Double wire sphincterotome

Abstract

The application provides a double-guide-wire sphincterotome, and relates to the field of medical devices.The double-guide-wire sphincterotome comprises a catheter sheath, the inside of the catheter sheath is provided with a cutting-wire cavity and two guide-wire cavities which are independent of each other, at least one side wall of the guide-wire cavities is provided with a quick exchange port; the guide-wire cavity connected with the quick exchange port is at least partially unsealed, and the continuously unsealed part accounts for 50%-99% of the length of the catheter sheath.The double-guide-wire sphincterotome provided by the application solves the technical problem of difficult superselection of a duodenal papilla sphincterotome guide wire in the prior art.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more specifically, to a double-wire sphincterotomy knife. Background Technology

[0002] The duodenal papillary sphincterotomy knife is a key instrument used in endoscopic sphincterotomy. Its core function is to incise the distal sphincter of the bile duct, thereby treating common bile duct stones or relieving biliary obstruction. In existing technology, this instrument mainly consists of a knife tube with an internal guidewire lumen, a retractable metal knife wire, and an operating handle. During use, the guidewire is inserted into the bile duct through the guidewire lumen. The knife tip is then advanced along the guidewire to the duodenal papilla, and the knife wire is tightened along the bile duct axis into a bowstring shape, closely adhering to the papillary prominence. A high-frequency current is then applied, and the retraction device gradually cuts the tissue with the knife wire, widening the bile duct opening to facilitate subsequent stone removal or stent placement. However, after insertion into the ampulla of Vater, this instrument faces the bifurcation of the bile duct and pancreatic duct. If the guidewire direction is not properly selected or the anatomical structure is unfavorable, the guidewire can easily slip into the pancreatic duct, making it difficult for the guidewire to enter the bile duct, leading to difficulties in guidewire overselection. Summary of the Invention

[0003] The purpose of this invention is to provide a dual-guidewire sphincterotomy knife to alleviate the technical problem of guidewire overselection difficulties in the prior art of duodenal papillary sphincterotomy knives.

[0004] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows: The dual-guidewire sphincterotomy knife provided by this invention includes a catheter sheath; The catheter sheath has an independent wire cutting chamber and two guide wire chambers inside, and at least one of the guide wire chambers has a quick exchange port on its side wall; The guidewire lumen connected to the quick exchange port is at least partially unclosed, and the continuously unclosed portion accounts for 50%-99% of the length of the catheter sheath.

[0005] Furthermore, the two guidewire lumens are a main guidewire lumen and a secondary guidewire lumen, respectively. The main guidewire lumen extends through the catheter sheath along its axial direction, and the main guidewire outlet of the main guidewire lumen is located at the distal end of the catheter sheath. The main guidewire lumen is used for the main guidewire to pass through, and the main guidewire can extend out of the main guidewire lumen from the main guidewire outlet. The sidewall of the catheter sheath is provided with a secondary guidewire outlet communicating with the secondary guidewire lumen. The secondary guidewire lumen is used for the secondary guidewire to pass through, and the secondary guidewire can extend out of the secondary guidewire lumen from the secondary guidewire outlet. The sidewall of the catheter sheath is provided with a cutting wire inlet and a cutting wire outlet that communicate with the cutting wire cavity. The cutting wire passes through the cutting wire cavity and extends into the cutting wire cavity from the cutting wire outlet.

[0006] Furthermore, along the axial direction of the catheter sheath, the auxiliary guidewire outlet is located on the side of the cutting wire inlet away from the distal end of the catheter sheath.

[0007] Furthermore, the distance between the distal ends of the main guide wire outlet and the secondary guide wire outlet is set to 2-25 mm.

[0008] Furthermore, the sidewall of the auxiliary guidewire outlet near the distal end of the catheter sheath serves as a guide surface, which is used to guide the auxiliary guidewire.

[0009] Furthermore, the guide surface is an arc shape that is concave towards the distal end of the catheter sheath.

[0010] Furthermore, when the main guide wire cavity contains the main guide wire and the secondary guide wire cavity contains the secondary guide wire, the angle α between the extension direction of the portion of the secondary guide wire extending from the secondary guide wire outlet and the extension direction of the main guide wire is set to 1-90°.

[0011] Furthermore, the cross-sectional area of ​​the main guide wire cavity is larger than the cross-sectional area of ​​the secondary guide wire cavity.

[0012] Furthermore, the interior of the catheter sheath has a flow cavity that is separated from both the guidewire lumen and the cutting lumen, and the flow cavity is used for aspiration or injection.

[0013] Furthermore, the sidewall of the catheter sheath is provided with a communication port that communicates with the flow cavity, and along the axial direction of the catheter sheath, the communication port is located between the main guidewire outlet and the auxiliary guidewire outlet.

[0014] Furthermore, the distance between the distal end of the connecting port and the main guide wire outlet is set to 0-50mm.

[0015] Furthermore, the axis of the main guidewire lumen is inclined from the proximal end to the distal end of the catheter sheath and gradually approaches the axis of the catheter sheath; the axis of the auxiliary guidewire lumen, the axis of the cutting lumen, and the axis of the flow lumen are all parallel to the axis of the catheter sheath.

[0016] Furthermore, in a cross-section perpendicular to the axis of the proximal end of the catheter sheath, and from the distal end to the proximal end of the catheter sheath, the cutting lumen is located above the flow lumen, and the main guide wire lumen and the secondary guide wire lumen are located on both sides of the cutting lumen; The angle between the cutting wire and the secondary guide wire extending from the secondary guide wire cavity is set to 5-135°.

[0017] Based on the above technical solutions, the technical effects achievable by this invention can be analyzed as follows: The dual-guidewire sphincterotomy knife provided by the present invention includes a catheter sheath, the interior of which has an independent cutting chamber and two guidewire chambers, and at least one guidewire chamber has a quick exchange port on its side wall; the guidewire chamber connected by the quick exchange port is at least partially unclosed, and the continuously unclosed part accounts for 50%-99% of the length of the catheter sheath.

[0018] The dual-guidewire sphincterotomy knife has at least three independent and non-communicating lumens: a cutting lumen and two guidewire lumens. The guidewire lumens are used for guidewire insertion. It is important to note that not both guidewire lumens necessarily contain a guidewire; selection depends on the specific situation. The cutting lumen is used for inserting the cutting wire. At least one guidewire lumen has a quick-exchange port on its side wall, allowing for the installation or removal of the guidewire within the corresponding lumen, reducing travel and enabling rapid extraction and separation. After successful cannulation during ERCP (Endoscopic Retrograde Cholangiopancreatography), i.e., after the guidewire enters the bile duct, the dual-guidewire sphincterotomy knife needs to be withdrawn, leaving the guidewire in place for subsequent treatment instrument introduction. If the entire guidewire lumen is closed, the double-guidewire sphincterotomy knife needs to travel along the entire guidewire before separating from it. Furthermore, the guidewire position must be fixed during this process to prevent it from leaving the bile duct as the double-guidewire sphincterotomy knife is withdrawn. Therefore, a long guidewire is required. This allows the surgeon to hold and fix the proximal end of the guidewire after the distal end of the double-guidewire sphincterotomy knife has been withdrawn from the endoscopic working lumen before switching to the exposed position of the distal guidewire of the papillomatomy knife. Additionally, all subsequent instruments must pass through the long guidewire to reach the surgical position, significantly increasing the overall surgical time. The guidewire lumen with rapid exchange function, due to its unclosed section, allows the guidewire to begin at the rapid exchange port during retraction of the double-guidewire sphincterotomy blade. This allows for dissection through the unclosed section and the blade, enabling the guidewire to be fixed near the proximal end of the endoscopic working channel during retraction without risk of guidewire dislodging from the bile duct. Furthermore, a shorter guidewire suffices for surgical requirements, reducing the time required for all subsequent instruments to reach the surgical site. The groove length of the catheter sheath should be between 50% and 99%. A groove length that is too short will not achieve the rapid exchange effect, while a groove length that is too long will affect the strength of the guide support or the closed portion.

[0019] When using this dual-guidewire sphincterotomy knife, if the guidewire in one of the guidewire lumen is inserted into the bile duct, subsequent surgical procedures can be performed directly. If the guidewire in the first guidewire lumen is inserted into the pancreatic duct, a secondary guidewire can be inserted through the other guidewire lumen to overselect the bile duct, eliminating the need to repeatedly retract the guidewire inserted into the pancreatic duct and overselect the bile duct, thus improving surgical efficiency. This dual-guidewire sphincterotomy knife, by adding angled channels, allows the guidewire to be inserted into the tissue in different directions, solving the problem of difficulty in overselecting the guidewire within the duodenal papilla in existing technologies. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 A schematic diagram of the structure of the dual-guidewire sphincterotomy knife provided in the embodiments of this application from a first-view perspective; Figure 2 A schematic diagram of the structure of the dual-guidewire sphincterotomy knife provided in the embodiments of this application from a second perspective; Figure 3 for Figure 2 Cross-sectional view at point AA; Figure 4 Schematic diagram of the internal structure of the first embodiment of the dual-guidewire sphincterotomy knife provided in this application. Figure 1 ; Figure 5 Schematic diagram of the internal structure of the dual-guidewire sphincterotomy knife provided in the embodiments of this application Figure 2 ; Figure 6 for Figure 2 Cross-sectional view at point BB; Figure 7 A schematic diagram of the dual-guidewire sphincterotomy knife combined with the handle provided in the embodiments of this application; Figure 8 This is a cross-sectional view of the proximal end of the catheter sheath in the dual-guidewire sphincterotomy knife provided in the embodiments of this application.

[0022] icon: 100 - Catheter sheath; 110 - Main guidewire lumen; 120 - Secondary guidewire lumen; 130 - Cutting wire lumen; 140 - Flow lumen; 111 - Main guidewire outlet; 121 - Secondary guidewire outlet; 122 - Guide surface; 131 - Cutting wire inlet; 132 - Cutting wire outlet; 141 - Connecting port; 112 - Quick exchange port; 200-cutting wire; 310 - Main guide wire; 320 - Secondary guide wire. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0024] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. Furthermore, the terms "first," "second," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0025] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setting" and "connection" should be interpreted broadly. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. It should be noted that, unless otherwise specified, features in the embodiments of this application can be combined with each other.

[0026] Example 1 See Figures 1 to 7 The dual-guidewire sphincterotomy knife provided in this embodiment of the invention includes a catheter sheath 100. The catheter sheath 100 has an independent wire cutting chamber 130 and two guidewire chambers inside. At least one guidewire chamber has a quick exchange port 112 on its side wall. The guidewire chamber connected by the quick exchange port 112 is at least partially unclosed, and the continuously unclosed part accounts for 50%-99% of the length of the catheter sheath.

[0027] Specifically, the catheter sheath 100 is made of a polymer material with elasticity and flexibility, such as polytetrafluoroethylene, polyether block amide, or polyurethane; the axis of the catheter sheath 100 is either straight or curved, which is not limited here. Preferably, the two guidewire lumens are a main guidewire lumen 110 and a secondary guidewire lumen 120, respectively. The main guidewire lumen 110 extends through the catheter sheath 100 along its axial direction, and the main guidewire outlet 111 of the main guidewire lumen 110 is located at the distal end of the catheter sheath 100; the main guidewire lumen 110 is used for the passage of the main guidewire 310, and the main guidewire 310 can extend out of the main guidewire lumen 110 from the main guidewire outlet 111; the sidewall of the catheter sheath 100 is provided with a secondary guidewire outlet 121 communicating with the secondary guidewire lumen 120, the secondary guidewire lumen 120 is used for the passage of the secondary guidewire 320, and the secondary guidewire 320 can extend out of the secondary guidewire lumen 120 from the secondary guidewire outlet 121. The main guidewire lumen 110 and the auxiliary guidewire lumen 120 are used for inserting the main guidewire 310 and the auxiliary guidewire 320, respectively. It is worth noting that the auxiliary guidewire lumen 120 does not necessarily contain the auxiliary guidewire 320; the auxiliary guidewire 320 needs to be selected based on the actual situation. The sidewalls of the main guidewire lumen 110 and / or the auxiliary guidewire lumen 120 are provided with quick-change ports 112. The quick-change ports 112 connect from the inside of the corresponding guidewire lumen to the outside of the catheter sheath 100, penetrating the sidewall of the corresponding guidewire lumen. The main guidewire lumen 110 or the auxiliary guidewire lumen 120 connected by the quick-change ports 112 is at least partially open, with the continuously open portion accounting for 50%-99% of the length of the catheter sheath 100; for example, this percentage can be set to 50%, 60%, or 99%. The sidewall of the catheter sheath 100 is provided with a cutting wire inlet 131 and a cutting wire outlet 132 communicating with the cutting wire cavity 130. The cutting wire 200 passes through the cutting wire cavity 130, and after exiting the cutting wire cavity 130 from the cutting wire outlet 132, it extends into the cutting wire cavity 130 from the cutting wire inlet 131. Further, see... Figure 7 The proximal end of the catheter sheath 100 is connected to the housing of the handle; the distal end of the cutting wire 200 extends from the cutting wire inlet 131 into the cutting wire cavity 130 and is fixedly connected to the inner wall of the cutting wire cavity 130. The proximal end of the cutting wire 200 is connected to the slider inside the handle, and the slider slides in cooperation with the housing. In use, the distal end of the catheter sheath 100 is brought close to the internal tissue, and the direction and position of the distal end of the catheter sheath 100 are adjusted by pushing, pulling or rotating the handle, and the main guide wire 310 and the auxiliary guide wire 320 are inserted into the pancreatic duct and bile duct, respectively. While keeping the position of the catheter sheath 100, the slider of the handle is slid backward to tighten the cutting wire 200, so that the cutting wire 200 is in the shape of an outwardly protruding and taut bowstring between the cutting wire inlet 131 and the cutting wire outlet 132. Electricity is applied and cutting is performed. After cutting is completed, the electric power is stopped, the cutting wire 200 is released, and the entire instrument is withdrawn. It is worth noting that in this article, "proximal" and "distal" are a set of directional concepts with the operator as a fixed reference; the proximal refers to the end closer to the operator's body center or the instrument handle, while the distal refers to the end farther from the operator's body center or the instrument handle, usually penetrating into the patient's body or contacting the target.

[0028] The catheter sheath 100 of the dual-guidewire sphincterotomy knife has at least three independent and non-communicating lumens: a cutting wire lumen 130 and two guidewire lumens. The guidewire lumens are used for inserting the guidewire. It is important to note that not both guidewire lumens necessarily contain a guidewire; selection depends on the specific situation. The cutting wire lumen 130 is used for inserting the cutting wire 200. At least one guidewire lumen has a quick-exchange port 112 on its side wall, allowing for the installation or removal of the guidewire within the corresponding lumen, reducing travel and enabling rapid extraction and separation. After successful cannulation during ERCP (Endoscopic Retrograde Cholangiopancreatography), i.e., after the guidewire enters the bile duct, the dual-guidewire sphincterotomy knife needs to be withdrawn, leaving the guidewire in place for subsequent treatment instrument introduction. If the entire guidewire lumen is closed, the double-guidewire sphincterotomy knife needs to travel along the entire guidewire before separating from it. Furthermore, the guidewire position must be fixed during this process to prevent it from leaving the bile duct as the double-guidewire sphincterotomy knife is withdrawn. Therefore, a long guidewire is required. This allows the surgeon to hold and fix the proximal end of the guidewire after the distal end of the double-guidewire sphincterotomy knife has been withdrawn from the endoscopic working lumen before switching to the exposed position of the distal guidewire of the papillomatomy knife. Additionally, all subsequent instruments must pass through the long guidewire to reach the surgical position, significantly increasing the overall surgical time. The guidewire lumen with rapid exchange function, due to its unclosed section, allows the guidewire to begin at the rapid exchange port during retraction of the double-guidewire sphincterotomy blade. This allows for dissection through the unclosed section and the blade, enabling the guidewire to be fixed near the proximal end of the endoscopic working channel during retraction without risk of guidewire dislodging from the bile duct. Furthermore, a shorter guidewire suffices for surgical requirements, reducing the time required for all subsequent instruments to reach the surgical site. The groove length of the catheter sheath should be between 50% and 99%. A groove length that is too short will not achieve the rapid exchange effect, while a groove length that is too long will affect the strength of the guide support or the closed portion.

[0029] When using this dual-guidewire sphincterotomy knife, if the guidewire in one of the guidewire lumen is inserted into the bile duct, the subsequent surgical procedures can be performed directly; if the guidewire in the first guidewire lumen is inserted into the pancreatic duct, the auxiliary guidewire 320 can be inserted through the other guidewire lumen to select the bile duct, without having to withdraw the guidewire inserted into the pancreatic duct and repeatedly select the bile duct, thus improving surgical efficiency.

[0030] This dual-guidewire sphincterotomy knife solves the problem of guidewire overselection difficulties in the duodenal papilla by adding angled channels, allowing the guidewire to be inserted into the tissue in different directions. The main guidewire outlet 111 of the main guidewire lumen 110 is located at the distal end of the duct sheath 100, allowing the main guidewire 310 to extend from the distal end of the duct sheath 100; the auxiliary guidewire outlet 121 is located on the lateral wall of the duct sheath 100, allowing the auxiliary guidewire 320 to extend from the lateral wall of the duct sheath 100. When using this dual-guidewire sphincterotomy knife, if the main guidewire 310 is inserted into the bile duct, subsequent surgical procedures can be performed directly; if the main guidewire 310 is inserted into the pancreatic duct, the auxiliary guidewire 320 can be inserted into the bile duct through the auxiliary guidewire lumen 120, eliminating the need to repeatedly try to retract the main guidewire 310 inserted into the pancreatic duct, thus improving surgical efficiency.

[0031] The following is a description of the structure of the double-wire sphincterotomy knife: Among the optional solutions provided in the embodiments of the present invention, see [link to relevant documentation]. Figure 2 and Figure 6 The proximal sidewall of the main wire cavity 110 is provided with a quick exchange port 112.

[0032] Specifically, the cross-section of the main wire cavity 110 at the quick exchange port 112 is C-shaped, and the gap in the middle of the C-shape is the quick exchange port 112, which is used to extract and separate the main wire 310 from the main wire cavity 110.

[0033] The quick-exchange port 112 is located at the proximal end of the main guide wire lumen 110, facilitating the extraction and dissection of the main guide wire 310. When the cutting blade is used to select the bile duct, quick exchange and withdrawal reduce surgical time and improve efficiency. Because the main guide wire lumen 110 can meet the main cannulation requirements, the auxiliary guide wire lumen 120 is usually unnecessary; therefore, the quick-exchange port 112 is frequently used in the main guide wire lumen 110. Preferably, the main guide wire lumen 110 has a quick-exchange port 112, resulting in better structural strength and ensuring that quick exchange can be achieved in most surgeries.

[0034] In the optional solution provided in the embodiments of the present invention, only the side wall of the proximal end of the main wire cavity 110 is provided with a quick exchange port 112.

[0035] Specifically, the cross-section of the main wire cavity 110 at the quick exchange port 112 is C-shaped, and the gap in the middle of the C-shape is the quick exchange port 112, which is used to extract and separate the main wire 310 from the main wire cavity 110.

[0036] The quick exchange port 112 is located at the proximal end of the main guidewire lumen 110, facilitating the extraction and dissection of the main guidewire 310. When selecting the bile duct with the double guidewire sphincterotomy knife, the quick exchange port 112 allows for rapid exchange and withdrawal, reducing surgical time and improving surgical efficiency. Furthermore, since the auxiliary guidewire 320 is not required after the main guidewire 310 is inserted into the bile duct, the quick exchange port 112 of the main guidewire lumen 110 is used frequently. Setting the quick exchange port 112 only in the main guidewire lumen 110 ensures the strength of the catheter sheath 100.

[0037] In the optional solution provided in the embodiments of the present invention, only the proximal sidewall of the auxiliary guidewire cavity 120 is provided with a quick exchange port 112.

[0038] Specifically, the cross-section of the secondary guide wire cavity 120 at the quick exchange port 112 is C-shaped, and the notch in the middle of the C-shape is the quick exchange port 112, which is used to extract and separate the secondary guide wire 320 from the secondary guide wire cavity 120.

[0039] The quick exchange port 112 is located at the proximal end of the auxiliary guide wire cavity 120, which facilitates the extraction and separation of the auxiliary guide wire 320.

[0040] In an optional embodiment of the present invention, a quick exchange port 112 is provided on the proximal sidewall of the main guide wire cavity 110, and a quick exchange port 112 is provided on the proximal sidewall of the secondary guide wire cavity 120.

[0041] Among the optional solutions provided in the embodiments of the present invention, see [link to relevant documentation]. Figure 1 Along the axial direction of the catheter sheath 100, the auxiliary guidewire outlet 121 is located on the side of the cutting wire inlet 131 away from the distal end of the catheter sheath 100.

[0042] The auxiliary guidewire outlet 121 is located before the cutting wire inlet 131, so that the cutting wire 200, the main guidewire outlet 111, and the auxiliary guidewire outlet 121 are respectively opposite to the corresponding tissues. More specifically, the location of the auxiliary guidewire outlet 121 on the distal side of the cutting wire inlet 131 away from the catheter sheath 100 conforms to human anatomy, making it easier for the auxiliary guidewire 320 to enter the bile duct when extended; and the location of the cutting wire inlet 131 between the main guidewire outlet 111 and the auxiliary guidewire outlet 121 does not affect the extension and retraction of the main guidewire 310 and the auxiliary guidewire 320. Preferably, the distance between the distal ends of the main guidewire outlet 111 and the auxiliary guidewire outlet 121 is set to 2-25 mm.

[0043] Among the optional solutions provided in the embodiments of the present invention, see [link to relevant documentation]. Figure 5 The side wall of the auxiliary guidewire outlet 121 near the distal end of the catheter sheath 100 is a guide surface 122, which is used to guide the auxiliary guidewire 320.

[0044] Specifically, the sidewall of the catheter sheath 100 is recessed inward to expose the auxiliary guidewire lumen 120, forming the auxiliary guidewire outlet 121.

[0045] The guide surface 122 is used to change the direction of the auxiliary guide wire 320 extending axially along the auxiliary guide wire cavity 120, so that the auxiliary guide wire 320 can extend out of the auxiliary guide wire cavity 120 at the auxiliary guide wire outlet 121.

[0046] In an optional embodiment of the present invention, the guide surface 122 is an arc shape that is concave towards the distal end of the catheter sheath 100.

[0047] The arc-shaped guide surface 122 is used to make the distal end of the auxiliary guide wire 320 extend in a direction away from the interior of the auxiliary guide wire cavity 120.

[0048] As another implementation, the guide surface 122 is set as an inclined surface, and the inclination angle of the inclined surface can be designed according to actual needs.

[0049] In the optional solution provided by the embodiments of the present invention, when the main guide wire cavity 110 is equipped with a main guide wire 310 and the secondary guide wire cavity 120 is equipped with a secondary guide wire 320, the angle α between the extension direction of the portion of the secondary guide wire 320 extending from the secondary guide wire outlet 121 and the extension direction of the main guide wire 310 is set to 1-90°.

[0050] Specifically, see Figure 2 The angle α between the extension direction of the auxiliary guidewire 320 extending from the auxiliary guidewire outlet 121 and the extension direction of the main guidewire 310 is set to 5-70°, which better conforms to the angles of the bile duct and pancreatic duct in human anatomy. Under the guidance of the guide surface 122, the auxiliary guidewire 320 partially extends out of the auxiliary guidewire cavity 120, and the axis of this extended portion forms an angle with the axis of the auxiliary guidewire cavity 120; the angle α between the axis of this extended portion of the auxiliary guidewire 320 and the extension direction of the main guidewire 310 is set to 5-70°, for example, 5°, 30°, 45°, 60°, or 70°, etc., and is not limited here.

[0051] The angle α between the extension direction of the part of the auxiliary guidewire 320 extending from the auxiliary guidewire outlet 121 and the extension direction of the main guidewire 310 is set to 1-90°. The specific angle α is set according to the human body condition, so that the main guidewire lumen 110 and the auxiliary guidewire lumen 120 are respectively opposite to the pancreatic duct and the bile duct, thereby enabling the main guidewire 310 to be easily inserted into the pancreatic duct and the auxiliary guidewire 320 to be easily inserted into the bile duct.

[0052] In the optional solution provided by the embodiments of the present invention, the cross-sectional area of ​​the main guide wire cavity 110 is larger than the cross-sectional area of ​​the secondary guide wire cavity 120, and the size of the main guide wire 310 is larger than the size of the secondary guide wire 320.

[0053] Specifically, both the main guide wire cavity 110 and the secondary guide wire cavity 120 have circular cross-sections, and the diameter of the main guide wire cavity 110 is larger than the diameter of the secondary guide wire cavity 120, so that the main guide wire cavity can accommodate a guide wire with a larger diameter, that is, the diameter of the main guide wire 310 is larger than the diameter of the secondary guide wire 320. Preferably, the main guide wire 310 placed in the main guide wire cavity 110 can be a 0.035-inch guide wire, and the secondary guide wire 320 placed in the secondary guide wire cavity 120 can be a 0.025-inch guide wire. There are two scenarios when using this double-guidewire sphincterotomy knife: the first is when the 0.035-inch main guidewire 310 is used for successful initial cannulation, as it provides better support; the second scenario is when cannulation is difficult, i.e., when the 0.035-inch main guidewire 310 is positioned in the pancreatic duct, a 0.025-inch auxiliary guidewire 320 is used to enter the bile duct through the auxiliary guidewire lumen 120, and the bile duct guidewire is retained when the double-wire sphincterotomy knife is finally withdrawn; the specific method depends on the actual needs.

[0054] The main guidewire lumen 110 is compatible with a 0.035-inch main guidewire 310, which is thicker and provides better support, making it easier to guide instruments along the direction of the main guidewire 310 and to overcome stenosis. Using this dual-guidewire sphincterotomy knife for cannulation can replace existing conventional papillary incision knives from the start of surgery. In most cases, cannulation is successful, meaning the guidewire smoothly enters the bile duct. Therefore, the main guidewire lumen 110 is designed to accommodate a 0.035-inch guidewire, allowing most procedures to be completed under the guidance of a 0.035-inch guidewire. In cases of difficult cannulation, where the main guidewire 310 consistently enters the pancreatic duct but fails to enter the bile duct, a second guidewire, the auxiliary guidewire lumen 120, can be inserted through it to successfully enter the bile duct.

[0055] In another embodiment, the cross-sectional area of ​​the main guide wire cavity 110 is larger than that of the secondary guide wire cavity 120, but the main guide wire 310 and the secondary guide wire 320 are of equal size. In this embodiment, both the main guide wire 310 and the secondary guide wire 320 use a 0.025-inch guide wire.

[0056] In another embodiment, the cross-sectional area of ​​the main guide wire cavity 110 is equal to the cross-sectional area of ​​the secondary guide wire cavity 120, and the main guide wire 310 and the secondary guide wire 320 are of equal size. In this embodiment, both the main guide wire 310 and the secondary guide wire 320 are 0.025-inch guide wires.

[0057] Example 2 The difference between the dual-guidewire sphincterotomy knife provided in this embodiment and the dual-guidewire sphincterotomy knife in the above embodiment is that: the catheter sheath 100 has a flow cavity 140 that is separated from both the guidewire lumen and the cutting lumen 130. The flow cavity 140 is used for aspiration or injection; once the pancreatic duct is cannulated, aspiration can be performed to reduce the pancreatic duct pressure when attempting to repeat the cannulation device.

[0058] Specifically, see Figure 2 The catheter sheath 100 has a communication port 141 on its side wall that communicates with the flow lumen 140. Along the axial direction of the catheter sheath 100, the communication port 141 is located between the main guidewire outlet 111 and the auxiliary guidewire outlet 121. Furthermore, the distance between the distal end of the communication port 141 and the main guidewire outlet 111 is set to 0-50 mm. The communication port 141 is located near the distal end of the catheter sheath 100, facilitating aspiration or infusion into the duodenum or ampulla of Vater. After insertion into the bile duct, the side communication port 141 does not directly enter the pancreatic duct but can be located behind the pancreatic duct, allowing effective access to the bile duct or branch bile ducts. Regardless of whether the main guidewire 310 enters the bile duct or pancreatic duct, tissue from the bile duct or branch bile duct can be aspirated. It is worth noting that in this embodiment, it is preferable that the two guidewire lumens are of equal size, and both guidewire lumens can accommodate a 0.025-inch guidewire. Of course, depending on the actual situation, the sizes of the two guidewire cavities may differ, and solutions for accommodating guidewires of different sizes should also be within the protection scope of this invention.

[0059] The connecting port 141 is located on the side wall of the catheter sheath 100 and communicates with the flow cavity 140. The flow cavity 140 can be connected to an external infusion device or an external aspiration device. The external infusion device can inject fluid into the tissue location where the connecting port 141 is located through the flow cavity 140 and the connecting port 141, which can effectively inject the required fluid without the need for other medical devices. The external aspiration device can aspirate the tissue location where the connecting port 141 is located through the flow cavity 140 and the connecting port 141, which can effectively reduce the amount of fluid in the bile duct or pancreatic duct and reduce the incidence of pancreatitis or cholangitis.

[0060] In the optional embodiment of the present invention, the axis of the main guidewire lumen 110 is inclined from the proximal end to the distal end of the catheter sheath 100 and gradually approaches the axis of the catheter sheath 100; the axis of the auxiliary guidewire lumen 120, the axis of the cutting wire lumen 130 and the axis of the flow lumen 140 are all parallel to the axis of the catheter sheath 100.

[0061] Specifically, the axes of the auxiliary guidewire lumen 120, the cutting wire lumen 130, and the flow lumen 140 are all parallel to the axis of the catheter sheath 100, thus shortening the lengths of the auxiliary guidewire lumen 120, the cutting wire lumen 130, and the flow lumen 140.

[0062] Among the optional solutions provided in the embodiments of the present invention, see [link to relevant documentation]. Figure 8 On a cross-section perpendicular to the axis of the proximal end of the catheter sheath 100, and from the distal end to the proximal end of the catheter sheath 100, the cutting wire cavity 130 is located above the flow cavity 140, and the main guide wire cavity 110 and the auxiliary guide wire cavity 120 are located on both sides of the cutting wire cavity 130, respectively; the angle between the cutting wire 200 and the auxiliary guide wire 320 extending from the auxiliary guide wire cavity 120 is set to 5-135°.

[0063] Specifically, the opening directions of the cutting wire inlet 131 and the cutting wire outlet 132 are the same, and they are spaced apart along the axial direction of the cutting cavity 130. The opening direction of the cutting wire inlet 131 and the opening direction of the connecting port 141 can be set to be opposite to avoid the opening direction of the cutting wire inlet 131 being the same as the opening direction of the connecting port 141, which would prevent both cutting and suction from being simultaneously achieved.

[0064] See Figure 8 When viewed from the distal to the proximal end of the dual-guidewire sphincterotomy blade, the auxiliary guidewire 320 is located to the right of the cutting wire 200, and the main guidewire 310 is located to the left of the cutting wire 200. If the angle between the auxiliary guidewire 320 and the cutting wire exceeds 180°, the positions of the main guidewire 310 and the auxiliary guidewire 320 will be reversed. When viewed in cross-section, the angle between the auxiliary guidewire 320 and the cutting wire 200 is between 5° and 135° when the auxiliary guidewire 320 is extended.

[0065] The following describes the usage of the double-guidewire sphincterotomy knife: a. Advance the duodenoscope into the second part of the duodenum.

[0066] b. Insert the double guidewire sphincterotomy knife through the instrument channel of the duodenoscope and insert it into the Audi sphincter.

[0067] c. Advance the guidewire into the bile duct. When encountering the bifurcation of the bile duct and pancreatic duct, attempt to selectively cannulate the bile duct using the guidewire 310 extending from the guidewire outlet 111.

[0068] Scenario 1: If selective cannulation of the bile duct is achieved quickly using the guide wire 310, an electric current is applied to incise the sphincter of Oddi. The rapid exchange function of the rapid exchange port 112 facilitates the rapid removal of the sphincter and allows for continued subsequent surgery.

[0069] Scenario 2: If selective cannulation of the bile duct using the main guidewire 310 is difficult (i.e., difficulty entering the bile duct due to orientation issues), insert the main guidewire 310 into the pancreatic duct for placement. Advance the double-guidewire sphincterotomy knife a few millimeters forward, allowing the lateral accessory guidewire 320, which may have a bile duct orifice, to fall. Simultaneously, use the distal end of the double-guidewire sphincterotomy knife to prevent the lateral accessory guidewire 320 from entering the pancreatic duct. Aspirate the flow lumen 140 to reduce pancreatic duct pressure and decrease the risk of pancreatitis. Then, extend the accessory guidewire 320 from the accessory guidewire outlet 121 and selectively cannulate the bile duct. After simultaneous placement of the bile duct and pancreatic duct, remove the double-guidewire sphincterotomy knife while maintaining the bile-pancreatic line in place. Withdraw the double-guidewire sphincterotomy knife. Place a pancreatic duct stent. Continue with biliary interventional treatment.

[0070] It is worth noting that aspirating pancreatic fluid during cannulation and placement of pancreatic duct stents is key to reducing the risk of post-ERCP pancreatitis.

[0071] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A double-guidewire sphincterotomy knife, characterized in that, include: Catheter sheath (100); The catheter sheath (100) has an independent wire cutting chamber (130) and two guide wire chambers inside, and at least one of the guide wire chambers has a quick exchange port (112) on its side wall. The guidewire lumen connected by the quick exchange port (112) is at least partially unclosed, and the continuously unclosed portion accounts for 50%-99% of the length of the catheter sheath (100).

2. The dual-guidewire sphincterotomy knife according to claim 1, characterized in that, The two guidewire lumens are a main guidewire lumen (110) and a secondary guidewire lumen (120). The main guidewire lumen (110) extends through the catheter sheath (100) along its axial direction, and the main guidewire outlet (111) of the main guidewire lumen (110) is located at the distal end of the catheter sheath (100). The main guidewire lumen (110) is used for the passage of the main guidewire (310), and the main guidewire (310) can extend out of the main guidewire lumen (110) from the main guidewire outlet (111). The sidewall of the catheter sheath (100) is provided with a sub-guidewire outlet (121) that communicates with the sub-guidewire cavity (120). The sub-guidewire cavity (120) is used for the sub-guidewire (320) to pass through, and the sub-guidewire (320) can extend out of the sub-guidewire cavity (120) from the sub-guidewire outlet (121). The sidewall of the catheter sheath (100) is provided with a cutting wire inlet (131) and a cutting wire outlet (132) communicating with the cutting wire cavity (130); the cutting wire (200) passes through the cutting wire cavity (130), and after extending out of the cutting wire cavity (130) from the cutting wire outlet (132), it extends into the cutting wire cavity (130) from the cutting wire inlet (131).

3. The dual-guidewire sphincterotomy knife according to claim 2, characterized in that, Along the axial direction of the catheter sheath (100), the auxiliary guidewire outlet (121) is located on the side of the cutting wire inlet (131) away from the distal end of the catheter sheath (100).

4. The dual-guidewire sphincterotomy knife according to claim 3, characterized in that, The distance between the distal ends of the main guide wire outlet (111) and the auxiliary guide wire outlet (121) is set to 2-25 mm.

5. The dual-guidewire sphincterotomy knife according to claim 3, characterized in that, The sidewall of the auxiliary guidewire outlet (121) near the distal end of the catheter sheath (100) is a guide surface (122), which is used to guide the auxiliary guidewire (320).

6. The dual-guidewire sphincterotomy knife according to claim 5, characterized in that, The guide surface (122) is an arc shape that is concave towards the distal end of the duct sheath (100).

7. The dual-guidewire sphincterotomy knife according to claim 2, characterized in that, When the main guide wire cavity (110) contains the main guide wire (310) and the auxiliary guide wire cavity (120) contains the auxiliary guide wire (320), the angle α between the extension direction of the portion of the auxiliary guide wire (320) extending from the auxiliary guide wire outlet (121) and the extension direction of the main guide wire (310) is set to 1-90°.

8. The dual-guidewire sphincterotomy knife according to claim 2, characterized in that, The cross-sectional area of ​​the main guide wire cavity (110) is larger than the cross-sectional area of ​​the secondary guide wire cavity (120).

9. The dual-guidewire sphincterotomy knife according to claim 2, characterized in that, The catheter sheath (100) has a flow chamber (140) inside, which is separated from both the guidewire lumen and the cutting lumen (130). The flow chamber (140) is used for aspiration or injection.

10. The dual-guidewire sphincterotomy knife according to claim 9, characterized in that, The sidewall of the catheter sheath (100) is provided with a communication port (141) communicating with the flow cavity (140), and along the axial direction of the catheter sheath (100), the communication port (141) is located between the main guide wire outlet (111) and the auxiliary guide wire outlet (121).

11. The dual-guidewire sphincterotomy knife according to claim 10, characterized in that, The distance between the distal end of the connecting port (141) and the main guide wire outlet (111) is set to 0-50 mm.

12. The dual-guidewire sphincterotomy knife according to claim 9, characterized in that, The axis of the main guidewire lumen (110) is inclined from the proximal end to the distal end of the catheter sheath (100) and gradually approaches the axis of the catheter sheath (100); the axes of the auxiliary guidewire lumen (120), the cutting wire lumen (130), and the flow lumen (140) are all parallel to the axis of the catheter sheath (100).

13. The dual-guidewire sphincterotomy knife according to claim 12, characterized in that, On a cross-section perpendicular to the axis of the proximal end of the catheter sheath (100), and from the distal end to the proximal end of the catheter sheath (100), the cutting lumen (130) is located above the flow lumen (140), and the main guide wire lumen (110) and the secondary guide wire lumen (120) are located on both sides of the cutting lumen (130); The angle between the cutting wire (200) and the auxiliary guide wire (320) extending from the auxiliary guide wire cavity (120) is set to 5-135°.

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