IP Library Granted Patent US 11,234,732
Granted Patent B2
US 11,234,732 · App. 17/420,528 · Granted Feb 1, 2022

System and method for a tissue resection margin measurement device

Inventors: Raphael Bueno (Brookline, MA); Jayender Jagadeesan (Bedford, MA); Alan D. Lucas (Brookline, MA)
Assignees: The Brigham and Women's Hospital, Inc.; Navigation Sciences, Inc.
A61B17/3468A61B17/068A61B17/320016A61B34/10A61B34/20A61B90/06A61B90/39A61B2017/008A61B2017/00119A61B2017/00809A61B2034/105A61B2034/2051A61B2090/067A61B2090/397A61B2090/3908
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Quick Facts
Patent No.
US 11,234,732
App. No.
17/420,528
Filed
Jul 2, 2021
Granted
Feb 1, 2022
Kind
B2
Art Unit
3771
USPC
606/170
Abstract

Embodiments of the invention provide a system and method for resecting a tissue mass. The system for resecting a tissue mass includes a first sensor for measuring a signal corresponding to the position and orientation of the tissue mass. The first sensor is dimensioned to fit inside of or next to the tissue mass. The system also includes a second sensor attached to a surgical instrument configured to measure the position and orientation of the surgical instrument. A controller is in communication with the first sensor and the second sensor, and the controller executes a stored program to calculate a distance between the first sensor and the second sensor. Accordingly, visual, auditory, haptic or other feedback is provided to the clinician to guide the surgical instrument to the surgical margin.

Claims (35)

1. A method for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure comprises at least one lumen, the method comprising:

advancing a scope along the at least one lumen until the distal end of the scope is disposed in the vicinity of the selected tissue mass;

advancing a fiducial sensor through the scope, into the anatomical structure, and securing the fiducial sensor to the anatomical structure in the vicinity of the tissue mass; and

detecting the position of the fiducial sensor within the anatomical structure,

wherein the fiducial sensor is part of a sensor assembly, and

further wherein the sensor assembly comprises the fiducial sensor and an electrical lead extending distally from the fiducial sensor, with the electrical lead preceding the fiducial sensor as the fiducial sensor advances through the scope.

2. A method according to claim 1 wherein the sensor assembly is advanced through the scope and into the anatomical structure using a deployment assembly which comprises a needle cannula and a pusher.

3. A method according to claim 2 wherein the sensor assembly is slidably disposed within the needle cannula, the needle cannula is advanced through the scope in order to advance the sensor assembly through the scope, and the sensor assembly is deployed out of the needle cannula and into the anatomical structure by advancing the pusher relative to the needle cannula or by retracting the needle cannula relative to the pusher.

4. A method according to claim 3 wherein the electrical lead is passed through an outer surface of the anatomical structure.

5. A method according to claim 4 wherein the electrical lead is passed through an outer surface of the anatomical structure before the sensor assembly is deployed out of the needle cannula and into the anatomical structure.

6. A method according to claim 5 wherein the needle cannula extends through an outer surface of the anatomical structure while the electrical lead is disposed within the needle cannula.

7. A method according to claim 6 wherein, after the distal portion of the electrical lead is carried through an outer surface of the anatomical structure, the needle cannula is retracted so as to expose the distal portion of the electrical lead extending through an outer surface of the anatomical structure.

8. A method according to claim 7 wherein the sensor assembly is released from the needle cannula and engages the anatomical structure after the distal portion of the electrical lead extends through an outer surface of the anatomical structure.

9. A method according to claim 4 wherein a surgical navigation system is used to determine the location where the electrical lead extends through an outer surface of an anatomical structure.

10. A method according to claim 9 wherein the surgical navigation system uses tracking of the fiducial sensor to determine the location where the electrical lead is to extend through an outer surface of an anatomical structure.

11. A method according to claim 1 wherein the electrical lead comprises a hydrophobic braided wire.

12. A method according to claim 1 wherein the electrical lead comprises an atraumatic tip.

13. A method according to claim 1 wherein the electrical lead comprises at least one barb which restricts proximal movement of the electrical lead.

14. A method according to claim 1 wherein the fiducial sensor comprises at least one barb which restricts distal movement of the fiducial sensor.

15. A method according to claim 1 wherein the electrical lead comprises at least one barb which restricts proximal movement of the electrical lead and wherein the fiducial sensor comprises at least one barb which restricts distal movement of the fiducial sensor.

16. A method according to claim 1 wherein the sensor assembly further comprises a proximal electrical lead for powering the fiducial sensor, wherein the proximal electrical lead extends through the scope while the fiducial sensor is advanced through the scope and secured to the anatomical structure in the vicinity of the tissue mass.

17. A method according to claim 16 wherein the fiducial sensor is tracked as the scope is inserted along the at least one lumen.

18. A method according to claim 16 wherein the fiducial sensor is tracked as the fiducial sensor is advanced through the scope, into the anatomical structure, and secured to the anatomical structure in the vicinity of the tissue mass.

19. A method according to claim 16 wherein the method further comprises, after the fiducial sensor is secured to the anatomical structure, detaching the proximal electrical lead from the sensor assembly after the sensor assembly is deployed in the anatomical structure.

20. A method according to claim 16 wherein the method further comprises, after the fiducial sensor is secured to the anatomical structure, powering the fiducial sensor through the electrical lead extending distally from the fiducial sensor.

21. A method for tracking a tissue mass disposed in or on an anatomical structure, wherein the anatomical structure comprises at least one lumen, the method comprising:

providing a sensor assembly comprising a fiducial sensor and an electrical lead extending distally from the fiducial sensor, and providing a deployment assembly comprising a needle cannula and a pusher, wherein the sensor assembly is slidably disposed in the needle cannula distal to the pusher;

advancing a scope along the at least one lumen until the distal end of the scope is disposed in the vicinity of the selected tissue mass;

advancing the needle cannula through the scope, into the anatomical structure, and through an outer surface of the anatomical structure;

retracting the needle cannula so as to expose a portion of the electrical lead extending through the outer surface of the anatomical structure;

supplying electrical power to the fiducial sensor via the electrical lead extending through the outer surface of the anatomical structure;

securing the fiducial sensor to the anatomical structure in the vicinity of the tissue mass by advancing the pusher relative to the needle cannula or by retracting the needle cannula relative to the pusher; and

detecting the position of the fiducial sensor within the anatomical structure.

22. A method according to claim 21 wherein the sensor assembly further comprises a proximal electrical lead for powering the fiducial sensor, wherein the proximal electrical lead is releasably attached to the fiducial sensor and extends through the pusher while the fiducial sensor is disposed in the needle cannula, and further wherein the proximal electrical lead powers the fiducial sensor while the fiducial sensor is disposed in the needle cannula.

23. A method according to claim 22 wherein the proximal electrical lead is detached from the fiducial sensor after electrical power is supplied to the fiducial sensor via the distal electrical lead.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 9, 2021
From: BUENO, RAPHAEL; JAGADEESAN, JAYENDER
To: THE BRIGHAM AND WOMEN'S HOSPITAL, INC.
Reel/Frame 056807/0294 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 9, 2021
From: LUCAS, ALAN D.
To: NAVIGATION SCIENCES, INC.
Reel/Frame 056807/0447 →
Continuity (3)
Provisional Application 63054921 · Jul 22, 2020
Provisional Application 62923137 · Oct 18, 2019
Related Publication 20210386449A1 · Dec 16, 2021
Cited By (4)
US 12,383,349 US 12,514,497 US 12,527,599 US 12,544,105