and the plurality of magnetic sensors are disposed within the probe.

16. The guidance system as defined in claim 14, wherein the magnetic element is a permanent magnet.

17. The guidance system as defined in claim 12, wherein each of the magnetic sensors are configured for detection of a magnetic field in three spatial dimensions.

18. The guidance system as defined in claim 17, wherein each of the magnetic sensors includes orthogonal sensor coils.

19. The guidance system as defined in claim 12, wherein the magnetic sensors are configured to continuously detect the magnetic field, and wherein the system is configured to continuously update the image, such that the position and orientation of the medical device with respect to the image is continuously updated as simultaneous movements of the probe and the medical device occur.