A nipple knife and a nipple cutting system

Abstract

The application provides a nipple incision knife and a nipple incision system, and relates to the technical field of endoscopy. The nipple incision knife comprises a sheath tube, the sheath tube has a guide wire guide channel, a knife wire channel, a distal end and a proximal end, the hole wall of the part close to the distal end of the guide wire guide channel has a first opening, the first opening penetrates the hole wall of the side of the guide wire guide channel away from the knife wire channel, and the size of the first opening is configured to be capable of allowing the head end of the visual guide wire to pass through. The nipple incision knife provided by the application can make the separation of the nipple incision knife and the visual guide wire not be restricted by the proximal connector, is convenient to operate and has high working efficiency.

Description

Technical Field

[0001] The present application relates to the technical field of endoscopes, and in particular to a papillomatomy knife and a papillomatomy system. Background Art

[0002] Biliary and pancreatic diseases are common clinical diseases, among which endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP), is a common method. With the emergence of visual guidewires, the difficulty of ERCP surgery can be reduced by applying visual guidewires to ERCP surgery. However, in the surgery to remove stones or polyps in the body, since the proximal end of the visual guidewire has a proximal connector, the size of the proximal connector is larger than the inner diameter of the papillotomy knife, and during the operation, the visual guidewire is left motionless, and the papillotomy knife is separated and removed from the visual guidewire, which obviously has the problem of being inconvenient to remove the papillotomy knife from the visual guidewire. Summary of the Invention

[0003] In view of this, the purpose of this application is to overcome the deficiencies in the prior art and to provide a nipple cutter and a nipple cutter system that can separate the nipple cutter and the visual guidewire without being restricted by the proximal connector, making operation convenient and work efficiency high.

[0004] This application provides the following technical solutions:

[0005] The present invention provides a nipple cutter, which comprises:

[0006] The sheath has a guide wire guide channel, a knife wire channel, a distal end and a proximal end. The hole wall of the guide wire guide channel near the distal end has a first opening. The first opening penetrates the hole wall of the guide wire guide channel on the side away from the knife wire channel. The size of the first opening is configured to allow the head end of the visual guide wire to pass through.

[0007] In some embodiments of the first aspect, the first opening extends to the end face of the distal end, and in the extension direction of the first opening, the first opening has a first section and a second section, the first section is far away from the distal end, and the second section is close to the distal end, the size of the first section is configured to allow the tip end of the visual guidewire to pass through, and the size of the second section is configured to limit the passage of the tip end of the visual guidewire.

[0008] In some embodiments of the first aspect, a portion of the sheath tube near the head end is an insertion section, and the insertion section can be entirely disposed within the papillary sphincter. The insertion section has an axial length L1 of the sheath tube, and a length L2 of the first opening in the axial direction of the sheath tube, and the following conditions are satisfied: L1>L2;

[0009] Alternatively, the sheath tube further has a liquid guiding channel, and the liquid guiding channel is extended along the axial direction of the sheath tube.

[0010] In some embodiments of the first aspect, the hole wall of the guidewire guide channel close to the proximal end has a second opening, and the second opening passes through the hole wall of the guidewire guide channel on the side away from the knife wire channel; wherein the width of the second opening is smaller than the outer diameter of the visible guidewire, and the two opposite side walls of the second opening are configured as elastic structures, and the elastic deformation of the side walls of the second opening enables the head end of the visible guidewire to pass through the second opening.

[0011] In some embodiments of the first aspect, the nipple cutter further includes a limiting member having two ends, one end of the limiting member is connected to the side wall on one side of the second opening, and the other end of the limiting member is connected to the side wall on the other side of the second opening, and the portion of the limiting member located at the second opening is set as a breakable zone, and the breaking of the breakable zone can separate the two ends of the limiting member.

[0012] In some embodiments of the first aspect, the second opening and the first opening are connected to each other, and the second opening and the first opening extend along the same busbar on the sheath; the width of the first opening is smaller than the outer diameter of the visual guidewire, and the two opposite side walls of the first opening are configured as elastic structures, and the elastic deformation of the side walls of the first opening enables the head end of the visual guidewire to pass through the first opening.

[0013] In some embodiments of the first aspect, the nipple cutter also includes an electric heating wire, the two ends of the limit member are respectively a fuse end and a fixed end, the fuse end has a first part and a second part, the first part is away from the fixed end, the second part is close to the fixed end, the first part is connected to the side wall of one side of the second opening, and the fixed end is connected to the side wall of the other side of the first opening; wherein, the electric heating wire is connected to the sheath tube, the electric heating wire abuts against the second part, the second part is configured to be able to be heated and melted, and the melting point of the second part is lower than the melting point of the sheath tube.

[0014] In some embodiments of the first aspect, the inner wall of the first part and one side of the second opening are connected, and the inner wall of the sheath tube connected to the first part is provided with a wire groove, the wire groove is extended along the axial direction of the sheath tube, and the electric heating wire is provided in the wire groove.

[0015] In some embodiments of the first aspect, the papillomatomy knife further includes a cutting wire, a cutting power supply and a fuse power supply, the electric heating wire and the guide wire are connected to one end of the distal end of the sheath, the cutting wire and the cutting power supply are electrically connected, and the electric heating wire is electrically connected to the fuse power supply through the guide wire.

[0016] In some embodiments of the first aspect, the limiting member is a flexible or elastic plastic band.

[0017] In a second aspect, the present application further provides a nipple incision system, which includes a nipple incision knife as described in any one of the above embodiments.

[0018] The embodiments of the present application have the following advantages:

[0019] The present application provides a papillotomy system, which requires the sheath to be connected to the visual guidewire in vitro before performing an inspection or operation, that is, the head end of the visual guidewire is inserted into the guidewire guide channel from the first opening, that is, the radial movement of the sheath is completely limited, and the sheath can be controlled to move along the visual guidewire. When the visual guidewire is installed on the sheath, the visual guidewire is partially located in the guidewire guide channel within most of the axial range of the sheath. When it is necessary to keep the visual guidewire in the target cavity (i.e., the nipple sphincter) but to withdraw the sheath, the operator limits the axial movement of the visual guidewire outside the patient's body and simultaneously pushes the sheath forward (i.e., toward the distal end) so that the first opening exceeds the head end of the visual guidewire, that is, the visual guidewire is detached from the sheath. At this point, the visual guidewire is not subjected to force or limited in the radial direction, and the separation can be completed by directly pulling out the sheath.

[0020] Obviously, the above design allows the doctor to easily remove the papillotomy knife from the guide wire without moving the visual guide wire, without interference from the proximal connector, thus solving the problem of inconvenience caused by the oversized proximal connector of the visual guide wire. In other words, the separation process between the papillotomy knife and the visual guide wire is simplified, reducing unnecessary complex steps during the operation. Furthermore, this design enables the papillotomy knife to be better used with different types of visual guide wires or other contents, increasing its wide range of application scenarios.

[0021] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0023] Figure 1 A schematic structural diagram of a papillomatomy knife provided in the first embodiment of the present application is shown from one perspective;

[0024] Figure 2 A schematic structural diagram of a papillomatomy knife provided in the first embodiment of the present application from another perspective is shown;

[0025] Figure 3 Shown Figure 1 Middle AA cross-sectional view;

[0026] Figure 4 A schematic structural diagram of a papillomatomy knife provided in Example 2 of the present application from one perspective is shown;

[0027] Figure 5 Shown Figure 4 Schematic diagram of the BB cutaway;

[0028] Figure 6 A schematic structural diagram of a papillomatomy knife provided in Example 3 of the present application from one perspective is shown;

[0029] Figure 7 A schematic structural diagram of a papillomatomy knife provided in Example 4 of the present application from one perspective is shown;

[0030] Figure 8 A structural schematic diagram of a papillomatomy knife provided in Example 5 of the present application is shown from one perspective.

[0031] Description of main component symbols:

[0032] 100-sheath; 110-first opening; 111-second section; 112-first section; 120-guidewire guide channel; 130-liquid guide channel; 140-blade wire channel; 150-second opening; 200-blade wire; 300-limiting member; 400-electric heating wire. DETAILED DESCRIPTION

[0033] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0034] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. Conversely, when an element is referred to as being "directly on" another element, there is no intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only.

[0035] In this application, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components or interactions between two components. Those skilled in the art will understand the specific meanings of these terms in this application based on specific circumstances.

[0036] 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 the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application belongs. The terms used in the template description herein are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0038] In the related art, biliary and pancreatic diseases are common clinical diseases, among which endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP) is a common means. With the emergence of visual guidewires, the difficulty of ERCP surgery can be reduced by applying visual guidewires to ERCP surgery. However, in the surgery to remove stones or polyps in the body, since the proximal end of the visual guidewire has a proximal connector, the size of the proximal connector is larger than the inner diameter of the papillotomy knife, and during the operation, the visual guidewire is left motionless, and the papillotomy knife is separated and removed from the visual guidewire. Obviously, there is a problem that it is inconvenient to remove the papillotomy knife from the visual guidewire.

[0039] like Figure 1 、 Figure 2 and Figure 3 As shown, in order to solve the above technical problems, an embodiment of the present application provides a papillomatomy knife, which includes a sheath 100. The sheath 100 has a guide wire guide channel 120, a knife wire channel 140, a distal end and a proximal end. The hole wall of the guide wire guide channel 120 near the distal end has a first opening 110. The first opening 110 penetrates the hole wall of the guide wire guide channel 120 on the side away from the knife wire channel 140. The size of the first opening 110 is configured to allow the tip end of the visible guide wire to pass through.

[0040] In these embodiments, the present application provides an improved papillotomy design that aims to solve the technical problems encountered when using a visual guidewire during endoscopic retrograde cholangiopancreatography (ERCP). In traditional designs, when a papillotomy is needed to treat problems such as stones or polyps in the body, the presence of a large connector at the proximal end of the visual guidewire makes it difficult to remove the papillotomy from the visual guidewire. To solve this problem, the present application proposes a new papillotomy design.

[0041] The papillary incision tool in the new design has a specially constructed sheath 100. This sheath 100 not only has a guide wire guide channel 120 for guiding the guide wire through, but also a knife wire channel 140 for cutting. Among them, the key is that a first opening 110 is provided near the distal end of the sheath 100. The special thing about this first opening 110 is that it passes through the hole wall of the guide wire guide channel 120 away from the knife wire channel 140, that is, the guide wire guide channel 120 can be connected to the outside world through the first opening 110, and its size has been carefully designed to ensure that the head end of the visual guide wire can pass smoothly. It should be noted that the visual guide wire can also be an ultra-thin endoscope.

[0042] For example, if the first opening 110 is a circular hole, the inner diameter of the first opening 110 is larger than the outer diameter of the tip of the visual guidewire. Of course, in other embodiments, the first opening 110 can also be configured as a square hole, an elliptical hole, an irregular hole, a triangular hole, etc., which are not specifically limited here. It is only necessary to ensure that the minimum width of the first opening 110 is larger than the outer diameter of the tip of the visual guidewire. Obviously, the above configuration can ensure that the tip of the visual guidewire can enter and exit the guidewire guide channel 120 from the first opening 110.

[0043] Before performing an examination or operation, the sheath 100 needs to be connected to the visual guidewire in vitro, that is, the head end of the visual guidewire is inserted into the guidewire guide channel 120 from the first opening 110, that is, the radial movement of the sheath 100 is completely limited, and the sheath 100 can be controlled to move along the visual guidewire. When the visual guidewire is installed on the sheath 100, the visual guidewire is partially located in the guidewire guide channel 120 within most of the axial range of the sheath 100. When it is necessary to keep the visual guidewire in the target cavity (i.e., the nipple sphincter) but to withdraw the sheath 100, the operator limits the axial movement of the visual guidewire outside the patient's body and pushes the sheath 100 forward (i.e., toward the distal end) at the same time so that the first opening 110 exceeds the head end of the visual guidewire, that is, the visual guidewire is detached from the sheath 100. At this time, the visual guidewire is not subjected to force or limited in the radial direction, and the separation can be completed by directly pulling out the sheath 100.

[0044] Obviously, the above design allows the doctor to easily remove the papillotomy knife from the guide wire without moving the visual guide wire, without interference from the proximal connector, thus solving the problem of inconvenience caused by the oversized proximal connector of the visual guide wire. In other words, the separation process between the papillotomy knife and the visual guide wire is simplified, reducing unnecessary complex steps during the operation. Furthermore, this design enables the papillotomy knife to be better used with different types of visual guide wires or other contents, increasing its wide range of application scenarios.

[0045] like Figure 1 As shown, in some embodiments, the first opening 110 extends to the end face of the distal end. In the extension direction of the first opening 110, the first opening 110 has a first section 112 and a second section 111. The first section 112 is far away from the distal end, and the second section 111 is close to the distal end. The size of the first section 112 is configured to allow the tip end of the visual guidewire to pass through, and the size of the second section 111 is configured to limit the passage of the tip end of the visual guidewire.

[0046] In these embodiments, the design of the first opening 110 is further refined to provide more precise control and convenient operation. Specifically, the first opening 110 is divided into two sections along the extension direction:

[0047] The first section 112 is located away from the distal end and is configured to be sized to allow the tip of a visual guidewire to pass through. The function of this section is to ensure that the visual guidewire can smoothly enter the guidewire guide channel 120 from the outside.

[0048] For example, if the first section 112 is a circular hole, the inner diameter of the first section 112 is larger than the outer diameter of the tip of the visual guidewire. Of course, in other embodiments, the first section 112 can also be configured as a square hole, an elliptical hole, an irregular hole, a triangular hole, etc., and there is no specific limitation here. It is only necessary to ensure that the minimum width of the first section 112 is larger than the outer diameter of the tip of the visual guidewire.

[0049] Second section 111: Located near the distal end of the sheath 100, second section 111 is sized to restrict the passage of the guidewire tip. The purpose of second section 111 is to prevent the guidewire tip from completely sliding out of the sheath 100, thereby maintaining the guidewire's ability to move along the guidewire guide channel 120 within the sheath 100. Simply put, the design of second section 111 effectively confines the guidewire tip within the sheath 100, preventing it from accidentally sliding out, particularly during a surgical procedure where the guidewire needs to remain fixed in place.

[0050] Exemplarily, the size of the second section 111 is smaller than the outer diameter of the head end of the visual guide wire, limiting the passage of the guide wire head. For example, the width of the second section 111 is smaller than the outer diameter of the visual guide wire.

[0051] Illustratively, the first opening 110 is extended along the axial direction of the sheath tube 100 .

[0052] When the papillotomy knife needs to be removed, the sheath 100 can be easily separated by simply pushing the first section 112 forward so that the first section 112 exceeds the head of the visual guide wire. At the same time, the presence of the second section 111 ensures that the guide wire will not easily slip out, providing additional safety.

[0053] For ease of understanding, the guidewire guide channel 120 is used to guide the visual guidewire through. The knife wire channel 140 is used to place a cutting tool. The first opening 110 penetrates the side wall of the guidewire guide channel 120 away from the knife wire channel 140 and extends to the distal end face of the sheath tube 100.

[0054] Before surgery, the tip of the visual guidewire is inserted through the first section 112 of the first opening 110 and into the guidewire guide channel 120. The ERCP procedure is performed using the visual guidewire, while the papillotomy is used to perform necessary incisions. When the papillotomy needs to be removed while maintaining the visual guidewire in place, the visual guidewire is secured and the sheath 100 is pushed forward, allowing the first section 112 of the first opening 110 to pass over the tip of the visual guidewire, thereby allowing the tip of the visual guidewire to exit the guidewire guide channel 120. The sheath 100 is then withdrawn, completing the separation process.

[0055] It should be noted that the sheath 100 has a certain elastic deformation ability. By extending the first opening 110 to the distal end face, the outer side of the distal end of the sheath 100 is squeezed, the first opening 110 shrinks, and the outer diameter of the distal end of the sheath 100 becomes smaller, thereby improving the insertion performance of the sheath 100.

[0056] like Figure 1 As shown, in some embodiments, the portion of the sheath 100 close to the head end is the insertion section, and the insertion section can be completely inserted into the nipple sphincter. The axial length of the insertion section in the sheath 100 is L1, and the axial length of the first opening 110 in the sheath 100 is L2, and it satisfies: L1>L2.

[0057] These embodiments aim to solve the technical problem of liquid leakage caused by the first opening 110 provided at the distal end when liquid is transported through the guide wire guide channel 120 .

[0058] Specifically, the portion of the sheath 100 near the tip is defined as the insertion segment, which is capable of being completely inserted into the papillary sphincter. The length L1 of the insertion segment is greater than the axial length L2 of the first opening 110 of the sheath 100, i.e., L1>L2. The first opening 110 is still divided into two sections, with the first section 112 allowing the tip of the visual guidewire to pass through, and the second section 111 restricting the tip of the visual guidewire from passing through. However, the length L2 of the first opening 110 is less than the length L1 of the insertion segment.

[0059] That is, because the length of the insertion section is greater than the length of the first opening 110, this ensures that when the sheath 100 is fully inserted into the papillary sphincter, the first opening 110 will not be exposed to the outside, and the sphincter is used to seal the first opening 110, thereby reducing the risk of liquid leakage from the first opening 110. Obviously, this embodiment not only increases the function of preventing liquid leakage, but also still maintains the original operational flexibility and convenience, allowing easy separation between the guide wire and the sheath 100.

[0060] It should be noted that, when liquid needs to be transported through the guide wire guide channel 120 , the length of the insertion section ensures that the first opening 110 will not be exposed to the outside, thereby reducing the risk of liquid leakage.

[0061] like Figure 3 As shown, in some embodiments, the sheath tube 100 further has a liquid guiding channel 130 , and the liquid guiding channel 130 is extended along the axial direction of the sheath tube 100 .

[0062] To solve the problem of leakage caused by the provision of the first opening 110, in these embodiments, if space permits, a complete circumferentially closed liquid-injection channel 130 may be additionally introduced to allow liquid or gas exchange between the distal end of the sheath tube 100 and the operator end.

[0063] For example, the liquid-conducting channel 130 is a circular hole. Of course, in other embodiments, the liquid-conducting channel 130 can also be configured as a directional hole, an elliptical hole, a triangular hole, etc.

[0064] like Figure 4 and Figure 5 As shown, in some embodiments, the hole wall of the guidewire guide channel 120 near the proximal end has a second opening 150, and the second opening 150 passes through the hole wall of the guidewire guide channel 120 on the side away from the knife wire channel 140; wherein, the width of the second opening 150 is smaller than the outer diameter of the visible guidewire, and the two opposite side walls of the second opening 150 are set as elastic structures, and the elastic deformation of the side walls of the second opening 150 can enable the head end of the visible guidewire to pass through the second opening 150.

[0065] In these embodiments, a second opening 150 is added to the guidewire guide channel 120 of the sheath 100 near the proximal end. This design enables a visible guidewire to enter and exit the guidewire guide channel 120, further enhancing the functionality and operational convenience of the papillotomy.

[0066] The second opening 150 is located in the part of the guidewire guide channel 120 close to the proximal end, and passes through the hole wall of the guidewire guide channel 120 away from the knife wire channel 140. The width of the second opening 150 is smaller than the outer diameter of the visual guidewire. The side wall of the second opening 150 is set to an elastic structure, which can be elastically deformed when the head end of the visual guidewire passes through under the action of external force. It should be noted that driving the visual guidewire to move will not cause the visual guidewire to fall out of the second opening 150. Obviously, the width of the second opening 150 is smaller than the outer diameter of the visual guidewire, and the side wall is elastic, so that it can return to its original shape after the visual guidewire passes through, to prevent the visual guidewire from falling out of the second opening 150 during the operation of the visual guidewire movement. In other words, the design of the elastic side wall ensures that the visual guidewire can pass through, but can be tightly closed after the visual guidewire passes, reducing the risk caused by accidental slipping out.

[0067] Furthermore, compared with the case where the visual guidewire is located outside the sheath 100, the visual guidewire and the sheath 100 enter the human body side by side, which will affect the insertion performance of the entire system. In this embodiment, due to the provision of the second opening 150, the visual guidewire can be located in the guidewire guide channel 120 during the intubation process, and the two overlap, thereby greatly improving the insertion performance.

[0068] Furthermore, in this embodiment, the second opening 150 is provided, and the deformation of the sheath tube 100 is utilized to facilitate reducing the outer diameter of the sheath tube 100 , thereby further improving the insertion performance.

[0069] It should be noted that the connection between the first opening 110 and the second opening 150 can enable the guidewire guide channel 120 to form a non-closed structure, which can not only improve the insertion performance, but also enable the visual guidewire to be detached from the sheath 100 by applying a slight force in the direction away from the second opening 150 when separating the visual guidewire, without the need to move the sheath 100 forward to detach the visual guidewire.

[0070] like Figure 6 As shown, in some embodiments, the nipple cutter further includes a limit member 300, which has two ends, one end of the limit member 300 is connected to the side wall on one side of the second opening 150, and the other end of the limit member 300 is connected to the side wall on the other side of the second opening 150, and the portion of the limit member 300 located at the second opening 150 is set as a breakable area, and the breaking of the breakable area can separate the two ends of the limit member 300.

[0071] In these embodiments, the design of the papillomatomy device further enhances its functionality and operational convenience by introducing a stopper 300 to control the opening and closing of the second opening 150. The stopper 300 is designed to be disconnected under certain conditions, thereby providing additional operational flexibility.

[0072] The ends of the stopper 300 are respectively connected to the side walls of the second opening 150, and the stopper 300 further restricts the visual guidewire within the guidewire guide channel 120. For example, to further enhance the connection stability between the visual guidewire and the sheath 100, a pre-fixed stopper 300, such as a flexible or elastic band, can be added to the second opening 150 to perform local positioning, thereby improving the overall posture stability of the visual guidewire.

[0073] Among them, the part of the limiter 300 located at the second opening 150 is set as a breakable area, which can be broken by a smaller force, so that the two ends of the limiter 300 are separated to open the second opening 150. At this time, the visual guide wire can be controlled to enter and exit the second opening 150.

[0074] Obviously, the design of the fragile zone of the stopper 300 allows the stopper 300 to be easily disconnected when needed, thereby opening the second opening 150 and facilitating the rapid passage of the visual guidewire. Even during normal operation, the stopper 300 can maintain the closed state of the second opening 150, reducing the risk of accidental slipping out.

[0075] Only when the papillotomy knife needs to be removed, the second opening 150 can be fully opened by disconnecting the limiting member 300, thereby more conveniently separating the guide wire from the sheath tube 100.

[0076] By utilizing the deformation of the elastic side wall, the head of the visual guidewire is inserted into the guidewire guide channel 120 through the second opening 150 in vitro. Alternatively, the opening on the proximal handle of the papillotomy knife that is connected to the guidewire guide channel 120 is utilized. No specific limitation is made here, as long as it can be achieved. At this time, the limiter 300 maintains the closed state of the second opening 150. The sheath 100 is inserted into the patient's bile and pancreatic duct system together with the visual guidewire, ensuring that the insertion section is completely penetrated into the papillary sphincter. ERCP surgery is performed using the visual guidewire, and the papillotomy knife is used to perform necessary cutting operations. When the papillotomy knife needs to be removed while the visual guidewire remains in place, the visual guidewire is fixed and the sheath 100 is pushed forward so that the first section 112 of the first opening 110 exceeds the head of the visual guidewire, thereby allowing the head of the visual guidewire to exit the guidewire guide channel 120. Appropriate force is then applied to disconnect the fragile area of ​​the stopper 300, fully opening the second opening 150, thereby making it easier to separate the guidewire from the sheath 100. The sheath 100 is then directly withdrawn to complete the separation process.

[0077] For example, the fragile zone is provided with score lines, that is, one or more fine score lines are provided on the stopper 300. These score lines make the material thinner at this location, making it easier to break. Of course, in other embodiments, the fragile zone is provided with a microporous structure, such that micropores or microcracks are provided in the fragile zone of the stopper 300. These micropores or microcracks will expand and cause fracture when subjected to force. Alternatively, the fragile zone is provided with grooves or notches, such that the grooves or notches provided in the fragile zone of the stopper 300 reduce the effective cross-sectional area of ​​the material, making it more prone to fracture.

[0078] like Figure 8 As shown, in some embodiments, the second opening 150 and the first opening 110 are connected, and the second opening 150 and the first opening 110 extend along the same busbar on the sheath 100; wherein, the width of the first opening 110 is smaller than the outer diameter of the visual guidewire, and the two opposite side walls of the first opening 110 are configured as elastic structures, and the elastic deformation of the side walls of the first opening 110 can enable the head end of the visual guidewire to pass through the first opening 110.

[0079] In these embodiments, by connecting the second opening 150 and the first opening 110 and extending along the same generatrix on the sheath 100, this design not only simplifies the structure but also provides a smoother operating experience. In addition, by introducing the stopper 300 with a breakable area, the stopper 300 can be easily and controllably disconnected, thereby simplifying the operating steps during the surgical procedure.

[0080] like Figure 7As shown, in some embodiments, the nipple cutter also includes an electric heating wire 400, and the two ends of the limit member 300 are respectively a fuse end and a fixed end, the fuse end has a first part and a second part, the first part is away from the fixed end, and the second part is close to the fixed end, the first part is connected to the side wall on one side of the second opening 150, and the fixed end is connected to the side wall on the other side of the first opening 110; wherein, the electric heating wire 400 is connected to the sheath tube 100, the electric heating wire 400 abuts the second part, the second part is configured to be able to be heated and melted, and the melting point of the second part is lower than the melting point of the sheath tube 100.

[0081] In these embodiments, the papillotomy device design is further enhanced by incorporating an electric heating wire 400 and a specific stopper 300 structure to achieve a controllable fusing function. This design enables the stopper 300 to be precisely fused when needed through electrical heating, thereby facilitating separation of the visual guidewire from the sheath 100.

[0082] The first portion of the fusible end of the stopper 300 is connected to one sidewall of the second opening 150. The second portion, located near the fixed end, is configured to be heated and fused, with a melting point lower than that of the sheath 100. The fixed end is connected to the other sidewall of the first opening 110. The electric heating wire 400 is connected to the sheath 100 and abuts the second portion of the stopper 300, enabling direct heat transfer.

[0083] When powered, the electric heating wire 400 heats the second portion of the stopper 300, causing it to reach its melting point and fuse. Clearly, heating the second portion of the stopper 300 by the electric heating wire 400 allows for precise control of the fuse time, ensuring quick and reliable disconnection of the stopper 300 when needed. Furthermore, because the melting point of the second portion is lower than that of the sheath 100, the stopper 300 can be safely fused without compromising the integrity of the sheath 100. This design simplifies the separation process during surgery and improves operational efficiency.

[0084] By utilizing the elastic side wall deformation of the second opening 150, the head of the visual guidewire is inserted into the guidewire guide channel 120 through the second opening 150 in vitro. Alternatively, the opening on the proximal handle of the papillotomy knife that is connected to the guidewire guide channel 120 is utilized, which is not specifically limited here. At this time, the limiter 300 maintains the closed state of the second opening 150. The sheath 100 is inserted into the patient's bile and pancreatic duct system together with the visual guidewire, ensuring that the insertion section is completely penetrated into the papillary sphincter. ERCP surgery is performed using the visual guidewire, and the papillotomy knife is used to perform necessary cutting operations. If liquid needs to be transported (such as contrast agent or flushing fluid), it can be transported through the liquid guide channel 130 without being affected by the first opening 110 and the second opening 150. When the papillotomy knife needs to be removed while maintaining the position of the visual guidewire, the visual guidewire is fixed and the sheath tube 100 is pushed forward so that the first section 112 of the first opening 110 exceeds the head of the visual guidewire, thereby allowing the head of the visual guidewire to exit the guidewire guide channel 120. The electric heating wire 400 is activated to heat the second portion of the limiter 300 until it reaches the melting point and fuses. After the fuse breaks, the second opening 150 is fully opened, facilitating the separation of the visual guidewire from the sheath tube 100. The sheath tube 100 is directly withdrawn to complete the separation process.

[0085] In an exemplary embodiment, the stopper 300 is a plastic soft strip. Of course, in other embodiments, the stopper 300 is made of other thermoplastics. The melting point of these materials should be lower than the melting point of the sheath tube 100 to ensure that the stopper 300 melts when heated without affecting the integrity of the sheath tube 100.

[0086] like Figure 7 As shown, in some embodiments, the first portion is connected to the inner wall of one side of the second opening 150, and the inner wall of the sheath tube 100 connected to the first portion is provided with a wire groove, which extends along the axial direction of the sheath tube 100, and the electric heating wire 400 is provided in the wire groove.

[0087] In these embodiments, the first part of the limiter 300 is connected to the inner wall of one side of the second opening 150, and a wire groove is provided on the inner wall of the sheath 100, and the electric heating wire 400 is provided in the wire groove. This design further enhances the compactness and safety of the structure, ensuring that the electric heating wire 400 can effectively heat and melt the limiter 300. The wire groove is provided on the inner wall of the sheath 100 connected to the first part. The wire groove extends along the axial direction of the sheath 100. The wire groove is used to accommodate the electric heating wire 400, ensuring that the electric heating wire 400 can stably contact the second part of the limiter 300. The electric heating wire 400 is provided in the wire groove and abuts against the second part of the limiter 300. When power is turned on, the electric heating wire 400 can heat the second part of the limiter 300, causing it to reach the melting point and melt.

[0088] Obviously, embedding the electric heating wire 400 in the wire groove makes the entire device more compact, reduces the possibility of external interference, and avoids increasing the outer diameter of the sheath tube 100. In addition, the electric heating wire 400 is protected in the wire groove, reducing the risk of accidental contact and improving the safety of the operation.

[0089] In some embodiments, the papillomatomy knife further includes a cutting wire 200, a cutting power supply and a fuse power supply, the electric heating wire 400 is connected to one end of the guide wire located at the distal end of the sheath 100, the cutting wire 200 is electrically connected to the cutting power supply, and the electric heating wire 400 is electrically connected to the fuse power supply through the guide wire.

[0090] In these embodiments, this design enables the nipple cutter to not only perform cutting operations but also to achieve controllable fusing of the limiting member 300 through the electric heating wire 400 .

[0091] The cutting wire 200 is electrically connected to a cutting power source, and the cutting power source can provide current to activate the cutting function. The cutting power source is used to provide electrical energy to the cutting wire 200 and control the cutting operation.

[0092] The fusing power supply is used to provide electric energy to the electric heating wire 400 and control the fusing of the limiting member 300 .

[0093] Through independent power supply control, the cutting and fusing operations can be precisely controlled separately, thereby improving the safety and reliability of the operation. The shared blade wire 200 forms a closed circuit, which can further simplify the circuit and help reduce the outer diameter of the sheath tube 100.

[0094] It should be noted that the electric heating wire 400, the blade wire 200, and the fuse power supply form a circuit. When the blade wire 200 is used for cutting, the cutting power supply is turned on and the electric heating wire 400 is in an open circuit. When the fuse power supply is turned on when the electric heating wire 400 is used, the electric heating wire 400 generates heat and fuses the second portion.

[0095] In some embodiments, the present application also provides a nipple incision system, which includes a nipple incision knife as described in any of the above embodiments.

[0096] Since the above-mentioned nipple cutter has the above-mentioned technical effects, the nipple cutter system including the nipple cutter should have the same technical effects, which will not be described in detail here.

[0097] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not limiting, and thus other examples of the exemplary embodiments may have different values.

[0098] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0099] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the scope of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. A papillomatomy knife, characterized in that: The papillomatomy knife comprises: A sheath having a guidewire guide channel, a knife wire channel, a distal end, and a proximal end; a first opening is formed in a wall of the guidewire guide channel near the distal end; the first opening extends through the wall of the guidewire guide channel on a side away from the knife wire channel; and the first opening is sized to allow the tip of a visual guidewire to pass through. The hole wall of the guide wire guide channel near the proximal end has a second opening, and the second opening penetrates the hole wall of the guide wire guide channel on a side away from the knife wire channel; wherein the width of the second opening is smaller than the outer diameter of the visual guide wire, and two opposite side walls of the second opening are configured as elastic structures, and the elastic deformation of the side walls of the second opening can enable the tip end of the visual guide wire to pass through the second opening; The nipple cutter further includes a limiting member having two ends, one of which is connected to a side wall on one side of the second opening, and the other of which is connected to a side wall on the other side of the second opening, and a portion of the limiting member located at the second opening is configured as a breakable zone, and the breaking of the breakable zone enables the two ends of the limiting member to be separated; The nipple cutter also includes an electric heating wire, and the two ends of the limit member are respectively a fuse end and a fixed end, the fuse end has a first part and a second part, the first part is far away from the fixed end, the second part is close to the fixed end, the first part is connected to the side wall of one side of the second opening, and the fixed end is connected to the side wall of the other side of the first opening; wherein, the electric heating wire is connected to the sheath tube, the electric heating wire abuts against the second part, the second part is configured to be able to be heated and melted, and the melting point of the second part is lower than the melting point of the sheath tube.

2. The nipple cutter according to claim 1, characterized in that: The first opening extends to the end face of the distal end. In the extension direction of the first opening, the first opening has a first section and a second section, the first section is far away from the distal end, and the second section is close to the distal end. The size of the first section is configured to allow the tip end of the visual guidewire to pass through, and the size of the second section is configured to limit the passage of the tip end of the visual guidewire.

3. The nipple cutter according to claim 2, characterized in that: The portion of the sheath tube close to the head end is an insertion section, and the insertion section can be completely inserted into the papillary sphincter. The insertion section has an axial length L1 of the sheath tube, and a length L2 of the first opening in the axial direction of the sheath tube, and the following conditions are satisfied: L1>L2; Alternatively, the sheath tube further has a liquid guiding channel, and the liquid guiding channel is extended along the axial direction of the sheath tube.

4. The papillomatomy knife according to claim 1, characterized in that: The second opening is connected to the first opening, and the second opening and the first opening extend along the same busbar on the sheath; wherein the width of the first opening is smaller than the outer diameter of the visual guidewire, and the two opposite side walls of the first opening are configured as elastic structures, and the elastic deformation of the side walls of the first opening enables the head end of the visual guidewire to pass through the first opening.

5. The nipple cutter according to claim 4, characterized in that: The first part is connected to the inner wall of one side of the second opening, and the inner wall of the sheath connected to the first part is provided with a wire groove, the wire groove extends along the axial direction of the sheath, and the electric heating wire is provided in the wire groove.

6. The papillomatomy knife according to claim 5, characterized in that: The papillomatomy knife also includes a cutting wire, a cutting power supply and a fuse power supply. The electric heating wire and the guide wire are connected at one end of the distal end of the sheath tube. The cutting wire and the cutting power supply are electrically connected. The electric heating wire is electrically connected to the fuse power supply through the guide wire.

7. The papillomatomy knife according to claim 1, characterized in that: The limiting member is a flexible or elastic plastic belt.

8. A papillary incision system, characterized in that: The papillomatomy system comprises the papillomatomy knife according to any one of claims 1 to 7.

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