Flexible cryotherapy device

Abstract

1. A cryotherapy system comprising: an endoscope including an elongated insertion tube having a distal tip shaped and sized to penetrate into a hollow organ; a working channel within the elongated insertion tube including a proximal opening and a distal opening at the distal tip; and a cryocatheter including at least one cryogenic fluid channel having at least one distal opening positioned for releasing cryogenic fluid into the hollow organ and at least one irrigation fluid channel having at least one irrigation fluid distal opening, wherein the cryocatheter is shaped and sized to controllably move within the working channel and extend at least partially from the distal opening of the working channel to position the at least one irrigation fluid distal opening at a selected distance and / or orientation relative to the distal tip of the elongated insertion tube.

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 / 232,221, filed August 12, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to a cryotherapy device, and more particularly, but not exclusively, to a flexible cryotherapy device. Summary of the Invention

[0003] Some examples of some embodiments of the present invention are described below.

[0004] Example 1. A cryotherapy device comprising: An endoscope comprising: an elongated insertion tube having a distal tip shaped and sized to penetrate into a hollow organ; a working channel in the elongate insertion tube having a proximal opening and a distal opening at the distal tip; The endoscope comprising: A cryocatheter, comprising: at least one cryogenic fluid channel having at least one distal opening arranged for discharging cryogenic fluid into the hollow organ; at least one irrigation fluid channel having at least one irrigation fluid distal opening of the at least one irrigation fluid channel; the cryocatheter comprising: Equipped with the cryo-catheter is shaped and sized to controllably move within the working channel and extend at least partially from a distal opening of the working channel to position the at least one irrigation fluid distal opening at a selected distance and / or orientation relative to the elongate insertion tube distal tip; The cryotherapy device.

[0005] Example 2. The device described in Example 1, wherein the endoscope comprises at least one optical element at the distal tip, and the cryocatheter moves within the working channel to position the at least one irrigation fluid distal opening at a selected distance and / or orientation relative to the optical element.

[0006] Example 3. The device described in Example 1, wherein the endoscope comprises at least one optical element at the distal tip defining a field of view (FOV) distal to the at least one optical element, and the cryocatheter is controllably moved within the working channel to position the at least one irrigation fluid distal opening at a selected distance and / or orientation relative to the FOV.

[0007] Example 4. A device according to any one of the preceding examples, wherein the at least one irrigation fluid channel comprises an outer wall, and the at least one irrigation fluid distal opening comprises a plurality of irrigation fluid distal openings distributed axially and / or circumferentially within the outer wall.

[0008] Example 5. The device of Example 4, wherein the cryocatheter controllably extends from the working channel according to an axial and / or circumferential distribution of the plurality of distal irrigation fluid openings within the outer wall.

[0009] Example 6. A device described in any one of Examples 4 or 5, wherein the multiple distal irrigation fluid openings are distributed in the outer wall within an area surrounding the at least one irrigation fluid channel.

[0010] Example 7. A device described in any one of Examples 4 or 5, wherein the multiple distal irrigation fluid openings are distributed in the outer wall within an area shaped as an arc that partially surrounds the at least one irrigation fluid channel.

[0011] Example 8. The apparatus of any one of the preceding examples, wherein the endoscope and / or the cryocatheter comprises at least one lock configured to lock the cryocatheter in a particular position and / or orientation relative to the distal tip of the elongated insertion tube.

[0012] Example 9. The apparatus of example 8, wherein the lock comprises an interference lock.

[0013] Example 10. An apparatus described in any one of the preceding examples, wherein the endoscope and / or the cryocatheter comprises at least one stopper configured to limit a maximum axial extension distance of the cryocatheter from a distal opening of the working channel.

[0014] Example 11. An apparatus according to any one of the preceding examples, wherein the cryocatheter and / or the endoscope are provided with one or more visual markings indicating the position and / or orientation of the cryocatheter within the working channel.

[0015] Example 12. A device according to any one of the preceding examples, wherein the at least one cryogenic fluid channel is coaxially disposed within the at least one cleaning fluid channel.

[0016] Example 13. A device described in any one of the above examples, wherein the cryocatheter has a distal tip, a distal opening of the at least one cryogenic fluid channel is located at the distal tip, and the at least one flushing fluid channel has at least one additional flushing fluid opening at the distal tip.

[0017] Example 14. The device of Example 13, wherein the irrigation fluid opening in the distal tip at least partially surrounds the distal opening of the at least one cryogenic fluid channel.

[0018] Example 15. A device according to any one of the preceding examples, wherein the maximum inner diameter of the working channel is 4 mm.

[0019] Example 16. A hollow split connector comprising at least three openings, an end of the hollow split connector operatively coupled to a proximal opening of the working channel, the end configured to form a flow path between the working channel and a first opening of the at least three openings, the second opening of the at least three openings having a seal configured to permit insertion of the cryo-catheter through the split connector into the working channel while preventing the release of fluid from the split connector through the connector. 4. The apparatus of any one of the preceding embodiments, comprising:

[0020] Example 17. The device described in Example 16, wherein the end of the split connector configured to be operably coupled to the proximal opening is tapered.

[0021] Example 18. The device described in Example 17, wherein the working channel comprises a one-way valve within the proximal opening of the working channel, and the tapered end of the split connector is shaped and sized to penetrate and open the one-way valve.

[0022] Example 19. The device of any one of Examples 16-18, wherein the split connector is a Y-split connector.

[0023] Example 20. The device of any one of Examples 16-19, wherein the seal comprises a leaf seal.

[0024] Example 21. A device described in any one of Examples 16 to 20, comprising at least one sensing channel between the cryocatheter and a wall of the working channel having at least one distal opening at the distal tip, and a third opening of the at least three openings of the split connector being a proximal opening of the at least one sensing channel.

[0025] Example 22. The device of Example 21, wherein the at least one sensing channel comprises a temperature sensing channel or a pressure sensing channel.

[0026] Example 23. A device described in any one of the above examples, comprising an overtube having a tubular body having a distal end shaped and sized to penetrate a hollow organ, the overtube surrounding the endoscope and defining at least one drainage flow passage between the endoscope and an inner surface of the tubular body disposed on the endoscope for draining fluid from the hollow organ, the at least one drainage flow passage comprising at least one distal inlet opening at the distal end of the tubular body and at least one proximal outlet opening.

[0027] Example 24. The device described in Example 23, wherein the overtube is selectively slidable over the endoscope.

[0028] Example 25. An apparatus described in any one of Examples 23 or 24, wherein the endoscope is coaxially disposed within the tubular body of the overtube.

[0029] Example 26. A device described in any one of Examples 23 to 25, wherein the distal end of the overtube is tapered and the at least one distal inlet opening is located on a surface of the tapered distal end.

[0030] Example 27. A device described in any one of Examples 23 to 25, wherein the distal end of the overtube is tapered and the at least one distal inlet opening is located on a surface of a non-tapered region of the overtube proximal to the tapered distal end.

[0031] Example 28. A device comprising an exhaust flow control valve coupled to the tubular body of the overtube between the at least one distal inlet opening and the at least one proximal opening of the tubular body of the overtube, the exhaust flow control valve being: at least one exit opening configured to evacuate fluid from the overtube; Equipped with The device of any one of Examples 23 to 27, wherein the overtube is provided with a seal between the exhaust flow control valve and the at least one proximal opening of the tubular body of the overtube, and the seal is shaped and sized to seal a gap between the overtube and the endoscope in the at least one exhaust flow path to prevent passage of fluid out of the at least one proximal opening of the tubular body of the overtube.

[0032] Example 29. The device of Example 28, wherein the discharge flow rate regulating valve comprises at least one additional outlet opening and a movable flow path selector configured to direct fluid flow from the at least one distal inlet opening of the discharge flow path toward the at least one outlet opening and / or toward the at least one additional outlet opening of the discharge flow rate regulating valve.

[0033] Example 30. The device described in Example 29, wherein at least one of the at least one outlet opening of the exhaust flow regulating valve, or the at least one additional outlet opening, comprises a check valve configured to allow passive exhaust of fluid from the exhaust flow path.

[0034] Example 31. An apparatus as described in any one of Examples 29 or 30, wherein at least one of the at least one first outlet opening or the at least one additional outlet opening of the exhaust flow control valve comprises a connector configured to operably connect a vacuum pump to the exhaust flow control valve.

[0035] Example 32. A device described in any one of Examples 23 to 31, comprising at least one sensing channel having a distal end, the at least one sensing channel moving along the elongated insertion tube between the overtube and the endoscope, the distal end of the at least one sensing channel being coupled to a distal tip of the insertion tube located distal to the overtube.

[0036] Example 33. The device described in Example 32, comprising a distal tip holder coupled to the distal tip of the elongated insertion tube, the distal tip holder configured to interconnect a distal end of the at least one sensing channel to the distal tip of the elongated insertion tube.

[0037] Example 34. The device described in Example 33, wherein the distal tip holder has at least one opening or at least one socket shaped and sized to receive the distal end of the sensing tube.

[0038] Example 35. A device described in any one of Examples 33 or 34, wherein the distal tip holder at least partially surrounds the distal tip of the elongated insertion tube.

[0039] Example 36. A device described in any one of Examples 32 to 35, wherein the at least one sensing channel comprises a temperature sensing channel or a pressure sensing channel.

[0040] Example 37. A device described in any one of Examples 32 to 36, wherein the maximum diameter of the working channel is in the range between 1 and 2 mm.

[0041] Example 38. A device described in any one of the above examples, wherein the cryocatheter comprises a distal section configured to extend from a distal opening of the working channel, and the device comprises at least one temperature sensing surface on the cryocatheter distal section for measuring temperature within a hollow organ.

[0042] Example 39. A device described in any one of the preceding examples, comprising at least one temperature sensing surface at least partially surrounding an outer surface of the cryocatheter.

[0043] Example 40. A device described in any one of the above examples, comprising at least one temperature sensor within the elongated insertion tube of the endoscope.

[0044] Example 41. An apparatus described in any one of the above-mentioned examples, wherein the at least one cryogenic fluid channel in the cryocatheter comprises a distal bendable portion configured to bend at least 45 degrees relative to a longitudinal axis of a portion of the at least one cryogenic fluid channel located proximal to the distal bendable portion without contracting.

[0045] Example 42. The device described in Example 4, wherein the distal bendable portion of the at least one cryogenic fluid channel has an outer diameter smaller than an outer diameter of the proximal portion of the at least one cryogenic fluid channel.

[0046] Example 43. The device described in Example 42, wherein the outer diameter of the distal bendable portion is within the range of 0.1 to 0.5 mm.

[0047] Example 44. A device described in any one of the above examples, wherein the maximum diameter of the cryotherapy device is 10 mm.

[0048] Example 45. A cryo-catheter comprising: an elongate body shaped and sized to penetrate a hollow organ and terminating in a bendable distal section, the bendable distal section having a distal tip; at least one cryogenic-fluid channel located within the bendable distal section, the at least one cryogenic-fluid channel having at least one distal opening at the distal tip configured to release cryogenic fluid from the at least one cryogenic-fluid channel; at least one irrigation fluid channel located within the bendable distal section, the irrigation fluid channel comprising at least one distal opening at the distal tip configured to release irrigation fluid from the at least one irrigation channel; Equipped with bending the bendable distal section at least 45 degrees relative to a section of the elongate body proximal to the bendable distal section reduces the cryogenic fluid flow rate through the distal opening by less than 10 percent compared to the cryogenic fluid flow rate through the distal opening when the bendable distal section is not bent. The cryocatheter.

[0049] Example 46. A cryocatheter as described in Example 45, wherein the bend radius of the bendable distal section is in the range of 5 to 20 mm.

[0050] Example 47. A cryocatheter described in any one of Examples 45 or 46, wherein the at least one cryogenic fluid channel comprises a bendable distal section having an outer diameter of less than 0.6 mm.

[0051] Example 48. A cryocatheter as described in Example 47, wherein the bendable distal section is configured to bend at least 45 degrees without compressing.

[0052] Example 49. A cryocatheter described in any one of Examples 45 to 48, wherein the elongated body has an outer diameter in the range of 1 mm to 3 mm.

[0053] Example 50. A cryocatheter described in any one of Examples 45 to 49, wherein the at least one cryogenic fluid channel is coaxially arranged within the at least one flushing fluid channel in the bendable distal section.

[0054] Example 51. A working channel split connector, comprising: a hollow body having at least three openings, an end of the hollow body configured to be coupled to a proximal opening of an endoscope working channel and to form a flow path between the proximal opening and a first of the at least three openings, the hollow body comprising a connector at a second opening of the at least three openings, the connector comprising a seal shaped and sized to permit passage of a cryo-catheter through the split connector and into the working channel while preventing fluid ejection from the split connector through the connector. 3. The working channel split connector.

[0055] Example 52. A connector as described in Example 51, wherein the end of the split connector is a tapered end shaped and sized to penetrate into the proximal opening of the working channel.

[0056] Example 53. A device described in any one of Examples 51 or 52, wherein the split connector is a Y-split connector.

[0057] Example 54. A connector described in any one of Examples 51 to 53, wherein the seal comprises a leaf seal.

[0058] Example 55. An overtube, an elongate tubular body including at least one distal opening and at least one proximal opening, the elongate tubular body defining an inner lumen and shaped and sized to at least partially penetrate within a hollow organ; at least one flow regulating valve fluidly connected to the inner lumen, the at least one flow regulating valve comprising a hollow body having at least one first outlet opening; a seal within the elongate tubular body between the at least one flow regulating valve and the at least one proximal opening of the elongate tubular body, the seal configured to prevent exit of fluid from the elongate tubular body inner lumen through the at least one proximal opening. The overtube.

[0059] Example 56. The at least one flow regulating valve comprises at least one second outlet opening; An overtube as described in Example 55, comprising: a movable flow path selector configured to direct fluid flow from the inner lumen toward the at least one first outlet opening and / or toward the at least one second outlet opening.

[0060] Example 57. An overtube described in any one of Examples 55 or 56, wherein the outer diameter of the overtube is less than 9 mm.

[0061] Example 58. An overtube described in any one of Examples 56 or 57, wherein the elongate tubular body has a distal end shaped and sized to penetrate the hollow organ, and the at least one distal opening is located within the wall of the elongate tubular body at the distal end.

[0062] Example 59. An overtube as described in Example 58, wherein the at least one distal opening comprises a plurality of openings distributed axially and / or circumferentially within the elongated tubular body at the distal end.

[0063] Example 60. An overtube described in any one of Examples 58 or 59, wherein the distal end of the elongated tubular body is tapered.

[0064] Example 61. An overtube described in any one of Examples 56 to 60, wherein the elongated tubular body is flexible.

[0065] Example 62. An overtube described in any one of Examples 56 to 61, wherein the outer surface of the elongated tubular body is smooth.

[0066] Example 63. An overtube described in any one of Examples 55 to 62, wherein at least one of the first outlets is provided with a check valve.

[0067] Example 64. An overtube described in any one of Examples 55 to 63, wherein the outer diameter of the overtube is in the range between 6 mm and 9 mm, and the inner diameter of the overtube is in the range between 5 mm and 7.5 mm.

[0068] Example 65. An overtube described in any one of Examples 55 to 64, wherein at least a portion of the tubular body is flexible and configured to bend at least 90 degrees without compressing or kinking.

[0069] Example 66 An overtube, an elongate tubular body having a wall defining an inner lumen, the inner lumen having at least one distal opening and at least one proximal opening, the elongate tubular body being shaped and sized to at least partially penetrate a hollow organ, the inner diameter of the tubular body inner lumen being in a range between 5.5 mm and 7.5 mm; at least one flow regulating valve fluidly connected to the inner lumen, the at least one flow regulating valve comprising at least one opening; At least a portion of the elongate tubular body is configured to bend at least 45 degrees without compressing or kinking. The overtube.

[0070] Example 67. An overtube as described in Example 66, wherein the outer diameter of the elongated tubular body is in the range between 6 mm and 9 mm.

[0071] Example 68. An overtube described in any one of Examples 66 or 67, wherein the elongated tubular body wall is formed from metal and coated with at least one coating layer in contact with the outer and / or inner surface of the elongated tubular body wall, and the at least one coating layer is configured to prevent leakage of material from the internal volume through the elongated tubular body wall.

[0072] Example 69. A cryotherapy method comprising: Navigating a distal section of a flexible endoscope having a working channel and a distal tip into a hollow organ; introducing a cryocatheter having a distal end into the hollow organ through the working channel of a flexible endoscope; controllably extending the cryocatheter distal end from the working channel into the hollow organ to a target distance relative to the distal tip; expelling cryogenic fluid from the distal end of the cryo-catheter into the hollow organ; and directing flushing fluid outwardly from the cryocatheter into the hollow organ before, during, and / or after said discharging. The cryotherapy method.

[0073] Example 70. The method described in Example 69, wherein the directing includes directing the cleaning fluid toward at least one optical element at the distal tip of the endoscope and / or outward toward a field of view (FOV) within the hollow organ distal to the at least one optical element.

[0074] Example 71. The method of any one of Examples 69 or 70, comprising bending the flexible endoscope distal section within the hollow organ at least 45 degrees relative to a longitudinal axis of a portion of the flexible endoscope located outside the hollow organ, and wherein the releasing comprises releasing the cryogenic fluid from the cryocatheter distal end as the flexible endoscope is bent.

[0075] Example 72. The method of any one of Examples 69 to 71, wherein the directing comprises directing irrigation fluid outwardly from the cryocatheter into the hollow organ through a plurality of distal irrigation fluid openings axially and / or circumferentially distributed within an outer wall of the cryocatheter.

[0076] Example 73. A method according to any one of Examples 69 to 72, comprising locking the position and / or orientation of the cryocatheter relative to the distal tip of the flexible endoscope after said controllably extending.

[0077] Example 74. A cryotherapy method comprising: Navigating a cryotherapy device including an endoscope and a cryocatheter within a hollow organ, the cryocatheter including at least one cryogenic fluid channel and at least one irrigation fluid channel; bending a bendable distal section of the endoscope disposed within the hollow organ at an angle of at least 45 degrees relative to a section of the endoscope located outside the hollow organ; and releasing a cryogenic fluid from at least one distal opening of the at least one cryogenic fluid channel located in the bendable distal section when the bendable distal section is bent. The cryotherapy method.

[0078] Example 75. The method described in Example 74, comprising releasing a cleaning fluid from at least one cleaning fluid opening of at least one cleaning fluid channel located in the bendable distal section when the bendable distal section is bent, wherein the cleaning fluid is released before, during, and / or after the release of the cryogenic fluid.

[0079] Example 76. A method as described in any one of Examples 74 or 75, wherein bending of the endoscope bendable distal section reduces the flow rate of the cryogenic fluid from the distal opening during the cryogenic fluid release by less than 10 percent compared to the flow of cryogenic fluid through the distal opening when the endoscope bendable distal section is not bent.

[0080] Example 77. A method for creating a passageway into a hollow organ, comprising: advancing a flexible sheath having an inner lumen having a width in the range of between 5 mm and 8 mm toward a hollow body organ within an anatomical body cavity; bending at least a portion of the flexible sheath at least 45 degrees during said advancing; and introducing a distal end of the flexible sheath having at least one opening of the inner lumen into the hollow organ. A method for creating a passageway into said hollow organ.

[0081] Example 78. The method of Example 77, wherein the bending includes bending at least a portion of the flexible sheath while reducing the cross-sectional width of the inner lumen of at least a portion by less than 10 percent compared to the cross-sectional width of the inner lumen when the at least a portion is not bent.

[0082] Example 79. The method of any one of Examples 77 or 78, comprising draining the hollow organ and / or introducing a fluid into the hollow organ via the flexible sheath inner lumen.

[0083] Example 80. Inserting an instrument into the hollow organ through the flexible sheath inner lumen; The method of any one of Examples 77-79, comprising using the instrument to remove particles larger than 4 mm from within the hollow organ via the flexible sheath inner lumen.

[0084] Example 81. The method of any one of Examples 77 to 80, wherein the advancing includes advancing the flexible sheath formed of a metal wall coated with at least one layer of coating within the anatomical body cavity, the at least one layer of coating sealing the contents of the interior volume from body tissue surrounding the flexible sheath during the bending.

[0085] 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.

[0086] 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]

[0087] [Figure 1] 1 is a flowchart illustrating a process for using a flexible cryotherapy device, according to some exemplary embodiments of the present invention. [Figure 2A] FIG. 1 is a block diagram of a cryotherapy device including a working channel, according to some exemplary embodiments of the present invention. [Figure 2B] FIG. 2B is a block diagram of the cryotherapy device of FIG. 2A having a cryo-catheter disposed within the working channel, according to some exemplary embodiments of the present invention. [Figure 2C] 1 is a flowchart of a detailed process for using a flexible cryotherapy device, according to some exemplary embodiments of the present invention. [Figure 3A] FIG. 1 is a schematic diagram of a cryotherapy apparatus, according to some exemplary embodiments of the present invention. [Figure 3B] FIG. 1 is a schematic diagram of a cryotherapy apparatus, according to some exemplary embodiments of the present invention. [Figure 3C]FIG. 1 is a schematic diagram of a cryotherapy apparatus, according to some exemplary embodiments of the present invention. [Figure 3D] 1 is a schematic front view of an endoscope of a cryotherapy apparatus, according to some exemplary embodiments of the present invention. [Figure 4] 1A-C are schematic illustrations of configurations of an introducer, such as an endoscope, when navigating within a hollow organ, according to some exemplary embodiments of the present invention. [Diagram 5] 1A-B are schematic diagrams of a cryo-fluid catheter, eg, a cryo-catheter, according to some embodiments of the present invention. [Figure 6] 1A-B are schematic diagrams of cryogenic fluid channels of a cryo-catheter, according to some exemplary embodiments of the present invention. [Figure 7] 1A-B are schematic diagrams illustrating the flow of flushing fluid and cryogenic fluid from a cryo-catheter, according to some embodiments of the present invention. [Figure 8] 1A-D are schematic diagrams illustrating a cryo-catheter travel stopper, eg, a cryo-catheter travel lock, for a cryotherapy device, according to some embodiments of the present invention. [Figure 9] 1A-B are schematic diagrams of a cleaning fluid flow director, according to some embodiments of the present invention. [Figure 10] 5A-D are schematic diagrams of different temperature sensors, according to some exemplary embodiments of the present invention. [Figure 11A] 1 is a schematic diagram illustrating an evacuation process and / or one or more evacuation paths of a cryotherapy device, according to some embodiments of the present invention. [Figure 11B] 1 is a schematic diagram illustrating an evacuation process and / or one or more evacuation paths of a cryotherapy device, according to some embodiments of the present invention. [Figure 11C] 1 is a schematic diagram illustrating an evacuation process and / or one or more evacuation paths of a cryotherapy device, according to some embodiments of the present invention. [Figure 11D] 1 is a schematic diagram illustrating an evacuation process and / or one or more evacuation paths of a cryotherapy device, according to some embodiments of the present invention. [Figure 11E] 1 is a schematic diagram illustrating an evacuation process and / or one or more evacuation paths of a cryotherapy device, according to some embodiments of the present invention. [Figure 12] 1A-C are schematic diagrams of the interface between an overtube and an endoscope, according to some embodiments of the present invention. [Figure 13] 1A-D are schematic diagrams of split connectors according to some embodiments of the present invention. [Figure 14A] FIG. 1 is a schematic diagram of a cryotherapy device including at least one sensing channel located outside the working channel, according to some embodiments of the present invention. [Figure 14B] FIG. 1 is a schematic diagram of a cryotherapy device including at least one sensing channel located outside the working channel, according to some embodiments of the present invention. [Figure 14C] FIG. 1 is a schematic diagram of a cryotherapy device including at least one sensing channel located outside the working channel, according to some embodiments of the present invention. [Figure 14D] FIG. 1 is a schematic diagram of a cryotherapy device including at least one sensing channel located outside the working channel, according to some embodiments of the present invention. [Figure 15A] 1 is a schematic diagram of an overtube, according to some exemplary embodiments of the present invention. [Figure 15B] 1 is a schematic diagram of an overtube, according to some exemplary embodiments of the present invention. [Figure 15C] 1 is a schematic diagram of an overtube, according to some exemplary embodiments of the present invention. [Figure 15D] 15B is a schematic cross-sectional view of the overtube shown in FIG. 15A taken along line AA, according to some exemplary embodiments of the present invention. [Figure 15E] 1A-1C are schematic cross-sectional views of overtubes having non-circular shapes, according to some exemplary embodiments of the present invention. [Figure 15F] 1 is a schematic diagram of an overtube having several sections, each having a different bending capacity, according to some exemplary embodiments of the present invention. FIG. [Figure 16A] 1A-1C are schematic diagrams illustrating advancement of an overtube into a hollow organ, according to some embodiments of the present invention. [Figure 16B] 1A-1C are schematic diagrams illustrating advancement of an overtube into a hollow organ, according to some embodiments of the present invention. [Figure 16C] 16A-16D are schematic diagrams illustrating irrigation of an inner lumen within a hollow organ (16C) and drainage of the hollow organ (16D), according to some embodiments of the present invention. [Figure 16D] 16A-16D are schematic diagrams illustrating irrigation of an inner lumen within a hollow organ (16C) and evacuation of the hollow organ (16D), according to some embodiments of the present invention. [Figure 16E] 1A-1C are schematic diagrams illustrating removal of objects from an inner lumen of a hollow organ using an instrument moving within an overtube, according to some embodiments of the present invention. [Figure 16F] 1A-1C are schematic diagrams illustrating removal of objects from an inner lumen of a hollow organ using an instrument moving within an overtube, according to some embodiments of the present invention. [Figure 16G] 1A-1C are schematic diagrams illustrating removal of objects from an inner lumen of a hollow organ using an instrument moving within an overtube, according to some embodiments of the present invention. [Figure 16H] 1A-1C are schematic diagrams illustrating removal of objects from an inner lumen of a hollow organ using an instrument moving within an overtube, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] The present invention, in some embodiments thereof, relates to a cryotherapy device, and more particularly, but not exclusively, to a flexible cryotherapy device.

[0089] An aspect of some embodiments relates to a flexible cryotherapy device having an elongated body with a bendable distal section, the elongated body including a cryogenic fluid channel and an irrigation fluid channel, each having at least one opening in the bendable distal section. In some embodiments, the bendable distal section is configured to bend at least 90 degrees, at least 150 degrees, at least 180 degrees, or any intermediate, smaller, or larger angle relative to the longitudinal axis of at least one section proximal to the bendable distal section. As used herein, the term proximal means closer to the end of the cryotherapy device located outside the subject's body, e.g., at the handle of the cryotherapy device, and the term distal means closer to the end of the cryotherapy device located within a hollow organ inside the subject's body, or closer to the hollow organ. In some embodiments, the flexible cryotherapy device has a maximum outer diameter of up to 10 mm, or any intermediate, smaller, or larger value, e.g., up to 8 mm, up to 7 mm, up to 6 mm, up to 4 mm, etc. In some embodiments, the bendable distal section is configured to bend within a hollow organ, such as a hollow organ having at least one natural opening. In some embodiments, the hollow organ comprises a bladder, a renal pelvis, a uterus, a stomach, or an abdomen. In some embodiments, the flexible cryotherapy device is used to treat a hollow organ disease. In some embodiments, the hollow organ disease comprises bladder cancer, interstitial cystitis, overactive bladder, superficial gastric neoplastic lesions, superficial gastric cancer, and / or abdominal wall tumors.

[0090] According to some exemplary embodiments, the flexible cryotherapy device includes an elongate body, optionally terminating in a distal bendable section, e.g., an insertion tube. In some embodiments, the maximum width of the cryogenic fluid channel in the distal bendable section is less than the maximum width of the cryogenic fluid channel in other regions of the elongate body. In some embodiments, the outer width, e.g., outer diameter, of the cryogenic fluid channel in the distal bendable section is in the range of 0.1-0.5 mm, e.g., 0.1-0.3 mm, 0.2-0.5 mm, 0.3-0.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the outer width, e.g., outer diameter, of the cryogenic fluid channel in at least one section of the insertion tube located proximal to the bendable distal section is in the range of 0.3-1.5 mm, e.g., 0.3-0.5 mm, 0.5-1 mm, 0.7-1.2 mm, 0.8-1.5 mm, or any intermediate, smaller, or larger value.

[0091] An aspect of some embodiments relates to ejecting irrigation fluid outwardly toward the periphery of an endoscope, e.g., at the distal end of an introducer, e.g., an endoscope. In some embodiments, the irrigation fluid is ejected from at least one irrigation channel, e.g., at least one irrigation tube located in a working channel of the endoscope. In some embodiments, the endoscope is a flexible endoscope, e.g., a cystoscope. As used herein, the term introducer refers to an introducing element that includes at least one working channel configured to navigate within a subject's body toward a desired target, e.g., into a hollow organ. In some embodiments, an endoscope is an example of an introducer.

[0092] In some embodiments, the cleaning fluid is emitted towards at least one optical element of the endoscope, optionally integrated within the endoscope. In some embodiments, the at least one optical element is located at a distal end of the endoscope. In some embodiments, the at least one optical element comprises at least one of a lens, a window, an optical sensor, a camera, an optical fiber end, at least one light emitting diode (LED), at least one optical sensor configured to sense light having a wavelength outside and / or within the visible spectrum. Optionally, the at least one optical element comprises an optical element of a narrow band imaging (NBI) system.

[0093] According to some embodiments, the cleaning liquid is emitted from the at least one opening directly towards the at least one optical element, in some embodiments, the cleaning liquid is emitted towards the optical element, for example, to displace mist, dust, and / or particles from the optical element and / or from the field of view of the optical element.

[0094] A potential advantage of directing the irrigation fluid outwardly from an irrigation tube in the working channel of the catheter may be to avoid the use of any external adapters to provide the irrigation fluid, which may block the FOV and / or retain mist, dust, and / or particles near the optical elements. Another potential advantage may be that directing the irrigation fluid from a central region of the device towards the periphery of the device may displace particles and droplets away from the device.

[0095] An aspect of some embodiments relates to a cryogenic fluid delivery catheter, e.g., a cryo-catheter, movable within a working channel of an endoscope, e.g., a cystoscope or ureteroscope. In some embodiments, the cryogenic fluid catheter includes a cryogenic fluid channel and a irrigation fluid channel. Optionally, the irrigation fluid channel includes one or more openings configured to deliver, e.g., spray, irrigation fluid toward at least one optical element of the endoscope.

[0096] According to some embodiments, the cryogenic fluid catheter is configured to extend from a distal opening of the working channel, optionally into the hollow organ. Alternatively or additionally, the cryogenic fluid catheter is withdrawn from the working channel, for example to allow insertion of other surgical tools into the hollow organ.

[0097] According to some embodiments, the cryo-fluid catheter and / or endoscope include at least one lock, e.g., an interference lock, configured to lock the cryo-fluid catheter in a particular axial, e.g., longitudinal, and / or angular position relative to the endoscope. In some embodiments, the at least one lock locks the cryo-fluid catheter in a particular position, optionally relative to the FOV and / or relative to at least one optical element of the endoscope. Locking the cryo-fluid catheter in a particular position optionally locks one or more of the irrigation fluid channel openings in an axial and / or angular position suitable for directing irrigation fluid towards the FOV and / or at least one optical element.

[0098] Potential advantages of having a movable cryogenic fluid catheter within the working channel of an endoscope may include: (1) allowing for forward flushing closer to the cryogenic fluid flow, e.g., to prevent or reduce frosting of the cryogenic catheter tip; (2) simplified connection to a unit that controls the flow of flushing fluid and the flow of cryogenic fluid through a single connection to the cryogenic catheter; and (3) using the working channel before and / or after the release of cryogenic fluid for other functions, e.g., to take a biopsy and / or use the working channel for evacuation of fluid.

[0099] Additional potential advantages may include retracting the catheter tip of the cryocatheter during guidance and / or steering of the endoscope within the body, for example to reduce potential harm to tissue between treatment sessions.

[0100] According to some embodiments, the cryo-catheter is configured to be introduced into the hollow organ via a working channel of an endoscope, for example for expelling a cryogenic fluid, e.g., a cryogenic fluid, and a flushing fluid within the hollow organ. One problem when having a steerable cryo-catheter is how to ensure a correct or optimal position of the flushing fluid opening relative to at least one optical element of the endoscope and / or relative to the field of view (FOV) between the at least one optical element and the wall of the hollow organ.

[0101] In some embodiments, one solution is to have irrigation fluid openings distributed circumferentially and / or axially on the wall of the cryo-catheter, for example to allow wide-angle release of irrigation fluid inside the hollow organ. Alternatively or additionally, another solution is to control the movement of the cryo-catheter inside the hollow organ according to the axial and / or circumferential distribution of the irrigation fluid openings in the cryo-catheter wall. In some embodiments, controlling the movement of the cryo-catheter comprises limiting the maximum extension distance of the cryo-catheter from the working channel, for example according to the axial and / or circumferential distribution of the irrigation fluid openings. Alternatively or additionally, controlling the movement of the cryo-catheter comprises limiting the rotation of the cryo-catheter inside the working channel, for example according to the axial and / or circumferential distribution of the irrigation fluid openings. Alternatively or additionally, controlling the movement of the cryo-catheter comprises locking the position of the cryo-catheter inside the working channel, for example according to the axial and / or circumferential distribution of the irrigation fluid openings. In some embodiments, it is important to control the movement of the cryo-catheter within the working channel, for example when bending the guidance region of the endoscope results in radial and / or axial movement of the cryo-catheter within the endoscope working channel.

[0102] Alternatively or additionally, another solution is to provide one or more visible indications, such as, for example, indications regarding the position and / or orientation of the cryo-catheter relative to the working channel and / or endoscope. In some embodiments, the indications include visual markings located on the cryo-catheter and / or endoscope, for example, near or at the insertion position of the cryo-catheter into the working channel. In some embodiments, the indications are located outside the body, such as, for example, at a proximal section of the endoscope and / or at a proximal section of the cryo-catheter. Optionally, the one or more indications are located near or at a proximal opening of the endoscope working channel through which the cryo-catheter is introduced into the working channel. In some embodiments, the one or more visual markings indicate the axial and / or radial position of the cryo-catheter within the working channel and / or the axial and / or radial position of the cryo-catheter within the hollow organ.

[0103] An aspect of some embodiments relates to a cryocatheter having an inner flexible cryogenic fluid channel configured to deliver cryogenic fluid toward at least one distal opening of the cryocatheter. In some embodiments, the inner flexible cryogenic fluid channel is bendable at least 90 degrees, such as at least 120 degrees, at least 180 degrees, or any intermediate, lesser, or greater value. Optionally, the cryocatheter is shaped and sized to be placed with a flexible endoscope, such as a cystoscope.

[0104] According to some embodiments, the inner flexible cryogenic fluid channel includes a flexible distal portion, which is optionally shaped and sized to be placed within a guidance region of a flexible endoscope. In some embodiments, the flexible distal portion is narrower than the width of at least one proximal portion of the cryogenic fluid channel. Alternatively or additionally, the flexible distal portion is formed from at least one material that is more flexible than at least one proximal section of the device. In some embodiments, the length of the flexible distal portion is in the range of 20-150 mm, e.g., 20-50 mm, 50-100 mm, 70-150 mm, etc., or any intermediate, smaller, or larger value. In some embodiments, the bend radius of the flexible distal section is in the range of 5-20 mm, e.g., 5-15 mm, 10-20 mm, etc., or any intermediate, smaller, or larger value. In some embodiments, the bend radius of at least one section of the cryogenic fluid channel located proximal to the flexible distal portion is in the range of 70 to 150 mm, e.g., 70 to 100 mm, 80 to 120 mm, 100 to 150 mm, etc., or any intermediate, smaller, or larger value range.

[0105] An aspect of some embodiments relates to an overtube, e.g., a sheath shaped and sized to at least partially surround a flexible endoscope and define a fluid evacuation lumen between the flexible endoscope and the overtube. In some embodiments, the sheath is an access sheath configured to create at least one access path, e.g., at least one channel, into a hollow organ. In some embodiments, the access sheath is configured to create at least one access channel between a location outside the body and a lumen of the hollow organ. In some embodiments, the fluid evacuation lumen is defined between a surface of the overtube and a surface of the flexible endoscope. In some embodiments, the maximum outer diameter of the overtube is less than 9 mm, e.g., less than 8 mm, less than 6 mm, or any intermediate, smaller, or larger value. Optionally, the flexible endoscope is coaxially disposed within the overtube.

[0106] According to some embodiments, the distal opening of the fluid drainage lumen is positioned at an axial, e.g., longitudinal, distance, e.g., up to 10 cm, up to 6 cm, up to 2 cm, etc., up to 15 cm, or any intermediate, lesser, or greater distance, from the distal tip of the endoscope to allow for drainage of fluid from the hollow organ in which the endoscope tip is positioned. In some embodiments, the overtube and / or endoscope include at least one lock configured to lock the overtube in a particular longitudinal position relative to the distal tip of the endoscope, e.g., to prevent uncontrolled longitudinal movement of the overtube when the endoscope is positioned within the hollow organ.

[0107] According to some embodiments, the distal opening of the fluid exhaust lumen is positioned a longitudinal distance, e.g., up to 8 cm, up to 5 cm, up to 2 cm, up to 10 cm, or any intermediate, smaller, or larger distance, from the distal opening of at least one of the cryogenic fluid channels, which optionally extends from the working channel of the flexible endoscope.

[0108] According to some embodiments, the fluid discharge lumen defined by the overtube is used to receive at least one additional channel terminating in at least one distal opening. In some embodiments, the at least one distal opening of the additional channel is located outside the fluid discharge lumen, e.g., near the distal tip of the endoscope. Optionally, the distal end of the additional channel is secured to the endoscope distal tip by a tip fixator, e.g., a tip holder, attached to the endoscope distal tip.

[0109] According to some embodiments, the at least one additional channel includes a temperature sensing channel or a pressure sensing channel. In some embodiments, the at least one additional channel travels along the endoscope body, within a fluid drainage lumen, or within a multi-lumen catheter that includes both drainage and sensing channels.

[0110] According to some embodiments, the sheath is flexible and configured to bend, for example, at least 90 degrees, at least 180 degrees, at least 270 degrees, etc., at an angle of at least 45 degrees, or any intermediate, lesser, or greater angle.

[0111] According to some exemplary embodiments, the inner lumen of the sheath, which forms at least one channel along the sheath length, has an inner width, e.g., inner diameter, in the range of between 5 mm and 7 mm, such as between 6 mm and 7 mm, between 5 mm and 7.5 mm, or any intermediate, smaller, or larger value.

[0112] According to some embodiments, at least one or all of the sections of the sheath are flexible, e.g., bendable, In some embodiments, bending of the flexible section at an angle of at least 45 degrees relative to a section of the sheath proximal to the flexible section, or relative to an unbent section of the sheath, optionally reduces the volume, i.e., local diameter, of the inner lumen of the sheath relative to the volume, i.e., local diameter, of the section of the lumen where the flexible section is unbent, e.g., by less than 10 percent, less than 5 percent, less than 20 percent, or any intermediate, smaller, or greater percentage value.

[0113] According to some embodiments, the flexible sheath is used to create a passageway within the hollow organ, for example to allow for at least one of draining the lumen of the hollow organ, removing objects from the lumen of the hollow organ, and / or introducing fluids into the lumen of the hollow organ, hi some embodiments, the passageway is created by advancing the flexible sheath within an existing anatomical body cavity, for example within the urethra, into the bladder.

[0114] A potential advantage of a flexible sheath with a wide inner lumen may be to allow easy drainage of fluids from the hollow organ and / or removal of large objects, such as large debris, large particles, stones, blood clots, and sediments from within the hollow organ, through the flexible sheath inner lumen. An additional potential advantage may be to allow for the insertion of wider and / or larger instruments into the hollow organ that would not fit within the working channel of an endoscope. In some embodiments, a wide inner lumen allows the flexible sheath to be used to create a wider access path into the hollow organ for drainage and / or to introduce instruments into the hollow organ without damaging the tissue surrounding the flexible sheath.

[0115] An aspect of some embodiments relates to an exhaust flow regulator valve coupled to a proximal opening of an exhaust channel of a cryotherapy device. In some embodiments, the exhaust flow regulator valve is configured to shift an exhaust path between two openings having different flow rates. In some embodiments, the exhaust flow regulator valve is coupled to an overtube and an endoscope to define at least one exhaust flow path between the overtube and the endoscope.

[0116] According to some embodiments, the exhaust flow regulator is configured to shift the exhaust flow path between at least one first opening of the flow regulator having a low flow rate, optionally used during the cryogenic fluid ejection cycle, and at least one opening of the flow regulator having a higher flow rate, optionally used when the cryogenic fluid is ejected from within the hollow organ. Optionally, the exhaust flow regulator shifts the exhaust flow between at least one opening used for passive ejection, e.g. an opening including a check valve, and at least one opening used for active ejection, e.g. by a pump.

[0117] According to some embodiments, the exhaust flow regulator valve shifts the exhaust path when actuating the release of cryogenic fluid within the hollow organ. In some embodiments, the exhaust flow regulator valve shifts the exhaust path when a cryogenic fluid activation button of the flow regulator valve is pressed or moved. Optionally, the exhaust flow path is mechanically shifted when the activation button is pressed and / or moved. Optionally, the exhaust flow path regulator valve shifts the exhaust flow from a single opening to two or more openings, for example, when pressure within the hollow organ rises above a predetermined value. Optionally, an electronic control changes the setting of the check valve according to the measured pressure, for example to control the pressure.

[0118] One aspect of some embodiments relates to a split connector for a working channel of an endoscope that allows for insertion of a catheter, such as a cryo-catheter, into the working channel and formation of a flow path between the catheter and the working channel wall without leakage of fluid from the catheter entry site. In some embodiments, the split connector includes an inner lumen having a first opening at an end of the split connector configured to penetrate into a check valve of the working channel and at least two separate openings, each at a different end of the split connector.

[0119] In some embodiments, at least one opening of the at least two separate openings includes a connector, such as, for example, a gasket, configured to receive a cryo-catheter within the split connector and within the working channel. Optionally, the gasket includes at least one seal that allows movement of the cryo-catheter within the split connector and working channel without allowing escape of fluid through the gasket. Additionally, at least one distinct opening of the at least two separate openings is shaped and sized to connect to a tube configured to allow a sealed fluid flow path between a tube and a lumen of the working channel surrounding the cryo-catheter.

[0120] According to some embodiments, the endoscope is a guide instrument that includes a working channel, e.g., a central working channel. In some embodiments, the endoscope, e.g., guide instrument, includes an elongate body, e.g., an insertion tube, having a distal tip. In some embodiments, the elongate body of the endoscope is shaped and sized to penetrate at least partially into a hollow organ, e.g., a body cavity, optionally without damaging tissue of the body cavity. In some embodiments, the endoscope includes a working channel disposed within and along the insertion tube and includes a distal opening at the distal tip of the endoscope.

[0121] According to some exemplary embodiments, in endoscopes having small diameter working channels, the width, e.g., the diameter of the working channel, is less than 2 mm, e.g., less than 1.8 mm, less than 1.5 mm, less than 1.2 mm, or any intermediate, smaller, or larger diameter. In some embodiments, the diameter of the working channel ranges between 1 and 2 mm, e.g., 1-1.5 mm, 1.4 mm-2 mm, 1.3 mm-1.7 mm, or any intermediate, smaller, or larger value.

[0122] According to some exemplary embodiments, a cryo-catheter sized to move within a small diameter working channel has an outer diameter that is less than 1.8 mm, e.g., less than 1.6 mm, less than 1.5 mm, less than 1.3 mm, or any intermediate, smaller, or larger value. In some embodiments, the cryo-catheter outer diameter is in the range between 1.2-1.8 mm, e.g., 1.2-1.6 mm, 1.5 mm-1.8 mm, 1.4 mm-1.7 mm, or any intermediate, smaller, or larger value. In some embodiments, the cryo-catheter includes at least one cryogenic fluid channel and at least one irrigation fluid channel, optionally coupled to one another. Optionally, the cryogenic fluid channel is disposed coaxially with the irrigation fluid channel.

[0123] According to some embodiments, the cryocatheter includes at least one proximal stop or lock, e.g., proximal to the handle of the endoscope, to limit movement of the cryocatheter within the working channel. Optionally, the at least one proximal stop or lock limits the extension of the cryocatheter from a distal opening of the working channel to a selected extension distance. In some embodiments, the extension distance is selected according to a location and / or orientation of an irrigation fluid opening of the cryocatheter relative to the distal tip of the endoscope or relative to the optical elements of the endoscope. In some embodiments, limiting the movement of the cryocatheter to position the at least one irrigation fluid opening in a desired orientation and location allows for efficient ejection of irrigation fluid, e.g., toward the optical elements and / or toward a field of view (FOV) between the target site and the optical elements within the hollow organ. Optionally, the FOV is located distal to the optical elements.

[0124] Alternatively or additionally, the cryocatheter and / or endoscope may include at least one distal lock or stop to limit movement of the cryocatheter within the working channel.

[0125] Optionally, the cryocatheter includes at least one proximal marking, e.g., a visual marking located outside the subject's body, to indicate the axial position and / or rotation of the cryocatheter, e.g., relative to the endoscope.

[0126] According to some exemplary embodiments, the cryo-catheter is configured to emit irrigation fluid within the hollow organ, hi some embodiments, the cryo-catheter emits irrigation fluid towards the optical element and / or towards the FOV at a flow rate of at least 0.25 liters / minute, such as at least 0.5 liters / minute, at least 1.0 liters / minute, at least 4 liters / minute, or any intermediate, lesser, or greater flow rate.

[0127] According to some embodiments, the cryogenic fluid channel in the cryocatheter includes an elongated channel terminating in a distal bendable section. In some embodiments, the distal bendable section is configured to bend at least 45 degrees relative to the proximal section of the elongated channel without contracting or collapsing the cryogenic fluid channel. In some embodiments, the distal bendable section is configured to bend at least 45 degrees relative to the proximal section of the elongated channel while decreasing the inner width of the bent section by less than 10%, e.g., less than 5%, less than 3%, less than 1%, or any intermediate, smaller, or greater percentage value, relative to the inner depth when the bent section is unbent or straight.

[0128] In some embodiments, the distal bendable section of the cryogenic fluid channel is thinner than the proximal section or the cryogenic fluid channel. Optionally, the distal bendable section of the cryogenic fluid channel has a thin wall, and is optionally formed from a thin walled material, such as, for example, Nitinol, titanium, stainless steel, PEEK, nylon, or braided plastic. In some embodiments, the outer width, e.g., outer diameter, of the distal bendable section is less than 0.6 mm, e.g., less than 0.5 mm, less than 0.4 mm, less than 0.2 mm, less than 0.1 mm, or any intermediate, smaller, or larger value. In some embodiments, the wall width of the distal bendable section is in the range of 0.02 mm to 0.2 mm.

[0129] In some embodiments, the bendable distal section of the cryogenic fluid channel is disposed within a guidance region of a cryo-catheter and / or within a guidance region of an endoscope of a cryotherapy device.

[0130] According to some embodiments, the cryogenic fluid channel and the irrigation fluid channel of the cryogenic catheter are coupled to each other in the guidance region of the endoscope, and are optionally coaxial with each other and / or located together in a single multi-lumen structure, for example to form a kink-resistant structure. Alternatively or additionally, the joint structure formed by at least one of the irrigation fluid channel and the cryogenic fluid channel is braided. Optionally, the irrigation fluid channel coupled to the cryogenic fluid channel is braided. Alternatively, the joint structure, such as that of the cryogenic catheter located in the guidance region of the endoscope insertion tube, is formed from one or more kink-resistant materials, such as, for example, Nitinol, titanium, stainless steel, PEEK, polytetrafluoroethylene (PTFE), and nylon, or any braided plastic.

[0131] According to some embodiments, the bendable distal section of the cryogenic-fluid channel includes at least one distal opening configured to release cryogenic fluid at a less than 10% reduction, such as less than 5%, less than 3%, or any intermediate, lesser, or greater percentage reduction in flow rate when bent at least 45 degrees compared to the cryogenic-fluid flow rate when the bendable distal section is unbent. In some embodiments, the pressure of the cryogenic fluid in the bendable distal section is lower, such as less than 10%, such as less than 5%, less than 3%, or any intermediate, lesser, or greater percentage value, compared to the pressure level of the cryogenic fluid in the proximal, unbent section of the cryogenic-fluid channel when the bendable distal section is bent at least 45 degrees.

[0132] According to some embodiments, the endoscope includes a working channel having an internal width, e.g., internal diameter, in the range of 1.8 mm to 2.8 mm, e.g., in the range of 1.8 mm to 2.8 mm, in the range of 2 mm to 3 mm, in the range of 2.5 mm to 3.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the working channel is located within an elongated insertion tube of the endoscope that terminates in a navigable distal end. In some embodiments, the navigable distal end is configured to bend at least 45 degrees, e.g., at least 90 degrees, at least 120 degrees, at least 180 degrees, or any intermediate, smaller, or larger value, relative to a longitudinal axis of a section of the insertion tube located proximal to the distal navigable section.

[0133] According to some exemplary embodiments, the radius of the bend of the navigable distal section is in the range of 5 mm to 30 mm, such as, for example, 5 mm to 20 mm, 7 mm to 25 mm, or any intermediate, smaller, or larger value.

[0134] According to some exemplary embodiments, the working channel having an inner diameter of up to 3.5 mm is sized to receive a cryocatheter having an outer diameter of less than 3 mm, e.g., less than 2 mm, less than 1.8 mm, or any intermediate, smaller, or larger value. In some embodiments, the cryocatheter includes at least one cryogenic fluid channel and at least one flushing fluid channel. Optionally, the cryocatheter includes at least one additional channel in the cryocatheter body, e.g., a sensing channel and / or a flow path, in addition to the at least one cryogenic fluid channel and the at least one flushing fluid channel. Optionally, the cryocatheter includes electrical wiring or optical fibers in the cryocatheter body. **In some embodiments, the at least one sensing channel is for sensing temperature and / or pressure. Optionally, the catheter includes at least one additional channel defined between the catheter body and the working channel. In some embodiments, the at least one additional channel is used for sensing temperature and / or pressure. Optionally, at least one additional channel is used to deliver fluid within the hollow period, for example in parallel with the cryogenic fluid and / or cleaning fluid.

[0135] 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.

[0136] Exemplary Process for Using a Flexible Cryotherapy Device According to some exemplary embodiments, the cryotherapy device is configured to penetrate into different hollow organs and release cryogenic fluid within the hollow organ. In some embodiments, the cryogenic fluid is released and optionally sprayed within the hollow organ as part of a treatment, for example to ablate tissue within the hollow organ. Optionally, the tissue is cancerous tissue.

[0137] According to some exemplary embodiments, at least one distal portion of a cryotherapy device, such as at least one distal portion of a cryo-catheter of the device, is flexible, e.g., bendable, at an angle greater than 45 degrees, such as 90 degrees, greater than 120 degrees, greater than 150 degrees, greater than 180 degrees, or any intermediate, smaller, or larger angle, relative to at least one portion of the cryo-catheter located proximal to the at least one distal portion.

[0138] Optionally, the outer diameter of the cryocatheter is less than 10 mm, such as less than 8 mm, less than 6 mm, or any intermediate, smaller, or larger value. Reference is now made to Figure 1, which illustrates a process for navigating a flexible cryocatheter within a hollow organ, according to some exemplary embodiments of the present invention.

[0139] According to some exemplary embodiments, a flexible cryocatheter is navigated within the hollow period at block 101. In some embodiments, the flexible cryocatheter includes a bendable distal section configured to bend at least 90 degrees, such as at least 120 degrees, at least 150 degrees, or any intermediate, lesser, or greater value. In some embodiments, the flexible cryocatheter includes at least one cryogenic fluid channel and at least one irrigation fluid channel, each having at least one distal opening in the bendable distal section. Optionally, the cryocatheter includes at least one optical element and / or at least one fluid drainage channel.

[0140] According to some exemplary embodiments, the cryocatheter is bent within the hollow organ, e.g., a bendable distal section of the cryocatheter, at block 105. In some embodiments, the bendable distal section is bent at least 45 degrees relative to at least one proximal section of the cryocatheter within the hollow organ. In some embodiments, the distal section of at least one of the cryo-fluid channel and the irrigation fluid channel is bent at least 45 degrees in accordance with the bending of the cryocatheter at block 105.

[0141] According to some exemplary embodiments, during and / or after penetration of the cryo-catheter into the hollow organ, the hollow organ is inflated, for example to allow visualization of the hollow organ lumen and / or visualization of the inner surface of the hollow organ wall. In some embodiments, the hollow organ is inflated with fluid from the cryo-catheter. Alternatively, the hollow organ is inflated with fluid from a channel located within the endoscope working channel, for example within a channel defined between the catheter wall and the working channel wall.

[0142] According to some exemplary embodiments, at block 107, the cryogenic fluid is discharged from a distal opening of at least one cryogenic fluid channel within the hollow organ. In some embodiments, the cryogenic fluid is discharged within the hollow organ while the cryogenic catheter distal section is bent at least 45 degrees, such as when the bendable distal section of the cryogenic catheter is bent at least 45 degrees. In some embodiments, the at least 45 degree bend of the cryogenic fluid channel located within the bendable distal section of the cryogenic catheter reduces the flow of the cryogenic fluid through the distal opening of the cryogenic fluid channel by less than 10 percent, such as less than 7 percent, less than 5 percent, less than 2 percent, compared to the flow of the cryogenic fluid through the distal opening when the bendable distal section is not bent.

[0143] According to some exemplary embodiments, optionally, before, during, and / or after the release of the cryogenic fluid at block 107, irrigation fluid is released from the irrigation fluid channel distal opening within the hollow organ at block 109. In some embodiments, the irrigation fluid is released while the cryo-catheter is bent at least 90 degrees.

[0144] According to some exemplary embodiments, the cryo-catheter is shaped and sized to be introduced into an endoscope, e.g., a flexible endoscope, where at least a distal portion of the flexible endoscope bends at an angle greater than 90 degrees, such as greater than 100 degrees, greater than 120 degrees, greater than 150 degrees, or any intermediate, lesser, or greater angle. In some embodiments, the cryo-catheter is shaped and sized to be placed within a working channel of the endoscope. Optionally, the cryo-catheter is configured to move, e.g., controllably move within the working channel.

[0145] According to some exemplary embodiments, the pressure in the hollow organ is increased by at least one of expanding the hollow organ, releasing the cryogenic fluid, and / or flushing the hollow organ. In some embodiments, the pressure level in the hollow organ is in the range of 5-100 mbar, 0-60 mbar, less than 20 mbar, more than 10 mbar, e.g., 0-50 mbar, 5-100 mbar, 20-200 mbar, etc., 0-200 mbar, or any intermediate, smaller, or larger value. In some embodiments, the maximum pressure level in the hollow organ is in the range of 50-200 mbar, e.g., 50-100 mbar, 100-200 mbar, 80-200 mbar, etc., 50-200 mbar, 50-200 mbar, 100-200 mbar, 80-200 mbar, or any intermediate, smaller, or larger value.

[0146] Exemplary Flexible Cryotherapy Device Structures According to some exemplary embodiments, the cryotherapy device is a flexible device or has a flexible distal section configured to bend at least 45 degrees, such as at least 90 degrees, at least 130 degrees, at least 150 degrees, or any intermediate, smaller, or larger angle, relative to at least one proximal section of the device. In some embodiments, the flexible cryotherapy device has an outer diameter of less than 10 mm, such as less than 8 mm, less than 7 mm, or any intermediate, smaller, or larger diameter. In some embodiments, the flexible distal section of the device is a guide section configured to bend, for example, to position the distal end of the device near a target tissue within a hollow organ.

[0147] According to some exemplary embodiments, a flexible cryotherapy device includes at least one distal optical element configured to enable visualization of the hollow organ and at least one cryogenic fluid channel configured to deliver cryogenic fluid from a cryogenic fluid source located outside the body to a distal opening of the cryogenic fluid channel shaped and sized to be placed in the hollow organ. In some embodiments, the distal opening of the cryogenic fluid channel is located within a flexible distal section of the device or distal to the distal section of the device. In some embodiments, the cryogenic fluid channel, e.g., a cryogenic fluid tube, is a thin tube, e.g., to allow flexibility and bending of the cryogenic fluid tube.

[0148] Optionally, the flexible cryotherapy device includes an irrigation channel configured to deliver and expel irrigation fluid within the hollow tissue and / or toward at least one distal optical element. Optionally, the irrigation channel and the cryogenic fluid channel are coaxially arranged relative to each other. Optionally, the cryogenic fluid channel is coaxially arranged within the irrigation fluid channel. Additionally or optionally, the flexible cryotherapy device includes at least one drain channel configured to drain fluid from the hollow organ. Exemplary components of a cryotherapy device are described in International Patent Application Publication No. WO2018142411, filed Feb. 04, 2018, the contents of which are incorporated herein by reference in their entirety.

[0149] According to some exemplary embodiments, a flexible cryotherapy device includes a flexible endoscope including at least one optical element, a working channel, and a cryo-catheter including at least one cryogenic fluid channel. In some embodiments, the cryo-catheter is shaped and sized to move, e.g., controllably move, within the working channel. Reference is now made to Figures 2A and 2B, which show a flexible cryotherapy device, according to some exemplary embodiments of the present invention.

[0150] According to some exemplary embodiments, the flexible cryotherapy device 202 includes an elongated body 204 having an elongated axis, a distal end 208, e.g., a navigable distal end, and a proximal end. In some embodiments, the elongated body 204 is an endoscope. In some embodiments, the elongated body 204 includes at least one optical element, e.g., an optical system 210, at the distal end. In some embodiments, the at least one optical element is configured to allow visualization of an area, e.g., a field of view (FOV), located distal to the distal end 208. In some embodiments, the at least one optical element includes a lens, a window, an optical sensor, or a camera. Additionally, the at least one optical element includes a light emitting source, e.g., a lamp, a light emitting diode (LED), and / or an optical fiber end.

[0151] According to some exemplary embodiments, the maximum outer width 214 of the cryotherapy device is in the range of 1 mm to 12 mm, such as, for example, 1 mm to 9 mm, 1 mm to 8 mm, 2 mm to 8 mm, 3 mm to 7 mm, or any intermediate, smaller, or larger value range.

[0152] Further, body 204 includes a working channel 212 passing therethrough. In some embodiments, the working channel has a maximum internal width 216 that is less than 2 mm, such as, for example, less than 1.8 mm, less than 1.6 mm, less than 1.4 mm, less than 1.2 mm, less than 1 mm, or any intermediate, smaller, or greater value. Optionally, working channel internal width 216 is in the range of 0.2 mm to 2 mm, such as, for example, 0.2 mm to 1.6 mm, 0.4 mm to 1.7 mm, 0.4 mm to 1.5 mm, or any intermediate, smaller, or greater value.

[0153] Alternatively, the maximum internal width 216 of the working channel 212 is greater than 1.6 mm, e.g., greater than 1.8 mm, greater than 2 mm, greater than 2.4 mm, greater than 3 mm, greater than 4 mm, etc., or any intermediate, smaller, or greater value. Optionally, the internal width 216 of the working channel is in the range of 1.6 mm to 6 mm, e.g., 1.6 mm to 5 mm, 2 mm to 4 mm, 2.5 mm to 5 mm, etc., or any intermediate, smaller, or greater value.

[0154] According to some exemplary embodiments, the cryotherapy device 202 includes at least one drain channel 218 having a distal opening 220 located at or near the distal end 208 of the body 204. In some embodiments, the at least one drain channel includes a drain tube located within the body 204. Alternatively, the at least one drain channel is formed within a lumen formed between an overtube that at least partially surrounds the body 204 and the body 204, e.g., an exterior surface of the body 204. In some embodiments, the at least one drain channel is shaped and sized to allow drainage, e.g., passive drainage or active drainage, of fluid from the hollow organ through the distal opening 220 of the at least one drain channel 218 and out via the at least one proximal opening 222.

[0155] According to some exemplary embodiments, device 202 includes at least one sensing channel 223 in endoscope 204. In some embodiments, at least one sensing channel 223 is configured to sense at least one parameter, e.g., an environmental parameter of the hollow organ, e.g., a humidity level, a temperature, and / or a pressure within the hollow organ. Optionally, device 202 includes at least one sensor associated with at least one sensing channel 223, e.g., coupled to or located within at least one sensing channel 223, for sensing the at least one parameter. In some embodiments, at least one sensing channel includes a temperature sensing channel and / or a pressure sensing channel. In some embodiments, at least one sensor includes a temperature sensor or a pressure channel.

[0156] According to some exemplary embodiments, the sensing channel 223 is disposed within the elongate body 204, e.g., travels within the elongate body to the distal end 208. Alternatively, the sensing channel 223 is disposed within the at least one exhaust channel 218, optionally between the overtube and the body 204. In some embodiments, the at least one sensing channel 223 is located within the body 204 and / or within at least one exhaust channel in a device having a narrow working channel 212, e.g., when the maximum width of the working channel 212 is less than 2 mm, e.g., less than 1.6 mm, less than 1.2 mm, or any intermediate, smaller, or larger value.

[0157] According to some exemplary embodiments, as shown, for example, in FIG. 2B , the device 202 optionally includes a cryo-fluid emitter, such as, for example, an elongated cryo-catheter 224 within the working channel 212. In some embodiments, the cryo-catheter 224 is shaped and sized to move, e.g., controllably move, within the working channel from a proximal opening of the working channel, optionally located outside the body, toward a distal opening 226 of the working channel 212 at the distal end 208. In some embodiments, the cryo-catheter 224 is controllably moved within the working channel manually or by using a motor, e.g., an electric motor, optionally operated by a user of the cryotherapy device. In some embodiments, the cryo-catheter is configured to extend at least partially from the distal opening 226 a distance, e.g., up to 5 cm, up to 2 cm, up to 0.5 cm, etc., such as up to 10 cm, or any intermediate, lesser, or greater distance.

[0158] In some embodiments, the cryo-catheter and / or body 204 includes a lock, such as a translation lock, configured to lock the cryo-catheter 224 in a particular orientation and / or position relative to the body 204. Optionally, the translation lock is configured to lock the cryo-catheter 224 in a particular orientation and / or position within the working channel 212.

[0159] According to some exemplary embodiments, the cryocatheter 224 is a flexible cryocatheter or has at least one flexible distal section. In some embodiments, the cryocatheter 224 has a maximum outer width in the range of 0.5 mm to 5 mm, such as in the range of 0.5 mm to 2 mm, in the range of 1 mm to 3 mm, in the range of 3 mm to 5 mm, or any intermediate, smaller, or larger value. In some embodiments, the flexible catheter or at least one distal section of the catheter is configured to bend at least 45 degrees, such as at least 90 degrees, at least 120 degrees, at least 150 degrees, or any intermediate, smaller, or larger value, for example, relative to the shaft 206 of the device 202 or relative to a more proximal section of the cryocatheter 224.

[0160] According to some exemplary embodiments, the cryo-catheter 224 includes at least one cryogenic fluid discharge channel, such as a cryogenic channel 230 disposed within the elongated cryogenic catheter 224. In some embodiments, the cryogenic channel includes at least one proximal opening operatively connected to a cryogenic fluid source and at least one distal opening disposed within the intermediate organ and configured to discharge a cryogenic fluid, also referred to herein as a cryogenic fluid into the hollow organ.

[0161] According to some exemplary embodiments, the cryo-catheter 224 includes at least one irrigation fluid channel, such as, for example, an irrigation channel 232. In some embodiments, the irrigation channel 232 is disposed within the elongate catheter 224. In some embodiments, the irrigation channel includes at least one proximal opening operatively connected to a irrigation fluid source and at least one distal opening configured to release irrigation fluid within the hollow organ, and optionally towards the at least one optical element 210. In some embodiments, the at least one irrigation fluid channel is formed by a tube.

[0162] According to some exemplary embodiments, the at least one flushing channel 232 and the at least one cryo-channel 230 are coupled to one another, e.g., coaxially coupled to one another. Alternatively, the at least one flushing channel 232 and the at least one cryo-channel 230 are optionally located side-by-side within the cryo-catheter body. Optionally, the at least one cryo-channel 230 is coaxially disposed within the at least one flushing channel 232. In some embodiments, movement of the cryo-catheter 224 within the working channel 212 causes the cryo-channels 230 to move together, optionally in synchrony with the flushing channel 232. Alternatively, the at least one flushing channel 232 is configured to move independently relative to the cryo-channel 230 within the cryo-catheter and / or within the working channel 212. Optionally, the movement of at least one of the cryo-catheter 224, the at least one cryo-channel 230, and / or the at least one flushing channel 232 includes axial movement and / or rotation.

[0163] Optionally, the cryocatheter 224 includes at least one sensing channel 234 used to sense at least one parameter of the hollow organ, such as, for example, at least one environmental parameter of the hollow organ, e.g., as described with respect to the sensing channel 224. In some embodiments, the cryocatheter 224 includes at least one sensing channel 234 when the working channel 212 is wide enough to accept the cryocatheter, such as, for example, when the width of the working channel is at least 1.8 mm, such as at least 2 mm, at least 1.6 mm, or any intermediate, smaller, or larger value.

[0164] According to some exemplary embodiments, device 202 optionally includes at least one additional channel 225, e.g., a sensing channel or a fluid channel, defined between an outer wall of cryo-catheter 224 and an inner wall of working channel 212. Optionally, at least one additional channel 225 terminates at working channel distal opening 226. In some embodiments, the at least one additional channel includes a temperature sensing channel and / or a pressure sensing channel, e.g., as described above with respect to channels 223 or 234. In some embodiments, device 202 optionally includes at least one additional channel when the inner diameter of working channel 212 is greater than 1.8 mm, e.g., greater than 2 mm, greater than 2.3 mm, or any intermediate, smaller, or greater value, e.g., to allow for the presence of both cryo-catheter 224 and the at least one additional channel 225 within the inner lumen of working channel 212.

[0165] According to some exemplary embodiments, at least one of the channels of the device 202 is formed from at least one tube. In some embodiments, the at least one tube is flexible or has a flexible region and / or is optionally formed from a flexible material. Alternatively or additionally, at least a portion of the tube is configured to bend at least 45 degrees, such as at least 90 degrees, at least 150 degrees, or any intermediate, smaller or larger angle, relative to an unbent portion of the tube, optionally without crimping or kinking. In some embodiments, the portion of the tube is configured to bend at least 45 degrees relative to an unbent portion of the tube while reducing the internal cross-sectional width of the bent portion by less than 10%, such as less than 5%, less than 3%, less than 1%, or any intermediate, smaller or larger percentage value relative to the internal cross-sectional width when the bent portion is unbent or straight.

[0166] According to some exemplary embodiments, the cryotherapy device 202 is operatively coupled to a control unit, for example as described in International Patent Application Publication No. WO2018142411, filed Feb. 04, 2018, the contents of which are incorporated herein by reference in their entirety. In some embodiments, the control unit is configured to control at least one of the release of cryogenic fluid from the at least one cryo-channel 230 and / or the release of irrigation fluid from the at least one irrigation channel 212, optionally according to a measurement of at least one parameter of the hollow organ.

[0167] Optionally, at least one control unit monitors the movement, e.g., guidance, of the cryotherapy device 202 and / or cryocatheter 224 toward and / or within the hollow organ. Exemplary control units and / or control of the cryotherapy device or cryocatheter are described in International Patent Application Publication No. WO2018142411, filed Feb. 04, 2018, the contents of which are incorporated herein by reference in their entirety.

[0168] Exemplary detailed cryotherapy process Reference is now made to FIG. 2C, which illustrates a detailed cryotherapy process using a flexible cryotherapy device, according to some exemplary embodiments of the present invention.

[0169] According to some exemplary embodiments, at block 250, an overtube is optionally placed around an elongated insertion tube of a flexible cryotherapy device. According to some exemplary embodiments, an overtube is optionally placed around an elongated insertion tube of a flexible cryotherapy device. In some embodiments, the elongated insertion tube is optionally inserted into an inner lumen of the overtube when the elongated insertion tube is outside the subject's body.

[0170] According to some exemplary embodiments, at block 252, a flexible cryotherapy device including a flexible endoscope is navigated into the hollow organ through an opening in the body. In some embodiments, a distal section of the flexible cryotherapy device is introduced into the hollow organ through at least one opening of the hollow organ. In some embodiments, the at least one opening of the hollow organ is an anatomical opening. Alternatively, the at least one opening of the hollow organ is a surgical opening formed by at least one surgical instrument, such as, for example, a scalpel, a scalpel, or scissors.

[0171] According to some exemplary embodiments, at block 254, a hollow organ is visualized, e.g., the lumen of the hollow organ. In some embodiments, at least one optical element located at a distal tip of a cryotherapy device, e.g., at a distal tip of an endoscope of a flexible cryotherapy device, is used to visualize the hollow organ. In some embodiments, a distal section of the endoscope is bent within the hollow device to position a distal opening of a working channel of the cryotherapy device, e.g., a working channel of the endoscope, at a target location within the hollow organ. Optionally, the endoscope is guided within the hollow organ to position the working channel distal opening proximate a distance of, e.g., less than 2 cm, less than 1 cm, less than 5 cm, or any intermediate, smaller, or larger distance, from a target tissue within the hollow organ.

[0172] Optionally, after visualizing the hollow organ, the cryotherapy device is removed from the hollow organ, for example when the specialist determines that no treatment is required.

[0173] According to some exemplary embodiments, at block 256, at least one surgical tool is optionally introduced into the hollow organ through the working channel. In some embodiments, the at least one surgical tool includes a biopsy device, a cold cup biopsy forceps, a coagulation device, and a radiofrequency therapy device. In some embodiments, the biopsy device extends from the working channel into the hollow organ and removes a biopsy sample from tissue within the hollow organ. After optionally removing the biopsy device from the working channel, the flexible cryotherapy device is removed from the body, e.g., a flexible endoscope of the cryotherapy device.

[0174] Optionally, an overtube is placed around the flexible endoscope of the cryotherapy apparatus at block 258. In some embodiments, an overtube is placed around the insertion tube of the flexible endoscope, as described at block 250.

[0175] According to some exemplary embodiments, a cryo-catheter is introduced into a working channel of a flexible endoscope at block 260. In some embodiments, the cryo-catheter is moved within the working channel into the hollow organ.

[0176] According to some exemplary embodiments, at block 261, the hollow organ is inflated, for example after penetration of the endoscope into the hollow organ. In some embodiments, the hollow organ is inflated, for example by ejecting a fluid, for example air, carbon dioxide, or other type of gas, into the hollow organ from the endoscope and / or cryo-catheter into the hollow organ. Optionally, the hollow organ is inflated by ejecting a cryogenic fluid and / or irrigation solution into the hollow organ from the endoscope and / or cryo-catheter. In some embodiments, fluid is ejected through at least one distal opening of the overtube during inflation of the hollow organ, for example to maintain a pressure level within the hollow organ within the target, optionally within a predetermined range of pressure levels.

[0177] According to some exemplary embodiments, at block 262, the cryocatheter, or at least a distal section of the cryocatheter, extends from the working channel into the hollow organ to a target distance from the endoscope. Optionally, the cryocatheter extends from the distal tip of the endoscope to a distance of up to 5 cm, such as up to 2 cm, up to 0.5 cm, etc. In some embodiments, the cryocatheter extends to a distance selected to position an opening of an irrigation fluid channel of the catheter at a target distance from the optical elements of the endoscope. Optionally, the cryocatheter extends to a distance selected to position an opening of an irrigation fluid channel of the catheter at a target orientation relative to the optical elements.

[0178] According to some exemplary embodiments, at block 264, the cryogenic fluid is released from at least one opening of a cryogenic fluid channel inside the hollow organ. In some embodiments, the cryogenic fluid is released and optionally sprayed toward the target tissue within the hollow organ. In some embodiments, the cryogenic fluid is released from an opening of a cryogenic fluid channel located in a portion of the cryo-catheter that extends from the working channel.

[0179] According to some exemplary embodiments, at block 266, irrigation fluid is discharged from within the working channel inside the hollow organ. In some embodiments, at block 264, the irrigation fluid is discharged in a timed relationship with the discharge of the cryogenic fluid, e.g., before, during, and / or after the discharge of the cryogenic fluid. In some embodiments, the irrigation fluid is discharged from at least one opening of an irrigation fluid channel, e.g., an irrigation fluid tube, disposed within the working channel of the endoscope. In some embodiments, the irrigation tube extends from the working channel into the hollow organ, with at least one opening of the irrigation tube disposed outside the working channel and inside the hollow organ. Optionally, the at least one opening of the irrigation tube is positioned and / or oriented within the hollow organ to discharge, and optionally direct, the irrigation fluid towards at least one optical element at the distal tip of the endoscope.

[0180] According to some exemplary embodiments, the irrigation fluid is directed outwardly towards the distal tip of the endoscope, such as towards at least one optical element at the distal tip. Alternatively or additionally, the irrigation fluid is directed towards the FOV and / or towards a treatment area or target site within the hollow organ.

[0181] Optionally, a flow of sensing fluid is introduced into the hollow organ before, during and / or after the release of the cryogenic fluid and / or cleaning fluid, in some embodiments the flow of sensing fluid is used to measure the pressure within the hollow organ.

[0182] According to some exemplary embodiments, at block 268, the cryocatheter is removed from the working channel.

[0183] According to some exemplary embodiments, at block 270, at least one additional instrument, e.g., a surgical tool, is optionally inserted into the working channel of the endoscope. Optionally, the at least one additional instrument is inserted into the hollow organ via the working channel. In some embodiments, the at least one additional instrument includes a biopsy device, a cutting instrument, a coagulation device, and / or a radiofrequency therapy device. In some embodiments, the at least one additional tool is configured to remove tissue from the hollow organ, e.g., tissue previously excised by the cryogenic fluid.

[0184] Exemplary Flexible Cryotherapy Device Reference is now made to Figures 3A-3B, which illustrate a flexible cryotherapy apparatus, according to some exemplary embodiments of the present invention.

[0185] According to some exemplary embodiments, a flexible cryotherapy device, such as device 302, includes an endoscope 304, such as a cystoscope, and a cryo-catheter 306 disposed, e.g., movably disposed, within a working channel of the endoscope 304. In some embodiments, the endoscope 304 includes an elongated body 308, such as an elongated insertion tube having a distal section 310 and a proximal section 312. In some embodiments, the elongated insertion tube terminates in the distal section 310, which is a guide section configured to contract and / or bend at least 45 degrees, such as, for example, 90 degrees, 120 degrees, 150 degrees, or any intermediate, lesser or greater angle.

[0186] According to some exemplary embodiments, the endoscope 304 includes a handle 314 operatively coupled to the insertion tube 308 at the proximal section 312. In some embodiments, the handle 314 is configured to control the navigation of the insertion tube 304 within the body and towards the target hollow organ, for example, by controlling the bending of the distal section 310 of the insertion tube 308. In some embodiments, the control handle 312 includes at least one guidance controller 316 operatively coupled to the insertion tube 308 and / or to the distal section 310 of the insertion tube 308. In some embodiments, the at least one guidance controller is configured to control the guidance of the distal section 310, for example, by applying a mechanical force to the insertion tube 308 and / or the distal section 310, for example, by stretching a cable attached to a guidance section, such as the distal section 310.

[0187] According to some exemplary embodiments, the device 302 includes at least one exhaust channel 318, such as an exhaust channel having at least one distal inlet opening 320 and at least one proximal outlet opening 322. In some embodiments, the at least one exhaust channel 318 is configured to exhaust fluids, e.g., liquids, gases, and / or particles, from a hollow organ into which the distal section 310 of the device 302 is introduced. In some embodiments, the fluids and / or particles are passively or actively introduced into the distal inlet opening 320 disposed within the hollow organ and exhausted from the at least one exhaust channel 318 via the at least one proximal outlet opening 322. In some embodiments, the passive exhaust includes exhaust based on a difference in pressure level between the hollow organ and the external environment. In some embodiments, the active exhaust includes exhaust using a vacuum pump that reduces the pressure level in the at least one exhaust channel compared to the pressure level in the hollow organ.

[0188] According to some exemplary embodiments, the device 302 includes at least one exhaust flow regulator 324 coupled to the at least one exhaust channel 318. Optionally, the exhaust flow regulator 324 includes at least one proximal outlet opening 322.

[0189] According to some exemplary embodiments, the at least one exhaust channel 318 is optionally formed by a tube that at least partially or completely surrounds the insertion tube 308. Optionally, the insertion tube 308 is coaxially disposed within the at least one exhaust channel 318. In some embodiments, the lumen of the at least one exhaust channel 318 through which fluids and / or particles are exhausted is formed, for example, between an overtube that forms the at least one exhaust channel and an outer surface of the insertion tube 318. In some embodiments, the at least one exhaust channel 318 is slidable, e.g., selectably slidable, relative to the insertion tube 308.

[0190] According to some exemplary embodiments, the at least one distal inlet opening 320 optionally comprises multiple openings in a wall of the exhaust channel 318, such as at a distal end of the exhaust channel 318. In some embodiments, the distal end is a tapered distal end shaped and sized to fit into and / or around the insertion tube 308. Optionally, the tapered distal end allows for a gradual transition between the exhaust channel and the insertion tube.

[0191] According to some exemplary embodiments, the endoscope 304 includes at least one optical element, such as, for example, optical element 326, at the distal tip 328 of the distal section 310. In some embodiments, the optical element includes at least one of a window, an aperture, an optical sensor, a camera, a lens, and / or a light source.

[0192] According to some exemplary embodiments, endoscope 304 includes a working channel that travels within an insertion tube 308 having at least one working channel distal opening 330 and at least one working channel proximal opening. In some embodiments, the working channel is shaped and sized to receive a cryo-catheter 306 that travels within the working channel and is optionally configured to extend from distal opening 330 when distal opening 330 is disposed within a hollow organ, for example.

[0193] 3B, the distal opening 334 of the exhaust channel is formed between an outer surface of the insertion tube 308 and an inner surface of a tube, such as an overtube 332 that forms the exhaust channel. In some embodiments, the distal opening 334 is shaped as a ring or arc, optionally at least partially surrounding the insertion tube 308.

[0194] According to some exemplary embodiments, the device 302 includes at least one insertion tube splitter 311, such as, for example, a splitting connector coupled to the insertion tube 308 and configured to split the proximal opening of the insertion channel into two or more openings.

[0195] According to some exemplary embodiments, as shown, for example, in FIG. 3C , the cryo-catheter 306 includes a cryo-fluid channel, such as, for example, a cryo-fluid tube 313 disposed, for example, coaxially within a flushing fluid channel 315. In some embodiments, the flushing fluid channel 315 includes multiple openings, for example, two or more flushing openings, in a wall of the channel 315. In some embodiments, the flushing openings are distributed around the circumference of the flushing fluid channel 315, for example, to enable ejection and / or direction of the flushing fluid towards the optical element 326.

[0196] According to some exemplary embodiments, the cryo-catheter 306 extends from a distal opening of the working channel 330 to position the opening 317 of the cryo-fluid channel 313 close to a distance of, for example, up to 3 cm, up to 2 cm, up to 1 cm, up to 0.5 cm, up to 4 cm, or any intermediate, lesser, or greater distance, from the target tissue within the hollow organ. Alternatively or additionally, the cryo-catheter 306 extends from the working channel 330 to a distance that places at least one irrigation opening of the plurality of irrigation openings at a desired location and / or orientation relative to the optical element 326. Optionally, the distal opening of the cryo-fluid channel 313, such as opening 317, is located distal to the irrigation fluid channel 315. Optionally, the cryo-fluid channel 313 is configured to move, such as, for example, to controllably move within the irrigation fluid channel 315. Alternatively, the cryo-fluid channel 313 and the irrigation fluid channel 315 are coupled to one another and optionally move synchronously or together.

[0197] Reference is now made to FIG. 3D, which illustrates an endoscope 304, such as a cystoscope, according to certain exemplary embodiments of the present invention.

[0198] According to some exemplary embodiments, the endoscope 304 includes an elongated insertion tube 308 terminating in a distal section 310, e.g., a navigable section, as described above. In some embodiments, the proximal end of the insertion tube is coupled to a handle 312. In some embodiments, the length 336 of the insertion tube 308 is in the range of 20-100 cm, e.g., 30-70 cm, 25-60 cm, 40-80 cm, etc., or any intermediate, smaller, or larger value range. In some embodiments, the length 338 of the distal section 310, e.g., a navigable section, is in the range of 3-9 cm, e.g., 3-8 cm, 4-7 cm, 5-9 cm, etc., or any intermediate, smaller, or larger value range.

[0199] Exemplary Endoscope Insertion Reference is now made to Figures 4A-4D, which illustrate the configuration of an endoscope, such as a flexible cystoscope, when entering a hollow organ, according to some exemplary embodiments of the present invention.

[0200] According to some exemplary embodiments, the cryotherapy device is introduced into the hollow organ by first navigating an endoscope into the hollow organ. In some embodiments, the endoscope includes an insertion tube that terminates in a flexible, e.g., bendable, distal section 310. In some embodiments, the insertion tube includes a working channel that terminates in a distal opening 330.

[0201] According to some exemplary embodiments, as shown, for example, in FIGS. 4A-4C, an overtube 332 disposed around the insertion tube 308 forms, together with a distal drainage opening 334, at least one drainage channel between the overtube 332 and the insertion tube 308. In some embodiments, the overtube 332 is located proximal to the distal section 310 during navigation of the endoscope and / or when the distal section 310 is disposed within the hollow organ. Optionally, the distal drainage opening 334 is disposed within the hollow organ, for example, to allow drainage of fluids and / or particles from within the hollow organ. Drainage of fluids and / or particles from within the hollow organ may be important to maintain the level of pressure within the hollow organ within a predetermined range of pressure levels, for example, to prevent high pressure levels that may cause damage to hollow organ tissue, and to prevent pressure levels that are too low for tissue distension, for example, for purposes of navigation and / or visualization inside the hollow organ.

[0202] According to some exemplary embodiments, the working channel opening 330 remains open during navigation of the endoscope into the hollow organ. Instead, the opening is closed with a removable plug 336 during the process of navigation of the endoscope into the hollow organ. In some embodiments, closing the opening 330 with the removable plug 336 may, for example, prevent tissue and unwanted bodily matter from entering the working channel 340 of the endoscope. In some embodiments, the removable plug 336 is coupled to a wire and / or flexible rod 338 that is optionally disposed within the working channel 340. Optionally, the wire and / or flexible rod 338 is coupled to the handle 312. In some embodiments, contraction of the wire and / or flexible rod 338 removes the plug 336 from the opening 330 to allow, for example, insertion of a cryo-catheter and / or other instrument into the hollow organ via the working channel 340.

[0203] Exemplary Cryofluid Catheter Reference is now made to Figures 5A and 5B, which illustrate a cryo-fluid catheter, eg, a cryo-catheter, according to certain exemplary embodiments of the present invention.

[0204] According to some exemplary embodiments, the cryo-catheter 502 includes an elongate body 504 having a distal section 506. In some embodiments, the cryo-catheter 502 includes at least one cryo-fluid conduit 508 having at least one distal opening 510 configured to or formed by the cryo-fluid conduit 508 to allow release of a cryo-fluid, e.g., a cryo-fluid, from a cryo-fluid channel 512 within the cryo-fluid conduit 508.

[0205] According to some exemplary embodiments, as shown, for example, in Figures 5B and 5C, the cryocatheter 502 includes at least one irrigation channel 514 disposed within the elongate body 504. In some embodiments, the irrigation channel 514 includes one or more, e.g., multiple, openings, for example, in the distal section 506 of the elongate body 504. In some embodiments, the irrigation channel opening is shaped, sized, and / or positioned to eject irrigation fluid from the irrigation channel 514 into the hollow organ. Optionally, the irrigation channel opening is shaped, sized, and / or positioned to direct irrigation fluid toward at least one optical element of the endoscope, such as, for example, optical element 326 shown in Figures 3A-3C.

[0206] In some embodiments, the washing fluid openings are axially and / or angularly distributed around the washing fluid channel 514. In some embodiments, the washing fluid openings are angularly distributed to completely surround the washing channel 514. Alternatively, the washing fluid openings are angularly distributed over an arc that defines an angle of at least 2 degrees, such as, for example, 5 degrees, 10 degrees, 30 degrees, 90 degrees, 180 degrees, or any intermediate, smaller, or larger angle. In some embodiments, the washing fluid openings have a maximum width or maximum diameter in the range of 0.01 mm to 2 mm, such as, for example, 0.01 mm to 1 mm, 0.05 mm to 0.7 mm, 0.1 mm to 1.5 mm, or any intermediate, smaller, or larger value.

[0207] According to some illustrative embodiments, the freezing channel 512 is coaxially disposed within the cleaning fluid channel 514. In some embodiments, the cryogenic fluid channel is joined, e.g., bordered, to the cleaning fluid channel 514 along, e.g., at least 40%, at least 50%, at least 70%, at least 80%, such as at least 30%, or any intermediate, smaller, or larger percentage value, of the length of the cryogenic fluid channel 512.

[0208] According to some exemplary embodiments, the flushing channel 514 includes at least one distal forward facing opening, such as, for example, opening 520, configured to direct flushing fluid in axial alignment with the cryogenic fluid discharged from opening 510. In some embodiments, the cryo-catheter 502 includes at least one flushing fluid flow director, such as, for example, flow director 522, optionally disposed within the flushing channel 514. In some embodiments, the flow director, such as, for example, flow director 522, is disposed within the distal end of the flushing channel 514, between the flushing channel 514 and the cryogenic fluid channel 512. In some embodiments, the flow director 522 includes an opening 520 that at least partially surrounds the cryogenic fluid channel 512 passing through the flow director 522. Optionally, the flow director is a flow regulator configured to regulate the amount of flushing fluid directed toward the optical element and the amount of flushing fluid directed toward the tip of the cryogenic fluid channel, such as, for example, toward opening 510.

[0209] According to some exemplary embodiments, the axial, e.g., longitudinal, distance 524 between the cryogenic-fluid channel opening 510 and the washing fluid channel opening is a fixed distance, e.g., in the range of (-) 1-0.1 mm, (-) 0.5-0.5 mm, 0-1 mm, 0-3 mm, 0-5 mm, 0-7 mm, etc., (-) 1-10 mm, or any intermediate, smaller, or larger value. In some embodiments, the cryogenic-fluid channel opening 510 is distal to the washing fluid channel opening. Instead, the cryogenic-fluid channel 512 is configured to move axially, e.g., to controllably move within the washing fluid channel 514, such that the axial distance 524 varies.

[0210] According to some exemplary embodiments, the cryo-catheter 502 includes at least one sensor or two or more sensors, such as, for example, a temperature sensor and / or a pressure sensor. In some embodiments, the at least one sensor is coupled to and / or disposed within the body 502. Optionally, the at least one sensor is disposed within at least one of the irrigation fluid channel, the cryogenic fluid channel, and / or within at least one additional channel.

[0211] According to some exemplary embodiments, the at least one sensor includes a thermocouple or temperature sensing surface, optionally shaped as an arc or as a ring. In some embodiments, the temperature sensing surface, such as, for example, temperature sensing surface 526, is coupled to an outer surface of body 504. Optionally, surface 526 is located proximal to the irrigation fluid opening, for example, to not impede and / or block the release of irrigation fluid through the irrigation fluid opening and / or to not be affected by the flow of irrigation fluid. Optionally, the temperature sensing surface is electrically connected to the control unit by electrical wiring 528, disposed within elongate body 504 of the cryocatheter.

[0212] Exemplary Cryogenic Fluid Channels Reference is now made to Figures 6A and 6B, which illustrate cryogenic fluid channels, according to some exemplary embodiments of the present invention.

[0213] According to some exemplary embodiments, the cryogenic-fluid channel of the cryo-catheter is flexible or has at least one flexible section, such as, for example, a distal section that terminates at a distal opening of the cryogenic-fluid channel. In some embodiments, as shown, for example, in FIG. 6A, the cryogenic-fluid channel is formed from an elongated cryogenic-fluid tube 602 that includes a distal flexible section 604. In some embodiments, the distal flexible section 604 is configured to bend at an angle 611 relative to a longitudinal axis 613 of the proximal section 606. In some embodiments, the angle 611 is at least 45 degrees, or any intermediate, smaller, or larger angle, such as, for example, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, etc.

[0214] According to some exemplary embodiments, the flexible section 604 is thinner than the proximal section 606, having a width or outer diameter ranging from 0.1 to 1.2 mm, such as 0.1 to 0.7 mm, 0.1 to 1 mm, 0.5 to 1.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the length of the distal section 604 of the cryogenic-fluid tube 602 is in the range of 20 to 150 mm, such as 20 to 50 mm, 30 to 100 mm, 50 to 150 mm, or any intermediate, smaller, or larger value. In some embodiments, the radius of curvature of the flexible section 604 is smaller than the radius of curvature of the proximal section 606.

[0215] According to some exemplary embodiments, as shown, for example, in FIG. 6B, a cryotherapy device, such as device 610, is introduced into a hollow organ, such as hollow organ 612. In some embodiments, an endoscope 614, at least partially surrounded by an overtube 616, is introduced into the hollow organ 612, optionally disposing a distal opening 617 of the overtube 616 within the hollow organ 612. In some embodiments, the endoscope 614 includes a distal guide section 618 and an insertion tube 620. Optionally, the insertion tube 620 terminates at the distal guide section. In some embodiments, the guide section 618 is configured to bend relative to the insertion tube 620, for example, at an angle of at least 45 degrees, such as at least 60 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, or any intermediate, lesser, or greater angle. In some embodiments, the guide section 618 bends once the endoscope is guided to a desired, selected, and / or predetermined location within the hollow organ 612. Optionally, the guide section 618 bends within the hollow organ 612 when at least one optical element of the endoscope, such as optical element 326 shown in Figures 3A-3C, is used to visualize the interior of the hollow organ 612.

[0216] According to some exemplary embodiments, the length of the navigable section 618 of the endoscope 614 is in the range of 20 mm to 150 mm, e.g., 50 to 150 mm, 70 mm to 120 mm, 30 to 100 mm, etc., or any intermediate, smaller, or larger value range. In some embodiments, the length of the insertion tube 620 is in the range of 250 to 400 mm, e.g., 250 to 400 mm, 350 to 450 mm, 400 to 700 mm, etc., or any intermediate, smaller, or larger value range. In some embodiments, the length of the distal flexible section 604 of the cryogenic-fluid tube 602 is at least the length of the navigating portion 618 or is selected according to the length of the navigating portion 618.

[0217] A potential advantage of placing a thin cryotube within the guidance region of the endoscope may be to allow bending of the cryotube along with bending of the guidance region while efficiently delivering cryogenic fluid through the cryotube into the hollow organ.

[0218] Example Flow of Fluid Reference is now made to Figures 7A-7B, which illustrate flow to and / or from a cryotherapy device, according to some exemplary embodiments of the present invention.

[0219] According to some exemplary embodiments, the distal section 306 of the cryo-catheter, disposed outside the working channel of the endoscope, includes at least one distal opening 510 of a cryogenic fluid tube 512 configured to direct, e.g., spray, a cryogenic fluid toward a target site 702 located distally of the cryo-catheter. In some embodiments, the irrigation fluid channel 514 includes at least one opening, e.g., openings 704 and 706, configured to direct irrigation fluid toward at least one optical element 326 of the endoscope. In some embodiments, the openings are disposed in a wall of the irrigation fluid channel 514, optionally on the periphery of the irrigation fluid channel. Alternatively or in addition, the irrigation fluid channel 514 includes at least one forward-facing distal opening, e.g., opening 708, configured to direct irrigation fluid toward the target area 702. Alternatively or in addition, the irrigation fluid channel 514 includes at least one opening in a wall of the irrigation fluid channel 514 configured to direct irrigation fluid toward a field of view (FOV) 710 located between the at least one optical element 326 and the target site.

[0220] According to some exemplary embodiments, the release of irrigation fluid from the irrigation channel into the hollow organ, e.g., toward the target site 702, toward the FOV 710, and / or toward at least one optical element 326, is performed synchronously and / or following the release of cryogenic fluid into the hollow organ, e.g., through the opening 510.

[0221] According to some exemplary embodiments, fluid and / or particles are exhausted through openings 334 in overtube 332. In some embodiments, exhausting of fluid and / or particles through openings 334 is optionally performed according to pressure levels within the hollow organ and / or to reach a particular range of pressure levels within the hollow organ.

[0222] According to some exemplary embodiments, as shown, for example, in FIG. 7B, the cryotherapy device includes at least one additional channel, such as, for example, a pressure sensing channel 712 located in the working channel of the endoscope. In some embodiments, the pressure sensing channel 712 is disposed between the working channel wall and the outer wall of the cryocatheter. Optionally, the pressure sensing channel 712 at least partially or completely surrounds the cryocatheter disposed in the working channel. In some embodiments, the pressure sensing mechanism uses a constant flow with a constant pressure drop through the channel, with a pressure sensor at the proximal end of the channel, for example, inside the control unit. Optionally, when the pressure in the hollow organ changes, the pressure sensor changes correspondingly so that the pressure drop through the channel remains constant, so that the pressure inside the hollow organ can be calculated according to the measured proximal pressure and the known constant pressure drop.

[0223] Alternatively, as shown, for example, in Figures 14A-14C, if the working channel of the endoscope is too narrow to accommodate the cryocatheter and the at least one sensing channel, e.g., a temperature sensing channel or a pressure sensing channel, the at least one sensing channel may be integrated into the endoscope or pass within a lumen formed between the overtube and the endoscope. Instead, the at least one sensing channel is located within an overtube that includes multiple inner lumens.

[0224] Exemplary Cryocatheter Stopper According to some exemplary embodiments, the cryo-catheter is movable within the working channel of the endoscope, for example, to allow advancement of the cryo-catheter distally of the endoscope to apply cryogenic fluid and / or irrigation fluid. Alternatively or additionally, the cryo-catheter is movable within the working channel, for example, to cover the cryo-catheter during navigation within the body towards the hollow organ and / or to allow retraction of the cryo-catheter from the working channel and insertion of at least one additional surgical tool into the hollow organ. In some embodiments, the cryotherapy device includes a stopper configured to limit or stop movement, e.g., axial movement and / or rotation, of the cryo-catheter within the working channel. Reference is now made to FIGS. 8A-8D, which illustrate a movement stopper, e.g., a movement lock, according to some exemplary embodiments of the present invention.

[0225] According to some exemplary embodiments, a cryotherapy device, such as device 802, includes a cryocatheter, such as cryocatheter 804, configured to move within a working channel 806 of device 802, such as a working channel of an endoscope of device 802. Optionally, cryocatheter 804 is fully retracted from working channel 806 or is not disposed within working channel 806, for example, when navigating the cryotherapy device within a target hollow organ.

[0226] According to some exemplary embodiments, as shown, for example, in FIG. 8A , the device 802 includes a stopper, e.g., lock 808, configured to stop or limit axial movement of the cryo-catheter 804 within the working channel 806. In some embodiments, the lock 808 includes at least one protrusion 810, e.g., a ridge, coupled to the working channel 806 and shaped and sized to fit into the channel 812 on the outer surface of the cryo-catheter. In some embodiments, the channel 812 at least partially surrounds the cryo-catheter 804. Optionally, the channel 812 is shaped as a ring. Alternatively, the channel is shaped as an arc. In some embodiments, when the protrusion 810 is inserted into the channel 812, the catheter 804 is locked into a particular axial location within the working channel 806, e.g., longitudinally, while optionally allowing the catheter 804 to rotate within the working channel 806 as the protrusion 810 moves within the channel 812. In some embodiments, the degree of rotation is determined based on the length of the channel 812.

[0227] According to some exemplary embodiments, a lock is coupled to the cryo-catheter 804 and a protrusion on the lock is shaped and sized to fit within the working channel 806 or within a locking element coupled to the working channel 806.

[0228] According to some exemplary embodiments, the lock includes a protrusion 816, e.g., a ridge, e.g., lock 814, as shown in, for example, FIGS. 8B-8D. In some embodiments, the lock 814 is configured to be coupled to a distal end of an endoscope 818. In some embodiments, the protrusion 816 is shaped and sized to fit within a pointed recess or pointed opening of the cryo-catheter, e.g., into an irrigation channel opening. In some embodiments, inserting the protrusion 816 into the pointed recess or pointed opening locks the cryo-catheter into a particular longitudinal and rotational position within the working channel. In some embodiments, locking the cryo-catheter into a particular longitudinal and rotational position allows for placement of a particular irrigation fluid opening around the cryo-catheter at a desired location relative to at least one optical element 326 and / or relative to the FOV 710, as shown in FIG. 7B.

[0229] Exemplary Cleaning Fluid Flow Director According to some exemplary embodiments, the cryotherapy device includes at least one irrigation fluid flow director configured to direct irrigation fluid from selected irrigation fluid openings in the irrigation channel in a particular direction. Reference is now made to Figures 9A and 9B, which show at least one irrigation fluid flow director, according to some exemplary embodiments of the present invention.

[0230] According to some exemplary embodiments, the cryotherapy device includes at least one irrigation flow director, such as, for example, an irrigation flow director 902 coupled to an endoscope 904. The irrigation flow director 902 is coupled, such as, for example, attached to a distal end 906 of the endoscope. In some embodiments, as shown, for example, in FIG. 9A, the irrigation flow director 902 partially surrounds a distal opening of a working channel of the endoscope 902 through which the cryocatheter 908 exits.

[0231] According to some exemplary embodiments, the director 902 is configured to block cleaning fluid openings positioned to direct cleaning fluid away from at least one optical element 326 while leaving unblocked cleaning fluid openings positioned to direct cleaning fluid towards the optical element 326.

[0232] According to some exemplary embodiments, the director 902 is shaped and sized to partially surround the irrigation fluid channel of the cryo-catheter 908. In some embodiments, the director 902 surrounds at least 25% of the circumference of the portion of the irrigation channel that includes the irrigation fluid openings, such as at least 50% of the circumference, at least 75% of the circumference, at least 80% of the circumference, at least 90% of the circumference, at least 95% of the circumference, or any intermediate, smaller, or larger percentage value of the circumference of the irrigation channel portion that includes the irrigation openings.

[0233] Optionally, lock 814 shown in Figures 8A-8D is used as a cleaning fluid director.

[0234] Exemplary Temperature Sensing According to some exemplary embodiments, the cryotherapy device includes at least one sensor for sensing the temperature in at least one channel of the cryo-catheter and / or in the hollow organ. In some embodiments, it is important to sense the temperature in the hollow organ, for example to avoid damaging tissue and / or affecting optical elements, if the temperature is lower than a predetermined value. Reference is now made to Figures 10A-10D, which show temperature sensing by a cryotherapy device, according to some exemplary embodiments of the present invention.

[0235] According to some exemplary embodiments, the cryotherapy device includes at least one temperature sensor, such as a thermal sensing surface 1002 coupled to an outer surface of a cryo-catheter 1004. In some embodiments, the thermal sensing surface 1002 is coupled to a surface of the cryo-catheter 1004 at a section configured to remain within a working channel of an endoscope 1008. In some embodiments, the thermal sensing surface 1002 at least partially surrounds the cryo-catheter 1004. Optionally, the thermal sensing surface is shaped as a ring or as an arc. In some embodiments, the thermal sensing surface 1002 is electrically connected by wires 1010 to a control unit located outside the subject's body. In some embodiments, the wires are disposed within the cryo-catheter located inside the working channel of the endoscope 1008. Optionally, the thermal sensing surface 1002 is configured to sense a temperature within the working channel, optionally near the working channel exit, such as at the working channel distal opening, such as near the cryo-catheter.

[0236] According to some exemplary embodiments, as shown, for example, in Figure 10C, a cryotherapy device includes at least one thermal sensing surface coupled to a distal section 1014 of a cryocatheter, for example a cryocatheter configured to be positioned outside a working channel of an endoscope within a hollow organ. Optionally, the sensing surface on the distal section 1014 of the cryocatheter is configured to sense a temperature within the hollow organ.

[0237] According to some exemplary embodiments, as shown, for example, in FIG. 10D, the cryotherapy device includes at least one sensor, such as, for example, a temperature sensor integrated into the endoscope 1018.

[0238] According to some exemplary embodiments, the cryotherapy device includes at least one temperature located on at least one of the surfaces of the cryo-catheter in a section disposed within a working channel of an endoscope of the device, the surface of the cryo-catheter in a section disposed outside the working channel, and / or integrated or coupled to the endoscope.

[0239] Exemplary Discharge According to some exemplary embodiments, the cryotherapy device includes at least one drainage channel configured to drain fluids from the hollow organ, for example to prevent buildup of pressure levels within the hollow organ, which may cause tissue damage and / or tissue tears. Reference is now made to Figures 11A-11C, which show a cryotherapy device having at least one drainage channel, according to some exemplary embodiments of the present invention.

[0240] According to some exemplary embodiments, the cryotherapy device 1102 includes an endoscope 1104, a cryocatheter 1106 disposed at least partially and optionally coaxially within the endoscope 1104, and an outer sheath, e.g., an overtube 1108, at least partially surrounding the endoscope 1104. In some embodiments, the overtube 1108 is selectively slidable on the endoscope, e.g., to control the distance between a distal opening of the overtube and the distal tip of the endoscope within the hollow organ. In some embodiments, the overtube 1108 forms at least one drainage channel within the lumen between the overtube 1108 and the endoscope 1104. In some embodiments, the overtube 1108 includes at least one distal inlet opening, e.g., a distal inlet 1110 shaped and sized to receive fluid from within the hollow organ, and at least one proximal outlet opening, e.g., a proximal outlet 1112 for releasing fluid drained from the drainage channel.

[0241] According to some exemplary embodiments, the device further includes at least one seal, such as, for example, a seal 1114 disposed in the at least one exhaust channel proximal to the outlet 1112. In some embodiments, the seal 1114 is disposed between the overtube 1108 and the endoscope 1104 and configured to seal the at least one exhaust channel proximal to the outlet 1112. Optionally, the seal 1114 is molded as a ring. In some embodiments, the seal 1114 is formed from rubber, silicone, or any other sealing material. Alternatively, the seal 1114 includes at least one leaf seal configured to allow relative movement and maneuverability between the overtube 1108 and the endoscope 1104 while preventing retrograde leakage such that exhaust is directed toward a planned outlet, such as, for example, a vent element optionally including a check valve 1113.

[0242] According to some illustrative embodiments, for example as shown in Figures 11A and 11B, the device includes at least one exhaust flow control valve 1116 fluidly connected to at least one exhaust channel and optionally includes at least one outlet opening of the exhaust channel, such as outlet 1112.

[0243] According to some exemplary embodiments, the exhaust flow regulator valve 1116 includes one or more outlet openings of at least one exhaust channel, such as at least one outlet opening for passive exhaust, e.g., outlet opening 112, and at least one outlet opening for active exhaust, e.g., outlet opening 1118. In some embodiments, outlet opening 1112 optionally includes a check valve 1113. In some embodiments, outlet opening 1118 optionally includes an adapter for connecting the exhaust flow regulator valve to an external exhaust device, such as, for example, to a pump.

[0244] Reference is now made to Figures 11D and 11E, which illustrate changes in ejection conditions, according to some exemplary embodiments of the present invention.

[0245] According to some exemplary embodiments, the flow regulator is configured to switch between at least two outlet openings, e.g., outlet openings 1112 and 1118, during operation of the cryotherapy device. In some embodiments, at least one opening, e.g., opening 1112, includes a check valve 1113. According to some exemplary embodiments, during a cryogenic operating cycle when the cryogenic fluid is released in the hollow organ, the check valve in opening 1112 is used for fluid evacuation, e.g., to maintain a minimum pressure level in the hollow organ. In some embodiments, as shown, e.g., in FIG. 11E, when the cryogenic fluid is released in the hollow organ, the pressure level rises and the flow regulator 1116 directs the flow in the evacuation channel towards the outlet 1118, which is configured to allow a higher flow rate compared to the opening of the check valve 1113.

[0246] According to some exemplary embodiments, the flow regulator 1116 alters the exhaust flow path between the two openings based on a signal received from at least one sensor, such as, for example, a pressure sensor. Optionally, the flow regulator 1116 alters the exhaust flow path between the two openings automatically, such as, for example, using a movable flow path selector, such as, for example, a movable seal, disposed within the flow regulator 1116. In some embodiments, the flow regulator movable seal is configured to move between at least one first state in which flow is directed toward opening 1112 and at least one second state in which flow is directed toward at least one different opening, such as, for example, toward opening 1118.

[0247] According to some exemplary embodiments, as shown, for example, in Figures 11D and 11E, the flow control valve 1116 includes a cryogenic release actuation button, such as, for example, actuation button 1120. In some embodiments, movement of the actuation button is configured to release cryogenic fluid from the cryo-catheter, for example, into a hollow organ, and to switch the discharge flow path from opening 1112 to opening 1118. In some embodiments, the actuation button electrically actuates the cryogenic fluid release, for example, when the actuation button is moved toward the flow control valve 1116 and an electrical contact 1122 of the button contacts an electrical contact 1124 on the flow control valve 1116. Additionally, movement of the actuation button 1120 mechanically moves the moveable seal. Alternatively, movement of the actuation button electrically actuates the cryogenic fluid release, for example, by actuating an electric motor to move the moveable seal.

[0248] Reference is now made to Figures 12A-12C, which illustrate overtubes having different distal ends, according to some exemplary embodiments of the present invention.

[0249] According to some exemplary embodiments, as shown, for example, in FIG. 12A , overtube 1230 surrounds endoscope 1232 and has at least one distal opening 1234 between endoscope 1232 and overtube 1230. In some embodiments, overtube 1230 and opening 1234 have substantially similar inner diameters, e.g., the inner diameter varies less than 0.5%, such as less than 0.3%, less than 0.1%, of the inner or outer diameter of the endoscope along at least 95% of the length of overtube 1230. Optionally, the wall of overtube 1230 is thin, e.g., having a thickness ranging from 0.05 mm to 0.1 mm, 0.8 mm to 0.2 mm, 0.1 mm to 0.3 mm, 0.05 mm to 0.4 mm, or any intermediate, smaller, or larger value.

[0250] According to some exemplary embodiments, as shown, for example, in FIG. 12B, an overtube 1236 surrounding an endoscope 1232 has a tapered distal end 1238. In some embodiments, the tapered distal end 1238 includes at least one or more distal openings of a drainage pathway formed between the overtube 1236 and the endoscope 1232. In some embodiments, the openings are located in a wall of the tapered distal end 1238. A potential advantage of locating the drainage openings at the tapered distal end of the cryotube may be to prevent blockage of the drainage openings by tissue attached to the non-tapered straight wall of the overtube. An additional potential advantage of a tapered end may be that the tapered end allows for easier and / or smoother insertion of the overtube into the body following insertion of the endoscope.

[0251] 12C, the overtube 1242 includes a tapered distal end 1244 and at least one or more distal openings 1246 of the exhaust channels located in a wall of a straight section of the overtube 1242. Optionally, the distal openings are located in the wall of the tapered region and in the wall of the straight region of the overtube.

[0252] Exemplary Split Connector According to some exemplary embodiments, for delivery of a cryo-catheter into a hollow organ and for using the working channel of the endoscope to form at least one channel between, for example, the cryo-catheter and a working channel wall, a connector, e.g., a split connector, is coupled to a proximal opening of the working channel.

[0253] Reference is now made to Figures 6A and 6B, which illustrate a split connector for a working channel of an endoscope, according to some exemplary embodiments of the present invention.

[0254] 13A, an endoscope 1302, such as, for example, an endoscope of a cryotherapy device, includes an insertion tube 1304 coupled to a handle 1306. In some embodiments, the handle 1306 is shaped and sized to allow for grasping the handle body with one or both hands while manipulating at least one button and / or switch on the handle 1306, for example, to control the insertion and guidance of the insertion tube 1304 within the subject's body.

[0255] According to some exemplary embodiments, the endoscope 1302 includes at least one working channel 1308 within the insertion tube 1304 and optionally along at least 50%, such as at least 60%, at least 80%, at least 90%, or any intermediate, lesser, or greater percentage value, of the entire length of the insertion tube 1304. Optionally, the working channel 1308 passes within the handle 1306. In some embodiments, the working channel 1308 includes at least one proximal opening, such as, for example, opening 1310, optionally disposed at a proximal end of the working channel. In some embodiments, the proximal opening 1310 includes at least one valve 1312, such as, for example, a one-way valve. In some embodiments, the valve 1312 includes a check valve, such as, for example, a duckbill check valve. Alternatively, the proximal opening of the working channel includes a lock without a valve.

[0256] 13B and 13C , a split connector, such as split connector 1314, includes a body 1316 that includes an inner lumen 1318. In some embodiments, the inner lumen includes an outlet opening at a first end 1320 of the body 1316 and two or more inlet openings, such as openings 1322 and 1324, each at a different end of the body 1318. In some embodiments, the split connector is a Y-connector. In some embodiments, the body 1318 includes at least one branch 1326 that splits the inner lumen 1318 into two spaced apart lumens, each terminating in an opening at openings 1322 and 1324.

[0257] According to some exemplary embodiments, as shown, for example, in FIG. 13D , the first end 1320 of the split connector 1314 is shaped and sized to penetrate into the opening 1310, optionally into the valve 1312, such as into a duckbill valve of the working channel. In some embodiments, the first end 1320 of the split connector 1314 is shaped and sized to form a flow path between the working channel and an inner lumen 1318 of the split connector 1314. In some embodiments, the split connector 1314 is locked into the opening 1310 of the working channel 1308 upon insertion of the first end 1320, which optionally includes a plug, into the duckbill valve. Optionally, the first end 1320 is a tapered end shaped and sized to fit into the check valve 1312, such as into a duckbill check valve. Optionally, opening 1310 includes a lock, such as, for example, a Luer lock, to allow coupling of split connector 1314 to working channel proximal opening 1310 .

[0258] According to some exemplary embodiments, at least one inlet opening of the split connector 1314 is connected to a tube 1311 forming a fluid flow path 1313, e.g., a sealed flow path, via a split connector 1314 having a working channel. Optionally, the flow path 1313 is used to deliver a pressure sensing flow into the working channel. In some embodiments, the different inlet openings of the split connector 1314 include a connector, e.g., a gasket 1326, that includes a seal 1328. In some embodiments, the seal 1326 includes a leaf seal configured to allow insertion of a cryo-catheter 1330 through the gasket 1326 and the split connector 1314 into the working channel of the endoscope without allowing egress of fluid through the connector 1326, e.g., fluid from the flow path 1313.

[0259] Exemplary Separated Channels According to some exemplary embodiments, the working channel of the endoscope is narrow, e.g., having a maximum inner diameter in the range of 1-6 mm, e.g., 1-5 mm, 2-5 mm, 2.5-5 mm, or any intermediate, smaller, or larger value. In some embodiments, a cryo-catheter disposed within the narrow working channel includes at least one irrigation fluid channel and at least one cryogenic fluid channel, while at least one additional channel, optionally used for sensing, is part of the endoscope, e.g., in one or more lumens of the overtube body or is located within the drainage channel. Optionally, the overtube includes at least one inner lumen, e.g., a drainage lumen and / or a sensing lumen. Reference is now made to FIGS. 14A-14C, which include at least one sensing channel of a cryotherapy device located outside the working channel, according to some exemplary embodiments of the present invention.

[0260] According to some exemplary embodiments, the working channel of the endoscope is narrow, allowing the cryo-catheter 1404 to be inserted without sufficient space between the cryo-catheter 1404 and the wall of the working channel to form at least one additional channel, such as, for example, a sensing channel. In some embodiments, the cryotherapy device 1402 including the endoscope 1406 includes an overtube 1410 that forms an exhaust channel between the overtube 1410 and the endoscope 1406. In some embodiments, at least one channel, such as, for example, two or more channels, such as, for example, channel 1412, optionally passes between the overtube 1410 and the endoscope 1406 within the exhaust channel. In some embodiments, the channel 1412 includes at least one pressure sensing channel and at least one temperature sensing channel. Alternatively, as shown, for example, in FIG. 10D, at least one sensing channel, such as, for example, two or more sensing channels, is integrated into the endoscope body, such as, for example, a single-use endoscope.

[0261] According to some exemplary embodiments, at least one or both of the channels 1412 extend from the overtube 1410 opening 1416 towards the distal tip 1418 of the endoscope 1406. In some embodiments, the cryotherapy device 1402 includes at least one tip holder 1414 coupled to the endoscope, e.g., at the distal tip 1418, and configured to hold the channel 1412, e.g., near the cryocatheter 1420. In some embodiments, holding one or both of the channels near the cryocatheter by the tip holder allows, e.g., to position the channel openings, e.g., openings 1422 and 1424, as close as possible to the target site within the hollow organ from which the cryogenic fluid is released by the cryocatheter, thereby optionally increasing the accuracy of sensing.

[0262] According to some exemplary embodiments, as shown, for example, in FIGURE 14A, tip holder 1414 at least partially surrounds endoscope distal tip 1418. Optionally, the tip holder is shaped as an arc. Alternatively, the tip holder is shaped as a ring, such as, for example, tip holder 1426 shown in FIGURE 14B. Optionally, a holder, such as, for example, holder 1426, holds two or more channels a short distance away from each other, for example, to allow separation between the channel openings.

[0263] According to some exemplary embodiments, at least one channel, or two or more channels passing through overtube 1410, such as channel 1412, are formed from tubing. In some embodiments, the tubing forming the channel coupled to tip holder 1426, as shown, for example, in FIG. 14C, is optionally loose, stretchy, and / or flexible, for example, to not interfere with bending of the guide section of the endoscope.

[0264] According to some exemplary embodiments, at least one sensing channel 1432 located on the outside of the endoscope 1434, optionally between the overtube 1436 and the endoscope 1434, as shown in FIG. 14D, is optionally used to introduce pressure flow and / or sense pressure within the hollow organ. In some embodiments, the sensing channel 1432 is held by a holder, such as holder 1426, and optionally coupled to the endoscope 1434. In some embodiments, coupling the sensing channel 1432 to the tip of the endoscope 1434 positions the distal opening 1438 near the FOV 710 and near the target site 702 within the hollow organ where the irrigation solution 1440 and cryogenic fluid 1442 are released from the cryo-catheter 1444.

[0265] Exemplary overtube According to some exemplary embodiments, the overtube is shaped as a tube having a lumen shaped and sized to receive an elongated surgical device, such as an endoscope or cryo-catheter, and form a fluid flow path between the elongated surgical device and the overtube. Reference is now made to Figures 15A-15C, which show types of overtubes, according to some exemplary embodiments of the present invention.

[0266] According to some exemplary embodiments, an overtube, such as overtube 1502, includes an elongated tubular body 1504 having an inner lumen 1505, a distal end 1506, and a proximal end 1508. In some embodiments, inner lumen 1505 includes at least one distal opening and at least one proximal opening 1512. In some embodiments, overtube 1502 includes at least one hollow flow regulator, such as flow regulator 1514, coupled to elongated tubular body 1504, such as between distal end 1506 and proximal end 1508.

[0267] According to some exemplary embodiments, the inner lumen 1505 is shaped and sized to receive an elongated body of a surgical device, such as an endoscope or cryo-catheter, and to define a fluid flow path between the surgical device body and the elongated tubular body of the overtube. In some embodiments, the overtube 1502 includes at least one seal, such as, for example, a seal 1516, disposed in the inner lumen between the at least one proximal opening 1512 and the flow regulator valve 1514. In some embodiments, the seal 1516 is configured to seal the fluid flow path between the surgical device body and the overtube, for example, to prevent leakage of fluid in the fluid flow path through the proximal opening 1512. In some embodiments, the seal 1516 includes an opening, optionally shaped as a ring, configured to receive the elongated body of the surgical device while sealing a gap between the elongated body of the surgical device and the overtube 1502.

[0268] According to some exemplary embodiments, the distal end of the overtube is tapered, e.g., distal end 1507, as shown in FIG. 15B. In some embodiments, the tapered distal end is shaped and sized to penetrate into a hollow organ or through a natural opening of the hollow organ, e.g., the urethra. In some embodiments, the overtube includes one or more openings 1530, e.g., multiple openings, in a wall of the overtube at the tapered distal end 1507. In some embodiments, the openings are axially and / or circumferentially distributed in the overtube wall at the tapered distal end 1507. In some embodiments, the openings are, e.g., inlet openings arranged and / or distributed in the overtube wall to allow efficient drainage of fluids from the hollow organ through the inlet openings into the overtube.

[0269] According to some exemplary embodiments, for example as shown in FIG. 15C, the openings 1530 are distributed axially and / or circumferentially in a non-tapered region of the overtube wall located proximal to the tapered distal end 1509.

[0270] Instead, the inlet openings are located in both the tapered end of the overtube wall and in the non-tapered region of the wall. In some embodiments, the size of the inlet openings ranges from 0.1 mm to 6 mm, e.g., 0.1 mm to 2 mm, 1 mm to 3 mm, 2 mm to 5 mm, etc., or any intermediate, smaller, or larger value.

[0271] According to some exemplary embodiments, the flow regulator valve 1514 is fluidly connected to the inner lumen 1505. Optionally, the flow regulator valve is integral with the elongated tubular body 1504. In some embodiments, the flow regulator valve 1514 includes at least one outlet opening, such as, for example, a first outlet opening 1515 and a second outlet opening 1517. In some embodiments, at least one of the first outlet opening 1515 and the second outlet opening 1517 optionally includes a one-way valve, such as, for example, a check valve, configured to allow passive drainage of fluid from the inner lumen 1505. Optionally, at least one of the first and second outlet openings includes a connector or lock, such as, for example, a luer lock, configured to allow connection of a tube, such as, for example, a suction tube, to the flow regulator valve 1514.

[0272] According to some exemplary embodiments, the outer diameter of the overtube 1502, such as the outer diameter of the body 1504, is, for example, up to 9 mm, up to 8 mm, up to 7 mm, etc., up to 10 mm, or any intermediate, smaller, or larger value.

[0273] According to some exemplary embodiments, the inner lumen 1505 is shaped and sized to receive an endoscope and / or cryo-catheter, such as an endoscope and / or cryo-catheter of a cryotherapy device, in some embodiments the diameter of the lumen is up to 8 mm, up to 7 mm, up to 6 mm, etc., up to 9 mm, or any intermediate, smaller, or larger value.

[0274] According to some exemplary embodiments, for example as shown in Figures 11A-11E, the flow regulating valve includes at least one movable flow path selector, e.g., a movable seal, configured to direct the flow of fluid from the inner lumen 1505 toward the outlet opening 1515 and / or toward the outlet opening 1517.

[0275] In some embodiments, the overtube includes at least one user input interface, such as, for example, an activation button, configured to actuate the release of the cryogenic fluid and / or select an exhaust flow path, such as, for example, an exhaust flow path through outlet opening 1515 and / or opening 1517.

[0276] Optionally, flow regulator 1514 includes at least one user input interface, such as, for example, an actuation button 1540, configured to actuate the release of the cryogenic fluid and / or select an exhaust flow path, such as, for example, an exhaust flow path through outlet opening 1515 and / or opening 1517. In some embodiments, the actuation button is operatively coupled to a movable flow path selector within flow regulator 1514.

[0277] According to some exemplary embodiments, at least a portion of the body configured to be placed within a subject's body or within a hollow organ is flexible and / or has a smooth outer surface, e.g., to prevent damage to tissue when penetrating into the hollow organ or through a natural orifice (e.g., the urethra).

[0278] Reference is now made to FIG. 15D, which illustrates cross section AA of an elongate body of a flexible sheath, such as the overtube shown in FIG. 15A, according to some exemplary embodiments of the present invention.

[0279] According to some exemplary embodiments, the elongate body of the flexible sheath has a large outer diameter, or average diameter, e.g., an outer diameter in the range of 6-10 mm, and a wall thickness in the range of between 0.05 mm and 0.3 mm, to allow for a large inner width, e.g., a large inner diameter of the elongate body. In some embodiments, having an elongate body with a large outer diameter, or average diameter and wall thickness, allows for a wide inner diameter of the sheath inner lumen, e.g., inner lumen 1505, suitable for the passage of surgical tools and / or the passage of large amounts of biological material, e.g., tissue, clots, debris, and fluids. In some embodiments, e.g., as shown in FIG. 15E, the elongate body 1570 has a non-circular cross-section, e.g., an oval, elliptical, or polygonal cross-section. In some embodiments, the outer surface 1572 or the inner surface 1574 of the body 1570 has a non-circular cross-section.

[0280] According to some exemplary embodiments, the elongated body 1504 has a maximum outer width value, such as a maximum outer diameter value ranging between 6 mm and 10 mm, such as a maximum outer diameter value ranging between 6 mm and 7 mm, 6.5 mm and 7.5 mm, 6.5 mm and 8 mm, or any intermediate, smaller, or larger value. In some embodiments, the cross-sectional shape of the elongated body may be circular, elliptical, or other, while maintaining a large average outer diameter and thin walls. In some embodiments, the elongated body 1504 has a maximum inner width value, such as a maximum inner diameter value ranging between 5 mm and 6 mm, 5.5 mm and 6.5 mm, 6 mm and 7 mm, 6.5 mm and 7.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the maximum wall thickness 1552 of the tubular body 1504 has a value in the range of between 0.05 mm and 0.3 mm, such as in the range of between 0.05 mm and 0.12 mm, between 0.1 mm and 0.13 mm, between 0.12 mm and 0.3 mm, between 0.1 mm and 0.15 mm, or any intermediate, smaller, or larger value.

[0281] According to some exemplary embodiments, the flexible sheath, e.g., at least a portion of the body 1504, is configured to bend at least about 90 degrees, e.g., at least about 95 degrees, at least about 100 degrees, at least about 110 degrees, or any intermediate, smaller, or larger bend angle. In some embodiments, the flexible sheath is optionally formed from a metal tube that is cut, e.g., using a laser, to create patterned cuts in the body wall to allow bending of the body. Additionally or optionally, the body, e.g., the outer surface of the body, is coated with a coating, e.g., a sealing coating, configured to seal the inner lumen of the body from the external environment outside the flexible sheath. In some embodiments, the coating includes at least one of a polymer, e.g., a Pebax® Jacket, e.g., a dip coating of TPU or silicone, a heat sink, e.g., a polyolefin heat sink. Alternatively or additionally, the inner surface of the body is coated with a coating.

[0282] According to some exemplary embodiments, the body 1504 comprises a braided tube. Optionally, the body is formed from a metal and / or carbon braid, optionally spirally wound to provide reinforcement for the body, and optionally coated with a polymer, such as, for example, a Pebax® Jacket.

[0283] According to some exemplary embodiments, the sheath, i.e., at least a portion of the body 1504, such as, for example, a distal portion of the body 1504, is flexible or has a flexible region and / or is optionally formed from a flexible material. Alternatively or additionally, the sheath, i.e., at least a portion of the body 1504, such as, for example, a distal portion of the body 1504, is configured to bend, optionally without compressing or twisting, at least 45 degrees, such as at least 90 degrees, at least 150 degrees, or any intermediate, lesser, or greater angle, relative to an unbent portion of the sheath or body 1504. In some embodiments, at least a portion of the sheath or sheath body is configured to bend at least 45 degrees relative to an unbent portion of the sheath while reducing the inner cross-sectional width of the bent portion by, for example, less than 5%, less than 3%, less than 1%, less than 10%, or any intermediate, lesser, or greater percentage value relative to the inner cross-sectional width when the bent portion is unbent or straight.

[0284] According to some exemplary embodiments, as shown in FIG. 15F, a flexible sheath, such as flexible sheath 1580, includes a body 1582 formed from two or more sections, each having a different bending limit. In some embodiments, the length of each section varies. In some embodiments, at least one of the two or more sections is not coated, e.g., with a lubricious coating or a pressure-retaining coating. In some embodiments, the body 1582, such as elongated body, has a proximal end 1584 configured to be placed outside a subject, e.g., a human subject, and a distal end 1586 configured to be introduced into a hollow organ within the subject. In some embodiments, the elongated body 1582 of the flexible sheath includes two or more sections, e.g., a first section 1588, optionally a proximal section, a second section 1590, optionally a third section 1592, optionally a major section of the body 1582, and a fourth section 1594, e.g., a distal section at the distal end 1586 of the body 1582. In some embodiments, each of the sections has a different length and / or a different bending limit.

[0285] According to some exemplary embodiments, the first section, e.g., the proximal section, has a length in the range of between 15 mm and 40 mm, e.g., in the range of between 20 mm and 40 mm, in the range of between 20 mm and 30 mm, in the range of between 30 mm and 40 mm, or any intermediate, smaller, or larger value. In some embodiments, the proximal section is non-bendable. In some embodiments, the proximal section optionally includes at least one connector configured to connect the proximal section of the body 1582 to a flow regulator or check valve. Optionally, the proximal section is not coated with an insulating coating.

[0286] According to some exemplary embodiments, the second section 1590 has a length ranging between 30 mm and 90 mm, such as between 40 mm and 90 mm, between 40 mm and 70 mm, between 40 mm and 60 mm, or any intermediate, smaller, or larger value. In some embodiments, the second portion is bendable to a minimum radius of curvature of up to 100 mm, such as a maximum radius of curvature of up to 200 mm, or any intermediate, smaller, or larger value. In some embodiments, the second portion is rigid and / or unbendable. Optionally, the second portion is coated.

[0287] In some exemplary embodiments, the third section 1592, e.g., the tumor section of the flexible sheath, optionally has a length greater than any other section of the flexible section. In some embodiments, the length of the tumor section is in the range of between 60 mm and 200 mm, e.g., in the range of between 70 mm and 130 mm, in the range of between 70 mm and 180 mm, or any intermediate, smaller, or larger value. In some embodiments, the tumor section is coated, e.g., with an insulating coating. In some embodiments, the coating optionally smoothes the outer surface of the sheath that is placed in contact with body tissue. In some embodiments, the tumor section 1592 is bendable to a radius of curvature in the range of between 30 mm and 100 mm, e.g., 30 mm and 60 mm, 50 mm and 100 mm, or any intermediate, smaller, or larger value.

[0288] According to some exemplary embodiments, the fourth section 1594, e.g., the distal section of the flexible sheath, has a length in the range between 20 mm and 60 mm, e.g., 20 mm and 40 mm, 30 mm and 50 mm, 40 mm and 60 mm, or any intermediate, smaller or larger value range. In some embodiments, the distal section 1594 is bendable to a radius of curvature in the range between 15 mm and 70 mm, e.g., to a radius of curvature in the range between 30 mm and 50 mm, or any intermediate, smaller or larger value range.

[0289] According to some exemplary embodiments, a flexible sheath, such as an overtube, is used alone or in conjunction with an endoscope and / or at least one instrument to perform a procedure within a hollow organ, such as within a bladder. In some embodiments, the flexible sheath is used to remove objects, such as tissue, debris, clots, sediments, and stones, from the hollow organ. Alternatively or additionally, the flexible sheath is used to drain the hollow organ.

[0290] Reference is now made to Figures 16A-16B, which illustrate navigation of a distal end of a flexible sheath into a hollow organ, according to certain exemplary embodiments of the present invention.

[0291] According to some exemplary embodiments, a flexible sheath, such as flexible sheath 1602, is introduced, optionally under visualization, into the bone cavity. In some embodiments, the flexible sheath is advanced, and optionally pushed, into the natural body opening leading to the hollow organ until a distal end 1604 of the flexible sheath, including at least one distal opening of the flexible sheath inner lumen, is disposed within the hollow organ 1606.

[0292] According to some exemplary embodiments, as shown, for example, in Figure 16A, a flexible sheath 1602 is advanced toward a hollow organ 1606 under visualization by an endoscope 1608 disposed within the flexible sheath inner lumen. In some embodiments, the endoscope 1608 extends at least partially from at least one distal opening 1610 of the flexible sheath inner lumen.

[0293] According to some exemplary embodiments, as shown, for example, in Figure 16B, the distal end 1604 of the flexible sheath 1602 is introduced into the hollow organ through an opening in the hollow organ. In some embodiments, the hollow organ 1606 includes a bladder, and the flexible sheath distal end 1604 is introduced into the bladder 1606 via the urethra 1606, optionally under visualization by an endoscope 1608, or any other optical assembly, disposed within the flexible sheath inner lumen, configured to visualize a field of view located distal to the distal end of the flexible sheath.

[0294] According to some exemplary embodiments, once the distal end of the flexible sheath is positioned within the hollow organ 1606, e.g., within the bladder, the flexible sheath 1602 is used to flush the hollow organ. In some embodiments, the inner lumen 1612 of the flexible sheath is used to deliver a fluid, e.g., a flushing solution, into the hollow organ 106, e.g., as shown in FIG. 16C. In some embodiments, flushing the hollow organ 1606 allows for particles, e.g., particles 1614, to be detached from the inner surface of the hollow organ. In some embodiments, particles 1614 include at least one of tissue particles, debris, blood clots, and / or sediments located within the hollow organ 1060. In some embodiments, a fluid, e.g., a flushing solution, is delivered from a flushing solution source fluidly coupled to the flexible sheath inner lumen, e.g., via a flow regulator of the flexible sheath, e.g., flow regulator 1514 shown in FIGS. 15-15C.

[0295] According to some exemplary embodiments, as shown, for example, in Figure 16D, the flexible sheath 1602 is used to drain the hollow organ 1606 via the flexible sheath inner lumen 1612. In some embodiments, draining the hollow organ 1606 allows for the removal of particles, for example, from the hollow organ 1606, and optionally from the body, via the inner lumen 1612. In some embodiments, the hollow organ is drained by applying a vacuum to the hollow organ via the flexible sheath inner lumen, for example, using a vacuum source coupled to the flexible sheath, such as to the flow control valve 114 of the flexible sheath.

[0296] According to some exemplary embodiments, the flow regulator valve allows for the coupling of two or more fluid and / or vacuum sources using two or more openings in the flow regulator valve. In some embodiments, the flow regulator valve includes a selector, for example, to allow fluid connection of a single fluid or vacuum source to the inner lumen. In some embodiments, the selector allows for switching between one or more fluid and / or one or more vacuum sources. Alternatively, the flexible sheath inner lumen is divided into separate channels, each connected to a different source, for example a fluid or vacuum source. Optionally, each of the channels includes at least one opening at the distal end of the flexible sheath.

[0297] According to some exemplary embodiments, as shown, for example, in Figures 16E and 16F, the flexible sheath allows for the introduction of one or more instruments into the hollow organ via a working channel of an endoscope 1608 located within the flexible sheath. In some embodiments, the one or more instruments include a grasper, such as, for example, forceps 1616, configured to grasp a large piece, such as, for example, a large stone located within the hollow organ 1606. In some embodiments, the flexible sheath 1602 is used to remove a stone 1618 from the hollow organ 1616 by retracting the forceps 1616 and / or endoscope 1608 via the flexible sheath inner lumen 1612 toward a proximal end of the flexible sheath located outside the body.

[0298] According to some exemplary embodiments, as shown, for example, in Figures 16G and 16H, the flexible sheath is used to introduce large instruments, e.g., large surgical instruments, that are too wide to be introduced into the working channel of an endoscope, into a hollow organ parallel to the endoscope, or without the endoscope in the flexible sheath inner lumen. In some embodiments, as shown, for example, in Figure 16G, an instrument 1620 and an endoscope 1608 are placed in an inner lumen 1612 of the flexible sheath 1602. In some embodiments, an instrument 1620 is placed between the endoscope 1620 and the inner surface of the inner lumen 1612, and optionally parallel to the endoscope 1620 within the inner lumen. In some embodiments, the inner lumen 1612 has an inner width, e.g., inner diameter, in the range between 5 mm and 8 mm, which optionally allows for the introduction of an instrument having a maximum width between 1 mm and 5 mm next to, and optionally parallel to, an endoscope, e.g., a cystoscope, e.g., a ureteroscope.

[0299] According to some exemplary embodiments, as shown, for example, in Figure 16H, the instrument 1620 is introduced into the hollow organ 1606 through the flexible sheath inner lumen 1612 without the use of an endoscope. Instead, the endoscope shown in Figure 16G is removed from the flexible sheath inner lumen to allow for capturing or grasping the large particle, and optionally removing the particle from the hollow organ 1606 by retracting the instrument within the flexible sheath inner lumen, as shown, for example, in Figure 16H. In some embodiments, the large particle is a particle, such as, for example, a solid particle, having a minimum outer width of at least 3 mm, such as, for example, at least 3.5 mm, at least 4 mm, at least 4.5 mm, at least 5 mm, or any intermediate, smaller, or larger value.

[0300] A potential advantage of having a flexible sheath with a wide inner lumen may be to allow insertion of larger instruments, such as large forceps, into hollow organs, such as into the bladder, that cannot be easily introduced into the working channel of an endoscope into the hollow organ, for example to remove large particles such as stones or debris.

[0301] It is expected that many related endoscopes having at least one working channel will be developed during the life of the patent which matures from this application, and the scope of the terms endoscope, cystoscope, and working channel are intended to include all such new technologies a priori.

[0302] The terms "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including, but not limited to."

[0303] The term "consisting of" means "including, comprising, or limited to."

[0304] 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.

[0305] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0306] 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.

[0307] 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, including 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 / range 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.

[0308] 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.

[0309] 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 or readily developed from known methods, means, techniques and procedures to the practitioner of the chemical, pharmacological, biological, biochemical and medical arts.

[0310] 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.

[0311] 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.

[0312] 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.

[0313] It is the intention of the applicants (applicants) that all publications, patents, and patent applications referenced herein are incorporated herein by reference in their entirety to the same extent 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 device comprising: a cryocatheter; The cryocatheter comprises: an elongate body shaped and sized to penetrate a hollow organ and terminating in a bendable distal section, the bendable distal section having a distal tip; at least one cryogenic fluid channel located within the bendable distal section, the at least one cryogenic fluid channel comprising at least one distal opening at the distal tip configured to release cryogenic fluid from the at least one cryogenic fluid channel; at least one irrigation fluid channel located within the bendable distal section, the at least one irrigation fluid channel comprising at least one distal opening at the distal tip configured to release irrigation fluid from the at least one irrigation fluid channel; when the bendable distal section, including the at least one cryogenic fluid channel and the at least one cleaning fluid channel, is bent at an angle of at least 45 degrees relative to a section of the elongate body proximal to the bendable distal section, the cryogenic fluid flow rate through the at least one distal opening of the at least one cryogenic fluid channel is reduced by less than 10 percent compared to the cryogenic fluid flow rate through the distal opening when the bendable distal section is not bent. The cryotherapy device.

2. 10. The cryotherapy device of claim 1, wherein the bendable distal section including the at least one cryogenic fluid channel and the at least one irrigation fluid channel is configured to bend at least 45 degrees without crimping or kinking.

3. 10. The cryotherapy device of claim 1, wherein the bendable distal section has a bend radius in the range of 5 mm to 30 mm.

4. 4. The cryotherapy device of claim 1, wherein the at least one cryogenic fluid channel in the elongate body is formed by an elongate cryogenic fluid tube having a distal flexible section at the bendable distal section and a proximal section, the distal flexible section having an outer diameter smaller than an outer diameter of the proximal section, whereby the distal flexible section is bendable at an angle of at least 45 degrees relative to the proximal section.

5. 5. The cryotherapy device of claim 4, wherein the distal flexible section of the at least one cryogenic fluid channel is configured to bend with a radius of curvature that is smaller than a radius of curvature of the proximal section.

6. 5. The cryotherapy device of claim 4, wherein the distal flexible section of the at least one cryogenic fluid channel has a length in the range of 20 mm to 150 mm.

7. 5. The cryotherapy device of claim 4, wherein the distal flexible section of the at least one cryogenic fluid channel has an outer diameter in the range of 0.1 mm to 2 mm.

8. 5. The cryotherapy device of claim 4, wherein the bendable distal section of the at least one cryogenic fluid channel has an outer diameter of less than 0.6 mm.

9. 5. The cryotherapy device of claim 4, wherein the wall of the distal flexible section has a wall thickness in the range of 0.02 mm to 0.2 mm.

10. The cryotherapy device of claim 4 , wherein the distal flexible section of the at least one cryogenic fluid channel is formed from nitinol, titanium, or stainless steel.

11. The cryotherapy device of claim 4 , wherein the at least one cryogenic fluid channel is coaxially disposed within the at least one irrigation fluid channel.

12. 5. The cryotherapy device of claim 4, wherein the cryocatheter is shaped and sized to be positioned within a working channel of a flexible endoscope and to protrude from a distal opening of the working channel.

13. The cryotherapy device of claim 4, wherein the elongate body has an outer diameter in the range of 1 mm to 3 mm.

14. 5. The cryotherapy device of claim 4, wherein the at least one irrigation fluid channel includes a plurality of openings in a wall of the at least one irrigation fluid channel at the bendable distal section, the plurality of openings being distributed circumferentially around the irrigation fluid channel.

15. A flexible endoscope, an elongated insertion tube having a distal tip shaped and sized to penetrate into a hollow organ; the flexible endoscope including a working channel within the elongated insertion tube, the working channel having a proximal opening and a distal opening at the distal tip, the working channel being shaped and sized to be positioned within the working channel; An overtube, the overtube comprising an elongate tubular body including at least one distal opening and at least one proximal opening, the elongate tubular body defining a lumen and having a shape and dimension to penetrate at least a portion into a hollow organ; 5. The cryotherapy device of claim 4, wherein the overtube surrounds the flexible endoscope and defines at least one drainage channel between the flexible endoscope and an inner surface of the tubular body located on the flexible endoscope to drain fluid from the hollow organ, the at least one drainage channel including at least one distal inlet opening and at least one proximal outlet opening located at a distal end of the tubular body.

16. 16. The cryotherapy device of claim 15, wherein the overtube is selectably slidable over the flexible endoscope.

17. 16. The cryotherapy device of claim 15, wherein the flexible endoscope is coaxially disposed within the tubular body of the overtube.

18. The overtube is at least one flow regulating valve fluidly connected to a lumen of the overtube, the at least one flow regulating valve including a hollow body having at least one first outlet opening; 16. The cryotherapy device of claim 15, comprising: a seal within the elongate tubular body between the at least one flow regulating valve and the at least one proximal opening of the elongate tubular body, the seal configured to prevent exit of fluid from the lumen of the elongate tubular body through the at least one proximal opening.

19. The at least one flow regulating valve is at least one second outlet opening; a movable flow path selector configured to direct fluid flow from the lumen towards the at least one first outlet opening and / or towards the at least one second outlet opening.

20. 16. The cryotherapy device of claim 15, wherein the outer diameter of the overtube is in the range between 6 mm and 9 mm, and the inner diameter of the overtube is in the range between 5 mm and 7.5 mm.

21. 16. The cryotherapy device of claim 15, wherein at least a portion of the elongate tubular body of the overtube is flexible and configured to bend at least 90 degrees without crimping or kinking.

Images