US-12616549-B2 - Methods and systems for controlled deployment of needles in tissue

US12616549B2US 12616549 B2US12616549 B2US 12616549B2US-12616549-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.

Inventors

Michael A. Munrow
Jordan Bajor
Malcolm G. Munro

Assignees

GYNESONICS, INC.

Dates

Publication Date: 20260505
Application Date: 20241106

Claims (20)

1 . A method of treating a uterine anatomy, the method comprising: providing a real-time image having an image of the uterine anatomy based on output by an imaging device; providing a safety boundary for display with the image of the uterine anatomy, wherein a position of the safety boundary with respect to the image of the uterine anatomy is based on a position of a medical apparatus with respect to the uterine anatomy, the medical apparatus having a tissue treatment device, and wherein the position of the safety boundary with respect to the image of the uterine anatomy is adjustable based on a movement of the medical apparatus relative to the uterine anatomy; providing a treatment boundary for display with the image of the uterine anatomy, wherein the treatment boundary is associated with a treatment element of the tissue treatment device, and is surrounded by the safety boundary; and delivering energy to the tissue treatment device to treat a target tissue of the uterine anatomy when an image of a sensitive anatomical structure in the real-time image is outside of the safety boundary.
2 . The method of claim 1 , further comprising adjusting the treatment boundary based on the movement of the medical apparatus relative to the uterine anatomy.
3 . The method of claim 1 , further comprising providing a guide for display with the image of the uterine anatomy, wherein the guide is configured to assist a user of the medical apparatus to position the medical apparatus.
4 . The method of claim 3 , wherein image of the uterine anatomy comprises an image of the target tissue, and wherein the guide is moveable with respect to the image of the target tissue in response to the movement of the medical apparatus.
5 . The method of claim 3 , wherein the guide predicts a path of the treatment element of the tissue treatment device.
6 . The method of claim 3 , wherein the guide has a curvilinear configuration.
7 . The method of claim 1 , wherein the treatment element of the tissue treatment device comprises a deployable needle configured to treat the target tissue of the uterine anatomy.
8 . The method of claim 7 , wherein the safety boundary is displayed with the image of the uterine anatomy after the needle is deployed.
9 . The method of claim 1 , wherein the medical apparatus comprises a probe configured for insertion transvaginally into a uterus, and wherein the imaging device is integrated with the probe.
10 . The method of claim 1 , wherein the target tissue is uterine fibroid, wherein the medical apparatus is configured to treat the uterine fibroid, and wherein the sensitive anatomical structure comprises serosa.
11 . The medical apparatus of claim 10 , wherein the target tissue is uterine fibroid, wherein the medical apparatus is configured to treat the uterine fibroid, and wherein the sensitive anatomical structure comprises serosa.
12 . A medical system configured to image and to treat a uterine anatomy, the medical system comprising: a controller; wherein the controller is configured to operatively couple with a medical apparatus; wherein the medical apparatus comprises an imaging device and a tissue treatment device; wherein the controller is configured to provide a real-time image having an image of the uterine anatomy based on output by the imaging device; wherein the controller is also configured to provide a safety boundary for display with the image of the uterine anatomy, wherein a position of the safety boundary with respect to the image of the uterine anatomy is based on a position of the medical apparatus with respect to the uterine anatomy, and wherein the position of the safety boundary with respect to the image of the uterine anatomy is adjustable based on a movement of the medical apparatus relative to the uterine anatomy; wherein the controller is also configured to provide a treatment boundary for display with the image of the uterine anatomy, wherein the treatment boundary is associated with a treatment element of the tissue treatment device, and is surrounded by the safety boundary; and wherein the controller is configured to provide energy to the tissue treatment device to treat a target tissue of the uterine anatomy when an image of a sensitive anatomical structure in the real-time image is outside of the safety boundary.
13 . The medical apparatus of claim 12 , wherein the controller is configured to adjust the treatment boundary based on the movement of the medical apparatus relative to the uterine anatomy.
14 . The medical apparatus of claim 12 , wherein the controller is configured to provide a guide for display with the image of the uterine anatomy, wherein the guide is configured to assist a user of the medical apparatus to position the medical apparatus.
15 . The medical apparatus of claim 14 , wherein the image of the uterine anatomy comprises an image of the target tissue, and wherein the guide is moveable with respect to the image of the target tissue in response to the movement of the medical apparatus.
16 . The medical apparatus of claim 14 , wherein the guide predicts a path of the treatment element of the tissue treatment device.
17 . The medical apparatus of claim 14 , wherein the guide has a curvilinear configuration.
18 . The medical apparatus of claim 12 , further comprising the medical apparatus, wherein the treatment element of the tissue treatment device comprises a deployable needle configured to treat the target tissue of the uterine anatomy.
19 . The medical apparatus of claim 18 , wherein the controller is configured to provide the safety boundary for display with the image of the uterine anatomy after the needle is deployed.
20 . The medical apparatus of claim 12 , further comprising the medical apparatus, wherein the medical apparatus comprises a probe configured for insertion transvaginally into a uterus, and wherein the imaging device is integrated with the probe.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 17/742,211, filed May 11, 2022; which is a continuation of U.S. patent application Ser. No. 16/841,201, filed Apr. 6, 2020; which is a continuation of U.S. patent application Ser. No. 15/595,659, filed May 15, 2017; which is a continuation of U.S. patent application Ser. No. 13/589,975, filed Aug. 20, 2012; which is a continuation of U.S. application Ser. No. 13/307,304, filed Nov. 30, 2011, now U.S. Pat. No. 8,262,577; which is a continuation of U.S. patent application Ser. No. 12/245,567, filed on Oct. 3, 2008, now U.S. Pat. No. 8,088,072; which claims the benefit of Provisional Application No. 60/979,613, filed on Oct. 12, 2007; the full disclosures of which are incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention. The present invention relates generally to medical methods and apparatus. More particularly, the present invention relates to methods and systems for controlling the deployment of needles using visual feedback from an ultrasonic or other image. Current medical treatments of organs and tissues within a patient's body often use a needle or other elongate body for delivery of energy, therapeutic agents or the like. Optionally the methods use ultrasound imaging to observe and identify a treatment target and the position of the needle relative to the treatment target. Of particular interest to the present invention, a treatment for uterine fibroids has recently been proposed which relies on the transvaginal positioning of a treatment device in the patient's uterus. A radiofrequency or other energy or therapeutic delivery needle is deployed from the device into the fibroid, and energy and/or therapeutic substances are delivered in order to ablate or treat the fibroid. To facilitate locating the fibroids and positioning the needles within the fibroids, the device includes an on-board ultrasonic imaging array with a field of view in a generally lateral direction from an axial shaft. A curved needle is advanced from the shaft and into the field of view so that the needle can be visualized and directed into the tissue and the targeted fibroid. The geometry of the needle deployment is advantageous since it permits the location and treatment of fibroids which are laterally adjacent to the shaft. While effective and very beneficial for patients, such needle ablation and treatment protocols face several challenges. First, initial deployment of the needle can be difficult, particularly for physicians who have less experience. While the physician can view the tissue and target anatomy in real time on an imaging screen, it can be difficult to precisely predict the path the needle will take and assess its final treatment position. While the needle can certainly be partially or fully retracted and redeployed, it would be advantageous to minimize the number of deployments required before treatment is effected. A second challenge comes after the needle has been deployed. While the position of the needle can be observed on the ultrasonic or other visual image, the treatment volume resulting from energy or other therapeutic delivery can be difficult to predict. As with initial positioning, experience will help but the need to exercise judgment and conjecture is best reduced. A third challenge is in assuring that nearby sensitive tissue structures, such as the serosa surrounding the myometrium, are not unintentionally damaged. As with judging the treatment volume, predicting the safety margin of the treatment can be difficult. For these reasons, it would be desirable to provide improved systems and methods for the deployment of energy delivery and other needles within ultrasonic or other imaging fields of view in energy delivery or other therapeutic protocols. It would be particularly useful to provide the treating physician with information which would assist in initial deployment of a needle in order to improve the likelihood that the needle will be properly positioned relative to a targeted anatomy to be treated. It would also be desirable, once the needle has been deployed, to provide feedback to the physician to assist in accurately predicting a treatment volume. Such information should allow the physician, if necessary, to reposition the needle in order to increase the likelihood of fully treating the anatomy. Furthermore, it would be desirable to provide feedback to the physician allowing the physician to assess a safety margin so that sensitive tissue structures are not damaged. All such feedback other information are preferably provided visually on the ultrasonic or other imaging screen so that the needle position can be quickly predicted, assessed, and treatment initiated. At least some of these objectives will be met by the inventions described hereinafter. 2. Description of the Background Art. U.S. Patent Publication No. 2006/0189972, published on Aug. 24, 2006 a