Device and method for identifying anatomical structures

• US 10,154,826 B2
• Filed: 07/12/2014
• Issued: 12/18/2018
• Est. Priority Date: 07/17/2013
• Status: Active Grant

• Current Assignee: Avaz Surgical, LLC
• Original Assignee: Tissue Differentiation Intelligence, LLC
• Inventors: Singh, Kern, Gupta, Sachin, Oelze, Michael
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): Yang, Yi-Shan
• Application Number:
  US14/329,940
• Publication Number:
  US 20160354056A1
• Time in Patent Office: 1,620 Days
• Field of Search: None
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 2017/00438 connectable to a finger
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 42/10 Surgical gloves
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A method for identifying a target anatomy by use of a device having an ultrasound transducer. Using the ultrasound transducer, a portion of a patient'"'"'s anatomy is scanned during a scanning process. A voltage trace of the patient'"'"'s anatomy is determined and compared to a predetermined trace. If the voltage trace of the patient'"'"'s anatomy matches the predetermined trace, a notification may be output.

Claims

1. A real-time, quantitative method for distinguishing nerve tissue from surrounding tissue during a medical procedure on a mammalian patient, the method comprising:

ultrasonically scanning, by an array of ultrasound transducers disposed on a device used in said procedure, a region of said patient'"'"'s anatomy to generate a b-mode image of said region of said patient'"'"'s anatomy;

identifying image texture and echogenicity information from a digital representation of anatomical structures in said b-mode image;

identifying at least one voltage trace associated with an anatomical tissue from at least one scan line from said digital representation of anatomical structures in said b-mode image;

comparing said at least one identified voltage trace to a predetermined voltage trace representing said nerve tissue;

determining a presence or an absence of a spectral signature of said nerve tissue in said at least one identified voltage trace based on the comparison;

determining said anatomical tissue associated with said at least one identified voltage trace to be said nerve tissue if said spectral signature of said nerve tissue is present;

upon a determination that said anatomical tissue associated with said at least one identified voltage trace is said nerve tissue, generating a 2-dimensional image of said nerve tissue on an output display displaying said b-mode image; and

generating at least one notification to a user to indicate a proximity of said device to said nerve tissue, wherein said at least one notification includes at least one of a color and an audible alarm indicating that said device is within a predetermined distance of said nerve tissue.

2. The method of claim 1, wherein said at least one notification enables avoidance of said nerve tissue as said device is advanced through said patient'"'"'s anatomy.

3. The method of claim 1, wherein said device is configured to be rotated about a longitudinal axis of said device for ultrasonically scanning a region of said patient'"'"'s anatomy extending radially away from said longitudinal axis of said device.

4. The method of claim 1, wherein said device is configured to create a pathway through said patient'"'"'s anatomy as said device is advanced through said patient'"'"'s anatomy towards a surgical site, without tearing said patient'"'"'s anatomy.

5. The method of claim 4, wherein said device is configured to expand said pathway to said surgical site.

6. The method of claim 1, wherein the comparing said at least one identified voltage trace to a predetermined voltage trace representing said nerve tissue comprises determining that a difference between said at least one identified voltage trace and said predetermined voltage trace representing said nerve tissue is less than a determined threshold.

7. The method of claim 1, wherein said predetermined distance is 1 mm.

8. The method of claim 1, wherein said array of ultrasound transducers comprises an array of capacitive micro machined ultrasonic transducers (CMUT).

9. The method of claim 1, wherein said spectral signature is resultant from said ultrasonically scanning.

10. A real-time, quantitative method for distinguishing nerve tissue from surrounding tissue during a medical procedure on a mammalian patient, the method comprising:

ultrasonically scanning, by a plurality of ultrasound transducers disposed on a device used in said procedure, a region of said patient'"'"'s anatomy to generate a b-mode image of said region of said patient'"'"'s anatomy, wherein at least one ultrasound transducer, of said plurality of ultrasound transducers, is angled with respect to a longitudinal axis of said device and configured to scan a region that extends at least partially radially away from said longitudinal axis of said device;

identifying image texture and echogenicity information from a digital representation of anatomical structures in said b-mode image;

identifying at least one voltage trace associated with anatomical tissue from at least one scan line from said digital representation of anatomical structures in said b-mode image;

comparing said at least one identified voltage trace to a predetermined voltage trace representing said nerve tissue;

determining a presence or an absence of a spectral signature of said nerve tissue in said at least one identified voltage trace based on the comparison;

determining said anatomical tissue associated with said at least one identified voltage trace to be said nerve tissue if said spectral signature of said nerve tissue is present;

upon a determination that said anatomical tissue associated with said at least one identified voltage trace is said nerve tissue, generating a 2-dimensional image of said nerve tissue on an output display displaying said b-mode image; and

generating at least one notification to a user to indicate a proximity of said device to said nerve tissue, wherein said at least one notification includes at least one of a color and an audible alarm indicating that said device is within a predetermined distance of said nerve tissue.

11. The method of claim 10, wherein said device is configured to be rotated about a longitudinal axis of said device for ultrasonically scanning a region of said patient'"'"'s anatomy extending radially away from said longitudinal axis of said device.

12. The method of claim 10, wherein the comparing said at least one identified voltage trace to a predetermined voltage trace representing said nerve tissue comprises determining that a difference between said at least one identified voltage trace and said predetermined voltage trace representing said nerve tissue is less than a determined threshold.

13. The method of claim 10, wherein said predetermined distance is 1 mm.

14. The method of claim 10, wherein said plurality of ultrasound transducers comprises an array of capacitive micro machined ultrasonic transducers (CMUT).

15. The method of claim 10, wherein said spectral signature is resultant from said ultrasonically scanning.

16. A system for distinguishing nerve tissue from surrounding tissue during a medical procedure on a mammalian patient, the system comprising:

a scanning device having an array of ultrasound transducers configured to scan a region of said patients anatomy;

a display device; and

a computing device in electrical communication with said display device and said scanning device, said computing device configured to;

ultrasonically scan, by said array of ultrasound transducers, said region of said patient'"'"'s anatomy to generate a b-mode image of said region of said patient'"'"'s anatomy;

identify image texture and echogenicity information from a digital representation of anatomical structures in said b-mode image;

identify at least one voltage trace associated with an anatomical tissue from at least one scan line from said digital representation of anatomical structures in said b-mode image;

compare said at least one identified voltage trace to a predetermined voltage trace representing said nerve tissue;

determine a presence or an absence of a spectral signature of said nerve tissue in said at least one identified voltage trace based on the comparison;

determine said anatomical tissue associated with said at least one identified voltage trace to be said nerve tissue if said spectral signature of said nerve tissue is present;

upon a determination that said anatomical tissue associated with said at least one identified voltage trace is said nerve tissue, generating a 2-dimensional image of said nerve tissue on said display device displaying said b-mode image; and

generate at least one notification to a user to indicate a proximity of said scanning device to said nerve tissue, wherein said at least one notification includes at least one of a color and an audible alarm indicating that said scanning device is within a predetermined distance of said nerve tissue.

17. The system of claim 16, wherein said at least one notification enables avoidance of said nerve tissue as said scanning device is advanced through said patient'"'"'s anatomy.

18. The system of claim 16, wherein the comparison comprises

a determination that a difference between said at least one identified voltage trace and said predetermined voltage trace representing said nerve tissue is less than a determined threshold.

19. The system of claim 16, wherein said array of ultrasound transducers comprises an array of capacitive micro machined ultrasonic transducers (CMUT).

20. The system of claim 16, wherein said spectral signature is resultant from said scan.