Systems and methods for guiding a medical instrument

• US 9,521,961 B2
• Filed: 12/23/2011
• Issued: 12/20/2016
• 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: Silverstein, Fred E., Golden, Robert N.
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US13/336,919
• Publication Number:
  US 20120143029A1
• Time in Patent Office: 1,824 Days
• Field of Search: 324/311, 324/322, 600407-480, 600/12, 600/30, 600/584
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/374 NMR or MRI
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• 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 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/4472 Wireless probes
• 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 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders

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. In other embodiments, a guidance system for guiding rigid or other medical instruments is disclosed, together with various example implementations thereof.

Claims

1. A tracking system, comprising:

a medical device, the medical device including a distal portion adapted for insertion into a body of a patient and a proximal portion adapted to remain external to the body of the patient, the proximal portion of the medical device at least temporarily having a magnetic element attached thereto;

a first medical imaging system configured to image a first body portion of the patient, the first medical imaging system configured to sense a magnetic field of the magnetic element in order to generate magnetic field strength data;

a tracking circuit configured to track movement of the medical device relative to the first medical imaging system, the tracking circuit including;

a processor configured to receive the magnetic field strength data and compute position data of the medical device, the position data of the medical device including three-dimensional data regarding a position of the distal portion of the medical device; and

a memory for storing the position data; and

a second medical imaging system configured to image a second body portion of the patient.

2. The tracking system as defined in claim 1, wherein the first medical imaging system includes a display configured to show an image of the distal portion of the medical device with respect to the first body portion of the patient.

3. The tracking system as defined in claim 2, wherein the first and second body portions imaged by the first and second medical imaging systems are similar in location within the patient.

4. The tracking system as defined in claim 3, wherein the image of the distal portion of the medical device, the image of the first body portion, and the image of the second body portion are superimposed atop one another.

5. The tracking system as defined in claim 3, wherein the first medical imaging system is ultrasound based and wherein the second medical imaging system is radiographically based and capable of producing a three dimensional image of the second body portion of the patient.

6. The tracking system as defined in claim 3, wherein the first medical imaging system is configured to track a position of a first medical device and wherein the second medical imaging system is configured to track a position of a second medical device, the positions of the first and second medical devices being depicted on the display.

7. The tracking system as defined in claim 1, wherein at least a distal tip of the medical device as tracked by the tracking circuit is depicted by a display of the first medical imaging system.

8. The tracking system as defined in claim 7, wherein the medical device includes a needle, and wherein the first medical imaging system is an ultrasound probe.

9. The tracking system as defined in claim 8, wherein the needle includes one of a straight, curved, and spiral shape, and wherein the needle further includes an ergonomically shaped handle to ease grasping by a user.

10. The tracking system as defined in claim 8, wherein the needle includes at least two spaced apart permanent magnets, the needle further being configured to deposit fiducial markers or markers in the body of the patient.

11. The tracking system as defined in claim 8, wherein the needle includes at least one marker that is detectable by an encoder disposed proximate the needle.

12. The tracking system as defined in claim 8, wherein the needle includes at least one of a biomarker, an ultrasound transceiver, a camera, and a radiofrequency identification (RFID) chip.

13. The tracking system as defined in claim 8, wherein the needle include at least one of an electrode for detecting ECG signals, a tissue removal blade and cavity, an anchor for securing the needle to tissue, a thermal ablation component, and a pressure sensor.

14. The tracking system as defined in claim 1, wherein the magnetic element is a permanent magnet.

15. The tracking system as defined in claim 14, further comprising a plurality of magnetic sensors associated with the first medical imaging system, the magnetic sensors configured to sense the magnetic field in three spatial dimensions.

16. The tracking system as defined in claim 15, wherein each of the magnetic sensors includes orthogonal sensor coils.

17. The tracking system as defined in claim 15, wherein the magnetic sensors are configured to continuously sense the magnetic field and to continuously generate the magnetic field strength data.

18. A method for tracking a medical device with respect to a body of a patient, the method comprising:

obtaining the medical device, the medical device including a proximal portion adapted to remain external to the body of the patient a distal portion adapted for insertion into the body of the patient, and a magnetic element located on the proximal portion, wherein the distal portion is rigid;

imaging a first body portion with a first medical imaging system, the first medical imaging system configured to detect a magnetic field of the magnetic element and to depict the distal portion of the medical device on a display;

detecting the magnetic field of the magnetic element in order to generate magnetic field strength data;

determining a position of the distal portion of the medical device according to the detected magnetic field strength data;

depicting on the display the position of the distal portion of the medical device together with the first body portion;

imaging a second body portion with a second medical imaging system; and

depicting the second body portion together with the position of the distal portion of the medical device and the first body portion.

19. The method for tracking as defined in claim 18, wherein the first and second body portions are substantially the same and images thereof are superimposed atop one another in an interlaced manner.

20. The method for tracking as defined in claim 18, wherein a first medical device is imaged by the first medical imaging system and wherein a second medical device is imaged by the second medical imaging system.

21. The method for tracking as defined in claim 20, wherein the second medical device is employed to produce an image of a virtual distal portion of the second medical device within the body of the patient.

22. The method for tracking as defined in claim 18, wherein the method is iteratively performed so as to track advancement of the medical device within the body of the patient.

23. The method for tracking as defined in claim 18, wherein the magnetic element is a permanent magnet.

24. The method for tracking as defined in claim 23, further comprising a plurality of magnetic sensors associated with the first medical imaging system, the magnetic sensors configured to detect the magnetic field in three spatial dimensions.

25. The method for tracking as defined in claim 24, wherein each of the magnetic sensors includes orthogonal sensor coils.

26. The method for tracking as defined in claim 24, wherein the magnetic sensors are configured to continuously detect the magnetic field and to continuously generate the magnetic field strength data.