Patent Description:
Benign prostatic hyperplasia (BPH) is a common disorder in middle-aged and older men, with prevalence increasing with age. At age <NUM>, more than one-half of men have symptomatic BPH, and by age <NUM>, nearly <NUM>% of men have microscopic evidence of an enlarged prostate. The severity of symptoms also increase with age with <NUM>% of patients in the <NUM>-<NUM> age bracket having moderate-to-severe symptoms, and <NUM>% of patients in their <NUM>'s suffering from moderate-to-severe symptoms.

The prostate early in life is the size and shape of a walnut and prior to the enlargement resulting from BPH, weighs about <NUM> grams. Prostate enlargement appears to be a normal process. With age, the prostate gradually increases in size to twice or more its normal size. The fibromuscular tissue of the outer prostatic capsule restricts expansion after the gland reaches a certain size. Because of such restriction on expansion, the intracapsular tissue will compress against and constrict the prostatic urethra, thus causing resistance to urine flow.

<FIG> is a sectional schematic view the male urogenital anatomy, with the walnut-sized prostate gland <NUM> located below the bladder <NUM> and bladder neck indicated at <NUM>. The walls <NUM> of bladder <NUM> can expand and contract to cause urine flow through the urethra <NUM>, which extends from the bladder <NUM>, through the prostate <NUM> and penis <NUM>. The portion of urethra <NUM> that is surrounded by the prostate gland <NUM> is referred to as the prostatic urethra <NUM>. The prostate <NUM> also surrounds the ejaculatory ducts <NUM> which have an open termination in the prostatic urethra <NUM>. During sexual arousal, sperm is transported from the testes <NUM> by the ductus deferens <NUM> to the prostate <NUM> which provides fluids that combine with sperm to form semen during ejaculation. On each side of the prostate, the ductus deferens <NUM> and seminal vesicles <NUM> join to form a single tube called an ejaculatory duct <NUM>. Thus, each ejaculatory duct <NUM> carries the seminal vesicle secretions and sperm into the prostatic urethra <NUM>.

Referring to <FIG>, the prostate glandular structure can be classified into three zones: the peripheral zone, transition zone, and central zone. The peripheral zone PZ, which is the region forming the postero-inferior aspect of the gland, contains <NUM>% of the prostate glandular elements in a normal prostate (<FIG>). A majority of prostate cancers (up to <NUM>%) arise in the peripheral zone PZ. The central zone CZ surrounds the ejaculatory ducts <NUM> and contains about <NUM>-<NUM>% of the prostate volume. The central zone is often the site of inflammatory processes. The transition zone TZ is the site in which benign prostatic hyperplasia develops, and contains about <NUM>-<NUM>% of the volume of glandular elements in a normal prostate (<FIG>), but can constitute up to <NUM>% of such volume in cases of BPH. The transition zone TZ consists of two lateral prostate lobes and the periurethral gland region indicated at <NUM>. As can be understood from <FIG>, there are natural barriers around the transition zone TZ, i.e., the prostatic urethra <NUM>, the anterior fibromuscular stroma FS, and a fibrous plane FP between the transition zone TZ and peripheral zone PZ. In <FIG>, the anterior fibromuscular stroma FS or fibromuscular zone can be seen and is predominantly fibromuscular tissue.

BPH is typically diagnosed when the patient seeks medical treatment complaining of bothersome urinary difficulties. The predominant symptoms of BPH are an increase in frequency and urgency of urination, and a significant decrease in the rate of flow during urination. BPH can also cause urinary retention in the bladder which in turn can lead to lower urinary tract infection (LUTI). In many cases, the LUTI then can ascend into the kidneys and cause chronic pyelonephritis, and can eventually lead to renal insufficiency. BPH also may lead to sexual dysfunction related to sleep disturbance or psychological anxiety caused by severe urinary difficulties. Thus, BPH can significantly alter the quality of life with aging of the male population.

BPH is the result of an imbalance between the continuous production and natural death (apoptosis) of the glandular cells of the prostate. The overproduction of such cells leads to increased prostate size, most significantly in the transition zone which traverses the prostatic urethra.

In early stage cases of BPH, pharmacological treatments can alleviate some of the symptoms. For example, alpha-blockers treat BPH by relaxing smooth muscle tissue found in the prostate and the bladder neck, which may allow urine to flow out of the bladder more easily. Such drugs can prove effective until the glandular elements cause overwhelming cell growth in the prostate.

More advanced stages of BPH, however, can only be treated by surgical or less-invasive thermal ablation device interventions. A number of methods have been developed using electrosurgical or mechanical extraction of tissue, and thermal ablation or cryoablation of intracapsular prostatic tissue. In many cases, such interventions provide only transient relief, and these treatments often cause significant peri-operative discomfort and morbidity.

In a prior art thermal ablation method, RF energy is delivered to prostate tissue as schematically depicted in <FIG> depicts the elongated prior art RF needle being penetrated into a plurality of locations in a prostate lobe. In a first aspect of the prior art method, the elongated RF needle typically is about <NUM> in length, together with an insulator that penetrates into the lobe. The resulting RF treatment thus ablates tissue away from the prostatic urethra <NUM> and does not target tissue close to, and parallel to, the prostatic urethra <NUM>. In another aspect of the prior art RF thermal ablation method, the application of RF energy typically extends for <NUM> to <NUM> minutes or longer which allows thermal diffusion of the RF energy to ablate tissue out to the capsule periphery. Such prior art RF energy delivery methods may not create a durable effect, since smooth muscle tissue and alpha adrenergic receptors are not uniformly ablated around the prostatic urethra or within the transition zone. As a result, tissue in the prostate lobes can continue to grow and impinge on the urethra thus limiting long-term effectiveness of the treatment.

Document <CIT> discloses systems and methods for prostate treatment. An energy delivery probe that can apply energy to tissue, such as a prostrate, to shrink, damage, denaturate the prostate. In some embodiments, the energy can be applied with a vapor media. The energy delivery probe can include a vapor delivery member configured to extend into a transition zone prostate tissue. A condensable vapor media can be delivered from the vapor delivery member into the transition zone tissue, wherein the condensable vapor media can propagate interstitially in the transition zone tissue and be confined in the transition zone tissue by boundary tissue adjacent to the transition zone tissue.

Document <CIT> discloses a magnetic linear actuator for deployable catheter tools. The linear actuator uses magnetic repulsion and attraction for moving a bobbin that can be attached to moving components that translate linear movements into the actuation of a tool that is attached to the linear actuator.

For better understanding of the invention, the present disclosure provides also further aspects, embodiments and examples which do not fall under the scope of the claim. In particular, the disclosed methods do not form part of the invention. According to the embodiments described above, a prostate treatment device can be provided comprising an introducer shaft sized and configured for transurethral access into a patient, a vapor generator configured to generate a condensable vapor, a vapor delivery needle in communication with the vapor generator and slidably disposed within the introducer shaft, and a magnetic actuator configured to apply magnetic force to the vapor delivery needle to move the vapor delivery needle between a retracted position inside the introducer shaft and an extended position at least partially outside of the introducer shaft.

In some embodiments, the magnetic actuator is configured to axially move the vapor delivery needle toward the extended position from the retracted position at a velocity ranging from <NUM> meter per second to <NUM> meters per second. In another embodiment, the vapor delivery needle can move between the retracted and extended positions (and vice versa) at a velocity ranging from <NUM> meter per second to <NUM> meters per second.

In other embodiments, the magnetic actuator is configured to cause a tip portion of the vapor delivery needle to penetrate into prostate tissue when moving toward the extended position from the retracted position. In some embodiments, the vapor delivery needle is sized and configured to extend into prostate tissue when the introducer shaft is positioned within a urethra of the patient.

In one embodiment, the magnetic actuator further comprises a first magnet carried by the vapor delivery needle, wherein the magnetic actuator is configured to move the first magnet and the vapor delivery needle proximally and distally along a longitudinal axis of the introducer shaft. In another embodiment, the magnetic actuator further comprises a second magnet carried in a frame of a handle of the device, the second magnet being configured to interact with the first magnet to move the vapor delivery needle proximally and distally along the longitudinal axis of the introducer shaft. In some embodiments, the frame is rotatable in the handle. In yet another embodiment, the magnetic actuator further comprises a third magnet carried in a second frame of the handle, the third magnet being configured to interact with the first and second magnets to move the vapor delivery needle proximally and distally along the longitudinal axis of the introducer shaft.

In some embodiments, the device can further include a grip adapted for manual control of the magnetic actuator to move the vapor delivery needle between the retracted position and the extended position. In another embodiment, the device comprises a gear rack coupled to the grip, the gear rack being configured to rotate the frame and the second magnet so as to engage or disengage from the first magnet.

In some embodiments, the device can comprise a lock configured to lock the vapor delivery needle in the retracted position. The device can further comprise a trigger adapted to release the lock to thereby move the vapor delivery needle to the extended position from the retracted position.

In one embodiment, the magnetic actuator is configured to apply a suitable magnetic force to cause the tip portion of the vapor delivery needle to withdraw from prostate tissue when moving to the retracted position. In some embodiments, the suitable magnetic force can range from <NUM> to <NUM> pounds of force during advancement and retraction. In one embodiment, the force can be at least <NUM> pounds of force.

In some embodiments, the device can further include a vapor actuator for actuating a flow of condensable vapor through the vapor delivery needle. The device can further comprise an interlock mechanism which permits actuation of the vapor actuator only if a releasable lock has been released.

In some embodiments, the magnetic actuator comprises at least one rare earth magnet. In other embodiments, the magnetic actuator comprises at least one neodymium or neodymium-iron-boron magnet.

In one embodiment, the magnetic actuator orients first and second magnets relative to one another to utilize repelling forces to move the vapor delivery needle along a longitudinal axis of the introducer shaft. In another embodiment, the magnetic actuator orients first and second magnets relative to one another to utilize attracting forces to move the vapor delivery needle along a longitudinal axis of the introducer shaft. In some embodiments, the magnetic actuator orients first and second magnets relative to one another to utilize attracting and repelling forces to move the vapor delivery needle along a longitudinal axis of the introducer shaft.

A non-claimed method of treating prostate tissue is also provided, comprising inserting a shaft of a prostate therapy device transurethrally until a working end of the shaft is proximate to the prostate tissue, actuating a magnetic assembly to advance a vapor delivery needle from the introducer into the prostate tissue, and delivering condensable vapor from the vapor delivery needle into the prostate tissue.

In some embodiments, the condensable vapor provides a thermal effect in the prostate tissue.

In one embodiment, the vapor delivery needle advances into the prostate tissue under the influence of repelling forces between first and second magnets of the magnetic assembly. In another embodiment, the vapor delivery needle advances into the prostate tissue under the influence of attracting forces between first and second magnets of the magnetic assembly. In some embodiments, the vapor delivery needle advances into the prostate tissue under the influence of attracting and repelling forces between first and second magnets of the magnetic assembly.

A prostate treatment device is also provided, comprising an introducer shaft sized and configured for transurethral access into a patient, a vapor generator configured to generate a condensable vapor, a vapor delivery needle in communication with the vapor generator and slidably disposed within the introducer shaft, and an actuation mechanism configured to apply force to move a distal portion of the vapor delivery needle from a retracted position inside the introducer shaft to an extended position outside of the introducer shaft.

In some embodiments, the actuation mechanism moves a distal tip of the vapor delivery needle outward from the introducer shaft a distance of less than <NUM>.

In another embodiment, the device comprises a controller configured to deliver a selected volume of condensable vapor through the needle that carries less than <NUM> calories of energy.

In some embodiments, the actuation mechanism comprises a spring. In other embodiments, the actuation mechanism comprises at least one magnet. In one embodiment, the actuation mechanism is configured to move the vapor delivery needle toward the extended position from the retracted position at a velocity ranging from <NUM> meter per second to <NUM> meters per second.

In one embodiment, the vapor delivery needle is sized and configured to extend into prostate tissue when the introducer shaft is positioned within a urethra of the patient.

In some embodiments, the actuation mechanism comprises a first magnet carried by the vapor delivery needle. In another embodiment, the actuation mechanism comprises a second magnet carried in a frame of a handle of the device, the second magnet being configured to interact with the first magnet to move the vapor delivery needle. In some embodiments, the frame is rotatable in the handle.

A non-claimed method of treating prostate tissue is provided, comprising inserting a shaft of a prostate therapy device transurethrally until a working end of the shaft is proximate to the prostate tissue, advancing a vapor delivery needle from the introducer into at least one site in prostate tissue to a depth of less than <NUM>, and delivering condensable vapor from the vapor delivery needle into the prostate tissue.

In some embodiments, the condensable vapor provides a thermal effect in the prostate tissue. In other embodiments, the condensable vapor delivers less than <NUM> calories of energy at each site.

In one embodiment, the vapor delivery needle advances into the prostate tissue under forces applied by a spring. In another embodiment, the vapor delivery needle advances into the prostate tissue under the influence of at least one magnet.

In order to better understand the invention and to see how it may be carried out in practice, some preferred embodiments are next described, by way of non-limiting examples only, with reference to the accompanying drawings, in which like reference characters denote corresponding features consistently throughout similar embodiments in the attached drawings.

In general, one method of the invention for treating BPH comprises introducing a heated vapor interstitially into the interior of a prostate, wherein the vapor controllably ablates prostate tissue. This method can utilize vapor for applied thermal energy of between <NUM> calories and <NUM> calories per each individual vapor treatment (and assumes multiple treatments for each prostate lobe) in an office-based procedure. The method can cause localized ablation of prostate tissue, and more particularly the applied thermal energy from vapor can be localized to ablate tissue adjacent the urethra without damaging prostate tissue that is not adjacent the urethra.

The present invention is directed to the treatment of BPH, and more particularly for ablating transitional zone prostate tissue without ablating central or peripheral zone prostate tissue.

In one embodiment, the present invention is directed to a device for treating a prostate using convective heating in a region adjacent the prostatic urethra.

In one non-claimed embodiment, the method of ablative treatment is configured to target smooth muscle tissue, alpha adrenergic receptors, sympathetic nerve structures and vasculature parallel to the prostatic urethra between the bladder neck region and the verumontanum region to a depth of less than <NUM>.

In one embodiment, the system includes a vapor delivery mechanism that delivers vapor media, including vapor media. The system can utilize a vapor source configured to provide vapor having a temperature of at least <NUM>° C, <NUM>° C, <NUM>° C, <NUM>° C, or <NUM>° C.

In another embodiment, the system further comprises a computer controller configured to deliver vapor for an interval ranging from <NUM> second to <NUM> seconds.

In another embodiment, the system further comprises a source of a pharmacologic agent or other chemical agent or compound for delivery with the vapor. These agents include, without limitation, an anesthetic, an antibiotic or a toxin such as Botox®, or a chemical agent that can treat cancerous tissue cells. The agent also can be a sealant, an adhesive, a glue, a superglue or the like.

Another non-claimed method provides a treatment for BPH that can use a transrectal or transperineal approach using a transrectal ultrasound system (TRUS) as an imaging means to image the prostate, and navigate a vapor delivery tool to the targeted treatment sites.

In another non-claimed method the tool or vapor delivery needle working end can be advanced manually or at least in part by a spring mechanism.

In another aspect, the system may contemporaneously deliver cooling fluids to the urethra during an ablation treatment to protect the interior lining of the urethra.

<FIG>, <FIG> and <FIG> depict one embodiment of probe <NUM> that is adapted for trans-urethral access to the prostrate and which provides viewing means to view the urethra as the probe is navigated to a site in the interior of the patient's prostate. The probe <NUM> further carries an extendable and retractable microcatheter member <NUM> (<FIG>) having a distal tip portion <NUM> (<FIG>) that can be penetrated into precise targeted locations in prostate lobes to ablate targeted tissue volumes.

In <FIG>, it can be seen that probe <NUM> has an elongate introducer portion <NUM> for insertion into the urethra and a handle portion <NUM> for gripping with a human hand. The key structural component of introducer portion <NUM> comprises a rigid introducer sleeve or extension sleeve <NUM> extending along longitudinal axis <NUM> with proximal end 114a and distal end 114b. The bore <NUM> in the rigid extension sleeve extends along longitudinal axis <NUM>. In one embodiment, referring to <FIG> and <FIG>, the extension sleeve <NUM> comprises a thin-wall stainless steel tube with bore <NUM> dimensioned to receive a commercially available viewing scope or endoscope <NUM>. The schematic cut-away view of <FIG> shows structural bulkhead <NUM> coupled to a medial portion <NUM> of extension sleeve <NUM>. The structure or bulkhead <NUM> comprises the structural member to which the molded handle having pistol grip <NUM>, and more particularly the right- and left-side mating handle parts, 125a and 125b, are coupled (<FIG>). The bulkhead can be a plastic molded part that can be fixed to sleeve <NUM> or rotationally coupled to sleeve <NUM>.

Referring to <FIG>, in which the molded handle left and right sides are not shown, it can be seen that bore <NUM> in sleeve <NUM> has a proximal open end <NUM> into which the endoscope <NUM> can be inserted. The proximal end portion 114a of extension sleeve <NUM> is coupled to an adapter mechanism <NUM> that releasably engages the endoscope <NUM> and rotationally aligns the scope <NUM> with the introducer portion <NUM>. The endoscope <NUM> has a proximal viewing end <NUM> and light connector <NUM> extending outward from the viewing end <NUM> for coupling a light source <NUM> to the endoscope. <FIG> illustrates that bore <NUM> in sleeve <NUM> has a diameter ranging from about <NUM> to <NUM> for accommodating various endoscopes <NUM>, while at the same time providing an annular space <NUM> for allowing an irrigation fluid to flow through bore <NUM> and outwardly from the introducer portion.

In one embodiment of system <NUM>, referring to <FIG>, the extendable-retractable microcatheter <NUM> comprises a thin-wall flexible polymer tube with a sharp tip that is axially slidable in a passageway <NUM> in the introducer portion <NUM>. <FIG>, <FIG> and <FIG> show that the introducer portion <NUM> comprises an elongate introducer body <NUM> of plastic or another suitable material that surrounds extension sleeve <NUM>. The introducer body <NUM> extends to a distal working end portion <NUM> having a blunt nose or tip <NUM> for advancing through the urethra. The elongate introducer body <NUM> is further configured with passageway <NUM> that accommodates the microcatheter member <NUM> as will be described below. Referring to <FIG>, the distal end portion <NUM> of the introducer body <NUM> is configured with openings <NUM> that open to central open region <NUM> that is distal to the distal lens <NUM> of endoscope <NUM> that allows for viewing of the urethra through the lens <NUM> of the endoscope during navigation. The endoscope <NUM> can have a lens with a <NUM>°, <NUM>° or other angle for viewing through openings <NUM>. As can be seen in <FIG>, the openings <NUM> have bridge elements <NUM> therebetween that function to prevent tissue from falling into central open region <NUM> of the introducer body <NUM>. In <FIG>, it can be seen that the working end portion <NUM> of the flexible microcatheter shaft <NUM> is disposed adjacent to open region <NUM> and thus can be viewed through the endoscope lens <NUM>.

<FIG> show the flexible microcatheter member or needle <NUM> de-mated from the probe <NUM> to indicate its repose shape. In one embodiment, the microcatheter <NUM> has a first (proximal) larger cross-section portion <NUM> that necks down to second (distal) cross-section portion <NUM> wherein the smaller cross-section portion <NUM> has a curved repose shape with the curve configured to conform without significant resistance to the contour of the curved axis <NUM> of the path followed by the working end <NUM> of the microcatheter <NUM> as it is moved from its non-extended position to its extended position as shown in <FIG>, <FIG>. In one embodiment, referring to <FIG>, the microcatheter's first cross section portion <NUM> comprises a thin wall outer sleeve <NUM> that is concentrically outward from inner microcatheter tube <NUM> that extends the length of the microcatheter member <NUM>. As can be seen in <FIG>, the outer sleeve <NUM> provides a thermally insulative air gap <NUM> around inner tubular member <NUM>. In one embodiment shown depicted in <FIG>, the outer sleeve <NUM> is configured with intermittent protrusions <NUM> that maintain the air gap <NUM> between the inner surface <NUM> of outer sleeve <NUM> and outer surface <NUM> of inner microcatheter tube. <FIG> shows that the outer sleeve <NUM> has necked down portion <NUM> that is bonded to inner microcatheter tube <NUM> by any suitable means such as ultrasonic bonding, adhesives or the like. Referring back to <FIG>, both the outer sleeve <NUM> and inner tubular member can comprise a high-temperature resistant polymer such as Ultem® that is suited for delivering a high temperature vapor as will be described below. In one embodiment, the microcatheter tube <NUM> has an outside diameter of <NUM>" with an interior lumen <NUM> of approximately <NUM>". Referring to <FIG>, one embodiment of working end portion <NUM> for delivering vapor media to tissue has a thin wall <NUM> with a plurality of outlet ports <NUM> therein that are configured for emitting a vapor media into tissue as will be described below. The outlet ports can range in number from about <NUM> to <NUM>, and in one embodiment consist of <NUM> outlets each having a diameter of. <NUM>" in six rows of two outlets with the rows staggered around the working end <NUM> as shown in <FIG>. In one embodiment shown in <FIG>, the distalmost tip <NUM> of the microcatheter tube <NUM> has a sharpened conical configuration that can be formed of the plastic material of tube <NUM>. As will be described below, it has been found that a polymeric needle and needle tip <NUM> is useful for its thermal characteristics in that its heat capacity will not impinge on vapor quality during vapor delivery.

<FIG> further illustrate that the distal tip portion <NUM> of microcatheter tube <NUM> has at least one marking <NUM> that contrasts with the color of the microcatheter tube <NUM> that is adapted for viewing through lens <NUM> of the endoscope <NUM>. In one embodiment, the distal tip portion has a series of annular marks <NUM> of a first color that contrasts with second color of tube <NUM>, wherein the marks are not visible through the endoscope lens <NUM> when the microcatheter tube <NUM> is in the non-extended position. After the microcatheter tube <NUM> is extended into tissue, the marks are visible through the lens <NUM> which indicates the tube <NUM> has been extended into tissue.

Returning now to <FIG> and <FIG>, the cut-away view of the handle portion <NUM> shows the microcatheter member <NUM> and associated assemblies in the non-extended position. <FIG> shows flanges 208a and 208b of cocking actuator <NUM> are disposed on either side of actuator collar <NUM> that is coupled to proximal end <NUM> of the slidable microcatheter member <NUM>. As can be understood from <FIG>, the downward-extending cocking actuator <NUM> is adapted to cock the flanges 208a, 208b and microcatheter <NUM> to a cocked position which corresponds to the non-extended position of the microcatheter <NUM>. In <FIG>, the actuator <NUM> is shown in a first position B (phantom view) and second positions B' following actuation with an index finger to thus cock the microcatheter member <NUM> to the second releasable non-extended position (or cocked position) B' from its extended position B. The flange 208a and actuator <NUM> is further shown in phantom view in the released position indicated at 208a'. In <FIG>, the flanges 208a, 208b and associated assemblies are configured for an axial travel range indicated at A that can range from about <NUM> to <NUM> which corresponds to the travel of the microcatheter <NUM> and generally to the tissue-penetration depth. In the embodiment of <FIG>, the flanges 208a, 208b and microcatheter member <NUM> are spring-actuatable to move from the non-extended position to the extended position by means of helical spring <NUM> disposed around sleeve <NUM>. As can be seen in <FIG>, the spring <NUM> is disposed between the slidable flange 208b and trigger block <NUM> that comprises a superior portion of the release trigger <NUM> which is adapted to release the microcatheter <NUM> from its cocked position.

<FIG> further illustrates the release trigger <NUM> releasably maintaining the flange 205a and microcatheter <NUM> in its cocked position wherein tooth portion <NUM> of the trigger <NUM> engages the lower edge of flange 205a. It can be understood from <FIG> that the release trigger <NUM> is configured to flex or pivot around living hinge portion <NUM> when trigger <NUM> is depressed in the proximal direction by the physician's finger actuation. After actuation of trigger <NUM> and release of the microcatheter <NUM> to move distally, the axial travel of the assembly is configured to terminate softly rather than abruptly as flange 208a contacts at least one bumper element <NUM> as depicted in <FIG>. The bumper elements <NUM> can comprise any spring or elastomeric element, and in <FIG> are shown as an elastomer element housed in a helical spring, which serve to cushion and dampen the end of the travel of the spring-driven microcatheter assembly. The bumper elements <NUM> are coupled to flange <NUM> which in turn is configured to be fixed between right- and left-side handle parts 125a and 125b (<FIG>).

Now turning to the energy-delivery aspect of the system, a vapor source <NUM> is provided for delivering a vapor media through the microcatheter member <NUM> to ablate tissue. The vapor source can be a vapor generator that can deliver a vapor media, such as vapor media, that has a precisely controlled quality to provide a precise amount of thermal energy delivery, for example measured in calories per second. Descriptions of suitable vapor generators can be found in the following <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT> all of which are incorporated herein by reference in their entirety. The vapor generation system also can comprise an inductive heating system similar to that described in <CIT>, <CIT>, and <CIT>. The system further includes a controller <NUM> that can be set to control the various parameters of vapor delivery, for example, the controller can be set to delivery vapor media for a selected treatment interval, a selected pressure, or selected vapor quality.

Referring to <FIG>, in one embodiment, the vapor source <NUM> is remote from the handle <NUM> and vapor media is carried to the handle by a flexible conduit <NUM> that couples handle and check valve <NUM> therein. In one embodiment, vapor can be re-circulating in conduit <NUM> until a solenoid in the vapor source is actuated to cause the vapor flow to thus provide an increased fluid pressure which opens the check valve <NUM> and allows the vapor media to flow through flexible tube <NUM> to valve <NUM> that can be finger-actuated by trigger <NUM>. In one embodiment depicted in <FIG>, the trigger <NUM> is urged toward a non-depressed position by spring <NUM> which corresponds to a closed position of valve <NUM>. The trigger <NUM> also can be coupled by an electrical lead (not shown) to controller <NUM>. Thus, actuating the trigger <NUM> can cause the controller to actuate a solenoid valve in the vapor generator to cause vapor flow through the relief valve. As a safety mechanism, the valve <NUM> in the handle is opened only by its actuation to thus permit the flow of vapor media through flexible tube <NUM> which communicates with inflow port portion <NUM> of collar <NUM> which in turn communicates with the lumen <NUM> in the microcatheter <NUM>. Thus, <FIG> illustrates the flow path and actuation mechanisms that provide vapor flow on demand from the vapor source <NUM> to the vapor outlets <NUM> in working end <NUM> of the microcatheter <NUM>.

As can be seen in <FIG>, the handle can also provide an interlock mechanism that prevents the actuation of vapor flow if the microcatheter release trigger is in the cocked position, wherein edge portion <NUM> coupled to release trigger <NUM> can engage notch <NUM> in trigger <NUM> to prevent depression of said trigger <NUM>.

Still referring to <FIG>, one embodiment of the system includes a fluid irrigation source <NUM> that is operatively coupled to the bore <NUM> in extension member <NUM> to deliver a fluid outward from the bore <NUM> to the open region <NUM> of the probe working end <NUM> (see <FIG>). As can be seen in <FIG>, the bore <NUM> is dimensioned to provide a space <NUM> for fluid irrigation flow around the endoscope <NUM>. In <FIG>, it can be seen that fluid source <NUM>, which can be a drip bag or controlled pressure source of saline or another fluid, is detachably coupled to tubing <NUM> in the handle which extends to a valve <NUM> that can be thumb-operated from actuators <NUM> on either side of the handle. The thumb actuator <NUM> also can control the rate of flow of the irrigation fluid by moving the actuator <NUM> progressively forward, for example, to open the valve more widely open. The fluid flows from valve <NUM> through tube <NUM> to a port or opening <NUM> in the extension sleeve <NUM> to thus enter the bore <NUM> of the sleeve.

<FIG> further depicts an aspiration source <NUM> operatively coupled to tubing <NUM> in the handle <NUM> which also can be actuated by valve <NUM> wherein the thumb actuator <NUM> can be rocked backwardly to allow suction forces to be applied through the valve <NUM> to tubing <NUM> that extends to port <NUM> in the extension member-which is the same pathway of irrigation flows. Thus, suction or aspiration forces can withdraw fluid from the working end of the device during a treatment.

Another aspect of one embodiment of probe <NUM> corresponding to the invention, referring to <FIG>, <FIG>, <FIG> and <FIG>, is the orientation of the microcatheter or needle <NUM> as it exits the working end <NUM> relative to the orientation of the pistol grip <NUM> of the handle portion <NUM>. In a method use further described below, the introducer will typically be introduced through the urethra with the pistol grip in a "grip-downward" orientation GD (<FIG>) with the pistol grip <NUM> oriented downwardly which comfortable for the physician. The treatment typically will include rotationally re-orienting the probe as indicated in <FIG> so that the microcatheter or needle <NUM> can be penetrated into prostate lobes at <NUM>° to about <NUM>° relative to a grip-downward position. <FIG> are schematic head-on views of the probe <NUM> in a prostate with the microcatheter <NUM> deployed showing the orientation of the handle pistol grip <NUM>, the deployed microcatheter <NUM> and the connector endoscope <NUM> which indicate the rotational orientation of the endoscope <NUM> and thus the orientation of the camera image on the monitor. As can be seen in <FIG>, the assembly of the introducer <NUM>, microcatheter <NUM> and endoscope <NUM> is rotatable within the handle within flanges 235A and 235B. In one embodiment, the system has click-stops at various angles, such as every <NUM>° between <NUM>° and <NUM>° relative to the grip-downward orientation GD of <FIG>. Thus <FIG> depict optional methods that the surgeon may use.

<FIG> depict the physician locking all components of the probe <NUM> in a single rotational orientation, and simply rotating his hand and pistol grip <NUM> to a selected orientation of greater that <NUM>° from the grip-down position GD, then releasing the microcatheter <NUM> to penetrate into the prostate lobe. After actuating the vapor delivery trigger, the vapor ablates regions indicted at <NUM>. It can be appreciated that the endoscope <NUM> is rotated so that the image on the monitor also is rotated. Thereafter, the physician rotates the probe as depicted in <FIG> to treat the other prostate lobe. This method may be preferred by physicians that are familiar with anatomical landmarks, opt for simplicity and are accustomed to viewing an image on the monitor which is rotated relative a true vertical axis of the patient anatomy.

<FIG> depict the physician utilizing the rotational feature of the probe and maintaining the handle pistol grip <NUM> in the grip-down orientation GD and rotating the introducer <NUM> and microcatheter <NUM> to the appropriate angles to treat the first and second lobes of the prostate. This method again is suited for physicians who are familiar with anatomical landmarks and are accustomed to viewing a rotated image on the monitor in the OR.

<FIG> depict the physician utilizing another embodiment of a probe to treat the two prostate lobes. In the embodiment of <FIG>, it can be seen that the endoscope <NUM> is locked in rotational orientation with introducer <NUM> and the microcatheter <NUM>-but not with the handle pistol grip. It can easily be understood that a probe can be made which allows rotational adjustment between the introducer <NUM> and microcatheter <NUM> relative to the handle pistol grip <NUM>-but that provides a bracket that rotationally locks the endoscope <NUM> to the handle pistol grip <NUM>. <FIG> depict the use of such an embodiment, wherein the physician can maintain the handle pistol grip <NUM> in the grip-down orientation GD and then rotates only the introducer <NUM> and microcatheter <NUM>. In this embodiment, the image on the monitor will remain vertical instead of rotated, which may be preferred by physicians accustomed to laparoscopy in which images are not rotated on the monitor when instruments are manipulated.

In another aspect of the invention, referring to <FIG>, the microcatheter <NUM> carries a temperature sensor or thermocouple <NUM> at a distal location therein, for example as indicated in <FIG>. The thermocouple is operatively connected to controller <NUM> to control vapor delivery. In one embodiment, an algorithm reads an output signal from the thermocouple <NUM> after initiation of vapor delivery by actuation of trigger <NUM>, and in normal operation the thermocouple will indicate an instant rise in temperature due to the flow of vapor. In the event, the algorithm and thermocouple <NUM> do not indicate a typical rise in temperature upon actuation of trigger <NUM>, then the algorithm can terminate energy delivery as it reflects a system fault that has prevented energy delivery.

In another embodiment, referring again to <FIG>, the microcatheter <NUM> can carry another temperature sensor or thermocouple <NUM> in a portion of microcatheter <NUM> that resides in passageway <NUM> of the introducer body <NUM>. This thermocouple <NUM> is also operatively connected to controller <NUM> and vapor source <NUM>. In one embodiment, an algorithm reads an output signal from thermocouple <NUM> after initiation of vapor delivery and actuation of actuator <NUM> that delivers an irrigation fluid from source <NUM> to the working end <NUM> of the probe. The delivery of irrigation fluid will maintain the temperature in the region of the thermocouple at a predetermined peak level which will not ablate tissue over a treatment interval, for example below <NUM>° C, below <NUM>° C or below <NUM>° C. If the temperature exceeds the predetermined peak level, the algorithm and controller can terminate vapor energy delivery. In another embodiment, a controller algorithm can modulate the rate of cooling fluid inflows based on the sensed temperature, and/or modulate the vapor flow in response to the sensed temperature. In an alternative embodiment, the thermocouple <NUM> can be in carried in a portion of introducer body <NUM> exposed to passageway <NUM> in which the microcatheter resides.

Referring to <FIG> and <FIG>, the device and method of this invention provide a precise, controlled thermal ablative treatment of tissue in the first and second lateral prostate lobes (or right- and left-side lobes), and additionally an affected median lobe in patients with an enlarged median lobe. In particular, the ablative treatment is configured to ablate stromal or smooth muscle tissue, to ablate alpha adrenergic (muscle constriction) receptors, to ablate sympathetic nerve structures, and to ablate vasculature in the treatment zone. More particularly, the method of ablative treatment is configures to target smooth muscle tissue, alpha adrenergic receptors, sympathetic nerve structures, and vasculature parallel to the prostatic urethra between the bladder neck region <NUM> and the verumontanum region <NUM> as depicted in <FIG>. The targeted ablation regions <NUM> have a depth indicated at D in <FIG> that is less than <NUM> from the prostatic urethra <NUM>, or less than <NUM>. Depending on the length of the patient's prostatic urethra <NUM>, the number of ablative energy deliveries can range from <NUM> to <NUM> and typically is <NUM> or <NUM>.

In a method of use, the physician would first prepare the patient for trans-urethral insertion of the extension portion <NUM> of the probe <NUM>. In one example, the patient can be administered a mild sedative orally or sublingually such as Valium, Lorazepam or the like from <NUM>-<NUM> minutes before the procedure. Of particular interest, it has been found that prostate blocks (injections) or other forms of anesthesia are not required due to lack of pain associated with an injection of a condensable vapor. The physician then actuates the needle-retraction actuator <NUM>, for example with an index finger, to retract and cock the microcatheter <NUM> by axial movement of the actuator (see <FIG>). By viewing the handle <NUM>, the physician can observe that the microcatheter <NUM> is cocked by the axial location of trigger <NUM>. A safety lock mechanism (not shown) can be provided to lock the microcatheter <NUM> in the cocked position.

Next, the physician advances the extension portion <NUM> of the probe <NUM> trans-urethrally while viewing the probe insertion on a viewing monitor coupled to endoscope <NUM>. After navigating beyond the verumontanum <NUM> to the bladder neck <NUM>, the physician will be oriented to the anatomical landmarks. The landmarks and length of the prostatic urethra can be considered relative to a pre-operative plan based on earlier diagnostic ultrasound images or other images, such as MRI images.

The physician can rotate the microcatheter-carrying probe about its axis to orient the microcatheter at an angle depicted in <FIG> to treat a first lobe. Thereafter, the treatment included cocking and releasing the microcatheter followed by vapor delivery, the moving and repeating the vapor injection for a total of three (or more) vapor injections in each lobe. <FIG> is a schematic view of a method the invention wherein three penetrations of the microcatheter <NUM> are made sequentially in a prostate lobe and wherein energy delivery is provided by vapor energy to produce slightly overlapping ablations or lesions to ablate the smooth muscle tissue, alpha adrenergic receptors, and sympathetic nerve structures in a region parallel to the prostatic urethra. The method of the invention, when compared to prior art, reduces the burden of ablated tissue and thus lessens the overall inflammatory response leading to more rapid tissue resorption and more rapid clinical improvement.

<FIG> is a saggital MRI image of an exemplary BPH treatment of a patient <NUM> week following the procedure, in which the treatment included the following steps and energy delivery parameters. The patient's prostate weighed <NUM> grams based on ultrasound diagnosis. Amparax (Lorazepam) was administered to the patient <NUM> minutes before the procedure. In the treatment of the patient in <FIG>, each treatment interval consisted of <NUM> seconds of vapor delivery at each of six locations (<NUM> injections in each lobe). Thus, the total duration of actual energy delivery was <NUM> seconds in the right and left prostate lobes. The energy delivered was <NUM> cal. /sec, or <NUM> cal. per treatment location <NUM> (<FIG>) and a total of <NUM>,<NUM> calories in total to create the ablation parallel to the prostatic urethra, which can be seen in the MRI of <FIG>. In the patient relating to the MRI image of <FIG>, the median lobe was also treated with a single <NUM> second injection of vapor, or <NUM> calories of energy. The vapor can be configured to delivery energy in the range of <NUM> cal. to <NUM> cal. In general, one method includes delivering less than <NUM> calories of energy to each site in the prostate.

By comparing the method of the present invention (<FIG>) with the prior art (<FIG>), it can be understood the method and apparatus of the present invention is substantially different than the prior art. <FIG> schematically depicts the prior art RF needle that is elongated, typically at about <NUM> in length, which ablates tissue away from the prostatic urethra and does not target tissue close to and parallel to the prostatic urethra. Second, the prior art RF energy delivery methods apply RF energy for <NUM> to <NUM> minutes or longer which allows thermal diffusion of effect to reach the capsule periphery, unlike the very short treatment intervals of the method of the present invention which greatly limit thermal diffusion. Third, the prior art RF energy delivery methods do not create a uniform ablation of tissue adjacent and parallel to the prostatic urethra to ablate smooth muscle tissue, alpha adrenergic receptors, and sympathetic nerve structures in a region parallel to the prostatic urethra.

One method corresponding to the invention is shown in the block diagram of <FIG>, which includes the steps of advancing a probe trans-urethrally to the patient's prostate, extending a energy applicator or microcatheter into prostate lobes in a plurality of locations to a depth of less than <NUM>, and then applying energy at each location to create an ablation zone in a continuous region parallel to at least a portion of the prostatic urethra.

Another method of the invention is shown in the block diagram of <FIG>, which includes the steps of advancing a probe trans-urethrally to the patient's prostate, extending a energy applicator or microcatheter into prostate lobes in a plurality of locations, and applying energy at each location for less than <NUM> seconds to thereby prevent thermal diffusion to peripheral portions of the lobes.

Another method of the invention is shown in <FIG>, which includes the steps of advancing a probe trans-urethrally to the patient's prostate, extending a energy applicator or microcatheter into prostate lobes in a plurality of locations, and applying energy at each location for a selected interval and irrigating the urethra with a cooling fluid throughout the selected interval of energy delivery. It has been found that such a flow of cooling fluid may be useful, and most important the flow of cooling fluid can be continuous for the duration of the treatment interval since such times are short, for example <NUM> to <NUM> seconds. Such a continuous flow method can be used in prior art methods, such as RF ablation methods of <FIG>, since the cooling fluid volume accumulates in the patient's bladder and the long treatment intervals would result in the bladder being filled rapidly. This would lead to additional steps to withdraw the probe, remove the excess fluid and then re-start the treatment.

<FIG> illustrate another probe <NUM> adapted to deliver condensable vapor to prostate tissue with vapor delivery through a microcatheter or vapor delivery needle as described above. The probe <NUM> of <FIG> can be configured with several different systems and mechanisms for vapor generation, vapor delivery, needle actuation, system function interlocks and for improved ergonomic function. In <FIG>, it can be seen that the probe <NUM> has a handle portion <NUM> coupled to elongate introducer portion <NUM> that is sized and adapted for insertion into the urethra. The introducer portion <NUM> can comprise a rigid introducer sleeve <NUM> (shown in <FIG>, <FIG>) extending along longitudinal axis <NUM> (<FIG>) with the introducer portion having a proximal end <NUM> (<FIG>) and a distal working end <NUM>. <FIG>, <FIG> and <FIG> illustrate that sleeve <NUM> has a lumen <NUM> therein that is dimensioned to receive an endoscope <NUM> (see <FIG> and <FIG>). An irrigation source <NUM> communicates with lumen <NUM> to provide a fluid flow around the endoscope to exit the working end <NUM>.

In one embodiment, referring to <FIG>, <FIG> and <FIG>, probe <NUM> includes an extendable-retractable microcatheter or vapor delivery needle <NUM> axially moveable in passageway <NUM> in sleeve <NUM> that is longitudinally coupled to sleeve <NUM>. In some embodiments, the microcatheter or needle <NUM> comprises a flexible polymer tube with a sharp tissue piercing tip. In the embodiment of <FIG>, <FIG> and <FIG>, both sleeves <NUM> and <NUM> can comprise thin-wall stainless steel tubes and can be welded together to provide a rigid structure. Referring to <FIG>, a polymer surface layer <NUM> can be disposed around the assembly of sleeves <NUM> and <NUM>, which in one embodiment can comprise a lubricious heat shrink material having a wall thickness ranging from <NUM>" to <NUM>".

As can be seen in <FIG>, the assembly of sleeves <NUM>, <NUM> and surface layer <NUM> can provide longitudinal air gaps 552a and 552b extending the length of sleeves <NUM> and <NUM>. <FIG> illustrate that the working end <NUM> of introducer portion <NUM> can comprise a distal body <NUM> of plastic or another suitable material with a blunt nose or tip <NUM> as described previously for advancing through the patient's urethra. The distal body <NUM> can be configured with side window <NUM> on either side of bridge elements <NUM> and needle window <NUM> as described in the previous embodiments. In <FIG>, the distal tip <NUM> of the microcatheter or needle <NUM> is shown locked in the non-extended or retracted position for when the physician is navigating the working end <NUM> of the probe toward a targeted site in the urethra, but which can be released from said locked position.

Now turning to <FIG>, probe <NUM> can be provided with a vapor generator <NUM> housed with the pistol-grip portion <NUM> of handle <NUM>. In some embodiments, the vapor generator can be an RF-based induction vapor generator. The vapor generator can be housed within the handle of the probe, as shown, or in other embodiments the vapor generator can be placed elsewhere within the probe or even external to the probe. The vapor generator can be coupled to an energy source, such as RF source <NUM> and controller <NUM>.

In one embodiment of an RF-based vapor generator, a RF coil <NUM> can be positioned around a helically-wound stainless steel tubing component <NUM> which can be inductively heated by the RF coil <NUM>. The water flow in the lumen of the helical stainless steel component can be converted to vapor instantly. The controller <NUM> can be configured to set and control all functional parameters of the probe, for example, parameters relating to vapor delivery intervals, pressure in the fluid flow into the vapor generator, vapor quality, irrigation flow rates, temperature monitoring, system cooling fans, over-ride mechanisms and the like. In <FIG>, a fluid source <NUM> can be coupled to inflow line <NUM> for delivering a treatment fluid or media such as sterile water to the vapor generator <NUM>. Referring to <FIG>, an outflow line <NUM> adapted to carry condensable vapor extends upwardly in the handle to flex-loop portion <NUM> that has a termination <NUM> that connects to a proximal end of the needle. From <FIG>, it can be understood that the flex-loop portion <NUM> of outflow line <NUM> is configured to accommodate the axial movement of the vapor delivery needle <NUM>. Referring back to <FIG>, the RF source <NUM> is coupled to RF coil <NUM> of the vapor generator <NUM> by power cord <NUM>.

Now turning to <FIG>, the sectional and exploded views of the handle portion <NUM> and components therein illustrate the microcatheter or vapor delivery needle <NUM> and the magnetic actuator system that is adapted to move the needle in a distal or extending stroke for penetrating into tissue. The magnetic system further can be utilized to provide a proximal or retracting stroke for withdrawing the vapor delivery needle from tissue. <FIG> and <FIG> show first and second rotatable blocks 600A and 600B that each carry magnets 602A, 602B with magnetic poles oriented as shown in <FIG>. A central extending-retracting block <NUM> also carries magnets <NUM> (see <FIG>) and is positioned between the first and second rotatable blocks 600A and 600B. As can be understood from <FIG>, the central block <NUM> is coupled to the vapor delivery needle and is configured to move distally and proximally between rotatable blocks 600A and 600B, and is keyed to not rotate, to thus extend the needle tip out of the working end <NUM> and to retract the needle tip back into the working end under the influence of magnetic fields. As also can be understood from <FIG>, the rotation of the first and second rotatable blocks 600A and 600B can move the magnets 602A, 602B therein (i) into a position that applies forces upon the magnets <NUM> in central block <NUM> or (ii) into a position wherein the magnets 602A, 602B will be spaced apart from magnets <NUM> so as to not apply force.

The magnetic actuator system can be configured to advance the vapor delivery needle a pre-determined distance. For example, when treating certain portions of prostate tissue transurethrally, the magnetic actuator system can be configured to advance the vapor delivery needle less than <NUM> from the shaft of the probe into the prostate. This pre-determined distance can be adjusted prior to therapy so as to ensure that the needle is placed directly into the proper position within the prostate.

The exploded view of several handle components in <FIG> illustrates a magnetic actuator subassembly. A gear rack <NUM> in the handle <NUM> is slidable proximally and/or distally when the grip body <NUM> is moved, for example, by the physician using his/her fingers or thumbs to engage and move axially the opposing grip elements 624a and 624b. The axial movement of the gear rack <NUM> then turns gear <NUM> which engages and rotates the first and second rotatable blocks 600A and 600B that each carry magnets 602A, 602B. The movement of the grip <NUM> further cocks the central block <NUM> into a proximal or retracted position (<FIG>) at the same time as it rotates the first and second rotatable blocks 600A and 600B. The mechanism further has a releasable latch that locks the central block <NUM> and needle <NUM> in the retracted or non-extended position. In this position, the magnets <NUM> of the central block <NUM> are oriented directly opposed to the magnets 602A of block 600A and a maximum stored energy is provided in this temporary locked position. In <FIG>, blocks 600A and 600B and central block <NUM> are shown spaced apart along longitudinal axis <NUM>.

Needle actuation trigger <NUM> (<FIG>) can be actuated to release the lock or latch which then allows the stored energy and forces of the magnets 602A and <NUM> to extend the central block <NUM> and the vapor delivery needle in its distal stroke. It can be understood that the stored energy or repelling forces of magnets 602A and <NUM> initially drive the central block distally. Further, it can be seen in <FIG> that the attracting forces of magnets <NUM> and 602B further drive the central block <NUM> distally. It has been found that the use of both expelling and attracting magnetic forces can provide a very high, consistent acceleration and a selected velocity over the extending stroke of the assembly. In some embodiments, the velocity of the vapor delivery needle in penetrating tissue can range from <NUM> meter per second to <NUM> meters per second.

<FIG> show needle actuation trigger <NUM> and further show an integrated actuator <NUM> which opens and closes an inflow tubing <NUM> coupled to the fluid source <NUM>. As can be seen <FIG>, a pinch valve <NUM> can be actuated by depressing actuator <NUM>-wherein depressing the actuator <NUM> causes fluid to be provided under a selected pressure and flow rate through tubing to the endoscope lumen <NUM>. A spring <NUM> urges the actuator toward the non-depressed position. <FIG> further illustrate that needle trigger <NUM> and the actuator <NUM> are integrated to be operated with a single finger pull. Further, in one embodiment, the trigger assembly is configured to permit actuation of trigger <NUM> only if the irrigation actuator <NUM> is actuated. Thus, an interlock can be provided so that irrigation fluid will be flowing into the urethra to provide for its distension when the needle is released and penetrates into tissue.

<FIG> further illustrates a vapor actuator or trigger <NUM> located below the needle actuation trigger <NUM>. By depressing vapor trigger <NUM>, a electrical switch <NUM> is actuated which signals the controller <NUM> to simultaneously actuate the fluid inflow from fluid source <NUM> and the RF source <NUM> to generate vapor for a treatment interval, which can be from <NUM> to <NUM> seconds or more as described previously. A typical treatment interval can be from <NUM> to <NUM> seconds. A spring <NUM> urges the vapor trigger <NUM> toward the non-depressed position.

As also can be understood from <FIG>, another interlock can be provided between the irrigation fluid actuator <NUM> and the vapor trigger <NUM> to insure that fluid is flowing into the urethra during the entire vapor delivery interval. This interlock can be useful to dissipate heat from sleeve <NUM> that houses the shaft of the vapor delivery needle <NUM> (see <FIG>) and to cool and protect the surface of the urethra adjacent the targeted treatment region that is being ablated by the vapor delivery.

<FIG> shows that an outflow tubing <NUM> is provided through the handle <NUM> which is coupled to the endoscope lumen <NUM>. By moving the endoscope outwardly through a duckbill seal <NUM>, a reverse flow of fluid from the patient's bladder can occur which is important for rapidly draining a full patient bladder.

The sectional views of <FIG> shows that the handle can comprise right and left-side mating handle parts are coupled to rotatable nose piece <NUM> and endoscope adapter <NUM> to allow independent rotation of the introducer portion <NUM> and/or the endoscope adapter <NUM> and endoscope relative to the pistol-grip handle portion <NUM> to provide the freedom of use illustrated in <FIG> above.

According to the embodiments described above, a prostate treatment device can be provided comprising an introducer shaft sized and configured for transurethral access into a patient, a vapor generator configured to generate a condensable vapor, a vapor delivery needle in communication with the vapor generator and slidably disposed within the introducer shaft, and a magnetic actuator configured to apply magnetic force to the vapor delivery needle to move the vapor delivery needle between a retracted position inside the introducer shaft and an extended position at least partially outside of the introducer shaft.

A method of treating prostate tissue is also provided, comprising inserting a shaft of a prostate therapy device transurethrally until a working end of the shaft is proximate to the prostate tissue, actuating a magnetic assembly to advance a vapor delivery needle from the introducer into the prostate tissue, and delivering condensable vapor from the vapor delivery needle into the prostate tissue.

A method of treating prostate tissue is provided, comprising inserting a shaft of a prostate therapy device transurethrally until a working end of the shaft is proximate to the prostate tissue, advancing a vapor delivery needle from the introducer into at least one site in prostate tissue to a depth of less than <NUM>, and delivering condensable vapor from the vapor delivery needle into the prostate tissue.

Claim 1:
A prostate treatment device (<NUM>), comprising:
an introducer shaft (<NUM>, <NUM>) sized and configured for transurethral access into a patient;
a vapor generator (<NUM>) configured to generate a condensable vapor;
a vapor delivery needle (<NUM>) in communication with the vapor generator (<NUM>) and slidably disposed within the introducer shaft (<NUM>, <NUM>); and
a magnetic actuator (600A, 600B, 602A, 602B, <NUM>, <NUM>) configured to apply magnetic force to the vapor delivery needle (<NUM>) to move the vapor delivery needle (<NUM>) between a retracted position inside the introducer shaft (<NUM>, <NUM>) and an extended position at least partially outside of the introducer shaft (<NUM>, <NUM>); and
a pistol grip (<NUM>), wherein the introducer shaft (<NUM>, <NUM>) is rotatably coupled to the pistol grip (<NUM>) and has a lumen (<NUM>) dimensioned to receive an endoscope (<NUM>, <NUM>), characterized in that the pistol grip comprises a bracket to rotationally lock the endoscope (<NUM>) received within the lumen of the introducer shaft (<NUM>, <NUM>) to the pistol grip (<NUM>).