Sheath assembly for endoscope

Abstract

A longitudinally folded sheath tube is deployable as an endoscope extends into the sheath tube and into a human body to sheath the endoscope. The sheathing canal is folded into a telescopic folding type or an accordion folding type, and the sheathing canal is provided with an end cover located at the far end and an end protection piece located at the near end. An endoscope may pass through the end guard and the folding sheath to fit into the end cap to be able to push the end cap from inside the folding sheath to unfold the sheath. Optionally, at least one external instrument channel is fixed on the end cover, and the external instrument channel penetrates through the sheath tube and extends out of the end protection piece, so that the expanded sheath tube simultaneously enables the endoscope and the external instrument channel to enter the sheath. Thus, the sheath may be a mating sheath to limit separation of the endoscope and the external instrument channel while easily deploying on the endoscope and the external instrument channel.

Description

Technical Field

[0001] The present invention relates to an endoscope for accessing surgical instruments to the gastrointestinal tract for performing minimally invasive surgery. Background Art

[0002] Some types of endoscopes consist of a flexible tube that a clinician inserts through the mouth or anus into the gastrointestinal (GI) tract. The clinician pushes the endoscope's external portion until the end of the endoscope approaches the surgical target in the GI tract. A common model of this endoscope includes two instrument channels, each with an opening at the end of the endoscope and another opening in the handle. Surgical instruments can be inserted through the handle openings and through the instrument channels to manipulate the surgical target at the end of the endoscope.

[0003] Some clinicians prefer endoscopes with more than two instrument channels. Some models lack instrument channels at all, and it would be beneficial to be able to upgrade these endoscopes rather than replace them. Therefore, there is a desire to expand the functionality of existing endoscopes. To this end, one approach has been to run plastic tubing along the body of the endoscope to provide external instrument channels. One approach involves wrapping the tubing and endoscope combination with tape. However, when the endoscope is bound to the tubing along its entire length, its flexibility is reduced, and insertion of the rigidified endoscope becomes more difficult. Furthermore, manual modification is time-consuming, and the quality of the modified products is inconsistent.

[0004] It has been proposed to attach external instrument channels to endoscopes via discrete connection points spaced apart along the endoscope to reduce endoscope stiffness. If two external instrument channels are attached to an endoscope in this manner, adjacent segments of the unattached external instrument channels may become entangled or twisted with each other due to the frequent twisting / twisting motions performed by clinicians attempting to insert the endoscope deeper. If entanglement occurs after the components have been inserted into the body, it will be difficult to separate the twisted segments, and the endoscope and any surgical instruments inserted into the external instrument channels will have difficulty responding to further manipulation.

[0005] A plastic sheath has been proposed to cover the assembled endoscope and external instrument channels. However, pulling the plastic sheath onto the assembly is difficult because the technician must repeatedly push different sections of the sheath to deploy the sheath onto the assembly, which is not only time-consuming but also increases the risk of infection due to excessive manipulation.

[0006] Therefore, it would be desirable to provide methods and / or apparatus that can add one or more external instrument channels to an endoscope with minimal loss of endoscope flexibility.

[0007] Furthermore, it is also desired to provide a sheath that can sheath an endoscope relatively quickly. Summary of the Invention

[0008] In a first aspect, the present invention proposes a sheath assembly for an endoscope, comprising: a hollow sheath having a distal end attached to an end cap and a proximal end attached to a ring of an end protector, the end protector being configured to allow the endoscope to extend through the ring and the hollow sheath to be assembled into the end cap; the sheath is folded into a plurality of folded portions, each folded portion being a circumferential segment of the sheath, which is longitudinally folded relative to an adjacent circumferential segment of the sheath; wherein the folded portion can unfold when the endoscope pushes the end cap away from the end protector.

[0009] Thus, the present invention provides a foldable sheath that allows for the sheathing of a longer length of the endoscope as it is further inserted into the sheath. This allows the distal-most folded portion of the sheath to unfold and lay over the portion of the endoscope that has just passed through the end guard. Because there is no need to pull the sheath onto the endoscope, there is no shearing force. This allows the endoscope to be easily layered within the adaptable sheath.

[0010] Typically, the end cap is sized to allow entry into the GI tract, but the end guard is too large to enter the mouth or anus. Therefore, pushing the endoscope inside the sheath into the body pushes the end cap further into the body, away from the inaccessible end guard.

[0011] Optionally, the sheath is folded into a series of telescoping folds. Typically, the telescoping folds comprise a longitudinal segment of the sheath that is folded around the sheath circumference to extend longitudinally over adjacent telescoping folds of the sheath. An end cap is attached to the distal end of the sheath, and the end cap is pulled out before the proximal folds to unfold the distal folds.

[0012] Preferably, the edge of each telescoping fold extends beyond the edge of the immediately adjacent telescoping fold. More preferably, the sheath assembly includes a plurality of eyelets, each eyelet attached to an overextended edge; the plurality of eyelets being aligned longitudinally along the sheath. The aligned eyelets can be inserted into a tubular member, such as an external instrument channel, within the sheath to restrict movement of the tubular member.

[0013] In some specific embodiments, the edge of the telescoping fold at the more distal end extends beyond the edge of the telescoping fold at the more proximal end next to it. In other embodiments, the edge of the telescoping fold at the more proximal end extends beyond the edge of the telescoping fold at the more distal end next to it.

[0014] Alternatively, the sheath is folded into accordion folds.

[0015] Generally, folding a sheath into a telescopic fold is easier because it requires fewer folds. Furthermore, when the moving end cap pulls on the sheath, the distal folds deploy first. However, there is greater slippage between the folds during sheath deployment. An accordion fold is more difficult to create, but deploying an accordion fold is smoother than deploying a telescopic fold because there is no slippage between the folds. Furthermore, an accordion fold provides a more compact sheath.

[0016] Preferably, the sheath assembly includes a plurality of eyelets attached to the accordion folds, and the plurality of eyelets are longitudinally aligned relative to the sheath. More preferably, the sheath assembly includes a second plurality of eyelets attached to the accordion folds, the second plurality of eyelets are longitudinally aligned relative to the sheath; and the plurality of eyelets and the second plurality of eyelets are spaced apart around the circumference of the sheath.

[0017] Preferably, the sheath assembly further comprises an inflatable balloon surrounding the end cap.

[0018] Preferably, the sheath assembly further comprises at least one external instrument channel extending from the end cap through the sheath and out of the ring on the tip protector.

[0019] More preferably, the sheath assembly comprises two external instrument channels extending from the end cap through the sheath and out of the ring on the end protector; the distal ends of the external instrument channels are arranged to converge with each other on the end cap.

[0020] Because the distal-most folded portion of the sheath is laid over the portion of the endoscope that has just passed through the end protector, the sheath can be pulled onto the endoscope with little or no manipulation; the unfolded portion of the sheath automatically lays over the passed portion of the endoscope. This enables the sheath to be fitted to an endoscope and two (or any number of) external instrument channels, preventing the endoscope and the external instrument channels from being stacked or twisted relative to each other while allowing the endoscope and the external instrument channels to slide relative to each other, thereby minimizing stiffness of the endoscope.

[0021] Typically, the sheath assembly includes two eyelets attached to the inner surface of the sheath and spaced apart about the circumference of the sheath; two external instrument channels pass through different ones of the eyelets; the eyelets are attached to the inner surface of the sheath at a distance from the end cap; wherein the distance (when the sheath is deployed) is less than or equal to half the length of the curved section of the endoscope, or the distance is less than or equal to 10 cm. The primary purpose of the eyelets is not to separate the external instrument channels, but to ensure that the distal ends of the external instrument channels do not rotate about the end cap. Most curved sections are approximately 18 to 20 cm long, and the 10 cm distance between the end cap and the eyelet location may be roughly in the middle of most curved sections.

[0022] On the other hand, the present invention provides a method for sheathing an endoscope, comprising the following steps: providing a hollow sheath folded into a plurality of folded portions, each folded portion being a circumferential segment of the sheath, which is folded longitudinally to an adjacent circumferential segment of the sheath; inserting the endoscope through the proximal end of the sheath; pushing more portions of the endoscope into the sheath, and pushing the distal end of the sheath further away from the proximal end of the sheath to unfold the sheath; wherein the folded portion of the sheath being unfolded is laid on a portion of the endoscope passing through the folded portion of the sheath being unfolded.

[0023] Although in most embodiments, the end cap is disposed at the distal end of the sheath, other attachment methods may be used between the distal end of the sheath and the endoscope tip, and the steps of the method are not necessarily limited to disposing the end cap at the distal end of the sheath.

[0024] Typically, pushing the distal end of the sheath further away includes the following steps: pushing the distal end of the sheath into the gastrointestinal tract of the human body.

[0025] Preferably, the method further comprises the step of providing at least one tube attached to the distal end of the sheath; wherein the expanding fold of the sheath is laid over the endoscope and the portion of the at least one tube passing through the expanding fold of the sheath.

[0026] This method of placing, laying or layering the unfolded folds or sections of the sheath on or against the through portion of the endoscope eliminates the need to pull the sheath onto the endoscope (and any tube attached to the distal end of the sheath), allowing the sheath to fit more snugly onto the sheath than with prior art techniques that require the sheath to be pulled onto the endoscope to sheath the endoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] It will be convenient to further describe the present invention with reference to the accompanying drawings which illustrate possible arrangements of the present invention, wherein like reference numerals refer to like parts. The present invention may also have other arrangements, and therefore the particularity of the accompanying drawings should not be construed as superseding the generality of the preceding description of the present invention.

[0028] Figure 1 is a diagram of a robotic endoscopic surgery system;

[0029] Figure 2 To be available in Figure 1 Photographs of the endoscopes used in the system;

[0030] Figure 3 Pluggable Figure 2 photos of endoscopic surgical instruments;

[0031] Figure 4 For example, Figure 2 Illustration of a steerable arm extending from the distal end of an endoscope;

[0032] Figure 5 for Figure 2 How to install the endoscope Figure 1 Illustration on the positioning cart in the system;

[0033] Figure 6 For extensions such as Figure 2 A schematic illustration of a sheath assembly illustrating the functionality of an endoscope;

[0034] Figure 7 for Figure 6Another schematic illustration of the sheath assembly shown;

[0035] Figure 8 for Figure 6 Another schematic illustration of the sheath assembly shown;

[0036] Figure 9 A set of schematic diagrams showing the sheath assembly in use;

[0037] Figure 10 for Figure 6 Illustration of variations of sheath assemblies;

[0038] Figure 11 is a diagram of a sheath assembly with an inflatable balloon;

[0039] Figure 12 for Figure 11 An illustration of an air bag in front view;

[0040] Figure 13 A photograph of the endoscope assembled in a prototype sheath assembly;

[0041] Figure 14 for Figure 13 The negative image of the selected part in ;

[0042] Figure 15 for Figure 13 Photos of the components disassembled into their parts;

[0043] Figure 16 is a schematic illustration of a variation of a sheath assembly;

[0044] Figure 17 is a schematic illustration of a variation of a sheath assembly;

[0045] Figure 18 is a schematic illustration of a variation of a sheath assembly;

[0046] Figure 19 is a schematic illustration of a variation of a sheath assembly;

[0047] Figure 20 is a schematic illustration of a variation of a sheath assembly;

[0048] Figure 21 is a schematic illustration of a variation of a sheath assembly;

[0049] Figure 22 is a schematic illustration of a variation of a sheath assembly;

[0050] Figure 23 is a schematic illustration of a variation of a sheath assembly;

[0051] Figure 24 is an illustration of one of the simplest variations of a sheath assembly;

[0052] Figure 25 is a diagram of another simplest variant of the sheath assembly;

[0053] Figure 26 is an illustration of preferred features in the end cap of the sheath assembly;

[0054] Figure 27 is a diagrammatic representation of preferred features in the end cap;

[0055] Figure 28 is an illustration of another preferred feature in the end cap;

[0056] Figure 29 is a diagram of a variation of an end protector;

[0057] Figure 30 An illustration of the end protection prototype. DETAILED DESCRIPTION

[0058] Figure 1 A robotic endoscopic surgery system is shown, which includes a medical device kit and a robotic device. The kit is used to support the deployment of a rigid endoscope 201 into the human urethra, such as Figure 1 As shown, a flexible endoscope 201 is deployed into the gastrointestinal (GI) tract of a human body, Figure 1 Typically, endoscopic surgery is performed using this system with a robotic instrument having an end effector at the distal end of the endoscope.

[0059] The main components of the kit include an operating table 101, a positioning cart 103, a control console 105, and a display monitor atop a stand 107. The positioning cart 103 is arranged in a straight line with the operating table 101. Distal to and approximately between the positioning cart 103 and the operating table 101 is a stand 107 with a display monitor. Proximally, the console 105 is located where the clinician sits to control the robotic instrument. This creates an open layout that allows the clinician to observe a real-time image of the endoscope's view on the display monitor while keeping an eye on the patient.

[0060] Figure 2 A photograph of a flexible endoscope 201 adapted for insertion into the GI tract via the mouth or anus is shown. An axially aligned handle 203 at the proximal end of endoscope 201 includes an adjuster 207 for curling a curved section 205 at the distal end of endoscope 201. A stem 209 extends from handle 203 and is used to connect to a video image processor in bracket 107 and to connect to a pump and container for delivering air and water through the endoscope and for collecting fluids aspirated from the GI tract by endoscope 201.

[0061] Endoscopic surgery begins with the clinician inserting endoscope 201 into the body, positioned on operating table 101, using manual manipulation. The distal end of endoscope 201 is equipped with a light source 403 and a camera 405, which transmit images of the endoscope's progress through the GI tract to a display monitor. When the distal end of endoscope 201 approaches the surgical target in the GI tract, the endoscope handle 203 is mounted on a bracket 109 extending from the positioning cart 103, keeping endoscope 201 as still as possible.

[0062] On the endoscope handle 203 are two proximal openings 211 for instrument channels, with distal openings located at the end of the endoscope. Each instrument channel can be inserted with a surgical instrument. If no surgical instrument is inserted, the endoscope 201 does not have surgical function.

[0063] Figure 3 The figure below is a photograph of a surgical instrument 300. A typical surgical instrument 300 comprises a 0.5- to 1.8-meter-long transmission tube 301. A small, approximately 3-centimeter-long robotic arm, called a maneuverable arm 303, is located at the distal end of the transmission tube 301. The maneuverable arm 303 has an end effector 401 at its distal end, which is used to perform surgical actions such as cutting, grasping, and suturing within the human body. A wire, attached to the maneuverable arm 303 and the end effector 401 at one end, passes through the transmission tube 301 and is connected at the other end to a spool within a coupler 305, which is connected to the positioning cart 103.

[0064] Figure 4 2 is a diagram showing two maneuverable arms 303 extending from an instrument channel at the distal end of an endoscope, below a light source 403 and a camera 405 also located at the distal end of the endoscope 201. As can be seen, each maneuverable arm 303 holds an end effector 401.

[0065] Figure 5 It shows how the endoscope 201 is mounted on the bracket 109. The actuator platform 501 on top of the positioning cart 103 has a receptacle for mating with the coupler of the surgical instrument 300.

[0066] The console 105 is a modified dentist's stool, also known as a surgical chair. Dentist's stools are common in clinics and are designed to allow dentists and doctors to sit ergonomically and move around the clinic. An electromagnetic field (EMF) generator on the console 105 generates EMF, which monitors the coordinates of two EMF-responsive controllers. The EMF generator is approximately the size of a brick, and the front edge of the seat is the only suitable mounting location. Therefore, the EMF is always in front of the clinician in the console 105. The actuator platform 501 operates the line wound on the spool in the coupler 305 to continuously reposition the manipulable arm 303 and the end effector 401 according to the coordinates of the controller held and moved by the clinician in the console 105 in the electromagnetic field (EMF) to operate the surgical target in the GI tract or urethra.

[0067] Figure 6 、 Figure 7 and Figure 8 Schematic illustrations of the sheath assembly 700 in different viewing angles and configurations. The sheath assembly 700 provides the possibility of efficiently and quickly sheathing the endoscope 201.

[0068] The sheath assembly 700 includes a sheath 711 made of a hollow cylinder of thin, foldable plastic. The distal end of the sheath surrounds a hoop serving as an end cap 701 and is sealed to the outer surface of the hoop. The end cap 701 has an inner bore having a diameter that is almost as small as the diameter of the endoscope 201. A narrow radial lip 703 extends beyond the inner surface of the end cap and is flush with the distal edge of the end cap 701. Thus, the end of the endoscope can be inserted into the end cap from the proximal end and securely mounted by the end cap. The endoscope is blocked by the lip and cannot extend beyond the distal end of the end cap 701. The lip 703 is narrow and does not interfere with the operation of the camera 405, light source 403, and instrument channel at the end of the endoscope.

[0069] On the other hand, the sheath is attached to the tip protector 715 at its circumference at the proximal opening and covers the ring located in the center of the tip protector.

[0070] The size of the end cap allows it to enter the mouth or anus and move into the GI tract. However, the size, shape or size of the end protector is such that the end protector cannot even move into the mouth or anus.

[0071] Two conduits 705 are integrated on the outer surface of one side of the end cover 701 , and their axes are parallel to the axis of the end cover 701 . Figure 6705 is shown in a side view, surrounded by a dashed line. Each conduit 705 is securely clamped to the distal end of the hollow tube without altering the internal shape of the hollow tube. The hollow tube serves as an external instrument channel 707, and thus its length exceeds the length of the portion of a typical endoscope 201 intended for insertion into the human body. A simple guideline is that the length of the external instrument channel 707 should be similar to or longer than the length of the instrument channel in an average or most commonly used flexible endoscope 201. Furthermore, the inner diameter of the external instrument channel 707 should be similar to the diameter of the instrument channel in most endoscopes 201. In this way, the external instrument channel 707 is compatible with both the length and circumference of existing surgical instruments 300, minimizing the likelihood of size mismatches. In a variation of this embodiment, the end cap 701 has only one conduit 705 (not shown) that clamps the external instrument channel 707.

[0072] The hollow tube used as the external instrument channel 707 preferably has the following features:

[0073] 1. Low bending resistance, at least lower than the bending resistance of the endoscope 201;

[0074] 2. Good anti-radial deformation structure, which prevents wrinkling when the tube is bent and keeps the instrument channel open;

[0075] 3. The smooth inner surface allows the surgical instrument 300 to pass through easily and repeatedly during surgery.

[0076] An example of a hollow tube with the above characteristics is a stainless steel spring embedded thermoplastic polyurethane tube (spring embedded tube). Basically, the spring embedded tube includes a "helical spring" coated with plastic and has a smooth inner and outer surface (which solves point 3).

[0077] The edges of the coils on one side of the coil spring can be expanded, allowing the coil spring to bend to the other side. Because there are a large number of coils per unit length of tube, the edges of a certain number of coils only need to be slightly expanded on the convex side to bend the coil spring to the concave side. Such a small movement will produce little or no bending resistance. Therefore, this spring-embedded tube has extremely low bending resistance and can be described as flexible. That is, the spring-embedded tube can bend in any direction with little to no structural bias or strength to maintain itself. Therefore, the external instrument channel 707 made of the spring-embedded tube can bend with the endoscope 201 along the folds of the GI tract with little or no resistance.

[0078] Furthermore, the coils of the spring are thinner at the edges but wider radially, which imparts resistance to radial deformation. Consequently, the external instrument channel 707 formed by the spring-embedded tube does not buckle, wrinkle, or fold sharply when curved within the GI tract. This helps ensure that the external instrument channel 707 remains unobstructed under normal circumstances.

[0079] In the case where the catheter on the end cap provides external instrument access, the distal end of the sheath 711 needs to surround the end cap 701 and the catheter 705 and seal to the outer surface of the end cap 701 and the catheter 705, preferably in an airtight manner. The edge of the sheath 711 can be pleated to fit neatly onto the end cap 701 and the catheter 705 to achieve an effective seal.

[0080] Another preferred feature of this embodiment is that the end cap 701 is placed in the center portion of the annular airbag 709. The airbag 709 is made of a plastic material that can be elastic or non-elastic. Figure 6 and Figure 7 Of the two, shown in a deflated state and folded against the sides of the end cap 701, Figure 8 The airbag 709 is shown in an inflated state.

[0081] The ring is a three-dimensional shape that is circular in plan view and has a vertically open center portion in the center. Basically, this is a donut shape, but the airbag preferably has a height-to-diameter ratio greater than that of an actual donut.

[0082] The outer surface of the central portion of the balloon 709 is sealed to the end cap 701, the catheter 705, any exposed portion of the inflation tube 710 on the outer surface of the end cap, and each side of the edge of the sheath 711 sealed to the end cap 701 by gluing, laminating or other means.

[0083] Inflation tube 710 is used to inflate balloon 709. Typically, inflation tube 710 is made of silicone or another highly flexible polymer. The distal end of inflation tube 710 is inserted through the annular center portion and into balloon 709. The remainder of the inflation tube extends between the sealed sheath 711 and end cap 701 (and catheter 705), passing through the hollow portion of sheath 711 and extending through the loop of end guard 715. Typically, inflation tube 710 is at least as long as external instrument channel 707.

[0084] Outside the end guard 715, the proximal end of the inflation tube 710 can be connected to the needle connector of the syringe 1501, allowing the syringe piston to inflate the airbag 709. The syringe can also be used to draw air from the inflation tube to deflate the airbag, particularly if the airbag is made of a non-elastic material that does not apply pressure to deflate the airbag. Preferably, a valve is provided near the proximal end of the inflation tube 710. The valve can be opened to allow air to enter or exit the airbag 709. The valve can be closed to prevent leakage of the inflated airbag 709 and to allow the syringe 1501 to be removed from the inflation tube 710. Preferably, a pressure relief valve is provided downstream between the valve and the end guard 715 to allow excess gas in the airbag 709 to be released, preventing the airbag 709 from rupturing or otherwise damaging the person.

[0085] For the sake of brevity, in some of the following paragraphs, the two external instrument channels 707 and the inflation tube 710 will be collectively referred to as "tubular members."

[0086] Thus, in its original, unused state, with the sheath in a folded configuration and a shortened channel length, it can be appreciated that the majority of the tubular member extends from within the folded sheath and beyond the loop of the end guard. However, as the endoscope is passed through the loop and the folded sheath (with the end cap mounted on its distal end) and inserted into the body, these tubular members are pulled back into the loop. This first unfolds the most distal folded portion of the sheath, positioning the unfolded portion of the sheath over or around the portion of the endoscope and tubular member that was just passed through; there is no need to pull or adjust the sheath over the endoscope and tubular member.

[0087] Thus, the end cap assembly provides the possibility of easily sheathing the endoscope and the tubular member into a conformable and even snug-fitting sheath.

[0088] Figure 9 A series of figures showing how an endoscope 201 can be inserted into a human body while being sheathed. The top figure shows the pre-insertion preparation, where the sheath assembly is about to be installed on the endoscope 201. The second figure shows the endoscope inserted into the ring and hollow folded sheath and the end cap (not visible in the figure) is inserted.

[0089] When the end cap of the sheath assembly is mounted on the end of the endoscope, the endoscope and the sheath assembly can be inserted into the human body.

[0090] The sheath assembly is then placed in the patient's mouth, and the patient wears a mouth guard to maintain open access to the mouth. The endoscope is pushed through the loop and mouth guard. The end cap attached to the end of the endoscope is slowly passed through the throat, esophagus, and then into the stomach. The end cap pulls on the expanded sheath.

[0091] Because the end guard is designed to be too large to enter the oral cavity, the end guard provides resistance, which the end cap counteracts, typically pulling the sheath through the distal-most fold first to deploy. The external instrument channel and inflation tube are pulled by the end cap to extend into the loop and sheath. Thus, the endoscope, external instrument channel, and inflation tube, which pass through the end guard and into the body's GI tract, are dynamically sheathed through the currently deployed section of the sheath.

[0092] The sheath assembly is used in the same manner when inserting an endoscope into the anus. The end cap attached to the end of the endoscope is pushed into the anal cavity. Because the end guard is designed to prevent entry into the anus, the end cap is moved further into the body and away from the end guard outside the body, pulling the folded sheath to unfold over the endoscope and the portion of the tubular member that has just been moved into the end guard.

[0093] The sheath 711 serves to bring the tubular member closer to the endoscope 201 while allowing the tubular member to slide relative to the endoscope 201. This sliding capability enables the endoscope 201 to move freely within the GI tract.

[0094] After the endoscope 201 is pushed into the target location within the human body, the clinician mounts the handle 203 of the endoscope 201 onto the bracket 109 extending from the positioning cart 103 to keep the endoscope 201 stationary. Subsequently, the clinician uses a large syringe 1501 to inject gas into the balloon 709 through the inflation tube 710, inflating the balloon to stabilize the position of the endoscope's distal end within the human body. The inflated balloon 709 stabilizes the distal end of the endoscope 201 by gently pressing against a large area of ​​the GI tract and provides traction for the insertion and removal of the surgical instrument 300. The inflated balloon also acts as a seal in the esophagus or colon, preventing air leakage during inflation.

[0095] The clinician then inserts a surgical instrument with the required end effector into each external instrument channel. Using the camera image, the clinician can observe whether the manipulator arm of the surgical instrument has extended from the external instrument channel and is ready to perform the operation. The clinician then connects the coupler of the surgical instrument to the actuator platform of the positioning cart. The clinician then sits in the console 105 and holds a controller to perform the surgical operation under the guidance of a real-time display of the situation in the GI tract. The coordinates of the controller moving in the EMF generated by the console 105 are sent to the actuator to be converted into the movement of the manipulator arm and the end effector in real time.

[0096] Figure 8 The sheath assembly 700 is shown in an operational state, wherein the distal end of the endoscope 201 passes through the loop 713 of the end protector 715 into the sheath 711 and is inserted into the end cap 701 . Figure 8 Also shown is the airbag 709 inflated completely around the end cap. Figure 8 The inserted figure is annular, that is, the appearance of the airbag 709.

[0097] Figure 11 The balloon 709 is shown inflated around the end cap 701 at the distal end of the endoscope 201. As can be seen, the sheath 711 is attached to the proximal edge of the end cap 701 and sheathes the external instrument channel 707 that is clamped to the catheter 705 at the end cap 701. Figure 11 It is shown that one end of the inflation tube 710 extends into the airbag 709 and enters the hollow portion of the sheath 711 between the sheath 711 and the surface of the end cap 701 . Figure 11 Each external instrument channel 707 is shown with a surgical instrument 300 inserted therein, and the manipulatable arm 303 of each surgical instrument 300 can be seen extending from the corresponding external instrument channel 707 and wielding the end effector 401 .

[0098] Figure 12 is an illustration of a preferred feature of the bladder 709 in a front view of the end cap 701 showing the bladder 709 inflated completely around the end cap 701 .

[0099] The central portion of the annular balloon 709 is non-concentric or eccentric relative to the circumference of the balloon 709. This allows the end cap 701 to be elevated above the axis of the GI tract by positioning the balloon 709 below the end cap 701 more than above it, as indicated by y > x, where x is the distance between the center of the tract and the top of the balloon 709, and y is the distance between the center of the tract and the bottom of the balloon 709. This configuration provides greater stability by reducing the possibility of axial twisting or flipping of the endoscope 201, leading to loss of control. It is important to note that the manipulation technique for inserting the endoscope 201 involves axially "twisting" the endoscope, and the balloon 709 is inflated only when the endoscope 201 reaches the target location and is no longer inserted, so the balloon 709 does not interfere with this manipulation technique. Furthermore, this configuration allows the endoscope tip to have a greater height, which provides greater space and directional options for the steerable arm 303 to approach the surgical target.

[0100] Figure 13 A photograph of endoscope 201 inserted into the prototype of "Sheath Assembly 700". Figure 14 for Figure 13 An enlarged image of the selected part is converted into a negative image. Figure 15 for Figure 13 The same assembly is shown disassembled to show another photograph of the parts.

[0101] Figure 13 The folded sheath 711 is not shown. Alternatively, Figure 13 The sheath 711 is shown fully deployed and covering the portion of the endoscope 201, the two external instrument channels 707, and the inflation tube 710 intended for insertion into the human body. As can be seen, the circumference of the sheath 711 is well-matched to the endoscope 201 and the tubular components within the sheath 711. Thus, the sheath 711 provides a limited radial space that allows the tubular components to be close together while not preventing all of the tubular components from sliding longitudinally relative to each other, thereby preventing stiffening of the assembly.

[0102] Figure 13 In the figure, a white rectangle is drawn with a solid line on the proximal opening of the sheath tube 711. The white rectangle represents the end protection member 715, which is not in the original photo. It can be seen that the external instrument channel 707 extends from the sheath tube 711 of the end protection member 715 toward the left side of the photo. Each external instrument channel 707 has a surgical instrument 300 inserted. The coupler 305 of each surgical instrument 300 is located at Figure 13As can be seen on the left side of the endoscope 201, the transfer tube 301 extends from each coupler 305 and into the external instrument channel 707. The maneuverable arm 303 at the other end of the transfer tube 301 extends from the external instrument channel 707. However, the external instrument channel 707 is obscured from view by the sheath 711 and the balloon 709. The syringe 1501 shown in the figure is connected to the proximal end of the inflation tube 710, which extends into the end guard 715 and the sheath 711 to connect to the balloon 709 at the end cap 701 (not visible). It can be seen that the balloon 709 is inflated around the distal half of the endoscope 201.

[0103] exist Figure 15 In the figure, the sheath assembly 700 is disassembled into multiple components and placed next to the endoscope 201, namely, the external instrument channel 707 clamped to the end cap catheter 705, the inflated balloon 709, the inflation tube 710 extending from the balloon 709 to the needle connector of the syringe 1501, and the expanded sheath 711 separated from the end cap 701. Figure 15 The surgical instrument 300 and the end guard 715 are not included.

[0104] Variants of sheath folding

[0105] exist Figure 6 、 Figure 7 and Figure 8 In the embodiment, the sheath is folded into an "accordion fold". That is, the sheath 711 folds on itself, alternating between inward folding and outward folding. Inward folding is achieved by folding a section of the sheath 711 to form an outer folded edge extending around the circumference of the sheath 711, while outward folding is achieved by folding a section of the sheath 711 to form an inner folded edge extending around the circumference of the sheath 711. In order to accommodate more sheath material in a smaller circumference, the inner edge tends to wrinkle more easily than the outer edge. Examples of suitable sheath materials are thin plastic sheets such as TPU or polyethylene (PE), which are easy to fold and safe for use in the human body.

[0106] Figure 10 One variation of a sheath assembly 700 is shown. Figure 10 The top view shows this variant in an unused position. As can be seen, the sheath 711 is folded into a "telescopic fold." The telescopic foldable sheath 711 is made by folding the sheath onto itself, using the circumference as the fold line. After folding the sheath multiple times in this manner, the sheath forms multiple nested sheaths, with each smaller sheath nested within the adjacent larger sheath.

[0107] Preferably, the sheath 711 tapers from proximal to distal. This taper gives each outer fold a slightly larger diameter to accommodate the adjacent inner fold. The outermost fold is the proximal end of the sheath 711 and is attached to the end guard 715; the innermost fold is the distal end of the sheath and is attached to the end cap 701.

[0108] exist Figure 10 715 . The end cap 701 is shown with a folded balloon 709 resting against the outer surface of the end cap. Two external instrument channels 707 and an inflation tube 710 attached to the end cap extend from the end cap 701 through the hollow folded sheath 711 and out of the loop 713 of the end cap 715. The bottom view shows the end cap 701 mounted to the end of the endoscope 201, which extends into the loop and through the hollow folded sheath 711. As more of the endoscope 201 is advanced, the endoscope 201 pushes the end cap 701 away from the end cap 715. The end cap 701, facing away from the end protector 715, pulls on the attached sheath 711, causing the inner telescoping folds to unfold before the outer folds, with the unfolded portion of the sheath 711 enveloping the tubular member and endoscope 201, which passes through the loop 713 in the end protector 715. The balloon 709 is shown uninflated. Because only the innermost folds of the telescoping folds contact the endoscope, the user only needs to guide one edge of the folds into the sheath and end protector, making it easier to install the end cap on the endoscope tip. In contrast, the edges of the accordion folds all face inward, which means that during installation, the endoscope tip must be carefully inserted through each fold, which can be difficult without an internal guide that creates a clear path from the proximal end of the sheath to the distal end.

[0109] Preferably, the length of the sheath 711 exceeds the length of the portion of the endoscope 201 typically intended for insertion into the body. Therefore, in some cases not every fold will unfold, and the bottom diagram shows that there are still folds remaining on the proximal side of the end guard 715.

[0110] The figure also shows a gap between the end protector 715 and the end cap 701 , which gap can be used to introduce lubricant into the folded portion of the sheath 711 .

[0111] Since the folded sheath tube 711 is located at the proximal side of the end protection member 715, rather than Figure 6 The situation of the embodiment is located between the end protector 715 and the end cap 701, which provides the possibility of using a breakable seal (not shown) around the edge of the loop 713 and the proximal edge of the end cap 701 to close the loop 713 in the end protector 715 with the end cap 701. Alternatively, the connection between the end protector and the end cap can be a snap or twist lock connection that can be disconnected after the endoscope is assembled.

[0112] It should be noted that the folding type of the sheath 711 mentioned herein, whether telescopic, accordion, or otherwise, is incidental and an independent feature and has no bearing on the feasibility or implementation of placing the main body of the folded sheath 711 proximal to the end guard 715. Furthermore, the sheath 711 can be folded in a variety of ways, depending on factors such as the flexibility of the material used for the sheath 711, the wall thickness of the sheath 711, the elasticity of the material, and the overall shape of the sheath 711.

[0113] Figure 16 Referring to a variation of the sheath 711, a schematic illustration of an expanded sheath 711 is provided, wherein three sets of eyelets 1601 are attached to the inner surface of the sheath 711 by suturing, laminating, or other means. To avoid cluttering the drawing, the endoscope is not shown. Each set of eyelets 1601 is longitudinally aligned relative to the sheath 711. Each of the two external instrument channels 707 and the inflation tube 710 passes through a different set of the three sets of eyelets 1601. The eyelets 1601 prevent segments of either the instrument channel or the inflation tube 710 from becoming entangled or twisted together by keeping the instrument channels and the inflation tube 710 spaced apart.

[0114] Figure 16 The insert diagram is a radial cross-section of sheath 711, showing three sets of eyelets distributed around the inner circumference of sheath 711. It can be seen that the cross-section of the inserted external instrument channel 707 or inflation tube 710 is inside the corresponding eyelet. The dotted circle in the center of sheath 711 represents the position of endoscope 201 when inserted into sheath 711, which is outside of eyelet 1601. Preferably, eyelet 1601 has a thin edge so that eyelets 1601 can be stacked on top of each other when sheath 711 is folded. Eyelet 1601 can be made of thin wire, plastic ring, flexible plastic, fabric, or string.

[0115] Figure 17 1 is an illustration of a variation of the sheath, not showing the endoscope, in which an eyelet 1601 is attached to the proximal end of each telescoping fold of the sheath 711. Each outer fold extends slightly beyond the edge of the adjacent inner fold in the proximal direction. For each of the three groups of eyelets 1601, each immediately adjacent eyelet 1601 in each group is attached to the proximal edge of the super-extended outer fold adjacent to each inner fold. Note that an eyelet need not be provided for each fold. Of course, the eyelets 1601 could be placed between the folds, but this would prevent pre-insertion of the instrument channel and inflation tube 710 at the factory. Thus, as Figure 17 As shown in the top figure in FIG, each set of holes 1601 has been pre-inserted with corresponding ones in the instrument channel and inflation tube 710.

[0116] Figure 18This is an illustration of a variation of a telescoping fold. In this case, the distal end of each outer fold extends beyond the adjacent nested inner fold. Typically, the sheath 711 tapers or narrows from distal to proximal. The outermost fold is connected to the end cap 701 and is initially pulled open by the inserted endoscope 201. An eyelet 1601 is provided at the over-extended distal edge of each outer fold. Figure 18 The upper left image shows a side view of the folded sheath 711 and eyelets 1601 without the end cap 701, while the upper right image shows a distal view of the left image, showing the arrangement of the three sets of eyelets 1601. The bottom image shows how the instrument channel and inflation tube 710 are inserted into the corresponding sets of eyelets 1601. In this embodiment, the folded sheath 711 is located between the end cap 701 and the end protector 715.

[0117] It should be noted that the sheath 711 does not always have to have a reducing structure to achieve telescopic folding. Other factors such as the wrinkling ability or elasticity of the sheath material may also support telescopic folding.

[0118] Figure 19 The diagram shows how the eyelet 1601 is attached to the accordion-fold sheath 711. As previously described, the accordion folds comprise a plurality of alternating inward radial folds and outward radial folds away from the axis of the sheath 711. Since one fold is not inserted into another as in a telescopic fold, the sheath 711 does not need to be tapered. The accordion fold is more compact than the telescopic fold, making it suitable for large-scale, compact storage and transportation. To accommodate excess sheath material that fits within a smaller circumference, the inner edges of the folds are susceptible to wrinkling. Therefore, the sheath 711 can be made of any thin, foldable plastic material, preferably a material that wrinkles easily, such as TPU or polyethylene (PE). The left-hand diagram shows the distal end of the folded sheath 711 sealed to the proximal edge of the end cap 701. Two external instrument channels 707 and the inflation tube 710 are shown extending from the end cap 701, through corresponding sets of eyelets 1601 in the folded sheath 711, and out of the loop 713 of the end guard 715. The right side diagram shows the deployed sheath 711 .

[0119] Figure 20 Shown is a variant of the folding sheath 711 in which the end cap is housed or nested inside the innermost telescoping fold. In this case, an eyelet 1601 is provided on each outer fold extending toward the proximal end, i.e. beyond the inner fold.

[0120] Generally, the length of the fold depends on the wall thickness of the sheath 711, the material used for the sheath 711, the tapering angle of the sheath 711, the location, diameter and thickness of the eyelet 1601, and the expected sheathed length of the endoscope 201.

[0121] Figure 21A variation of sheath 711 is shown, in which the inflation tube 710 does not pass through any of the eyelets 1601, but rather through separate sets of eyelets for the instrument channels. Because two sets of eyelets 1601 are sufficient to provide three isolated spaces for the three tubular members, the inflation tube 710 does not require a third set of eyelets 1601. Thus, the inflation tube 710 shares space with the inserted endoscope 201.

[0122] Figure 22 Show Figure 21 A variation of the use of sheath 711 is shown, wherein an inflation tube 710 surrounds each eyelet of a set of eyelets.

[0123] Figure 23 A variation of sheath 711 is shown in which three sets of eyelets are provided, but each set of eyelets is spaced a greater distance apart. Furthermore, the positions of eyelets 1601 along sheath 711 are staggered between the three sets of eyelets. This allows for a smaller number of eyelets 1601 to be provided while maximizing the effectiveness of eyelets 1601 in preventing entanglement of the tubular member.

[0124] Figure 24 One of the simplest embodiments is shown, where a folded sheath 711 is attached to an end cap 701 that can be fixed to the end of an endoscope 201. There is no inflation balloon 709 and inflation tube, nor is there an external instrument channel 707 attached to the end cap 701. The end cap 701 is simply a hoop without any catheter 705 attached. Figure 24 In the embodiment, the main body of the folded sheath 711 is placed proximal to the end protector 715. In a simple embodiment, where the sheath 711 is attached only to the end cap 701 and the end protector 715 at both ends, other folding and arrangement configurations are possible. This embodiment serves only to allow the sheath 711 to cover the endoscope 201 and does not provide additional functionality. Its advantage is that it reduces contamination on the outer surface of the endoscope 201.

[0125] Figure 25 Another simple embodiment is shown, comprising only an end cap 701, without an external instrument channel 707, a balloon 709, and an inflation tube 710. In this case, the end cap 701 is nested within a telescoping, folding sheath 711. The folded sheath 711 and nested end cap 701 are placed against the distal side of the end guard 715.

[0126] In some variations of the sheath 711, each instrument channel is provided with only one eyelet 1601 rather than a set of eyelets 1601. The single eyelet 1601 is provided on the inner surface of the sheath 711 near the end cap 701 to limit the degree to which the outer instrument channel 707 can twist about the end cap 701.

[0127] End cap and end protection variants

[0128] Figure 26The figure is a front view of the end cap 701 with preferred features, showing the bore as the vertex of a triangular arrangement formed by the bore and two conduits 705 located on either side below the bore and serving as the base. Other components of the sheath assembly 700 are not shown. The conduits 705 are spaced apart along the circumference of the bore, and the axes of the conduits 705, and thus the axis of the instrument channel held in the bore and the axis of the surgical instrument 300 that can be inserted into the instrument channel, form equal angles a° with respect to the axis of the bore on either side of a line of symmetry passing through the axis of the bore. Figure 27 As can be seen in the plan view, the guide tubes 705 are positioned at an angle b° on opposite sides of the bore axis, allowing the steerable arms 303 to converge toward a point forward of the endoscope's distal end. Angles a° and b° depend on the thickness and circumference of the endoscope 201, which in turn depend on the number of channels and other contents within the endoscope 201. However, for most endoscopes 201 suitable for colonoscopy, angles a° and b° are typically 15° for the external instrument channel.

[0129] Figure 28 An end cap 715 is shown having another preferred feature. The end cap 715 is made of plastic and comprises a hoop for fitting over the end of an endoscope. However, the hoop is separated into two opposing ends in a longitudinal direction across the hoop. The opposing ends on either side of the separation can be closed by a one-way locking mechanism comprising a serrated strip provided on one of the opposing ends and a clip with teeth provided on the other end, the teeth abutting against the serrations to prevent loosening. An advantage of this feature is that the end cap 715 can be well fitted to endoscopes 201 of different brands and slightly different thicknesses and can be securely attached to the end of the endoscope without the need for additional tape to prevent the end cap from twisting or shifting. The hoop has a shield extending in a distal direction to prevent intestinal tissue from obscuring the camera 405.

[0130] In a variation of the end protector 715, as Figure 29 Schematically, a plurality of rings 713 are provided on the end protection member 715. The diameter of each ring 713 corresponds to a specific tubular component passing through the end protection member 715, and the position of the ring in the end protection member 715 is roughly determined by the arrangement of the tubular components on the end cover 701. Figure 29 In the orientation shown in FIG, the largest loop 713 (i.e., the loop at the top) is used to insert the endoscope 201, which is then passed through the center portion of the folded sheath and assembled to the end cap 701 through the end. The lowest loop is used to extend the inflation tube out of the sheath. The two loops at the same vertical position are used to extend the external instrument channel out of the sheath.

[0131] Figure 30A prototype of an end protector 715 is shown having a corrugated outer surface around the cover profile for better gripping and also having separate loops 713 for the endoscope 201 , two external instrument channels 707 and inflation tube 710 .

[0132] Thus, embodiments of the present invention include a longitudinally foldable sheath capable of unfolding and sheathing an endoscope positioned within the sheath when the endoscope is inserted into a human body. In other words, embodiments of the present invention include a sheath assembly for an endoscope comprising: a hollow sheath having a proximal end attached to a distal end of an end cap and attached to a loop of an end protector, the end protector being configured to allow the endoscope to extend through the loop and the hollow sheath to fit within the end cap; the sheath being folded into a plurality of folds, each fold being a circumferential segment of the sheath that is longitudinally folded relative to an adjacent circumferential segment; wherein the folds are capable of unfolding when the endoscope pushes the end cap away from the end protector.

[0133] Use of this embodiment includes using a method for sheathing an endoscope, the method comprising the following steps: providing a hollow sheath folded into a plurality of folds, each fold being a circumferential segment of the sheath that is longitudinally folded relative to an adjacent circumferential segment of the sheath; inserting the endoscope through the proximal end of the sheath; pushing more of the endoscope into the sheath and pushing the distal end of the sheath further away from the proximal end of the sheath to unfold the sheath; wherein the folded portion of the sheath being unfolded is laid on a portion of the endoscope that passes through the folded portion of the sheath being unfolded.

[0134] While preferred embodiments of the invention have been described in the foregoing description, it will be understood by those skilled in the relevant art that numerous changes or modifications may be made in the details of design, construction or operation without departing from the scope of the invention as defined in the appended claims.

[0135] For example, when "circumference" is used to describe the radial cross-section of the sheath, the sheath may be elliptical or diamond-shaped in the radial cross-section, and the folding manner of such a sheath in the longitudinal direction on a portion of the sheath is the same as the described embodiment.

Claims

1. A sheath assembly for an endoscope, comprising: a hollow sheath having a distal end attached to the end cap and a proximal end attached to the collar of the end guard, the end guard being configured to allow an endoscope to extend through the collar and the hollow sheath to fit within the end cap; The sheath tube is folded into a plurality of folded portions, each of the folded portions being a circumferential segment of the sheath tube, the circumferential segment being folded longitudinally to an adjacent circumferential segment of the sheath tube; wherein, The fold is deployable when the endoscope pushes the end cap away from the end protector.

2. The sheath assembly for an endoscope according to claim 1, wherein The size of the end cap allows the end cap to enter the human gastrointestinal tract, while the size of the end protector prevents the end protector from entering the human mouth or anus.

3. The sheath tube assembly for an endoscope according to claim 1 or 2, wherein The sheath is folded into a series of telescoping folds.

4. The sheath assembly for an endoscope according to claim 3, wherein The telescoping fold comprises a longitudinal section of the sheath tube that is folded along the circumference of the sheath tube to extend longitudinally over the sheath tube immediately adjacent the telescoping fold.

5. The sheath assembly for an endoscope according to claim 4, wherein The edge of each telescoping fold extends beyond the edge of the immediately adjacent telescoping fold.

6. The sheath assembly for an endoscope according to claim 5, comprising a plurality of holes on the inside of the sheath, each hole being attached to the super-extended edge adjacent to the telescopic fold; The plurality of eyelets are longitudinally aligned on the sheath.

7. The sheath assembly for an endoscope according to claim 6, comprising a second plurality of eyelets, each eyelet being attached to the super-extended edge; The second plurality of holes are longitudinally aligned on the sheath; wherein The plurality of eyelets and the second plurality of eyelets are spaced apart on the circumference of the sheath.

8. The sheath assembly for an endoscope according to claim 1 or 2, wherein The sheath is folded into an accordion fold.

9. The sheath assembly for an endoscope according to claim 8, comprising a plurality of eyelets attached to the accordion fold; and The plurality of eyelets are longitudinally aligned relative to the sheath.

10. The sheath assembly for an endoscope according to claim 9, comprising a second plurality of eyelets attached to the accordion fold, the second plurality of eyelets being longitudinally aligned relative to the sheath; and The plurality of eyelets and the second plurality of eyelets are spaced apart on the circumference of the sheath.

11. The sheath assembly for an endoscope according to claim 1 or 2, further comprising an inflatable balloon surrounding the end cap. 12 . The sheath assembly for an endoscope according to claim 11 , wherein the end cap is eccentrically disposed within the balloon.

13. The sheath tube assembly for endoscope according to claim 1 or 2, comprising At least one external instrument channel extends from the end cap through the sheath and from the collar on the tip protector.

14. The sheath assembly for an endoscope according to claim 13, further comprising Two external instrument channels extend from the end cap through the sheath and out of the ring on the tip protector.

15. The sheath assembly for an endoscope according to claim 14, further comprising The distal ends of the external instrument channels are arranged to converge on the end cap.

16. The sheath assembly for an endoscope according to claim 15, comprising two eyelets attached to the inner surface of the sheath and spaced apart on the circumference of the sheath; The two external instrument channels pass through different holes in the two holes respectively; The eyelet is attached to the inner surface of the sheath at a distance from the end cap.

17. The sheath assembly for an endoscope according to claim 15, comprising two eyelets attached to the inner surface of the sheath and spaced apart on the circumference of the sheath; The two external instrument channels pass through different holes in the two holes respectively; The eyelet is attached to the inner surface of the sheath at a distance from the end cap; wherein the distance is less than or equal to half the length of the curved section of the endoscope or the distance is less than or equal to 10 centimeters.

18. A method for sheathing an endoscope, comprising the steps of: providing a hollow sheath tube folded into a plurality of folds, each of the folds being a circumferential segment of the sheath tube that is folded longitudinally relative to an adjacent circumferential segment of the sheath tube; inserting an endoscope through the proximal end of the sheath; Pushing more of the endoscope into the sheath and pushing the distal end of the sheath further away from the proximal end of the sheath to unfold the sheath; wherein, The folded portion of the sheath being deployed is laid on a portion of the endoscope that passes through the folded portion of the sheath being deployed.

19. The method of sheathing an endoscope according to claim 18, wherein pushing the distal end of the sheath further away comprises the following steps: The distal end of the sheath is pushed into the gastrointestinal tract of the human body.

20. The method for sheathing an endoscope according to claim 19, further comprising the steps of: providing at least one tube attached to the distal end of the sheath; in The expanding folded portion of the sheath is laid on the endoscope and the portion of the at least one tube that passes through the expanding folded portion of the sheath.

Images