Endoscope mounting system

Abstract

An attachment system is provided for removably attaching an additional channel to an endoscope, the attachment system comprising a sleeve for receiving, in use, a distal end of the endoscope and the distal end of the additional channel, the sleeve defining a sleeve channel through which, in use, the distal end of the endoscope and the distal end of the additional channel extend, the sleeve comprising a sleeve body having a first open end and a second open end, and a break-away mechanism for breaking the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope.

Description

Technical Field

[0001] The present disclosure relates to an endoscopic attachment system, and more particularly, but not exclusively, to an endoscopic attachment system for removably attaching an additional working channel thereto.

Background Art

[0002] An endoscope is a medical device used to access a patient's target anatomical structure for diagnostic or therapeutic purposes. An endoscope typically includes an elongated body having a distal end that can be inserted into a patient's anatomical structure. The elongated body typically has one or more working channels (also referred to as "native working channels") that allow the passage of functional instruments such as balloons, forceps, catheters, scissors, suction devices, optical fibers, and cameras, and that transmit light to enable visualization. Different types of endoscopes include bronchoscopes, gastric cameras, colonoscopes, and the like.

[0003] In certain situations, it is desirable to provide one or more additional working channels in addition to the native working channels of an endoscope for additional functionality. Also, in certain situations, it is desirable to be able to operate the additional working channels and the native working channels of an endoscope independently. An example of operating the additional working channels and the endoscope independently includes the ability to separate the additional working channels from the endoscope while both are within the patient such that one remains within the patient and the other is removed.

[0004] Systems have been proposed for attaching additional working channels to an endoscope, but do not allow for controllable separation from the endoscope at that location.

[0005] Therefore, there is a need for an endoscopic attachment system that overcomes or reduces at least some of the above problems.

Summary of the Invention

Problems to be Solved by the Invention

[0006] The purpose of this disclosure is to improve at least some of the shortcomings present in the prior art. [Means for solving the problem]

[0007] According to certain aspects and embodiments of this technology, at least one additional working channel may be attached to an endoscope and operated independently from the endoscope in situ within the patient. This can provide clinicians with more control during the procedure, which can translate into safer outcomes for the patient. The additional working channel is an external channel to the endoscope's inherent working channel and is interchangeably referred to as an "additional channel".

[0008] Accordingly, certain aspects and embodiments of the present technology provide a mounting system for assembling the distal ends of an endoscope and an additional channel in a manner that allows them to be released together. The mounting system includes a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel. A breaking mechanism is provided for breaking the sleeve to allow separation of the distal end of the endoscope and the distal end of the additional channel while the sleeve is in the patient's original position. The breaking mechanism can be deployed by a user of the mounting system from the near end of the endoscope outside the patient.

[0009] In one embodiment, a mounting system is provided for detachably attaching an additional channel to an endoscope, the mounting system comprising a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve comprising a sleeve body having a first open end and a second open end, defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel extend during use, and a breaking mechanism for breaking the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope. The breaking mechanism can be operated from outside the patient while the sleeve is in the patient's original position. This allows for separate operation of the additional channel and the endoscope.

[0010] In certain embodiments, the sleeve body is attached to the breaking mechanism.

[0011] In certain embodiments, the breaking mechanism can be deployed in close proximity to the sleeve.

[0012] In a particular embodiment, the breaking mechanism comprises a blade mechanism positioned to cut the sleeve body between a first open end and a second open end when relative movement is applied between the sleeve body and the blade mechanism, and a rope for applying the relative movement between the sleeve body and the blade mechanism.

[0013] In certain embodiments, the blade mechanism comprises a blade mechanism body having a first arm coupled to a second arm, and a blade positioned between the first arm and the second arm, wherein the first arm is arranged to extend along the outside of the sleeve body and the second arm is arranged to extend along the inside of the sleeve body.

[0014] In certain embodiments, the blade mechanism is hooked onto the distal end or the near end of the sleeve body.

[0015] In certain embodiments, the rope is a sleeve rope comprising a first end attached to a sleeve body and a second end extending adjacent to the first end and positioned to be operated by a user to move the sleeve body.

[0016] In certain embodiments, the first end of the sleeve rope has a looped portion that extends through the sleeve channel around the sleeve body. The second end may be attached to the blade mechanism body.

[0017] In certain embodiments, the rope is a bladed rope comprising a first end attached to the blade mechanism body and a second end extending adjacent to the first end and positioned to be operated by the user to move the blade mechanism body.

[0018] In certain embodiments, the breaking mechanism is a snare mechanism comprising a first end attached to the sleeve body and a second end extending adjacently from the first end and positioned to be operated by the user to break the sleeve body. The first end of the snare mechanism may include a looped portion extending through a sleeve channel around the sleeve body.

[0019] In certain embodiments, the mounting mechanism further comprises a fragile portion on the sleeve body extending between a first open end and a second open end, and the snare mechanism is positioned to contact the fragile portion when actuated to break the fragile portion. The fragile portion may comprise perforations. The perforations may be arranged as a single row extending between the first open end and the second open end, or the perforations may be arranged as two rows, each row extending between the first open end and the second open end.

[0020] In certain embodiments, the mounting system further includes a slit adjacent to the perforation, on the distal or proximal edge of the sleeve body.

[0021] In a particular embodiment, where the breaking mechanism is a removable strip on the sleeve body, the removable strip is defined by two rows of perforations on the sleeve body extending between a first open end and a second open end, and the removable strip is operable at one end to break the perforations in order to remove the removable strip.

[0022] In certain embodiments, the breaking mechanism is a removable strip on the sleeve body, defined by two rows of perforations on the sleeve body extending between a first and a second open end, and the removable strip is configured such that the actuation of the removable strip is able to break at least some of the perforations, causing the sleeve body to break so as to allow separation of the distal end of an additional channel from the distal end of the endoscope.

[0023] In certain embodiments, a tab wire is further provided that is connected at a first end to one end of the removable strip, extends proximally from the first end, and has a second end arranged to be operable to remove the removable strip.

[0024] In certain embodiments, a tab wire having a first end and a second end is further provided, the first end being connected to the removable strip, and by pulling the second end of the tab wire, at least some of the perforations are broken.

[0025] In certain embodiments, the first end of the tab wire is connected to the removable strip by a tab. The tab may extend from one end of the removable strip. A tether may be provided to connect the removable strip removed from the sleeve body. The tether may be attached to the sleeve body at one end and to the removable strip at the other end.

[0026] In certain embodiments, the attachment system further comprises a tensioning mechanism for providing tension to the sleeve. The tensioning mechanism comprises at least one pin having a hook portion and a hook arm extending from the hook portion, the at least one pin being insertable into the sleeve by the hook arm extending along the outer surface of the sleeve body, and the hook portion extending over the distal edge of the sleeve body or over the proximal edge of the sleeve body in use.

[0027] In certain embodiments, at least one pin is attached to an additional channel. The additional channel may have, for example, a sheath defining a channel for hosting a guide wire, and the at least one pin is attached to the sheath.

[0028] In certain embodiments, at least one pin is attached to an additional channel and comprises two pins spaced circumferentially from each other. In use, the additional channel, endoscope and attachment system are assembled and the hook arm secures the sleeve. In certain embodiments, the sleeve body is secured along more than 50% of its length, for example along a distance of 5 - 15 mm. Advantageously, the securing ensures that the endoscope and additional channel move together within the patient and can follow the deflection curvature of the endoscope. In prior art systems providing a thin loop or lanyard type attachment of the endoscope and additional channel, deflection of the endoscope causes displacement of the additional channel at the endoscope tip. This means that prior art systems cannot be guided along a non - straight path, for example within the upper airway of a patient.

[0029] In certain embodiments, the tension mechanism comprises an adjustable portion on the sleeve body and the adjustable portion can be actuated to adjust (conform) the cross - sectional area of the sleeve. The adjustable portion may extend longitudinally along the sleeve body and, in certain embodiments, comprises a thread extending through the sleeve body that can be pulled to make the cross - sectional area of the sleeve smaller.

[0030] In certain embodiments, the thread extends in a zig - zag configuration longitudinally along the sleeve body.

[0031] In certain embodiments, the sleeve body has a slit extending longitudinally between the first and second open ends of the sleeve body, the slit being defined by a first slit edge and a second slit edge, and the thread is arranged to extend alternately through the first and second slit edges to bring the first and second slit edges of the sleeve body closer together.

[0032] In certain embodiments, the mounting system further comprises a plurality of loops extending from the first and second slit edges, each loop of which is arranged to receive a thread. In certain embodiments, the loops on the first slit edge are arranged in an internal finger-like configuration relative to the loops on the second slit edge.

[0033] In certain embodiments, the mounting system further includes an anti-rotation device configured to obstruct or limit non-axial movement between the additional channel and the endoscope. In some embodiments, the anti-rotation device may allow relative axial movement between the additional channel and the endoscope. The anti-rotation device may be detachably mounted on one or both of the additional channel and the endoscope.

[0034] In certain embodiments, the anti-rotation device includes a wing clip. The wing clip has a body positioned to stay around the additional channel or endoscope, or to attach to the additional channel or endoscope in other ways. The wing clip is positioned to restrict or reduce relative movement between the additional channel and the endoscope.

[0035] In certain embodiments, the body of the wing clip has a first open end and a second open end, defining a cylindrical channel through which an additional channel or endoscope can extend. The body may be U-shaped. The body may have a lateral (longitudinal) opening to facilitate the positioning of the wing clip around the additional channel or endoscope. A pair of wings may extend from a lateral opening edge defining the lateral opening. The pair of wings may spread apart, defining an area for receiving one or the other of the additional channel or endoscope. In embodiments where the wing clip is attached to an additional channel, the pair of wings are on the outer surface of the endoscope, restricting rotational movement between the additional channel and the endoscope.

[0036] In certain embodiments, the wing clip does not remain in the additional channel but is positioned below it and attached to it, for example, using adhesive or melting. Thus, the body of the wing clip may define a shallower U-shape. In such embodiments, the overall dimensions of the additional channel do not increase.

[0037] In certain embodiments, the mounting system further includes an additional channel, which comprises a sheath sized and shaped to house a guide wire.

[0038] In certain embodiments, the additional channel further includes a steering cable for independent positioning of the additional channel.

[0039] In certain embodiments, the mounting system further includes an endoscope. In certain embodiments, the endoscope has a working channel that allows one or more of visualization and aspiration.

[0040] In certain embodiments, the endoscope is a bronchoscope.

[0041] In another embodiment, a mounting system is provided for detachably attaching an additional channel to an endoscope, the mounting system comprising a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel in use, defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel extend in use, a sleeve body having a first open end and a second open end, and a breaking mechanism for breaking the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope, the breaking mechanism comprising a removable strip defined by two rows of perforations on the sleeve body extending between the first and second open ends, and the removable strip being operable at one end to break the perforations to remove the removable strip, the mounting system further comprising a tension mechanism having an adjustable portion on the sleeve body, the tension mechanism being operable to adjust the cross-sectional area of ​​the sleeve body.

[0042] In certain embodiments, the adjustable portion comprises a thread extending longitudinally along the sleeve body and through the sleeve body, which can be pulled to reduce the cross-sectional area of ​​the sleeve body.

[0043] In certain embodiments, the threads extend along the sleeve body in a zigzag configuration along the longitudinal direction.

[0044] In certain embodiments, the sleeve body has a slit extending longitudinally between first and second open ends of the sleeve body, the slit being defined by a first slit edge and a second slit edge, and the thread is arranged to extend alternately through the first slit edge and the second slit edge to bring the first and second slit edges of the sleeve body closer together when operated.

[0045] In certain embodiments, the mounting system further comprises a plurality of loops extending from the first and second slit edges, each of which is positioned to receive a thread.

[0046] In certain embodiments, the loop on the first slit edge is positioned in an internal finger-like configuration relative to the loop on the second slit edge.

[0047] In certain embodiments, the removable strip further comprises a tab rope having a first end connected to one end of the removable strip, extending in close proximity from the first end and positioned to be operable to pull the removable strip and break the perforation.

[0048] In certain embodiments, the removable strip further comprises a tab rope having a first end and a second end, the first end being connected to the removable strip, and pulling the second end of the tab rope to break at least some of the perforations.

[0049] In certain embodiments, the mounting system further includes a tab extending from one end of the removable strip, with the first end of the tab rope attached to the tab. In certain embodiments, the tab rope is connected to the removable strip by the tab.

[0050] In certain embodiments, the mounting system further includes a tether for connecting a removed removable strip to the sleeve. The tether may be attached to the removable strip at one end and to the sleeve body at the other end.

[0051] In yet another aspect, mounting systems according to any of the embodiments described herein and kits with additional channels as described herein are provided.

[0052] In certain embodiments, the mounting system includes a sleeve for receiving the distal end of an endoscope and the distal end of an additional channel during use, the sleeve comprising a sleeve body having a first open end and a second open end, defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel extend during use, and a breaking mechanism for breaking the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope, the breaking mechanism comprising a removable strip portion of the sleeve body, which, when removed, breaks the sleeve body. The removable strip can be removed by pulling it on a tab rope attached to the removable strip portion. The removable strip may be connected to the sleeve by a tether so that it remains attached to the sleeve even after the sleeve body has been broken. The tab rope may have a handle attached thereto for user operation. In certain embodiments, the mounting system includes a tension mechanism which is a thread stretched through the sleeve body. By pulling the thread, the cross-sectional area of ​​the sleeve body can be reduced. The thread may have one or two handles attached to one or both ends for user operation. The sleeve body and handles may be removably attached to packaging such as cardboard backing.

[0053] In certain embodiments, the kit further includes an endoscope.

[0054] In certain embodiments, the additional channel includes a sheath sized and shaped to house a guide wire.

[0055] In certain embodiments, the kit further comprises a biopsy device. In certain embodiments, the biopsy device comprises a cryo-biopsy device.

[0056] In certain embodiments, the kit further includes an anti-rotation device that can be releasably attached to the additional channel and / or endoscope and can be configured to prevent or limit undesirable relative movement of the additional channel and / or endoscope. Undesirable relative movement may be relative rolling relative to one another. In certain embodiments, the anti-rotation device is a wing clip.

[0057] In another embodiment, a mounting system is provided for detachably attaching an additional channel to an endoscope, comprising a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve comprising a sleeve body having a first open end and a second open end, defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel extend during use, and a tension mechanism comprising an adjustable portion on the sleeve body, the adjustable portion of which can be operated to adjust the cross-sectional area of ​​the sleeve body.

[0058] In certain embodiments, the adjustable portion comprises a thread extending longitudinally along the sleeve body and through the sleeve body, which can be pulled to reduce the cross-sectional area of ​​the sleeve body.

[0059] In certain embodiments, the threads extend longitudinally along the sleeve body in a zigzag configuration.

[0060] In certain embodiments, the sleeve body has a longitudinally extending slit between the first and second open ends of the sleeve body, and the thread is arranged to extend alternately through the first and second slit edges of the sleeve body to bring them closer together when operated.

[0061] In certain embodiments, the mounting system further comprises a plurality of loops extending from the first and second slit edges, each of which is positioned to receive a thread.

[0062] In certain embodiments, the loop on the first slit edge is positioned in an internal finger-like configuration relative to the loop on the second slit edge.

[0063] In certain embodiments, the removable strip further comprises a tab rope having a first end connected to one end of the removable strip, extending in close proximity from the first end and positioned to be operable to pull the removable strip and break the perforation.

[0064] In certain embodiments, the removable strip further comprises a tab rope having a first end and a second end, the first end being connected to the removable strip, and the second end being able to break at least some of the perforations by pulling.

[0065] In certain embodiments, the mounting system further includes a tab extending from one end of the removable strip, with the first end of the tab rope attached to the tab. In certain embodiments, the tab rope is connected to the removable strip by the tab.

[0066] In certain embodiments, the mounting system further includes a tether for connecting the removed removable strip to the sleeve.

[0067] In certain embodiments, the tensioning mechanism comprises at least one pin having a hook portion, and a hook arm extending from the hook portion, wherein the at least one pin is insertable into the sleeve body via a hook arm extending along the outer surface of the sleeve body, and the hook portion extends either over the distal edge of the sleeve body or over the near edge of the sleeve body during use.

[0068] In certain embodiments, at least one pin is attached to an additional channel or endoscope. In certain embodiments, at least one pin is attached to an additional channel or endoscope, and there are two pins that are spaced circumferentially apart from each other.

[0069] In yet another embodiment, a method for performing a biopsy is provided, which includes the steps of positioning an assembly of a sleeve, an endoscope, and an additional channel at a target tissue site in a patient; deploying a break mechanism to separate the endoscope and the additional channel; and removing one of the endoscope and the additional channel while the other of the endoscope and the additional channel remains in the target tissue site.

[0070] In yet another embodiment, a method is provided for removably assembling an endoscope with an additional channel, the method comprising the step of surrounding the distal end of the endoscope and the distal end of the additional channel with a mounting system, as defined herein.

[0071] In another embodiment, a mounting system is provided for mounting together the distal end of an endoscope and the distal end of an additional channel, comprising a sleeve and including a tension system for changing the cross-sectional area of ​​the sleeve.

[0072] In yet another embodiment, a kit is provided comprising the above-mentioned attachment system for the endoscope and an additional channel system. The additional channel system may include one or more tools that can be delivered and removed through the additional channel sheath. In a particular embodiment, the kit is a biopsy kit, and the additional channel system comprises a biopsy system. The biopsy system may include a biopsy device (such as a cryocatheter or probe), and optionally a balloon occlusion device.

[0073] In certain embodiments, aspects and embodiments of the present technology can be used during lung biopsy procedures. In these embodiments, the endoscope is a bronchoscope.

[0074] Lung biopsy procedures require forceps or a cryo-biopsy device to remove lung tissue, a deployable balloon occlusion device to control post-biopsy bleeding, and an optical working channel for airway visualization during biopsy and balloon deployment. The developers noted specific shortcomings in typical lung biopsy procedures. The balloon occlusion device must first be delivered into the lung space for post-biopsy control bleeding. Currently, to achieve this, the guidewire is first delivered to the target airway in the lung space through the bronchoscopic working channel, and then the bronchoscope must be completely removed from the lung to free the guidewire and allow the balloon occlusion device to be loaded onto the guidewire. This results in a loss of airway visualization during that time. The balloon occlusion device is left deflated for subsequent use during the procedure.

[0075] The bronchoscope is then repositioned within the patient's airway adjacent to the guidewire using a non-expanding balloon occlusion device. To enable tissue biopsy, a biopsy device (e.g., forceps device, cryo-biopsy device) is inserted into the bronchoscope's inherent working channel, and the biopsy device and bronchoscope are guided together to the target biopsy site using the bronchoscope's deflection / steering mechanism. The presence of the biopsy probe inside the bronchoscope's working channel can negatively affect suction performance, as the biopsy device is approximately 2 mm wide, roughly equivalent to the working channel of the bronchoscope. This can cause discomfort to the patient and affect the operator's ability to adequately visualize the biopsy process.

[0076] To take a cryo-biopsy, a cryo-cycle (approximately 5-10 seconds) is initiated in a cryogenic delivery system to freeze the tissue sample and attach it to the cryogenic probe tip of the biopsy device. The frozen tissue sample attached to the probe tip of the biopsy device is then extracted from the lung biopsy site by pulling the probe tip of the biopsy device away from the site. An alternative to cryo-biopsy is biopsy with forceps.

[0077] During the extraction of a frozen tissue sample, the balloon device deploys when the probe tip, which has the attached tissue sample, approaches the balloon. The deployed balloon creates a barrier for any bleeding that may occur during tissue sample extraction, mitigating the safety risk of blood entering the lung passages and causing suffocation. The balloon is typically left deployed for about 5 minutes.

[0078] Tissue samples are typically larger than the bronchoscopy working channel, and therefore the only way to remove the tissue sample without destruction, damage, or loss is to remove the bronchoscope and biopsy device together. This means that the operator no longer has visual control of the airway and is unable to monitor whether bleeding is occurring, whether the deployed balloon is in the correct position, and the severity of the bleeding.

[0079] Guidelines for lung biopsy recommend 3 to 5 biopsies from multiple locations within the lung, and even from multiple lobes, to increase diagnostic certainty. For subsequent biopsies, the bronchoscope must be returned to its initial position, and the process is repeated with subsequent tissue samples.

[0080] If biopsies are desired at different locations, the entire procedure, including the initial placement of the guidewire and balloon occlusion device, must be repeated. In the case of five biopsies at five different locations, the bronchoscope can be inserted and removed from the lung up to 10 times (five times to place the bleeding control balloon and five times to retrieve the tissue sample). Furthermore, in about 30% of cases, additional insertion / removal cycles may be required because the retrieved tissue sample is damaged or has fallen out of the biopsy device.

[0081] In aspects and embodiments of this technology, the endoscope is a bronchoscope, and the additional channel includes a guidewire for advancing a balloon occlusion device and a biopsy device. In certain embodiments, the guidewire can be pre-loaded with the balloon occlusion device before the additional channel is attached to the bronchoscope in the sleeve of the mounting system, and before insertion into the patient. In this way, the bronchoscope connected by the mounting system and the balloon occlusion device with the pre-loaded guidewire can be delivered together to the target site. When the balloon occlusion device is in the correct position in the patient's lung during use, the sleeve can be ruptured to separate the balloon occlusion device from the bronchoscope.

[0082] This represents a significant improvement over conventional systems where the guidewire is first delivered to the patient's target site through the bronchoscope's inherent working channel. The guidewire is then released by completely removing the bronchoscope from the lung, losing visual control of the pulmonary airway, after which the balloon occlusion device is loaded onto the guidewire. Loading the balloon catheter onto the guidewire while it is still inside the patient is a difficult and cumbersome process for the clinician, as they must support the relatively heavy bronchoscope while maintaining the guidewire in place in the patient's lung and positioning the occlusion device on the guidewire. If the patient is in a reclined seated position, the instruments must be held in place by the clinician relative to the patient's position. It is not uncommon for the guidewire to slip from the patient's lung position during the loading process.

[0083] The system's sleeve connects both the distal end of the additional channel and the distal end of the bronchoscope, and the rupture mechanism allows for in-situ separation. The assembled bronchoscope and additional channel are both positioned within the patient's airway, and the rupture mechanism allows for the separation of the bronchoscope and additional channel in their original location within the patient.

[0084] The mounting system allows the biopsy device to be removed independently of the bronchoscope. Meanwhile, the operator can use the bronchoscope to continuously visualize the airway and determine the presence or severity of bleeding, and whether the balloon occlusion device is properly deployed and effective in controlling bleeding.

[0085] The advantages of this technology include one or more of the ability to maintain visual control of the airway during balloon occlusion device insertion, maintain visual control of the airway during cryobiops tissue retrieval, enable airway management via fluid aspiration through the bronchoscopic working channel, minimize bronchoscopic insertion and withdrawal into the lung, and maintain or improve the safety profile and effectiveness of current cryobiopsidical procedures.

[0086] The operator may be a clinician or practicing physician, such as a respiratory physician, thoracic surgeon, endoscopist, intensive care physician, or radiologist.

[0087] As used herein and in the appended claims, the singular forms "a," "an," and "the" should be reserved to include plural subjects unless the content clearly indicates otherwise.

[0088] As used herein, the term “about” in relation to a given value or range means a value or range that is within 20%, preferably within 10%, and more preferably within 5% of the given value or range.

[0089] As used herein, the term "and / or" shall be interpreted as each specific disclosure of two particular mechanisms or components having or not having the other. For example, "A and / or B" shall be interpreted as each specific disclosure of (i) A, (ii) B, and (iii) A and B, as each would be described separately herein.

[0090] These and other aspects and characteristics of non-limiting embodiments will become apparent to those skilled in the art upon further consideration of the following descriptions of specific non-limiting embodiments in conjunction with the accompanying drawings.

[0091] Further aspects and advantages of the present invention will be better understood by referring to the related descriptions below. [Brief explanation of the drawing]

[0092] [Figure 1] This is a perspective view of a mounting system including a sleeve and a breaking mechanism which is a snare mechanism, according to a specific embodiment of the present technology. [Figure 2] Figure 1 shows a perspective view of the mounting system assembled with an endoscope and an additional channel, according to a specific embodiment of this technology. [Figure 3]This is an end view of the mounting system shown in Figure 2, according to a specific embodiment of this technology. [Figure 4] This is a side view of a mounting system with an alternative sleeve according to a specific other embodiment of the present technology. [Figure 5A] Figure 4 is a perspective view of the sleeve according to a specific other embodiment of the present technology. [Figure 5B] Figure 4 is a top view of the sleeve according to a specific other embodiment of this technology. [Figure 6] This is a side view of an alternative embodiment of the mounting system of Figure 1, which includes a tensioning mechanism at a first position, according to a specific embodiment of the present technology. [Figure 7] This figure shows the mounting system of Figure 6, which is equipped with a tensioning mechanism at a second position, according to a specific embodiment of the present technology. [Figure 8] This is a side view of another embodiment of a mounting system with a sleeve and blade mechanism, which is a breaking mechanism, according to a particular embodiment of the present technology. [Figure 9] This is a top view of an alternative mounting system with a sleeve and blade mechanism, which is a breaking mechanism, according to a specific other embodiment of the present technology. [Figure 10] This is a side view of a mounting mechanism, which includes a sleeve and a removable strip, and a breaking mechanism, according to a particular other embodiment of the present technology. [Figure 11] Figure 10 is an end view of the mounting mechanism according to a specific other embodiment of this technology. [Figure 12] Figure 10 is a top perspective view of the mounting mechanism, including a tensioning mechanism, according to a specific embodiment of this technology. [Figure 13] This is a bottom perspective view of the mounting mechanism shown in Figure 12, according to a specific embodiment of this technology. [Figure 14] This is an enlarged view of the tension mechanism shown in Figure 12, according to a specific embodiment of this technology. [Figure 15A] This is a perspective view of an alternative mounting system for the items shown in Figures 12 to 15, according to a specific embodiment of this technology. [Figure 15B]This is a plan view of the sleeve shown in Figure 15A when it is unfolded, according to a specific embodiment of this technology. [Figure 16A] This is a perspective view of a mounting system including an alternative sleeve according to a specific other embodiment of the present technology. [Figure 16B] This is a plan view of the sleeve of the mounting system shown in Figure 16A when it is expanded, according to a specific embodiment of this technology. [Figure 17A] This is a perspective view of a wing clip for use in a mounting system according to a specific embodiment of the present technology. [Figure 17B] Figure 17A is a perspective view of the wing clip, attached to an additional channel and assembled with an endoscope, according to a specific embodiment of the present technology. [Figure 18] Figure 12 is a plan view of a kit including the mounting system according to a specific embodiment of this technology. [Figure 19A] Figure 18 shows an exploded perspective view from the near end of an additional channel and a freeze probe, which may be part of the kit according to a specific embodiment of this technology. [Figure 19B] This is an assembled perspective view from the near end of an additional channel and a freezing probe, which may be part of the kit shown in Figure 18, according to a specific embodiment of the present technology. [Figure 19C] Figure 16B is a magnified view of the assembled additional channel and freeze probe according to a specific embodiment of this technology. [Figure 20] This is a plan view of a balloon that may be part of the kit shown in Figure 18, according to a specific embodiment of the present technology. [Figure 21] Figures 19A and 19B show a perspective view from the near end of an additional channel and cryoprobe attached to a bronchoscope, according to a specific embodiment of the present technology. [Modes for carrying out the invention]

[0093] The drawings are not necessarily isometric and may be illustrated by dashed lines, graphic symbols, and partial drawings. In certain examples, details that are not necessary for understanding the embodiment or that would be difficult to grasp may be omitted.

[0094] Next, various non-limiting embodiments of the endoscope mounting system will be described in detail. Other non-limiting embodiments, modifications and equivalents will be obvious to those skilled in the art in view of the non-limiting embodiments disclosed herein, and it should be understood that these variations are within the scope of the appended claims.

[0095] Furthermore, it will be apparent to those skilled in the art that certain structural and operational details of the non-limiting embodiments discussed below may be modified or omitted entirely (i.e., not essential). In other examples, well-known methods, procedures, and components are not described in detail.

[0096] This disclosure is not limited to the details of the configuration and arrangement of components described or shown in the drawings. Other embodiments of the disclosure are possible and can be carried out or implemented in various ways. The expressions and terms used herein are for illustrative purposes only and should not be considered limiting. The use of “includes,” “equipped with,” or “has,” “contains,” “accompanied by,” and variations thereof herein means including the items listed therein and optionally additional items. In the following description, the same numerical reference means similar elements.

[0097] To provide a broader assembly 16 comprising an endoscope 14 and an additional channel 12, a mounting system 10 is provided for detachably attaching the additional channel 12 to the endoscope 14. The additional channel 12 can be thought of as an addition to the endoscope's inherent working channel 18 and located outside of it. The assembly 16 can be inserted into a target position inside the patient to perform various functions through the additional channel 12 and the endoscope 14's inherent working channel 18. The mounting system 10 allows for the insertion of both the endoscope 14 and the additional channel 12, which are mounted together as the assembly 16. The mounting system 10 also allows for the removal of the endoscope 14 and the additional channel 12 so that one can be removed from the target position while the other remains in place. The removal of the additional channel 12 from the endoscope 14 can be controlled by a user of the mounting system 10 from outside the patient. In certain embodiments, the additional channel 12 comprises a sheath 20 defining the additional channel 12. It should be understood that embodiments of the mounting system 10 can be used with any type of additional channel 12 and any type of endoscope 14. The additional channel 12 and endoscope can be used to deliver any type of device.

[0098] Referring to Figures 1 to 14, the mounting system 10 includes a sleeve 24 for receiving the distal end 26 of the endoscope 14 and the distal end 28 of the additional channel 12 when in use. The sleeve 24 has a sleeve body 30 that defines a sleeve channel 32 within it. The sleeve body 30 has a first open end 34 and a second open end 36. The distal end 26 of the endoscope 14 and the distal end 28 of the additional channel 12 extend through the sleeve channel 32 between the first and second open ends 34, 36 of the sleeve body 30 when in use. The sleeve body 30 has a distal edge 38 and a proximal edge 40 at the first and second open ends 34, 36, respectively. The first open end 34 may also be called the distal end, and the second open end 36 may be called the proximal end. In certain embodiments, the sleeve body 30 is cylindrical, but in certain other embodiments, the shape of the sleeve body 30 may be different. Sleeve bodies 30 having cross-sectional shapes including teardrops, ellipses, etc., are within the scope of this disclosure. In the embodiments of Figures 1 to 15, the sleeve body 30 has an integrated single-layer structure. In the embodiment of Figure 16, the sleeve body 30 has the packaging configuration described below with reference to Figures 16A and 16B.

[0099] In certain embodiments, the length 42 of the sleeve body 30 (the longitudinal dimension between the first and second open ends 34, 36) is greater than about 5 mm, preferably about 10-15 mm. The sleeve 24 is not of the "loop" or "lasso" type. The length 42 of the sleeve body 30 is greater than the diameter 44 of the sleeve body 30. In certain embodiments, this provides stability and restricts relative movement between two or more of the sleeve 24, the endoscope 14, and the additional channel 12.

[0100] The diameter 44 of the sleeve 24 is fixed in certain embodiments (Figures 1 to 11) or adjustable in other embodiments (Figures 12 to 16).

[0101] The sleeve 24 may be formed from any suitable material that is biocompatible and sterilizable, and therefore suitable for insertion into the human body. The tensile properties of the material of the sleeve body 30 are such that they allow for tight contact during the implantation procedure and have tensile strength that can be broken using a force applied by the user. Examples of the sleeve body 30 include, but are not limited to, polyurethane, polyether block amide (e.g., PEBAX®), silicone, fluoroethylene propylene, polyvinyl chloride, polyester, perfluoroalkoxyalkane, polypropylene, latex, natural rubber, synthetic rubber (e.g., polychloroprene such as Neoprene®, perfluoroelastomer such as Kalrez®, nitrile rubber such as Buna®, ethylene propylene diene rubber such as EPDM®), and elastomer materials.

[0102] The mounting system 10 also includes a breaking mechanism 46 for breaking the sleeve body 30 to allow separation of the distal end 28 of the additional channel 12 from the distal end 26 of the endoscope 14. The sleeve 24 can be said to have a complete configuration in which the sleeve body 30 extends around the distal end 26 of the endoscope 14 and the distal end 28 of the additional channel 12, and a broken or open configuration in which the sleeve body 30 is broken longitudinally between the first open end 34 and the second open end 36 of the sleeve body 30. The sleeve body 30 can be said to have a planar configuration when broken. Breaking means tearing, cutting, splitting, peeling, unfolding, etc. The breaking mechanism 46 can be unfolded from outside the patient, close to the sleeve 24, when in use.

[0103] In certain embodiments, the sleeve body 30 has a tether 48 that can be operated in close proximity to the outside of the sleeve body 30 and the patient during use, so that if the sleeve body 30 breaks, the sleeve 24 can be moved away from the site. In some embodiments, the sleeve 24 is completely removed from the patient after breaking. In other embodiments, if the patient is connected to a ventilator, the sleeve 24 is moved away from the patient into the ventilator tube by pulling it on the tether 48. This prevents the sleeve 24 from becoming entangled in the additional channel 12 or the endoscope 14. Moving the sleeve 24 away from the site after it breaks also prevents it from obstructing the view of the camera of the endoscope 14 or the additional channel 12.

[0104] In certain other embodiments, the sleeve body 30 is attached to one or more of the endoscope 14, the additional channel 12, and the rupture mechanism 46. The sleeve body 30 remains attached after its rupture. The attachment of the sleeve body 30 to one or more of the endoscope 14, the additional channel 12, and the rupture mechanism 46 may be by any means such as adhesive or a tether. In this way, the sleeve 24 can be removed from the target location in the patient together with the endoscope 14 or the additional channel 12.

[0105] Various embodiments of the fracture mechanism 46 are conceivable and are described below.

[0106] In certain embodiments, the mounting system 10 also includes a tensioning mechanism 50 in combination with one of the various breaking mechanisms 46. Various embodiments of the tensioning mechanism 50 are also described below.

[0107] Fracture mechanism Snare mechanism Referring to Figures 1 to 7, in certain embodiments, the breaking mechanism 46 is a snare mechanism 52, which, upon deployment, breaks the sleeve body 30, allowing the separation of the endoscope 14 and the additional channel 12, freeing one or both from the sleeve channel 22. The snare mechanism 52 is connected to the sleeve body 30 at a first end 54, extends adjacent to the sleeve 24, and can be deployed by the user at a second end 56. In certain embodiments, the second end 56 of the snare mechanism 52 is a cord that extends outside the patient when in use for independent operation by the user. In other embodiments, the second end 56 may be incorporated into the handle of the endoscope (not shown). The first end 54 of the snare mechanism 52 is a loop of material that extends around the sleeve body 30 through the first and second open ends 34, 36 of the sleeve 24 (best shown in Figures 1, 2, 4, and 6). The first end 54 is also referred to herein as the looped portion, and the second end 56 is referred to as the tail portion. The sleeve body 30 may include one or more fragile parts 58 to facilitate the breakage of the sleeve body 30 when the breakage mechanism 46 is deployed.

[0108] In the specific embodiments shown in Figures 1 to 4 and Figure 6, the fragile portion 58 is provided with a single row of perforations 60. One or more slits 62 may be provided adjacent to the perforations 60 on the distal edge 38 or the nearby edge 40 of the sleeve body 30 to facilitate the breakage of the sleeve body 30 (Figures 4 and 5).

[0109] In other embodiments, the fragile portion 58 is provided with a double row of perforations 60 (Figures 5A, 5B, and 10-13).

[0110] In yet another embodiment, the fragile portion 58 comprises a thin portion of the sleeve body 30 (not shown).

[0111] Blade mechanism In certain embodiments, the breaking mechanism 46 includes a blade mechanism 64 positioned to cut the sleeve body 30 between a first open end 34 and a second open end 36 when relative movement is applied between the sleeve body 30 and the blade mechanism 64 (best shown in Figures 8 and 9).

[0112] The blade mechanism 64 comprises a blade mechanism body 66 that can be hooked onto the distal edge 38 or the proximal edge 40 of the sleeve body 30. The blade mechanism body 66 comprises a first arm 68, a second arm 70, and a blade 72 positioned between the first arm 68 and the second arm 70. The first and second arms 68, 70 may be substantially parallel to each other. When in use, at least a portion of the first arm 68 extends along the outside 74 of the sleeve body 30, and at least a portion of the second arm 70 extends along the inside 76 of the sleeve body 30. The blade 72 is positioned relative to the distal or proximal edge 38, 40 of the sleeve body 30 and is arranged to cut the sleeve body 30 when the blade mechanism 64 is deployed. Deploying the blade mechanism 64 involves relative movement between the blade mechanism 64 and the sleeve body 30. Therefore, the blade mechanism 64 includes a rope 78 associated with either the sleeve 24 or the blade mechanism body 66 to perform the relative movement.

[0113] In the embodiment shown in Figure 8, the cord 78 is associated with the sleeve 24 and is referred to herein as the “sleeve cord” 78a. The sleeve cord 78a is positioned to move the sleeve body 30 relative to the blade 72, which causes the blade mechanism 64 to cut the sleeve body 30. The sleeve cord 78a may have a snare mechanism similar to the snare mechanism 52 shown in Figures 1-4 and 6, having a looped portion at a first end 54 that forms a loop through the sleeve body 30, and a tail portion at a second end 56 that extends close to the sleeve 24 and is deployable by the user. In certain embodiments, the second end 56 is a cord that extends outside the patient when in use for independent operation by the user. In other embodiments, the second end 56 may be incorporated into the handle of the endoscope (not shown). Relative movement of the sleeve body 30 and the blade 72 is produced by pulling the second end 56 of the sleeve cord 78a away from the first open end 34 of the sleeve body 30. In this case, the blade mechanism body 66 is fixed to the distal end 26 of the endoscope 14 or the distal end 28 of the additional channel 12.

[0114] The embodiment in Figure 9 differs from the embodiment in Figure 8 in that the rope 78 is associated with the blade mechanism body 66 instead of the sleeve 24 and is referred to herein as the “blade rope” 78b. The blade rope 78b has a first end 80 connected to the blade mechanism body 66 and a second end 82 extending adjacent to the sleeve 24, and is deployable by the user at the second end 82 through an endoscope handle (not shown), etc. Pulling the second end 82 of the blade rope 78b causes relative movement of the sleeve body 30 and the blade 72. In this case, the sleeve body 30 is fixed to the distal end 26 of the endoscope 14 or the distal end 28 of the additional channel 12.

[0115] In another embodiment, the sleeve rope 78a is attached to the sleeve 24 at its first end and to the blade mechanism body 66 or the blade rope 78b at its second end, as before. The sleeve rope 78a and the blade rope 78b may have a common second end such that tension on the common second end causes both the blade mechanism 64 and the snare mechanism 52 to deploy.

[0116] Removable strip Next, a breaking mechanism 46 with a removable strip 84 is shown, with reference to Figures 10–13. The removable strip 84 comprises a portion of the removable sleeve body 30. One or more removable strips 84 may be provided. The removable strip 84 comprises two lines of perforations 60 defined within the sleeve body 30, defining two fragile lines that extend longitudinally along the sleeve body 30 between the first and second open ends 34, 36. Breaking along the two lines of perforations 60 allows for the removal of the removable strip 84, and thus the opening of the sleeve body 30 to the breaking configuration, thereby allowing the separation of the contents of the sleeve channel 22. The removable strip 84 is also referred to herein as a "tension tab".

[0117] Tab 86 is provided at one end of the removable strip 84. In certain embodiments, tab 86 extends from the distal edge 38 of the sleeve body 30. A tab rope 88 is attached to tab 86 to apply tension to remove the removable strip 84. The tab rope 88 has a first end 90 attached to tab 86 and a second end 92 extending close to the sleeve body 30, which can be pulled by a user of the mounting system 10 (e.g., through an endoscope handle) to tear the perforation 60 and remove the removable strip 84. Tab 86, and the portion of the sleeve body 30 not containing tab 86, may be a single piece.

[0118] A tether 94 (Figure 13) is provided on the other end of the removable strip 84 to tether the removable strip 84 to the sleeve 30. The tether 94 causes the perforated wire 60 to break and remove the removable strip 84, and when the sleeve body 30 is operated within the break configuration, the removable strip 84 remains attached to the sleeve body 30.

[0119] The removable strip 84 may differ from the one shown in the illustration in that the two lines of the perforation 60 do not necessarily have to be parallel to each other. They may be linear or nonlinear.

[0120] In other embodiments, instead of two lines of perforation 60, a single line of perforation 60 is provided along with tabs 86 and tab ropes 88. By pulling on tabs 86, the sleeve 30 is broken along the single line of perforation 60.

[0121] Other breaking mechanisms 46, not shown, also fall within the scope of this technology, such as using a snare mechanism 52 to break the sleeve body 30 through a single or double line of the perforation 60.

[0122] tension mechanism In certain embodiments, the mounting system 10 also includes a tensioning mechanism 50. The tensioning mechanism 50 can perform one or more of the following functions: (1) providing tension to the sleeve body 30 during the operation of the breaking mechanism 46 or during the breaking itself; (2) adapting the cross-sectional surface area / diameter 44 of the sleeve body 30 to accommodate the diameters of different endoscopes 14 and / or additional channels 12 (i.e., enabling the sleeve body 30 to have a "free size" function); and (3) holding the endoscope 14 and additional channels 12 closer together (before the sleeve 30 breaks) to limit or prevent relative longitudinal movement between the endoscope 14 and additional channels 12. In certain embodiments, the tensioning mechanism 50 is positioned during the assembly of the mounting system 10 with the endoscope 14 and additional channels 12 (opposite to during the initial positioning of the mounting system 10).

[0123] pin In a particular embodiment, the tensioning mechanism 50 comprises at least one pin 98 having a hook portion 100 and a hook arm 102, the at least one pin 98 being insertable into the sleeve body 30 with the hook portion 100 extending over the distal edge 38 of the sleeve body 30 and the hook arm 102 extending longitudinally along the outer surface 74 of the sleeve body 30. When in position, the contact of the hook arm 102 with the sleeve body 30 provides tension to the sleeve body 30 to facilitate the breakage of the sleeve body 30.

[0124] Two pins 98 are provided in embodiments of Figures 6 and 7, where the breaking mechanism 46 includes a snare mechanism 52 and the sleeve body 30 contains a row of perforations 60. The two pins 98 are attached to the distal end 28 of the additional channel 12 and are spaced circumferentially apart from each other (Figure 6). The opening jaws 104 of the hook portions 100 face the distal edge 38 of the sleeve body 30. When in use, the additional channel 12 is pulled in close proximity to engage the hook portions 100 of each pin 98 with the sleeve body 30 (Figure 7). As can be seen, the two pins 98 are positioned so that one is on either side of the line of perforations 60 and, when engaged with the sleeve 24, create tension on the sleeve body 30 around the line of perforations 60 to facilitate breaking of the perforations 60 using the snare mechanism 52. The pins 98 may be made of metal or any other suitable material.

[0125] An additional function of the pins 98 is, in certain embodiments, to prevent or limit relative movement between the endoscope 14 and the additional channel 12 by tightening the sleeve 24. In this regard, in certain embodiments, the two pins 98 may be considered as a pair of "wings" on the sleeve 24 when assembled, so that the pins 98 grip the sleeve 24 to prevent the additional channel 12 from moving relative to the endoscope 14. By avoiding or limiting relative movement between the additional channel 12 and the endoscope 14, a consistent field of view is achieved at the distal end 26 of the endoscope 14 (relative movement between the additional channel 12 and the endoscope 14 alters the field of view of the device inside the lung).

[0126] In other embodiments (not shown), the pin 98 may be provided at the second end 36 of the sleeve body 30 such that the hook portion 100 extends over the adjacent edge 40 of the sleeve body 30 when in use.

[0127] In certain embodiments, pin 98 is attached to the distal end 26 of the endoscope 14 instead of the additional channel 12. Pin 98 can be attached to the endoscope 14 either directly or by a clip (not shown).

[0128] Although the pin 98 embodiment of the tension mechanism 96 is shown in combination with the snare mechanism 52, this embodiment of the tension mechanism 50 can be used in other embodiments of the breaking mechanism 46.

[0129] Adjustable part of the sleeve Referring next to Figures 12-14 and Figures 16A and 16B, in a particular embodiment, the tensioning mechanism 50 includes an adjustable portion 106 on the sleeve body 30. The adjustable portion 106 can be actuated to adjust the cross-sectional area of ​​the sleeve body 30. While an embodiment of the adjustable portion 106 is illustrated in combination with a removable strip 84 and a breaking mechanism 46, this embodiment of the tensioning mechanism 50 can be used with other embodiments of the breaking mechanism 46. The adjustable portion 106 includes a thread 108 that extends longitudinally along the sleeve body 30 and extends back and forth through the sleeve body 30, which can be pulled to reduce the cross-sectional area of ​​the sleeve 24. The adjustable portion 106 is similar to a corset arrangement.

[0130] The sleeve body 30 has a longitudinal split 110 defined by a first slit edge 112 and a second slit edge 114. The first and second slit edges 112 and 114 are held together by a thread 108 that extends back and forth between the first and second slit edges 112 and 114. Loops 116 can be provided on both the first slit edge 112 and the second slit edge 114 through which the thread 108 can extend. The loops 116 may be arranged in an internal finger-like configuration. The thread 108 extends alternately through the loops 116 on either side of the longitudinal split 110. The first end 118 of the thread 108 extends from the first end 34 of the sleeve body 30, and the second end 120 of the thread 108 extends from the second end 36 of the sleeve body 30. By pulling both the first and second ends 118 and 120 of the thread 108, the first slit edge 112 and the second slit edge 114 are brought closer together, narrowing the longitudinal split 110 and reducing the cross-sectional surface area of ​​the slit body 30.

[0131] In other embodiments (not shown), the sleeve body 30 is a single cylindrical piece (similar to that shown in Figure 10) and may include a thread 108 and optionally a loop 116.

[0132] In certain embodiments, one or more of the loops 116 have an internal surface 122 that provides sufficient friction to hold the thread 108 in a tensile position. In other embodiments, the thread 108 may be tied through the loops 116 to attach the thread 108 to the loops 116.

[0133] This embodiment of the tensioning mechanism 50 can also be used to adjust the cross-sectional area of ​​the sleeve body 30 to accommodate different sizes and shapes of endoscopes 14 and additional channels 12. Thus, the mounting mechanism 10 can provide a “free-size” system that can be incorporated into a larger combination of endoscopes 14 and additional channels 12. In such use, the thread 108 can be pulled to an appropriate tension and tied to fix its position before delivery to the patient. In certain aspects of this disclosure, the sleeve 24 may be equipped with the tensioning mechanism 50 without the breaking mechanism 46. The tensioning mechanism 50 also works to restrict or avoid relative movement between the endoscope 14 and additional channels 12 in the sleeve 24 during use. Relative movement means one or more of relative longitudinal and radial movement. As previously described, this can help maintain a consistent field of view of the device from video images. The mounting system 10 in Figures 15A and 15B differs from those in Figures 12 and 13 in that the single wire of the perforation 60 is provided on the sleeve 24 and the tether 94 is omitted. Pulling the tab 86 causes the sleeve 24 to break along the single wire of the perforation 60.

[0134] Packaging configuration Referring next to Figures 16A and 16B, a specific embodiment of the mounting system 10 is shown in which the sleeve body 30 has a packaging configuration instead of the single-layer configuration of Figures 1 to 15. In the packaging configuration, the sleeve body 30 is a flat material piece having two free longitudinal ends 124 and support pins 126 attached to the flat sleeve body 30. The tether 128 is attached to the support pins 126. When in use, the flat sleeve body 30 is wrapped around the endoscope 14 and additional channel 12 before being delivered to the patient's target site. By pulling the tether 128, the sleeve body 30 is unwound, allowing separation of the endoscope 14 and additional channel 12.

[0135] Anti-rotation device Next, referring to Figures 17A and 17B, a specific embodiment of an anti-rotation device that can be used in any embodiment of the mounting system 10 described herein to prevent or limit undesirable relative movement of the additional channel 12 and the endoscope 14 is shown. In a specific embodiment, the undesirable relative movement is the relative rotation of the additional channel 12 and the endoscope 14.

[0136] As shown in Figures 17A and 17B, the anti-rotation device includes a wing clip 130. The wing clip 130 comprises a U-shaped body 132 that defines a channel for receiving the additional channel 12. The U-shaped body wraps at least partially around the circumferential surface of the additional channel 12. The body 132 has two open ends 134, 136 and an opening side 138 through which the additional channel 12 can be secured by the wing clip 130. A pair of wings 140 extend from the edge of the opening side and spread outward in a mirror-image configuration. When the additional channel 12 is assembled with the endoscope 14 during use (Figure 17B), the wings 140 are relative to the endoscope 14 to prevent or limit rotational movement of the additional channel 12 relative to the endoscope 14. The wing clip 130 may be formed by thermoforming a plastic material.

[0137] In certain other embodiments, the anti-rotation device may be configured differently from the wing clip 130. For example, instead of an anti-rotation device that can be detachably attached to the additional channel 12, the anti-rotation device may be configured to be attached to the outer surface of the additional channel 12. In these embodiments, the anti-rotation device may include a wedge-shaped projection extending outward from the outer surface of the additional channel 12.

[0138] It should be understood that the mounting system 10 may be suitable for use with any type of endoscope 14, such as a bronchoscope. The bronchoscope may have a working channel that allows one or more of the following: visualization and aspiration. The mounting system 10 may also be used as a retrofit to an existing endoscope 14, in which case the endoscope 14, additional channel 12, and mounting system 10 may be assembled before delivery to the patient's target tissue site. The additional channel 12 may comprise one or more additional channels. In certain embodiments, the additional channel 12 comprises a sheath 20 for housing a guidewire, a balloon occlusion device, and / or a biopsy device, along which a guidewire can be advanced. The additional channel 12 may further comprise a steering cable that allows for independent positioning of the additional channel 12 to the endoscope 14. The additional channel 12 may comprise a sheath 20 that houses a guidewire and is sized and shaped to allow movement of one or more biopsy devices, such as a balloon occlusion device and a cryo-biopsy device, along the guidewire.

[0139] kit Next, referring to Figures 18 to 21, in a particular embodiment, the mounting system 10 is provided as a kit 150, which comprises the following components: mounting system 10 (sleeve 24, break mechanism 46, and optionally tension mechanism 50); additional channel 12; freezing probe for insertion into the additional channel 12 (e.g., freezing probe 166 in Figures 19A to 19C, 20, and 21); gas delivery assembly for cooling the freezing probe; one or more balloons for bleeding control (e.g., balloon 194 in Figure 20); and one or more anti-rotation devices such as wing clips 130.

[0140] One embodiment of the kit 150 according to this technology is shown at least in part in Figures 18 to 21. As clearly shown in Figure 18, the sleeve 24 includes a corset-like adjustable portion 106 on a sleeve body 30 having a thread 108 extending therefrom, and includes a tensioning mechanism 50, shown in Figures 12 to 14 and 16A to 16B, having first ends 118 and second ends 120 of the thread 108 extending from both sides of the sleeve body 30. The sleeve 24 also includes a removable strip 84 having a tab 86 at one end. Attached to the tab 86 is the first end 90 of a tab rope 88. The removable strip 84 is removed by applying tension by pulling on the second end 92 of the tab rope 88.

[0141] First and second rings 152 and 154 are provided, attached to the first and second ends 118 and 120 of the thread 108, respectively. A third ring 156 is provided, attached to the second end 92 of the tab rope 88. The first, second, and third rings 152, 154, and 156 are detachably attached to the support 158 ​​of the kit 150. The sleeve 24 is also attached to the support 158 ​​via a tube 160 to which the sleeve 24 is detachably attached. One or more of the first, second, and third rings 152, 154, and 156 and the tube 160 can be attached to the support 158 ​​by means of adhesive, adhesive tape, Velcro®, etc.

[0142] As can be seen from Figure 18, the kit 150 may also include an additional channel 12 (its distal end shown in Figure 18) equipped with a wing clip 130 as an anti-rotation device to prevent or limit rotational movement of the additional channel 12 relative to the endoscope 14, in the embodiment of Figure 18. Figure 18 also shows the distal end of the endoscope 14. However, it should be understood that the endoscope 14 does not have to constitute part of the kit 150 in certain embodiments.

[0143] Assembly of these components of kit 150 involves inserting the distal end of the endoscope 14 into the tube 160 and sliding the sleeve 24 away from the tube 160 over the distal end of the endoscope 14. The additional channel 12 is then slid within the sleeve 24 adjacent to the distal end of the endoscope 14. The wing clip 130 prevents or limits the rolling of the additional channel 12 relative to the endoscope 14 during assembly and use. The sleeve 24 has a loose configuration at this stage in which the thread 108 is not pulled to tighten the sleeve 24. The first and second rings 152, 154 are then removed from the support 158 ​​and pulled to tighten the sleeve 24 around the endoscope 14 and the additional channel 12. In this regard, once the desired tension is applied, the first and second ends 118, 120 of the thread 108 can be tied together, and the first and second rings 152, 154 can be removed by cutting or the like. The third ring 156 remains attached to the tab rope 88 until use in the patient, provided that it can be pulled to break the fragile bond and remove the sleeve 24.

[0144] Freezing probe Figures 19A to 19C show the proximity end 162 of the additional channel 12. The proximity end 162 is provided with a fixing mechanism for securing an insert within the sleeve channel 22 of the additional channel 12. In the illustrated embodiment, the insert is equipped with a freezing probe 166, but any other type of insert may be used. The fixing mechanism is equipped with a positioning screw 164 that can contact the insert and advance within the sleeve channel 22 to fix it in place. In other embodiments, the fixing mechanism may be any other type of fixing mechanism, such as a screw, bolt, or clamp.

[0145] The cryoprobe 166 is sized and shaped to be received within the additional channel 12 and has a connector 168 at its nearest end 170 that is configured to be removably attached to a cooling assembly (not shown). An exhaust opening 174 is provided distal to the connector 168 for gas discharge during cryobioscopy. The cryoprobe 166 is configured such that the exhaust opening 174 remains exposed when the cryoprobe 166 and the additional channel 12 are assembled and in use. A marker 178 is provided on the outside of the cryoprobe 166 to indicate the distance from the distal end of the cryoprobe 166 to the distal end of the cryoprobe 166. Markers 178 may be provided to indicate one or more extensions, for example, 0 cm (i.e., distal ends are coplanar), 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, and 20 cm. The freezing probe 166 comprises an inner tube (not shown) and an outer tube defining a channel between them, and a sealed distal end with a slender tip. The inner tube may be a capillary tube having an inner diameter of any suitable size. For example, in certain embodiments, the inner diameter is in the range of about 0.01 cm to about 0.03 cm. In certain embodiments, the inner diameter is about 0.02 cm. In certain embodiments, the inner diameter is in the range of about 0.007 inches to about 0.01 inches and 0.008 inches. In certain embodiments, the diameter of the outer tube may be approximately 0.017 cm to approximately 0.3 cm, or approximately 0.066 inches to approximately 0.118 inches. In certain embodiments, the diameter of the outer tube is 0.066 inches. In certain other embodiments, the diameter of the outer tube is 0.118 inches. The inner tube is coaxial with the outer tube and extends within the outer tube from the connector 168 to the distal tip of the freezing probe 166.

[0146] During use, the cooling assembly is configured to cool the distal tip of the freezing probe 166 in order to perform cryotherapy and / or cryotherapy on tissue in contact with the distal tip. Without being bound by any theory, the cooling of the distal tip can be defined by the Joule-Thomson effect, etc., by the advancement of a gas or liquid by the cooling assembly through the inner tube from high pressure (at the near end) to low pressure (at the distal tip). Cooling occurs as the advanced liquid or gas expands at the distal tip as it exits the inner tube. The gas then advances toward the near end of the freezing probe 166 before exiting through the discharge opening 174.

[0147] Pressurized gas from the cooling assembly is propelled through the inner tube of the freezing probe 166 and rapidly expands and vaporizes due to heat transfer from the surrounding tissue at the distal tip, thereby enabling cooling. The low-pressure gas can then flow upward between the inner and outer tubes and be released through the discharge opening 174. The cooling assembly can control cooling through the release of gas or liquid and pressure.

[0148] balloon In certain embodiments, the kit 150 includes a balloon 194 that can be attached to the distal end of the endoscope 14 and the additional channel 12 for in-use dilation, for example, to stop bleeding (Figure 20).

[0149] Anti-rotation device In certain embodiments, the kit 150 includes one or more anti-rotation devices for preventing or limiting undesirable movement of the additional channel 12 relative to the endoscope 14. In certain embodiments, as described above and shown in Figure 18, the anti-rotation device is a wing clip 130. The wing clip 130 may be attachable to either the additional channel 12 or the endoscope. In other embodiments not shown, the anti-rotation device may differ from the wing clip 130 shown and described herein. The anti-rotation device may have any suitable configuration for preventing or limiting undesirable movement of the additional channel 12 relative to the endoscope 14, such as relative rolling or rotation. The anti-rotation device may be detachably attached to either or both the additional channel 12 and the endoscope 14.

[0150] It should be understood that any of the above components of Kit 150 may be provided separately for use with other components not described herein. It should also be understood that other embodiments of the kit components may be included in the kit. For example, Kit 150 may include another embodiment of the sleeve 24, such as those illustrated and described in relation to Figure 10 or Figure 15. Kit 150 may include other embodiments of the anti-rotation device. The kit may include the cooling assembly 172 and the freeze probe.

[0151] How to use During use, the assembly 16, including the mounting system 10, endoscope 14, and additional channel 12, is delivered to the patient's target tissue. At appropriate times, the rupture mechanism 46 is deployed to separate the endoscope 14 from the additional channel 12. Optionally, the tension mechanism 50 may be deployed to facilitate the rupture of the sleeve 24, if it has not already been applied during the assembly of the mounting system 10 to the endoscope 14 and additional channel 12. The endoscope 14 and additional channel 12 can then be made to function separately from each other. At a minimum, this means that one of the endoscope 14 and additional channel 12 can be removed from the patient while the other remains in the patient.

[0152] Modifications and variations will be conceivable to those skilled in the art after reviewing this disclosure. The disclosed mechanisms may be implemented in any combination and subcombination (including numerous independent combinations and subcombinations) with one or more other mechanisms described herein. The various mechanisms described or illustrated above, including all their components, may be combined with or integrated with other systems. Furthermore, certain mechanisms may be omitted or not implemented. Examples of modifications, substitutions, and alterations will be evident to those skilled in the art and can be made without departing from the scope of the information disclosed herein.

[0153] It should be understood that the invention is not limited to the specific embodiments described and illustrated herein, but includes all modifications and variations that fall within the scope of the invention as defined in the appended claims. [Aspect 1] A mounting system for detachably attaching an additional channel to an endoscope, A sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, comprising a sleeve body having a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and having a first open end and a second open end, A mounting system comprising a tension mechanism having an adjustable portion on the sleeve body, wherein the adjustable portion is a tension mechanism that can be operated to adjust the cross-sectional area of ​​the sleeve body. [Aspect 2] The mounting system according to embodiment 1, wherein the adjustable portion comprises a thread extending longitudinally along the sleeve body and through the sleeve body, which can be pulled to reduce the cross-sectional area of ​​the sleeve body. [Aspect 3] The mounting system according to embodiment 2, wherein the thread extends in a zigzag configuration along the sleeve body in the longitudinal direction. [Aspect 4] The mounting system according to embodiment 2 or 3, wherein the sleeve body has a slit extending longitudinally between the first and second open ends of the sleeve body, the slit being defined by a first slit edge and a second slit edge, and the thread is arranged to extend alternately through the first slit edge and the second slit edge to bring the first and second slit edges of the sleeve body closer together when operated. [Aspect 5] The mounting system according to embodiment 4, further comprising a plurality of loops extending from the first and second slit edges, wherein each of the plurality of loops is arranged to receive the thread. [Aspect 6] The mounting system according to embodiment 5, wherein the loop on the first slit edge is arranged in an internal finger-like configuration with respect to the loop on the second slit edge. [Aspect 7] The mounting system according to any one of embodiments 1 to 6, wherein the removable strip further comprises a tab rope having a first end and a second end, the first end being connected to the removable strip, and the mounting system according to any one embodiment 1 to 6, wherein pulling the second end of the tab rope causes at least some of the perforations to break. [Aspect 8] The mounting system according to embodiment 7, wherein the first end of the tab rope is connected to the removable strip by a tab. [Aspect 9] The mounting system according to any one of embodiments 1 to 8, further comprising a tether for connecting the removed removable strip to the sleeve. [Aspect 10] The mounting system according to embodiment 1, wherein the tensioning mechanism comprises at least one pin having a hook portion and a hook arm extending from the hook portion, the at least one pin being insertable into the sleeve by the hook arm extending along the outer surface of the sleeve body, and the hook portion extending on the distal edge of the sleeve body or on the near edge of the sleeve body when in use. [Aspect 11] The mounting system according to embodiment 10, wherein at least one of the pins is attached to the additional channel or the endoscope. [Aspect 12] The mounting system according to embodiment 10, wherein the at least one pin is attached to the additional channel or the endoscope and comprises two pins spaced circumferentially apart from each other. [Explanation of symbols]

[0154] 10. Mounting System 12 additional channels 14 Endoscopy 16 Assembly 18 working channels 20 sheaths 22 Sleeve Channels 24 sleeves 26 Distal end 28 Distal end 30 sleeves 32 Sleeve Channels 34 First opening 36 Second opening 38 Distal margin 40 Proximity edge 42 Length 44 diameter 46. ​​Fracture Mechanism 48 Tether 50. Density Mechanism 52 Snare mechanism 54 First end 56 Second end 58 Fragile parts 60 perforation 64 Blade Mechanism 66 Blade mechanism body 68 First Arm 70 Second Arm 72 Blades 74 Outside 76 Inside 78 Rope 78a Sleeve rope 78b Blade rope 80 First end 82 Second end 84 Removable strips 86 tabs 88 Tab Group 90 First end 92 Second end 94 Tether 96 Tension mechanism 98 pins 100 Hook part 102 Hook Arm 104 Open jaw 106 Adjustable part 108 threads 110 Long Split 112 First slit edge 114 Second slit edge 116 loops 118 First end 120 Second end 122 Internal surface 124 Free longitudinal end 126 Support pins 128 tether 130 Wing Clip 132 Main unit 134 Open end 136 Open end 138 Opening side 140 Wing 150 kit 152 The First Ring 154 The Second Ring 156 The Third Ring 158 Support 160 tube 162 Proximity terminal 164 Positioning screws 166 Freezing probe 168 connectors 170 Proximity terminal 172 Cooling Assembly 174 Discharge opening 178 Marker 194 Balloons

Claims

1. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and comprising a sleeve body having a first open end and a second open end, The sleeve body is ruptured to allow separation of the distal end of the additional channel from the distal end of the endoscope, The breaking mechanism comprises a blade mechanism arranged to cut the sleeve body between the first and second open ends when relative movement is applied between the sleeve body and the blade mechanism, and a rope for applying the relative movement between the sleeve body and the blade mechanism. The mounting system comprises a blade mechanism body having a first arm coupled to a second arm, and a blade positioned between the first arm and the second arm, wherein the first arm is arranged to extend along the outside of the sleeve body and the second arm is arranged to extend along the inside of the sleeve body.

2. The mounting system according to claim 1, wherein the sleeve body is attached to the breaking mechanism.

3. The mounting system according to claim 1 or 2, wherein the breaking mechanism can be deployed in close proximity to the sleeve body.

4. The mounting system according to claim 1, wherein the blade mechanism is hooked onto the distal end or the near end of the sleeve body.

5. The mounting system according to any one of claims 1 to 4, wherein the rope is a sleeve rope and comprises a first end attached to the sleeve body and a second end extending from the first end and arranged to be operated by a user to move the sleeve body.

6. The mounting system according to claim 5, wherein the first end of the sleeve rope has a loop portion that extends around the sleeve body through the sleeve channel.

7. The blade mechanism comprises a blade mechanism body having a first arm coupled to a second arm, and a blade positioned between the first arm and the second arm. The mounting system according to claim 5 or 6, wherein the second end is attached to the blade mechanism body.

8. The blade mechanism comprises a blade mechanism body having a first arm coupled to a second arm, and a blade positioned between the first arm and the second arm. The mounting system according to any one of claims 1 to 7, wherein the rope is a blade rope and comprises a first end attached to the blade mechanism body and a second end extending from the first end and arranged to be operated by a user to move the blade mechanism body.

9. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and comprising a sleeve body having a first open end and a second open end, The sleeve body is ruptured to allow separation of the distal end of the additional channel from the distal end of the endoscope, Mounting system, wherein the breaking mechanism is a snare mechanism having a first end attached to the sleeve body and a second end extending from the first end and arranged to be operated by a user to break the sleeve body.

10. The mounting system according to claim 9, wherein the first end of the snare mechanism is provided with a loop portion that extends around the sleeve body through the sleeve channel.

11. A mounting system according to claim 9 or 10, further comprising a fragile portion on the sleeve body extending between the first open end and the second open end, wherein the snare mechanism is positioned to contact the fragile portion when activated to break the fragile portion.

12. The mounting system according to claim 11, wherein the fragile part is provided with a perforation.

13. The mounting system according to claim 12, wherein the perforations are arranged as a single row extending between the first open end and the second open end, or the perforations are arranged as two rows, each row extending between the first open end and the second open end.

14. The mounting system according to claim 12 or 13, further comprising a slit adjacent to the perforation at the distal or proximal edge of the sleeve body.

15. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and comprising a sleeve body having a first open end and a second open end, The sleeve body is ruptured to allow separation of the distal end of the additional channel from the distal end of the endoscope, Mounting system wherein the breaking mechanism is a removable strip on the sleeve body, the removable strip is defined by two rows of perforations on the sleeve body extending between the first and second openings, and the removable strip is configured such that the action of the removable strip can break at least some of the perforations to break the sleeve body so as to allow separation of the distal end of the additional channel from the distal end of the endoscope.

16. The mounting system according to claim 15, further comprising a tab rope having a first end and a second end, wherein the first end is connected to the removable strip, and pulling the second end of the tab rope causes at least some of the perforations to break.

17. The mounting system according to claim 16, wherein the first end of the tab rope is connected to the removable strip by a tab.

18. The mounting system according to any one of claims 15 to 17, further comprising a tether connected in part to the removable strip and in the other part to the sleeve body, for connecting the removable strip to the sleeve body when the perforation is broken.

19. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and comprising a sleeve body having a first open end and a second open end, The sleeve body is ruptured to allow separation of the distal end of the additional channel from the distal end of the endoscope, The sleeve further comprises a tension mechanism for providing tension to the sleeve, The tensioning mechanism comprises at least one pin having a hook portion, and a hook arm extending from the hook portion, wherein the at least one pin is insertable into the sleeve via the hook arm extending along the outer surface of the sleeve body, and the hook portion extends over the distal edge of the sleeve body or over the near edge of the sleeve body when in use, in a mounting system.

20. The mounting system according to claim 19, wherein at least one of the pins is attached to the additional channel.

21. The mounting system according to claim 20, wherein the at least one pin is attached to the additional channel and comprises two pins spaced circumferentially apart from each other.

22. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, and comprising a sleeve body having a first open end and a second open end, The sleeve body is ruptured to allow separation of the distal end of the additional channel from the distal end of the endoscope, The sleeve further comprises a tension mechanism for providing tension to the sleeve, The tensioning mechanism is provided with an adjustable portion on the sleeve body, and the adjustable portion can be operated to adjust the cross-sectional area of ​​the sleeve, in the mounting system.

23. The mounting system according to claim 22, wherein the adjustable portion comprises a thread extending longitudinally along the sleeve body and through the sleeve body which can be pulled to reduce the cross-sectional area of ​​the sleeve.

24. The mounting system according to claim 23, wherein the thread extends along the sleeve body in a zigzag configuration in the longitudinal direction.

25. The mounting system according to claim 23 or 24, wherein the sleeve body has a slit extending longitudinally between the first and second open ends of the sleeve body, the slit being defined by a first slit edge and a second slit edge, and the thread is arranged to extend alternately through the first slit edge and the second slit edge to bring the first and second slit edges of the sleeve body closer together.

26. The mounting system according to claim 25, further comprising a plurality of loops extending from the first and second slit edges, wherein each of the plurality of loops is arranged to receive the thread.

27. The mounting system according to claim 25, wherein the loop on the first slit edge is arranged in an internal finger-like configuration with respect to the loop on the second slit edge.

28. The mounting system according to any one of claims 1 to 27, further comprising the additional channel, wherein the additional channel comprises a sheath having a size and shape for housing a guide wire.

29. The mounting system according to claim 28, wherein the additional channel further comprises a steering cable for independent positioning of the additional channel.

30. The mounting system according to any one of claims 1 to 29, further comprising the endoscope.

31. The mounting system according to claim 30, wherein the endoscope has a working channel that enables one or more of visualization and aspiration.

32. The mounting system according to claim 30 or 31, wherein the endoscope is a bronchoscope.

33. A mounting system for detachably attaching an additional channel to an endoscope, The endoscope is provided with a sleeve for receiving the distal end of the endoscope and the distal end of the additional channel during use, the sleeve having a sleeve body with a first open end and a second open end defining a sleeve channel through which the distal end of the endoscope and the distal end of the additional channel pass during use, A breaking mechanism for breaking the sleeve body to allow separation of the distal end of the additional channel from the distal end of the endoscope, comprising a breaking mechanism defined by two rows of perforations on the sleeve body extending between a first open end and a second open end, and comprising a removable strip that is operable to break the perforations to open the sleeve body, thereby allowing separation of the distal end of the additional channel from the distal end of the endoscope, the mounting system further comprises A mounting system comprising a tension mechanism having an adjustable portion on the sleeve body, wherein the tension mechanism can be operated to adjust the cross-sectional area of ​​the sleeve body.

34. The mounting system according to claim 33, wherein the adjustable portion comprises a thread extending longitudinally along the sleeve body and through the sleeve body which can be pulled to reduce the cross-sectional area of ​​the sleeve body.

35. The mounting system according to claim 34, wherein the thread extends in a zigzag configuration along the sleeve body in the longitudinal direction.

36. The mounting system according to claim 34 or 35, wherein the sleeve body has a slit extending longitudinally between the first and second open ends of the sleeve body, the slit being defined by a first slit edge and a second slit edge, and the thread is arranged to extend alternately through the first slit edge and the second slit edge to bring the first and second slit edges of the sleeve body closer together when operated.

37. The mounting system according to claim 36, further comprising a plurality of loops extending from the first and second slit edges, wherein each of the plurality of loops is arranged to receive the thread.

38. The mounting system according to claim 37, wherein the loop on the first slit edge is arranged in an internal finger-like configuration with respect to the loop on the second slit edge.

39. The mounting system according to any one of claims 33 to 38, wherein the removable strip further comprises a tab rope having a first end and a second end, the first end being connected to the removable strip, and the second end being actuated to break at least some of the perforations.

40. The mounting system according to claim 39, wherein the first end of the tab rope is connected to the removable strip by a tab.

41. The mounting system according to any one of claims 33 to 40, further comprising a tether for connecting the removable strip to the sleeve.

42. A kit comprising the mounting system according to any one of claims 1 to 32 or 33 to 41, and the additional channel.

43. The kit according to claim 42, wherein the additional channel comprises a sheath having a size and shape suitable for housing a guide wire.

44. The kit according to claim 42 or 43, further comprising a biopsy device, wherein optionally the biopsy device comprises a cryo-biopsy device.

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