Nipple incision system

Abstract

The invention provides a nipple incision system, and relates to the technical field of endoscopes. The nipple incision system comprises a nipple incision knife and a superfine endoscope, and the nipple incision knife is provided with a guide wire guide channel; the superfine endoscope is provided with an insertion tube, and the insertion tube can be arranged in the guide wire guide channel in a penetrating mode and can move along the guide wire guide channel. According to the nipple incision system, the scheme of X-ray auxiliary observation is replaced, X-ray auxiliary observation does not need to be used, and the influence of contrast agent infiltration or indwelling on biliary tract recovery of a patient can be reduced.

Description

Technical Field

[0001] The present application relates to the technical field of endoscopes, and in particular to a papillary incision 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. During the ERCP procedure, X-rays are required to assist in observation for inserting guidewires and finding lesions. Obviously, there are problems of radiation exposure to doctors and patients, as well as slow recovery caused by contrast agent infiltration or retention in the patient's bile duct. 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 papillary incision system to replace the X-ray assisted observation solution. It does not require X-ray assisted observation and can reduce the impact of contrast agent infiltration or retention on the patient's bile duct recovery.

[0004] This application provides the following technical solutions:

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

[0006] A nipple cutter having a guide wire guide channel;

[0007] An ultra-thin endoscope comprises an insertion tube, the insertion tube can be inserted into the guide wire guide channel, and the insertion tube can move along the guide wire guide channel.

[0008] In some embodiments of the first aspect, the papillotomy tool comprises:

[0009] The sheath is provided with the guidewire guide channel, the sheath has a distal end and a proximal end; and the hole wall of the guidewire guide channel has a breakable area, the breakable area extends along the preset path, and the end faces of the distal end and the proximal end of the sheath are respectively located on the preset path, so that the rupture of the breakable area can enable the hole wall of the guidewire guide channel to form a non-closed structure.

[0010] In some embodiments of the first aspect, the breakable zone is provided with a breaking groove, and the breaking groove is extended along the preset path.

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

[0012] In some embodiments of the first aspect, there are multiple rupture grooves, and the multiple rupture grooves are arranged at intervals along the circumference of the sheath tube.

[0013] In some embodiments of the first aspect, the sheath has a first tube wall portion and a second tube wall portion, and the first tube wall portion and the second tube wall portion are arranged in sequence along the circumference of the sheath; wherein the guide wire guide channel is surrounded by the first tube wall portion and the second tube wall portion, the first tube wall portion and the second tube wall portion are detachably connected, and the second tube wall is located in the breakable area.

[0014] In some embodiments of the first aspect, the first tube wall portion is connected to the second tube wall portion via a connector, and the connector comprises at least one of the following:

[0015] Snap-on, easy-release adhesive and safety catch.

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

[0017] In some embodiments of the first aspect, the wall of the sheath tube has a first opening, the first opening is connected to the guide wire guide channel, and the first opening extends from the end surface of the distal end of the sheath tube to the end surface of the proximal end, and the width of the first opening is smaller than the outer diameter of the insertion tube.

[0018] In some embodiments of the first aspect, the papillomatomy device further comprises:

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

[0020] In some embodiments of the first aspect, the papillomatomy device further comprises:

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

[0022] In some embodiments of the first aspect, the papillomatomy device further comprises:

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

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

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

[0026] The present application provides a papillary incision system that can use an ultra-thin endoscope to directly replace the traditional guide wire, which is equivalent to an ultra-thin endoscope that not only has the function of a guide wire, but also can observe the internal conditions of the common bile duct, pancreatic duct and papillary sphincter without the use of X-rays. In other words, visualization is achieved in this way, thereby avoiding the need to use X-rays. Of course, since the use of X-rays and contrast agents is reduced, the risks of radiation exposure to patients and the side effects or prolonged recovery period that may be caused by contrast agents can be reduced in theory.

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

[0028] 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

[0029] 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.

[0030] Figure 1 A schematic structural diagram showing a nipple cutting knife of a nipple cutting system provided in the first embodiment of the present application in a straightened state;

[0031] Figure 2 A schematic structural diagram showing a nipple cutting knife of a nipple cutting system provided in the first embodiment of the present application in a bent state;

[0032] Figure 3 A schematic structural diagram showing a perspective of a nipple cutting knife of a nipple cutting system provided in the first embodiment of the present application;

[0033] Figure 4 A schematic structural diagram showing a perspective of a nipple cutting knife of a nipple cutting system provided in the second embodiment of the present application;

[0034] Figure 5 A schematic structural diagram showing a perspective of a nipple cutting knife of a nipple cutting system provided in a third embodiment of the present application;

[0035] Figure 6 A schematic structural diagram showing an initial state of a nipple cutting knife of a nipple cutting system provided in the second embodiment of the present application is shown;

[0036] Figure 7 A schematic structural diagram showing a nipple cutting knife of a nipple cutting system provided in the second embodiment of the present application in a separated state;

[0037] Figure 8 A schematic structural diagram of a nipple cutting knife of a nipple cutting system provided in a fourth embodiment of the present application is shown;

[0038] Fig. 9 A schematic structural diagram of a nipple cutting knife of a nipple cutting system provided in Example 5 of the present application is shown.

[0039] Description of main component symbols:

[0040] 100-sheath; 110-distal end; 120-proximal end; 130-first hole; 140-second hole; 150-knife wire channel; 160-guide wire guide channel; 170-fracture groove; 180-first tube wall portion; 190-second tube wall portion; 200-knife wire; 300-first handpiece; 400-second handpiece; 500-head end tube; 510-head end; 520-tail end; 600-second opening. DETAILED DESCRIPTION

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] In the related technologies, bile and pancreatic diseases are common clinical diseases, among which endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP) is a common method. During the ERCP procedure, X-rays are required to assist in observation for inserting guidewires and finding lesions. Obviously, there are problems of radiation exposure to doctors and patients, as well as slow recovery caused by contrast agent infiltration or retention in the patient's bile duct.

[0047] like Figure 1 and Figure 2As shown, in order to solve the above-mentioned technical problems, an embodiment of the present application provides a nipple incision system, which includes a nipple incision knife and an ultra-fine endoscope. The nipple incision knife has a guide wire guide channel 160; the ultra-fine endoscope has an insertion tube, which can be inserted into the guide wire guide channel 160 and can move along the guide wire guide channel 160.

[0048] In these embodiments, the papillotomy system is designed to improve some problems in the traditional ERCP procedure, especially to reduce the reliance on X-rays and reduce the effect of contrast agents on patients. The papillotomy knife has a guide wire guide channel 160. The ultra-thin endoscope has an insertion tube that can pass through the guide wire guide channel 160. The outer diameter of the insertion tube is very thin and can move along the channel, that is, the ultra-thin endoscope can be controlled to enter and exit the guide wire guide channel 160.

[0049] Generally, the inner diameter of the guidewire guide channel 160 is larger than the outer diameter of the insertion tube of the ultra-thin endoscope, so that the insertion tube can be easily controlled to move in the guidewire guide channel 160. Of course, the guidewire guide channel 160 is not only used for passing the guidewire, but also for passing other contents.

[0050] For example, a lubricating layer is provided on the inner wall of the guide wire guide channel 160 to reduce the movement resistance of the insertion tube and reduce the wear on the endoscope lens. Optionally, a lubricating liquid is applied to the guide wire guide channel 160 to form a lubricating layer on the inner wall of the guide wire guide channel 160. Of course, a coating layer can also be provided.

[0051] Obviously, this method can use an ultra-thin endoscope to directly replace the traditional guidewire, which is equivalent to an ultra-thin endoscope that not only has the function of a guidewire, but also can observe the internal conditions of the common bile duct, pancreatic duct and papillary sphincter without the use of X-rays. In other words, this method can achieve visualization operations, thus avoiding the need to use X-rays. Of course, since the use of X-rays and contrast agents is reduced, the risks of radiation exposure to patients and the side effects or prolonged recovery period that may be caused by contrast agents can theoretically be reduced.

[0052] It should be noted that with the help of more intuitive visual feedback (from the ultra-fine endoscope), surgeons can more accurately locate the lesion and perform precise cutting, which improves the success rate of the operation while reducing unnecessary tissue damage. To facilitate understanding of the above effects, the premise is that X-ray angiography has overlapping images, which makes it impossible to observe or accurately judge some lesions, such as inflammation in the papillary sphincter. Obviously, the use of an ultra-fine endoscope to replace the guide wire in this application is more conducive to diagnosis, and by controlling the deflection control of the ultra-fine endoscope, it is more conducive to controlling the insertion direction of the ultra-fine endoscope, reducing the difficulty of the operation, intuitively discovering or judging problems such as mucosal damage, reducing complications and secondary diseases, and can perform stone removal and lithotripsy operations on stones in the gallbladder duct, gallbladder neck, and gallbladder body.

[0053] like Figure 1 , Figure 2 , Figure 3 and Figure 4 In some embodiments, the papillotomy device includes a sheath 100, which is provided with a guide wire guide channel 160, and the sheath 100 has a distal end 110 and a proximal end 120; and the hole wall of the guide wire guide channel 160 has a breakable area, which extends along a preset path, and the end faces of both ends of the sheath 100 are respectively located on the preset paths, so that the breakage of the breakable area can enable the hole wall of the guide wire guide channel 160 to form a non-closed structure.

[0054] In these embodiments, it should be noted that in the use of the traditional ERCP papillotomy knife and the guide wire, the length of the guide wire is usually more than twice the length of the papillotomy knife, that is, during the process of withdrawing the papillotomy knife, the guide wire is always partially under the control of the operator, and the guide wire is held to prevent it from falling off into the tissue or the current position, and the outer diameter of the guide wire in the extension direction is basically the same. However, in this system, the ultra-thin endoscope that realizes the guide wire function has a proximal end 120 connector, which is connected to the proximal end 120 of the insertion tube, and the proximal end 120 connector is used to transmit images, etc. The outer contour of the above-mentioned proximal end 120 connector is much larger than the guide wire guide channel 160, so there is a problem that it is inconvenient to remove the papillotomy knife from the ultra-thin endoscope. Based on this, this embodiment is mainly to solve this problem, so as to achieve the removal of the papillotomy knife without passing through the proximal end 120 connector.

[0055] In the design of the papillotomy device provided in this embodiment, a special breakable area is provided in the guide wire guide channel 160 on the sheath tube 100. The main purpose of this design is to allow the hole wall of the guide wire guide channel 160 to break along a preset path under certain circumstances, so that the hole wall of the guide wire guide channel 160 forms a non-closed structure.

[0056] Obviously, when the papillotomy knife needs to be removed, the fragile area is broken, so that a crack connecting to the outside world is formed on the hole wall of the guide wire guide channel 160, and then in the process of pulling out the papillotomy knife, the insertion tube is controlled to move out of the guide wire guide channel 160 from the crack, thereby completing the separation of the ultra-fine endoscope and the papillotomy knife.

[0057] Furthermore, if an emergency occurs during the operation, such as when the instrument is stuck or other complications occur, the instrument can be quickly removed from the patient's body by breaking the breakable area, thereby reducing damage to the patient.

[0058] It should be noted that the material strength of the fragile zone should be lower than that of other parts of the sheath 100, but it should not be so fragile that it breaks easily during normal use. Special materials or processing techniques (such as local thinning, punching, etc.) are required to achieve this goal. At the same time, there needs to be a reliable method to trigger the rupture of the fragile zone, which can be achieved by mechanical force (such as pulling), thermal energy or other means. It is very important to ensure that the mechanism is safe and controllable.

[0059] Furthermore, although it provides additional operational flexibility, care must be taken to ensure that the fracture does not produce sharp edges that may damage internal tissues, or that fragments remain in the body and cause infection. Therefore, these risks must be fully considered in the design and appropriate measures must be taken to avoid them.

[0060] For example, in this embodiment, the preset path is set to extend along the axial direction of the sheath tube 100. Of course, in other embodiments, the preset path can also be set to an S-shaped path or other curved paths, as long as the formation of the cleft is guaranteed.

[0061] like Figure 3 As shown, in some embodiments, the breakable area is provided with a breaking groove 170, and the breaking groove 170 is extended along a preset path.

[0062] In these embodiments, in the design of the nipple cutter, by providing a fracture groove 170, also called a stress concentration groove or a preset fracture line, in the fragile area, the fracture path of the material can be more accurately controlled and guided.

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

[0064] It should be noted that the position, depth and width of the rupture groove 170 need to be carefully designed to ensure that the rupture groove 170 can work in the expected manner at the right time. For example, if the rupture groove 170 is too deep, it may cause accidental rupture; while if the rupture groove 170 is too shallow, it may not work effectively.

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

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

[0067] When it is time to remove the ultra-thin endoscopic instrument, the physician can activate the breaking mechanism using a specialized tool or by simply stretching / rotating the instrument.

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

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

[0070] In these embodiments, when the fracture groove 170 is located on the outer wall of the sheath tube 100, this design is generally to provide a controllable separation mechanism while maintaining the integrity of the guidewire guide channel 160. Even if the outer part is fractured, the inner channel where the guidewire or endoscope is located remains closed and continuous, ensuring that the instrument can continue to pass smoothly.

[0071] Furthermore, by providing the rupture groove 170 on the outer wall of the sheath tube 100 , it is easy to identify the position of the rupture groove 170 , and external force can be applied more directly to trigger the rupture.

[0072] like Figure 3 As shown, in some embodiments, there are multiple fracture grooves 170 , and the multiple fracture grooves 170 are arranged at intervals along the circumference of the sheath tube 100 .

[0073] In these embodiments, when there are multiple rupture grooves 170 and these rupture grooves 170 are arranged at intervals along the circumference of the sheath tube 100, this design can provide a more delicate and controllable separation mechanism. By arranging multiple rupture grooves 170 on the circumference of the sheath tube 100, local rupture can be achieved at different positions, which increases flexibility during surgery.

[0074] For complex anatomical structures or specific surgical requirements, doctors can select appropriate fracture grooves 170 to adjust the position or shape of the instrument to better complete the surgical operation. In addition, reliability is enhanced, and even if a fracture groove 170 fails to work as expected, other fracture grooves 170 can still be used as backup solutions to ensure the reliability of the entire system.

[0075] The distance between the fracture grooves 170 needs to be determined according to the specific size and use requirements of the sheath tube 100 and the diameter of the insertion tube of the ultra-thin endoscope. Reasonable spacing helps to maintain the overall strength of the sheath tube 100, while ensuring that each fracture groove 170 can function independently, and by removing the portion between adjacent fracture grooves 170, a large-sized crack is formed, which is convenient for removing the insertion tube.

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

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

[0078] In these embodiments, the sheath tube 100 is designed to be composed of two parts: a first tube wall part 180 and a second tube wall part 190. The first tube wall part 180 and the second tube wall part 190 are sequentially arranged along the circumference of the sheath tube 100, and together enclose to form a guide wire guide channel 160. Obviously, the key to this design is that the first tube wall part 180 and the second tube wall part 190 are detachably connected, and the second tube wall part 190 is located in the fragile area.

[0079] The first tube wall portion 180 and the second tube wall portion 190 are connected by a snap-on or detachable manner (such as snap, thread, adhesive, etc.). The guide wire guide channel 160 is a complete pipeline formed by the first tube wall portion 180 and the second tube wall portion 190 .

[0080] Among them, this detachable connection mode allows the doctor to separate the first wall portion 180 and the second wall portion 190 of the sheath tube 100 when necessary. Manual tools or specific mechanisms can be used to achieve quick disassembly. When the insertion tube is removed, the second wall portion 190 is removed to change the shape of the guide wire guide channel 160 or completely open the channel, and then remove the insertion tube.

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

[0082] Snap-on, easy-release adhesive and safety catch.

[0083] In some embodiments, the first tube wall portion 180 and the second tube wall portion 190 are connected by connectors. These connectors can be snaps, easy-to-release glue or safety bolts, etc. Each connection method has its own specific advantages and application scenarios.

[0084] Among them, snap-fit: snap-fit ​​is a mechanical connection method, usually including a raised part and a corresponding groove. The connection is achieved by pressing the raised part into the groove.

[0085] Easy-to-release adhesive: Easy-to-release adhesive is a special adhesive that can be easily separated under the application of a certain external force. When using adhesive to connect, the surface is flat, without obvious protrusions or depressions, reducing potential irritation to surrounding tissues. The adhesive can be easily separated by pulling or other methods when needed, while remaining firm under normal operation.

[0086] Safety pin: A safety pin is a mechanical locking device that usually includes an insertion hole and a removable pin. The connection is achieved by inserting the pin and locking it. The safety pin provides additional security to ensure that it will not be easily separated in unexpected circumstances. The doctor can visually check whether the safety pin is locked in place, which increases the transparency of the operation.

[0087] Obviously, the connector selected must be compatible with the sheath 100 material to ensure long-term stability and biocompatibility. The connector design should be convenient for doctors to operate under endoscopy, especially in confined spaces. Whichever connector is selected, it must ensure that it will not accidentally separate under normal use conditions, but can be quickly and safely removed when needed.

[0088] For example, Figure 5 As shown, the first tube wall portion 180 and the second tube wall portion 190 are bonded by easy-to-remove adhesive, and a breaking groove is provided at the bonding point between the first tube wall portion 180 and the second tube wall portion 190 to facilitate the first tube wall portion 180 and the second tube wall portion 190.

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

[0090] In these embodiments, the proximal end 120 of the sheath 100 is provided with a first handpiece 300 and a second handpiece 400, respectively. The first handpiece 300 and the second handpiece 400 correspond to the first tube wall portion 180 and the second tube wall portion 190, and the first handpiece 300 and the second handpiece 400 can be detachably connected, so that the first tube wall portion 180 and the second tube wall portion 190 can be controlled to separate by using the first handpiece 300 and the second handpiece 400.

[0091] The sheath tube 100 has a distal end 110 and a proximal end 120 , wherein the distal end 110 generally refers to the portion that enters the patient's body, and the proximal end 120 refers to the portion that is held by the operator (doctor).

[0092] The first hand piece 300 and the second hand piece 400 can be connected and separated by a detachable manner (such as a snap, an easy-to-release glue or a safety bolt, etc.).

[0093] Obviously, the doctor can more conveniently manipulate the sheath tube 100 through the first handpiece 300 and the second handpiece 400, thereby improving the operation accuracy and comfort during the operation. In addition, the design of the first handpiece 300 and the second handpiece 400 can provide a better grip, reduce hand fatigue, and prevent the sheath tube from falling off.

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

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

[0096] Illustratively, the first handpiece 300 is an operating handle of a papillotomy knife.

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

[0098] In these embodiments, a first opening is provided on the wall of the sheath tube 100, the first opening is communicated with the guide wire guide channel 160, and extends from the distal end 110 end surface of the sheath tube 100 to the proximal end 120 end surface, and optionally, the first opening is extended along the axial direction of the sheath tube 100. In addition, the width of the first opening is designed to be smaller than the outer diameter of the insertion tube of the ultra-thin endoscope, so as to increase the difficulty of the insertion tube being separated from the guide wire guide channel 160 from the first opening.

[0099] In short, since the width of the first opening is smaller than the outer diameter of the insertion tube, this can prevent the insertion tube from accidentally coming out of the first opening, making it easier to control the insertion tube to move along the guide wire guide channel 160. Even if accidental movement or pulling occurs during operation, the insertion tube will remain in the guide wire guide channel 160 and will not slip out through the first opening.

[0100] The width of the first opening does not necessarily have to be larger than the outer diameter of the insertion tube. When the insertion tube is removed, the first opening can be temporarily enlarged by utilizing the flexibility of the sheath tube 100 .

[0101] like Figure 8 As shown, in some embodiments, the papillomatomy device also includes a head end tube 500, the head end tube 500 has a head end 510 and a tail end 520, the tail end 520 and the distal end 110 of the sheath tube 100 are detachably connected, the guide wire guide channel 160 and the head end tube 500 are connected, and the outer diameter and the inner diameter of the head end 510 are gradually reduced in the direction away from the sheath tube 100, the inner hole of the tail end 520 is set with equal diameter, and the head end tube 500 is set as a transparent structure.

[0102] In these embodiments, the papillotomy knife further includes a head end tube 500, the outer diameter and inner diameter of the head end 510 of the head end tube 500 are gradually reduced in the direction away from the sheath tube 100, forming a cone or a tapered shape, which is conducive to the insertion of the head end tube 500 into the papillary sphincter. The tail end 520 is detachably connected to the distal end 110 of the sheath tube 100, and the inner hole of the tail end 520 is set with equal diameter. Among them, the head end tube 500 is designed as a transparent structure, which can support the papillary sphincter after the head end tube 500 is inserted into the papillary sphincter, so that a cavity is formed in the head end tube 500, and then the camera of the head end 510 of the ultra-fine endoscope can observe the situation inside the papillary sphincter, so that the doctor can directly observe and diagnose the internal condition of the papillary sphincter, reducing the blind spot of diagnosis.

[0103] It should be noted that in order for the ultra-thin endoscope to pass through the duodenal endoscope lifting forceps as a carrier, it must have a certain degree of flexibility, that is, the ultra-thin endoscope is difficult to move when it encounters greater resistance. After crossing the duodenal papilla, there is still a sphincter in the front of the common bile duct and the pancreatic duct, which is naturally kept tightly closed. An ultra-thin endoscope that does not have a tapered head end 510 and sufficient axial rigidity cannot pass through the inner hole of the sphincter and may even cause bending. Therefore, in this application, the papillomatomy knife constitutes a guide channel in its intended use, and the papillomatomy knife is inserted into the nipple only for positioning before the papillary incision, and can guide the insertion tube of the ultra-thin endoscope into the papillary sphincter.

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

[0105] For example, in this embodiment, the end surface of the tail end 520 is aligned with and bonded to the end surface of the distal end 110, so that after the sheath tube 100 is torn, the head end tube 500 can be disconnected from the sheath tube 100 (under stress). After the sheath tube 100 is torn, the head end tube 500 can be disconnected from the sheath tube 100 and left at the position of the proximal end 120 connector close to the insertion tube. Of course, in other embodiments, the head end tube 500 and the sheath tube 100 are connected by a relatively low-strength connection process using ultrasonic welding or laser welding, or the head end tube 500 and the sheath tube 100 can also be connected by gluing, chemical welding, in-mold injection molding, etc.

[0106] For example, Fig. 9 As shown, the side wall of the head end tube 500 is arranged at the second opening 600, the second opening 600 and the inner hole connecting tube of the head end tube 500 are arranged, and the second opening 600 extends from the end face of the head end 510 to the end face of the tail end 520, so that the insertion tube can be removed from the second opening 600 after the head end tube 500 and the sheath tube 100 are separated.

[0107] In some embodiments, the papillomatomy device also includes a head end tube 500, the head end tube 500 has a head end 510 and a tail end 520, the tail end 520 and the distal end 110 of the sheath tube 100 are integrated, the guide wire guide channel 160 and the head end tube 500 are connected, and the outer diameter and inner diameter of the head end 510 are gradually reduced in the direction away from the sheath tube 100, the inner hole of the tail end 520 is set with equal diameter, and the head end tube 500 is set as a transparent structure; wherein, the end faces of both ends of the head end tube 500 are respectively located on preset paths.

[0108] In these embodiments, the outer diameter and inner diameter of the head end 510 are gradually reduced in the direction away from the sheath tube 100, forming a cone or a tapered shape. The tail end 520 is integrated with the distal end 110 of the sheath tube 100, and the inner hole of the tail end 520 is set with equal diameter. The head end tube 500 is designed as a transparent structure so that the doctor can directly observe the situation outside the head end tube 500. The end faces of both ends of the head end tube 500 are respectively located on the preset path, which means that the head end tube 500 can be broken along the preset path under certain conditions, which is convenient for separating the head end tube 500 and the insertion tube. The integrated setting of the tail end 520 and the sheath tube 100 reduces the connection points and improves the stability and reliability of the overall structure. The outer diameter and inner diameter of the head end 510 are gradually reduced, which helps to enter the narrow papillary sphincter more smoothly and reduce damage to the tissue.

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

[0110] In these embodiments, the papillotomy knife further includes a blade wire 200, also referred to as a cutting wire or an electric cutting wire, and a dedicated blade wire channel 150 is provided on the sheath 100. The outer wall of the sheath 100 is provided with a first hole 130 and a second hole 140 spaced apart in a direction away from the distal end 110, and the first hole 130 and the second hole 140 are respectively connected to the blade wire channel 150. One end of the blade wire 200 passes through the first hole 130 and is fixed in the blade wire channel, and the other end passes through the second hole 140 and the blade wire channel. The portion of the blade wire 200 between the first hole 130 and the second hole 140 is exposed outside the sheath 100 and is in a relaxed state, and can be used for cutting by tightening the blade wire 200.

[0111] The blade wire 200 is used to cut tissues, is usually made of metal material, and can be single or multiple strands. The blade wire channel 150 is a dedicated channel provided inside the sheath tube 100, used to guide and protect the blade wire 200. The first hole 130 and the second hole 140 are two holes on the outer wall of the sheath tube 100, used to lead the blade wire 200 out of the sheath tube 100.

[0112] Among them, the portion of the blade wire 200 between the first hole 130 and the second hole 140 is in a relaxed state, which is convenient for tightening and cutting when needed, so as to weaken the mucosal scraping and damage caused by the inability of the blade wire 200 to be stretched when the sheath 100 enters the narrow channel of the nipple sphincter in a straight line.

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

[0114] In these embodiments, the sheath 100 is preformed, and the initial angle between the distal end 110 and the proximal end 120 of the sheath 100 ranges from 0° to 45°. 0°: indicates that the distal end 110 and the proximal end 120 of the sheath 100 are aligned in a straight line. 45°: indicates that the distal end 110 of the sheath 100 has a more obvious bending angle relative to the proximal end 120. Obviously, this setting adapts to the anatomical structure and facilitates the sheath 100 to enter the papillary sphincter in a straight line, especially the direction of the bile duct and pancreatic duct. In other words, the appropriate initial angle can help the sheath 100 enter the target area more smoothly and reduce friction and damage to surrounding tissues.

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

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

[0117] 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.

[0118] 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 papillary incision system, characterized in that: The papillary incision system comprises: A nipple cutter having a guide wire guide channel; An ultra-thin endoscope comprises an insertion tube, the insertion tube can be inserted into the guide wire guide channel, and the insertion tube can move along the guide wire guide channel.

2. The nipple incision system according to claim 1, characterized in that: The nipple cutter comprises: The sheath is provided with the guidewire guide channel, the sheath has a distal end and a proximal end; and the hole wall of the guidewire guide channel has a breakable area, the breakable area extends along a preset path, and the end faces of the distal end and the proximal end of the sheath are respectively located on the preset path, so that the rupture of the breakable area can enable the hole wall of the guidewire guide channel to form a non-closed structure.

3. The nipple incision system according to claim 2, characterized in that: The breakable area is provided with a breaking groove, and the breaking groove is extended along the preset path.

4. The nipple incision system according to claim 3, characterized in that: The fracture groove is located on the outer wall of the sheath tube.

5. The nipple incision system according to claim 3 or 4, characterized in that: There are multiple fracture grooves, and the multiple fracture grooves are arranged at intervals along the circumference of the sheath tube.

6. The nipple incision system according to claim 3, characterized in that: The sheath tube has a first tube wall portion and a second tube wall portion, and the first tube wall portion and the second tube wall portion are arranged in sequence along the circumference of the sheath tube; wherein the guide wire guide channel is surrounded by the first tube wall portion and the second tube wall portion, the first tube wall portion and the second tube wall portion are detachably connected, and the second tube wall is located in the breakable area.

7. The nipple incision system according to claim 6, characterized in that: The first tube wall portion is connected to the second tube wall portion via a connecting member, and the connecting member includes at least one of the following: Snap-on, easy-release adhesive and safety catch.

8. The nipple incision system according to claim 7, characterized in that: A first hand piece is disposed at a portion of the first tube wall portion located at the proximal end, and a second hand piece is disposed at a portion of the second tube wall portion located at the proximal end. The first hand piece and the second hand piece are detachably connected.

9. The nipple incision system according to claim 2, characterized in that: The tube wall of the sheath tube has a first opening, the first opening is connected to the guide wire guide channel, and the first opening extends from the end surface of the distal end of the sheath tube to the end surface of the proximal end, and the width of the first opening is smaller than the outer diameter of the insertion tube.

10. The nipple incision system according to claim 2, characterized in that: The nipple cutter also includes: A head end tube, wherein the head end tube has a head end and a tail end, the tail end and the distal end of the sheath tube are detachably connected, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end gradually decrease in the direction away from the sheath tube, the inner hole of the tail end is set with equal diameter, and the head end tube is set as a transparent structure.

11. The nipple incision system according to claim 2, characterized in that: The nipple cutter also includes: A head end tube, wherein the head end tube has a head end and a tail end, the tail end and the distal end of the sheath tube are integrated, the guide wire guide channel is connected to the head end tube, and the outer diameter and inner diameter of the head end are gradually reduced in the direction away from the sheath tube, the inner hole of the tail end is set with equal diameter, and the head end tube is set as a transparent structure; wherein the end faces of the two ends of the head end tube are respectively located on the preset path.

12. The papilla incision system according to claim 10 or 11, characterized in that: The nipple cutter also includes: The sheath tube also has a knife wire channel, the outer wall of the sheath tube is provided with a first hole and a second hole spaced apart in a direction away from the distal end, and the first hole and the second hole are respectively connected to the knife wire channel, one end of the knife wire is passed through the first hole and fixed to the knife wire channel, the other end of the knife wire is passed through the second hole and the knife wire channel, the portion of the knife wire between the first hole and the second hole is located outside the sheath tube, and the portion of the knife wire between the first hole and the second hole is in a relaxed state.

13. The nipple incision system according to claim 12, characterized in that: An initial angle formed between the distal end and the proximal end of the sheath is 0° to 45°.

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