IP Library Granted Patent US 11,826,207
Granted Patent B2
US 11,826,207 · App. 15/595,659 · Granted Nov 28, 2023

Methods and systems for controlled deployment of needles in tissue

Inventors: Michael Munrow (Belmont, CA); Jordan Bajor (Palo Alto, CA); Malcolm G. Munro (Tarzana, CA)
Assignee: Gynesonics, Inc
A61B90/36A61B10/0045A61B18/1477A61M5/46A61B90/11A61B2010/045A61B2018/1425A61B2034/107A61B2090/378
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Quick Facts
Patent No.
US 11,826,207
App. No.
15/595,659
Granted
Nov 28, 2023
Kind
B2
Abstract

Needles are deployed in tissue under direct ultrasonic or other imaging. To aid in deploying the needle, a visual needle guide is projected on to the image prior to needle deployment. Once the needle guide is properly aligned, the needle can be deployed. After needle deployment, a safety boundary and treatment region are projected on to the screen. After confirming that the safety boundary and treatment regions are sufficient, the patient can be treated using the needle.

Claims (56)

1. A method for treating uterine anatomy, the method comprising:

positioning a probe proximate to the uterine anatomy;

using the probe to provide a real-time image of the uterine anatomy;

predicting, using a processing unit, a projected treatment region based on a position of a tissue treatment device;

projecting, using the processing unit, the projected treatment region on the real-time image, the projected treatment region on the real-time image including at least a portion of the uterine anatomy to be treated, and wherein the projected treatment region is defined by a line spaced away from and completely surrounding a treatment element of the tissue treatment device;

projecting, using the processing unit, a safety boundary on the real-time image based on the position of the tissue treatment device, wherein the safety boundary and the projected treatment region are separate and distinct from one another, and wherein the projected safety boundary is defined by a line spaced away from and completely surrounding the line defining the projected treatment region;

displaying, using the processing unit, the real-time image with the projected treatment region and projected safety boundary projected thereon;

adjusting the safety boundary on the displayed real-time image so that a sensitive anatomical structure is outside of the safety boundary, wherein the safety boundary is adjusted by adjusting the position of the tissue treatment device; and

treating the uterine anatomy with the tissue treatment device after adjusting the safety boundary on the real-time image.

2. The method of claim 1 , wherein the treatment element of the tissue treatment device comprises a deployable needle configured to ablate the uterine anatomy.

3. The method of claim 2 , wherein at least one of the projected treatment region and the safety boundary is predicted based on a position of the deployable needle prior to the needle being deployed.

4. The method of claim 2 , wherein at least one of the projected treatment region and the safety boundary is predicted based on a position of the deployable needle after the needle is deployed.

5. The method of claim 1 , wherein the treatment element of the tissue treatment device comprises an array of RF ablation needles.

6. The method of claim 1 , wherein the probe comprises the tissue treatment device.

7. The method of claim 1 , wherein the probe and the tissue treatment device are delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

8. The method of claim 1 , wherein using the probe to provide the real-time image of the uterine anatomy comprises using the probe to provide a real time image of a uterine fibroid to be treated, wherein the projected treatment region includes at least a portion of the uterine fibroid, wherein the sensitive anatomical structure comprises serosa, and wherein treating the uterine anatomy with the tissue treatment device comprises treating the uterine fibroid.

9. The method of claim 1 , wherein adjusting the safety boundary correspondingly adjusts the treatment region.

10. A method for treating uterine anatomy, the method comprising:

providing a real-time image of the uterine anatomy using a probe positioned proximate to the uterine anatomy;

predicting a safety boundary based on a position of a tissue treatment device;

projecting the safety boundary on the real-time image, wherein the safety boundary is defined by a line spaced away from and completely surrounding a treatment element of the tissue treatment device;

projecting a treatment region for the uterine anatomy on the real-time image, wherein the treatment region is defined by a line completely surrounded by the line defining the safety boundary;

displaying the real-time image with the projected safety boundary and projected treatment region projected thereon to a user;

adjusting the position of the tissue treatment device so that a sensitive anatomical structure is outside of the safety boundary on the displayed real-time image, wherein adjusting the position of the tissue treatment device correspondingly adjusts a position of the treatment region on the displayed real-time image; and

treating the uterine anatomy with the tissue treatment device after adjusting the safety boundary on the image.

11. The method of claim 10 , wherein the treatment element of the tissue treatment device comprises a deployable needle configured to ablate the uterine anatomy.

12. The method of claim 11 , wherein the safety boundary is predicted based on a position of the deployable needle prior to the needle being deployed.

13. The method of claim 11 , wherein the safety boundary is predicted based on a position of the deployable needle after the needle is deployed.

14. The method of claim 10 , wherein the tissue treatment element of the tissue treatment device comprises an array of RF ablation needles.

15. The method of claim 10 , wherein probe comprises the tissue treatment device.

16. The method of claim 10 , wherein the probe and the tissue treatment device are delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

17. The method of claim 10 , wherein using the probe to provide the real-time image of the uterine anatomy comprises using the probe to provide a real time image of a uterine fibroid to be treated, wherein the sensitive anatomical structure comprises serosa, and wherein treating the uterine anatomy with the tissue treatment device comprises treating the uterine fibroid.

18. A method for treating uterine anatomy, the method comprising:

providing a real-time image of the uterine anatomy using a probe positioned proximate the uterine anatomy;

predicting a projected treatment region based on a position of a tissue treatment device;

projecting the projected treatment region on the real-time image, the projected treatment region on the real-time image including at least a portion of uterine anatomy to be treated and being defined by a line spaced away from and completely surrounding a treatment element of the tissue treatment device;

displaying the real-time image with the projected treatment region projected thereon to a user;

adjusting the position of the tissue treatment device so that a sensitive anatomical structure is outside of the projected treatment region on the displayed real-time image, wherein adjusting the position of the tissue treatment device correspondingly adjusts a position of the projected treatment region on the displayed real-time image; and

treating the uterine anatomy with the tissue treatment device after projecting the projected treatment region onto the real-time image and displaying the real-time image,

wherein the treatment element of the tissue treatment device comprises a deployable needle configured to ablate the uterine anatomy.

19. The method of claim 18 , wherein the projected treatment region is predicted based on a position of the deployable needle prior to the needle being deployed.

20. The method of claim 18 , wherein the projected treatment region is predicted based on a position of the deployable needle after the needle is deployed.

21. The method of claim 18 , wherein the tissue treatment element of the tissue treatment device comprises an array of RF ablation needles.

22. The method of claim 18 , wherein probe comprises the tissue treatment device.

23. The method of claim 18 , wherein the probe and the tissue treatment device are delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

24. The method of claim 18 , wherein using the probe to provide the real-time image of the uterine anatomy comprises using the probe to provide a real time image of a uterine fibroid to be treated, and wherein treating the uterine anatomy with the tissue treatment device comprises treating the uterine fibroid.

25. A method for treating uterine anatomy, the method comprising:

overlaying a real-time image of the uterine anatomy including an anatomical feature to be treated with projected needle treatment information of a tissue treatment device positioned proximate to the uterine anatomy, wherein the tissue treatment device comprises a deployable needle, wherein the projected needle treatment information is predicted based on a projected position of the needle prior to the needle being deployed into the uterine anatomy, and wherein the projected needle treatment information includes a boundary defined by a line spaced away from and completely surrounding the projected position of the needle;

aligning the projected needle treatment information on the real-time image with the anatomical feature to be treated;

recalculating the boundary based on an actual position of the needle deployed into the anatomical feature to be treated; and

treating the anatomical feature by delivering energy through the deployable needle after aligning the projected needle treatment information on the real-time image and after recalculating the boundary.

26. The method of claim 25 , wherein the anatomical feature to be treated comprises a uterine fibroid.

27. The method of claim 25 , wherein the projected needle treatment information comprises a projected needle deployment path.

28. The method of claim 25 , wherein the projected needle treatment information comprises a projected therapy region based on the projected needle position predicted prior to the needle being deployed into the uterine anatomy.

29. The method of claim 28 , wherein the boundary of the projected needle treatment information comprises a safety boundary on the projected needle position predicted prior to the needle being deployed into the uterine anatomy.

30. The method of claim 25 , further comprising overlaying the image of the uterine anatomy with a projected therapy region after the needle is deployed into the uterine anatomy.

Assignments (5)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 070236/0154 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: GYNESONICS, INC.
Reel/Frame 075455/0789 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Feb 14, 2025
From: GYNESONICS, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 070236/0154 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SPELLING OF THE THIRD ASSIGNOR'S LAST NAME PREVIOUSLY RECORDED ON REEL 042384 FRAME 0671. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 19, 2017
From: MUNROW, MICHAEL; BAJOR, JORDAN; MUNRO, MALCOLM G.
To: GYNESONICS, INC.
Reel/Frame 042503/0315 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2017
From: MUNROW, MICHAEL; BAJOR, JORDAN; MUNROW, MALCOLM G.
To: GYNESONICS, INC.
Reel/Frame 042384/0671 →
Continuity (5)
Continuation 13589975 · Aug 20, 2012
Continuation 13307304 · Nov 30, 2011
Continuation 12245567 · Oct 3, 2008
Provisional Application 60979613 · Oct 12, 2007
Related Publication 20170245838A1 · Aug 31, 2017
Cited By (1)
US 12,616,549