Cryotherapy System

Abstract

A cryotherapy system includes: an elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity; a cryogenic inflow path fluidly connecting a cryogenic fluid source to a nozzle at the distal end of the cryotherapy device, wherein the cryogenic inflow path is configured to allow cryogenic flow from the cryogenic fluid source through the nozzle to a target region within the body cavity; a port opening configured to allow the cryogenic fluid to be released outside the body; a cryogenic controller in the cryogenic inflow path under a control circuit, wherein the cryogenic controller is configured to control the flow of the cryogenic fluid toward the nozzle and / or toward the port opening; and the control circuitry, wherein the control circuitry determines the cryogenic fluid flow distribution between the port opening and the nozzle.

Description

[0001] Related applications

[0002] This application is a divisional application of application number 201880019421.5 (PCT application number PCT / IL2018 / 050124), filed on February 4, 2018, entitled "Flow Control of Cryotherapy Device".

[0003] Field of Invention and Background Art

[0004] In some embodiments of the invention, the invention relates to ablation, including cryoablation, cryosurgery, or cryotherapy devices, and more specifically, but not exclusively, to cryotherapy for body cavity diseases.

[0005] Cryoablation, cryosurgery, or cryotherapy is a technique that uses cryoablation to destroy or ablate a target area that may have undesirable symptoms, lesions, or free nerve endings. Methods of tissue destruction through cryoablation include direct cellular damage caused by ice crystal formation, and delayed damage that may be caused by apoptosis (regulated cell death) and / or vascular effects. Cryotherapy utilizes pressurized coolants (e.g., CO2, LN2, and / or nitrous oxide) to directly inject cryofluids onto the treated tissue and / or to induce an indirect Joule-Thompson effect (using coolants such as argon, nitrogen, and / or krypton).

[0006] The use of cryoablation for tumors is expanding, primarily due to its ease of technique and low morbidity. A potential secondary advantage of in-situ freezing of malignant diseases is the cryo-immune response, an anti-tumor immune response triggered by the natural absorption of malignant tissue. Clinical reports suggest that cryoablation may induce a systemic anti-tumor immune response, which has also been confirmed in animal models.

[0007] Body cavities can include the bladder, uterus, etc. Bladder cancer is one of the most common cancers. When diagnosed early, most patients diagnosed with bladder cancer also have superficial lesions and are of a lower nature; however, others are diagnosed at later stages, where the cancer is more invasive and aggressive, and therefore can be treated surgically (including cystectomy). Bladder cancer has a high recurrence rate; therefore, treatment and follow-up are crucial to preventing recurrence and progression. Cryotherapy is recommended to improve the treatment of bladder lesions, reduce recurrence, and potentially increase bladder preservation rates.

[0008] Another example of bladder disease is interstitial cystitis (IC), also known as painful bladder syndrome, a chronic condition characterized by pain in the bladder and / or pelvis, ranging from mild discomfort to severe pain. While there is currently no reliable cure for interstitial cystitis, medications and other treatments are available to relieve the pain. For example, intrabladder injections of botulinum toxin are thought to block the sensory nerves that transmit pain in the bladder. Cryotherapy, which ablates / damages free nerve endings, is suggested to improve the treatment of interstitial cystitis and similar conditions in order to increase patient comfort over a longer period.

[0009] Regarding uterine diseases and lesions, hysteroscopic procedures can be used to avoid major surgeries such as hysterectomy or myomectomy. Uterine lesions may include submucous fibroids or large polyps, or menorrhagia with normal endometrium. Other uterine-related conditions include thin endometrium and / or Asherman's syndrome (AS), both of which can impair fertility. Cryotherapy is recommended to improve the treatment of uterine diseases and lesions, simplifying treatment and potentially increasing uterine preservation rates. Cryotherapy often helps endometrial regeneration, thus leading to an increased probability of successful conception.

[0010] No known cryotherapy device has been inserted into a body cavity via the working channel of an endoscope. On the other hand, catheter devices inserted endoscopically for the treatment of the gastrointestinal tract (GI) are known in the art. The main difference between current devices for treating the gastrointestinal tract and those required for body cavity treatment lies in the size of the body cavity to be inserted (the diameter of the esophagus or colon is significantly larger), the need for sensing and closed-loop pressure control to keep the lumen open and avoid excessive pressure, the need to handle water, and even residual fluid that may affect ablation efficacy, and can lead to significant visualization difficulties. For example, some cryotherapy devices include the use of a cryofluid jet, where a cryofluid or coolant exits through a nozzle and is applied directly to the tissue in a jet form. In some cryotherapy devices utilizing jets, an additional aspiration channel is required to evacuate the expanding fluid from the jet, thereby preventing undesirable cavity expansion or tissue perforation. Due to the lack of sensing devices and appropriate control mechanisms, known aspiration channels do not have the ability to control the lumen volume or pressure. In addition, the distance between the nozzle and the target area is not clearly defined, so the treatment outcome is unpredictable, and doctors may find it difficult to follow cryosurgery protocols.

[0011] Regardless of whether an endoscope is used, there is no known use of cryotherapy devices in combination with intracavitary immunomodulatory therapy.

[0012] Therefore, there is a need for an improved endoscopic cryotherapy device that allows for the ablation of tissue within a body cavity, wherein the device has the ability to control pressure and / or volume, and also the ability to operate in moist or even liquid-containing conditions. There is also a need for an improved cryotherapy device that has the ability to drain expanding coolant fluid through a limited-size body cavity inlet. There is also a need to specifically define the distance between the cryojet and the treated tissue. Furthermore, there is a need to improve cryoimmunotherapy and adapt it for intracavitary cryoablation. Summary of the Invention

[0013] The following are some examples of embodiments of the present invention:

[0014] Example 1: A cryotherapy system, characterized in that: the cryotherapy system comprises:

[0015] An elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity, comprising:

[0016] A cryogenic inflow path fluidly connects a cryogenic fluid source to a distal end of the cryotherapy device, wherein the cryogenic inflow path is configured to allow cryogenic fluid to enter the body cavity from the cryogenic fluid source;

[0017] An optical component configured to visualize a field of view between the distal end and a target region within the body cavity;

[0018] A wash inflow path fluidly connects a wash fluid source to at least one wash opening configured to direct the wash fluid toward the optical component at the distal end and / or toward the field of view; wherein the wash inflow path is configured to guide the wash fluid from the wash fluid source, through the wash inflow path and through the opening, to the optical component to allow washing of the optical component.

[0019] Example 2: The system described in Example 1 includes:

[0020] At least one cryogenic flow regulator is located on the cryogenic inflow path, the cryogenic flow regulator being configured to control the flow of the cryogenic fluid into the body cavity through the cryogenic inflow path;

[0021] A control unit, connected to the cryotherapy device, and comprising:

[0022] A control circuit is connected to the at least one cryogenic flow regulator and configured to control the flow of the cryogenic fluid into the body cavity by sending a signal to the cryogenic flow regulator.

[0023] Example 3: The system described in Example 2 includes:

[0024] At least one wash flow regulator is located on the wash inflow path and connected to the control circuit, wherein the wash flow regulator controls the flow of the wash through the wash inflow path in response to a signal from the control circuit.

[0025] Example 4: The system described in Example 3, wherein when the flow of the cryogenic fluid stops, the control circuit sends a signal to the washing flow regulator to adjust the washing flow entering the body cavity.

[0026] Example 5: The system described in Example 2 includes at least one purge flow regulator on the cryogenic inflow path and connected to the control circuit. When the cryogenic fluid flow from the cryogenic fluid source stops, the control circuit is configured to control the flow of low-pressure fluid through the cryogenic inflow path.

[0027] Example 6: A system according to any one of Examples 2 to 5, wherein the device includes at least one outflow path configured to discharge fluid from a distal opening toward a proximal opening of the cryotherapy device; and

[0028] At least one outflow regulator is located on the outflow path and configured to control the discharge of fluid from the body cavity through the at least one outflow path.

[0029] Example 7: The system described in Example 6, wherein the outflow regulator includes a check valve configured to open when the pressure within the body cavity is higher than a predetermined value.

[0030] Example 8: The system described in either Example 6 or 7, wherein the outflow regulator includes a valve connected to the control circuit, wherein the control circuit opens the valve when the pressure within the body cavity is higher than a predetermined value.

[0031] Example 9: The system described in any one of Examples 2 to 8, wherein the cryotherapy system includes at least one pressure sensor connected to the control circuit and configured to measure body cavity pressure or multiple changes in the body cavity pressure, wherein the control circuit controls the flow in the cryogenic inflow path and / or the washing inflow path based on the measurement value of the at least one sensor.

[0032] Example 10: The system described in any one of Examples 2 to 9, wherein the cryotherapy system includes at least one temperature sensor connected to the control circuit and configured to measure multiple temperature levels and / or multiple temperature changes within the body cavity, wherein the control circuit controls the flow of the cryogenic fluid into the body cavity through the cryogenic inflow path based on the measured multiple temperature values.

[0033] Example 11: The system described in any of the preceding examples, wherein the distal end of the cryotherapy device is shaped and sized to be introduced into an integral cavity, the cavity including a bladder.

[0034] Example 12: The system described in any of the preceding embodiments, wherein the cryotherapy device includes a washing fluid guide at the washing opening and configured to guide the washing fluid to the optical components and / or to the field of view.

[0035] Example 13: The system described in Example 12, wherein the washing fluid guide includes a nozzle and / or a deflecting surface.

[0036] Example 14: The system described in any of the preceding examples, wherein the optical component includes at least one lens and / or at least one illumination source.

[0037] Example 15: The system described in any of the preceding examples, wherein the washing fluid comprises a warm fluid with a temperature above 15 degrees Celsius.

[0038] Example 16: A cryotherapy system, comprising:

[0039] An elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity, comprising:

[0040] A cryogenic inflow path fluidly connects a cryogenic fluid source to a cryogenic fluid opening at the distal end of the cryotherapy device and is configured to allow cryogenic fluid to enter the body cavity;

[0041] At least one cryogenic flow regulator is located on the cryogenic inflow path and is configured to control the flow of cryogenic fluid through the cryogenic inflow path into the body cavity;

[0042] At least one purge flow regulator is provided on a purge fluid path that partially overlaps with the cryogenic inflow path, and when the cryogenic fluid flow stops, the purge flow regulator is configured to allow a low-pressure purge fluid to flow into the body cavity through the cryogenic inflow path, thereby reducing the backflow of the cryogenic fluid from the body cavity into the cryogenic inflow path.

[0043] Example 17: The system described in Example 16, wherein the cryotherapy device includes an outflow path extending from the body cavity and outside the body, and

[0044] At least one outflow regulator is located on the outflow path and configured to control the flow of fluid out of the body cavity.

[0045] Example 18: The system described in Example 17, wherein the outflow regulator includes a check valve configured to open when the pressure within the body cavity is higher than a predetermined value.

[0046] Example 19: The system described in Example 17, wherein the cryotherapy system comprises:

[0047] A control unit, connected to the cryotherapy device, and comprising:

[0048] A control circuit is connected to the at least one cryogenic flow regulator and the at least one purge flow regulator, wherein when the cryogenic flow regulator is closed, the control circuit opens the purge flow regulator to allow low-pressure fluid to enter the body cavity through the cryogenic inflow path.

[0049] Example 20: The system described in any of Examples 16 to 19, wherein the cryotherapy system includes at least one sensor connected to the control circuit, the control circuit being configured to measure multiple pressure levels within the body cavity.

[0050] Example 21: The system described in Example 19, wherein the outflow regulator is connected to the control circuit, and when a pressure within the body cavity exceeds a predetermined pressure value, the control circuit is configured to notify the outflow regulator to open the outflow path by sending a signal.

[0051] Example 22: The system described in Example 20, wherein the control circuit determines whether the plurality of pressure levels within the body cavity are higher than a predetermined pressure value, and in response to the determination, sends a signal to the cryogenic flow regulator to regulate the flow of cryogenic fluid through the cryogenic inflow path.

[0052] Example 23: The system described in either Example 21 or 22, wherein the predetermined pressure value is in the range of 25 to 100 millibars.

[0053] Example 24: The system described in any of Examples 19 to 23, wherein the cryotherapy system includes at least one temperature sensor connected to the control circuit and configured to measure multiple temperature levels within the body cavity or the outflow path.

[0054] Example 25: The system described in Example 24, wherein the control circuit determines whether the measured temperature within the body cavity is lower than a predetermined temperature value, and in response to the temperature determination, sends a signal to the cryogenic flow regulator to regulate the flow of cryogenic fluid through the cryogenic inflow path.

[0055] Example 26: The system described in Example 25, wherein the control circuit, in response to the temperature, sends a signal to the outflow regulator to regulate the outflow.

[0056] Example 27: The system described in any of Examples 24 to 26, wherein the low-pressure fluid comprises a warm low-pressure fluid with a temperature above 15 degrees Celsius, wherein the control circuit, in response to the temperature, opens the purge flow regulator to allow the warm low-pressure fluid to flow through the cryogenic inflow path into the body cavity.

[0057] Example 28: The system described in any of Examples 25 to 27, wherein the predetermined temperature value is 10°C.

[0058] Example 29: The system described in any of Examples 16 to 28, wherein the cryotherapy device includes at least one volume subdivision configured to define a treatment space within the body cavity, the treatment space being between a distal end of the cryotherapy device and a target region within the body cavity.

[0059] Example 30: The system described in Example 29, wherein the control circuit is configured to control multiple temperature levels and / or multiple humidity levels within the treatment space.

[0060] Example 31: The system described in either Example 29 or 30, wherein the volumetric separator has fluid flow around the cryogenic fluid opening.

[0061] Example 32: The system described in any of Examples 16 to 31, wherein the body cavity includes a bladder, and the distal end of the cryotherapy device is shaped and sized to be inserted into the bladder.

[0062] Example 33: The system described in any of Examples 16 to 32, wherein the low-pressure purge fluid is warm enough to reduce the accumulation of frozen particles in the cryogenic inflow path.

[0063] Example 34: A method for controlling fluid within an integrated cavity, comprising the following steps:

[0064] The cryogenic fluid is injected into the body cavity through a cryogenic inflow path and a cryogenic nozzle of a cryotherapy device that is at least partially positioned within the body cavity;

[0065] By introducing a washing solution into a treatment space through a washing inflow path of the cryotherapy device, the treatment space between the cryo-nozzle and a target area within the body cavity is cleared; and

[0066] The injection and / or clearance are varied according to multiple pressure levels within the body cavity.

[0067] Example 35: The method of Example 34, wherein the method includes inflating the body cavity with a low-pressure fluid prior to the injection step.

[0068] Example 36: The method of any one of Examples 34 or 35, wherein the method includes discharging at least some of the cryofluid from the body cavity through an outflow path of the cryotherapy device according to multiple pressure levels within the body cavity.

[0069] Example 37: The method described in any of Examples 34 to 36, wherein the alteration step includes: adjusting the introduction of the cryogenic substance if the plurality of pressure values ​​are higher than a predetermined value.

[0070] Example 38: The method described in Example 37, after the adjustment step, includes discharging at least some of the cryogenic substance from the cryogenic inflow path.

[0071] Example 39: The method of any of Examples 37 or 38 includes purging low-pressure fluid through the cryogenic inflow path and the cryogenic nozzle to prevent clogging of the cryogenic nozzle after the conditioning step.

[0072] Example 40: The method of any one of Examples 34 to 39 includes visualizing the treatment space through an optical component of the cryotherapy device.

[0073] Example 41: The method of Example 40, wherein the cleaning step includes: washing the optical component with the washing fluid.

[0074] Example 42: The method of any one of Examples 40 or 41, wherein the optical components include one or more of a light source, a lens, an optical sensor, and / or a fiber bundle.

[0075] Example 43: The method of any of Examples 36 to 42, wherein if the plurality of pressure values ​​are higher than a predetermined pressure value, the discharge step includes opening a flow regulator in the outflow path.

[0076] Example 44: The method of any one of Examples 36 to 43, wherein the discharge step includes activating a pump to generate negative pressure within the outflow path.

[0077] Example 45: The method described in any of Examples 34 to 44 includes determining a distance and / or an angle between a distal end of the cryotherapy device and the target region.

[0078] Example 46: The method of Example 45, wherein the method includes modifying at least one cryotherapy parameter according to the decision step, the cryotherapy parameter including the injection duration and / or pressure of the cryofluid.

[0079] Example 47: The method of any one of Examples 45 or 46, wherein the step of determining a distance and / or an angle includes spraying a fluid from the cryotherapy device toward the target area and determining the distance and / or the angle by visualizing the size and / or shape of an indentation formed by the fluid in the target area.

[0080] Example 48. A cryotherapy system, comprising:

[0081] An elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity, comprising:

[0082] A cryogenic inflow path fluidly connects a cryogenic fluid source to the distal end of the cryotherapy device, wherein the shape and size of the cryogenic inflow path are adapted to allow the cryogenic fluid to be sprayed into a selected target area within the body cavity through a cryogenic opening at the distal end;

[0083] At least one outflow path is configured to allow fluid to flow from a distal opening at the distal end toward a proximal opening located outside the body cavity;

[0084] At least one sensor is located in the outflow path and is configured to measure at least one microenvironment parameter;

[0085] At least one volumetric separator is configured to define a treatment space between the distal end and the selected target region by reducing fluid mixing between a treatment space and other parts of the body cavity;

[0086] A control unit, connected to the cryotherapy device, includes:

[0087] A control circuit is connected to the at least one sensor, wherein the control circuit determines multiple levels of the at least one microenvironment parameter within the defined treatment space based on signals received from the at least one sensor.

[0088] Example 49: The system described in Example 48, wherein the microenvironment parameters include pressure, temperature and / or humidity levels.

[0089] Example 50: The system described in either Example 48 or 49, wherein the volume sub-divider includes fluid surrounding the cryogenic opening.

[0090] Example 51: A cryotherapy system, comprising:

[0091] An elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity, comprising:

[0092] A cryogenic inflow path connects a cryogenic fluid source to the distal end of the cryotherapy device.

[0093] An optical component configured to visualize a field of view between the distal end and a target region within the body cavity;

[0094] A control unit, connected to the cryotherapy device, includes:

[0095] A control circuit is connected to the optical component, wherein the control circuit is configured to determine a geometric relationship between the distal end and the target region based on a plurality of signals received from the optical component.

[0096] Example 52: The system described in Example 51, wherein the optical component includes at least one illumination source configured to project a light spot onto the target area, wherein the control circuit determines the geometric relationship between the distal end and the target area based on the size and / or shape of the light spot.

[0097] Example 53: The system described in any of Examples 51 or 52, wherein the cryotherapy device includes at least one foldable element in an inner cavity of the cryotherapy device, the cryotherapy device being configured to unfold into the body cavity and at least partially contact the target area at a contact point;

[0098] The control circuit determines the geometric relationship between the distal end and the target region based on the visualization of the contact point.

[0099] Example 54: The system described in any of Examples 51 to 53, wherein the cryogenic inflow path is connected to a low-pressure fluid source configured to release a low-pressure fluid flow through the cryogenic inflow path to the target area, the low-pressure fluid flow having sufficient force to cause a temporary indentation on a surface of the target area, and

[0100] The control circuit determines the geometric relationship between the distal end and the target region based on visualization of the size, shape, and depth of the indentation.

[0101] Example 55: The system described in any of Examples 51 to 54, wherein the geometric relationship includes the distance and / or angle between the distal end and the target region.

[0102] Example 56: A control unit for a cryotherapy device, comprising:

[0103] A control circuit is connected to at least one inflow regulator on an inflow path of a cryotherapy apparatus configured to allow fluid to flow into a body cavity, and the control circuit is connected to at least one outflow regulator on an outflow path of the cryotherapy apparatus configured to allow fluid to drain from the body cavity.

[0104] The control circuit controls the inflow regulator and the outflow regulator to adjust multiple pressure levels within the body cavity to a pressure level below a predetermined pressure value.

[0105] Example 57: The control unit described in Example 56, wherein the control circuit controls the inflow regulator and the outflow regulator to adjust multiple temperature levels within the body cavity to a temperature level higher than a predetermined temperature value.

[0106] Example 58: The control unit described in any one of Examples 56 or 57, characterized in that: the control circuit controls the inflow regulator and the outflow regulator according to a plurality of signals received from an interface connected to the control circuit, so as to regulate an environmental parameter within the body cavity.

[0107] Embodiments of the present invention relate to a cryotherapy device, comprising:

[0108] At least one inflow channel;

[0109] At least one outflow channel;

[0110] Control device for controlling the discharge of expanding cryogenic fluid from the integrated cavity; and

[0111] A visualization device used to visualize a field of view;

[0112] The surgical control device receives data from at least one sensor that collects data about at least one parameter of the surgical cavity, wherein the surgical cryotherapy device is introduced into the cavity via an endoscope or a sheath.

[0113] According to some embodiments, the device further includes a rolling component, wherein the inflow channel points toward the rolling component.

[0114] According to some embodiments, the device further includes an extension that separates a distal end of the device from a treatment area, or at least partially separates a treatment volume from a surrounding volume of the body cavity, or performs both functions simultaneously. According to some embodiments, the distal end of the visualization device, the inflow channel, or both are located within the treatment volume. According to some embodiments, the extension separates the inflow channel and the outflow channel. According to some embodiments, the sensing device is located within the treatment volume, outside the treatment volume, or both inside and outside the treatment volume.

[0115] According to some embodiments, the surgical extension includes folded, partially folded, and unfolded configurations, wherein the volume and shape of the surgical treatment volume vary depending on the configuration of the extension. According to some embodiments, the extension includes multiple support components, multiple extendable components, multiple compliant components, multiple non-compliant components, multiple semi-compliant components, multiple flexible components, non-flexible components, or any combination thereof. According to some embodiments, the extension includes multiple overlapping components, and the degree of overlap between said multiple overlapping components is variable. According to some embodiments, the extension includes any number of vents.

[0116] According to some embodiments, a distal end of the device includes a swiveling component, the swiveling component including at least one inflow nozzle that rotates together with the swiveling component.

[0117] According to some embodiments, the inflow channel and the outflow channel are the same channel. According to some embodiments, the total diameter of the inflow channel, the outflow channel, and any other introduced channel or device is between 0.8 and 9.0 mm. According to some embodiments, at least one tube or catheter is fed through at least one channel, wherein the tube or catheter is at least partially flexible, bendable, kink-resistant, or any combination thereof. According to some embodiments, at least one inflow channel and at least one outflow channel are part of a multi-channel manufactured or extruded tube or catheter. According to some embodiments, the inflow channel, the outflow channel, or both are at least partially braided, coiled, or simultaneously braided and coiled.

[0118] According to some embodiments, the inflow channel is attached to at least one inflow nozzle, wherein the inner diameter of any one inflow nozzle is in the range of 0.05 to 0.3 mm. According to some embodiments, the outflow channel is attached to at least one outflow opening, wherein the inner diameter of any one outflow opening is in the range of 0.5 to 4.0 mm.

[0119] A further embodiment of the present invention relates to a method for treating intracavitary tissues, the method comprising:

[0120] A cryotherapy device, including a visualization device, is introduced into the body cavity through an endoscope or a sheath;

[0121] Visualize a field of view using a visualization device;

[0122] Cryofluid is injected directly or indirectly into the body cavity through at least one inflow channel of the cryotherapy device, causing the cryofluid to expand directly or indirectly within the body cavity, thereby freezing at least part of the treated tissue; and

[0123] The expanded cryogenic fluid is evacuated from the body cavity directly or indirectly through at least one outflow channel of the cryotherapy device;

[0124] The evacuation of the cryogenic fluid is controlled by a control device that receives data from at least one sensor that collects data about at least one parameter of the body cavity.

[0125] According to some embodiments,

[0126] Inject the cryogenic fluid into the field of view;

[0127] A treatment area or volume is within the field of view;

[0128] The cryogenic fluid is discharged from the field of view; or any combination thereof.

[0129] According to some embodiments, the cryotherapy device further includes directly or indirectly injecting at least one additional fluid into the body cavity through at least one inflow channel, wherein the additional fluid holds the body cavity above a defined pressure, dries at least a portion of the treated volume or area, or any combination thereof. According to some embodiments, the defined pressure is between 10 and 20 millibars. According to some embodiments, the additional fluid is selected from CO2, air, argon, N2, low-pressure gases, and / or warm gases.

[0130] According to some embodiments, the cryotherapy device includes a rolling component, and the method includes:

[0131] Injecting the cryogenic fluid into or onto the rolling component; and

[0132] The rolling component is rolled over at least a portion of the treated tissue in the body cavity.

[0133] According to some embodiments, the cryotherapy device includes an extension that is formed as follows:

[0134] The distance between the distal end of the cryotherapy device and the treated tissue;

[0135] A treatment volume that at least partially separates the volume surrounding the body cavity; or

[0136] Including both of the above, wherein the method includes:

[0137] Inject the cryogenic fluid into the treatment area;

[0138] The treatment volume is visualized via the visualization device, with its distal end located within or outside the treatment volume; and

[0139] Optionally, the additional fluid is injected into the treatment volume, wherein the additional fluid reduces the humidity in the treatment volume, maintains the pressure in the body cavity or the treatment volume above a defined pressure, or includes both of the above.

[0140] According to some embodiments, the device includes additional sensing devices, wherein the distal ends of each sensing device are located within, outside, or both of the treatment volume. According to some embodiments, the configuration of the extension is changed during the cryotherapy, such that the extension is folded, partially folded, unfolded, or any combination thereof during the cryotherapy, thereby changing the volume and shape of the treatment volume.

[0141] According to some embodiments, the distal end of the cryotherapy device includes a swiveling component, the swiveling component including at least one inflow nozzle through which the cryofluid is injected, the inflow nozzle rotating together with the swiveling component to facilitate the coverage area or volume of the cryofluid.

[0142] According to some embodiments, at least one inflow channel and at least one outflow channel are the same channel, wherein the flow direction through them is controlled by the control device. According to some embodiments, at least one inflow channel and at least one outflow channel are part of a multi-channel manufactured or extruded tube or conduit. According to some embodiments, acute-angle movement of the endoscope or the sheath does not cause kinking of the inflow or outflow channel. According to some embodiments, the inflow channel and the outflow channel are at least partially bendable, flexible, or kink-resistant. According to some embodiments, the inflow channel, the outflow channel, or both are at least partially braided, coiled, or comprise both of the above.

[0143] According to some embodiments, the body cavity is a bladder, cervix, prostate, urethra, ureter, stomach, or uterus. According to some embodiments, body fluid is drained from the body cavity through at least one outflow channel. According to some embodiments, the control device receives multiple parameters relating to the internal pressure in the treated body cavity, the temperature of the treated body cavity, flow rate, flow time, or any combination thereof.

[0144] According to some embodiments, the cryogenic fluid is indirectly injected into the body cavity, wherein it is injected into the folded component. According to some embodiments, the folded component is a cryogenic balloon. According to some embodiments, the cryogenic fluid is injected into the catheter, wherein the catheter is inserted into the body cavity but the body cavity has an opening into the body cavity, and wherein the expanded cryogenic fluid is evacuated from the catheter.

[0145] According to some embodiments, the cryogenic fluid is injected together with at least one additional active component. According to some embodiments, the active component is a biological, immunological, chemical, nanoparticle, or chemical entity. According to some embodiments, the active ingredient is selected from mitomycin C, doxorubicin, and dendritic cells.

[0146] According to some examples, the cryogenic fluid is selected from liquid nitrogen, carbon dioxide (CO2), nitrous oxide (N2Q), or any combination thereof.

[0147] Further embodiments of the present invention relate to a cryotherapy device for treating at least one target region within the body cavity via an endoscope or a sheath, the device comprising:

[0148] Folded ablation cryotherapy balloon;

[0149] Device for introducing a folded cryogenic balloon into the body cavity via an endoscope or a sheath;

[0150] Device for deploying the cryoballoon within the body cavity; and

[0151] A visualization device for visualizing a field of view, the field of view including at least a portion of the deployed cryogenic balloon and at least a portion of the target region.

[0152] According to some embodiments, the cryogenic balloon has multiple regions with different degrees of compliance, wherein the multiple regions of the cryogenic balloon function in delivering cryogenic temperatures to the target region through balloon inflation, balloon movement, or both. According to some embodiments, the cryogenic balloon includes at least one supporting, non-compliant region and at least one active, compliant, or semi-compliant region, wherein the visualization device visualizes a field of view including the supporting region, a portion of the active region, or both.

[0153] According to some embodiments, the apparatus for deploying a cryoballoon within the body cavity includes a cryofluid ejector, another fluid ejector, or any combination thereof, wherein any ejector is any number of nozzles, and optionally, any nozzle rotates about an axis to any degree. According to some embodiments, the cryoballoon is compliant, semi-compliant, non-compliant, or any combination thereof. According to some embodiments, the diameter or average diameter of the cryoballoon is less than 2.5 mm when folded.

[0154] A further embodiment of the present invention relates to a cryotherapy device for treating at least one treatment area within a body cavity via an endoscope or sheath, the device comprising:

[0155] A scrolling component;

[0156] Device for introducing rolling components into a body cavity via an endoscope or sheath;

[0157] A device for injecting the cryogenic fluid into the rolling component.

[0158] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as understood by one of ordinary skill in the art to which this invention pertains. Although similar or identical methods or materials as described herein may be used to practice or test embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the definitions contained in the patent specification shall prevail. Furthermore, materials, methods, and embodiments are for illustrative purposes only and are not intended to necessarily limit the respective embodiments.

[0159] As will be understood by those skilled in the art, some embodiments of the present invention may be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present invention may be in the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable media having computer-readable program code embodied thereon. Implementation of the methods and / or systems of some embodiments of the present invention may involve manually, automatically, or in combination thereof performing and / or completing selected tasks. Furthermore, the actual instruments and apparatus of some embodiments of the methods and / or systems according to the present invention may implement several selected tasks by hardware, by software, or by firmware and / or by a combination thereof, for example, using an operating system.

[0160] For example, the hardware for performing the selected task according to embodiments of the invention can be implemented as a chip or circuit. As for the software, the selected task according to embodiments of the invention can be implemented as multiple software instructions, executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to exemplary embodiments of the systems and / or methods described herein are executed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes volatile storage for storing instructions and / or data and / or non-volatile storage for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is provided. Optionally, a display and / or user input device, such as a keyboard or mouse, are provided.

[0161] Any combination of one or more computer-readable media can be used in some embodiments of the present invention. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example,, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples (not an exhaustive list) of computer-readable storage media will include the following: an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or a suitable combination thereof. In the context of this document, a computer-readable storage medium can be any tangible medium capable of containing or storing a program for use, and connected to an instruction execution system, apparatus, or device.

[0162] Computer-readable signal media may include propagated data signals containing computer-readable program code, such as in baseband or as part of a carrier wave. Such propagated signals may take any of a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium, but not a computer-readable storage medium, and may communicate, propagate, or transport a program for use, connected to an instruction execution system, apparatus, or device.

[0163] The program code embodied in computer-readable media and / or data and thus used may be transmitted using any suitable medium, including, but not limited to, wireless, wired, optical fiber, radio frequency (RF), or any suitable combination thereof.

[0164] Computer program code used to perform operations of some embodiments of the present invention can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, C++, etc., and conventional procedural programming languages ​​such as the "C" programming language or similar programming languages. The program code can be executed entirely on the user's computer, or partly on the user's computer, as a standalone software package, partly on the user's computer, partly on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer can be connected to the user's computer via any type of network including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0165] Embodiments of the present invention are described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products. It will be understood that individual blocks in the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to create a machine, such that the instructions are executed via the processor of the computer or other programmable data processing apparatus to establish means for implementing the functions / actions specified in one or more blocks of the flowchart illustrations and / or block diagrams.

[0166] These computer program instructions may also be stored in a computer-readable medium that can instruct a computer, other programmable data processing apparatus or other apparatus to operate in a particular manner, such that the instructions stored in the computer-readable medium produce an object, including instructions that implement the functions / actions specified in one or more blocks of a flowchart and / or block diagram.

[0167] Computer program instructions may also be loaded onto a computer, other programmable data processing apparatus or other apparatus to cause a series of operational steps to be performed on the computer, other programmable apparatus or other apparatus to produce a flow executed by the computer, such that the instructions, which execute on the computer or other programmable apparatus, provide a flow for implementing the functions / actions specified in one or more blocks of a flowchart and / or block diagram.

[0168] Some of the methods described in this article are typically designed to be used only by a computer and may be infeasible or impractical to perform purely manually by a human expert. Human experts who wish to perform similar tasks manually, such as determining the contact force between a wheel and a surface, may expect to use entirely different methods, such as leveraging the expertise and / or pattern recognition capabilities of the human brain, which would be more efficient than manually performing the steps described in this article. Attached Figure Description

[0169] Some embodiments of the invention have been described herein by way of example only, with reference to the accompanying drawings. Please now refer specifically to the drawings, where it is emphasized that the details shown are exemplary and for the purpose of illustrative discussion of embodiments of the invention. The description in this regard, taken with reference to the drawings, will make it clear to those skilled in the art how to practice embodiments of the invention.

[0170] In the diagram:

[0171] Figure 1A This is a block diagram of a cryotherapy system according to some embodiments of the present invention.

[0172] Figure 1B This is a flowchart of a general cryotherapy procedure according to some embodiments of the present invention.

[0173] Figures 1C to 1F The following are schematic longitudinal cross-sectional views illustrating a cryotherapy apparatus according to some embodiments of the present invention, wherein multiple views are introduced into the body cavity being treated via an endoscope during cryotherapy.

[0174] Figure 2A , Figure 2B and Figure 2C Several schematic longitudinal sectional views of a cryotherapy system according to some embodiments of the present invention are shown, specifically illustrating means by which fluid can enter and exit the treatment area.

[0175] Figure 3 A schematic longitudinal sectional view of a cryotherapy system according to some embodiments of the present invention is shown, specifically illustrating the means by which the distal end of the device is positioned and fixed.

[0176] Figures 4A to 4E Multiple schematic longitudinal sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown;

[0177] Figures 4F to 4H Multiple schematic transverse sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown;

[0178] Figures 5A to 5D Several schematic longitudinal sectional views of a cryotherapy device introduced via an endoscope at an acute angle according to some embodiments of the present invention are shown.

[0179] Figures 6A to 6E Several schematic longitudinal sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, including multiple specific nozzles providing multiple different types of jets;

[0180] Figure 7A and Figure 7B Several schematic longitudinal sectional views of a cryotherapy device introduced via an endoscope according to some embodiments of the present invention are shown, in particular the inflow and outflow channels using the endoscope.

[0181] Figure 8A and Figure 8B Several schematic longitudinal sectional views of a cryotherapy device introduced through an endoscope within a body cavity being treated during an ablation procedure, according to some embodiments of the invention.

[0182] Figure 8C and Figure 8D Several schematic longitudinal sectional views of an expanded cryotherapy device introduced through an endoscope within a body cavity being treated during an ablation procedure, according to some embodiments of the invention.

[0183] Figures 8E to 8G Several schematic longitudinal sectional views of an expanded cryotherapy device introduced into a body cavity during an ablation procedure, according to some embodiments of the present invention, are shown.

[0184] Figure 9A and Figure 9B Multiple schematic longitudinal sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, specifically showing multiple cryoballoons.

[0185] Figures 10A to 10DSeveral schematic longitudinal sectional views of a cryotherapy device according to another embodiment of the present invention are shown, the cryotherapy device being introduced into the body cavity being treated via an endoscope or sheath during cryotherapy.

[0186] Figure 11 A schematic longitudinal sectional view of a cryotherapy system according to some embodiments of the present invention is shown, which illustrates multiple flow paths and means by which fluid can enter and exit the body cavity being treated.

[0187] Figure 12A and Figure 12B Several schematic longitudinal sectional views of a rolling cryotherapy device having a roller are shown according to some embodiments of the present invention.

[0188] Figure 13 A schematic longitudinal sectional view of a distal end of the cryotherapy apparatus according to some embodiments of the present invention is shown, including an extension portion.

[0189] Figure 14 A schematic longitudinal sectional view of the distal end of a cryotherapy device according to some embodiments of the present invention is shown, the cryotherapy device including a rotating nozzle.

[0190] Figure 15A and Figure 15B Several schematic longitudinal sectional views of a cryotherapy device according to some embodiments of the present invention are shown. The cryotherapy device is introduced via an endoscope and includes inflow and outflow channels using the endoscope.

[0191] Figures 16A to 16C Several schematic longitudinal sectional views of an expanded cryotherapy device during an ablation procedure, according to some embodiments of the present invention, are shown, the expanded cryotherapy device including an extension.

[0192] Figure 16D and Figure 16E Multiple schematic top views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, including an extension.

[0193] Figures 17A to 17F Several schematic cross-sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, including an extension.

[0194] Figures 18A to 18C Multiple schematic transverse cross-sectional views showing the visualization means of an endoscope and the distal end of a cryotherapy device according to some embodiments of the present invention, including an extension.

[0195] Figures 19A to 19CMultiple schematic transverse sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, including an extension portion.

[0196] Figure 20A and Figure 20B Several schematic cross-sectional views of the distal end of a cryotherapy device according to some embodiments of the present invention are shown, including a washing inflow path.

[0197] Figure 21A A flowchart showing a coolant flow and a low-pressure flow through a cryotherapy apparatus according to some embodiments of the present invention is shown.

[0198] Figure 21B A flowchart illustrating the process of flow and / or cleaning control according to some embodiments of the present invention.

[0199] Figures 22A to 22F The graph shows the pressure change within the body cavity as a function of flow and time, according to some embodiments of the present invention; and

[0200] Figures 23A to 23G Several schematic diagrams show the distal end of a cryotherapy device according to some embodiments of the present invention, which has different distance and angle measuring devices. Figure 23E and Figure 23G These are multiple schematic top views of a target area after the projection of a beam of light or a low-pressure stream.

[0201] It should be understood that, for the sake of simplicity and clarity, the components shown in the figures are not necessarily drawn to scale. For example, the dimensions of some components may be exaggerated relative to others for clarity. Furthermore, where deemed appropriate, repeated reference numerals in the figures may indicate corresponding or similar components. Detailed Implementation

[0202] In some embodiments of the invention, the invention relates to ablation, including cryoablation, cryosurgery, or cryotherapy devices, and more specifically, but not exclusively, to cryotherapy for body cavity diseases.

[0203] One aspect of some embodiments relates to performing cryotherapy while controlling at least one microenvironmental parameter within a body cavity. In some embodiments, the parameter is controlled within a defined treatment space, such as a treatment space between a cryotherapy device and a target region. In some embodiments, the parameter is controlled to allow for better observation of the treatment area.

[0204] According to some embodiments, the parameters are controlled by controlling the flow into the treatment space through at least one inflow path of the cryotherapy apparatus. Optionally or additionally, at least one parameter is controlled by controlling the discharge of material from the treatment space, optionally through at least one outflow path of the cryotherapy apparatus. In some embodiments, the flow within the treatment space is controlled to increase the efficacy of the cryotherapy, for example, to allow for better adhesion to the target tissue. Optionally or additionally, the flow within the treatment space is controlled to increase the safety of the cryotherapy, for example, by not exceeding the maximum pressure and / or temperature values ​​that could cause tissue damage.

[0205] According to some embodiments, the flow into the treatment space is controlled, for example, to allow the washing of an optical component, such as a lens and / or a light source. Optionally or additionally, the flow is controlled, for example, to allow the removal of vapors, cryogenic mists, and / or droplets across the field of view between the optical component and the target area within the treatment space. In some embodiments, the removal of vapors, cryogenic mists, and / or droplets in the treatment space allows for improved and / or optimized cryotherapy and visualization of the treatment area, for example, within the body cavity. In some embodiments, the flow into the treatment space is controlled to allow, for example, expansion of the body cavity before and / or during the cryotherapy procedure. Optionally or additionally, the flow through a nozzle for spraying cryogenic fluid is controlled to prevent droplets or frozen particles from clogging the nozzle.

[0206] According to some embodiments, the treatment space is defined by adjusting the geometric parameters of the treatment space. In some embodiments, for example, to better control the microenvironmental parameters affecting cryotherapy within the body cavity, a treatment area and / or volume between the cryotherapy device and the target region may optionally be divided by a volume sub-divider configured to define a treatment space within the body cavity, which is configured to define the treatment space between the distal end and the selected target region by reducing fluid mixing between the treatment space and other parts of the body cavity. In some embodiments, the volume sub-divider includes a geometric element. In some embodiments, the geometric element, such as an extension, a cone, or a skirt, may optionally extend from the distal end of the cryotherapy device located within the body cavity. Optionally or additionally, the volume sub-divider includes a surrounding fluid flow around a distal end of the cryotherapy device, or around a cryogenic inflow opening at a distal end of the cryotherapy device. In some embodiments, the ambient fluid flow, such as ambient air or airflow, creates a virtual cone around the distal end or the cryofluid opening, which defines a treatment space within the body cavity. Optionally, a focused gas flow is used to generate the ambient fluid flow, optionally a low-pressure gas surrounding the cryofluid within the body cavity.

[0207] According to some embodiments, the geometry allows for better control, for example, by limiting a controlled volume within the body cavity, of visually perceptible vapors and / or humidity within the body cavity, such as during and / or between cryoablation cycles. In some embodiments, the deployed geometry allows for the creation of a separate microenvironment within the body cavity, optionally having different, lower or higher humidity, pressure, and / or temperature.

[0208] According to some embodiments, the pressure within the body cavity increases during cryotherapy. In some embodiments, the pressure increases due to the expansion of a low-pressure gas within the body cavity, for example, to allow for better visualization and / or access to a selected target area. Optionally or additionally, the pressure within the body cavity increases due to the expansion of a cryogenic fluid within the body cavity. In some embodiments, to reduce the pressure level, for example, to not exceed a maximum permissible pressure value, a control unit regulates the flow into the body cavity via at least one inflow path. In some embodiments, the flow into the body cavity is stopped and / or at least partially diverted to a flow path outside the body. Alternatively, at least one flow regulator connected to an outflow path is opened to expel some material from the body cavity. In some embodiments, the flow regulator is opened passively. Alternatively, the flow regulator is opened actively, for example, by an electrical signal. In some embodiments, the flow regulator includes a valve, such as a check valve, and / or a pump, such as a vacuum pump. In some embodiments, the flow regulator is used to control the pressure within the body cavity.

[0209] According to some embodiments, the maximum pressure value is determined based on the type of tissue and / or the duration of pressure. In some embodiments, the pressure value during a cryotherapy session lasting 30 to 70 minutes within the body cavity (e.g., the bladder) includes a conventional expansion pressure in the range of 10 to 30 mbar, a higher pressure value in the range of 20 to 50 mbar, and allows peak values ​​in the range of 50 to 150 mbar for a duration of 1 second or less during a 10 to 30 second cycle of cryotherapy. In some embodiments, the maximum pressure value during a cryotherapy session lasting 30 to 70 minutes within the body cavity (e.g., the bladder) is approximately 80 mbar, such as 50 mbar, 60 mbar, 70 mbar, or any intermediate, smaller, or larger value.

[0210] According to some embodiments, the temperature within the body cavity decreases during cryotherapy, for example, due to the expansion of the cryocoolant. In some embodiments, the temperature within the body cavity is controlled, for example, by controlling the flow of the coolant into the body cavity. Alternatively or additionally, the temperature is controlled by opening an outflow path to expel substances from the body cavity. In some embodiments, a warm washing fluid (e.g., a warm gas) is introduced into the body cavity, for example, to increase the temperature level within the treatment space. Additionally or alternatively, the heated gas is directed toward a lens of the optical assembly, for example, to maintain the lens at a constant temperature and / or prevent water droplets from condensing on the lens surface.

[0211] One aspect of some embodiments relates to performing cryotherapy within the body cavity by adjusting treatment-related geometric parameters. In some embodiments, a geometric relationship is determined, such as the distance and / or angle between a distal end of a cryotherapy device located within the body cavity and a target region within the body cavity. Optionally, at least one cryotherapy parameter, such as the duration of cryofluid injection, the time between injections, and / or the cryofluid pressure, is determined and / or adjusted based on the determined distance and / or angle.

[0212] According to some embodiments, the distance and / or angle are determined based on the unfolding of at least one geometric element. In some embodiments, the geometric element, such as an extension, a cone, or a skirt, may optionally unfold from a distal end of a portion of the cryotherapy device located within the body cavity.

[0213] According to some embodiments, the geometry, for example, allows determining the distance and / or angle between the cryotherapy nozzle of the cryotherapy device located within the body cavity and a selected target region. In some embodiments, the development of a geometry of known size and / or shape may, for example, allow determining the distance to the selected target region and / or the angle between the cryotherapy nozzle and the target region by visualizing a contact point between the geometry and the inner surface of the cavity. Optionally or additionally, the distance to the target region is determined by receiving a signal when the geometry contacts the inner surface.

[0214] According to some embodiments, the focused airflow, such as low-pressure gas from the cryo-nozzle, allows determination of the distance between the cryo-nozzle and a selected target area, and / or an angle between the cryo-nozzle and the target area. In some embodiments, the distance and / or angle are determined by visualizing the contact point between the gas and the inner surface of the cavity. Optionally, the focused airflow is delivered through the cryo-nozzle between multiple cryoablation sessions. In some embodiments, the focused airflow partially deforms the shape of the inner surface of the cavity, for example by forming an indentation or an elliptical deformation at the contact point on the inner surface. In some embodiments, visualization of the size and / or shape of the indentation allows, for example, determination of the distance to the target area and / or the angle between the cryotherapy device and the target area.

[0215] According to some exemplary embodiments, distance and / or angle are determined by visualizing a projected light spot on the surface of the target region. In some embodiments, distance and / or angle are determined based on changes in the shape and / or size and / or color of the light spot. In some embodiments, the light spot is generated by a beam of light from a light source positioned at the distal end of the cryotherapy device located within the body cavity. Optionally, the light source is generated by a laser light source or any other light source capable of generating a focused light source. In some embodiments, the distance and / or angle between the cryotherapy device and the target region are determined by visualizing the target region, optionally at least partially, along with the cryotherapy device, and processing the image using one or more image processing algorithms.

[0216] One aspect of some embodiments involves performing cryotherapy while applying a washing fluid (also referred to herein as a cleaning substance) into the body cavity. In some embodiments, the washing fluid, such as a gas, optionally a low-pressure gas, is introduced into the body cavity while a coolant is sprayed onto a target area. Optionally or additionally, the washing fluid is introduced into the body cavity between the spray cycles.

[0217] In some embodiments, the washing fluid is pushed into the body cavity through at least one opening at the proximal or distal end of the cryotherapy device.

[0218] In some embodiments, the washing fluid is pushed into the body cavity to expand it. In some embodiments, the body cavity is expanded to allow better observation of a target area for cryotherapy. Optionally or additionally, the body cavity is expanded to allow better manipulation of the distal end of the cryotherapy device to a selected target area.

[0219] According to some embodiments, the washing fluid is introduced into the body cavity to clean an optical component of the cryotherapy device, such as a lens. In some embodiments, the washing gas removes moisture and / or dirt that may be covering the lens from the lens. Optionally or additionally, the washing fluid is introduced into the body cavity to wash the field of view (FOV) between the optical component and the target area. In some embodiments, the washing fluid is used to wash away cold water vapor, for example, to remove fog from the optical component. In some embodiments, fog and / or cryogenic droplets formed by the interaction of cryogenic gas and liquid particles expanding in the humidification space of the body cavity are washed away from the field of view.

[0220] According to some embodiments, the washing fluid, optionally a warm washing fluid, creates a dynamic buffer (optical wash) around the lens surface, for example, to prevent fog residue (or evacuated fog) from flowing toward the lens. In some embodiments, the washing fluid pushes fog and / or frozen particles away from the optical assembly. Optionally or additionally, the warm washing fluid maintains the optical assembly (e.g., the lens of the optical assembly) at a constant warm temperature to prevent fog or droplets from forming on the lens surface.

[0221] According to some embodiments, the washing fluid is used for pressure measurement. In some embodiments, due to pressure changes within the body cavity, pressure changes can be measured closer to the washing pressure source (i.e., upstream, such as inside the control unit), thereby allowing for the measurement / approximate measurement of the pressure within the body cavity (and, for example, for use with control devices and / or safety devices).

[0222] According to some embodiments, and as previously described, the washing fluid is optionally used simultaneously for two or more of the following: washing optical components, clearing fog from the field of view, optionally expanding the body cavity during cryotherapy, and measuring the pressure level of the body cavity. In some embodiments, a control unit of the cryotherapy apparatus controls the flow distribution between the flow toward the optical components and the flow to clear fog from the field of view. Optionally or additionally, the control unit controls and coordinates the flow and timing of the washing fluid and the cryocoolant injection, for example, not exceeding a maximum pressure value in the body cavity. In some embodiments, the control unit controls the washing fluid to flow into the body cavity alone or in combination with the cryocoolant or in combination with a purge fluid, such as a low-pressure fluid through the nozzle, to ensure, for example, that the expansion level of the washing fluid is above a minimum pressure value.

[0223] One aspect of some embodiments relates to preventing clogging of a cryogenic nozzle in a cryogenic inflow path by controlling the flow through the nozzle. In some embodiments, the flow through the cryogenic nozzle is controlled to prevent clogging when the cryogenic coolant flow stops. In some embodiments, a purge flow is initiated through the cryogenic nozzle when the coolant flow stops. In some embodiments, the purge fluid is a flow of a non-cryogenic gas, optionally a low-pressure gas. In some embodiments, when the cryogenic coolant flow stops, a port is opened, optionally for a predetermined period of time, to release residual cryogenic fluid retained in the inflow path. Alternatively, the port is opened for a period of time, the duration of which is adjusted according to the amount of residual cryogenic coolant retained in the cryogenic inflow path.

[0224] According to some embodiments, the cryogenic fluid described in this application includes a cryogenically compressed fluid—liquid CO2—with a pressure level of about 50 to 80 bar in the cryogenic source. Alternatively, the cryogenic fluid includes a fluid, such as nitrogen, with a pressure of about 200 bar in the cryogenic fluid source. In some embodiments, the cryogenic fluid is at a pressure of a few bar, for example, 1 to 10 bar, but expands into a gas, such as LN2 or liquid nitrogen, optionally at a liquid:gas ratio of about 1:1000. In some embodiments, and without being bound by any theory, the expansion of the high-pressure fluid within the body cavity reduces the fluid pressure and produces a cryogenic effect, such as the Joule-Thomson effect.

[0225] According to some embodiments, the washing fluid comprises a low-pressure gas having a pressure of 1 to 4 bar at its source, and optionally at a pressure of tens of millibars when expanded into the bladder. In some embodiments, any low-pressure gas may be used for washing and / or expanding the body cavity. Optionally, a stored high-pressure gas, for example in an inner cavity of the cryotherapy device, is used after pressure reduction, before being released into the body cavity. A possible advantage of using the same type of gas for washing and cryoablation is that separate sources for cryoablation and washing are not required. A possible advantage of using air as the washing fluid is that it reduces the need for additional cylinder / canister connections / replacements / space / cost, etc. In some embodiments, the washing fluid is heated and / or dried, for example to reduce fogging inside the treatment space and / or for washing the optical components. In some embodiments, when the washing gas is stored in a cylinder / canister, its water content (parts per million, PPM) is much lower than that of conventional air.

[0226] According to some embodiments, the washing fluid is introduced into the body cavity at a rate of at least 4 liters per minute (air value), such as 5 liters per minute (air value), 7 liters per minute (air value), 10 liters per minute (air value), or any intermediate, smaller, or larger value. In some embodiments, the purging of the low-pressure fluid (e.g., low-pressure gas) is introduced into the body cavity at a rate of up to 1 liter per minute (air value), such as 1 liter per minute (air value), 0.7 liters per minute (air value), 0.5 liters per minute (air value), or any intermediate, smaller, or larger value. In some embodiments, the cryogenic fluid is introduced into the body cavity at a flow rate of at least 5 liters per minute, such as 5 liters per minute, 7 liters per minute, 10 liters per minute, or any intermediate, smaller, or larger value.

[0227] One aspect of some embodiments relates to applying cryotherapy to a large target area or a large treatment space through a movable cryo-inflow opening. In some embodiments, the cryotherapy device includes a cryo-inflow path having a movable nozzle, for example, a nozzle that rotates to multiple selected directions and / or multiple selected angles, for example, allowing coverage of a large target area within a body cavity. In some embodiments, the nozzle rotates about an axis. Optionally or additionally, the cryotherapy device includes a rotating element combined with a cryo-nozzle. In some embodiments, the cryo-fluid is jetted through the nozzle, which is capable of rotating together with the rotating element, thereby facilitating coverage of the area or volume within the body cavity.

[0228] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, those skilled in the art will understand that the invention can be practiced without these specific details. In other instances, well-known methods, processes, and components have not been described in detail so as not to obscure the invention.

[0229] It should be noted that, unless otherwise specifically stated, the terms "lumen," "treated lumen," and "targeted lumen," as used herein, are interchangeable. Similarly, unless otherwise specifically stated, the terms "treated tissue," "treated area (treated region)," "targeted tissue," and "targeted area (targeted region)," etc., are interchangeable. Furthermore, the reference to elements at the distal end of the sensing device is intended to indicate a portion of the parameters required for sensing by the sensing device, even if a particular sensing element is not specifically located at the distal end of the sensing device.

[0230] Embodiments of the present invention relate to multiple devices and systems for cryotherapy, which can be introduced into the body cavity via an endoscope or any other suitable device (e.g., direct insertion of a catheter into the cavity without visualization or using an external imaging device, such as ultrasound, CT, etc.). The present invention also relates to cryotherapy methods within body cavities. According to some embodiments, the cryotherapy methods include multiple cryoimmunotherapy procedures.

[0231] It should be noted that the term "endoscope" as used herein is intended to include any type of known endoscope, as well as any type of sheath, catheter, tube, etc., which can be inserted into the body and through any necessary working channels, visualization devices, etc., that can be placed within the body cavity. Therefore, the endoscope may include inherent visualization devices or other devices that can be inserted through any type of sheath, etc., such that the visualization device can be changed throughout the procedure; for example, several different types of visualization devices may be used. It should be noted that the term "visual device" or any other equivalent term used herein is intended to include optical devices, ultrasound, MRI, X-rays, etc. Any other sensors may also be inherent in the endoscope or can be inserted into the body cavity through it. It should be noted that the term "working channels" or any other equivalent term used herein can refer to an integral path through the endoscope or a path available through any device, such as a sheath, catheter, tube, etc., that can be inserted into the body cavity through any of its devices and / or sensors, such as visualization devices.

[0232] According to some embodiments, the cryotherapy device includes two or more channels, tubes, catheters, etc., that allow for the injection of pressurized fluid and the drainage of dilution fluid, wherein the pressurized fluid is injected into the body cavity through at least one channel, and the dilution fluid is drained from the body cavity through at least one second channel. It should be noted that, unless otherwise specifically mentioned, catheters, tubes, etc., are used interchangeably herein. According to some embodiments, at least one injection channel and at least one drainage channel are inserted into the body cavity via an endoscope. According to some embodiments, any channel can be fed through any other channel. According to other embodiments, the same channel can be used for injection and aspiration, using any suitable type of sensor and / or dedicated algorithm to control the flow direction, relative volume, and time. It should be noted that although pressurized and dilution fluids are related to the above, according to any of the above embodiments, any type of fluid can be introduced / released from the system. It should be noted that, as is known in the art, the term "fluid" includes both gases and liquids.

[0233] Embodiments of the present invention also include various cryotherapy devices comprising at least one evacuation device and a control device, through which the evacuation of expanded fluid and, possibly, the injection of pressurized fluid are controlled. The control device may be automatic, predefined, electronic, manual, etc. The cryotherapy device may also include any number or type of sensors, from which the control device receives data and controls evacuation and / or injection based on multiple predetermined values, manually determined values, or values ​​that may change during the process. Without such a control device, pressure may accumulate in the target organ, potentially leading to rupture, as the evacuation may be insufficient. Furthermore, it may be necessary to control the internal pressure of the target body cavity to prevent it from dropping below a certain predefined value. In particular, if the pressure is too low (e.g., below 10 mbar), it may be difficult or even impossible to operate within the body cavity and / or to visually observe its interior, as the cavity may collapse under low pressure. Therefore, the control device ensures that the pressure is not too high, causing damage to the body cavity, or too low, causing it to collapse. Furthermore, the treated body cavity may contain bodily fluids (e.g., urine from the bladder). Due to the cryotherapy process, these fluids may freeze, potentially hindering the drainage of the consumed cryogenic fluids. Therefore, it is important to include sensors in the system, according to which the control device controls evacuation and, if necessary, injection, ensuring that the treated body cavity is not damaged. According to some embodiments, any number of sensors are inserted into the body cavity. According to some embodiments, any number of external sensors, such as ultrasound, X-rays, etc., can be used in conjunction with multiple internal sensors, or can replace multiple internal sensors.

[0234] According to some embodiments, inflow can be stopped when the pressure within the body cavity exceeds approximately 30 to 100 millibars. According to some embodiments, outflow continues until the pressure within the body cavity falls below approximately 20 to 10 millibars. According to some embodiments, inflow can be stopped when the temperature within the body cavity falls below approximately 5 to 100°C. According to some embodiments, inflow can begin when the temperature within the body cavity exceeds approximately 15 to 200°C. According to some embodiments, temperature, pressure, and any other suitable parameters can be used to control the system.

[0235] Therefore, according to the present invention, lumens such as the uterus, stomach, bladder, renal pelvis, urethra, and ureter can be treated, even if gas cannot be safely expelled naturally from them. According to some embodiments, the kinetics of the system include the injection and evacuation of a cryogenic fluid, while monitoring and controlling the injection and evacuation throughout the process to prevent the liquid or vapor within the body cavity from freezing, thereby preventing blockages, etc. According to some embodiments, in addition to injecting the cryogenic fluid, the system includes an additional fluid injection source for introducing a non-cryofluid into the body cavity when needed. For example, fluid can be injected into the body cavity to maintain a certain volume of the cavity, allowing the user to perform necessary operations while visually observing the interior of the cavity. This may be necessary between any two cryogenic cycles or after the last cryogenic cycle. Furthermore, fluid can be injected into the body cavity to dry the interior or areas therein. According to some embodiments, the body cavity can be dried with dry and / or warm gas, and the pressure within the body cavity can be maintained above a predetermined value, such as 10 mbar, for example using gases such as CO2, air, argon, N2, etc. The combination of injection, evacuation, and control provides the necessary power for the normal operation of the system. Furthermore, it can even treat lumens with small-diameter inlets, such as the ureter, because the diameters of the injection and drainage tubes can be relatively small (the total diameter of all tubes is about 0.8 to 4 mm or the diameter of all tubes is about 4.0 to 9.0 mm, especially if a visualization device is included, etc.), and a single tube or two adjacent tubes can be used to further limit the diameter, as each additional tube used increases the total diameter. It should be noted that small diameters, such as a total diameter of about 0.8 to 9.0 mm, can include not only injection and drainage channels but also any other channels, devices, sensors, etc., introduced therein, such as a visualization device introduced into the body cavity. According to some embodiments, the total diameter of the inflow and outflow channels is between about 0.8 and 4.0 mm. The diameter of the outer sheath can be between about 5.0 and 9.0 mm, and the outer diameter of the visualization device is between about 3.0 and 5.0 mm.

[0236] According to some embodiments, it treats conditions of the bladder, cervix, stomach, prostate, urethra, ureter, or uterus. According to further embodiments, it treats bladder cancer, cervical cancer, stomach cancer, prostate cancer, urethral cancer, ureteral cancer, or uterine cancer. It can also treat benign prostatic hyperplasia. It can also treat painful conditions in the bladder, stomach, cervix, prostate, or uterus. According to further embodiments, it can treat any type of urinary tract disease, including upper gastrointestinal cancer, interstitial cystitis, bladder pain syndrome, overactive bladder (OAB), etc.

[0237] The distal end of the cryotherapy device may include any number of orifices, nozzles, slits, etc., through which fluid can be injected / introduced / released into the body cavity. According to some embodiments, the fluid can be injected into the body cavity along with any other substance, such as chemotherapy, immunotherapy, and / or other chemical or biological agents. Additional substances can be introduced simultaneously before and / or after cryotherapy for optimal results. The introduced fluid is also referred to herein as a “coolant,” “cryofluid,” etc. It should be noted that the coolant is capable of ablating / freezing any desired treatment area. According to some embodiments, the distal end of the cryotherapy device includes a nozzle designed to spray fluid directly onto the target area and / or its surrounding environment. The distal end of the cryotherapy device may further include a evacuation device to evacuate the expanded fluid from the body cavity. According to some embodiments, the cryofluid is selected from liquid nitrogen, carbon dioxide (CO2), nitrous oxide (N2O), or any combination thereof. According to some embodiments, the cryofluid is selected from argon, nitrogen, krypton, or any combination thereof, which may be additionally relevant when the cryofluid does not directly contact body tissue. According to other embodiments, it may further include any additional substances, such as chemotherapy, immunotherapy, and / or other therapeutic agents, such as chemical or biological agents. According to some embodiments, additional substances are introduced into the body cavity before, during, and / or after cryotherapy.

[0238] It should be noted that the terms "target area," "treatment area," "treatment cavity," and "target body cavity" are interchangeable and intended to encompass any type of condition. Cryotherapy can be used for conditions such as lesions (including cancerous and benign tumors, cysts, polyps, etc.), nerves / nerve endings, and various symptoms, even if their specific origins are not yet fully understood.

[0239] According to other embodiments, the coolant is retained within and expands in the injection channel (e.g., catheter, tube body, etc.) so that the cold temperature is delivered to the tissue through the mediating distal portion of the cryotherapy device. According to such embodiments, because the coolant is retained in the injection channel, it is not necessary to remove the coolant from the body cavity.

[0240] According to some embodiments, the distal mediating portion of the cryotherapy device is a cryoballoon, which is introduced into the body cavity to be treated via an endoscope. The cryoballoon may be non-compliant, allowing it to withstand high pressure. If the balloon is non-compliant, its size is selected based on the size of the body cavity into which it is inserted or the shape of a treatment area. According to other embodiments, the balloon may be semi-compliant or compliant. According to yet another embodiment, different portions of the cryoballoon may have different compliance. Different parameters of the balloon, including the compliance of its various portions, the shape of the cryoballoon, the size of the cryoballoon, etc., may be determined based on the body cavity to be treated, the target area within the body cavity, etc. The balloon may be circular, elliptical, tubular, or have any flat or partially flat surface. Depending on the intended use, the balloon may also be wide in some areas and narrow in others. When inflated or partially inflated, the balloon may only partially contact the treatment area, rather than using the entire lumen of the balloon. According to other embodiments, the inflation of the cryoballoon, for example in the urethra or ureter, can bring the balloon or a portion thereof into contact with the entire circumference of the treatment area. According to some embodiments, an external force (such as movement by the user of the device) may accompany the inflation, bringing at least a portion of the cryoballoon into contact with the treatment area.

[0241] According to some embodiments, when folded (when inserted through an endoscope or a working channel), the diameter or average diameter of the cryogenic balloon is less than 2.5 mm. According to some embodiments, when folded (when inserted through an endoscope or a working channel), the diameter or average diameter of the cryogenic balloon is less than 2.0 mm. According to some embodiments, when folded (when inserted through an endoscope or a working channel), the diameter or average diameter of the balloon is less than 1.5 mm.

[0242] Furthermore, the balloon can be expanded, partially expanded, and / or moved to contact the target area, and the movement of the balloon can be externally controlled by the user and / or by any suitable mechanical and / or electronic device. The balloon inflation and / or movement can be further controlled based on data received from any internal or external sensors.

[0243] It should be noted that the terms "injection channel" and "exhaust channel" are also used in this article in relation to "catheter" and "tube".

[0244] According to some embodiments, the cryotherapy device may include a flexible or kink-resistant catheter, such as a braided or coiled tube, which can allow sharp angular movement, thus making it easy to target the area regardless of its location in the body.

[0245] According to some embodiments, the cryotherapy device includes a single nozzle located at the distal end of the device, allowing the operator to perform treatment within the endoscopic field of view. According to other embodiments, the device includes at least two nozzles, wherein any two nozzles can be positioned relative to each other in the same or different directions. For example, one nozzle may be pointed downwards in the distal direction, while other nozzles may be laterally pointed from the distal end of the device at any desired angle and distance, thereby allowing treatment in different directions, treating different portions of the same target area, different target areas, etc. According to some embodiments, any one or more of the nozzles has an open and closed configuration. Furthermore, any one of the nozzles can be partially opened or closed at any desired time period. According to some embodiments, any number of nozzles can be electronically controlled, allowing the user of the device to use any number of existing nozzles at any point in time according to the desired treatment. According to some embodiments, the user predefines the specific nozzles to be used. According to other embodiments, during the procedure, any one of the nozzles can be opened, partially opened, or closed at any point in time as needed via any appropriate means, including designated sensors, computerized applications, user commands, etc.

[0246] According to some embodiments, a folded component (e.g., a cryotherapy balloon) can be attached to any part of the distal end of the cryotherapy device. Thus, the injected cryofluid, along with any other suitable pressure source, inflates the balloon, which then freezes at least part of the treated tissue. According to some embodiments, inflating the balloon by any other suitable pressure source before injecting the cryofluid allows the balloon to be prepared for cryotherapy, the system to be checked or tested, or certain parameters thereof. The inflation of the balloon, including the inflation rate, size, etc., can be controlled by any number of sensors, as detailed above regarding the injection through the nozzles. Furthermore, any of the plurality of nozzles can be connected to the cryotherapy balloon outside the nozzle, such that when the cryofluid leaves the nozzle, the balloon connected to the outside of the nozzle inflates.

[0247] Therefore, according to some embodiments, the cryofluid is directly injected into the body cavity, i.e., it comes into direct contact with at least a portion of the tissue within the body cavity. According to such embodiments, the cryofluid is injected directly into the body cavity through any number of nozzles, orifices, slits, and / or valves, as detailed herein. Furthermore, if the cryofluid is injected directly into the body cavity, it can also be directly evacuated from the body cavity by any method detailed herein. According to other embodiments, the cryofluid can be introduced into the body cavity indirectly, such that it does not come into direct contact with the tissue within the body cavity; instead, it is injected into any suitable component located within the body cavity, such as a catheter, cryoballoon, tubing, etc., which does not have an opening into the body cavity. The cryofluid expands within the component, thereby cooling at least a portion of the treated tissue. The cryofluid can then be evacuated from the body cavity from the injection point. The cryofluid can be evacuated by active or passive means.

[0248] According to some embodiments, the folded component is a cryogenic balloon that expands within the body cavity and / or is filled with coolant to treat the desired area.

[0249] According to other embodiments of the invention, either of the existing "inflow" and "outflow" channels of an endoscope can be used to introduce material into or evacuate material from the body cavity (e.g., evacuate fluid dilated by cryotherapy).

[0250] According to some embodiments, the cryotherapy is performed in combination with any other type of treatment, including intracavitary chemotherapy and / or immunotherapy agents. It should be noted that the cryofluid may be injected along with any other active component. As described above, additional active components may be introduced concurrently with, before, and / or after the cryotreatment.

[0251] Frozen tissue cells are removed from the body via cryotherapy, particularly through the lymphatic system, where an immune response is triggered that can act on such cells in any part of the body, not just the cryotreated area. According to some embodiments, introducing additional active components into the body cavity before or during cryotherapy can cause the treated tissue to respond differently to cryotherapy, and when introduced into the lymphatic system, the cells proceed along with the additional active ingredients, potentially leading to an enhanced immune response.

[0252] The additional active ingredient can be any immunological, chemical, chemotherapeutic, biological, or nanoparticle entity, including but not limited to mitomycin C, doxorubicin, dendritic cells, etc.

[0253] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited to its application to the construction details and configurations of components and / or methods set forth in the following description and / or drawings and / or embodiments. The invention can have other embodiments or be practiced or implemented in various ways.

[0254] Exemplary cryotherapy system:

[0255] According to some exemplary embodiments, a cryotherapy system includes a cryotherapy probe and a control unit, the cryotherapy probe being configured to be at least partially inserted into an integrated cavity, and the control unit being connected to the cryotherapy device. In some embodiments, the control unit is located outside the body. Reference now is made to... Figure 1A It describes a cryotherapy system according to some exemplary embodiments of the present invention.

[0256] According to some exemplary embodiments, the cryotherapy system 1000 includes a cryotherapy probe, such as a cryotherapy device 1002, and a control unit 1004 connected to the cryotherapy device 1002. In some embodiments, the cryotherapy device 1002 is an elongated probe having a distal end 1021, optionally shaped and sized to be introduced into the body cavity and facing a target region on the inner surface of the body cavity, and a proximal end 1025, optionally positioned outside the body cavity. In some embodiments, the cryotherapy device 1002 is cylindrical and has a diameter at the distal end 1021 of the cryotherapy device, and its surrounding sheath is in the range of 3 to 15 mm, for example 3 mm, 5 mm, 7 mm, 9 mm, or any intermediate, smaller, or larger value. In some embodiments, the diameter of a cryotherapy device excluding the sheath is in the range of 0.3 to 5 mm, for example 0.5 mm, 1 mm, 2 mm, or any intermediate, smaller, or larger value. In some embodiments, the cryotherapy device 1002 is shaped and sized to be introduced into the body cavity through a working channel of an endoscope. Alternatively, the cryotherapy device 1002 is introduced into the body cavity through a sheath 1024.

[0257] According to some exemplary embodiments, the cryotherapy device 1002 includes at least one flow path, such as a channel passing through a cavity of the cryotherapy device from the proximal end 1025 to the distal end 1021. In some embodiments, the at least one flow path serves as an inflow path toward the distal end 1021 and into the body cavity, and as an outflow path from the body cavity toward the proximal end 1025. In some embodiments, the cryotherapy device 1002 includes at least one inflow path, such as an inflow channel 1006, for delivering fluid or gas into the body cavity. Additionally or optionally, the cryotherapy device 1002 includes at least one outflow path, such as an outflow channel 1010, for discharging fluid, particles, and / or gas from the body cavity.

[0258] According to some exemplary embodiments, the outflow path, such as outflow channel 1010, includes at least one outflow flow regulator, such as a valve 1023 for controlling the passage of a substance (e.g., gas or fluid) through the outflow path. In some embodiments, the at least one valve includes at least one check valve configured to open, optionally passively, when the pressure within the body cavity exceeds a predetermined value. Optionally, the outflow flow regulator is located near the proximal end 1025 of the cryotherapy device 1002, which is located outside the body.

[0259] According to some exemplary embodiments, the inflow channel 1006 includes at least one face-forward cryogenic nozzle configured to inject cryogenic fluid, such as injecting cryogenic gas and / or cryogenic liquid toward a selected target area in the inner surface of the body cavity. Optionally, the cryogenic fluid is stored under high pressure. In some embodiments, and without being bound by any theory, the expansion of the high-pressure cryogenic fluid within the body cavity rapidly reduces the fluid pressure, resulting in a cryogenic effect within the body cavity, such as the Joule-Thomson effect.

[0260] According to some exemplary embodiments, the cryogenic nozzle is an adjustable cryogenic nozzle configured to spray the cryogenic fluid into a target area at an angle less than or greater than 90 degrees. Alternatively, the cryogenic nozzle is a fixed-angle cryogenic nozzle, fixed at an angle other than 90 degrees, such as 15 degrees, 30 degrees, 45 degrees, 55 degrees, or any angle less than or greater than 90 degrees. In some embodiments, the adjustable cryogenic nozzle is configured to control the amount of sprayed cryogenic fluid released through the nozzle into the body cavity, for example, by adjusting the opening diameter of the cryogenic nozzle.

[0261] According to some exemplary embodiments, the cryotherapy device 1002 includes at least one optical component, such as an optical path, optionally an optical channel 1018, for transmitting images and / or visual signals of tissue facing the distal end 1021 of the cryotherapy device 1002 to an external optical sensor, such as an optical sensor in the control unit 1004, or an external optical component, such as an optical component of a different control unit. Alternatively, the optical component includes at least one optical sensor, such as an optical sensor 1022 located at the distal end 1021 of the cryotherapy device 1002, configured to sense visual signals of tissue facing the distal end 1021 of the cryotherapy device 1002, such as images and / or visual signals of a target region within the body cavity. Alternatively, the optical component includes a sensor, optionally an ultrasound sensor or a magnetic resonance sensor. In some embodiments, the cryotherapy device 1002 includes at least one illumination source, such as illumination source 1019. In some embodiments, the illumination source 1019 is positioned at the distal end 1021 of the cryotherapy device, optionally facing the tissue of the body cavity. Alternatively, at least one light source is located within a channel, such as an optical channel 1018, within the cryotherapy device. In some embodiments, the optical channel 1018 is or includes an optical fiber, a set of optical fibers, or an optical fiber cable, or includes an optical fiber, a set of optical fibers, or an optical fiber cable. In some embodiments, when the optical channel 1018 is or includes an optical fiber, a set of optical fibers, or an optical fiber cable, or includes an optical fiber, a set of optical fibers, or an optical fiber cable, the light source is located outside the body, and optionally, the optical sensor is located outside the body.

[0262] According to some exemplary embodiments, the cryotherapy device 1002 includes at least one flow path, such as a washing channel 1014, for delivering washing gas into the body cavity, optionally a low-pressure gas. In some embodiments, the washing gas is used to expand the body cavity, for example to allow better observation of the inner surface of the cavity and / or to allow greater access to desired areas within the body cavity, optionally for selecting areas for cryotherapy. Additionally or alternatively, the washing gas is sprayed through a washing gas nozzle onto the treated area, for example to blow away condensed particles and / or condensed particle clouds formed by the interaction of the cryogas with the humidified environment within the body cavity.

[0263] According to some exemplary embodiments, the washing channel 1014 includes at least one forward-facing washing nozzle facing the tissue at the distal end of the cryotherapy device. Optionally, the forward-facing washing nozzle is configured to inject gas (e.g., low-pressure gas) into the space between the cryotherapy device 1002 and the target area. In some embodiments, the forward-facing nozzle is an adjustable washing nozzle, for example, to allow the washing gas to be injected laterally or at an angle to the target area. In some embodiments, the forward-facing washing nozzle injects washing gas into the field of view of the optical sensor 1022 or into the field of view of the optical channel 1018.

[0264] According to some exemplary embodiments, the washing channel 1014 includes at least one opening, such as a front washing opening and / or a lateral washing opening, optionally located near the distal end 1021 of the cryotherapy device 1002. In some embodiments, the cryotherapy device includes at least one washing guide at the washing opening (e.g., a nozzle and / or deflecting surface), configured to direct the washing fluid toward the field of view of the optical components, such as a lens and / or optical sensor 1022, or into the field of view of the optical channel 1018. Optionally, the at least one washing guide is an adjustable washing guide, for example configured to allow the washing gas to be sprayed at an angle to reach the field of view.

[0265] According to some exemplary embodiments, at least one wash flow regulator on the wash inflow path is configured to regulate the amount of wash fluid released through the wash opening, optionally in response to a signal received from the control unit.

[0266] According to some exemplary embodiments, the cryotherapy device 1002 includes at least one foldable element, such as foldable elements 1001 and 1003. In some embodiments, the at least one foldable element is configured to fold within the cavity of the cryotherapy device and can be unfolded, optionally unfolding near the distal end 1021 of the cryotherapy device 1002. In some embodiments, the at least one foldable element unfolds into the space between the distal end 1021 of the cryotherapy device 1002 and the target region. In some embodiments, the space is referred to as the treatment space. In some embodiments, the foldable element includes an extension, a cone, or a skirt. In some embodiments, the foldable element unfolds within the treatment space, for example, to determine the distance or angle between the distal end of the cryotherapy device and the target region. Alternatively, the foldable element unfolds within the treatment space, for example, to determine the distance and / or angle between the cryo-nozzle and the target region. In some embodiments, at least two foldable elements or a tapered foldable element unfolds to narrow the treatment space, for example, by creating a microenvironment within an interior space formed by the unfolded foldable elements.

[0267] According to some exemplary embodiments, the control unit 1004 includes at least one control circuit, such as control circuit 1026. In some embodiments, the control circuit controls the flow of cryogenic fluid through the inflow path, such as inflow channel 1006. In some embodiments, the control circuit 1026 controls the flow of the cryogenic fluid by controlling at least one cryogenic flow regulator, such as a valve located in the inflow path and / or at least one valve between a cryogenic source 1034 and the inflow channel 1006, for example, at least one valve in a pipe connecting the cryogenic source 1006 and the control unit 1004 and / or at least one valve in a pipe connecting the cryogenic source and the inflow path. Optionally or additionally, the control unit 1004 controls at least one valve of the cryogenic source, such as an outlet valve of the cryogenic source.

[0268] According to some exemplary embodiments, the control circuit 1026 controls the flow of a washing fluid through the washing inflow path (e.g., washing channel 1014). In some embodiments, the control circuit 1026 controls the flow of the washing fluid by controlling at least one washing flow regulator, such as a valve located on the washing inflow path, for example, washing channel 1014. Optionally or additionally, the control circuit 1026 controls the flow of the washing fluid by controlling at least one flow regulator between a washing source 1008 and the washing channel 1014, for example, at least one valve in a pipe connecting the washing source 1008 and the control unit 1004 and / or at least one valve in a pipe connecting the washing source 1008 and the washing channel 1014. Alternatively or additionally, the control circuit 1026 controls at least one valve of the washing source, such as an outlet valve of the washing source 1008.

[0269] According to some exemplary embodiments, the control circuit 1026 controls the flow of fluid, such as gas and / or liquid discharged from the body cavity through the outflow path, for example, outflow channel 1010. In some embodiments, the control circuit controls the flow through the outflow channel 1010 by controlling an outflow flow regulator, such as an outflow valve, for example, valve 1023, located in or near a proximal end of the outflow channel. Alternatively or additionally, the control circuit 1026 controls the activation of an exhaust pump 1007, for example, a vacuum pump connected to the outflow channel. In some embodiments, the exhaust pump 1007 is used to actively exhaust fluid, such as liquid or gas, from the body cavity through the outflow path of the cryotherapy device. Optionally, the control circuit 1026 controls at least one exhaust flow regulator, for example, an exhaust valve on a tube connecting the exhaust pump 1007 and the outflow channel.

[0270] According to some exemplary embodiments, the control circuit controls an optical component, such as an optical sensor, e.g., optical sensor 1022, located on the cryotherapy device 1002. Optionally or additionally, the control circuit 1026 controls at least one optical sensor in the controller. In some embodiments, the control circuit 1026 optionally controls the opening or closing of an optical device channel 1018 by controlling an aperture within the optical device channel 1018. In some embodiments, the control circuit controls the activation of the optical device 1010, for example, through visualization.

[0271] According to some exemplary embodiments, the cryotherapy device 1002 includes at least one sensor 1011 located at a distal end 1021, for example, to sense at least one environmental parameter of the body cavity. In some embodiments, the environmental parameter includes temperature, pressure and / or humidity levels or any other environmental parameter. Optionally or additionally, the cryotherapy device 1002 includes at least one sensor, such as sensor 1005, which is at least partially located within the flow regulator for sensing the environmental parameter.

[0272] According to some exemplary embodiments, sensor 1011 and / or sensor 1005 are electrically connected to the control circuit 1026. Optionally or additionally, the control circuit 1026 is electrically connected to one or more sensors located inside or outside the body. In some embodiments, one or more sensors are positioned near or at a distance from the target cryoablation area. Alternatively, in some embodiments, at least one sensor sends measured environmental parameter values ​​to the control circuit 1026. In some embodiments, the control circuit stores the measured values ​​in a memory 1028. In some embodiments, the memory 1028 includes multiple predetermined values ​​for at least one environmental parameter, such as a maximum pressure value, a maximum temperature value, or any other predetermined environmental parameter value or its indication value. In some embodiments, the memory 1028 contains at least one cryotherapy protocol, at least one cryotherapy parameter value or its indication value. In some embodiments, the memory includes log files relating to the operation of the cryotherapy device 1002 or the cryotherapy system 1000.

[0273] According to some exemplary embodiments, the control unit 1002 includes at least one interface 1030 electrically connected to the control circuit 1026. In some embodiments, the interface 1030 includes a sound source and / or a display. In some embodiments, the control circuit 1026 signals the interface 1030 to generate at least one indication, such as a human-detectable indication from the cryotherapy device or the cryotherapy system to a user. In some embodiments, for example, when a measured environmental parameter value within the body cavity exceeds a predetermined value, the control circuit 1026 signals the interface 1030 to generate an alarm.

[0274] According to some exemplary embodiments, the control circuit 1026 is electrically connected to at least one cryogenic flow regulator, such as a valve, on the cryogenic inflow path. In some embodiments, the control circuit regulates the flow through the cryogenic inflow path, for example, by reducing the flow within the inflow path, for example, by stopping the flow within the inflow path, and / or by increasing the flow within the inflow path, for example, by transmitting a signal to the cryogenic flow regulator. In some embodiments, the control circuit regulates the cryogenic fluid flow within the cryogenic inflow path, for example, when the pressure within the body cavity is higher than a predetermined pressure value. Alternatively, the control circuit regulates the cryogenic fluid flow within the cryogenic inflow path, for example, when the temperature within the body cavity is lower than a predetermined temperature value.

[0275] According to some exemplary embodiments, the control circuit 1026 controls at least one purge flow regulator on the cryogenic inflow path. In some embodiments, the purge flow regulator is configured to control the flow of low-pressure fluid through the cryogenic inflow path and optionally into the body cavity through the cryogenic nozzle, for example, when the cryogenic fluid flow is stopped, reduced, or regulated by the control circuit.

[0276] According to some exemplary embodiments, the control circuit 1026 is connected to the outflow regulator, such as a valve. In some embodiments, the control circuit regulates the outflow regulator, for example by opening the outflow path, such as when the pressure within the body cavity is higher than a predetermined value and / or when the temperature is lower than a predetermined temperature value. According to some exemplary embodiments, the control unit 1004 includes a power source, such as power source 1032. Alternatively, the control unit 1004 is connected to an external power source via a wire. In some embodiments, the power source includes a battery, optionally a rechargeable battery.

[0277] According to some exemplary embodiments, a control unit, such as control unit 1004, is connected to at least one inflow path of a cryotherapy device, configured to allow fluid to flow from a fluid flow source into the body cavity. Optionally, the control unit is connected to at least one inflow flow regulator on the inflow path, configured to regulate the fluid flow through the inflow path and into the body cavity.

[0278] In some embodiments, the control unit, such as control unit 1004, is connected to at least one outflow path of a cryotherapy device and is configured to allow fluid to drain from the body cavity. Optionally, the control unit is connected to at least one outflow regulator, such as a valve or check valve on the outflow path, and is configured to regulate the drainage of fluid from the body cavity through the outflow path.

[0279] In some embodiments, the control unit 1004 controls the inflow regulator and the outflow regulator to adjust multiple pressure levels within the body cavity to a pressure level below a predetermined value. Optionally or additionally, the control unit 1004 controls the inflow regulator and the outflow regulator to adjust the temperature level within the body cavity to a temperature level above a predetermined temperature value.

[0280] According to some exemplary embodiments, the washing source 1008 includes a fluid container, such as a gas container or a liquid container. In some embodiments, the cryogenic source 1006 includes a container for a cryogenic fluid, such as liquid nitrogen, liquid carbon dioxide, or any other cryogenic compound, which can be stored as a liquid or gas at room temperature under high or low pressure.

[0281] According to some exemplary embodiments, at least one of the washing source 1008, the optics 1036, the cryosource 1006, and / or the drain pump 1007 is part of the cryotherapy system. Alternatively, the washing source 1008, the optics 1010, the cryosource 1006, and / or the drain pump 1007 are multiple external components optionally connected to the system 1000.

[0282] Exemplary cryotherapy procedure:

[0283] According to some exemplary embodiments, a cryotherapy is used to ablate substances, such as tissue, lesions, or tumors, from the inner surface of a body cavity (e.g., the bladder). In some embodiments, during the cryoablation, also referred to in some examples as cryoablation, some cells or tissue on the inner surface of the bladder are ablated, for example, in cases where the cells or tissue are cancerous or tumorigenic cells. In some embodiments, the expanding coolant substance causes some cells and / or a portion of tissue on the inner surface of the body cavity to die with a rapid ablation effect, such as immediate necrosis, or a slow ablation process, such as cell apoptosis caused by the body's destruction of cells.

[0284] Now for reference Figure 1B A cryotherapy procedure according to some exemplary embodiments of the present invention is described.

[0285] According to some exemplary embodiments, in step 1050, at least a portion of the cryotherapy device is introduced into the body cavity. In some embodiments, a cryotherapy device, for example... Figure 1A The cryotherapy device 1002 of the cryotherapy system 1000 shown is inserted into the body cavity through the working channel of an endoscope. Alternatively, the cryotherapy device is introduced into the body cavity through a sheath, such as an endoscope sheath or a dedicated sheath for the cryotherapy device.

[0286] According to some exemplary embodiments, the body cavity expands in step 1052. In some embodiments, the device is at least partially inserted into the body cavity to allow the cavity to expand. In some embodiments, the body cavity is expanded to allow better examination of the inner surface of the body cavity, for example, by an optical sensor, optionally a camera of the cryotherapy device or an optical sensor of a different device. Optionally or additionally, the body cavity is expanded to allow better access to different regions or multiple selected target regions within the body cavity. In some embodiments, the body cavity is expanded by allowing a washing fluid, optionally a low-pressure gas, to pass through it. In some embodiments, during the expansion of the body cavity, the pressure within the body cavity is monitored by at least one sensor located within the body cavity or in an outflow channel of the cryotherapy device, such as outflow channel 1010. Optionally or additionally, the pressure is monitored by measuring the pressure or pressure change within a washing flow path, optionally by a pressure sensor located in the washing flow path. In some embodiments, the pressure is monitored by at least one sensor, such as a pressure sensor located outside the body. In some embodiments, the expansion of the body cavity is controlled by the control circuit, such as control circuit 1026, optionally based on multiple signals received from at least one sensor. In some embodiments, the body cavity is expanded to a desired or selected degree of expansion.

[0287] According to some exemplary embodiments, the cavity expands by a washing fluid directed toward the optical component, for example, to keep the optical component, such as a lens, clean and / or dry and / or maintain it at a specific temperature. Alternatively or additionally, the cavity expands by a purge flow of a low-pressure fluid through the cryogenic nozzle.

[0288] According to some exemplary embodiments, in step 1054, the inner surface of the body cavity is visualized. In some embodiments, the inner surface is visualized at least by an optical sensor of the cryotherapy device, such as optical sensor 1022, which may optionally be a camera. Alternatively, the inner surface of the body is visualized by at least one optical sensor located outside the body cavity, which receives optical signals through an optical channel inside the cryotherapy device, such as optical channel 1018. In some embodiments, the optical signals are received by an optical unit, such as optical device 1010, which may optionally be located outside the body. In some embodiments, when the body cavity is visualized, at least one light source is activated, such as a light source on the cryotherapy device located inside the body cavity or a light source located outside the body.

[0289] According to some exemplary embodiments, a target area for cryotherapy is determined in step 1056. In some embodiments, the target area is determined based on the analysis of multiple images displaying the surface of the body cavity. Optionally, the target area is determined based on the imaging results and / or other clinical data.

[0290] According to some exemplary embodiments, the cryotherapy device or its distal end (e.g., distal end 1021) is guided to a selected distance from the determined target area, such as a distance of up to 50 mm from the target area, or a distance of 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, or any intermediate, smaller, or larger distance from the target area. Additionally or alternatively, the cryotherapy device or the distal end is guided to a selected angle having the determined target area. In some embodiments, the distal end of the cryotherapy device is passively guided by rotating the distal end of an endoscope at a selected angle. Optionally or additionally, at least a portion of the cryotherapy device is actively guided to the desired target area and / or to a desired angle between the opening of the cryogenic inflow path and tissue in a selected target area.

[0291] According to some exemplary embodiments, the distance to the target area is determined in step 1060. In some embodiments, the distance between the distal end of the cryotherapy device and the target area is determined by unfolding a ruler or attachment of known length, such as a wire, and contacting the target area on the surface of the body cavity. In some embodiments, the distance is determined optically by a light beam (e.g., a laser beam). Optionally, the distance is measured by an optical distance meter, such as a laser meter connected to the cryotherapy device, which is optionally located at the distal end of the cryotherapy device.

[0292] According to some exemplary embodiments, the distance between the cryotherapy device (e.g., the distal end of the cryotherapy device) and the target area is determined by releasing an air or gas jet from an inflow path of the cryotherapy device. The washing channel 1014 extends from the cryo-nozzle toward the target area and visualizes the effect of the air or gas jet on the tissue. In some embodiments, the air or gas jet forms an indentation at the contact site with the inner surface of the body cavity. Optionally, the distance from the contact site and / or the angle between the cryotherapy device and the target area is determined by visualizing the depth, size, and / or shape of the indentation. In some embodiments, at least one parameter value of the cryotherapy process, such as the duration of the cryotherapy and / or the pressure and / or amount of cryofluid required to achieve the desired therapeutic outcome, is determined based on the distance and / or angle.

[0293] According to some exemplary embodiments, the treatment space is established in step 1062. In some embodiments, the treatment space is established by unfolding at least one foldable element, such as a cone or a garment, surrounding a treatment space between the cryotherapy device and the target area within the body cavity. In some embodiments, the treatment space is established to reduce damage to tissues surrounding the target area due to the release of the cryofluid. Alternatively and / or additionally, the treatment space is established to allow for better control of multiple microenvironmental parameters within the limited volume of the treatment space.

[0294] According to some exemplary embodiments, in step 1064, the cryotherapy device is aimed at the target area. In some embodiments, the distal end of the cryotherapy device is aimed at the target area. Optionally or additionally, the nozzle is optionally an adjustable nozzle configured to spray the cryofluid and aimed at the target area.

[0295] According to some exemplary embodiments, in step 1066, the cryogenic fluid is applied. In some embodiments, the cryogenic fluid is applied, for example, by spraying it into the target area through the nozzle. In some embodiments, the cryogenic fluid is applied while the body cavity expands, optionally as air or gas entering the body cavity through a different inflow channel. Alternatively, when the cryogenic fluid is applied, the body cavity expands solely by applying the cryogenic fluid and optionally by the expansion of the cryogenic fluid within the body cavity. Alternatively, the body cavity expands solely by the washing fluid, which optionally keeps the optics dry and / or maintains a near-constant temperature.

[0296] According to some exemplary embodiments, in step 1068, cryogenic washing and / or optical washing are applied. In some embodiments, the washing fluid, such as a gas, optionally a low-pressure gas, is applied between multiple injections of the cryogenic fluid. Alternatively, the washing is applied during the injection of the cryogenic fluid. Optionally, the washing fluid is used to expand the body cavity. In some embodiments, the washing is applied through a washing inflow path, for example... Figure 1AThe washing channel 1014 is shown. In some embodiments, the washing is applied to a space in front of a distal opening of the optical channel 1018 and / or a space in front of the optical sensor 1022 and / or the light source 1019, for example, to remove and / or push away particles formed by the cryogenic fluid within the body cavity. Alternatively or additionally, the washing is applied to the space between the cryogenic nozzle and the target area to remove particles. In some embodiments, particle removal allows for better visualization of the application of the cryogenic fluid at the target area 1066. In some embodiments, the washing fluid comprises a warm gas or warm fluid with a temperature above 15 degrees Celsius, such as 15 degrees Celsius, 20 degrees Celsius, 25 degrees Celsius, or any intermediate, lower, or higher temperature value. In some embodiments, the warm fluid is used, for example, to increase the temperature within the body cavity and optionally reduce humidity.

[0297] According to some exemplary embodiments, in step 1070, substances from the body cavity are evacuated. In some embodiments, some substances (e.g., liquids, particles, gases) are discharged from the body cavity through an outflow channel within the cryotherapy device, for example... Figure 1A The outflow channel 1010 is shown. In some embodiments, when the pressure within the body cavity exceeds a predetermined value, the substance is passively evacuated, for example, by opening a valve, such as a check valve in the outflow path. Optionally or additionally, the substance is actively evacuated by actively generating a negative pressure in the outflow path, optionally by activating a vacuum pump. In some embodiments, the substance is evacuated between or during the injection of the cryogenic fluid in step 1066. In some embodiments, the substance is evacuated when the pressure exceeds a predetermined pressure value. Alternatively, the substance is evacuated when the temperature within the body cavity is below a predetermined value.

[0298] According to some exemplary embodiments, in step 1072, the target area is visualized. In some embodiments, the target area is visualized after the cryofluid is sprayed, for example, to determine the effect of the cryofluid on the target area. Optionally, the target area is visualized to determine the success of the cryotherapy. In some embodiments, if the treatment is ineffective, the device may optionally be aimed at a different target area and / or positioned relative to the target area at a different angle and / or distance.

[0299] According to some exemplary embodiments, in step 1074, the cryotherapy device is retracted from the body cavity. In some embodiments, the cryotherapy device is retracted when a desired goal is achieved during the cryotherapy, such as cryoablation of the target area. Optionally, the device is retracted to allow redirection to a different area within the body cavity.

[0300] An exemplary cryotherapy device within an integrated cavity:

[0301] Now for reference Figure 1C and Figure 1F It shows a schematic longitudinal sectional view of an embodiment of a cryotherapy device according to some exemplary embodiments of the present invention, such as cryotherapy device 10, which is supplied to the body cavity 11 to be treated via an endoscope 16.

[0302] According to some exemplary embodiments, such as Figure 1C As shown, a jet stream 13 comprising expanding high-pressure (or compressed) cryogenic fluid may be ejected from the distal end 14 of the device 10 and directed to a treatment area 12, which may be a treatment area 12, which may be an area of ​​a benign or cancerous tumor, cyst, polyp, free nerve ending or certain symptoms (pain, etc.) occurring, even if its specific origin is unknown, the treatment area 12 may be frozen to treat or ablate.

[0303] According to some exemplary embodiments, such as Figure 1D As shown, the body cavity 11 may include more than one target region, such as regions 12a, 12b, and 12c. Therefore, in some embodiments, the distal end 14 of the device 10 may include more than one nozzle (not shown), wherein jet streams 13a, 13b, and 13c originating from each nozzle are directed toward each target region. According to some exemplary embodiments, the distal end 14 includes a plurality of nozzles, each nozzle having an open and closed configuration. The nozzles can be used (i.e., opened) according to their relative position to the target regions, such that the nozzles directed toward the target regions are opened, and thus, the cryogenic fluid exiting those nozzles is directly jetted into the plurality of target regions.

[0304] According to some exemplary embodiments, such as Figure 1E As shown, the device 10 includes an inflow fluid 133 and an outflow fluid 177, the inflow fluid 133 providing a plurality of jet streams 13 (or any number of jet streams, such as...). Figure 1B As shown), the outflow fluid 177 is, for example, fluid 17 used to evacuate the expansion from the body cavity 11. In some embodiments, an enlarged portion of the device 10 shows a tube for the inflow fluid 133 positioned within a tube for the outflow fluid 177; however, according to different embodiments, they may be positioned relative to each other. Furthermore, there may be any number of outflow and inflow tubes.

[0305] According to some exemplary embodiments, such as Figure 1F As shown, the endoscope 16 can also be used at an acute angle to allow the jet 13 to reach the treatment area 12, regardless of where the treatment area 12 is located in the body cavity 11.

[0306] An exemplary cryotherapy system with inflow and outflow devices:

[0307] Now refer to Figure 2A , Figure 2B and Figure 2C According to some exemplary embodiments of the invention, this paper shows several schematic longitudinal sectional views of a cryotherapy system, specifically illustrating means of fluid inflow and outflow from the treatment area. According to some exemplary embodiments, a cryotherapy system, such as cryotherapy system 20, includes a pressurized coolant source 201 and a discharge device 202. In some embodiments, the discharge device 202 may be dedicated to cryotherapy system 20, a general discharge means, an outlet to the ambient atmosphere, or any other suitable means by which substances, such as expanding fluids, can be discharged from the system. According to some embodiments, the discharge device 202 includes suction provided by any suitable pump, vacuum, etc. According to some embodiments, the evacuation device 202 may be attached to the proximal end of cryotherapy device 10. According to some embodiments, the evacuation device 202 is attached to cryotherapy device 10 via a junction 28.

[0308] According to some exemplary embodiments, for example Figure 2A and Figure 2B As shown, a cryotherapy catheter 224 is inserted into an endoscope 16 such that its distal end 24 reaches the distal end of the endoscope, while the proximal end of the cryotherapy catheter 25 remains outside the proximal end of the endoscope 16. According to some embodiments, the proximal end connects to a junction 28, as detailed herein. According to some embodiments of the invention, simultaneous inflow of fluid 133 and outflow of fluid 177 is permitted. Figure 2B In some embodiments, the seal 28a can prevent potential mixing between the two fluids. In some embodiments, when the two fluids are coaxially oriented within the endoscope, it may be necessary to separate the fluids outside the endoscope. An optional suction trap 203 can collect the evacuated fluid and can protect the evacuation device 202 from contamination.

[0309] According to some embodiments, for example, as shown in Figure 1. Figure 2C As shown, the junction 28 includes a valve 28b that controls the inflow fluid 133 and the outflow fluid 177 so that they do not flow simultaneously; instead, the valve 28b determines whether to activate the inflow 133 or whether to activate the outflow 177. In some embodiments, the valve 28b can be operated by any suitable means, including multiple predefined settings, electronic devices, manual operation, etc. In some embodiments, the control of the valve 28b can take into account pressure, time, target area response, etc.

[0310] According to some embodiments, inflow can be stopped when the pressure within the body cavity is higher than about 30 to 100 millibars. According to some embodiments, outflow can continue until the pressure within the body cavity is lower than about 20 to 10 millibars. According to some embodiments, inflow can be stopped when the temperature within the body cavity is lower than about 5 to 100°C. According to some embodiments, inflow can be initiated when the temperature within the body cavity is higher than about 15 to 200°C. According to some embodiments, temperature, pressure, and any other suitable parameters can be used to control the system.

[0311] According to some embodiments, a cryotherapy system may include a control mechanism, such as... Figure 1A The control unit 1004 shown controls coolant injection and / or expanded fluid discharge. In some embodiments, the control mechanism may include a plurality of predetermined parameters (e.g., circulation) and / or may include a plurality of parameters defined based on feedback from data collected from the system by any suitable sensor, such as distal pressure, distal temperature, proximal pressure, proximal temperature, comparison of inflow and outflow, operating time, and other optional measurement parameters. In some embodiments, when implementing such feedback-dependent control, the associated sensing and control means will be part of the embodiments (e.g., CPU, firmware, flow sensor, pressure sensor, clock, etc.).

[0312] Now refer to Figure 3 This diagram shows a schematic longitudinal sectional view of an embodiment of a cryotherapy system according to some exemplary embodiments of the present invention, specifically the location and possible fixation of the distal end of the device. According to some embodiments, the cryotherapy system, such as cryotherapy system 20, includes a pressurized coolant source 201 and a vacuum device 202, which is optionally interconnected at a junction 28 with the proximal end 35 of the cryotherapy device 10. In some embodiments, an optional vacuum collector 203 may be used to collect the vacuumed fluid as needed.

[0313] Exemplarily defining the distance between the distal end of the catheter and the distal end of the endoscope:

[0314] According to some embodiments, a fixation mechanism is implemented to define the distance between the distal end of the cryotherapy device (e.g., the distal end 24 of the catheter) and the distal end of the endoscope 16. In some embodiments, the fixation device may be attached to the proximal end 35 of the cryotherapy device 10. In some embodiments, a plurality of notches 35a provide a specific distance between the distal end 24 of the catheter and the distal end of the endoscope 16, and a limiter 35b can be moved and / or fixed according to each specific notch or graduation relative to the operator's definition of the desired distance. The desired distance may be predefined, controlled by any suitable electronic device, manually controlled, etc. The desired distance may change during operation of the device or may remain constant throughout the cryotherapy. The limiter 35b may be fixed in a notch 35a by any suitable fixation device, such as a clip, screw, elastic band, etc.

[0315] Exemplary cryotherapy device distal end:

[0316] Now for reference Figures 4A to 4D This image shows a schematic longitudinal sectional view of the distal end of a cryotherapy device according to some embodiments of the invention. According to some exemplary embodiments, any number of tubes / conduits can be used separately within and from the system. It should also be noted that, according to some exemplary embodiments, any suitable configuration of these multiple tubes / conduits relative to each other is possible, including one within another, two adjacent tubes, etc. Some embodiments include a tube / conduit comprising a plurality of paths through which fluid can flow in any defined direction. According to some embodiments, the distal end 24 includes a plurality of paths for the simultaneous flow of pressurized coolant into fluid 133 (ejected through nozzle 49) and outflow of expanded fluid effluent 177.

[0317] According to some embodiments, such as Figure 4A As shown, the distal end 24 has an inflow nozzle 49 and an outflow opening 407 in a plane that is close to or similar to the plane.

[0318] According to other embodiments, such as Figure 4B As shown, the inflow nozzle 49 and the outflow opening 407 are positioned in different planes at the distal end 24. In some embodiments, when they are in different planes, the inflow and outflow may not interfere with each other, thereby optimizing the freezing efficiency of the inflow fluid 133 and the discharge of the outflow fluid 177.

[0319] According to other embodiments, such as Figure 4CAs shown, the outflow opening 407 is positioned at a varying distance from the inflow nozzle 49, for example, having an inclined cross-section. In some embodiments, this can also provide inflow and outflow that do not interfere with each other. In some embodiments, by having a varying distance between the inflow nozzle 49 and the outflow opening 407, the fluid discharged through the outflow opening 407 should not interfere with the inflow fluid 133, although still at least partially close to the nozzle 49, making it possible for the outflow fluid 177 to be effectively discharged / drawn through the outflow opening.

[0320] According to other embodiments, such as Figure 4D As shown, the distal end 24 includes a plurality of side outflow openings 407. In some embodiments, the side outflow openings 407 may be circumferential or partially circumferential. These side openings space the openings for the outflowing fluid 177 and the inflowing fluid 133 from each other, preventing them from interfering with each other. Furthermore, due to the presence of multiple outflow openings 407, fluid can be effectively discharged even though they are located on the sides of the distal end 24.

[0321] Now refer to Figure 4E This image shows a schematic longitudinal sectional view of the distal end 24 of a cryotherapy device according to another embodiment of the invention. According to some embodiments, the distal end 24 does not include any opening into the treated cavity, allowing coolant to remain and expand within the distal end 24. According to such embodiments, the transfer of cold temperature into the tissue is mediated by the mediating region 44. Therefore, no pressure is created in the treated cavity. According to some embodiments, to further optimize temperature drop, i.e., freezing of the treated area, the feedback coil 409 may utilize the already cooled, expanded fluid flowing out of the fluid 177 to pre-cool the pressurized coolant flowing into the fluid 133.

[0322] According to some embodiments, the mediating region 44 is made of a rigid material such as stainless steel, copper, or brass. According to other embodiments, the mediating region 44 may be at least partially made of an expandable or inflatable material (e.g., a balloon), thereby enabling the distal end 24 to conform to the geometry of the body cavity being treated, thus optimizing the treatment. According to yet another embodiment, the expandable / inflatable portion of the mediating region 44 may be expanded / inflated such that it does not necessarily fill the treated cavity, but is able to contact or surround the target area. According to some embodiments, the expandable / inflatable portion of the mediating region 44 is expanded / inflated automatically or manually according to a number of predetermined parameters based on signals received from any suitable sensor. Furthermore, the rate and size of expansion / inflation may vary throughout the cryotherapy. As described above, the mediating region can be made of compliant materials (15% to 200%, such as polyurethane, nylon elastomers, and other thermoplastic elastomers), non-compliant materials (0% to 8%, such as PET, nylon, and others), or semi-compliant materials (5% to 15%, such as polyamides and engineered nylons as polyether block amides). Prepared using PET and polyurethane, it can have any suitable size and shape, and can be further mediated by expansion and / or movement by the user, mediated by external movement, to bring it into contact with the area being treated. In some embodiments, the expansion and / or movement can be controlled by any suitable means, and can be further controlled based on data collected by any internal or external sensors.

[0323] Now for reference Figures 4F to 4H A schematic cross-sectional view of the cryotherapy device is shown. According to some embodiments, inflow fluid 133 flows through tube / conduit 33 located within tube / conduit 77, and outflow fluid 177 flows through tube / conduit 77. According to some embodiments, tube / conduit 33 and 77 can be separated from each other and positioned as needed during or before the cryotherapy treatment. According to several other embodiments, tube / conduit 33 and 77 are integrated together such that essentially only one such tube / conduit exists, including channels for outflow fluid 177 and inflow fluid 133. Therefore, two tubes can be used to create a desired shape or otherwise, and can be extruded to have multiple suitable channels. It should be noted that, although... Figure 4F The embodiment presented shows a tube 33 inside a tube 77, but according to other embodiments, the tube 77 may be placed inside or beside the tube 33. Figure 4G and Figure 4H The embodiment shown is similar, in which the position of any tube can be changed according to system / user requirements. Furthermore, according to some embodiments, the outer tube (tube 77 in the figure) can be the working channel of the endoscope, through which tube 33 (or vice versa) passes.

[0324] According to another embodiment, such as Figure 4G and Figure 4H As shown, the cross-section of the distal end 24 has several openings, through which the outflowing fluid 177 passes, while the inflowing fluid 133 passes through the other openings. Depending on system / user requirements, any one of the openings can be used as an inflow, outflow, or a sensing channel. The sensing channel is a channel through which at least one sensor passes, and data collected from said sensor can be used to control the system and its use. Furthermore, depending on various predetermined conditions and parameters defined by data received electronically or manually from any suitable sensor, any channel can be used for outflow or inflow at different time points during cryotherapy. It should be noted that, although... Figures 4A to 4H This is a specific embodiment of the display device at the distal end, but any other embodiment including any number or location of inflow / outflow tubes can be implemented. It should also be noted that any such tube can be prepared from a combination of several tubes manufactured and / or extruded.

[0325] According to other embodiments, any number of paths / tubes / catheters passing through endoscope 16 can serve as sensing means, which may be needed in controlling the pressure or temperature of the body cavity, such as pressure sensing and / or temperature sensing, or for any other required sensors. Additional sensing means may include sensors for calculating the volume of the body cavity (e.g., initial volume and volume changes due to inflow and outflow of fluid), sensors for detecting the thickness of the body cavity walls (e.g., via ultrasound or laser), etc.

[0326] Exemplary angle of cryotherapy device:

[0327] Now refer to Figures 5A to 5D It shows a schematic longitudinal sectional view of a cryotherapy device according to some embodiments of the present invention, the cryotherapy device being inserted into the body cavity via an endoscope in an acute-angled shape. According to some embodiments, a cryotherapy device (e.g., Figure 5A The cryotherapy device 10 shown is inserted into the working channel of the endoscope 16 such that the distal end 24 of the cryotherapy device 10 reaches the distal end of the endoscope 16. In some embodiments, when the angle (including acute angle) of the endoscope 16 is necessary for passage through certain channels and / or for aiming at the treatment area, no kink must be formed in the cryotherapy device 10. In some embodiments, such as kink 505a, as... Figure 5AAs shown, this may interfere with the inflow and outflow of fluid through the cryotherapy device 10. Therefore, the cryotherapy device 10 may include a tube / catheter that is flexible, bendable, and / or kink-resistant, such as a braided tube 505b. Figure 5B ) or coiled tube 505c Figure 5C This helps to form angles, including acute angles, allowing targeting of any treated area within the entire treated body cavity, and access to the body cavity through any necessary channels. According to some embodiments, the cryotherapy device 10 includes a tube / catheter wherein only certain portions of the tube / catheter are flexible, bendable, and / or kink-resistant. According to other embodiments, the cryotherapy device 10 includes a tube / catheter that is flexible, bendable, and / or kink-resistant along its entire length.

[0328] According to some embodiments, the cryotherapy device may include a non-rigid, flexible, semi-expandable catheter 54a. Figure 5D It can be expanded by one of the multiple fluids in the device (pressurized or expanding fluid) until the working channel geometry is formed. This is especially important when the working channel undergoes an angle. According to some embodiments, a more rigid component 54b can be found around the distal end of the conduit. Figure 5D This allows the rigid component to help maintain the shape and orientation of the orifice of the conduit, even during expansion, in order to maintain the desired jet flow 53.

[0329] Example nozzle:

[0330] Now for reference Figures 6A to 6E A schematic longitudinal sectional view of the distal end of a cryotherapy device according to some embodiments of the present invention is shown, specifically illustrating embodiments of nozzles / orifices / valvees flowing into a tubing / conduit and the associated inflow and jetting of cryofluid. According to embodiments of the present invention, a cryotherapy device may include a pressurized coolant tubing / conduit through which cryofluid flows until it exits the tubing / conduit through a nozzle / orifice / valve, thereby entering the body cavity to be treated. Such nozzles / orifices / valve can be designed in any suitable manner such that the cryofluid flow into the body cavity, possibly directed towards the area to be treated. According to one embodiment, for example... Figure 6A As shown, an inflow path, for example, inflow fluid 133 exits the pipe body 60 via an orifice (nozzle / orifice) 69a, which is an opening at the distal end of the pipe body 60. It should be noted that although not shown, any of the orifices / nozzles described herein may include any type of valve, etc.

[0331] According to some embodiments, such as Figure 6BAs shown, the inflow fluid 133 exits through an orifice (nozzle / orifice) 69b, which has a reduced diameter relative to the diameter of the tube body 60. This reduced diameter can provide for the injection of cryogenic fluid at a defined pressure onto the treated area and / or can achieve a more effective and accurate Joule-Thompson effect.

[0332] According to some embodiments of the present invention, such as Figure 6A and Figure 6B As shown, the orifice / nozzle / orifice / 69a or 69b is aligned in the direction of the tube body 60 to produce a frontal jet of the inflow fluid 133. According to other embodiments of the invention, the orifice / nozzle / orifice points in any suitable direction, including on one side of the tube body 60. According to some embodiments, the jet direction exiting any of the plurality of nozzles can be changed by an element in the nozzle, which can point in any suitable direction, wherein the direction of the element can be changed automatically or manually by an electronic device, in response to data received from any suitable sensor, etc.

[0333] According to some embodiments, such as Figure 6C As shown, any number of orifices may exist in the pipe body 60, allowing the inflowing fluid 133 to exit through multiple orifices 69c. Furthermore, the orifices 69c can be set in any desired configuration, and furthermore, each orifice may include a valve that can be closed, opened, or partially opened as needed.

[0334] According to some embodiments, and according to other embodiments, the nozzle is part of the tube body 60, such as Figure 6D As shown, nozzle 69d is an additional component attached or connected to tube body 60 by any suitable means. Such connection or attachment may arise from manufacturing advantages or limitations. According to some embodiments, any nozzle may have a specific shape or size, for example, as... Figure 6E As shown, a conical nozzle 69e can be used. In some embodiments, the size and shape of the nozzle, as well as the number of nozzles, can be optimized for various treatments, such as the size or type of the treatment area / lesion, the size of the body cavity in which the treatment area / lesion is found, the size and shape of the inflatable cryoballoon, etc. In some embodiments, additional processes, such as heat treatment or machining, may be required to achieve the specific shape of the nozzle 69e. In some embodiments, the inner diameter of any inflow or injection nozzle can be in the range of about 0.05 to 0.3 mm, while the inner diameter of any discharge or outflow nozzle can be in the average range of about 0.5 to 4 mm. It should be noted that the cross-section of the nozzle can be any suitable shape, including circular, non-circular, elliptical, slit-shaped, etc.

[0335] Exemplary discharge path:

[0336] Now refer to Figure 7A and Figure 7B This image shows a schematic transverse cross-sectional view of the distal end of a cryotherapy device inside an endoscope according to some embodiments of the invention. The endoscope has inflow and outflow paths, such as inflow and outflow channels. According to some embodiments, the distal end 24 of the cryotherapy device directs the inflow fluid 133 of a coolant jet to the target area to be treated. The cryotherapy catheter is inserted from the proximal end of the endoscope through its inflow channel.

[0337] According to some embodiments of the present invention, and as Figure 1A As detailed in Figure 6, the expanded coolant and any other fluids present in the treated organ are drained via a catheter / tube inserted into the organ through the endoscope, such as a cryotherapy device inserted into the organ through a working channel of the endoscope. According to some embodiments, evacuation can be performed via one or more inherent tubes or pathways, which may be part of the endoscope or can be added to or delivered through it. For example, some endoscopes have an opening on their posterior side (e.g., cystoscopic and hysteroscopic resectoscopes) into which a cryotherapy device can be inserted. In such endoscopes, at least partial drainage can be performed via the posterior side 773, while some evacuation can be performed via an outflow outlet 771 and / or an inflow inlet 772. It should also be noted that such openings can be used to control the inflow, outflow, and the body cavity pressure affected by the inflow / outflow.

[0338] According to some embodiments of the invention, the opening of the discharge tube / conduit may be in close proximity to the inflow fluid 133 or in the same or similar plane as the inflow fluid 133 (see, for example...). Figure 7A (The opening 77a shown). According to other embodiments, a plurality of circumferentially oriented discharge openings 77b are provided, such as... Figure 7B As shown in the diagram, the position, number, size, diameter, etc., of the discharge pipes can be changed and defined as needed. Furthermore, any opening can be fitted with a valve that allows the opening to open, close, or partially close, so that any opening can be used as needed. The operation of the valves can be electronic, manual, or automatic, based on signals received from any suitable sensor, etc.

[0339] Exemplary folded ablation component:

[0340] Now refer to Figure 8A and Figure 8B This image shows a schematic longitudinal cross-sectional view of multiple cryotherapy devices being delivered into the treated body cavity via an endoscope during an ablation procedure according to some embodiments of the invention. In some embodiments, such as Figure 8A The dedicated ablation component 83a shown or Figure 8B The dedicated ablation component 83a shown can be an deployable cryogenic balloon (e.g.) Figure 4E (As shown in the middle section).

[0341] According to some exemplary embodiments, in order to treat the target area 82, a cryotherapy device, such as an ablation device 80, is inserted into the endoscope 16 through its working channel, such that the distal end 24 of the device is disengaged from the distal end of the endoscope within the body cavity 81, and as... Figure 8A As shown, the proximal end 85 of the device remains outside the proximal end of the endoscope and outside the patient being treated. According to some embodiments of the invention, a dedicated ablation component 83a deploys within the body cavity 81 to treat the target area 82, such as... Figure 8A As shown.

[0342] According to other embodiments of the invention, a wider ablation component 83b unfolds within the body cavity 81 to simultaneously treat multiple target regions 82 and 82b, as well as more regions, such as... Figure 8B As shown. If necessary, the entire body cavity can be treated.

[0343] Reference Figure 8C and Figure 8D This image shows a schematic longitudinal cross-sectional view of a cryotherapy expansion device introduced via an endoscope into the treated body cavity during an ablation procedure, according to some embodiments of the invention. In some embodiments, the expansion component may include several regions, each with a different level of compliance. In some embodiments, the expansion component may consist of non-compliant or semi-compliant portions (0-8%), see [link to documentation]. Figure 8C and Figure 8D The element 83c shown, and the semi-compliant or compliant portion (5-200%), see [reference needed]. Figure 8C and Figure 8D The element 83d is shown. According to some embodiments, element 83c can be made of any suitable type of metal or plastic. According to some embodiments, element 83c can have a folding and unfolding configuration.

[0344] According to some embodiments, the cold energy is delivered to the tissue via a compliant / semi-compliant element 83d. As shown, according to some embodiments, only a portion of the cryoballoon may contact the treated area, while other areas within the treated body cavity do not directly contact the cryoballoon. In some embodiments, element 83d may be an expandable component, wherein element 83c may be a structural element designed to maintain and / or partially define the shape of element 83d. In some embodiments, the expandable component 83d may be held deployed within the endoscope 16. Figure 8CAnd its shape is such that when it expands (by flowing into fluid 133 or other means), element 83d is directed toward the target region to transfer cold energy thereto.

[0345] Now refer to Figures 8E to 8G The diagram shows a schematic longitudinal cross-sectional view of a cryotherapy expansion device introduced into the body cavity during an ablation procedure according to some embodiments of the present invention. Figure 8E The expansion component within the body cavity near the treatment area 82c is shown, and it has a movable portion 83d. Figure 8F The expansion component exhibits an active area of ​​83d1 with low compliance (0 to 8%), while Figure 8G The diagram shows an expansion member with an active area 83d2 having high compliance or semi-compliance (5 to 200%). As shown, since the contact between the device and the treatment area is optimal, using a high-compliance or semi-compliance expansion element allows the device to fit optimally into the treatment area.

[0346] Now refer to Figure 9A and Figure 9B This shows a schematic longitudinal sectional view of the distal end 93 of an ablation device according to some embodiments of the present invention. According to some embodiments, Figure 9A The folded distal end 934a shown may include multiple support ribs and a cryoballoon component. According to some embodiments of the invention, the folded distal end 934a is inserted into the body cavity through a sheath 99 (which may be the working channel of the endoscope itself) by pushing a catheter or wire 931. However, the ablated distal end 934a is positioned within the body cavity near the target region (see [link to original text]). Figure 8A and 8B The user can manipulate the lever (or lever, valve, faucet, or controller) 933 to deploy the distal ablation end 934b, as shown. Figure 9B As shown, the ablation and freezing mechanism is then activated.

[0347] Exemplary cryotherapy device with a visualization device inside an endoscope:

[0348] Now for reference Figures 10A to 10D , and Figure 1A Related to the embodiments shown, a schematic longitudinal sectional view of another embodiment of a cryotherapy device, such as cryotherapy device 10, is shown, wherein the cryotherapy device 10 is introduced into the body cavity 11 to be treated via an endoscope 16.

[0349] According to some embodiments, such as Figure 10A As shown, the endoscope 16 may include a visualization device 18 for visualizing the field of view 19, wherein the jet stream 13 and / or the treatment area 12 are within the field of view 19.

[0350] According to other embodiments, and for example as Figures 10B to 10D As shown, endoscope 16 is a sheath-like device, which can be inserted into the body cavity through the sheath by various means, such as using space 188, for example... Figure 10D As shown. Therefore, the sheath 16 can allow insertion of different types of visualization devices 18 for observation of the field of view 19, cryotherapy devices 14, etc. In some embodiments, the outflow fluid 177 may have a dedicated outflow channel, for example, such as... Figure 10D As shown, it can flow through the free space 188 of the endoscope. Figure 10D ).

[0351] An exemplary cryotherapy system has a device for injecting fluid:

[0352] Now for reference Figure 11 It shows a schematic longitudinal sectional view of a cryotherapy system, similar to Figure 1A The system may be as shown in Figure 2, but specifically illustrates the flow paths and means of fluid inflow and outflow from the treated body cavity according to some embodiments. The invention includes, for example, devices for injecting fluids other than cryofluids. According to some embodiments, the cryotherapy system 20 includes a pressurized coolant source 201 and discharge devices 202a and 202b. It should be noted that either or both of discharge devices 202a and 202b may be used, and any other suitable discharge device may also be used. In some embodiments, the system 20 further includes an inflow path 204a for directing fluid into the body cavity, and an outflow path 204b for draining fluid from the body cavity. It should be noted that any suitable number of inflow and outflow paths may be used. In some embodiments, discharge devices 202a and / or 202b may be dedicated to the cryotherapy system 20 and may also be any known discharge device, including an outlet to the ambient atmosphere, or any other suitable device by which other substances (e.g., expanded fluid) can be discharged from the system. According to some embodiments, the discharge devices 202a and / or 202b include suction provided by any suitable pump, vacuum device, etc. According to some embodiments, the discharge devices (e.g., discharge devices 202a and / or 202b) may be attached to the proximal end of the cryotherapy device, for example... Figure 1A The cryotherapy device 1002 shown can optionally be attached to the proximal end of the outflow path or Figure 11 The outflow path 204b is shown. According to some embodiments, an optional suction collector (e.g., suction collector 203) can collect the discharged fluid and can protect the discharge device (e.g., discharge device 202a and / or 202b) from contamination.

[0353] According to some embodiments, such as Figure 11As shown, the inflow and outflow fluids can originate from a combination of multiple sources, such as source 201. It should be noted that any number of sources can be used together or in any desired order. According to some embodiments, source 201 can be reduced (e.g., pressure and / or flow rate decreased) by any one or both of pressure reducers 206, thereby providing pressurized coolant 205 at different times or simultaneously and / or reducing the inflow of fluid 207 (e.g., by using...). Figure 11 Path 208 is shown. It should be noted that different sources (not shown) can be used, and as detailed herein, the same source can also be used to provide different pressures and / or flow rates. According to some embodiments, path 205 can be used to deliver coolant to target tissue, while path 207 can be used to maintain body cavity expansion and / or for dehydration between cycles of cryotherapy. Thus, in some embodiments, the pressure of the fluid in each of paths 205, 207, etc., can be the same or different, and can be varied over time as needed. According to other embodiments, path 208 can be used in parallel with path 205 and can be used for pressure measurement, expansion control, and / or as a dehydration device.

[0354] According to other embodiments, instead of using pressure reducer 206, fluids 207 and 208 can originate from an additional pressure source (not shown) and optionally be delivered via a dedicated pump.

[0355] According to some embodiments, such as Figure 11 As shown, discharge devices 202a and / or 202b can be used simultaneously or at different times. In some embodiments, while source 202a may have the capability to handle high pressure and / or high flow rates, source 202b may also have fine-tuning capabilities to allow for accuracy and / or allow the system to provide lower pressure, lower flow rates, etc.

[0356] According to some exemplary embodiments, various pressure and discharge devices can operate according to any suitable means, including predefined settings, electronic devices, manual operation, etc. In some embodiments, control of different devices (205, 206, 207, 208, 202a, 202b) can take into account pressure, time, target area response, etc.

[0357] According to some embodiments, inflow can be stopped when the pressure within the cavity exceeds approximately 30 to 100 millibars. According to some embodiments, outflow can continue until the pressure within the body cavity falls below approximately 20 to 10 millibars. According to some embodiments, inflow can be stopped when the temperature within the body cavity falls below approximately 5 to 100°C. According to some embodiments, inflow can begin when the temperature within the body cavity exceeds approximately 15 to 200°C. According to some embodiments, temperature and pressure, as well as any other suitable parameters, can be used to control the system.

[0358] According to some embodiments, the cryotherapy system may include a control unit, such as a control mechanism, that controls coolant injection and / or expanded fluid discharge. The control mechanism may include multiple predetermined parameters (e.g., circulation) and / or may include multiple parameters defined based on feedback from data collected from the system by any suitable sensor, measuring multiple parameters such as distal pressure, distal temperature, proximal pressure, proximal temperature, comparison of inflow and outflow, runtime, and other optional measurable parameters. In some embodiments, when implementing such feedback-dependent control, associated sensing and control devices, such as control circuitry (e.g., CPU, firmware, flow sensor, pressure sensor, clock, etc.), may be included in or operate adjacent to these devices.

[0359] Exemplary rolling cryotherapy device:

[0360] Now refer to Figure 12A and Figure 12B It shows several schematic longitudinal sectional views of a rolling cryotherapy device 54 according to some embodiments of the present invention, including those that can be externally ( Figure 12A ) or inside ( Figure 12B Cooled rolling component 53. According to some embodiments, cryotherapy device 54 (e.g., in...) Figure 12A The image shows a rolling component 53 that has the ability to absorb low-temperature energy (e.g., made of metal) from an external source (in the form of a jet stream 13) and cool the treated tissue. According to other embodiments, and as for example... Figure 12B As shown, the rolling component 53 may have an internal cooling jet 13 that expands within the rolling component 53. According to some embodiments, the rolling component 53 is cooled both externally and internally. According to some embodiments, cryotherapy can be performed by rolling the component 53 over the treatment area 52, rather than by directly spraying coolant onto the treatment area 52. According to some embodiments, the rolling component 53 can be replaced with any component capable of delivering freezing energy to the treatment area 52, such as a sliding component or an ironing component.

[0361] Exemplary geometry of a cryo tip:

[0362] Now for reference Figure 13 It shows a schematic longitudinal sectional view of the distal end of a cryotherapy device according to an additional embodiment shown in Figure 4.

[0363] According to some embodiments, such as Figures 4A to 4C As shown, the distal end 24 has an inflow nozzle 49 and an outflow opening 407 in a plane that is close to or similar to the plane.

[0364] According to other embodiments, such as Figure 13 As shown, the inflow nozzle 49 and the outflow opening 407 are separated by an extension 4100 (e.g., conical, skirt-shaped, wing-shaped). In some embodiments, due to the separation between the inflow nozzle 49 and the outflow opening 407, the inflow and outflow do not interfere with each other when the extension 4100 is used, thereby optimizing the freezing efficiency of the inflow fluid 133 and the discharge of the outflow fluid. Additionally, according to some embodiments, the extension 4100 controls the size of the treatment area at least to some extent, because it essentially separates the treatment area and the untreated area at least partially, and isolates the treatment area so that only the treatment area can receive cryogenic energy, etc. According to some embodiments, the extension 4100 separates the distal end of the cryotherapy device from the treatment area. In some embodiments, when the extension 4100 separates the distal end of the cryotherapy device from the treatment area, it may or may not separate the inflow fluid 133 and the outflow fluid 177, separate the treatment area and the untreated area, or separate the treatment area 4200 and the surrounding body cavity volume, as detailed herein. In this regard, in some embodiments, the distal end of the cryotherapy device is intended to include the distal end of any element of the cryotherapy device, including endoscopes / sheaths, inflow or outflow channels, optical or visualization devices, etc.

[0365] According to some embodiments, the extension 4100 defines a treatment space, such as a treatment volume 4200, which is essentially a volume formed between the treatment area and the extension 4100 at the distal end of the cryotherapy device. Thus, the treatment volume 4200 is at least partially separated from the surrounding volume of the cavity being treated. It should be noted that although the extension 4100 does not necessarily contact the treatment area to avoid forming a closed volume, the treatment volume 4200 is defined as the volume formed if the extension 4100 is extended to contact the treatment area.

[0366] According to some embodiments, the extension 4100 at least partially separates the treatment volume from the surrounding body cavity volume, thereby maintaining hydration levels in the treatment volume and several conditions necessary for visualization of the treatment area and / or the treatment volume. Specifically, as described above, in some embodiments, various fluids other than the cryogenic fluid may be introduced, which may dry out or at least reduce humidity in the treatment area and / or the treatment volume 4200. In some embodiments, hydrated gases or even liquids may also be vented from the treatment volume to enhance visibility. In some embodiments, when the treatment area and / or the treatment volume 4200 is at least partially separated from the surrounding lumen environment by any element, such as the extension 4100, it is optionally easier to control conditions in the treatment volume and on the treatment area, including its hydration levels and the visibility conditions therein.

[0367] Now for reference Figure 14 (involving) Figures 6A to 6E The image shows a schematic longitudinal sectional view of the distal end of a cryotherapy device according to some embodiments of the invention, specifically showing a rotating or at least partially rotating nozzle / orifice / valve flowing into the tubing / conduit and the associated inflow jet of cryofluid. It should be noted that, similarly, any such rotating element may also be provided with the outflow tubing / conduit.

[0368] According to some exemplary embodiments, such as Figures 6A to 6E As shown, the jet of cryogenic fluid (or any other fluid) can be directed in a specific direction (forward, lateral, etc.). According to other embodiments, a combination of multiple directions (e.g., forward, lateral) can assist in uniformly cooling a region / volume while simultaneously covering it with the jet. In some embodiments, a combination of multiple jet directions can also be used when expanding an expandable device of a specific geometry, such that not only can the expandable device be expanded, but it can also be optionally cooled uniformly (e.g., for a flatter-shaped airbag).

[0369] According to some embodiments, the nozzle is part of the tube body 60. Figures 6A to 6C According to other embodiments, such as... Figure 14As shown, nozzle 69c is part of attachment component 601, which is attached or connected to tube body 60 by any suitable means that allows it to rotate at least partially (e.g., about an axis). It should be noted that although only one nozzle 69c is shown, any number of such nozzles may be included and can be positioned at any point on component 601. In some embodiments, the inner diameter of any inflow nozzle or injection nozzle may be in the range of about 0.05 to 0.3 mm, and note that the cross-section of the nozzle may be of any suitable shape, including circular, non-circular, elliptical, slit-shaped, etc. According to some embodiments, a rotating nozzle (e.g., 69c as part of 601) can provide coverage of an area / volume by spraying, such that the area / volume is uniformly cooled. In some embodiments, when expanding an expandable device of a certain geometry, a combination of multiple spray directions may also be used, such that not only is an expandable device expanded, but it is also uniformly cooled (e.g., a flatter-shaped airbag). It should be noted that component 601 can rotate about any suitable axis and can be further rotated by any amount of degree. In some embodiments, rotation can be controlled manually, mechanically, automatically through feedback, through multiple predefined parameters, or through any other suitable means. According to some embodiments, since the tube 60 and nozzle 69c are not in a straight line, the inflow action example 133 can cause assembly 601 to rotate about any suitable axis.

[0370] An exemplary distal end of a cryotherapy device with a visualization device:

[0371] Now for reference Figure 15A and Figure 15B , display according to Figure 7A and Figure 7B The images show multiple schematic cross-sectional views of the distal end of a cryotherapy device within an endoscope having inflow and outflow channels in some embodiments. According to some embodiments, the distal end 24 of the cryotherapy device directs the inflow fluid 133 of a coolant jet 13 to the target treatment area. In some embodiments, the cryotherapy catheter is inserted from the proximal end of the endoscope through its inflow channel. In some embodiments, a visualization device 78 is inserted through the endoscope to visualize the treatment area before, during, and / or after the cryotherapy procedure.

[0372] According to some embodiments of the invention, the opening to the discharge tube / conduit may be closely adjacent to or on the same or similar plane as the jet flow 13 (e.g., ...). Figure 15A (As shown). According to other embodiments, and as... Figure 15BAs shown, the cryotherapy device 76 may include an extension 7100. In some embodiments, the extension 7100 can control the conditions of the treatment volume 7200 and the treatment area and its conditions by at least partially separating the treatment volume 7200 and / or the treatment area from the surrounding body cavity environment. As described above, in some embodiments, the separation of the treatment volume 7200 and / or the treatment area from the general environment of the body cavity can control the dehydration of the treatment volume 7200 and / or the treatment area and provide better visualization of the treatment volume 7200, the treatment area, etc. (e.g., via visualization device 78). In some embodiments, compared to the extension 4100, such as Figure 13 As shown, both cryotherapy and visualization devices can be included within the treatment volume of 7200, however... Figure 13 In the illustrated embodiment, only the cryotherapy device is present within the internal volume of the extension, i.e., the treatment volume 4200. In some embodiments, the sensing device 25 may be located outside the treatment volume 7200, such as... Figure 15B As shown, this is for controlling the surrounding body cavity environment. In some other embodiments, the sensing device may be within the treatment volume 7200 to control conditions within the treatment volume 7200. According to some embodiments, multiple sensors may be placed both outside and inside the treatment volume 7200 to optionally control the treatment volume and the surrounding lumen environment.

[0373] According to some embodiments, the extension 7100 separates the distal end of the cryotherapy device from the treatment area. In some embodiments, when the extension 7100 separates the distal end of the cryotherapy device from the treatment area, it may or may not be separated between the inflow fluid 13 and the outflow fluid 17, between the treatment area and the non-treatment area, or between the treatment volume 7200 and the surrounding body cavity volume, as detailed herein. In this regard, in some embodiments, the distal end of the cryotherapy device is intended to include the distal end of any element of the cryotherapy device, including endoscopes / sheaths, inflow or outflow channels, optical or visualization devices, etc.

[0374] In some embodiments, this defined distance, particularly the distance between the cryojet 13 and the target region, can optimize the predictability and potential efficacy of cryoablation results.

[0375] In some embodiments, a defined distance between the cryotherapy device and the target area, or the tissue within the target area, is 5 mm, 10 mm, 15 mm, 20 mm, or any intermediate, smaller, or larger distance. In some embodiments, the minimum distance for spraying the cryofluid is at least 4 mm, for example 4 mm, 5 mm, 6 mm, or any intermediate, smaller, or larger value. In some embodiments, spraying the cryofluid at a distance of less than 4 mm can cause the tip / nozzle to adhere to the tissue, for example, due to the adhesive properties of cryotherapy. Additionally, when using a tapered cryonozzle or cryotip, distances closer to 4 mm increase the risk of tissue puncture.

[0376] Exemplary expandable cryotherapy device:

[0377] Now refer to Figures 16A to 16C It shows a schematic longitudinal sectional view of an expandable cryotherapy device during an ablation procedure according to some embodiments of the present invention. Figure 16A The expandable component 83 is shown in its folded configuration. In some embodiments, when the expandable component 83 is in its folded configuration, the distal end 24 of the cryotherapy device may be adjacent to the treatment area 82, allowing the visualization device 18 to clearly observe the treatment area 82, providing a clear field of view 19.

[0378] Figure 16BThe expandable component 83 shown according to some exemplary embodiments has an active region / section / part / element 83a and a support region / section / part / element 83b. In some embodiments, the support element 83b may be an integral part of the expandable component 83, for example, the support element 83b may be a painted area of ​​the expandable component 83, a surface treatment area of ​​the folded component 83, etc. According to other embodiments, the support element 83b may be an added or external element, added to, fused to, or adjacent to the folded component 83. In some embodiments, the support element 83b may have several functions in addition to providing support for the expandable component 83. In some embodiments, for example, the support element 83b may absorb the illumination from the visualization device 18 to overcome any type of glare, allowing the user to see the surroundings of the treatment area 82. Optionally or additionally, the support element 83b may be coated with an anti-reflective dye and / or its surface may undergo any suitable type of surface treatment to make it more light-absorbing (diffuse reflection versus specular reflection). For example, the support element 83b cannot transfer cold energy (e.g., it may be double-walled in the area or may be made of insulating material). Additionally, the support element 83b can provide support such that the active element 83a has a relatively flat shape rather than a perfectly circular shape; for example, the active element 83a may be shaped as a cone or bell.

[0379] Figure 16C The distal end 24 of the device is shown during active cryotherapy according to some exemplary embodiments. In some embodiments, such as... Figure 16C As shown, when the active element 83a comes into contact with the treatment area 82, the visualization device 18 will visualize the supporting element 83b covering the active element 83a, which may be useful, as described below. It should also be noted that the active element 83a can be equivalent to... Figures 8C to 8G Any of the elements 83d, 83d1, and / or 83d2 detailed herein, therefore any embodiment detailed herein with respect to 83d, 83d1, and / or 83d2 is considered to be possible. Figures 16B to 16E Possible embodiments of element 83a in the text.

[0380] Now refer to Figure 16D and Figure 16E A schematic top view 19 (from which) of the distal end 24 of a cryotherapy device according to some embodiments of the present invention is shown. Figure 16C (The visualization device 18 looks out). According to some embodiments, such as... Figure 16DAs shown, the support element 83b1 can completely block the visualization of the active expansion element 83a while still allowing good visualization of the surrounding environment 82 of the treated tissue. In some embodiments, this blocking may be necessary when the active element 83a causes reflections (glare) that interfere with the ability to perform the ablation procedure.

[0381] According to other embodiments, such as Figure 16E As shown, the support element 83b2 can only partially obstruct the visualization of the active expansion element 83a, while allowing some visualization of the active element 83a and the surrounding environment 82 of the treated tissue. The support element 83b2 can be designed to provide only this partial obstruction when the active component 83a does not cause interference reflections, and the support element 83b2 primarily serves as a support to shape the expandable active component 83a, for example, the active component 83a can present a relatively flat shape.

[0382] According to some embodiments, the expandable assembly may use a simple front-flow nozzle to cool the expandable volume (from the inside). According to some embodiments, the expandable assembly is expanded by a cryogenic fluid. According to some embodiments, the expanding component may be expanded by any combination and / or sequence of fluids. According to other embodiments, special internal nozzles, such as... Figure 14 The rotating nozzle shown (or as) Figure 6B and Figure 6C The combination of the front nozzle and the side nozzle described herein can help distribute cryogenic fluid into the formed expandable component (e.g., as described above). Figures 16B to 16E (as shown in the flatter balloon).

[0383] An exemplary cryotherapy device with multiple geometric extensions:

[0384] Now refer to Figures 17A to 17F This image shows a schematic longitudinal sectional view of the distal end 90 of a cryotherapy device according to some embodiments of the present invention. According to some embodiments, such as... Figure 17A As shown, during intracavitary screening or insertion into the body cavity, multiple components of the cryotherapy device can be held within the endoscope or sheath 16 while using input from the visualization device 18 to guide the sheath / endoscope to the vicinity of the treatment area. According to some embodiments, the multiple components of the cryotherapy device include an extension, a sensing device 25, and a cryotherapy catheter 24, wherein the extension can be in different configurations, including a folded configuration 93a. Figure 17A ) and an expanded configuration 93b ( Figure 17BThe configuration may include, but is optional, any other folded portion. In some embodiments, the distal end 90 may also include a dedicated drainage device. According to other embodiments, the remaining volume within the working channel or sheath may be used as a vacuum device. According to some embodiments, the user may manipulate the lever 933 (or lever, valve, faucet, or controller) to unfold the distal component and then actuate the ablation mechanism, such as... Figure 17B As shown. In some embodiments, the unfolded extension 93b may include a plurality of support ribs or wires and a plurality of support members (e.g., flexible polymer), and is similar to extensions 4100 and 7100 (respectively in...). Figure 13 and Figure 15B As shown in the image, the treatment area and / or treatment volume 930b can be at least partially separated from the general body cavity environment, and conditions within the internal volume defined by the extension (i.e., treatment volume 930b) can be further controlled. In some embodiments, cryotherapy and visualization techniques can both be included within the treatment space 930b. In some embodiments, the sensing device 25 can be located outside the treatment space 930b, such as... Figure 17B As shown, this is to control the surrounding body cavity environment. In some other embodiments, the sensing device may be located inside the treatment volume 930b or both inside and outside the treatment volume 930b to improve mutual control. Figure 17C This illustrates, according to some exemplary embodiments of the invention, the initiation of cryotherapy within body cavity 11.

[0385] In some embodiments, the cryogenic jet 13 treats the treatment area 12 while simultaneously directing or pushing the discharge fluid 17 beyond the treatment volume 930b, for example, defined by the extended extension 93b. According to some embodiments, such as... Figure 17B and Figure 17C As shown, assuming the extended portion 93b contacts or approaches the tissue surrounding the treatment area 12, the extended portion 93b can also define the distance between the cryojet stream 13 and the treatment area 12. In some embodiments, such a defined distance can help optimize multiple ablation parameters and the treatment outcome.

[0386] According to other embodiments, such as Figures 17D to 17F As shown, a user can manipulate the controller (or lever, valve, faucet, or rod) 933 to change the geometry and / or function of the extensions (e.g., 903a, 903b, 903c). According to some embodiments, for example... Figure 17DAs shown, the extension 903a can be positioned around the visualization device 18, for example, optionally as a smoothing element, which allows the endoscope 16 to be inserted into the body cavity while the visualization device 18 visualizes the cavity and its path without interfering with other components (e.g., cryotherapy catheter 24, sensing device 25, etc.) until those components are needed to initiate the ablation procedure.

[0387] According to some embodiments, such as Figure 17E As shown, extension 903b can be used similarly to extension 93b, such as... Figure 17B and Figure 17C As shown, according to the operation of controller 933. In some embodiments, similar to extension 93b ( Figure 17B and Figure 17C The predetermined geometry of the extension 903b can define the distance between the cryogenic jet 13 and the treatment area, thereby optimizing the performance of the device. According to other embodiments, such as... Figure 17F As shown, the controller 933 can be used to utilize the additional geometry of the extension 903c to apply different set points (e.g., distance from tissue) or to allow ablation during different constraints (e.g., limited space, uneven target area, acute angle). Therefore, the controller 933 can be used to control the internal volume defined by the extension, i.e., the treatment volume 9030c, and the distance from the distal end of the device to the treatment area.

[0388] Exemplary geometric extension:

[0389] Now for reference Figures 18A to 18C It shows a schematic transverse sectional view of the distal end of an endoscopic visualization device and a cryotherapy device according to some embodiments of the present invention. According to some embodiments, such as... Figure 18A As shown, extension 903a (in Figure 17D (Seen in a longitudinal sectional view) can be made of overlapping blades or several materials (e.g., rigid blade 903a1 and flexible blade 903a2). In some embodiments, when the extension 903b is deployed, as... Figure 18B As shown (and in Figure 17E (As shown in the longitudinal sectional view), overlapping blades 903b1 and 903b2, or different materials, may optionally form conical or skirt-shaped isolation extensions 903. For example... Figure 18B As shown, both the visualization device 18 and the cryotherapy catheter 24 are within a treatment volume (e.g., cone-shaped, skirt-shaped) defined by the extended portion, allowing the user to observe the ablation process.

[0390] According to other embodiments, such as Figure 18CAs shown, before unfolding and use, the extension 93 can be folded inside the endoscope or sheath 16 (93a, in Figure 17A (Seen in longitudinal sectional view). In some embodiments, the extension can then be partially extended, for example by partially extending it beyond the endoscope / shroud, such as... Figure 17D , Figure 17F and Figure 18A As shown. Furthermore, the extension can optionally be fully extended, for example, as... Figure 17B , Figure 17C , Figure 17E and Figure 18B As shown. It should be noted that any part of the cryotherapy can be performed when the extension is fully folded, partially folded, and / or fully unfolded.

[0391] Now refer to Figures 19A to 19C This image shows a schematic cross-sectional view of the distal end of a cryotherapy apparatus according to some embodiments of the invention, specifically showing the means for isolating the treatment area / volume. According to some embodiments, such as... Figure 19A As shown, the extended portion 93b may include a port 94 to allow the expanded fluid 17 to drain or exit from the internal volume defined by the extension 93b and flow to the discharge device opening (not shown). In some embodiments, the extension 93b (or tapered, skirt-shaped) may be formed by a support structure (such as Nitino, a superelastic material wire / rib) and a braided / polymer / folded surface, or by rigid and flexible overlapping blades (e.g., in... Figure 18A and Figure 18B Prepared as shown in the figure.

[0392] According to some embodiments, the extended portion 93b may be positioned at a specific, possibly predetermined distance from the treatment area 112, so that the expanded fluid 17 can naturally exit the internal volume defined by the extended portion 93b. According to other embodiments, such as... Figure 19A As shown, the extended portion 93b is adjacent to or in contact with the treatment area 112, such that the opening 94 allows the expanded fluid 17 to flow to the multiple discharge device openings (now shown).

[0393] Figure 19B The illustration shows an extension (or conical, skirt-like) 93b1 including a flat end 94a in some exemplary embodiments according to the invention. In some embodiments, the extension 93b1 is held at a specific, possibly predetermined distance from the treatment area, or when the tissue is not smooth, or when the dilated fluid 17 can leave the internal volume defined by the extension 93b1 by any suitable means, for example... Figure 19B The extension 93b1 can be used as shown. According to other embodiments, such as... Figure 19CAs shown, the extended portion 93b2 includes a passage within the wall of the extension 94b to allow the expanded fluid 17 to flow out of the internal volume defined by the extension. In some embodiments, such as... Figure 19C As shown, the extension 93b2 may include openings of different sizes and positions.

[0394] An exemplary cryotherapy device has a washing inflow path at its distal end:

[0395] According to some exemplary embodiments, the cryotherapy device includes at least one inflow washing path, for example, to allow the introduction of a washing fluid (e.g., washing liquid or washing gas) into a body cavity. In some embodiments, the washing fluid is introduced into the body cavity through at least one washing opening, such as at least one side opening and / or at least one front opening located at the distal end of the cryotherapy device, optionally near an opening of the inflow path for releasing a coolant substance. In some embodiments, the at least one side opening is positioned at a selected angle to guide the washing fluid to a distal opening of an optical component and / or an optical channel. In some embodiments, the cryotherapy device includes at least one washing flow guide, such as a nozzle or a deflecting surface in the at least one washing opening. In some embodiments, the at least one guide is configured to guide the washing fluid to a field of view and / or a selected treatment space within the body cavity between the optical component, the cryotherapy device, and the target region.

[0396] Now for reference Figure 20A and Figure 20B The distal end of a cryotherapy device according to some exemplary embodiments of the present invention is depicted, the cryotherapy device having at least one inflow washing path into the body cavity.

[0397] According to some exemplary embodiments, the distal end (e.g., distal end 1113) of a cryotherapy device is shaped and sized for insertion into the body cavity, for example, through a working channel of an endoscope or within a sheath, optionally into a rigid sheath 1116. In some embodiments, the distal end 1113 is guided toward a target area, such as the tissue 1104 to be treated on the inner surface of the body cavity.

[0398] According to some exemplary embodiments, the cryotherapy device includes at least one inflow path for delivering coolant into the body cavity for cryoablation of the treated tissue. In some embodiments, the coolant is delivered via a cryogenic inflow path, such as a cryogenic inflow channel. In some embodiments, the cryogenic jet 1106 is sprayed through a nozzle onto the treated tissue in the target area.

[0399] According to some exemplary embodiments, the cryotherapy device includes at least one optical element, such as optics 1110. In some embodiments, optics 1110 allows visualization within a field of view 1112, optionally allowing visualization of the effects of the cryojet 1106 on the treated tissue. In some embodiments, during the release of the coolant into the body cavity, condensate particles may optionally form due to the interaction of the coolant material with droplets in a humidified environment within the body cavity. In some embodiments, the formation of the condensate particles creates a particle cloud that obstructs or limits visualization of the cryojet's effects.

[0400] According to some exemplary embodiments, the cryotherapy device includes at least one wash inflow path for delivering wash fluid into the body cavity, for example, a gas pushing the condensed particles away from the field of view 1112. In some embodiments, the wash fluid passes through the wash inflow path and through an opening, such as an opening 1115 facing the treated tissue, for example, allowing cryogenic washing 1108. Optionally or additionally, the wash inflow path includes at least one lateral opening, such as a lateral opening 1117 for introducing wash fluid, near the distal opening of the optics 1110, for example, to allow optical washing 1114.

[0401] According to some exemplary embodiments, such as Figure 20B As shown, the cryotherapy device includes at least one outflow path, for example, allowing the drainage of some gas, particles, and / or liquid from the body cavity, also referred to herein as a purge. In some embodiments, such as... Figure 20B As shown, the outflow path is a path surrounding the inflow path and the optics, optionally enclosed within the sheath, such as a rigid sheath 1116. In some embodiments, the outflow path is used to return or evacuate consumed gas 1118. In some embodiments, the outflow path is defined by the space within the rigid sheath and the space between the inflow path and / or the optics 1110.

[0402] Exemplary flow control:

[0403] According to some exemplary embodiments, flow within the body cavity is regulated, for example, to avoid tissue damage due to high pressure levels and / or low temperature levels. In some embodiments, flow is regulated to allow for an effective cryotherapy procedure and / or better visualization of the target area.

[0404] Now for reference Figure 21A This describes one scheme of multiple flow control elements according to some exemplary embodiments of the present invention.

[0405] According to some exemplary embodiments, a cryogenic coolant is stored in a cryogenic source 1202 and delivered to a nozzle 1208 via at least one inflow path (e.g., a cryogenic flow path of a cryotherapy device). In some embodiments, a cryogenic flow regulator (e.g., a cryogenic controller 1204) is located in the cryotherapy device (e.g., cryotherapy device 1002) and / or in a control unit (e.g., Figure 1A (See control unit 1004 shown). In some embodiments, the cryogenic controller 1204 controls the flow rate, such as the percentage of cryogenic fluid, for example, cryogenic coolant flowing to nozzle 1208 or through port 1206, configured to allow the cryogenic coolant to be released outside the body. In some embodiments, the cryogenic controller is under the control of control circuitry 1026. In some embodiments, the cryogenic controller includes a valve, such as a solenoid valve, having an inner orifice that is normally closed by a spring (typically closed) and opened by an inductive force of a solenoid, which opens the flow path.

[0406] According to some exemplary embodiments, the control circuit signals the cryocontroller to allow 100% flow toward the nozzle 1208 and optionally 0% flow toward the port 1206. Alternatively, the control circuit signals the cryocontroller to allow 0% flow toward the nozzle 1208 and 100% flow toward the port 1206. In some embodiments, the control circuit determines the cryocoolant flow distribution between the port 1206 and the nozzle 1208 based on the pressure level and / or temperature within the body cavity or the flow path. Optionally or additionally, the control circuit determines the cryocoolant flow distribution between the port 1206 and the nozzle 1208 based on the distance from the target region, or based on the angle between the distal end of the cryotherapy device or the cryo nozzle and the target region.

[0407] According to some exemplary embodiments, a low-pressure source 1210 is connected to a washing opening 1218, such as a washing opening, via a different inflow path of a cryotherapy device. In some embodiments, the washing opening includes a slot or a notch. In some embodiments, an adjustment mechanism, such as a regulator 1212, adjusts the flow of the low-pressure gas through the cryogenic flow path toward the nozzle 1208. In some embodiments, when the cryogenic coolant flow is stopped, the low-pressure gas is directed by the regulator 1212 toward the cryogenic nozzle 1208, and the opening may be closed, for example, to “clean” the nozzle and / or prevent moisture from entering when the cryogenic flow is closed. Additionally or alternatively, when the distal end of the cryotherapy device approaches a target tissue, the tissue is marked by the low-pressure flow of the cryogenic nozzle 1208, for example by shallow indentation, indicating that the distal end of the cryotherapy device or the tip of a cryocatheter is sufficiently close to the tissue, for example, to initiate optimized cryotherapy and / or to prevent the tip from puncturing the body cavity wall and / or to prevent tissue adhesion of the cryogenic flow.

[0408] According to some exemplary embodiments, the low-pressure flow is guided by a regulating mechanism 1214 toward a washing control unit 1216, which determines the flow rate and pressure flow through the washing opening 1218. In some embodiments, the low-pressure flow washes the treatment space and / or is guided toward the optics of the cryotherapy apparatus, for example, between or during multiple coolant injections, to wash the optical field of view.

[0409] Exemplary controls during cryotherapy:

[0410] According to some exemplary embodiments, at least one microenvironmental parameter is controlled within the treatment space of the cryotherapy. In some embodiments, a cryotherapy system determines a treatment space within an integrated cavity. In some embodiments, the treatment space is determined to control at least one microenvironmental parameter in a confined space and optionally in a more controlled space.

[0411] In some embodiments, the treatment space for cryotherapy is determined based on a distance between the cryotherapy device and a selected target area. Optionally or additionally, the treatment space is determined based on the angle between the cryotherapy device and the treatment area. Optionally, the treatment space is determined based on the field of view of an imager of the cryotherapy device.

[0412] According to some exemplary embodiments, the efficacy of cryotherapy within the body cavity is controlled. In some embodiments, the release of the cryocoolant substance into the body cavity is controlled. Additionally or optionally, the drainage of the cryocoolant fluid from the body cavity is controlled. In some embodiments, the effect of the cryocoolant substance on the tissues within the body cavity is controlled, for example, to enhance the therapeutic effect.

[0413] According to some exemplary embodiments, at least one safety parameter is controlled during a cryotherapy procedure. In some embodiments, the pressure and / or temperature within the body cavity during the cryotherapy procedure are controlled. In some embodiments, if the pressure within the body cavity exceeds a predetermined pressure value, the introduction of cryofluid into the body cavity is stopped. Optionally or additionally, the introduction of non-cariogenic gas used to purge and / or expand the body cavity is stopped. In some embodiments, some fluids, such as cariogenic gas or caryogenic liquid, are discharged through an outflow channel, passively discharged by opening a check valve, or actively discharged by an actuated pump (e.g., a vacuum pump).

[0414] Exemplary control within a defined treatment space:

[0415] According to some exemplary embodiments, a treatment space is defined by restricting the space between the cryotherapy device and the target region, for example, to better visualize the target region. In some embodiments, the treatment space is defined by at least one extension, such as a cone or skirt, optionally an extended and / or extended element. In some embodiments, at least one extension contacts the inner surface of the body cavity, optionally surrounding a selected target region. Optionally or additionally, the treatment space is defined by a conical flow formed by a washing flow.

[0416] According to some exemplary embodiments, at least one environmental parameter is controlled within the defined treatment space, such as an environmental parameter that affects the visualization of the target area. In some embodiments, the environmental parameter includes temperature and / or humidity in the treatment space.

[0417] According to some exemplary embodiments, the temperature level within the defined treatment space is controlled by discharging some cryogenic fluid from the defined space. Alternatively, hot air is introduced into the defined treatment space through the inflow path of the cryotherapy device. Alternatively, an IR light source is used to irradiate the treatment space to increase the temperature level or to make visualization possible through mist. In some embodiments, the humidity level within the defined treatment space is controlled by introducing a gas for dehydrating the space.

[0418] According to some exemplary embodiments, the defined treatment area is cleared of mist or formed particles by using a washing fluid, for example, to remove moisture from the field of view, thereby better visualizing the target area. Alternatively, some mist particles may be discharged from the defined space through an outflow path in the cryotherapy device.

[0419] Exemplary flow control process:

[0420] According to some exemplary embodiments, during and / or after a cryotherapy procedure, at least one microenvironmental parameter, such as pressure, temperature, and / or humidity, is monitored within the body cavity. In some embodiments, the flow of low-pressure fluid and / or coolant into the body cavity is controlled based on the measurement of at least one microenvironmental parameter, for example, to prevent the pressure from exceeding a maximum value or to reduce the temperature within the body cavity below a predetermined value. Reference now is made to... Figure 21B A flow control process according to some exemplary embodiments of the present invention is described.

[0421] According to some exemplary embodiments, at least a portion of a cryotherapy device is introduced into an integrated cavity, as previously described in step 1050.

[0422] According to some exemplary embodiments, in step 1220, the body cavity expands. In some embodiments, the body cavity expands by low-pressure flow, or by a combination of low-pressure flow and expanding coolant flow.

[0423] According to some exemplary embodiments, in step 1222, the pressure level within the body cavity is determined. In some embodiments, multiple pressure levels are determined based on signals received from at least one sensor, such as a pressure sensor located within the body cavity, and / or based on at least one sensor located outside the body cavity or within the flow path (e.g., outflow path) of the cryotherapy device. In some embodiments, the pressure level within the body cavity is determined by monitoring the pressure level and / or pressure changes within the wash inflow path, and optionally by a sensor located outside the body. Alternatively, the sensor is located within a portion of the wash inflow path located inside the body.

[0424] According to some exemplary embodiments, in step 1224, if the determined post-expansion pressure is normal and / or within a desired value range, the coolant is introduced into the body cavity to freeze-ablate a selected target area. In some embodiments, the coolant is introduced over a predetermined period. Alternatively, in step 1226, if the determined pressure level is too high, at least some of the gas within the body cavity may optionally be expelled through an outflow channel.

[0425] According to some exemplary embodiments, in step 1228, washing is initiated and introduced into the body cavity. Alternatively, in step 1220, washing fluid is used to expand the body cavity. In some embodiments, during purging, washing fluid is introduced through the cryo-jet nozzle or through a washing inflow channel. For example, washing an optical component and / or the treatment space between the distal end of the cryotherapy device and the target region. Optionally or additionally, washing is used around the cryo-jet, for example, to push the cryo-jet away from the optical component and / or to create a virtual cone / skirt that optionally defines a microenvironment.

[0426] According to some exemplary embodiments, in step 1230, the pressure and / or temperature within the body cavity are determined. In some embodiments, the pressure is determined after cryoablation and / or post-washing to determine whether the pressure within the body cavity does not exceed a maximum permissible pressure value. Alternatively or additionally, the temperature is determined before, during, and after cryotherapy to determine whether the introduced coolant has reduced the temperature level within the body cavity below a predetermined value. In some embodiments, in step 1224, if the pressure and the temperature are within permissible values, a continuous stream of cryoablation coolant may be introduced into the body cavity.

[0427] According to some exemplary embodiments, in step 1238, if the pressure is within a normal range but the temperature is too low, the cryoablation process is stopped. In some embodiments, in step 1240, at least some fluid, such as gas or liquid, within the body cavity is evacuated. Optionally or additionally, in step 1242, warm air is introduced into the body cavity, for example, to increase the temperature within the body cavity. Alternatively, during the cryotherapy, and optionally during the expansion of the body cavity, hot gas is introduced into the body cavity through an inflow washing channel. In some embodiments, in step 1230, after some gas has been evacuated and / or warm air has been introduced into the body cavity, the pressure and / or temperature are determined.

[0428] According to some exemplary embodiments, in step 1232, if the pressure within the body cavity is too high, cryoablation is stopped, and optionally, in step 1234, washing is stopped. In some embodiments, in step 1236, some of the gas within the body cavity is evacuated.

[0429] Exemplary pressure monitoring within body cavities:

[0430] Now for reference Figures 22A to 22FPressure monitoring is depicted within a predetermined pressure level range within the body cavity. According to some exemplary embodiments, in pressure graph 1502, it is desirable to maintain the pressure between a minimum expansion pressure value 1508 and a maximum expansion pressure value 1506. In some embodiments, when a washing flow, a cryogenic flow, and a purging flow are actuated, as shown in graph 1504, the pressure level within the body cavity changes accordingly.

[0431] In some embodiments, the pressure within the body cavity is maintained above a minimum expansion pressure value, for example to allow better visualization of a target area and / or better access to the target area. In some embodiments, the minimum pressure within the bladder is at least 10 mbar, such as 10 mbar, 12 mbar, 15 mbar, or any intermediate value, smaller or larger. In some embodiments, the pressure within the body cavity is maintained below a maximum pressure value, for example to prevent tissue damage. In some embodiments, the maximum pressure within the bladder is about 30 mbar.

[0432] According to some exemplary embodiments, such as Figure 22A As shown, in step 1516, during a cryogenic actuation cycle, when washing and purging flows are applied, the pressure is within the desired range, between a minimum pressure value 1508 and a maximum pressure value 1506. In some embodiments, in step 1510, when the cryogenic flow is actuated, the pressure increases above the maximum permissible pressure value until the cryogenic flow is stopped in step 1512.

[0433] According to some exemplary embodiments, such as Figure 22B As shown, in step 1520, when a constant washing and purging flow is actuated in the overall flow, and when the discharge opening is wide, the pressure within the body cavity is lower than the minimum pressure value 1508. In some embodiments, due to the low expansion pressure, the body cavity partially or completely collapses, preventing good visualization of the target area and / or limiting or preventing the guidance of the cryotherapy device within the body cavity, which may reduce the efficacy of cryoablation therapy. In some embodiments, in step 1510, when the cryoflow is actuated, the overall flow 1518 results in the total pressure being within the desired range during cryoablation.

[0434] According to some exemplary embodiments, such as Figure 22C As shown, when a valve, such as a check valve, is used, the discharge of fluid from the body cavity can be optionally controlled, and the constant flow 1522 ensures that the pressure (e.g., when the cryogenic flow is not actuated) is higher than the minimum pressure required for expansion. In some embodiments, when the cryogenic flow is actuated, the pressure increases but remains below the maximum pressure value. In some embodiments, this is both safe and allows for operation within the body cavity, for example, by allowing good visualization and the ability to manipulate within the body cavity.

[0435] According to some exemplary embodiments, such as Figure 22D As shown, active feedback regarding flow control is used to maintain the pressure within the body cavity below a maximum pressure value. In some embodiments, in step 1510, a cryogenic flow is actuated to introduce coolant into the body cavity using a washing flow. In some embodiments, in step 1524, the cryogenic and washing flows increase the pressure level to a maximum permissible pressure value, optionally measured by a sensor, optionally through the inflow path (e.g., the inflow washing path). In some embodiments, when the pressure level reaches the maximum permissible pressure level, an active flow controller or active flow regulator stops the cryogenic flow. Additionally, if the pressure continues to increase, the active flow controller also stops the washing flow.

[0436] According to some exemplary embodiments, the "washing" flow serves several purposes, such as to constantly expand the cavity, for example, to prevent partial or complete collapse, to optionally allow for good visualization and the ability to manipulate within the cavity. Additionally or alternatively, the washing flow is used to clean optical components, such as an optical lens, from moisture and other contaminants, and optionally to maintain the optics of the optical component at a relatively constant temperature, for example, within a temperature level variation range of up to 30%, such as 10%, 15%, 20%, or any intermediate smaller or larger percentage variation. In some embodiments, the washing flow is used to wash away cold, moist gases (mist) from the optics ("cryogenic washing"—creating insulation around the cryogenic jet) and optionally to construct a dynamic buffer solution ("optical washing") around the lens surface, making it difficult for mist residue (or expelled mist) to flow towards the lens. Alternatively and / or additionally, cryogenic washing is used for pressure measurement. In some embodiments, pressure changes within the body cavity can be measured closer to the washing pressure source (i.e., upstream – for example, inside the console) to measure / estimate the pressure within the body cavity, and may optionally be used, for example, for control devices and / or safety devices.

[0437] According to some exemplary embodiments, such as Figure 22E As shown, in step 1528, active control of the washing flow is applied, for example, to ensure that the pressure level is between the minimum pressure value required for the expansion of the body cavity and below the maximum pressure value. Optionally, controlling the washing flow rate allows for savings in washing fluid, for example, during long-term observation or visualization between multiple cryo-jet sessions. In some embodiments, in step 1504, when cryotherapy is applied, the active washing flow control is stopped.

[0438] According to some exemplary embodiments, such as Figure 22FAs shown, in addition to active flow control, active control of the discharge of substances from the body cavity is also actuated. In some embodiments, when cryogenic flow is actuated in step 1510, an active discharge control is actuated in step 1532, for example by actuating a vacuum pump, to discharge some fluid and / or other substances from the body cavity, which will optionally reduce the pressure level.

[0439] For example, determine a distance and an angle from a target area:

[0440] According to some exemplary embodiments, the distance between the distal end of the cryotherapy device and the target area is determined, for example, to allow for better control of the coolant's effect on the tissue. In some embodiments, spraying coolant too close to the tissue may damage deeper tissues not selected as targets for cryotherapy. Alternatively, spraying coolant from a distance into the target area may result in ineffective treatment, for example, due to fogging and / or difficulty in visualization. Furthermore, determining the distance to the target area allows, for example, adjustment of at least one parameter of the cryotherapy procedure, such as coolant pressure and / or the duration of coolant spray.

[0441] According to some exemplary embodiments, such as Figure 23A As shown, the distal end 1602 of the cryotherapy device advances toward the target region 1608. In some embodiments, when the cryofluid flow stops, a low-pressure gas flow 1604 is optionally released from the washing flow path 1612 toward the target region 1608 and / or through a cryo-nozzle via a purge flow. In some embodiments, the pressure of the low-pressure gas creates an indentation 1622 on the surface of the body cavity. In some embodiments, the distance 1610 between the distal end 1602 and the target region 1608 is determined by visualizing the depth and / or shape of the indentation 1622 using an optical device 1614.

[0442] According to some exemplary embodiments, such as as shown in FIG23, the distal end 1603 of the cryotherapy device includes at least one illumination source 1620 configured to project a light beam toward the target region 1608. In some embodiments, the distance 1610 between the distal end 1603 and the target region 1608 is determined by visualizing the size and / or shape of the projection point 1621 at the target region 1608, for example by manual or automatic image processing. Optionally or additionally, the cryotherapy device includes a photometer, optionally a laser photometer, for measuring the distance to the target region.

[0443] According to some exemplary embodiments, such as Figure 23CAs shown, the cryotherapy device includes at least one foldable element, such as foldable element 1626, which may optionally be an extension, skirt, or cone. Optionally, the foldable element has a known length in an unfolded state. In some embodiments, during guidance toward a target region, the foldable element 1626 is configured to fold within an interior cavity of the cryotherapy device and unfold upon reaching the target region. In some embodiments, when the elements unfold, they contact tissue near or at the target region. In some embodiments, the contact point between the foldable element and the tissue is visualized to allow, for example, determining the distance 1610 between the distal end 1605 and the target region.

[0444] According to some exemplary embodiments, such as Figure 23D and Figure 23E As shown, the angle between the distal end 1702 and the target area 1711 is determined by the shape and size of the light spot 1712 projected onto the target area. In some embodiments, such as... Figure 23D As shown, beam 1708 is projected from an illumination source at a 90-degree angle 1710 onto target area 1711. In some embodiments, visualization of the shape and / or size of the light spot can determine the relative angle between the distal ends. In some embodiments, when projected at a 90-degree angle, light spot 1712 has a minimum size, length, and / or diameter relative to other projection angles. Optionally, when projected at a 90-degree angle, the light spot has a circular shape, such as... Figure 23E The target area is shown in the top view.

[0445] According to some exemplary embodiments, such as Figure 23F As shown, beam 1708 is projected at an angle 1716 greater than 90 degrees. In some embodiments, when the beam is projected at an angle greater than 90 degrees, spot 1714 is larger and optionally more elliptical than spot 1712, for example as... Figure 23G A top view of the target area 1711 is shown. Optionally or additionally, similar to the lighting effect, the purging flow can produce the same elliptical shape related to the angle, or a larger circle related to the greater distance between the freezing tip and the target tissue being treated.

[0446] According to some exemplary embodiments, at least one parameter of the cryotherapy may optionally be automatically modified or adjusted based on a determined distance and / or angle, such as the pressure of the cryofluid to be released into the body cavity, the position of the distal end of the cryotherapy device, and / or the duration of the cryojet. In some embodiments, a new treatment space and / or a new viewing angle are defined based on a determined angle and / or distance. In some embodiments, the flow direction of the washing fluid is adjusted or modified, for example, to guide the washing fluid toward the newly defined treatment space and / or toward the newly defined field of view.

[0447] The foregoing specific embodiments illustrate the practice of the present invention. Therefore, it should be understood that other means known to those skilled in the art or disclosed herein may be employed without departing from the scope of the appended claims.

[0448] It is anticipated that many related cryotherapy devices will be developed during the patent period of this application. The scope of the term cryotherapy device is intended to include all such new technologies in advance. As used herein with regard to quantity or value, the term “about” means “within 10%”.

[0449] The terms “comprises”, “comprising”, “includes”, “including”, “having”, and their morphological variations refer to “including but not limited to”.

[0450] The term "consisting of" means "including and limited to".

[0451] The term "essentially consisting of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if the additional ingredients, steps, and / or components do not substantially alter the essential or novel characteristics of the claimed composition, method, or structure.

[0452] As used herein, the singular forms “a,” “an,” and “at least one” include plural references unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include multiple compounds, including mixtures thereof.

[0453] Throughout this application, various embodiments of the invention may be presented in the form of a range. It should be understood that this range description is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of the invention. Therefore, it should be assumed that the range description specifically discloses all possible sub-ranges and single numerical values ​​within those ranges. For example, a range description from 1 to 6 should be assumed to specifically disclose sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single digits within those ranges, such as 1, 2, 3, 4, 5, and 6, regardless of the range itself.

[0454] Whenever a range of numbers is indicated herein (e.g., “10 to 15”, “10 to 15”, or any pair of numbers connected by another such range indication), it means including any referenced number (fraction or integer) within the range indicated, including the range limit, unless otherwise clearly stated in the text. The terms “range between” the first and second indicated numbers and “to”, “up to”, “until”, “through” (or another such range indication term) and “range between” the second indicated number are interchangeable herein and refer to the first and second indicated numbers, and all fractions and integers in between.

[0455] Unless otherwise stated, the figures used herein and any ranges of figures based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by those skilled in the art.

[0456] As used herein, the term "method" refers to the manner, means, technique, and procedures used to accomplish a particular task, including but not limited to those manner, means, techniques, and procedures that are known or readily developed by practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine from known manner, means, techniques, or procedures.

[0457] As used herein, the term “treatment” includes abrogate, substantially inhibiting, reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the clinical or aesthetic manifestations of a condition.

[0458] It is understood that certain features of this invention, described in separate embodiments for clarity, may also be provided in combinations of a single embodiment. Conversely, for brevity, various features described in a single embodiment may also be provided separately, in any suitable sub-combination, or in embodiments applicable to any other description of the invention. Specific features described in the various embodiments are not considered essential features of those embodiments unless the embodiment would not function without those elements.

[0459] While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to include all alternatives, modifications, and variations falling within the scope of the appended claims.

[0460] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent as if each individual publication, patent, or patent application were specifically and individually identified and incorporated herein by reference. Furthermore, any references cited or indicated should not be construed as an admission that such references are prior art to the present invention. Heading portions in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations.

Claims

1. A cryotherapy system, characterized in that: The cryotherapy system includes: An elongated cryotherapy device having a proximal end and a distal end, the distal end being shaped and sized to be positioned within an integral cavity, comprising: A cryogenic inflow path fluidly connects a cryogenic fluid source to a nozzle at the distal end of the cryotherapy device, wherein the cryogenic inflow path is configured to allow cryogenic flow from the cryogenic fluid source through the nozzle to a target region within the body cavity; An opening in the cryogenic inflow path is configured to allow the cryogenic fluid to be released from the cryogenic inflow path into the body. A cryogenic controller in the cryogenic inflow path under a control circuit, wherein the cryogenic controller is configured to control the flow of the cryogenic fluid toward the nozzle and / or toward the inlet opening; An optical component configured to visualize a field of view between the optical component and the target region within the body cavity; A wash inflow path is provided within the elongated cryotherapy device, wherein the wash inflow path fluidly connects a wash fluid source to at least one wash opening configured to direct the wash fluid toward one or both of the optical components and the field of view within the body cavity. The control circuit determines the cryogenic fluid flow distribution between the inlet opening and the nozzle.

2. The system according to claim 1, characterized in that: The control circuit determines the cryogenic fluid flow distribution between the inlet opening and the nozzle based on a pressure level within the body cavity or multiple flow paths.

3. The system according to claim 1, characterized in that: The control circuit determines the distribution of cryogenic fluid flow between the inlet opening and the nozzle based on a temperature within the body cavity or multiple flow paths.

4. The system according to claim 1, characterized in that: The control circuit determines the distribution of cryogenic fluid flow between the inlet opening and the nozzle based on a distance from the target area.

5. The system according to claim 1, characterized in that: The control circuit determines the distribution of cryofluid flow between the inlet opening and the nozzle based on an angle between the distal end of the cryotherapy device or the nozzle and the target area.

6. The system according to claim 1, characterized in that: When the flow of the cryogenic fluid through the cryogenic inflow path stops, the control circuit sends a signal to the cryogenic controller to release the cryogenic fluid through the port opening.

7. The system according to claim 1, characterized in that: When the flow of cryogenic fluid through the cryogenic inflow path stops, the control circuit signals the cryogenic controller to release the residual cryogenic fluid through the port opening.

8. The system according to claim 7, characterized in that: The control circuit sends a signal to the cryogenic controller to open the port opening for a period of time, the time being adjusted according to the amount of residual cryogenic fluid remaining in the cryogenic fluid flow.

9. The system according to claim 1, characterized in that: The elongated cryotherapy device includes an optical component configured to visualize a field of view between the optical component and the target region within the body cavity.

10. The system according to claim 1, characterized in that: The elongated cryotherapy device is shaped and sized to be introduced into the body cavity through a working channel of an endoscope.

11. The system according to any one of claims 1 to 10, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

12. The system according to claim 1, characterized in that: The elongated cryotherapy device includes: An outflow path extends from the body cavity and outside the body, and At least one check valve in the outflow path, the check valve being configured to open when the pressure within the body cavity exceeds a predetermined value.

13. The system according to claim 12, characterized in that: The washing fluid is configured to remove and / or push away particles within the body cavity during and / or after the cryogenic flow.

14. The system according to claim 13, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

15. The system according to claim 1, characterized in that: The at least one washing opening is configured to aim the washing fluid toward one or both of the optical component and the field of view, wherein the washing inflow path is configured to release a fluid flow through the at least one washing opening to a target area, the fluid flow having sufficient force to cause a temporary indentation on a surface of the target area. A control unit, connected to the cryotherapy device, and comprising: A control circuit is connected to the optical component, wherein the control circuit is configured to determine a geometric relationship between the distal end and the target region based on a plurality of signals received from the optical component, wherein the control circuit determines the geometric relationship based on visualization of the size, shape and depth of the indentation.

16. The system according to claim 15, characterized in that: The control circuit is configured to determine at least one parameter of a cryotherapy procedure based on the geometric relationship.

17. The system according to claim 15, characterized in that: The geometric relationship includes the distance and / or angle between the distal end and the target region.

18. The system according to any one of claims 15 to 17, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

19. The system according to claim 1, characterized in that: The elongated cryotherapy device includes: At least one foldable element is located within an interior cavity of the cryotherapy device, the cryotherapy device being configured to unfold into the body cavity and at least partially contact the target region at a contact point, wherein the optical components are configured to visualize the contact point between the foldable element and the target region.

20. The system according to claim 19, characterized in that: The at least one foldable element includes at least one geometric element having a known size and / or shape.

21. The system according to claim 20, characterized in that: The at least one geometric element includes an extension, a cone, or a skirt.

22. The system according to any one of claims 19 to 21, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

23. The system according to claim 1, characterized in that: The optical components of the elongated cryotherapy device include at least one irradiation source configured to project a spot of light onto the target area. A control unit, connected to the cryotherapy device, and comprising: A control circuit is connected to the optical component, wherein the control circuit is configured to determine a geometric relationship between the distal end and the target region based on the size and / or shape of the light spot.

24. The system according to claim 23, characterized in that: The target region is a target region on an inner surface of the body cavity.

25. The system according to claim 23, characterized in that: The control circuit is configured to determine at least one parameter of a cryotherapy procedure based on the geometric relationship.

26. The system according to claim 23, characterized in that: The geometric relationship includes the distance and / or angle between the distal end and the target region.

27. The system according to any one of claims 23 to 26, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

28. The system according to claim 1, characterized in that: The elongated cryotherapy device includes: A folding component configured to unfold within the body cavity and contact a target region within the body cavity, wherein the folding component includes at least one supporting non-compliant region and at least one movable compliant region, the at least one movable compliant region being configured to transfer low temperature to the target region; The cryogenic inflow path is configured to allow cryogenic flow from the cryogenic fluid source to the folded component, wherein the cryogenic flow to the folded component causes the folded component to unfold and freeze at least a portion of the treated tissue at the target region; The optical component is configured to visualize a field of view, the field of view including a portion of the supporting non-compliant region and / or the active compliant region.

29. The system according to claim 28, characterized in that: The folding component includes a cryogenic balloon configured to inflate within the body cavity when the cryogenic fluid flows into the cryogenic balloon.

30. The system according to claim 29, characterized in that: The cryoballoon is attached to the distal end of the elongated cryotherapy device.

31. The system according to claim 29, characterized in that: The cryogenic balloon includes at least one supporting non-compliant region and at least one mobile compliant region, wherein the expansion of the cryogenic balloon within the body cavity causes the at least one mobile compliant region to contact the target region.

32. The system according to any one of claims 29 to 31, characterized in that: The body cavity includes at least one of a bladder, a cervix, a prostate, a urethra, a ureter, a stomach, a uterus, and a renal pelvis, and the distal end of the elongated cryotherapy device is shaped and sized to be inserted into the body cavity.

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