Steam therapy system and method

Abstract

A vapor delivery system is provided that may include any of several features. One feature of the vapor delivery system is the ability to apply condensable vapor energy to tissue (e.g., the prostate) to shrink, damage, or denature the prostate. In some embodiments, the vapor delivery system may include safety features including prostate capsule detection, needle tracking, and treatment tracking. A method for the safe and effective treatment of prostate tissue is presented.

Description

[[TECHNICAL FIELD]]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority from U.S. Provisional Patent Application No. 63 / 161,857, filed March 16, 2021, entitled "VAPOR THERAPY SYSTEMS AND METHODS", which is incorporated herein by reference in its entirety. CITATION OF DOCUMENTS

[0002] All publications mentioned herein, including patents and patent applications, are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

[0003] The present invention relates to devices and related methods for minimally invasive treatment of prostate cancer. [[BACKGROUND ART]]

[0004] The human male prostate can be divided into three zones: the peripheral zone, the transition zone, and the central zone. The peripheral zone (PZ) contains about 70% of the volume of the male prostate. This subcapsular portion on the posterior surface of the prostate surrounds the distal urethra, and 70 to 80% of all prostate cancers arise in the tissue of the peripheral zone. The central zone (CZ) surrounds the ejaculatory ducts and contains about 20 to 25% of the volume of the prostate. The central zone is often the site of inflammatory processes. The transition zone (TZ) is the site where benign prostatic hyperplasia (BPH) develops, and contains about 5 to 10% of the volume of glandular elements in a normal prostate, but can constitute up to 80% of such volume in cases of BPH. The transition zone includes two outer prostatic lobes and the periurethral glandular area. There exists a natural barrier around the transition zone, namely the prostatic urethra, the anterior fibromuscular stroma (FS), and the fibrous plane (FP) between the transition zone and the peripheral zone. The anterior fibromuscular stroma (FS) or fibromuscular zone is primarily composed of fibromuscular tissue.

[0005] Approximately 70-80% of prostate cancers originate in the peripheral region of the prostate and can remain confined to that area. In recent years, there has been growing interest in local therapies for prostate cancer. These therapies treat only the muscle tissue in which cancer is found through biopsy. Prior local therapies (e.g., those using RF ablation energy) cannot limit treatment to the peripheral tissue or to the tissue within the prostate. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] This invention was made to solve the problems of the above-mentioned conventional technology. [Means for solving the problem]

[0007] A prostate treatment system is provided, the system comprising: an introduction shaft sized and configured to provide transurethral access to the patient; a cartridge coupled to the introduction shaft; a vapor generator located within the cartridge and configured to generate condensable vapor; a handle detachably attached to the cartridge, including an actuator for controlling the vapor delivery function, which may be designed to function as a handle while the introduction shaft is inserted into the urethra and as a remote controller when the handle is removed and replaced with an introduction shaft stabilizer device; a needle slidably positioned within the introduction shaft and communicating with the vapor generator; and a magnet attached to the needle. The system includes a solenoid actuator positioned around a magnet, which enables controlled movement of a needle that deploys into tissue, advances at a constant speed or in intermittent steps, and retracts into the shaft; sensors positioned on the needle and on the shaft; an external transrectal ultrasound system (TRUS) that provides real-time images of the prostate during therapy; a needle guide system (NGS) that translates sensor data into the position of the needle tip and the direction of travel within the tissue and displays this information on the TRUS image; and a group of electronic devices positioned on the cartridge, handle, and external console that communicate with each other and with the user to ensure safe and effective delivery of vapor to the target tissue and to prevent vapor delivery from missing the target tissue.

[0008] In some embodiments, a prostate treatment system is provided which includes an imaging system configured to provide real-time images of the patient's prostate; an introduction shaft sized and configured to provide transurethral access into the patient; a vapor delivery needle slidably positioned within the introduction shaft and configured to vibrate to enhance the visibility of the vapor delivery needle in real-time images from the imaging system; and a forwarding mechanism coupled with a therapy needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic portion into the patient's prostate.

[0009] In some embodiments, the system further includes a magnet coupled to a vapor delivery needle, and the forward mechanism includes a push-pull solenoid driver configured to move the magnet to advance and retract the vapor delivery needle.

[0010] In some embodiments, the solenoid driver is configured to vibrate the vapor delivery needle during vapor delivery.

[0011] In some embodiments, the system further includes a piezoelectric crystal located on or inside the introduction shaft, which is electrically coupled to a signal generator and configured to vibrate a vapor delivery needle during vapor delivery.

[0012] In another embodiment, the system further includes a piezoelectric crystal positioned on or within a vapor delivery needle, which is electrically coupled to a signal generator and configured to vibrate the vapor delivery needle during vapor delivery.

[0013] In some embodiments, the system includes a balloon positioned on or inside the introduction shaft, which is operationally coupled to the supply lumen, and the rapid inflation and deflation of the balloon is configured to vibrate the vapor delivery needle during vapor delivery.

[0014] In another embodiment, the system includes a balloon positioned on or inside a vapor delivery needle, which is operationally coupled to a supply lumen, and the rapid inflation and deflation of the balloon is configured to vibrate the vapor delivery needle during vapor delivery.

[0015] In some embodiments, the system includes a shape memory foil positioned on or inside the introduction shaft, which is electrically coupled to a signal generator and is configured to vibrate a vapor delivery needle during vapor delivery by vibrating when an electric current from the signal generator passes through the shape memory foil.

[0016] In one embodiment, the system further includes a shape memory foil disposed on or inside a vapor delivery needle, the shape memory foil being electrically coupled to a signal generator, and the shape memory foil vibrates when an electric current from the signal generator passes through the shape memory foil, thereby causing the vapor delivery needle to vibrate during vapor delivery.

[0017] In some embodiments, the system includes a solenoid coil located on or inside the introduction shaft, which is configured to vibrate the vapor delivery needle during vapor delivery by striking the introduction shaft or the vapor delivery needle.

[0018] In another embodiment, the system includes a solenoid coil located on or within the vapor delivery needle, which is configured to vibrate the vapor delivery needle during vapor delivery by striking the introduction shaft or the vapor delivery needle.

[0019] In some embodiments, the imaging system includes a Doppler ultrasound imaging system.

[0020] A method for treating a patient's prostate is provided, the method comprising the steps of: inserting a therapy device shaft transurethrally into the patient; advancing a therapy needle from the shaft through the patient's urethral prostatic region into the patient's prostate; delivering therapy into the prostate from the therapy needle; vibrating the therapy needle; and visualizing the vibrating therapy needle under real-time imaging.

[0021] In some embodiments, the step of visualizing the vibrating therapeutic needle further includes providing a real-time Doppler ultrasound image of the vibrating therapeutic needle.

[0022] In another embodiment, the step of delivering the therapy further includes delivering steam therapy into the prostate gland from a therapy needle.

[0023] In some embodiments, advancing the therapy needle from the shaft further comprises actuating a solenoid needle driver magnetically coupled to the therapy needle.

[0024] In one embodiment, vibrating the therapy needle further comprises vibrating the therapy needle with a solenoid needle driver.

[0025] In another embodiment, vibrating the therapy needle further comprises vibrating a piezoelectric crystal disposed on or within the shaft with a signal generator.

[0026] In some embodiments, vibrating the therapy needle further comprises vibrating a piezoelectric crystal disposed on or within the therapy needle with a signal generator.

[0027] In one embodiment, vibrating the therapy needle further comprises rapidly inflating and deflating a balloon disposed on or within the shaft with a signal generator.

[0028] In another embodiment, vibrating the therapy needle further comprises rapidly inflating and deflating a balloon disposed on or within the therapy needle with a signal generator.

[0029] In some embodiments, vibrating the therapy needle further comprises vibrating a shape memory foil disposed on or within the shaft with a signal generator.

[0030] In a further embodiment, vibrating the therapy needle further comprises vibrating a shape memory foil disposed on or within the therapy needle with a signal generator.

[0031] A prostate treatment device is provided, the device comprising: an introduction shaft sized and configured to provide transurethral access into a patient; a vapor delivery needle slidably disposed within the introduction shaft; one or more electrodes disposed on the vapor delivery needle; one or more lead wires electrically connected to one or more electrodes and configured to extend along the length of the vapor delivery needle; an advancement mechanism coupled with a therapy needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic portion into the patient's prostate; and a PCB located proximal to the advancement mechanism, comprising an exit hole for one or more lead wires and a PCT interconnect configured to electrically connect one or more lead wires to flexible wire lead wires extending proximal from the advancement mechanism.

[0032] In some embodiments, one or more lead wires include slack between the point where one or more lead wires extend from the exit hole and the point where one or more lead wires are connected to the PCT interconnect.

[0033] In another embodiment, slack is provided on one or more wire leads to accommodate the difference in thermal expansion between one or more wire leads and the vapor delivery needle during vapor delivery.

[0034] A prostate treatment device is provided, the device including an introduction shaft sized and configured to provide transurethral access into a patient, a vapor delivery needle slidably positioned within the introduction shaft, a device body coupled to the introduction shaft and the vapor delivery needle, and a handle including one or more controllers for operating the prostate treatment device, the handle being detachable from the device body and configured to control the operation of the prostate treatment device both when the handle is attached to the device body and when it is detached from the device body.

[0035] In some embodiments, the handle is configured to control the delivery of steam.

[0036] In another embodiment, the handle is configured to control the delivery of saline solution.

[0037] In some embodiments, the handle is configured to control the forward and backward movement of the vapor delivery needle.

[0038] A surgical treatment system is provided, the system comprising a patient table, a horizontal adjustment rail, and a first stabilizer arm coupled to the horizontal adjustment rail, the first stabilizer arm having an unlocked state in which the first stabilizer arm is adjustable to any desired bend or position, and a locked state in which the bend or position of the first stabilizer arm is locked in a fixed position, the first stabilizer arm being axially adjustable relative to the patient table along the horizontal adjustment rail, and the horizontal adjustment rail A coupled second stabilizer arm, the second stabilizer arm includes an unlocked state in which the second stabilizer arm is adjustable to any desired bend or posture, and a locked state in which the bend or posture of the second stabilizer arm is locked in a fixed position, the second stabilizer arm is axially adjustable relative to the patient table along a horizontal adjustment rail, an imaging system coupled to the first stabilizer arm, and a therapy system coupled to the second stabilizer arm.

[0039] In some embodiments, the therapy system includes a steam therapy system.

[0040] In another embodiment, the imaging system includes a transrectal imaging probe.

[0041] To provide a better understanding of the present invention and to illustrate how it can be put into practice, several preferred embodiments are described below, with reference to the accompanying drawings, as non-limiting examples. However, throughout all similar embodiments in the accompanying drawings, similar reference numerals refer to corresponding features. [Brief explanation of the drawing]

[0042] [Figure 1] This shows one embodiment of a steam delivery system. [Figure 2A] ~ [Figure 2B] This document illustrates one embodiment of a set of sensors and transmitters for tracking the position of the TRUS probe, the tip of the vapor delivery needle, and the distal end of the shaft of the vapor delivery device. [Figure 2C] ~ [Figure 2D] This shows one embodiment of a vapor delivery needle, which includes a lead wire that passes from the tip of the needle through a hole in the wall of the delivery device needle. [Figure 2E] This is one embodiment of a vapor delivery needle including an NGS coil. [Figure 2F] This chart shows the change in bioelectrical impedance measurements against frequency when the needle tip contacts the prostatic capsule wall. [Figure 2G] ~ [Figure 2H] This describes one embodiment in which the tension of the sensor lead wire is relieved when the sensor lead wire exits the vapor delivery needle. [Figure 2I] This shows an electrical model of the resistance and capacitance of a tissue. [Figure 3A] ~ [Figure 3D] This describes one embodiment in which the handle of the steam delivery device is removed from the cartridge of the steam delivery device and used as a remote controller. [Figure 4A] ~ [Figure 4B] This demonstrates the operation of a flexible and lockable arm that allows the delivery device and TRUS probe to be stabilized at a user-selected position. [Figure 5A] ~ [Figure 5C] This shows one embodiment of a removable handle for a steam delivery device. [Figure 6A] ~ [Figure 6B] This shows how the stabilizer arm is attached to the cartridge of the steam delivery device. [Figure 7A] ~ [Figure 7C] This document describes one embodiment of a steam generation coil, including a method for mounting the steam generation coil on a printed circuit board. [Figure 8] This shows one embodiment of a cartridge for a steam delivery device, illustrating the configuration of the heating element and solenoid. [Figure 9A] ~ [Figure 9B] An example of a temperature sensor at the tip of a vapor delivery needle is shown. [Figure 10A] ~ [Figure 10G] This invention illustrates an embodiment for illuminating the tip of a delivery device needle in an ultrasound image. [Modes for carrying out the invention]

[0043] Generally, one method of treating prostate cancer involves introducing heated steam into the prostate through the interstitium, which controls the ablation of the prostate tissue. This method, performed as an outpatient procedure, utilizes steam, allowing for the application of 50-600 calories of thermal energy per steam therapy session (and this method assumes multiple treatments per prostate lobe). This method makes it possible to induce local ablation of prostate tissue without damaging the urethral prostatic portion or the tissues outside the prostate.

[0044] This disclosure relates to the treatment of prostate cancer, and more particularly to the ablation of peripheral prostate tissue without ablation of central or transitional prostate tissue.

[0045] The system may include a steam delivery mechanism for delivering a steam medium containing water vapor. The system may utilize a steam source configured to supply steam with a temperature of at least 60 to 140°C. In another embodiment, the system further includes a computer controller configured to deliver steam over a time range of 1 to 30 seconds.

[0046] In some embodiments, the system further includes a source of pharmacological substances or other chemicals or compounds delivered with the vapor. Such substances may include, but are not limited to, anesthetics, antibiotics, or toxins (such as Botox®), or chemicals capable of treating cancer tissue cells. Furthermore, such substances may include sealants, adhesives, glues, strong cyanoacrylate adhesives, etc. In some embodiments, reflective or anechoic substances may be delivered with the vapor to enhance the visibility of the vapor under ultrasound imaging, which is useful, for example, to locate the needle tip on the image. Gases such as air are reflective.

[0047] In some embodiments, a prostate treatment device may be provided which includes an introduction shaft sized and configured to provide transurethral access to a patient; a vapor generator configured to generate condensable vapor; a vapor delivery needle communicating with the vapor generator and slidably disposed within the introduction shaft; and an actuator configured to move the vapor delivery needle between a retracted position within the introduction shaft and an extended position where at least a portion is outside the introduction shaft, and to advance or retract the needle continuously or stepwise to tissue at any location between the urethral prostatic portion and the prostatic capsule.

[0048] This disclosure relates to the safe and effective delivery of vapor for tissue ablation. A vapor delivery device may include a shaft configured to provide transurethral access to a patient's prostate, a vapor generator, and a vapor delivery needle which may include one or more vapor delivery ports. In one embodiment, vapor is delivered through the holes of the vapor delivery needle to ablate cancerous or precancerous tissue. In a preferred embodiment, the vapor delivery needle is configured to puncture the urethral prostatic portion and advance to one or more sites within the prostate to which vapor is to be delivered. Multiple puncture sites may be spaced apart such that the tissue ablation zones within the prostate partially overlap, and may not be close enough to each other to allow vapor delivered to one site to exit through the entry hole of the preceding puncture site.

[0049] More specifically, this disclosure relates to navigating a vapor delivery device, including a vapor delivery needle, into and throughout the prostate gland to ablate cancerous tissue without penetrating the prostatic capsule. The vapor is delivered to a site surrounded by the tissue targeted for ablation. Sensors on the vapor delivery device and on a TRUS (transrectal ultrasound system) probe indicate the needle tip position to the operator on the TRUS image. An animation superimposed on the ultrasound image can show the computer-calculated trajectory of the needle tip as it is deployed from a given location in the urethra. In the case of prior art vapor delivery devices, the operator is required to hold the delivery device fixed in one place as the needle is deployed and advanced to the target site where the vapor is to be delivered. Even a slight movement of the delivery device may result in the needle being delivered to a location from which the target tissue cannot be accessed. Further needle deployment may be required to access the target tissue. If there are multiple holes penetrating the urethral wall and prostatic tissue, especially if they are densely packed, the vapor may escape through adjacent holes, resulting in inadequate treatment of the target tissue. If the operator moves the delivery device after needle deployment and while navigating to the target tissue, the trajectory created by penetrating the tissue becomes larger, potentially causing vapor to escape into the proximal urethra, resulting in inadequate treatment of the target tissue and potentially damaging the urethral wall. These issues are addressed herein.

[0050] In some embodiments, after the shaft has advanced into the prostatic urethra, the vapor delivery device handle may be detached from the device cartridge. The cartridge may then be attached to a stabilizer arm, which is fixedly mounted to the patient table. The segmented stabilizer arm may be moved freely until the shaft tip, observed by cystoscopy and ultrasound imaging, is in the desired position. A motor then acts on the stabilizer arm, locking each segment firmly into place and holding the delivery device cartridge in the desired position. The cartridge, delivery device shaft, and needle may rotate to address tissue in any orientation at that position. The needle may then penetrate the urethral wall and extend into the prostate to the desired position where vapor is delivered. The delivery device handle, detached from the cartridge, is used by the operator as a remote controller for needle movement and delivery of irrigating saline and vapor. When moving the delivery device to a different location within the prostatic urethra, the stabilizer arm may be unlocked and relocked to deliver vapor to the new site. In some embodiments, the stabilizer arm is a robotic arm controlled by a system computer.

[0051] In another embodiment, electrodes are positioned at the needle tip to measure the tissue electrical impedance in the vicinity of the needle tip. Tissue impedance (both resistance and capacitance) changes abruptly from the cellular tissue within the prostate to the fibrous tissue within the capsule wall. A coil of thin wire located slightly proximal to the vapor delivery hole on the needle tip constitutes a tracking device that determines the position of the needle tip relative to the TRUS image. Thin wire leads from both the impedance electrodes and the coil sensor are fed through a lumen extruded into the wall of the vapor delivery needle, and the tension is released where they exit from the proximal end of the needle. The sensor leads exiting the needle are designed to allow thermal expansion of the needle and to allow the needle to move during deployment and navigation.

[0052] Vapor delivery for ablation of a selected region or zone of the prostate in which cancer has been found may involve raising the temperature of the tissue for a period of time sufficient to denature and kill the tissue cells. Disclosed is a temperature sensor located at the tip of a vapor delivery needle that allows for measurement of the temperature of the tissue near the needle tip to be performed before vapor delivery (to confirm that the tissue has not yet reached the ablation temperature), during vapor delivery (to confirm that vapor delivery is safe and effective), and after vapor delivery (to confirm that the tissue has reached the ablation temperature). In some embodiments, the temperature measurement is derived from the electrical resistance of a coil of wire used for needle tip tracking. In one embodiment, an AC current is applied to the coil and detected by an external magnetic tracking sensor, while the AC resistance of the coil (voltage amplitude across the coil divided by current amplitude) is measured simultaneously. The coil resistance increases linearly with temperature.

[0053] Alternative or additional systems and methods for detecting the position of the needle tip and displaying it on the TRUS image are also disclosed. In some embodiments, the needle tip is vibrated with a small amplitude, and this amplitude is sufficient to detect these movements with the Doppler function of the TRUS system. When the needle moves, it is displayed in blue on the TRUS image when moving toward the TRUS probe and in red when moving toward the TRUS probe. A solenoid needle driver in the device cartridge includes means for vibrating the needle with an amplitude and frequency selected by the system or operator. Other methods for periodically moving the needle are also disclosed. In some embodiments, a piezoelectric element at the needle tip receives an ultrasonic signal from the TRUS probe and displays its position on the TRUS image. In another embodiment, a small balloon attached to the delivery needle is inflated with a gas such as air through the lumen of the needle wall, and this is displayed brightly on the ultrasonic image. As an alternative to the balloon, a resonant fluid or gas may pass through a channel in the needle wall in pulse form and exit near the needle tip. This pulsed fluid is displayed on a Doppler-mode ultrasound image.

[0054] Steam delivery system

[0055] Figure 1 shows a steam delivery system 100, which includes a steam delivery device 102, an imaging system 104 such as a transrectal ultrasound system (TRUS), a steam console 106, a cystoscope system 108, a needle guide system (NGS) 110, a saline delivery system 122, and one or more displays 112.

[0056] The vapor delivery device 102 may include a shaft 114, which includes a vapor delivery needle 115 configured to penetrate the urethral wall and deploy into the prostatic tissue. The shaft extends from a vapor delivery device cartridge 116, which is detachably attached to the handle or handpiece 118 of the delivery device. In one embodiment, the handpiece may be configured to act as a remote controller for controlling the operation of the vapor delivery device when detached. The vapor delivery device may further include a stabilizer 120, which is flexible and movable but may become a rigid arm that holds and secures the cartridge to the patient when activated. The vapor delivery device may further include a push-pull solenoid needle driver in the cartridge to control all movement of the needle, and a magnetic sensor in the cartridge to monitor the position of the needle driver magnet, and thus the position of the needle relative to the shaft.

[0057] The system may further include a cable that supplies power to a cartridge and relays signals from sensors, the sensors being a sensor deployed inside the cartridge to measure the temperature of a heating element and the position of a needle in a solenoid, and a sensor deployed on the needle and shaft to measure tissue impedance and to measure signals from an external tracking antenna; a fluid conduit that delivers sterile water to a steam generator inside the cartridge at a pressure measured in a fluid driver; a fluid conduit that delivers saline solution for cooling the shaft during steam therapy and for removing debris from the field of view of a cystoscope; and a lumen extending inside the cartridge and shaft that detachably houses a cystoscope for examination of the urethra and bladder and for monitoring the deployment and retraction of the needle of the delivery device.

[0058] Continuing to refer to Figure 1, the system may further include a steam delivery console 106, which includes a steam generator, a console computer, and one or more power supplies having capacity to power the electronics, as well as auxiliary equipment such as a fluid pump and tracking system elements. The computer and electronics may be configured to monitor the function of the delivery device and user commands, to adjust and process sensor inputs, to calculate the 3D trajectory of the needle and shaft position and orientation, to process ultrasound and cystoscopy images and integrate them with animation and tracking software, and to communicate with the console user. Furthermore, the console may include a pumping system configured to cause a flow of sterile water, saline irrigation, and peripradiostatinal saline delivery from the console into one or more needles 122. The console may further include sensors to measure sterile water / steam line pressure, console internal temperature, and current and voltage of the electronics. Furthermore, the console may include a steam therapy monitor that displays real-time information on the progress of steam therapy from the steam delivery device, which includes displays of critical sensor outputs and system status. The console may also provide users with technical information regarding system monitoring and maintenance.

[0059] As described above, the system may be configured to use or to work in conjunction with the cystoscope system 108, which may include a measuring device and one or more displays. The cystoscope system may include a cystoscope, which is inserted through a steam delivery device and configured to provide real-time images of the urinary tract and the delivery device needle before, during, and after needle deployment. In some embodiments, the steam delivery device may include a lumen within its shaft configured to house the cystoscope. The displays of the cystoscope system may be configured to display real-time cystoscopic images to the user during treatment and therapy. In some embodiments, the cystoscope system may include an integrated camera (e.g., a small CMOS sensor).

[0060] The system may further include a needle guide system (NGS) 110, which may include many elements. In one embodiment, the NGS may include a transmitter or antenna array configured to generate a sinusoidal magnetic field from one or more array elements, and one or more magnetic field sensors integrated on the needle tip of the vapor delivery device and configured to measure the sinusoidal magnetic field. The NGS may further include magnetic field sensors mounted on the shaft tip of the delivery device and on the TRUS probe. Using software in the console, the magnetic sensor data may be converted into the position and orientation of the needle tip and shaft tip relative to the TRUS probe. This information may be displayed on one or more displays 112, which include the predicted and / or actual trajectory of the needle on the TRUS image, the marked location of vapor therapy delivery, the predicted ablation zone on the TRUS image, and an animated TRUS image merged with NGS or other data. In some embodiments, a magnetic field is transmitted from the needle tip coil, which is received by an array of magnetic sensors located within the TRUS probe.

[0061] The system may further include an imaging system 104, which may include, for example, a TRUS system. The imaging system may be configured to provide real-time images of the prostate in one or more views (for example, in axial and sagittal images). In this embodiment, the imaging system may include an imaging rectal probe incorporating an NGS sensor, a TRUS probe stabilizer, a TRUS image processor and monitor, and a controller for selecting image views and parameters.

[0062] One or more displays 112 may be configured to display images of the therapy (e.g., TRUS images) overlaid with steam therapy information, including NGS tracking information.

[0063] Software within the system console 106 aggregates the position, trajectory, animation, and other information of the NGS needle and probe onto the TRUS image. The annotated TRUS image is then displayed on the system monitor 112 along with the cystoscopy image.

[0064] The system may optionally include one or more saline delivery needles 122, which may be used to inject or apply saline to the outside and surrounding tissues of the prostate under image guidance to cool the perigritis tissue during steam therapy. The layer of saline delivered around the prostate can enable ultrasound contrast imaging that clarifies the image of the prostatic capsule on TRUS images.

[0065] NGS Tracking System

[0066] Figures 2A-2B show the components of a needle guide system (NGS), which may include a magnetic field generator 224, a tracking console 226, and one or more sensors positioned on the vapor delivery device and / or imaging system as shown. For example, referring to Figure 2B, sensor 1 may be positioned on the vapor delivery needle 215, sensor 2 may be positioned on the shaft 214 of the vapor delivery device, and sensor 3 may be positioned on the shaft of the TRUS probe 204. The magnetic field generator 224 may include an array of coils configured to generate a sinusoidal magnetic field at multiple positions and in multiple orientations. These sensors may be configured to detect the sinusoidal magnetic field from the magnetic field generator, and the console 226 may be configured to use this data to calculate the position (x,y,z) of the sensors relative to the magnetic field generator 224, as well as the polar azimuth angle and azimuth angle (θ,φ), to provide the position and orientation of the needle tip and shaft tip relative to the TRUS probe 204 and TRUS image. The TRUS probe image may be processed by the vapor delivery console 226 so as to superimpose the positions of the shaft tip and needle tip onto the ultrasound image. In some embodiments, animation may be added, which shows the shaft, needle tip, and potential positions of the needle tip when unfolded from the current shaft position, along with a cone of uncertainty, the position and range of the previous vapor delivery shot, etc.

[0067] Figure 2A is an enlarged view of the steam delivery needle 215 of the steam delivery device, showing a sensor or NGS tracking coil 217, one or more bioimpedance electrodes 219 (described later), and one or more steam delivery ports 221.

[0068] The needle tip magnetic sensor 217 may include a coil (magnet wire) of a thin, insulated wire, as shown in Figures 2A and 2E. The wire may be wound around a foil of a permeable material such as alloy 48, and / or the coil may be wound around a permeable metal such as nickel to increase the sensor sensitivity. Wires with gauges in the range of AWG#48 to AWG#58 may be used. Thinner wires allow for an increase in the number of windings in the coil 217, and they can be wound within notches cut into the wall of the needle. The voltage induced in the coil or sensor 217 by the magnetic field generator is proportional to the number of windings in the coil. However, as the wire becomes thinner, the signal-to-noise ratio approaches a constant value. This is because, if the amount of wire is constant, the Johnson noise generated in the resistance of the wire is also proportional to the number of windings in the coil. If the wire is made heavier, the Johnson noise becomes smaller than the amplifier noise, and the amplifier noise is independent of the number of windings in the coil. In one example, the coil is wound to a depth of 65 microns, and a 3 mm long slot is etched into the wall of a 1.25 mm diameter needle. The signal-to-noise ratio increases as the wire gets thinner down to #56 gauge. There is no significant improvement in the signal-to-noise ratio between #56 and #58 gauge wires. #56 wire is selected for the coil because it is easier to handle than the thinner #58 wire.

[0069] Figure 2E shows an example of a coil magnetic sensor 217 wound around a slot near the tip of a vapor delivery needle 215. Lead wires 228a from the coil and lead wires 228b from the bioimpedance electrode may extend from the tip of the needle to the proximal end, where they connect to a wire extending to the vapor console. These lead wires cannot pass through the vapor delivery lumen 231 without disturbing the vapor flow. Instead, they are routed through a slot 230 extruded into the wall of the needle along its entire length, as shown in Figures 2C-2D. The bioimpedance lead wires 228b each pass through separate holes, while the lead wires 228a from the coil are twisted together and pass through one lumen, as shown in Figure 2E. In one embodiment, the coil lead wires are twisted together to prevent the induction of spurious voltages in the space between the wires. In some embodiments, only two lumen passes through the vapor delivery wall, as shown in Figure 2D. These two lumens 230 may be used for two bioimpedance leads 228b as shown in the figure, but not for the NGS coil. Alternatively, these leads may be used for two twisted pairs, one for the NGS coil and the other for measuring the coil voltage for monitoring the coil temperature. Figure 2D shows a cross-section of the needle tip at the location of the vapor delivery hole 221. This position and shape of the lumens 230 makes it possible for the vapor delivery hole 221 to be completely free of obstructions.

[0070] Figure 2E also shows the bioimpedance electrode 219 and lead wire 228b in more detail. A sinusoidal current of constant amplitude can pass between the two biocapacitance electrodes. The current flows through the tissue near the needle tip, between the tip electrodes. The voltage between the electrodes may then be measured. The impedance amplitude is equal to the ratio of the voltage to the current amplitude. The phase shift between the voltage and current is also measured. As the needle tip approaches the prostatic capsule, an increase in impedance amplitude is observed. This is because, relatively speaking, the conductivity and capacitance of the cellular tissue in the prostate are higher, while the conductivity and capacitance of the fibrous tissue, including the capsule, are lower. The impedance is measured after the vapor delivery needle is deployed into the prostate. Subsequently, the ratio of the measured impedance to the impedance at initial deployment, after the needle has moved, is a preferred alert parameter. The impedance measured after deployment provides a patient-to-patient baseline. This ratio may be independent of tissue and environmental factors that vary between patients and between procedures.

[0071] Figure 2F shows a chart of the ratio of the impedance amplitude in the prostatic capsule to the impedance amplitude after deployment within the prostatic tissue (reference impedance), measured in excised human prostates, against frequency. Furthermore, Figure 2F shows the ratio of the impedance amplitude after needle puncture of the prostatic capsule to the initial tissue impedance, against frequency. It is important to alert the user when the needle approaches the capsule, and even more importantly, when the needle punctures the capsule. Steam therapy may be applied near the capsule but should not be applied outside the capsule within the periprostatic tissue. The impedance ratio was found to be maximum in the preferred frequency range of 10–50 kHz. Accurate amplitude and phase measurements can be performed with low-cost electronic equipment in this range, where there are few environmental noise sources. The frequency that provides optimal contrast between tissue and capsule (and between capsule and periprostatic tissue for detecting capsule puncture) is determined by the size, shape, material, and surface finish of the electrodes, as well as their separation and position on the needle tip. Any modification or improvement of these parameters requires new experiments to determine the optimal frequency (Figure 2F). A preferred frequency is 15 kHz.

[0072] Referring to Figures 2G and 2H, the proximal end of the steam delivery needle 215 is connected to a magnet carrier 223, which is configured to move the needle between a stowed position within the steam equipment shaft and an extended position where the steam delivery needle extends outward from the shaft. This connection may be made, for example, by a needle adhesive attachment 225. The lead wires already described (e.g., the lead wires 228a and 228b described above) may exit through a hole in the wall of the magnet carrier 223. Here, the thin wire lead wires 228a and 228b (which are electrically coupled to the bioimpedance electrodes and / or NGS coil) are connected to an interconnect PCB 232, exit the board as a flexible wire lead wire 234, are placed in a cable, and plugged into the steam console. In some embodiments, slack is given to the thin wire lead wire 228b to accommodate the difference in thermal expansion between the wire and the steam delivery needle during steam delivery. Furthermore, slack may be given to the flexible wire lead wire 234 to accommodate the movement of the magnet and needle during the deployment, retraction, and intervention movements of the needle.

[0073] The prostate tissue may be modeled as a parallel connection of a resistor and a capacitor, as shown in Figure 2I. As the needle tip enters the prostate tissue and approaches the capsule, the resistance and capacitance change. The values ​​of the tissue's resistance and capacitance are derived from the parallel RC tissue model and equations in Figure 2I, with respect to the absolute value of the impedance and the phase shift between current and voltage. The resistance of the prostate tissue is smaller than that of the fibrous capsule. This is partly because the capsule has a lower water content. The capacitance of the tissue capsule is smaller than that of the prostate tissue. This is because the prostate tissue is cytoplasmic, while the fibrous capsule is acellular (the cell membrane contributes to the capacitance). Both the high resistance and low capacitance of the capsule result in a high impedance in the parallel model in Figure 2I, which leads to a high impedance ratio, as shown in Figure 2F. In one embodiment, saline solution may be delivered into the tissue surrounding the prostate. Because the resistance of saline solution is relatively low, the impedance decreases as the needle penetrates the capsule, as shown in Figure 2F.

[0074] Before (idle mode) and during steam therapy, concentrated sterile water may be continuously injected from the steam delivery needle, and a layer of sterile water may cover the bioimpedance electrode. Sterile water has a much higher resistance than saline and tissue. On the other hand, the capacitance of sterile water is equivalent to that of saline and tissue. Therefore, the change in capacitance between the tissue and the coating may be more significant than the change in resistance or absolute impedance in the presence of sterile water. In some measurement systems, the absolute impedance value |Z| may become large enough to saturate the voltage amplifier in the presence of sterile water, and although accurate phase measurements can still be obtained, the calculations of R and C become less meaningful. This problem can be avoided by measuring the phase shift and reporting sin(φ) as a bioimpedance signal in the range of 0 to 1, where sin(φ) is 0 if the tissue is purely resistive and 1 if the tissue is purely capacitive. In one embodiment, the phase angle φ itself is reported. The tissue model in Figure 2I is perhaps the simplest model to explain tissue resistance at DC and capacitive coupling at high frequencies. To date, much more complex models have been proposed to explain intracellular electrical resistance (e.g., adding a resistor in series with a capacitor), non-cellular capacitance in parallel with cellular capacitance and resistance, and other implications. In advanced systems, it is possible to evaluate the parameters in these models by matching the model parameters with data acquired over a certain frequency range. Tissue models can also explain a charge separation layer that adds capacitance and resistance (in parallel with tissue capacitance and resistance) in addition to the tissue capacitance and resistance in the vicinity of the electrodes. The contribution of this “double layer” to capacitance approaches zero in pure water. In general, any combination of measured impedance and phase shift, and / or calculated resistance and capacitance, can be incorporated into the biocapacitance system to optimize the contrast between prostatic tissue and the prostatic capsule, and / or the contrast between the prostatic capsule and the periprostatic tissue.

[0075] In BPH steam therapy, the needle depth is fixed at 12 mm for steam delivery, whereas in contrast, prostate cancer therapy requires access to tissue at all depths within the prostate. In a preferred embodiment, the steam delivery needle described herein is accessible to all locations along the needle trajectory, which reaches approximately 26 mm. While a BPH method deploys and delivers steam over 9 seconds, in contrast, cancer treatment requires slow needle advancement along the needle trajectory to one or more sites after deployment. During navigation and steam delivery, the delivery device must be fixed and held in one place. If the needle moves, the flow path around the needle widens, potentially causing steam to backflow and be released into the urethra, which could result in inadequate treatment at the target site and potentially damage the urethral mucosa. This problem can be corrected by delivering the needle to a nearby location for retreatment. However, if the two insertion holes are close together, steam delivered to the second site may leak into the urethra through the first needle trajectory. If the physician holding the delivery device moves or rotates it even slightly before deployment, the needle may be deployed to a location that cannot access the target tissue. To minimize this problem, it is conceivable that two physicians perform the procedure. That is, one person stably holds the delivery device while viewing the cystoscopic image of the needle, and the other operates the TRUS system. A simpler procedure requiring only one physician is desirable.

[0076] Figures 3A-3B show one embodiment of the steam delivery device 302, and in particular, the controller 318 of the steam delivery device 302, which can also be used as a removable handle. Referring to Figures 3A-3B, it can be seen that the controller 318 of the steam delivery device 302 can be removed from the cartridge 316 at the removal point 332. When removed, the controller may be used as a remote controller having one or more buttons, levers, or adjustment knobs 334 configured to control the operation of the steam delivery device including the cartridge (e.g., steam / saline delivery, cleaning, needle advance / retraction, and other functions of the device during therapy). Both the handle and the cartridge have cables connected to the console, thereby allowing the handle and cartridge to communicate with each other even when removed. As further shown in Figure 3A, the cartridge and / or controller 318 may further include a mounting point 336 for a removable stabilizer arm, which will be described in detail later.

[0077] In another embodiment, the controller 318 does not function as a handle for the delivery device. Figure 3C shows a remote controller 318 separated from the device, and Figure 3D shows a controller 318 without mechanical handle functionality, detachably mounted to the cartridge 318. The remote controller may be kept detached from the cartridge or connected to the delivery device for use. The remote controller includes several buttons, levers, switches, and / or adjustment knobs 334, which the operator can use to control the forward or backward movement of the vapor delivery needle, the on / off of the therapy, the flow of cooling saline through the probe to the distal urethra, and the flow of perigritis saline to the tissue surrounding the prostate during therapy. In some embodiments, the operator can use toggle switches to change the ultrasound and camera views of the prostate and the delivery device probe. The ultrasound image may be either a sagittal view or an axial view, or a combination of views, and the cystoscope camera indicates the needle injection site. The view combination and image size may be selected with toggle switches.

[0078] A preferred embodiment of the present disclosure includes a stabilizer arm 420 shown in Figure 4A. The stabilizer arm is configured to be removablely attached to the cartridge 416 after the controller described above has been removed from the cartridge 416. In one example, the stabilizer arm is attached to the cartridge 416 by a coupler 422, which may include a lock control mechanism for switching the stabilizer arm between a locked and unlocked state. The controller then operates as a remote controller for the functions of the steam therapy described above while the cartridge 416 is attached to the stabilizer arm 420. The stabilizer arm may further be coupled to a motor 424 by a coupler 426. The stabilizer arm includes a plurality of individual links 421, each individual link 421 having an open end on one side and a rounded “ball joint” end on the other side configured to connect to the open end of an adjacent link. A DC motor 424 is located at the proximal end of the arm and coupled to a cable (not shown), which passes through the center of each link and connects to the furthest link of the stabilizer arm. If there is slack in this motor cable, the arm can be adjusted to any desired bend or position. Activating the motor and tightening the cable pulls each link simultaneously, locking them in place. Motor control may be performed by an adjustment knob on the coupler 422, as described above. During use, when the shaft tip reaches the target position in the urethra, a switch near the top of the stabilizer arm activates the stabilizer motor 424 shown in Figure 4, locking each segment of the stabilizer arm simultaneously into a three-dimensional arc. The operator then releases the cartridge, which remains fixed in the desired position and arc relative to the patient table. The operator may unlock the stabilizer arm and change its position. The delivery device shaft is rotatable to a selected angle, allowing the needle to retract.

[0079] Similarly, referring to Figure 4B, the TRUS probe 404 may be mounted on a stabilizer arm, similar to the cartridge described above. In the embodiment of Figure 4B, two separate stabilizer arms 420 are used, one for the TRUS probe 404 and the other for the cartridge / vapor delivery device 402. As described above, the operation and deactivation of the stabilizer arms may be switched by a switch at the top of the arm (e.g., a switch on the coupler between the arm and the probe). Leads from the TRUS probe, as well as from an optional NGS sensor fixedly mounted to the TRUS probe, may extend to the TRUS console. The TRUS probe may be set up by operating the adjustable clamp 423 shown in the figure, which allows for proper positioning of the probe and stabilizer arms relative to the patient on the patient seat 427 along a horizontal adjustment rail 425. As shown, the patient seat 427 is also rotatable / adjustable by a pivot 429. With the stabilizer arm deactivated, the TRUS probe is inserted into the desired position within the patient's rectum. The stabilizer arm then operates to hold the cradle in a fixed position and orientation relative to the patient. The TRUS probe may then be advanced or retracted to adjust the position of the sagittal imaging plane, and rotated to adjust the plane of the axial imaging plane.

[0080] The needle deployment, advancement, and vapor delivery proceed with little to no disruption to the needle trajectory. This is because the cartridge and shaft are held in a stable position by the stabilizer. This allows a single operator to concentrate on the TRUS image to ensure that the vapor is delivered to the target location without backflow into the urethra. After vapor has been delivered to one or more sites along the needle trajectory, the needle retracts into the shaft, the stabilizer arm motor stops, and each segment of the stabilizer arm is unlocked. The single physician can then manually move the cartridge and shaft to the next position in the urethra and repeat the procedure.

[0081] In some embodiments, both the delivery device cartridge and the TRUS probe are mounted on motor-controlled stabilizer arms. In some embodiments, the segmented shafts of the two stabilizer arms may be covered with flexible waterproof sleeves to protect the arms and prevent water ingress. Electromagnetic tracking sensors (i.e., needle guide system (NGS) sensors) may be fixedly mounted on both the delivery device shaft tip and the TRUS probe. This makes it possible to display the position of the probe tip on the TRUS image. Once the two stabilizer arms are locked in place, the position of the delivery device shaft tip remains stable even as the delivery device needle is deployed and advances. The deployed length of the needle can be measured by magnetic position sensors within the cartridge, which measure the position of the needle advance magnet relative to the needle's stowed position to provide information indicating the needle tip position. With the device stabilized, the needle deploys in a predictable arc shape. Software can estimate the position of the needle tip after deployment from the measured deployed length of the needle and the predicted needle arc, and the estimated position can be displayed on the TRUS image along with a cone of uncertainty. The operator can then make slight adjustments to the ultrasound imaging plane to ensure the needle is clearly visible in the ultrasound image. As the needle advances, the TRUS adjustment knob can be used to advance or retract the TRUS probe and imaging plane to maintain focus on the needle tip. A pair of stabilizers prevents the TRUS probe and delivery device cartridge from moving relative to each other while the needle is moving. Prior art TRUS stabilizers are large and cumbersome. The motor-driven locking arm described herein provides a slim and easy-to-use stabilizer.

[0082] Figures 5A-5C show a simple and ergonomic system for attaching and detaching the delivery device handle (controller) 518 to and from the cartridge 516. As shown, to attach the handle (controller) to the cartridge, the cartridge's engagement feature 519 is hooked onto the handle's notch 538, the handle is swung upward, and the handle is pushed in until it clicks into place within the cartridge. As shown, the handle (controller) may include a spring-loaded actuator 540. Once the handle is clicked into place, the actuator's arm 541 fits snugly into the cartridge's slot 543. To release the handle, the spring-loaded actuator 540 is pushed in, the handle is removed, and it is replaced by the stabilizer arm.

[0083] Referring to Figures 6A-6B, a similar mechanism may be used when attaching the stabilizer arm 620 to the cartridge 616 of the steam delivery device. For example, one or more notches or complementary engaging parts may be used to connect the two components. In one embodiment, they may be held in place by one or more spring-loaded actuators 642. When the two are connected, the stabilizer can be clicked into place (locked). Pushing in the actuator 642 releases the stabilizer from the cartridge. In the illustrated embodiment, the stabilizer can be attached to the cartridge even when the handle is still attached to the cartridge. In another embodiment, the location where the stabilizer is attached to the cartridge is the same as the location where the handle is attached to the cartridge (therefore, the handle must be removed before attaching the stabilizer).

[0084] Prior art steam delivery devices use an RF current flowing through a coil, which inductively couples with a heating element tube, pumping sterile water through the heating element tube to generate steam. The ohmic heat generated in the RF coil contributes little to heating the water flowing through the inductive coil, but adds considerable heat to the delivery device, raising its temperature. In this disclosure, a DC current flows directly through the heating element tube 744 via a specially designed high-current connector 746 electrically connected to the PCB 748 shown in Figures 7A-7B. As shown, the high-current connector 746 may include a notch or cutout designed and configured to serve as a cradle for the heating element tube 744 or to hold the heating element tube 744. In this example, two high-current connectors 746 hold and support the entire tube 744, with the first connector holding the inlet portion of the tube, which extends axially along the length of the steam delivery device, and the second high-current connector holding the coiled portion of the tube, which extends substantially radially or perpendicularly to the inlet portion. The DC current may be supplied from a 24-volt, 0-25 ampere medical-grade DC power supply located within the system console. By measuring and multiplying the voltage across the heating element and the current flowing through it, an accurate real-time measurement of the power lost by the heating element can be obtained. The heating element power may be servo-controlled by a pulse-width modulation (PWM) circuit within the console to a set power level. The system's calorie-per-second steam output is proportional to the heating element power via an efficiency factor. By controlling the heating element power, the calorie output is controlled independently of any changes in the electrical load of the heating element. In contrast to RF heating elements, the temperature of the cartridge wall surrounding the DC heating element is always low enough for the operator to comfortably grip.

[0085] The heating elements in Figures 7A-7B may be manufactured from Inconel 625 stainless steel, which is chosen because of its relatively high electrical resistance, and in particular because its electrical resistance is almost independent of temperature over the nominal operating range of 20-300°C. Sterile water at room temperature enters the heating element 744, and steam exits the heating element at temperatures above 100°C, so a temperature gradient exists along the tube. If the electrical resistance of the heating element tube increases with temperature, the resistance at the distal end of the tube will be higher, and more ohms I will be present at the distal end of the tube. 2 R-heat will be dissipated. This will lead to a decrease in the efficiency of conversion to steam and an excessively high steam outlet temperature. Inconel 625 may be covered with a thin-walled polyimide tube that has excellent electrical insulation and high-temperature stability. The windings of the insulated heating element may be pre-stressed to ensure good thermal contact between the windings. This reduces the temperature gradient along the tube and improves the efficiency of steam generation. As the temperature inside the heating element rises, more heat can be released to the delivery device cartridge by conduction, convection, and radiation. High temperatures on the cartridge can be a safety concern. The higher the efficiency (the smaller the heat loss), the more stable the steam calorie output. For these reasons, it is important to minimize heat loss from the heating element.

[0086] In the designs shown in Figures 7A-7B, conductive heat loss is minimized by performing mechanical mounting at the low-temperature input end of the heating element, with only the electrical connector in contact with the heating element at the high-temperature distal end. High-current connectors 746 made of brass, stainless steel, or Inconel may be welded or mechanically mounted to the heating element, or soldered to thick, low-resistance patterns on a PCB (printed circuit board) 748. These patterns provide mechanical stability and a connection with very low electrical resistance. The PCB provides a landing point for other electrical leads in the system as they exit through the delivery device cable. A thermocouple may be welded to the distal end of the heating element to monitor the steam outlet temperature, and the console may use the thermocouple to shut down the system if the steam outlet temperature falls outside a specified range. In some embodiments, the thermocouple is welded to the distal side of the electrical connector. This is because if the thermocouple is placed proximal to the distal connector post, the DC current flowing along the length of the heating element tube across both ends of the thermocouple will generate an IR voltage drop. Thermocouples cannot distinguish the IR voltage drop from the voltage drop across the dissimilar metals that comprise the thermocouple. When a thermocouple is welded to the proximal side of a distal connector, a stray voltage appears at the thermocouple joint, which is interpreted by software as a temperature reading error. The stray voltage varies from device to device because it depends on the material distribution of the thermocouple's weld ball. On the distal side of the distal connector, there is no current flow and therefore no stray voltage.

[0087] In some embodiments, the thermocouple may be positioned proximal to the distal connector, for example, to quickly detect bubbles that could significantly reduce convective cooling of the tube. The current flowing through the tube at the location of the bubble will rapidly heat the tube at that location, and this event is detected by the thermocouple placed proximal to the distal connector. The IR voltage drop error in the thermocouple reading can be reduced by mounting the two thermocouple leads around the tube so that their potentials are the same. A thin layer of electrical insulating material may be placed between the thermocouple and the heating element tube to insulate the weld ball from the heating element. As an alternative technique, for example, an RTD (resistance thermometer) may be used, which is unaffected by the current flowing through the heating element tube. In one embodiment, a thin insulated wire is wound around the tube to form a coil. The resistance of this coil is monitored. For coil wire materials such as copper or platinum, the resistance of the coil increases linearly with temperature over the operating temperature range (20-300°C). The coil may be made non-inductive by folding and winding a wire twice its length (to prevent the induction of noise voltage). RTDs are generally more accurate and robust than thermocouples and are easier to connect to external electronic equipment. Other types of thermometers that can be used for this application include thermistors and tip-mount optical thermometers. In some embodiments, two or more miniature thermometers may be installed along the length of the heating element tube.

[0088] A sensor may be configured to measure the pressure of the sterile water delivered to the heating element 744. The water pressure is affected by the generation of steam within the heating element 744. For example, if bubbles pass through the heating element and cause spikes in both pressure and temperature, a measurable pressure change occurs. If the water pressure exceeds a preset value for a preset period of time, power to the heating element may be automatically shut down.

[0089] In a preferred embodiment shown in Figure 7C, sterile water is pushed by a syringe 755 through a water delivery tube of the delivery system into a heating element tube 744. A stepper motor (not shown) moves the plunger shaft 759 forward and backward, allowing the syringe plunger 757 to move forward and backward. An O-ring 756 may be provided between the plunger and the syringe. The plunger and plunger shaft can be coupled with a magnet 761, which allows a disposable syringe to be removed from the console plunger shaft 759. As the plunger shaft moves forward, force is applied to the plunger 757 through a load cell 763 and a load cell button 765. The pressure can then be calculated by dividing the force measured between the load cell and the load cell button by the cross-sectional area of ​​the plunger. In one example, as the force increases from 0 to 50 pounds, the load cell button moves a total of 18 microns relative to the load cell. A 0.5 mm gap between the dowel pin 767 and the load cell adapter 769 is sufficient to accommodate slight displacement of the load cell button. Lead wires from the load cell exit the console's electronics from the proximal side of the plunger shaft. The load cell measures pressure and pressure changes throughout the sterile water delivery line, including the heating element tube and steam delivery needle. An increase in pressure may indicate a blockage in the flow (e.g., due to debris in the steam delivery hole). A decrease in pressure may indicate a leak in the fluid delivery line. Pressure and temperature measurements are processed in real time by the console software, which provides engineering data and enables automatic system alerts and shutdowns. Abrupt pressure changes are detected with a resolution of approximately + / - 25 mmHg.

[0090] The load cell in Figure 7C measures pressure when the plunger shaft moves forward. No pressure is measured when the plunger shaft moves backward. The dowel pin 767 in Figure 7C allows the load cell adapter to retract. The syringe plunger retracts due to attraction between the magnets in Figure 7C. In some embodiments, the dowel pin is made of a paramagnetic metal that is attracted to the plunger magnet. The magnetic attraction between the dowel pin and the adapter positions and stabilizes the load cell at the center, while this magnetic attraction does not interfere with force measurement.

[0091] Figure 8 shows the heating element incorporated into the delivery device cartridge. A solenoid needle driver 866 and a Hall effect magnetic sensor 868 are also shown. The magnetic sensor 868 measures the magnetic field of a magnet that drives the deployment and retraction of the vapor delivery needle by moving a magnet attached to the needle. At the illustrated position, the average of the readings from these two Hall sensors is found to be approximately linear with respect to the magnet's position (and therefore the needle's position). The average of the Hall sensor readings also detects the magnetic field of the solenoid coil, which is proportional to the current flowing through the solenoid coil. It has been found that the contribution of the solenoid current can be removed by subtracting a term proportional to the measured solenoid current from the average of the Hall sensor signals. Thus conditioned, the Hall signal is simply proportional to the magnet's position. To calibrate the position signal, the average of the Hall signal is measured during the setup of the device at the needle's home position (retracted) and its fully deployed position. The console software then calculates and displays the magnet's position relative to its fully retracted position. The Hall sensor is electrically connected to the PCB, and leads extend from there through a cable to the console.

[0092] Figure 8 also shows one or more flushing buttons 870 located on the cartridge. As the shaft advances through the urethra and rotates to the selected angle, the user can use these buttons to perform a flush to clear the cystoscope's view. The flushing buttons are also doubled on the handle, which can be used as a remote controller.

[0093] Needle tip temperature sensor

[0094] A thermometer or thermocouple installed at or near the tip of the vapor delivery needle provides diagnostic information about the tissue before, during, and after therapy. Examples of temperature sensors incorporated into the needle tip are shown in Figures 9A-9B. This includes one or more miniature thermocouples 903 (Figure 9A) embedded in the wall of the needle, and the electrical resistance of a wire coil 905 (Figure 9B), the resistance of which increases linearly with temperature. The wire coil may include insulated copper or platinum wires, both of which have resistance that increases linearly with temperature over a range from room temperature to 300°C. In some embodiments, the wire coil includes a needle guide system (NGS) sensing coil or an NGS transmitting coil. The resistance of the coil may be measured by passing a constant amplitude DC or AC current through the coil and measuring the voltage amplitude across the coil's leads. AC current is preferred because noise sources can be removed by bandpass filtering at the frequency of the AC current. The ratio of voltage to current amplitude is the electrical resistance of the coil. The electrical resistance of a coil is given by the following equation as a function of temperature:

[0095] R=R0[1+α(T-T0)] However, R is the coil resistance at temperature T, R0 is the coil resistance at a known temperature T0 (e.g., room temperature), and α is the temperature coefficient of resistance, which is equal to 0.00393 / °C for both copper and platinum. Rearranging the above equation to solve for temperature yields the following equation.

[0096] T = T0 + (R / R0 - 1) / α

[0097] If the temperature measuring coil is also an NGS sensor, the coil can function as a thermometer for short periods between NGS sensor measurements. If the temperature measuring coil is also an NGS transmitter, a constant amplitude AC transmission current flows continuously through the coil, and simultaneous and continuous temperature calculations are possible by measuring the voltage amplitude across the coil. If the driving current of the NGS coil causes a temperature rise, a new term may be added to the temperature equation to compensate. The temperature sensor leads pass through conduits within the walls of the vapor delivery needle, as already illustrated and described.

[0098] In some embodiments, the lead wire for measuring voltage is attached to the distal lead wire of the coil shown in Figure 9B and also passes through one or more conduits of a steam delivery needle (as shown in Figures 2C-2E). When T0 is at room temperature, T0 may be measured at the beginning of the procedure by one or more temperature sensors in the steam delivery system (e.g., thermocouples at the coil outlet of the steam generator), and at the same time, the coil resistance R0 at room temperature may be measured.

[0099] Measuring the temperature near the tip of a vapor delivery needle has various diagnostic applications. Since tissue ablation requires a temperature-dependent rise in tissue temperature over a certain period, the needle tip temperature serves as an indicator of whether the tissue has reached the ablation temperature for a sufficient amount of time. When the needle tip moves from one treatment site to another (for example, by the needle withdrawing or being inserted into another tissue), the tissue temperature indicates whether that other tissue has been treated, thereby minimizing the number of therapy sessions. In another embodiment, a small puff of vapor may be delivered to explore the temperature response of tissue at a given site. This measurement can indicate the total amount of calories (i.e., vapor volume) required to cause damage of a given size at that site. In general, measuring the temperature of tissue near the needle tip is a valuable diagnostic tool.

[0100] The vapor delivery system of this disclosure uses ultrasound imaging combined with cystoscopy images and real-time tracking of the needle tip to evaluate the needle position and guide the needle to a selected location within the prostate for vapor delivery. The operator views the ultrasound image during the procedure, and the NGS needle tip position is calculated from NGS sensor data and marked on the ultrasound image. The needle tip is displayed on the ultrasound image if it is within the plane of the ultrasound image. In some embodiments, the ultrasound imaging plane is adjustable to align with the NGS tracking position. Another method of viewing the needle on the ultrasound image is desirable, with or without the assistance of NGS tracking.

[0101] Figure 10A shows one embodiment of a vapor delivery device 1002 and vapor delivery system 1000 configured to display a vapor delivery needle 1015 on an ultrasound image without the assistance of NGS tracking. A vapor delivery device in any embodiment of Figures 10-10G may include any of the features described herein and above, which include an introduction shaft sized and configured to provide transurethral access to a patient, a therapy needle or vapor needle slidably disposed within the introduction shaft, a forwarding mechanism (e.g., a solenoid driver) coupled with the therapy needle and configured to advance the therapy needle from the introduction shaft through the urethral prostatic portion into the patient's prostate, and the like.

[0102] In the embodiment shown in Figure 10A, the needle 1015 may be coupled to a needle driver magnet 1065, which is configured to be vibrated by the same needle driver solenoid (e.g., solenoid 866 in Figure 8) responsible for the deployment / retraction of the vapor delivery needle. In one embodiment, the solenoid may vibrate the needle with an amplitude and frequency that causes the needle to appear bright in the ultrasonic image in Doppler imaging mode, generated by the imaging system 1004. Figure 10A shows the ultrasonic image 1005 and the Doppler image 1007. In Doppler mode, the needle appears blue when approaching the ultrasonic crystal and red when moving away from the ultrasonic crystal. In the Doppler ultrasonic image of Figure 10A, the needle is vibrated with a peak-to-peak amplitude of 0.25 mm and a frequency of 16.7 Hz (period of 60 milliseconds). The Doppler image of the needle appears blue and red as it periodically approaches and moves away from the TRUS crystal.

[0103] Another embodiment of vibrating the needle tip is shown in Figure 10B. In this embodiment, a piezoelectric crystal 1009 may be mounted on the shaft of the vapor delivery device. For example, the piezoelectric crystal may be embedded in the shaft or mounted on the surface of the shaft. In this embodiment, the crystal is shown to be mounted near the tip of the shaft, but naturally, wherever it is mounted on or inside the shaft, the vapor delivery needle 1015 will vibrate as a result. When this crystal is vibrated by the signal generator, the needle vibrates within its outer surface, and as a result, the vibrating needle is displayed on the Doppler ultrasound image.

[0104] Figures 10C–10E show three other embodiments for vibrating the needle tip. In the embodiment of Figure 10C, a balloon 1011 installed on or inside the shaft rapidly inflates and deflates to vibrate the needle tip. In some embodiments, the balloon may be inflated and deflated using water, air, fluid, or gas, with a supply lumen feeding the balloon, and the balloon passing through a lumen inside the shaft. Similarly, in Figure 10D, the foil 1013 may be configured such that the foil 1013 vibrates when current from a signal generator passes through the shape memory foil 1013 installed on or inside the shaft. The foil may include a thermomechanical film whose shape changes when current is applied to both ends of the foil. As will be understood by those skilled in the art, current leads may extend along the length of the shaft to supply current to the shape memory foil. In the embodiment shown in Figure 10E, a small solenoid coil 1015, positioned on or inside the shaft, may be configured to strike or contact the needle 1015 to impart external vibration. In these embodiments, a periodic movement of the needle tip is induced by an element positioned on the underside of the shaft, enabling the needle tip to be found on the Doppler ultrasound image. In alternative embodiments, the vibrating members shown in Figures 10A-10E may be positioned on the needle tip itself rather than on the shaft as described above.

[0105] Two alternative embodiments for visualizing the needle tip are shown in Figures 10F-10G. In the embodiment of Figure 10F, the piezoelectric crystal 1017 may be located at, on, or inside the needle tip. A lead wire may extend to the crystal using the needle lumen. This crystal may be used as a transmitter operating at the frequency of the TRUS imaging probe. The crystal appears as a bright reflection on the ultrasound image. Unlike reflected ultrasound, the transmission from the needle tip is unidirectional, and the received needle pulse appears to be at half the distance of the reflected pulse. Compensation may be performed in software, and the compensation may be corrected on the display. Smaller ultrasound crystals operating at much higher frequencies (e.g., in the range of 40-60 MHz) may be better physically suited to smaller diameter needles. In this case, high-frequency bursts may be delivered in bursts at the TRUS imaging frequency. The needle tip crystal, as a receiver, receives ultrasound from the TRUS crystal array and calculates the position of the needle tip relative to the ultrasound image. This location may be displayed on the ultrasound image.

[0106] Referring to the embodiment in Figure 10G, the inflatable balloon 1019 may be attached to or connected to the vapor delivery needle. When inflated with gas, the balloon can be brightly displayed under ultrasound guidance, as shown in the ultrasound image 1021, and the contrast provided by this may improve the needle's localization / visualization.

[0107] In any of the embodiments shown in Figures 10A to 10G, it is possible to install a vibrating element on or inside the shaft, or on or inside the vapor delivery needle.

[0108] While embodiments of the present invention have been described in detail up to this point, it should be noted that this description is for illustrative purposes only, and the above description of the present invention is not exhaustive. Specific features of the present invention are shown in some drawings, and not in others. This is purely for convenience, and any feature may be combined with other features according to the present invention. Modifications and alternative forms will be obvious to those skilled in the art. Such alternative and modified forms are included in the claims. Each feature shown in the dependent claims may be combined and included in the scope of the present invention. The present invention also encompasses embodiments as if the dependent claims were written in a multi-dependent claim format, where the dependent claims refer to other dependent claims as alternatives. [Note 1] An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle slidably disposed within the introduction shaft, wherein the vapor delivery needle is configured to vibrate in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system, A forward-moving mechanism, coupled to the aforementioned therapeutic needle, is configured to advance the vapor delivery needle through the introduction shaft into the urethral prostatic region and into the patient's prostate gland. A prostate treatment system that includes this. [Note 2] The prostate treatment system according to Appendix 1, further comprising a magnet coupled to the vapor delivery needle, wherein the forward mechanism comprises a push-pull solenoid driver configured to move the magnet to advance and retract the vapor delivery needle. [Note 3] The prostate treatment system according to Appendix 2, wherein the solenoid driver is configured to vibrate the vapor delivery needle during vapor delivery. [Note 4] The prostate treatment system according to Appendix 1, further comprising a piezoelectric crystal disposed on or within the introduction shaft, wherein the piezoelectric crystal is electrically coupled to a signal generator to vibrate the vapor delivery needle during vapor delivery. [Note 5] The prostate treatment system according to Appendix 1, further comprising a piezoelectric crystal disposed on or within the vapor delivery needle, wherein the piezoelectric crystal is electrically coupled to a signal generator to vibrate the vapor delivery needle during vapor delivery. [Note 6] The prostate treatment system according to Appendix 1, further comprising a balloon positioned on or within the introduction shaft, wherein the balloon is operationally coupled to a supply lumen, and the rapid inflation and deflation of the balloon is configured to vibrate the vapor delivery needle during vapor delivery. [Note 7] The prostate treatment system according to Appendix 1, further comprising a balloon disposed on or within the vapor delivery needle, wherein the balloon is operationally coupled to a supply lumen, and the rapid inflation and deflation of the balloon is configured to cause the vapor delivery needle to vibrate during vapor delivery. [Note 8] The prostate treatment system according to Appendix 1, further comprising a shape memory foil disposed on or within the introduction shaft, wherein the shape memory foil is electrically coupled to a signal generator and is configured to vibrate the vapor delivery needle during vapor delivery by vibrating when an electric current from the signal generator passes through the shape memory foil. [Note 9] The prostate treatment system according to Appendix 1, further comprising a shape memory foil disposed on or within the vapor delivery needle, wherein the shape memory foil is electrically coupled to a signal generator and is configured to vibrate the vapor delivery needle during vapor delivery by vibrating when an electric current from the signal generator passes through the shape memory foil. [Note 10] The prostate treatment system according to Appendix 1, further comprising a solenoid coil disposed on or within the introduction shaft, wherein the solenoid coil is configured to vibrate the vapor delivery needle during vapor delivery by striking the introduction shaft or the vapor delivery needle. [Note 11] The prostate treatment system according to Appendix 1, further comprising a solenoid coil disposed on or within the vapor delivery needle, wherein the solenoid coil is configured to vibrate the vapor delivery needle during vapor delivery by striking the introduction shaft or the vapor delivery needle. [Note 12] The imaging system includes a Doppler ultrasound imaging system, as described in Appendix 1, for the prostate treatment system. [Note 13] A method for treating a patient's prostate, The steps include inserting the shaft of the therapy device transurethrally into the patient, The steps include: passing the therapeutic needle through the shaft to the patient's urethral prostate region and advancing it into the patient's prostate; The steps include delivering the therapy into the prostate gland from the aforementioned therapy needle, The steps include vibrating the aforementioned therapeutic needle, The steps include visualizing the vibrating therapeutic needle in real-time imaging, A method that includes this. [Note 14] The method according to Appendix 13, wherein the step of visualizing the vibrating therapeutic needle further includes providing a real-time Doppler ultrasound image of the vibrating therapeutic needle. [Note 15] The method according to Appendix 13, wherein the step of delivering the therapy further includes delivering the steam therapy into the prostate from the therapy needle. [Note 16] The method according to Appendix 13, wherein the step of advancing the therapeutic needle from the shaft further includes acting on a solenoid needle driver magnetically coupled to the therapeutic needle. [Note 17] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes vibrating the therapeutic needle with the solenoid needle driver. [Note 18] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes vibrating a piezoelectric crystal disposed on or inside the shaft with a signal generator. [Note 19] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes vibrating a piezoelectric crystal disposed on or inside the therapeutic needle with a signal generator. [Note 20] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes rapidly inflating or deflating a balloon located on or inside the shaft using a signal generator. [Note 21] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes rapidly inflating or deflating a balloon placed on or inside the therapeutic needle using a signal generator. [Note 22] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes vibrating a shape memory foil disposed on or inside the shaft with a signal generator. [Note 23] The method according to Appendix 16, wherein the step of vibrating the therapeutic needle further includes vibrating a shape memory foil disposed on or inside the therapeutic needle with a signal generator. [Note 24] It is a prostate treatment device, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle is slidably disposed within the introduction shaft, One or more electrodes arranged on the vapor delivery needle, One or more lead wires are electrically connected to one or more electrodes and are configured to extend along the length of the vapor delivery needle, A forward-moving mechanism, coupled to the aforementioned therapeutic needle, is configured to advance the vapor delivery needle through the introduction shaft into the urethral prostatic region and into the patient's prostate gland. A PCB located proximal to the forward mechanism, comprising: an exit hole for one or more lead wires; and a PCT interconnect configured to electrically couple the one or more lead wires to flexible wire lead wires extending proximal to the forward mechanism; A prostate treatment device that includes [unclear]. [Note 25] The prostate treatment device according to Appendix 24, wherein the one or more lead wires include slack between the location where the one or more lead wires extend from the exit hole and the location where the one or more lead wires are connected to the PCT interconnect. [Note 26] The prostate treatment device according to Appendix 25, wherein the slack is provided in the one or more wire lead wires to accommodate the difference in thermal expansion between the one or more wire lead wires and the vapor delivery needle during vapor delivery. [Note 27] It is a prostate treatment device, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle is slidably disposed within the introduction shaft, The apparatus body is coupled to the introduction shaft and the vapor delivery needle, A handle including one or more controllers for operating the prostate treatment device, the handle being detachable from the device body and configured to control the operation of the prostate treatment device whether the handle is attached to the device body or detached from the device body, A prostate treatment device that includes [unclear]. [Note 28] The prostate treatment device according to Appendix 27, wherein the handle is configured to control the delivery of steam. [Note 29] The prostate treatment device according to Appendix 27, wherein the handle is configured to control the delivery of saline solution. [Note 30] The prostate treatment device according to Appendix 27, wherein the handle is configured to control the forward and backward movement of the vapor delivery needle. [Note 31] Patient table and Horizontal adjustment rail and A first stabilizer arm coupled to the horizontal adjustment rail, the first stabilizer arm includes an unlocked state in which the first stabilizer arm is adjustable to any desired bend or posture, and a locked state in which the bend or posture of the first stabilizer arm is locked in a fixed position, the first stabilizer arm is axially adjustable relative to the patient table along the horizontal adjustment rail, A second stabilizer arm coupled to the horizontal adjustment rail, the second stabilizer arm includes an unlocked state in which the second stabilizer arm is adjustable to any desired bend or posture, and a locked state in which the bend or posture of the second stabilizer arm is locked in a fixed position, the second stabilizer arm is axially adjustable relative to the patient table along the horizontal adjustment rail, The imaging system coupled to the first stabilizer arm, The therapy system coupled to the second stabilizer arm, A surgical treatment system that includes this. [Note 32] The aforementioned therapeutic system includes a steam therapy system, as described in Appendix 31, as a surgical therapeutic system. [Note 33] The imaging system is the surgical treatment system described in Appendix 31, which includes a transrectal imaging probe.

Claims

1. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft sized and configured to provide transurethral access to the patient, and a piezoelectric crystal placed on or inside the introduction shaft, A vapor delivery needle slidably disposed within the introduction shaft, wherein the piezoelectric crystal is electrically coupled to a signal generator and configured to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

2. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle slidably disposed within the introduction shaft, and a piezoelectric crystal disposed on or within the vapor delivery needle, wherein the piezoelectric crystal is electrically coupled to a signal generator and configured to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

3. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft sized and configured to provide transurethral access to the patient, and a balloon positioned on or inside the introduction shaft, A vapor delivery needle slidably disposed within the introduction shaft, wherein the balloon is operationally coupled to the supply lumen, and the rapid inflation and deflation of the balloon is configured to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

4. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle slidably disposed within the introduction shaft, and a balloon disposed on or within the vapor delivery needle, wherein the balloon is operationally coupled to the supply lumen, and the balloon is configured to rapidly inflate and deflate to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

5. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft sized and configured to provide transurethral access to the patient, and a shape memory foil placed on or inside the introduction shaft, A vapor delivery needle slidably disposed within the introduction shaft, wherein the shape memory foil is electrically coupled to a signal generator and is configured to vibrate during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system by vibrating when an electric current from the signal generator passes through the shape memory foil, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

6. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle slidably disposed within the introduction shaft, and a shape memory foil disposed on or within the vapor delivery needle, wherein the shape memory foil is electrically coupled to a signal generator and is configured to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system by vibrating when an electric current from the signal generator passes through the shape memory foil, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

7. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft sized and configured to provide transurethral access to the patient, and a solenoid coil positioned on or inside the introduction shaft, A vapor delivery needle slidably disposed within the introduction shaft, wherein the solenoid coil is configured to vibrate the vapor delivery needle during vapor delivery in order to enhance the visibility of the vapor delivery needle in the real-time image from the imaging system by striking the introduction shaft or the vapor delivery needle, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

8. An imaging system configured to provide real-time images of a patient's prostate, An introduction shaft, sized and configured to provide transurethral access to the patient, A vapor delivery needle slidably disposed within the introduction shaft, and a solenoid coil disposed on or within the vapor delivery needle, wherein the solenoid coil is configured to vibrate the vapor delivery needle during vapor delivery in order to improve the visibility of the vapor delivery needle in the real-time image from the imaging system by striking the introduction shaft or the vapor delivery needle, A forward mechanism is coupled to the vapor delivery needle and configured to advance the vapor delivery needle from the introduction shaft through the urethral prostatic region to the patient's prostate, A prostate treatment system that includes this.

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