Biliary drainage tube

Abstract

This application discloses a bile duct drainage tube, comprising a connected, hollow tubular main body, a second helical structure, and two first helical structures, both of which are spirally coiled. The two first helical structures are located at both ends of the bile duct drainage tube, and the second helical structure is located between the two first helical structures. The coiled shape of the first helical structure can be held within the bile duct, providing radial support; and the helical design increases the contact area and friction with the luminal wall, thereby helping the bile duct drainage tube to remain relatively stable in a preset position. The second helical structure is located within the bile duct, and the diseased tissue within the bile duct wraps around the second helical structure. This provides resistance to displacement of the bile duct drainage tube in case of displacement, preventing the entire drainage tube from retracting into or dislodging from the bile duct, thus making it less prone to displacement even under external force. This effectively prevents displacement of the bile duct drainage tube caused by external force pulling due to large patient movements such as violent coughing, turning over, or getting out of bed, or by excessive pressure within the bile duct.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a bile duct drainage tube. Background Technology

[0002] Bile duct drainage tubes are important medical devices in the fields of gastroenterology, hepatobiliary surgery, and interventional radiology. They are widely used in percutaneous transhepatic cholangiopancreatography (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP)-guided biliary stent / drainage tube implantation. Bile duct drainage tubes are used to facilitate the drainage of bile from the intrahepatic bile ducts to the duodenum or externally in cases of biliary obstruction (such as bile duct stones, benign or malignant bile duct strictures) or biliary tract injury.

[0003] Common bile duct drainage tubes are typically flexible tubular structures. When implanted in a patient, one end of the tube is positioned inside the target bile duct, while the other end is positioned outside. Both ends of the tube are equipped with specific barbs or spiral structures to prevent displacement.

[0004] However, if the patient's physical activity is large, such as violent coughing, turning over, or getting up, the bile duct drainage tube may be pulled by external force, or the pressure inside the bile duct may be too high, causing the bile duct drainage tube to shift. Utility Model Content

[0005] This application provides a bile duct drainage tube to solve the problem that existing bile duct drainage tubes are prone to displacement when subjected to external traction.

[0006] This application provides a bile duct drainage tube, comprising: a tubular main body, a second spiral structure, and two first spiral structures, all of which are hollow; multiple tubular main bodies are arranged at intervals along a first direction, which is the length direction of the bile duct drainage tube; one of the first spiral structures is connected between two adjacent tubular main bodies at the beginning, and the other first spiral structure is connected between two adjacent tubular main bodies at the end, the first spiral structure being in a spiral coiled state; the second spiral structure is located between the two first spiral structures and is connected between any two adjacent tubular main bodies in the middle, the second spiral structure being in a spiral coiled state.

[0007] In some implementations, there are one or more second helical structures; one or more second helical structures are spaced between two first helical structures, and each second helical structure is connected to two adjacent tubular bodies.

[0008] In some implementations, the planes containing the two first helical structures are parallel; the planes containing the second helical structures are parallel, and both are parallel to the planes containing the first helical structures.

[0009] In some implementations, the planes containing the two first helical structures are parallel; the planes containing each second helical structure are parallel and perpendicular to the planes containing the first helical structures.

[0010] In some implementations, the planes containing the two first spiral structures are parallel; the planes containing some of the second spiral structures are parallel, and both are parallel to the planes containing the first spiral structures; the planes containing some of the second spiral structures are parallel, and both are perpendicular to the planes containing the first spiral structures.

[0011] In some implementations, the spiral winding state of the second spiral structure is the same as that of the first spiral structure; one of the first spiral structures, at least one second spiral structure, another first spiral structure, and an adjacent tubular body are continuously spirally wound along a first direction.

[0012] In some implementations, the middle portion of each first spiral structure is coiled 360°; the middle portion of each second spiral structure is coiled 360°.

[0013] In some implementations, the spiral winding state of the second spiral structure is different from that of the first spiral structure; the second spiral structure includes multiple sub-spiral structures, which are formed by continuous spiral winding around a first direction, and the plane of each sub-spiral structure is parallel and perpendicular to the plane of the first spiral structure; the sub-spiral structures at the beginning and end are respectively connected to the adjacent tubular body.

[0014] In some implementations, the projections of the two first spiral structures' circular planes along the first direction intersect.

[0015] In some implementations, the size of the second helical structure is smaller than the size of the first helical structure.

[0016] In some implementations, the tubular body, the first spiral structure, and the second spiral structure are provided with multiple spaced drainage holes; each drainage hole is connected to the hollow region of the tubular body, the hollow region of the first spiral structure, and the hollow region of the second spiral structure.

[0017] This application provides a bile duct drainage tube, comprising a connected, hollow tubular main body, a second helical structure, and two first helical structures, both of which are spirally coiled. The two first helical structures are located at both ends of the bile duct drainage tube, and the second helical structure is located between the two first helical structures. The first helical structures at both ends play a crucial anchoring role: on the one hand, the coiled shape of the first helical structure can be held within the bile duct, providing radial support; on the other hand, the helical design increases the contact area and friction with the luminal wall, thereby helping the bile duct drainage tube to remain relatively stable in a preset position, resisting the thrust of some bile flow and intestinal peristalsis. The second helical structure is located within the bile duct, facilitating the wrapping of the second helical structure by the diseased tissue within the bile duct, further preventing displacement of the bile duct drainage tube and preventing the entire bile duct drainage tube from retracting into or dislodging from the bile duct; furthermore, the second helical structure can buffer compliance and provide displacement resistance when the bile duct drainage tube shifts, making it less prone to displacement even under external force. This effectively prevents the bile duct drainage tube from shifting due to external forces pulling on it or excessive pressure within the bile duct caused by the patient's large physical activity, such as violent coughing, turning over, or getting out of bed. Attached Figure Description

[0018] To more clearly illustrate the technical solution of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the structure of a biliary stent provided by existing technology;

[0020] Figure 2 This is a first structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application;

[0021] Figure 3 This is a second structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application;

[0022] Figure 4 This is a third structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application;

[0023] Figure 5 This is a schematic diagram of a scenario where a bile duct drainage tube is implanted in the body, as provided in an embodiment of this application.

[0024] Figure 6 This is a schematic diagram of the first structure of the second type of bile duct drainage tube provided in the embodiments of this application;

[0025] Figure 7This is a second structural schematic diagram of the second type of bile duct drainage tube provided in the embodiments of this application;

[0026] Figure 8 This is a third structural schematic diagram of the second type of bile duct drainage tube provided in the embodiments of this application;

[0027] Figure 9 This is a schematic diagram of the first structure of the third type of bile duct drainage tube provided in the embodiments of this application;

[0028] Figure 10 This is a second structural schematic diagram of the third type of bile duct drainage tube provided in the embodiments of this application.

[0029] Illustration:

[0030] 1-Support body, 2-Pig tail spiral structure;

[0031] 100-Bile duct drainage tube, 10-Tube-shaped main body, 20-First spiral structure, 30-Second spiral structure, 31-First sub-spiral structure, 32-Second sub-spiral structure, 33-Third sub-spiral structure, 40-Drainage hole;

[0032] 200-Pushing device, 201-Pushing end, 202-Straightening tube. Detailed Implementation

[0033] The technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. Other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are all within the protection scope of this application.

[0034] It should be noted that many specific details are set forth in the following description in order to provide a full understanding of this application. However, this application may also be implemented in other ways different from those described herein. Therefore, the scope of protection of this application is not limited to the specific embodiments disclosed below.

[0035] In the description of this application, it should be understood that the terms "upper," "lower," "left," "right," "front," and "rear," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. In this application, unless otherwise expressly specified and limited, the first feature being "upper" or "lower" than the second feature can mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium.

[0036] In this application, the use of terms such as "first," "second," etc., is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features.

[0037] In the description of this specification, references to terms such as "some embodiments," "exemplary," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the embodiments of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0038] The terminology used in the implementation section of this application is only for explaining specific embodiments of this application and is not intended to limit this application. The embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0039] Endoscopic retrograde cholangiopancreatography (ERCP) is a minimally invasive interventional procedure performed via the duodenal papilla under endoscopy to conduct pancreatic and cholangiopancreatography and a series of treatments. It plays an important role in the treatment of pancreatic or bile duct diseases.

[0040] During surgery, a bile duct drainage tube (also known as a biliary stent) is typically used to effectively drain accumulated bile, reduce biliary pressure, relieve obstructive jaundice and related symptoms (such as itching and liver dysfunction), control biliary tract infection, create favorable conditions for subsequent treatment, or serve as a palliative treatment. The use of a bile duct drainage tube maintains unobstructed bile duct drainage and relieves biliary obstruction. For diseases such as common bile duct stones and acute suppurative cholangitis, improving bile drainage alleviates the condition and is one of the key techniques for treating benign and malignant biliary tract diseases.

[0041] Figure 1 This is a schematic diagram of the structure of a biliary stent provided by existing technology.

[0042] like Figure 1 As shown, the biliary stent includes a stent body 1 and a pigtail spiral structure 2. The two pigtail spiral structures 2 are located at opposite ends of the stent body 1. Both the stent body 1 and the pigtail spiral structure 2 are made of plastic.

[0043] Both the stent body 1 and the pigtail spiral structure 2 are hollow circular tube structures, allowing the stent body 1 and the two pigtail spiral structures 2 to be connected. The pigtail spiral structure 2 has a nearly circular, coiled appearance, while the stent body 1 has a strip-shaped appearance, so that the biliary stent forms a double pigtail stent.

[0044] When implanted in a patient, the biliary stent has one end inside the bile duct and the other end outside. The double-pigtail design of the biliary stent conforms well to the natural curvature of the bile duct lumen. When the patient moves, the biliary stent is not prone to axial movement due to the fixation at both ends, thus effectively preventing large displacement of the biliary stent within the lumen.

[0045] However, when patients engage in large-scale physical activities, such as violent coughing, turning over, or getting out of bed, the biliary stent can be easily stretched by external forces, or the pressure inside the bile duct may be too high, causing the biliary stent to shift.

[0046] To address the aforementioned technical problems, this application provides a bile duct drainage tube 100, which adds multiple turns or wavy spiral structures to the middle region of the double pigtail structure to effectively prevent displacement.

[0047] Figure 2 This is a first structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application; Figure 3 This is a second structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application; Figure 4 This is a third structural schematic diagram of the first type of bile duct drainage tube provided in the embodiments of this application. Wherein, Figure 2 , Figure 3 and Figure 4 The structure is shown from different perspectives.

[0048] like Figure 2 and Figure 3 As shown, in some embodiments, the first type of bile duct drainage tube 100 provided in this application includes: a tubular body 10, which is hollow, a second spiral structure 30, and two first spiral structures 20.

[0049] To facilitate the description of structural orientation and location, this embodiment of the application establishes a three-dimensional coordinate system based on the bile duct drainage tube 100, wherein the x-axis direction is the width direction of the bile duct drainage tube 100, the y-axis direction is the length direction of the bile duct drainage tube 100, and the z-axis direction is the thickness direction of the bile duct drainage tube 100. Furthermore, this embodiment of the application defines the length direction of the bile duct drainage tube 100 as a first direction D1, which is parallel to the y-axis direction.

[0050] In some embodiments, the tubular body 10 is an elongated tubular structure, and multiple tubular bodies 10 are arranged at intervals along a first direction D1, with the length direction of each tubular body 10 being parallel to the first direction D1. The number of tubular bodies 10 is related to the position and number of the first helical structure 20 and the position and number of the second helical structure 30, and is not specifically limited here.

[0051] In some embodiments, two first spiral structures 20 are respectively adjacent to two ends of the bile duct drainage tube 100, one of the first spiral structures 20 is connected between two adjacent tubular bodies 10 at the head end, and the other first spiral structure 20 is connected between two adjacent tubular bodies 10 at the tail end.

[0052] For example, when the tubular body 10 includes five, the first spiral structure 20 on the left is connected between the first tubular body 10 and the second tubular body 10, and the first spiral structure 20 on the right is connected between the fourth tubular body 10 and the fifth tubular body 10.

[0053] The first spiral structure 20 is in a spiral coiled state, and the overall appearance of the first spiral structure 20 is a near-circular structure, such as a circle.

[0054] In some embodiments, the circular planes containing the two first spiral structures 20 are parallel and both are parallel to the first direction D1. Further, the circular planes containing the two first spiral structures 20 coincide. For example, the first centerline z1 of the left first spiral structure 20 and the second centerline z2 of the right first spiral structure 20 are parallel, and both the first centerline z1 of the left first spiral structure 20 and the second centerline z2 of the right first spiral structure 20 are perpendicular to the first direction D1. Here, the centerline refers to the center line of the near-circular structure (circle shape), and the centerline of the first spiral structure 20 is perpendicular to the circular plane containing the first spiral structure 20.

[0055] One end of the first spiral structure 20 is connected to the adjacent tubular body 10, and the middle part is coiled around the center line 360° before the other end is connected to another adjacent tubular body 10.

[0056] This allows the two first helical structures 20 to form a double-pigtail structure for the bile duct drainage tube 100. When the bile duct drainage tube 100 is implanted into the patient, one of the first helical structures 20 is placed outside the patient's bile duct, while the remaining portion is placed inside. The first helical structure 20 plays a crucial anchoring role: on the one hand, the coiled shape of the first helical structure 20 can be engaged inside the bile duct, providing radial support; on the other hand, the helical design increases the contact area and friction with the luminal wall, thereby helping the bile duct drainage tube 100 to remain relatively stable in the preset position, resisting the thrust of some bile flow and intestinal peristalsis. Thus, the two first helical structures 20 achieve the effect of interlocking the bile duct drainage tube 100 with the bile duct, preventing displacement of the bile duct drainage tube 100. The outer sides of the two first helical structures 20 are also connected to a tubular body 10 parallel to the first direction D1. Utilizing this extended tubular body 10 can improve bile drainage efficiency and ensure unobstructed bile duct drainage.

[0057] like Figure 4 As shown, in some embodiments, the projections of the two first spiral structures 20 onto the circular plane along the first direction D1 are intersecting, that is, the projections of the two first spiral structures 20 onto the xz plane are intersecting.

[0058] The two first spiral structures 20 are tilted relative to the xz plane, and the tilting directions of the two first spiral structures 20 are opposite. For example, the first centerline z1 of the front first spiral structure 20 and the second centerline z2 of the rear first spiral structure 20 are not parallel, the projections of the two first spiral structures 20 on the xz plane intersect, and the first centerline z1 and the second centerline z2 are at an angle.

[0059] In this way, when the bile duct drainage tube 100 is inserted into the patient's bile duct, the two intersecting and inclined first spiral structures 20 can be positioned in two different directions to prevent the end of the bile duct drainage tube 100 from dislodging from or retracting into the bile duct. For example, if slight displacement occurs, the first spiral structure 20 located inside the bile duct can be engaged with the inner wall of the bile duct to prevent it from dislodging, or the first spiral structure 20 located outside the bile duct can be engaged with the outer wall of the bile duct to prevent it from retracting into the bile duct.

[0060] See you again Figure 2 and Figure 3 As shown, in some embodiments, the second spiral structure 30 is located between two first spiral structures 20 and between any two adjacent tubular bodies 10 in the middle. One end of the second spiral structure 30 is connected to the adjacent tubular body 10, and the other end is connected to another adjacent tubular body 10.

[0061] The number of second spiral structures 30 is one or more; one or more second spiral structures 30 are spaced between two first spiral structures 20, and each second spiral structure 20 is connected to two adjacent tubular bodies 10.

[0062] In some embodiments, the number of second spiral structures 30 determines the number of tubular bodies 10. For example, when the number of second spiral structures 30 is one (not shown in the figure), the number of tubular bodies 10 is four. The first spiral structure 20 on the left connects the first tubular body 10 and the second tubular body 10, the second spiral structure 30 connects the second tubular body 10 and the third tubular body 10, and the first spiral structure 20 on the right connects the third tubular body 10 and the fourth tubular body 10.

[0063] When the number of the second helical structure 30 is two, such as Figure 2 and Figure 3 As shown, there are five tubular bodies 10. The first spiral structure 20 on the left connects the first tubular body 10 and the second tubular body 10. The second spiral structure 30 on the left connects the second tubular body 10 and the third tubular body 10. The second spiral structure 30 on the right connects the third tubular body 10 and the fourth tubular body 10. The first spiral structure 20 on the right connects the fourth tubular body 10 and the fifth tubular body 10.

[0064] In some embodiments, the second helical structure 30 is in a spiral coiled state, and the spiral coiled state of the second helical structure 30 is the same as that of the first helical structure 20.

[0065] For example, the overall appearance of the second spiral structure 30 is a near-circular structure, such as a circle. One end of the second spiral structure 30 is connected to the adjacent tubular body 10, and after the middle part is coiled around the center line 360°, the other end is connected to another adjacent tubular body 10, so that the second spiral structure 30 presents a circle shape.

[0066] In some embodiments, the circular planes of each second spiral structure 30 are parallel and parallel to the first direction D1. When the circular planes of each first spiral structure 20 are parallel, the circular planes of each second spiral structure 30 are also parallel to the circular planes of the first spiral structure 20. That is, the circular shapes of the second spiral structures 30 and the first spiral structures 20 both face the same direction.

[0067] The centerline of each second spiral structure 30 is perpendicular to the plane of the spiral structure 30, and each centerline is perpendicular to the first direction D1. For example, when there are two second spiral structures 30, the third centerline z3 of the left second spiral structure 30 and the fourth centerline z4 of the right second spiral structure 30 are both perpendicular to the first direction D1. The third centerline z3 and the fourth centerline z4 are parallel and both are parallel to the z-axis direction. The centerlines (z3, z4) of the second spiral structure 30 are parallel to the centerlines (z1, z2) of the first spiral structure 20.

[0068] In some embodiments, when the projections of the circular planes containing the two first spiral structures 20 along the first direction D1 intersect, the projection of the centerline (z3, z4) of the second spiral structure 30 onto the yz plane is parallel to the projection of the centerline (z1, z2) of the first spiral structure 20 onto the yz plane. That is, the circular shapes of the second spiral structure 30 and the circular shapes of the first spiral structure 20 are approximately oriented in the same direction.

[0069] In some embodiments, one first spiral structure 20, at least one second spiral structure 30, and another first spiral structure 20 and their respective adjacent tubular bodies 10 are continuously spirally wound along a first direction D1.

[0070] Thus, the two ends of the bile duct drainage tube 100 are formed into a double pigtail structure by two first spiral structures 20, and the middle part is formed into a multi-turn structure by at least one second spiral structure 30, so that the bile duct drainage tube 100 forms a continuous multi-turn spiral structure. For example, when there are two first spiral structures 20 and two second spiral structures 30, the bile duct drainage tube 100 is a spiral structure that is continuously coiled four times along the first direction D1 at intervals.

[0071] When the drainage tube 100 is inserted into the patient's body, each of the second spiral structures 30 and a portion of one of the first spiral structures 20 are placed inside the bile duct, while the other first spiral structure 20 is located outside the bile duct. The second spiral structure 30 being located inside the bile duct facilitates the use of diseased tissue within the bile duct to encapsulate the second spiral structure 30, thereby further preventing displacement of the bile duct drainage tube 100 and preventing the entire bile duct drainage tube 100 from retracting into or dislodging from the bile duct. If the bile duct drainage tube 100 retracts into the bile duct, it cannot be removed, potentially leading to bile duct perforation and worsening the patient's condition.

[0072] In some embodiments, the size of the second helical structure 30 is smaller than the size of the first helical structure 20. For example, the inner diameter of the second helical structure 30 is smaller than the inner diameter of the first helical structure 20.

[0073] In this way, when the catheter drainage tube is implanted into the patient's body, the small size of the second spiral structure 30 can reduce the pressure in the bile duct when the lesion tissue in the bile duct wraps around the second spiral structure 30, and can make the lesion tissue wrap around the second spiral structure 30 more effectively, thereby improving the effect of preventing displacement.

[0074] In some embodiments, the tubular body 10, the first spiral structure 20, and the second spiral structure 30 are respectively provided with a plurality of spaced drainage holes 40.

[0075] The drainage holes 40 can be distributed at equal intervals or at unequal intervals; the diameter of each drainage hole 40 can be the same or different; each drainage hole 40 can be distributed on one surface of the structure body or on two opposite surfaces of the structure body. The embodiments of this application do not specifically limit this. The structure body includes any one of the tubular body 10, the first spiral structure 20, and the second spiral structure 30.

[0076] Each drainage hole 40 is connected to the hollow region of the tubular body 10, the hollow region of the first spiral structure 20, and the hollow region of the second spiral structure 30.

[0077] In this way, when using the bile duct drainage tube 100 for bile drainage, drainage holes 40 can be used simultaneously for drainage, which can increase the drainage volume, improve drainage efficiency, and reduce the risk of blockage, thereby reducing infection and alleviating the discomfort of organ traction during the drainage process.

[0078] In some embodiments, the tubular body 10, the first spiral structure 20, and the second spiral structure 30 can all be made of plastic material and can be integrally molded into a single structure, so that the structure of the bile duct drainage tube 100 is stable and forms a continuous spiral structure including double pig tails and multiple turns.

[0079] In some embodiments, the overall length of the bile duct drainage tube 100 can be changed by setting different numbers of second spiral structures 30 and / or the length of the single-segment tubular body 10, and the overall width of the bile duct drainage tube 100 can also be changed by changing the inner diameter of the second spiral structure 30 and / or the first spiral structure 20.

[0080] In this way, bile duct drainage tubes 100 of different sizes can be manufactured to suit different application scenarios. For example, the appropriate size of bile duct drainage tube 100 can be selected according to factors such as etiology, obstruction location, and length.

[0081] Figure 5 This is a schematic diagram of a scenario where a bile duct drainage tube is implanted in the body, as provided in an embodiment of this application.

[0082] like Figure 5As shown in (a), the bile duct drainage tube 100 has a multi-loop structure. To facilitate the implantation of the bile duct drainage tube 100 into the patient's body, the bile duct drainage tube 100 can be straightened by the pushing device 200 before being pushed into the patient's body.

[0083] For example, the pushing device 200 may include a pushing end 201 and a straightening tube 202. The straightening tube 202 is a tubular structure with openings at both ends. One end of the pushing end 201 is located inside the straightening tube 202 and can move within the straightening tube 202.

[0084] When inserting the bile duct drainage tube 100 into the patient's body, the bile duct drainage tube 100 is placed into the straightening tube 202 for straightening. The bile duct drainage tube 100 is made of plastic, which is relatively soft and will not break after straightening. The right opening end of the straightening tube 202 is inserted into the bile duct, and the bile duct drainage tube 100 is pushed to the right using the pushing end 201 and then removed from the right opening end of the straightening tube 202.

[0085] It should be noted that the pushing device 200 may also adopt other structures and working principles. The embodiments of this application are merely illustrative of the structure and working principle of a pushing device 200.

[0086] like Figure 5 As shown in (b), after implantation, the pusher 200 is withdrawn, and the bile duct drainage tube 100 returns to its initial state after the external force is removed, so that the end of the bile duct drainage tube 100 with one of the first spiral structures 20 is placed on the outside of the bile duct, and the other part is placed on the inside of the bile duct.

[0087] For example, the first helical structure 20 and two second helical structures 30 on the right are located inside the bile duct, while the first helical structure 20 on the left is located outside the bile duct.

[0088] The bile duct drainage tube 100 opens the narrowed bile duct through its own tension, forming a rigid or semi-rigid tube, thus restoring normal bile duct function. Bile within the bile duct flows from the proximal end of the obstruction (e.g., the liver side) to the distal end (e.g., the intestine side or an external drainage bag) through the lumen formed by the bile duct drainage tube 100 under pressure difference. Simultaneously, bile from the proximal end of the obstruction can be collected through the drainage hole 40 on the bile duct drainage tube 100. Relying on gravity or a weak bile duct-vena cava pressure difference, the bile is drained out of the body through the bile duct drainage tube 100 (external drainage) or simultaneously flows into the intestine (internal drainage).

[0089] For example, bile can enter the bile duct drainage tube 100 through the opening of the tubular body 10, which communicates with the right first spiral structure 20, and flow along the lumen of the bile duct drainage tube 100 to the left first spiral structure 20, and then out through the opening of the leftmost tubular body 10. Simultaneously, bile can also enter the lumen of the bile duct drainage tube 100 through the drainage hole 40, flow along the lumen to the left first spiral structure 20, and then out through the opening of the leftmost tubular body 10 and the drainage hole 40 on the tubular body 10.

[0090] In this way, the bile duct drainage tube 100 can effectively drain stagnant bile, reduce biliary pressure, relieve obstructive jaundice and related symptoms (such as itching and liver function impairment), control biliary tract infection, create favorable conditions for subsequent treatment, or serve as a palliative treatment. The use of the bile duct drainage tube 100 can maintain unobstructed bile duct drainage and relieve biliary obstruction. For diseases such as common bile duct stones and acute suppurative cholangitis, improving bile drainage can alleviate the condition, making it one of the key technologies for treating benign and malignant biliary tract diseases.

[0091] The bile duct drainage tube 100 provided in this embodiment includes a first spiral structure 20 with multiple turns at both ends and a second spiral structure 30 with multiple turns in the middle region. The first spiral structure 20 at both ends plays a crucial anchoring role: on the one hand, the coiled shape of the first spiral structure 20 can be secured inside the bile duct, providing radial support; on the other hand, the spiral design increases the contact area and friction with the luminal wall, thereby helping the bile duct drainage tube 100 to remain relatively stable in a preset position, resisting the thrust of some bile flow and intestinal peristalsis. The second spiral structure 30 is located inside the bile duct, facilitating the wrapping of the second spiral structure 30 by the diseased tissue within the bile duct, further preventing displacement of the bile duct drainage tube 100 and preventing the bile duct drainage tube 100 from retracting entirely into or dislodging from the bile duct; furthermore, the second spiral structure 30 can buffer compliance and provide displacement resistance when the bile duct drainage tube 100 shifts, making it less prone to displacement even under external force. This effectively prevents the bile duct drainage tube 100 from shifting due to external force pulling on the tube or excessive pressure within the bile duct caused by the patient's large physical activity, such as violent coughing, turning over, or getting up.

[0092] Figure 6 This is a schematic diagram of the first structure of the second type of bile duct drainage tube provided in the embodiments of this application; Figure 7 This is a second structural schematic diagram of the second type of bile duct drainage tube provided in the embodiments of this application; Figure 8 This is a third structural schematic diagram of the second type of bile duct drainage tube provided in the embodiments of this application. Wherein, Figure 6 , Figure 7 and Figure 8 The structure is shown from different perspectives.

[0093] like Figure 6 and Figure 7 As shown, in some embodiments, the second type of bile duct drainage tube 100 provided in this application includes: a tubular body 10, which is hollow, a second spiral structure 30, and two first spiral structures 20.

[0094] It should be noted that the structure of the second spiral structure 30 differs from that of the first type of bile duct drainage tube 100. This application embodiment only provides an illustrative description of the differences, and the rest can be referred to the content of the first type of bile duct drainage tube 100, which will not be repeated here.

[0095] In some embodiments, the spiral winding state of the second spiral structure 30 is different from the spiral winding state of the first spiral structure 20.

[0096] The plane containing each second spiral structure 30 is parallel and perpendicular to the first direction D1. The centerline of each second spiral structure 30 is parallel to the first direction D1.

[0097] In some embodiments, when the planes containing each first helical structure 20 are parallel, the planes containing each second helical structure 30 are perpendicular to the planes containing the first helical structure 20. That is, the planes containing the second helical structure 30 and the planes containing the first helical structure 20 face different directions.

[0098] like Figure 8 As shown, in some embodiments, when the projections of the two first spiral structures 20 onto the circular plane along the first direction D1 are intersecting, the projection of the centerline of the second spiral structure 30 onto the yz surface is perpendicular to the projection of the centerline of the first spiral structure 20 onto the yz surface.

[0099] For example, taking one second spiral structure 30 as an example, the fifth center line z5 of the second spiral structure 30 is parallel to the first direction D1. The projection of the fifth center line z5 of the second spiral structure 30 on the yz surface is perpendicular to the projection of the first center line z1 of the first spiral structure 20 on the left on the yz surface, and also perpendicular to the projection of the second center line z2 of the first spiral structure 20 on the right on the yz surface.

[0100] In some embodiments, the second spiral structure 30 may include multiple sub-spiral structures, the centerlines of which coincide and are all parallel to the first direction D1; the multiple sub-spiral structures continuously spiral around the first direction D1, so that the overall appearance of the second spiral structure 30 presents a wave shape. The plane of each sub-spiral structure is parallel and perpendicular to the plane of the first spiral structure 20. That is, the opening direction of the wave shape of the second spiral structure 30 and the opening direction of the circle shape of the first spiral structure 20 are in different directions.

[0101] For example, when the second spiral structure 30 includes three sub-spiral structures, namely the first sub-spiral structure 31, the second sub-spiral structure 32, and the third sub-spiral structure 33, the centerline of the first sub-spiral structure 31, the centerline of the second sub-spiral structure 32, and the centerline of the third sub-spiral structure 33 are all the fifth centerline z5. The circular plane containing the first sub-spiral structure 31, the circular plane containing the second sub-spiral structure 32, and the circular plane containing the third sub-spiral structure 33 are parallel and perpendicular to the circular plane containing the first spiral structure 20. The first sub-spiral structure 31, the second sub-spiral structure 32, and the third sub-spiral structure 33 continuously spiral around the first direction D1, so that the second spiral structure 30 presents a wave-like shape.

[0102] The sub-spiral structures located at the beginning and end are respectively connected to the adjacent tubular body 10. For example, the outer end of the first sub-spiral structure 31 is connected to the adjacent tubular body 10, and the outer end of the third sub-spiral structure 33 is connected to the adjacent tubular body 10.

[0103] It should be noted that, in order to adapt to the state of the sub-spiral structures at both ends, the adjacent tubular main body 10 can be adapted to be in an inclined and bent state, so that the tubular main body 10 and the corresponding sub-spiral structure can be connected at the connection point, avoiding sharp edges in the overall appearance of the bile duct drainage tube 100, thereby avoiding injury to the bile duct and preventing the patient's condition from worsening.

[0104] In this way, the two ends of the bile duct drainage tube 100 are formed by two first spiral structures 20 to form a double pig tail structure, and the middle part is formed by at least one second spiral structure 30 to form a wave structure, so that the bile duct drainage tube 100 forms a spiral structure of "double pig tail + wave".

[0105] When the drainage tube 100 is implanted into the patient, each of the second spiral structures 30 and a portion of one of the first spiral structures 20 are placed inside the bile duct, while the other first spiral structure 20 is located outside the bile duct. The second spiral structure 30 being located inside the bile duct facilitates the use of diseased tissue within the bile duct to encapsulate the second spiral structure 30, thereby preventing displacement of the bile duct drainage tube 100 and preventing the entire bile duct drainage tube 100 from retracting into or dislodging from the bile duct.

[0106] The bile duct drainage tube 100 provided in this embodiment includes a first spiral structure 20 with multiple turns at both ends and a second spiral structure 30 with a wavy shape in the middle region. The first spiral structure 20 at both ends plays a crucial anchoring role: on the one hand, the coiled shape of the first spiral structure 20 can be held inside the bile duct, providing radial support; on the other hand, the spiral design increases the contact area and friction with the luminal wall, thereby helping the bile duct drainage tube 100 to remain relatively stable in a preset position and resist the thrust of some bile flow and intestinal peristalsis. The second spiral structure 30 is located inside the bile duct, which facilitates the wrapping of the second spiral structure 30 by the diseased tissue inside the bile duct, thereby further preventing the bile duct drainage tube 100 from shifting, preventing the bile duct drainage tube 100 from retracting into or dislodging from the bile duct; and, when the bile duct drainage tube 100 shifts, the second spiral structure 30 can also be used to buffer compliance and provide displacement resistance, making the bile duct drainage tube 100 less prone to displacement even under external force. This effectively prevents the bile duct drainage tube 100 from shifting due to external force pulling on the tube or excessive pressure within the bile duct caused by the patient's large physical activity, such as violent coughing, turning over, or getting up.

[0107] Figure 9 This is a schematic diagram of the first structure of the third type of bile duct drainage tube provided in the embodiments of this application; Figure 10 This is a second structural schematic diagram of the third type of bile duct drainage tube provided in the embodiments of this application. Wherein, Figure 9 and Figure 10 The structure is shown from different perspectives.

[0108] like Figure 9 and Figure 10 As shown, in some embodiments, the third type of bile duct drainage tube 100 provided in this application includes: a tubular body 10, which is hollow, two first spiral structures 20, and at least two second spiral structures 30.

[0109] It should be noted that the difference between the first type of bile duct drainage tube 100 and the second type of bile duct drainage tube 100 lies in the structure of the second spiral structure 30. This application embodiment only provides an illustrative description of the differences. The remaining structural contents can be referred to the structural contents of the first type of bile duct drainage tube 100 and the second type of bile duct drainage tube 100, and will not be repeated here.

[0110] In some embodiments, the number of second spiral structures 30 is at least two, and the at least two second spiral structures 30 have different shapes. The second spiral structures 30 with different shapes are connected through adjacent tubular bodies 10. The spiral winding state of some second spiral structures 30 is the same as that of the first spiral structure 20, and the spiral winding state of some second spiral structures 30 is different from that of the first spiral structure 20. For example, the at least two second spiral structures 30 include at least a second spiral structure 30 with a circular shape (such as the second spiral structure 30 on the right) and a second spiral structure 30 with a wavy shape (such as the second spiral structure 30 on the left).

[0111] The second spiral structure 30, which has the same spiral winding state as the first spiral structure 20, has a nearly circular overall appearance, such as a circle. The plane of each second spiral structure 30 in this part is parallel and parallel to the first direction D1, and the centerline of each second spiral structure 30 in this part is perpendicular to the first direction D1.

[0112] In some embodiments, when the circular planes of each first spiral structure 20 are parallel, the circular planes of each second spiral structure 30 are parallel to the circular planes of the first spiral structure 20. For example, when there is one second spiral structure 30 in a circular shape, the third center line z3 of the second spiral structure 30 is perpendicular to the first direction D1, and the third center line z3 of the second spiral structure 30 is parallel to the first center line z1 of the first spiral structure 20.

[0113] In some embodiments, when the projections of the circular planes containing the two first spiral structures 20 along the first direction D1 intersect, the centerline projection of this portion of the second spiral structure 30 is parallel to the centerline projection of the first spiral structure 20. For example, when there is only one circular second spiral structure 30, the third centerline z3 of the second spiral structure 30 is perpendicular to the first direction D1, and the projection of the third centerline z3 of the second spiral structure 30 onto the yz plane is parallel to the projection of the centerlines (z1, z2) of the first spiral structure 20 onto the yz plane.

[0114] In this way, the circular shape of the second spiral structure 30 and the circular shape of the first spiral structure 20 can both face the same direction, or approximately face the same direction.

[0115] It should be noted that the structure of the second spiral structure 30, which presents a circular shape, can be referred to the second spiral structure 30 used in the first type of bile duct drainage tube 100100, and will not be repeated here.

[0116] For the portion of the second spiral structure 30 that differs from the spiral coiling state of the first spiral structure 20, the overall appearance of this portion of the second spiral structure 30 presents a wave-like shape. The plane containing each spiral structure 30 in this portion is parallel and perpendicular to the first direction D1, and the centerline of this portion of the second spiral structure 30 is parallel to the first direction D1.

[0117] In some embodiments, when the circular plane containing each first spiral structure 20 is parallel, the circular plane containing each second spiral structure 30 is perpendicular to the circular plane containing the first spiral structure 20. For example, when there is only one second spiral structure 30 in a wave shape, the fifth center line z5 of the second spiral structure 30 is parallel to the first direction D1, and the fifth center line z5 of the second spiral structure 30 is perpendicular to the first center line z1 of the first spiral structure 20.

[0118] In some embodiments, when the projections of the circular planes containing the two first spiral structures 20 along the first direction D1 intersect, the centerline projection of this portion of the second spiral structure 30 is perpendicular to the centerline projection of the first spiral structure 20. For example, when there is only one wavy second spiral structure 30, the fifth centerline z5 of the second spiral structure 30 is parallel to the first direction D1, and the projection of the fifth centerline z5 of the second spiral structure 30 onto the yz plane is perpendicular to the projection of the centerlines (z1, z2) of the first spiral structure 20 onto the yz plane.

[0119] In this way, the opening direction of the wave-shaped second spiral structure 30 and the opening direction of the circular shape of the first spiral structure 20 can be in different directions.

[0120] It should be noted that the structure of the second spiral structure 30, which presents a wave-like shape, can be referred to the second spiral structure 30 used in the second type of bile duct drainage tube 100, and will not be repeated here.

[0121] Thus, the two ends of the bile duct drainage tube 100 are formed by two first spiral structures 20 to form a double pig tail structure, and the middle part includes at least one second spiral structure 30 in the form of a circle and at least one second spiral structure 30 in the form of a wave, so that the bile duct drainage tube 100 forms a spiral structure of "double pig tail + multiple circles + waves".

[0122] When the drainage tube 100 is implanted into the patient, various forms of the second helical structure 30 and a portion of one of the first helical structures 20 are placed inside the bile duct, while the other first helical structure 20 is located outside the bile duct. The different forms of the second helical structures 30 are located inside the bile duct, and their orientations differ. This allows for better encapsulation of the corresponding second helical structure 30 by utilizing diseased tissue within the bile duct from different directions, thus improving encapsulation and preventing displacement of the bile duct drainage tube 100. It also prevents the bile duct drainage tube 100 from retracting entirely into or dislodging from the bile duct.

[0123] The bile duct drainage tube 100 provided in this embodiment includes a first spiral structure 20 with multiple turns at both ends, and at least two second spiral structures 30 with wavy and multiple turns respectively in the middle region. The first spiral structures 20 at both ends play a key anchoring role: on the one hand, the coiled shape of the first spiral structure 20 can be locked inside the bile duct, providing radial support; on the other hand, the spiral design can increase the contact area and friction with the lumen wall, thereby helping the bile duct drainage tube 100 to be relatively stably maintained in a preset position, resisting the thrust of some bile flow and intestinal peristalsis. The second helical structure 30, in various forms, is located within the bile duct. This allows the diseased tissue within the bile duct to encapsulate the second helical structure 30, further preventing displacement of the bile duct drainage tube 100 and preventing it from retracting entirely into or dislodging from the bile duct. Furthermore, the second helical structure 30 provides cushioning and resistance to displacement should the bile duct drainage tube 100 shift, making it less prone to displacement even under external force. This effectively prevents displacement of the bile duct drainage tube 100 caused by factors such as vigorous patient activity (e.g., violent coughing, turning over, getting out of bed), which could easily lead to external traction or excessive pressure within the bile duct.

[0124] It should be noted that those skilled in the art, upon considering the specification and practicing the application disclosed herein, will readily conceive of other embodiments of this application. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not disclosed herein. The specification and embodiments are to be considered exemplary only, and the true scope of this application is indicated by the following claims.

[0125] It should be understood that this application is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this application is limited only by the appended claims.

Claims

1. A bile duct drainage tube, characterized in that, include: All of them consist of a hollow tubular main body, a second spiral structure, and two first spiral structures; The plurality of tubular bodies are arranged at intervals along a first direction, the first direction being the length direction of the bile duct drainage tube; One of the first spiral structures is connected between two adjacent tubular bodies at the head end, and the other first spiral structure is connected between two adjacent tubular bodies at the tail end. The first spiral structure is in a spiral coiled state. The second spiral structure is located between the two first spiral structures and is connected between any two adjacent tubular bodies in the middle. The second spiral structure is in a spiral coiled state.

2. The bile duct drainage tube according to claim 1, characterized in that, The number of the second helical structure is one or more; One or more second spiral structures are spaced between two first spiral structures, and each second spiral structure is in communication with two adjacent tubular bodies.

3. The bile duct drainage tube according to claim 2, characterized in that, The two spiral structures are located in parallel planes; Each of the second spiral structures is located in a plane that is parallel to the plane of the first spiral structure.

4. The bile duct drainage tube according to claim 2, characterized in that, The two spiral structures are located in parallel planes; Each of the second spiral structures is located in a plane that is parallel to the spiral plane of the first spiral structure.

5. The bile duct drainage tube according to claim 2, characterized in that, The two spiral structures are located in parallel planes; The plane containing the second spiral structure is parallel to the plane containing the first spiral structure; The plane containing the second spiral structure is parallel to the plane containing the first spiral structure.

6. The bile duct drainage tube according to claim 3 or 5, characterized in that, The spiral winding state of the second spiral structure is the same as that of the first spiral structure; One of the first spiral structures, at least one of the second spiral structures, another of the first spiral structures, and adjacent tubular bodies are formed by continuous spiral winding along the first direction.

7. The bile duct drainage tube according to claim 6, characterized in that, The middle portion of each of the first spiral structures is coiled 360°. The middle portion of each of the second spiral structures is coiled 360°.

8. The bile duct drainage tube according to claim 4 or 5, characterized in that, The spiral winding state of the second spiral structure is different from that of the first spiral structure. The second spiral structure includes multiple sub-spiral structures, which are formed by continuously spiraling around the first direction. The plane of each sub-spiral structure is parallel to the plane of the first spiral structure. The sub-spiral structures located at both ends are respectively connected to the adjacent tubular main body.

9. The bile duct drainage tube according to claim 1, characterized in that, The projections of the two spiral planes containing the first spiral structures along the first direction intersect.

10. The bile duct drainage tube according to claim 1, characterized in that, The size of the second spiral structure is smaller than the size of the first spiral structure.

11. The bile duct drainage tube according to claim 1, characterized in that, The tubular body, the first spiral structure, and the second spiral structure are each provided with a plurality of spaced drainage holes; Each of the drainage holes is connected to the hollow region of the tubular body, the hollow region of the first spiral structure, and the hollow region of the second spiral structure, respectively.

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