Duodenal papilla sphincter incision knife with pressure measuring function

Abstract

The duodenal papilla sphincter incision knife with the pressure measuring function comprises an outer sheath tube, a guide wire, a metal wire and a handle, the outer sheath tube comprises a drainage tube section I, a drainage tube section II, a drainage tube section III and a drainage tube section IV which are sequentially connected from head to tail, and the handle is connected with the tail end of the drainage tube section IV. A mounting groove is formed in the tube wall of the drainage tube section II, a pressure sensor is arranged in the mounting groove, one end of a metal wire is connected with the tube wall of the outer sheath tube, and the other end of the metal wire is inserted into the outer sheath tube and the handle; the guide wire is inserted through the handle, sequentially penetrates through the drainage tube section IV, the drainage tube section III, the drainage tube section II and the drainage tube section I and penetrates out. According to the invention, common bile duct or pancreatic duct intubation can be carried out under the assistance of the guide wire, the pressure of common bile duct, pancreatic duct and duodenal papilla sphincter is detected while papilla sphincter is incised under an endoscope, and the incised size of the papilla sphincter is determined according to the pressure value, so that the papilla sphincter is prevented from being incised too small or too large.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a duodenal papilla sphincterotomy knife with a pressure measuring function. Background Art

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is an important surgical procedure for treating common bile duct stones, obstructive jaundice, acute pancreatitis, bile duct strictures, and bile leaks, offering advantages such as minimal trauma, faster recovery, and high reproducibility. Endoscopic sphincterotomy (EST) is a key technique in therapeutic ERCP. By incising the duodenal sphincter, EST relieves stenosis, facilitating stone removal and the placement of accessories such as bile duct stents.

[0003] EST also carries certain complications. If the sphincterotomy is too small, it can hinder stone removal and accessory insertion, leading to a higher incidence of postoperative pancreatitis. If the sphincterotomy is too large, the incidence of postoperative bleeding and bile leakage is high, disrupting the tightness of the bile duct and even leading to reflux cholangitis, bile duct stones, and bile duct cancer. Therefore, the size of the EST has long been a topic of research for clinical endoscopists. Currently, EST is divided into three main types: large, medium, and small. However, individual differences in the sphincterotomy are considerable, and the incidence of postoperative complications varies with the degree of incision. To address this individual variability, there is currently no unified standard for EST.

[0004] The duodenal sphincter is an important structure for maintaining the tightness of the bile duct. Factors such as hypertrophy, stenosis, and excessive length of the duodenal sphincter can lead to increased bile and pancreatic duct pressure. Relaxation of the duodenal sphincter and a large EST can lead to decreased pancreatic and bile duct pressure. Therefore, bile and pancreatic duct pressure is an important indicator of bile and pancreatic duct tightness, and the size of the EST can be determined by testing the bile and pancreatic duct pressure.

[0005] Currently, bile and pancreatic pressure measurement primarily utilizes water perfusion. A pressure-measuring catheter with a side hole is inserted through a duodenoscope. Water flows out of the side hole at a constant, low rate (0.15–0.40 mL / min) through the water perfusion system. The resistance overcome by the water overflow is the local pressure. This pressure is transmitted through the water column to an external pressure transducer, where it is converted into an electrical signal. After processing by a recorder and computer, the resulting signal is graphically and numerically generated. Depending on the type of pressure-measuring catheter, it can be categorized as: water-perfusion catheters, aspirable liquid-perfusion catheters, and cuff-type pressure-measuring catheters. Because water perfusion pressure measurement measures indirect pressure, it has low accuracy, is complex to perform, and has a high incidence of postoperative complications. Therefore, it is rarely used in domestic hospitals and has been a slow development. Microsensor pressure measurement is a new direct pressure measurement method that has emerged recently abroad. It does not require a water perfusion system, is simpler to perform, and provides more accurate data. This method utilizes a solid-state pressure-measuring catheter and is primarily used in urology to measure renal pelvic pressure during cystoscopy or percutaneous nephrolithotomy. Currently, no solid-state pressure-measuring catheters are available for use in the bile and pancreas. Even with the advent of an endoscopic bile and pancreatic pressure measurement catheter, it is impossible to monitor the changes in bile duct pressure during EST incision in real time. The size of the duodenal sphincterotomy is determined by the EST-pressure measurement-EST method, which is a cumbersome operation. Summary of the Invention

[0006] In order to solve the above-mentioned technical problems, a duodenal papilla sphincterotomy knife with a pressure measuring function is provided.

[0007] The technical means adopted in the present invention are as follows:

[0008] A duodenal papilla sphincterotomy knife with a pressure measurement function comprises: an outer sheath, a guide wire, a metal wire and a handle. The outer sheath comprises drainage tube segment I, drainage tube segment II, drainage tube segment III and drainage tube segment IV, which are connected in sequence from beginning to end. The handle is connected to the tail end of drainage tube segment IV. An installation groove is provided on the wall of drainage tube segment II. A pressure sensor is provided in the installation groove. One end of the metal wire is connected to the wall of the outer sheath, and the other end is inserted into the interior of the outer sheath and the handle. The guide wire is inserted through the handle, passes through drainage tube segment IV, drainage tube segment III, drainage tube segment II, drainage tube segment I in sequence, and exits.

[0009] Furthermore, the drainage tube section I is conical in shape and is a double-channel tube, with a guidewire channel I and an injection channel I provided inside.

[0010] Furthermore, the drainage tube segment II is a three-channel tube, which is provided with a guidewire channel II, an injection channel II and a data line channel I inside. The guidewire channel II is connected to the guidewire 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 by a metal pipe, and the installation groove is opened on the metal pipe.

[0012] Furthermore, the drainage tube segment III is a three-channel tube, which is provided with a guidewire channel III, an injection channel III and a data line channel II inside. 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 line channel II is connected to the data line channel I of the drainage tube segment II.

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

[0014] Furthermore, the drainage tube segment IV is a four-channel drainage tube, which is provided with a guidewire channel VI, an injection channel VI, a metal wire channel and a data cable channel III. The guidewire channel VI is connected to the guidewire 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 guidewire connector, an injection connector and a data line connector, the guidewire connector is connected to the guidewire channel VI of the drainage tube segment IV, the injection connector is connected to the injection channel VI of the drainage tube segment IV, and the data line connector is connected to the data line channel III of the drainage tube segment IV.

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

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

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

[0019] 1. The duodenal papilla sphincterotomy with pressure measurement function provided by the present invention can perform bile duct / pancreatic duct intubation with the assistance of a 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 sphincterotomy knife with a pressure measurement function provided by the present invention can measure the pressure of the duodenal papilla, common bile duct and pancreatic duct during the sphincterotomy process, determine the length of the sphincterotomy, avoid insufficient or excessive incision and the occurrence of related complications, and achieve truly precise sphincterotomy.

[0021] Based on the above reasons, the present invention can be widely promoted in fields such as medical treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] 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.

[0023] Figure 1 It is a structural schematic diagram of the present invention.

[0024] Figure 2 It is a cross-sectional view of the drainage tube section I of the present invention.

[0025] Figure 3 It is a cross-sectional view of the drainage tube section III of the present invention.

[0026] Figure 4 It is a cross-sectional view of the drainage tube segment IV of the present invention.

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

[0028] 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. 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 DESCRIPTION

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] The present invention provides a duodenal papilla sphincterotomy knife with a pressure measurement function, comprising: an outer sheath, a guide wire, a metal wire 7 and a handle 5. The outer sheath comprises a drainage tube segment I1, a drainage tube segment II2, a drainage tube segment III3 and a drainage tube segment IV4 which are connected in sequence from beginning to end. The handle 5 is connected to the tail end of the drainage tube segment IV4. An installation groove is provided on the tube wall of the drainage tube segment II2. A pressure sensor 6 is provided in the installation 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 through the drainage tube segment IV4, the drainage tube segment III3, the drainage tube segment II2, the drainage tube segment I1 in sequence, and then passes out.

[0037] As a preferred embodiment, the drainage tube segment Ⅰ1 is conical and is a double-channel tube with a guidewire channel Ⅰ11 and an injection channel Ⅰ12 provided inside.

[0038] As a preferred embodiment, drainage tube segment II2 is a three-channel tube, which is provided with a guidewire channel II, an injection channel II and a data line channel I inside. The guidewire channel II is connected to the guidewire channel I11 of drainage tube segment I1, and the injection channel II is connected to the injection channel I12 of drainage tube segment I1.

[0039] As a preferred embodiment, the drainage pipe section II2 is wrapped with a metal pipe, and the installation groove is opened on the metal pipe.

[0040] As a preferred embodiment, the drainage tube segment III3 is a three-channel tube, which is provided with a guide wire channel III31, an injection channel III32 and a data line channel II33 inside. The guide wire channel III31 is connected to the guide wire 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 line channel II33 is connected to the data line channel I of the drainage tube segment II2.

[0041] As a preferred embodiment, a metal ring is provided at the connection between the drainage tube segment III3 and the drainage tube segment 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 tail end wall of the drainage tube segment III3, and the other end of the metal wire 7 enters the outer sheath through the side hole.

[0042] As 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 line 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 line channel III43 is connected to the data line channel II33 of the drainage tube segment III3.

[0043] As a preferred embodiment, the handle 5 is provided with a guide wire connector 51, an injection connector 53 and a data line connector 52. The guide wire connector 51 is connected to the guide wire channel VI41 of the drainage tube segment IV4, the injection connector 53 is connected to the injection channel VI42 of the drainage tube segment IV4, and the data line connector 52 is connected to the data line channel III43 of the drainage tube segment IV4.

[0044] As a preferred embodiment, a wristband is provided at the end of the handle 5, which is connected to a connecting rod 9, which 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 band, and the other end enters the metal wire channel 44 through the side hole, passes through the metal wire channel 44, and then connects to the connecting rod 9. The metal wire 7 is located outside the outer sheath between the metal band and the side hole.

[0045] As a preferred embodiment, the pressure sensor 6 is connected to a data line 8 , which is connected to an external existing device and can output the pressure value detected by the pressure sensor 6 .

[0046] The above-mentioned guidewire channel I11, guidewire channel II, guidewire channel III31, and guidewire channel VI41 are connected in sequence from beginning to end to form a guidewire channel. The guidewire is inserted from the guidewire connector 51, passes through the guidewire channel VI41, guidewire channel III31, guidewire channel II, guidewire channel I11 in sequence, and exits from the guidewire channel I11.

[0047] The injection channel I 12 , the injection channel II, the injection channel III 32 , and the injection channel VI 42 are sequentially connected from the beginning to the end to form an injection channel, and the tail end of the injection channel VI 42 is connected to the injection connector 53 .

[0048] The data line channel I and the data line channel II 33 are connected to form a data line channel. The tail end of the data line channel II 33 is connected to the data line connector 52. The data line is inserted through the data line connector 52 and passes through the data line channel II 33 and the data line channel I in sequence to connect to the pressure sensor 6.

[0049] The outer diameter of the outer sheath is 7Fr, the outer diameter of the head end opening of the drainage tube segment Ⅰ1 is 5Fr, the inner diameter of the guidewire channel is 1mm, the data line channel is 0.5mm, and the length is 3 to 4m.

[0050] The present invention can perform common bile duct or pancreatic duct cannulation with the assistance of a guidewire, detect the pressures of the common bile duct, pancreatic duct and duodenal papillary sphincters while performing endoscopic sphincterotomy, determine the size of the papillary sphincterotomy based on the pressure value, and avoid the papillary sphincterotomy being too small or too large.

[0051] Use of the present invention:

[0052] (1) 2 days before surgery, it is forbidden to use drugs that affect the bile duct and SO, such as scopolamine butylbromide and nitroglycerin, and fast for 12 hours before surgery.

[0053] (2) Oral lidocaine or dyclonine jelly is administered as an oropharyngeal mucosal anesthetic before the operation. The body position is the same as that of ERCP, with the patient lying on the left side, biting the mouth, and receiving oxygen through a nasal cannula.

[0054] (3) The examination is performed by a skilled physician. After the duodenoscope is passed through the digestive tract, the duodenoscope is straightened to locate the main duodenal papilla.

[0055] (4) The incision knife with a guide wire is inserted into the common bile duct and a small amount of contrast agent is injected to confirm the common bile duct.

[0056] (5) The incision knife enters the upper part of the common bile duct and duodenum, and the pressure in the common bile duct is recorded after the pressure curve stabilizes.

[0057] (6) Pull the incisor back, withdrawing 1-2 mm at a time, and measuring the pressure at each point for 30-60 seconds. The high-pressure area seen when the catheter is pulled back is the SO base pressure. At the same time, the high-amplitude wave based on the high-pressure zone can be recorded, based on which the amplitude, interval, and propagation direction of the peristaltic wave can be calculated.

[0058] (7) Continue to perform the incision. When the incision enters the duodenum, the pressure in the duodenum can be recorded, and the pressure measurement is completed.

[0059] (8) If necessary, repeated SO pressure measurement or pancreatic duct cannulation can be performed to measure pancreatic duct pressure.

[0060] 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 duodenal papilla sphincterotomy knife with a manometry function, characterized in that: include: An outer sheath, a guide wire, a metal wire (7) and a handle (5), wherein the outer sheath comprises a drainage tube segment I (1), a drainage tube segment II (2), a drainage tube segment III (3) and a drainage tube segment IV (4) connected in sequence from the beginning to the end, the handle (5) is connected to the tail end of the drainage tube segment IV (4), a mounting groove is provided on the tube wall of the drainage tube segment II (2), 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 through the drainage tube segment IV (4), the drainage tube segment III (3), the drainage tube segment II (2), the drainage tube segment I (1) in sequence, and then passes out.

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

3. The duodenal papilla sphincterotomy knife with a pressure measurement function according to claim 1, characterized in that: The drainage tube section II (2) is a three-channel tube, which is provided with a guide wire channel II, an injection channel II and a data line channel I. 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 sphincterotomy knife with a pressure measurement function according to claim 3, characterized in that: The drainage pipe section II (2) is wrapped by a metal pipe, and the installation groove is opened on the metal pipe.

5. The duodenal papilla sphincterotomy knife with a pressure measurement function according to claim 1, characterized in that: The drainage tube section III (3) is a three-channel tube, and is provided with 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 section II (2), the injection channel III (32) is connected to the injection channel II of the drainage tube section II (2), and the data line channel II (33) is connected to the data line channel I of the drainage tube section II (2).

6. The duodenal papilla sphincterotomy knife with a pressure measurement function according to claim 5, characterized in that: A metal ring is provided at the connection between the drainage tube segment III (3) and the drainage tube segment 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 wall of the tail end of the drainage tube segment III (3), and the other end of the metal wire (7) enters the outer sheath through the side hole.

7. The duodenal papilla sphincterotomy knife with a pressure measurement function according to claim 1, characterized in that: The drainage tube segment 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 line channel III (43). The guide wire channel VI (41) is connected to the guide wire channel III (31) of the drainage tube segment III (3), the injection channel VI (42) is connected to the injection channel III (32) of the drainage tube segment III (3), and the data line channel III (43) is connected to the data line channel II (33) of the drainage tube segment III (3).

8. The duodenal papilla sphincterotomy knife with a 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 line connector (52); the guide wire connector (51) is communicated with the guide wire channel VI (41) of the drainage tube segment IV (4); the injection connector (53) is communicated with the injection channel VI (42) of the drainage tube segment IV (4); and the data line connector (52) is communicated with the data line channel III (43) of the drainage tube segment IV (4).

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

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

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