Nipple incision knife and nipple incision system

Abstract

The invention provides a nipple incision knife and a nipple incision system, and relates to the technical field of endoscopes. The nipple incision knife comprises a sheathing canal, the sheathing canal is provided with a guide wire guiding channel, a knife wire channel, a far end and a near end, a first opening is formed in the hole wall of the part, close to the far end, of the guide wire guiding channel, the first opening penetrates through the hole wall of the side, away from the knife wire channel, of the guide wire guiding channel, and the size of the first opening is configured to allow the head end of a visible guide wire to pass through. According to the nipple incision knife, separation of the nipple incision knife and the visual guide wire is not restrained or limited by the near-end connector, operation is convenient, and working efficiency is high.

Description

Technical Field

[0001] The present application relates to the technical field of endoscopes, and in particular to a papillotomy knife and a papillotomy 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 removal surgery of 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 the present application is to overcome the deficiencies in the prior art and to provide a nipple cutter and a nipple cutter system, which can enable the separation of the nipple cutter and the visual guide wire to be free from the constraints of the proximal connector, facilitate operation, and increase work efficiency.

[0004] This application provides the following technical solutions:

[0005] The present application provides a nipple cutter, the nipple cutter comprising:

[0006] 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 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 a side away from the knife wire channel. The size of the first opening is configured to allow the tip end of a visible guide wire to pass through.

[0007] In some embodiments of the first aspect, the first opening extends to the end surface 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 close to the head end is an insertion section, and the insertion section can be completely inserted into the nipple sphincter, and the length of the insertion section in the axial direction of the sheath tube is L1, and the length of the first opening in the axial direction of the sheath tube is L2, and the following conditions are satisfied: L1>L2;

[0009] Alternatively, the sheath tube further has a fluid guiding channel, and the fluid 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 near the proximal end has a second opening, and the second opening penetrates the hole wall of the guidewire 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 visible guidewire, and two opposite side walls of the second opening are arranged 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 limit piece, the limit piece having two ends, one of the two ends of the limit piece is connected to the side wall on one side of the second opening, the other end of the two ends of the limit piece is connected to the side wall on the other side of the second opening, and the portion of the limit piece 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 limit piece.

[0012] In some embodiments of the first aspect, the second opening is connected to the first opening, and the second opening and the first opening are extended along the same busbar on the sheath; the width of the first opening is smaller than the outer diameter of the visual guidewire, and two opposite side walls of the first opening are arranged as elastic structures, and the elastic deformation of the side walls of the first opening enables the tip 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 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.

[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 arranged in the wire groove.

[0015] In some embodiments of the first aspect, the nipple cutter 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, the nipple incision system comprising 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. Before performing an inspection or operation, the sheath 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 from the first opening, that is, the radial movement of the sheath is completely limited, and the movement of the sheath along the visual guidewire can be controlled. 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 the sheath needs to be withdrawn, the operator limits the axial movement of the visual guidewire outside the patient's body, and at the same time 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 time, the visual guidewire is not subjected to force or limitation 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, thereby solving the problem of inconvenience in operation 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 the breadth of its application scenarios.

[0021] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and understandable, 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 drawings required for use in the embodiments will be briefly introduced below. 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 related drawings can be obtained based on these drawings without paying creative work.

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

[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 Shows Figure 1 Middle AA section view;

[0026] Figure 4 A schematic structural diagram of a papillomatomy knife provided in the second embodiment of the present application from one viewing angle is shown;

[0027] Figure 5 Shows Figure 4 BB cutaway diagram;

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

[0029] Figure 7 A schematic structural diagram of a papillomatomy knife provided in a fourth embodiment of the present application from one viewing angle 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-guide wire guide channel; 130-liquid guide channel; 140-knife wire channel; 150-second opening; 200-knife wire; 300-limiting member; 400-electric heating wire. DETAILED DESCRIPTION

[0033] The embodiments of the present application are described in detail below, and 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 cannot be understood 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 a central 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 a central element at the same time. In contrast, 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 clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0036] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

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

[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 having 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 close to 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, and the size of the first opening 110 is configured to allow the tip end of a visible guide wire to pass through.

[0040] In these embodiments, the present application provides an improved papillotomy design, which is intended to solve the technical problems encountered when using a visual guidewire during endoscopic retrograde cholangiopancreatography (ERCP). In the traditional design, when a papillotomy is needed to treat problems such as stones or polyps in the body, it is difficult to remove the papillotomy from the visual guidewire due to the presence of a large connector at the proximal end of the visual guidewire. In order 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 has 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 penetrates 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 is carefully designed to ensure that the head end of the visible guide wire can pass smoothly. It should be noted that the visible guide wire can also be an ultra-thin endoscope.

[0042] For example, the first opening 110 is a circular hole, and the inner diameter of the first opening 110 is larger than the outer diameter of the head end of the visual guidewire. Of course, in other embodiments, the first opening 110 can also be set as a square hole, an elliptical hole, an irregular hole, a triangular hole, etc., which is not specifically limited here, and it is only necessary to ensure that the minimum width of the first opening 110 is larger than the outer diameter of the head end of the visual guidewire. Obviously, the above arrangement can ensure that the head end of the visual guidewire enters and exits the guidewire guide channel 120 from the first opening 110.

[0043] Before performing an examination or surgery, the sheath 100 needs to be connected to the visual guidewire in vitro, that is, the head end of the visual guidewire is inserted from the first opening 110 into the guidewire guide channel 120, 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 the sheath 100 needs to be withdrawn, the operator limits the axial movement of the visual guidewire outside the patient's body, and at the same time pushes the sheath 100 forward (i.e., to the distal end) 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 limitation 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, thereby solving the problem of inconvenience in operation 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 the breadth of its application scenarios.

[0045] like Figure 1 As shown, in some embodiments, the first opening 110 extends to the end face of the distal end, and 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 far from the distal end, and the size of the first section 112 is configured to allow the head end of the visual guide wire to pass through. The function of this section is to ensure that the visual guide wire can smoothly enter the guide wire guide channel 120 from the outside.

[0048] For example, the first section 112 is a circular hole, and the inner diameter of the first section 112 is larger than the outer diameter of the head end of the visual guidewire. Of course, in other embodiments, the first section 112 can also be set as a square hole, an elliptical hole, an irregular hole, a triangular hole, etc., which is not specifically limited here, and it is only necessary to ensure that the minimum width of the first section 112 is larger than the outer diameter of the head end of the visual guidewire.

[0049] The second section 111 is close to the distal end of the sheath 100. The size of the second section 111 is configured to limit the passage of the head end of the visual guidewire. The function of the second section 111 is to prevent the head of the visual guidewire from completely sliding out of the sheath 100, thereby keeping the visual guidewire able to move along the guidewire guide channel 120 in the sheath 100. In short, the design of the second section 111 can effectively limit the head of the visual guidewire within the sheath 100, avoiding the risk of the guidewire accidentally sliding out, especially when the guidewire position needs to be kept fixed during surgery.

[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 nipple cutter needs to be removed, the sheath tube 100 can be easily separated by simply pushing the first section 112 forward to make the first section 112 exceed the head of the visual guide wire. At the same time, the second section 111 ensures that the guide wire will not slip out easily, providing additional safety protection.

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

[0054] Before the operation, the head of the visual guidewire is inserted into the guidewire guide channel 120 through the first section 112 of the first opening 110. The ERCP operation is performed using the visual guidewire, and the papillotomy knife is used to perform necessary cutting operations. When it is necessary to remove the papillotomy knife while keeping the position of the visual guidewire unchanged, 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 withdraw from the guidewire guide channel 120. The sheath tube 100 is directly withdrawn to complete 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 an 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] In these embodiments, the technical problem that the first opening 110 provided at the distal end causes liquid leakage when the guide wire guide channel 120 is used to transport liquid is solved.

[0058] Specifically, the portion of the sheath 100 near the head end is defined as the insertion section, which can be completely inserted into the papillary sphincter. The length L1 of the insertion section is greater than the length L2 of the first opening 110 in the axial direction of the sheath 100, that is, L1>L2. The first opening 110 is still divided into two sections, the first section 112 allows the head of the visual guide wire to pass through, and the second section 111 restricts the head of the visual guide wire from passing through. However, the length L2 of the first opening 110 is smaller than the length L1 of the insertion section.

[0059] That is, since the length of the insertion section is greater than the length of the first opening 110, it is ensured that when the sheath tube 100 is fully inserted into the papillary sphincter, the first opening 110 will not be exposed to the outside, and the first opening 110 is sealed with the help of the sphincter, 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 the guide wire and the sheath tube 100 to be easily separated.

[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 first opening 110, in these embodiments, if space permits, a complete circumferentially closed liquid-injection channel 130 may be additionally introduced to allow the distal end of the sheath tube 100 and the operator end to exchange liquid or gas.

[0063] Exemplarily, 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 penetrates 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 arranged as elastic structures, and the elastic deformation of the side walls of the second opening 150 enables 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 ease of operation of the papillotomy device.

[0066] The second opening 150 is located in the part of the guide wire guide channel 120 close to the proximal end, and passes through the hole wall of the guide wire guide channel 120 away from the side of the knife wire channel 140. The width of the second opening 150 is smaller than the outer diameter of the visual guide wire. The side wall of the second opening 150 is set as an elastic structure, which can be elastically deformed when the head end of the visual guide wire passes through under the action of external force. It should be noted that driving the visual guide wire to move will not cause the visual guide wire to slip out of the second opening 150. Obviously, the width of the second opening 150 is smaller than the outer diameter of the visual guide wire, and the side wall is elastic, so that it can return to its original state after the visual guide wire passes through, so as to prevent the visual guide wire from slipping out of the second opening 150 during the operation of the visual guide wire movement. In other words, the design of the elastic side wall ensures that the visual guide wire can pass through, but can be tightly closed after the visual guide wire 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 reduce 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 slightly applying 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 also includes a limit member 300, which has two ends, one of the two ends of the limit member 300 is connected to the side wall of one side of the second opening 150, and the other end of the two ends of the limit member 300 is connected to the side wall of 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 zone, and the breaking of the breakable zone can separate the two ends of the limit member 300.

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

[0072] The two ends of the stopper 300 are respectively connected to the side walls of the second opening 150, and the visual guidewire is further restricted in the guidewire guide channel 120 by the stopper 300. 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 at 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 breakable area of ​​the stopper 300 makes it easy to disconnect the stopper 300 when needed, thereby opening the second opening 150 to facilitate the rapid passage of the visual guide wire. Even during normal operation, the stopper 300 can keep the second opening 150 closed, 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 stopper 300, so that the guide wire can be separated from the sheath tube 100 more conveniently.

[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, which is not specifically limited 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. Perform ERCP surgery using the visual guidewire, and use the papillotomy knife to perform necessary cutting operations. When the papillotomy knife needs to be removed while the position of the visual guidewire remains unchanged, 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 withdraw from the guidewire guide channel 120, and appropriate force is applied to disconnect the breakable area of ​​the stopper 300 so that the second opening 150 is fully opened, thereby making it easier to separate the guidewire from the sheath tube 100. The sheath tube 100 is directly pulled out to complete the separation process.

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

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

[0079] In these embodiments, the second opening 150 is connected to the first opening 110 and extends along the same generatrix on the sheath tube 100. This design not only simplifies the structure but also provides a smoother operation experience. In addition, by introducing the stopper 300 with a breakable area, the stopper 300 can be conveniently and controllably disconnected, thereby simplifying the operation steps during the operation.

[0080] like Figure 7As shown, in some embodiments, the nipple cutter also includes an electric heating wire 400, 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 far away from the fixed end, 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 and the second part are abutted, 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 design of the papillotomy knife is further enhanced by introducing 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 accurately fused by electric heating when necessary, thereby facilitating the separation of the visual guidewire from the sheath 100.

[0082] The first part of the fuse end of the stopper 300 is connected to one side wall of the second opening 150. The second part is close to the fixed end and is configured to be heated and fused, and its melting point is lower than the melting point of the sheath 100. The fixed end is connected to the other side wall of the first opening 110. The electric heating wire 400 is connected to the sheath 100 and abuts against the second part of the stopper 300, and can be directly heat-conducted.

[0083] When powered on, the electric heating wire 400 can heat the second part of the stopper 300 to make it reach the melting point and melt. Obviously, by heating the second part of the stopper 300 with the electric heating wire 400, the melting time can be accurately controlled to ensure that the stopper 300 is quickly and reliably disconnected when needed. And because the melting point of the second part is lower than the melting point of the sheath 100, the stopper 300 can be safely melted without affecting the integrity of the sheath 100. This design simplifies the separation steps during surgery and improves operating efficiency.

[0084] By utilizing the deformation of the elastic side wall 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 to ensure 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 delivery (such as contrast agent or flushing fluid) is required, it can be delivered through the liquid guide channel 130 without being affected by the first opening 110 and the second opening 150. When it is necessary to remove the papillotomy knife while keeping the position of the visual guidewire unchanged, fix the visual guidewire and push the sheath tube 100 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 withdraw from the guidewire guide channel 120. Start the electric heating wire 400 to heat the second part of the limiter 300 to reach the melting point and melt. After breaking, the second opening 150 is fully opened, which facilitates the separation of the visual guidewire from the sheath tube 100. The sheath tube 100 is directly pulled out to complete the separation process.

[0085] Exemplarily, the stopper 300 is a plastic soft belt. Of course, in other embodiments, the stopper 300 is provided with other thermoplastic plastics. 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 part 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 part is provided with a wire groove, which is extended along the axial direction of the sheath tube 100, and the electric heating wire 400 is arranged in the wire groove.

[0087] In these embodiments, the first part of the stopper 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 fuse the stopper 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 stopper 300. The electric heating wire 400 is provided in the wire groove and abuts against the second part of the stopper 300. When powered on, the electric heating wire 400 can heat the second part of the stopper 300, so that it reaches the melting point and fuses.

[0088] Obviously, embedding the electric heating wire 400 in the wire groove makes the whole 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 nipple cutter also includes a cutting wire 200, a cutting power supply and a fuse power supply, the electric heating wire 400 is connected to the guide wire at one end of 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 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 current can be provided by the cutting power source to activate the cutting function. The cutting power source is used to provide electrical energy to the cutting wire 200 to 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 accurately controlled respectively, thereby improving the safety and reliability of the operation. In addition, the common 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 knife wire 200 and the fuse power supply form a circuit. When the knife 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 part.

[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 as 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, further definition and explanation thereof is not required in subsequent drawings.

[0099] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A nipple cutting knife, characterized in that: The nipple cutter comprises: 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 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 a side away from the knife wire channel. The size of the first opening is configured to allow the tip end of a visible guide wire to pass through.

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, 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 nipple sphincter. The length of the insertion section in the axial direction of the sheath tube is L1, and the length of the first opening in the axial direction of the sheath tube is L2, and the following conditions are satisfied: L1>L2; Alternatively, the sheath tube further has a fluid guiding channel, and the fluid guiding channel is extended along the axial direction of the sheath tube.

4. The nipple cutter according to claim 1 or 2, characterized in that: The hole wall of the guide wire guide channel close to the proximal end has a second opening, and the second opening penetrates the hole wall of the guide wire 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 guide wire, and the two opposite side walls of the second opening are arranged as elastic structures, and the elastic deformation of the side walls of the second opening enables the head end of the visible guide wire to pass through the second opening.

5. The nipple cutter according to claim 4, characterized in that: The nipple cutter also includes a limit piece, which has two ends, one of which is connected to the side wall of one side of the second opening, and the other of which is connected to the side wall of the other side of the second opening, and a portion of the limit piece 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 limit piece.

6. The nipple cutter according to claim 5, characterized in that: The second opening is connected to the first opening, and the second opening and the first opening are extended 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 arranged as elastic structures, and the elastic deformation of the side walls of the first opening enables the tip end of the visual guidewire to pass through the first opening.

7. The nipple cutter according to claim 6, characterized in that: The nipple cutter also includes an electric heating wire, and the two ends of the limit piece 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.

8. The nipple cutter according to claim 7, 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 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 arranged in the wire groove.

9. The nipple cutter according to claim 8, characterized in that: The nipple cutter also 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 tube, 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.

10. The nipple cutter according to claim 5, characterized in that: The limiting member is a flexible or elastic plastic belt.

11. A papillary incision system, characterized in that: The papillotomy system comprises the papillotomy knife according to any one of claims 1 to 10.

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