Biliary drainage tube to prevent duodenal papilla bleeding

Abstract

The present invention provides a bile duct drainage tube for preventing duodenal papilla bleeding, comprising a drainage tube body, an inner core and a pusher; the head tube section of the drainage tube body is provided with at least two side holes, the middle tube section of the drainage tube body is attached with a cylindrical balloon, the tail tube section of the drainage tube body is provided with a one-way injection valve, the head of the injection valve is connected with the balloon; the balloon is cylindrical after being filled; the head of the inner core includes a channel I and a needle tube, the channel I is inserted into the lumen of the drainage tube body and passes out, and the needle tube is inserted through the tail end of the injection valve; the tail of the inner core is located in the lumen of the pusher; the tail includes a channel II connected with the channel I and a channel III connected with the needle tube; the base of the inner core is provided with a channel IV connected with the channel II and a channel V connected with the channel III, and the channel V is connected with a balloon injection connector. While draining bile, the filled balloon can compress the duodenal papilla sphincter, and can prevent the occurrence of postoperative cholangitis and duodenal papilla bleeding.

Description

Technical Field

[0001] The present invention relates to the field of minimally invasive medical technology and surgical instrument technology, and in particular to an intra-biliary drainage tube for preventing duodenal papilla bleeding, which is a minimally invasive surgical instrument for draining bile and preventing duodenal papilla bleeding. Background Art

[0002] Endoscopic endoscopic resection (ERCP) is an important measure for the treatment of hepatobiliary and pancreatic diseases, including common bile duct stones, bile duct injury, bile duct stenosis, and biliary complications after liver transplantation. Compared with traditional open surgery, this technology has the advantages of less trauma, higher safety factor, and faster recovery, but it still has complications such as bleeding, acute pancreatitis, perforation, and acute cholangitis. With the increase in therapeutic ERCP, the incidence of post-ERCP complications is also on the rise, among which the incidence of duodenal papilla bleeding is as high as 2.4% to 10.4%.

[0003] Bleeding during ERCP can be stopped directly under endoscopy. The methods of hemostasis include drug spraying, local injection, electrocoagulation, hemostatic clamps, and metal stent compression. Among the various endoscopic treatment measures, the placement of a fully covered self-expanding metal stent can exert mechanical compression on the entire papillary tissue, and has the most thorough hemostatic effect. It is especially suitable for patients with poor liver function, jaundice, and coagulation disorders caused by oral anticoagulants such as aspirin. However, the use of fully covered metal stents to prevent bleeding has the following disadvantages: (1) The price of fully covered metal stents is as high as 20,000 yuan, which limits their widespread clinical application; (2) After the metal stent is placed across the duodenal papilla, the tightness of the duodenal papilla is destroyed, and intestinal fluid and chyme in the intestine can easily flow back into the bile duct through the metal stent, causing cholangitis and bile duct stones; (3) After the papilla wound heals, a second endoscopic operation is required to remove the metal stent, and some patients need to use a balloon to clean up the chyme that has flowed back into the bile duct. Summary of the invention

[0004] According to the above-mentioned fully coated metal stent, the price is as high as 20,000 yuan, which limits its wide clinical application; after the metal stent is placed across the duodenal papilla, the tightness of the duodenal papilla is destroyed, and the intestinal fluid and chyme in the intestine easily flow back into the bile duct through the metal stent, causing cholangitis and bile duct stones; after the papilla wound heals, a secondary endoscopic operation is required to remove the metal stent, and some patients need to use a balloon to clean the chyme refluxed in the bile duct. A biliary drainage tube for preventing duodenal papilla bleeding is provided. The present invention mainly uses the side hole to drain bile, and compresses the duodenal papilla sphincter through the filled balloon to prevent the occurrence of postoperative cholangitis and duodenal papilla bleeding.

[0005] The technical means adopted by the present invention are as follows:

[0006] An intra-biliary drainage tube for preventing duodenal papilla bleeding comprises: a drainage tube body, an inner core and a pusher;

[0007] The drainage tube body is a single-channel straight tube; the head tube section of the drainage tube body is provided with at least two side holes, the middle tube section of the drainage tube body is attached with a cylindrical balloon, the tail tube section of the drainage tube body is provided with a one-way injection valve, and the head of the injection valve is connected with the balloon; the balloon is cylindrical after being filled, and the upper and lower ends of the balloon are respectively fixed to the tube wall of the middle tube section by metal rings;

[0008] The inner core is a double-channel tube, including a head, a tail and a base; the head includes a channel I and a needle tube, both of which are single-channel tubes, the channel I is inserted into the lumen of the drainage tube body and passes out, and the needle tube is inserted through the silicone joint at the tail end of the injection valve;

[0009] The propeller is an outer sleeve, the tail portion is located in the lumen of the propeller, and the head end of the tail portion is close to the tail end of the drainage tube body; the tail portion includes channel II and channel III, both of which are single-channel tubes, and the channel II is connected to the channel I; the channel III is connected to the needle tube;

[0010] The bottom end of the tail is connected to the base, and the base is a double-channel base, which is provided with a channel IV and a channel V, and the channel IV is connected to the channel II; the channel V is connected to the channel III, and the channel V is L-shaped and connected to the balloon injection connector provided on the side wall of the base;

[0011] The channel I, the channel II and the channel IV constitute a guide wire channel.

[0012] Furthermore, the diameter of the drainage tube is 7Fr, 8.5Fr or 10Fr, and the length of the drainage tube is 7cm or 9cm.

[0013] Furthermore, the length of the balloon is 5 cm, and the expanded diameter of the balloon is 8 mm, 10 mm, 12 mm, 14 mm or 16 mm.

[0014] Furthermore, the propeller is provided with a handle.

[0015] Compared with the prior art, the present invention has the following advantages:

[0016] 1. The intra-biliary drainage tube for preventing duodenal papilla bleeding provided by the present invention can compress the duodenal papilla sphincter while draining bile, thereby preventing the occurrence of postoperative cholangitis and duodenal papilla bleeding.

[0017] 2. The intra-biliary drainage tube for preventing duodenal papilla bleeding provided by the present invention can prevent intestinal fluid and chyme from flowing back into the common bile duct during use.

[0018] 3. The intra-biliary drainage tube for preventing duodenal papilla bleeding provided by the present invention has a balloon that compresses the papilla, thereby preventing bleeding and preventing displacement.

[0019] 4. The intra-biliary drainage tube for preventing duodenal papilla bleeding provided by the present invention is simple to manufacture and has low cost.

[0020] 5. The bile duct drainage tube for preventing duodenal papilla bleeding provided by the present invention can pull out the inner core by fixing the propeller, thereby realizing the separation of the drainage tube.

[0021] In summary, the application of the technical solution of the present invention can solve the problems that the fully covered metal stent in the prior art is priced as high as 20,000 yuan, which limits its wide clinical application; after the metal stent is placed across the duodenal papilla, the airtightness of the duodenal papilla is destroyed, and the intestinal fluid and chyme in the intestine can easily flow back into the bile duct through the metal stent, causing cholangitis and bile duct stones; after the papilla wound heals, a secondary endoscopic operation is required to remove the metal stent, and some patients need to use a balloon to clean the chyme refluxed in the bile duct.

[0022] Based on the above reasons, the present invention can be widely promoted in the fields of minimally invasive medical technology and surgical instruments. 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 drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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 creative labor.

[0024] Figure 1 It is a schematic diagram of the structure of an intrabiliary drainage tube for preventing duodenal papilla bleeding in a specific embodiment of the present invention.

[0025] Figure 2 It is a schematic diagram of the intrabiliary drainage tube for preventing duodenal papilla bleeding in a specific embodiment of the present invention in a working state (balloon filled).

[0026] Figure 3 It is a schematic structural diagram of the drainage tube body in a specific implementation manner of the present invention.

[0027] Figure 4 It is a schematic diagram of the structure of the drainage tube body in a specific embodiment of the present invention (balloon filling).

[0028] Figure 5 It is a schematic diagram of the structure of the inner core in a specific embodiment of the present invention.

[0029] Figure 6 It is a schematic diagram of the structure of a propeller in a specific implementation manner of the present invention.

[0030] In the figure: 1. drainage tube body; 11. side hole; 12. balloon; 2. inner core; 21. channel I; 22. needle tube; 23. channel II; 24. channel III; 3. pusher; 31. handle; 4. base; 41. balloon injection connector; 42. channel IV; 43. channel V; 5. injection valve. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments 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.

[0032] 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 by no means 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 creative work are within the scope of protection of the present invention.

[0033] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0034] Unless otherwise specifically stated, the relative arrangement of the parts and steps described in these embodiments, the numerical expressions and numerical values ​​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 drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be regarded as part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0035] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the 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 contours of each component itself.

[0036] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. 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 figure. For example, if the device in the accompanying 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.

[0037] 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. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0038] like Figure 1-6As shown, the present invention provides a bile duct drainage tube for preventing duodenal papilla bleeding, comprising: a drainage tube body 1, an inner core 2 and a pusher 3; wherein the diameter of the drainage tube is 7Fr, 8.5Fr or 10Fr, and the length of the drainage tube is 7cm or 9cm.

[0039] The drainage tube body 1 is a single-channel straight tube; the head tube section of the drainage tube body 1 is provided with at least two side holes 11 for draining bile; the middle tube section of the drainage tube body 1 is attached with a cylindrical balloon 12, and the tail tube section of the drainage tube body 1 is provided with a one-way injection valve 5, and the head of the injection valve 5 is connected with the balloon 12; the balloon 12 is cylindrical after being filled, and the upper and lower ends of the balloon 12 are respectively fixed to the tube wall of the middle tube section by metal rings; wherein, the length of the balloon 12 is 5 cm, and the expanded diameter of the balloon 12 is 8 mm, 10 mm, 12 mm, 14 mm or 16 mm.

[0040] The inner core 2 is a double-channel tube, including a head, a tail and a base 4; the head includes a channel I 21 and a needle tube 22, both of which are single-channel tubes. The channel I 21 is inserted into the lumen of the drainage tube body 1 and passes through it. The needle tube 22 is a steel needle, which penetrates into the connecting head (i.e., the injection valve 5) of the balloon 12 through the silicone joint (which can also be a rubber joint) at the tail end of the injection valve 5. After the needle tube 22 pierces into or is pulled out of the silicone joint, the sealing of the silicone joint ensures that the liquid will not flow out.

[0041] The thruster 3 is an outer sleeve, the tail portion is located in the lumen of the thruster 3, and the head end of the tail portion is close to the tail end of the drainage tube body 1; the tail portion includes channel II 23 and channel III 24, both of which are single-channel tubes; channel II 23 is connected to channel I 21 and both are plastic tubes; channel III 24 is connected to the needle tube 22.

[0042] The bottom end of the tail is connected to the base 4, which is a double channel, and is provided with a channel IV 42 and a channel V 43, wherein the channel IV 42 is connected to the channel II; the channel V (43) is connected to the channel III 24, and the channel V 43 is L-shaped and is connected to the balloon injection connector 41 provided on the side wall of the base 4 (the end of the L-shaped horizontal pipe section of the channel V 43 is connected to the balloon injection connector 41, and the L-shaped vertical pipe section is connected to the channel III 24). Wherein, the channel I 21, the channel II 23 and the channel IV 42 constitute a guide wire channel.

[0043] The pusher 3 is provided with a handle 31, which is convenient for fixing the pusher 3 during clinical operation. The handle 31 is provided on the pusher 3, which can improve the fixing effect of the pusher 3, and the phenomenon of directly holding the pusher 3 and causing deformation of the drainage tube will not occur.

[0044] During clinical operation, the device is inserted through the duodenal forceps under the guidance of a guide wire. After the tail end of the balloon 12 is exposed, the balloon injection connector 41 is connected to the syringe, and the normal saline containing contrast agent is injected through the inner core 2 to fill part of the balloon 12. The position of the balloon 12 is adjusted so that the protruding part of the balloon 12 is close to the nipple opening, and the balloon 12 is continuously filled to the maximum diameter. After that, the left hand holds the handle 31 and keeps it still, and the handle 31 and the pusher 3 are fixed by holding the handle 31, and the right hand holds the base 4, and the base 4 is withdrawn, and the inner core 2 and the guide wire are quickly pushed out, and the needle tube 22 of the inner core 2 is separated from the one-way injection valve 5, the inner core 2 is separated from the drainage tube body 1, and the pusher 3 is separated from the drainage tube body 1, so as to withdraw the pusher 3, the inner core 2 and the guide wire, and complete the purpose of the bile duct drainage tube and the balloon 12 compressing the duodenal papilla to prevent bleeding.

[0045] Removal of the drainage tube body 1: After the balloon 12 compresses the duodenal papilla for a long time, the drainage tube body 1 may fall off by itself and be discharged from the body with the peristalsis of the duodenum. If it does not fall off by itself, the balloon 12 can be cut open with a needle knife to release the gas, and the tail end of the drainage tube body 1 can be dragged out with a snare.

[0046] 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 aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned 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 bile duct drainage tube for preventing duodenal papilla bleeding, characterized in that: include: A drainage tube body (1), an inner core (2) and a propeller (3); The drainage tube body (1) is a single-channel straight tube; the head tube section of the drainage tube body (1) is provided with at least two side holes (11); the middle tube section of the drainage tube body (1) is attached with a cylindrical balloon (12); the tail tube section of the drainage tube body (1) is provided with a one-way injection valve (5); the head of the injection valve (5) is connected to the balloon (12); the balloon (12) is cylindrical after being filled, and the upper and lower ends of the balloon (12) are respectively fixed to the tube wall of the middle tube section by metal rings; The inner core (2) is a double-channel tube, comprising a head, a tail and a base (4); the head comprises a channel I (21) and a needle tube (22), both of which are single-channel tubes; the channel I (21) is inserted into the lumen of the drainage tube body (1) and passes out; the needle tube (22) is inserted through the silicone joint at the tail end of the injection valve (5); The propeller (3) is an outer sleeve, the tail portion is located in the lumen of the propeller (3), and the head end of the tail portion is close to the tail end of the drainage tube body (1); the tail portion includes a channel II (23) and a channel III (24), both of which are single-channel tubes, the channel II (23) is connected to the channel I (21); the channel III (24) is connected to the needle tube (22); The bottom end of the tail portion is connected to the base (4), the base (4) is a double channel, and is provided with a channel IV (42) and a channel V (43), the channel IV (42) is connected to the channel II; the channel V (43) is connected to the channel III (24), the channel V (43) is L-shaped, and is connected to a balloon injection connector (41) provided on the side wall of the base (4); The channel I (21), the channel II (23) and the channel IV (42) constitute a guide wire channel; The channel II (23) is connected to the channel I (21) and both are plastic tubes.

2. The intra-biliary drainage tube for preventing duodenal papilla bleeding according to claim 1, characterized in that: The diameter of the drainage tube is 7Fr, 8.5Fr or 10Fr, and the length of the drainage tube is 7cm or 9cm.

3. The intra-biliary drainage tube for preventing duodenal papilla bleeding according to claim 1 or 2, characterized in that: The length of the balloon (12) is 5 cm, and the expanded diameter of the balloon (12) is 8 mm, 10 mm, 12 mm, 14 mm or 16 mm.

4. The intra-biliary drainage tube for preventing duodenal papilla bleeding according to claim 3, characterized in that: The propeller (3) is provided with a handle (31).

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