Cryotherapy device

Abstract

We provide a cryotherapy device for treating hollow organ diseases. [Solution] A cryotherapy system comprising: a main body, a proximal end and a distal end, configured to be positioned inside a hollow organ, a cryogenic path that fluidly connects a cryogenic fluid source to the distal end of the device and is configured to allow the flow of cryogenic fluid into the hollow organ; an optical assembly inside the main body configured to visualize the view between the distal end of the device and a target site inside the hollow organ; a cleaning path including at least one cleaning opening at the distal end of the device, configured to connect a cleaning fluid source to at least one cleaning opening and to discharge cleaning fluid 217 inside the hollow organ; and at least one flow reducer in the cleaning path configured to narrow the internal lumen of the cleaning path through which the cleaning fluid flows.

Description

Technical Field

[0001] Related Applications This application claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 188,015, filed on May 13, 2021, the entire content of which is incorporated herein by reference.

[0002] This application is related to International Application PCT / IL2018 / 050124, filed on February 4, 2018, and the entire content thereof is incorporated herein by reference as if fully set forth herein.

Background Art

[0003] In some embodiments, the present invention relates to cryotherapy devices, and more particularly, but not limited thereto, to cryotherapy devices for treating hollow organ diseases.

Summary of the Invention

[0004] Some examples of some embodiments of the present invention listed below may include more than one example feature and / or fewer features than all features of an example.

[0005] Example 1. A cryotherapy system, An elongate cryotherapy device having an elongate body, a proximal end, and a distal end, the device being sized and shaped to be disposed within a hollow organ, A cryogenic inflow passage within the elongate body that fluidly connects a cryogenic fluid source to the distal end of the cryotherapy device, the cryogenic inflow passage being configured to enable a cryogenic flow from the cryogenic fluid source to the hollow organ, An optical assembly having a distal end within the elongate body configured to visualize a field of view between the distal end of the device and a target site within the hollow organ, A cleaning inlet passage inside the elongated body, having at least one cleaning opening at the distal end of the device, wherein a cleaning fluid source is fluidly connected to the at least one cleaning opening and configured to discharge the cleaning fluid inside the hollow organ, and The elongated cryotherapy device comprising, At least one flow reducer, positioned within the cleaning inlet, is shaped and sized to narrow the internal lumen of the cleaning inlet through which the cleaning fluid flows. The cryotherapy system comprising the above-mentioned features.

[0006] Example 2. The system according to Example 1, wherein at least one flow reducer blocks at least 10% of the lumen of the lavage inlet.

[0007] Example 3. The system according to either Example 1 or 2, wherein the at least one opening is located in the wall of the cleaning inlet to direct the cleaning fluid to the optical assembly at the distal end and / or to the distal field of view (FOV) of the optical assembly.

[0008] Example 4. The system according to Example 3, wherein the at least one flow reducer is located distal to the at least one cleaning opening and is configured to increase the cleaning fluid pressure in a portion of the cleaning inlet passage having the at least one opening.

[0009] Example 5. The system according to Example 3, wherein the at least one flow reducer is located within a portion of the cleaning inlet passage having the at least one cleaning opening.

[0010] Example 6. The system according to Example 5, wherein the at least one flow reducer is in fluid communication with the at least one opening and comprises at least one channel, or aligned openings forming a channel, and is configured to direct cleaning fluid through the at least one flow reducer to the at least one cleaning opening or to draw it into the cleaning inlet from the hollow organ.

[0011] Example 7. The system according to any one of Examples 3 to 6, wherein the irrigation inlet is provided with at least one distal irrigation opening at the distal end of the irrigation inlet, configured to release irrigation fluid into the treatment space in the hollow organ located distal to the elongated cryotherapy device.

[0012] Example 8. The system according to Example 7, wherein the at least one flow reducer is positioned in the cleaning inlet proximal to the at least one cleaning opening.

[0013] Example 9. The system according to Example 7, wherein the at least one distal irrigation opening is an opening in the at least one flow reducer.

[0014] Example 10. The system according to any one of Examples 7 to 9, wherein the cryogenic inflow passage comprises at least one distal opening configured to release a cryofluid into the therapeutic space and / or toward a therapeutic target within the hollow organ, and the at least one irrigation opening at least partially surrounds the distal opening of the cryogenic inflow passage.

[0015] Example 11. The system according to any one of Examples 3 to 10, wherein at least one flow reducer is in contact with the inner surface of the cleaning inlet and / or the outer surface of the low-temperature inlet.

[0016] Example 12. The system according to Example 11, wherein the at least one flow reducer is formed as a ring, an arc contacting the inner surface of the cleaning inflow path, and / or an outer surface of the low-temperature inflow path.

[0017] Example 13. The system according to Example 11, wherein the at least one flow reducer includes a protrusion extending from the inner surface of the cleaning inflow path and / or the outer surface of the low-temperature inflow path.

[0018] Example 14. The system according to any one of Examples 3 to 13, wherein the at least one opening includes a plurality of openings axially and / or obliquely distributed in a part of the wall of the cleaning inflow path facing the optical assembly and / or the FOV.

[0019] Example 15. The system according to any one of Examples 1 to 13, wherein the at least one opening includes a plurality of openings axially and / or obliquely distributed in a part of the wall of the cleaning inflow path at least partially surrounding the inner lumen of the cleaning inflow path.

[0020] Example 16. The system according to any one of Example 14 or 15, wherein the plurality of openings have different shapes and / or sizes.

[0021] Example 17. The system according to any one of Examples 14 to 16, wherein the plurality of openings are evenly distributed in the wall portion.

[0022] Example 18. The system according to any one of Examples 14 to 16, wherein the plurality of openings are distributed with different densities of openings per area of the wall portion.

[0023] Example 19. The system according to Example 1, wherein the at least one flow reducer is located proximal to the at least one cleaning opening and is configured to accelerate the flow velocity of the cleaning fluid exiting the hollow organ through the at least one cleaning opening.

[0024] Example 20. The system according to Example 1, wherein the at least one flow reducer is located at the distal end of the cleaning fluid inlet passage and is aligned with the at least one cleaning opening, and has one or more openings that allow the cleaning fluid to pass into the at least one cleaning opening through the one or more flow reducer openings.

[0025] Example 21. The cryotherapy device comprises the at least one fluid discharge channel inside the elongated body, having at least one first discharge opening at the distal end of the fluid discharge channel and at least one second discharge opening around the wall of the discharge channel, wherein the second discharge opening is located proximal to the first discharge opening. The at least one fluid discharge channel is configured to remove fluid and / or particles from the hollow organ through the at least one first discharge opening and / or the at least one second discharge opening. The system described in any one of the prior art examples.

[0026] Example 22. The system according to Example 21, wherein the cryotherapy device comprises at least one discharge seal located in the at least one fluid discharge channel between the at least one first discharge opening and the at least one second discharge opening, and configured to block at least 10% of the discharge fluid flow rate through the at least one first discharge opening.

[0027] Example 23. The system according to Example 22, wherein the distal end of the optical assembly is positioned distal to the second discharge opening, and the at least one discharge seal is positioned between the distal end of the optical assembly and the at least one second discharge opening.

[0028] Example 24. The system according to any one of Examples 21 to 23, comprising an outer sleeve surrounding the device, wherein the at least one second discharge opening is an opening in the outer sleeve or is in fluid communication with at least one opening in the outer sleeve.

[0029] Example 25. The system according to any one of the prior arts, wherein the at least one cleaning opening has a maximum width or maximum diameter in the range of 0.01 mm to 2 mm.

[0030] Example 26. The system according to any one of the prior art, wherein the low-temperature inlet and the cleaning inlet are coaxial along at least 30% of the length of the cleaning inlet.

[0031] Example 27. The system according to any one of Examples 1 to 25, wherein the washing inlet at least partially surrounds the cold inlet along at least 30% of the length of the cold inlet.

[0032] Example 28. The system according to any one of the prior arts, wherein the surface of the optical assembly at the distal end of the optical assembly is curved or inclined with respect to the long axis of the cryotherapy device, and the at least one cleaning opening is positioned and shaped and sized to discharge cleaning fluid toward the surface of the optical assembly.

[0033] Example 29. The system according to Example 28, wherein the surface of the optical assembly at the distal end of the optical assembly is substantially perpendicular to the long axis or positioned at an angle between 5 and 90 degrees with respect to the long axis.

[0034] Example 30. It is a cryotherapy system, An elongated cryotherapy device having an elongated body, a proximal end, and a distal end, wherein the device is shaped and sized so as to be placed inside a hollow organ. A low-temperature inflow passage inside the elongated main body, which fluidly connects the low-temperature fluid source to the distal end of the cryotherapy device, the low-temperature inflow passage being configured to allow low-temperature flow from the low-temperature fluid source to the hollow organ, The at least one fluid discharge channel inside the elongated body has at least one first discharge opening at the distal end of the fluid discharge channel and at least one second discharge opening around the wall of the discharge channel, wherein the first discharge opening is located distal to the at least one second discharge opening, The at least one fluid discharge channel configured to remove fluid and / or particles from the hollow organ through the at least one first discharge opening and / or the at least one second discharge opening, A discharge seal located within the at least one fluid discharge path between the at least one first discharge opening and the at least one second discharge opening, and configured to block at least 10% of the discharge fluid flow rate through the at least one first discharge opening. The elongated cryotherapy device comprising The cryotherapy system comprising the above-mentioned features.

[0035] Example 31. An optical assembly having a distal end, at least partially disposed inside the elongated body, configured to visualize a field of view between the distal end of the device and a target site inside the hollow organ. Equipped with, The distal end of the optical assembly is positioned distal to the at least one second discharge opening, and the at least one discharge seal is positioned between the distal end of the optical assembly and the at least one second discharge opening. The system described in Example 30.

[0036] Example 32. The system according to Example 31, comprising an outer sleeve surrounding the device, wherein the at least one second discharge opening is an opening in the outer sleeve or is in fluid communication with at least one opening in the outer sleeve.

[0037] Example 33. It is a cryotherapy system, An elongated cryotherapy device having an elongated body, a proximal end, and a distal end, wherein the device is shaped and sized so as to be placed inside a hollow organ. A low-temperature inflow passage inside the elongated main body, which fluidly connects the low-temperature fluid source to the distal end of the cryotherapy device, the low-temperature inflow passage being configured to allow low-temperature flow from the low-temperature fluid source to the hollow organ, The cleaning inlet inside the elongated body of the device is provided with a plurality of cleaning openings distributed axially and / or obliquely in the wall of the cleaning inlet at the distal end of the device, wherein the cleaning inlet is configured to fluidly connect a cleaning fluid source to the plurality of cleaning openings, and to discharge the cleaning fluid into the hollow organ through at least one of the plurality of cleaning openings. The elongated cryotherapy device comprising, The cryotherapy system comprising the above-mentioned features.

[0038] Example 34. The system according to Example 33, wherein the plurality of cleaning openings are evenly distributed in the wall.

[0039] Example 35. The system according to Example 33, wherein the plurality of cleaning openings are distributed at varying densities per area of ​​the wall.

[0040] Example 36. The system according to any one of Examples 33 to 35, wherein the plurality of cleaning openings have different shapes and / or widths.

[0041] Example 37. The system according to any one of Examples 33 to 36, wherein the plurality of openings are divided into two or more groups of openings according to the shape and / or width of the openings, and the openings of each of the two or more groups have similar shapes and / or widths.

[0042] Example 38. The system according to any one of Examples 33 to 37, wherein the plurality of cleaning openings surround the cleaning inlet and / or are located in part of the wall of the cleaning inlet along the cleaning inlet.

[0043] Example 39. The system according to any one of Examples 33 to 37, wherein the plurality of cleaning openings are located in a portion of the wall of the cleaning inlet, surrounding at least 10% of the inlet and / or maintaining an axial distance of at least 0.05 mm between two adjacent openings.

[0044] Example 40. The system according to any one of Examples 33 to 39, wherein the plurality of cleaning openings have a maximum width or maximum diameter in the range of 0.01 mm to 2 mm.

[0045] Example 41. An optical assembly having a distal end, located inside the elongated body, configured to visualize a field of view between the distal end of the device and a target site inside the hollow organ, wherein at least some of the plurality of openings are oriented toward the distal end of the optical assembly and are positioned in the wall of the cleaning inlet to deliver cleaning fluid toward the distal end of the optical assembly A system comprising any one of Examples 33 to 40.

[0046] Example 42. The system according to any one of Examples 33 to 35, wherein the cleaning inlet includes a constricted portion, and at least some of the plurality of openings are located in the wall of the constricted portion to apply an suction force to the fluid in the hollow organ.

[0047] Example 43. It is a cryotherapy system, An elongated cryotherapy device having an elongated body, a proximal end, and a distal end, wherein the device is shaped and sized so as to be placed inside a hollow organ. A low-temperature inflow passage inside the elongated body, which fluidly connects a low-temperature fluid source to the distal end of the cryotherapy device, the low-temperature inflow passage having an opening configured to deliver low-temperature fluid from the low-temperature fluid source to the hollow organ, The elongated cryotherapy device comprising, Equipped with, At least one surface of the apparatus at the distal end is pre-treated to prevent or reduce the adhesion and / or formation of one or more droplets on the pre-treated surface. The aforementioned cryotherapy system.

[0048] Example 44. The system according to Example 43, wherein the apparatus comprises a cleaning inlet inside the elongated body, which is configured to release a cleaning fluid into the hollow organ and has at least one cleaning opening at the distal end of the apparatus, and the at least one pre-treated surface is the outer surface of the cleaning inlet.

[0049] Example 45. The device comprises an optical assembly having a distal end inside the elongated body, configured to visualize the field of view within the hollow organ between the distal end of the device and a target site inside the hollow organ, The at least one pre-treated surface is the outer surface of the optical assembly. The system described in either Example 43 or 44.

[0050] Example 46. The system according to any one of Examples 43 to 45, wherein at least one of the surfaces is coated with a hydrophilic coating or a hydrophobic coating.

[0051] Example 47. Cryotherapy is a method of treatment. Introducing a cryotherapy device into a hollow organ, The cryofluid is delivered to the hollow organ through the cryofluid inflow channel of the cryotherapy device, Discharging the cleaning fluid before, during, and / or after delivering the cryofluid into the hollow organ through at least one cleaning opening of a cleaning fluid inlet having a constricted portion. The cryotherapy method, including the above.

[0052] Example 48. The method according to Example 47, wherein the cleaning discharge includes accelerating the flow velocity of the cleaning fluid into the hollow organ by the constricted portion of the cleaning fluid inlet passage.

[0053] Example 49. The method according to either Example 47 or 48, wherein the discharge includes discharging the cleaning fluid into the hollow organ through the wall of the cleaning fluid inlet and at least one cleaning opening located proximal to or within the constricted portion.

[0054] Example 50. The method according to any one of Examples 47 to 49, wherein the discharge includes discharging the cleaning fluid into the hollow organ through a distal opening facing forward of the cleaning fluid inlet.

[0055] Example 51. The method according to any one of Examples 47 to 50, wherein the introduction includes introducing the cryotherapy device into the hollow organ via a sleeve.

[0056] Example 52 The method according to Example 51, comprising discharging fluid from the hollow organ through at least one opening around the sleeve.

[0057] Example 53. The method according to Example 52, comprising visualizing the therapeutic space within the hollow organ through at least one lens or aperture located within the hollow organ, wherein the discharge includes discharging the fluid through at least one opening around the sleeve and proximal to the at least one lens or aperture.

[0058] Example 54. The method according to any one of Examples 47 to 53, wherein the at least one cleaning opening comprises a plurality of cleaning openings having different sizes and / or widths or diameters, and the discharge comprises discharging the cleaning fluid through the plurality of openings in different directions within the hollow organ and / or at different distances within the hollow organ, depending on the shape, size and / or diameter of each of the plurality of openings.

[0059] Example 55. The method according to any one of Examples 47 to 54, wherein the hollow organ includes a single opening, and the introduction includes introducing the cryotherapy device into the hollow organ through the single opening.

[0060] Example 56. The method according to any one of Examples 47 to 55, wherein the hollow organ includes a bladder, and the introduction includes introducing the cryotherapy device into the bladder through the ureter.

[0061] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Similar or equivalent methods and materials may be used in the practice or testing of embodiments of the present invention, but exemplary methods and / or materials are described below. In case of any conflict, the patent specification, including definitions, shall prevail. Furthermore, the materials, methods, and examples are merely examples and are not necessarily intended to be limiting.

[0062] As those skilled in the art will understand, some embodiments of the present invention may be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present invention may take the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, which may be commonly referred to herein as “circuits,” “modules,” or “systems.” Furthermore, some embodiments of the present invention may take the form of computer program products embodied in one or more computer-readable media in which computer-readable program code is embodied. Implementation of some embodiments of the present invention methods and / or systems may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. Furthermore, according to the actual instrumentation and setup of some embodiments of the methods and / or systems of this disclosure, some selected tasks may be performed by hardware, software, or firmware, and / or in combination thereof, for example, using an operating system.

[0063] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a set of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to exemplary embodiments of the method and / or system described herein are performed by a data processor, such as a computing platform, for executing a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, such as a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, network connectivity is also provided. A display and / or user input devices such as a keyboard or mouse are also optionally provided.

[0064] Some embodiments of the present invention may utilize any combination of one or more computer-readable media. A computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may, for example, be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any preferred combination thereof. More specific examples of computer-readable storage media may include electrical connections having one or more communication lines, portable computer diskettes, hard disks, random access memory (RAM), read-only memory (ROM), electrically erasable PROM (EEPROM or flash memory), optical fibers, compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any preferred combination thereof. In the context of this document, a computer-readable storage medium may be any tangible medium that can contain or store programs for use by, or in connection with, an instruction execution system, apparatus, or device.

[0065] A computer-readable signal medium may include, for example, a propagating data signal in which computer-readable program code is embodied, either in the baseband or as part of a carrier wave. Such a propagating signal may take any of various forms, including but not limited to electromagnetic, optical, or any combination thereof. A computer-readable signal medium may be any computer-readable medium, rather than a computer-readable storage medium, that is for use by, or connected to, an instruction execution system, apparatus, or device, and can communicate, propagate, or transport a program.

[0066] Program code and / or data used thereby, embodied on a computer-readable storage medium, may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, or any suitable combination thereof.

[0067] Computer program code for performing operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including, for example, object-oriented programming languages ​​such as Java, Smalltalk, and C++, and conventional procedural programming languages ​​such as, for example, the C programming language or a similar programming language. The program code can run as a standalone software package, entirely on the user's computer, partially on the user's computer, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, 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 (for example, via the Internet using an Internet Service Provider).

[0068] Some embodiments of the present invention are described below with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It will be understood that each block in a flowchart and / or block diagram, and combinations of blocks in a flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions may be provided to a general-purpose computer processor, a dedicated computer, or other programmable data processing device for manufacturing machines, thereby creating means for performing functions / actions specified in the flowchart and / or block diagram of a block or a group of blocks, through which instructions executed via the processor of the computer or other programmable data processing device.

[0069] Furthermore, these computer program instructions may be stored in a computer-readable medium that can instruct a computer, other programmable data processing device, or other device to function in a particular way, thereby manufacturing a product which includes instructions that perform functions / actions specified in a block or a series of block flowcharts and / or block diagrams.

[0070] Computer program instructions may be loaded onto a computer, other programmable device, or other device to create a computer implementation process, such that the instructions executed on the computer or other programmable device perform a series of operational steps, providing a process for carrying out functions / actions specified in a block or multi-block flowchart and / or block diagram.

[0071] Some of the methods described herein are generally designed for computer use only and may not be suitable or practical for human professionals to perform entirely manually. Human professionals who wish to perform similar tasks manually, such as determining the pressure and / or temperature within a body cavity, may be expected to employ entirely different methods, such as methods that leverage their expertise and / or the pattern recognition capabilities of the human brain, which would be far more efficient than performing the steps of the methods described herein manually.

[0072] Several embodiments of the present invention will be described herein, merely as examples, with reference to the accompanying drawings. While the drawings are referred to in detail here, it should be emphasized that the illustrated details are intended to illustrate the embodiments of the present invention in an illustrative manner. In this regard, the description with reference to the drawings will make it clear to those skilled in the art how embodiments of the present invention can be put into practice. [Brief explanation of the drawing]

[0073] [Figure 1A] This is a flowchart of a process for applying a cleaning fluid and controlling the flow rate of the cleaning fluid, according to some exemplary embodiments of the present invention. [Figure 1B] This is a block diagram of a system for the delivery of cryotherapy according to some exemplary embodiments of the present invention. [Figure 2A] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device positioned in a body lumen, according to some exemplary embodiments of the present invention. [Figure 2B] Figure 2A is a schematic front view of the distal end of a cryotherapy device according to some exemplary embodiments of the present invention. [Figure 3] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, where droplets are located at different locations in the cryotherapy device, according to some exemplary embodiments of the present invention. [Figure 4A]This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, showing several exemplary embodiments of the cryotherapy device, which have multiple irrigation fluid openings at different locations on the device. [Figure 4B] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, showing several exemplary embodiments of the cryotherapy device, which have multiple irrigation fluid openings at different locations on the device. [Figure 4C] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, showing several exemplary embodiments of the cryotherapy device, which have multiple irrigation fluid openings at different locations on the device. [Figure 4D] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, showing several exemplary embodiments of the cryotherapy device, which have multiple irrigation fluid openings at different locations on the device. [Figure 5A] This is a schematic diagram of a cleaning fluid channel having two types of cleaning fluid openings distributed axially and circumferentially on the outer surface of the cleaning fluid channel, according to some exemplary embodiments of the present invention. [Figure 5B] This is a schematic diagram of a cleaning fluid channel having two types of cleaning fluid openings distributed axially and circumferentially on the outer surface of the cleaning fluid channel, according to some exemplary embodiments of the present invention. [Figure 5C] This is a schematic diagram of a cleaning fluid channel having openings divided into different regions, according to some exemplary embodiments of the present invention, wherein the openings in one region are partially distributed circumferentially on the outer surface of the cleaning fluid channel. [Figure 5D] This is a schematic diagram of a cleaning fluid channel having openings divided into different regions, according to some exemplary embodiments of the present invention, wherein the openings in one region are partially distributed circumferentially on the outer surface of the cleaning fluid channel. [Figure 5E] This is a schematic diagram of a cleaning fluid channel having openings divided into different regions, according to some exemplary embodiments of the present invention, wherein the openings in one region are partially distributed circumferentially on the outer surface of the cleaning fluid channel. [Figure 6A]This is a schematic diagram showing the distribution of cleaning fluid openings when covering the entire surface of the distal end of a visualization assembly, which optionally includes a window or lens, according to some exemplary embodiments of the present invention. [Figure 6B] This is a schematic diagram showing the distribution of cleaning fluid openings when covering the entire surface of the distal end of a visualization assembly, which optionally includes a window or lens, according to some exemplary embodiments of the present invention. [Figure 6C] This is a schematic diagram showing the distribution of cleaning fluid openings when partially covering the surface of the distal end of a visualization assembly, which optionally includes a window or lens, according to some exemplary embodiments of the present invention. [Figure 6D] This is a schematic diagram showing the distribution of cleaning fluid openings when partially covering the surface of the distal end of a visualization assembly, which optionally includes a window or lens, according to some exemplary embodiments of the present invention. [Figure 6E] This is a schematic cross-sectional view of the distal end of a cryotherapy device, including at least one discharge flow seal, according to some exemplary embodiments of the present invention. [Figure 6F] This is a schematic cross-sectional view of the distal end of a cryotherapy device, including at least one discharge flow seal, according to some exemplary embodiments of the present invention. [Figure 7A] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device having a flow reducer, such as an internal reducer in a washing fluid channel, according to some exemplary embodiments of the present invention. [Figure 7B] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device having a flow reducer, such as an internal reducer in a washing fluid channel, according to some exemplary embodiments of the present invention. [Figure 7C] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, according to some exemplary embodiments of the present invention, which has an internal reducer with an integrated channel and / or opening within a washing fluid channel. [Figure 7D]This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device, according to some exemplary embodiments of the present invention, having an internal reducer in a washing fluid channel and a plurality of separate openings distributed on the surface of the channel. [Figure 8A] This is a schematic cross-sectional view of the distal end of cryotherapy having at least one flow reducer located distal to the washing opening, such as a washing fluid opening in an additional flow reducer, according to some exemplary embodiments of the present invention. [Figure 8B] This is a schematic cross-sectional view of the distal end of cryotherapy having at least one flow reducer located distal to the washing opening, such as a washing fluid opening in an additional flow reducer, according to some exemplary embodiments of the present invention. [Figure 8C] This is a schematic cross-sectional front view showing a flow reducer having an opening surrounding a distal end cryofluid opening, according to some exemplary embodiments of the present invention. [Figure 8D] According to some exemplary embodiments of the present invention, this is a schematic cross-sectional view showing the distal end of a cryotherapy device including a washing fluid flow reducer having a plurality of openings and a discharge flow seal. [Figure 8E] According to some exemplary embodiments of the present invention, this is a schematic cross-sectional view showing the distal end of a cryotherapy device including a washing fluid flow reducer having a plurality of openings and a discharge flow seal. [Figure 8F] According to some exemplary embodiments of the present invention, this is a schematic cross-sectional view showing the distal end of a cryotherapy device including a cleaning fluid flow reducer, spaced-out cleaning fluid openings, and a discharge flow seal. [Figure 8G] According to some exemplary embodiments of the present invention, this is a schematic cross-sectional view showing the distal end of a cryotherapy device including a cleaning fluid flow reducer, spaced-out cleaning fluid openings, and a discharge flow seal. [Figure 9] This is a schematic longitudinal cross-sectional view of the distal end of a cryotherapy device according to some exemplary embodiments of the present invention, where at least a portion of the outer surface of the cryotherapy device exposed to cryofluid in a body lumen is a rough, non-smooth surface. [Figure 10]Figures A to C are longitudinal cross-sectional views of the distal end of a cryotherapy device having an upright vertical surface (10A), an inclined surface (10B), or a curved surface (10C) at the distal end, according to some exemplary embodiments of the present invention. [Modes for carrying out the invention]

[0074] The present invention relates, in some embodiments, to a cryotherapy device, and more particularly to a cryotherapy device for treating hollow organ diseases. In some embodiments, hollow organ diseases include bladder cancer, interstitial cystitis, overactive bladder, superficial gastric neoplastic lesions, superficial gastric cancer, and / or abdominal wall tumors.

[0075] Some embodiments relate to controlling the flow rate of a lavage fluid within a body cavity, such as a hollow organ, in order to interfere with existing droplets and / or to prevent droplet formation on the surface of a cryotherapy device within a body cavity. In some embodiments, the flow rate of the lavage fluid in at least one lavage inlet, such as a lavage fluid channel in a cryotherapy device, is controlled by at least one flow reducer, such as an internal reducer located within the lavage fluid channel. In some embodiments, the at least one flow reducer narrows the lavage fluid channel by at least 10%, for example, at least partially blocking it, such as at least 30%, at least 50%, at least 70%, at least 90%, or any intermediate, smaller or larger reduction ratio of the lavage fluid channel.

[0076] According to some embodiments, at least one flow reducer in the cleaning fluid channel controls the flow rate of cleaning fluid through one or more distal openings of the cleaning fluid channel, such as an opening facing forward, which is optionally directed toward a target site. In some embodiments, at least one flow reducer controls at least one of the pressure of the cleaning fluid exiting the opening, the velocity of the cleaning fluid exiting the one or more distal openings of the cleaning fluid channel, and / or direction. Optionally, at least one flow reducer is located at the distal end of the cleaning fluid channel and narrows and / or shapes one or more distal openings of the cleaning fluid channel.

[0077] According to some embodiments, at least one flow reducer includes one or more openings or channels around the flow reducer, configured to direct cleaning fluid liquid into lateral openings around a cleaning channel. In some embodiments, the width of the flow reducer opening determines at least one of the amount of cleaning fluid directed to the cleaning channel opening and / or the pressure of the cleaning fluid within the flow reducer opening. In some embodiments, for example, the angle of the channel within the flow reducer with respect to the axis of the cleaning fluid channel determines the angle of the spray of cleaning fluid from the cleaning channel to the outside. In some embodiments, the velocity of the cleaning fluid within the channel with respect to the width of the reducer opening controls the pressure within the fluid channel, and for example, a high speed and / or narrow opening of the cleaning fluid flow may generate negative pressure within the cleaning fluid channel.

[0078] According to some exemplary embodiments, at least one internal reducer channel and / or opening is shaped, sized, and / or aligned to spray the cleaning fluid at a selected deflection angle in the range of 10 to 170 degrees, such as 10 to 50 degrees, 30 to 100 degrees, 90 to 170 degrees, or any intermediate smaller or larger angle, with respect to the outer surface of the cleaning fluid channel. Alternatively or further, multiple internal reducer channels and / or openings are shaped, sized, and / or aligned to spray the cleaning fluid at impact angles in the range of 0 to 90 degrees, such as 0 to 30 degrees, 10 to 40 degrees, 20 to 70 degrees, 50 to 90 degrees, or any intermediate smaller or larger angle or range of angles, with respect to the surface of the cryotherapy device and / or the optical surface, for example, within a body lumen.

[0079] According to some exemplary embodiments, the cryotherapy apparatus includes at least one flow reducer in the cleaning fluid channel, positioned slightly away from an opening on the periphery of the cleaning fluid channel, such as a transverse opening facing the surface of an optionally defined visualization assembly, which in some embodiments is referred to herein as an optical assembly. In some embodiments, the proximal end of the at least one flow reducer is positioned at a distance of at least 0.5 mm from the periphery opening, such as at a distance of at least 1 mm, at least 5 mm, at least 20 mm, or any intermediate, smaller, or larger distance from the at least one opening on the periphery of the cleaning fluid channel.

[0080] One aspect of several embodiments relates to a laundering fluid channel opening on the periphery of a laundering fluid channel having a predetermined arrangement, size, and distribution for controlling the flow rate and direction of a laundering fluid within a body lumen, for example. In some embodiments, a plurality of laundering fluid openings are distributed axially and / or circumferentially around at least one laundering fluid channel within a body lumen. In some embodiments, for example, to interfere with existing droplets already adhering to a surface and / or to prevent the adhesion or formation of droplets on a surface, the plurality of laundering fluid openings are optionally shaped, sized, arranged, and / or positioned to direct the laundering fluid to a surface at the distal end of the cryotherapy device that is exposed to droplet formation or adhesion. Alternatively or further, for example, to clear a flow path and prevent blockage of the discharge path by droplets, the plurality of laundering fluid openings are optionally shaped, sized, arranged, and / or positioned to direct the laundering fluid into the lumen of at least one discharge path. Alternatively, or further, to create, for example, a flow protection space, multiple cleaning fluid openings are optionally shaped, sized, arranged, and / or positioned to direct the cleaning fluid into the space between the visualization assembly and the treatment site.

[0081] According to some embodiments, the multiple openings have similar shapes and / or sizes at their discretion. Alternatively, at least some of the openings have different shapes and / or sizes at their discretion. In some embodiments, the multiple openings have sizes such as a maximum width or maximum diameter in the range of 0.01 mm to 2 mm, for example, 0.01 mm to 2 mm, for example, 0.05 mm to 0.5 mm, 0.07 mm to 1 mm, 0.8 mm to 2 mm, or any intermediate, smaller or larger range.

[0082] According to some embodiments, the multiple openings are distributed axially and / or circumferentially on the outer surface of the cleaning fluid channel, for example, within at least one region of the wall facing at least one selected location, such as at least one portion of the wall facing the field of view (FOV) between the visualization assembly and the treated tissue, at least one region of the wall facing the visualization assembly, and / or at least one region of the wall facing the lumen or opening of the discharge channel. In some embodiments, the multiple openings are distributed circumferentially along the periphery of the cleaning fluid channel. Alternatively or further, at least some of the multiple openings are distributed along a portion of the periphery, such as along an arc making an angle smaller than 360 degrees, smaller than 180 degrees, smaller than 90 degrees, or any intermediate smaller or larger value. Alternatively or further, at least some of the multiple openings are distributed along a portion of the surface connected to or adjacent to the cleaning fluid channel.

[0083] According to some embodiments, the multiple cleaning openings are located in part of the wall of the cleaning channel, for example, surrounding the cleaning inlet and / or along the cleaning inlet. Furthermore or alternatively, the multiple cleaning openings are located in part of the wall of the cleaning inlet, surrounding at least 5% of the inlet, for example, in a range of at least 10%, at least 20%, at least 30%, or any intermediate, smaller, or larger value, and / or between two adjacent openings, maintaining an axial distance of at least 0.05 mm, for example, at least 0.2 mm, at least 1 mm, or any intermediate, smaller, or larger value.

[0084] According to some embodiments, at least some of the multiple openings have different shapes and / or sizes. In some embodiments, at least some of the multiple openings are arranged in an array of openings. In some embodiments, the multiple openings are evenly distributed within the array. Alternatively, the distance between at least some adjacent openings within the array varies.

[0085] A potential benefit of controlling the flow rate of the cleaning fluid may be the efficient removal of droplets that obstruct visualization, such as droplets on optical lenses, droplets on tubes, and droplets inside discharge paths, which may promote or move low-temperature frost to sensitive locations.

[0086] According to some embodiments, cryotherapy devices are designed with different shapes and / or sizes of lavage fluid openings depending on the clinical application, the hollow organ, and / or the humidity level within the hollow organ. For example, in some embodiments, when the lavage pressure is low and the ambient pressure outside the body lumen is high, the lavage fluid opening is optionally designed to be very small, such as in the range of 0.01mm to 0.3mm, 0.01 to 0.1mm, 0.01mm to 0.5mm, 0.5 to 0.2mm, or any intermediate smaller or larger range, in order to prevent fluid from entering the lavage channel from the body. Conversely, when the lavage pressure is high and / or the ambient pressure outside the body lumen is low, the size of the lavage fluid opening is in the range of 0.5 to 2mm, such as in the range of 0.5mm to 1mm, 0.7mm to 1.5mm, 1mm to 2mm, or any intermediate smaller or larger range. In some embodiments, a cryotherapy device having a specific arrangement of irrigation flow openings is selected according to a specific clinical application and / or a specific hollow organ.

[0087] One aspect of several embodiments relates to directing the discharge of fluids and particles from a therapeutic space within a body lumen around a visualization assembly of a cryotherapy device. In some embodiments, the discharge of fluids from the therapeutic space and / or body lumen is directed to one or more discharge openings located proximal to the distal end of the visualization assembly. In some embodiments, one or more discharge openings are openings in the outer sleeve of the cryotherapy device located within a body lumen. In some embodiments, one or more discharge openings are openings of at least one discharge channel passing through the inner lumen of the sleeve, or are directed to the opening of at least one discharge channel.

[0088] According to some embodiments, the cryotherapy device includes at least one discharge seal, such as a distal discharge seal configured to at least partially block the discharge of fluid and particles through a distal, for example, forward-facing opening of the discharge channel. In some embodiments, the forward-facing opening is an opening of the discharge channel directed toward the target of cryotherapy treatment in the treatment space and / or body lumen. In some embodiments, at least one distal discharge seal reduces the passage of fluid and particles through the forward-facing opening of the discharge channel by at least 50%, for example, by at least 60%, at least 70%, at least 80%, at least 90%, or any intermediate, smaller, or larger percentage.

[0089] According to some exemplary embodiments, the distal discharge seal is axially positioned on the cryotherapy device proximal to the distal end of the visualization assembly. In some embodiments, the distal discharge seal is located between the distal end of the visualization assembly and the discharge opening of the outer sleeve. In some embodiments, when the discharge seal blocks the passage of fluid and particles, the fluid and particles around the visualization assembly are directed towards the discharge opening of the outer sleeve.

[0090] According to some embodiments, the distal discharge seal is an adjustable seal. In some embodiments, for example, the size of at least one opening of the seal can be adjusted to increase or decrease the flow rate of fluid and / or particles to at least one discharge channel. In some embodiments, the seal opening size is adjusted in response to a signal received from at least one sensor indicating an increase in pressure within the body lumen and / or closure of the discharge opening of the outer sleeve, which is optional.

[0091] One aspect of several embodiments relates to modifying or pre-treating the surface of a cryotherapy device to prevent or reduce droplet adhesion and / or formation on the modified surface. In some embodiments, at least a portion of the surface is modified to be a non-smooth, rough surface. In some embodiments, the non-smooth, rough surface is modified, for example, to reduce the adhesion or adhesion behavior between the droplet and the surface.

[0092] According to some exemplary embodiments, the pre-treated surface is optionally formed during manufacturing, for example, by coating the surface with a hydrophilic or hydrophobic coating. Alternatively, a non-smooth, rough surface is formed, for example, by sandblasting, electroetching, or other surface heat treatments.

[0093] One aspect of several embodiments relates to draining fluid from a hollow organ through at least one discharge side opening. In some embodiments, the at least one discharge side opening is located around the body of the cryotherapy device, for example, a sleeve. In some embodiments, the at least one discharge opening comprises a plurality of discharge openings. In some embodiments, the plurality of discharge openings are distributed axially and / or obliquely in the wall of the cryotherapy device, for example, in the wall of a sleeve.

[0094] According to some embodiments, at least some of the multiple openings are located proximal to the distal end of the visualization assembly, optionally including lenses, apertures, and / or illumination.

[0095] Potential benefits of surface treatment may include preventing or reducing droplet accumulation or formation, reducing the droplet profile and forming one or more thin layers instead of droplets in areas where access to the cleaning fluid is restricted or where the flow of the cleaning fluid is not strong enough to dry or break the droplets, such as by directing the liquid.

[0096] According to some embodiments, the methods, systems, and apparatus described herein are used, for example, to treat bladder cancer by delivering cryofluids to malignant tissue, such as cancerous tissue, within the bladder.

[0097] According to some embodiments, the cryotherapy device optionally includes an elongated body, such as a tubular body. In some embodiments, at least one cleansing fluid channel passes through the elongated body and optionally surrounds the cryofluid channel of the device at least partially. In some embodiments, the cleansing fluid is optionally discharged outward from at least one opening of the cleansing channel toward at least a portion of the visualization assembly located between the opening of the cleansing channel and the outer surface of the device body.

[0098] According to some embodiments, as described herein, controlling the discharge of cleaning fluid toward the visualization assembly and / or toward the FOV is performed in devices that do not include a cryofluid channel, such as a device that includes a visualization assembly and a cleaning fluid channel. In some embodiments, the device includes a flow reducer, at least one of a plurality of openings or channels for controlling the discharge of cleaning fluid toward the visualization assembly. A potential advantage of including a cryofluid channel is that it may be possible to reduce the number of devices inserted into the hollow organ.

[0099] Before describing in detail at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited in its application to the details of configuration and arrangement of components and / or methods described in the following description and / or shown in the drawings and / or examples. Other embodiments of the present invention are possible, or it can be practiced or implemented in various ways.

[0100] Exemplary general process for applying cleaning fluid For example, cryotherapy and other cryoexcision treatments are performed by a cryotherapy device within a body cavity, such as a hollow organ. In some embodiments, the body cavity is optionally a body cavity having a narrow single opening. In some embodiments, the body cavity optionally contains body fluids and / or moisture. In some embodiments, the release of cryofluid within the body cavity may cause droplet and / or frost formation within the body cavity, on at least one surface of the cryotherapy device, within at least one lumen of the cryotherapy device, and / or on the surface of an additional device inserted into the body cavity. In some embodiments, a cleaning fluid is applied to prevent, reduce, and remove droplet and / or frost. Hereinafter, Figure 1A shows a process for the application of a cleaning fluid within a body cavity, such as a hollow organ, according to some exemplary embodiments of the present invention.

[0101] According to some exemplary embodiments, in block 40, at least a portion of the cryotherapy device is introduced into a body lumen. In some embodiments, the distal end of the cryotherapy device is optionally introduced into a body lumen. In some embodiments, the distal end of the cryotherapy device includes at least one cryofluid discharge opening configured to introduce cryofluid into a body lumen, and at least one discharge opening configured to remove fluid from the body lumen. In some embodiments, the distal end of the cryotherapy device optionally includes at least one wash fluid opening for delivery of wash fluid into the body lumen. In some embodiments, the distal end of the cryotherapy device further includes a visualization assembly, such as at least one of a lens, optical sensor, camera, optical fiber end, or optical fiber bundle end configured to enable visualization of the body lumen, for example, the inner surface of the body lumen. In some embodiments, the visualization means is configured to enable visualization of the therapeutic space between the distal end and / or the distal end of the cryotherapy device and the inner surface of the body lumen.

[0102] According to some exemplary embodiments, the internal cavity, such as a hollow organ, includes the bladder, kidney, pelvis, uterus, stomach, or abdomen. In some embodiments, the cryotherapy device is introduced into the internal cavity in block 40 through a body opening, such as an anatomical opening in the internal cavity, or through an invasive port, such as a minimally invasive port. In some embodiments, the minimally invasive port includes a laparoscopic port, such as a laparoscopic port. In some embodiments, the internal cavity includes the bladder, and the cryotherapy device is optionally introduced into the bladder through the urethra in block 40. Alternatively, the device is introduced into the abdomen through a laparoscopic trocar, into the uterus through the vagina, or into the stomach through the esophagus.

[0103] According to some exemplary embodiments, the cleaning fluid is optionally applied, for example, by being discharged into the body lumen in block 45. In some embodiments, the cleaning fluid is applied, for example, to clear the visualization field or to widen a narrow opening when navigating the device into and / or within the body lumen. In some embodiments, the cleaning fluid is optionally applied, for example, to enable clear visualization of the inner surface of the body lumen and / or a target area on the inner surface.

[0104] According to some exemplary embodiments, the cleaning fluid is optionally discharged into the body lumen in block 45 through at least one cleaning opening located around the cleaning fluid inlet. In some embodiments, the cleaning fluid inlet includes a constricted section where the flow velocity is accelerated. In some embodiments, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located proximal to the constricted section. Alternatively or further, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located in the constricted section. Alternatively or further, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located distal to the constricted section.

[0105] According to some exemplary embodiments, the body lumen is optionally expanded in block 50. In some embodiments, the body lumen is expanded before introduction of the cryotherapy device into the body lumen. Alternatively, the body lumen is expanded by the cryotherapy device. In some embodiments, the body lumen is expanded, for example, to allow for better visualization of the inner surface of the body lumen. Alternatively or further, the body lumen is expanded to flatten the inner surface of the body lumen, for example, to allow for better access to a target site within the body lumen, such as to a target site on the inner surface of the body lumen, for example, to a cryofluid released within the body lumen.

[0106] According to some exemplary embodiments, the body lumen is optionally expanded in block 50 by releasing an expandable cryofluid into the body lumen through at least one opening of the cryotherapy device. Alternatively or further, a lavage fluid is optionally released in block 50 into the body lumen through at least one opening of the cryotherapy device to expand the body lumen.

[0107] According to some exemplary embodiments, the cryofluid is released into a body lumen in block 60. In some embodiments, the cryofluid is optionally released through at least one opening, such as a nozzle at the distal end of the cryotherapy device. In some embodiments, the released cryoflu expands and lowers the temperature inside the body lumen, for example, in defined target tissue within the body lumen to excise tissue at the target site. Optionally, the cryoflu is directed towards the target site or into the therapeutic space between the distal end of the cryotherapy device and the target site.

[0108] According to some exemplary embodiments, the body lumen is visualized in block 65. In some embodiments, the body lumen is visualized in block 60 in relation to the release of cryofluid, for example, before, during, and after the release of cryofluid. In some embodiments, at least one of the target sites or therapeutic spaces within the body lumen is visualized in block 65. In some embodiments, the body lumen is visualized by a visualization assembly, for example, an optical assembly located at the distal end of the cryotherapy device.

[0109] According to some exemplary embodiments, block 70 optionally receives instructions regarding the formation of droplets and / or frost within the body lumen. In some embodiments, the instructions are visual instructions received from a visualization assembly. Alternatively, the instructions are received from at least one sensor in the cryotherapy device, such as from at least one sensor located at the distal end of the cryotherapy device and / or along the cryotherapy device. In some embodiments, the at least one sensor includes a temperature sensor, a flow sensor, a humidity sensor, and / or an image sensor. In some embodiments, a control unit coupled to the cryotherapy device, such as a control circuit of a control unit, receives instructions based on signals received from the visualization assembly and / or at least one sensor.

[0110] According to some exemplary embodiments, the cleaning fluid is applied in block 80. In some embodiments, the cleaning fluid is applied in response to instructions optionally received in block 70. Alternatively, the application of the cleaning fluid is a preventative process, for example, the cleaning fluid is applied without receiving instructions in block 70. In some embodiments, the cleaning fluid is applied intermittently, optionally in short bursts. In some embodiments, the cleaning fluid is applied intermittently, for example, every 0.1 seconds, every 0.5 seconds, every 2 seconds, or any intermediate, shorter, or longer time period. In some embodiments, the cleaning fluid, for example, the cleaning fluid or cleaning gas, is applied into a body cavity. In some embodiments, the cleaning fluid is applied toward at least one of the following surfaces located in a body cavity: a visualization assembly, a therapeutic target, at least a portion of the therapeutic space, or at least one surface of the cryotherapy device located in a body cavity. In some embodiments, the cleaning fluid is applied to prevent the formation of droplets and / or frost within the body cavity. Alternatively, or further, a cleaning fluid may be optionally applied to prevent droplet adhesion and / or accumulation within the body cavity, on the surface or openings of the cryotherapy device, and / or on the visualization assembly. Alternatively, or further, a cleaning fluid may be optionally applied to prevent frost adhesion and / or accumulation within the body cavity, on the surface or openings of the cryotherapy device, and / or on the visualization assembly. Alternatively, or further, a cleaning fluid may be optionally applied to clear the field of view (FOV) of the visualization assembly.

[0111] According to some exemplary embodiments, the irrigation fluid is applied in block 80 through at least one opening in the cryotherapy device, such as at least one opening at the distal end of the cryotherapy device. In some embodiments, the at least one opening includes multiple openings. In some embodiments, the multiple openings are located at two or more locations at the distal end of the cryotherapy device.

[0112] According to some exemplary embodiments, the cleaning fluid is discharged into the body lumen in block 80 through at least one cleaning opening located around the cleaning fluid inlet. In some embodiments, the cleaning fluid inlet includes a constricted section where the cleaning fluid velocity is accelerated. In some embodiments, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located proximal to the constricted section. Alternatively or further, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located in the constricted section. Alternatively or further, the cleaning fluid is optionally discharged into the body lumen through at least one cleaning fluid opening located distal to the constricted section.

[0113] According to some exemplary embodiments, the flow rate of the cleaning fluid is controlled by block 90. ​​In some embodiments, the flow rate of the cleaning fluid is controlled by applying the cleaning fluid through openings having a predetermined size, a predetermined shape, and / or a predetermined location. In some embodiments, all cleaning fluid openings are the same size and / or shape. Alternatively, at least some of the cleaning fluid openings have different shapes and / or sizes. In some embodiments, the size, shape, and / or location of the openings allows control of the distribution and / or direction of the cleaning fluid within the body lumen. Alternatively, or further, the size, shape, and / or location of the openings determine the distribution and / or direction of the cleaning fluid with respect to at least one outer surface of the cryotherapy device and / or visualization assembly.

[0114] According to some exemplary embodiments, the flow rate of the cleaning fluid is controlled in block 90, for example, by controlling the amount of cleaning fluid directed to the opening in the cryotherapy device. In some embodiments, the amount of cleaning fluid directed to the opening is controlled, for example, by controlling the width of the cleaning fluid channel in the cryotherapy device. Alternatively or further, the amount of cleaning fluid directed to the opening is controlled, for example, by controlling or restricting the internal cross-section of the channel through which the cleaning fluid flows. Further or alternatively, the amount of cleaning fluid directed to the opening is controlled, for example, by opening a valve in the cleaning fluid channel, for example, at least a valve.

[0115] According to some exemplary embodiments, the fluid is discharged from the body cavity in block 100. In some embodiments, the fluid is discharged from the body cavity to maintain a target, such as a predetermined pressure and / or temperature level within the body cavity. Alternatively or further, the fluid is discharged from the body cavity in block 65, for example, to allow for better visualization. Alternatively or further, in some embodiments, the fluid is discharged from the body cavity in blocks 45 and / or 80 before, during, and / or after the application of the cleaning fluid. Alternatively or further, the fluid is optionally automatically discharged from the body cavity in response to signals received from at least one temperature and / or at least one pressure sensor.

[0116] According to some exemplary embodiments, the fluid is discharged in block 40 through at least one discharge side opening in an elongated hollow body, such as a sleeve or overtube used during the introduction of the cryotherapy device. In some embodiments, the at least one discharge side opening is an opening around the sleeve or overtube. In some embodiments, the at least one discharge side opening is located within the body lumen. Alternatively or further, the fluid is discharged through at least one distal opening of at least one discharge channel of the cryotherapy device located within the body lumen.

[0117] Exemplary cryotherapy system According to some exemplary embodiments, the cryotherapy system includes a cryotherapy probe configured to be at least partially inserted into a body lumen and a control unit connected to a cryotherapy device. In some embodiments, the control unit is located outside the body. Hereinafter, Figure 1B shows a cryotherapy system according to some exemplary embodiments of the present invention.

[0118] According to some exemplary embodiments, the cryotherapy system 100 includes a cryotherapy probe, such as a cryotherapy device 102, and a control unit 104 connected to the cryotherapy device 102. In some embodiments, the cryotherapy device 102, such as the body of a cryotherapy device, is an elongated probe that can be optionally introduced into a body lumen and has a distal end 121 shaped and sized to face a target site within the inner surface of the lumen, and a proximal end 125 optionally located outside the body lumen. Optionally, the cryotherapy device 102, such as the body of a cryotherapy device, is hollow to allow for the arrangement of one or more flow paths, one or more channels, and / or assemblies, such as an optical assembly within the device body. In some embodiments, the cryotherapy device 102 is cylindrical and has a diameter in the sleeve around it and a distal end 121 of the cryotherapy device in the range of 3 to 15 mm, such as 3 mm, 5 mm, 7 mm, 9 mm, or any intermediate, smaller, or larger value. In some embodiments, the diameter of the cryotherapy device without the sleeve is in the range of 0.3 to 5 mm, such as 0.3 to 0.8 mm, 0.5 to 1.5 mm, 0.8 to 2 mm, 0.5 mm, or any intermediate, smaller or larger range. In some embodiments, the cryotherapy device 102 is shaped and sized to be introduced into the body lumen through the working channel of an endoscope. Alternatively, the cryotherapy device 102 is introduced into the body lumen through a hollow, elongated body of the cryotherapy system, such as a sleeve 124. Alternatively, the external form of the cryotherapy device 102 is constructed / has a dedicated structure to be introduced into the body lumen (e.g., a dedicated scope + cryotherapy element).

[0119] Alternatively, the cryotherapy system includes an endoscope with an optional visualization assembly and a cryotherapy device without the visualization assembly, which is introduced through the working channel of the endoscope.

[0120] According to some exemplary embodiments, the cryotherapy device 102 includes at least one flow path from a proximal end 125 to a distal end 121, such as a lumen or a channel passing through the lumen of the cryotherapy device. In some embodiments, the at least one flow path is used as an inflow path into the body lumen toward the distal end 121 and as an outflow path from the body lumen toward the proximal end 125. In some embodiments, the cryotherapy device 102 includes at least one path, such as an inflow channel 106 for delivering fluid into the body lumen. Furthermore or optionally, the cryotherapy device 102 includes at least one outflow path, such as an outflow channel 110 for discharging fluid, liquid, particles, and / or gas from the body lumen.

[0121] According to some exemplary embodiments, an outflow channel, such as an outflow channel 110, includes at least one flow control valve, such as a valve 123, for controlling the passage of material, such as a fluid or particles, through the outflow channel. In some embodiments, the at least one valve 123 includes at least one check valve, which is optionally configured to open passively when the pressure inside the body lumen exceeds a predetermined value. Optionally, the outflow flow control valve is located outside the body, near the proximal end 125 of the cryotherapy device 102.

[0122] According to some exemplary embodiments, the inlet channel 106 includes at least one cryogenic nozzle 129, such as a forward-facing cryogenic nozzle and / or a sideways-facing cryogenic nozzle, configured to spray a cryogenic fluid, such as a cryogenic gas and / or cryogenic liquid, toward a selected target site on the inner surface of the lumen. 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 lumen causes a rapid decrease in the fluid's pressure, resulting in cryogenic effects within the body lumen, such as the Joule-Thomson effect.

[0123] According to some exemplary embodiments, the cryogenic nozzle 129 is an adjustable cryogenic nozzle configured to spray cryogenic fluid toward a target site at an angle less than or greater than 90 degrees. Alternatively, the cryogenic nozzle 129 is a fixed-angle cryogenic nozzle fixed at an angle less than or greater than 90 degrees, such as 15 degrees, 30 degrees, 45 degrees, 55 degrees, or any intermediate angle different from 90 degrees. Alternatively, the angle is 90 degrees. In some embodiments, the adjustable cryogenic nozzle is configured to control the amount of sprayed cryogenic fluid discharged into the lumen through the nozzle by, for example, adjusting the opening diameter of the cryogenic nozzle. Alternatively or further, the amount of sprayed cryogenic fluid discharged into the lumen through the nozzle is controlled by opening at least one flow valve.

[0124] According to some exemplary embodiments, the cryotherapy device 102 includes at least one optical assembly, such as a wire, optical fiber, optical prism, optical path, or optionally an optical channel 118, for delivering images and / or visual signals of tissue facing the distal end 121 of the cryotherapy device 102 to an optical sensor located outside the body, such as an optical sensor in a control unit 104, or to an external optical assembly, such as an optical assembly of a different control unit. Alternatively, the optical assembly includes at least one optical sensor, such as an optical sensor 122 at the distal end 121 of the cryotherapy device 102, configured to detect visual signals of tissue facing the distal end 121 of the cryotherapy device 102, such as images and / or visual signals of a target site in a body lumen. Alternatively, the optical assembly includes a sensor, optionally an ultrasound (US) sensor, or a magnetic resonance (MR) sensor.

[0125] According to some exemplary embodiments, the cryotherapy device 102 includes at least one illumination source, such as an illumination source 119. In some embodiments, the illumination source 119 is located at the distal end 121 of the cryotherapy device, optionally directed toward the tissue of the body lumen. Alternatively, at least one light source is located inside a channel within the cryotherapy device, such as an optical channel 118.

[0126] According to some exemplary embodiments, the optical channel 118 is or includes at least one optical fiber, a group of optical fibers, or an optical fiber cable. In some embodiments, when the optical channel 118 is or includes at least one optical fiber, a group 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. Alternatively or optionally, the optical channel 118 includes at least one LED light, optionally connected to an external unit by a wire.

[0127] According to some exemplary embodiments, the cryotherapy apparatus 102 includes at least one flow path, such as a scrubbing channel 114, for the introduction of a scrubbing fluid, such as a gas or liquid, into a lumen, such as a body lumen. In some embodiments, the introduction of a scrubbing fluid, such as a scrubbing gas, is used to inflate the body lumen, for example, to allow good visualization of the inner surface of the lumen and / or to allow good access to a desired area within the body lumen, such as an area optionally selected for cryotherapy. Furthermore or alternatively, the scrubbing fluid is sprayed into the treatment site through a scrubbing opening, optionally including a nozzle, to remove or blow away condensed particles and / or clouds of condensed particles, for example. Optionally, condensed particles and / or clouds of condensed particles are formed by the interaction of the cryogenic gas with the humidified environment inside the body lumen.

[0128] According to some exemplary embodiments, the cleaning channel 114 includes at least one cleaning opening, such as 2, 3, 4, 5, 6, 10, 100, or any more or intermediate number of cleaning openings. In some embodiments, the cleaning channel 114 includes a plurality of cleaning openings. In some embodiments, the plurality of cleaning openings or at least some of the cleaning openings have the same width or diameter, optionally. In some embodiments, at least some of the cleaning openings are optionally lateral openings. Alternatively, at least some of the cleaning openings are forward-facing openings.

[0129] According to some exemplary embodiments, the cleaning openings are distributed axially and / or obliquely in the walls of a cleaning channel, such as the walls of a cleaning inlet.

[0130] According to some exemplary embodiments, at least one or at least some of the cleaning openings include at least one cleaning opening at the distal end of the cryotherapy device, such as a cleaning opening facing tissue. In some embodiments, at least one cleaning opening is optionally a cleaning opening facing forward. In some embodiments, at least one cleaning opening is configured to spray, for example, a gas, such as a low-pressure gas, into the space between the cryotherapy device 102 and the target site. In some embodiments, at least one cleaning opening is an adjustable opening to allow, for example, the spraying of a cleaning fluid, such as a gas or liquid, laterally or at an angle to the target site, such as at a predetermined angle to the outer surface of the cleaning fluid channel or to the surface of the target site. In some embodiments, at least one opening sprays a cleaning fluid, such as a gas or liquid, into the field of view (FOV) of the optical sensor 122 or into the FOV of the optical channel 118.

[0131] According to some exemplary embodiments, the cryotherapy apparatus 102 includes at least one cleaning director at the cleaning opening, such as a deflection surface, configured to direct the cleaning fluid toward an optical assembly, such as a lens, and / or into the field of view of an optical sensor 122, or into the field of view of an optical channel 118. Optionally, at least one cleaning director is an adjustable cleaning director configured to allow the spraying of a cleaning gas at an angle to the field of view, for example.

[0132] According to some exemplary embodiments, at least one cleaning flow control valve on the cleaning inlet is configured to adjust the amount of cleaning fluid discharged through the cleaning opening in response to a signal optionally received from a control unit and / or in a predetermined order.

[0133] According to some exemplary embodiments, the control unit 104 includes at least one control circuit, such as a control circuit 126. In some embodiments, the control circuit 126 controls the flow rate of cryogenic fluid through an inlet passage, such as an inlet channel 106. In some embodiments, the control circuit 126 controls the flow rate of cryogenic fluid by controlling at least one cryogenic flow control valve, such as a valve located inside the inlet passage and / or at least one valve between the cryogenic source 134 and the inlet channel 106. Alternatively or further, the control unit 104 controls at least one valve of the cryogenic source 134, such as an outlet valve of the cryogenic source 134.

[0134] According to some exemplary embodiments, the control circuit 126 controls the flow rate of cleaning fluid through a cleaning inlet passage, such as a cleaning channel 114. In some embodiments, the control circuit 126 controls the flow rate of cleaning fluid by controlling at least one cleaning flow control valve, such as a valve, located in the cleaning passage, such as a cleaning channel 114. Alternatively or further, the control circuit 126 controls the flow rate of cleaning fluid by controlling at least one flow control valve between the cleaning source 108 and the cleaning channel 114, such as at least one valve. Alternatively or further, the control circuit 126 controls at least one valve of the cleaning source, such as an outlet valve of the cleaning source 108. In some embodiments, the cleaning source 108 includes a pump, such as a pump configured to compress air. Alternatively, the cleaning source 108 includes a container for cleaning fluid.

[0135] According to some exemplary embodiments, the cleaning channel 114 includes at least one flow reducer 103 within the lumen of the cleaning channel 114. In some embodiments, the flow reducer 103 is shaped and sized to narrow the cleaning channel 114. In some embodiments, the flow reducer is in contact with the wall of the cleaning channel and / or the wall of the cryofluid inlet channel 106. In some embodiments, the flow reducer 103 blocks at least 10% of the cleaning fluid flow rate in the cleaning channel 114, such as at least 20%, at least 30%, at least 50%, at least 60%, at least 70%, or any intermediate, smaller or larger percentage value.

[0136] According to some exemplary embodiments, the flow reducer is shaped as an arc that contacts the wall of the cleaning channel and / or the wall of the cryofluid inlet channel 106. Optionally, the flow reducer 103 is shaped as a tube coaxially positioned within the cleaning channel 114. In some embodiments, the flow reducer 103 includes a projection that protrudes from the wall of the cleaning channel and / or from the wall of the cryofluid inlet channel 106 into the cleaning channel 114, the projection optionally coaxially positioned within the cleaning fluid channel 114.

[0137] According to some exemplary embodiments, the flow reducer 103 includes at least one, for example, a plurality of channels optionally located around the flow reducer, configured to direct the cleaning fluid into the body lumen. In some embodiments, at least one flow reducer channel is aligned with at least one side opening in the wall of the cleaning channel 114. Optionally, at least one flow reducer channel is formed from two or more openings in the flow reducer wall, for example, around the flow reducer.

[0138] According to some exemplary embodiments, the control circuit 126 controls the flow rate of a fluid, such as a gas and / or liquid, leaving the body lumen through an outflow passage, such as an outflow channel 110. In some embodiments, the control circuit controls the flow rate through the outflow channel 110 by controlling an outflow flow rate regulating valve, such as a valve 123, such as an outflow valve inside or near the proximal end of the outflow channel. Alternatively, or further, the control circuit 126 controls the operation of a discharge pump 107, such as a vacuum pump connected to the outflow channel. In some embodiments, the discharge pump 107 is used to actively discharge a fluid, such as a liquid and / or gas and / or particles, leaving the body lumen through the outflow passage of the cryotherapy device. Optionally, the control circuit 126 controls at least one discharge flow rate regulating valve, such as a discharge valve on a pipe connecting the discharge pump 107 and the outflow channel. Alternatively, exhaust is performed via a check valve. Alternatively, exhaust is performed via a check valve.

[0139] According to some exemplary embodiments, the control circuit 126 controls an optical assembly, such as an optical sensor, such as an optical sensor 122, located on, for example, a cryotherapy device holder 102. Alternatively, or further, the control circuit 126 controls at least one optical sensor in a control unit 104. In some embodiments, the control circuit 126 controls the opening or closing of an optical channel 118 by optionally controlling the aperture in the optical channel 118. In some embodiments, the control circuit controls the operation of an optical system 110, such as a visualization means.

[0140] According to some exemplary embodiments, the cryotherapy device 102 includes at least one sensor 111 located at the distal end 121 for detecting, for example, at least one environmental parameter of the body lumen. In some embodiments, the environmental parameter includes temperature level, pressure level, and / or humidity level, or any other environmental parameter. Alternatively or further, the cryotherapy device 102 includes at least one sensor, such as sensor 105, located at least partially within the outflow path for detecting environmental parameters such as outflow volume, outflow temperature, and / or outflow humidity.

[0141] According to some exemplary embodiments, sensors 111 and / or 105 are electrically connected to a control circuit 126. Alternatively, or further, the control circuit 126 is electrically connected to one or more sensors located inside or outside the body. In some embodiments, one or more sensors are located near the target site of cryoexcision or slightly away from the target site of cryoexcision. In some embodiments, at least one of the sensors transmits measured environmental parameter values ​​to the control circuit 126. In some embodiments, the control circuit stores the measurements in a memory 128. In some embodiments, the memory 128 includes predetermined values ​​for at least one environmental parameter, such as a maximum pressure value, a minimum temperature value, or any other predetermined environmental parameter value or index thereof. In some embodiments, the memory 128 includes at least one cryotherapy protocol, at least one cryotherapy parameter value or index thereof. In some embodiments, the memory includes log files related to the operation of the cryotherapy device 102 or the operation of the cryotherapy system 100.

[0142] According to some exemplary embodiments, the control unit 104 includes at least one user interface 130 functionally connected to the control circuit 126, such as being connected electrically, optically, or wirelessly. In some embodiments, the user interface 130 includes a sound source and / or a display. In some embodiments, the control circuit 126 transmits a signal to the user interface 130 to generate at least one indicator for the user of the cryotherapy device or cryotherapy system, such as a human-detectable indicator. In some embodiments, the control circuit 126 transmits a signal to the user interface 130 to generate an alarm, for example, when a measured environmental parameter value inside a body cavity exceeds a predetermined value.

[0143] According to some exemplary embodiments, the control circuit 126 is functionally connected to at least one cryogenic flow control valve on the cryogenic inlet, such as a valve. In some embodiments, the control circuit 126 adjusts the flow rate through the cryogenic inlet, for example, by sending a signal to the cryogenic flow control valve, such as reducing the flow rate in the inlet, stopping the flow in the inlet, and / or increasing the flow rate in the inlet. In some embodiments, the control circuit 126 adjusts the cryogenic fluid flow rate in the cryogenic inlet, for example, when the pressure inside the body lumen is higher than a predetermined pressure value. Alternatively, the control circuit 126 adjusts the cryogenic fluid flow rate in the cryogenic inlet, for example, when the temperature inside the body lumen is below a predetermined value, or when it receives an input signal from a user of the system.

[0144] According to some exemplary embodiments, the control circuit 126 controls at least one purge flow control valve on the cryogenic inlet. In some embodiments, the purge flow control valve is configured to control the flow rate of low-pressure fluid through the cryogenic inlet and optionally through the cryogenic nozzle into the body lumen, for example, when the flow of cryogenic fluid is stopped, reduced, or regulated by the control circuit.

[0145] According to some exemplary embodiments, the control circuit 126 is connected to an outflow control valve, such as a valve. In some embodiments, the control circuit adjusts the outflow control valve, for example, by opening the outflow passage when the pressure inside the body lumen is higher than a predetermined value and / or the temperature is lower than a predetermined temperature value.

[0146] According to some exemplary embodiments, the control unit 104 includes a power supply, such as a power supply 132. Alternatively, the control unit 104 is connected to an external power supply, for example, by electrical wiring, optically, or wirelessly. In some embodiments, the power supply includes a battery, optionally a rechargeable battery.

[0147] According to some exemplary embodiments, a control unit, such as control unit 104, is connected to at least one inlet of the cryotherapy device, configured to allow fluid flow from a fluid source into a body lumen. Optionally, control unit 104 is connected to at least one inlet flow control valve on the inlet, configured to regulate the fluid flow through the inlet into the body lumen.

[0148] In some embodiments, a control unit, such as control unit 104, is connected to at least one outflow passage of the cryotherapy device, configured to allow the discharge of fluid from the body lumen. Optionally, control unit 104 is connected to at least one outflow regulator, such as a valve or check valve on the outflow passage, configured to regulate the discharge of fluid from the body lumen through the outflow passage.

[0149] In some embodiments, the control unit 104 controls the inlet and outlet regulators to adjust the pressure level inside the body lumen to a pressure level below a predetermined value. Alternatively, or further, the control unit 104 controls the inlet and outlet regulators to adjust the temperature level inside the body lumen to a temperature level higher than a predetermined value.

[0150] According to some exemplary embodiments, the cleaning source 108 includes a fluid container, such as a gas container or a liquid container. Alternatively, the cleaning source 108 includes a pump configured to pressurize air. In some embodiments, the cryogenic source 134 includes a container of a cryogenic fluid, such as liquid nitrogen, liquid carbon dioxide, or any other cryogenic compound that can be stored as a liquid or gas at high or low pressure at room temperature. Alternatively, the cryogenic source 134 includes a closed-loop internal tank, optionally including at least one thermoelectric cooler (TEC).

[0151] According to some exemplary embodiments, at least one of the water source 108, optical system 138, cryogenic source 134, and / or discharge pump 107 is part of the cryotherapy system 100. Alternatively, at least one of the irrigation source 108, optical system 136, cryogenic source 134, and / or discharge pump 107 is an external element that can be connected to the system 100.

[0152] Exemplary cryotherapy Herein, Figures 2A and 2B illustrate some exemplary embodiments of the present invention, showing cryotherapy systems within body cavities.

[0153] According to some exemplary embodiments, a cryotherapy device coupled to a control unit 202, such as a control console, is introduced through an internal opening, such as a surgical or anatomical opening, while the control unit 202 remains outside the subject's body. In some embodiments, the cryotherapy device is introduced and navigated into a body lumen 204, for example, through an internal lumen opening, such as an anatomical or surgical opening. In some embodiments, the cryotherapy device is introduced and navigated into the body lumen 204 within an endoscope working channel or within a rigid or flexible structure, such as a sleeve 208.

[0154] According to some exemplary embodiments, the distal end 206 of the cryotherapy device is introduced into a body lumen. In some embodiments, the distal end 206 includes at least one cryofluid outflow channel 210 inside the lumen of the cryotherapy device, configured to deliver cryofluid from a cryofluid source coupled to a control unit 202 to a cryofluid opening 212. In some embodiments, the cryofluid opening 212 is configured to release cryofluid, for example, by spraying cryofluid into a body lumen 204. In some embodiments, the cryofluid is optionally sprayed toward the tissue 214 at the treatment site.

[0155] According to some exemplary embodiments, the distal end 206 includes at least one fluid outflow channel 216 within the body lumen of the cryotherapy device, configured to deliver a lavage fluid 217 from a lavage fluid source coupled to a control unit 202 to a plurality of lavage fluid openings, such as a plurality of lavage fluid openings 218 and 220, at the distal end 206 of the cryotherapy device. In some embodiments, the lavage fluid openings are located at different locations along the distal end 206. In some embodiments, at least some of the lavage fluid openings are lateral openings. Alternatively, or further, at least some of the lavage fluid openings are forward-facing openings, such as openings facing the treatment site.

[0156] According to some exemplary embodiments, the distal end 206 includes at least one visualization assembly, such as a visualization assembly 222. In some embodiments, the distal end 224 of the visualization assembly 222 is located in a body cavity. In some embodiments, the distal end 224 includes at least one aperture, illumination, window, and lens, such as a forward-facing aperture, a forward-facing window, or a forward-facing lens, configured to enable visualization of the therapeutic space between the distal end 206 and the target site and / or tissue 214 within the target site. In some embodiments, at least one of the therapeutic space, the target site, and the target tissue 214 is within the field of view (FOV) 226 of the visualization assembly 222, such as the FOV of the distal end 224 of the visualization assembly. In some embodiments, the distal end 224, such as the aperture, optionally includes a lens and / or a transparent window. In some embodiments, the visualization assembly 222 includes a visualization channel within the cryotherapy device, terminating at an aperture 224 at the distal end 206 of the cryotherapy device. In some embodiments, at least some of the cleaning fluid openings, such as opening 218, discharge cleaning fluid toward the distal end 224, for example, so that at least a portion of the visualization assembly, such as a lens, illumination end unit, window, or aperture located at the distal end of the visualization assembly, is directed toward and / or directed toward the distal end 224 of the visualization assembly for cleaning.

[0157] According to some exemplary embodiments, the cryotherapy device includes at least one drainage channel, such as at least one drainage channel 228, configured to drain fluid, such as cryofluid and / or cleansing fluid, from a body cavity to a tank optionally located outside the body. Alternatively or further, the drainage channel 228 drains body fluid from the body cavity to the tank or releases the drained body fluid into the room environment outside the body. In some embodiments, the at least one drainage channel 228 includes at least one opening at the distal end 206 of the cryotherapy device. In some embodiments, the at least one drainage opening, such as an at least one drainage opening 230, is an opening on the outer surface of the cryotherapy device configured to drain fluid from a body cavity. In some embodiments, the at least one drainage opening is a forward-facing opening, a lateral opening, or an opening facing at least one of tissue 214, a target site, a treatment space, or a lateral treatment volume, where unwanted fluid and particles accumulate.

[0158] According to several exemplary embodiments, for example as described in International Patent Application WO2018142411A1, a control unit 202 coupled to the cryotherapy apparatus optionally controls the flow through at least one of the cryofluid outflow channel 210, at least one discharge channel 228, and at least one wash fluid outflow channel 216. Optionally, the control unit controls the flow through at least one of the cryofluid outflow channel 210, at least one discharge channel 228, and at least one wash fluid outflow channel 216 based on signals received from at least one sensor indicating temperature, pressure changes, and / or pressure, humidity changes, and / or humidity changes.

[0159] According to some exemplary embodiments, as shown in Figure 2B, for example, the cryofluid 215 is discharged from at least one opening of the cryofluid outflow channel 210, and the cleansing fluid is discharged from opening 218 toward the visualization assembly 222, for example toward the distal end 224 of the visualization assembly. In some embodiments, the fluid 227 is discharged from the body lumen through at least one discharge channel 228.

[0160] Exemplary formation of droplets and / or frost According to some exemplary embodiments, the release of cryofluids within a body cavity, such as a body cavity that optionally comes into contact with body fluids, may cause condensation and the formation of condensed particles, such as droplet formation. Alternatively, or even further, the release of cryofluids may cause the body fluids to freeze. In some embodiments, the formation of droplets and / or frost on one or more surfaces of the cryotherapy device may obstruct the removal of fluid from the body cavity, the visualization of the treatment space and / or target site, and / or block the flow through one or more channels of the cryotherapy device. Hereinafter, Figure 3 is referenced, illustrating the formation of droplets and / or frost at one or more locations on a cryotherapy device according to some exemplary embodiments of the present invention.

[0161] According to some exemplary embodiments, at least one droplet, such as droplet 302, is formed on a surface and / or adheres to a surface of the visualization assembly 222, such as to the distal end 224 of the visualization. In some embodiments, droplet 302 is formed on and / or adheres to an aperture, illumination end unit, lens, and / or window located at the distal end 224. In some embodiments, the formation and / or adhesion of at least one droplet 302 to the distal end 224 obstructs the visualization of the target tissue 214 and / or narrows the FOV 226.

[0162] According to some exemplary embodiments, at least one droplet, such as droplet 304, is formed and / or adheres to a surface of the cryotherapy device, such as the surface at the distal end 206 of the cryotherapy device. In some embodiments, the surface is optionally the inner surface of the cryotherapy device, such as the surface of one or more channels and / or lumens of the cryotherapy device. In some embodiments, the formation and / or adhesion of at least one droplet 304 optionally obstructs the visualization of the target tissue 214, for example, if at least one droplet 304 is located within the FOV 226. Alternatively or further, the formation and / or adhesion of at least one droplet 304 to the surface of the cryotherapy device optionally obstructs the movement of the distal end 206 within the body lumen and / or the flow of cryotherapy tissue in one or more lumens. For example, the formation or adhesion of at least one droplet 304 on the surface optionally blocks one or more openings of at least one of the at least one cryofluid outflow channel 210, at least one cleaning fluid outflow channel 216, and at least one discharge channel 228.

[0163] According to some exemplary embodiments, at least one droplet, such as droplet 306, is formed within the internal lumen of the cryotherapy device, for example, in the internal lumen of at least one channel of the cryotherapy device located at the distal end 206. In some embodiments, at least one droplet 306 adheres to the inner surface of the internal lumen of the cryotherapy device, for example, on the inner surface of at least one channel of the cryotherapy device located at the distal end 206. In some embodiments, at least one droplet 306 adheres to the inner surface of at least one internal lumen of the discharge channel 228, at least one cryofluid outflow passage 210, and at least one wash fluid outflow channel 216. In some embodiments, the adhesion of at least one droplet 306 to the inner surface of the channel optionally blocks the flow through the channel, for example optionally, blocking the discharge of fluid through at least one discharge channel 228.

[0164] According to some exemplary embodiments, at least one droplet is either in a liquid state or frozen.

[0165] According to some exemplary embodiments, the cleaning fluid is released through one or more openings, such as opening 218, to prevent the formation of at least one droplet and / or the adhesion of at least one droplet to at least one surface of the cryotherapy device. Alternatively, or further, the cleaning fluid is released through one or more openings, such as opening 218, to break up or dry at least one droplet, such as a droplet that has adhered to at least one surface of the cryotherapy device. In some embodiments, a control unit coupled to the cryotherapy device, such as control unit 202 shown in Figure 2A or control unit 104 shown in Figure 1B, signals at least one valve located on the cleaning fluid flow path to open. Alternatively, or further, the control unit activates at least one pump coupled to the cleaning fluid flow path to deliver the cleaning fluid toward the distal end 206. In some embodiments, in response to a signal indicating the formation of at least one droplet and / or frost, the control unit signals at least one valve and / or activates at least one pump. Alternatively, or further, the control unit transmits a signal to at least one valve and / or activates at least one pump in response to a signal indicating the adhesion and / or accumulation of at least one droplet and / or frost on at least one surface of the cryotherapy device. Alternatively, the control unit transmits a signal to at least one valve and / or activates at least one pump at a predetermined interval or in response to an input signal from the user.

[0166] Exemplary prevention of droplet formation and / or removal of droplets According to some exemplary embodiments, a cleaning fluid is released to prevent the formation of droplets and / or frost within the body cavity. In some embodiments, droplets form and / or accumulate in areas that are difficult for the released cleaning fluid to access. Furthermore, the amount of cleaning fluid that can be released within the body cavity is limited due to rising pressure and temperature. In some embodiments, as a result of flow rate and pressure limitations, an unlimited amount of cleaning fluid cannot be used. Optionally, potentially harmful droplets may build and / or remain in areas where there is no flow of cleaning fluid, or where the flow of cleaning fluid is not strong enough to dry or destroy the droplets.

[0167] Herein, Figures 4A and 4B are shown illustrating a cryotherapy apparatus having a washing fluid outflow channel with a plurality of small openings in one or more locations of the cryotherapy apparatus, according to some exemplary embodiments of the present invention.

[0168] According to some exemplary embodiments, the cryotherapy device includes at least one lavage fluid outflow channel 216 at the distal end 401 of the cryotherapy device, having a plurality of openings 402 configured to release a lavage fluid 404 inside a body lumen. In some embodiments, the plurality of openings 402 are shaped and sized to direct the lavage fluid toward the distal end 224 of a visualization assembly 222, such as a lens, aperture, illumination end unit, and / or window located at the distal end 224.

[0169] According to some exemplary embodiments, the multiple openings 402 have diameters or widths in the range of 0.01 mm to 2 mm, such as 0.05 mm to 0.5 mm, 0.07 mm to 1 mm, 0.8 mm to 2 mm, or any intermediate, smaller, or larger range value. In some embodiments, the number of multiple openings 402 is in the range of 3 to 1000, such as 3 to 50, 20 to 100, 50 to 500, 300 to 1000, etc. Optionally, the multiple openings 402 are arranged in an array where the minimum distance between two adjacent openings is in the range of 0.2 to 5 mm, such as 0.2 to 2 mm, 1 to 3 mm, 2 to 5 mm, etc.

[0170] According to some exemplary embodiments, as shown, for example, in Figure 4B, at least some of the plurality of cleaning fluid openings 413 are positioned distally to the distal end 224 of the visualization assembly. In some embodiments, at least some of the cleaning fluid openings 413 are optionally positioned proximal to the cryofluid 212 and distal to the distal end 224 to create a flow protection space 412 between, for example, the cryofluid outlet opening 212 and the distal end 224 of the visualization assembly. In some embodiments, the flow protection space is created by the cleaning fluid exiting through the plurality of openings 413 located distal to the distal end 224 of the visualization assembly. Optionally, the flow protection space 412 is created around the openings 212 using cleaning fluid exiting through additional cleaning fluid openings located, for example, on the opposite side of the openings 413. In some embodiments, the created flow protection space 412 prevents or reduces the flow of cryofluid, such as cryofluid mist, toward the visualization assembly, such as toward a lens or window located toward the distal end 224.

[0171] Alternatively, or further, the cleaning fluid 414 released through the multiple openings 413 obstructs, removes, and / or dries existing droplets, such as drop 420, adhering to at least one surface of the cryotherapy device at the distal end 410 of the cryotherapy device. Alternatively, or further, the cleaning fluid 414 released through the multiple openings 413 obstructs, removes, and / or dries existing droplets, such as drop 302, adhering to the lens or window at the distal end 224 of the visualization assembly. Alternatively, or further, the cleaning fluid 414 released through the multiple openings 413 dries areas, spaces, and / or volumes partially surrounding at least one channel of the cryotherapy device, such as at least one cryofluid outflow channel, at least one cleaning fluid channel, and / or discharge channel, or at least one of their openings.

[0172] According to some exemplary embodiments, as shown in Figure 4C, for example, at least one cleaning fluid channel includes a plurality of openings, such as opening 430, which are directed toward and / or toward at least one discharge channel 228. In some embodiments, the flow of cleaning fluid through opening 430 obstructs and / or dries one or more droplets in at least one discharge channel 228, for example, optionally, to prevent the at least one discharge channel 228 from being blocked by frost.

[0173] According to some exemplary embodiments, for example as shown in Figure 4D, at least one cleaning channel 438 of the cryotherapy device includes openings 440, 442, and 444 located at different axial and / or radial positions along the distal end 436 of the cryotherapy device. In some embodiments, at least some of the cleaning fluid openings, such as opening 442, are located in axial and / or radial locations between the distal end 224 of the visualization assembly and the cryofluid opening 212 to discharge and / or direct the cleaning fluid, for example, to form a flow protection space 412. Alternatively or further, at least some of the cleaning fluid openings, such as opening 442, are located axially and / or radially along the distal end 436 of the cryotherapy device to direct the flow of cleaning fluid toward and / or along the surface of the distal end of the cryotherapy device.

[0174] Alternatively, or furthermore, at least some of the cleaning fluid openings, such as opening 444, are located at least partially axially and / or radially on the distal end 224 of the visualization assembly to discharge and / or direct cleaning fluid toward, for example, a lens or window located at the distal end 224.

[0175] Alternatively, or furthermore, at least some of the washing fluid openings, such as opening 440, are located in axial and / or radial positions along the cryotherapy distal end 436 facing at least one discharge channel.

[0176] According to some exemplary embodiments, the radial and / or axial position of the cleaning fluid openings, the size and / or shape of the openings, the number of openings in an array of openings, and / or the distance between adjacent openings in the array of openings are selected to enable optimization of the cleaning fluid flow, for example, the amount and / or pressure of the cleaning fluid released into the body lumen. Alternatively or further, the radial and / or axial position of the cleaning fluid openings, the size and / or shape of the openings, the number of openings in an array of openings, and / or the distance between adjacent openings in the array of openings are selected to prevent the formation of droplets or frost, and / or to obstruct and dry any droplets that have already formed.

[0177] According to some exemplary embodiments, a cleaning fluid opening, such as an opening 442, configured to discharge and / or direct the cleaning fluid to create a flow protection space 412, has a width or diameter in the range of 0.01 mm to 2 mm, such as 0.05 mm to 0.5 mm, 0.07 mm to 1 mm, 0.8 mm to 2 mm, or any intermediate, smaller or larger range value.

[0178] In some embodiments, the openings 442 are arranged in an array having 3 to 500 openings, such as 3 to 50 openings, 30 to 200 openings, 100 to 250 openings, 250 to 500 openings, or any intermediate, smaller or larger range of openings. In some embodiments, the openings are arranged radially or aligned. In some embodiments, the distance between adjacent openings in the array is fixed. Alternatively, the distance between adjacent openings in the array varies.

[0179] According to some exemplary embodiments, a cleaning fluid opening, such as opening 440, configured to discharge and / or direct cleaning fluid toward at least one discharge channel, has a width or diameter in the range of 0.01 mm to 2 mm, such as 0.05 mm to 0.5 mm, 0.07 mm to 1 mm, 0.8 mm to 2 mm, or any intermediate smaller or larger range. In some embodiments, the openings 442 are arranged in an array having 5 to 500 openings, such as 5 to 50 openings, 3 to 50 openings, 30 to 200 openings, 100 to 250 openings, 250 to 500 openings, or any intermediate smaller or larger range. In some embodiments, the multiple openings are arranged radially or aligned. In some embodiments, the distance between adjacent openings in the array is fixed. Instead, the distance between adjacent openings in the array varies.

[0180] According to some exemplary embodiments, cleaning fluid openings, such as opening 444, configured to discharge and / or direct cleaning fluid toward a visualization assembly, have a width or diameter in the range of 0.01 mm to 2 mm, such as 0.05 mm to 0.5 mm, 0.07 mm to 1 mm, 0.8 mm to 2 mm, or any intermediate, smaller or larger range of values. In some embodiments, the openings 444 are arranged in an array having 3 to 500 openings, such as 3 to 50 openings, 3 to 50 openings, 30 to 200 openings, 100 to 250 openings, 250 to 500 openings, or any intermediate, smaller or larger range of openings. In some embodiments, the multiple openings are arranged radially or aligned. In some embodiments, the distance between adjacent openings in the array is fixed. Instead, the distance between adjacent openings in the array varies.

[0181] Exemplary cleaning fluid opening According to some exemplary embodiments, a cleaning fluid opening, such as a cleaning fluid opening at the distal end of the cryotherapy device, is formed and sized to allow obstruction and / or removal of droplets from a particular area of ​​the cryotherapy device and is axially positioned along the longitudinal axis of the cryotherapy device or at least one cleaning fluid channel, and / or has a circumferential distribution. In some embodiments, the particular area includes at least a portion of the visualization assembly, at least one discharge channel, and at least one surface of the cryotherapy device.

[0182] According to some exemplary embodiments, the cleaning fluid openings have the same shape and / or size. Alternatively, at least some or all of the cleaning fluid openings have different shapes and / or sizes and / or are arranged in a random arrangement. In some embodiments, the cleaning fluid openings are evenly distributed around the perimeter of at least one cleaning fluid channel. Further or optionally, the cleaning fluid openings are distributed around the entire perimeter of at least one cleaning fluid channel. Alternatively, the cleaning fluid openings are distributed around a portion of the perimeter, such as an arc smaller than, for example, 360 degrees, less than 270 degrees, less than 180 degrees, less than 90 degrees, or any intermediate, smaller or larger value.

[0183] Herein, we refer to Figures 5A and 5B, which show an arrangement of cleaning fluid openings evenly distributed around at least one cleaning fluid channel, according to some exemplary embodiments of the invention.

[0184] According to some exemplary embodiments, the multiple openings are distributed axially around the cleaning fluid channel 502 along the longitudinal axis 500 of the cleaning fluid channel 502. In some embodiments, the multiple openings are optionally distributed axially along a region having a length 504. Furthermore, the multiple openings are distributed circumferentially around the cleaning fluid channel 502. In some embodiments, two adjacent cleaning fluid openings, such as openings 510 and 512 having similar axial positions, have an equal circumferential distance from each other, as shown, for example, in Figure 5B. In some embodiments, the cleaning fluid openings completely surround the cleaning fluid channel.

[0185] According to some exemplary embodiments, all of the multiple openings have the same shape and size, for example, width or diameter. Alternatively, as shown in Figure 5A, for example, the multiple openings comprise two or more groups of openings having different shapes and / or sizes. For example, the first group of openings 506 includes a larger size than the second group of openings 508. In some embodiments, as shown in Figures 5A and 5B, for example, the multiple openings, such as openings 506 and 508, are evenly distributed, for example, having similar distances between two adjacent openings on the circumference of the cleaning fluid channel 502. Alternatively, the shape, size, number, location, and / or arrangement of the openings are random.

[0186] Herein, Figures 5C to 5E are referenced, showing cleaning fluid openings of different sizes and circumferential distributions according to some exemplary embodiments of the invention.

[0187] According to some exemplary embodiments, the cleaning fluid openings are distributed axially along the periphery of the cleaning fluid channel 520. In some embodiments, at least some of the cleaning fluid openings, such as opening 522 located axially within region 522, are optionally distributed circumferentially only in part of the periphery of the cleaning channel 520, as shown, for example, in Figure 5D. In some embodiments, different groups of cleaning fluid openings, such as opening 528 located in region 524, are axially spaced apart from opening 526 in region 522. In some embodiments, opening 528, as shown, for example in Figure 5E, is distributed circumferentially along its entire periphery and optionally surrounds the cleaning channel 520.

[0188] According to some exemplary embodiments, the cleaning channel includes two or more types of fluid openings that differ from each other in at least one of size, shape, width diameter, axial distribution, and circumferential distribution. Furthermore, or optionally, when the two or more types of cleaning fluid openings are arranged in separate arrays or in a single array in a random order, they differ in the density of openings per array, for example, the number of openings per area size. In some embodiments, each array optionally has a different axial length along the periphery of the cleaning fluid.

[0189] Exemplary collision According to some exemplary embodiments, the cryotherapy apparatus includes a plurality of openings at the distal end of the cryotherapy apparatus that at least partially face the distal end of the visualization assembly. In some embodiments, the plurality of openings at least partially face a lens or window located at the distal end of the visualization assembly. In some embodiments, the plurality of openings are located around at least one cleaning fluid channel. Alternatively or further, the plurality of openings are located around a cryofluid outflow channel. In some embodiments, the plurality of openings are configured for at least one gas jet impact, flushing, and / or cleaning the visualization assembly from droplets and / or other particles.

[0190] Herein, Figures 6A and 6B are shown illustrating some exemplary embodiments of the present invention, which include openings for gas injection impacts that are shaped, sized, and / or distributed to cover the entire area of ​​a visualization assembly surface, such as a lens, illumination end unit, or window.

[0191] According to some exemplary embodiments, the cryotherapy apparatus includes a plurality of openings, for example, at the distal end of the cryotherapy apparatus, configured to spray a jet of fluid, such as gas, onto the surface 602 of the visualization assembly 604. In some embodiments, the surface 602 includes a lens, an illumination end unit, or a window. In some embodiments, a plurality of openings, such as openings 606, 608, 610, and 612, are distributed around a channel 614. In some embodiments, the channel 614 includes a cleaning fluid channel. In some embodiments, the plurality of openings are distributed circumferentially along 616, forming angles less than 180 degrees, such as less than 120 degrees, less than 100 degrees, less than 90 degrees, or any intermediate smaller or larger value. Alternatively, the openings are distributed circumferentially on a 360-degree circle surrounding the channel 614. Instead, the openings are distributed circumferentially along arcs forming angles of 180 degrees or more, such as 200 degrees or more, 250 degrees or more, 300 degrees or more, or any intermediate smaller or larger angle. In some embodiments, the length of the arc is predetermined according to the width or diameter 620 of the visualization assembly surface 602.

[0192] According to some exemplary embodiments, at least some of the multiple openings have different sizes and / or shapes at any choice. Alternatively, or further, the multiple openings are distributed around the channel 614 as an array. In some embodiments, the density of openings in the array, such as the number of openings per unit area, is equal along the entire area of ​​the array. Alternatively, the density of openings varies, for example, between different regions of the array, or randomly. In some embodiments, the different sizes and / or shapes of the openings allow for different spray cones of liquid and / or gas from, for example, each opening type.

[0193] According to some exemplary embodiments, the length of the circumferential arc, the distribution of the openings, the different types of openings, and / or the density of the openings are predetermined or selected to cover a selected area of ​​the surface 602, such as covering the entire area of ​​the surface 602.

[0194] Instead, as shown in Figures 6C and 6D, for example, the openings, such as openings 630 and 632, are distributed around the channel 614 along an arc making an angle 634 smaller than the angle 616. In some embodiments, the fluid, such as gas, released from openings 630 and 632 covers less than 90% of the surface 602, such as less than 70%, less than 60%, less than 50%, or any intermediate smaller or larger percentage value. In some embodiments, the fluid, such as gas, released toward the surface 602 from openings 630 and 632 forms a removal zone 634 having an area smaller than the area of ​​the surface 602. In some embodiments, this makes it possible to optimize the spray intensity and / or gas volume while clearing the main portion, such as up to 80%, up to 70%, up to 50%, of the FOV between the surface 602 and the tissue to be treated with the cryofluid.

[0195] Exemplary seal According to some exemplary embodiments, the flow of the discharge fluid is directed using one or more seals that are shaped, sized, and / or located at the distal end of the cryotherapy device, such that the fluid is directed towards the opening of at least one discharge channel. Hereinafter, Figures 6E and 6F are shown illustrating a cryotherapy device having a distal end with at least one seal, such as a front seal, according to some exemplary embodiments of the present invention.

[0196] According to some exemplary embodiments, the distal end 650 of the cryotherapy device includes an outer sleeve 652 defining an inner channel 653 having a distal end, such as a rigid or flexible distal end, which can be introduced into a body lumen, such as a hollow organ. In some embodiments, the cryotherapy device includes a visualization assembly 222 in the channel 653 having a distal end 224 at the distal end 650 of the cryotherapy device. Furthermore, the cryotherapy device includes at least one cryofluid outflow channel 210 moving within the channel 653 and having one or more openings 212 at the cryofluid distal end 650, optionally directed toward a target tissue 214. Optionally, one or more openings 212 are located distal to the visualization distal end 224 to allow spraying of the cryoflu from the optical system toward the target tissue at a distance sufficient to prevent droplet formation on the visualization surface at the visualization distal end 224, for example.

[0197] According to some exemplary embodiments, the cryotherapy device includes at least one lavage fluid inlet channel 216 within the channel 653. In some embodiments, the lavage fluid channel 216 includes one or more openings, such as an opening 218 on the periphery of the channel 216, which optionally face toward a visualization assembly 222, such as the distal end 224 of the visualization assembly. In some embodiments, one or more openings 218 are configured to direct the lavage fluid 217 toward the distal end 224, such as toward the surface of the visualization assembly at the distal tumor 224. Alternatively or further, one or more openings 218 are configured to direct the lavage fluid 217 distally toward the distal end 224, for example, to prevent the flow of cryofluid toward the surface of the visualization assembly at the distal end 224. Further or alternatively, the lavage fluid channel 216 includes one or more forward-facing openings, such as an opening 220, which are shaped and sized to direct the lavage fluid toward the target site 214 and / or FOV 226. Optionally, opening 220 surrounds opening 212. Optionally, cleaning fluid channel 216 surrounds cryofluid channel 210.

[0198] According to some exemplary embodiments, the cryotherapy device includes at least one drainage channel, such as a drainage channel 228, configured to drain fluids and particles from a body cavity, such as a hollow organ. In some embodiments, the distal end of the drainage channel 228 is located at the distal end 650 of the cryotherapy device, and the proximal end of the drainage channel 228 is located outside the body cavity, such as outside the body. In some embodiments, one or more openings within the sleeve 652, such as an opening 230 on the periphery of the sleeve 652, are shaped and sized to allow fluids and particles to enter the drainage channel 228 from the body cavity. Furthermore, the drainage channel includes one or more forward-facing openings, optionally facing a target site 214, configured to allow fluids and particles to enter and be drained into the drainage channel 228. In some embodiments, at least one wall of the drainage channel 228 is optionally formed by the sleeve 652.

[0199] According to some exemplary embodiments, as shown, for example, in Figure 6E, the distal end 650 of the cryotherapy device includes a seal, such as a seal 654, configured to block at least a portion of the forward discharge of fluid and particles into the discharge channel 228. In some embodiments, the seal 654 is located distal to one or more openings in the outer sleeve 652, such as opening 230. In some embodiments, the seal 654 is located proximal to the distal end 224 of the visualization assembly, such as between the distal end 224 of the visualization assembly and one or more openings 230.

[0200] According to some exemplary embodiments, the seal 654 allows the flow of fluid 656 and particles to be directed, for example, to surround the distal end 224 of the visualization assembly, and to enter the discharge channel through one or more openings around the sleeve 652, proximal to the sleeve 652, and into the discharge channel 228. A potential advantage of discharging fluid and particles through one or more proximal openings to the distal end of the visualization assembly may be to avoid mist and cold air from the visualization assembly, for example, from the optical system. In some embodiments, the seal 654 includes at least one opening 654, such as opening 660, configured to allow the passage and discharge of at least 5% of fluid and particles through the seal 654, such as at least 10%, at least 30%, at least 50%, at least 70%, or any intermediate, smaller or larger percentage, into the discharge channel 228, compared to an unsealed open discharge channel. In some embodiments, the seal 654 blocks the passage of at least 30% of the fluid and particles into the discharge channel 228, such as at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 95%, or any intermediate, smaller or larger percentage.

[0201] According to some exemplary embodiments, at least one opening 660 in the seal 654 is located between the surface of the visualization assembly 222 and the inner surface of the sleeve 652. A potential advantage of having an opening in the seal may be that it allows for discharge from the body lumen if an opening to a discharge channel around the sleeve, such as a discharge opening, becomes blocked or closed.

[0202] Example internal reducer According to some exemplary embodiments, the cryotherapy device includes at least one internal reducer within the cleaning fluid flow path. In some embodiments, the at least one internal reducer controls the amount and / or pressure of the cleaning fluid directed to a plurality of cleaning fluid openings. In some embodiments, controlling the amount and / or pressure of the cleaning fluid directed to the cleaning openings makes it possible to control, for example, the shape and / or size of the spray cone or removal zone formed by the cleaning fluid discharged from the cleaning openings.

[0203] Here, Figure 7A is shown, illustrating the distal end of the cryotherapy device, such as the distal end 702, where a cleaning fluid directed to a cryofluid-affected area, such as a cryofluid-induced lavage, and a cleaning fluid directed to a visualization assembly are delivered through the same flow path, such as the same channel. In some embodiments, high-pressure cryofluid is introduced into a cryofluid outflow channel, such as a cryofluid channel, while low-pressure cleaning fluid is introduced into at least one cleaning fluid channel. In some embodiments, as shown in Figure 7A, for example, the cryotherapy device includes a connector 704 having a first inlet 706 for low-pressure cleaning fluid and a second inlet 708 for high-pressure cryofluid. In some embodiments, the connector 704 allows for coaxial flow of cryofluid and cleaning fluid, for example, within at least two coaxial channels. In some embodiments, the cleaning fluid channel is coaxial and surrounds the cryofluid channel along at least 50%, for example, at least 70%, at least 90%, of the length of the cryofluid channel. Potential advantages of having a coaxial arrangement of the cleaning fluid channel and the cryofluid channel may include reducing the space and / or volume of the device and increasing its strength (e.g., in the case of sensitive tubes such as cryo nozzles), allowing the cryofluid channel to be maintained at a target temperature by isolating it from the body using the cleaning fluid channel, as well as allowing radial flow around the cryofluid nozzle to prevent mist and / or to clear mist from the optical system.

[0204] According to some exemplary embodiments, as shown, for example, in Figures 7A and 7B, at least one cleaning fluid channel 716 includes at least one internal reducer 710 within the lumen of the channel 716. In some embodiments, the internal reducer 210 is configured to divert at least a portion of the cleaning fluid toward a cleaning fluid opening, such as an opening 712, which is at least partially directed toward a visualization assembly, such as an optical assembly. In some embodiments, the internal reducer 710 diverts at least a portion of the cleaning fluid toward the optical cleaning opening 712, while the remainder of the cleaning fluid flow flows toward at least one cryogenic cleaning opening 719. In some embodiments, the cleaning fluid 217 released from the cryogenic cleaning opening 719 is delivered to clear the space 722 between the distal end 702 and the treatment tissue 214 and / or to clear the FOV 722. Furthermore, optical cleaning fluids such as the cleaning fluid 217 are delivered to perform at least one of the following: clearing the lens, preventing liquid particles on the lens from interfering, and forming a flow protection space 412.

[0205] According to some embodiments, for example as shown in Figure 7C, the cryotherapy device 740 includes at least one internal reducer 710 having an integrated channel and / or opening, such as channel 742. In some embodiments, the integrated channel and / or opening, such as channel 742, is configured to direct the cleaning fluid in a selected direction. In some embodiments, for example as shown in Figure 7C, channel 742 is oriented at a deflection angle 744 with respect to the outer surface 746 of the cleaning fluid channel facing the distal end 224 of the visualization assembly. In some embodiments, the number of channels and / or openings facing the visualization assembly, and / or the inner width or inner diameter of each channel, is predetermined to reach a specific impact angle 748 with respect to the surface of the lens or window at the distal end 224 of the visualization assembly. In some embodiments, the deflection angle of a channel, such as channel 742, is an angle in the range between 1° and 90°, such as between 1° and 40°, between 1° and 20°, between 30° and 60°, between 45° and 90°, or any intermediate range of smaller or larger values.

[0206] According to some exemplary embodiments, as shown, for example, in Figure 7D, the cryotherapy device 750 includes at least one internal reducer 752 within the internal lumen of at least one lavage fluid channel 755. In some embodiments, the lavage fluid channel 755 includes a plurality of openings arranged around the channel 755, optionally as an array. In some embodiments, the openings, such as opening 754, are shaped and sized and / or oriented to discharge the lavage fluid at a deflection angle 744 relative to the outer surface 746 of the lavage channel. Alternatively or further, the openings, such as opening 754, are shaped and sized and / or oriented to spray the lavage fluid at a deflection angle that produces a specific impact angle 748.

[0207] According to some exemplary embodiments, the openings, such as an opening, are inclined openings configured to discharge cleaning fluid at a specific deflection angle 744 or to reach a specific impact angle 748. In some embodiments, having an internal reducer 752 and a plurality of openings 754 optionally arranged as an array enables efficient control over the amount of cleaning fluid directed to the visualization assembly, such as efficient control over optical system cleaning. In some embodiments, as shown, for example in Figure 7D, the internal reducer 752 separating the optical system cleaning from the low-temperature cleaning 217 is coupled with adjustable directional jets, such as openings 754, which are shaped, sized, and / or oriented to reach a specific deflection angle 744 and / or a specific impact angle 748.

[0208] According to some exemplary embodiments, a flow reducer having one or more channels directed toward a cleaning fluid opening, and / or a cleaning fluid opening, as shown, for example, in Figures 7C to 7D, can generate negative pressure or reduced positive pressure near one or more channels and / or openings within the cleaning fluid channel, which can optionally lead to a Venturi effect. In some embodiments, the negative pressure causes suction from the outside into the cleaning fluid channel through one or more channels and / or openings.

[0209] In some embodiments, by placing at least one flow reducer within the cleaning fluid channel, at least a portion of the channel is narrowed, and the flow velocity within the constricted portion is accelerated. In some embodiments, the increase in flow velocity creates a Venturi effect within the constricted portion, optionally reducing positive pressure or creating negative pressure within the constricted portion. In some embodiments, the pressure reduction creates an attractive force through the cleaning fluid opening in the constricted region, which optionally leads to the attraction of one or more droplets accumulating on a surface outside the cleaning fluid channel, such as, for example, on at least one surface of the device within a hollow organ and / or on at least one surface of the visualization assembly.

[0210] According to some exemplary embodiments, the distal end of the cryotherapy device, such as the distal end 802, for example, as shown in Figure 8A, includes a lavage fluid channel 755 and a cryofluid channel 210. Optionally, the lavage fluid channel 755 and the cryofluid channel 210 are coaxial, and for example, the lavage fluid channel 755 at least partially surrounds the cryofluid channel 210. In some embodiments, the lavage fluid channel includes one or more internal flow reducers, such as a flow reducer 804 within the internal lumen of the lavage fluid channel 755. In some embodiments, the flow reducer 804 is attached to the inner surface of the lavage fluid channel 755 and optionally at least partially surrounds the internal lumen of the lavage fluid channel 755. In some embodiments, the flow reducer 804 is attached to the inner surface of the lavage fluid channel 755 and is shaped as a ring, tube, or an arc less than 360 degrees, such as less than 270 degrees, less than 180 degrees, or any intermediate smaller or larger value.

[0211] According to some exemplary embodiments, the flow reducer includes one or more openings, such as an opening 806, which are shaped and sized to deliver cleaning fluid from the cleaning fluid channel to the outside. In some embodiments, the opening 806 aligns with and / or is fluid-connected to an opening in the wall of the cleaning fluid channel 755. In some embodiments, the opening 806 is positioned to direct the cleaning fluid to a surface of the visualization assembly, such as a surface at the distal end 224 of the visualization assembly. Alternatively or further, the opening 806 is configured to direct the cleaning fluid to the distal end 224 and / or to a space located distally in the space between the outer surface of the cleaning fluid channel and the distal end 224 of the visualization assembly.

[0212] According to some exemplary embodiments, an internal flow reducer, such as a flow reducer 810, narrows the internal lumen of the cleaning fluid channel, optionally leading to an acceleration of the flow velocity within the cleaning fluid channel. In some embodiments, the accelerated flow velocity reduces the pressure within the opening 806, optionally leading to the suction of fluid and particles into the cleaning fluid channel 755 through the opening 806.

[0213] According to some exemplary embodiments, as shown, for example, in Figure 8A, the lavage channel includes at least one additional flow reducer 810 located distal to the flow reducer 804 and / or opening 806. In some embodiments, at least one flow reducer 810 is configured to regulate the flow pressure and / or velocity of the lavage fluid exiting through the distal opening 812 of the lavage fluid channel 755. Optionally, the distal opening 812 is an opening that faces forward, for example, towards a therapeutic target. Optionally, the distal opening 812 is adjacent to the distal opening 720 of the cryofluid channel 210. Optionally, the distal opening 812 of the lavage fluid channel at least partially surrounds the distal opening 720 of the cryofluid channel.

[0214] According to some exemplary embodiments, the position of at least one flow reducer 810 relative to the cleaning fluid channel opening 806 controls the cleaning fluid pressure level near the opening and / or the pressure level generated within the cleaning fluid channel 755 near the opening 806. In some embodiments, as shown in Figure 8B, for example, positioning the flow reducer 810 close to the cleaning fluid opening 806, such as at a distance of up to 5 cm, up to 3 cm, up to 1 cm, or any intermediate, less, or more, increases the pressure in the cleaning fluid channel 755 proximal to the flow reducer 810, such as near the opening 806.

[0215] According to some exemplary embodiments, as shown in Figures 8B and 8C, the flow reducer 810 is located near the distal opening 812 of the cleaning fluid channel, for example, at a distance of less than 5 cm, less than 1 cm, less than 0.5 cm, or any intermediate smaller or larger distance from the distal opening 812. In some embodiments, the reducer 810 is shaped and sized to control the flow and / or direction of the cleaning fluid exiting the distal opening 812. Optionally, the reducer 810 controls the flow, such as the pressure and / or direction of the cleaning fluid exiting the distal opening 812 relative to the cryofluid sprayed from the distal opening 720 toward the target site. In some embodiments, as shown in Figure 8C, for example, the reducer 810 includes at least one opening 820, such as two, three, four, or more openings, shaped and sized to control the pressure and / or direction of the cleaning fluid exiting the distal opening 812. In some embodiments, the reducer 810 reduces the internal lumen of the cleaning fluid channel 755 by at least 10%, such as at least 30%, at least 50%, at least 70%, at least 90%, or any intermediate, smaller or larger percentage.

[0216] Exemplary apparatus having discharge seal and reducer Herein, Figures 8D and 8G are shown illustrating a cryotherapy apparatus having at least one cleaning fluid flow reducer and at least one fluid flow discharge seal according to some exemplary embodiments of the present invention.

[0217] According to some exemplary embodiments, as shown, for example, in Figures 8D and 8E, the distal end 640 of the cryotherapy device is configured to be introduced into a body lumen, such as a hollow organ. In some embodiments, the cryotherapy device includes at least one lavage fluid channel 216 and at least one cryofluid channel 210. Optionally, the lavage fluid channel 216 and the cryofluid channel 210 are coaxial. Optionally, or further, the lavage fluid channel 216 at least partially surrounds the cryofluid channel 210.

[0218] According to some exemplary embodiments, the cleaning fluid channel 216 includes at least one opening, such as a plurality of openings 821 and 823 passing through the wall of the cleaning fluid channel 216. In some embodiments, the openings 821 and 823 are located within the cleaning fluid channel at a position facing at least one surface of the visualization assembly 222. In some embodiments, the openings 821 and 823 face at least one surface at the distal end 224 of the visualization assembly. Alternatively, or further, the openings are located in the wall of the cleaning fluid channel and face a space 825 distal to the distal end 224 of the visualization assembly. In some embodiments, the openings are configured to direct the cleaning fluid toward the distal end of the visualization assembly, for example, to prevent droplet formation on at least one surface of the visualization assembly and / or to dry and / or prevent one or more existing droplets from forming.

[0219] According to some exemplary embodiments, the cleaning fluid channel 216 includes at least one flow reducer, such as a flow reducer 827 located at the distal end of the cleaning fluid channel 216. In some embodiments, the flow reducer 827 includes at least one opening, such as a plurality of openings 829 and 833, configured to deliver the cleaning fluid through the flow reducer 827 and openings in the wall of the cleaning fluid channel 216. In some embodiments, as described above in Figures 7C and 7D, for example, the flow in a constricted region within the cleaning fluid channel may create negative pressure and suction through one or more side openings in the flow reducer, such as opening 831. In some embodiments, the increase in flow velocity in the constricted region of the flow reducer lumen creates a Venturi effect that reduces the pressure within the flow reducer. Optionally, the reduced pressure creates an suction force through opening 831, for example. In some embodiments, the flow reducer opening is optionally aligned with an opening in the cleaning fluid channel wall located around the cleaning fluid channel 216. Instead, the flow reducer opening includes an opening in the wall of the cleaning fluid channel 216.

[0220] According to some exemplary embodiments, at least some of the flow reducer openings are configured to direct the cleaning fluid proximal to the cryofluid distal opening 720 and optionally into the space between the distal opening 720 and the distal end 224 of the visualization assembly. Alternatively or further, at least some of the flow reducer openings are configured to direct the cleaning fluid into a space at least partially surrounding the cleaning fluid channel to prevent, for example, the adhesion and / or formation of at least one droplet on the outer surface of the cleaning fluid channel. Alternatively or further, at least some of the flow reducer openings are configured to apply suction into the cleaning fluid channel 216 for, for example, fluids and / or particles within a body lumen.

[0221] According to some exemplary embodiments, the flow reducer 827 is an elongated reducer having an axial length of at least 0.5 mm along the longitudinal axis of the cleaning fluid channel 216, such as at least 1 mm, at least 5 mm, or any intermediate smaller or larger length. In some embodiments, the flow reducer 827 forms the distal opening 812 of the cleaning fluid channel. In some embodiments, the flow reducer forms the opening 812 in a ring shape surrounding the cryofluid channel 210, as shown, for example, in Figure 8E. In some embodiments, the ring-shaped opening 812 has a constant width. Alternatively, the ring-shaped opening 812 has a variable width.

[0222] According to some exemplary embodiments, the cryotherapy device includes at least one discharge channel, such as a discharge channel 228, configured to remove fluid and / or particles from a body lumen through at least one discharge opening, such as a discharge opening 230 of the outer sleeve 652 of the cryotherapy device. In some embodiments, as illustrated, for example, in Figures 6E and 6F, the cryotherapy device includes at least one discharge seal 654 at the distal end 650, configured to block at least 30% of the discharge fluid flow rate through the distal forward opening of the discharge channel 228, such as at least 50%, at least 70%, at least 90%, or any intermediate, smaller or larger percentage value. In some embodiments, the discharge seal 654 is located distal to the discharge opening 230. Optionally, the discharge seal 654 is located between the distal end 224 of a visualization assembly 222, which optionally includes an aperture and / or lens, and the discharge opening 230. Optionally, the seal 654 completely blocks discharge through the distal forward opening of the discharge channel 228.

[0223] According to some exemplary embodiments, as shown, for example in Figures 8F and 8G, the lavage fluid channel at the distal end 680 of the cryotherapy device includes at least one flow reducer 860 at the distal end of the lavage fluid channel. In some embodiments, the flow reducer 860 is solid. In some embodiments, the flow reducer 860 is short, having an axial length of less than 10 mm, such as less than 5 mm, less than 1 mm, or any intermediate, smaller or larger length. In some embodiments, the flow reducer 860 includes at least one opening, such as openings 870 and 872, through which the lavage fluid exits the lavage fluid channel forward. In some embodiments, the openings 870 and 872 are spaced apart. Alternatively, the openings 870-872 are interconnected. In some embodiments, the opening 870 surrounds at least one distal opening 720 of the cryofluid channel 210, as shown, for example in Figure 8G.

[0224] According to some exemplary embodiments, the flow reducer 860 is configured to control and / or direct the exit of the cleaning fluid from the distal opening 862 of the cleaning fluid channel. In some embodiments, the distal opening 862 is located at a distance 866 proximal to the cryofluid distal opening 720.

[0225] According to some exemplary embodiments, the flow reducer 860 is configured to separate at least one cryofluid outflow channel 210 from at least one cleaning fluid outflow channel 216, and to maintain a fixed distance between the walls of the at least one cryofluid outflow channel 210 and the at least one cleaning fluid outflow channel 216. In some embodiments, maintaining the fixed distance allows, for example, heat transfer between the cryofluid outflow channel 210 and the cleaning fluid outflow channel 216. Furthermore or alternatively, the flow reducer 860 is configured to fix the opening 862 of the cleaning outflow channel 216 and the cryofluid opening 720 at a predetermined longitudinal distance 866. In some embodiments, the longitudinal separation distance 866 is in the range of 0 to 2 mm, such as 0 to 0.2 mm, 0.1 to 0.5 mm, 0.4 to 1 mm, 0.5 to 2 mm, or any intermediate, smaller or larger value.

[0226] According to some exemplary embodiments, the cleaning fluid channel 216 includes openings in the channel wall facing the distal end 224 of the visualization assembly, such as openings 821 and 823. Furthermore, the cleaning fluid channel includes one or more additional openings in the channel wall, such as opening 868, configured to direct the cleaning fluid into the space between the cryofluid channel distal opening 720 and the distal end 224 of the visualization assembly. In some embodiments, the cleaning opening 821 is shaped and sized and / or positioned to direct the cleaning fluid into the surface of the visualization assembly, such as lighting and / or lenses, which are optionally located at the distal end 224. In some embodiments, the cleaning fluid directed through openings 821 and 823 pushes particles and / or droplets away from the surface of the visualization assembly. In some embodiments, openings 867 and 868 are shaped and sized and / or positioned to direct the cleaning fluid into a space 725 where mist and / or gas accumulate.

[0227] Exemplary pre-treated surface According to some exemplary embodiments, to prevent at least one droplet from adhering to and / or forming on at least one surface of the cryotherapy apparatus, the surface is pre-treated, for example, by coating to acquire a rough texture. Alternatively, or further, the surface is pre-treated to reduce the size and / or shape of the droplets by optionally directing the liquid to form a thin layer instead of droplets. Herein, Figure 9 is referenced, showing a cryotherapy apparatus having at least one channel with a rough exposed outer surface according to some exemplary embodiments of the present invention.

[0228] According to some exemplary embodiments, the distal end 802 of the cryotherapy device includes at least one surface exposed to the environment of the body lumen being treated, such as a surface 906. According to some embodiments, the exposed surface 906 is the outer surface of at least one irrigation fluid channel 904. In some embodiments, at least a portion of the exposed surface 906 is pre-treated, such as by pre-coating, or manufactured to obtain a rough surface 906. In some embodiments, the exposed rough surface is optionally located between the distal end 224 of the visualization assembly and the opening 910 of the cryofluid outflow channel 912. Furthermore or alternatively, the exposed rough surface is located within the FOV 226. In some embodiments, the generated rough surface 906 optionally reduces light reflection within the FOV 226 compared to a smooth surface.

[0229] According to some exemplary embodiments, to produce a rough surface 906, the surface is coated with a hydrophilic or hydrophobic coating, sandblasting, electroetching, or other surface heat treatment. In some embodiments, the surface is coated with chemical treatment, electrochemical treatment, and / or mechanical treatment.

[0230] Exemplary visualization assembly with inclined distal end Herein, Figures 10A–10C are referenced, showing visualization assemblies having a planar, inclined, or curved surface at the distal end, according to some exemplary embodiments of the present invention.

[0231] According to some exemplary embodiments, the visualization assembly includes a surface at its distal end that faces a body cavity, such as a target site in a body cavity. In some embodiments, as shown, for example in Figure 10A, the surface 1102 at the distal end of the visualization assembly 1104 has an angle of about 90 degrees with respect to the longitudinal axis 1105, such as the long axis of the cryotherapy device. Alternatively, as shown, for example in Figure 10B, the inclined surface 1106 at the distal end of the visualization assembly 1108 has an angle of less than 90 degrees with respect to the axis 1105, such as less than 50 degrees, less than 45 degrees, less than 20 degrees, in the range of 90 and 5 degrees, or in the range of 50 and 30 degrees. In some embodiments, the inclination of the angled surface is forward-facing, such as inward. Alternatively, the surface at the distal end of the visualization assembly has a reverse-facing inclination, such as outward.

[0232] According to some exemplary embodiments, for example, as shown in Figure 10C, the distal end surface 1112 of the visualization assembly 1110 is curved.

[0233] The terms "comprises," "comprising," "includes," "has," and "having," along with their cognates, all mean "to include (prepare for) something, but not necessarily."

[0234] The phrase "consisting of" means "to include (or be equipped with) and be limited to."

[0235] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or parts, provided that these additional components, steps, and / or parts do not substantially alter the basic and novel properties of the claimed composition, method, or structure.

[0236] As used herein, the singular forms "a," "an," and "the" refer to multiple subjects unless the context clearly indicates otherwise. For example, the terms "a compound" or "at least one compound" may refer to multiple compounds, including mixtures thereof.

[0237] Throughout this application, embodiments of the present invention may be presented by reference to a range form. It should be understood that such range forms are merely for convenience and brevity and should not be interpreted as inflexible limitations on the scope of the invention. Therefore, a range form should be considered to specifically disclose not only the individual numerical values ​​within that range, but also all possible subranges. For example, a range form such as "1-6" should be considered to specifically disclose subranges such as "1-3," "1-4," "1-5," "2-4," "2-6," and "3-6," as well as the individual numerical values ​​within those ranges, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0238] Where a range of numbers is given herein (for example, "10-15", "10-15", or any pair of numbers linked by such other range expressions), unless the context clearly indicates otherwise, it means that the range includes any numbers (fractions or integers) within the limits of the indicated range, including the limits of the range. The phrases "range / ranging / ranges between" between the first number and the second number, and "range / ranging / ranges from" "to", "up to", "until", or "through" the first number and the second number, are used interchangeably herein and mean that the range includes all numbers, both first and second, and all fractions and integers between them.

[0239] Unless otherwise indicated, the numerical values and any numerical ranges based thereon used in this specification are approximations within the range of reasonable measurement accuracy and rounding errors understood by those skilled in the art.

[0240] As used herein, the term "method" refers to methods, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods, means, techniques, and procedures known to practitioners of the arts of chemistry, pharmacology, biology, biochemistry, and medicine, or readily developed from known methods, means, techniques, and procedures.

[0241] As used herein, the term "treat" includes preventing the progression of a condition, substantially inhibiting, delaying, or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of the clinical or aesthetic symptoms of a condition.

[0242] It is understood that certain features of the invention that are described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention that are described in the context of a single embodiment for brevity may also be provided separately, or in any suitable subcombination, or as suitable in any other described embodiment of the invention. Specific features described in the context of various embodiments should not be considered essential features of those embodiments, except where the embodiment would not function without those elements.

[0243] Although the invention has been described in connection with its particular embodiments, it will be obvious to those skilled in the art that many alternative, modification, and variation forms will be apparent. Accordingly, it is intended to embrace all such alternative, modification, and variation forms that fall within the spirit and broad scope of the appended claims.

[0244] All publications, patents, and patent applications described herein are incorporated herein by reference in their entirety, as if explicitly and individually noted, where each individual publication, patent, or patent application is indicated to be incorporated herein by reference. Furthermore, any citation or specification of any reference in this application should not be construed as an acknowledgment that such reference is available as prior art of the present invention. Where section headings are used, they should not necessarily be construed as restrictive. Furthermore, any priority document(s) of this application are incorporated herein by reference in their entirety.

Claims

1. It is a cryotherapy system, An elongated cryotherapy device having an elongated body, a proximal end, and a distal end, having a shape and size such that it is placed inside a hollow organ. The low-temperature inflow passage inside the elongated body is configured to allow low-temperature flow from a low-temperature fluid source to the hollow organ, The cryotherapy system comprises the elongated cryotherapy device, which includes a cleaning inlet passage inside the elongated body, the cleaning inlet passage having a plurality of lateral openings distributed in the axial and / or angular directions in a portion of the wall of the cleaning inlet passage, and a cleaning fluid source being fluidly connected to the plurality of lateral openings and configured to release the cleaning fluid within the hollow organ.

2. The system according to claim 1, wherein the plurality of lateral openings at least partially surround the internal lumen of the cleaning inlet passage.

3. The system according to claim 1, wherein the plurality of lateral openings are evenly distributed in a portion of the wall of the washing inlet passage.

4. The system according to claim 1, wherein the plurality of lateral openings surround at least 10% of the perimeter of the cleaning inlet and / or maintain an axial distance of at least 0.05 mm between any two adjacent lateral openings and are located on a portion of the wall of the cleaning inlet.

5. The plurality of lateral openings are shaped, sized, arranged, and / or positioned to direct the cleaning fluid to the surface portion of the cryotherapy device that is exposed for droplet formation or adhesion, according to claim 1.

6. The system according to claim 1, wherein at least a portion of the plurality of lateral openings are oriented to spray cleaning fluid at a predetermined angle between 10 and 170 degrees with respect to the outer surface of the cleaning fluid channel.

7. The system according to claim 6, wherein at least a portion of the plurality of lateral openings are oriented to spray the cleaning fluid at a predetermined angle between 10 and 170 degrees, in the opposite direction to the flow direction in the cleaning fluid channel.

8. The system according to claim 1, wherein the irrigation inlet is provided with at least one distal anterior irrigation opening at the distal end of the irrigation inlet, configured to discharge irrigation fluid into the treatment space within the hollow organ located distal to the elongated cryotherapy device and / or toward the treatment object.

9. The system according to claim 8, wherein the at least one distal front cleaning opening at least partially surrounds the distal opening of the low-temperature inflow passage.

10. The system according to claim 1, comprising an optical assembly, wherein the plurality of lateral openings are arranged in the wall of the cleaning inlet to direct cleaning fluid to the optical assembly at the distal end and / or to a distal field of view (FOV) relative to the optical assembly.

11. The system according to claim 10, wherein the surface of the optical assembly at the distal end of the optical assembly is curved or inclined with respect to the long axis of the cryotherapy device, and the plurality of lateral openings are arranged to discharge cleaning fluid toward the curved or inclined surface of the optical assembly and are shaped and / or sized to discharge cleaning fluid toward the curved or inclined surface of the optical assembly.

12. The system according to claim 10, wherein the surface of the optical assembly at the distal end of the optical assembly is substantially perpendicular to the long axis of the cryotherapy device, or is positioned at an angle between 5 and 90 degrees with respect to the long axis, and the plurality of lateral openings are positioned and shaped and / or sized to discharge cleaning fluid toward the surface of the optical assembly.

13. The system according to claim 1, comprising at least one sleeve surrounding the elongated cryotherapy device, the at least one sleeve defining at least one discharge channel between the outer surface of the elongated cryotherapy device and the at least one sleeve, the at least one sleeve comprising one or more fluid discharge openings in the hollow organ, the plurality of lateral openings being arranged and / or oriented to discharge the cleaning fluid toward the at least one discharge channel and / or the one or more fluid discharge openings in order to prevent blockage of the at least one discharge channel.

14. The system according to any one of claims 1 to 13, wherein the maximum width or maximum diameter of each of the plurality of lateral openings is between 0.01 mm and 2 mm.

15. The system according to claim 14, wherein the maximum width or diameter of each of the plurality of lateral openings is between 0.01 mm and 1 mm.

16. The system according to claim 14, wherein the low-temperature inlet and the cleaning inlet are coaxial along at least 30% of the length of the cleaning inlet.

17. The system according to claim 1, wherein the elongated cryotherapy apparatus comprises at least one flow reducer positioned distal to the plurality of lateral openings within the lavage inlet passage, the at least one flow reducer having a shape and size such that it sufficiently blocks the internal lumen of the lavage inlet passage in order to increase the amount of lavage fluid passing through the plurality of lateral openings.

18. The system according to claim 17, wherein the irrigation inlet is provided with at least one distal anterior irrigation opening at the distal end of the irrigation inlet, which is configured to discharge an irrigation fluid into a therapeutic space in the hollow organ located distal to the elongated cryotherapy device, and the at least one distal anterior irrigation opening is an opening in the at least one flow reducer.

19. The system according to claim 17, wherein the at least one flow reducer blocks at least 10% of the internal lumen of the cleaning inlet.

20. The system according to claim 17, wherein the at least one flow reducer is in contact with the inner surface of the cleaning inlet and / or the outer surface of the low-temperature inlet.

21. The system according to claim 1, wherein at least some of the plurality of lateral openings are of different shapes and / or sizes.

22. The system according to claim 1, wherein the plurality of lateral openings are distributed in a portion of the wall of the washing inlet passage such that the density of openings per unit area differs.

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