Methods and systems for real-time planning and monitoring of ablation needle deployment within an organization

Abstract

To provide a suitable method and system for real-time planning and monitoring of ablation needle deployment within an organization. [Solution] A control handle of the treatment probe is operated to advance and / or deploy one or more treatment structures into the tissue. The treatment probe is coupled to a display that shows an image field containing the target tissue for treatment. Virtual treatment and safety boundaries are overlaid on the image field. The boundaries include virtual stopping positions for the needle and tine. A joystick or directional pad on the probe handle is operable independently of the user interface to advance and / or deploy one or more treatment structures and can be operated to adjust the size and / or position of these boundaries. Sensors in the probe detect the real-time position of one or more treatment structures, and the sensed position is displayed in real time. The user can observe the display and deploy one or more treatment structures to the displayed virtual stopping positions.

Description

[Technical Field]

[0001] (cross reference) This application claims the benefit of U.S. Provisional Application No. 62 / 421,669 (filed November 14, 2017), which is incorporated herein by reference.

[0002] The subject matter of the present application is related to the subject matter of the following applications: U.S. Patent Application No. 12 / 245,567, filed on October 3, 2008, and currently U.S. Patent No. 8,088,072, issued on January 3, 2012, Attorney Docket No. 31992-709.201; U.S. Patent Application No. 13 / 307,304, filed on November 30, 2011, and currently U.S. Patent No. 8,262,577, issued on September 11, 2012, Attorney Docket No. 31992-709.301; U.S. Patent Application No. 13 / 589,975, filed on August 20, 2012, Attorney Docket No. 31992-709.302); U.S. Patent Application No. 12 / 198,861, filed on August 26, 2008, Attorney Docket No. 31992-711.201); U.S. Patent Application No. 13 / 023,383, filed on February 8, 2011, and currently U.S. Patent No. 8,206,300, Attorney Docket No. 31992-711.301); U.S. Patent Application No. 14 / 989,732, filed on January 6, 2016, Attorney Docket No. 31992-711.302); U.S. Patent Application No. 13 / 484,076, filed on May 30, 2012, Attorney Docket No. 31992-711.501); U.S. Patent Application No. 12 / 712,969, filed on February 25, 2010, and currently U.S. Patent No. 8,262,574, issued on September 11, 2012, Attorney Docket No. 31992-712.201); U.S. Patent Application No. 13 / 589,956, filed on August 20, 2012, Attorney Docket No. 31992-712.401); U.S. Patent Application No. 13 / 801,782, filed on March 13, 2013, Attorney Docket No. 31992-714.201); and, U.S. Patent Application No. 13 / 801,840, filed on March 13, 2013, and currently U.S. Patent No. 8,992,427, Attorney Docket No. 31992-714.202); and, U.S. Provisional Patent Application No. 62 / 421,119, filed on November 11, 2016, Attorney Docket No. 31992-717.101). The contents of the above applications are hereby incorporated herein by reference in their entirety.

[0003] (Statement Regarding Government Support of Research) None

[0004] (Field of the Invention) This invention generally relates to medical methods and apparatus. More specifically, it relates to a method and system for controlling needle deployment using therapeutic and safety boundaries projected onto an image of the tissue being treated.

[0005] Current medical procedures involving organs and tissues within a patient's body often involve the use of needles or other elongated devices for delivering energy, therapeutic drugs, etc. Optionally, methods utilize ultrasound imaging to observe and identify the treatment target and track the needle's position relative to the target.

[0006] Of particular interest to the present invention is the recent proposal of treatments for uterine fibroids that rely on transvaginal or laparoscopic positioning of a therapeutic probe or device within the patient's uterus. Radiofrequency or other energy or therapeutic delivery needles are deployed from the device into the fibroid, and energy and / or therapeutic substances are delivered to excise or treat the fibroid. To facilitate the locating of the fibroid and positioning of the needle within it, the therapeutic device includes an ultrasound imaging array with a field of view that is adjustable substantially forward or laterally with respect to the axial shaft carrying the needle. The needle is advanced across the field of view from the shaft so that it can be visualized and directed into the tissue and target fibroid.

[0007] While effective and highly beneficial for patients, such needle resection and treatment protocols face several challenges. Firstly, the initial deployment of the needle can be difficult, especially for less experienced physicians. Although physicians can visualize the tissue and target biostructure in real time on the imaging screen, accurately predicting the path the needle will take and assessing its final treatment location can be difficult. While the needle can certainly be partially or completely withdrawn and redeployed, it would be advantageous to minimize the number of deployments required before treatment is achieved.

[0008] Another challenge arises after the needle is deployed. While the needle's position can be observed using ultrasound or other visual imaging, the therapeutic volume resulting from energy or other therapeutic deliveries can be difficult to predict. As with initial positioning, experience will be helpful, but it would be desirable to reduce the need to make judgments and guesses.

[0009] U.S. Patent No. 8,088,072, by the same applicant as this application, describes a system for projecting safety and treatment boundaries onto real-time images of fibroids or other tissue structures being treated. While highly effective when used with a single needle, the system of Patent No. 8,072 is not optimized for use with multiple needle / tine assemblies, such as those taught in jointly owned U.S. Patents No. 8,206,300 and No. 8,262,574.

[0010] U.S. Patent No. 8,992,427, assigned to the assignee of this application, describes a system for implementing an ablation procedure by sliding and / or rotating a knob on a device handle. During the procedure, the operation of the control knob may often be sub-ideal. For example, the use of the control knob during the procedure may not be as intuitive as ideal for an inexperienced physician. In implementing the procedure, the user may often shift their attention from observing the imaging field, often a display indicating the treatment and safety areas, to the operation of the control handle.

[0011] For these reasons, it would be desirable to provide improved systems and methods for energy delivery and other needle deployment within ultrasound or other imaging fields in energy delivery and other therapeutic protocols. It would be particularly useful to provide the treating physician with information that would assist in the initial deployment of multiple needles or tines in order to improve the likelihood that the needle assembly will be properly positioned relative to the target biostructure being treated. It would also be desirable to provide the physician with feedback to help accurately predict the treatment volume. Such information should allow the physician to reposition the probe if necessary to increase the likelihood of completely treating the biostructure. Furthermore, it would be desirable to provide the physician with feedback to enable them to assess safety boundaries so that sensitive tissue structures are not damaged. All such feedback or other information is preferably provided virtually on the ultrasound or other imaging screen so that needle position can be quickly predicted, assessed, and treatment initiated. This is even more desirable if the feedback information is presented on the display screen in response to probe manipulation, while minimizing the need to input data or commands on the system controller or display, and even more desirable if such probe manipulation can set controlled stops or other limits on the range of subsequent needle deployment. It would be even more desirable to provide a therapist with intuitive controls for manipulating the treatment probe in response to feedback, and still more desirable to provide a therapist with integrated controls involving both the system controller and display as well as the treatment probe. It would be even more desirable to enable the therapist to reposition the treatment probe already placed in the surgical field without completely removing and reinserting the treatment probe. At least some of these objectives will be satisfied by the present invention as described below. [Background technology]

[0012] U.S. Patents 8,992,427 (Patent Document 1), 8,088,072, 8,206,300, and 8,262,574 are described above and are incorporated herein by reference. U.S. Patent 7,918,795 (Patent Document 2), by the same applicant as this application, describes a probe useful for both imaging and treating uterine fibroids, the probe can be used in the system and method of this application and is incorporated herein by reference. Other patent and published applications by the same applicant describing probes useful for treating uterine fibroids in a system include U.S. Patents 7,874,986 (Patent Document 3) and 7,815,571, and U.S. Patent Publications 2007 / 0179380 and 2008 / 0033493. See also U.S. Patent No. 6,050,992 and U.S. Patent Publication No. 2007 / 0006215. [Prior art documents] [Patent Documents]

[0013] [Patent Document 1] U.S. Patent No. 8,992,427 [Patent Document 2] U.S. Patent No. 7,918,795 [Patent Document 3] U.S. Patent No. 7,874,986 [Overview of the Initiative] [Means for solving the problem]

[0014] The present invention provides a method and system for deploying a needle structure within tissue. While a needle structure may in some cases comprise a single needle, in most cases it will comprise multiple needles or an assembly of needles and tines, as will be described in further detail below. Needle structures are typically intended to deliver treatment to tissue, most typically configured to deliver radiofrequency energy, plasma energy, therapeutic ultrasound energy, microwave energy, heat, cryotherapy, or other forms of energy to excise or otherwise modify target tissue or target biostructures within the tissue. Alternatively, or in combination, needle structures may also provide drug or other substance delivery, dissection, or other tissue therapies that can be achieved using needle structures.

[0015] The method and system of the present invention may be particularly suitable for treating uterine fibroids in a patient, wherein a therapeutic probe, carrying a needle structure and an imaging transducer, typically an ultrasound imaging transducer, is introduced transvaginally or transcervically into the uterus, or otherwise into and through the outside of the uterus or other organs or tissue target, laparoscopically. The therapeutic probe may be manipulated in the uterus to deliver resection energy to the fibroid, as will be described in more detail below. In most embodiments of the present invention, the needle structure is "virtually" deployed on a real-time image of the tissue prior to the actual deployment of the needle in the actual tissue. The therapeutic and / or safety boundaries within the tissue will also be determined and adjusted as needed prior to and / or during the actual deployment of the needle structure. In many embodiments, the actual position of the needle structure may be tracked, and the corresponding therapeutic and safety boundaries may be projected on the screen in real time. In many embodiments, both the deployment of the needle structure and the adjustment of the displayed therapeutic and safety boundaries are controlled using the handles of the therapeutic probe. The therapeutic and safety boundaries can be checked before treatment is initiated.

[0016] The method and system of the present invention further stipulate that, once virtual deployment parameters are selected using a virtual image, the needle structure can actually be deployed into the actual tissue in a location and / or pattern that matches the virtual deployment configuration. The system can track the position of the treatment probe and / or needle structure within the uterus, and thus, as the treatment probe is moved by the treating physician and the needle structure is advanced, the treatment and safety boundaries, which can be projected onto a real-time image of the tissue, can be calculated and / or updated. One or more control elements on the treatment probe handle can be operated to move, translate, enlarge, shrink, or otherwise adjust or reposition the displayed treatment and safety boundaries. In many embodiments, one or more control elements can be operated to establish one or more “stop” positions corresponding to a user-desired limit and / or user-defined deployment pattern for needle deployment, which would typically be within the treatment and safety boundaries. The treatment area and / or safety boundary can be calculated by the system based on the user-defined “stop” positions, as well as energy delivery data supplied to, or that may be generated by, the system controller. Once the treatment area and / or safety boundary are properly established and positioned on the real-time image relative to the biological structure being treated, the physician can hold the treatment probe in place and deploy the needle structure using the control handle, typically during the initial imaging and treatment setup phase, until it reaches its pre-set “stop” position within the treatment probe. In some cases, the stop can be automatically set by the physician manipulating the treatment and / or safety boundary on the screen using controls on the treatment probe. In alternative embodiments, the physician can manipulate the treatment probe and advance the needle structure while viewing the safety and / or treatment boundary in real time without anticipating a virtual projection.

[0017] In exemplary embodiments, at least one primary or central needle will be deployed from the treatment probe, and multiple tines or secondary needles will be deployed from the primary or central needle. In most cases, there will be a single primary needle that is deployed distally from the shaft of the treatment probe along its central axis. Multiple tines will then be advanced from the single needle in a pattern that branches distally. In other embodiments, multiple needles or tines may be advanced from the treatment probe without using a primary or central needle. In such cases, the needles or tines will typically expand or branch into a three-dimensional array as they are advanced distally.

[0018] Exemplary anatomical features that can be imaged and subsequently treated include fibroids, tumors, encapsulated tissue masses, pseudoencapsulated tissue masses, etc. Of particular interest to the present invention, the treatment probe may be positioned within the uterus, and the needle structure may be deployed in proximity to or within a fibroid located within the myometrial tissue of the uterus. In such cases, it would also be desirable to image the serosa surrounding the myometrial and / or other sensitive anatomical features that can be damaged by the energy-mediated treatment described herein.

[0019] As used herein, the treatment area is defined by a treatment boundary calculated by the system controller or established by the user, based on a needle structure deployment configuration (either set by a virtual “stopper” or calculated in real time as the needle structure is deployed) and energy delivery parameters set by or entered into the system controller. The energy or other treatment delivered by the needle structure deployed in a selected pattern at a selected location will effectively treat the target tissue to achieve excision or other therapeutic outcomes. As described below, it would therefore be desirable to manipulate the treatment probe and the needle structure stopper and / or the actual needle structure so that the treatment area at least partially surrounds the biostructure to be treated as seen on the system’s real-time image display.

[0020] As will be further used herein, the safety area is defined by a safety boundary, which is calculated by the system or established by the user. Similar to the treatment area, the safety boundary is calculated or established by the user based on a virtual “stopping point” of the needle structure set or adjusted by the physician on the treatment probe, the actual position of the needle structure, and / or energy delivery parameters entered into or set by the system controller. The safety boundary will differ from the treatment boundary in that it will be set at a minimum threshold distance beyond the boundary of the tissue treatment area where the risk of tissue damage is reduced or completely eliminated.

[0021] In a first aspect of the present invention, a method for deploying a needle structure in tissue includes the step of positioning a treatment probe having a deployable needle structure near the surface of the tissue to be treated, for example, adjacent to the uterine wall over the myometrium of the uterus. Typically, a real-time image of the tissue can be provided and projected onto a display connected to a controller using an imaging transducer such as an ultrasound array carried by the treatment probe. The real-time image includes the anatomical feature to be treated, such as a fibroid. At least one of a treatment area and a safety area can be projected onto the real-time image prior to the deployment of the needle structure. The size and / or positioning of the boundaries of the treatment area and / or safety area can then be adjusted on the real-time image, still prior to the deployment of the needle structure. After the boundaries of the treatment area and / or safety area are appropriately positioned on the real-time image relative to the biostructure to be treated, the needle structure can be deployed from the treatment probe into the tissue to provide treatment within the treatment / safety boundary projected after the boundary has been adjusted.

[0022] The boundaries of the treatment area and / or safety area can be moved or adjusted in several ways. First, manual movement of the medical probe by the physician will move the real-time image of the tissue and biological structures projected on the screen relative to the treatment / safety boundary projected on the screen. Since the position of the treatment and / or safety boundary projected on the screen may depend on the calculated position of the needle structure, it will be understood that movement of the treatment probe itself will move the calculated needle position within the real-time image. In addition to such overall movement of the treatment probe within the uterus, the position of the treatment or safety area projected on the real-time image can be adjusted by control on the treatment probe, for example, by manually operating a joystick or directional pad on the control handle of the treatment probe. The treatment probe includes one or more sensors and can directly detect the translational position of the slide for the needle / tine and / or the shaft for the needle / tine. For example, the needle / tine can be translated using one or more servos that can also provide position information for the needle / tine. The positions of the needle and tine can thereby be determined and tracked by the system controller and used to calculate the position of the treatment and / or safety boundary.

[0023] In other embodiments, the position and size of the treatment and / or safety boundary can also be adjusted outside of the controller, on the display screen, and / or on the treatment probe control handle using a suitable interface such as a keyboard, joystick, mouse, touch panel, touch screen, etc. Once the treatment and / or safety boundary is properly (virtually) positioned on the screen, the controller can control the deployment of the needle structure on the treatment probe. For example, the controller can position a servo motor on the treatment probe and position the needle / tine.

[0024] While the position and / or size of the treatment and / or safety margin is being adjusted, virtual needle location information can be projected onto the real-time image. For example, the needle location information can comprise a plurality of references or markers projected onto the real-time image so as to indicate the projected position of the needle tip or other needle position information. In other cases, it may be possible to project a full image of the length of the needle as it progresses through the tissue (but prior to actual deployment). The needle location information will, of course, preferably be updated as the projected target position is adjusted, allowing the physician to visualize where the needle will be after needle deployment. Further, virtual stop portions regarding the needle / tine based on the treatment and safety margins can be displayed to show the user the extent to which the needle / tine is to be deployed.

[0025] In another aspect of the invention, a system for treating anatomical features in tissue comprises a real-time image display, a treatment probe, and a control handle. The treatment probe can carry a deployable needle structure and an imaging transducer, and the transducer can be connected to the real-time image display. Control elements on the control handle can be operated to control at least one of the position and size of the treatment and / or safety region projected onto the real-time image.

[0026] An exemplary needle structure can comprise a needle and a plurality of tines that can be advanced from the needle. The tines can take on a pattern that diverges distally as they are advanced from the needle.

[0027] The treatment system can optionally further comprise a controller connectable to the treatment probe for delivering energy to the needle structure. In addition to the control handle, the controller can be configured to allow the user to control the projected treatment size and / or the projected safety region size based on the energy level delivered by the controller.

[0028] In a further aspect of the present invention, the imaging and therapeutic delivery system may include an imaging component comprising an imaging shaft having a proximal end and a distal end, and an imaging transducer at the distal end. The needle component may include a needle shaft having a distal end and a proximal end, and a needle structure arranged relative to each other on or within the shaft, and may be configured to be detachably attached to the imaging shaft, with the shafts positioned side by side with their respective axes parallel.

[0029] In a specific example, an imaging transducer on an imaging shaft may be rotatably mounted at the distal end of the imaging shaft, and the distal end of a needle shaft may be positioned proximal to the rotatably mounted imaging transducer when the needle shaft is mounted on the imaging shaft. The needle structure within the needle shaft typically reciprocates distally along the axis of the needle shaft, and the imaging transducer rotates away from the axis of the needle shaft when the needle shaft is mounted on the imaging shaft. The imaging component may further include an imaging handle section mounted at the proximal end of the imaging shaft, and the needle component may further include a needle handle section mounted at the proximal end of the needle shaft. In such embodiments, the imaging handle section and the needle handle section may typically form a complete handle when the needle shaft is mounted on the imaging shaft. The imaging handle section typically has an interior that holds circuitry configured to connect the imaging transducer to an external imaging display and the needle handle section, including a mechanism for advancing the tyne needle structure, and the imaging handle section typically further includes a mechanism for rotatable the imaging transducer relative to the imaging shaft.

[0030] In a further aspect of the present invention, a method for deploying multiple tines from a needle in tissue includes the step of providing a real-time image of the tissue, including the anatomical feature to be treated, on a display. The needle is typically inserted distally into the tissue, close to the anatomical feature, and the tines can be deployed further into the tissue from the needle. As in the previous embodiment, the tines typically branch radially as they are advanced distally from the needle to increase the amount of tissue being treated. At least one of a treatment boundary and a safety boundary can be projected onto the display in response to the tine deployment. The range of tine deployment can be adjusted to change the size and / or shape of the treatment and / or safety boundary projected onto the display. The actual needle and tine deployment locations may be provided, as indicated by one or more sensors in the treatment probe, and can be relied upon to position and reposition the safety and / or treatment boundaries on the real-time image until the physician is satisfied that the subsequent treatment will be both safe and effective, using the actually deployed needle and tine configuration. In addition to the actual needle and tine deployment, the projected treatment and / or safety boundary will naturally also depend on the intended output and duration of the treatment, in a manner similar to the projection of the virtual boundary discussed previously. After the acceptable size and / or safety boundary is achieved, the treatment can be delivered through the tine. In certain embodiments, tine deployment may be tracked via sensors in a needle / tine deployment mechanism on the treatment probe used to deploy the needle and tine. In such cases, needle penetration would involve advancing the needle from the treatment probe that has penetrated the tissue. Typically, the range of needle deployment from the treatment probe will also be relied upon in determining the safety and / or treatment boundary projected on the display.

[0031] In a further aspect of the present invention, a system for treating anatomical features in tissue comprises a real-time display connected to a controller. The system can project and adjust the size of at least one of a treatment boundary or a safety boundary onto the display. A treatment probe can be provided, having a deployable needle structure and an imaging transducer, which is connectable to the controller and the display. The treatment probe may carry at least one servo-driven motor, which is connected to and driven by a controller and / or control element on the treatment probe handle. The control element and / or controller may be configured to drive the servo motor to position the needle structure to provide treatment that can be effective over the area defined by the treatment boundary and cannot extend significantly beyond the safety boundary.

[0032] In specific embodiments of the system, the needle structure may comprise a needle and a plurality of tines that can advance from the needle in a distally branching pattern. At least one servomotor may comprise a first servomotor for driving the needle and a second servomotor for driving the plurality of tines. The system typically includes a user interface configured to allow the user to virtually adjust the size and / or position of the treatment and / or safety boundary on a display. In some cases, as previously described, the interface may be on the treatment probe itself, such as a control element for the treatment probe handle. In other cases, the interface may comprise a more conventional keyboard, mouse, rollerball, touchscreen, voice activation, etc., connected to a controller, to allow the user to virtually position the needle structure prior to actually positioning it. In yet another embodiment, the treatment probe may comprise a servomotor for positioning the needle structure and / or a sensor for detecting the extent to which the needle structure is deployed. In such cases, the user can position the needle structure using a servo (without generating a virtual projection of the safety and / or therapeutic boundary) and observe the projected safety and / or therapeutic boundary as it is calculated and projected by the system controller. In all cases, the system can only be used to deliver energy or other treatment after it has been confirmed that the deployment of the needle structure meets the requirements of the safety and / or therapeutic boundary.

[0033] In a further aspect of the present invention, a method for treating tissue is provided. Exemplary tissue treatment methods may include distinctly different planning and real-time monitoring steps. In the planning phase, the user may control the displayed graphical representation of safety and / or treatment boundaries for ablation. These boundaries may be controlled using any number of input devices such as switches, gestures, and voice control. The target depths of the needle and tines are established during the planning phase and may be shown on the display as a graphical planning guide. In exemplary embodiments, the safety and / or treatment boundaries are controlled via a joystick or directional pad on the probe handle. Many of the ablation devices described herein have two stages: one stage for needle deployment and one stage for tine deployment. Often, it may be desirable for the needle of the ablation device to be advanced into the tissue to a desired depth and to maintain the advanced needle position before the tines are deployed, so that the desired geometric shape of the deployed tines is not altered during treatment and the graphical guides are not invalidated. The planning phase can allow users to trade off shallower, broader tissue ablation for deeper, narrower ablation.

[0034] During the deployment phase, sensors within the treatment probe may monitor the real-time position of the introducer needle, tine, and / or their individual deployment shafts, and a display console may display the detected position and the progress of deployment. When the deployment of the needle and / or tine matches a planned value, the system may indicate the match to the user through visual, auditory, tactile, or other feedback. In exemplary embodiments, display markers corresponding to the needle and / or tine may be aligned with and / or overlap with a displayed graphical planning guide. If the user continues to deploy the needle and / or tine beyond the planned depth, the system may indicate an error and command the user to retract the needle and / or tine. For example, the system may display a visual warning or indicate a display marker corresponding to the needle and / or tine that is outside a safety boundary. In many embodiments, the system may link the displayed real-time position of the needle and tine with a graphical planning guide and display the graphical planning guide in response to the detected real-time position of the needle and tine. In some embodiments, the system allows the user to input adjustments to position sensors that can be maintained by the system.

[0035] In some embodiments, the planning stage may be optionally omitted, and a graphical planning guide can reflect the real-time positions of the insertion needle and tines. The depth of the graphical planning guide may reflect the depth of the insertion needle deployment, and the size of the graphical planning guide may reflect the electrode deployment. Adjustments to the sensor inputs may be input by the user.

[0036] In some embodiments, a planning and monitoring control switch (e.g., a joystick or directional pad (i.e., a D-pad)) acts as a user interface element, performing functions typically performed by a mouse or keyboard, such as feature or menu selection and cursor drawing.

[0037] The treatment probe may be equipped with one or more sensors that can detect the position of one or more of the needle, tine, and / or their individual deployment shafts relative to the device handle. The sensors may be any type of position sensor, such as a linear potentiometer, magnetic sensor, LVDT sensor, or pulse encoder, to name a few examples. The sensors may sense movement relative to the introduction needle location or relative to the treatment probe handle of the device. The same or different types of sensors may be used for the needle, tine, and / or their individual deployment shafts.

[0038] In a further aspect of the present invention, a method for deploying a needle structure within tissue is provided. An exemplary method for deploying a needle structure within tissue may include providing a real-time image of the tissue, including the anatomical feature to be treated, on a display connected to a controller. A treatment probe having a deployable needle structure may further be displayed as the treatment probe is positioned near the anatomical feature. In addition, at least one of a treatment area or a safety area may be projected onto the real-time image. The method may further include adjusting at least one of the size or position of the projected boundary of the projected image of the treatment area and / or safety area on the real-time image. Adjusting the size and / or position of the projected boundary may, in some cases, include user adjustment of a first user interface of the handle of the treatment probe. Furthermore, the deployable needle structure may be displayed on the real-time image when the needle structure is deployed from the treatment probe. In practicing the method, the needle structure may provide treatment within the projected boundary after it has been positioned relative to the treatment probe and tissue and the projected boundary has been adjusted, and the treatment probe may be positioned near the anatomical feature in the tissue. In addition, the needle structure can be deployed from the treatment probe by user adjustment of a second user interface on the handle of the treatment probe. In some embodiments, at least one of the size or position of the projected boundary is readjusted after the needle has been positioned relative to the treatment probe and tissue and has provided treatment.

[0039] In some embodiments, the first user interface of the treatment probe handle may include a joystick or a directional pad. Optionally, parameters associated with the projected boundary may be adjusted by adjusting the joystick or directional pad. For example, adjusting the size and / or position of the projected boundary may include adjusting the size of the projected boundary, which is adjusted by one or more of the following: pushing the joystick or directional pad in a first direction to enlarge the projected boundary, or pushing the joystick or directional pad in a second direction opposite to the first direction to reduce the projected boundary. As another example, adjusting the size and / or position of the projected boundary may include adjusting the position of the projected boundary, which is adjusted by one or more of the following: pushing the joystick or directional pad in a third direction to advance the projected boundary, or pushing the joystick or directional pad in a fourth direction opposite to the third direction to retract the projected boundary. Typically, a joystick, directional pad, or other user interface will remain stationary relative to the treatment probe handle when the size and / or position of the projected boundary is being adjusted. Alternatively, or in addition, the position of the projected boundary may be adjusted by manually repositioning the treatment probe relative to anatomical features.

[0040] In some embodiments, the handle of the therapeutic probe may further include a second user interface for deploying one or more of a needle structure and a plurality of tines advanceable from the needle structure. The second user interface may include one or more slider mechanisms on the handle of the therapeutic probe. The exemplary therapeutic probe may, alternatively or in addition, include a plurality of tines advanceable from the needle structure. In such cases, the method may further include detecting the real-time position of the plurality of tines when the plurality of tines are deployed and displaying the plurality of tines on a real-time image in response to the detected real-time position. In the methods described herein, projecting at least one of a treatment area or a safety area onto a real-time image may include projecting one or more tine stop indicators for the plurality of tines onto the real-time image. The plurality of tines may be advanced so that a virtual representation of the plurality of tines meets the tine stop indicators. In many embodiments, the first user interface of the handle is adjusted to adjust the position of the tine stop indicators after the plurality of tines have been advanced in this manner. Typically, one or more tine stop indicators for the plurality of tines are positioned within the anatomical feature to be treated. In some embodiments, the method may further include driving a servo motor of a treatment probe to deploy a plurality of tines. In some embodiments, displaying the plurality of tines on a real-time image may include detecting the real-time positions of the plurality of tines and displaying virtual representations of the plurality of tines in response to the detected real-time positions. In such cases, the positions of the virtual representations of the plurality of tines may further be updated in real time.

[0041] In some embodiments, the method may further include delivering energy through a plurality of tines to treat an anatomical feature. In such cases, the method may further include controlling at least one of the treatment power or treatment time to limit the extent of tissue treatment to a treatment area and / or safety area. In some embodiments, the method may further include delivering energy through a needle structure to treat an anatomical feature. In such cases, the method may further include controlling at least one of the treatment power or treatment time to limit the extent of tissue treatment to a treatment area and / or safety area. In some embodiments, projecting at least one of the treatment area or safety area onto a real-time image may include projecting one or more needle stop indicators for the needle structure onto a real-time image. One or more needle stop indicators may be configured to be near or within the anatomical feature to be treated. The needle structure may be advanced so that a virtual representation of the needle structure meets one or more needle stop indicators. The user interface of the handle may be adjusted to adjust the position of the needle stop indicators after the needle structure has been advanced in this manner. In some embodiments, the method may further include driving a servo motor of the treatment probe to deploy the needle structure. In implementing the method, displaying the needle structure on a real-time image may include detecting the real-time position of the needle structure and displaying a virtual representation of the needle structure in response to the detected real-time position. In some embodiments, the method may further include updating the position of the virtual representation of the needle structure in real time.

[0042] In yet another aspect of the present invention, a system for treating anatomical features within tissue may be provided. The system may comprise a treatment probe comprising a handle, a probe body, and a needle structure deployable from the probe body for treating anatomical features; and a real-time display coupled to the treatment probe and configured to display a real-time image and project the deployed needle structure and at least one of a treatment area or safety area onto the real-time image, wherein the handle comprises a first user interface for adjusting one or more of the size or position of one or more boundaries of at least one of the treatment area or safety area. In many embodiments, the position of the first user interface remains stationary relative to the handle when one or more of the size or position of one or more boundaries is being adjusted.

[0043] In some embodiments, the therapeutic probe may comprise a plurality of tines deployable from a needle structure. In such cases, the real-time display may be configured to display a virtual representation of the plurality of tines in response to the detected positions of the plurality of tines. Optionally, the therapeutic probe may comprise one or more sensors for detecting the positions of the plurality of tines. In some embodiments, the system's real-time display may be configured to show one or more tine stop indicators for the plurality of tines. The first user interface of the handle may be configured to adjust to reposition the one or more tine stop indicators after the plurality of tines have been deployed so that the virtual representation of the plurality of tines meets the one or more tine stop indicators. Alternatively, or in addition, the handle of the therapeutic probe may further comprise a second user interface for deploying the plurality of tines. In such cases, the second user interface may comprise a sliding mechanism.

[0044] In some embodiments, the handle of the treatment probe may further include a second user interface for deploying the needle structure. In such cases, the second user interface may include a sliding mechanism. In some embodiments, the treatment probe of the system may include a servo for driving multiple tines. Alternatively, or in addition, the treatment probe may include a servo for driving the needle structure. In some embodiments, the real-time display of the system may be configured to display a virtual representation of the needle structure in response to the detected position of the needle structure. In such cases, the treatment probe may include one or more sensors for detecting the position of the needle structure. Alternatively, or in addition, the real-time display of the system may be configured to show one or more needle stop indicators for the needle structure. In some embodiments, the first user interface of the handle may be configured to adjust to reposition the needle stop indicator after the needle structure has been deployed so that the virtual representation of the needle structure meets the needle stop indicator. In some embodiments, the first user interface may be configured to adjust one or more of the position or size of the boundary of the treatment area or safety area. The adjustment may be handled through various means. For example, the first user interface may include a joystick or directional pad on the handle of the treatment probe. The joystick or directional pad may be configured to be pushed in a first direction to enlarge the projected boundary, and to be pushed in a second direction opposite to the first direction to reduce the projected boundary. Optionally, the joystick or directional pad may be configured to be pushed in a third direction to advance the projected boundary, and in some cases further, to be pushed in a fourth direction opposite to the third direction to retract the projected boundary. The present invention provides, for example, the following: (Item 1) A method for deploying a therapeutic structure within tissue, wherein the method is To provide real-time images of the tissue, including the anatomical features to be treated, on a display connected to the controller, When the probe is positioned near the anatomical feature, the probe having a deployable therapeutic structure is displayed, Projecting at least one of the treatment area or safety area onto the real-time image, Adjusting at least one of the size or position of the projected boundary of the projected image of the treatment area and / or safety area on the real-time image, wherein adjusting the size and / or position of the projected boundary includes user adjustment of a first user interface on the handle of the probe, When the treatment structure is deployed from the probe, the deployable treatment structure is displayed on the real-time image. Includes, The treatment structure is positioned relative to the probe and tissue to provide treatment within the projected boundary after the projected boundary has been adjusted. A method wherein the probe is positioned near the anatomical feature within the tissue, the therapeutic structure is deployed from the probe by user operation of a second user interface on the handle of the probe, and the deployment of the therapeutic structure from the probe by adjusting the second user interface is independent of the adjustment of the first user interface for adjusting the size and / or position of the projected boundary. (Item 2) The method according to item 1, further comprising readjusting the size or at least one of the projected boundary after the therapeutic structure has been positioned relative to the probe and the tissue in order to provide treatment. (Item 3) The method according to item 1, wherein the position of the projected boundary is adjusted by manually repositioning the probe relative to the anatomical feature. (Item 4) The method according to item 1, wherein the first user interface of the handle of the probe comprises a joystick or a directional pad. (Item 5) The method according to item 4, wherein adjusting the size and / or position of the projected boundary includes adjusting the size of the projected boundary, the size of the projected boundary being adjusted by one or more of the following: the joystick or directional pad being pushed in a first direction to enlarge the projected boundary, or the joystick or directional pad being pushed in a second direction opposite to the first direction to reduce the projected boundary. (Item 6) The method of item 5, wherein the joystick or directional pad remains stationary relative to the handle of the probe when the size and / or position of the projected boundary is being adjusted. (Item 7) The method of item 4, wherein adjusting the size and / or position of the projected boundary includes adjusting the position of the projected boundary, the position of the projected boundary being adjusted by one or more of the following: the joystick or directional pad being pushed in a third direction to advance the projected boundary, or the joystick or directional pad being pushed in a fourth direction opposite to the third direction to retract the projected boundary. (Item 8) The method of item 7, wherein the joystick or directional pad remains stationary relative to the probe handle when the size and / or position of the projected boundary is being adjusted. (Item 9) The method according to item 1, wherein the second user interface on the handle of the probe comprises one or more slider mechanisms coupled to the therapeutic structure. (Item 10) The treatment structure is the method according to item 1, wherein the treatment structure comprises a needle structure. (Item 11) The method according to item 10, wherein the therapeutic probe further comprises a plurality of tines that can be advanced from the needle structure, and the method further comprises detecting the real-time position of the plurality of tines when the plurality of tines are deployed, and displaying a virtual representation of the plurality of tines on the real-time image in response to the detected real-time position. (Item 12) The method according to item 11, wherein projecting the at least one of the treatment area or the safety area onto the real-time image includes projecting one or more tine stop indicators for the plurality of tines onto the real-time image. (Item 13) The method of item 12, further comprising advancing the plurality of tines such that the virtual representation of the plurality of tines meets the tine stop indicator. (Item 14) The method of item 13, further comprising adjusting the first user interface of the handle and adjusting the position of the tine stop indicator after the plurality of tines have been advanced such that the virtual representation of the plurality of tines meets the tine stop indicator. (Item 15) The method according to item 12, wherein the one or more stopping positions for the plurality of tines are configured to be located within an anatomical feature to be treated. (Item 16) The method according to item 11, further comprising driving the servo motor of the treatment probe to deploy the plurality of tines. (Item 17) The method according to item 11, wherein displaying the plurality of tines on the real-time image includes detecting the real-time positions of the plurality of tines and displaying virtual representations of the plurality of tines in response to the detected real-time positions. (Item 18) The method of item 17, further comprising updating the positions of the virtual representations of the plurality of tines in real time. (Item 19) The method according to item 11, further comprising delivering energy through the plurality of tines to treat the anatomical features. (Item 20) The method according to item 19, further comprising controlling at least one of the treatment power or treatment time to limit the extent of the tissue treatment to the treatment area and / or safety area. (Item 21) The method according to item 1, further comprising delivering energy through the therapeutic structure to treat the anatomical features. (Item 22) The method according to item 21, further comprising controlling at least one of the treatment power or treatment time to limit the extent of the tissue treatment to the treatment area and / or safety area. (Item 23) The method according to item 1, further comprising driving the servo motor of the probe to deploy the treatment structure. (Item 24) The method according to item 1, wherein projecting at least one of the treatment area or the safety area onto the real-time image includes projecting one or more stopping positions for the treatment structure onto the real-time image. (Item 25) The method according to item 24, wherein the one or more insertion positions for the therapeutic structure are configured to be in the vicinity of or within the anatomical feature to be treated. (Item 26) The method according to item 24, wherein displaying the treatment structure on the real-time image includes detecting the real-time position of the treatment structure and displaying a virtual representation of the treatment structure in response to the detected real-time position. (Item 27) The method according to item 26, further comprising updating the position of the virtual representation of the therapeutic structure in real time. (Item 28) The method of item 26, further comprising advancing the treatment structure such that the virtual representation of the treatment structure meets the needle stop indicator. (Item 29) The method of item 28, further comprising adjusting the first user interface of the handle and adjusting the position of the needle stop indicator after the needle structure has been advanced so that the virtual representation of the needle structure meets the needle stop indicator. (Item 30) A system for treating anatomical features within tissue, wherein the system is A probe comprising a handle, a probe body, and a therapeutic structure deployable from the probe body for treating the anatomical features, A real-time display coupled to the probe and Equipped with, The real-time display is configured to display a real-time image and to project the deployed treatment structure and at least one of the treatment area or safety area onto the real-time image. The handle includes a first user interface for adjusting one or more of the size or position of one or more boundaries of at least one of the treatment area or safety area, The handle comprises a second user interface for deploying the therapeutic structure from the probe, wherein the deployment of the therapeutic structure from the probe by adjusting the second user interface is independent of the adjustment of the first user interface for adjusting the size and / or position of the projected boundary. system. (Item 31) The aforementioned treatment structure is the system described in item 30, comprising a needle structure. (Item 32) The system according to item 31, wherein the probe further comprises a plurality of tines that can be deployed from the needle structure. (Item 33) The system according to item 32, wherein the real-time display is configured to display a virtual representation of the plurality of tines in response to the detected positions of the plurality of tines. (Item 34) The system according to item 33, wherein the therapeutic probe comprises one or more sensors for detecting the positions of the plurality of tines. (Item 35) The system according to item 32, wherein the real-time display is configured to show one or more tine stop indicators for the plurality of tines. (Item 36) The system according to item 35, wherein the first user interface of the handle is configured to adjust to reposition the one or more tine stop indicators after the multiple tines have been unfolded, such that the virtual representations of the multiple tines meet the one or more tine stop indicators. (Item 37) The treatment probe comprises a servo for driving the plurality of tines, as described in item 32. (Item 38) The system according to item 30, wherein the second user interface comprises one or more sliding mechanisms coupled to the treatment structure. (Item 39) The system according to item 30, wherein the treatment probe is equipped with a servo for driving the treatment structure. (Item 40) The system according to item 30, wherein the real-time display is configured to display a virtual representation of the therapeutic structure in response to the detected position of the therapeutic structure. (Item 41) The system according to item 40, wherein the treatment probe comprises one or more sensors for detecting the position of the treatment structure. (Item 42) The system according to item 40, wherein the real-time display is configured to show a stop indicator for the needle structure. (Item 43) The system according to item 42, wherein the first user interface of the handle is configured to adjust to reposition the stop indicator after the treatment structure has been unfolded so that the virtual representation of the treatment structure meets the stop indicator. (Item 44) The system according to item 30, wherein the first user interface comprises a joystick or directional pad on the handle of the treatment probe. (Item 45) The system according to item 44, wherein the joystick or directional pad is configured to be pushed in a first direction to enlarge the projected boundary, and the joystick or directional pad is configured to be pushed in a second direction opposite to the first direction to reduce the projected boundary. (Item 46) The system according to item 44, wherein the joystick or directional pad is configured to be pushed in a third direction to advance the projected boundary, and the joystick or directional pad is configured to be pushed in a fourth direction opposite to the third direction to retract the projected boundary.

[0045] (Citation by reference) All publications, patents, and patent applications described herein are incorporated herein by reference to the same extent as each individual publication, patent, and patent application is specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawing]

[0046] Novel features of the present invention are described in detail in the appended claims. A deeper understanding of the features and advantages of the present invention will be obtained by referring to the following embodiments for carrying out the invention, which describe illustrative embodiments in which the principles of the present invention are utilized, and to the accompanying drawings.

[0047] [Figure 1]Figure 1 is a schematic diagram of the system of the present invention, which comprises a system controller, an image display, and a therapeutic probe having a deployable needle structure and an imaging transducer.

[0048] [Figure 2] Figure 2 is a perspective view of the therapeutic probe of the present invention.

[0049] [Figure 3] Figure 3 is a diagram of the therapeutic probe shown in Figure 2, illustrating the imaging components of the probe separated from the needle component, with multiple sections cut and multiple sections magnified.

[0050] [Figure 3A] Figure 3A illustrates the distal end of the needle component, which is connected to the distal end of the imaging component.

[0051] [Figure 4] Figure 4 shows a schematic diagram of the therapeutic probe of the present invention.

[0052] [Figure 5] Figure 5 illustrates the distal portion of a treatment probe introduced into the uterine cavity to image fibroids within the uterine muscle layer.

[0053] [Figure 6A] Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0054] [Figure 6B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0055] [Figure 7A]Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0056] [Figure 7B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0057] [Figure 8A] Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0058] [Figure 8B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0059] [Figure 9A] Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0060] [Figure 9B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0061] [Figure 10A]Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0062] [Figure 10B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0063] [Figure 11A] Figures 6A, 7A, 8A, 9A, 10A, and 11A illustrate screenshots of a real-time image display as the therapeutic and safety boundaries are being adjusted using a therapeutic probe, according to the principles of the present invention.

[0064] [Figure 11B] Figures 6B, 7B, 8B, 9B, 10B, and 11B illustrate the manipulation of handles corresponding to the repositioning of the treatment and safety boundary projection images on the real-time images in Figures 10A–15A.

[0065] [Figure 12] Figures 12A, 12B, 12C, and 12D illustrate the provision of references and markers on a real-time image where the reference and marker correspond to the location of the needle tip.

[0066] [Figure 13] Figure 13 illustrates a flowchart of a method for treating tissue according to the present invention.

[0067] [Figure 14] Figure 14 illustrates a system diagram in which needle tracking data is used to track the needle position. [Modes for carrying out the invention]

[0068] As illustrated in Figure 1, a system 10 constructed according to the principles of the present invention may include a system controller 12, an imaging display 14, and a therapeutic probe 16. The system controller 12 would typically be a microprocessor-based controller that allows both therapeutic and imaging parameters to be set in a conventional manner. The display 14 would typically be contained in a common enclosure 18 together with the controller 12, but could be provided in a separate enclosure. The therapeutic probe 16 may include an imaging transducer 20 that can be connected to the controller 12 by an imaging code 24. The controller 12 may supply power to the therapeutic probe 16 via the therapeutic code 22. The therapeutic probe 16 may also communicate with the controller 12 via the therapeutic code 22, for example, to provide one or more of the following: control signals, feedback signals, position signals, or status signals. The controller 12 would typically further include an interface for the therapeutic physician to input information into the controller 12, such as a keyboard, touchscreen, control panel, mouse, joystick, or directional pad (i.e., D-pad). Optionally, a touch panel may be part of the imaging display 14. The energy delivered to the treatment probe 16 by the controller 12 may be radio frequency (RF) energy, microwave energy, therapeutic plasma, heating, cryotherapy, or any other conventional energy-mediated therapy. Alternatively, or in addition, the treatment probe 16 may be adapted to deliver drugs or other therapeutic agents to the tissue biostructure being treated. In some embodiments, the probe 16 is plugged into an ultrasound system and a separate radio frequency (RF) generator. Interface lines connect the ultrasound system and the RF generator.

[0069] Referring here to Figures 2 and 3, the therapeutic probe 16 may comprise a needle component 26 and an imaging component 28. The needle component 26 and the imaging component 28 may be constructed as separate units or assemblies that can be detachably attached to each other for use. After use, the needle component 26 may be separated and typically discarded, while the imaging component 28 may be sterilized for reuse. The therapeutic probe 16 is shown in its fully assembled configuration in Figure 2 and in its disassembled configuration in Figure 3. In other embodiments of the present invention, the needle component 26 and the imaging component 28 may be incorporated into a single integrated handle unit. The needle component 26 may comprise a handle portion 27 having a control element 30 on its upper surface. The control element 30 may comprise a joystick, a directional pad (i.e., a D-pad), or other user interface. Although the control element 30 is illustrated as being on the handle portion 27, it should be understood that it may be located anywhere on the therapeutic probe 16. For example, the control element 30 may be located at any location along the handle portion 27 (e.g., near the distal end, near the proximal end, or somewhere in between). As another example, the control element may be located on the side of the treatment probe (e.g., distal or proximal to the tine slide 40). As yet another example, the control element may be located on the imaging component 28. Optionally, the control element may face downward. Although specific examples are given, the control element may be located on any component or element of the system described throughout. For example, the control element does not have to be located on the treatment probe 16, but may be provided as part of or coupled to the common enclosure 18, controller 12, and / or display. In some cases, the control element may be provided as a standalone unit coupled to the system via wired and / or wireless connections. The control element 30 may communicate with the controller 12 and perform functions such as adjusting the display 14, adjusting treatment parameters, adjusting the size and / or position of the target area and / or safety area shown on the display 14, and / or other functions as described in more detail below.Optionally, the control element 30 may enable the user to draw markings or lines to identify or document areas of interest (e.g., during the procedures discussed herein). For example, markings or lines may be created on the displayed image as the control element is operated and markings are drawn. Optionally, during the procedures discussed herein, the control element 30 may enable the user to interact with and / or control the controller 12 and access information sources (e.g., MRI images and / or clinical / artificial intelligence databases), which may help improve the quality of the procedure. For example, access to information sources may be done using menu items described herein as the control element is operated and menu items are navigated. In some cases, menu items may be accessed on the displayed image as the control element is operated and information sources are accessed (e.g., via menu items).

[0070] The needle 56 is unfolded from the needle shaft 34, and the needle 56 and optional tines 57 together may form a needle structure which can be constructed as previously described in, for example, jointly owned U.S. Patents 8,992,427, 8,206,300 and 8,262,574, which are incorporated herein by reference in their entirety.

[0071] The handle portion 27 of the needle component 26 may further include a fluid injection port 32 that allows saline or other fluid to be injected through the needle shaft 34 into a target area in the tissue being treated, such as the uterus. The needle handle 27 may also include a needle slide 36, a needle release portion 38, and a tine slide 40 used to deploy the needle 56 and tine 57. The needle slide 36 can slide forward to advance the needle 56 and slide backward to retract the needle 56. The tine slide 40 can slide forward to advance the tine 57 and slide backward to retract the tine 57. In some embodiments, the needle 56 and tine 57 may be coupled to one or more servos in the body of the handle portion 27 configured to actuate the needle 57 and tine 57, and the needle 56 and tine 57 may be actuated by actinguating a control element 30 and / or a controller 12. In many embodiments, the needle 56 must be deployed first before the tine 57 can be deployed. The imaging cord 24 may be attached to the proximal end of the handle portion 27 of the imaging component 28 for connection to the controller 12, as previously described.

[0072] The imaging component 28 may comprise a handle portion 29 and an imaging shaft 44. A deflection lever 46 on the handle portion 29 can be retracted to deflect the imaging transducer 20 downward, as shown by the dashed line in Figure 3. A needle component release lever 48 is connected to a pair of latches 50 that engage with a hook 52 on the bottom surface of the handle portion 27 of the needle component 26. The needle component 26 can first be releasably attached to the imaging component 28 by capturing a pair of wings 58 (only one of which is shown in Figure 3) on the needle shaft 34 below a hook 60 on the imaging shaft 44, as shown in Figure 3A. The bottom surface of the needle handle portion 27 may then be lowered to cover the top surface of the imaging handle portion 29 so that the hook 52 engages with the latches 50 to form a complete assembly of the treatment probe 16, and together the handle portions form a complete handle for use in the procedure. After use, the needle component release lever 48 may be pulled to release the hook 52 from the latch 50, allowing the handle portions 27 and 29 to be separated.

[0073] During use, as will be described in more detail below, the control element 30 may be used to both position (translate) and adjust the size of the virtual treatment area projected onto the display 14 of the system 10. The control element 30 may be pressed forward (up) and backward (down) to translate the position of the treatment / safety area on the image, for example. The control element 30 may be pressed left and / or right to adjust the size of the boundary of the treatment / safety area. For example, the control element 30 may be pressed to the left to reduce the boundary, while the control element 30 may be pressed to the right to enlarge the boundary. Once the virtual boundary of the treatment / safety area is set on the real-time image, the needle and tine may be automatically advanced to the corresponding deployed position by moving the needle slide 36 and tine slide 40 until their movement is stopped by the user, as recommended by the stop unit. The position of the treatment / safety area may also depend on where the physician holds the treatment probe 16 in the target tissue. Therefore, the advancement of the needle 56 and tine 57 using slides 36 and 40 will result in proper placement of the needle and tine within the target tissue only if the treatment probe position is kept stable, given the time required for the stopper to be set until the needle / tine advancement is complete.

[0074] In a preferred embodiment, the control element 30 may also be operated to adjust the length and / or power of delivery during the treatment protocol. For example, the control element 30 may be pressed to select a different control menu from those for adjusting the boundary, and one of the selectable menus may allow the power delivery parameters to be adjusted by pressing up / down to adjust the time length for power delivery, pressing left / right to adjust the amount of power delivered, etc. Another menu may include a menu for deploying the needle 56 and tine 57 by operating the control element 30, as in the embodiment, where the needle 56 and tine 57 are articulated using one or more servos in the handle component 27 of the needle component 26. Yet another menu may be selected to allow the control element 30 to move a cursor on the display 14. Thus, the control element 30 may be used to virtually define the treatment / safety area based not only on the extent to which the tine has been advanced, but also on the amount of energy being delivered to the target tissue.

[0075] Optionally, the control element may also be operated to perform marking (e.g., on a display). For example, during a procedure or treatment described herein, the user may use the control element 30 to mark, identify, and / or document an area of ​​interest. Marking, identification, and / or documentation may be implemented in some cases using the display 14. For example, the control element 30 may be used to mark an area of ​​interest displayed on the display unit (e.g., in real time during a procedure) (e.g., using dots, lines, shapes, circles, polygons, etc.). The markings made may, in some cases, be saved or recorded for further use. Optionally, marking, identification, or documentation may be implemented by the control element by selecting a different menu, as substantially described above. Alternatively, marking may be available to be implemented by the control unit while selecting a given menu described above, as further described below.

[0076] Optionally, the control element may also be operated to access information sources. In some cases, information sources may be accessed to assist and / or improve the procedures described herein. Information sources may include, but are not limited to, magnetic resonance imaging (MRI) images, clinical databases, and / or artificial intelligence databases. For example, during a procedure or treatment described herein, the user may use the control element 30 to access information sources. In some cases, access may be implemented on the display 14. For example, the control element 30 may be used to access information sources that are used to display relevant information on the display 14. Optionally, access to information sources may implement algorithms that automatically or semi-automatically analyze the information on the display and help improve the procedures or treatments described herein. Optionally, access to information sources may be implemented by the control element by selecting a different menu, as substantially described above. Alternatively, access to information sources may be available to be implemented by the control unit while selecting a given menu described above, as further described below.

[0077] In some cases, a given menu may be provided (or selected) so that the control element 30 can provide multiple functionalities as described herein. For example, the control element 30 may provide two, three, four, five, six, seven, eight, nine, ten, or more functionalities (e.g., positioning (translating) and adjusting the size of a virtual treatment area, adjusting the length and / or power of delivery between treatment protocols, deploying needles and tines, moving a cursor on a display, making markings, accessing information sources, etc.) within a single menu. For example, the control element 30 may be equipped with various mechanisms (e.g., movable, rotatable, pressable, etc.). A first mechanism may control a first functionality, while a second mechanism may control a second functionality. For example, movement of the control element may position and / or adjust the size of a virtual treatment area, while rotation of the control element may adjust the length and / or power of delivery between treatment protocols. As another example, moving a control element may allow the cursor to move on the display, while pressing a control element may allow the control element to draw a mark or line, identifying or documenting an area of ​​interest.

[0078] Figure 4 shows a schematic diagram of the needle component 26 of the treatment probe 16. As shown in Figure 4, the needle component 26 may comprise one or more needle position sensors 37 and one or more tine position sensors 41. The needle position sensor 37 may be coupled to the handle end portion of the needle deployment shaft 34. The forward and backward movement of the needle 56 by the slide 36 can thereby be tracked by the needle position sensor 37. The needle position sensor 37 may generate a position signal for the needle deployment shaft 34, which may be transmitted to the controller 12 through the treatment code 22, from which the position of the needle 56 can be determined. Similarly, the tine position sensor 41 may be coupled to the handle end portion of the tine deployment shaft located within the needle deployment shaft 34. The forward and backward movement of the tine 57 by the slide 40 can thereby be tracked by the needle position sensor 37. The tine position sensor 41 may generate a position signal for the tine deployment shaft, which may be transmitted to the controller 12 through the treatment code 22, from which the position of the tine 56 can be determined. The needle position sensor 37 and tine position sensor 41 may comprise any type of position sensor, such as a linear encoder, linear potentiometer, magnetic sensor, linear variable differential transformer (LVDT) sensor, resistor sensor, or pulse encoder. The positions of the needle 56 and / or tine 57 can be tracked in real time by the position sensors 37, 41 and the controller 12. The calculated treatment and safety boundaries are displayed and adjusted on the display unit 14 as the positions of the needle 56 and tine 57 are tracked, and can be updated as needed, if moved. Alternatively, or in combination, the needle 56 and tine 57 may be translated using one or more servo motors, which may also provide positional information about the needle 56 and tine 57.

[0079] The physician can adjust the control element 30 and, if desired, locate the boundaries of the treatment / safety area to be shown on the visual display 14.

[0080] A specific advantage of the method and system is that the physician can manipulate the therapeutic / safety boundary across the target biostructure by either manipulating the control element 30 (pressing forward / backward, left / right) to move the boundary relative to (or within) the real-time image, or by manipulating the entire therapeutic probe 16 to obtain a therapeutic boundary across the tumor while maintaining a safety boundary away from sensitive biostructure, thereby moving the entire real-time image relative to the target biostructure. Thus, the physician can use the virtual target interface to confirm in advance that the resection will be effective and safe before advancing any needle into the patient tissue.

[0081] Referring here to Figure 5, the system 10 of the present invention can be used to treat fibroids F located in the myometrium M within the uterus U, which is beneath the uterine wall UW (endometrium) and surrounded by the serosal wall SW. The treatment probe 16 can be introduced into the uterus transvaginally and transcervically (or alternatively, laparoscopically), and the imaging transducer 20 can be deployed to image the fibroid within the field of view indicated by the dashed line.

[0082] Once the fibroid is positioned on the display 14 as shown in Figure 6A, the control element 30 on the handle component 27 can be used to locate and measure the therapeutic boundary TB and safety boundary SB. Initially, as shown in Figure 6A, the virtual boundary lines TB and SB may not be positioned over the fibroid, nor may they be properly measured to treat the fibroid, and the control element 30 may be positioned in a neutral position as shown in Figure 6B. Prior to actual needle and tine deployment, the physician will want to position and measure the boundary lines TB and SB for proper treatment. Once the image transducer 20 is already positioned against the uterine wall UW, one way to advance the therapeutic and safety boundary lines TB and SB is to move the boundaries forward by manipulating the control element 30, such as by pressing the control element 30 forward in the direction of arrow U, as shown in Figure 7B. This operation can move the therapeutic and safety boundary lines TB and SB forward along axis AL. This operation can also generate a virtual boundary on the real-time image display 14, as shown in Figure 7A, and move it across the image of the fibroid. If the therapeutic and safety boundaries TB and SB need to be retracted, the control element 30 can be operated by pressing the control element 30 backward in the direction of arrow D, as shown in Figure 7B.

[0083] However, as shown in Figure 7A, the size of the treatment boundary TB may be insufficient to treat the fibroid because the boundary does not extend across the image of the fibroid. Therefore, it may be necessary to enlarge the treatment boundary TB by manipulating the control element 30, such as by pressing the control element 30 to the right in the direction of arrow R+, as shown in Figure 8B. This can enlarge both the treatment boundary TB and the safety boundary SB, as shown in Figure 8A. Here, the enlarged virtual treatment boundary TB may be sufficient to treat the fibroid, and the safety boundary SB extends across the serosal wall SW, as also shown in Figure 8A. Therefore, there is a risk that the treatment may affect the more sensitive tissue surrounding the uterus, and the virtual safety boundary SB may need to be retracted again by manipulating the control element 30 in the opposite direction, such as by pressing the control element 30 to the left in the direction of arrow L-, as shown in Figure 9B. This procedure can reduce the size of both the safety and treatment boundaries SB and TB, as shown in Figure 9A, allowing the physician to be confident that the treatment will be effective because the treatment boundary TB completely surrounds the fibroid on the real-time image display, and that the treatment will be safe because the safety boundary SB is located within the myometrium M on the real-time image display and does not cross the serosal wall SW.

[0084] While keeping the treatment probe 16 stable, the physician then advances the needle slide 36, as shown in Figure 10B, and expands the needle 56 into the fibroid F, as shown in Figure 10A. The explanatory diagram in Figure 10A includes a representation of the treatment probe 16, which may correspond to the physical probe present in the patient. The remainder of Figure 10A corresponds to the image present on the target display 14. The treatment and safety boundary TB, SB may determine a virtual stop indicator or criterion 142 with respect to the needle 56. The target display 14 may include a position indicator 140 with respect to the needle 56, often the tip of the needle 56. In some cases, the position of the virtual stop indicator or criterion 142 may correlate with the size and position of the treatment and safety boundary TB and SB. In other cases, the position of the virtual stop indicator or criterion 142 may be adjusted independently of the treatment and safety boundary TB and SB. The needle 56 may be advanced until the needle position indicator 140 overlaps with the stop criterion 142. In many embodiments, the stop criterion 142 can be “locked” with the needle position indicator 140 after overlap occurs. In conventional therapeutic probes, the advancement of the needle structure is stopped using a mechanical stop, which cannot be adjusted after the needle structure has been fully advanced. In the present invention, the stop criterion 142 is a virtual guide for stopping the needle structure and can be further adjusted even after the needle 56 has been advanced to the initial position of the stop criterion 142.

[0085] The target display 14 may include position indicators 144 relating to the tips of the tines 57, often tines 56, as shown in Figure 11A. The therapeutic and safety boundaries TB and SB may also determine multiple virtual stop indicators or references 144 relating to the tines 57, as shown in Figure 10A. In many embodiments, the position of the tines may be determined from a needle position sensor 37, as indicated by a tine position indicator 143 on the target display 14, as shown in Figure 11B. In some cases, the position of the virtual stop indicators or references 144 may correlate with the size and position of the therapeutic and safety boundaries TB and SB. In other cases, the position of the virtual stop indicators or references 144 may be adjusted independently of the therapeutic and safety boundaries TB and SB. In conventional therapeutic probes, the advancement of multiple tines is stopped using a mechanical stop, which cannot be adjusted after the multiple tines have been fully advanced. In this invention, the stopping criterion 144 is a virtual guide for stopping the multiple tines, and can be further adjusted even after the multiple tines 57 have been advanced to the initial position of the stopping criterion 144.

[0086] After the needle 56 is fully deployed, as indicated by the overlap of the needle position indicator 140 and the stop criterion 142, the tine 57 may be deployed by advancing the tine slide 40 until the tine position indicator 143 overlaps with the stop criterion 144 for the tine, as shown in Figure 11B. Optionally, the treatment probe 16 may be rotated around its central axis (typically aligned with the axis of the needle 56) to ensure that the treatment and safety boundary TB, SB is in the plane of the entire field of view centered on the fibroid. The display 14 may show the position of the treatment and safety boundary TB and SB in real time relative to the target fibroid F and serosal wall SW. The tine may be configured as shown in Figure 11A, and power may be supplied to the tine 57 (and optionally the needle 56) to achieve treatment within the boundary depicted by the virtual treatment boundary TB. Again, Figure 11A may mix both the virtual image that would be present on the display 14, as well as the physical presence of the treatment probe 16.

[0087] Referring here to Figures 12A to 12D, the controller 12 can be programmed to display references and markers on the image display 14, where the references and markers represent specific locations on the “virtual” needle and / or tine. For example, as shown in Figure 12A, marker 142 may represent a desired position on the needle 56, e.g., a location where the tip of the needle 56 is intended to advance, relative to and from which the tine is intended to diverge. Additional markers 140 may be provided, which represent the actual tip of the needle 56 in real time. Multiple additional markers 143 may represent the tips of the tines, as shown in Figure 11A. The use of such references or markers can help the physician verify that the actual needle 56 and tine 57 are properly deployed. The physician should be able to observe real-time images of the actual needle 56 and tine 57 during deployment, and the associated tip should move until the needle tip reaches marker 142, as indicated by the overlap of markers 140 and 142, and the tine tip strikes marker 144, as indicated by the overlap of markers 143 and 144 (or alternatively, alternative targets 146 and 148 in Figures 12B-12D, as described below).

[0088] Figure 12B is similar to Figure 12A, except that the reference point representing the tip of the tine 57 is depicted as an arc 146 representing a series of possible positions for the distal tip of each tine. Such additional information may be useful to physicians when determining both the accuracy of treatment and the safety risks. As shown in Figure 12B, each arc has a radius equal to the logical electrode unfolded length. As shown in Figure 12C, all arcs 148 have the same radius, measured from the origin located at the tip 142. Finally, in Figure 12D, the arcs in Figure 12C are joined into a continuous arc, intended to present a clearer visual representation for use by physicians.

[0089] A physician or other user may virtually position the treatment boundary TB and / or safety boundary SB on the display screen 14 using an interface other than the control element 30, as described in the previous embodiment. For example, the treatment and / or safety boundary TB and SB may be positioned on a display screen having a real-time image of the uterine biostructure using a keyboard, mouse, rollerball, touchscreen, voice activation, or any other conventional interface used with a computer and other display. The virtual treatment and / or safety boundary TB and SB will be set relative to the actual position of the needle shaft 34, which can be tracked by the system using an image of the shaft in the tissue. After the physician is satisfied with the positioning of the virtual treatment and / or safety boundary TB and SB, the physician can then manually advance the needle 56 while the system controller 12 monitors its advancement through sensors 37 and 41 in the needle component housing 27. Through visual, audible, or other means, the system may alert the physician when the needle 56 has advanced by an appropriate distance. After the needle is locked, the user can then manually advance the tine 57 while the controller 12 monitors its position via sensors 37 and 41. The system can again alert the physician when the tine 57 has been deployed by an appropriate amount within the limits of the virtual treatment and / or safety boundaries TB and SB. The system 12 can then alert the physician that treatment may be initiated.

[0090] Figure 13 shows a method 1300 for treating tissue according to the present invention. The systems and devices described herein may be used to implement method 1300, including any combination of the steps and their substeps.

[0091] In step 1301, a real-time display, such as the display 14 described above, may be provided.

[0092] In step 1306, the therapeutic area TR may be displayed as described herein.

[0093] In step 1311, the safety area SR may be displayed as described herein.

[0094] In step 1316, the therapeutic area TR and safety area SR may overlap with the target tissue. For example, this overlap can be achieved by advancing the therapeutic probe 16 toward the uterine wall UW and target fibroid F, as shown in Figure 6A.

[0095] In step 1321, target criteria for the needle and tine may be displayed on the display 14, etc. These target criteria may be located within one or more of the therapeutic area TR or safety area SR, as described above with respect to Figures 10A, 11A, and 12A-12D.

[0096] In step 1331, the needle may be advanced and aligned with its individual target criterion, as described above with respect to Figure 10A. Once aligned, the user may operate the control element 30 or other user interface so that further advancement or retraction of the needle, as shown on the display, also advances or retracts the target criterion, thereby locking the needle position indicating the criterion and the needle target criterion. In this way, the therapeutic target area is aligned with the needle position and can be adjusted as appropriate, typically in real time. Once the needle position indicating the criterion is locked with the needle target criterion, the size and / or position of the therapeutic area TR and / or safety area SR can also be adjusted in real time.

[0097] In step 1336, the tine may be advanced and aligned with its individual target criterion, as described above with respect to Figure 11A. Even when the needle position indicating the criterion is locked with the needle target criterion, the size and / or position of the treatment area TR and / or safety area SR may still be adjusted as well.

[0098] In step 1341, the position of the treatment area TR may be adjusted by operating or activating the control element 30 or other user interface, as described herein.

[0099] In step 1346, the position of the safety area SR may be adjusted by operating or activating the control element 30 or other user interface, as described herein.

[0100] In step 1351, the size of the treatment area TR may be adjusted by operating or activating the control element 30 or other user interface, as described herein.

[0101] In step 1356, the size of the safety area SR may be adjusted by operating or activating the control element 30 or other user interfaces, as described herein.

[0102] In step 1361, the target tissue is ablated using the treatment probe 16, etc., once the treatment area TR and safety area SR are measured and positioned as desired, and the needle and tine are positioned to their desired locations.

[0103] The steps described above illustrate a method 1300 for treating tissue within a patient according to many embodiments, but those skilled in the art will recognize many modifications based on the teachings described herein. The steps may be completed in different orders. Steps may be added or removed. Some steps may consist of substeps. Many steps may be repeated as many times as is beneficial for treatment.

[0104] Referring here to Figure 14, the system and method of the present invention may rely on internal needle tracking, such as the use of a position sensor in the handle component of the needle component of the therapeutic probe. The position sensor may track and / or determine the real-time position of the needle and tine within the tissue. The system controller can then rely on the real-time data to determine whether the needle remains within the boundaries so that safe and effective treatment can be achieved.

[0105] Preferred embodiments of the present invention are shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, alterations, and substitutions will be conceivable to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in practicing the invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

[Claim 1] The invention described herein.

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