Single-person operated duodenal sphincter incision knife

By designing a single-person-operated dual-channel duodenal sphincter incision, the problems of complexity and high complications in the prior art that require assistant assistance are solved, and efficient and safe cannulation operation is achieved.

CN120550313APending Publication Date: 2025-08-29SHANGHAI RUIFAN MEDICAL TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202510794444.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-13
Publication Date
2025-08-29

AI Technical Summary

Technical Problem

The current duodenal papillary sphincter surgery is complicated and requires assistant assistance. The success rate of intubation is low and the injection channel is small, resulting in unclear biliary tract display, high complications, and high rate of intubation failure.

Method used

A single-person-operated duodenal sphincter incision is designed, using a dual-channel outer sheath, with guidewire drawn through the side wall, handle control, guidewire and injection channel independently designed to increase the success rate of cannula and reduce complications.

Benefits of technology

It realizes efficient cannulation for single-person operation, reduces the incidence of complications, improves the clarity of biliary tract display and the success rate of cannulation, and reduces the complexity of operation.

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Abstract

The duodenal sphincter incision knife operated by one person comprises an outer sheath tube, a guide wire, a metal wire and a handle, and the guide wire is inserted into the outer sheath tube through the tube wall of the outer sheath tube and penetrates out of the head end of the outer sheath tube; the handle is connected to the tail portion of the outer sheath tube, one end of the metal wire is fixedly connected with the front portion of the outer sheath tube, and the other end of the metal wire is inserted into the outer sheath tube and connected with the handle. The guide wire channel is a double-channel tube, the guide wire enters the guide wire channel through the side wall, and the outer diameter of the guide wire channel is smaller than that of a conventional three-channel tube; the guide wire is led out through the side wall of the tube wall, an operator can operate the guide wire to be inserted into the common bile duct or the pancreatic duct without the help of an assistant on the basis of fixing the outer sheath tube, and the success rate of intubation is increased.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a single-operated duodenal sphincterotomy knife. Background Art

[0002] With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has gradually replaced surgery in the treatment of some biliary and pancreatic diseases, offering less trauma and faster recovery. Examples include common bile duct stones, bile duct injury, bile duct stenosis, and biliary complications after liver transplantation. Direct duodenoscope examination and imaging can even reveal conditions that are not apparent with conventional imaging studies, such as duodenitis, juxtapapillary diverticula, and abnormal biliopancreatic junction.

[0003] A sphincterotomy is an essential accessory for ERCP procedures. It assists with guidewire cannulation of the bile or pancreatic duct, thereby reducing the incidence of postoperative complications such as pancreatitis and cholangitis. By incising the sphincterotomy, obstruction or stricture in the bile and pancreatic outflow tract can be relieved, facilitating the removal of common bile duct stones and the placement of stents in the common bile or pancreatic duct.

[0004] The sphincterotomy knife currently in clinical use has a cylindrical body and a conical head. The blade is a three-channel tube, including an injection channel, a metal wire channel and a guide wire channel. The metal wire passes through the front end tube wall and is fixed on the head end tube wall. By tightening the metal wire to make its head completely arched, the direction of the guide wire insertion is adjusted, and the sphincterotomy of the duodenal papilla is completed. The arched sphincterotomy knife has the following shortcomings: 1. The guide wire is generally led out through the sphincterotomy knife handle, and the operator controls the position of the front end of the duodenoscope and the depth of the sphincterotomy knife entering and exiting the duodenoscope. The guidewire is inserted into the common bile duct or pancreatic duct by an assistant. It is difficult for the operator to operate the guidewire for intubation. If the assistant lacks experience, intubation often fails, and even causes complications such as perforation, acute pancreatitis, and bleeding. 2. The outer sheath of the duodenal sphincter currently used is generally a three-channel tube with an outer diameter of 7Fr. Under the premise of ensuring that the guidewire and metal wire can pass through the outer sheath smoothly, the inner diameter of the injection channel is relatively small. The resistance to contrast agent injection through this channel is large, the bile duct is not clearly displayed, and the accuracy of disease diagnosis is reduced; the efficiency of withdrawing contrast agent and bile and other fluids through this channel is reduced, and the incidence of complications such as contrast agent-related cholangitis and liver damage is increased; the efficiency of bile duct flushing is low, and mud-like stones can easily block the contrast channel, which is not conducive to the extraction of mud-like stones and bile sludge; 3. After successful bile duct intubation, during the process of withdrawing the sphincterotomy knife through the common bile duct into the duodenum or replacing other accessories with the duodenoscope forceps, if the operator does not cooperate well, the guidewire often withdraws from the common bile duct along with the sphincterotomy knife, requiring a second common bile duct intubation. Summary of the Invention

[0005] In response to the above technical problems, a single-operated duodenal sphincterotomy knife is provided.

[0006] The technical means adopted in the present invention are as follows:

[0007] A single-operated duodenal head sphincterotomy knife comprises: an outer sheath, a guide wire, a metal wire and a handle. The guide wire is inserted into the interior of the outer sheath through the wall of the outer sheath and exits from the head end of the outer sheath; the handle is connected to the tail end of the outer sheath, one end of the metal wire is fixedly connected to the front end of the outer sheath, and the other end is inserted into the interior of the outer sheath and connected to the handle.

[0008] Furthermore, the outer sheath comprises a drainage tube segment I, a drainage tube segment II and a drainage tube segment III which are sequentially connected from the beginning to the end, and the tail end of the drainage tube segment III is connected to the handle.

[0009] Furthermore, the drainage tube section I is a double-channel tube with a conical head end, and a guide wire channel I and an injection channel I are provided inside.

[0010] Furthermore, the drainage tube segment II is a double-channel tube, with a guidewire channel II and an injection channel II provided inside, and the guidewire channel II and the injection channel II are respectively connected to the guidewire channel I and the injection channel I of the drainage tube segment I.

[0011] Furthermore, a side hole I is provided on the wall of the tail end of the drainage tube section II, and the side hole I is connected to the tail end of the guidewire channel II. The guidewire passes through the side hole I, the guidewire channel II, the guidewire channel I in sequence and then exits.

[0012] Furthermore, one end of the metal wire is fixed to the outer head end of the drainage tube segment II, a side hole II is provided on the tail end wall of the drainage tube segment II, and the other end of the metal wire enters the outer sleeve through the side hole II.

[0013] Furthermore, a wristband is provided at the tail of the handle, a connecting rod is connected to the wristband, and the other end of the metal wire is connected to the connecting rod.

[0014] Furthermore, the drainage tube segment III is a double-channel drainage tube, which is provided with an injection channel III and a metal wire channel. The injection channel III is connected to the injection channel II of the drainage tube segment II, and the metal wire is located in the metal wire channel.

[0015] Furthermore, the handle is provided with an injection connector, which is communicated with the injection channel III of the drainage tube section III, and the contrast agent is injected through the connector.

[0016] Compared with the prior art, the present invention has the following advantages:

[0017] 1. The single-operated duodenal sphincterotomy provided by the present invention has a double-channel outer sheath. Under the premise of the same outer diameter, the injection channel is larger, the resistance to injection of contrast agent, withdrawal of bile, and bile duct flushing is small, and the efficiency is higher.

[0018] 2. The present invention provides a single-operated duodenal head sphincterotomy. The guide wire is led out through the side wall of the front end of the outer sheath. The operator can complete the guide wire intubation into the common bile duct or pancreatic duct while operating the duodenoscope, thereby increasing the success rate of intubation and reducing the incidence of complications, thereby reducing the influence of the assistant's experience on the success rate of intubation and the incidence of complications.

[0019] 3. The single-operated duodenal sphincterotomy provided by the present invention can freely enter and exit the common bile duct and the duodenoscope channel while fixing the guide wire, and will not cause the guide wire to fall out of the common bile duct due to lack of cooperation between the operator and the assistant.

[0020] Based on the above reasons, the present invention can be widely promoted in fields such as medical treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0022] Figure 1 It is a structural schematic diagram of the present invention.

[0023] Figure 2 It is a cross-sectional view of the drainage tube section I of the present invention.

[0024] Figure 3 It is a cross-sectional view of the drainage tube section III of the present invention.

[0025] Figure 4 This is a schematic diagram of the present invention when in use.

[0026] In the figure: 1. Drainage tube segment I; 11. Guide wire channel I; 12. Injection channel I; 2. Drainage tube segment II; 3. Drainage tube segment III; 31. Injection channel III; 32. Metal wire channel; 4. Handle; 5. Metal wire; 6. Connecting rod; 7. Injection connector. DETAILED DESCRIPTION

[0027] It should be noted that, in the absence of conflict, the embodiments and features of the embodiments of the present invention can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0028] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is in no way intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0029] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0030] Unless otherwise specified, the relative arrangement of the parts and steps, numerical expressions and numerical values ​​set forth in these embodiments do not limit the scope of the present invention. At the same time, it should be clear that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to actual proportional relationships. The technology, methods and equipment known to those of ordinary skill in the relevant art may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be considered as a part of the specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of the exemplary embodiments can have different values. It should be noted that similar numbers and letters represent similar items in the following drawings, and therefore, once an item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0031] In the description of the present invention, it should be understood that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "horizontal, vertical, vertical, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention: the directional words "inside and outside" refer to the inside and outside relative to the outline of each component itself.

[0032] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used herein to describe the spatial positional relationship of a device or feature to other devices or features as shown in the figures. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figures. For example, if the device in the drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below their position devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0033] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0034] The present invention provides a single-operated duodenal papilla sphincterotomy knife, comprising: an outer sheath, a guide wire, a metal wire 5 and a handle 4. The guide wire is inserted into the interior of the outer sheath through the wall of the outer sheath and passes out from the head end of the outer sheath; the handle 4 is connected to the tail end of the outer sheath, one end of the metal wire 5 is fixedly connected to the front part of the outer sheath, and the other end is inserted into the interior of the outer sheath and connected to the handle 4.

[0035] As a preferred embodiment, the outer sheath includes a drainage tube segment I1, a drainage tube segment II2 and a drainage tube segment III3 which are sequentially connected from the beginning to the end, and the tail end of the drainage tube segment III3 is connected to the handle 4.

[0036] As a preferred embodiment, the drainage tube segment Ⅰ1 is a double-channel tube with a conical head end, and a guidewire channel Ⅰ11 and an injection channel Ⅰ12 are provided inside.

[0037] As a preferred embodiment, the drainage tube segment II2 is a double-channel tube with a guidewire channel II and an injection channel II provided therein. The guidewire channel II and the injection channel II are respectively connected to the guidewire channel I11 and the injection channel I12 of the drainage tube segment I1.

[0038] As a preferred embodiment, a side hole I is provided on the wall of the tail end of the drainage tube segment II2, and the side hole I is connected to the tail end of the guidewire channel II. The guidewire passes through the side hole I, the guidewire channel II, the guidewire channel I11 in sequence and then exits.

[0039] In a preferred embodiment, one end of the metal wire 5 is fixed to the outer tip of the drainage tube segment II 2. A side hole II is provided in the wall of the tail end of the drainage tube segment II 2. The other end of the metal wire 5 enters the outer sheath through the side hole II. The metal wire 5 between the side hole II and the outer tip of the drainage tube segment II 2 is located outside the outer sheath.

[0040] As a preferred embodiment, a wristband is provided at the tail of the handle 4 , a connecting rod 6 is connected to the wristband, and the other end of the metal wire 5 is connected to the connecting rod 6 .

[0041] As a preferred embodiment, the drainage tube segment III3 is a dual-channel drainage tube, which is provided with an injection channel III31 and a metal wire channel 32 inside. The injection channel III31 is connected to the injection channel II of the drainage tube segment II2, and the metal wire 5 is located in the metal wire channel 32.

[0042] As a preferred embodiment, an injection connector 7 is provided on the handle 4 , which is communicated with the injection channel III31 of the drainage tube segment III3 , and the contrast agent is injected through the connector.

[0043] The guide wire channel I 11 and the guide wire channel II are connected from beginning to end to form a guide wire channel.

[0044] The injection channel I 12 , the injection channel II and the injection channel III 31 are connected from beginning to end to form the injection channel.

[0045] The outer diameter of the angiography catheter (outer sheath) is 7Fr, the outer diameter of the head opening is 5Fr, the inner diameter of the guide wire channel is 1mm, the inner diameter of the injection channel is 1mm, the inner diameter of the metal wire channel is 0.5mm, the length of the tapered head is 10mm, the length of the electric knife metal wire at the head end is 2cm, and the diameter of the metal wire is 0.5mm.

[0046] The present invention is a double-channel tube. The guide wire enters the guide wire channel through the side wall. Its outer diameter is thinner than that of a conventional three-channel tube. The guide wire is led out through the side wall of the tube. On the basis of fixing the outer sheath, the operator can operate the guide wire to insert it into the common bile duct or pancreatic duct without the help of an assistant, thereby increasing the success rate of intubation.

[0047] Use of the present invention:

[0048] The operator holds the duodenoscope in his left hand, inserts it through the mouth, passes the duodenoscope through the esophagus into the stomach, and enters the duodenum through the pylorus. He finds the duodenal papilla, adjusts the insertion depth of the duodenoscope, and the angles of the large and small knobs to prepare for bile duct or pancreatic duct intubation.

[0049] The guidewire is inserted through the guidewire hole on the side wall of the front end of the sphincterotomy tool. When the tip of the guidewire is close to the tip of the sphincterotomy tool, the guidewire and sphincterotomy tool are simultaneously inserted through the duodenoscope channel. The tool is then pulled out through the end of the duodenoscope and placed close to the duodenal papilla. The operator adjusts the lifting forceps with his left hand to control the angle of the sphincterotomy tool tip. He holds the guidewire with his right hand and repeatedly inserts and retracts the guidewire until it enters the common bile duct or pancreatic duct. With the guidewire fixed, the sphincterotomy tool can freely enter and exit the common bile duct or pancreatic duct to complete operations such as angiography, bile extraction, flushing, sphincterotomy, and withdrawal of the sphincterotomy tool.

[0050] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A single-operated duodenal sphincterotomy knife, characterized in that: include: An outer sheath tube, a guide wire, a metal wire (5) and a handle (4), wherein the guide wire is inserted into the interior of the outer sheath tube through the tube wall of the outer sheath tube and passes through the head end of the outer sheath tube; the handle (4) is connected to the tail end of the outer sheath tube, one end of the metal wire (5) is fixedly connected to the front end of the outer sheath tube, and the other end is inserted into the interior of the outer sheath tube and connected to the handle (4).

2. The single-operated duodenal sphincterotomy device according to claim 1, characterized in that: The outer sheath comprises a drainage tube segment I (1), a drainage tube segment II (2) and a drainage tube segment III (3) which are sequentially connected from head to tail, and the tail end of the drainage tube segment III (3) is connected to a handle (4).

3. The single-operated duodenal sphincterotomy device according to claim 2, characterized in that: The drainage tube section I (1) is a double-channel tube with a conical head end, and is provided with a guide wire channel I (11) and an injection channel I (12) inside.

4. The single-operated duodenal sphincterotomy device according to claim 2, characterized in that: The drainage tube section II (2) is a double-channel tube, and is provided with a guide wire channel II and an injection channel II therein. The guide wire channel II and the injection channel II are respectively connected to the guide wire channel I (11) and the injection channel I (12) of the drainage tube section I (1).

5. The single-operated duodenal sphincterotomy device according to claim 4, characterized in that: A side hole I is provided on the wall of the tail end of the drainage tube section II (2), and the side hole I is connected to the tail end of the guide wire channel II. The guide wire passes through the side hole I, the guide wire channel II, the guide wire channel I (11) in sequence and then exits.

6. The single-operated duodenal sphincterotomy device according to claim 2, characterized in that: One end of the metal wire (5) is fixed to the outer head end of the drainage tube section II (2), and a side hole II is provided on the tail end wall of the drainage tube section II (2). The other end of the metal wire (5) enters the outer sleeve through the side hole II.

7. The single-operated duodenal sphincterotomy device according to claim 6, characterized in that: A wristband is provided at the tail of the handle (4), a connecting rod (6) is connected to the wristband, and the other end of the metal wire (5) is connected to the connecting rod (6).

8. The single-operated duodenal sphincterotomy device according to claim 2, characterized in that: The drainage tube section III (3) is a double-channel drainage tube, and is provided with an injection channel III (31) and a metal wire channel (32) therein. The injection channel III (31) is connected to the injection channel II of the drainage tube section II (2), and the metal wire (5) is located in the metal wire channel (32).

9. The single-operated duodenal sphincterotomy device according to claim 2, characterized in that: The handle (4) is provided with an injection connector (7), which is in communication with the injection channel III (31) of the drainage tube section III (3), and the contrast agent is injected through the connector.