Single-person operation of duodenal sphincter incision knife

By designing a single-operator duodenal sphincter cutter, which employs a dual-channel outer sheath and side-wall guidewire structure, the problem of requiring an assistant to assist in the operation in existing technologies has been solved, improving the success rate of cannulation and the clarity of bile duct visualization, and reducing the risk of complications.

CN224421701UActive Publication Date: 2026-06-30SHANGHAI RUIFAN MEDICAL TECHNOLOGY CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
SHANGHAI RUIFAN MEDICAL TECHNOLOGY CO LTD
Filing Date
2025-06-13
Publication Date
2026-06-30

AI Technical Summary

Technical Problem

The existing duodenal sphincter incision knife requires an assistant during operation, has a low success rate of cannulation and is prone to complications, has a small inner diameter of injection channel which leads to unclear visualization of the bile duct and low flushing efficiency, and the guidewire is prone to dislodgement, affecting the accuracy and safety of diagnosis.

Method used

A single-operation duodenal head sphincter cutter was designed, which adopts a dual-channel outer sheath and guidewires are brought out through the side wall. Combined with the handle and wire structure, it enables single-operation guidewire insertion and increases the inner diameter of the injection channel, simplifying the operation process.

Benefits of technology

It improved the success rate of intubation, reduced the incidence of complications, enhanced the clarity of bile duct visualization and irrigation efficiency, and reduced the risk of complications.

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Abstract

This invention provides a single-operated duodenal sphincter cutter, comprising: an outer sheath, a guidewire, a metal wire, and a handle. The guidewire is inserted into the interior of the outer sheath through its wall and exits from its tip. The handle is connected to the tail of the outer sheath. One end of the metal wire is fixedly connected to the front of the outer sheath, and the other end is inserted into the interior of the outer sheath and connected to the handle. This invention features a dual-channel tube, with the guidewire entering the guidewire channel through the side wall. Its outer diameter is thinner than that of a conventional three-channel tube. The guidewire is led out through the side wall of the tube. With the outer sheath fixed in place, the operator can insert the guidewire into the common bile duct or pancreatic duct without the assistance of an assistant, increasing the success rate of cannulation.
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Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a single-person operation duodenal sphincter cutter. Background Technology

[0002] With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has gradually replaced surgery in the treatment of some biliary and pancreatic diseases. It is less invasive and allows for faster recovery, and is used for conditions such as common bile duct stones, bile duct injuries, bile duct strictures, and biliary complications after liver transplantation. Through direct visualization and contrast imaging with a duodenoscope, diseases that may be missed by conventional imaging examinations can even be detected, such as duodenal papillitis, para-papillary diverticula, and bile-pancreatic malconnection.

[0003] The duodenal papillary sphincter is an essential accessory in ERCP procedures. It assists in the insertion of guidewires into the bile duct or pancreatic duct, thereby reducing the incidence of postoperative complications such as pancreatitis and cholangitis. By incising the duodenal papillary sphincter, obstruction or stenosis of the bile and pancreatic outflow tract can be relieved, facilitating the removal of common bile duct stones and the placement of stents into the common bile duct or pancreatic duct.

[0004] Currently, the duodenal papillary sphincterotomy knife used clinically has a cylindrical body and a conical tip. The blade is a three-channel tube, including an injection channel, a wire channel, and a guidewire channel. The wire passes through the front wall and is fixed to the tip wall. By tightening the wire to make the tip fully arched, the direction of the guidewire insertion can be adjusted, and the duodenal papillary sphincterotomy can be completed. This arched duodenal papillary sphincterotomy knife has the following shortcomings: 1. The guidewire is generally led out through the handle of the duodenal papillary sphincterotomy knife, and the operator controls the orientation of the tip of the duodenoscope and the depth of the duodenal papillary sphincterotomy knife's insertion and withdrawal from the duodenoscope. 1. The guidewire is inserted into the common bile duct or pancreatic duct by an assistant. Because the operator has difficulty manipulating the guidewire for cannulation, if the assistant lacks experience, cannulation often fails, and may even lead to complications such as perforation, acute pancreatitis, and bleeding. 2. The currently used duodenal papillary sphincter sheath 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 smoothly through the outer sheath, the inner diameter of the injection channel is relatively small. Injecting contrast agent through this channel results in high resistance, unclear visualization of the bile duct, and reduced diagnostic accuracy. It also reduces the efficiency of aspirating contrast agent and bile through this channel, increasing the incidence of complications such as contrast agent-related cholangitis and liver damage. Furthermore, the low efficiency of bile duct irrigation makes it easy for sludge-like stones to block the contrast channel, hindering the removal of these stones and biliary sludge. 3. After successful bile duct cannulation, during the process of retracting the duodenal sphincter through the common bile duct into the duodenum or changing other accessories using the duodenoscope, if the operators do not coordinate well, the guidewire often exits the common bile duct along with the duodenal sphincter, requiring a second bile duct cannulation. Utility Model Content

[0005] In response to the aforementioned technical problems, a single-operator duodenal sphincter incision knife is provided.

[0006] The technical means adopted in this utility model are as follows:

[0007] A single-operated duodenal sphincter cutter includes: an outer sheath, a guidewire, a metal wire, and a handle. The guidewire 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 part 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 includes drainage tube segment I, drainage tube segment II, and drainage tube segment III connected sequentially from head to tail, with the tail end of drainage tube segment III connected to the handle.

[0009] Furthermore, the drainage tube section I is a dual-channel tube with a conical tip, and has a guide wire channel I and an injection channel I inside.

[0010] Furthermore, the drainage tube section II is a dual-channel tube, with a guidewire channel II and an injection channel II inside. 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 section I.

[0011] Furthermore, the drainage tube section II has a side hole I on its tail end wall. 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, and the guide wire channel I in sequence, and then exits.

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

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

[0014] Furthermore, the drainage tube section III is a dual-channel drainage tube, with an injection channel III and a metal wire channel inside. The injection channel III is connected to the injection channel II of the drainage tube section II, and the metal wire is located inside the metal wire channel.

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

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

[0017] 1. The single-operation duodenal sphincter cutter provided by this utility model has a double-channel outer sheath. Under the premise of the same outer diameter, the injection channel is larger, and the resistance to injection of contrast agent, aspiration of bile, and bile duct flushing is small, resulting in higher efficiency.

[0018] 2. The single-operator duodenal sphincter cutter provided by this utility model has a guidewire that is led out through the front side wall of the outer sheath. The operator can insert the guidewire into the common bile duct or pancreatic duct while operating the duodenoscope, which increases the success rate of insertion and reduces the incidence of complications. It also reduces the influence of the assistant's experience on the success rate of insertion and the incidence of complications.

[0019] 3. The single-operation duodenal sphincter cutter provided by this utility model can freely enter and exit the common bile duct and duodenoscope channel while fixing the guidewire, and will not cause the guidewire to dislodge from the common bile duct due to poor coordination between the operator and the assistant.

[0020] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of this utility model.

[0023] Figure 2 This is a cross-sectional view of the drainage pipe section I of this utility model.

[0024] Figure 3 This is a cross-sectional view of the drainage pipe section III of this utility model.

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

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

[0027] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0028] This utility model provides a single-person operated duodenal papillary sphincter cutter, 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 exits 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 of the outer sheath, and the other end is inserted into the interior of the outer sheath and connected to the handle 4.

[0029] In a preferred embodiment, the outer sheath includes drainage tube segment I1, drainage tube segment II2 and drainage tube segment III3 connected sequentially from head to tail, with the tail end of drainage tube segment III3 connected to handle 4.

[0030] In a preferred embodiment, the drainage tube segment I1 is a dual-channel tube with a conical head, and has a guide wire channel I11 and an injection channel I12 inside.

[0031] In a preferred embodiment, the drainage tube segment II2 is a dual-channel tube, with a guidewire channel II and an injection channel II inside. 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.

[0032] In a preferred embodiment, the drainage tube section II2 has a side hole I on its tail end wall. 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, and the guide wire channel I11 in sequence and then exits.

[0033] In a preferred embodiment, one end of the metal wire 5 is fixed to the outer end of the drainage tube section II2, and a side hole II is provided on the wall of the tail end of the drainage tube section II2. 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 end of the drainage tube section II2 is located outside the outer sheath.

[0034] In a preferred embodiment, the handle 4 is provided with a wristband at the end, and a connecting rod 6 is connected to the wristband. The other end of the metal wire 5 is connected to the connecting rod 6.

[0035] As a preferred embodiment, the drainage tube segment Ⅲ3 is a dual-channel drainage tube, which has 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.

[0036] In a preferred embodiment, the handle 4 is provided with an injection connector 7, which is connected to the injection channel 331 of the drainage tube section 3, and the contrast agent is injected through the connector.

[0037] The aforementioned guidewire channels I11 and II are connected from beginning to end to form a guidewire channel.

[0038] Injection channels I12, II, and III31 are connected from beginning to end to form an injection channel.

[0039] The angiography catheter (outer sheath) has an outer diameter of 7 Fr, an outer diameter of 5 Fr at the tip opening, an inner diameter of 1 mm for the guidewire channel, an inner diameter of 1 mm for the injection channel, an inner diameter of 0.5 mm for the metal wire channel, a tapered tip length of 10 mm, and a 2 cm long and 0.5 mm diameter electrosurgical wire at the tip.

[0040] This utility model is a dual-channel tube. The guidewire enters the guidewire channel through the side wall, and its outer diameter is thinner than that of a conventional three-channel tube. The guidewire is led out through the side wall of the tube. With the outer sheath tube fixed, the operator can insert the guidewire into the common bile duct or pancreatic duct without the help of an assistant, increasing the success rate of cannulation.

[0041] Use of this utility model:

[0042] The operator holds the duodenoscope in their left hand and inserts it through the mouth. The duodenoscope passes through the esophagus into the stomach, then through the pylorus into the duodenum. The operator locates the duodenal papilla and adjusts the insertion depth, the large and small knob angles of the duodenoscope to prepare for bile duct or pancreatic duct cannulation.

[0043] The guidewire is inserted through the guidewire hole on the side wall of the duodenal papillary sphincter. When the tip of the guidewire is close to the tip of the duodenal papillary sphincter, the guidewire and the duodenal papillary sphincter are simultaneously inserted through the duodenoscope's forceps channel. The duodenal sphincter is then brought out through the end of the duodenoscope and close to the duodenal papilla. The operator uses their left hand to adjust the lifting forceps to control the angle of the tip of the duodenal papillary sphincter, while holding the guidewire in their right hand. By repeatedly inserting and pulling the guidewire, it is guided into the common bile duct or pancreatic duct. Once the guidewire is fixed, the duodenal papillary sphincter can freely enter and exit the common bile duct or pancreatic duct to complete procedures such as contrast imaging, bile aspiration, irrigation, duodenal papillary sphincter incision, and withdrawal of the duodenal papillary sphincter.

[0044] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. A single-operation duodenal sphincter incision knife, characterized in that, include: The outer sheath, guide wire, metal wire (5) and handle (4) are provided. 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 (4) is connected to the tail end of the outer sheath. One end of the metal wire (5) is fixedly connected to the front of the outer sheath, and the other end is inserted into the interior of the outer sheath and connected to the handle (4).

2. The single operator duodenal cap sphincterotome of claim 1, wherein, The outer sheath includes drainage tube segment I (1), drainage tube segment II (2) and drainage tube segment III (3) connected sequentially from head to tail, with the tail end of drainage tube segment III (3) connected to the handle (4).

3. The single operator duodenal cap sphincterotome of claim 2, wherein, The drainage tube section I (1) is a double-channel tube with a conical head, and has a guide wire channel I (11) and an injection channel I (12) inside.

4. The single operator duodenal cap sphincterotome of claim 2, wherein, The drainage tube section II (2) is a dual-channel tube with a guide wire channel II and an injection channel II inside. 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 operator duodenal cap sphincterotome of Claim 4, wherein, The drainage tube section II (2) has a side hole I on its tail end wall. 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, and the guide wire channel I (11) in sequence and then exits.

6. The single operator duodenal cap sphincterotome of claim 2, wherein, One end of the metal wire (5) is fixed to the outer end of the drainage pipe section II (2). The drainage pipe section II (2) has a side hole II on the pipe wall at the tail end. The other end of the metal wire (5) enters the outer sleeve through the side hole II.

7. The single-use, twelve foot Sphincterotome of claim 6, wherein: The handle (4) is provided with a wristband at the end, and a connecting rod (6) is connected to the wristband. The other end of the metal wire (5) is connected to the connecting rod (6).

8. The single operator duodenal cap sphincterotome of claim 2, wherein, The drainage tube section Ⅲ (3) is a dual-channel drainage tube, with an injection channel Ⅲ (31) and a metal wire channel (32) inside. 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 inside the metal wire channel (32).

9. The single operator duodenal cap sphincterotome of claim 2, wherein, The handle (4) is provided with an injection connector (7), which is connected to the injection channel (31) of the drainage tube section III (3) and the contrast agent is injected through the connector.