IP Library Granted Patent US 12708332
Granted Patent B2
US 12708332 · App. 19/161,145 · Granted Aug 18, 2026

System and method for percutaneous deployment of sensors

Inventors: Jayender Jagadeesan (Bedford, MA); Raphael Bueno (Brookline, MA); Alan D. Lucas (Brookline, MA); Timothy W. Robinson (Sandown, NH); Laurence A. Roth (Windham, NH)
Assignees: The Brigham and Women's Hospital, Inc.; Navigation Sciences, Inc.
A61B6/12A61B1/2676A61B5/055A61B5/064A61B5/6852A61B5/742A61B6/032A61B6/4441A61B8/085
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Quick Facts
Patent No.
US 12708332
App. No.
19/161,145
Granted
Aug 18, 2026
Kind
B2
Abstract

A method for tracking the location of a tissue mass comprising disposing a J-bar and electrical lead assembly within a needle cannula lumen; disposing the needle cannula within an outer cannula lumen; inserting the outer cannula into the anatomy of the patient; moving the needle cannula distally relative to the outer cannula; applying a force so that the J-bar and electrical lead assembly moves distally such that the fiducial sensor is anchored proximate to the tissue mass; moving the outer cannula and needle cannula proximally in concert, until the distal end of the outer cannula and the distal end of the needle cannula are disposed at the surface of the skin; applying a force so that the expandable basket moves distally, such that the expandable basket is disposed at the surface of the patient's skin with the electrical lead extending between the fiducial sensor and the expandable basket.

Claims (70)

1 . A method for tracking the location of a tissue mass located within an anatomical structure in the body of a patient, the method comprising:

tracking the location of the tissue mass based on diagnostic images and a virtual model;

providing a system comprising: a deployment system comprising: an outer cannula comprising a distal end, a proximal end, and an outer cannula lumen extending therebetween; a needle cannula comprising a distal end, a proximal end, and a needle cannula lumen extending therebetween,

a needle cannula comprising a distal end, a proximal end, and a needle cannula lumen extending therebetween, the needle cannula being sized to be slidably received within the outer cannula lumen;

a pusher comprising a distal end and a proximal end, the distal end of the pusher being slidably received within the needle cannula;

a J-bar and electrical lead assembly comprising:

a fiducial sensor comprising at least one mount for mounting the fiducial sensor to tissue, wherein the fiducial sensor is configured to assume (i) a radially-reduced profile when the fiducial sensor is radially constricted, and (ii) a radially-expanded profile when the fiducial sensor is not radially constricted;

an expandable basket configured to assume (i) a radially-reduced profile when the expandable basket is radially constricted, and (ii) a radially-expanded profile when the expandable basket is not radially constricted;

an electrical lead configured to extend between the fiducial sensor and the expandable basket to electrically connect the fiducial sensor to the expandable basket;

at least one connector mounted to the expandable basket in electrical communication with the electrical lead, such that electrical power supplied to the at least one connector powers the fiducial sensor;

disposing the J-bar and electrical lead assembly within the needle cannula lumen such that the fiducial sensor is disposed adjacent to the distal end of the needle cannula, the expandable basket is disposed proximal to the fiducial sensor, and the electrical lead is disposed intermediate the fiducial sensor and the expandable basket;

disposing the pusher within the needle cannula lumen such that the distal end of the pusher is disposed proximal to the expandable basket;

disposing the needle cannula within the outer cannula lumen;

inserting the outer cannula into the anatomy of the patient until the distal end of the outer cannula is disposed against the anatomical structure;

moving the needle cannula distally relative to the outer cannula such that the needle cannula enters into the anatomical structure and moves distally to the location of the tissue mass,

applying a distally-directed force against the expandable basket using the pusher so that the J-bar and electrical lead assembly disposed within the needle cannula lumen moves distally, and/or applying a distally-directed force against the J-bar and electrical lead assembly using the pusher while moving the needle cannula proximally so that the position of the J-bar and electrical lead assembly is maintained while the needle cannula is withdrawn proximally, until the fiducial sensor is not constrained by the needle cannula, such that the fiducial sensor assumes the radially-expanded profile at a location proximate to the tissue mass, and such that the at least one mount anchors the fiducial sensor in the anatomical structure;

moving the outer cannula and needle cannula proximally in concert, whereby to move the expandable basket proximally, until the distal end of the outer cannula and the distal end of the needle cannula are disposed at the surface of the patient's skin;

applying a distally-directed force against the expandable basket using the pusher so that the expandable basket disposed within the needle cannula lumen moves distally, and/or applying a distally-directed force against the expandable basket using the pusher while moving the needle cannula and outer cannula proximally so that the position of the expandable basket is maintained while the needle cannula and outer cannula are withdrawn proximally, until the expandable basket is not constrained by the needle cannula or the outer cannula, such that the expandable basket assumes the radially-expanded profile at the surface of the patient's skin, and such that the electrical lead extends between the fiducial sensor and the expandable basket.

2 . The method according to claim 1 wherein the at least one mount of the fiducial sensor comprises a prong configured to engage tissue.

3 . The method according to claim 1 wherein the expandable basket comprises a radially-expandable structure formed of a shape memory material, wherein the radially-expandable structure is spring biased to assume the radially-expanded profile when the radially-expanded structure is not radially constrained; and

wherein the radially-expandable structure comprises a proximal end mounted to the electrical lead, a distal end comprising the at least one connector, and an internal volume between the distal end and the proximal end of the radially-expandable structure.

4 . The method according to claim 3 wherein the expandable structure comprises an open structure defined by a plurality of legs when the radially-expandable structure assumes the radially-expanded profile.

5 . The method according to claim 1 wherein the at least one connector of the expandable basket forms a socket configured to receive a plug.

6 . The method according to claim 1 wherein the electrical lead extending between the fiducial sensor and the expandable basket forms a deformable spring comprising a plurality of turns, such that as the expandable basket is moved away from the fiducial sensor, the electrical lead unspools to extend the variable distance between the fiducial sensor and the expandable basket.

7 . The method according to claim 1 wherein, prior to inserting the outer cannula into the anatomy of the patient, the intended position of the J-bar and electrical lead assembly is selected by locating the tissue mass and the anatomical structure using an imaging modality, and further wherein the imaging modality comprises one of: diagnostic or intraprocedural computed tomography (CT), C-arm computed tomography (CT), and magnetic resonance imaging (MRI).

8 . The method according to claim 7 wherein, the fiducial sensor assumes the radially-expanded profile at a location proximate to the tissue mass, power is supplied to the fiducial sensor to determine the position of the fiducial sensor in the frame of reference of the imaging modality, and further wherein an image produced by the imaging modality is modified to show the position of the fiducial sensor in the image.

9 . The method according to claim 1 wherein, after the expandable basket is deployed in the radially-expanded configuration in contact with the patient's skin, the position of the fiducial sensor relative to the tissue mass within the anatomical structure is confirmed using an imaging modality, and further wherein the imaging modality comprises one of: diagnostic or intraprocedural computed tomography (CT), C-arm computed tomography (CT), and magnetic resonance imaging (MRI).

10 . The method according to claim 1 wherein the distal end of the needle cannula forms a sharp distal tip configured to pierce tissue.

11 . A system for tracking the location of a tissue mass located within an anatomical structure in the body of a patient, the system comprising:

diagnostic images to track the location of the tissue mass and a virtual model;

a deployment system comprising: an outer cannula comprising a distal end, a proximal end, and an outer cannula lumen extending therebetween;

a needle cannula comprising a distal end, a proximal end, and a needle cannula lumen extending therebetween, the needle cannula being sized to be slidably received within the outer cannula lumen;

a pusher comprising a distal end and a proximal end, the distal end of the pusher being slidably received within the needle cannula;

a J-bar and electrical lead assembly comprising:

a fiducial sensor comprising at least one mount for mounting the fiducial sensor to tissue, wherein the fiducial sensor is configured to assume (i) a radially-reduced profile when the fiducial sensor is radially constricted, and (ii) a radially-expanded profile when the fiducial sensor is not radially constricted;

an expandable basket configured to assume (i) a radially-reduced profile when the expandable basket is radially constricted, and (ii) a radially-expanded profile when the expandable basket is not radially constricted;

an electrical lead configured to extend between the fiducial sensor and the expandable basket to electrically connect the fiducial sensor to the expandable basket;

at least one connector mounted to the expandable basket in electrical communication with the electrical lead, such that electrical power supplied to the at least one connector powers the fiducial sensor;

wherein the J-bar and electrical lead assembly is disposed within the needle cannula lumen such that the fiducial sensor is disposed proximal to the distal end of the needle cannula, the expandable basket is disposed proximal to the fiducial sensor, and the electrical lead is disposed intermediate the fiducial sensor and the expandable basket;

wherein the pusher is disposed within the needle cannula lumen such that the distal end of the pusher is disposed proximal to the expandable basket; and

wherein the needle cannula is disposed within the outer cannula lumen to be selectively movable relative thereto.

12 . The system according to claim 11 wherein the at least one mount of the fiducial sensor comprises a prong configured to engage tissue.

13 . The system according to claim 11 wherein the expandable basket comprises a radially-expandable structure formed of a shape memory material, wherein the radially-expandable structure is spring biased to assume the radially-expanded profile when the radially-expanded structure is not radially constrained; and

wherein the radially-expandable structure comprises a proximal end mounted to the electrical lead, a distal end comprising the at least one connector, and an internal volume between the distal end and the proximal end of the radially-expandable structure.

14 . The system according to claim 13 wherein the expandable structure comprises an open structure defined by a plurality of legs when the radially-expandable structure assumes the radially-expanded profile.

15 . The system according to claim 11 wherein the at least one connector of the expandable basket forms a socket configured to receive a plug.

16 . The system according to claim 11 wherein the electrical lead extending between the fiducial sensor and the expandable basket forms a deformable spring comprising a plurality of turns, wherein the deformable spring is configured such that as the expandable basket is moved away from the fiducial sensor, the electrical lead unspools to extend the variable distance between the fiducial sensor and the expandable basket.

17 . The system according to claim 11 wherein the distal end of the needle cannula forms a sharp distal tip configured to pierce tissue.

18 . A method for tracking the location of a tissue mass located within an anatomical structure in the body of a patient, the method comprising:

tracking the location of the tissue mass based on diagnostic images and a virtual model;

providing a system comprising:

a deployment system comprising: an outer cannula comprising a distal end, a proximal end, and an outer cannula lumen extending therebetween;

a needle cannula comprising a distal end, a proximal end, and a needle cannula lumen extending therebetween, the needle cannula being sized to be slidably received within the outer cannula lumen;

a pusher comprising a distal end and a proximal end, the distal end of the pusher being slidably received within the needle cannula;

a J-bar and electrical lead assembly comprising:

a fiducial sensor comprising at least one mount for mounting the fiducial sensor to tissue, wherein the fiducial sensor is configured to assume (i) a radially-reduced profile when the fiducial sensor is radially constricted, and (ii) a radially-expanded profile when the fiducial sensor is not radially constricted;

an expandable basket configured to assume (i) a radially-reduced profile when the expandable basket is radially constricted, and (ii) a radially-expanded profile when the expandable basket is not radially constricted;

an electrical lead configured to extend between the fiducial sensor and the expandable basket to electrically connect the fiducial sensor to the expandable basket;

at least one connector mounted to the expandable basket in electrical communication with the electrical lead, such that electrical power supplied to the at least one connector powers the fiducial sensor;

disposing the J-bar and electrical lead assembly within the needle cannula lumen such that the fiducial sensor is disposed proximal to the distal end of the needle cannula, the expandable basket is disposed proximal to the fiducial sensor, and the electrical lead is disposed intermediate the fiducial sensor and the expandable basket;

disposing the pusher within the needle cannula lumen such that the distal end of the pusher is disposed proximal to the expandable basket;

disposing the needle cannula within the outer cannula lumen;

inserting the outer cannula into the anatomy of the patient until the distal end of the outer cannula is disposed against an outer surface of the anatomical structure;

moving the needle cannula distally relative to the outer cannula such that the needle cannula enters into the anatomical structure and moves distally to the location of the tissue mass,

applying a distally-directed force against the expandable basket using the pusher so that the J-bar and electrical lead assembly disposed within the needle cannula lumen moves distally, and/or applying a distally-directed force against the J-bar and electrical lead assembly using the pusher while moving the needle cannula proximally so that the position of the J-bar and electrical lead assembly is maintained while the needle cannula is withdrawn proximally, until the fiducial sensor is not constrained by the needle cannula, such that the fiducial sensor assumes the radially-expanded profile at a location proximate to the tissue mass, and such that the at least one mount anchors the fiducial sensor in the anatomical structure;

moving the outer cannula and needle cannula proximally in concert, whereby to move the expandable basket proximally, until the distal end of the outer cannula and the distal end of the needle cannula are disposed at the outer surface of the anatomical structure;

applying a distally-directed force against the expandable basket using the pusher so that the expandable basket disposed within the needle cannula lumen moves distally, and/or applying a distally-directed force against the expandable basket using the pusher while moving the needle cannula and outer cannula proximally so that the position of the expandable basket is maintained while the needle cannula and outer cannula are withdrawn proximally, until the expandable basket is not constrained by the needle cannula or the outer cannula, such that the expandable basket assumes the radially-expanded profile at the outer surface of the anatomical structure, and such that the electrical lead extends between the fiducial sensor and the expandable basket.

19 . The method according to claim 18 wherein the electrical lead extending between the fiducial sensor and the expandable basket forms a deformable spring comprising a plurality of turns, such that as the expandable basket is moved away from the fiducial sensor, the electrical lead unspools to extend the variable distance between the fiducial sensor and the expandable basket.

20 . The method according to claim 1 wherein, prior to inserting the outer cannula into the anatomy of the patient, the intended position of the J-bar and electrical lead assembly is planned by locating the tissue mass and the anatomical structure using an imaging modality, and further wherein the imaging modality comprises one selected from the group consisting of:

diagnostic or intraprocedural computed tomography (CT), C-arm computed tomography (CT), and magnetic resonance imaging (MRI).