Double wire papillary sphincterotome
By designing a dual-guidewire nipple sphincter cutter, we have achieved cannulation with the two guidewires not interfering with each other, simplifying the operation process, improving the success rate of cannulation, reducing the risk of complications, and solving the problems of complex operation and difficult cannulation in existing technologies.
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
- 2026-07-03
AI Technical Summary
The current duodenal sphincter incision technique is complex, difficult for assistants to operate, has a high failure rate for intubation, and is prone to complications such as perforation, acute pancreatitis, and bleeding. In addition, bile duct intubation is difficult and prolongs the operation time.
A dual-guidewire nipple sphincter cutter is designed, comprising an outer sheath, a handle, a first guidewire, and a second guidewire. The outer sheath has multiple guidewire channels and injection channels. The second guidewire is led out through the front side wall of the outer sheath, enabling cannulation with the two guidewires not interfering with each other. The assistant and the operator control the two guidewires respectively, increasing the success rate of cannulation.
The dual guidewire design simplifies the procedure, reduces the risk of cannulation failure, improves the success rate of bile duct and pancreatic duct cannulation, reduces complications, and reduces reliance on the assistant's experience.
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Figure CN224441414U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and more specifically, to a double-guidewire nipple 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. When an assistant inserts a guidewire into the common bile duct or pancreatic duct, the operator often faces difficulties in manipulating the guidewire, and insufficient assistant experience frequently leads to insertion failure, potentially causing complications such as perforation, acute pancreatitis, and bleeding. 2. For more difficult bile duct cannulation, after the guidewire enters the pancreatic duct, it needs to be left in place and the papillary incision knife withdrawn. A second guidewire is then reinserted into the papillary incision knife for cannulation. Due to the influence of the first guidewire, adjusting the angle of the papillary incision knife is difficult, and the insertion angle of the second guidewire changes little, leading to bile duct cannulation failure. In this case, a stent needs to be placed in the pancreatic duct before attempting bile duct cannulation. This not only prolongs the cannulation time but the placed pancreatic duct stent still interferes with bile duct cannulation. Utility Model Content
[0005] In response to the aforementioned technical problems, a dual-guidewire nipple sphincter cutter is provided.
[0006] The technical means adopted in this utility model are as follows:
[0007] A dual-guidewire nipple sphincter cutter includes: an outer sheath, a handle, a first guidewire, a second guidewire, and a metal wire. The first guidewire is inserted into the outer sheath through its wall and exits through the wall. The handle is connected to the tail end of the outer sheath. The second guidewire is inserted into the outer sheath through the handle and exits through its head end. One end of the metal wire is fixedly connected to the wall of the outer sheath, and the other end is inserted into the outer sheath and connected to the handle.
[0008] Furthermore, the outer sheath includes drainage tube segment I, drainage tube segment II, drainage tube segment III and drainage tube segment IV connected sequentially from head to tail, with the tail end of drainage tube segment IV 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 three-channel tube, with a guidewire channel II, an injection channel II, and a guidewire channel III 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. The opening of the guidewire channel III is opened on the side wall of the drainage tube section II.
[0011] Furthermore, the drainage tube segment III is a three-channel tube, with a guidewire channel IV, an injection channel III, and a guidewire channel V inside. The guidewire channel IV, the injection channel III, and the guidewire channel V are respectively connected to the guidewire channel II, the injection channel II, and the guidewire channel III of the drainage tube segment II.
[0012] Furthermore, a side hole I is opened on the end wall of the drainage tube section III. The side hole I is connected to the end of the guide wire channel V. The second guide wire is inserted through the side hole I, passes through the guide wire channel V and the guide wire channel III in sequence, and exits from the opening of the guide wire channel III.
[0013] Furthermore, a side hole II is opened on the tail end of the drainage tube section III. One end of the metal wire is fixedly connected to the outer head end of the drainage tube section III, and the other end is inserted into the outer sheath tube through the side hole II.
[0014] Furthermore, the drainage tube section IV is a three-channel drainage tube, which has a guide wire channel VI, an injection channel IV and a metal wire channel inside. The guide wire channel VI is connected to the guide wire channel IV of the drainage tube section III, the injection channel IV is connected to the injection channel III of the drainage tube section III, and the metal wire is located in the metal wire channel.
[0015] Furthermore, the handle is provided with a wristband, a guidewire connector (51) and an injection connector (52). The guidewire connector (51) is connected to the guidewire channel VI of the drainage tube section IV, and the first guidewire is inserted through the guidewire connector (51). The injection connector (52) is connected to the injection channel IV of the drainage tube section IV, and the contrast agent is injected through the injection connector (52).
[0016] Furthermore, the handle is provided with a wristband, the wristband is connected to a connecting rod, and the other end of the metal wire is connected to the connecting rod.
[0017] Compared with the prior art, the present invention has the following advantages:
[0018] 1. The dual-guidewire nipple sphincter cutter provided by this utility model has a three-channel outer sheath tube, which enables dual-guidewire insertion while keeping the outer diameter of the cutter unchanged, and the two guidewires do not interfere with each other.
[0019] 2. The double-guidewire sphincter cutter provided by this utility model has a double guidewire channel. The second guidewire is led out through the front side wall of the outer sheath. The second guidewire is at a certain angle to the first guidewire. If the first guidewire enters the pancreatic duct, the second guidewire is more likely to enter the common bile duct, increasing the success rate of bile duct cannulation.
[0020] 3. The double guidewire sphincterotomy knife provided by this utility model has a double guidewire channel. The second guidewire is led out through the front side wall of the outer sheath. The direction of the guidewire exiting the sphincterotomy knife is at a certain angle to the axis of the sphincterotomy knife. It is easier to insert the cannula into the pancreatic duct through the tip of the sphincterotomy knife, and it is easier to insert the cannula into the common bile duct through the side hole, so as to achieve selective bile duct or pancreatic duct cannulation.
[0021] 4. The dual-guidewire nipple sphincter cutter provided by this utility model allows for cannulation by an assistant through the guidewire drawn from the tip of the nipple cutter, and cannulation by the operator through the guidewire drawn from the side wall of the nipple cutter. This two-person cannulation increases the success rate of cannulation and reduces the requirement for the assistant's experience.
[0022] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description
[0023] 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.
[0024] Figure 1 This is a schematic diagram of the structure of this utility model.
[0025] Figure 2 This is a cross-sectional view of the drainage pipe section I of this utility model.
[0026] Figure 3 This is a cross-sectional view of the drainage pipe section III of this utility model.
[0027] Figure 4 This is a cross-sectional view of the drainage pipe section IV of this utility model.
[0028] Figure 5 This is a schematic diagram of the insertion of the first and second guide wires according to this utility model.
[0029] 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. Guide wire channel IV; 32. Guide wire channel V; 33. Injection channel III; 4. Drainage tube section IV; 41. Guide wire channel VI; 42. Injection channel IV; 43. Metal wire channel; 5. Handle; 51. Guide wire connector; 52. Injection connector; 6. Opening; 7. Metal wire; 8. Side hole I; 9. Side hole II; 10. Connecting rod. Detailed Implementation
[0030] 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.
[0031] This utility model provides a double-guidewire nipple sphincter cutter, comprising: an outer sheath, a handle 5, a first guidewire, a second guidewire, and a metal wire 7. The first guidewire is inserted into the outer sheath through the wall of the outer sheath and exits through the wall of the outer sheath. The handle 5 is connected to the tail end of the outer sheath. The second guidewire is inserted into the outer sheath through the handle 5 and exits through the head end of the outer sheath. One end of the metal wire 7 is fixedly connected to the wall of the outer sheath, and the other end is inserted into the outer sheath and connected to the handle 5.
[0032] In a preferred embodiment, the outer sheath includes drainage tube segment I1, drainage tube segment II2, drainage tube segment III3 and drainage tube segment IV4 connected sequentially from head to tail, with the tail end of drainage tube segment IV4 connected to handle 5.
[0033] 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.
[0034] In a preferred embodiment, the drainage tube segment II2 is a three-channel tube, which has a guidewire channel II, an injection channel II and a guidewire channel III 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. The opening 6 of the guidewire channel III is opened on the side wall of the drainage tube segment II2.
[0035] In a preferred embodiment, the drainage tube segment Ⅲ3 is a three-channel tube, which has a guidewire channel Ⅳ31, an injection channel Ⅲ33 and a guidewire channel Ⅴ32 inside. The guidewire channel Ⅳ31, the injection channel Ⅲ33 and the guidewire channel Ⅴ32 are respectively connected to the guidewire channel Ⅱ, the injection channel Ⅱ and the guidewire channel Ⅲ of the drainage tube segment Ⅱ2.
[0036] In a preferred embodiment, a side hole I8 is opened on the end wall of the drainage tube section III3. The side hole I8 is connected to the end of the guide wire channel V32. The second guide wire is inserted through the side hole I8, passes through the guide wire channel V32 and the guide wire channel III in sequence, and exits from the opening 6 of the guide wire channel III.
[0037] In a preferred embodiment, a side hole II9 is formed on the wall of the tail end of the drainage tube segment III3. One end of the metal wire 7 is fixedly connected to the outer end of the drainage tube segment III3, and the other end is inserted into the outer sheath through the side hole II9. The metal wire 7 between the side hole II9 and the outer end of the drainage tube segment III3 is located outside the outer sheath.
[0038] In a preferred embodiment, the drainage tube section IV4 is a three-channel drainage tube, which is provided with a guide wire channel VI41, an injection channel IV42 and a metal wire channel 43. The guide wire channel VI41 is connected to the guide wire channel IV31 of the drainage tube section III3, the injection channel IV42 is connected to the injection channel III33 of the drainage tube section III3, and the metal wire 7 is located in the metal wire channel 43.
[0039] In a preferred embodiment, the handle 5 is provided with a wristband, a guidewire connector 51 and an injection connector 52. The guidewire connector 51 is connected to the guidewire channel VI41 of the drainage tube section IV4, and the first guidewire is inserted through the guidewire connector 51. The injection connector 52 is connected to the injection channel IV42 of the drainage tube section IV4, and the contrast agent is injected through the injection connector 52.
[0040] In a preferred embodiment, the handle 5 is provided with a wristband, which is connected to a connecting rod 10, and the other end of the metal wire 7 is connected to the connecting rod 10.
[0041] In a preferred embodiment, the second guidewire is at a certain angle to the first guidewire.
[0042] The aforementioned guidewire channels I11, II, IV31, and VI41 are connected from beginning to end to form the first guidewire channel. The first guidewire is inserted from the guidewire connector 51, passes through the guidewire channels VI41, IV31, II, and I11 in sequence, and exits from the opening at the beginning of the guidewire channel I11.
[0043] Injection channels I12, II, III33, and IV42 are connected from beginning to end to form an injection channel.
[0044] Guidewire channel Ⅲ and guidewire channel Ⅴ32 constitute the second guidewire channel.
[0045] The angiography catheter (outer sheath) has an outer diameter of 7 Fr, the drainage segment I1 has an outer diameter of 5 Fr, the guidewire channel has an inner diameter of 1 mm, the injection channel has an inner diameter of 1 mm, the metal wire channel has an inner diameter of 0.5 mm, the tapered tip has a length of 10 mm, the tip electrosurgical wire has a length of 2 cm, and the wire diameter is 0.5 mm.
[0046] This invention is a three-channel tube. An assistant can use a guidewire to assist in inserting the cannula into the pancreatic duct through a sphincter of Oddi. Without increasing the diameter of the sphincter of Oddi, the surgeon can operate a second guidewire to insert the cannula into the common bile duct through the side wall of the tube, enabling two-person, multi-angle cannulation and increasing the success rate of bile duct cannulation.
[0047] Use of this utility model:
[0048] 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 angle of the large and small knobs, in preparation for bile duct or pancreatic duct cannulation.
[0049] The assistant inserts the guidewire into the common bile duct through the guidewire hole on the side wall of the front end of the papillary sphincter, indicating successful cannulation. If the guidewire fails to enter the common bile duct after multiple attempts, it indicates difficult bile duct cannulation. (1) The guidewire enters the pancreatic duct. At this time, the guidewire is left in the pancreatic duct. The papillary sphincter is withdrawn, and a second guidewire is inserted through the side hole at the front end of the papillary sphincter. The guidewire and the papillary sphincter are simultaneously inserted through the duodenoscope channel. The slit is brought out through the end of the duodenoscope and close to the duodenal papilla. The operator adjusts the forceps with their left hand to control the angle of the tip of the sphincter of Oddi, and holds the second guidewire with their right hand. By repeatedly inserting and pulling the guidewire, the second guidewire is brought into the common bile duct. (2) If the guidewire does not enter the pancreatic duct, the guidewire and sphincter of Oddi are withdrawn. The guidewire is then inserted through the side hole at the tip of the sphincter of Oddi. The guidewire and sphincter of Oddi are simultaneously inserted through the duodenoscope forceps channel. The cutter is brought out through the end of the duodenoscope and placed close to the duodenal papilla. The operator adjusts the forceps with their left hand to control the angle of the tip of the sphincter of Oddi, and holds the guidewire with their right hand. By repeatedly inserting and pulling the guidewire, the guidewire is brought into the common bile duct.
[0050] 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 double guide wire papillary sphincterotome, characterized in that include: The outer sheath, handle (5), first guide wire, second guide wire and metal wire (7) are provided. The first guide wire is inserted into the outer sheath through the wall of the outer sheath and exits through the wall of the outer sheath. The handle (5) is connected to the tail end of the outer sheath. The second guide wire is inserted into the outer sheath through the handle (5) and exits through the head end of the outer sheath. One end of the metal wire (7) is fixedly connected to the wall of the outer sheath, and the other end is inserted into the outer sheath and connected to the handle (5).
2. The double guide-wire papillosphincterotomy knife according to claim 1, characterized in that The outer sheath includes drainage tube segment I (1), drainage tube segment II (2), drainage tube segment III (3) and drainage tube segment IV (4) connected sequentially from head to tail, with the tail end of drainage tube segment IV (4) connected to the handle (5).
3. The double guide-wire papillosphincterotomy knife according to claim 2, characterized in that 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 double guide-wire papillosphincterotomy knife according to claim 2, characterized in that The drainage tube section II (2) is a three-channel tube with a guide wire channel II, an injection channel II and a guide wire channel III 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). The opening (6) of the guide wire channel III is opened on the side wall of the drainage tube section II (2).
5. The double guide-wire papillosphincterotomy knife according to claim 2, characterized in that The drainage tube section Ⅲ (3) is a three-channel tube, with a guidewire channel Ⅳ (31), an injection channel Ⅲ (33) and a guidewire channel Ⅴ (32) inside. The guidewire channel Ⅳ (31), the injection channel Ⅲ (33) and the guidewire channel Ⅴ (32) are respectively connected to the guidewire channel Ⅱ, the injection channel Ⅱ and the guidewire channel Ⅲ of the drainage tube section Ⅱ (2).
6. The double guide-wire papillosphincterotomy knife according to claim 5, characterized in that The drainage tube section Ⅲ (3) has a side hole Ⅰ (8) on its tail end wall. The side hole Ⅰ (8) is connected to the tail end of the guide wire channel Ⅴ (32). The second guide wire is inserted through the side hole Ⅰ (8), passes through the guide wire channel Ⅴ (32) and the guide wire channel Ⅲ in sequence, and exits from the opening (6) of the guide wire channel Ⅲ.
7. The dual-guidewire nipple sphincter cutter according to claim 5, characterized in that, The drainage tube section Ⅲ (3) has a side hole Ⅱ (9) on its tail end wall. One end of the metal wire (7) is fixedly connected to the outer head end of the drainage tube section Ⅲ (3), and the other end is inserted into the outer sheath tube through the side hole Ⅱ (9).
8. The dual guide-wire papillosphincterotomy knife according to claim 2, characterized in that The drainage tube section IV (4) is a three-channel drainage tube, which is provided with a guide wire channel VI (41), an injection channel IV (42) and a metal wire channel (43). The guide wire channel VI (41) is connected to the guide wire channel IV (31) of the drainage tube section III (3), and the injection channel IV (42) is connected to the injection channel III (33) of the drainage tube section III (3). The metal wire (7) is located in the metal wire channel (43).
9. The dual guide-wire papillosphincterotomy knife according to claim 2, characterized in that The handle (5) is provided with a wristband, a guidewire connector (51) and an injection connector (52). The guidewire connector (51) is connected to the guidewire channel VI (41) of the drainage tube section IV (4), and the first guidewire is inserted through the guidewire connector (51). The injection connector (52) is connected to the injection channel IV (42) of the drainage tube section IV (4), and the contrast agent is injected through the injection connector (52).
10. The dual guide-wire papillosphincterotomy knife according to claim 1, characterized in that The handle (5) is provided with a wristband, which is connected to a connecting rod (10). The other end of the metal wire (7) is connected to the connecting rod (10).