LEAK REMOVAL FOR CRYOGENIC TREATMENT.

Abstract

The exhaust gas disposal apparatus and methods for cryogenic treatment are described herein. The apparatus generally includes a housing with an inlet for fluid connection to a water source and an outlet for fluid connection to a drain, and a suction chamber in fluid communication with the housing. The suction chamber is further configured to be detachably coupled to an exhaust gas collection tank containing a volume of exhaust gas. The introduction of water through the inlet creates a pressure reduction within the suction chamber, whereby the exhaust gas is drawn from the collection tank and enters the housing to dissolve in the water and exit through the drain.

Description

This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 056,153 filed on July 24, 2020, the contents of which are incorporated herein by reference in their entirety. FIELD OF INVENTION The present invention relates to medical devices. In particular, the present invention relates to methods and apparatus for evacuating the exhaust gases generated by the cryoablative treatment of tissue regions. BACKGROUND OF THE INVENTION In recent decades, therapeutic intervention within a body cavity or lumen has developed rapidly with regard to energy delivery via radiofrequency ablation. While successful in several fields, radiofrequency ablation has several significant drawbacks, including incomplete ablation, frequent lack of visualization during catheter insertion, the possibility of overlapping during treatment (with some areas receiving twice the energy of others), tissue charring and the need for frequent debridement, frequent requirements for additional energy doses after debridement, and potential perforation of the body cavity or lumen due to the rigidity of the RF electrodes. Minimally invasive devices and methods can be used that deliver thermal energy to a desired area or extract energy from a desired area, in a consistent and controlled manner that does not inadvertently char or freeze certain tissues or create an excessive risk of unwanted damage to organs or lumens. However, devices that use cryoablative fluids such as nitrous oxide require the removal of these spent gases from the body after treatment. These exhaust gases can be temporarily collected within an evacuation system or container, but will eventually require disposal. Collected exhaust gases can be vented to the atmosphere, but this may expose the user to the gases. Therefore, an effective exhaust gas removal system or method is desired to effectively remove exhaust gases after a treatment procedure. SUMMARY OF THE INVENTION A treatment set for cryoablative treatment of tissue, such as uterine tissue, typically involves expanding a lining that fits snugly against the uterine walls. This lining may be inflated with a gas or a liquid. Once the elongated stem is inserted through the cervix and into the uterus, the distal opening of the stem may be positioned distal to the internal os, and the lining may be unfurled from within the stem or from an external sheath. The cooling probe may then be inserted into the lining. As the cryoablative agent (e.g., cryoablative fluid) is introduced and distributed throughout the lining, the escape catheter may also define one or more openings to allow the cryoablative fluid to vent or escape from within the lining.With the cryoablative fluid discharged in a completely gaseous state, the evacuation exhaust line can be vented to the surrounding environment or, optionally, connected to a sweep system to collect the discharged gas and limit exposure. In one variation, an exhaust gas collection bag can be supported by a pole and connected to the exhaust line to collect the exhaust fluids or gases. The evacuation exhaust line can be detachably connected to the collection bag via a pipe connector located near or at the bottom of the collection bag. Once an ablation treatment is complete and the resulting exhaust gases are captured in the bag, the spent nitrous gas (e.g., nitrous oxide gas) can be vented from the bag to the atmosphere. However, the bag can also be evacuated through the plumbing system of the suite or room where the bag is located by dissolving the nitrous gas in water, which can then be drained directly into the sink. In this way, the nitrous gas can be vented directly from the bag into the sink drain without the need for atmospheric venting or personnel exposure. Consequently, the drained mixture of water and nitrous gas can be disposed of through the plumbing system while remaining at environmentally acceptable levels. Typically, the evacuation assembly may include an assembly housing through which the fluid lines are enclosed.The assembly housing can be placed inside a sink and may include an inlet pipe attached to the housing for seamless connection to a water faucet. The assembly housing may also include an integrated base for mounting on or in fluid communication with a drain inside the sink. With the bag filled with exhaust nitrous gas, the faucet can be opened to initiate water flow. The water enters the inlet pipe, passes through the assembly housing where the flow can be restricted to reduce pressure, and continues to the drain. The restricted fluid flow creates low pressure within a suction junction extending from the housing, creating a Venturi effect.This low pressure created inside the suction junction can draw the exhaust gas from the bag, through the exhaust line and into contact with the water flowing through the housing where the exhaust gas can dissolve in the flowing water to drain directly into the drain. While the evacuation assembly was described as attached to or attachable to the exhaust bag, the evacuation assembly (or any of the variations of the assembly in this description) can alternatively be seamlessly coupled directly to the treatment assembly to extract exhaust gases directly from the device during a treatment procedure. Furthermore, the evacuation assembly can also be used in any number of other procedures in which nitrous exhaust gases are generated, such as cardiac ablation procedures or any other cryogenic procedure, and gases other than nitrous can also be used with the evacuation assembly as desired. A variation of the cryogenic exhaust gas disposal apparatus, the apparatus generally comprises a housing having an inlet for fluid connection to a water source and an outlet for fluid connection to a drain, and a suction chamber in fluid communication with the housing, wherein the suction chamber is further configured to be detachably coupled to an exhaust gas collection tank containing a volume of exhaust gas. The introduction of water through the inlet creates a pressure reduction within the suction chamber, whereby the exhaust gas is drawn from the collection tank and enters the housing to dissolve in the water and exit through the drain.A variation of a method for evacuating cryogenic exhaust gas may generally comprise receiving a flow of water through an inlet of a housing, passing the water flow through the housing so as to reduce the pressure within a suction chamber, drawing a volume of cryogenic exhaust gas into the suction chamber through the reduced pressure so that the cryogenic exhaust gas dissolves in the water flow, and passing the water flow and dissolved cryogenic exhaust gas to a drain. Another variation of the cryogenic exhaust gas disposal system may generally comprise a housing having an inlet for fluid coupling to a water source and an outlet for fluid coupling to a drain, a suction chamber in fluid communication with the housing, wherein the suction chamber is further configured to be detachably coupled to an exhaust gas collection tank having a volume of exhaust gas, wherein the introduction of water through the inlet generates a pressure reduction within the suction chamber so that the volume of exhaust gas is drawn from the exhaust gas collection tank and enters the housing to dissolve in the water and exit through the drain, and an exhaust gas collection apparatus containing the volume of exhaust gas to be fluidly coupled to the suction chamber through an exhaust line. BRIEF DESCRIPTION OF THE FIGURES Figure 1A shows a side view of an integrated treatment assembly. Figure IB shows an example of the advanced assembly through the cervix and into the uterus where the sheath can be retracted through the handle assembly to deploy the balloon. Figure 1C shows a perspective view of a cryoablation assembly that has a handle assembly that can integrate the electronics and pump assembly within the handle itself. Figure ID shows the handle assembly in an exploded perspective view illustrating some of the components that can be integrated within the handle. Figure 1E shows an example of the system's operation during a pretreatment inflation process. Figure 1F shows an example of the system's operation during a treatment process. Figure 1G shows an example of the system's operation during a defrosting and ventilation process. Figures 2A and 2B show cross-sectional side views of yet another variation of a cooling probe that uses a single infusion line in combination with a portable supply line. Figures 3A and 3B show perspective and top views of the expanded lining with four pairs of open supply ports exposed in opposite directions. Figures 4A to 4C show side and overall views of another variation of the treatment set. Figures 5A and 5B show examples of collection systems that can be used to collect the discharged liquid or gas. Figure 6 shows another example of a collection system that uses a bag to collect the discharged liquid or gas. Figure 7 illustrates an example of how the contents of the spent exhaust gases contained within the bag can be dissolved directly in water to drain into a sink in the room where the bag is located. Figures 8A and 8B schematically illustrate the flow path through the assembly casing versus an example of an evacuation assembly. Figures 9A and 9B show perspective views of a variation of the evacuation assembly separate from the sink and also fixed inside the sink. Figures 10A and 10B show perspective views of another variation of the evacuation assembly that has a sliding joining mechanism separate from the sink and also attached inside the sink. Figures 11A and 1IB show perspective views of another variation of the evacuation assembly that has a joining base with a suction mechanism separate from the sink and also fixed inside the sink. Figures 12A and 12B show perspective views of another variation of the evacuation assembly that has a diverter switch to create suction within a separate base of the sink and also attached within the sink. Figures 13A and 13B show perspective views of another variation of the evacuation assembly that has a housing that can be attached directly to the separate faucet from the sink and also attached inside the sink. Figures 14A and 14B show perspective views of another variation of the evacuation assembly that has a base that can contain a tank separate from the sink and also fixed inside the sink. Figures 15A and 15B show perspective views of another variation of the evacuation assembly that has a housing that can be attached directly to the separate faucet from the sink and also attached inside the sink. Figure 16 shows a perspective view of another variation of the evacuation assembly that has a housing that can also be attached directly to the tap. Figures 17A and 17B show perspective views of another variation of the evacuation assembly that has a housing that is oriented horizontally with respect to the sink, separate from the sink and also attached within the sink. Figures 18A and 18B show perspective views of another variation of the zoonnn / eznz / E / YiAi evacuation assembly that has a housing that is oriented vertically relative to the sink, separate from the sink and also attached within the sink. DETAILED DESCRIPTION OF THE INVENTION The cooling probe 22, as well as the globe assembly, can be configured in various ways, for example, in an integrated treatment assembly 10, as shown in the side view of Figure 1A. In this variation, the assembly 10 can integrate the elongated stem 18 having the liner or globe 20 extending therefrom, with the cooling probe 22 positioned movably within the stem 18 and the liner 20. A separate movable shroud 12 can be positioned over the elongated stem 18, and both the elongated stem 18 and the shroud 12 can be attached to a handle assembly 14. The handle assembly 14 can further comprise an actuator 16 for controlling the translation of the shroud 12 for supplying and deploying the liner 20. With the sheath 12 positioned over the elongated stem 18 and the lining 20, the assembly 10 can advance through the cervix and into the UT uterus, where the sheath 12 can be retracted through the handle assembly 14 to deploy the lining 20, as shown in Figure IB. As described above, once the lining 20 is initially deployed from the sheath 12, it can be expanded by an initial burst of a gas, e.g., air, carbon dioxide, etc., or by the cryoablative fluid. In particular, the conical portions of the lining 20 can be expanded to ensure contact with the uterine horn. The handle assembly 14 can also be used to actuate and control the longitudinal position of the cooling probe 22 relative to the elongated stem 18 and the lining 20, as indicated by the arrows.In another variation of the treatment assembly, Figure 1C shows a perspective view of a cryoablation assembly having a handle assembly 24 that can integrate the electronic and pump assembly 28 within the handle itself. An exhaust pipe 26 attached to the handle assembly 24 can also be seen for evacuating excess or exhausted cryoablative fluid or gas from the liner 20. Any of the cryoablative fluids or gases described herein can be used, for example, liquid-to-gas phase change of a compressed gas such as nitrous oxide (N₂O), carbon dioxide (CO₂), argon, etc. The cooling probe 22 can be seen extending from the sheath 12 while surrounded or enclosed by the liner or globe 20.Therefore, the assembly of handle 24 with attached cooling probe 22 and liner 20 can provide a single device that can provide liner 20 pretreatment inflation or inflation, active cryoablation treatment and / or post-treatment thawing cycles. The 24-handle assembly can also optionally incorporate a display to provide any number of indicators and / or alerts to the user. For example, an LCD screen can be provided on the 24-handle assembly (or on a separate control unit connected to the 24-handle assembly) where the display counts down the treatment time in seconds as the ablation occurs. The display can 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 guidance. Furthermore, the display can be configured to have multiple color-coded outputs, for example, green, yellow, and red. When the assembly is operating in the ideal use case, the LED can display a solid green color.When the device requires user input (for example, when it is paused and the user needs to press the button to restart treatment), the LED may blink or turn yellow. Additionally, when the device malfunctions and treatment stops, the LED may blink or turn solid red. Figure ID shows the handle assembly 24 in an exploded perspective view to illustrate some of the components that can be integrated within the handle 24. As shown, the liner 20 and wrap 12 can be coupled to a wrap bearing assembly 32 and a sliding base block assembly 34 to control the amount of treatment length exposed along the cooling probe 22 (and as described in more detail below). An actuatable wrap control 36 can also be attached to the sliding base block assembly 34 to manually control the treatment duration of the cooling probe 22.Together with the electronic and pump assembly 28 (which may optionally incorporate a processor or programmable controller in electrical communication with any of the mechanisms within the handle 24), an exhaust valve 30 (e.g., solenoid-operated) may be coupled to the exhaust line 26 to control not only the flow of the escape cryoablation fluid or gas but also to create or increase back pressure during treatment, as described in more detail below. In an example of how the handle assembly 24 can provide treatment, Figures 1E to 1G illustrate schematic side views of how the components can be integrated and used together. As described herein, once the sheath 12 and / or lining 20 advance and are initially introduced into the uterus, the lining 20 can be expanded or inflated in a pretreatment inflation to expand the lining 20 in contact with the uterine tissue surfaces in preparation for cryoablation treatment.As illustrated in the side view of Figure 1E, an integrated pump 38 within the handle assembly 24 can be actuated, and a valve 42 (e.g., actuated or passive) fluidly coupled to the pump 38 (as indicated schematically by an O above the pump 38 and valve 42) can be opened so that ambient air can be drawn through, for example, an integrated air filter 40 along the handle 24, and pass through an air line 44 within the handle and into an exhaust block 46. The exhaust block 46 and the air line 44 can be fluidly coupled to the tubular exhaust channel extending from the handle 24, which is also connected to the cooling probe 22. As air is drawn into the lining 20 (indicated by the arrows), the lining 20 can expand to come into contact with the surface of the surrounding uterine tissue. A cryoablative fluid line 48, which also extends and integrates within the handle assembly 24, can be seamlessly coupled to an actuated valve 50, for example, solenoid-operated, which can be closed manually or automatically (as indicated schematically by an "X" on the valve 50) by a controller to prevent the introduction of the cryoablative fluid or gas into the liner 20 during the expansion of the pretreatment liner. An infusion line 52 can be seamlessly coupled to the valve 50 and can also be coupled along the sheath 12 and the probe 22, as described in more detail below. The exhaust valve 30 coupled to the exhaust line 26 can also be closed (as indicated schematically by an "X" on the valve 30) manually or automatically by the controller to prevent air from escaping from the exhaust block 46. During this initial expansion of the lining, the lining 20 can be expanded gradually and in a controlled manner to minimize any pain the patient may experience when the uterine cavity is opened. Therefore, the lining 20 can be expanded gradually by injecting small amounts of air. Optionally, the pump 38 can be programmed and controlled by a processor or microcontroller to expand the lining 20 according to an algorithm (for example, rapidly increasing the pressure to 10 mm Hg and then decreasing the acceleration as the pressure increases to 85 mm Hg) that can be stopped or paused by the user. Furthermore, the lining 20 can be expanded to a volume sufficient to occupy space within the uterine cavity. After the initial pressure increase, the pressure within the lining 20 can optionally be increased in bursts or pulses.Additionally, visualization (e.g., via hysteroscope or abdominal ultrasound) can be used optionally during controlled gradual expansion to determine when the uterine cavity is fully open and no longer requires pressurization. In another variation, the lining can be cyclically inflated and deflated to fully expand it. Inflations and deflations can be partial or complete, depending on the desired expansion. In another alternative variation, the system could also use the amount of air pumped into the lining 20 as a mechanism to detect whether the device is in a false trajectory within the body instead of the uterine cavity being treated. The system could use the amount of time the pump 38 is running to track how much air has been introduced into the lining 20. If the pump 38 fails to reach certain pressure levels within a predetermined time, the controller can indicate that the device is in a false trajectory. There could also be a limit on the amount of air allowed to be introduced into the lining 20 as a way to detect whether the probe 22 has been inserted, for example, into the peritoneal cavity.If too much air is introduced into the liner 20 (for example, the air volume tracked by the controller exceeds a predetermined level) before certain pressures are reached, the controller may indicate a leak or that the liner 20 is not fully restricted by the uterine cavity. The liner 20 may also incorporate a release feature that is set to rupture if the liner 20 is not restricted. If the system attempts to pump the liner 20 to the treatment pressure (for example, 140 mmHg), the release feature will rupture before that pressure is reached. Once the lining 20 has expanded enough to come into contact with the surface of the uterine tissue, cryoablation treatment can begin. As shown in the side view of Figure 1F, the air pump 38 can be turned off and the valve 42 can be closed (as indicated schematically by an X over the pump 38 and the valve 42) to prevent further air infusion into the lining 20. With the cryoablative fluid or gas pressurized within line 48, the valve 50 can be opened (as indicated schematically by an O over the valve 50) to allow the cryoablative fluid or gas to flow through the infusion line 52 connected to the valve 50. The infusion line 52 can pass through or along the sheath 12 and along the probe 22 where it can introduce the cryoablative fluid or gas into the interior of the lining 20 for infusion against the lining 20 in contact with the surrounding tissue surface.During or after treatment, the exhaust valve 30 can also be opened (as indicated schematically by an O above valve 30) to allow the discharged fluid or gas to escape or be extracted from inside the liner and proximally through the cooling probe 22, as well as through the distal tip opening. The fluid or gas can escape from the liner 20 due to a pressure differential between the inside of the liner and the exhaust outlet, and / or the fluid or gas can be actively extracted from inside the liner, as described in more detail herein. The spent fluid or gas can then be removed proximally through the probe 22 and through the lumen enclosed by the sheath 12, the exhaust block 46, and the exhaust tube 26, through which the spent fluid or gas can be vented.With the treatment fluid or gas thus introduced through the infusion line 52 into the lining 20 and then withdrawn, the cryoablative treatment can be applied without interruption. Once treatment is complete, the uterine cavity tissue can be allowed to thaw. During this process, the cryoablative fluid supply is stopped through the infusion line 52 by closing valve 50 (as indicated schematically by an X over valve 50), while any remaining cryoablative fluid or gas is expelled from the lining 20 through the probe 22, through the lumen enclosed by the sheath 12, and the exhaust line 26, as shown in Figure 1G. Optionally, pump 38 and valve 42 can be switched on and off, and the exhaust valve 30 can also be switched on and off to push ambient air into the lining 20 to facilitate its thawing into the uterine cavity.Optionally, heated or room temperature air or fluid (e.g. saline solution) can also be pumped into the liner 20 to further facilitate thawing of the tissue region. As the spent cryoablative gas or fluid is removed from the liner 20, a drip-prevention system can be optionally incorporated into the handle. For example, a passive system incorporating a vented trap can be integrated into the handle. This trap allows exhaust gas to escape but captures any vented liquid. The exhaust line 26 can be lengthened to allow any vented liquid to evaporate, or it can be coiled to increase the surface area of ​​the exhaust gas tube and promote evaporation. Alternatively, an active system can be integrated into the handle or attached to handle 24, where a heat sink can be connected to a temperature sensor and an electrical circuit controlled by a processor or microcontroller. The heat sink can promote heat transfer and evaporate any leaking liquid. When the temperature of the heat sink reaches the boiling point of, for example, nitrous oxide (around -86 °C), handle 10 zoonnn / eznz / E / YiAi can be configured to slow down or stop the delivery of the cryoablative fluid or gas to the uterine cavity. The pretreatment air infusion, as well as the treatment and thawing methods, can be used with any of the coating, probe, or apparatus variations described herein. Furthermore, the pretreatment, treatment, and posttreatment procedures can be used together in a single procedure, or different aspects of these procedures can be used in varying combinations depending on the desired results. Additionally and / or optionally, handle 24 may incorporate an orientation sensor to facilitate maintaining it in a convenient treatment orientation. One variation may incorporate a weighted ball that covers the exhaust line 26 so that when handle 24 is maintained in the desired vertical orientation, treatment can continue uninterrupted. However, if handle 24 moves out of its desired orientation, the ball may be configured to roll out of position and activate a visual and / or audible alarm to alert the user. In another variation, an electronic gyroscopic sensor may be used to maintain handle 24 in the desired treatment orientation. Figures 2A and 2B show cross-sectional side views of yet another variation of a cooling probe that uses a single infusion line in combination with a movable supply line. To accommodate various sizes and shapes of uterine cavities, the cooling probe may have a sliding adjustment that can be set, for example, according to the measured length of the patient's uterine cavity. The adjustment can be moved along the sheath along the exhaust tube, as well as the supply line within the infusion line. The sheath can restrict the sheath and also control its deployment within the cavity. In this variation, an infusion line 52 (as described above) can pass from the handle assembly along or within the sheath and into the lining 20. The infusion line 52 can be aligned along the probe 22 so that it is parallel to the longitudinal axis of the probe 22 and extends toward the distal tip 66 of the probe 22. Alternatively, the infusion line 52 can be positioned along the probe 22 so that it remains exposed to the corners of the lining 20 that extend toward the horns. With the infusion line 52 positioned accordingly, the length of the line 52 within the lining 20 can have multiple openings formed along its length that act as supply ports for the infused cryoablative fluid or gas.A separate translational supply line 64, for example, formed by a Nitinol tubing defining an infusion lumen therethrough, can be slidably positioned along the infusion line 52 so that the supply line 64 can move (as indicated by the arrows in Figure 2A) relative to the infusion line 52 which remains stationary relative to the probe 22. The openings along the infusion line 52 can be positioned so that they are exposed to the sides of the inner lining 20, for example, drilled transversely. As the cryoablative fluid or gas is introduced through the delivery line 64, the infused cryoablative fluid or gas 68 can pass through the infusion line 52 and then exit through the defined openings along the infusion line 52. By adjusting the translational position of the delivery line 64, the delivery line 64 can also cover a selected number of the openings, resulting in a series of open delivery ports 60 as well as closed delivery ports 62 that are obstructed by the position of the delivery line 64 relative to the infusion line 52, as shown in the top view of Figure 2B. By repositioning the delivery line 64 accordingly, the number of open delivery ports 60 and closed delivery ports 62 can be adjusted depending on the desired treatment duration and further ensures that only the desired regions of the uterine tissue are exposed to the infused cryoablative fluid or gas 68. Once the number of open delivery ports 60 has been appropriately selected, the infused cryoablative fluid or gas 68 can bypass the closed delivery ports 62 obstructed by the delivery line 64, and the fluid or gas can be expelled through the open delivery ports 60 in a transverse direction as indicated by the infusion spray direction 70. The terminal end of the infusion line 52 can be obstructed to prevent distal release of the infused fluid or gas 68 from its distal end.Although in other variations, the terminal end of the infusion line 52 can be left unobstructed and open. Figures 3A and 3B show top and perspective views of the expanded liner 20 with four pairs of open delivery ports 60 exposed in opposite directions. Because the infused fluid or gas 68 can be injected into the liner 20, for example, as a liquid, at a relatively high pressure, the injected cryoablative fluid can be sprayed through the open delivery ports 60 in a transverse or perpendicular direction relative to the cooling probe 22. The laterally infused cryoablative fluid 70 can be sprayed against the inside of the liner 20 (which comes into contact with the surrounding tissue surface) so that the cryoablative fluid 70 coats the inner walls of the liner 20 due to the turbulent flow that causes strong mixing.As the cryoablative fluid 70 coats the lining surface, the sprayed fluid 70 absorbs heat from the tissue walls, causing rapid tissue cooling while simultaneously evaporating the cryogenic fluid as a gas flowing through the cooling probe 22. This rapid cooling and evaporation of the cryoablative fluid 70 facilitates rapid and deep tissue ablation. During treatment, the temperature inside the cavity typically drops to, for example, -86°C within 2–3 seconds of the procedure's initiation. While the inner walls of the lining 20 are initially coated with the cryoablative fluid 70, a portion of the cryoablative fluid 70 may no longer change phase as the procedure progresses. Although four pairs of open delivery ports 60 are shown, the number of exposed openings can be adjusted to fewer than four pairs or more than four pairs depending on the position of the delivery line 64 and also the number of openings defined along the infusion line 52, as well as the spacing between the openings. Furthermore, the position of the openings can also be adjusted so that the sprayed fluid 70 can be sprayed in alternative directions instead of laterally, as shown. Additionally and / or alternatively, further openings can be defined along other regions of the infusion line 52. Other variations of the features and methods of the treatment set that may be used in combination with any of the features and methods described herein may be found in the following patent applications: zoonnn / eznz / E / YiAi United States Patent Application 13 / 361,779 filed on January 30, 2012 (United States Publication 2012 / 0197245); United States Patent Application 13 / 900,916 filed on May 23, 2013 (United States Publication 2013 / 0296837); United States Patent Application 14 / 019,898 (United States Publication 2014 / 0012156); United States Patent Application 14 / 019,928 (United States Publication 2014 / 005648); United States Patent Application 14 / 020,265 filed on September 6, 2013 (United States Publication 2014 / 0005649); United States Patent Application 14 / 020,306 filed on September 2013 (United States Publication 2014 / 0025055); United States Patent Application 14 / 020,350 filed on September 6, 2013 (United States Publication 2014 / 0012244); United States Patent Application 14 / 020,397 filed on September 6, 2013 (United States Publication 2014 / 0012243); United States Patent Application 14 / 020,452 filed on September 6, 2013 (United States Publication 2014 / 0005650); United States Patent Application 14 / 086,050 filed on November 21, 2013 (United States Publication 2014 / 0074081); United States Patent Application 14 / 086,088 filed on November 21, 2013 (United States Publication 2014 / 0088579); United States Patent Application 14 / 029,641 filed on September 17, 2013 (United States Publication 2015 / 0080869); and United States Patent Application 14 / 265,799 filed on April 30, 2014 (United States Publication 2015 / 0289920). Each of the above patent applications is incorporated herein by reference in its entirety and for any purpose in this description. Yet another variation of the treatment assembly 80 is shown in the side and partial cross-sectional side views of Figures 4A and 4B, which illustrate a housing 82 having a handle 84 and a reservoir housing 88 extending from and directly attached to the handle 84. Figure 4C further illustrates a perspective view of the treatment assembly 80 and some of its internally contained components. The sheath 12, which has the lining 20, can extend from the housing 82, while an actuator 86 can be located, for example, along the handle 84 to allow the operator to initiate the cryoablative treatment. A reservoir or container 92, which completely contains the cryoablative agent (as described herein), can be inserted and retained within the reservoir housing 88. The reservoir housing 88 and / or the handle 84 can further incorporate a reservoir coupling control 90, which can be actuated, for example, by rotating the control 90 relative to the handle 84, to initially open the fluid communication with the reservoir or container 92 to charge the system for treatment. The reservoir 92 can be inserted into the reservoir housing 88 and securely coupled with a reservoir valve 94, which can be coupled to the coupling control 14 of the reservoir 90. The valve 94 can be set to open the reservoir 92 for treatment or for venting the cryoablative agent discharged during or after treatment. An inlet flow modulation control unit 96 (e.g., an actuatable solenoid mechanism) can be coupled directly to the reservoir valve 94, and the cryoablative fluid line 48 can be coupled directly to the modulation control unit 96 and, via the shroud 12 and the fluid communication within the liner 20, as described herein. During or after treatment, the discharged cryoablative fluid can be evacuated through the exhaust block 46 contained within the housing and then through the exhaust line 98 coupled to the exhaust block 46. The exhaust line 98 can extend through the handle 84 and the reservoir housing 88 and terminate in an exhaust line opening 100 which can be attached to another exhaust gas collection line. With the cryoablative agent discharged in a completely gaseous state, the evacuation exhaust line 140 can be vented to the surrounding environment or optionally connected to a scavenging system to collect the discharged gas and limit exposure. Figures 5A and 5B show views of the sample collection bag assembly that can be optionally used with the treatment assembly. Scavenging systems may incorporate features such as orifices or valves to prevent any vacuum applied by the scavenging unit from interfering with the backpressure within the treatment device. Figure 5A shows an inflated collection bag 150 that can be expanded in width, connected to the evacuation exhaust line 140 via a shut-off valve 152 (e.g., a one-way valve). The collection bag 150, which can be reusable or disposable, can be supported by a pole 156 and may also incorporate a release plug 154 that allows venting of the collected gas during or after a treatment procedure is completed. Similarly, Figure 5B shows an accordion-type manifold 160 also supported by a post 156 and a connector 166 attached to the manifold 160. The evacuation exhaust line 140 can be detachably coupled to the manifold 160 via a shut-off valve 162 (e.g., a one-way valve) and can also incorporate a release plug 164 to vent any collected gas during or after a treatment procedure. The vertical expansion manifold 160 can define a hollow passage through the center of the vertical bellows that allows the connector 166 (e.g., a rigid rod or flexible cable) to pass through and support the base of the manifold 160. The connector 166 also prevents the manifold 160 from tipping to one side when inflated. As gas enters through the bottom of the manifold 160, the bellows can inflate upward. In yet another variation, Figure 6 shows an exhaust gas collection bag 170 that can also be supported by the post 156. The exhaust evacuation line 140 can be removably attached to the collection bag 170 via a pipe connector 172 located near or at the bottom of the collection bag 170. The bag 170 itself can be formed from two layers of lubricating materials that are bonded or welded (e.g., RF dielectric welding) around its periphery along its edges 178. Furthermore, the collection bag 170 can be configured to form an extension 174 that protrudes from the bag 170 and creates an opening 176 for passing a hook through or providing an attachment point. This opening can be reinforced to withstand, for example, 2 pounds for at least 1 hour.The 170 collection bag can be designed to hang, for example, from an IV stand as shown, so that it is kept off the ground to keep it clean in case a user wishes to reuse it several times. The 170 bag can be manufactured from, for example, a polyurethane film selected for its lubricity, elasticity, clarity, low cost, and RF dielectric weldability. Polyurethane films may be commercially available from API Corporation (DT 2001FM). The film may be as thin as, for example, 0.003 inches. Because the 170 bag inflates at relatively low pressures, the lubricity of the layers prevents the film layers from sticking together and allows the bag to inflate easily. In addition, to accommodate potential volume increases associated with higher temperatures, the 170 bag material also exhibits elasticity; for example, the film elongation may be on the order of 800%. The bag may be manufactured to have a burst pressure of at least greater than or equal to, for example, >0.21 kg / cm² (3 psi).The Bag 170 can also be manufactured to be at least partially transparent, so that the clarity of the bag results in an object that visually occupies less space in the procedure room because objects can be seen through it. The Bag 170 and its variations are described in greater detail in U.S. Patent Application 15 / 288,766 filed October 7, 2016 (U.S. Publication 2017 / 0112559), which is incorporated herein in its entirety for all purposes. Once an ablation treatment is completed and the resulting exhaust gases are captured in bag 170, the spent nitrous gas (e.g., nitrous oxide gas) can be vented from bag 16 zoonnn / eznz / E / YiAi 170 to the atmosphere. However, the 170 bag can also be vented through the plumbing system of the suite or room in which it is located by dissolving the nitrous gas in water, which can then be drained directly down the sink. In this way, the nitrous gas can be vented directly from the 170 bag into the sink drain without the need for atmospheric venting or personnel exposure. Consequently, the drained mixture of water and nitrous gas can be disposed of through the plumbing system while remaining at environmentally acceptable levels. The 170 bag and any of its various modalities and treatment devices can be used in any combination with the exhaust gas evacuation systems described herein. Figure 7 illustrates an example of how the spent exhaust gas contained within bag 170 can be dissolved directly in water for drainage, for example, into a sink in the room where bag 170 is located. The exhaust line 140, as shown in Figure 6, can be detached from the treatment assembly 80 and connected to an evacuation assembly 180 while line 140 remains fluidly coupled to bag 170. Alternatively, a separate line can be coupled between bag 170 and evacuation assembly 180. The evacuation assembly 180 may generally comprise an assembly housing 182 through which the fluid lines are enclosed. The assembly housing 182 may be placed inside a sink 190 and may include an inlet pipe 184 coupled to the housing 182 for fluid connection to a water tap 192. The assembly housing 182 may further include a base 186 integrated with the assembly housing 182 for fluid connection to or communication with a drain 194 within the sink 196. With the bag 170 filled with the exhaust nitrous gas, the tap may be opened to initiate the flow of water from the tap 192 so that the water enters the inlet pipe 184, passes through the assembly housing 182 where the water flow may be restricted to reduce pressure, and continues to the drain 194.The restricted fluid flow creates low pressure within a suction junction 188 extending from the housing 182 to create a Venturi effect. This low pressure created within the suction junction 188 can then draw exhaust gas from the bag 170, through the exhaust line 140, and into contact with the water flowing through the housing 182, where the exhaust gas can dissolve in the flowing water to drain directly into the drain 194. zoonnn / eznz / E / YiAi Although the evacuation assembly 180 was described as attached or attachable to the escape bag The evacuation assembly 170 (or any of the variations of the assembly described herein) can alternatively be seamlessly coupled directly to the treatment assembly 80 to extract exhaust gases directly from the device during a treatment procedure. Furthermore, the evacuation assembly 180 can also be used in any number of other procedures where nitrous exhaust gases are generated, such as cardiac ablation procedures or any other cryogenic procedure, and gases other than nitrous can also be used with the evacuation assembly 180 as desired. Figure 8A schematically illustrates the flow path through the housing of assembly 182, which is shown in Figure 8B for reference. The flow assembly 200 is illustrated with inlet 184' corresponding to inlet pipe 184. A contraction section 202 reduces the cross-sectional area of ​​inlet 184', which then continues through a throat section 204. This throat section increases the cross-sectional area through a diffuser section 206 and continues to outlet 182' for drainage 194. The suction chamber 188' can be seamlessly coupled to the exhaust line 140 to directly draw exhaust gas from the bag 170 into the suction chamber 188', where the gas can be dissolved directly into the water passing through the flow assembly 200. To create the Venturi effect with the flow assembly 200, the cross-sectional areas of the inlet 184' and outlet 182', as well as the cross-sectional areas of the contraction section 202, throat section 204, and diffuser section 206, can be varied depending on the desired suction speed for draining the exhaust gases. In one variation, with an inlet water temperature of 23 °C (74 °F) and a flow rate of 0.57 m3 / h (2.1 GPM (gallons per minute)) from tap 192, the flow assembly 200 can generate sufficient suction force to create an exhaust flow rate of 0.48 m3 / h (17 SCFH (standard cubic feet per hour)) under standardized temperature and pressure conditions through the exhaust line 140. For a given volume of bag 170, the flow assembly 200 can completely empty bag 170 of the exhaust gas in 13 min. A flow rate of 0.34 m3 / h (1.5 GPM) of tap water 192 through flow assembly 200 can generate an exhaust flow rate of 0.28 m3 / h (10 SCFH) through exhaust line 140 and a flow rate of 0.22 m3 / h (1 GPM) of water through flow assembly 200 can generate an exhaust flow of around 0.11 m3 / h (4 SCFH) through exhaust line 140.If the inlet water temperature were increased, for example, to 48 °C (118 °F), the corresponding exhaust flow rate could be 0.45 m3 / h (16 SCFH). zoonnn / eznz / E / YiAi In alternative variations of flow assembly 200, with an inlet water flow rate of 0.57 m³ / h (2.1 GPM), the exhaust flow rate can be increased, for example, to 0.70 m³ / h (25 SCFH). Other variations of the flow assembly 200 design can be altered to increase or decrease the corresponding exhaust flow rate. While the water temperature may not significantly affect the suction force generated to extract exhaust gases, the water temperature, as well as the temperature of the exhaust gases (e.g., nitrous oxide), can affect gas solubility. As the water and / or gas temperature decreases, gas solubility increases. Therefore, the water and / or gas temperature may need to be altered or varied depending on the desired solubility and the rate of gas dissolution in the water stream. For example, if the exhaust gas dissolves in the water stream too slowly as the suction force draws the exhaust into the housing, undissolved gas may accumulate and potentially escape below base 186 or drain 194 instead of dissolving in the water and passing through drain 194. Consequently, the suction pressure generated by the Venturi effect can be adjusted to combine the flow of water and exhaust gases (e.g., nitrous oxide) at the appropriate solubility ratio to minimize the amount of water and the time required to dissolve the exhaust gases in the water and empty the exhaust gas collection bag 170. If the Venturi effect (suction force) is too high, too much nitrous oxide gas may enter the housing 182 and remain in gaseous form, which could build up pressure under the sealing base 186 and cause the exhaust gases to escape from the perimeter of the base 186. Conversely, if the Venturi effect (suction force) is too weak, it may take a relatively longer time to vent the exhaust gas collection bag 170. Figures 9A and 9B show perspective views of the drainage assembly 180 separate from the sink and also attached within the sink 190. The assembly 180 can be coupled to the inlet pipe 184, which can be a flexible length of pipe having a union or coupling 210 for attaching to the faucet 192 in a fluid-tight seal. The length of the inlet pipe 184 can be flexible to accommodate the relative positioning of the assembly 180 with respect to the positioning of the faucet 192. The base 186 can incorporate a suction mechanism or sealing ring 212, which can also include an opening for fluid outlet. The base 186 can also be wide enough to be placed directly over the drain 194 at the bottom of the sink 196 so that a fluid seal can be formed around the drain 194 19 zoonnn / rznz / E / YiAi to prevent leakage or escape of water and dissolved nitrous gas. Figures 10A and 10B illustrate perspective views of another variation of a drainage assembly 220 separate from the sink and also integrated within the sink 190. In this variation, the drainage assembly 220 may include an assembly housing 222 attached to a flexible inlet pipe 224 having a union or coupling 210 for connecting to the faucet 192 in a fluid-tight seal. The suction chamber 236 may extend from the housing 222 to connect to the drainage line 140. The assembly housing 222 may further include a fluid outlet 234 for direct connection to the drain 194. A union base 226 having one or more clamping arms 228 may extend radially from the housing 222 and project distally with corresponding suction unions 230.When the assembly 220 is placed inside the sink 190, the fluid outlet 234 can be placed directly into the drain 194 and the joining base 226 can be slid down into the housing 222, as indicated by the arrows, allowing the suction joints 230 to attach to the floor of the sink 196 to maintain a position of the housing of the assembly 222 during evacuation. Figures 11A and 11B illustrate perspective views of yet another variation of a drain assembly 240 separate from the sink and also attached within the sink 190. In this variation, the drain assembly 240 may include an assembly housing 242 attached to a flexible inlet pipe 244 having a union or coupling 250 for attaching to the faucet 192 in a fluid-tight seal. The suction chamber 248 can extend from the housing 242 to join the evacuation line 140. The housing of the assembly 242 can further include a fluid outlet 246 that can be attached to a base for direct placement over the drain 194. The base 252 can be attached to a fluidly coupled pump 254 through the opening 256, which can allow the base 252 to be suctioned into the sink 196 around the drain 194 to create a fluid-tight connection.When the assembly 240 is placed inside the sink 190, the base 252 can be placed directly over the drain 194 and the pump 254 can be operated to secure the base 252 to the floor of the sink 196 to maintain a position of the housing of the assembly 242 during evacuation. Figure 12A shows a perspective view of the evacuation assembly 240, but where the base 262 is configured to create a suction force by using the low pressure generated by the flow assembly within the housing 242 instead of a separate pump. When water is introduced through assembly 240, a diverter switch 260 on the suction chamber 248 can be actuated to close the evacuation line 140 and instead connect to a second line 20 in fluid communication with a suction chamber in the base 262. Once the base 262 is sufficiently adhered within the sink, the diverter switch 260 can be actuated again to generate suction within the suction chamber 248. Alternatively, the chamber 248 can be closed to allow a second flow assembly within the base 262 to generate a suction force to adhere the base 262.A switch or actuator 264, as illustrated in the detailed perspective view of Figure 12B, can be used for this purpose. In other variations, instead of incorporating a diverter switch or actuator, the flow can be automatically diverted to the base until a suction force threshold is reached to secure the base to the sink. Once the threshold level is reached, a valve with a predetermined shut-off pressure or a separate pressure-monitoring controller can be used to automate the flow. Figures 13A and 13B illustrate perspective views of yet another variation of a separate drain assembly 270, also integrated within the sink 190. In this variation, the drain assembly 270 may include an assembly housing 272 having a union or coupling 274 for directly attaching the housing 272 to the faucet 192 in a fluid-tight seal. The suction chamber 280 may extend from the housing 272 to connect to the drain line 140. The assembly housing 272 may further include a fluid outlet 276 that can be attached to a base 278 having a suction cup around a sealing ring for direct placement over the drain 194. Figures 14A and 14B illustrate perspective views of yet another variation of a separate drain assembly 290, also integrated within the sink 190. In this variant, the drain assembly 290 may include a housing 292 connected to a flexible inlet pipe 294, which has a union or coupling 296 for connection to the faucet 192 in a fluid-tight seal. The suction chamber may be contained within the housing 292 for connection to the drain line 140. The housing 292 may contain a reservoir 298, for example, 2.5 L, to hold a volume of water that acts as a weight, preventing the housing 292 from moving when placed over the drain 194. A diverter switch 300 may be actuated to initially divert the water flow to the reservoir 298 within the housing 292.Once sufficiently full, the diverter switch 300 can be actuated to allow water flow through the fluid assembly within the housing 292. The housing of the assembly 292 may further include a fluid outlet that can be positioned directly over the drain 194. zoonnn / eznz / E / YiAi Figures 15A and 15B illustrate perspective views of yet another variation of a 310 evacuation assembly, separate from the sink and also integrated within the sink 190. In this variation, the evacuation assembly 310 may include an assembly housing 312 having a union or coupling 314 for attaching the housing 312 directly to the faucet 192 in a fluid-tight seal. With the fluid assembly contained within the housing 312, a flexible outlet pipe 316 may be attached to the housing 312 and extend to a base 318 for positioning over the drain 194. The evacuation line 140 may be attached directly to a suction chamber contained within the housing 312. Figure 16 shows a perspective view of a similar embodiment in which the evacuation assembly 320 may have a housing oriented to extend vertically with a joint or coupling 324 that can be coupled to the tap 192 to directly connect the housing 322 to the tap 192. The evacuation line 140 can be directly connected to a suction chamber contained within the housing 322, and the housing 322 can further incorporate a diverter switch 326 that can be actuated to couple or uncouple the water flow from the tap 192. Figures 17A and 17B illustrate perspective views of yet another variation of a drain assembly 330 separate from the sink and also attached within the sink 190. In this variation, the drain assembly 330 may include an assembly housing 332 attached to a flexible inlet pipe 334 having a union or coupling 336 for attaching to the faucet 192 in a fluid-tight seal. The suction chamber 340 can extend from the housing 332 to join the exhaust line 140. The housing 332 can also be joined directly to a base 338 or can incorporate a pipe to connect between the housing 332 and the base 338, which can be placed directly over the drain 194. In this variation, the housing 332 can also be oriented to extend horizontally relative to the sink 196 to facilitate the diffusion of exhaust gases from the exhaust line 140 to dissolve in the water flowing through the housing 332.Alternatively, the housing 332 can be angled relative to the sink 196. Figures 18A and 18B illustrate perspective views of yet another variation of a drainage assembly 350 separate from the sink and also attached within the sink 190. In this variation, the drainage assembly 350 may include an assembly housing 352 attached to a flexible inlet pipe 360 ​​via a union or coupling 354. The suction chamber 358 may extend from the housing 352 to connect to the drainage line 140. The housing 352 may also be attached directly to a base 356 that can be positioned directly over the drain 194. In this variation, the housing 352 may also be oriented to extend vertically relative to the sink 196. Although illustrative examples are described above, it will be evident to a person skilled in the art that various changes and modifications can be made to the invention. Furthermore, several of the apparatuses or procedures described above are also intended to be used in combination with each other, to the extent possible. The appended claims are intended to cover such changes and modifications that fall within the true spirit and scope of the invention.

Claims

1. A cryogenic exhaust gas disposal apparatus comprising: a housing having an inlet for fluid coupling to a water source and an outlet for fluid coupling to a drain; a fluid-communicating suction chamber with the housing, wherein the suction chamber is further configured to be detachably coupled to an exhaust gas collection tank having a volume of exhaust gas, wherein the introduction of water through the inlet generates a pressure reduction within the suction chamber so that the volume of exhaust gas is drawn from the exhaust gas collection tank and enters the housing to dissolve in the water and exit through the drain.

2. The apparatus according to claim 1, wherein a first cross-sectional area defined by the inlet is larger than a second cross-sectional area defined by the outlet.

3. The apparatus according to claim 1, wherein the inlet comprises an inlet pipe having a union or coupling for seamless connection to a tap.

4. The apparatus according to claim 1, wherein the outlet comprises an outlet pipe.

5. The apparatus according to claim 1 further comprising a base through which the outlet passes and which fits smoothly into the drain within a sink.

6. The apparatus according to claim 5, wherein the base can be slidably moved along the housing.

7. The apparatus according to claim 5, wherein the base comprises one or more suction members for attachment around the drain.

8. The apparatus according to claim 5, wherein the base comprises a reservoir for receiving a volume of water. zoonnn / rznz / E / YiAi 9. The apparatus according to claim 5, wherein the base is in fluid communication with the suction chamber, so that the base can be actuated to adhere to the drain by means of a suction force.

10. A method for evacuating cryogenic exhaust gases, comprising: receiving a flow of water through an inlet of a housing; passing the water flow through the housing so as to reduce the pressure within a suction chamber; drawing a volume of cryogenic exhaust gas into the suction chamber through the reduced pressure so that the cryogenic exhaust gas dissolves in the water flow; and passing the water flow and the dissolved cryogenic exhaust gas to a drain.

11. The method according to claim 10, wherein receiving the water flow comprises receiving water from a tap fluidly coupled to the inlet.

12. The method according to claim 10, wherein passing the water flow through the casing comprises restricting the flow in such a way as to reduce the pressure.

13. The method according to claim 10, wherein extracting the volume of the cryogenic exhaust gases comprises extracting the volume from an exhaust gas collection bag fluidly coupled to the suction chamber.

14. The method according to claim 10, wherein extracting the cryogenic exhaust gas volume comprises extracting the volume from a cryogenic ablation device fluidly coupled to the suction chamber.

15. The method according to claim 10, wherein the passage of the water flow and the dissolved cryogenic exhaust gas comprises sealing a base of the housing around the drain.

16. The method according to claim 15, wherein sealing the base comprises extracting a vacuum within the base so that the base is joined to a surface near the drain.

17. A cryogenic exhaust gas disposal system comprising: a housing having an inlet for fluid coupling to a water source and an outlet for fluid coupling to a drain; a fluid-communicating suction chamber with the housing, wherein the suction chamber is further configured to be detachably coupled to an exhaust gas collection tank having an exhaust gas volume, wherein the introduction of water through the inlet generates a pressure reduction within the suction chamber so that the exhaust gas volume is drawn from the exhaust gas collection tank and enters the housing to dissolve in the water and exit through the drain; and an exhaust gas collection apparatus containing the exhaust gas volume for fluid coupling to the suction chamber via an exhaust line.

18. The system of claim 17, wherein the exhaust gas collection apparatus comprises: a first layer and a second layer joined along a periphery and forming an enclosed volume, wherein the periphery defines rounded corners and an extension member; a pipe connector positioned along the first layer and extending through the first layer in fluid communication with the enclosed volume, wherein the pipe connector is near a lower edge of the first layer and configured to couple to the exhaust line; and a drain closure positioned along the first layer and extending through the first layer in fluid communication with the enclosed volume, wherein the drain closure is located near the lower edge.

19. The system of claim 17 further comprising a tissue handling system configured to be seamlessly coupled to the exhaust gas collection apparatus, the tissue handling system comprising: an elongated probe having a distal tip and flexible length; at least one infusion lumen positioned through or along the elongated probe, wherein the infusion lumen defines one or more openings along its length;at least one delivery lumen slidably positioned through or along the infusion lumen, wherein translation of the delivery lumen relative to the infusion lumen controls a number of unobstructed openings along the infusion lumen such that proximal retraction of the delivery lumen relative to the infusion lumen from a first location increases the number of unobstructed openings, and distal translation of the delivery lumen relative to the infusion lumen from the first location decreases the number of unobstructed openings; and a sheath expandingly enclosing the probe such that a cryoablative fluid introduced through the unobstructed openings is sprayed into contact with an inner surface of the sheath and coats the inner surface.

20. The system of claim 17, wherein the inlet of the exhaust gas elimination system is configured to smoothly couple to a tap.

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