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 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 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. 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 transitional zone which traverses the prostatic urethra.

In early stage cases of BPH, treatments can alleviate 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 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 there often is 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 method, the application of RF energy typically extends for <NUM> to <NUM> minutes or longer which allows thermal diffusion of the ablation to reach 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. As a result, tissue in the lobes can continue to grow and impinge on the urethra thus limiting long term effectiveness of the treatment. Documents <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT> disclose relevant background art.

The invention is defined in the appended independent claim. The methods described hereinafter are exemplary only and do not form part of the invention. In some embodiments, a method for treating benign prostatic hyperplasia of a prostate of a patient is provided, comprising inserting a vapor delivery needle through a urethral wall of the patient in a plurality of locations into a prostate lobe, delivering condensable water vapor through the needle into the prostate at each location, and ablating a continuous lobe region parallel to the urethral wall.

In some embodiments, the continuous lobe region is between a bladder neck and a verumontanum of the patient.

In some embodiments, the inserting step comprises inserting a tip of the vapor delivery needle <NUM> or less through the urethral wall into the prostate lobe.

In other embodiments, the ablating step comprises ablating the continuous lobe region extending less than <NUM> away from the urethral wall.

In some embodiments, the delivering step comprises delivering the condensable water vapor for less than <NUM> seconds.

In one embodiment, the method can further comprise introducing a cooling fluid into the urethra during the delivering step. Some embodiments further comprise inserting a vapor delivery tool shaft into the urethra, the vapor delivery needle being at least partially disposed within the shaft, the cooling fluid being introduced into the urethra through the shaft. Another embodiment is provided, further comprising introducing the cooling fluid into the urethra during the entire time condensable water vapor is delivered into the prostate.

Some embodiments can further comprise sensing a temperature within the urethra and controlling delivery of the condensable vapor based on the sensed temperature. In one embodiment, the sensing a temperature step comprises sensing a temperature of the vapor delivery needle.

In some embodiments, the method further comprises viewing the inserting step through an endoscope. In other embodiments, the method further comprises inserting a vapor delivery tool shaft into the urethra, the vapor delivery needle and the endoscope being at least partially disposed within the shaft. The method can further comprise introducing a cooling fluid into the urethra during the delivering step, the cooling fluid being introduced into the urethra through the shaft around the endoscope. In some embodiments, the method further comprises viewing with the endoscope a mark on the vapor delivery needle that is visible only when the needle is in one of a retracted position or a deployed position.

In some embodiments, the plurality of locations in the prostate lobe comprise a first plurality of locations longitudinally spaced along the urethra, the method further comprising inserting the vapor delivery needle through the urethral wall in a second plurality of locations in the prostate, the second plurality of locations being radially displaced from the first plurality of locations.

Another method for treating benign prostatic hyperplasia of a prostate of a patient is provided, comprising ablating a region of the prostate less than <NUM> away from urethra without ablating a peripheral lobe portion of the prostate.

In some embodiments, the method further comprises inserting an energy-emitting section of a needle into the prostate, wherein the ablating step comprises delivering energy to the prostate via the needle.

In some embodiments, the inserting step comprises inserting the needle transurethrally.

In other embodiments, the inserting step comprises inserting the needle transurethrally into the prostate in a plurality of locations, the region of the prostate comprising a continuous lobe region parallel to the urethral wall.

In an additional embodiment, the inserting step comprises inserting the needle transrectally.

A method for treating benign prostatic hyperplasia (BPH) is provided comprising positioning an energy-emitting section of needle in a plurality of locations in a prostate lobe adjacent the prostatic urethra, and delivering energy at each location for less than <NUM> seconds to thereby confine thermal ablation to lobe tissue adjacent the prostatic urethra and preventing thermal diffusion to peripheral lobe tissue.

In some embodiments, energy is delivered from a condensable vapor media.

In other embodiments, energy is delivered from a needle member introduced through a transurethral access path.

In some embodiments, the method further comprises introducing a cooling fluid into the urethra during the application of energy.

A method for treating benign prostatic hyperplasia of a prostate of a patient is provided, comprising inserting a vapor delivery needle through a urethral wall of the patient into the prostate, viewing the inserting step via an endoscope disposed in the urethra, delivering condensable water vapor through the needle into the prostate, and ablating prostate tissue within the prostate.

In some embodiments, the method further comprises inserting a vapor delivery tool shaft into the urethra, the needle and the endoscope both being at least partially disposed within the shaft.

Additionally, the method can further comprise, after the ablating step, retracting the needle, rotating the shaft and the needle within the urethra, inserting the vapor delivery needle through the urethral wall into a different location in the prostate, delivering condensable water vapor through the needle into the prostate, and ablating prostate tissue within the prostate.

In some embodiments, the method comprises supporting the shaft with a handle, the rotating step comprising rotating the handle with the shaft. In other embodiments, the method comprises supporting the shaft with a handle, the rotating step comprising rotating the shaft without rotating the handle. In some embodiments, the rotating step further comprises rotating the shaft and the needle without rotating the endoscope.

In one embodiment, the viewing step further comprises viewing a mark on the needle that is visible only when the needle is in one of a retracted position or a deployed position.

A vapor therapy system is provided, comprising a shaft adapted to be inserted into a male urethra, a vapor delivery needle in the shaft, the needle comprising a vapor exit port, a scope bore in the shaft sized to accommodate an endoscope, the bore having an opening oriented to permit a user to view a distal end of the vapor delivery needle through the endoscope, a water vapor source, and a vapor delivery actuator adapted to deliver water vapor from the water vapor source into the vapor delivery needle and out of the vapor exit port.

In some embodiments, the needle is movable between a retracted position in which a distal needle tip is within the shaft and a deployed position in which the distal needle tip extends from the shaft.

One embodiment of the system further comprises a vapor needle deployment mechanism adapted to move a tip of the needle transverse to the shaft. In some embodiments, the deployment mechanism is adapted to move the needle tip no more than <NUM> from the shaft.

In some embodiments, the system further comprises a marking on a distal tip portion of the vapor delivery needle. In one embodiment, the marking is visible through the bore when the needle is in the deployed position but not visible through bore opening when needle is in the retracted position.

Some embodiments of the system further comprise a needle-retraction actuator adapted to retract the needle into the shaft.

In some embodiments, the needle is configured to deliver water vapor over a predetermined length less that <NUM> from shaft. In other embodiments, the needle comprises a non-energy applicator portion that does not include a vapor exit port. In some embodiments, the non-energy applicator portion is approximately the thickness of the male urethra.

In some embodiments, the needle is a flexible polymer tube with sharp tip.

In other embodiments, the needle is insulated. In one embodiment, the insulated needle comprises a central bore surrounded by insulative air gap and an outer sleeve.

In some embodiments, the system further comprises an irrigation liquid source and an irrigation passage in the shaft extending from the irrigation liquid source to an irrigation liquid outlet. In one embodiment, the irrigation passage is within the bore. In another embodiment, the system comprises an irrigation actuator configured to irrigate a cooling fluid from the irrigation liquid source through the irrigation liquid outlet. In one embodiment, the irrigation liquid source is connected to the irrigation passage. In another embodiment, the irrigation actuator is configured to irrigate the cooling fluid when the vapor delivery actuator delivers water vapor.

In some embodiments, the system further comprises an interlock to prevent water vapor delivery without irrigation of the cooling fluid.

In some embodiments, the system further comprises a bridge element in the opening of the bore configured to prevent tissue from falling into the opening of the bore.

In some embodiments, the shaft has blunt distal tip and the opening of the bore is proximal to a distal end of the shaft.

In some embodiments, the system further comprises a handle connected to the shaft through an adjustably rotatable connector such that shaft can be rotated with respect to the handle. In some embodiments, the rotatable connector comprises rotational stops at preset angles.

In some embodiments, the system further comprises a temperature sensor operably connected to a controller to control vapor delivery based on a sensed temperature. In one embodiment, the temperature sensor is configured to sense needle temperature. In another embodiment, the temperature sensor is configured to sense shaft temperature.

A vapor therapy system is provided, comprising a shaft adapted to be inserted into a male urethra, vapor delivery needle in the shaft, the needle comprising a vapor exit port, a vapor needle deployment mechanism adapted to move a tip of the needle transverse to the shaft no more than <NUM> from the shaft, a water vapor source, and a vapor delivery actuator adapted to deliver water vapor from the water vapor source into the vapor delivery needle and out of the vapor exit port.

In some embodiments, the vapor needle deployment mechanism comprises an actuator adapted to deploy an actuation force on the needle to deploy the needle.

In other embodiments, the vapor needle deployment mechanism further comprises a needle deployment spring.

In some embodiments, the system further comprises a vapor delivery interlock adapted to prevent delivery of water vapor from the vapor delivery needle unless the needle is deployed.

In some embodiments, the needle deployment mechanism further comprises a limit stop adapted to limit a deployment distance of the needle.

In some embodiments, the system further comprises a needle-retraction actuator adapted to retract the needle into the shaft.

According to the invention, the system further comprises a scope bore in the shaft sized to accommodate an endoscope, the bore having an opening oriented to permit a user to view a distal end of the vapor delivery needle through the endoscope.

In other embodiments, the system further comprises a marking on a distal tip portion of the vapor delivery needle. In one embodiment, the marking is visible through the bore opening when the needle is in a deployment position but the marking is not visible through the bore opening when the needle is in a retracted position.

In some embodiments, the needle is a flexible polymer tube with a sharp tip.

In other embodiments, the needle is insulated. In some embodiments, the insulated needle comprises a central bore surrounded by an insulative air gap and an outer sleeve.

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 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 energy of between <NUM> calories and <NUM> calories per lobe in an office-based procedure. The method can cause localized ablation of prostate tissue, and more particularly the applied 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 peripheral zone prostate tissue.

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

In one embodiment, the method of ablative treatment is configured to target smooth muscle tissue, alpha adrenergic receptors, and sympathetic nerve structures 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 water vapor. 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. The agent can be an anesthetic, and antibiotic or a toxin such as Botox®. The agent can also be a sealant, an adhesive, a glue, a superglue or the like.

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

In another method, the tool or 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> of the system of the invention that is adapted for trans-urethral access to the prostrate and which provides viewing means to view the urethra as the probe in 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 form <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 water vapor, 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>. The vapor generation system also can comprise an inductive heating system similar to that described in applications <CIT>, <CIT>,<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 couple 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> can also 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>, 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 will typically 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 using his 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 are region indicted at <NUM>. It can be appreciated that the endoscope <NUM> is rotated so that the image on the monitor is also 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 that 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 a probe can be made that allows rotational adjustment between the introducer <NUM> and microcatheter <NUM> relative to the handle pistol grip <NUM>-but that provided 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, 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 and 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 provide a precise, controlled thermal ablative treatment o tissue in 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, and to ablate sympathetic nerve structures. More in particular, the method of ablative treatment is configures to target smooth muscle tissue, alpha adrenergic receptors, and sympathetic nerve structures 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 orally or sublingually 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> transurethrally 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 vapor injections in each lobe. <FIG> is a schematic view of a method 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, 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> gms 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> 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> to <NUM> cal/sec.

By comparing the method (<FIG>) with the prior art (<FIG>), it can be understood that the method and apparatus of the present disclosure are 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 disclosure 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 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 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 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.

Claim 1:
A vapor therapy system (<NUM>), comprising:
a shaft (<NUM>) adapted to be inserted into a male urethra;
a vapor delivery needle (<NUM>) in the shaft (<NUM>), the needle comprising a vapor exit port (<NUM>);
a water vapor source (<NUM>); and
a vapor delivery actuator (<NUM>) adapted to deliver water vapor from the water vapor source into the vapor delivery needle and out of the vapor exit port,
characterized in that the system further comprises a scope bore (<NUM>) in the shaft (<NUM>) sized to accommodate an endoscope (<NUM>), the bore (<NUM>) having an opening oriented to permit a user to view a distal end (<NUM>) of the vapor delivery needle (<NUM>) through the endoscope.