A nipple incision system

Abstract

This application provides a nipple incision system, relating to the field of endoscopic technology. The nipple incision system includes a nipple incision knife and an ultra-thin endoscope. The nipple incision knife has a guidewire guiding channel; the ultra-thin endoscope has an insertion tube that can pass through the guidewire guiding channel and move along the guidewire guiding channel. The nipple incision system provided by this application replaces the method of using X-ray-assisted observation, eliminating the need for X-ray-assisted observation and reducing the impact of contrast agent infiltration or placement on the patient's bile duct recovery.

Description

Technical Field

[0001] This application relates to the field of endoscopic technology, and more particularly to a nipple incision system. Background Technology

[0002] Biliary and pancreatic diseases are common in clinical practice, and endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP), is a commonly used method. During ERCP, X-rays are used to assist in the insertion of guidewires and the detection of lesions, which obviously poses the problem of radiation exposure for both doctors and patients, as well as the problem of slow recovery caused by contrast agent infiltration or indwelling in the bile duct. Summary of the Invention

[0003] In view of this, the purpose of this application is to overcome the shortcomings of the prior art and provide a nipple incision system to replace the method of using X-ray-assisted observation, which eliminates the need for X-ray-assisted observation and can reduce the impact of contrast agent infiltration or retention on the patient's bile duct recovery.

[0004] This application provides the following technical solution:

[0005] This application provides a nipple incision system, the nipple incision system comprising:

[0006] A nipple incision knife, wherein the nipple incision knife has a guide wire guiding channel;

[0007] An ultra-thin endoscope having an insertion tube that can pass through the guide wire guide channel and move along the guide wire guide channel.

[0008] In some embodiments of the first aspect, the nipple cutter includes:

[0009] The sheath has a guide wire guiding channel and has a distal end and a proximal end. The orifice wall of the guide wire guiding channel has a breakable region that extends along a preset path. The distal end and proximal end face of the sheath are located on the preset path, so that the breakage of the breakable region can cause the orifice wall of the guide wire guiding channel to form a non-closed structure.

[0010] In some embodiments of the first aspect, the fracture zone is provided with a fracture groove that extends along the preset path.

[0011] In some embodiments of the first aspect, the fracture groove is located on the outer wall of the sheath.

[0012] In some embodiments of the first aspect, the number of fracture grooves is multiple, and the multiple fracture grooves are spaced apart along the circumference of the sheath.

[0013] In some embodiments of the first aspect, the sheath has a first wall portion and a second wall portion, which are arranged sequentially along the circumference of the sheath; wherein the guide wire guiding channel is formed by the first wall portion and the second wall portion, the first wall portion and the second wall portion are detachably connected, and the second wall portion is located in the breakable zone.

[0014] In some embodiments of the first aspect, the first pipe wall portion is connected to the second pipe wall portion by a connector, the connector comprising at least one of the following:

[0015] Clips, easy-release adhesive, and safety bolts.

[0016] In some embodiments of the first aspect, the sheath has a distal end and a proximal end, a first handhold is provided on the portion of the first tube wall located at the proximal end, and a second handhold is provided on the portion of the second tube wall located at the proximal end, the first handhold and the second handhold being detachably connected.

[0017] In some embodiments of the first aspect, the sheath wall has a first opening communicating with the guidewire guide channel, and the first opening extends from the distal end face of the sheath to the proximal end face, and the width of the first opening is less than the outer diameter of the insertion tube.

[0018] In some embodiments of the first aspect, the nipple cutter further includes:

[0019] The head end tube has a head end and a tail end, the tail end and the distal end of the sheath tube are detachably connected, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end gradually decrease in the direction away from the sheath tube, the inner hole of the tail end is set with a constant diameter, and the head end tube is set with a transparent structure.

[0020] In some embodiments of the first aspect, the nipple cutter further includes:

[0021] The head end tube has a head end and a tail end, the tail end and the distal end of the sheath are integrally formed, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end gradually decrease in the direction away from the sheath tube, the inner hole of the tail end is of equal diameter, and the head end tube is made of transparent structure; wherein, the end faces of the two ends of the head end tube are respectively located on the preset path.

[0022] In some embodiments of the first aspect, the nipple cutter further includes:

[0023] The sheath also has a wire channel. The outer wall of the sheath has a first hole and a second hole spaced apart in the direction away from the distal end. The first hole and the second hole are respectively connected to the wire channel. One end of the wire passes through the first hole and is fixed to the wire channel. The other end of the wire passes through the second hole and the wire channel. The portion of the wire located between the first hole and the second hole is located outside the sheath and is in a relaxed state.

[0024] In some embodiments of the first aspect, the initial included angle formed between the distal end and the proximal end of the sheath is 0° to 45°.

[0025] The embodiments of this application have the following advantages:

[0026] This application provides a nipple incision system that uses an ultra-thin endoscope to directly replace the traditional guidewire. Essentially, the ultra-thin endoscope not only functions as a guidewire but also allows for visualization of the common bile duct, pancreatic duct, and sphincter of Oddi, eliminating the need for X-rays. In other words, this method achieves visualization during the procedure, thus avoiding the need for X-rays. Naturally, by reducing the use of X-rays and contrast agents, the risks to patients from radiation exposure and potential side effects or prolonged recovery periods caused by contrast agents can be theoretically reduced.

[0027] Furthermore, with the help of more intuitive visual feedback (from the ultra-thin endoscope), surgeons can more accurately locate the lesion and perform precise cuts, improving the success rate of the surgery while reducing unnecessary tissue damage.

[0028] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0029] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This diagram illustrates the structure of a nipple incision system according to Embodiment 1 of this application, with the nipple incision blade in a straightened state.

[0031] Figure 2 This diagram illustrates the structure of a nipple incision system according to Embodiment 1 of this application, showing the nipple incision blade in a bent state.

[0032] Figure 3 This illustration shows a schematic diagram of the nipple incision knife of a nipple incision system provided in Embodiment 1 of this application from one perspective;

[0033] Figure 4 This illustration shows a schematic diagram of the nipple incision knife of a nipple incision system provided in Embodiment 2 of this application from one perspective;

[0034] Figure 5 This illustration shows a schematic diagram of the nipple incision knife of a nipple incision system provided in Embodiment 3 of this application from one perspective;

[0035] Figure 6 This diagram illustrates the initial state of the nipple cutting blade of a nipple cutting system provided in Embodiment 2 of this application.

[0036] Figure 7 This diagram illustrates the structure of a nipple incision system in a separated state according to Embodiment 2 of this application.

[0037] Figure 8 A schematic diagram of the structure of a nipple cutting blade in a nipple cutting system provided in Embodiment 4 of this application is shown;

[0038] Figure 9 A schematic diagram of the nipple incision knife of a nipple incision system provided in Embodiment 5 of this application is shown.

[0039] Explanation of key component symbols:

[0040] 100-Sheath; 110-Distal end; 120-Proximal end; 130-First hole; 140-Second hole; 150-Wire channel; 160-Wire guide channel; 170-Fracturing groove; 180-First tube wall portion; 190-Second tube wall portion; 200-Wire; 300-First handhold; 400-Second handhold; 500-Head end tube; 510-Head end; 520-Tail end; 600-Second opening. Detailed Implementation

[0041] The embodiments of this application are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this application, and should not be construed as limiting this application.

[0042] It should be noted that when an element is said to be "fixed" to another element, it can be directly on the other element or there may be an intervening element. When an element is said to be "connected" to another element, it can be directly connected to the other element or there may be an intervening element. Conversely, when an element is said to be "directly" on another element, there is no intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0043] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0044] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the template description is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0046] Among related technologies, biliary and pancreatic diseases are common in clinical practice, and endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP), is a commonly used method. During ERCP, X-rays are needed to assist in the insertion of guidewires and the detection of lesions, which obviously poses the problem of radiation exposure to doctors and patients, as well as the problem of slow recovery caused by contrast agent infiltration or indwelling in the bile duct of patients.

[0047] like Figure 1 and Figure 2As shown, in order to solve the above-mentioned technical problems, this application provides a nipple incision system. The nipple incision system includes a nipple incision knife and an ultra-fine endoscope. The nipple incision knife has a guide wire guiding channel 160. The ultra-fine endoscope has an insertion tube that can pass through the guide wire guiding channel 160 and can move along the guide wire guiding channel 160.

[0048] In these embodiments, this nipple incision system is designed to improve upon some problems encountered during conventional ERCP procedures, particularly reducing reliance on X-rays and minimizing the impact of contrast agents on patients. The system includes a nipple incision knife with a guidewire guide channel 160. An ultra-fine endoscope has an insertion tube capable of passing through the guidewire guide channel 160; the insertion tube has a very small outer diameter and can move along the channel, meaning that the ultra-fine endoscope can be controlled to enter and exit the guidewire guide channel 160.

[0049] Generally, the inner diameter of the guidewire guide channel 160 is larger than the outer diameter of the insertion tube of the ultra-fine endoscope, so as to facilitate easy control of the movement of the insertion tube within the guidewire guide channel 160. Of course, the guidewire guide channel 160 is not only used for inserting guidewires, but also for inserting other contents, etc.

[0050] For example, a lubricating layer is provided on the inner wall of the guidewire guide channel 160 to reduce the movement resistance of the insertion tube and reduce wear on the endoscope lens. Optionally, a lubricating layer is formed on the inner wall of the guidewire guide channel 160 by applying lubricant inside the guidewire guide channel 160. Of course, a coating layer can also be provided.

[0051] Clearly, this method allows the use of an ultra-thin endoscope to directly replace the traditional guidewire. Essentially, the ultra-thin endoscope not only functions as a guidewire but also allows for visualization of the common bile duct, pancreatic duct, and sphincter of Oddi, without the need for X-rays. In other words, this method achieves visualization during the procedure, thus avoiding the need for X-rays. Naturally, by reducing the use of X-rays and contrast agents, it theoretically reduces the risks of radiation exposure for patients and the potential side effects or prolonged recovery period caused by contrast agents.

[0052] It should be noted that, with the aid of more intuitive visual feedback (from the ultra-thin endoscope), surgeons can more accurately locate lesions and perform precise incisions, improving surgical success rates while reducing unnecessary tissue damage. For ease of understanding of these effects, it is necessary to consider the possibility of image overlap during X-ray imaging, which can prevent the observation or accurate assessment of certain lesions, such as inflammation within the sphincter of Oddi. Clearly, this application's use of an ultra-thin endoscope instead of a guidewire is more conducive to diagnosis. Furthermore, controlling the deflection of the ultra-thin endoscope allows for better control of its insertion direction, reducing surgical difficulty, enabling direct detection or assessment of mucosal damage, reducing complications and secondary illnesses, and facilitating the removal and fragmentation of stones in the cystic duct, gallbladder neck, and gallbladder body.

[0053] like Figure 1 , Figure 2 , Figure 3 and Figure 4 In some embodiments, the nipple cutter includes a sheath 100, which is provided with a guide wire guiding channel 160. The sheath 100 has a distal end 110 and a proximal end 120. The orifice wall of the guide wire guiding channel 160 has a breakable region that extends along a preset path. The end faces of both ends of the sheath 100 are located on the preset path, so that the breakage of the breakable region can cause the orifice wall of the guide wire guiding channel 160 to form a non-closed structure.

[0054] In these embodiments, it should be noted that in the conventional ERCP use of a nipple incision knife and guidewire, the guidewire length is typically more than twice that of the nipple incision knife. This means that during the withdrawal of the nipple incision knife, a portion of the guidewire is always under the operator's control to prevent it from dislodging from the tissue or the current location, and the guidewire's outer diameter is generally consistent in its extension direction. However, in this system, the ultra-thin endoscope that functions as the guidewire has a proximal 120 connector, which connects to the proximal 120 of the insertion tube. The proximal 120 connector is used for image transmission, etc. The outline of the aforementioned proximal 120 connector is much larger than the guidewire guide channel 160, which presents a problem of difficulty in removing the nipple incision knife from the ultra-thin endoscope. Therefore, this embodiment mainly aims to solve this problem, enabling the nipple incision knife to be removed without passing through the proximal 120 connector.

[0055] In the nipple cutter design provided in this embodiment, the guide wire guide channel 160 on the sheath 100 is provided with a special breakage zone. The main purpose of this design is to allow the hole wall of the guide wire guide channel 160 to break along a preset path under certain conditions, thereby forming a non-closed structure of the hole wall of the guide wire guide channel 160.

[0056] Obviously, when it is necessary to remove the nipple incision knife, by breaking the fragile area, a crack is formed in the wall of the guide wire guide channel 160 to connect with the outside. Then, during the process of withdrawing the nipple incision knife, the insertion tube is controlled to move out of the guide wire guide channel 160 from the crack, thus completing the separation of the ultra-fine endoscope and the nipple incision knife.

[0057] Furthermore, in case of emergencies during surgery, such as instruments getting stuck or other complications occurring, the instruments can be quickly removed from the patient's body by breaking the fragile area, reducing harm to the patient.

[0058] It should be noted that the material strength of the vulnerable zone should be lower than that of other parts of the sheath 100, but it cannot be so brittle as to break easily during normal use. Special materials or processing techniques (such as localized thinning or perforation) are required to achieve this. Simultaneously, a reliable method is needed to trigger fracture in the vulnerable zone, which could be achieved through mechanical force (e.g., tension), heat, or other means. Ensuring that this mechanism is safe and controllable is crucial.

[0059] Furthermore, while providing additional operational flexibility, it's crucial to ensure that fractures don't create sharp edges that could damage internal tissues, or that fragments remaining in the body could cause infection. Therefore, these risks must be fully considered in the design, and appropriate measures must be taken to mitigate them.

[0060] For example, in this embodiment, the preset path extends along the axial direction of the sheath 100. Of course, in other embodiments, the preset path may also be an S-shaped path or other curved paths, as long as a slit is formed.

[0061] like Figure 3 As shown, in some embodiments, the fragile zone is provided with a fracture groove 170, which extends along a preset path.

[0062] In these embodiments, the design of the nipple cutter allows for more precise control and guidance of the material's fracture path by setting a fracture groove 170, also known as a stress concentration groove or a preset fracture line, in the fracture zone.

[0063] The fracture groove 170 guides the fracture direction. The fracture groove 170 is set along a preset path. When sufficient force is applied, the material will preferentially fracture along the direction of this fracture groove 170. Due to the presence of the fracture groove 170, the strength of local areas is reduced, making it easier to fracture when needed.

[0064] It should be noted that the location, depth, and width of the fracture groove 170 need to be carefully designed to ensure that the fracture groove 170 can function as intended at the right time. For example, if the fracture groove 170 is too deep, it may cause unexpected fracture; while if the fracture groove 170 is too shallow, it may not function effectively.

[0065] Furthermore, the overall material of the sheath 100 should have good biocompatibility and mechanical properties, while appropriate brittleness is required at the fracture groove 170 to ensure reliable fracture.

[0066] For example, the fracture groove 170 can be manufactured using precision machining techniques such as laser cutting or micro-milling. The choice of process depends on the material properties and the dimensional requirements of the final product. Machining accuracy is crucial for maintaining the consistency and reliability of the fracture groove 170.

[0067] When it is necessary to remove ultra-thin endoscopic instruments, doctors can use specialized tools or simply stretch / rotate the instruments to activate the breakage mechanism.

[0068] For example, in this embodiment, the cross-section of the fracture groove 170 is set to V-shape. Of course, in other embodiments, it can also be set to square, arc shape, etc.

[0069] like Figure 3 As shown, in some embodiments, the fracture groove 170 is located on the outer wall of the sheath 100.

[0070] In these embodiments, when the fracture groove 170 is located on the outer wall of the sheath 100, this design is typically intended to provide a controlled separation mechanism while maintaining the integrity of the guidewire guide channel 160. Even if an external fracture occurs, the internal channel containing the guidewire or endoscope remains closed and continuous, ensuring that the instrument can continue to pass smoothly.

[0071] Furthermore, by providing a fracture groove 170 on the outer wall of the sheath 100, the location of the fracture groove 170 can be easily identified, and external force can be applied more directly to trigger the fracture.

[0072] like Figure 3 As shown, in some embodiments, there are multiple fracture grooves 170, which are spaced apart along the circumference of the sheath tube 100.

[0073] In these embodiments, when there are multiple fracture grooves 170 and these fracture grooves 170 are spaced apart circumferentially along the sheath 100, this design can provide a more precise and controllable separation mechanism. By providing multiple fracture grooves 170 circumferentially along the sheath 100, local fractures can be achieved at different locations, which increases the flexibility during the surgical procedure.

[0074] For complex anatomical structures or specific surgical needs, surgeons can select appropriate fracture grooves 170 to adjust the position or shape of instruments for better surgical procedures. Furthermore, to enhance reliability, even if one fracture groove 170 fails to function as expected, other fracture grooves 170 can serve as backups, ensuring the reliability of the entire system.

[0075] The distance between the fracture grooves 170 needs to be determined based on the specific dimensions and usage requirements of the sheath 100, as well as the diameter of the insertion tube of the ultra-fine endoscope. A reasonable spacing helps maintain the overall strength of the sheath 100, while ensuring that each fracture groove 170 can function independently. Furthermore, by removing the portion between adjacent fracture grooves 170, it is beneficial to form a large-sized rift, facilitating the removal of the insertion tube.

[0076] For example, in this embodiment, there are two fracture grooves 170, and the fracture grooves 170 are located on the side of the sheath tube 100 away from the cutter wire channel 150. Of course, in other embodiments, the number of fracture grooves 170 may also be three, four, five, six, etc.

[0077] like Figure 4 As shown, in some embodiments, the sheath 100 has a first tube wall portion 180 and a second tube wall portion 190, which are arranged sequentially along the circumference of the sheath 100; wherein, the guide wire guide channel 160 is formed by the first tube wall portion 180 and the second tube wall portion 190, the first tube wall portion 180 and the second tube wall portion 190 are detachably connected, and the second tube wall is located in the breakable area.

[0078] In these embodiments, the sheath 100 is designed to consist of two parts: a first wall portion 180 and a second wall portion 190. The first wall portion 180 and the second wall portion 190 are arranged sequentially along the circumference of the sheath 100 and together form the guide wire guiding channel 160. Clearly, the key to this design is that the first wall portion 180 and the second wall portion 190 are detachably connected, and the second wall portion 190 is located in the breakage zone.

[0079] The first pipe wall portion 180 and the second pipe wall portion 190 are connected by a snap-on / snap-off method (such as clips, threads, adhesives, etc.). The guide wire guide channel 160 is a complete pipe formed by the first pipe wall portion 180 and the second pipe wall portion 190.

[0080] This detachable connection allows the physician to separate the first wall portion 180 and the second wall portion 190 of the sheath 100 when needed. Quick disassembly can be achieved using manual tools or a specific mechanism. Upon removal of the insertion tube, the second wall portion 190 is removed, thereby altering the shape of the guidewire guidance channel 160 or fully opening the channel, allowing for the removal of the insertion tube.

[0081] like Figure 4 As shown, in some embodiments, the first pipe wall portion 180 is connected to the second pipe wall portion 190 via a connector, the connector including at least one of the following:

[0082] Clips, easy-release adhesive, and safety bolts.

[0083] In some embodiments, the first pipe wall portion 180 and the second pipe wall portion 190 are connected by connectors. These connectors may be snap-fit, easy-release adhesive, or safety bolts, etc. Each connection method has its specific advantages and application scenarios.

[0084] Among them, a snap-fit ​​is a mechanical connection method, which typically includes a protruding part and a corresponding groove. The connection is achieved by pressing the protruding part into the groove.

[0085] Easy-release adhesive: Easy-release adhesive is a special type of adhesive that can be easily separated under applied force. When using adhesive dispensing, the surface is smooth, without noticeable bumps or depressions, reducing potential irritation to surrounding tissues. The adhesive can be easily separated by pulling or other methods when needed, while remaining firmly attached under normal operation.

[0086] Safety pin: A safety pin is a mechanical locking device that typically consists of an insertion hole and a movable plug. Connection is achieved by inserting the plug and locking it. Safety pins provide an extra layer of security, ensuring that the connection will not easily disengage in unexpected situations. Doctors can visually inspect whether the safety pin is locked in place, increasing the transparency of the procedure.

[0087] Clearly, the chosen connector must be compatible with the sheath 100 material to ensure long-term stability and biocompatibility. The connector design should facilitate endoscopic manipulation, especially in confined spaces. Regardless of the connector chosen, it must ensure that it will not accidentally disengage under normal use conditions, but can be quickly and safely disassembled when needed.

[0088] For example, such as Figure 5 As shown, the first pipe wall portion 180 and the second pipe wall portion 190 are bonded together with easy-to-remove adhesive, and a fracture groove is provided at the bonding point between the first pipe wall portion 180 and the second pipe wall portion 190 to facilitate the bonding of the first pipe wall portion 180 and the second pipe wall portion 190.

[0089] like Figure 6 and Figure 7 As shown, in some embodiments, the sheath 100 has a distal end 110 and a proximal end 120, a first handhold 300 is provided on the portion of the first tube wall 180 located at the proximal end 120, and a second handhold 400 is provided on the portion of the second tube wall 190 located at the proximal end 120, and the first handhold 300 and the second handhold 400 are detachably connected.

[0090] In these embodiments, the proximal end 120 portion of the sheath 100 is provided with a first hand-held member 300 and a second hand-held member 400, which correspond to the first tube wall portion 180 and the second tube wall portion 190, and the first hand-held member 300 and the second hand-held member 400 can be detachably connected, thereby allowing the separation of the first tube wall portion 180 and the second tube wall portion 190 to be controlled using the first hand-held member 300 and the second hand-held member 400.

[0091] The sheath 100 has a distal end 110 and a proximal end 120. The distal end 110 usually refers to the part that enters the patient's body. The proximal end 120 refers to the part held by the operator (doctor).

[0092] The first handpiece 300 and the second handpiece 400 can be connected and separated by a detachable method (such as a snap-fit, easy-release adhesive, or safety bolt).

[0093] Clearly, the surgeon can more easily manipulate the sheath 100 using the first handpiece 300 and the second handpiece 400, improving the precision and comfort of the procedure. Furthermore, the design of the first handpiece 300 and the second handpiece 400 provides a better grip, reduces hand fatigue, and helps prevent slippage.

[0094] When needed, the doctor can quickly separate the first handpiece 300 and the second handpiece 400 to change the shape of the sheath 100 or remove a portion of it to facilitate the removal of the insertion tube.

[0095] The shape and size of the first handpiece 300 and the second handpiece 400 should conform to ergonomic principles to ensure that the doctor does not feel uncomfortable during prolonged operation. The surface treatment should prevent slippage and increase grip stability. For example, both the first handpiece 300 and the second handpiece 400 are provided with finger insertion holes.

[0096] For example, the first handpiece 300 is the operating handle of a nipple cutter.

[0097] In some embodiments, the sheath 100 has a first opening in its wall, which communicates with the guide wire guide channel 160. The first opening extends from the end face of the distal end 110 of the sheath 100 to the end face of the proximal end 120, and the width of the first opening is smaller than the outer diameter of the insertion tube.

[0098] In these embodiments, a first opening is provided on the wall of the sheath 100, which communicates with the guidewire guide channel 160 and extends from the distal end face 110 of the sheath 100 to the proximal end face 120. Optionally, the first opening extends axially along the sheath 100. Furthermore, the width of the first opening is designed to be smaller than the outer diameter of the insertion tube of the ultra-fine endoscope, increasing the difficulty for the insertion tube to detach from the first opening from the guidewire guide channel 160.

[0099] In simple terms, because the width of the first opening is smaller than the outer diameter of the insertion tube, this prevents the insertion tube from accidentally slipping out of the first opening, making it easier to control the movement of the insertion tube along the guide wire guide channel 160. Even if accidental movement or pulling occurs during operation, the insertion tube will remain within the guide wire guide channel 160 and will not slip out through the first opening.

[0100] The first opening does not necessarily need to be wider than the outer diameter of the insertion tube. When removing the insertion tube, the flexibility of the sheath 100 can be used to temporarily enlarge the first opening.

[0101] like Figure 8 As shown, in some embodiments, the nipple cutter further includes a head tube 500, which has a head end 510 and a tail end 520. The tail end 520 is detachably connected to the distal end 110 of the sheath 100. The guide wire guide channel 160 communicates with the head tube 500. The outer diameter and inner diameter of the head end 510 gradually decrease in the direction away from the sheath 100. The inner hole of the tail end 520 is of equal diameter. The head tube 500 is configured as a transparent structure.

[0102] In these embodiments, the nipple incision knife also includes a tip tube 500. The outer and inner diameters of the tip 510 of this tip tube 500 gradually decrease in the direction away from the sheath 100, forming a tapered or tapered shape, which facilitates the insertion of the tip tube 500 into the nipple sphincter. The tail end 520 is detachably connected to the distal end 110 of the sheath 100, and the inner hole of the tail end 520 is of equal diameter. The tip tube 500 is designed to be transparent, supporting the nipple sphincter after insertion, creating a cavity within the tip tube 500. This allows the camera at the tip 510 of the ultra-fine endoscope to observe the internal condition of the nipple sphincter, enabling doctors to directly observe and diagnose the internal condition of the nipple sphincter and reduce diagnostic blind spots.

[0103] It should be noted that in order to pass through the duodenal endoscope forceps used as a carrier, the ultra-thin endoscope must possess a certain degree of flexibility; that is, the ultra-thin endoscope will have difficulty advancing when encountering significant resistance. After crossing the duodenal papilla, there are still sphincters anterior to the common bile duct and pancreatic duct, which naturally remain closed. An ultra-thin endoscope without a tapered tip 510 and sufficient axial rigidity cannot pass through the sphincter's inner foramen and may even bend. Therefore, in this application, the papillary incision knife serves as a guiding channel in its intended use. The insertion of the papillary incision knife into the papilla is solely for positioning before papillary incision, guiding the insertion tube of the ultra-thin endoscope into the papillary sphincter.

[0104] The tail end 520 is detachably connected to the distal end 110 of the sheath 100, the head end 510 can better guide the insertion tube of the endoscope and balance the wall thickness of the head end 510 in all directions, and the tail end 520 is used for detachable connection to the distal end 110.

[0105] For example, in this embodiment, the end face of the tail end 520 is aligned and bonded to the end face of the distal end 110, allowing the head end tube 500 to disconnect from the sheath tube 100 after the sheath tube 100 is torn (under force). After tearing the sheath tube 100, the head end tube 500 can disconnect from the sheath tube 100 and remain at the proximal end 120 connector near the insertion tube. Of course, in other embodiments, the head end tube 500 and the sheath tube 100 can be connected using a relatively low-strength connection process such as ultrasonic welding or laser welding, or they can also be connected by adhesive bonding, chemical welding, in-mold injection molding, etc.

[0106] For example, such as Figure 9 As shown, the sidewall of the head tube 500 is provided in the second opening 600. The second opening 600 and the inner hole of the head tube 500 are connected by a tube. The second opening 600 extends from the end face of the head end 510 to the end face of the tail end 520. Therefore, after the head tube 500 and the sheath tube 100 are separated, the insertion tube can be removed from the second opening 600.

[0107] In some embodiments, the nipple cutter further includes a head tube 500, which has a head end 510 and a tail end 520. The tail end 520 is integrated with the distal end 110 of the sheath 100. The guide wire guide channel 160 is connected to the head tube 500. The outer diameter and inner diameter of the head end 510 gradually decrease in the direction away from the sheath 100. The inner hole of the tail end 520 is of equal diameter. The head tube 500 is a transparent structure. The end faces of the two ends of the head tube 500 are respectively located on a preset path.

[0108] In these embodiments, the outer and inner diameters of the tip 510 gradually decrease in the direction away from the sheath 100, forming a tapered or tapered shape. The tail end 520 is integrally formed with the distal end 110 of the sheath 100, and the inner diameter of the tail end 520 is constant. The tip tube 500 is designed to be transparent, allowing the physician to directly observe the external condition of the tip tube 500. The two end faces of the tip tube 500 are located on a predetermined path, meaning that the tip tube 500 can break along the predetermined path under certain conditions, facilitating separation of the tip tube 500 from the insertion tube. The integral formation of the tail end 520 with the sheath 100 reduces connection points and improves the stability and reliability of the overall structure. The gradually decreasing outer and inner diameters of the tip end 510 facilitate smoother entry into the narrow nipple sphincter muscle, reducing tissue damage.

[0109] like Figure 1 and Figure 2 As shown, in some embodiments, the nipple cutter further includes a scalpel 200, and the sheath 100 also has a scalpel channel 150. The outer wall of the sheath 100 is provided with a first hole 130 and a second hole 140 spaced apart in the direction away from the distal end 110, and the first hole 130 and the second hole 140 are respectively connected to the scalpel channel 150. One end of the scalpel 200 passes through the first hole 130 and is fixed to the scalpel channel, and the other end of the scalpel 200 passes through the second hole 140 and the scalpel channel. The portion of the scalpel 200 located between the first hole 130 and the second hole 140 is located outside the sheath 100, and the portion of the scalpel 200 located between the first hole 130 and the second hole 140 is in a relaxed state.

[0110] In these embodiments, the nipple cutter also includes a cutting wire 200, also known as a cutting wire or electro-cutting wire, with a dedicated cutting wire channel 150 provided on the sheath 100. The outer wall of the sheath 100 has a first hole 130 and a second hole 140 spaced apart in a direction away from the distal end 110, and the first hole 130 and the second hole 140 communicate with the cutting wire channel 150, respectively. One end of the cutting wire 200 passes through the first hole 130 and is fixed within the cutting wire channel, while the other end passes through the second hole 140 and the cutting wire channel. The portion of the cutting wire 200 located between the first hole 130 and the second hole 140 is exposed outside the sheath 100 and is in a relaxed state, but can be used for cutting by tightening the cutting wire 200.

[0111] The scalpel wire 200 is used for cutting tissue and is usually made of metal; it can be single-stranded or multi-stranded. The scalpel wire channel 150 is a dedicated channel provided inside the sheath tube 100 for guiding and protecting the scalpel wire 200. The first hole 130 and the second hole 140 are two holes on the outer wall of the sheath tube 100 for leading the scalpel wire 200 out of the sheath tube 100.

[0112] The portion of the scalpel 200 between the first hole 130 and the second hole 140 is in a relaxed state, which facilitates tightening and cutting when needed, thereby reducing mucosal scraping and damage caused by the inability of the scalpel 200 to be elongated when the sheath 100 enters the narrow passage of the nipple sphincter in a straight line.

[0113] In some embodiments, the initial included angle formed between the distal end 110 and the proximal end 120 of the sheath 100 is 0° to 45°.

[0114] In these embodiments, the sheath 100 is pre-formed, with an initial angle between its distal end 110 and proximal end 120 ranging from 0° to 45°. 0° indicates that the distal end 110 and proximal end 120 of the sheath 100 are aligned in a straight line. 45° indicates that the distal end 110 of the sheath 100 has a more pronounced curvature relative to the proximal end 120. Clearly, this configuration adapts to the anatomical structure, facilitating the straight entry of the sheath 100 into the sphincter of Oddi, particularly along the course of the bile duct and pancreatic duct. In other words, an appropriate initial angle helps the sheath 100 enter the target area more smoothly, reducing friction and damage to surrounding tissues.

[0115] For example, in this embodiment, the initial included angle formed between the distal end 110 and the proximal end 120 of the sheath 100 is 0°. Of course, in other embodiments, the initial included angle formed between the distal end 110 and the proximal end 120 of the sheath 100 is 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, etc.

[0116] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not as limitations; therefore, other examples of exemplary embodiments may have different values.

[0117] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0118] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. A nipple incision system, characterized in that, The nipple incision system includes: A nipple incision knife, wherein the nipple incision knife has a guide wire guiding channel; An ultra-thin endoscope, the ultra-thin endoscope having an insertion tube that can pass through the guide wire guide channel and can move along the guide wire guide channel; The nipple cutting knife includes: The sheath has a guide wire guiding channel and has a distal end and a proximal end. The orifice wall of the guide wire guiding channel has a breakable area that extends along a preset path. The end faces of the distal end and the proximal end of the sheath are located on the preset path, so that the breakage of the breakable area can cause the orifice wall of the guide wire guiding channel to form a non-closed structure. The fragile zone is provided with a fracture groove, which extends along the preset path. The sheath has a first tube wall portion and a second tube wall portion, which are arranged sequentially along the circumference of the sheath; wherein, the guide wire guiding channel is formed by the first tube wall portion and the second tube wall portion, the first tube wall portion and the second tube wall portion are detachably connected, and the second tube wall is located in the breakable zone.

2. The nipple incision system according to claim 1, characterized in that, The fracture groove is located on the outer wall of the sheath.

3. The nipple incision system according to claim 2, characterized in that, The number of fracture grooves is multiple, and the multiple fracture grooves are arranged at intervals along the circumference of the sheath.

4. The nipple incision system according to claim 3, characterized in that, The first pipe wall portion is connected to the second pipe wall portion via a connector, the connector comprising at least one of the following: Clips, easy-release adhesive, and safety bolts.

5. The nipple incision system according to claim 4, characterized in that, The first tube wall portion located at the proximal end is provided with a first hand-held component, and the second tube wall portion located at the proximal end is provided with a second hand-held component, and the first hand-held component and the second hand-held component are detachably connected.

6. The nipple incision system according to claim 1, characterized in that, The sheath has a first opening in its wall, which communicates with the guide wire guide channel. The first opening extends from the distal end face of the sheath to the proximal end face, and the width of the first opening is smaller than the outer diameter of the insertion tube.

7. The nipple incision system according to claim 1, characterized in that, The nipple cutting knife also includes: The head end tube has a head end and a tail end, the tail end and the distal end of the sheath tube are detachably connected, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end gradually decrease in the direction away from the sheath tube, the inner hole of the tail end is set with a constant diameter, and the head end tube is set with a transparent structure.

8. The nipple incision system according to claim 1, characterized in that, The nipple cutting knife also includes: The head end tube has a head end and a tail end, the tail end and the distal end of the sheath are integrally formed, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end gradually decrease in the direction away from the sheath tube, the inner hole of the tail end is of equal diameter, and the head end tube is made of transparent structure; wherein, the end faces of the two ends of the head end tube are respectively located on the preset path.

9. The nipple incision system according to claim 8, characterized in that, The nipple cutting knife also includes: The sheath also has a wire channel. The outer wall of the sheath has a first hole and a second hole spaced apart in the direction away from the distal end. The first hole and the second hole are respectively connected to the wire channel. One end of the wire passes through the first hole and is fixed to the wire channel. The other end of the wire passes through the second hole and the wire channel. The portion of the wire located between the first hole and the second hole is located outside the sheath and is in a relaxed state.

10. The nipple incision system according to claim 9, characterized in that, The initial included angle formed between the distal end and the proximal end of the sheath is 0° to 45°.

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