Cryotherapy device

Abstract

1. A cryotherapy system comprising: an elongated device having a body, a proximal end, and a distal end, the elongated device configured to be disposed within a hollow organ, the elongated device including a cryopathway fluidly connecting a cryopathic source with the distal end of the device, the cryopathway configured to enable flow of cryopathic fluid into the hollow organ, an optical assembly within the body configured to visualize a field of view between the device distal end and a target site within the hollow organ, the irrigation path including at least one irrigation opening at the device distal end, the irrigation path configured to connect a irrigation fluid source with the at least one irrigation opening and release irrigation fluid within the hollow organ, and at least one flow reducer in the irrigation path configured to narrow an internal lumen through which the irrigation 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 May 13, 2021, the entire contents of which are incorporated herein by reference.

[0002] This application is related to International Application No. PCT / IL2018 / 050124, filed February 4, 2018, the entire contents of which are incorporated by reference as if fully set forth herein. [Background technology]

[0003] The present invention, in some embodiments thereof, relates to a cryotherapy apparatus, and more particularly, but not exclusively, to a cryotherapy apparatus for treating hollow organ disease. Summary of the Invention

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

[0005] Example 1. 1. A cryotherapy system comprising: an elongated cryotherapy device having an elongated body, a proximal end, and a distal end, the device shaped and sized to be placed inside a hollow organ; a cryogenic inlet channel within the elongate body fluidly connecting a cryogenic fluid source with the distal end of the cryotherapy device, the cryogenic inlet channel configured to allow 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 device distal end and a target site within the hollow organ; an irrigation inlet channel within the elongate body, the irrigation inlet channel comprising at least one irrigation opening at the device distal end, the irrigation inlet channel configured to fluidly connect a irrigation fluid source to the at least one irrigation opening and to discharge irrigation fluid within the hollow organ; the elongated cryotherapy device comprising: at least one flow reducer disposed within the irrigation inlet passage shaped and sized to narrow an interior lumen of the irrigation inlet passage through which the irrigation fluid flows; The cryotherapy system comprising:

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

[0007] Example 3. The system of any one of Examples 1 or 2, wherein the at least one opening is disposed in a wall of the irrigation inlet channel to direct irrigation fluid to the optical assembly at the distal end and / or to a field of view (FOV) distal to the optical assembly.

[0008] Example 4. 4. The system of example 3, wherein the at least one flow reducer is located distal to the at least one irrigation opening and configured to increase irrigation fluid pressure within a portion of the irrigation inlet channel that includes the at least one opening.

[0009] Example 5. 4. The system of example 3, wherein the at least one flow reducer is disposed within a portion of the wash inlet passage that includes the at least one wash opening.

[0010] Example 6. The system of Example 5, wherein the at least one flow reducer comprises at least one channel, or aligned openings forming channels, in the at least one flow reducer in fluid communication with the at least one opening, and is configured to direct irrigation fluid through the at least one flow reducer to the at least one irrigation opening or to draw irrigation fluid from the hollow organ into the irrigation inflow path.

[0011] Example 7. The system of any one of Examples 3-6, wherein the irrigation inlet comprises at least one distal irrigation opening at a distal end of the irrigation inlet configured to release irrigation fluid into a treatment space within the hollow organ distal to the elongated cryotherapy device.

[0012] Example 8. 8. The system of example 7, wherein the at least one flow reducer is disposed within the irrigation inlet path proximate to the at least one irrigation opening.

[0013] Example 9. 8. The system of example 7, wherein the at least one distal flushing opening is an opening in the at least one flow reducer.

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

[0015] Example 11. 11. The system of any one of Examples 3-10, wherein the at least one flow reducer contacts an inner surface of the cleaning inlet and / or an outer surface of the cold inlet.

[0016] Example 12. 12. The system of example 11, wherein the at least one flow reducer is shaped as a ring, an arc contacting the inner surface of the wash inlet, and / or an outer surface of the cold inlet.

[0017] Example 13. 12. The system of example 11, wherein the at least one flow reducer comprises a protrusion extending from the inner surface of the wash inlet and / or the outer surface of the cold inlet.

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

[0019] Example 15. The system of any one of Examples 1-13, wherein the at least one opening comprises a plurality of openings distributed axially and / or obliquely in a portion of the wall of the irrigation inlet at least partially surrounding the irrigation inlet inner lumen.

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

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

[0022] Example 18. The system of any one of Examples 14-16, wherein the plurality of openings are distributed with a varying density of openings per area of ​​the wall portion.

[0023] Example 19. The system of Example 1, wherein the at least one flow reducer is located proximal to the at least one irrigation opening and is configured to accelerate a flow rate of irrigation fluid through the at least one irrigation opening and out into the hollow organ.

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

[0025] Example 21. the cryotherapy device comprises at least one fluid discharge channel within the elongate body having at least one first discharge opening at a distal end of the at least one fluid discharge channel and at least one second discharge opening around a wall of the at least one fluid discharge channel, the second discharge opening being 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 through the at least one second discharge opening. 2. The system of any one of the preceding examples.

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

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

[0028] Example 24. The system of any one of Examples 21-23, further comprising an outer sleeve surrounding the device, and wherein the at least one second exhaust 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 of any one of the preceding examples, wherein the at least one irrigation opening has a maximum width or maximum diameter in the range of 0.01 mm to 2 mm.

[0030] Example 26. The system of any one of the preceding examples, wherein the cold inlet and the wash inlet are coaxial along at least 30% of a length of the wash inlet.

[0031] Example 27. 26. The system of any one of Examples 1-25, wherein the cleaning inlet at least partially surrounds the cold inlet along at least 30% of the length of the cold inlet.

[0032] Example 28. 11. The system of claim 1, wherein a surface of the optical assembly at a distal end of the optical assembly is curved or angled relative to a longitudinal axis of a cryotherapy device, and the at least one irrigation opening is positioned and shaped and sized to emit irrigation fluid toward the optical assembly surface.

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

[0034] Example 30. 1. A cryotherapy system comprising: an elongated cryotherapy device having an elongated body, a proximal end, and a distal end, the device shaped and sized to be placed inside a hollow organ; a cryogenic inlet channel within the elongate body fluidly connecting a cryogenic fluid source with the distal end of the cryotherapy device, the cryogenic inlet channel configured to allow cryogenic flow from the cryogenic fluid source to the hollow organ; at least one fluid exhaust passage within the elongate body having at least one first exhaust opening at a distal end of the at least one fluid exhaust passage and at least one second exhaust opening around a wall of the at least one fluid exhaust passage, the first exhaust opening being located distal to the at least one second exhaust 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 through the at least one second discharge opening; at least one exhaust seal located in the at least one fluid exhaust flow path between the at least one first exhaust opening and the at least one second exhaust opening and configured to block at least 10% of the exhaust fluid flow rate through the at least one first exhaust opening; The elongated cryotherapy device comprises: The cryotherapy system comprising:

[0035] Example 31. an optical assembly having a distal end disposed at least partially within the elongate body, the optical assembly configured to visualize a field of view between the device distal end and a target site within the hollow organ; Equipped with a distal end of the optical assembly is disposed distal to the at least one second exhaust opening, and the at least one exhaust seal is disposed between the optical assembly distal end and the at least one second exhaust opening. The system of Example 30.

[0036] Example 32. The system of Example 31, comprising an outer sleeve surrounding the device, and wherein the at least one second exhaust 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. 1. A cryotherapy system comprising: an elongated cryotherapy device having an elongated body, a proximal end, and a distal end, the device shaped and sized to be placed inside a hollow organ; a cryogenic inlet channel within the elongate body fluidly connecting a cryogenic fluid source with the distal end of the cryotherapy device, the cryogenic inlet channel configured to allow cryogenic flow from the cryogenic fluid source to the hollow organ; an irrigation inlet channel within the elongate body, the irrigation inlet channel comprising a plurality of irrigation openings at a distal end of the device, the irrigation inlet channel being axially and / or obliquely distributed in a wall of the irrigation inlet channel, the irrigation inlet channel fluidly connecting a irrigation fluid source to the plurality of irrigation openings, the irrigation inlet channel being configured to discharge irrigation fluid within the hollow organ through at least one of the plurality of irrigation openings; said elongated cryotherapy device comprising: The cryotherapy system comprising:

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

[0039] Example 35. 34. The system of example 33, wherein the plurality of cleaning openings are distributed at a varying density of openings per area of ​​the wall.

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

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

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

[0043] Example 39. The system of any one of Examples 33-37, wherein the plurality of irrigation openings are located in a portion of the wall of the irrigation inlet conduit that surrounds at least 10% of the circumference of the inlet conduit and / or maintains an axial distance of at least 0.05 mm between two adjacent openings.

[0044] Example 40. The system of any one of Examples 33-39, wherein the plurality of irrigation 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 within the elongate body configured to visualize a field of view between the device distal end and a target site within the hollow organ, at least some of the plurality of openings facing toward the distal end of the optical assembly and disposed in the wall of the irrigation inlet channel to deliver irrigation fluid toward the optical assembly distal end; The system of any one of Examples 33 to 40, comprising:

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

[0047] Example 43. 1. A cryotherapy system comprising: an elongated cryotherapy device having an elongated body, a proximal end, and a distal end, the device shaped and sized to be placed inside a hollow organ; a cryo-fluid inlet channel within the elongate body fluidly connecting a cryo-fluid source with the distal end of the cryotherapy device, the cryo-fluid inlet channel comprising an opening configured to deliver cryo-fluid from the cryo-fluid source to the hollow organ; said elongated cryotherapy device comprising: Equipped with at least one surface of the device at the distal end is pre-treated to prevent or reduce the deposition and / or formation of one or more liquid droplets on the pre-treated surface; The cryotherapy system.

[0048] Example 44. The system of Example 43, wherein the device comprises at least one irrigation opening at a distal end of the device and an irrigation inlet channel within the elongate body configured to release irrigation fluid within the hollow organ, and the at least one pre-treated surface is an exterior surface of the irrigation inlet channel.

[0049] Example 45. the device comprising an optical assembly having a distal end within the elongate body configured to visualize a field of view within the hollow organ between the device distal end and a target site within the hollow organ; the at least one pretreated surface is an exterior surface of the optical assembly; The system of any one of Examples 43 or 44.

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

[0051] Example 47. 1. A cryotherapy method comprising: introducing a cryotherapy device into the hollow organ; delivering cryofluid to the hollow organ through a cryofluid inlet line of the cryotherapy device; Discharging irrigation fluid before, during, and / or after delivery of the cryofluid into the hollow organ through at least one irrigation opening of an irrigation fluid inlet conduit having a constricted portion; The cryotherapy method comprising:

[0052] Example 48. The method of example 47, wherein the irrigation discharge comprises accelerating a flow rate of the irrigation fluid into the hollow organ through the constricted portion of the irrigation fluid inlet channel.

[0053] Example 49. The method of any one of Examples 47 or 48, wherein the discharging comprises discharging the irrigation fluid into the hollow organ through at least one irrigation opening located at a wall of the irrigation fluid inlet channel and proximal to or within the constricted portion.

[0054] Example 50. The method of any one of Examples 47-49, wherein the discharging comprises discharging the irrigation fluid into the hollow organ through a forward-facing distal opening of the irrigation fluid inlet channel.

[0055] Example 51. The method of any one of Examples 47-50, wherein the introducing comprises introducing the cryotherapy device into the hollow organ through a sleeve.

[0056] Example 52 The method of example 51, comprising draining fluid from the hollow organ through at least one opening around the sleeve.

[0057] Example 53. The method of Example 52, comprising visualizing a treatment space within the hollow organ through which the cryofluid is delivered by at least one lens or aperture located within the hollow organ, wherein the draining comprises draining 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 of any one of Examples 47 to 53, wherein the at least one irrigation opening comprises a plurality of irrigation openings having different sizes and / or widths or diameters, and the discharging comprises discharging the irrigation fluid through the plurality of openings in different directions within the hollow organ and / or to different distances within the hollow organ depending on the shape, size and / or diameter of each opening of the plurality of openings.

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

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

[0061] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0062] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, a method, or a computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, which may be generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied therein. Implementation of the methods and / or systems of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and implementation of some embodiments of the methods and / or systems of the present disclosure, some selected tasks could be implemented by hardware, software, or firmware, and / or a 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 number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, 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 medium(s). The computer readable medium may be a computer readable signal medium or a computer readable storage medium. The computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples of computer readable storage media would include an electrical connection with one or more communication lines, a portable computer diskette, a hard disk, a random access memory (RAM), a read only memory (ROM), an electrically erasable PROM (EEPROM or flash memory), an optical fiber, a compact disk read only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device.

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

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

[0067] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages, such as Java, Smalltalk, C++, and conventional procedural programming languages, such as the "C" programming language or similar. The program code may run entirely on the user's computer, partially on the user's computer as a stand-alone software package, 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 may 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 may be connected to an external computer (e.g., via the Internet using an Internet Service Provider).

[0068] Some embodiments of the present invention are described below with reference to flowchart illustrations 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 of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, a special purpose computer, or other programmable data processing apparatus to manufacture a machine, such that the instructions, executing via the processor of the computer or other programmable data processing apparatus, create means for performing the functions / acts specified in the flowchart and / or block diagram of a block or blocks.

[0069] These computer program instructions may also be stored on a computer-readable medium that can instruct a computer, other programmable data processing apparatus, or other device to function in a particular manner, such that the instructions stored on the computer-readable medium produce an article of manufacture that includes instructions implementing the functions / acts specified in the flowcharts and / or block diagrams of a block or blocks.

[0070] The computer program instructions may be loaded onto a computer, other programmable data processing apparatus, or other device to create a computer-implemented process such that the instructions executing on the computer or other programmable apparatus cause a series of operational steps to be executed by the computer or other programmable apparatus to provide a process for performing the functions / acts specified in the flowcharts and / or block diagrams of a block or blocks.

[0071] Some of the methods described herein are generally designed for computational use only and may not be suitable or practical for fully manual execution by a human expert. A human expert wishing to manually execute a similar task, such as determining pressure and / or temperature within a body lumen, may be expected to use an entirely different method, e.g., one that utilizes expert knowledge and / or the pattern recognition capabilities of the human brain, which would be much more efficient than performing the steps of the methods described herein manually.

[0072] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which: Reference will now be made specifically to the drawings in detail, stressing that the particulars shown are for the purpose of illustrating and discussing embodiments of the invention by way of example, and in this regard the description made with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief description of the drawings]

[0073] [Figure 1A] 1 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] FIG. 1 is a block diagram of a system for delivery of cryotherapy, according to some exemplary embodiments of the present invention. [Figure 2A] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device disposed within a body lumen, according to some exemplary embodiments of the present invention. [Figure 2B] FIG. 2B is a schematic front view of the distal end of the cryotherapy device of FIG. 2A, in accordance with some exemplary embodiments of the present invention. [Diagram 3] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device with droplets at different locations on the cryotherapy device, according to some exemplary embodiments of the present invention. [Figure 4A]1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having multiple irrigation fluid openings at different locations of the device according to some exemplary embodiments of the cryotherapy device. [Figure 4B] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having multiple irrigation fluid openings at different locations of the device according to some exemplary embodiments of the cryotherapy device. [Figure 4C] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having multiple irrigation fluid openings at different locations of the device according to some exemplary embodiments of the cryotherapy device. [Figure 4D] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having multiple irrigation fluid openings at different locations of the device according to some exemplary embodiments of the cryotherapy device. [Figure 5A] 1A-1C are schematic diagrams of a washing fluid channel having two types of washing fluid openings distributed axially and circumferentially on the outer surface of the washing fluid channel, according to some exemplary embodiments of the present invention. [Figure 5B] 1A-1C are schematic diagrams of a washing fluid channel having two types of washing fluid openings distributed axially and circumferentially on the outer surface of the washing fluid channel, according to some exemplary embodiments of the present invention. [Figure 5C] FIG. 1 is a schematic diagram of a cleaning fluid channel having openings divided into different regions, the openings of one region being distributed partially circumferentially on the outer surface of the cleaning fluid channel, in accordance with some exemplary embodiments of the present invention. [Figure 5D] FIG. 1 is a schematic diagram of a cleaning fluid channel having openings divided into different regions, the openings of one region being distributed partially circumferentially on the outer surface of the cleaning fluid channel, in accordance with some exemplary embodiments of the present invention. [Figure 5E] FIG. 1 is a schematic diagram of a cleaning fluid channel having openings divided into different regions, the openings of one region being distributed partially circumferentially on the outer surface of the cleaning fluid channel, in accordance with some exemplary embodiments of the present invention. [Figure 6A]1A-1C are schematic diagrams illustrating the distribution of irrigation fluid openings when covering the entire surface of a visualization assembly distal end, optionally including a window or lens, in accordance with some exemplary embodiments of the present invention. [Figure 6B] 1A-1C are schematic diagrams illustrating the distribution of irrigation fluid openings when covering the entire surface of a visualization assembly distal end, optionally including a window or lens, in accordance with some exemplary embodiments of the present invention. [Figure 6C] 1A-1C are schematic diagrams illustrating the distribution of irrigation fluid openings when partially covering a surface of a visualization assembly distal end, optionally including a window or lens, in accordance with some exemplary embodiments of the present invention. [Figure 6D] 1A-1C are schematic diagrams illustrating the distribution of irrigation fluid openings when partially covering a surface of a visualization assembly distal end, optionally including a window or lens, in accordance with some exemplary embodiments of the present invention. [Figure 6E] 1A-1C are schematic cross-sectional views of a distal end of a cryotherapy device including at least one exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 6F] 1A-1C are schematic cross-sectional views of a distal end of a cryotherapy device including at least one exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 7A] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having a flow reducer, such as an internal reducer in an irrigation fluid channel, according to some exemplary embodiments of the invention. [Figure 7B] 1A-1D are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having a flow reducer, such as an internal reducer in an irrigation fluid channel, according to some exemplary embodiments of the invention. [Figure 7C] 1A-1C are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having an internal reducer with integrated channels and / or openings in the irrigation fluid channels, according to some exemplary embodiments of the invention. [Figure 7D]1A-1C are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device having an internal reducer in an irrigation fluid channel and a number of separate openings distributed on the surface of the channel, according to some exemplary embodiments of the invention. [Figure 8A] 1A-1C are schematic cross-sectional views of cryotherapy distal ends having at least one flow reducer located distal to an irrigation opening, such as an irrigation fluid opening in an additional flow reducer, according to some exemplary embodiments of the invention. [Figure 8B] 1A-1C are schematic cross-sectional views of cryotherapy distal ends having at least one flow reducer located distal to an irrigation opening, such as an irrigation fluid opening in an additional flow reducer, according to some exemplary embodiments of the invention. [Figure 8C] 1 is a schematic cross-sectional front view illustrating a flow reducer having an opening surrounding a distal end cryofluid opening, according to some exemplary embodiments of the present invention. FIG. [Figure 8D] 1 is a schematic cross-sectional view of a distal end of a cryotherapy apparatus including an irrigation fluid flow reducer having multiple openings and an exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 8E] 1 is a schematic cross-sectional view of a distal end of a cryotherapy apparatus including an irrigation fluid flow reducer having multiple openings and an exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 8F] 1 is a schematic cross-sectional view of a distal end of a cryotherapy device including an irrigation fluid flow reducer, spaced apart irrigation fluid openings, and an exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 8G] 1 is a schematic cross-sectional view of a distal end of a cryotherapy device including an irrigation fluid flow reducer, spaced apart irrigation fluid openings, and an exhaust flow seal, according to some exemplary embodiments of the present invention. [Figure 9] 1A-1C are schematic longitudinal cross-sectional views of a distal end of a cryotherapy device, in which at least a region of an outer surface of the cryotherapy device exposed to cryofluid in a body lumen is a rough, non-smooth surface, according to some exemplary embodiments of the present invention. [Figure 10]10A-10C are longitudinal cross-sectional views of the distal end of a cryotherapy device having an upright vertical surface at the distal end (10A), an inclined surface at the distal end (10B), or a curved surface at the distal end (10C), according to some exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] The present invention, in some embodiments thereof, relates to a cryotherapy device, and more particularly, but not exclusively, to a cryotherapy device for treating hollow organ diseases, including, in some embodiments, bladder cancer, interstitial cystitis, overactive bladder, superficial gastric neoplastic lesions, superficial gastric cancer, and / or abdominal wall tumors.

[0075] An aspect of some embodiments relates to controlling the flow rate of irrigation fluid within a body lumen, such as a hollow organ, to disrupt existing droplets and / or prevent the formation of droplets on a surface of a cryotherapy device within the body lumen. In some embodiments, the flow rate of irrigation fluid within at least one irrigation inlet, such as an irrigation fluid channel of a cryotherapy device, is controlled by at least one flow reducer, such as an internal reducer located within the irrigation fluid channel. In some embodiments, the at least one flow reducer narrows the irrigation fluid channel by at least 10%, such as at least 30%, at least 50%, at least 70%, at least 90%, or any intermediate, smaller, or larger reduction in the irrigation fluid channel, such as at least partially blocking the irrigation fluid channel.

[0076] According to some embodiments, at least one flow reducer in the irrigation fluid channel controls the flow rate of irrigation fluid through one or more distal openings of the irrigation fluid channel, optionally facing the target site, e.g., forward-facing openings. In some embodiments, the at least one flow reducer controls at least one of the pressure of the irrigation fluid exiting through the opening, the flow rate and / or the direction of the irrigation fluid exiting through the one or more distal openings of the irrigation fluid channel. Optionally, the at least one flow reducer is located at a distal end of the irrigation fluid channel and narrows and / or shapes the one or more distal openings of the irrigation fluid channel.

[0077] According to some embodiments, at least one flow reducer includes one or more openings or channels around the periphery of the flow reducer configured to direct cleaning fluid liquid to openings lateral to the periphery of the 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 in the flow reducer opening. In some embodiments, for example, the angle of the channel in the flow reducer relative to the axis of the cleaning fluid channel determines the angle of outward spray of the cleaning fluid from the cleaning channel. In some embodiments, the cleaning fluid flow rate in the channel relative to the width of the reducer opening controls the pressure in the fluid channel, for example a high speed and / or narrow opening of the cleaning fluid flow can generate a negative pressure in 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 irrigation fluid at a selected deflection angle in the range of 10-170 degrees, such as 10-50 degrees, 30-100 degrees, 90-170 degrees, or any intermediate, smaller, or larger angle relative to the exterior surface of the irrigation fluid channel. Alternatively or additionally, a plurality of internal reducer channels and / or openings are shaped, sized, and / or aligned to spray the irrigation fluid at an impingement angle in the range of 0-90 degrees, such as 0-30 degrees, 10-40 degrees, 20-70 degrees, 50-90 degrees, or any intermediate, smaller, or larger angle or range of angles relative to the surface of the cryotherapy device, for example, within the body lumen.

[0079] According to some exemplary embodiments, the cryotherapy device includes at least one flow reducer in the irrigation fluid channel located a short distance from the periphery opening of the irrigation fluid channel, e.g., a lateral opening facing a surface of a visualization assembly, optionally referred to herein in some embodiments as an optical assembly. In some embodiments, the proximal end of the at least one flow reducer is located at a distance of at least 0.5 mm from the periphery opening, e.g., at least 1 mm, at least 5 mm, at least 20 mm, or any intermediate, smaller, or larger distance from the at least one periphery opening of the irrigation fluid channel.

[0080] An aspect of some embodiments relates to irrigation fluid channel openings on the circumference of the irrigation fluid channel with a predetermined arrangement, size, and distribution, for example, to control the flow rate and direction of irrigation fluid within the body lumen. In some embodiments, the plurality of irrigation fluid openings are distributed axially and / or circumferentially around at least one irrigation fluid channel within the body lumen. In some embodiments, the plurality of irrigation fluid openings are optionally shaped, sized, arranged, and / or positioned to direct irrigation fluid toward a surface at the distal end of the cryotherapy device that is exposed to droplet formation or deposition, for example, to disrupt existing droplets already deposited on the surface and / or to prevent droplet deposition or formation on the surface. Alternatively or additionally, the plurality of irrigation fluid openings are optionally shaped, sized, arranged, and / or positioned to direct irrigation fluid toward the lumen of at least one drainage flow channel, for example, to clear the flow channel and prevent droplets from blocking the drainage flow channel. Alternatively or additionally, the multiple irrigation fluid openings are optionally shaped, sized, arranged, and / or positioned to direct irrigation fluid into the space between the visualization assembly and the treatment site, e.g., to create a flow protection space.

[0081] According to some embodiments, the plurality of openings optionally have similar shapes and / or sizes. Alternatively, at least some of the openings optionally have different shapes and / or sizes. In some embodiments, the plurality of openings have a size, such as a maximum width or maximum diameter, in the range of 0.01 mm to 2 mm, e.g., 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 plurality of openings are distributed axially and / or circumferentially on the outer surface of the irrigation fluid channel, for example in at least one region of the wall facing at least one selected location, such as, for example, in at least a portion of the wall facing a 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 a lumen or opening of the exhaust channel. In some embodiments, the plurality of openings are distributed circumferentially along the circumference of the irrigation fluid channel. Alternatively or in addition, at least some of the plurality of openings are distributed along a portion of the circumference, such as, for example, along an arc that subtends an angle of less than 360 degrees, less than 180 degrees, less than 90 degrees, or any intermediate, smaller, or larger value. Alternatively or in addition, at least some of the plurality of openings are distributed along a portion of the surface that connects to or is adjacent to the irrigation fluid channel.

[0083] According to some embodiments, the plurality of irrigation openings are located in a portion of the wall of the irrigation channel, e.g., surrounding and / or along the irrigation inlet. Additionally or alternatively, the plurality of irrigation openings are located in a portion of the wall of the irrigation inlet that surrounds at least 5%, e.g., at least 10%, at least 20%, at least 30%, or any intermediate, smaller, or larger range of the inlet circumference, and / or maintains an axial distance of at least 0.05 mm between two adjacent openings, e.g., 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 plurality of openings have different shapes and / or sizes. In some embodiments, at least some of the plurality of openings are arranged in an array of openings. In some embodiments, the plurality of openings are evenly distributed within the array. Alternatively, the distance between at least some adjacent openings in the array varies.

[0085] A potential advantage of controlling the flow rate of the cleaning fluid may be to allow efficient removal of droplets that impede visualization, for example, droplets on optical lenses, on tubing, and inside the drainage path, which may promote or displace low temperature frost in sensitive locations.

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

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

[0088] According to some embodiments, the cryotherapy device includes at least one exhaust seal, such as a distal exhaust seal configured to at least partially block the exhaust of fluids and particles through a distal, e.g., forward-facing, opening of the exhaust channel. In some embodiments, the forward-facing opening is the opening of the exhaust channel that faces the target of the cryotherapy treatment within the treatment space and / or body lumen. In some embodiments, the at least one distal exhaust seal reduces the passage of fluids and particles through the forward-facing opening of the exhaust channel by at least 50%, such as by at least 60%, by at least 70%, by at least 80%, by at least 90%, or any intermediate, smaller, or larger percentage value.

[0089] According to some exemplary embodiments, the distal exhaust seal is axially located on the cryotherapy device proximal to the visualization assembly distal end. In some embodiments, the distal exhaust seal is located between the distal end of the visualization assembly and the exhaust opening of the outer sleeve. In some embodiments, blocking the passage of fluids and particles by the exhaust seal directs fluids and particles around the visualization assembly towards the exhaust opening of the outer sleeve.

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

[0091] One aspect of some embodiments relates to modifying or pretreating a surface of a cryotherapy device to prevent or reduce adhesion and / or formation of droplets on the modified surface. In some embodiments, at least a portion of the surface is modified to have a non-smooth, rough surface. In some embodiments, the non-smooth, rough surface alters, e.g., reduces, the adhesive forces or behavior of adhesive forces between the droplet and the surface.

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

[0093] An aspect of some embodiments relates to draining fluid from a hollow organ through at least one drain side opening. In some embodiments, the at least one drain side opening is located at the periphery of a cryotherapy device body, such as a sleeve. In some embodiments, the at least one drain opening comprises a plurality of drain openings. In some embodiments, the plurality of drain openings are distributed axially and / or obliquely in a wall of the cryotherapy body, such as in a wall of a sleeve.

[0094] According to some embodiments, at least some of the plurality of openings are located proximal to a distal end of a visualization assembly, which optionally includes a lens, aperture, and / or illumination.

[0095] Potential benefits of treating the surface may be to prevent or reduce the accumulation or formation of droplets, reduce the drip profile, e.g., by directing the liquid where access to the cleaning fluid is limited or where the flow of the cleaning fluid is not strong enough to dry or break up the droplets, to form one or more thin layers instead of droplets.

[0096] According to some embodiments, the methods, systems, and devices described herein are used to treat bladder cancer by targeted delivery of cryofluoride 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 irrigation fluid channel passes through the elongated body and optionally at least partially surrounds a cryofluid channel of the device. In some embodiments, the irrigation fluid is optionally discharged outwardly from at least one opening of the irrigation channel toward at least a portion of the visualization assembly located between the opening of the irrigation channel and an outer surface of the device body.

[0098] According to some embodiments, controlling the release of irrigation fluid towards the visualization assembly and / or towards the FOV as described herein is performed in an apparatus that does not include a cryofluid channel, for example an apparatus that includes a visualization assembly and an irrigation fluid channel. In some embodiments, the apparatus includes a flow reducer, at least one of a plurality of openings or channels for controlling the release of irrigation fluid towards the visualization assembly. A potential advantage of including a cryofluid channel is that it may allow for a reduction in the number of devices inserted into the hollow organ.

[0099] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0100] Exemplary General Process for Applying Cleaning Fluid Cryoablation treatment, e.g., cryotherapy, is performed in a body lumen, e.g., a hollow organ, by a cryotherapy device. In some embodiments, the body lumen is a body lumen, optionally having a narrow single opening. In some embodiments, the body lumen optionally contains body fluids and / or moisture. In some embodiments, the release of cryofluid in the body lumen may cause the formation of droplets and / or frost in the body lumen, on at least one surface of the cryotherapy device, in at least one lumen of the cryotherapy device, and / or on the surface of an additional device inserted in the body lumen. In some embodiments, a cleaning fluid is applied to at least one of prevent, reduce, and remove the droplets and / or frost. Reference is now made to FIG. 1A, which illustrates a process for application of a cleaning fluid in a body lumen, e.g., a hollow organ, according to some exemplary embodiments of the present invention.

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

[0102] According to some exemplary embodiments, the body 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 body cavity at block 40 through a body opening, such as an anatomical opening of the body cavity, or 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 body cavity includes the bladder, and the cryotherapy device is optionally introduced into the bladder at block 40 through the urethra. 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, a irrigation fluid is optionally applied, e.g., released into the body lumen at block 45. In some embodiments, the irrigation fluid is applied, e.g., to clear the visualization field or to dilate narrow openings when navigating the device into and / or within the body lumen. In some embodiments, the irrigation fluid is optionally applied, e.g., to allow clear visualization of the interior surface of the body lumen and / or the target site therein.

[0104] According to some exemplary embodiments, the irrigation fluid is optionally discharged into the body lumen at block 45 through at least one irrigation opening located around the irrigation fluid inlet path. In some embodiments, the irrigation fluid inlet path includes a constriction where the flow rate accelerates. In some embodiments, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located proximal to the constriction. Alternatively or in addition, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located at the constriction. Alternatively or in addition, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located distal to the constriction.

[0105] According to some exemplary embodiments, the body lumen is optionally expanded at block 50. In some embodiments, the body lumen is expanded prior to 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 better visualization of the inner surface of the body lumen. Alternatively or additionally, the body lumen is expanded to flatten the inner surface of the body lumen, for example, to allow better access of the cryofluid released in the body lumen to a target site in the body lumen, for example, to a target site on the inner surface of the body lumen.

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

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

[0108] According to some exemplary embodiments, the body lumen is visualized at block 65. In some embodiments, the body lumen is visualized in a timed relationship to the release of the cryofluid at block 60, e.g., before, during, and after the release of the cryofluid. In some embodiments, at least one target site or treatment space within the body lumen is visualized at block 65. In some embodiments, the body lumen is visualized by a visualization assembly, e.g., an optical assembly located at a distal end of the cryotherapy apparatus.

[0109] According to some exemplary embodiments, at block 70, an indication regarding the formation of droplets and / or frost in the body lumen is optionally received. In some embodiments, the indication is a visual indication received from a visualization assembly. Alternatively, the indication is received from at least one sensor of the cryotherapy device, such as, for example, from at least one sensor located at a distal end of 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, for example, a control circuit of the control unit, receives the indication based on signals received from the visualization assembly and / or the at least one sensor.

[0110] According to some exemplary embodiments, the irrigation fluid is applied at block 80. In some embodiments, the irrigation fluid is applied in response to an instruction, optionally received at block 70. Alternatively, the application of the irrigation fluid is a preventative process, e.g., the irrigation fluid is applied without receiving an instruction at block 70. In some embodiments, the irrigation fluid is applied intermittently, optionally in short bursts. In some embodiments, the irrigation fluid is applied intermittently, e.g., every 0.1 seconds, every 0.5 seconds, every 2 seconds, or any intermediate, shorter, or longer time period. In some embodiments, the irrigation fluid, e.g., irrigation fluid or irrigation gas, is applied within the body lumen. In some embodiments, the irrigation fluid is applied toward at least one of the visualization assembly, the treatment target, at least a portion of the treatment space, and at least one surface of the cryotherapy device located in the body lumen. In some embodiments, the irrigation fluid is applied to prevent the formation of droplets and / or frost within the body lumen. Alternatively or additionally, a cleaning fluid is optionally applied to prevent the adhesion and / or accumulation of droplets within the body lumen, on the surfaces or openings of the cryotherapy device, and / or on the visualization assembly. Alternatively or additionally, a cleaning fluid is optionally applied to prevent the adhesion and / or accumulation of frost within the body lumen, on the surfaces or openings of the cryotherapy device, and / or on the visualization assembly. Alternatively or additionally, a cleaning fluid is optionally applied to clear the field of view (FOV) of the visualization assembly.

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

[0112] According to some exemplary embodiments, the irrigation fluid is discharged into the body lumen at block 80 through at least one irrigation opening located around the irrigation fluid inlet path. In some embodiments, the irrigation fluid inlet path includes a constriction where the irrigation fluid flow rate accelerates. In some embodiments, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located proximal to the constriction. Alternatively or in addition, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located at the constriction. Alternatively or in addition, the irrigation fluid is optionally discharged into the body lumen through at least one irrigation fluid opening located distal to the constriction.

[0113] According to some exemplary embodiments, the flow rate of the irrigation fluid is controlled in block 90. ​​In some embodiments, the flow rate of the irrigation fluid is controlled by applying the irrigation fluid through openings having a predetermined size, a predetermined shape, and / or a predetermined location. In some embodiments, the size and / or shape of all the irrigation fluid openings are identical. Alternatively, at least some of the irrigation fluid openings have different shapes and / or sizes. In some embodiments, the size, shape, and / or location of the openings allows for controlling the distribution and / or direction of the irrigation fluid within the body lumen. Alternatively or additionally, the size, shape, and / or location of the openings determines the distribution and / or direction of the irrigation 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 flow path in the cryotherapy device. Alternatively or additionally, 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. Additionally or alternatively, the amount of cleaning fluid directed to the opening is controlled, for example, by opening at least a valve, such as, for example, a valve in the cleaning fluid channel.

[0115] According to some exemplary embodiments, fluid is evacuated from the body lumen at block 100. In some embodiments, fluid is evacuated from the body lumen to maintain a target, e.g., a predetermined pressure and / or temperature level within the body lumen. Alternatively or additionally, fluid is evacuated from the body lumen at block 65, e.g., to allow for better visualization. Alternatively or additionally, in some embodiments, fluid is evacuated from the body lumen before, during, and / or after application of the cleaning fluid at blocks 45 and / or 80. Alternatively or additionally, fluid is evacuated from the body lumen, optionally automatically, 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 at block 40 through at least one discharge side opening in an elongated hollow body, such as a sleeve or overtube used during introduction of the cryotherapy device. In some embodiments, the at least one discharge side opening is a peripheral opening of the sleeve or overtube. In some embodiments, the at least one discharge side opening is disposed within the body lumen. Alternatively or additionally, the fluid is discharged through at least one distal opening of at least one discharge channel of the cryotherapy device disposed 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 the cryotherapy device. In some embodiments, the control unit is located outside the body. Reference is now made to FIG. 1B, which illustrates 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, e.g., a cryotherapy device 102, and a control unit 104 connected to the cryotherapy device 102. In some embodiments, the cryotherapy device 102, e.g., the body of the cryotherapy device, is an elongated probe having a distal end 121 that is optionally introduceable into a body lumen and shaped and sized to face a target site within the inner surface of the lumen, and a proximal end 125 that is optionally positioned outside the body lumen. Optionally, the cryotherapy device 102, e.g., the body of the cryotherapy device, is hollow to allow for placement of one or more flow paths, one or more channels, and / or assemblies, e.g., an optical assembly, within the device body. In some embodiments, the cryotherapy device 102 is cylindrical and has a diameter at the distal end 121 of the cryotherapy device and a sleeve around it that ranges from 3 to 15 mm, e.g., 3 mm, 5 mm, 7 mm, 9 mm, or any intermediate, smaller, or larger value. In some embodiments, the diameter of the cryotherapy device, excluding the sleeve, ranges from 0.3 to 5 mm, such as, for example, 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 a working channel of an endoscope. Instead, the cryotherapy device 102 is introduced into the body lumen through a hollow elongated body of the cryotherapy system, such as, for example, the sleeve 124. Instead, the geometry of the cryotherapy device 102 is constructed / has a structure dedicated to being introduced into the body lumen (e.g., a dedicated scope + cryo-element).

[0119] Instead, the cryotherapy system includes an endoscope, optionally including a visualization assembly, and a cryotherapy device, not including a visualization assembly, that is introduced through a working channel of the endoscope.

[0120] According to some exemplary embodiments, the cryotherapy device 102 includes at least one flow path, such as a channel passing through a lumen or lumen of the cryotherapy device from the proximal end 125 to the distal end 121. 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 pathway, such as, for example, an inflow channel 106, for delivering fluid into the body lumen. Additionally or optionally, the cryotherapy device 102 includes at least one outflow path, such as, for example, an outflow channel 110, for evacuating fluids, liquids, particles, and / or gases from the body lumen.

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

[0122] According to some exemplary embodiments, the inlet channel 106 includes at least one cryo-nozzle 129, e.g., a forward-facing cryo-nozzle and / or a side-facing cryo-nozzle, configured to spray a cryogenic fluid, e.g., a cryogenic gas and / or a cryogenic liquid, toward a selected target site on the inner surface of the lumen. Optionally, the cryogenic fluid is stored at high pressure. In some embodiments, and without being bound by any theory, expansion of the high pressure cryogenic fluid within the body lumen causes the pressure of the fluid to drop rapidly, resulting in a cryogenic effect within the body lumen, e.g., the Joule-Thomson effect.

[0123] According to some exemplary embodiments, the cryo-nozzle 129 is an adjustable cryo-nozzle configured to spray the cryo-fluid toward the target site at an angle less than or greater than 90 degrees. Alternatively, the cryo-nozzle 129 is a fixed angle cryo-nozzle fixed at an angle different from 90 degrees, such as 15 degrees, 30 degrees, 45 degrees, 55 degrees, or any intermediate, lesser, or greater angle different from 90 degrees. Alternatively, the angle is 90 degrees. In some embodiments, the adjustable cryo-nozzle is configured to control the amount of atomized cryo-fluid discharged through the nozzle into the lumen, for example, by adjusting the opening diameter of the cryo-nozzle. Alternatively or additionally, the amount of atomized cryo-fluid discharged through the nozzle into the lumen 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, for example, electrical wires, optical fibers, optical prisms, optical paths, optionally optical channels 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, for example, an optical sensor in the control unit 104, or to an external optical assembly, such as, for example, an optical assembly of a different control unit. Alternatively, the optical assembly includes at least one optical sensor, such as, for example, 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, for example, 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, for example, illumination source 119. In some embodiments, illumination source 119 is disposed at a distal end 121 of the cryotherapy device, optionally facing the tissue of the body lumen. Alternatively, the at least one light source is disposed within a channel within the cryotherapy device, such as, for example, optical channel 118.

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

[0127] According to some exemplary embodiments, the cryotherapy device 102 includes at least one flow path, such as, for example, the irrigation channel 114, for the insertion of an irrigation fluid, such as, for example, a gas or liquid, into a lumen, such as, for example, a body lumen. In some embodiments, the insertion of an irrigation fluid, such as, for example, an irrigation gas, is used to expand the body lumen, for example, to allow better visualization of the inner surface of the lumen and / or to allow better access to a desired area, such as an area selected for cryotherapy, within the body lumen. Additionally or alternatively, the irrigation fluid is sprayed into the treatment site through an irrigation opening, optionally including a nozzle, for example, to remove or blow away condensation particles and / or a cloud of condensation particles. Optionally, the condensation particles and / or a cloud of condensation 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 washing channel 114 includes at least one washing opening, such as, for example, 2, 3, 4, 5, 6, 10, 100, or any greater or intermediate number of washing openings. In some embodiments, the washing channel 114 includes multiple washing openings. In some embodiments, the multiple washing openings or at least some of the washing openings optionally have the same width or diameter. In some embodiments, at least some of the washing openings are optionally sideways openings. Alternatively, at least some of the washing openings are forward-facing openings.

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

[0130] According to some exemplary embodiments, at least one or at least some of the irrigation openings include at least one irrigation opening at a distal end of the cryotherapy device, e.g., an irrigation opening facing the tissue. In some embodiments, the at least one irrigation opening is an irrigation opening that is optionally forward-facing. In some embodiments, the at least one irrigation opening is configured to spray, e.g., gas, e.g., low pressure gas, into a space between the cryotherapy device 102 and the target site. In some embodiments, the at least one irrigation opening is an adjustable opening, e.g., to allow spraying of the irrigation fluid, e.g., gas or liquid, laterally or at an angle relative to the target site, e.g., at a predetermined angle relative to an outer surface of the irrigation fluid channel or relative to a surface of the target site. In some embodiments, the at least one opening sprays the irrigation fluid, e.g., gas or liquid, into a 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 device 102 includes at least one irrigation director at the irrigation opening, e.g., a deflection surface, configured to direct irrigation fluid towards an optical assembly, e.g., a lens, and / or into the FOV of the optical sensor 122 or into the FOV of the optical channel 118. Optionally, the at least one irrigation director is an adjustable irrigation director configured to enable spray of irrigation gas, e.g., at an angle into the FOV.

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

[0133] According to some illustrative embodiments, the control unit 104 includes at least one control circuit, such as, for example, control circuit 126. In some embodiments, the control circuit 126 controls the flow rate of the cryogenic fluid through an inlet conduit, such as, for example, the inlet channel 106. In some embodiments, the control circuit 126 controls the flow rate of the cryogenic fluid by controlling at least one cryogenic flow regulating valve, such as, for example, a valve disposed within the inlet conduit and / or at least one valve between the cryogenic source 134 and the inlet channel 106. Alternatively or additionally, the control unit 104 controls at least one valve of the cryogenic source 134, such as, for example, an outlet valve of the cryogenic source 134.

[0134] According to some exemplary embodiments, the control circuit 126 controls the flow rate of the cleaning fluid through a cleaning inlet, such as the cleaning channel 114. In some embodiments, the control circuit 126 controls the flow rate of the cleaning fluid by controlling at least one cleaning flow rate regulator, such as a valve, disposed in a cleaning flow path, such as the cleaning channel 114. Alternatively or additionally, the control circuit 126 controls the flow rate of the cleaning fluid by controlling at least one flow rate regulator, such as at least one valve, between the cleaning source 108 and the cleaning channel 114. Alternatively or additionally, 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 of cleaning fluid.

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

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

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

[0138] According to some exemplary embodiments, the control circuit 126 controls the flow rate of fluids, e.g., gases and / or liquids, exiting the body lumen through an outlet passage, e.g., the outlet channel 110. In some embodiments, the control circuit controls the flow rate through the outlet channel 110 by controlling an outlet flow regulator valve, e.g., an outlet valve in or near the proximal end of the outlet channel, e.g., valve 123. Alternatively or additionally, the control circuit 126 controls the operation of an evacuation pump 107, e.g., a vacuum pump connected to the outlet channel. In some embodiments, the evacuation pump 107 is used to actively evacuate fluids, e.g., liquids and / or gases and / or particles, exiting the body lumen through the outlet passage of the cryotherapy device. Optionally, the control circuit 126 controls at least one evacuation flow regulator valve, e.g., an evacuation valve on a tube connecting the evacuation pump 107 and the outlet channel. Alternatively, the evacuation is performed through a check valve.

[0139] According to some exemplary embodiments, the control circuitry 126 controls an optical assembly, such as, for example, an optical sensor disposed on the cryotherapy device 102, such as, for example, the optical sensor 122. Alternatively or additionally, the control circuitry 126 controls at least one optical sensor in the control unit 104. In some embodiments, the control circuitry 126 controls the opening or closing of the optical channel 118, optionally by controlling an aperture in the optical channel 118. In some embodiments, the control circuitry controls the operation of the optical system 110, such as, for example, 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 sensing at least one environmental parameter, for example, of the body lumen. In some embodiments, the environmental parameter includes a temperature level, a pressure level, and / or a humidity level, or any other environmental parameter. Alternatively or additionally, the cryotherapy device 102 includes at least one sensor disposed at least partially within the outlet tract, for example, sensor 105, for sensing an environmental parameter, for example, an outlet flow rate, an outlet temperature, and / or an outlet humidity.

[0141] According to some exemplary embodiments, the sensor 111 and / or the sensor 105 are electrically connected to the control circuit 126. Alternatively or additionally, the control circuit 126 is electrically connected to one or more sensors located inside or outside the body. In some embodiments, the one or more sensors are located near the cryoablation target site or at a distance from the cryoablation target site. In some embodiments, at least one of the sensors transmits a measured environmental parameter value to the control circuit 126. In some embodiments, the control circuit stores the measured value in the memory 128. In some embodiments, the memory 128 includes a predetermined value of at least one environmental parameter, such as, for example, a maximum pressure value, a minimum temperature value, or any other predetermined environmental parameter value, or an indicator thereof. In some embodiments, the memory 128 includes at least one cryotherapy protocol, a value of at least one cryotherapy parameter, or an indicator thereof. In some embodiments, the memory includes a log file 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 operatively connected, e.g., electrically, optically, or wirelessly, to the control circuitry 126. In some embodiments, the user interface 130 includes an audio source and / or a display. In some embodiments, the control circuitry 126 sends a signal to the user interface 130 to generate at least one indication, e.g., a human detectable indication, for a user of the cryotherapy device or system. In some embodiments, the control circuitry 126 sends a signal to the user interface 130 to generate an alarm, e.g., when a measured environmental parameter value within the body lumen exceeds a predetermined value.

[0143] According to some exemplary embodiments, the control circuit 126 is operatively connected to at least one cold flow regulator, e.g., a valve, on the cold inlet line. In some embodiments, the control circuit 126 regulates the flow rate through the cold inlet line, e.g., by delivering a signal to the cold flow regulator valve, e.g., to decrease the flow rate in the inlet line, e.g., to stop the flow in the inlet line, and / or to increase the flow rate in the inlet line. In some embodiments, the control circuit 126 regulates the cold fluid flow rate in the cold inlet line, e.g., when the pressure in the body lumen is higher than a predetermined pressure value. Alternatively, the control circuit 126 regulates the cold fluid flow rate in the cold inlet line, e.g., 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 regulator valve on the cold inlet line. In some embodiments, the purge flow regulator valve is configured to control the flow rate of low pressure fluid through the cold inlet line, and optionally through the cold nozzle, into the body lumen, for example, when the flow of the cold fluid is stopped, reduced, or adjusted by the control circuit.

[0145] According to some exemplary embodiments, the control circuit 126 is connected to an outlet flow regulator, such as a valve, in some embodiments, the control circuit regulates the outlet flow regulator, such as by opening an outlet passage, when, for example, the pressure in the body lumen is above a predetermined value and / or the temperature is below a predetermined temperature value.

[0146] According to some exemplary embodiments, the control unit 104 includes a power source, such as power source 132. Alternatively, the control unit 104 is connected to an external power source, for example by electrical wiring, optically, or wirelessly. In some embodiments, the power source 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 channel of the cryotherapy device configured to allow fluid flow from a fluid flow source into the body lumen. Optionally, control unit 104 is connected to at least one inlet flow regulator valve on the inlet channel configured to regulate the flow of fluid through the inlet channel into the body lumen.

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

[0149] In some embodiments, the control unit 104 controls the inflow regulator and the outflow regulator to adjust the pressure level within the body lumen to reach a pressure level below a predetermined value. Alternatively or additionally, the control unit 104 controls the inflow regulator and the outflow regulator to adjust the temperature level within the body lumen to a temperature level above a predetermined temperature value.

[0150] According to some exemplary embodiments, the cleaning source 108 includes a fluid container, such as, for example, 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 cryogenic fluid, such as, for example, liquid nitrogen, liquid carbon dioxide, or any other cryogenic compound that can be stored as a liquid or gas at room temperature at high or low pressure. 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, the optical system 138, the cold source 134, and / or the evacuation pump 107 are part of the cryotherapy system 100. Alternatively, at least one of the irrigation source 108, the optical system 136, the cold source 134, and / or the evacuation pump 107 are external elements connectable to the system 100.

[0152] Exemplary cryotherapy Reference is now made to Figures 2A and 2B, which illustrate a cryotherapy system within a body lumen, according to certain exemplary embodiments of the present invention.

[0153] According to some exemplary embodiments, a cryotherapy device coupled to a control unit 202, e.g., a control console, is introduced through an opening in the body, e.g., 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 the body lumen 204, e.g., through an opening in the body lumen, e.g., an anatomical or surgical opening. In some embodiments, the cryotherapy device is introduced and navigated into the body lumen 204 within a working channel of an endoscope or within a rigid or flexible structure, e.g., a sleeve 208.

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

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

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

[0157] According to some exemplary embodiments, the cryotherapy device includes at least one drainage flow path, such as at least one drainage channel 228, configured to drain fluids, such as cryofluids and / or cleaning fluids, from the body cavity to, for example, a reservoir, optionally located outside the body. Alternatively or additionally, the drainage channel 228 drains the body fluids from the body cavity to a reservoir or releases the drained body fluids to an outside body room environment. 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, for example, drainage opening 230, is an opening on the exterior of the cryotherapy device configured to drain fluids from the body cavity. In some embodiments, the at least one drainage opening is a forward-facing opening, a side opening, or an opening facing at least one of the tissue 214, the target site, the treatment space, or a side treatment volume, where unwanted fluids and particles may accumulate.

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

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

[0160] Exemplary Formation of Droplets and / or Frost According to some exemplary embodiments, the release of cryofluoride in a body lumen, for example a body lumen that optionally contacts a body fluid, may cause condensation and the formation of condensed particles, for example the formation of droplets. Alternatively or additionally, the release of cryofluoride may cause the body fluid to freeze. In some embodiments, the formation of droplets and / or frost on one or more surfaces of the cryotherapy device may prevent the removal of fluid from the body lumen, visualization of the treatment space and / or target site, and / or block flow through one or more channels of the cryotherapy device. Reference is now made to FIG. 3, which illustrates the formation of droplets and / or frost at one or more locations of the cryotherapy device, according to some exemplary embodiments of the present invention.

[0161] According to some exemplary embodiments, at least one droplet, such as, for example, droplet 302, is formed on a surface and / or adheres to a surface of the visualization assembly 222, such as, for example, to the visualization distal end 224. In some embodiments, the 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 adherence of the at least one droplet 302 to the distal end 224 obstructs 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 attached to a surface of the cryotherapy device, such as a surface at the distal end 206 of the cryotherapy device. In some embodiments, the surface is optionally an interior surface of the cryotherapy device, such as a surface of one or more channels and / or lumens of the cryotherapy device. In some embodiments, the formation and / or attachment of the at least one droplet 304 optionally impedes visualization of the target tissue 214, for example, when the at least one droplet 304 is located within the FOV 226. Alternatively or additionally, the formation and / or attachment of the at least one droplet 304 to a surface of the cryotherapy device optionally impedes movement of the distal end 206 within the body lumen and / or flow of cryotherapy tissue in one or more lumens. For example, the formation or deposition 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 outlet channel 210, the at least one cleaning fluid outlet channel 216, and the at least one exhaust channel 228.

[0163] According to some exemplary embodiments, at least one droplet, such as droplet 306, is formed within an internal lumen of the cryotherapy device, such as 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 an internal surface of the internal lumen of the cryotherapy device, such as the internal 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 an internal surface of an internal lumen of at least one of the exhaust channel 228, the at least one cryofluid outlet 210, and the at least one irrigation fluid outlet channel 216. In some embodiments, the adhesion of at least one droplet 306 to an internal surface of the channel optionally blocks flow through the channel, such as, for example, optionally blocking the evacuation of fluid through the at least one exhaust channel 228.

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

[0165] According to some exemplary embodiments, the cleaning fluid is discharged through one or more openings, such as, for example, opening 218, to prevent the formation of at least one droplet and / or the attachment of at least one droplet to at least one surface of the cryotherapy device. Alternatively or additionally, the cleaning fluid is discharged through one or more openings, such as, for example, opening 218, to break up or dry at least one droplet, such as, for example, droplets attached to at least one surface of the cryotherapy device. In some embodiments, a control unit coupled to the cryotherapy device, such as, for example, control unit 202 shown in FIG. 2A or control unit 104 shown in FIG. 1B, signals at least one valve located on the cleaning fluid flow path to open. Alternatively or additionally, 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 additionally, the control unit sends a signal to the at least one valve and / or activates the at least one pump in response to a signal indicative of the formation and / or accumulation of at least one liquid droplet and / or frost on at least one surface of the cryotherapy device. Alternatively, the control unit sends a signal to the at least one valve and / or activates the at least one pump at a predetermined time period or in response to an input signal from a user.

[0166] Exemplary Droplet Formation Prevention and / or Droplet Removal According to some exemplary embodiments, the cleaning fluid is emitted to prevent the formation of droplets and / or frost within the body lumen. In some embodiments, the droplets form and / or accumulate in areas that are difficult to access with the emitted cleaning fluid. Furthermore, the amount of cleaning fluid that can be emitted within the body lumen is limited due to increased pressure and temperature. In some embodiments, as a result of flow rate and pressure limitations, unlimited amounts of cleaning fluid cannot be used. Optionally, potentially harmful droplets may build up and / or remain in locations 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] Reference is now made to Figures 4A and 4B, which illustrate a cryotherapy device having an irrigation fluid outlet channel with multiple small openings at one or more locations on the cryotherapy device, according to some exemplary embodiments of the present invention.

[0168] According to some exemplary embodiments, the cryotherapy device includes at least one irrigation effluent outlet channel 216 at a distal end 401 of the cryotherapy device having a plurality of openings 402 configured to release irrigation fluid 404 inside the body lumen. In some embodiments, the plurality of openings 402 are shaped and sized to direct the irrigation fluid toward the distal end 224 of the 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 plurality of openings 402 have a diameter or width in the range of 0.01 mm to 2 mm, e.g., 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 the plurality of openings 402 is in the range of 3 to 1000, e.g., 3 to 50, 20 to 100, 50 to 500, 300 to 1000, etc. Optionally, the plurality of openings 402 are arranged in an array in which the minimum distance between two adjacent openings is in the range of 0.2 to 5 mm, e.g., 0.2 to 2 mm, 1 to 3 mm, 2 to 5 mm, etc.

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

[0171] Alternatively or additionally, the cleaning fluid 414 discharged through the plurality of openings 413 disturbs, removes, and / or dries existing droplets, such as droplets 420, adhering to at least one surface of the cryotherapy device at the distal end 410 of the cryotherapy device. Alternatively or additionally, the cleaning fluid 414 discharged through the plurality of openings 413 disturbs, removes, or dries existing droplets, such as droplets 302, adhering to a lens or window at the distal end 224 of the visualization assembly. Alternatively or additionally, the cleaning fluid 414 discharged through the plurality of openings 413 dries an area, space, and / or volume partially surrounding at least a channel of the cryotherapy device, such as at least one cryofluid outflow channel, at least one cleaning fluid channel, and / or an exhaust channel, or at least one opening thereof.

[0172] 4C , the at least one cleaning fluid channel includes a plurality of openings, such as, for example, opening 430, that are oriented and / or directed towards the at least one exhaust channel 228. In some embodiments, the flow of cleaning fluid through opening 430 disrupts and / or dries one or more droplets in the at least one exhaust channel 228, for example, optionally to prevent blocking of the at least one exhaust channel 228 by frost.

[0173] According to some exemplary embodiments, as shown in, for example, FIG. 4D , at least one irrigation 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 irrigation fluid openings, such as opening 442, are located at axial and / or radial locations between the distal end 224 of the visualization assembly and the cryofluid opening 212, for example, to eject and / or direct irrigation fluid to form the flow protection space 412. Alternatively or additionally, at least some of the irrigation fluid openings, such as opening 442, are positioned axially and / or radially along the cryotherapy distal end 436, for example, to direct a flow of irrigation fluid toward and / or along a surface of the cryotherapy device distal end.

[0174] Alternatively or additionally, at least some of the irrigation fluid openings, such as opening 444, are located at least partially in axial and / or radial locations at visualization assembly distal end 224, for example to eject and / or direct irrigation fluid toward a lens or window located at distal end 224.

[0175] Alternatively or additionally, at least some of the irrigation fluid openings, such as opening 440, are located at axial and / or radial positions along the cryotherapy distal end 436 that point towards at least one exhaust channel.

[0176] According to some exemplary embodiments, the radial and / or axial location of the irrigation fluid openings, the size and / or shape of the openings, the number of openings in the array of openings, and / or the distance between adjacent openings in the array of openings are selected to, for example, enable optimization of the flow of irrigation fluid, such as, for example, the amount and / or pressure of irrigation fluid released into the body lumen. Alternatively or additionally, the radial and / or axial location of the irrigation fluid openings, the size and / or shape of the openings, the number of openings in the 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 disrupt and dry out droplets that have already formed.

[0177] According to some exemplary embodiments, the cleaning fluid openings, such as opening 442, configured to emit and / or direct cleaning fluid to create flow protection space 412 have a width or diameter in the range of 0.01 mm to 2 mm, such as, 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 value.

[0178] In some embodiments, the openings 442 are arranged in an array having between 3 and 500 openings, e.g., between 3 and 50 openings, between 3 and 200 openings, between 100 and 250 openings, between 250 and 500 openings, or any intermediate, smaller, or larger range of openings. In some embodiments, the multiple openings are arranged or aligned radially. 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, the cleaning fluid openings, such as opening 440, configured to eject and / or direct cleaning fluid toward at least one exhaust channel, 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 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 of openings. In some embodiments, the multiple openings are arranged or aligned radially. 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, the irrigation fluid openings, such as opening 444, configured to emit and / or direct irrigation fluid toward the 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 radially arranged 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 Wash Fluid Openings According to some exemplary embodiments, the irrigation fluid openings, such as the irrigation fluid openings at the distal end of the cryotherapy device, are shaped and sized to allow for obstruction and / or removal of droplets from a particular area of ​​the cryotherapy device, axially disposed along a longitudinal axis of the cryotherapy device or at least one irrigation fluid channel, and / or have a circumferential distribution. In some embodiments, the particular area includes at least one of at least a portion of the visualization assembly, at least one drain 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 distributed evenly along the circumference of the at least one cleaning fluid channel. Additionally or optionally, the cleaning fluid openings are distributed along the entire circumference of the at least one cleaning fluid channel. Alternatively, the cleaning fluid openings are distributed along a portion of the circumference, such as an arc of less than 360 degrees of the circumference, such as less than 270 degrees, less than 180 degrees, less than 90 degrees, or any intermediate, smaller, or larger value.

[0183] Reference is now made to Figures 5A and 5B, which illustrate an arrangement of washing fluid openings evenly distributed around at least one washing fluid channel, according to some exemplary embodiments of the invention.

[0184] According to some exemplary embodiments, the plurality of openings is axially distributed around the washing fluid channel 502 along the longitudinal axis 500 of the washing fluid channel 502. In some embodiments, the plurality of openings is optionally axially distributed along a region having a length 504. Furthermore, the plurality of openings is circumferentially distributed around the circumference of the washing fluid channel 502. In some embodiments, two adjacent washing fluid openings have equal circumferential distances, such as openings 510 and 512 having similar axial positions as shown in FIG. 5B. In some embodiments, the washing fluid openings completely surround the washing fluid channel.

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

[0186] Reference is now made to Figures 5C-5E, which illustrate cleaning fluid openings having different sizes and circumferential distributions, according to some exemplary embodiments of the invention.

[0187] According to some exemplary embodiments, the washing fluid openings are distributed axially along the circumference of the washing fluid channel 520. In some embodiments, at least some of the washing fluid openings, such as openings 522 axially located in region 522, are optionally distributed circumferentially around only a portion of the circumference of the washing channel 520, as shown, for example, in FIG. 5D. In some embodiments, a different group of washing fluid openings, such as openings 528 located in region 524, are axially spaced apart from openings 526 in region 522. In some embodiments, openings 528, as shown, for example, in FIG. 5E, are distributed circumferentially along the entire circumference, optionally surrounding the washing channel 520.

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

[0189] Example Conflicts According to some exemplary embodiments, the cryotherapy device includes a plurality of openings at a distal end of the cryotherapy device, the plurality of openings at least partially facing the distal end of the visualization assembly. In some embodiments, the plurality of openings at least partially facing a lens or window located at the distal end of the visualization assembly. In some embodiments, the plurality of openings is located around at least one cleaning fluid channel. Alternatively or additionally, the plurality of openings is located around a cryofluid outlet. In some embodiments, the plurality of openings is configured for at least one gas jet impingement, flashing, and / or cleaning the visualization assembly from droplets and / or other particles.

[0190] Reference is now made to Figures 6A and 6B, which show openings for gas jet impingement shaped, sized, and / or distributed to cover the entire area of ​​a visualization assembly surface, such as a lens, illumination end unit, or window, in accordance with some exemplary embodiments of the present invention.

[0191] According to some exemplary embodiments, the cryotherapy device includes a plurality of openings, e.g., at a distal end of the cryotherapy device, configured to spray a jet of fluid, e.g., gas, onto a 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, the plurality of openings, e.g., openings 606, 608, 610, and 612, are distributed around a channel 614. In some embodiments, the channel 614 includes an irrigation fluid channel. In some embodiments, the plurality of openings are distributed circumferentially along an angle 616 that is less than 180 degrees, e.g., less than 120 degrees, less than 100 degrees, less than 90 degrees, or any intermediate, lesser, or greater value. Instead, the openings are distributed circumferentially on a 360 degree circle surrounding the channel 614. Instead, the openings are circumferentially distributed along an arc that subtends an angle of 180 degrees or greater, such as 200 degrees or greater, 250 degrees or greater, 300 degrees or greater, or any intermediate, smaller, or greater 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 plurality of openings have optionally different sizes and / or shapes. Alternatively or additionally, the plurality of openings are distributed around the periphery of the channel 614 as an array. In some embodiments, the density of the openings in the array, e.g., the number of openings per area, is equal along the entire area of ​​the array. Alternatively, the density of the openings varies, e.g., between different regions of the array, or randomly. In some embodiments, the different sizes and / or shapes of the openings allow, e.g., different spray cones of liquid and / or gas from each opening type.

[0193] According to some exemplary embodiments, the circumferential arc length, 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 ​​surface 602, such as to cover the entire area of ​​surface 602.

[0194] Instead, as shown in, for example, Figures 6C and 6D, the openings, for example openings 630 and 632, are distributed around the channel 614 along an arc that forms an angle 634 that is less than angle 616. In some embodiments, the fluid, such as gas, emitted from the openings 630 and 632 covers less than 90%, such as less than 70%, less than 60%, less than 50%, or any intermediate, lesser, or greater percentage value of the surface 602. In some embodiments, the fluid, such as gas, emitted from the openings 630 and 632 toward the surface 602 forms a removal zone 634 having an area that is less than the area of ​​the surface 602. In some embodiments, this allows optimization of the jet strength and / or gas volume while clearing a major portion, such as up to 80%, up to 70%, up to 50% of the FOV between the surface 602 and the tissue being treated with the cryofluid.

[0195] Exemplary Seals According to some exemplary embodiments, the flow of the evacuation fluid is directed using one or more seals that are shaped, sized, and / or disposed at the distal end of the cryotherapy device to direct the fluid to the opening of at least one evacuation channel. Reference is now made to Figures 6E and 6F, which show 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 cryotherapy device distal end 650 includes an outer sleeve 652 defining an inner channel 653 having a distal end, e.g., a rigid or flexible distal end, that can be introduced into a body lumen, e.g., a hollow organ. In some embodiments, the cryotherapy device includes a visualization assembly 222 in a channel 653 having a distal end 224 at the cryotherapy device distal end 650. Additionally, the cryotherapy device includes at least one cryofluid outflow channel 210 traveling within said channel 653, and optionally has one or more openings 212 at the cryofluid distal end 650 that face the target tissue 214. Optionally, the one or more openings 212 are located distal to the visualization distal end 224 to allow spraying of the cryofluid from the optics toward the target tissue, e.g., at a distance sufficient to prevent the formation of droplets on the visualization surface at the visualization distal end 224.

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

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

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

[0200] According to some exemplary embodiments, the seal 654 allows for directing the flow of fluid 656 and particles, for example, to surround the visualization assembly distal end 224, and into the exhaust channel through one or more openings around the sleeve 652, proximal to the sleeve 652, and into the exhaust channel 228. A potential advantage of exhausting fluid and particles through one or more openings proximal to the visualization assembly distal end may be to avoid mist and cold air from the visualization assembly, for example, from the optics. In some embodiments, the seal 654 includes at least one opening 654, for example opening 660, configured to allow passage and exhaust of at least 5% of fluid and particles through the seal 654, for example, at least 10%, at least 30%, at least 50%, at least 70%, or any intermediate, lesser, or greater percentage into the exhaust channel 228, as compared to an unblocked open exhaust channel. In some embodiments, the seal 654 blocks the passage of at least 30% of fluids and particles into the exhaust 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 greater percentage.

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

[0202] Exemplary Internal Reducer According to some exemplary embodiments, the cryotherapy device includes at least one internal reducer in the irrigation fluid flow path. In some embodiments, the at least one internal reducer controls the amount and / or pressure of irrigation fluid directed to the irrigation fluid openings. In some embodiments, controlling the amount and / or pressure of irrigation fluid directed to the irrigation openings allows for control of, for example, the shape and / or size of a spray cone or removal zone formed by the irrigation fluid emitted from the irrigation openings.

[0203] Reference is now made to FIG. 7A, which illustrates a distal end of a cryotherapy device, e.g., distal end 702, where a cleaning fluid directed to an area affected by the cryofluid, e.g., low temperature cleaning, and a cleaning fluid directed to a visualization assembly are delivered through the same flow path, e.g., the same channel. In some embodiments, high pressure cryofluid is introduced into a cryofluid outlet, e.g., a cryofluid channel, while low pressure cleaning fluid is introduced into at least one cleaning fluid channel. In some embodiments, e.g., as shown in FIG. 7A, 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 cryofluid and cleaning fluid, e.g., in at least two coaxial channels. In some embodiments, the cleaning fluid channel is coaxial, e.g., surrounding the cryofluid channel along at least 50%, e.g., at least 70%, at least 90%, of the length of the cryofluid channel. Potential advantages of having a coaxial arrangement of the irrigation fluid channel and the cryofluid channel may be to reduce the space and / or volume of the device, increase strength (e.g., for sensitive tubes such as the cryo-nozzle), allow the cryo-channel to be maintained at a target temperature by isolating it from the body using the irrigation fluid channel, and allow radial flow around the cryo-nozzle, for example to prevent mist and / or sweep mist away from the optics.

[0204] According to some exemplary embodiments, as shown in, for example, FIGS. 7A and 7B, at least one irrigation 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 irrigation fluid toward an irrigation fluid opening, such as, for example, opening 712, that faces at least partially toward a visualization assembly, such as, for example, an optical assembly. In some embodiments, the internal reducer 710 diverts at least a portion of the irrigation fluid toward the optics irrigation opening 712, while the remainder of the irrigation fluid flow flows toward at least one cold irrigation opening 719. In some embodiments, the irrigation fluid 217 discharged from the cold irrigation 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. Additionally, the optics irrigation fluid, such as irrigation fluid 217, is delivered to at least one of clear the lens, obstruct liquid particles on the lens, and form a flow protection space 412.

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

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

[0207] According to some exemplary embodiments, the openings, e.g., apertures, are angled openings configured to emit cleaning fluid at a particular deflection angle 744 or to reach a particular impact angle 748. In some embodiments, having an internal reducer 752 and multiple openings 754, optionally arranged in an array, allows for efficient control over the amount of cleaning fluid directed at the visualization assembly, e.g., efficient control over optics cleaning. In some embodiments, as shown, e.g., in FIG. 7D, an internal reducer 752 that separates the optics cleaning from the cold cleaning 217 is combined with an adjustable directional jet, e.g., apertures 754, that is shaped, sized, and / or oriented to reach a particular deflection angle 744 and / or a particular impact angle 748.

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

[0209] In some embodiments, by disposing at least one flow reducer in the irrigation fluid channel, at least a portion of the channel is narrowed and the flow rate within the constriction is accelerated. In some embodiments, the increased flow rate creates a Venturi effect within the constriction, optionally reducing the positive pressure or creating a negative pressure within the constriction. In some embodiments, the reduced pressure creates a suction force through the irrigation fluid opening in the constriction area, optionally leading to the suction of one or more droplets that accumulate on a surface outside the irrigation fluid channel, such as, for example, on at least one surface of the device within the hollow organ and / or on at least one surface of the visualization assembly.

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

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

[0212] According to some exemplary embodiments, an internal flow reducer, such as flow reducer 810, narrows the internal lumen of the irrigation fluid channel, optionally leading to an accelerated flow rate in the irrigation fluid channel. In some embodiments, the accelerated flow rate reduces the pressure in opening 806, optionally leading to aspiration of fluid and particles through opening 806 into irrigation fluid channel 755.

[0213] According to some exemplary embodiments, as shown, for example, in FIG. 8A , the irrigation channel includes at least one additional flow reducer 810 located distal to the flow reducer 804 and / or the opening 806. In some embodiments, the at least one flow reducer 810 is configured to adjust the flow pressure and / or flow rate of the irrigation fluid exiting through a distal opening 812 of the irrigation fluid channel 755. Optionally, the distal opening 812 is a forward-facing opening, e.g., toward the treatment target. Optionally, the distal opening 812 is adjacent to the distal opening 720 of the cryofluid channel 210. Optionally, the irrigation fluid channel distal opening 812 at least partially surrounds the cryofluid channel distal opening 720.

[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 proximate the opening and / or the pressure level generated within the cleaning fluid channel 755 proximate the opening 806. In some embodiments, for example as shown in FIG. 8B, placing the flow reducer 810 closer to the cleaning fluid opening 806, for example up to 5 cm, up to 3 cm, up to 1 cm, or any intermediate, lesser or greater distance from the opening 806, increases the pressure in the cleaning fluid channel 755 proximal to the flow reducer 810, for example 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 irrigation fluid channel, such as, for example, 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 irrigation fluid exiting the distal opening 812. Optionally, the reducer 810 controls the flow, such as the pressure and / or direction, of the irrigation 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, for example, 2, 3, 4, or more openings, shaped and sized to control the pressure and / or direction of the irrigation fluid exiting the distal opening 812. In some embodiments, the reducer 810 reduces the interior lumen of the washing 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 greater percentage.

[0216] Exemplary Apparatus Having a Discharge Seal and a Reducer Reference is now made to Figures 8D and 8G, which illustrate a cryotherapy apparatus having at least one irrigation fluid flow reducer and at least one fluid flow exhaust 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 cryotherapy device distal end 640 is configured to be introduceable into a body lumen, for example, a hollow organ. In some embodiments, the cryotherapy device includes at least one irrigation fluid channel 216 and at least one cryofluid channel 210. Optionally, the irrigation fluid channel 216 and the cryofluid channel 210 are coaxial. Optionally or additionally, the irrigation fluid channel 216 at least partially surrounds the cryofluid channel 210.

[0218] According to some exemplary embodiments, the washing fluid channel 216 includes at least one opening, such as, for example, a plurality of openings 821 and 823 through a wall of the washing fluid channel 216. In some embodiments, the openings 821 and 823 are disposed within the washing fluid channel at a location that faces 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 additionally, the openings are located in the washing fluid channel wall and face a space 825 distal to the visualization assembly distal end 224. In some embodiments, the openings are configured to direct washing fluid toward the visualization assembly distal end, for example, to prevent the formation of droplets on at least one surface of the visualization assembly and / or to dry and / or disrupt one or more existing droplets.

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

[0220] According to some exemplary embodiments, at least some of the flow reducer openings are configured to direct irrigation fluid proximal to the cryofluid distal opening 720, and optionally to a space between the distal opening 720 and the visualization assembly distal end 224. Alternatively or in addition, at least some of the flow reducer openings are configured to direct irrigation fluid to a space at least partially surrounding the irrigation fluid channel, e.g., to prevent adhesion and / or formation of at least one droplet on an exterior surface of the irrigation fluid channel. Alternatively or in addition, at least some of the flow reducer openings are configured to apply suction into the irrigation fluid channel 216, e.g., to fluids and / or particles within the 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 shapes the distal opening 812 of the cleaning fluid channel. In some embodiments, the flow reducer shapes the opening 812 in a ring shape that surrounds the cryofluid channel 210, as shown, for example, in FIG. 8E. In some embodiments, the ring-shaped opening 812 has equal widths. Alternatively, the ring-shaped opening 812 has variable widths.

[0222] According to some exemplary embodiments, the cryotherapy device includes at least one exhaust flow path, e.g., exhaust channel 228, configured to remove fluid and / or particles from the body lumen through at least one exhaust opening, e.g., exhaust opening 230 of the outer sleeve 652 of the cryotherapy device. In some embodiments, as illustrated, e.g., in FIG. 6E and FIG. 6F, the cryotherapy device includes at least one exhaust seal 654 at the distal end 650 configured to block at least 30%, e.g., at least 50%, at least 70%, at least 90%, or any intermediate, lesser, or greater percentage value, of the exhaust fluid flow rate through the distal front opening of the exhaust channel 228. In some embodiments, the exhaust seal 654 is disposed distal to the exhaust opening 230. Optionally, the exhaust seal 654 is disposed between the distal end 224 of the visualization assembly 222, which optionally includes an aperture and / or lens, and the exhaust opening 230. Optionally, the seal 654 completely blocks exhaust through the distal front opening of the exhaust channel 228.

[0223] According to some exemplary embodiments, as shown, for example, in FIG. 8F and FIG. 8G, the irrigation fluid channel of the cryotherapy device distal end 680 includes at least one flow reducer 860 at the distal end of the irrigation 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 irrigation fluid forwardly exits the irrigation fluid channel. In some embodiments, the openings 870 and 872 are spaced apart. Instead, 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 FIG. 8G.

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

[0225] According to some exemplary embodiments, the flow reducer 860 is configured to separate the at least one cryofluid outlet channel 210 and the at least one cleaning fluid outlet channel 216 and maintain a fixed distance between the walls of the at least one cryofluid outlet channel 210 and the at least one cleaning fluid outlet channel 216. In some embodiments, maintaining a fixed distance allows, for example, heat transfer between the cryofluid outlet channel 210 and the cleaning fluid outlet channel 216. Additionally or alternatively, the flow reducer 860 is configured to fix the opening 862 of the cleaning outlet 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 0-2 mm, for example, 0-0.2 mm, 0.1-0.5 mm, 0.4-1 mm, 0.5-2 mm, or any intermediate, smaller, or larger value.

[0226] According to some exemplary embodiments, the washing fluid channel 216 includes an opening in a channel wall facing the visualization assembly distal end 224, such as, for example, openings 821 and 823. Additionally, the washing fluid channel includes one or more additional openings in the channel wall, such as, for example, opening 868, configured to direct washing fluid into a space between the cryofluid channel distal opening 720 and the visualization assembly distal end 224. In some embodiments, the washing opening 821 is shaped and sized and / or positioned to direct washing fluid into a surface of the visualization assembly, such as, for example, an illumination and / or lens optionally located at the distal end 224. In some embodiments, the washing fluid directed through openings 821 and 823 displaces particles and / or droplets from the visualization assembly surface. In some embodiments, openings 867 and 868 are shaped and sized and / or positioned to direct washing fluid into space 725 where mist and / or gas accumulates.

[0227] Exemplary Pretreated Surfaces According to some exemplary embodiments, to prevent the attachment and / or formation of at least one droplet on at least one surface of the cryotherapy device, the surface is pretreated, for example coated to obtain a rough texture. Alternatively or additionally, the surface is pretreated to reduce the size and / or shape of the droplets, optionally by directing the liquid to form a thin layer instead of droplets. Reference is now made to FIG. 9, which shows a cryotherapy device 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 cryotherapy device distal end 802 includes at least one surface exposed to the environment of the body lumen to be treated, such as surface 906. According to some embodiments, the exposed surface 906 is an exterior surface of at least one irrigation fluid channel 904. In some embodiments, at least a region of the exposed surface 906 is pre-treated, e.g., pre-coated, or manufactured to obtain a roughened surface 906. In some embodiments, the exposed roughened surface is optionally located between the visualization assembly distal end 224 and the opening 910 of the cryofluid outflow channel 912. Additionally or alternatively, the exposed roughened surface is located within the FOV 226. In some embodiments, the generated roughened surface 906 optionally reduces light reflection within the FOV 226 as compared to a smooth surface.

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

[0230] Exemplary Visualization Assembly Having a Angled Distal End Reference is now made to Figures 10A-10C, which illustrate a visualization assembly having a planar, angled, or curved surface at its distal end, according to some exemplary embodiments of the present invention.

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

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

[0233] The terms "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including, but not limited to."

[0234] The term "consisting of" means "including, comprising, or limited to."

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

[0236] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0237] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as "1 to 6" should be considered to have specifically disclosed subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", and individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0238] When a range of values ​​is given herein (e.g., any pair of values ​​joined by "10-15," "10 to 15," or another such range designation), it is meant to include any number (fractional or integer) within the limits of the stated range, inclusive of the limits of the range, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first recited value and a second recited value, and the phrases "range / ranging / ranges from" a first recited value "to," "up to," "until," or "through" a second recited value, are used interchangeably herein and are meant to include the first recited value and the second recited value, and all fractional and integer numbers therebetween.

[0239] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within reasonable measurement precision and rounding errors that one of ordinary skill in the art would understand.

[0240] The term "method" as used herein refers to methods, means, techniques and procedures for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to the practitioner of the chemical, pharmacological, biological, biochemical and medical arts or readily developed from known methods, means, techniques and procedures.

[0241] As used herein, the term "treating" includes preventing, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

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

[0243] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0244] It is the intention of the applicants (applicants) that all publications, patents, and patent applications mentioned herein are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated herein by reference in their entirety.

Claims

1. 1. A cryotherapy system comprising: an elongated cryotherapy device having an elongated body, a proximal end, and a distal end, the device shaped and sized to be placed inside a hollow organ; a cold inlet passage within the elongate body, the cold inlet passage configured to allow cold flow from a cold fluid source to the hollow organ; an irrigation inlet channel within the elongate body, the irrigation inlet channel comprising at least one lateral irrigation opening in a wall of the irrigation inlet channel, the irrigation inlet channel being configured to fluidly connect a irrigation fluid source to the at least one lateral irrigation opening and to discharge irrigation fluid within the hollow organ; the elongated cryotherapy device comprising: at least one flow reducer disposed within the irrigation inlet passage distal to the at least one lateral irrigation opening, the at least one flow reducer shaped and sized to sufficiently block an internal lumen of the irrigation inlet passage to increase irrigation fluid through the at least one lateral irrigation opening.

2. The system of claim 1 , wherein the at least one flow reducer blocks at least 10% of an interior lumen of the irrigation inlet line.

3. The system of claim 1 , wherein the at least one flow reducer contacts an inner surface of the wash inlet and / or an outer surface of the cold inlet.

4. The system of claim 1 , wherein at least a portion of the at least one flow reducer is shaped as a ring or an arc that contacts an inner surface of the wash inlet and / or an outer surface of the cold inlet.

5. The system of claim 1 , wherein the at least one lateral irrigation opening has a maximum width or diameter in the range of 0.01 mm to 2 mm.

6. The system described in claim 1, wherein the low temperature inlet and the cleaning inlet are coaxial along at least 30% of the length of the cleaning inlet.

7. The system described in claim 1, wherein the cleaning inlet at least partially surrounds the low temperature inlet along at least 30% of the length of the low temperature inlet.

8. The system described in claim 1, wherein at least one flow reducer has an integrated channel and / or opening.

9. The system described in claim 8, wherein the integrated channels and / or openings of the at least one flow reducer are shaped and sized to release cleaning fluid into a treatment space within the hollow organ distal to the elongated cryotherapy device.

10. The system of claim 9, wherein the cold inlet passage has at least one distal front opening configured to release cryofluid into the treatment space and / or toward a treatment target within the hollow organ, and the integrated channels and / or openings of the at least one flow reducer at least partially surround a distal opening of the cold inlet passage.

11. 2. The system of claim 1, wherein the irrigation inlet comprises at least one distal front irrigation opening at a distal end of the irrigation inlet configured to release irrigation fluid into a treatment space within the hollow organ distal to the elongated cryotherapy device.

12. The system of claim 11 , wherein the at least one distal front flush opening is an opening in the at least one flow reducer.

13. 13. The system of claim 12, wherein the cryo inflow conduit comprises at least one distal front opening configured to release cryofluid into the treatment space and / or toward a treatment target within the hollow organ, and the at least one distal front irrigation opening at least partially surrounds a distal opening of the cryo inflow conduit.

14. The system of claim 1, comprising an optical assembly, wherein the at least one lateral cleaning opening is positioned in a wall of the cleaning inlet passage to direct cleaning fluid toward the optical assembly at the distal end and / or toward a field of view (FOV) distal to the optical assembly.

15. 15. The system of claim 14, wherein the at least one lateral irrigation opening comprises a plurality of openings distributed axially and / or obliquely in a portion of a wall of the irrigation inlet facing the optical assembly and / or the FOV.

16. The system of claim 14 , wherein the at least one lateral flushing opening comprises a plurality of lateral flushing openings distributed axially and / or obliquely in a portion of a wall of the flushing inlet channel.

17. The system described in claim 16, wherein the at least one horizontal cleaning opening is oriented to spray cleaning fluid at a predetermined angle relative to an outer surface of the cleaning fluid channel.

18. The system described in claim 16, wherein the plurality of lateral openings at least partially surround an internal lumen of the cleaning inlet passage.

19. The system of claim 16 , wherein at least some of the plurality of lateral openings have different shapes and / or sizes.

20. The system of claim 16 , wherein the plurality of lateral openings are evenly distributed in the wall portion.

21. The system of claim 16 , wherein the plurality of lateral openings are distributed with a varying density of openings per area of ​​the wall portion.

22. The system described in claim 16, wherein the plurality of horizontal openings are divided into two or more groups of openings according to the shape and / or width of the openings, the openings in each of the two or more groups having similar shapes and / or widths.

23. The system described in claim 16, wherein the plurality of lateral openings are located in a portion of the wall of the cleaning inlet conduit surrounding at least 10% of a circumference of the cleaning inlet conduit and / or maintaining an axial distance of at least 0.05 mm between two adjacent openings of the plurality of lateral openings.

24. the cryotherapy device comprises at least one fluid discharge channel within the elongate body having at least one first discharge opening at a distal end of the at least one fluid discharge channel and at least one second discharge opening around a wall of the at least one fluid discharge channel, the second discharge opening being located proximal to the first discharge opening; The system of claim 1 , wherein the at least one fluid exhaust flow path is configured to remove fluid and / or particles from the hollow organ through the at least one first exhaust opening and / or through the at least one second exhaust opening.

25. 25. The system of claim 24, wherein the cryotherapy device comprises at least one exhaust seal located in the at least one fluid exhaust flow path between the at least one first exhaust opening and the at least one second exhaust opening and configured to block at least 10% of the exhaust fluid flow rate through the at least one first exhaust opening.

26. The device of claim 20, further comprising an optical assembly having a distal end within the elongated body configured to visualize a field of view between a distal end of the device and a target site within the hollow organ; 26. The system of claim 25, wherein a distal end of the optical assembly is disposed distal to the second exhaust opening, and the at least one exhaust seal is disposed between the distal end of the optical assembly and the at least one second exhaust opening.

27. 25. The system of claim 24, comprising an outer sleeve surrounding the device, the at least one second exhaust opening being an opening in the outer sleeve or in fluid communication with at least one opening in the outer sleeve.

28. 15. The system of claim 14, wherein a surface of the optical assembly at a distal end of the optical assembly is curved or angled relative to a longitudinal axis of a cryotherapy device, and the at least one lateral irrigation opening is positioned and shaped and sized to emit irrigation fluid toward the surface of the optical assembly.

29. 30. The system of claim 28, wherein a surface of the optical assembly at a distal end of the optical assembly is substantially perpendicular to the longitudinal axis or disposed at an angle between 5 degrees and 90 degrees to the longitudinal axis.

30. 10. The system of claim 1, wherein at least one surface of the cryotherapy device at the distal end is pre-treated to prevent or reduce adhesion and / or formation of one or more liquid droplets on the pre-treated surface.

31. 31. The system of claim 30, wherein the at least one pretreated surface is an exterior surface of the cleaning inlet.

32. 32. The system of claim 30 or 31, wherein the at least one surface is coated with a hydrophilic or hydrophobic coating.

Images