A nipple incision knife and nipple incision system

Abstract

This application provides a nipple incision knife and nipple incision system, relating to the field of endoscopic technology. The nipple incision knife includes a sheath with a guidewire channel and an injection channel. The portion of the guidewire channel near the distal end of the sheath serves as an observation channel, and the distal end of the injection channel near the sheath communicates with the observation channel. The observation channel has an observation section, the sidewalls of which are entirely transparent. The nipple incision knife provided by this application can open up the tissue outside the cavity, forming an observation cavity between the guidewire and the cavity, while also exposing the cavity entrance, facilitating observation using the guidewire.

Description

Technical Field

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

[0002] As imaging modules for acquiring images become increasingly miniaturized, visual guidewires have gradually emerged in the market, replacing traditional X-ray observation with direct visualization. However, visual guidewires require direct visualization to locate and enter the ductal inlet. In particular, the pancreatic duct inlet is often located within the sphincter of Ovum; if only a visual guidewire is inserted, the sphincter cannot be opened, and the pancreatic duct inlet cannot be observed. Utility Model Content

[0003] In view of this, the purpose of this application is to overcome the shortcomings of the prior art and provide a nipple incision knife and nipple incision system that can open up the tissue outside the cavity, that is, form an observation cavity between it and the visual guidewire, and expose the cavity entrance, so that the visual guidewire can be used for observation.

[0004] This application provides the following technical solution:

[0005] This application provides a nipple cutting knife, the nipple cutting knife comprising:

[0006] The sheath has a guidewire channel and an injection channel. The portion of the guidewire channel near the distal end of the sheath is an observation channel, and the end of the injection channel near the distal end of the sheath is connected to the observation channel. The observation channel has an observation section, and the sidewalls of the observation section are all transparent.

[0007] In some embodiments of the first aspect, the wall of the observation section is of equal thickness, the axis of the observation section is set as a straight line, and the head end of the visual guide wire passing through the observation section is coaxially arranged with the observation section.

[0008] In some embodiments of the first aspect, the nipple cutter further includes at least one of the following technical solutions:

[0009] First item: The outer diameter of the observation section is set to be constant;

[0010] Second: The observation segment includes at least two observation sub-segments, which are connected sequentially, and in the direction away from the proximal end of the sheath, the outer diameter of any two adjacent observation sub-segments decreases from large to small.

[0011] In some embodiments of the first aspect, the observation channel has a connecting segment, the distal end of the connecting segment and the proximal end of the observation segment are connected, and the proximal end of the connecting segment is connected to the distal ends of the scalpel channel and the injection channel, respectively; wherein, the connecting segment includes at least two connecting sub-segments, the at least two connecting sub-segments are connected sequentially, and in the direction away from the observation segment, the outer diameter of any two adjacent connecting sub-segments decreases from large to small.

[0012] In some embodiments of the first aspect, the nipple cutter further includes a guide positioning element disposed on the connecting section, the guide positioning element having a positioning hole, the tip of the visual guide wire passing through the positioning hole, the tip of the visual guide wire and the positioning hole being clearance-fitted, and at least one end of the positioning hole facing away from the observation section being provided with a chamfer.

[0013] In some embodiments of the first aspect, the nipple cutter further includes a wire connector, the nipple cutter further includes a wire, the sheath has a distal wire hole, the distal wire hole is disposed in the guide tube, and the distal wire hole and the connecting section are connected in communication; wherein, the distal end of the wire passes through the distal wire hole and is connected to the wire connector.

[0014] In some embodiments of the first aspect, the sheath includes a main tube and a guide tube connected in sequence, the main tube and the guide tube being disposed within the main tube, the portion of the guide tube outside the observation channel being a base channel, the base channel being disposed within the main tube, and the observation channel being disposed within the guide tube.

[0015] In some embodiments of the first aspect, at least one of the main tube and the guide tube is provided with a limiting member, and the other of the main tube and the guide tube is provided with a limiting groove, the limiting member being located within the limiting groove.

[0016] In some embodiments of the first aspect, the nipple cutter further includes at least one of the following technical solutions:

[0017] First item: The limiting member includes a wire connector, the limiting groove includes a wire limiting groove, the inner wall of the guide tube is provided with the wire limiting groove, one end of the wire connector is inserted and fixed to the wire channel, and the other end of the wire connector is located in the wire limiting groove.

[0018] Second item: The limiting component includes a liquid injection connector, the limiting groove includes a liquid injection limiting groove, the inner wall of the guide tube is provided with the liquid injection limiting groove, one end of the liquid injection connector is connected to the far end of the main tube, the other end of the liquid injection connector is located in the liquid injection limiting groove, the liquid injection connector has a through-hole connecting channel, one end of the connecting channel is connected to the observation channel, and the other end is connected to the liquid injection channel;

[0019] Thirdly: The guide tube and the main tube are eccentrically arranged, and the guide tube and the guide wire channel are coaxial or nearly coaxially arranged;

[0020] Fourth item: The cross-section of the guide wire channel of the connecting section is elliptical.

[0021] Secondly, this application also provides a nipple incision system, the nipple incision system including a visual guidewire and a nipple incision knife as described in any of the above embodiments, the visual guidewire being inserted through the guidewire channel.

[0022] The embodiments of this application have the following advantages:

[0023] This application provides a nipple incision scalpel with a completely transparent sidewall of the observation section of the sheath, allowing the physician to directly observe the tissue outside the sheath through this transparent portion. This significantly improves the clarity of observation, especially in complex anatomical structures, such as the pancreatic duct inlet. By configuring the observation channel without any obstructions or blocking components around its periphery, a wide field of view is ensured, reducing blind spots and enabling the physician to comprehensively and accurately assess the target area. Furthermore, injecting saline or other fluids through the injection channel can effectively expand the tissue, exposing important structures such as the pancreatic duct inlet. This not only helps the physician more accurately locate the target area but also reduces the risk of misoperation due to close tissue adhesion.

[0024] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0025] 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.

[0026] Figure 1 This illustration shows a schematic diagram of a nipple incision knife provided in one embodiment of this application from a structural perspective.

[0027] Figure 2This illustration shows a schematic diagram of the guide tube of a nipple cutter according to an embodiment of this application from one perspective;

[0028] Figure 3 This illustration shows a schematic diagram of the guide tube of a nipple cutter according to another embodiment of this application from one perspective;

[0029] Figure 4 This illustration shows a schematic diagram of the guide tube of a nipple cutter according to another embodiment of this application from one perspective.

[0030] Figure 5 This illustration shows a schematic diagram of a nipple incision knife provided in another embodiment of this application from one perspective;

[0031] Figure 6 This illustration shows a structural schematic diagram from another perspective of a nipple incision knife provided in yet another embodiment of this application;

[0032] Figure 7 This illustration shows a structural schematic diagram from yet another perspective of a nipple incision knife provided in another embodiment of this application.

[0033] Explanation of key component symbols:

[0034] 100-Sheath;

[0035] 110 - Guide tube; 111 - Observation section; 112 - Connecting section;

[0036] 120 - Main tube;

[0037] 130 - Guidewire channel; 131 - Basic channel; 132 - Observation channel;

[0038] 140 - Distal cutter hole;

[0039] 150-Cut wire channel;

[0040] 200-Knife wire connector;

[0041] 300-Injection Connection;

[0042] 400-blade wire;

[0043] 500 - Guide positioning element; 510 - Positioning hole. Detailed Implementation

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] In related technologies, the papillary incision knife is a surgical instrument commonly used to incise the duodenal papilla sphincter for endoscopic retrograde cholangiopancreatography (ERCP). Using the echo of contrast agent under X-ray, a guidewire can be guided and inserted to the site requiring treatment, after which other instruments are guided by the guidewire to reach their target locations for various surgical procedures.

[0050] As imaging modules for acquiring images become increasingly miniaturized, visual guidewires have gradually emerged in the market. These guidewires utilize direct visualization instead of traditional X-ray observation, offering the following advantages: 1) They transform two-dimensional X-ray images, which are limited by the patient's anesthetized position and thus the viewing direction, into more intuitive and information-rich three-dimensional images; 2) They allow observation of lesions such as mucosal ulcers that are invisible to X-rays; 3) They eliminate the need for contrast agents. However, visual guidewires require direct visualization to locate and enter the ductal inlets. In particular, the pancreatic duct inlet is often located within the sphincter of Oddi. If only a visual guidewire is inserted, the sphincter cannot be opened, and the pancreatic duct inlet cannot be observed. Furthermore, although the field of view is relatively wide after entering the common bile duct, if the patient has ductal stenosis, it is impossible to observe and enter the sub-lumen.

[0051] like Figure 1 and Figure 2 As shown, in order to solve the above-mentioned technical problems, this application provides a nipple incision knife. The nipple incision knife includes a sheath 100. The sheath 100 has a guide wire channel 130 and an injection channel. The portion of the guide wire channel 130 near the distal end of the sheath 100 is an observation channel 132. The end of the injection channel near the distal end of the sheath 100 is connected to the observation channel 132. The observation channel 132 has an observation section 111. The sidewalls of the observation section 111 are all transparent.

[0052] In these implementations, with the development of imaging technology, especially the miniaturization of imaging modules, a new tool called the visual guidewire has emerged on the market. The visual guidewire allows doctors to directly observe the internal condition without X-ray assistance. However, this technology has limitations when dealing with certain specific locations, such as the pancreatic duct inlet. Because these locations are usually hidden inside the sphincter muscles of the nipple, effective observation and manipulation are difficult to achieve using only the visual guidewire.

[0053] Clearly, this application aims to solve the above-mentioned problems and provide an improved nipple incision knife and system. This system can not only help to open up external tissues and expose the cavity entrance, but also be used in conjunction with a visual guidewire to form a clear observation space, thereby improving the safety and accuracy of the operation.

[0054] The sheath 100, as the main structural component of the entire nipple incision device, has the following characteristics:

[0055] Guidewire channel 130: Used to guide a visual guidewire or other manipulatory tools into the body. The portion of the guidewire channel 130 near the distal end of the sheath 100 is configured as an observation channel 132. The inner diameter of the observation channel 132 is configured to allow the injection channel and the scalpel wire channel 150 to communicate with it. The total inner diameter of the portion of the sheath 100 near the proximal end is larger than the total inner diameter of the portion near the distal end, facilitating the convergence of the guidewire channel 130 and the injection channel. This allows the tip of the visual guidewire to be positioned in the middle of the distal end of the sheath 100. Furthermore, the observation channel 132 has no obstructions or blocking components on its periphery, facilitating observation of tissues outside the sheath 100 by the visual guidewire.

[0056] Injection channel: One end near the distal end of the sheath 100 is connected to the observation section 111, which can inject liquid to expand tissue or clean the field of view.

[0057] Cutting wire channel 150: Used to receive and guide the cutting wire 400 (or cutting wire), enabling it to smoothly reach the target position for necessary cutting operations. A portion of the cutting wire 400 is not located in the cutting wire channel 150, but the distal end of the cutting wire 400 is fixedly connected to the sheath 100. This facilitates bending of the head of the sheath 100 by pulling the cutting wire 400. The cutting wire channel 150 is typically located in the center or on one side of the sheath 100, arranged parallel to the guide wire channel 130 and the injection channel, but remaining independent to avoid mutual interference.

[0058] It is important to note that the observation segment 111 is located in the guidewire channel 130 near the distal end of the sheath 100. Its sidewalls are completely transparent. The observation segment 111 is inserted into the cavity to open the inner wall tissue, allowing the surgeon to directly observe the internal condition using a visual guidewire. When using the nipple incision knife of this application, an appropriate amount of saline or other fluid can be injected into the observation segment 111 through the injection channel to help open the surrounding tissue and expose important structures such as the pancreatic duct inlet. Simultaneously, the transparent observation segment 111, used in conjunction with the visual guidewire, provides the surgeon with clear visual feedback, ensuring the precision and safety of the surgical procedure.

[0059] like Figure 2 and Figure 3 As shown, in some embodiments, the wall thickness of the observation section 111 is set to be the same, the axis of the observation section 111 is set to be a straight line, and the head end of the visible guide wire passing through the observation section 111 is coaxially arranged with the observation section 111.

[0060] In these embodiments, the observation section 111 with uniform wall thickness ensures that the optical performance of the entire transparent area is uniform and consistent, avoiding inconsistent light refraction or reflection caused by uneven wall thickness, thereby improving the clarity and accuracy of observation.

[0061] Furthermore, the uniform wall thickness design simplifies the manufacturing process, reduces production costs, and improves product quality and consistency. The axis of the observation segment 111 is set as a straight line, making the internal space of the entire observation segment 111 more regular, which is conducive to the linear movement of the visual guidewire, reduces bending and twisting, and ensures the stability and accuracy of the guidewire tip. Clearly, the straight-line design facilitates visual calibration, making it easier for doctors to determine the position and direction of the guidewire tip during observation, thus improving the precision of the operation.

[0062] Furthermore, the tip of the visual guidewire and the observation segment 111 are coaxially positioned, ensuring that the tip of the visual guidewire is always centered in the observation segment 111. This minimizes blind spots and improves the comprehensiveness and clarity of observation. Additionally, the coaxial design allows the surgeon to more intuitively control the movement of the guidewire during the procedure, reducing operational difficulty and improving surgical efficiency and safety.

[0063] For example, the observation segment 111 and the tip of the visual guidewire are fitted with a clearance to control their coaxiality. Of course, in other embodiments, the observation segment 111 is provided with a stepped hole, and the small-diameter end of the observation segment 111 and the tip of the visual guidewire are fitted with a clearance, so that the external situation can be observed through the side wall of the large-diameter end of the stepped hole by the tip of the visual guidewire.

[0064] like Figure 2 As shown, in some embodiments, the outer diameter of the observation segment 111 is set to be constant.

[0065] In these embodiments, the outer diameter of the observation segment 111 remains consistent throughout its length, ensuring that the outer surface of the entire observation segment 111 is smooth and uniform. The constant outer diameter design ensures uniform light distribution inside the observation segment 111, avoiding inconsistent light refraction or reflection caused by inconsistent outer diameters, thereby improving the clarity and accuracy of observation.

[0066] Furthermore, the smooth and uniform outer surface reduces friction and interference with surrounding tissues, making the observation segment 111 easier to insert and move, thus reducing tissue damage and enhancing operational stability. Additionally, the equal-diameter design makes the observation segment 111 more stable during insertion and movement, reducing wobbling and deviation, and ensuring the guidewire tip remains in the intended position.

[0067] For example, the portion of the sheath 100 located in the observation section 111 is configured as a straight section. Optionally, the outer diameter of the portion of the sheath 100 located in the observation section 111 is smaller than the outer diameter of the portion of the sheath 100 located outside the observation section 111, which facilitates the insertion of the distal end of the sheath 100 into the nipple sphincter.

[0068] like Figure 3As shown, in some embodiments, the observation segment 111 includes at least two observation sub-segments connected in sequence, and in the direction away from the proximal end of the sheath 100, the outer diameter of any two adjacent observation sub-segments decreases from large to small.

[0069] In these embodiments, the observation segment 111 of the nipple incision knife has been further optimized to improve the flexibility of insertion and operation. Specifically, the outer diameter of the observation segment gradually decreases from the proximal end to the distal end. This design makes the observation segment 111 more flexible during insertion and allows it to pass more easily through narrow or tortuous cavities.

[0070] Furthermore, the gradient outer diameter design reduces the contact area with the inner wall of the cavity, thereby reducing resistance during insertion and movement, making the operation smoother.

[0071] Furthermore, although the outer diameter gradually decreases, the sidewalls of each observation segment remain transparent and of uniform thickness, ensuring uniform light distribution and maintaining the clarity of observation.

[0072] like Figure 2 and Figure 3 As shown, in some embodiments, the guide tube 110 has a connecting section 112, the distal end of the connecting section 112 is connected to the proximal end of the observation section 111, and the proximal end of the connecting section 112 is connected to the distal ends of the scalpel channel 150 and the injection channel, respectively; wherein, the connecting section 112 includes at least two connecting sub-segments, the at least two connecting sub-segments are connected sequentially, and in the direction away from the observation section 111, the outer diameter of any two adjacent connecting sub-segments decreases from large to small.

[0073] In these embodiments, the structure of the nipple incision knife has been further optimized, particularly the design of the connecting segment 112 of the observation channel 132. The specific benefits of this design are as follows:

[0074] In this embodiment, the guide tube 110 also includes a fixing section. From the fixing section to the connecting section 112 and then to the observation section 111, the outer diameter gradually decreases. This design makes the entire device more flexible during insertion and allows it to pass more easily through narrow or winding cavities. The gradual outer diameter design reduces the contact area with the inner wall of the cavity, thereby reducing resistance during insertion and movement, making the operation smoother. Furthermore, the inner diameter of the observation channel 132 is also set to gradually decrease in the same direction to facilitate the guidance of the liquid entering the injection channel and the tip of the visual guidewire into the observation section 111. It can be understood that the outer diameter of the portion of the sheath 100 located in the observation channel 132 gradually decreases.

[0075] Although the outer diameter gradually decreases, the sidewalls of each connecting segment remain transparent, ensuring uniform light distribution and maintaining clear observation. From the fixed segment to the connecting segment 112 and then to the observation segment 111, the outer diameter gradually decreases, allowing the entire device to gradually adapt to the shape of the cavity during insertion, reducing sudden resistance or jamming and improving operational stability.

[0076] For example, the connecting segment 112 is configured as a tapered structure, that is, the inner diameter of the connecting segment 112 gradually decreases in the direction away from the proximal end of the sheath 100. Of course, the number of connecting segments can be 2, 3, 4, 5 or 6, etc.

[0077] like Figure 3 As shown, in some embodiments, the nipple cutting knife also includes a guide positioning member 500, which is disposed in the fixed section. The guide positioning member 500 has a positioning hole 510, and the tip of the visible guide wire passes through the positioning hole 510. The tip of the visible guide wire and the positioning hole 510 are in clearance fit, and at least one end of the positioning hole 510 facing away from the observation section 111 is provided with a chamfer.

[0078] In these embodiments, the positioning hole 510 on the guide positioning member 500 can precisely guide the tip of the visible guidewire, ensuring that the tip of the guidewire is always in the expected position, thus improving the accuracy of the operation. The clearance fit between the tip of the visible guidewire and the positioning hole 510 ensures the free movement of the guidewire while avoiding excessive shaking, thus ensuring the stability and accuracy of the guidewire.

[0079] In other words, the positioning hole 510 of the guide positioning element 500 can fix the tip of the visual guidewire, reducing the offset and shaking of the tip of the visual guidewire during insertion and movement. Furthermore, the stable position of the tip of the visual guidewire allows the doctor to observe the target area more clearly, reducing misjudgments caused by inaccurate guidewire positioning.

[0080] The positioning hole 510 has a chamfer at least at one end away from the observation section 111, which makes it easier for the guide wire tip to enter the positioning hole 510, reduces the resistance during insertion, and improves the flexibility of insertion.

[0081] For example, the guide positioning element 500 is set as a positioning ring with a circular cross-section, and the positioning ring and the fixing section are bonded or interference-fitted.

[0082] like Figures 1 to 3 As shown, in some embodiments, the nipple cutter further includes a wire connector 200, and the nipple cutter also includes a wire 400. The sheath 100 has a distal wire 400 hole, which is disposed in the guide tube 110 and is connected to the fixing section. The distal end of the wire 400 passes through the distal wire hole 140 and is connected to the wire connector 200.

[0083] In these embodiments, the distal end of the scalpel wire 400 is connected to the scalpel wire connector 200 through a distal scalpel wire 400 hole, ensuring the stability and reliability of the scalpel wire 400 during operation and reducing the risk of the scalpel wire 400 falling off. The scalpel wire connector 200 provides a stable connection point, allowing doctors to more precisely control the movement and cutting operation of the scalpel wire 400.

[0084] It should be noted that the closer the starting position of the scalpel wire 400 is to the tip, the less depth the nipple cutter needs to penetrate the nipple for normal cutting, thus increasing flexibility. Therefore, the distal scalpel wire hole 140 needs to be located in the fixed section to reduce the distance between the starting position of the scalpel wire 400 and the tip of the sheath tube 100, thereby improving flexibility. Furthermore, setting it in the fixed section avoids interference with the field of view of the observation section 111.

[0085] like Figure 1 As shown, in some embodiments, the sheath 100 includes a main tube 120 and a guide tube 110, which are connected in sequence. The scalpel channel 150 and the injection channel are disposed within the main tube 120. The portion of the guide wire channel 130 located outside the observation channel 132 and the third segment is a basic channel 131, which is disposed within the main tube 120. The observation channel 132 is disposed within the guide tube 110.

[0086] In these embodiments, the sheath 100 of this application adopts a segmented design, namely, the segmented design of the main tube 120 and the guide tube 110 makes the layout of each functional channel more reasonable, and each part can focus on its specific function, improving the overall design rationality. Among them, the main tube 120 is mainly responsible for accommodating the basic channel 131, the blade channel 150 and the injection channel, while the guide tube 110 focuses on the observation channel 132, making the function of each part more clear and focused.

[0087] The wire channel 150 and the liquid injection channel within the main tube 120 are independently set to avoid mutual interference, making the operation more flexible and precise. The guide tube 110 is specially equipped with an observation channel 132 on the guide wire channel 130, which ensures the transparency and optical performance of the observation section 111 and improves the clarity and stability of the observation.

[0088] It should be noted that the distal ends of the guidewire channel 130 and the injection channel converge at the observation channel 132. That is, a portion of the guidewire channel 130 near the distal end is located within the guide tube 110, and another portion of the guidewire channel 130 near the proximal end is located within the main tube 120.

[0089] Obviously, this setup helps reduce the difficulty of production and processing. In other words, by processing the guide tube 110 and the main tube 120 separately, the guide tube 110 only needs to be processed to form the observation channel 132, and the main tube 120 only needs to be processed to form the guide wire channel 130, the cutter wire channel 150, and the liquid injection channel. Subsequently, the proximal end face of the guide tube 110 and the distal end face of the main tube 120 can be bonded together.

[0090] like Figure 1 and Figure 4 As shown, in some embodiments, one of the main tube 120 and the guide tube 110 is provided with a limiting member, which is located in both the main tube 120 and the guide tube 110. The other of the main tube 120 and the guide tube 110 is provided with a limiting groove, and the limiting member is located in the limiting groove.

[0091] In these embodiments, the connection structure of the nipple cutter has been further optimized. By introducing limiting elements and limiting grooves, a stable connection and precise alignment between the main tube 120 and the guide tube 110 are ensured, reducing the risk of loosening and separation at the connection point.

[0092] Clearly, the cooperation between the limiting component and the limiting groove can resist torsional forces, ensuring that rotation or misalignment will not occur during operation, thus improving the stability of the overall structure. The design of the limiting component and the limiting groove ensures that the main tube 120 and the guide tube 110 can be precisely aligned during connection, avoiding functional failure or connection alignment difficulties caused by poor alignment.

[0093] Furthermore, the manufacturing process has been simplified, and production efficiency has been improved. Doctors or technicians can quickly and accurately connect the main tube 120 and the guide tube 110.

[0094] For example, the limiting groove is an open groove provided on the inner wall of the guide tube 110, such as an arc groove, a V-shaped groove, etc. Of course, the limiting groove can also be a hole structure opened on the end face of the guide tube 110.

[0095] For example, the limiting element is cylindrical or cylindrical to mate with the arc-shaped groove, improving positioning accuracy. Alternatively, the limiting state can be set as a triangle to mate with the V-shaped groove.

[0096] Optionally, the limiting member and the limiting groove can be configured as a snap-fit ​​or interference fit. Alternatively, the limiting member and the limiting groove can be bonded together, etc.

[0097] like Figure 4 As shown, in some embodiments, the limiting member includes a wire connector 200, the limiting groove includes a wire 400 limiting groove, the inner wall of the guide tube 110 is provided with a wire 400 limiting groove, one end of the wire connector 200 is inserted and fixed to the wire channel 150, and the other end of the wire connector 200 is located in the wire 400 limiting groove.

[0098] In these embodiments, by designing the limiting member as a wire connector 200 and providing a wire 400 limiting groove on the inner wall of the guide tube 110, the stability and precise control of the wire 400 are ensured.

[0099] One end of the wire connector 200 is fixed to the wire channel 150, ensuring a stable connection of the wire 400 and reducing the shaking and deviation of the wire 400 during operation. Using the wire connector as a limiting element helps reduce the overall number of parts. The other end of the wire connector 200 is located within the limiting groove of the wire 400, further restricting the movement range of the wire 400 and ensuring its stability and precise control.

[0100] Clearly, the design of the wire connector 200 and the wire 400 limiting groove ensures a secure connection between the main tube 120 and the guide tube 110, reducing the risk of loosening and separation at the connection point. The limiting groove design can resist torsional forces, ensuring that rotation or misalignment will not occur during operation.

[0101] Furthermore, the cutting wire connector 200 forms a limiting element, meaning that the cutting wire connector 200 is at least partially located inside the guide tube 110, which helps to shorten the distance between the cutting wire 400 and the distal end face of the sheath tube 100, thereby improving the flexibility of the nipple cutter.

[0102] like Figure 4 As shown, in some embodiments, the limiting member includes an injection connector 300, the limiting groove includes an injection limiting groove, the inner wall of the guide tube 110 is provided with the injection limiting groove, one end of the injection connector 300 is connected to the far end of the main tube, the other end of the injection connector 300 is located in the injection limiting groove, the injection connector 300 has a through-hole, one end of the through-hole is connected to the observation channel 132, and the other end is connected to the injection channel.

[0103] In these embodiments, as described above, one end of the injection connector 300 is fixed to the distal end of the main tube 120, and the other end is located within the injection limiting groove, ensuring a stable connection between the injection channel and the observation channel 132 and reducing the risk of loosening and separation at the connection point. The design of the injection limiting groove can resist torsional forces, ensuring that rotation or misalignment will not occur during operation, thus improving the stability of the overall structure.

[0104] The fit between the injection connector 300 and the injection limiting groove ensures precise alignment between the injection channel and the observation channel 132, preventing injection blockage or leakage due to misalignment. The design of the transfer channel allows the injection fluid to be evenly delivered from the injection channel to the observation channel 132, ensuring uniform distribution and improving the injection effect.

[0105] Additionally, when water pressure is insufficient, it makes the liquid easier to eject rather than flow arbitrarily (or even backflow). This is achieved through two main mechanisms: first, utilizing the Coanda effect to improve the direction of flow while simultaneously lengthening the flow path of the narrow tube, bringing the opening of the narrow tube closer to the distal end; and second, increasing the pressure, making it easier to eject, since the tube has a certain thickness.

[0106] like Figure 5 and Figure 6 As shown, in some embodiments, the guide tube 110 and the main tube 120 are eccentrically arranged, and the guide tube 110 and the basic channel 131 are coaxial or nearly coaxially arranged.

[0107] In these embodiments, due to process limitations, if the observation section 111 through which the visual guide wire is inserted and the base channel 131 are not concentric, the tip of the visual guide wire is rigid, and the resulting axial offset will prevent the visual guide wire from passing through the observation section 111. Therefore, the guide tube 110 and the main tube 120 are eccentrically arranged, and the guide tube 110 and the guide wire channel 130 are coaxial or nearly coaxial.

[0108] like Figure 7 As shown, in some embodiments, the cross-section of the guide wire channel of the connecting segment is elliptical.

[0109] In these embodiments, the guide wire channel 130 of the nipple cutter contains a visible guide wire. The visible guide wire sometimes exits the sheath 100 via an opening groove on the side of the sheath 100. This opening groove creates a non-closed structure in the guide wire channel 130. However, exiting is an active action; the guide wire does not exit during normal use. This requires that the gap between the two not be too large, and some restraint is necessary. However, if the restraint is too large, it will be difficult to exit or may damage the visible guide wire. Therefore, compared to a fully enclosed circular cross-section, an elliptical cross-section provides both restraint and a larger gap.

[0110] In some embodiments, this application also provides a nipple incision system, which includes a visual guidewire and a nipple incision knife as described in any of the above embodiments, wherein the visual guidewire is inserted through the guidewire channel 130.

[0111] Since the aforementioned nipple incision knife has the aforementioned technical effects, the nipple incision system including the aforementioned nipple incision knife should have the same technical effects, which will not be elaborated here.

[0112] 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.

[0113] 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.

[0114] 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 cutting knife characterized by, The nipple cutting knife includes: The sheath has a guidewire channel and an injection channel. The portion of the guidewire channel near the distal end of the sheath is an observation channel, and the end of the injection channel near the distal end of the sheath is connected to the observation channel. The observation channel has an observation section, and the sidewalls of the observation section are all transparent.

2. The nipple cutting lance according to claim 1, characterized in that The observation section has a uniform wall thickness, and its axis is set as a straight line. The head end of the visual guide wire passing through the observation section is coaxial with the observation section.

3. The nipple cutting lance according to claim 2, characterized in that The nipple cutting knife further includes at least one of the following technical solutions: First item: The outer diameter of the observation section is set to be constant; Second: The observation segment includes at least two observation sub-segments, which are connected sequentially, and in the direction away from the proximal end of the sheath, the outer diameter of any two adjacent observation sub-segments decreases from large to small.

4. The nipple cutting lance according to claim 3, characterized in that The observation channel has a connecting section, the distal end of the connecting section and the proximal end of the observation section are connected, and the proximal end of the connecting section is connected to the distal ends of the scalpel channel and the injection channel respectively; wherein, the connecting section includes at least two connecting sub-segments, the at least two connecting sub-segments are connected sequentially, and in the direction away from the observation section, the outer diameter of any two adjacent connecting sub-segments decreases from large to small.

5. The nipple cutting lance according to claim 4, characterized in that The nipple cutting knife also includes a guide positioning component, which is disposed on the connecting section. The guide positioning component has a positioning hole, and the tip of the visual guide wire passes through the positioning hole. The tip of the visual guide wire and the positioning hole are in clearance fit, and at least one end of the positioning hole facing away from the observation section is provided with a chamfer.

6. The nipple incision knife according to claim 4, characterized in that, The sheath includes a main tube and a guide tube, which are connected in sequence. The wire channel and the injection channel are located inside the main tube. The portion of the wire channel outside the observation channel is a basic channel, which is located inside the main tube. The observation channel is located in the guide tube.

7. The nipple incision knife according to claim 6, characterized in that, The nipple cutting knife also includes a wire connector, and the nipple cutting knife also includes a wire. The sheath has a distal wire hole, which is located in the guide tube and is connected to the connecting section. The distal end of the wire passes through the distal wire hole and is connected to the wire connector.

8. The nipple incision knife according to claim 7, characterized in that, At least one of the main tube and the guide tube is provided with a limiting member, and the other of the main tube and the guide tube is provided with a limiting groove, with the limiting member located within the limiting groove.

9. The nipple incision knife according to claim 8, characterized in that, The nipple cutting knife further includes at least one of the following technical solutions: First item: The limiting member includes a wire connector, the limiting groove includes a wire limiting groove, the inner wall of the guide tube is provided with the wire limiting groove, one end of the wire connector is inserted and fixed to the wire channel, and the other end of the wire connector is located in the wire limiting groove. Second item: The limiting component includes a liquid injection connector, the limiting groove includes a liquid injection limiting groove, the inner wall of the guide tube is provided with the liquid injection limiting groove, one end of the liquid injection connector is connected to the far end of the main tube, the other end of the liquid injection connector is located in the liquid injection limiting groove, the liquid injection connector has a through-hole connecting channel, one end of the connecting channel is connected to the observation channel, and the other end is connected to the liquid injection channel; Thirdly: The guide tube and the main tube are eccentrically arranged, and the guide tube and the guide wire channel are coaxial or nearly coaxially arranged; Fourth item: The cross-section of the guide wire channel of the connecting section is elliptical.

10. A nipple incision system, characterized in that, The nipple incision system includes a visual guidewire and a nipple incision knife as described in any one of claims 1 to 9, wherein the visual guidewire passes through the guidewire channel.

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