Sheath placement device and method of use

Abstract

The present invention discloses a sheath placement device and a method for using the same. The sheath placement device includes an inner layer member having an operating handle and an insertion portion connected to the operating handle, the insertion portion having an imaging portion; an outer sheath having a drainage port and a distal open end; the insertion portion operatively inserted into the outer sheath and at least partially operatively extended from the distal open end; and a first passageway operatively spaced apart from the outer sheath to form a connection between the drainage port and the distal open end; and a middle layer member operatively inserted between the outer sheath and the insertion portion and at least partially operatively extended from the distal open end; when the middle layer member is withdrawn from between the inner layer member and the outer sheath, a first passageway is formed between the inner layer member and the outer sheath. Compared to existing technologies, this system is easy to use and can simplify surgical procedures while reducing surgical costs, lowering surgical risks, and alleviating patient pain.

Description

Technical Field

[0001] The present invention relates to medical devices, and in particular to a sheath placement device and a method of using the same. Background Art

[0002] Existing treatments often require the use of medical equipment. For example, ureteral stone lithotripsy, transoral cholangiopancreatoscopic gallstone lithotripsy, and treatment of ureteral adhesions and cysts all require the insertion of equipment into the lesion site of the human body. However, existing equipment has many shortcomings.

[0003] For example, for the treatment of ureteral stone fragmentation, two surgical methods are currently used clinically: flexible ureteroscopic lithotripsy and rigid ureteroscopic lithotripsy.

[0004] During rigid ureterolithotripsy, a rigid ureteroscope is used through the urethra and bladder to reach the location of the ureteral stone, and a holmium laser is used to crush the stone. Conventional rigid ureteroscopes have a relatively large outer diameter, and during surgery, the ureter is stimulated and contracts due to the insertion of the rigid ureteroscope. Consequently, the space between the ureter and the rigid ureteroscope is very narrow, making it difficult for fluids injected through the rigid ureteroscope to flow back into the body. However, during holmium laser lithotripsy, the laser energy is converted into heat in addition to crushing the stone. Without continuous water circulation, prolonged lithotripsy can easily cause thermal damage to the ureter.

[0005] In order to avoid thermal damage to the ureter and allow space for intraoperative fluid reflux, ureteroscopic lithotripsy requires the use of a rigid ureteroscope to first inspect and initially dilate the affected ureter. The rigid ureteroscope stops when it reaches a certain position in the ureter, and then a guide wire is inserted through the second channel of the rigid ureteroscope. After the rigid ureteroscope is withdrawn, the ureteroscopic sheath is inserted along the guide wire. After the ureteroscopic sheath is successfully inserted, the ureteroscopic sheath is inserted along the ureteroscopic sheath to complete the lithotripsy. However, as mentioned above, when using a ureteroscopic soft endoscope to treat ureteral stones, a rigid ureteroscope and a guide wire are required during the operation, and the surgical steps are cumbersome. At the same time, the insertion of the ureteral guide sheath along the guide wire is an operation performed under non-direct vision, which can easily cause artificial damage to the ureter, increase the surgical risk during the operation, and increase the patient's pain. In addition, the use of multiple devices is also costly.

[0006] In addition, during the oral cholecystopancreatoscopic lithotripsy, a duodenoscope is inserted through the mouth, and the bile duct is inserted into the opening of the pancreatic duct. Then, after contrast agent is injected, an X-ray is taken to display the bile and pancreatic ducts, and the gallstones are removed from the mouth under the scope. If the diameter of the gallbladder stone is less than 1 cm, a preliminary sphincterotomy (EST) can be used to remove the stone. Mechanical lithotripsy is difficult for large-diameter gallstones, confluence stones, and impacted stones, and a sub-scope is required. The sub-scope is pushed into the bile duct through the duodenoscope's forceps channel, and the laser is inserted into the working channel. When the stone site is reached, the laser can be used to crush the stone under direct vision. The oral cholecystopancreatoscopic technique does not require surgery, is less painful, has high repeatability, and can be removed in multiple times.

[0007] However, oral cholangiopancreatoscopic laser lithotripsy, as a relatively safe technique, still has adverse reactions or complications. During the operation, normal saline is injected into the bile duct to maintain a clear visual field. Because the bile duct is thin and the scope is thick, there is not enough space for water to escape, which will lead to increased pressure in the bile duct, and the patient will experience nausea, vomiting, and postoperative diarrhea. If the amount of normal saline injected during the operation is reduced, the stone powder during the lithotripsy will cause a decrease in the clarity of the visual field. The surgeon is very likely to damage the bile duct wall and bleed when operating the laser. At the same time, the heat generated by continuous laser lithotripsy will cause thermal damage to the bile duct. Summary of the Invention

[0008] The object of the present invention is to provide a sheath placement device and a method for using the same. The system is easy to use, reduces surgical risks and alleviates patient pain, and has low cost.

[0009] In order to solve the above technical problems, an embodiment of the present invention provides a sheath placement device, comprising:

[0010] an inner layer member having an operating handle and an insertion portion connected to the operating handle, wherein the insertion portion has an imaging portion;

[0011] an outer sheath, the outer sheath being provided with a drainage port and having a distal open end; the insertion portion being operably inserted into the outer sheath and at least partially operably extending from the distal open end; and the insertion portion and the outer sheath being operably spaced apart to form a first passage communicating with the drainage port and the distal open end; and

[0012] A middle layer member is operably inserted between the outer sheath and the insertion portion and operably extends at least partially from the distal opening end; when the middle layer member exits from between the inner layer member and the outer sheath, the first channel is formed between the inner layer member and the outer sheath.

[0013] Compared to the prior art, the present invention utilizes an inner layer, outer sheath, and middle layer to assemble the system. Leveraging the imaging function of the imaging unit, the system can be guided into the human body to the working area. The middle layer can be inserted between the outer sheath and the insertion unit, blocking the first channel between the inner layer and the distal opening of the outer sheath. This prevents foreign matter from entering the first channel through the distal opening when the system enters the human body, nor does the presence of the distal opening cause tissue contusion. Once the system reaches its working position, the middle layer can be removed from the outer sheath, leaving the first channel open. Working tools can pass through the channel to perform tasks such as crushing stones or draining fluids. Liquids can enter the channel from the distal opening and be discharged from the drain port, allowing the system to operate smoothly. As can be seen from the above, the system has fewer components and a simple structure. Furthermore, without requiring multiple components to enter and exit the human body in multiple steps, and with the first channel for fluid transport, the system is simple and convenient to operate, saving surgical time. Full intraoperative visualization is provided, ensuring safe operation, making the procedure safer and less painful for the patient, and reducing costs.

[0014] In one embodiment, a second channel extending along an extension direction of the insertion portion is provided in the insertion portion, and the second channel passes through the insertion portion.

[0015] In one embodiment, the middle layer component and the inner layer component are detachably connected.

[0016] In one embodiment, the middle layer component is a middle layer expansion tube, and the insertion portion is operable to insert or remove the middle layer expansion tube; and the middle layer expansion tube is detachably connected to the insertion portion.

[0017] In one embodiment, the portion of the middle layer located between the inner layer and the outer sheath is operable to fill an area between the inner layer and the distal open end of the outer sheath.

[0018] In one embodiment, the middle expansion tube comprises a tube body and a connection adapter connected to the tube body;

[0019] The insertion portion has a docking portion connected to the connection adapter, and the docking portion is close to the operating handle; 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.

[0020] In one embodiment, the insertion portion has a sheath, and an 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.

[0021] In one embodiment, the end of the middle 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 middle expansion tube in a direction away from the operating handle.

[0022] In one embodiment, the first rounded corner guide surface and the second rounded corner guide surface are adjacent to each other and extend into the same plane.

[0023] In one embodiment, the outer sheath has a first sheath body and a second sheath body extending from the first sheath body, the drainage port is arranged on the first sheath body, and the distal opening end is arranged on the second sheath body; wherein the diameter of the cross section of the second sheath body gradually decreases in a direction away from the first sheath body.

[0024] In one embodiment, a drainage tube communicating with the first channel protrudes from the side wall of the outer sheath, and the drainage port is provided on the drainage tube.

[0025] In one embodiment, the insertion portion has a sheath, and the light source portion and the imaging portion are disposed in the sheath; the second channel passes through the sheath;

[0026] An end portion of the sheath away from the operating handle is partially opened and communicates with the inner cavity of the sheath, and one end of the light source portion and the imaging portion are located at the end of the sheath away from the operating handle;

[0027] Wherein, a liquid inlet extension tube is provided on the operating handle, and the liquid inlet extension tube is communicated with the inner cavity of the sheath.

[0028] In one embodiment, when the middle layer component is located between the outer sheath and the inner layer component to the working position, the middle layer component is tightly connected to the outer sheath and the inner layer component.

[0029] In one embodiment, the outer sheath has a hydrophilic coating and is made of a polymer material; the middle layer is made of a polymer material or a metal material and is rigid.

[0030] In one embodiment, the outer sheath has a proximal open end, and the insertion portion is at least partially located outside the proximal open end.

[0031] In one embodiment, the sheathing device is a natural cavity sheathing device.

[0032] An embodiment of the present invention provides a natural cavity sheath placement device, including the sheath placement device as described in any one of the above.

[0033] An embodiment of the present invention provides a method for using a sheath placement device, using any of the sheath placement devices described above, comprising the following steps:

[0034] inserting the inner layer into the middle layer;

[0035] inserting the middle layer member inserted with the inner layer member into the outer sheath;

[0036] inserting the assembled outer sheath, the middle layer, and the inner layer together into a working area;

[0037] withdrawing the middle layer and the inner layer together from the outer sheath;

[0038] separating the inner layer and the middle layer;

[0039] Insert the inner member into the outer sheath.

[0040] In one embodiment, in the step of inserting the middle layer member into the outer sheath, the middle layer member extends from the distal open end.

[0041] In one embodiment, during the step of inserting the assembled outer sheath, the middle layer, and the inner layer into the working area, the imaging unit is fully started. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] One or more embodiments are exemplarily illustrated by pictures in the corresponding drawings. These exemplifications do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements. Unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0043] Figure 1 2 is a schematic structural diagram of a sheath placement device according to an embodiment of the present invention;

[0044] Figure 2 yes Figure 1 A partial enlarged view of middle A;

[0045] Figure 3 is an exploded view of a sheathing device according to one embodiment of the present invention;

[0046] Figure 4 is a cross-sectional view of a sheathing device according to one embodiment of the present invention;

[0047] Figure 5 yes Figure 4 A partial enlarged view of middle B;

[0048] Figure 6 yes Figure 4 A partial enlarged view of center C;

[0049] Figure 7 is an enlarged view of the end portion of the sheath device inserted into the human body according to one embodiment of the present invention;

[0050] Figure 8 A method for using a sheathing device according to an embodiment of the present invention;

[0051] Among them, 100, sheath placement device; 1, inner layer; 11, operating handle; 12, insertion part; 121, sheath; 122, light source part; 123, imaging part; 124, docking part; 2, outer sheath; 21, first sheath body; 22, second sheath body; 20, drainage port; 201, distal opening end; 202, proximal opening 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 channel; 91, first interface; 92, second interface. DETAILED DESCRIPTION

[0052] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, each embodiment of the present invention will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will appreciate that in each embodiment of the present invention, many technical details are provided to help readers better understand the present application. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed in the present application can still be implemented.

[0053] In the following description, for the purpose of illustrating the various disclosed embodiments, certain specific details are set forth in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other cases, well-known devices, structures, and techniques associated with this application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0054] Unless the context requires otherwise, throughout the specification and claims, the word "comprise" and variations such as "include" and "have" should be construed in an open, inclusive sense, that is, should be interpreted to mean "including, but not limited to."

[0055] The following will describe in detail various embodiments of the present invention in conjunction with the accompanying drawings to provide a clearer understanding of the objectives, features and advantages of the present invention. It should be understood that the embodiments shown in the accompanying drawings are not intended to limit the scope of the present invention, but are only intended to illustrate the essential spirit of the technical solution of the present invention.

[0056] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0057] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It should be noted that the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0058] In the following description, in order to clearly show the structure and working mode of the present invention, many directional words will be used for description, but words such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and should not be understood as restrictive terms.

[0059] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

[0060] One embodiment of the present invention relates to a sheath placement device. The sheath placement device can be a natural cavity sheath placement device, such as for use in the ureter. The following description uses the sheath placement device in the ureter as an example. It is understood that the sheath placement device can also be used in other applications, such as renal cysts or gallstone lithotripsy.

[0061] like Figure 1 、 Figure 3 and Figure 4 As shown, the sheath placement device 100 comprises an inner member 1, an outer sheath 2, and a middle dilator tube 3. The inner member 1 has an operating handle 11 and an insertion portion 12 connected to the operating handle 11. The insertion portion 12 is provided with a second channel 8 extending along the extension direction of the insertion portion 12. The second channel 8 penetrates the insertion portion 12 and can be used to insert a device such as a laser fiber, an occluder, or a basket-like working instrument. Of course, it can also be used without inserting any instrument. In this case, the insertion portion 12 can be made of a polymer shell or other materials. The outer sheath 2 has a drainage port 20, and one end of the outer sheath 2 is a distal open end 201. The insertion portion 12 is inserted into the outer sheath 2 and at least partially extends from the distal open end 201. The operating handle 11 is located outside the insertion portion 12. The diameter of the insertion portion 12 is smaller than the inner diameter of the outer sheath 2. A first channel connecting the drainage port 20 and the distal open end 201 can be formed between the insertion portion 12 and the outer sheath 2. The insertion portion 12 can be inserted into the middle-layer dilator tube 3. The insertion portion 12 and the middle-layer dilator tube 3 are inserted into the outer sheath 2 together. When inserted into the outer sheath 2, the middle-layer dilator tube 3 blocks the first passage between the inner layer 1 and the distal open end 201 of the outer sheath 2. The middle-layer dilator tube 3 and the inner layer 1 can partially extend from the distal open end 201. It is understood that in some embodiments, a partial gap may exist between the middle layer and the outer sheath 2 or the inner layer 1. Furthermore, in some embodiments, the insertion portion may not have a second passage, and any instrument may not be inserted. For example, if the insertion portion 12 itself is an optical fiber, the imaging portion may be a camera disposed at the end of the optical fiber.

[0062] Preferably, after the middle expansion tube 3 is inserted into the outer sheath 2 to the working position, the middle expansion tube 3 is tightly connected to the outer sheath or the inner layer 1, that is, the middle expansion tube 3 is tightly attached to the inner layer 1, the middle expansion tube 3 is tightly attached to the outer sheath 2, or the middle expansion tube 3 is tightly attached to the distal opening of the outer sheath 2. The working position is the position of the middle layer, the outer sheath 2, and the inner layer 1 when they are assembled and ready for insertion into the human body.

[0063] Specifically, if Figure 1 、 Figure 2 、 Figure 3 and Figure 4 As shown, when inserting the sheath device 100 into the ureter, the middle layer dilator 3 is first placed over the inner layer member 1. The middle layer dilator 3 and the inner layer member 1 are then inserted into the outer sheath 2. The inner layer member 1, the outer sheath 2, and the middle layer dilator 3 enter the ureter together. During the entry into the ureter, the inner layer member 1 is used for camera guidance to locate the stone location, i.e., the working area. After reaching the working position, the middle layer dilator 3 is placed over the inner layer member 1 and pulled out of the outer sheath 2. The middle layer dilator 3 is then withdrawn from the inner layer member 1 and the inner layer member 1 is inserted into the outer sheath 2. At this time, a gap is formed between the inner layer member 1 and the outer sheath 2 to form a first channel. The inner layer member 1 extends from the distal open end 201, and the working tool extends from the second channel 8 to crush the stone. During the stone crushing process, water or other liquid flows from the inner layer member 1 into the working area and then flows from the distal open end 201 into the first channel, and then flows from the first channel into the drain port 20 for discharge. Of course, the inner layer has a certain degree of toughness, and the portion of the inner layer extending from the distal open end 201 can be bent and redirected. It is understood that the sheath placement device 100 can not only enter the ureter to crush stones, but can also crush stones in other areas, and is not limited to ureteral stone surgery as described in this embodiment. Alternatively, when draining fluid from the body, it can also flow out through the second channel 8. In this case, the space between the outer sheath 2 and the inner layer 1 is used for fluid inlet.

[0064] As can be seen from the above, the inner layer 1, outer sheath 2, and middle layer 3 are assembled together. The camera function of the inner layer 1 can be used to guide the system into the ureter and reach the working area. The middle layer 3 can be inserted between the outer sheath 2 and the insertion portion 12 to block the first channel between the inner layer 1 and the distal open end 201 of the outer sheath 2. When the system enters the ureter, no foreign matter will enter the first channel through the distal open end 201, and the presence of the distal open end 201 will not cause tissue contusion. When the system reaches the working position, the middle layer can be removed from the outer sheath 2, thereby opening the first channel. The working instrument can pass through the second channel 8 to perform work such as lithotripsy. During the lithotripsy process, liquid can enter the first channel from the distal open end 201 and be discharged from the drain port 20, allowing the system to be used smoothly. As can be seen from the above, the system has fewer components and a simple structure, and does not require multiple components to enter and exit the ureter in multiple steps. It is simple and convenient to operate, saves surgical time, and the entire process is visible during the operation. The operation is safe, making the operation safer and reducing the patient's pain, and the cost is low.

[0065] It can be understood that in this embodiment, the middle layer expansion tube 3 is a hollow tube into which the inner layer part 1 can be inserted. In other embodiments, the middle layer expansion tube 3 can be inserted into the outer sheath 2 side by side with the inner layer part 1 and a rod-shaped or other structural part. In this case, the middle layer expansion tube 3 can be called a middle layer part. When the sheath placement device 100 enters the ureter, the middle layer part can block the first channel between the inner layer part 1 and the outer sheath 2 at the distal open end 201.

[0066] Furthermore, if Figure 1 and Figure 3 As shown, the middle dilator tube 3 is detachably connected to the inner member 1. Specifically, when the sheath placement device 100 is inserted into the ureter, the middle dilator tube 3 is fixed to the inner member 1, preventing displacement of the middle dilator tube 3 during operation, thereby ensuring safer and more reliable operation. It is understood that in other embodiments, the middle dilator tube 3 may also be detachably connected to the outer sheath 2.

[0067] Furthermore, the insertion portion 12 can be operated to insert or remove the middle expansion tube 3, and the middle expansion tube 3 is detachably connected to the insertion portion 12. It is understandable that in other embodiments, the middle expansion tube 3 can also be detachably connected to the operating handle 11.

[0068] Specifically, if Figure 1 、 Figure 3 and Figure 4As shown, the middle-layer expansion tube 3 has a tube body 31 and a connection adapter 32 connected to the tube body 31. The insertion portion 12 has a docking portion 124 connected to the connection adapter 32, and the docking portion 124 is close to the operating handle 11. When the insertion portion 12, the outer sheath 2, and the middle-layer expansion tube 3 are assembled together, the connection adapter 32 is located between the outer sheath 2 and the operating handle 11. In order to position the middle-layer expansion tube 3 relative to the outer sheath 2, the outer sheath 2 has a first interface 91 at one end close to the operating handle 11, and the first interface 91 is docked with a second interface 92 on the middle-layer expansion tube 3, and the second interface 92 is embedded in the first interface 91 and matches the inner contour of the first interface 91. The inner diameters of both the first interface 91 and the second interface 92 gradually increase toward the direction of the operating handle 11. The docking portion 124 is threadably connected to the insertion portion 12. After the insertion portion 12, outer sheath 2, and middle-layer dilator tube 3 are inserted into the working position, the insertion portion 12 and middle-layer dilator tube 3 are removed from the outer sheath 2. The middle-layer dilator tube 3 is then loosened from the insertion portion 12 and removed from the end of the insertion portion 12 away from the operating handle 11. It is understood that in other embodiments, the docking portion 124 and the insertion portion 12 are connected by a snap-fitting member, such as a protrusion on the docking portion 124 and a notch on the insertion portion 12, into which the protrusion fits. In one embodiment, the insertion portion 12 and the connection adapter 32 are connected via a Luer interface. This allows the middle and inner components to be fixedly connected.

[0069] In addition, if Figure 4 and Figure 7As shown, the insertion portion 12 has a sheath 121, and a light source portion 122 and an imaging portion 123 arranged in the sheath 121. The end portion of the sheath 121 away from the operating handle 11 is partially opened and communicates with the inner cavity of the sheath 121, and one end of the light source portion 122 and the imaging portion 123 are located at the end of the sheath 121 away from the operating handle 11. The second channel 8 passes through the sheath 121. The operating handle 11 is provided with a liquid inlet extension tube, which is communicated with the inner cavity of the sheath 121. The light source portion 122 can be a light guide fiber, and the imaging portion 123 includes a lens. One end of the light guide fiber and the lens are located at the end of the sheath 121 away from the operating handle 11, and light is provided to the light source portion 122 through the lighting component. A duct fiber 122 can be extended in the cable 7, and the cable also has a power signal transmission wire for supplying power to the imaging portion 123 and the lighting component. Specifically, the light source unit 122 enters the human body through the sheath 121 to illuminate one end, and working instruments such as laser fibers or guidewires can be extended from the second channel 8 to work. Due to the provision of the light source unit 122, the light source unit 122 has good toughness and low cost, and is not easily damaged. The sheath 121 of the inner layer 1 can be a soft sheath. The provision of the light source unit 122 ensures the overall quality of the inner layer 1 during use and is not easily damaged. In addition, in some embodiments, the light source unit 122 includes an LED lamp, which is directly provided at the end of the sheath 121 away from the operating handle 11; or in some embodiments, the second channel may not be provided inside the insertion portion, that is, the insertion portion does not have the sheath 121, and no instrument can be inserted. For example, if the insertion portion 12 itself is an optical fiber, the imaging unit can be a camera provided at the end of the optical fiber.

[0070] like Figure 2 、 Figure 4 and Figure 6 As shown, in order to reduce damage to the human body when the insertion portion 12 is inserted into the human body, the end of the sheath 121 away from the operating handle 11 has a first rounded guide surface 4, and the first rounded guide surface gradually converges toward the axis of the insertion portion 12 in the direction away from the operating handle 11. The middle expansion tube 3 and the insertion portion 12 have a distal open end 201 that partially extends out of the outer sheath 2. The end of the middle expansion tube 3 will directly contact the human body. In order to reduce damage to the human body, the end of the middle expansion tube 3 away from the operating handle 11 has a second rounded guide surface 5, and the second rounded guide surface 5 gradually converges toward the axis of the middle expansion tube 3 in the direction away from the operating handle 11.

[0071] Preferably, the first and second rounded guide surfaces 5 are adjacent and extend into the same plane. That is, when the middle dilator tube 3 and the insertion portion 12 are inserted into the human body, a portion of the insertion portion 12 extends from the end of the middle dilator tube 3 extending from the outer sheath 2. The extension line of the second rounded guide surface 5 extends over the first rounded guide surface, allowing the portion of the insertion portion 12 extending outside the middle dilator tube 3 to form a smooth transition with the second rounded guide surface 5, making entry into the human body smoother and preventing damage to human tissue.

[0072] Further, such as Figure 4 and Figure 5 As shown, the outer sheath 2 includes a first sheath body 21 and a second sheath body 22 extending from the first sheath body 21. The drainage port 20 is provided on the first sheath body 21, and the distal opening 201 is provided on the second sheath body 22. The diameter of the cross section of the second sheath body 22 gradually decreases as it moves away from the first sheath body 21. That is, the outer diameter of the second sheath body 22 gradually decreases toward the distal opening 201, while the inner diameter remains unchanged. Preferably, the outer diameter of the second sheath body 22 gradually decreases toward the distal opening 201, so that the outer surface of the second sheath body 22, the first rounded guide surface 5, and the second rounded guide surface 5 are adjacent and extend into the same plane.

[0073] In addition, a drainage pipe 6 communicating with the first channel protrudes and extends from the side wall of the outer sheath 2 , and the drainage pipe 6 is provided on the drainage pipe 6 .

[0074] Furthermore, the inner diameter of the outer sheath 2 along its extension direction is equal, and the outer diameter of the portion of the insertion portion 12 located in the outer sheath 2 along its extension direction is equal. When the insertion portion 12 is located in the outer sheath 2, the first channel between the insertion portion 12 and the outer sheath 2 extends along the length direction of the outer sheath 2, and the space between the first channel along its extension direction remains uniform, allowing the liquid flowing out of the inner layer 1 to flow smoothly when flowing out through the first channel.

[0075] In this embodiment, illumination within the inner layer 1 is provided by optical fibers, and the sheath 121 is a soft sheath. The inner layer 1 can be a disposable consumable. The middle layer expansion tube 3 is rigid and can be made of a polymer or metal material, also a disposable consumable. Similarly, the outer sheath 2 is also a disposable consumable.

[0076] Furthermore, the outer sheath 2 has a proximal open end 202 , and the insertion portion is at least partially located outside the proximal open end 202 .

[0077] Furthermore, the outer sheath has a hydrophilic coating, and the outer sheath is made of a polymer material.

[0078] Understandably, in other embodiments, the sheath placement device can be used for gallstone lithotripsy or renal cysts. Before gallstone lithotripsy, the middle dilation tube 3 is removed. Since the channel between the inner member 1 and the outer sheath 2 and the second channel 8 can be used in conjunction, saline or water can be injected and then drained, thereby reducing surgical risks and alleviating patient pain. Alternatively, the sheath placement device can be used for renal cysts, where medication is injected through the second channel 8 of the inner member 1, and the cystic fluid is drawn out from between the inner member 1 and the outer sheath 2 by a syringe through the drainage port.

[0079] Another embodiment of this embodiment also provides a method for using the sheathing device, such as Figure 3 and Figure 8 As shown, the above-mentioned sheath placement device is used, including the following steps:

[0080] Step 100, inserting the inner layer component into the middle layer component 1;

[0081] Step 200 , inserting the middle layer member with the inner layer member 1 inserted into the outer sheath 2 ;

[0082] Step 300 , inserting the assembled outer sheath 2 , middle layer component, and inner layer component 1 into the working area;

[0083] Step 400 , withdrawing the middle layer member and the inner layer member 1 from the outer sheath 2 ;

[0084] Step 500 , separating the inner layer 1 from the middle layer, that is, pulling the inner layer 1 out of the middle layer.

[0085] Step 600 : insert the inner layer into the outer sheath 2 .

[0086] Specifically, the cooperation between the middle layer component and the inner layer component 1 and the outer sheath 2 has been mentioned in the above embodiment of the sheath placement device and will not be described in detail here.

[0087] Furthermore, in step 200 , the middle layer member extends from the distal open end 201 .

[0088] Furthermore, during step 300 , the imaging unit 123 starts working throughout the entire process.

[0089] While preferred embodiments of the present invention have been described in detail above, it should be understood that aspects of the embodiments can be modified, if necessary, to employ aspects, features and concepts of the various patents, applications and publications to provide further embodiments.

[0090] 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 limited to the specific embodiments disclosed in the specification and claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which these claims are entitled.

[0091] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present invention, and that in actual applications, various changes may be made thereto in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A sheathing device, characterized in that: include: an inner layer member, the inner layer member having an operating handle and an insertion portion connected to the operating handle, the insertion portion having an imaging portion, and a second channel provided in the insertion portion; An outer sheath, wherein the outer sheath is provided with a drainage port and has a distal open end; the insertion portion is operably inserted into the outer sheath and at least partially operably extends from the distal open end; and the insertion portion and the outer sheath are operably spaced apart to form a first passage connecting the drainage port and the distal open end; as well as, a middle layer member operatively inserted between the outer sheath and the insertion portion and operatively extended at least partially from the distal open end; After the middle layer member is withdrawn from between the inner layer member and the outer sheath, the inner layer member is inserted into the outer sheath, forming the first channel between the inner layer member and the outer sheath. During the stone crushing process, water and other liquids flow into one of the first channel or the second channel and then discharge from the other of the first channel or the second channel. The middle layer is made of polymer material or metal material and has rigidity; The middle layer component is a hollow tube, which assembles the inner layer component, the outer sheath and the middle layer component together. The inner layer component is inserted into the middle layer component. With the help of the camera function of the inner layer component, the sheath placement device can be guided into the ureter to reach the working area. In the process of reaching the working area, the middle layer component can be inserted between the outer sheath and the insertion part to block the first channel between the inner layer component and the distal open end of the outer sheath.

2. The sheathing device according to claim 1, characterized in that The inserting portion is provided with a second channel extending along an extending direction of the inserting portion, and the second channel passes through the inserting portion.

3. The sheathing device according to claim 1, characterized in that The middle layer component is detachably connected to the inner layer component.

4. The sheathing device according to claim 2, characterized in that The middle layer component is a middle layer expansion tube, and the insertion portion can be operably inserted into or pulled out of the middle layer expansion tube; and the middle layer expansion tube is detachably connected to the insertion portion.

5. The sheathing device according to claim 4, characterized in that The portion of the middle layer located between the inner layer and the outer sheath is operable to fill an area between the inner layer and the distal open end of the outer sheath.

6. The sheathing device according to claim 4, characterized in that The middle-layer expansion tube comprises a tube body and a connection adapter connected to the tube body; The insertion portion is provided with a docking portion connected to the connection adapter, and the docking portion is close to the operating handle.

7. The sheathing device according to claim 4, characterized in that The insertion portion has a sheath, and an 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.

8. The sheathing device according to claim 7, characterized in that The end of the middle 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 middle expansion tube in a direction away from the operating handle.

9. The sheathing device according to claim 8, characterized in that The first rounded corner guide surface and the second rounded corner guide surface are adjacent to each other and extend into the same plane.

10. The sheathing device according to claim 1, characterized in that: The outer sheath comprises a first sheath body and a second sheath body extending from the first sheath body, the drainage port is arranged on the first sheath body, and the distal opening end is arranged on the second sheath body; wherein the diameter of the cross section of the second sheath body gradually decreases in a direction away from the first sheath body.

11. The sheathing device according to claim 1, characterized in that: A drainage pipe communicating with the first channel protrudes from the side wall of the outer sheath, and the drainage port is provided on the drainage pipe.

12. The sheathing device according to claim 2, characterized in that: The insertion portion has a sheath, and the light source portion and the imaging portion are arranged in the sheath; the second channel passes through the sheath; An end portion of the sheath away from the operating handle is partially opened and communicates with the inner cavity of the sheath, and one end of the light source portion and the imaging portion are located at the end of the sheath away from the operating handle; Wherein, a liquid inlet extension tube is provided on the operating handle, and the liquid inlet extension tube is communicated with the inner cavity of the sheath.

13. The sheathing device according to claim 1, characterized in that When the middle layer component is located between the outer sheath and the inner layer component to the working position, the middle layer component is tightly connected to the outer sheath and the inner layer component.

14. The sheathing device according to claim 1, characterized in that The outer sheath has a hydrophilic coating and is made of a polymer material.

15. The sheathing device according to claim 1, characterized in that The outer sheath has a proximal open end, and the insertion portion is at least partially located outside the proximal open end.

16. The sheathing device according to claim 1, characterized in that The sheath placement device is a natural cavity sheath placement device.

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