Duodenal papilla sphincterotomy knife with pressure measurement function

Abstract

The utility model provides a duodenum papilla sphincter muscle incision knife with pressure measurement function, including outer sheath, guide wire, wire and handle, the outer sheath includes the drainage tube section I, drainage tube section II, drainage tube section III and drainage tube section IV connected in proper order from head to tail, the tail end of drainage tube section IV is connected with handle, the pipe wall of drainage tube section II is opened with the installation groove, is equipped with pressure sensor in the installation groove, one end of wire is connected with the pipe wall of outer sheath, and the other end inserts the inside of outer sheath and handle, guide wire inserts through handle, passes through drainage tube section IV, drainage tube section III, drainage tube section II, drainage tube section I in proper order, and is worn out. The utility model can be under the assistance of guide wire to carry out the common bile duct or pancreatic duct intubation, detects the pressure of common bile duct, pancreatic duct and duodenum papilla sphincter muscle while carrying out endoscopic under papilla sphincter muscle incision, determines the size of papilla sphincter muscle incision through pressure value, avoids that papilla sphincter muscle is too small or too big.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a duodenal papillary sphincter cutter with pressure measurement function. Background Technology

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is an important surgical procedure for treating diseases such as common bile duct stones, obstructive jaundice, acute pancreatitis, bile duct stricture, and bile leakage. It offers advantages such as less trauma, faster recovery, and high repeatability. Endoscopic sphincterotomy (EST) is a key technique in therapeutic ERCP. By incising the duodenal papillary sphincter, it can relieve papillary sphincter stricture, facilitating stone removal and the placement of biliary stents and other accessories.

[0003] EST also carries certain complications. If the duodenal papillary sphincter incision is too small, it hinders stone removal and accessory placement, leading to a higher incidence of postoperative pancreatitis. Conversely, if the duodenal papillary sphincter incision is too large, the incidence of postoperative bleeding and bile leakage is higher, and damage to the biliary duct's closure can even lead to reflux cholangitis, bile duct stones, and bile duct cancer. Therefore, the size of the EST has always been a research topic for clinical endoscopists. Currently, EST is mainly divided into three types: large incision, medium incision, and small incision. However, there is significant individual variation in the size of the duodenal papillary sphincter, and the incidence of postoperative complications varies depending on the degree of incision. There is currently no unified standard for EST to address this individual variation.

[0004] The sphincter of Oddi is an important structure for maintaining the closure of the bile duct. Factors such as hypertrophy, stenosis, and excessive length of the sphincter of Oddi can lead to increased pressure in the bile and pancreatic ducts. Conversely, relaxation of the sphincter of Oddi and a large EST can lead to decreased pressure in the pancreatic and bile ducts. Therefore, bile and pancreatic duct pressure is an important indicator of the closure of the bile and pancreatic ducts, and the size of the EST can be determined by measuring the bile and pancreatic duct pressure.

[0005] Currently, biliary and pancreatic manometry mainly uses water irrigation. A manometry catheter with a side hole is inserted through a duodenoscope. Water flows out of the side hole at a constant low speed (0.15–0.40 mL / min) through the irrigation system. The resistance that the water needs to overcome when overflowing is the local pressure. This pressure is transmitted through the water column to an external pressure transducer and converted into an electrical signal. After processing by a recorder and computer, a graphical and numerical value can be obtained. Depending on the type of catheter, manometry can be divided into: water irrigation catheters, aspirable fluid irrigation catheters, and cuff-type manometry catheters. Because water irrigation manometry measures indirect pressure, its accuracy is low, and the operation is complex with a high rate of postoperative complications. Therefore, few hospitals in China have adopted this method, and its development has been slow. Miniature sensor manometry is a new direct manometry method that has emerged abroad in recent years. It does not require a water irrigation system, is simpler to operate, and provides more accurate measurement data. This method uses a solid-state manometry catheter and is mainly used in urology to measure renal pelvis pressure during cystoscopy or percutaneous nephrolithotomy. Currently, there are no solid-state manometry catheters applicable to the biliary and pancreatic system. Even with the availability of endoscopic bile and pancreatic manometry catheters, it is impossible to monitor changes in bile duct pressure in real time during EST incision. Determining the size of the duodenal papillary sphincter incision through EST-manometry-EST is a cumbersome procedure. Utility Model Content

[0006] In response to the aforementioned technical problems, a duodenal papillary sphincter incision knife with pressure measurement function is provided.

[0007] The technical means adopted in this utility model are as follows:

[0008] A duodenal sphincter cutter with pressure measurement function includes: an outer sheath, a guide wire, a metal wire, and a handle. The outer sheath includes drainage segments I, II, III, and IV connected sequentially from head to tail. The handle is connected to the tail end of drainage segment IV. A mounting groove is formed on the wall of drainage segment II, and a pressure sensor is installed in the mounting groove. One end of the metal wire is connected to the wall of the outer sheath, and the other end is inserted into the outer sheath and the handle. The guide wire is inserted through the handle, passes sequentially through drainage segment IV, drainage segment III, drainage segment II, and drainage segment I, and exits.

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

[0010] Furthermore, the drainage tube segment II is a three-channel tube, which has a guide wire channel II, an injection channel II and a data cable channel I inside. The guide wire channel II is connected to the guide wire channel I of the drainage tube segment I, and the injection channel II is connected to the injection channel I of the drainage tube segment I.

[0011] Furthermore, the drainage pipe section II is wrapped with a metal pipe, and the mounting groove is formed on the metal pipe.

[0012] Furthermore, the drainage tube segment III is a three-channel tube, internally equipped with a guidewire channel III, an injection channel III, and a data cable channel II. The guidewire channel III is connected to the guidewire channel II of the drainage tube segment II, the injection channel III is connected to the injection channel II of the drainage tube segment II, and the data cable channel II is connected to the data cable channel I of the drainage tube segment II.

[0013] Furthermore, a metal ring is provided at the connection between the drainage tube section III and the drainage tube section II. One end of the metal wire is fixedly connected to the outside of the metal ring. A side hole is provided on the tube wall at the tail end of the drainage tube section III. The other end of the metal wire enters the outer sheath tube through the side hole.

[0014] Furthermore, the drainage tube segment IV is a four-channel drainage tube, which has a guide wire channel VI, an injection channel VI, a metal wire channel and a data cable channel III inside. The guide wire channel VI is connected to the guide wire channel III of the drainage tube segment III, the injection channel VI is connected to the injection channel III of the drainage tube segment III, and the data cable channel III is connected to the data cable channel II of the drainage tube segment III.

[0015] Furthermore, the handle is provided with a guide wire connector, an injection connector, and a data cable connector. The guide wire connector is connected to the guide wire channel VI of the drainage tube section IV, the injection connector is connected to the injection channel VI of the drainage tube section IV, and the data cable connector is connected to the data cable channel III of the drainage tube section IV.

[0016] Furthermore, the handle is provided with a wristband at its tail end, and the wristband is connected to a connecting rod, which is connected to the other end of a metal wire.

[0017] Furthermore, the pressure sensor is connected to a data cable.

[0018] Compared with the prior art, the present invention has the following advantages:

[0019] 1. The duodenal papilla sphincter cutter with pressure measurement function provided by this utility model can perform bile duct / pancreatic duct cannulation with the assistance of guidewire and measure the pressure of the duodenal papilla, common bile duct and pancreatic duct, providing direct evidence for the diagnosis of diseases such as bile / pancreatic juice outflow obstruction, biliary hypertension and pancreatic duct hypertension.

[0020] 2. The duodenal papilla sphincter cutter with pressure measurement function provided by this utility model can measure the pressure of the duodenal papilla, common bile duct and pancreatic duct during the papilla sphincter cut procedure, determine the length of the duodenal papilla sphincter cut, avoid insufficient or excessive cut and related complications, and achieve truly precise duodenal papilla sphincter cut.

[0021] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description

[0022] 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.

[0023] Figure 1 This is a schematic diagram of the structure of this utility model.

[0024] Figure 2 This is a cross-sectional view of the drainage pipe section I of this utility model.

[0025] Figure 3 This is a cross-sectional view of the drainage pipe section III of this utility model.

[0026] Figure 4 This is a cross-sectional view of the drainage pipe section IV of this utility model.

[0027] Figure 5 This is a schematic diagram of the present invention in use.

[0028] In the diagram: 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. Guide wire channel III; 32. Injection channel III; 33. Data cable channel II; 4. Drainage tube segment IV; 41. Guide wire channel VI; 42. Injection channel VI; 43. Data cable channel III; 44. Metal wire channel; 5. Handle; 51. Guide wire connector; 52. Data cable connector; 53. Injection connector; 6. Pressure sensor; 7. Metal wire; 8. Data cable; 9. Connecting rod. Detailed Implementation

[0029] 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.

[0030] This utility model provides a duodenal papillary sphincter cutter with pressure measurement function, including: an outer sheath, a guide wire, a metal wire 7, and a handle 5. The outer sheath includes drainage tube segments I1, II2, III3, and IV4 connected sequentially from head to tail. The handle 5 is connected to the tail end of drainage tube segment IV4. A mounting groove is opened on the wall of drainage tube segment II2, and a pressure sensor 6 is installed in the mounting groove. One end of the metal wire 7 is connected to the wall of the outer sheath, and the other end is inserted into the outer sheath and the handle 5. The guide wire is inserted through the handle 5, passes sequentially through drainage tube segment IV4, drainage tube segment III3, drainage tube segment II2, and drainage tube segment I1, and exits.

[0031] In a preferred embodiment, the drainage tube segment I1 is conical in shape and is a dual-channel tube, with a guide wire channel I11 and an injection channel I12 inside.

[0032] 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 data cable channel I inside. The guidewire channel II is connected to the guidewire channel I11 of the drainage tube segment I1, and the injection channel II is connected to the injection channel I12 of the drainage tube segment I1.

[0033] In a preferred embodiment, the drainage pipe section II2 is wrapped with a metal pipe, and the installation groove is opened on the metal pipe.

[0034] In a preferred embodiment, the drainage tube segment Ⅲ3 is a three-channel tube, which has a guidewire channel Ⅲ31, an injection channel Ⅲ32 and a data cable channel Ⅱ33 inside. The guidewire channel Ⅲ31 is connected to the guidewire channel Ⅱ of the drainage tube segment Ⅱ2, the injection channel Ⅲ32 is connected to the injection channel Ⅱ of the drainage tube segment Ⅱ2, and the data cable channel Ⅱ33 is connected to the data cable channel Ⅰ of the drainage tube segment Ⅱ2.

[0035] In a preferred embodiment, a metal ring is provided at the connection between drainage tube section III3 and drainage tube section II2. One end of the metal wire 7 is fixedly connected to the outside of the metal ring. A side hole is provided on the tube wall at the tail end of drainage tube section III3. The other end of the metal wire 7 enters the outer sheath tube through the side hole.

[0036] In a preferred embodiment, the drainage tube segment IV4 is a four-channel drainage tube, which is provided with a guide wire channel VI41, an injection channel VI42, a metal wire channel 44, and a data cable channel Ⅲ43. The guide wire channel VI41 is connected to the guide wire channel Ⅲ31 of the drainage tube segment III3, the injection channel VI42 is connected to the injection channel Ⅲ32 of the drainage tube segment III3, and the data cable channel Ⅲ43 is connected to the data cable channel Ⅱ33 of the drainage tube segment III3.

[0037] In a preferred embodiment, the handle 5 is provided with a guide wire connector 51, an injection connector 53 and a data cable connector 52. The guide wire connector 51 is connected to the guide wire channel VI41 of the drainage tube section IV4, the injection connector 53 is connected to the injection channel VI42 of the drainage tube section IV4, and the data cable connector 52 is connected to the data cable channel Ⅲ43 of the drainage tube section IV4.

[0038] In a preferred embodiment, the handle 5 has a wristband at its tail, which is connected to a connecting rod 9. The connecting rod 9 is connected to the other end of the metal wire 7. Specifically, one end of the metal wire 7 is fixed to the outside of the metal ring, and the other end enters the metal wire channel 44 through a side hole, passes through the metal wire channel 44, and connects to the connecting rod 9. The metal wire 7 between the metal ring and the side hole is located outside the outer sheath.

[0039] In a preferred embodiment, the pressure sensor 6 is connected to a data cable 8, which is connected to an external device and can output the pressure value detected by the pressure sensor 6.

[0040] The aforementioned guide wire channels I11, II, III31, and VI41 are connected sequentially from beginning to end to form a guide wire channel. The guide wire is inserted from the guide wire connector 51, passes through the guide wire channel VI41, III31, II, and I11 in sequence, and exits from the guide wire channel I11.

[0041] Injection channels I12, II, III32, and VI42 are connected sequentially from beginning to end to form an injection channel, and the end of injection channel VI42 is connected to injection connector 53.

[0042] Data cable channel I and data cable channel II 33 are connected to form a data cable channel. The tail end of data cable channel II 33 is connected to data cable connector 52. The data cable is inserted through data cable connector 52 and passes through data cable channel II 33 and data cable channel I in sequence to connect to pressure sensor 6.

[0043] The outer diameter of the outer sheath is 7 Fr, the outer diameter of the head opening of drainage section I1 is 5 Fr, the inner diameter of the guidewire channel is 1 mm, the data cable channel is 0.5 mm, and the length is 3-4 m.

[0044] This invention allows for cannulation of the common bile duct or pancreatic duct with guidewire assistance. While performing endoscopic sphincterotomy, the pressure of the common bile duct, pancreatic duct, and duodenal sphincterotomy is monitored. The size of the sphincterotomy is determined by the pressure values, thus avoiding the sphincterotomy being too small or too large.

[0045] Use of this utility model:

[0046] (1) Do not use drugs that affect the bile duct and SO for 2 days before the operation, such as scopolamine bromide, nitroglycerin, etc. Fast for 12 hours before the operation.

[0047] (2) Before the operation, oral lidocaine or dacronin gel was administered to the oropharyngeal mucosa. The patient was in the same position as in ERCP, lying prone on the left side, biting down on the mouth and receiving oxygen via nasal cannula.

[0048] (3) The examination is performed by a skilled physician. After the duodenoscope is inserted into the digestive tract, the endoscope is straightened to locate the main duodenal papilla.

[0049] (4) The scalpel with guide wire was inserted into the common bile duct and a small amount of contrast agent was injected to confirm that it was the common bile duct.

[0050] (5) The incision knife is inserted into the upper part of the common bile duct and the pressure is recorded after the pressure curve stabilizes.

[0051] (6) Pull the cutting blade back, withdrawing 1-2 mm each time, and measure the pressure at each point for 30-60 seconds. The high-pressure zone seen when pulling back the conduit is the SO base pressure. At the same time, the high amplitude wave on the high-pressure base can be recorded, and the amplitude, interval, and propagation direction of the creep wave can be calculated.

[0052] (7) Continue with the posterior incision knife. Once the incision knife enters the duodenum, the pressure inside the duodenum can be recorded, and the pressure measurement ends.

[0053] (8) If necessary, SO pressure measurement or pancreatic duct cannulation measurement of pancreatic duct pressure can be repeated.

[0054] 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 duodenal papilla sphincter incision knife with pressure measurement function, characterized in that, include: The outer sheath, guide wire, metal wire (7), and handle (5) are provided. 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. The handle (5) is connected to the tail end of drainage tube segment IV (4). A mounting groove is opened on the tube wall of drainage tube segment II (2), and a pressure sensor (6) is provided in the mounting groove. One end of the metal wire (7) is connected to the tube wall of the outer sheath, and the other end is inserted into the interior of the outer sheath and the handle (5). The guide wire is inserted through the handle (5), passes sequentially through drainage tube segment IV (4), drainage tube segment III (3), drainage tube segment II (2), and drainage tube segment I (1), and then exits.

2. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The drainage tube section I (1) is conical in shape and is a dual-channel tube, with a guide wire channel I (11) and an injection channel I (12) inside.

3. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The drainage tube section II (2) is a three-channel tube, which has a guide wire channel II, an injection channel II and a data cable channel I inside. The guide wire channel II is connected to the guide wire channel I (11) of the drainage tube section I (1), and the injection channel II is connected to the injection channel I (12) of the drainage tube section I (1).

4. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 3, characterized in that, The drainage pipe section II (2) is wrapped with a metal pipe, and the installation groove is opened on the metal pipe.

5. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The drainage tube segment Ⅲ (3) is a three-channel tube, which has a guide wire channel Ⅲ (31), an injection channel Ⅲ (32) and a data line channel Ⅱ (33) inside. The guide wire channel Ⅲ (31) is connected to the guide wire channel Ⅱ of the drainage tube segment Ⅱ (2), the injection channel Ⅲ (32) is connected to the injection channel Ⅱ of the drainage tube segment Ⅱ (2), and the data line channel Ⅱ (33) is connected to the data line channel Ⅰ of the drainage tube segment Ⅱ (2).

6. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 5, characterized in that, A metal ring is provided at the connection between the drainage tube section III (3) and the drainage tube section II (2). One end of the metal wire (7) is fixedly connected to the outside of the metal ring. A side hole is provided on the tube wall at the tail end of the drainage tube section III (3). The other end of the metal wire (7) enters the outer sheath tube through the side hole.

7. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The drainage tube section IV (4) is a four-channel drainage tube, which is provided with a guide wire channel VI (41), an injection channel VI (42), a metal wire channel (44) and a data cable channel III (43). The guide wire channel VI (41) is connected to the guide wire channel III (31) of the drainage tube section III (3), the injection channel VI (42) is connected to the injection channel III (32) of the drainage tube section III (3), and the data cable channel III (43) is connected to the data cable channel II (33) of the drainage tube section III (3).

8. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The handle (5) is provided with a guide wire connector (51), an injection connector (53) and a data cable connector (52). The guide wire connector (51) is connected to the guide wire channel VI (41) of the drainage tube section IV (4). The injection connector (53) is connected to the injection channel VI (42) of the drainage tube section IV (4). The data cable connector (52) is connected to the data cable channel III (43) of the drainage tube section IV (4).

9. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The handle (5) is provided with a wristband at the end, and the wristband is connected to a connecting rod (9), which is connected to the other end of the metal wire (7).

10. The duodenal papilla sphincter incision knife with pressure measurement function according to claim 1, characterized in that, The pressure sensor (6) is connected to a data cable (8).

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