Surgical device guidance and monitoring devices, systems, and methods

• US 10,154,799 B2
• Filed: 08/10/2017
• Issued: 12/18/2018
• Est. Priority Date: 08/12/2016
• Status: Active Grant

• Current Assignee: Elucent Medical, Inc.
• Original Assignee: Elucent Medical, Inc.
• Inventors: van der Weide, Daniel W., van der Weide, Noah, Rudie, Eric N., Miel, David, Wilke, Lee G., Lee, Jr., Fred T.
• Primary Examiner(s): LAURITZEN, AMANDA L
• Application Number:
  US15/674,455
• Publication Number:
  US 20180042517A1
• Time in Patent Office: 495 Days
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• 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 5/0068 Confocal scanning
• 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 5/064 using markers A61B5/062 takes precedence
• 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 5/6886 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 6/4241 using energy resolving detectors, e.g. photon counting
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: G06K 7/10386 the interrogation device being of the portable or hand-handheld type, e.g. incorporated in ubiquitous hand-held devices such as PDA or mobile phone, or in the form of a portable dedicated RFID reader
• CPC Class Codes: H01Q 1/2208 : associated with components used in interrogation type services, i.e. in systems for information exchange between an interrogator/reader and a tag/transponder, e.g. in Radio Frequency Identification [RFID] systems methods or arrangements for sensing record carriers, e.g. for reading patterns G06K7/00; record carrier for use with machines and with at least a part designed to carry digital markings G06K19/00
• CPC Class Codes: H01Q 1/2225 : used in active tags, i.e. provided with its own power source or in passive tags, i.e. deriving power from RF signal

Abstract

Provided herein are systems, devices, assemblies, and methods for localization of one or more tags in a patient.

Claims

1. A system comprising:

a) an attachment component comprising at least one location emitter, wherein said attachment component is configured to be attached to a hand-held medical device with a device tip;

b) a display component attached to, or integral with, said attachment component, wherein said display component comprises a display screen, and

c) a tag, said tag comprising an antenna, wherein said tag is physically separate from, and not physically linked to, any of;

said attachment component, said display component, and said hand-held medical device; and

wherein said display screen is configured to receive data about the position of said tag and said medical device from a computer system, wherein said computer system is configured to receive information from a plurality of witness stations and generate said data, and

wherein said display screen displays;

i) a tag indicator which corresponds to the physical location of said tag, and

ii) at least one of the following additional indictors;

A) a total distance indicator which indicates the distance of said device tip to said tag,

B) a medical device indicator which corresponds to the location of said medical device with respect to said tag,

C) a tag-tip vector indicator which provides a representation of the two-dimensional distance, and two-dimensional location, of said device tip to said tag; and

D) a depth indicator which provides an indication of how high above, or below, the device tip is with respect to said tag.

2. The system of claim 1, wherein said tag emits a sideband at a defined frequency upon activation by a magnetic field.

3. The system of claim 1, further comprising said hand-held medical device.

4. The system of claim 1, wherein said attachment component comprises at least two location emitters.

5. The system of claim 1, wherein said attachment component:

i) comprises a sheath that slides over said hand-held medical device, or ii) clips on to said hand-held medical device.

6. The system of claim 1, further comprising a remote activating device that generates a magnetic field within a region of said tag and said at least one location emitter.

7. The system of claim 1, wherein said display screen has an area between 3 and 18 square inches.

8. The system of claim 1, wherein said display component is moveable with respect to said attachment component such that said display screen may be viewed in different positions.

9. The system of claim 1, wherein said tag indicator comprises a schematic image of said tag.

10. The system of claim 1, wherein said display screen is at least partially see through, which allows a user to view images on said display screen, while still being able to look through said display screen.

11. The system of claim 1, wherein medical device indicator comprises a schematic image of said hand-held medical device.

12. The system of claim 1, wherein said tag-tip vector indicator does not provide depth to tag information.

13. The system of claim 1, wherein said total distance indicator comprises at least one of a numerical representation and a graphical magnitude symbol.

14. The system of claim 1, wherein said depth indicator comprises at least one of a numerical representation and graphical magnitude symbol.

15. The system of claim 1, wherein said at one of said additional indicators comprises at least two of said additional indicators.

16. The system of claim 1, wherein said at least one of said additional indicators comprises at least three of said additional indicators.

17. The system of claim 1, wherein said display screen further displays one or more guides for performing a procedure.

18. The system of claim 1, wherein said one or more guides comprises symbols directing a user how to move said hand-held medical device to accomplish a task.

19. The system of claim 1, wherein said tag emits a sideband at a frequency defined by a number programmed into said tag.

20. The system of claim 1, further comprising a remote activating device comprising a pad configured to be placed in proximity to a patient having said tag embedded in said patient.

21. The system of claim 1, further comprising said plurality of witness stations, wherein said plurality of witness stations each comprise a lock-in amplifier tuned to a frequency of a sideband from said tag.

22. The system of claim 1, wherein said one or more location emitters comprise an antenna, wherein said emitters emits sidebands at defined frequencies upon activation by a magnetic field.

23. The system of claim 1, wherein said one or more emitters comprise at least two emitters positioned to permit a plurality of witness stations to detect orientation of said hand-held medical device relative to said tag.

24. The system of claim 1, wherein said display screen further displays a directional indicator which provides information for moving or positioning the medical device.

25. The system of claim 24, wherein said directional indicator comprises an image of said medical device that is distinct from said medical device indicator.

26. The system of claim 1, further comprising said plurality of witness stations, each said witness station comprising an antenna configured to detect information:

i) emitted from said tag or changes in a magnetic field generated by a remote activating device in response to said tag; and

ii) emitted from said at least one location emitter or changes in a magnetic field generated by said remote activating device in response to said at least one emitter.

27. The system of claim 26, further comprising said remote activating device, wherein said remote activating device generates a magnetic field.

28. The system of claim 1, wherein said tag antenna comprises a coil antenna.

29. The system of claim 28, wherein said coil antenna resonates at 100-200 kHz.

30. The system of claim 28, wherein said coil antenna is coupled to an integrated circuit.