Patent Description:
The present invention relates to medical devices. In particular, the present invention relates to apparatus for the cryoablative treatment of tissue regions using a hand piece and base tethered to one another.

Treatment systems of the aforementioned type are known from <CIT>, wherein similar systems are known from <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>. While the delivery of energy via radiofrequency ablation is used in several arenas, radiofrequency ablation has several major downsides, including incomplete ablation, frequent lack of visualization during catheter insertion, potential for overlap during treatment (with some areas receiving twice as much energy as other areas), charring of tissues and requirements for frequent debridement, frequent requirements for additional doses of energy after debridement, and potential perforation of the body cavity or lumen due to the rigidity of the RF electrodes.

Other treatments involve the delivery of a cryogenic agent for ablating the contacted tissue within the body of a subject. Yet such systems require a connection to a reservoir of a cryoablative fluid for delivery of the fluid as well as withdrawal of any exhausted fluid from the patient body.

The current state of the art would benefit from minimally invasive devices and methods which deliver thermal energy to a desired area or extract energy from a desired area using a system which is ergonomic and facilitates ease of use by the practitioner.

The present invention provides for a treatment system as defined by claim <NUM>. Preferred embodiments of the invention are laid down in the dependent claims. A cryoablation treatment assembly includes a base station preferably having a reservoir housing and electronics which may be detached entirely from a hand piece having a sheath and liner assembly such that the treatment assembly is formed as a two-part or multi-component system which may be tethered or otherwise connected to one another. The hand piece may be separated from the base station which incorporates the reservoir and controller. A flexible connection may attach the hand piece with the base station where the hand piece may either be permanently coupled to the base station via the connection or where the hand piece may be detachable from the connection and/or from the base station.

The treatment system generally comprises a hand piece having an elongate probe with a distal tip and a flexible length, at least one infusion lumen positioned through or along the elongate probe, and a liner expandably enclosing the probe such that a cryoablative fluid introduced through one or more unobstructed openings along the infusion lumen is sprayed into contact with an interior surface of the liner and coats the interior surface. The system also includes a base station having a reservoir of the cryoablative fluid and a connection having an elongate flexible body coupling the hand piece and the base station, wherein the connection defines at least one fluid lumen for delivery of the cryoablative fluid from the reservoir and to the infusion lumen within the hand piece.

One variation of a method, presently not claimed, for treating tissue may generally comprise securing a reservoir assembly within a receiving channel of a base station, and positioning a hand piece in proximity to a tissue region of interest, wherein the hand piece has an elongate probe with a distal tip and a flexible length, at least one infusion lumen positioned through or along the elongate probe, and a liner expandably enclosing the probe such that a cryoablative fluid introduced through one or more unobstructed openings along the infusion lumen is sprayed into contact with an interior surface of the liner and coats the interior surface. The method may also include infusing the cryoablative fluid from the reservoir assembly through a connection having an elongate flexible body and in fluid communication with the infusion lumen within the hand piece.

In controlling or modulating the flow of the cryoablative agent, the inflow reservoir or canister valve which is fluidly coupled with the reservoir or canister may be utilized. Such a valve may generally comprising a valve body, a reservoir interface extending from the valve body and configured for fluidly coupling with the reservoir or canister containing the cryoablative agent, a modulation control interface defined along the body and configured for fluidly coupling to a modulation control interface, a valve stem seated within a valve stem channel defined within the valve body, an inflow lumen defined through the valve body and extending between the reservoir interface and the modulation control interface, where the valve stem is movable between a first position which obstructs the inflow lumen and a second position which opens the inflow lumen, a venting lumen defined through the valve body and extending between the reservoir interface and a vent opening, and a vent piston which is movable between a first position which obstructs the venting lumen and a second position which opens the venting lumen. Alternatively, the valve stem may be configured to include three positions including a first position which obstructs the inflow lumen, a second position which opens the inflow lumen, and a third optional position which opens the venting lumen.

To facilitate the liner expanding and conforming readily against the tissue walls of the uterus, the liner may be inflated with a gas or liquid. Once the elongate shaft has been introduced through the cervix and into the uterus, the distal opening of the shaft may be positioned distal to the internal os and the liner may be deployed either from within the shaft or from an external sheath. The liner may be deployed and allowed to unfurl or unwrap within the uterus. The cooling probe may be introduced through the shaft and into the liner interior. As the cryoablative agent (e.g., cryoablative fluid) is introduced into and distributed throughout the liner interior, the exhaust catheter may also define one or more openings to allow for the cryoablative fluid to vent or exhaust from the interior of the liner.

A coolant reservoir, e.g., nitrous oxide canister, may be fluidly coupled to the handle and/or elongate shaft via a coolant valve which may be optionally controlled by the microcontroller. The coolant reservoir may be in fluid communication with the cooling probe assembly and with the interior of the balloon. Additionally, an exhaust lumen in communication with the elongate probe and having a back pressure valve may also include a pressure sensor where one or both of the back pressure sensor and/or valve may also be in communication with the microcontroller.

Yet another variation of the treatment assembly may incorporate a housing having a handle and a reservoir housing extending from and attached directly to the handle. The sheath having the liner may extend from the housing while an actuator may be located, for instance, along the handle to enable the operator to initiate the cryoablative treatment. A reservoir or canister fully containing the cryoablative fluid may be inserted and retained within the reservoir housing. The reservoir housing and/or the handle may further incorporate a reservoir engagement control which may be actuated, e.g., by rotating the control relative to the handle, to initially open fluid communication with the reservoir or canister to charge the system for treatment.

In an alternative variation, the reservoir housing and the electronics may be detached entirely from the sheath and liner assembly such that the treatment assembly is formed as a two-part or multi-component system which may be tethered or otherwise connected to one another. Rather than incorporating the reservoir housing and controller, the hand piece may be separated from a base station which incorporates the reservoir and controller. A flexible connection may attach the hand piece with the base station where the hand piece may either be permanently coupled to the base station via the connection or where the hand piece may be detachable from the connection and/or from the base station.

Because the treatment system is separated into at least two components which are in communication with one another, the system may provide an ergonomic hand piece which is relatively light yet still provides efficient treatment to the patient while remaining attached to its base station via the flexible connection. With the base station separated and housing the reservoir and multiple electronic and actuation components, the hand piece may be easily handled by the practitioner during treatment relative to the base station and the patient body.

The hand piece may optionally incorporate a display, e.g., LCD display, which shows various treatment parameters or indicators of the assembly. A control, e.g., thumbwheel, slide, etc., may also be incorporated for controlling functions such as positioning of the sheath and/or probe or other function. One or more actuators, e.g., button, switch, etc., may be incorporated as well for controlling functions such as infusing the cryoablative fluid into the liner or exhausting the fluid from the liner.

Other mechanisms such as a potentiometer, e.g., linear potentiometer, may be incorporated for detecting and/or monitoring the position of the sheath relative to the hand piece housing. A pressure sensor may also be incorporated for detecting and/or monitoring the pressure within the liner prior to, during, and/or after a treatment. Additionally, an inflow control, e.g., inflow solenoid, may be incorporated into the hand piece for controlling the inflow of the cryoablative fluid into the hand piece from the base station.

While the hand piece may be detachable from the base station and/or connection, an infusion attachment including, e.g., sheath, liner, and cooling probe, may also be removable and/or replaceable from the rest of the hand piece allowing for the replacement of the infusion attachment while reusing the hand piece. The hand piece may be maintained at a treatment location for sterilization while the infusion attachment may be disposed, refurbished, or repurposed on-site or at another location.

The connection may be coupled to the hand piece via a releasable connector, e.g., quick-connect mechanism, and it may be coupled to the base station also via a second releasable connector, e.g., quick-connect mechanism. The connection may enable the connection between the hand piece and base station to allow for the passage of various fluids and signals such as the cryoablation fluid, high pressure gas, electrical signals, pneumatic signals, etc. while remaining flexible enough so that the hand piece may be moved and adjusted relative to the patient independently of the base station which may remain in a stationary position relative to the patient.

The base station has a housing which may include a display, e.g., LCD touchscreen, etc., for enabling interaction with or the display of parameters, messages, or warnings to the practitioner. A programmable microcontroller may be integrated within the base station and is in electrical communication with the hand piece either through the connection or wirelessly to control the treatment parameters as well as to receive and process signals from the hand piece such as pressure readings, sheath positioning, etc. or any number of other signals. The microcontroller may also control the various parameters within the base station as well.

The base station may also incorporate a pump which may be fluidly coupled to the hand piece and used to draw the spent exhaust from the interior of the liner, through the hand piece and connection, and then through the base station to, e.g., an exhaust collection assembly. A pneumatics controller, which may also include a pump, may be incorporated into the base station and may be in fluid communication with the liner for controlling the infusion or withdrawal of air within the liner, e.g., when monitoring the liner for leaks or for initially expanding the liner within the patient body. At least one actuator, e.g., button, may also be integrated for initiating treatment steps or facilitating control of the base station during treatment. A reservoir assembly may also be included within the base station but may be removable from the base station.

The cooling probe <NUM> as well as the balloon assembly may be variously configured, for instance, in an integrated treatment assembly <NUM> as shown in the side view of <FIG>. In this variation, the assembly <NUM> may integrate the elongate shaft <NUM> having the liner or balloon <NUM> extending therefrom with the cooling probe <NUM> positioned translatably within the shaft <NUM> and liner <NUM>. A separate translatable sheath <NUM> may be positioned over the elongate shaft <NUM> and both the elongate shaft <NUM> and sheath <NUM> may be attached to a handle assembly <NUM>. The handle assembly <NUM> may further comprise an actuator <NUM> for controlling a translation of the sheath <NUM> for liner <NUM> delivery and deployment.

With the sheath <NUM> positioned over the elongate shaft <NUM> and liner <NUM>, the assembly <NUM> may be advanced through the cervix and into the uterus UT where the sheath <NUM> may be retracted via the handle assembly <NUM> to deploy the liner <NUM>, as shown in <FIG>. As described above, once the liner <NUM> is initially deployed from the sheath <NUM>, it may be expanded by an initial burst of a gas, e.g., air, carbon dioxide, etc., or by the cryoablative fluid. In particular, the tapered portions of the liner <NUM> may be expanded to ensure contact with the uterine cornu. The handle assembly <NUM> may also be used to actuate and control a longitudinal position of the cooling probe <NUM> relative to the elongate shaft <NUM> and liner <NUM> as indicated by the arrows.

In another variation of the treatment assembly, <FIG> shows a perspective view of a cryoablation assembly having a handle assembly <NUM> which may integrate the electronics and pump assembly <NUM> within the handle itself. An exhaust tube <NUM> may also be seen attached to the handle assembly <NUM> for evacuating exhausted or excess cryoablative fluid or gas from the liner <NUM>. Any of the cryoablative fluids or gases described herein may be utilized, e.g., compressed liquid-to-gas phase change of a compressed gas such as nitrous oxide (N<NUM>O), carbon dioxide (CO<NUM>), Argon, etc. The cooling probe <NUM> may be seen extending from sheath <NUM> while surrounded or enclosed by the liner or balloon <NUM>. Hence, the handle assembly <NUM> with coupled cooling probe <NUM> and liner <NUM> may provide for a single device which may provide for pre-treatment puff-up or inflation of the liner <NUM>, active cryoablation treatment, and/or post-treatment thaw cycles.

The handle assembly <NUM> may also optionally incorporate a display for providing any number of indicators and/or alerts to the user. For instance, an LCD display may be provided on the handle assembly <NUM> (or to a separate control unit connected to the handle assembly <NUM>) where the display counts down the treatment time in seconds as the ablation is occurring. The display may also be used to provide measured pressure or temperature readings as well as any number of other indicators, symbols, or text, etc., for alerts, instructions, or other indications. Moreover, the display may be configured to have multiple color-coded outputs, e.g., green, yellow, and red. When the assembly is working through the ideal use case, the LED may be displayed as a solid green color. When the device requires user input (e.g. when paused and needing the user to press the button to restart treatment) the LED may flash or display yellow. Additionally, when the device has faulted and treatment is stopped, the LED may flash or display a solid red color.

<FIG> shows the handle assembly <NUM> in a perspective exploded view to illustrate some of the components which may be integrated within the handle <NUM>. As shown, the liner <NUM> and sheath <NUM> may be coupled to a sheath bearing assembly <NUM> and slider base block assembly <NUM> for controlling the amount of exposed treatment length along the cooling probe <NUM> (and as described in further detail below). An actuatable sheath control <NUM> may be attached to the slider base block assembly <NUM> for manually controlling the treatment length of the cooling probe <NUM> as well. Along with the electronics and pump assembly <NUM> (which may optionally incorporate a programmable processor or controller in electrical communication with any of the mechanisms within the handle <NUM>), an exhaust valve <NUM> (e.g., actuated via a solenoid) may be coupled to the exhaust line <NUM> for controlling not only the outflow of the exhausted cryoablation fluid or gas but also for creating or increasing a backpressure during treatment, as described in further detail below.

In one example of how the handle assembly <NUM> may provide for treatment, <FIG> illustrate schematic side views of how the components may be integrated and utilized with one another. As described herein, once the sheath <NUM> and/or liner <NUM> has been advanced and initially introduced into the uterus, the liner <NUM> may be expanded or inflated in a pre-treatment puff up to expand the liner <NUM> into contact against the uterine tissue surfaces in preparation for a cryoablation treatment. As illustrated in the side view of <FIG>, a pump <NUM> integrated within the handle assembly <NUM> may be actuated and a valve <NUM> (e.g., actuatable or passive) fluidly coupled to the pump <NUM> may be opened (as indicated schematically by an "O" over both the pump <NUM> and valve <NUM>) such that ambient air may be drawn in through, e.g., an air filter <NUM> integrated along the handle <NUM>, and passed through an air line <NUM> within the handle and to an exhaust block <NUM>. The exhaust block <NUM> and air line <NUM> may be fluidly coupled to the tubular exhaust channel which extends from the handle <NUM> which is further attached to the cooling probe <NUM>. As the air is introduced into the interior of the liner <NUM> (indicated by the arrows), the liner <NUM> may be expanded into contact against the surrounding uterine tissue surface.

A cryoablative fluid line <NUM> also extending into and integrated within the handle assembly<NUM> may be fluidly coupled to an actuatable valve <NUM>, e.g., actuated via a solenoid, which may be manually closed or automatically closed (as indicated schematically by an "X" over the valve <NUM>) by a controller to prevent the introduction of the cryoablative fluid or gas into the liner <NUM> during the pre-treatment liner expansion. An infusion line <NUM> may be fluidly coupled to the valve <NUM> and may also be coupled along the length of the sheath <NUM> and probe <NUM>, as described in further detail below. The exhaust valve <NUM> coupled to the exhaust line <NUM> may also be closed (as indicated schematically by an "X" over the valve <NUM>) manually or automatically by the controller to prevent the escape of the air from the exhaust block <NUM>.

During this initial liner expansion, the liner <NUM> may be expanded in a gradual and controlled manner to minimize any pain which may be experienced by the patient in opening the uterine cavity. Hence, the liner <NUM> may be expanded gradually by metering in small amounts of air. Optionally, the pump <NUM> may be programmed and controlled by a processor or microcontroller to expand the liner <NUM> according to an algorithm (e.g., e.g. ramp-up pressure quickly to <NUM> Hg and then slow-down the ramp-up as the pressure increases to <NUM> Hg) which may be stopped or paused by the user. Moreover, the liner <NUM> may be expanded to a volume which is just sufficient to take up space within the uterine cavity. After the initial increase in pressure, the pressure within the liner <NUM> may be optionally increased in bursts or pulses. Moreover, visualization (e.g., via a hysteroscope or abdominal ultrasound) may be optionally used during the controlled gradual expansion to determine when the uterine cavity is fully open and requires no further pressurization. In yet another variation, the liner <NUM> may be cyclically inflated and deflated to fully expand the liner. The inflations and deflations may be partial or full depending upon the desired expansion.

In yet another alternative variation, the system could also use an amount of air pumped into the liner <NUM> as a mechanism for detecting whether the device is in a false passage of the body rather than the uterine cavity to be treated. The system could use the amount of time that the pump <NUM> is on to track how much air has been pushed into the liner <NUM>. If the pump <NUM> fails to reach certain pressure levels within a predetermined period of time, then the controller may indicate that the device is positioned within a false passage. There could also be a limit to the amount of air allowed to be pushed into the liner <NUM> as a way to detect whether the probe <NUM> has been pushed, e.g., out into the peritoneal cavity. If too much air is pushed into the liner <NUM> (e.g., the volume of air tracked by the controller exceeds a predetermined level) before reaching certain pressures, then the controller may indicate the presence of a leak or that the liner <NUM> is not fully constrained by the uterine cavity. The liner <NUM> may also incorporate a release feature which is configured to rupture if the liner <NUM> is not constrained such that if the system attempts to pump up the liner <NUM> to treatment pressure (e.g., <NUM> mmHg), the release feature will rupture before reaching that pressure.

Once the liner <NUM> has been expanded sufficiently into contact against the uterine tissue surface, the cryoablation treatment may be initiated. As shown in the side view of <FIG>, the air pump <NUM> may be turned off and the valve <NUM> may be closed (as indicated schematically by an "X" over the pump <NUM> and valve <NUM>) to prevent any further infusion of air into the liner <NUM>. With the cryoablative fluid or gas pressurized within the line <NUM>, valve <NUM> may be opened (as indicated schematically by an "O" over the valve <NUM>) to allow for the flow of the cryoablative fluid or gas to flow through the infusion line <NUM> coupled to the valve <NUM>. Infusion line <NUM> may be routed through or along the sheath <NUM> and along the probe <NUM> where it may introduce the cryoablative fluid or gas within the interior of liner <NUM> for infusion against the liner <NUM> contacted against the surrounding tissue surface.

During treatment or afterwards, the exhaust valve <NUM> may also be opened (as indicated schematically by an "O" over the valve <NUM>) to allow for the discharged fluid or gas to exit or be drawn from the liner interior and proximally through the cooling probe <NUM>, such as through the distal tip opening. The fluid or gas may exit from the liner <NUM> due to a pressure differential between the liner interior and the exhaust exit and/or the fluid or gas may be actively drawn out from the liner interior, as described in further detail herein. The spent fluid or gas may then be withdrawn proximally through the probe <NUM> and through the lumen surrounded by the sheath <NUM>, exhaust block <NUM>, and the exhaust tube <NUM> where the spent fluid or gas may be vented. With the treatment fluid or gas thus introduced through infusion line <NUM> within the liner <NUM> and then withdrawn, the cryoablative treatment may be applied uninterrupted.

Once a treatment has been completed, the tissue of the uterine cavity may be permitted to thaw. During this process, the cryoablative fluid delivery is halted through the infusion line <NUM> by closing the valve <NUM> (as indicated schematically by an "X" over the valve <NUM>) while continuing to exhaust for any remaining cryoablative fluid or gas remaining within the liner <NUM> through probe <NUM>, through the lumen surrounded by sheath <NUM>, and exhaust line <NUM>, as shown in <FIG>. Optionally, the pump <NUM> and valve <NUM> may be cycled on and off and the exhaust valve <NUM> may also be cycled on and off to push ambient air into the liner <NUM> to facilitate the thawing of the liner <NUM> to the uterine cavity. Optionally, warmed or room temperature air or fluid (e.g., saline) may also be pumped into the liner <NUM> to further facilitate thawing of the tissue region.

As the spent cryoablative fluid or gas is removed from the liner <NUM>, a drip prevention system may be optionally incorporated into the handle. For instance, a passive system incorporating a vented trap may be integrated into the handle which allows exhaust gas to escape but captures any vented liquid. The exhaust line <NUM> may be elongated to allow for any vented liquid to evaporate or the exhaust line <NUM> may be convoluted to increase the surface area of the exhaust gas tube to promote evaporation.

Alternatively, an active system may be integrated into the handle or coupled to the handle <NUM> where a heat sink may be connected to a temperature sensor and electrical circuit which is controlled by a processor or microcontroller. The heat sink may promote heat transfer and causes any liquid exhaust to evaporate. When the temperature of the heat sink reaches the boiling temperature of, e.g., nitrous oxide (around -<NUM>), the handle may be configured to slow or stop the delivery of the cryoablative fluid or gas to the uterine cavity.

The pre-treatment infusion of air as well as the methods for treatment and thawing may be utilized with any of the liner, probe, or apparatus variations described herein. Moreover, the pre-treatment, treatment, or post-treatment procedures may be utilized altogether in a single procedure or different aspects of such procedures may be used in varying combinations depending upon the desired results.

Additionally and/or optionally, the handle <NUM> may incorporate an orientation sensor to facilitate maintaining the handle <NUM> in a desirable orientation for treatment. One variation may incorporate a ball having a specific weight covering the exhaust line <NUM> such that when the handle <NUM> is held in the desirable upright orientation, the treatment may proceed uninterrupted. However, if the handle <NUM> moved out of its desired orientation, the ball may be configured to roll out of position and trigger a visual and/or auditory alarm to alert the user. In another variation, an electronic gyroscopic sensor may be used to maintain the handle <NUM> in the desired orientation for treatment.

<FIG> show cross-sectional side views of yet another variation of a cooling probe which utilizes a single infusion line in combination with a translatable delivery line. To accommodate various sizes and shapes of uterine cavities, the cooling probe may have a sliding adjustment that may be set, e.g., according to the measured length of the patient's uterine cavity. The adjustment may move along the sheath along the exhaust tube as well as the delivery line within the infusion line. The sheath may constrain the liner <NUM> and also control its deployment within the cavity.

In this variation, an infusion line <NUM> (as described above) may pass from the handle assembly and along or within the sheath and into the interior of liner <NUM>. The infusion line <NUM> may be aligned along the probe <NUM> such that the infusion line <NUM> is parallel with a longitudinal axis of the probe <NUM> and extends towards the distal tip <NUM> of the probe <NUM>. Moreover, the infusion line <NUM> may be positioned along the probe <NUM> such that the line <NUM> remains exposed to the corners of the liner <NUM> which extend towards the cornua. With the infusion line <NUM> positioned accordingly, the length of the line <NUM> within the liner <NUM> has multiple openings formed along its length which act as delivery ports for the infused cryoablative fluid or gas. A separate translating delivery line <NUM>, e.g., formed of a Nitinol tube defining an infusion lumen therethrough, is slidably positioned through the length of the infusion line <NUM> such that the delivery line <NUM> may be moved (as indicated by the arrows in <FIG>) relative to the infusion line <NUM> which remains stationary relative to the probe <NUM>.

The openings along the length of the infusion line <NUM> may be positioned such that the openings are exposed to the sides of the interior of the liner <NUM>, e.g., crossdrilled. As the cryoablative fluid or gas is introduced through the delivery line <NUM>, the infused cryoablative fluid or gas <NUM> passes through the infusion line <NUM> and then out through the openings defined along the infusion line <NUM>. By adjusting the translational position of the delivery line <NUM>, the delivery line <NUM> may also cover a selected number of the openings resulting in a number of open delivery ports <NUM> as well as closed delivery ports <NUM> which are obstructed by the delivery line <NUM> position relative to the infusion line <NUM>, as shown in the top view of <FIG>.

By translating the delivery line <NUM> accordingly, the number of open delivery ports <NUM> and closed delivery ports <NUM> may be adjusted depending on the desired treatment length and further ensures that only desired regions of the uterine tissue are exposed to the infused cryoablative fluid or gas <NUM>. Once the number of open delivery ports <NUM> has been suitably selected, the infused cryoablative fluid or gas <NUM> may bypass the closed delivery ports <NUM> obstructed by the delivery line <NUM> and the fluid or gas may then be forced out through the open delivery ports <NUM> in a transverse direction as indicated by the infusion spray direction <NUM>. The terminal end of the infusion line <NUM> may be obstructed to prevent the distal release of the infused fluid or gas <NUM> from its distal end. Although in other variations, the terminal end of the infusion line <NUM> may be left unobstructed and opened.

<FIG> show top and perspective views of the expanded liner <NUM> with four pairs of the open delivery ports <NUM> exposed in apposed direction. Because the infused fluid or gas <NUM> may be injected into the liner <NUM>, e.g., as a liquid, under relatively high pressure, the injected cryoablative liquid may be sprayed through the open delivery ports <NUM> in a transverse or perpendicular direction relative to the cooling probe <NUM>. The laterally infused cryoablative fluid <NUM> may spray against the interior of the liner <NUM> (which is contacted against the surrounding tissue surface) such that the cryoablative liquid <NUM> coats the interior walls of the liner <NUM> due to turbulent flow causing heavy mixing. As the cryoablative liquid <NUM> coats the liner surface, the sprayed liquid <NUM> may absorb heat from the tissue walls causing rapid cooling of the tissue while also evaporating the liquid cryogen to a gas form that flows out through the cooling probe <NUM>. This rapid cooling and evaporation of the cryoablative liquid <NUM> facilitates the creation of a fast and deep ablation over the tissue. During treatment, the temperature within the cavity typically drops, e.g., - <NUM>° C, within <NUM>-<NUM> seconds after the procedure has started. While the interior walls of the liner <NUM> are first coated with the cryoablative liquid <NUM>, a portion of the cryoablative liquid <NUM> may no longer change phase as the procedure progresses.

While four pairs of the open delivery ports <NUM> are shown, the number of exposed openings may be adjusted to fewer than four pairs or more than four pairs depending on the positioning of the delivery line <NUM> and also the number of openings defined along the infusion line <NUM> as well as the spacing between the openings. Moreover, the positioning of the openings may also be adjusted such that the sprayed liquid <NUM> may spray in alternative directions rather than laterally as shown. Additionally and/or alternatively, additional openings may be defined along other regions of the infusion line <NUM>.

Further variations of the treatment assembly features and methods which may be utilized in combination with any of the features and methods described herein may be found in the following <CIT>;<CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; and <CIT>. They may also be found in the following <CIT> (<CIT>); <CIT> (<CIT>); <CIT> (<CIT>); and <CIT> (<CIT>).

Yet another variation, not part of the present invention, of the treatment assembly <NUM> is shown in the side and partial cross-sectional side views of <FIG> which illustrate a housing <NUM> having a handle <NUM> and a reservoir housing <NUM> extending from and attached directly to the handle <NUM>. <FIG> further illustrates a perspective assembly view of the treatment assembly <NUM> and some of its components contained internally.

The sheath <NUM> having the liner <NUM> may extend from the housing <NUM> while an actuator <NUM> may be located, for instance, along the handle <NUM> to enable the operator to initiate the cryoablative treatment. A reservoir or canister <NUM> fully containing the cryoablative agent (as described herein) may be inserted and retained within the reservoir housing <NUM>. The reservoir housing <NUM> and/or the handle <NUM> may further incorporate a reservoir engagement control <NUM> which may be actuated, e.g., by rotating the control <NUM> relative to the handle <NUM>, to initially open fluid communication with the reservoir or canister <NUM> to charge the system for treatment.

The reservoir or canister <NUM> may be inserted into the reservoir housing <NUM> and into secure engagement with a reservoir or canister valve <NUM> which may be coupled to the reservoir engagement control <NUM>. The valve <NUM> may be adjusted to open the reservoir or canister <NUM> for treatment or for venting of the discharged cryoablative agent during or after treatment. An inflow modulation control unit <NUM> (e.g., an actuatable solenoid mechanism) may be coupled directly to the reservoir or canister valve <NUM> and the cryoablative fluid line <NUM> may be coupled directly to the modulation control unit <NUM> and through the sheath <NUM> and into fluid communication within the liner <NUM>, as described herein.

During or after treatment, the discharged cryoablative fluid may be evacuated through the exhaust block <NUM> contained within the housing and then through the exhaust line <NUM> coupled to the exhaust block <NUM>. The exhaust line <NUM> may extend through the handle <NUM> and the reservoir housing <NUM> and terminate at an exhaust line opening <NUM> which may be attached to another exhaust collection line, as further described herein.

In yet another variation, the reservoir housing <NUM> and the electronics may be detached entirely from the sheath <NUM> and liner <NUM> assembly such that the treatment assembly is formed as a two-part or multi-component system which may be tethered or otherwise connected to one another. One example is illustrated in the perspective assembly view of <FIG> which shows a tethered system <NUM> having a hand piece <NUM> which may incorporate the sheath <NUM> and cooling probe <NUM> having the delivery line <NUM> surrounded by the liner <NUM>, as described above. However, rather than incorporating the reservoir housing <NUM> and controller, the hand piece <NUM> of the present invention is separated from a base station <NUM> which incorporates the reservoir and controller, as described in further detail below. A flexible connection <NUM> attaches the hand piece <NUM> with the base station <NUM> where the hand piece <NUM> may either be permanently coupled to the base station <NUM> via the connection <NUM> or where the hand piece <NUM> may be detachable from the connection <NUM> and/or from the base station <NUM>.

<FIG> illustrates a representative assembly view of the tethered treatment assembly having various components and further shows in one variation how the hand piece <NUM> and base station <NUM> may be separately configured. The hand piece <NUM> may optionally incorporate a display <NUM>, e.g., LCD display, which shows various treatment parameters or indicators of the assembly. A control <NUM>, e.g., thumbwheel, slide, etc., may also be incorporated for controlling functions such as positioning of the sheath <NUM> and/or probe <NUM> or other function. One or more actuators <NUM>, e.g., button, switch, etc., may be incorporated as well for controlling functions such as infusing the cryoablative fluid into the liner <NUM> or exhausting the fluid from the liner <NUM>.

Other mechanisms such as a potentiometer <NUM>, e.g., linear potentiometer, may be incorporated for detecting and/or monitoring the position of the sheath <NUM> relative to the hand piece <NUM> housing. A pressure sensor <NUM> may also be incorporated for detecting and/or monitoring the pressure within the liner <NUM> prior to, during, and/or after a treatment. Additionally, an inflow control <NUM>, e.g., inflow solenoid, may be incorporated into the hand piece <NUM> for controlling the inflow of the cryoablative fluid into the hand piece <NUM> from the base station <NUM>.

While the hand piece <NUM> may be detachable from the base station <NUM> and/or connection <NUM>, an infusion attachment <NUM> including, e.g., sheath <NUM>, liner <NUM>, and cooling probe <NUM>, may also be removable and/or replaceable from the rest of the hand piece <NUM> allowing for the replacement of the infusion attachment <NUM> while reusing the hand piece <NUM>. The hand piece <NUM> may be maintained at a treatment location for sterilization while the infusion attachment <NUM> may be disposed, refurbished, or repurposed on-site or at another location.

The connection <NUM> may be coupled to the hand piece <NUM> via a releasable connector <NUM>, e.g., quick-connect mechanism, and it may be coupled to the base station <NUM> also via a second releasable connector <NUM>, e.g., quick-connect mechanism. Connection <NUM> may enable the connection between the hand piece <NUM> and base station <NUM> to allow for the passage of various fluids and signals such as the cryoablation fluid, high pressure gas, electrical signals, pneumatic signals, etc. while remaining flexible enough so that the hand piece <NUM> may be moved and adjusted relative to the patient independently of the base station <NUM> which may remain in a stationary position relative to the patient.

The base station <NUM> has a housing which may include a display <NUM>, e.g., LCD touchscreen, etc., for enabling interaction with or the display of parameters, messages, or warnings to the practitioner. A disposable sterile cover, e.g., transparent cover, may be optionally provided for placement upon or over the display <NUM> or the entire base station <NUM> so that the practitioner may interact with the display <NUM> during a procedure while maintaining sterility of the base station <NUM>. Additionally and/or alternatively in other variations, a foot pedal <NUM> may be coupled to the base station <NUM> to provide a user interface to the practitioner for interacting with the base station <NUM>.

A programmable microcontroller <NUM> may be integrated within the base station <NUM> and is in electrical communication with the hand piece <NUM> either through the connection <NUM> or wirelessly to control the treatment parameters as well as to receive and process signals from the hand piece <NUM> such as pressure readings, sheath positioning, etc. or any number of other signals. The microcontroller <NUM> may also control the various parameters within the base station <NUM> as well.

The base station <NUM> may also incorporate a pump <NUM> which may be fluidly coupled to the hand piece <NUM> and used to draw the spent exhaust from the interior of the liner <NUM>, through the hand piece <NUM> and connection <NUM>, and then through the base station <NUM> to, e.g., an exhaust collection assembly. A pneumatics controller <NUM>, which may also include a pump, may be incorporated into the base station <NUM> and may be in fluid communication with the liner <NUM> for controlling the infusion or withdrawal of air within the liner <NUM>, e.g., when monitoring the liner <NUM> for leaks or for initially expanding the liner <NUM> within the patient body. At least one actuator <NUM>, e.g., button, may also be integrated for initiating treatment steps or facilitating control of the base station <NUM> during treatment. A reservoir assembly <NUM> may also be included within the base station <NUM> but may be removable from the base station <NUM>, as described in further detail below.

Turning now to the hand piece <NUM>, <FIG> shows a schematic view of one variation of the hand piece <NUM> where the infusion attachment <NUM>, as mentioned above, may be removably coupled to a distal end of the housing of the hand piece via a coupling mechanism <NUM> which may secure the infusion attachment <NUM> for use but which may also de-couple the infusion attachment <NUM> for replacement or disposal. The infusion attachment <NUM> may include a base <NUM> which couples to the housing of the hand piece <NUM> and which also supports components such as the insulating sheath <NUM> from which the liner <NUM> and cooling probe <NUM> extend. The infusion attachment <NUM> may also include the incorporate an inflow line <NUM> through which the cryoablative fluid <NUM> is infused into the liner interior and an exhaust line <NUM> through which the exhaust <NUM> is drawn from the liner interior. The base <NUM> may also optionally incorporate one or more lights <NUM>, e.g., LED, for providing illumination as the device is inserted into the patient body.

Additionally and/or optionally, the sheath <NUM> may also incorporate one or more heating elements <NUM>, e.g., strip heaters, along the length or a portion of the length of the sheath <NUM>. The heating elements <NUM> may be positioned along an outer surface of the sheath <NUM> or within the sheath <NUM>. During use, these heating elements <NUM> may be heated when the cryoablative fluid is delivered through the sheath <NUM> during a procedure and/or when the exhaust is evacuated from the liner <NUM> interior in order to prevent damage to tissue, e.g., cervix, contacting the sheath <NUM>.

Because the heating elements <NUM> may draw its power from the base station <NUM> power supply <NUM> (or from a stationary outlet) which provides for a larger power source, the heating elements <NUM> may enable thermal protection for the contacted cervical tissue while potentially eliminating insulation for the sheath <NUM>. This may result in a sheath <NUM> having a relatively smaller diameter which in turn may result in greater sheath <NUM> flexibility for increased comfort for the patient during device insertion, use, and removal.

Within the hand piece <NUM>, its distal end may be configured to fluidly couple with the inflow line <NUM> and exhaust line <NUM> within the infusion attachment <NUM> when the two are coupled to one another. A valve <NUM>, e.g., solenoid valve, may be in fluid communication with the inflow line <NUM> to provide control for metering the flow of cryoablative fluid into the liner <NUM> and a pressure sensor <NUM> may be in fluid communication with exhaust line <NUM> via pressure line <NUM> to enable monitoring of the pressure within the interior of the liner <NUM>. An electrical line <NUM> may be connected to the pressure sensor <NUM> for transmitting electrical signals to and/or from the pressure sensor <NUM> to the microcontroller <NUM> located within the base station <NUM>. Although the pressure sensor <NUM> may be housed within the hand piece <NUM> itself to ensure the fastest transmission of pressure readings within the liner <NUM>, the pressure sensor may instead be housed externally of the hand piece <NUM> such as within the base station <NUM> or external to the system in which case the pressure sensor may communicate with the microcontroller wirelessly or via a wired connection.

Additionally, one or more control mechanisms such as control <NUM>, e.g., thumbwheel, slide, etc., may be incorporated for controlling features such as deploying or retracting the sheath <NUM>. Also, one or more actuators such as actuator <NUM>, e.g., button, switch, etc., may be integrated for actuating any number of features or for providing various inputs into the device. A display <NUM>, e.g., LCD display, for prompting and alerting the user through the treatment as well as for displaying any number of parameters to the user may also be integrated into the hand piece <NUM>. The hand piece <NUM> may also incorporate one or more visual, auditory, or haptic mechanisms (e.g., LED, speaker, vibratory motor, etc.) to provide an alert to the user for any number of actions or alarms.

Although various electronics are illustrated within both the base station <NUM> and hand piece <NUM>, other variations of the system may utilize the various electronics and/or components positioned entirely within the base station <NUM> or entirely within the hand piece <NUM>. The components disposed within the base station <NUM> are not intended to be limiting and other variations of the system may incorporate any number of components within the hand piece <NUM> and base station <NUM>.

The various connections for the hand piece <NUM> may be routed through connector <NUM>, which is further illustrated respectively in the end and side views of <FIG>. As described herein, the connector <NUM> may be removably detached via a securement mechanism which not only mechanically attaches the hand piece <NUM> to the connector <NUM>, but also seals and maintains the high pressure lines and low pressure pneumatic lines as well as maintains the electrical signals to and from the microcontroller. The end view shown in <FIG> illustrates one variation of how the individual lumens may be positioned relative to one another. As shown, the ablation agent lumen <NUM>, exhaust lumen <NUM>, and pneumatic lumen <NUM> may be disposed relative to one another and one or more electrical contacts and actuator lumens <NUM> may be aligned adjacent to one another.

Additionally and/or optionally, the connector <NUM> may have embedded electronics which are configured to identify the connection to either the appropriate hand piece <NUM> and/or base station <NUM> and verify that the connection was properly made using, e.g., proximity sensors, hall effects sensors, RFID chips, etc. The base station <NUM> and hand piece <NUM> may also incorporate embedded electronics to verify authenticity of the connected device or verify that the user is not attempting to re-use the device. For instance, both the hand piece <NUM>, base station <NUM>, and the base station reservoir <NUM> may utilize embedded or connected electronics such as RFID markers for tracking or identification purposes.

As described above, the reservoir assembly <NUM> is secured within the base station <NUM> and may be removed at the completion of treatment for refurbishing or disposal. The reservoir assembly <NUM> may contain not only the reservoir of the cryoablative fluid for the treatment procedure, but the assembly <NUM> may also incorporate a power supply or battery for providing power to the base station <NUM> and hand piece <NUM> as well. Moreover, the assembly <NUM> may also optionally incorporate any number of additional components as well.

The entire system, including the base station <NUM>, may be used in a sterile condition or maintained within a sterile field during a procedure while the reservoir <NUM> and/or electronics may be removed for refurbishment and reuse after the completion of a procedure. Because the system is provided as several components, the reservoir <NUM> and/or electronics may be alternatively provided in a non-sterile condition for use in the base station <NUM> which may be maintained in a sterile condition. In yet another alternative, the base station <NUM>, including the reservoir <NUM> and/or electronics, may be maintained outside of the sterile field while the hand piece <NUM> and connector <NUM> are maintained within the sterile field during a procedure.

<FIG> shows a schematic view of one variation illustrating how the reservoir assembly <NUM> may provide the cryoablative fluid once secured to the base station <NUM>. The assembly <NUM> may incorporate the power supply <NUM>, as shown, while the reservoir <NUM> contains the cryoablative fluid within. Once secured to the base station <NUM>, a port <NUM> may be aligned within a receiving channel within the base station <NUM> to engage with a base fluid lumen <NUM> leading from the port <NUM> to the base connector <NUM> to and the hand piece <NUM>. A base exhaust lumen <NUM> may also extend within the base station <NUM> from the base connector <NUM> while urged via pump <NUM> through an exhaust lumen <NUM> for deposition or infusion within an exhaust reservoir <NUM> which may be separated from the base station <NUM> and connected via the exhaust lumen <NUM>. Alternatively, the exhaust from exhaust lumen <NUM> may be vented to the environment instead. In the event that a separate exhaust reservoir <NUM> is used, such an exhaust reservoir may take the form of an expandable liner, bag, or other container. Examples of exhaust reservoirs which may be used with the devices disclosed herein are described in further detail in <CIT>,.

In other variations, the exhaust reservoir <NUM> may be integrated within the base station <NUM> or fluidly coupled externally of the base station <NUM>. The exhaust reservoir <NUM> may be comprised of a pressurized container, such as a bottle, which receives the exhaust and is then pressurized by the pump <NUM> within the exhaust reservoir <NUM>. The pressurized container may be disengaged from the pump <NUM> for disposing the pressurized exhaust contained within and then reattached later.

By having the exhaust reservoir <NUM> and pump <NUM> separated from the hand piece <NUM>, the back pressure in the hand piece <NUM> may be isolated from the external environment. For instance, a user may connect the scavenging suction from pump <NUM> to the exhaust port <NUM> on the base station <NUM> and any pressure or vacuum drawn on the base station <NUM> from the vacuum may be isolated so as to not impact the hand piece <NUM> and distal end pressure.

<FIG> illustrates a schematic view of an example of how the base station <NUM> may incorporate a releasable connector <NUM>, e.g., quick-connect mechanism, for attachment of the base station <NUM> to an external exhaust reservoir <NUM>. Also shown are the display <NUM>, actuator <NUM>, and reservoir assembly <NUM>, as described above.

Aside from the transfer of fluids between the base station <NUM> and hand piece <NUM>, the flexible connection <NUM> also incorporates an actuator cable <NUM>, e.g., cable, wire, or any structural element which is capable of transmitting a linear movement through the connector <NUM> and to the hand piece <NUM>, as shown in the schematic view of <FIG>. The actuator cable <NUM> may transmit a linear movement to the same actuator cable <NUM> or a separate cable within the hand piece <NUM> which may be coupled to the sheath <NUM>. The actuator cable <NUM> can be coupled to the hand piece <NUM> via connector <NUM> and/or to the base station <NUM> via connector <NUM>. Once coupled to the base station <NUM> and hand piece <NUM>, the actuator cable <NUM> may be translated, e.g., in the direction of actuation <NUM>, via a motor <NUM> such that the linear movement of the actuator cable <NUM> is transmitted through the connector <NUM>, hand piece <NUM>, and to the sheath <NUM> so that the delivery line <NUM> is moved distally or proximally as indicated by the longitudinal translation <NUM> during use in a procedure preferably to cover a selected number of the openings resulting in a number of open delivery ports <NUM>, as described herein.

Turning back to the base station <NUM>, <FIG> shows a schematic view of some of the components which may be incorporated within a housing. The reservoir assembly <NUM>, which may be removable from the housing of the base station <NUM>, may incorporate the power supply <NUM>, such as a battery, within an enclosure to which the reservoir <NUM> is connected and contains the cryoablative fluid <NUM> within. The reservoir <NUM> may have a port <NUM> extending or defined along the reservoir <NUM> as shown in this variation as extending from a bottom surface of the reservoir <NUM> when the reservoir assembly <NUM> is secured within the base station <NUM>. Because the port <NUM> extends from a bottom surface of the reservoir <NUM>, the cryoablative fluid <NUM> contained within may effectively flow out of the reservoir <NUM> thereby eliminating any need for a sipper tube or other lumen to extend into the interior of reservoir <NUM> and also ensures that the entire contents of the reservoir <NUM> may be emptied.

In the event that the reservoir <NUM> is oriented so that its port <NUM> extends from a top surface when secured within the base station <NUM>, the reservoir <NUM> may be vented of excess fluid <NUM> by using a sipper tube <NUM> which extends into the interior of the reservoir <NUM>, as shown in <FIG>. This variation of the reservoir <NUM> utilizing the sipper tube <NUM> may be used in combination with any of the features of the base station <NUM> or the system as described herein.

In the event that the reservoir <NUM> is used as a heat sink, the venting lumen <NUM> may be separate from the sipper tube <NUM>. A valve <NUM>, which is fluidly coupled to a venting lumen <NUM>, may remain closed during use while fluid lumen <NUM> is opened. When fluid lumen <NUM> is closed, valve <NUM> may be opened in order to vent any gaseous cryoablative fluid <NUM>". If the cryoablative fluid <NUM>, is drawn up through the sipper tube <NUM> in liquid form <NUM>', it will not extract the heat from the internal reservoir walls. (If the cryoablative fluid <NUM> were to convert into its gaseous form, heat from the internal reservoir walls would be extracted. ) The gaseous form <NUM>" of the cryoablative fluid <NUM> exiting from the separate venting lumen <NUM> through the port in the top of the reservoir <NUM> reduces the pressure within the reservoir <NUM> which will cause the liquid cryoablative fluid <NUM>' at the bottom of the reservoir <NUM> to convert to a gaseous form <NUM>" before exiting through the venting lumen <NUM> in the top of the reservoir <NUM>. This liquid-to-gas phase change within the reservoir <NUM> will extract heat from the walls of the reservoir <NUM> causing the reservoir <NUM> temperature to drop and thereby using the reservoir <NUM> as a heat sink.

The cryoablative fluid <NUM> may be retained within the reservoir <NUM> by a seal <NUM> within the port <NUM> such that when the reservoir assembly <NUM> is secured within a reservoir assembly receiving channel <NUM> defined within the base station <NUM>, a piercing manifold <NUM> extending within the receiving channel <NUM> is positioned to pierce the seal <NUM> and extend at least partially within the reservoir <NUM> in a sealed manner to enable the fluid within to flow into the manifold <NUM> and through the base fluid lumen <NUM> which extends through the base station <NUM> to the connection <NUM>. In other variations, rather than utilizing a piercing manifold <NUM>, the port receiving channel may instead be configured to open a valve into the reservoir <NUM> and the manifold <NUM> may be omitted. This variation may be utilized particularly if the reservoir <NUM> is to be reused.

A pressure sensor <NUM> may be optionally fluidly connected to base fluid lumen <NUM> so that the internal pressure from the fluid <NUM> within the reservoir <NUM> may be monitored by the microcontroller <NUM> which may be connected to the pressure sensor <NUM> via electrical connection <NUM>. The pressure sensor <NUM> may also be configured as a mass sensor so that the pressure sensor <NUM> can be used to verify that the reservoir <NUM> is ready for treatment.

The microcontroller <NUM> may be electrically connected to not only to the components within the base station <NUM> but it may also communicate with the hand piece <NUM> and the various components within the hand piece <NUM> via one or more electrical connections <NUM> which may connect from the microcontroller <NUM> to the hand piece <NUM> via the connections <NUM> through the connection <NUM>.

In other variations, rather than having a reservoir <NUM> be replaceable, the base station <NUM> may alternatively house a reservoir which is permanently integrated within the base station <NUM> such that the reservoir <NUM> is refillable by an external source. The base station <NUM> may have internal regulators and pressure switches to automate the process of filling the internal reservoir.

The base exhaust lumen <NUM> may also be seen extending from the connector <NUM> and through the base station <NUM> in fluid communication with the pump <NUM>, which may also be in electrical communication with and controlled by the microcontroller <NUM>, and through an exhaust lumen <NUM>. A thermal mass/evaporator <NUM> connected to the pump <NUM> may be positioned within the receiving channel <NUM> of the base station <NUM> such that the thermal mass/evaporator <NUM> contacts the reservoir <NUM> directly in order to facilitate evaporation of any remaining liquid cryogen that is exhausted.

Additionally, the base station <NUM> may also include a pneumatic lumen <NUM> leading to the connector <NUM> and fluidly coupled to a pneumatic control <NUM> (e.g., solenoids, tubing, valves, etc.) and a pump <NUM> for providing the air (or other gas) which may be used for infusion into the liner <NUM> during a procedure. The pneumatic control <NUM> and/or pump <NUM> may also be electrically coupled to the microcontroller <NUM> for controlling the operation of the pneumatic control <NUM>. The pneumatic lumen <NUM> and/or pump <NUM> may also optionally incorporate one or more heating elements which may be used to warm air being infused into the liner <NUM> in order to facilitate patient comfort and/or to facilitate removal of the device by thawing the frozen tissue contacted by the liner.

Additionally and/or optionally, the base station <NUM> may also integrate a temperature sensor <NUM> which is electrically coupled to the microcontroller <NUM> and positioned within the receiving channel <NUM> for contacting the reservoir <NUM>. The temperature sensor <NUM> may be used to monitor the reservoir temperature and may also be configured with one or more heating elements which may be controlled by the microcontroller <NUM> to regulate the temperature of the reservoir <NUM> in order to maintain the system within optimal treatment parameters.

As the reservoir assembly <NUM> may be removable from the base station <NUM>, the reservoir assembly <NUM> may be secured within the receiving channel <NUM> via any number of engagement mechanisms <NUM>, e.g., threaded features or other mating features which help to ensure that the reservoir is fully seated and sealed within the receiving channel <NUM>. Because the reservoir assembly <NUM> may contain the power supply <NUM> (although in other variations the power may be supplied to the base station <NUM> via an external power source, e.g., wall outlet, etc.), the housing of the assembly <NUM> may contain one or more electrical contacts <NUM> which may connect with or contact complementary electrical contacts <NUM> located on the base station <NUM>. The electrical contacts <NUM> located on the base station <NUM> may be electrically coupled to the various components within the base station via a power supply connection <NUM> as well as to the hand piece through connection <NUM> via a power supply line <NUM>. Hence, when the reservoir assembly <NUM> is fully seated within the base station <NUM>, the power supply <NUM> may supply the requisite to the components within the base station <NUM> as well as the hand piece <NUM>.

The reservoir assembly <NUM> is shown in the schematic view of <FIG> removed from the base station <NUM>. The reservoir <NUM>, port <NUM>, electrical contacts <NUM>, and seal <NUM> are shown for clarity purposes. Because the reservoir assembly <NUM> may be removable from the base station <NUM>, the base station <NUM> may have the microcontroller <NUM> programmable to detect or monitor for a mating sensor or electronics in the assembly <NUM> which can be used to verify whether the reservoir <NUM> is full or discharged, e.g., to prevent re-use of a partially empty reservoir <NUM>. After the end of a treatment procedure, the reservoir assembly <NUM> may be removed from the base station <NUM> to allow for the insertion of a new reservoir assembly and the discharged reservoir assembly <NUM> may be either refurbished or disposed after use.

While the microcontroller <NUM> may be programmed to monitor the use of the reservoir assembly <NUM>, the reservoir assembly <NUM> may also include a separate microcontroller <NUM> which may be electrically connected to a pressure sensor <NUM> for monitoring a pressure level of the fluid <NUM> within the reservoir <NUM> as well as being electrically connected to the power supply <NUM> for determining its charge level and to the contacts <NUM> for determining whether the power supply <NUM> has made sufficient contact with the base station contacts. Aside from monitoring pressure and power levels, the base microcontroller <NUM> may also be programmed to monitor various parameters of the reservoir assembly <NUM> such as current or historic temperature, humidity, power levels, etc..

Additionally, the microcontroller <NUM> may also be programmed to lock to the base station <NUM> after installation to prevent the detachment of a full or partially full reservoir assembly via optional interlocks which may be configured to deactivate after completion of a treatment and/or venting of the reservoir <NUM>.

The volume of the reservoir <NUM> may also be varied depending on the desired amount of fluid <NUM> for treatment. For instance, the reservoir <NUM> may be configured to hold enough of the fluid <NUM> for a single treatment or for multiple treatments. Alternatively, the base station <NUM> may be integrated with a non-removable reservoir <NUM> so that the base station <NUM> may be interfaced or connected to a large external reservoir used to supply the fluid for treatment and/or to recharge the reservoir <NUM>.

Claim 1:
A treatment system, comprising:
a hand piece (<NUM>) having an elongate probe (<NUM>) with a distal tip and a length, at least one infusion lumen positioned through or along the elongate probe (<NUM>), at least one delivery lumen slidingly positioned through or along the infusion lumen, and a liner (<NUM>) expandably enclosing the probe such that a cryoablative fluid introduced through one or more unobstructed openings along the infusion lumen is sprayed into contact with an interior surface of the liner (<NUM>) and coats the interior surface;
a base station (<NUM>) having a reservoir (<NUM>) of the cryoablative fluid and a motor; and
a connection (<NUM>) having an elongate flexible body coupling the hand piece (<NUM>) and the base station (<NUM>)such that the hand piece (<NUM>) is positionable independently of the base station (<NUM>) and the reservoir (<NUM>), wherein the connection (<NUM>) defines at least one fluid lumen for delivery of the cryoablative fluid from the reservoir (<NUM>) and to the infusion lumen within the hand piece (<NUM>) and wherein the connection (<NUM>) further includes an actuator cable detachably coupled to the motor and to the at least one delivery lumen in the hand piece (<NUM>) such that actuation of the motor translates the at least one delivery lumen distally or proximally relative to the at least one infusion lumen; wherein the cryoablative fluid is introduced through the delivery lumen (<NUM>) and subsequently passed to the infusion lumen (<NUM>).