Nipple sphincter incision knife with double guide wires

Abstract

The invention provides a double-guide-wire nipple sphincter incision knife which comprises an outer sheath tube, a handle, a first guide wire, a second guide wire and a metal wire, and the first guide wire is inserted into the outer sheath tube through the tube wall of the outer sheath tube and penetrates out of the tube wall of the outer sheath tube; the handle is connected with the tail end of the outer sheath tube, and the second guide wire is inserted into the outer sheath tube through the handle and penetrates out of the head end of the outer sheath tube. One end of the metal wire is fixedly connected to the tube wall of the outer sheath tube, and the other end of the metal wire is inserted into the outer sheath tube and connected with the handle. During use, an assistant can implement the guide wire to assist the nipple sphincter incision knife in intubation into the pancreatic duct, an operator can operate the second guide wire to enter the common bile duct through intubation on the side wall of the duct wall on the basis that the duct diameter of the nipple incision knife is not increased, double-person multi-angle intubation is achieved, and the bile duct intubation success rate is increased.

Description

Technical Field

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

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

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

[0004] The sphincterotomy knife currently in clinical use has a cylindrical body and a conical head. The blade is a three-channel tube, including an injection channel, a metal wire channel and a guide wire channel. The metal wire passes through the front end tube wall and is fixed on the head end tube wall. By tightening the metal wire to make its head completely arched, the direction of the guide wire insertion is adjusted, and the sphincterotomy of the duodenal papilla is completed. The arched sphincterotomy knife has the following shortcomings: 1. The guide wire is generally led out through the sphincterotomy knife handle, and the operator controls the position of the front end of the duodenoscope and the depth of the sphincterotomy knife entering and exiting the duodenoscope. An assistant operates the guidewire to insert into the common bile duct or pancreatic duct. Because it is difficult for the operator to operate the guidewire for intubation, if the assistant lacks experience, it often leads to intubation failure, and even causes complications such as perforation, acute pancreatitis, and bleeding; 2. Less difficult bile duct intubation. After the guidewire enters the pancreatic duct, the guidewire needs to be left in place and the papillomatomy unit needs to be withdrawn. The papillomatomy unit with a second guidewire is reinserted for intubation. Due to the influence of the first guidewire, it is difficult to adjust the angle of the papillomatomy unit, and the intubation angle of the second guidewire changes little, resulting in failure of bile duct intubation. At this time, a stent needs to be placed in the pancreatic duct before bile duct intubation is performed. Not only does it prolong the intubation time, but the inserted pancreatic duct stent still interferes with bile duct intubation. Summary of the Invention

[0005] In response to the above-mentioned technical problems, a double-guidewire sphincterotomy knife is provided.

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

[0007] A double-guidewire sphincterotomy knife comprises: an outer sheath, a handle, a first guide wire, a second guide wire and a metal wire, wherein the first guide wire is inserted into the interior of the outer sheath through the wall of the outer sheath and passes out from the wall of the outer sheath; the handle is connected to the tail end of the outer sheath, and the second guide wire is inserted into the interior of the outer sheath through the handle and passes out from the head end of the outer sheath; one end of the metal wire is fixedly connected to the wall 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, drainage tube segment III and drainage tube segment IV which are sequentially connected from the beginning to the end, and the tail end of the drainage tube segment IV is connected to the handle.

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

[0010] Furthermore, the drainage tube segment II is a three-channel tube, which is provided 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 segment I, and the opening of the guidewire channel III is opened on the side wall of the drainage tube segment II.

[0011] Furthermore, the drainage tube segment III is a three-channel tube, which is provided with a guidewire channel IV, an injection channel III and a guidewire channel V. The guidewire channel IV, injection channel III and guidewire channel V are respectively connected to the guidewire channel II, injection channel II and guidewire channel III of the drainage tube segment II.

[0012] Furthermore, a side hole I is opened on the wall of the tail end of the drainage tube segment III, and the side hole I is connected to the tail end of the guidewire channel V. The second guidewire is inserted through the side hole I, passes through the guidewire channel V and the guidewire channel III in sequence, and passes out from the opening of the guidewire channel III.

[0013] Furthermore, a side hole II is opened on the tail end wall of the drainage tube segment III, one end of the metal wire is fixedly connected to the outer head end of the drainage tube segment III, and the other end is inserted into the outer sheath through the side hole II.

[0014] Furthermore, the drainage tube segment IV is a three-channel drainage tube, which is provided with a guidewire channel VI, an injection channel IV and a metal wire channel. The guidewire channel VI is connected to the guidewire channel IV of the drainage tube segment III, and the injection channel IV is connected to the injection channel III of the drainage tube segment III. 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 segment 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 segment IV, and the contrast agent is injected through the injection connector (52).

[0016] Furthermore, a wristband is provided on the handle, 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 double-guidewire sphincterotomy provided by the present invention has an outer sheath of a three-channel tube. Under the premise of keeping the outer diameter of the sphincterotomy unchanged, double-guidewire intubation is achieved without the two guidewires interfering with each other.

[0019] 2. The double-guidewire sphincterotomy provided by the present invention has a double guidewire channel. The second guidewire is led out through the side wall of the front end 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, thereby increasing the success rate of bile duct intubation.

[0020] 3. The double-guidewire sphincterotomy provided by the present invention has a double guidewire channel. The second guidewire is led out through the side wall of the front end of the outer sheath. The direction in which the guidewire exits the sphincterotomy is at a certain angle to the axial direction of the sphincterotomy. It is easier to enter the pancreatic duct by inserting a cannula through the tip of the sphincterotomy, while it is easier to enter the common bile duct by inserting a guidewire through the side hole, thereby realizing selective bile duct or pancreatic duct cannulation.

[0021] 4. The double-guidewire sphincterotomy provided by the present invention can be operated by an assistant to insert the guidewire led out through the end of the sphincterotomy head, and the guidewire led out through the side wall of the sphincterotomy can be inserted by the operator. Two people can insert the cannula, which increases the success rate of intubation and reduces the requirement for the assistant's experience.

[0022] Based on the above reasons, the present invention can be widely promoted in fields such as medical treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] 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.

[0024] Figure 1 It is a structural schematic diagram of the present invention.

[0025] Figure 2 It is a cross-sectional view of the drainage tube section I of the present invention.

[0026] Figure 3 It is a cross-sectional view of the drainage tube section III of the present invention.

[0027] Figure 4 It is a cross-sectional view of the drainage tube segment IV of the present invention.

[0028] Figure 5 Schematic diagram of inserting the first guide wire and the second guide wire according to the present invention.

[0029] 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 IV; 32. Guide wire channel V; 33. Injection channel III; 4. Drainage tube segment 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 DESCRIPTION

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] The present invention provides a double-guidewire sphincterotomy knife, comprising: an outer sheath, a handle 5, a first guide wire, a second guide wire and a metal wire 7, wherein the first guide wire is inserted into the interior of the outer sheath through the wall of the outer sheath and passes 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 interior of the outer sheath through the handle 5 and passes 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 interior of the outer sheath and connected to the handle 5.

[0038] As 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 in sequence from head to tail, and the tail end of drainage tube segment IV4 is connected to the handle 5.

[0039] As a preferred embodiment, the drainage tube segment Ⅰ1 is a double-channel tube with a conical head end, and a guidewire channel Ⅰ11 and an injection channel Ⅰ12 are provided inside.

[0040] As a preferred embodiment, the drainage tube segment II2 is a three-channel tube, which is provided 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 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.

[0041] As a preferred embodiment, the drainage tube segment III3 is a three-channel tube, which is provided with a guidewire channel IV31, an injection channel III33 and a guidewire channel V32. 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.

[0042] As a preferred embodiment, a side hole I8 is opened on the wall of the tail end of the drainage tube segment III3, and the side hole I8 is connected to the tail 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 passes out from the opening 6 of the guide wire channel III.

[0043] As a preferred embodiment, a side hole II9 is ​​formed in 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 tip 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 tip of the drainage tube segment III3 is located outside the outer sheath.

[0044] As a preferred embodiment, the drainage tube segment 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 segment III3, and the injection channel IV42 is connected to the injection channel III33 of the drainage tube segment III3. The metal wire 7 is located in the metal wire channel 43.

[0045] As 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 segment 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 segment IV4, and the contrast agent is injected through the injection connector 52.

[0046] As a preferred embodiment, a wristband is provided on the handle 5 , the wristband is connected to a connecting rod 10 , and the other end of the metal wire 7 is connected to the connecting rod 10 .

[0047] As a preferred embodiment, the second guide wire is at a certain angle to the first guide wire.

[0048] The above-mentioned guidewire channel I11, guidewire channel II, guidewire channel IV31, and guidewire channel VI41 are connected from beginning to end to form a first guidewire channel. The first guidewire is inserted from the guidewire connector 51, passes through the guidewire channel VI41, guidewire channel IV31, guidewire channel II, and guidewire channel I11 in sequence, and exits from the head end opening of the guidewire channel I11.

[0049] The injection channel I 12, the injection channel II, the injection channel III 33, and the injection channel IV 42 are connected from beginning to end to form the injection channel.

[0050] The guide wire channel III and the guide wire channel V 32 constitute a second guide wire channel.

[0051] The outer diameter of the angiography catheter (outer sheath) is 7Fr, the outer diameter of the head opening of the drainage tube segment Ⅰ1 is 5Fr, the inner diameter of the guide wire channel is 1mm, the inner diameter of the injection channel is 1mm, the inner diameter of the metal wire channel is 0.5mm, the length of the tapered head is 10mm, the length of the electric knife metal wire at the head end is 2cm, and the diameter of the metal wire is 0.5mm.

[0052] The present invention is a three-channel tube. An assistant can implement a guidewire-assisted sphincterotomy to insert a cannula into the pancreatic duct. Without increasing the diameter of the papillomatomy tube, the operator can operate a second guidewire to insert a cannula through the side wall of the tube into the common bile duct, thereby realizing double-person multi-angle cannulation and increasing the success rate of bile duct cannulation.

[0053] Use of the present invention:

[0054] The operator holds the duodenoscope in his left hand and inserts it through the mouth. The duodenoscope enters the stomach through the esophagus and the duodenum through the pylorus. He finds the duodenal papilla and adjusts the depth of insertion into the duodenum, the angles of the large and small knobs, and prepares for bile duct or pancreatic duct intubation.

[0055] The assistant inserts the guidewire through the guidewire hole on the front side of the sphincterotomy tool into the common bile duct, indicating successful intubation. If the guidewire still fails to enter the common bile duct after multiple intubations, it indicates difficult bile duct intubation. (1) The guidewire enters the pancreatic duct. At this time, the guidewire is left in the pancreatic duct, the sphincterotomy tool is withdrawn, and a second guidewire is inserted through the side hole at the front end of the sphincterotomy tool. The guidewire and sphincterotomy tool are inserted simultaneously through the duodenoscope channel. The tool is led out through the end of the duodenoscope and placed close to the duodenal papilla. The operator adjusts the lifting forceps with his left hand to control the angle of the sphincterotomy tip, and holds the second guide wire with his right hand. By repeatedly inserting and pulling back the guide wire, the second guide wire enters the common bile duct. (2) If the guide wire does not enter the pancreatic duct, withdraw the guide wire and the sphincterotomy knife, insert the guide wire through the side hole at the front end of the sphincterotomy knife, and insert the guide wire and sphincterotomy knife simultaneously through the duodenoscope channel. The knife is led out through the end of the duodenoscope and close to the duodenal papilla. The operator adjusts the lifting forceps with his left hand to control the angle of the sphincterotomy tip, and holds the guide wire with his right hand. By repeatedly inserting and pulling back the guide wire, the guide wire enters the common bile duct.

[0056] 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 double-guidewire sphincterotomy device, characterized in that: include: An outer sheath tube, a handle (5), a first guide wire, a second guide wire and a metal wire (7), wherein the first guide wire is inserted into the inner part of the outer sheath tube through the tube wall of the outer sheath tube and passes through the tube wall of the outer sheath tube; the handle (5) is connected to the tail end of the outer sheath tube, the second guide wire is inserted into the inner part of the outer sheath tube through the handle (5) and passes through the head end of the outer sheath tube; one end of the metal wire (7) is fixedly connected to the tube wall of the outer sheath tube, and the other end is inserted into the inner part of the outer sheath tube and connected to the handle (5).

2. The double-guidewire sphincterotomy device according to claim 1, characterized in that: The outer sheath comprises a drainage tube segment I (1), a drainage tube segment II (2), a drainage tube segment III (3) and a drainage tube segment IV (4) which are sequentially connected from the beginning to the end, and the tail end of the drainage tube segment IV (4) is connected to the handle (5).

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

4. The double-guidewire sphincterotomy device according to claim 2, 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 guide wire channel III. 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-guidewire sphincterotomy device according to claim 2, characterized in that: The drainage tube section III (3) is a three-channel tube, which is provided with a guide wire channel IV (31), an injection channel III (33) and a guide wire channel V (32). The guide wire channel IV (31), the injection channel III (33) and the guide wire channel V (32) are respectively connected to the guide wire channel II, the injection channel II and the guide wire channel III of the drainage tube section II (2).

6. The double-guidewire sphincterotomy device according to claim 5, characterized in that: A side hole I (8) is opened on the wall of the tail end of the drainage tube section III (3), and 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 comes out from the opening (6) of the guide wire channel III.

7. The double-guidewire sphincterotomy device according to claim 5, characterized in that: A side hole II (9) is opened on the wall of the tail end of the drainage tube segment III (3); one end of the metal wire (7) is fixedly connected to the outer head end of the drainage tube segment III (3), and the other end is inserted into the outer sheath through the side hole II (9).

8. The double-guidewire sphincterotomy device 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) inside. 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 double-guidewire sphincterotomy device according to claim 2, characterized in that: The handle (5) is provided with a wristband, a guide wire connector (51) and an injection connector (52). The guide wire connector (51) is communicated with the guide wire channel VI (41) of the drainage tube segment IV (4), and a first guide wire is inserted through the guide wire connector (51); the injection connector (52) is communicated with the injection channel IV (42) of the drainage tube segment IV (4), and a contrast agent is injected through the injection connector (52).

10. The double-guidewire sphincterotomy device according to claim 1, characterized in that: The handle (5) is provided with a wristband, the wristband is connected to a connecting rod (10), and the other end of the metal wire (7) is connected to the connecting rod (10).

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