Sheath placement device and method of use

Abstract

A sheath placement device (100), The device includes an inner layer member (1), an outer sheath (2), and a middle layer member (3), the inner layer member (1) having an operating handle (11) and an insertion section (12) connected to the operating handle (11), the insertion section (12) having an imaging section (123), a drainage port (20) provided in the outer sheath (2), and the outer sheath (2) having a distal open end (201), the insertion section (12) being operably inserted into the outer sheath (2) and at least a portion of the insertion section (12) operably protruding from the distal open end, A first passageway communicating the drainage port (20) and the distal open end (201) is formed between the insertion section (12) and the outer sheath (2) with an operably spaced interval, and the middle member (3) is operably inserted between the outer sheath (2) and the insertion section (12) with at least a portion operably protruding from the distal open end (201), and the first passageway is formed between the inner layer member (1) and the outer sheath (2) after the middle member (3) is withdrawn from between the inner layer member (1) and the outer sheath (2). This device simplifies the surgical procedure, while reducing surgical costs, surgical risks, and patient pain.

Description

[Technical Field]

[0001] This patent application claims priority from the following Chinese patent applications:

[0002] "Submission date: January 10, 2023, Application number: 2023100342224, Invention name: Sheath placement device and method of use thereof" The entire text of the above application is incorporated herein by reference.

[0003] The present invention relates to medical devices, and more particularly to sheath placement devices and methods of use thereof. [Background technology]

[0004] Many existing treatments require the use of medical equipment, such as ureteral stone lithotripsy, oral cholangiopancreatoscopic gallstone lithotripsy, ureteral adhesion treatment, and cyst treatment, which require the insertion of equipment into the lesion, but the existing equipment has various shortcomings.

[0005] For example, for the treatment of ureteral stones, currently, two surgical methods are mainly used in clinical practice: flexible ureteroscope lithotripsy and rigid ureteroscope lithotripsy.

[0006] In rigid ureteral lithotripsy, a rigid ureteroscope is used to reach the ureteral stone location via the urethra and bladder, and a holmium laser is used to perform the stone removal treatment. Currently, the outer diameter of a typical rigid ureteroscope is relatively large, and the ureter is stimulated and contracted during surgery by the placement of the rigid ureteroscope, leaving a very narrow space between the ureter and the rigid ureteroscope, making it difficult to return the fluid injected through the rigid ureteroscope during surgery. However, with holmium laser lithotripsy, the laser energy is converted into heat in addition to stone fragmentation, and without continuous water circulation, prolonged stone fragmentation is likely to cause thermal damage to the ureter.

[0007] To avoid thermal injury to the ureter and ensure adequate fluid circulation during surgery, ureteral lithotripsy requires first using a rigid ureteroscope to inspect and initially dilate the patient's ureter. The rigid ureteroscope reaches a certain point in the ureter and then stops. A guidewire is then inserted through the rigid ureteroscope's second channel. After the rigid ureteroscope is removed, a ureteral sheath is inserted along the guidewire. After successful insertion, the ureteral sheath is then inserted back into the ureteral sheath to complete the lithotripsy procedure. However, the use of a ureteral lithotripsy requires the use of a rigid ureteroscope and guidewire during surgery, making the surgical procedure complicated. Furthermore, inserting a ureteral guidewire is performed under blind guidance, which can easily injure the ureter and increase surgical risks and patient discomfort. Furthermore, the use of multiple instruments is costly.

[0008] In oral cholangiopancreatoscopy, a duodenoscope is inserted through the mouth, the bile duct is inserted into the opening of the pancreatic duct, and then contrast is injected and an X-ray is taken to visualize the bile duct. Gallstones can then be removed through the mouth under endoscopic guidance. Gallstones less than 1 cm in diameter can be removed using an anterior sphincterotomy (EST) technique. Larger gallstones, stones at the bile duct confluence, and impacted stones are difficult to remove mechanically, requiring the use of a submirror. The submirror is inserted into the bile duct through the duodenoscope clamp path, and a laser beam is inserted into the working channel. Once the stone is located, it can be crushed with the laser under direct vision. Using oral cholangiopancreatoscopy, the procedure is painless, repeatable, and allows for repeated removal.

[0009] Although oral cholangiopancreatoscopic laser lithotripsy is a relatively safe technique, side effects and complications still exist. During surgery, saline is irrigated into the bile duct to ensure a clear view. However, the large size of the choledochoscope means there is insufficient space for drainage, which increases intraductal pressure and can lead to nausea, vomiting, and postoperative diarrhea. If the amount of saline irrigation is reduced during surgery, stone powder during the lithotripsy process can reduce the degree of visual cleansing, and the surgeon's manipulation of the laser can easily damage the bile duct wall, causing bleeding. At the same time, the heat generated by the continued laser lithotripsy can also cause thermal damage to the bile duct.

[0010] Summary of the Invention SUMMARY OF THE INVENTION An object of the present invention is to provide a sheath placement device and method of use that is convenient to use, reduces surgical risks, alleviates patient discomfort, and is low cost.

[0011] In order to solve the above technical problem, an embodiment of the present invention provides a sheath placement device, comprising an inner layer member, an outer sheath, and a middle layer member; The inner layer member has an operating handle and an insertion section connected to the operating handle, and the insertion section has an imaging section; a drainage port is provided in the outer sheath, and the outer sheath has a distal open end; the insertion portion is operably inserted into the outer sheath and at least a portion of the insertion portion operably protrudes from the distal open end; and a first passage is formed between the insertion portion and the outer sheath, operably spaced apart, the first passage communicating between the drainage port and the distal open end; The middle layer member is operably inserted between the outer sheath and the insertion portion, and at least a portion of the middle layer member operably protrudes from the distal open end, and after the middle layer member withdraws from between the inner layer member and the outer sheath, a first passage is formed between the inner layer member and the outer sheath.

[0012] Unlike the prior art, the embodiment of the present invention assembles an inner layer member, an outer sheath, and a middle layer member into one unit, and the imaging function of the imaging unit can be used to guide the system into the human body and reach the operating region. The middle layer member can be inserted between the outer sheath and the insertion section, and the first passage between the distal open ends of the inner layer member and the outer sheath can be blocked. When the system is inserted into the human body, foreign objects cannot enter the first passage through the distal open end, and the distal open end does not damage tissue. When the system reaches the operating position, the middle layer member can be retracted from the outer sheath, thereby opening the first passage. An operating device can pass through the passage to perform operations such as lithotripsy and drainage, and fluid can enter the passage from the distal open end and be discharged through the drainage port, allowing the system to be used smoothly. As can be seen from the above, this system has few parts, a simple structure, and does not require multiple parts to enter and exit the human body in multiple steps. The first passage allows the fluid to circulate, the operation is simple and convenient, saves surgery time, the entire procedure is visible during surgery, the operation is safe, the surgery is safer, the patient's pain is reduced, and the cost is low.

[0013] In one embodiment, the insert portion is provided with a second passage extending in the extension direction of the insert portion, and the second passage penetrates the insert portion.

[0014] In one embodiment, the middle layer member and the inner layer member are removably connected.

[0015] In one embodiment, the middle layer member is a middle layer dilation tube, the insertion portion operably inserts or removes the middle layer dilation tube, and the middle layer dilation tube and the insertion portion are removably connected.

[0016] In one embodiment, the portion of the middle layer member located between the inner layer member and the outer sheath operably fills the area between the inner layer member and the distal open end of the outer sheath.

[0017] In one embodiment, the middle-layer expansion tube has a tube body and a connection adapter connected to the tube body, The insertion portion has a butt portion connected to the connection adapter, the butt portion being adjacent to the operating handle, and when the insertion portion, the outer sheath and the middle-layer expansion tube are assembled together, the connection adapter is located between the outer sheath and the operating handle.

[0018] In one embodiment, the insertion portion has a sheath, and one end of the sheath away from the operating handle has a first rounded guide surface, and the first rounded guide surface gradually converges toward the axis of the insertion portion in a direction away from the operating handle.

[0019] In one embodiment, one end of the mid-layer expansion tube away from the operating handle has a second rounded guide surface, which gradually converges toward the axis of the mid-layer expansion tube in a direction away from the operating handle.

[0020] In one embodiment, the first and second rounded guide surfaces are adjacent and coextensive.

[0021] In one embodiment, the outer sheath has a first sheath body and a second sheath body extending from the first sheath body, the drain port is provided in the first sheath body, the distal open end is provided in the second sheath body, and the cross-sectional diameter of the second sheath body gradually decreases in a direction away from the first sheath body.

[0022] In one embodiment, a drain tube protrudes from a side wall of the outer sheath and extends in communication with the first passage, and the drain port is provided in the drain tube.

[0023] In one embodiment, the insertion portion includes a sheath, a light source portion and an imaging portion provided in the sheath, and the second passage passes through the sheath; an end of the sheath remote from the operating handle that is partially open and communicates with an inner cavity of the sheath, and one end of the light source unit and the imaging unit are located at the end of the sheath remote from the operating handle; The operating handle is provided with a liquid suction extension tube that communicates with the inner cavity of the covering sheath.

[0024] In one embodiment, when the middle layer member is positioned between the outer sheath and the inner layer member in the operative position, there is a tight connection between the middle layer member and the outer sheath and the inner layer member.

[0025] In one embodiment, the outer sheath has a hydrophilic coating, said outer sheath is a polymeric material, said middle layer member is a polymeric or metallic material, and said middle layer member is rigid.

[0026] In one embodiment, the outer sheath has a proximal open end and the insert is at least partially outside the proximal open end.

[0027] In one embodiment, the sheath placement device is a natural canal sheath placement device.

[0028] An embodiment of the present invention provides a natural canal sheath placement device including any of the sheath placement devices described above.

[0029] An embodiment of the present invention provides a method for using a sheath placement device using any of the sheath placement devices described above, the method for using the sheath placement device comprising the steps of: inserting the inner layer member into the middle layer member; inserting the middle layer member with the inner layer member inserted into the outer sheath; inserting the assembled outer sheath, middle layer member, and inner layer member together into an operating region; removing both the middle layer member and the inner layer member from the outer sheath; separating the inner layer member and the middle layer member; and inserting the inner layer into the outer sheath.

[0030] In one embodiment, in the step of inserting the middle layer member with the inner layer member inserted into the outer sheath, the middle layer member protrudes from the distal open end.

[0031] In one embodiment, the imaging unit activates the operation throughout the entire process of inserting the assembled outer sheath, middle layer member, and inner layer member into an operating region. [Brief explanation of the drawings]

[0032] One or more embodiments are illustratively described by figures in the drawings corresponding thereto, and these illustrative descriptions do not constitute limitations on the embodiments, and elements in the drawings having the same reference numerals are represented as similar elements, and unless otherwise stated, the figures in the drawings do not constitute proportional limitations. [Figure 1] 1 is a schematic diagram of the configuration of a sheath placement device according to one embodiment of the present invention. [Figure 2] FIG. 2 is an enlarged view of a portion A in FIG. [Figure 3] FIG. 1 is an exploded perspective view of a sheath placement device according to one embodiment of the present invention. [Figure 4] 1 is a cross-sectional view of a sheath placement device according to one embodiment of the present invention. [Figure 5] FIG. 5 is an enlarged view of a portion B in FIG. [Figure 6] FIG. 5 is an enlarged view of a portion C in FIG. [Figure 7] 1 is an enlarged view of the end of a sheath placement device according to one embodiment of the present invention that is inserted into the human body. [Figure 8] 10 illustrates a method of using a sheath placement device according to one embodiment of the present invention.

[0033] Here, 100, sheath placement device, 1, inner layer member, 11, operating handle, 12, insertion portion, 121, covering sheath, 122, light source portion, 123, imaging portion, 124, butt portion, 2, outer sheath, 21, first sheath body, 22, second sheath body, 20, drainage port, 201, distal open end, 202, proximal open end, 3, middle layer expansion tube, 31, tube body, 32, connection adapter, 4, first rounded guide surface, 5, second rounded guide surface, 6, drainage tube, 7, cable, 8, second passage, 91, first interface, 92, second interface.

[0034] MODE FOR CARRYING OUT THE INVENTION In order to clarify the objectives, technical solutions and advantages of the embodiments of the present invention, the following detailed description of each embodiment of the present invention is given with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details are provided in each embodiment of the present invention to help readers better understand the present application. However, the technical solutions claimed for protection in the present application can be realized without these technical details or various changes or modifications based on the following embodiments.

[0035] In the following description, for purposes of explaining various disclosed embodiments, specific details are set forth to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the art will recognize that embodiments can be practiced without one or more of these specific details. In other instances, well-known devices, structures, and techniques relevant herein may not be shown or described in detail to avoid unnecessarily confusing the description of the embodiments.

[0036] Unless the context otherwise requires, throughout the specification and claims, the word "comprises" and variations thereof, such as "includes" and "having," are to be understood in their open and inclusive sense, i.e., to be interpreted as "including, but not limited to."

[0037] In order to more clearly understand the objectives, features and advantages of the present invention, the following detailed description of the embodiments of the present invention will be given with reference to the accompanying drawings. It should be understood that the embodiments shown in the drawings are not intended to limit the scope of the present invention, but are intended to describe the essential spirit of the technical solution of the present invention.

[0038] References throughout the specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in an embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout the specification are not necessarily all referring to the same embodiment. Also, particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0039] As used in this specification and the appended claims, the singular forms "a," "an," and "said" include plural referents unless the context clearly dictates otherwise. The term "or" is generally used in its sense including "and / or" unless the context clearly dictates otherwise.

[0040] In the following description, many directional terms are used to clearly indicate the configuration and operation of the present invention, but terms such as "front," "rear," "left," "right," "outside," "inside," "outward-facing," "inward-facing," "up," and "down" should be understood as terms of convenience rather than as limiting terms.

[0041] Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings.

[0042] One embodiment of the present invention relates to a sheath placement device. The sheath placement device may be a natural canal sheath placement device, for example, for use in the ureter, and the following description will be directed to the use of the sheath placement device in the ureter. It is understood that the sheath placement device may also be used in other locations, such as kidney cysts and gallstones.

[0043] As shown in FIGS. 1, 3, and 4, the sheath placement device 100 includes an inner layer member 1, an outer sheath 2, and a middle layer dilatation tube 3. The inner layer member 1 has an operating handle 11 and an insertion section 12 connected to the operating handle 11. The insertion section 12 has a second passage 8 extending in the extension direction of the insertion section 12, which penetrates the insertion section 12 and may be used to insert, for example, a laser fiber, a sealer, or a basket actuation device. Of course, the insertion section 12 may also be used without inserting any device, in which case the insertion section 12 may be a shell of a polymer material or a shell of another material. The outer sheath 2 has a drainage port 20, one end of the outer sheath 2 is a distal open end 201, the insertion section 12 is inserted into the outer sheath 2, and at least a portion of the insertion section 12 operably protrudes from the distal open end 201, and the operating handle 11 is located outside the insertion section 12. The diameter of the insertion section 12 is smaller than the inner diameter of the outer sheath 2, and a first passageway connecting the drainage port 20 and the distal open end 201 may be formed at a distance between the insertion section 12 and the outer sheath 2. The insertion section 12 may be inserted into the middle dilating tube 3, and the insertion section 12 may be inserted into the outer sheath 2 together with the middle dilating tube 3. When the middle dilating tube 3 is inserted into the outer sheath 2, it blocks the first passageway between the inner member 1 and the distal open end 201 of the outer sheath 2, and the middle dilating tube 3 may partially protrude from the distal open end 201 together with the inner member 1. It is understood that in some embodiments, there may be a partial gap between the middle member and the outer sheath 2 or the inner member 1. Also, in some embodiments, there may be no second passageway inside the insertion section, and no device may be able to be inserted therein. For example, the insertion section 12 itself may be an optical fiber, and the imaging unit may be a camera installed at the end of the optical fiber.

[0044] Preferably, after the middle layer expansion tube 3 is inserted into the outer sheath 2 and reaches the working position, the middle layer expansion tube 3 is closely connected to the outer sheath or the inner layer member 1, i.e., the middle layer expansion tube 3 and the inner layer member 1 are closely attached, the middle layer expansion tube 3 and the outer sheath 2 are closely attached, or the middle layer expansion tube 3 and the distal open end of the outer sheath 2 may be closely attached. The working position is the position when the middle layer member, the outer sheath 2, and the inner layer member 1 are assembled and can be inserted into the human body for operation.

[0045] Specifically, as shown in Figures 1, 2, 3 and 4, when inserting the sheath placement device 100 into the ureter, first the middle layer expansion tube 3 is placed over the outside of the inner layer member 1, and the middle layer expansion tube 3 is inserted into the outer sheath 2 together with the inner layer member 1, and the inner layer member 1, outer sheath 2 and middle layer expansion tube 3 are advanced into the ureter together, and as they advance into the ureter, the inner layer member 1 acts as an imaging guide, making it possible to find the operating area, which is the location of the stone. After reaching the operating position, the middle dilating tube 3 is placed over the inner member 1 and removed from the outer sheath 2. The middle dilating tube 3 is then removed from the inner member 1, and the inner member 1 is inserted into the outer sheath 2 alone. At this time, a gap is formed between the inner member 1 and the outer sheath 2, forming a first passageway. The inner member 1 protrudes from the distal open end 201, and the operating device protrudes from the second passageway 8 to crush the stone. During the stone crushing process, water or other liquid flows from the inner member 1 into the operating region, enters the first passageway from the distal open end 201, and then flows from the first passageway into the drainage port 20 for discharge. Of course, the inner member has a certain degree of flexibility, and the portion of the inner member protruding from the distal open end 201 can be bent and redirected. It should be understood that the sheath placement device 100 can be used to crush stones in other areas in addition to entering the ureter to crush stones, and is not limited to the ureteral stone surgery described herein. Alternatively, when draining from the body, the fluid can flow out through the second passageway 8, with the gap between the outer sheath 2 and the inner layer member 1 being used for fluid entry.

[0046] From the above, the inner layer member 1, the outer sheath 2, and the middle layer member 3 can be assembled together, and the imaging function of the inner layer member 1 can be used to guide the system into the ureter and reach the operating area. The middle layer member 3 can be inserted between the outer sheath 2 and the insertion section 12, blocking the first passage between the inner layer member 1 and the distal open end 201 of the outer sheath 2. When the system enters the ureter, foreign objects will not enter the first passage through the distal open end 201, and tissue will not be crushed by the presence of the distal open end 201. When the system reaches the operating position, the middle layer member can be retracted from the outer sheath 2, thereby opening the first passage. The operating device can pass through the second passage 8 to perform an operation such as lithotripsy. During the lithotripsy process, liquid can enter the first passage from the distal open end 201 and be discharged through the drainage port 20, allowing the system to be used smoothly. As can be seen from the above, this system has few parts, a simple structure, and does not require multiple parts to enter and exit the ureter in multiple steps. It is easy and convenient to operate, saves surgical time, allows visibility of the entire procedure during surgery, is safe to operate, makes surgery safer, reduces patient pain, and is low cost.

[0047] In this embodiment, the middle layer expansion tube 3 is a hollow duct and the inner layer member 1 can be inserted into it, while in other embodiments, the middle layer expansion tube 3 may be a rod-shaped or other structure and is inserted into the outer sheath 2 alongside the inner layer member 1, in which case the middle layer expansion tube 3 is called the middle layer member, and it can be understood that when the sheath placement device 100 enters the ureter, the middle layer member can block the first passage between the inner layer member 1 and the outer sheath 2 at the distal open end 201.

[0048] 1 and 3, the middle dilatation tube 3 is detachably connected to the inner layer member 1. Specifically, when the sheath placement device 100 is inserted into the ureter, the middle dilatation tube 3 and the inner layer member 1 are fixed together, preventing the middle dilatation tube 3 from being displaced during operation, making the operation safer and more reliable. It is understood that in other embodiments, the middle dilatation tube 3 may be detachably connected to the outer sheath 2.

[0049] Furthermore, the insertion section 12 operably inserts or extracts the middle layer dilation tube 3, and the middle layer dilation tube 3 is removably connected to the insertion section 12. It is understood that in other embodiments, the middle layer dilation tube 3 may also be removably connected to the operating handle 11.

[0050] Specifically, as shown in FIGS. 1, 3, and 4, the middle-layer expansion tube 3 has a tubular body 31 and a connection adapter 32 connected to the tubular body 31. The insertion section 12 has a butt section 124 connected to the connection adapter 32, which is adjacent to the operating handle 11. When the insertion section 12, outer sheath 2, and middle-layer expansion tube 3 are assembled together, the connection adapter 32 is located between the outer sheath 2 and the operating handle 11. To position the middle-layer expansion tube 3 and the outer sheath 2 relative to each other, the outer sheath 2 has an end near the operating handle 11 that has a first interface 91 that butts against a second interface 92 on the middle-layer expansion tube 3, and the second interface 92 is fitted into the first interface 91 and matches the inner contour of the first interface 91. The inner diameters of parts of both the first interface 91 and the second interface 92 gradually increase toward the operating handle 11. The butt portion 124 may be threadedly connected to the insertion portion 12. After the insertion portion 12, outer sheath 2, and middle dilation tube 3 are inserted into the operating position, the insertion portion 12 and middle dilation tube 3 are removed from the outer sheath 2 together. The middle dilation tube 3 and the insertion portion 12 are then loosened, and the middle dilation tube 3 is pulled out from the end of the insertion portion 12 that is farther from the operating handle 11. In other embodiments, the butt portion 124 and the insertion portion 12 are engaged via an engaging member. For example, the butt portion 124 may have a protrusion and the insertion portion 12 may have a notch, and the protrusion may fit into the notch. In one embodiment, the insertion portion 12 and the connection adapter 32 are butted together via a luer interface. That is, a fixed connection between the middle layer member and the inner layer member can be achieved.

[0051] 4 and 7, the insertion section 12 has a covering sheath 121, and a light source section 122 and an imaging section 123 provided in the covering sheath 121. One end of the covering sheath 121 remote from the operating handle 11 is partially open and communicates with the inner cavity of the covering sheath 121, and one end of the light source section 122 and the imaging section 123 are located at the end of the covering sheath 121 remote from the operating handle 11. The second passage 8 passes through the covering sheath 121. The operating handle 11 is provided with a liquid suction extension tube that communicates with the inner cavity of the covering sheath 121. The light source unit 122 may be a light-guiding fiber, and the imaging unit 123 may include a lens. One end of the light-guiding fiber and the lens is located at one end of the sheath 121 remote from the operating handle 11. Light is supplied to the light source unit 122 by an illumination member. The light-guiding fiber 122 may extend through the cable 7, and the cable may include a signal transmission conductor for supplying power to the imaging unit 123 and the illumination member. Specifically, the light source unit 122 illuminates at one end that passes through the sheath 121 and enters the human body, and an operating device such as a laser fiber or guide wire can be operated by protruding from the second passage 8. The provision of the light source unit 122 makes the light source unit 122 relatively tough, inexpensive, and less susceptible to breakage. The sheath 121 of the inner layer member 1 may be a soft sheath, ensuring overall quality and resistance to breakage when the light source unit 122 is installed in the inner layer member 1 and used. In addition, in some embodiments, the light source unit 122 includes an LED lamp and is installed directly at one end of the sheath 121 away from the operating handle 11, or in some embodiments, there may be no second passage inside the insertion portion, i.e., in this case, the insertion portion may not have the sheath 121 and no equipment may be inserted, for example, the insertion portion 12 itself may be an optical fiber and the imaging unit may be a camera installed at the end of the optical fiber.

[0052] 2, 4, and 6, in order to reduce damage to the human body when inserting the insertion section 12 into the human body, the covering sheath 121 has a first rounded guide surface 4 at one end remote from the operating handle 11, which gradually converges toward the axis of the insertion section 12 in the direction away from the operating handle 11. The middle-layer expansion tube 3 and the insertion section 12 partially extend from the distal open end 201 of the outer sheath 2, and the end of the middle-layer expansion tube 3 comes into direct contact with the human body. In order to reduce damage to the human body, the middle-layer expansion tube 3 has a second rounded guide surface 5 at one end remote from the operating handle 11, which gradually converges toward the axis of the middle-layer expansion tube 3 in the direction away from the operating handle 11.

[0053] Preferably, the first rounded guide surface and the second rounded guide surface 5 are adjacent to each other and extend on the same plane. That is, when the mid-layer expansion tube 3 and the insertion section 12 are fitted together and inserted into the human body, a part of the insertion section 12 extends from one end of the mid-layer expansion tube 3 that extends from the outer sheath 2, the extension line of the second rounded guide surface 5 extends onto the first rounded guide surface, and the part of the insertion section 12 that extends out of the mid-layer expansion tube 3 transitions smoothly with the second rounded guide surface 5, allowing for smoother entry into the human body and preventing damage to human tissue.

[0054] 4 and 5, the outer sheath 2 has a first sheath body 21 and a second sheath body 22 extending from the first sheath body 21, the drain port 20 is provided in the first sheath body 21, the distal open end 201 is provided in the second sheath body 22, and the diameter of the cross section of the second sheath body 22 gradually decreases in the direction away from the first sheath body 21, i.e., the outer diameter of the second sheath body 22 gradually decreases toward the distal open end 201, while the inner diameter remains unchanged. Preferably, the outer diameter of the second outer sheath 22 gradually decreases toward the distal open end 201, so that the outer surface of the second outer sheath 22, the first rounded guide surface 5, and the second rounded guide surface 5 are adjacent to each other and extend on the same plane.

[0055] Furthermore, a drainage pipe 6 that communicates with the first passageway projects and extends from the side wall of the outer sheath 2;

[0056] Furthermore, the outer sheath 2 has the same inner diameter along its extension direction, and the portion of the insertion portion 12 located within the outer sheath 2 has the same outer diameter along its extension direction; when the insertion portion 12 is located within the outer sheath 2, the first passage between the insertion portion 12 and the outer sheath 2 extends in the length direction of the outer sheath 2, and the space between the first passages is maintained uniform along their extension direction, so that when liquid flowing out from within the inner layer member 1 flows through the first passage, the flow is smooth.

[0057] In this embodiment, the illumination in the inner layer member 1 uses a light-guiding fiber, the covering sheath 121 is a soft sheath, and the inner layer member 1 may be a disposable consumable. The middle layer expansion tube 3 is rigid and may be made of a polymeric or metallic material, and may also be a disposable consumable. Similarly, the outer sheath 2 is also a disposable consumable.

[0058] Furthermore, the outer sheath 2 has a proximal open end 202 , and at least a portion of the insertion portion is located outside the proximal open end 202 .

[0059] Additionally, the outer sheath has a hydrophilic coating, and the outer sheath is a polymeric material.

[0060] In another embodiment, the sheath placement device can be used for gallstone crushing or renal cysts. Before gallstone crushing, the middle dilating tube 3 is removed, and the passage between the inner layer member 1 and the outer sheath 2 is used in conjunction with the second passage 8 to inject saline or water and drain the used water, thereby reducing surgical risks and alleviating patient discomfort. Alternatively, the sheath placement device can be used for renal cysts, injecting medication through the second passage 8 in the inner layer member 1, and using a syringe to extract cyst fluid through the drainage port and allow it to flow out from between the inner layer member 1 and the outer sheath 2.

[0061] Another embodiment of this embodiment provides a method of using the sheath placement device employing the sheath placement device described above, as shown in FIGS. 3 and 8, and includes the following steps.

[0062] In step 100, the inner layer member is inserted into the middle layer member 1.

[0063] In step 200, the middle layer member with the inner layer member 1 inserted therein is inserted into the outer sheath 2.

[0064] In step 300, the assembled outer sheath 2, middle layer member and inner layer member 1 are inserted together into the working region.

[0065] In step 400, the middle layer member and the inner layer member 1 are removed together from the outer sheath 2.

[0066] In step 500, the inner layer member 1 is separated from the middle layer member, that is, the inner layer member 1 is extracted from the middle layer member.

[0067] In step 600, the inner layer member is inserted into the outer sheath 2.

[0068] Specifically, the fitting between the middle layer member, the inner layer member 1 and the outer sheath 2 has been mentioned in the above-mentioned embodiment of the sheath placement device, and will not be described in detail here.

[0069] Furthermore, in step 200, the middle layer member protrudes from the distal open end 201.

[0070] Furthermore, during step 300, the imaging unit 123 starts operating throughout the entire process.

[0071] While preferred embodiments of the present invention have been described in detail above, it will be understood that aspects of the embodiments can be modified, if necessary, to employ aspects, features, and concepts of various patents, applications, and publications to provide further embodiments.

[0072] These and other changes can be made to the embodiments in light of the above detailed description. In general, in the claims, the terms used should not be construed as being limited to the specific embodiments disclosed in the specification and claims, but should be understood to include all possible embodiments along with all equivalents to which the claims are entitled.

[0073] Those skilled in the art will understand that the above embodiments are specific embodiments for realizing the present invention, and that in actual applications, various changes in form and details can be made without departing from the spirit and scope of the present invention.

Claims

1. 1. A sheath placement device, comprising: An inner layer member, an outer sheath, and a middle layer member, the inner layer member has an operating handle and an insertion section connected to the operating handle, the insertion section having an imaging section; a drainage port is provided in the outer sheath, and the outer sheath has a distal open end, the insertion portion is operably inserted into the outer sheath, and at least a portion of the insertion portion operably protrudes from the distal open end, and a first passage is formed between the insertion portion and the outer sheath, the first passage communicating between the drainage port and the distal open end, and the first passage is operably spaced apart from the first passage; A sheath placement device characterized in that the middle layer member is operably inserted between the outer sheath and the insertion portion, at least a portion of which operably protrudes from the distal open end, and after the middle layer member withdraws from between the inner layer member and the outer sheath, a first passage is formed between the inner layer member and the outer sheath.

2. 2. The sheath placing device according to claim 1, wherein the insertion portion is provided with a second passage extending in an extending direction of the insertion portion, the second passage penetrating the insertion portion.

3. 2. The sheath placement device according to claim 1, wherein the middle layer member and the inner layer member are detachably connected.

4. The sheath placement device according to claim 2, characterized in that the middle layer member is a middle layer dilation tube, the insertion portion operably inserts or extracts the middle layer dilation tube, and the middle layer dilation tube and the insertion portion are detachably connected.

5. The sheath placement device of claim 4, characterized in that the portion of the middle layer member positioned between the inner layer member and the outer sheath operably fills the area between the inner layer member and the distal open end of the outer sheath.

6. The middle-layer expansion tube has a tube body and a connection adapter connected to the tube body, 5. The sheath placing device according to claim 4, wherein the insertion portion has a butt portion connected to the connection adapter, the butt portion being adjacent to the operating handle.

7. The outer sheath placement device according to claim 4, characterized in that the insertion portion has a covering sheath, and one end of the covering sheath away from the operating handle has a first rounded guide surface, and the first rounded guide surface gradually converges toward the axis of the insertion portion in a direction away from the operating handle.

8. The sheath placement device according to claim 7, characterized in that one end of the mid-layer expansion tube away from the operating handle has a second rounded guide surface, and the second rounded guide surface gradually converges toward the axis of the mid-layer expansion tube in a direction away from the operating handle.

9. 9. The sheath placing device according to claim 8, wherein the first rounded guide surface and the second rounded guide surface are adjacent to each other and extend in the same plane.

10. 2. The sheath placement device of claim 1, wherein the outer sheath has a first sheath body and a second sheath body extending from the first sheath body, the drainage port is provided in the first sheath body, the distal open end is provided in the second sheath body, and the diameter of the cross section of the second sheath body gradually decreases in a direction away from the first sheath body.

11. The sheath placement device according to claim 1, characterized in that a drainage tube that communicates with the first passage protrudes and extends from a side wall of the outer sheath, and the drainage port is provided in the drainage tube.

12. the insertion portion has a covering sheath, and a light source portion and the imaging portion provided in the covering sheath, and the second passage penetrates the covering sheath; One end of the sheath, which is remote from the operating handle, is partially open and communicates with an inner cavity of the sheath, and one end of the light source unit and the imaging unit are located at the one end of the sheath, which is remote from the operating handle, 3. The sheath placing device according to claim 2, wherein the operating handle is provided with an extension liquid suction tube that communicates with the inner cavity of the covering sheath.

13. The sheath placement device according to claim 1, characterized in that when the middle layer member is positioned in the operating position between the outer sheath and the inner layer member, the middle layer member is tightly connected to the outer sheath and the inner layer member.

14. The sheath placement device of claim 1, wherein the outer sheath has a hydrophilic coating, the outer sheath is made of a polymeric material, the middle layer member is made of a polymeric material or a metallic material, and the middle layer member is rigid.

15. 2. The sheath placement device according to claim 1, wherein the outer sheath has a proximal open end, and at least a portion of the insertion portion is located outside the proximal open end.

16. 2. The sheath placement device according to claim 1, wherein the sheath placement device is a natural canal sheath placement device.

17. 1. A method of using a sheath placement device, comprising: Using the sheath placement device according to any one of claims 1 to 16, Inserting the inner layer member into the middle layer member; inserting the middle layer member with the inner layer member inserted into the outer sheath; inserting the assembled outer sheath, middle layer member, and inner layer member together into an operating region; removing both the middle layer member and the inner layer member from the outer sheath; separating the inner layer member and the middle layer member; and inserting the inner layer member into the outer sheath.

18. 18. A method for using a sheath placement device according to claim 17, wherein in the step of inserting the middle layer member with the inner layer member inserted into the outer sheath, the middle layer member protrudes from the distal open end.

19. A method for using the sheath placement device described in claim 17, characterized in that the imaging unit activates its operation throughout the entire process of inserting the assembled outer sheath, the middle layer member, and the inner layer member together into the operating area.

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