A dilation balloon and papillary incision system

Abstract

The present application provides an expansion balloon and papillary incision system, which relates to the field of endoscope technology. The expansion balloon includes a sheath and a balloon, the sheath has a guide wire guide channel, an infusion channel, a distal end and a proximal end, the hole wall of the guide wire guide channel near the distal end has a first side opening, the first side opening penetrates the hole wall of the guide wire guide channel, and the size of the first side opening is configured to allow the head end of the visual guide wire to pass through; the balloon is arranged at the distal end of the sheath, the balloon and the first side opening are spaced apart in the direction away from the distal end of the sheath, and the infusion channel is located at one end of the distal end and is connected to the balloon. The expansion balloon provided by the present application can make the separation of the expansion balloon and the visual guide wire not restricted by the proximal connector, convenient operation, and high work efficiency.

Description

Technical Field

[0001] The present application relates to the technical field of endoscopes, and in particular to an expansion balloon and papillary incision system. Background Art

[0002] Biliary and pancreatic diseases are common clinical diseases, among which endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP) is a common method. With the emergence of visual guidewires, the difficulty of ERCP surgery can be reduced by applying visual guidewires to ERCP surgery. However, in the surgery to remove stones or polyps in the body, since the proximal end of the visual guidewire has a proximal connector, the size of the proximal connector is larger than the inner diameter of the guidewire guide channel of the expansion balloon, and during the operation, it is necessary to leave the visual guidewire in place after the papilla is expanded by the expansion balloon, and separate and remove the expansion balloon from the visual guidewire. Obviously, the limitation of the proximal connector makes it inconvenient to remove the expansion balloon from the visual guidewire. Summary of the Invention

[0003] In view of this, the purpose of this application is to overcome the deficiencies in the prior art and to provide an expansion balloon and papillary incision system that can separate the expansion balloon and the visual guidewire without being restricted by the proximal connector, making operation convenient and work efficient.

[0004] This application provides the following technical solutions:

[0005] An embodiment of the present application provides an expansion balloon, the expansion balloon comprising:

[0006] A sheath having a guidewire guide channel, an infusion channel, a distal end, and a proximal end; a hole wall of the guidewire guide channel near the distal end has a first side opening, the first side opening penetrates the hole wall of the guidewire guide channel, and the size of the first side opening is configured to allow the tip end of the visual guidewire to pass through;

[0007] A balloon is arranged at the distal end of the sheath tube, the balloon and the first side opening are spaced apart in a direction away from the distal end of the sheath tube, and the infusion channel is connected to the balloon at one end of the distal end.

[0008] In some embodiments of the first aspect, one end of the infusion channel penetrates the outer wall of the sheath tube and forms a second side opening;

[0009] The balloon is formed by a capsule membrane and an outer wall of a sheath tube. The second side opening is located in a region of the outer wall of the sheath tube covered by the capsule membrane. The second side opening is communicated with the balloon.

[0010] In some embodiments of the first aspect, the dilation balloon further comprises:

[0011] A plurality of limiting members, the plurality of limiting members are spaced apart along the extension direction of the sheath tube, the two ends of the limiting members are respectively connected to the corresponding side of the sheath tube, a limiting hole is formed between the limiting member and the sheath tube, and the visual guide wire is movably passed through the limiting hole;

[0012] Alternatively, the expansion balloon further comprises:

[0013] A plurality of limiting members are arranged at intervals along the extension direction of the sheath tube, the two ends of the limiting member are respectively connected to the corresponding side of the sheath tube, a limiting hole is formed between the limiting member and the sheath tube, and the visual guide wire is movably passed through the limiting hole; wherein, the part between the two ends of the limiting member is set as a breakable area, and the breaking of the breakable area can separate the two ends of the limiting member.

[0014] In some embodiments of the first aspect, the hole wall of the guidewire guide channel near the proximal end has a third side opening, the third side opening penetrates the hole wall of the guidewire guide channel, and the third side opening extends along the extension direction of the sheath tube; wherein the size of the third side opening is configured to allow the tip end of the visual guidewire to pass through.

[0015] In some embodiments of the first aspect, the third side opening is located at one end of the distal end and is communicated with the first side opening, and the third side opening and the first side opening extend along a same generatrix on the sheath tube.

[0016] In some embodiments of the first aspect, the third side opening includes a plurality of first sub-segments and a plurality of second sub-segments, and the plurality of first sub-segments and the plurality of second sub-segments are alternately arranged in the extension direction of the third side opening; wherein, the width of the first sub-segment is not less than the outer diameter of the visual guidewire, the width of the second sub-segment is less than the outer diameter of the visual guidewire, and the two opposite side walls of the second sub-segment are set as elastic structures, and the elastic deformation of the side walls of the second sub-segment can enable the head end of the visual guidewire to pass through.

[0017] In some embodiments of the first aspect, the dilation balloon further comprises:

[0018] A plurality of limit members are arranged at intervals along the extension direction of the sheath tube, one end of the limit member is connected to the side wall of one side of the third side opening, the other end of the limit member is connected to the side wall of the other side of the third side opening, and the portion of the limit member located at the third side opening is set as the breakable zone, and the breaking of the breakable zone can separate the two ends of the limit member.

[0019] In some embodiments of the first aspect, the sheath includes an insertion section and a connecting section, the insertion section and the connecting section are connected in sequence in a direction away from the distal end, the outer diameter of the insertion section is smaller than the outer diameter of the connecting section, the end of the infusion channel located at the distal end is arranged at the connecting section, and the end of the guidewire guide channel located at the distal end is arranged at the insertion section; wherein, the balloon includes a working section and a connecting section, the working section is arranged at the insertion section, the other end of the connecting section is arranged at the connecting section, and the connecting section and the infusion channel are connected.

[0020] In some embodiments of the first aspect, the working section is arranged to extend circumferentially along the sheath tube;

[0021] The connecting section is extended along the circumference of the sheath tube and is formed with two ends, with a gap between the two ends of the connecting section.

[0022] In some embodiments of the first aspect, when the balloon is in an inflated state and an uninflated state, an outer diameter of the working section is smaller than an outer diameter of the connecting section.

[0023] In a second aspect, the present application also provides a papillary incision system, which includes an expansion balloon as described in any one of the above embodiments.

[0024] The embodiments of the present application have the following advantages:

[0025] The present application provides an expansion balloon, which, by providing a first side opening on the guidewire guide channel of the sheath, allows the visual guidewire to be separated from the expansion balloon without removing its proximal connector. This simplifies the operating steps during the operation and improves the efficiency of the operation. That is, the design of the first side opening allows the head end of the visual guidewire to pass through, making it easier to remove the expansion balloon from the visual guidewire during the operation. This reduces the operational inconvenience caused by the oversized proximal connector. In addition, since the visual guidewire can be more easily separated from the expansion balloon, the surgeon can safely remove the expansion balloon without interfering with the visual guidewire, reducing the risk of damage to the visual guidewire, thereby improving the overall safety of the operation. Furthermore, since the visual guidewire can better maintain stability during the operation and can obtain images inside the surgical cavity, the surgeon can more accurately control the operating instruments, thereby improving the success rate of the operation.

[0026] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0028] Figure 1 A schematic structural diagram of an expansion balloon provided in Example 1 of the present application from one perspective is shown;

[0029] Figure 2 A schematic diagram of the assembly structure of an expansion balloon and a visual guidewire provided in Example 1 of the present application is shown;

[0030] Figure 3 A schematic structural diagram of an expansion balloon provided in Example 2 of the present application from one perspective is shown;

[0031] Figure 4 A schematic structural diagram of an expansion balloon provided in Example 2 of the present application from another perspective is shown;

[0032] Figure 5 A schematic diagram of the assembly structure of an expansion balloon and a visual guidewire provided in Example 2 of the present application is shown;

[0033] Figure 6 A schematic structural diagram of an expansion balloon provided in Example 3 of the present application from one perspective is shown;

[0034] Figure 7 A schematic structural diagram of an expansion balloon provided in Example 4 of the present application from one perspective is shown;

[0035] Figure 8 A schematic structural diagram of a dilatation balloon provided in Example 5 of the present application is shown from one perspective;

[0036] Figure 9 A schematic structural diagram of a dilatation balloon provided in Example 6 of the present application is shown from one perspective;

[0037] Figure 10 A structural schematic diagram of an expansion balloon provided in Example 7 of the present application is shown from one perspective.

[0038] Description of main component symbols:

[0039] 100-sheath;

[0040] 200-balloon; 210-working section; 220-connecting section;

[0041] 300 - infusion channel; 310 - second side opening;

[0042] 400 - guidewire guide channel; 410 - first side opening; 420 - third side opening; 421 - first subsection; 422 - second subsection;

[0043] 500-visible guidewire;

[0044] 600-Limiting parts. DETAILED DESCRIPTION

[0045] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0046] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. Conversely, when an element is referred to as being "directly on" another element, there is no intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only.

[0047] In this application, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components or interactions between two components. Those skilled in the art will understand the specific meanings of these terms in this application based on specific circumstances.

[0048] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application belongs. The terms used in the template description herein are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0050] In the related art, biliary and pancreatic diseases are common clinical diseases, among which endoscopic treatment, especially endoscopic retrograde cholangiopancreatography (ERCP) is a common means. With the emergence of visual guidewires, the difficulty of ERCP surgery can be reduced by applying visual guidewires to ERCP surgery. However, in the surgery to remove stones or polyps in the body, since the proximal end of the visual guidewire has a proximal connector, the size of the proximal connector is larger than the inner diameter of the guidewire guide channel of the expansion balloon, and during the operation, it is necessary to leave the visual guidewire in place after the papilla is expanded by the expansion balloon, and separate and remove the expansion balloon from the visual guidewire. Obviously, the limitation of the proximal connector makes it inconvenient to remove the expansion balloon from the visual guidewire.

[0051] like Figure 1 and Figure 2 As shown, in order to solve the above technical problems, an embodiment of the present application provides an expansion balloon, which includes a sheath 100 and a balloon 200. The sheath 100 has a guidewire guide channel 400, an infusion channel 300, a distal end, and a proximal end. The hole wall of the guidewire guide channel 400 near the distal end has a first side opening 410. The first side opening 410 penetrates the hole wall of the guidewire guide channel 400. The size of the first side opening 410 is configured to allow the tip end of the visual guidewire 500 to pass through.

[0052] The balloon 200 is disposed at the distal end of the sheath 100 . The balloon 200 and the first side opening 410 are spaced apart in a direction away from the distal end of the sheath 100 . The distal end of the infusion channel 300 is connected to the balloon 200 .

[0053] In these embodiments, the present application aims to solve the problem of the inconvenience of separating the dilation balloon and the visual guidewire 500 during ERCP (endoscopic retrograde cholangiopancreatography) surgery using a visual guidewire 500. In the traditional method, a common guidewire is used in conjunction with the dilation balloon. The common guidewire does not have a proximal connector, so there is no interference problem. However, the proximal connector of the visual guidewire 500 is large in size and cannot pass through the guidewire guide channel 400 used for the dilation balloon, resulting in complicated operation when the two need to be separated.

[0054] Specifically, the sheath 100 is the main component of the system and has two main channels: a guidewire guide channel 400 and an infusion channel 300. The guidewire guide channel 400 is used to guide the visual guidewire 500 through, while the infusion channel 300 is used to deliver fluid to inflate the balloon 200. The guidewire guide channel 400 has a first side opening 410 near the distal end of the sheath 100. The first side opening 410 is sized to allow the tip of the visual guidewire 500 to pass through.

[0055] In other words, the first side opening 410 penetrates the wall of the guidewire guide channel 400 and is sized to allow the tip of the visual guidewire 500 to pass through. This allows the visual guidewire 500 to freely pass through or exit the sheath 100 without being restricted by the size of the proximal connector.

[0056] For example, the first side opening 410 is in the shape of an elongated hole, and optionally, the elongated hole is provided with an arc chamfer. Of course, in other embodiments, the first side opening 410 can also be provided in a shape of a quasi-circular, circular, triangular, trapezoidal, etc.

[0057] Furthermore, the balloon 200 is fixed to the distal end of the sheath 100 and is maintained at a distance from the first side opening 410. One end of the infusion channel 300 is connected to the balloon 200, allowing liquid or gas to be injected into the balloon 200 through the infusion channel 300 to expand it, thereby expanding the lesion (nipple incision). This prevents the inflated balloon 200 and the surrounding tissue from squeezing the visual guidewire 500 that has not entered the guidewire guide channel 400, thereby damaging the visual guidewire 500.

[0058] It should be noted that before performing an examination or surgery, the sheath 100 and the visual guidewire 500 must be connected in vitro. Specifically, the tip of the visual guidewire 500 is inserted into the guidewire guide channel 400 through the first side opening 410. This fully limits the radial movement of the sheath 100, allowing the sheath 100 to move along the visual guidewire 500. When the visual guidewire 500 is installed on the sheath 100, the visual guidewire 500 is located outside the guidewire guide channel 400 for most of the axial range of the sheath 100. To maintain the visual guidewire 500 within the target cavity (i.e., the papillary sphincter) but to withdraw the sheath 100, the operator limits the axial movement of the visual guidewire 500 outside the patient's body and simultaneously pushes the sheath 100 forward (i.e., distally) so that the first side opening 410 extends beyond the tip of the visual guidewire 500, thereby disengaging the visual guidewire 500 from the sheath 100. At this time, the visual guidewire 500 is not subjected to radial force or restriction, and the separation can be completed by directly withdrawing the sheath tube 100. This arrangement can also reduce the outer diameter of the portion of the sheath tube 100 located between the first side opening 410 and the proximal end, which is conducive to controlling the movement of the sheath tube 100.

[0059] Therefore, the expansion balloon provided by the present application allows the visual guidewire 500 to be separated from the expansion balloon without removing its proximal connector, simplifying the surgical procedure and improving efficiency. Obviously, the structure of the visual guidewire 500 can directly observe the lesion, which also helps to improve the safety and success rate of the surgery.

[0060] like Figure 1 and Figure 2 As shown, in some embodiments, one end of the infusion channel 300 penetrates the outer wall of the sheath tube 100 and forms a second side opening 310; the balloon 200 is formed by the capsule membrane and the outer wall of the sheath tube 100, and the second side opening 310 is located in the area where the outer wall of the sheath tube 100 is covered by the capsule membrane, and the second side opening 310 and the balloon 200 are connected.

[0061] In these specific embodiments, one end of the infusion channel 300 is not only connected to the balloon 200, but also penetrates the outer wall of the sheath 100 through the second side opening 310. This design further optimizes the filling mechanism of the balloon 200 and provides more operational flexibility.

[0062] One end of the infusion channel 300 passes through the outer wall of the sheath 100, forming a second side opening. This second side opening 310 is located in the area of ​​the outer wall of the sheath 100 covered by the balloon membrane and communicates with the interior of the balloon 200. This means that liquid or gas can enter the interior of the balloon 200 through the second side opening 310, causing it to inflate.

[0063] For example, the second side opening 310 is in the shape of an elongated hole, and optionally, the elongated hole is provided with an arc chamfer. Of course, in other embodiments, the second side opening 310 can also be provided in a shape of a quasi-circular, circular, triangular, trapezoidal, etc.

[0064] The balloon 200 is composed of a capsule membrane and the outer wall of the sheath tube 100. The capsule membrane covers the distal portion of the sheath tube 100, and when liquid or gas enters the interior of the capsule membrane through the second side opening 310, the balloon 200 will expand. The design of the second side opening 310 allows liquid or gas to directly enter the interior of the balloon 200, thereby accelerating the filling speed of the balloon 200 and improving surgical efficiency. In addition, since the second side opening 310 is formed on the outer wall of the sheath tube 100, rather than being transferred to the balloon 200 through the interior of the sheath tube 100, the diameter of the sheath tube 100 can be reduced, making it more flexible when passing through narrow channels. Furthermore, the balloon 200 structure formed by the capsule membrane and the outer wall of the sheath tube 100 is more stable and not easily deformed during the filling process, thereby ensuring the reliability of the balloon 200 during use.

[0065] It should be noted that in order to reduce the impact on the visible guidewire 500, the second side opening 310 is located on the outer wall of the sheath 100, away from the guidewire guide channel 400 where the visible guidewire 500 is located, so that no additional pressure or interference will be generated on the visible guidewire 500 when the balloon 200 is filled.

[0066] For example, the capsule membrane and the outer wall of the sheath tube 100 are sealed and connected by bonding. Of course, in other embodiments, the capsule membrane and the outer wall of the sheath tube 100 are sealed and connected by thermoplastic bonding.

[0067] For ease of understanding, in actual surgery, when nipple dilation is required through an expansion balloon, the balloon 200 can be quickly inflated through the second side opening 310. After the surgery is completed, the visual guidewire 500 can be easily separated from the expansion balloon without complicating the operation due to the problem of the proximal connector.

[0068] like Figure 2 As shown, in some embodiments, the expansion balloon also includes a plurality of limit members 600, and the plurality of limit members 600 are arranged at intervals along the extension direction of the sheath tube 100, and the two ends of the limit members 600 are respectively connected to the corresponding side of the sheath tube 100, and a limit hole is formed between the limit member 600 and the sheath tube 100, and the visible guide wire 500 is movably passed through the limit hole.

[0069] In these embodiments, the expansion balloon further includes a plurality of stoppers 600 , which are spaced apart along the extension direction of the sheath 100 to provide positioning and support for the visual guidewire 500 .

[0070] A plurality of limiting members 600 are arranged at intervals along the extension direction of the sheath tube 100, and the two ends of each limiting member 600 are respectively connected to the corresponding side of the sheath tube 100. In this way, limiting holes are formed between the limiting members 600 and the sheath tube 100. The visual guide wire 500 is movably inserted into these limiting holes. The design of the limiting holes allows the visual guide wire 500 to maintain a relatively stable position outside the sheath tube 100 while being able to move freely.

[0071] Clearly, the above design improves the stability of the visual guidewire 500: the design of the stopper 600 and the stopper hole further stabilizes the position of the visual guidewire 500 outside the sheath 100, reducing swinging or movement of the visual guidewire 500 during surgery, thereby improving surgical precision. One function of the stopper 600 is to prevent the visual guidewire 500 from accidentally falling out of the sheath 100 during surgery. The stopper hole constrains the visual guidewire 500, preventing it from easily slipping out during surgery, ensuring surgical safety. The presence of the stopper 600 makes the movement of the visual guidewire 500 outside the sheath 100 more controllable. The surgeon can easily adjust the position of the visual guidewire 500 through the stopper hole without having to worry about the guidewire sliding freely outside the sheath 100. The stopper hole design reduces friction between the visual guidewire 500 and the patient's body cavity, thereby reducing wear and tear on the visual guidewire 500 during movement and extending the service life of the visual guidewire 500.

[0072] When the visual guidewire 500 and the dilation balloon need to be separated, the design of the stopper 600 makes the operation easier. First, the sheath 100 is pushed distally to separate the distal end of the sheath 100 from the visual guidewire 500. Then, the sheath 100 is pulled back and the stopper 600 is interrupted or destroyed in vitro to open the stopper hole. The visual guidewire 500 can be smoothly separated from the dilation balloon without removing the proximal connector, thereby improving surgical efficiency.

[0073] In some embodiments, the expansion balloon also includes a plurality of limit members 600, which are arranged at intervals along the extension direction of the sheath 100, and the two ends of the limit member 600 are respectively connected to the corresponding side of the sheath 100, and a limit hole is formed between the limit member 600 and the sheath 100, and the visual guide wire 500 is movably passed through the limit hole; wherein, the part between the two ends of the limit member 600 is set as a breakable area, and the breaking of the breakable area can separate the two ends of the limit member 600.

[0074] In these embodiments, the expansion balloon further includes a plurality of stoppers 600, which are spaced apart along the extension direction of the sheath 100, and the ends of the stoppers 600 are respectively connected to corresponding sides of the sheath 100. Stopper holes are formed between the stoppers 600 and the sheath 100, and the visual guidewire 500 is movably inserted into these stopper holes. In particular, the portion between the ends of the stopper 600 is configured as a breakable zone, and the breaking of the breakable zone can separate the two ends of the stopper 600, thereby facilitating the separation of the visual guidewire 500 and the sheath 100.

[0075] Multiple stoppers 600 are spaced apart along the extension direction of the sheath 100. Each stopper 600 has two ends connected to one side of the sheath 100, forming a stopper hole. The visual guidewire 500 is movably inserted into the stopper hole, which stabilizes the position of the visual guidewire 500 on the sheath 100 while still allowing for free movement. The middle portion of the stopper 600 is configured as a breakable zone that can break under specific conditions, thereby separating the two ends of the stopper 600.

[0076] The presence of the limiter 600 makes the position of the visual guidewire 500 on the sheath 100 more stable, reduces the swinging or movement of the visual guidewire 500 during the operation, and thus improves the accuracy of the operation. The design of the limiter 600 makes the movement of the visual guidewire 500 on the sheath 100 more controllable, and the surgeon can easily adjust the position of the visual guidewire 500 through the limiter hole without having to worry about the guidewire sliding arbitrarily in the patient's body cavity. The design of the limiter hole reduces the friction between the visual guidewire 500 and the patient's body cavity, thereby reducing the wear and tear that may occur to the visual guidewire 500 during movement and extending the service life of the visual guidewire 500.

[0077] When the visual guidewire 500 and the expansion balloon need to be separated, the design of the breakable area allows the limiter 600 to break under appropriate circumstances, thereby making it easier to separate the visual guidewire 500 from the expansion balloon and improving surgical efficiency.

[0078] For example, the fragile zone is provided with score lines, that is, one or more fine score lines are provided on the limiter 600. These score lines make the material thinner in this area and easier to break. Of course, in other embodiments, the fragile zone is provided with a microporous structure, and micropores or microcracks are provided in the fragile zone of the limiter 600. These micropores or microcracks will expand and cause fracture when subjected to force. Alternatively, the fragile zone is provided with grooves or notches, and grooves or notches are provided in the fragile zone of the limiter 600. These grooves or notches reduce the effective cross-sectional area of ​​the material, making it easier to break. Alternatively, the limiter 600 can also be made of a fragile material.

[0079] Alternatively, the stopper 600 and the outer wall of the sheath tube 100 may be detachably connected to each other, thereby enabling separation and connection between the two. For example, one end of the stopper 600 is fixedly connected to the outer wall of the sheath tube 100, while the other end is connected to the outer wall of the sheath tube 100 by a removable adhesive, thereby facilitating disassembly and assembly.

[0080] like Figure 3 、 Figure 4 and Figure 5As shown, in some embodiments, the hole wall of the guidewire guide channel 400 near the proximal end has a third side opening 420, the third side opening 420 passes through the hole wall of the guidewire guide channel 400, and the third side opening 420 is extended along the extension direction of the sheath tube 100; wherein, the size of the third side opening 420 is configured to allow the head end of the visual guidewire 500 to pass through.

[0081] In these embodiments, a third side opening 420 is provided in the wall of the guidewire guide channel 400 near the proximal end. The third side opening 420 penetrates the wall of the guidewire guide channel 400 and extends along the extension direction of the sheath tube 100. The size of the third side opening 420 is configured to allow the tip end of the visual guidewire 500 to pass through.

[0082] A third side opening 420 is provided near the proximal end of the guidewire guide channel 400. The third side opening 420 penetrates the wall of the guidewire guide channel 400 and extends along the extension direction of the sheath 100. The size of the third side opening 420 is designed to allow the tip end of the visual guidewire 500 to pass through. This means that the tip end of the visual guidewire 500 can enter and exit the guidewire guide channel 400 at the third side opening 420.

[0083] That is, the design of the third side opening 420 allows the visual guidewire 500 to enter and exit the proximal portion through the side opening, thereby enabling the tip end of the visual guidewire 500 to be located within the guidewire guide channel 400 during intubation, thereby reducing the outer diameter of the sheath 100 and preventing the portion of the sheath 100 and the visual guidewire 500 that is parallel to each other from being squeezed by the duodenal elevator, thereby preventing the visual guidewire 500 from being damaged. It should be noted that, although the portion of the visual guidewire 500 that is parallel to the dilation balloon does not enter the nipple, the exposed visual guidewire 500 will be directly subjected to force when passing through the duodenal elevator in parallel.

[0084] Furthermore, when it is necessary to separate the visual guide wire 500 and the dilation balloon, after the visual guide wire 500 is removed from the first side opening 410, the presence of the third side opening 420 allows the visual guide wire 500 to be directly removed from the proximal portion, thereby making the separation operation more convenient and improving the efficiency of the operation.

[0085] In addition, the visual guide wire 500 is introduced and exited through the third side opening 420 , thereby avoiding possible wear or damage to the visual guide wire 500 during distal operations, thereby improving the durability of the visual guide wire 500 .

[0086] For example, in this embodiment, the width of the third side opening 420 is smaller than the outer diameter of the visual guidewire 500 , and the sheath 100 is elastic, so the visual guidewire 500 can enter and exit the third side opening 420 through elastic deformation of the third side opening 420 .

[0087] like Figure 6 As shown, in some embodiments, the distal end of the third side opening 420 is communicated with the first side opening 410 , and the third side opening 420 and the first side opening 410 extend along the same generatrix on the sheath tube 100 .

[0088] In these embodiments, the third side opening 420 is not only provided at the portion of the guidewire guide channel 400 near the proximal end, but is also communicated with the first side opening 410 at the distal end, and the third side opening 420 and the first side opening 410 extend along the same generatrix on the sheath tube 100. This design further optimizes the movement path of the visual guidewire 500 within the sheath tube 100.

[0089] The third side opening 420 is located at the proximal portion of the guidewire guide channel 400 and is in communication with the distal first side opening 410. The third side opening 420 and the first side opening 410 extend along the same generatrix on the sheath 100, meaning they are arranged in the same plane and form a continuous path for the visual guidewire 500 to pass through.

[0090] The design of the third side opening 420 communicating with the first side opening 410 allows the visual guidewire 500 to move freely throughout the entire length of the sheath 100, enhancing the flexibility of the visual guidewire 500. Because the third side opening 420 and the first side opening 410 are connected and extend along the same generatrix, the visual guidewire 500 can enter and exit the third side opening 420 at any location on the proximal or distal end. This facilitates the separation operation and improves surgical efficiency.

[0091] Obviously, through the above arrangement, the visual guidewire 500 can be located in the guidewire guiding channel 400, avoiding the visual guidewire 500 and the sheath tube 100 from being in parallel, reducing the overall outer diameter, and facilitating intubation.

[0092] like Figure 8 As shown, in some embodiments, the third side opening 420 includes a plurality of first sub-segments 421 and a plurality of second sub-segments 422, and the plurality of first sub-segments 421 and the plurality of second sub-segments 422 are alternately arranged in the extension direction of the third side opening 420; wherein, the width of the first sub-segment 421 is not less than the outer diameter of the visual guidewire 500, the width of the second sub-segment 422 is less than the outer diameter of the visual guidewire 500, and the two opposite side walls of the second sub-segment 422 are set as elastic structures, and the elastic deformation of the side walls of the second sub-segment 422 can enable the head end of the visual guidewire 500 to pass through.

[0093] In these embodiments, the third side opening 420 includes a plurality of first sub-segments 421 and a plurality of second sub-segments 422, which are alternately arranged in the extending direction of the third side opening 420. Specifically, the width of the first sub-segment 421 is not less than the outer diameter of the visual guidewire 500, while the width of the second sub-segment 422 is less than the outer diameter of the visual guidewire 500. The two opposing side walls of the second sub-segment 422 are configured as elastic structures, such that the side walls of the second sub-segment 422 can pass the tip of the visual guidewire 500 when elastically deformed.

[0094] Specifically, the width of the first sub-segment 421 is no less than the outer diameter of the visual guidewire 500, allowing the visual guidewire 500 to pass freely within these sections. The width of the second sub-segment 422 is less than the outer diameter of the visual guidewire 500, but the sidewalls are elastic, allowing the tip of the visual guidewire 500 to pass through when elastically deformed. Multiple first sub-segments 421 and multiple second sub-segments 422 are alternately arranged along the extension direction of the third side opening 420, forming an "alternating wide and narrow" structure.

[0095] Obviously, the width of the first sub-segment 421 is large enough to accommodate the visual guide wire 500, making the visual guide wire 500 more stable in these sections and reducing swinging. Although the second sub-segment 422 is smaller in width, since the side wall is an elastic structure, the visual guide wire 500 can be allowed to pass through by elastic deformation when needed. That is to say, during surgery, the visual guide wire 500 is limited by the second sub-segment 422 to keep it in the guide wire guide channel 400, preventing the visual guide wire 500 from detaching from the sheath 100. The elastic design of the second sub-segment 422 reduces the friction and wear of the visual guide wire 500 when passing through, protects the surface of the visual guide wire 500, and extends its service life. This alternating design allows the visual guide wire 500 to be adjusted in multiple positions, thereby improving the flexibility of surgical operations.

[0096] When the visual guide wire 500 and the expansion balloon need to be separated, the visual guide wire 500 can be easily removed through the elastically deformed second sub-segment 422 , thereby simplifying the separation process.

[0097] For example, the third side opening 420 is formed by cutting. Of course, a pre-molding arrangement can also be used.

[0098] like Figure 7 As shown, in some embodiments, the expansion balloon also includes a plurality of limit members 600, and the plurality of limit members 600 are arranged at intervals along the extension direction of the sheath 100, one end of the two ends of the limit member 600 is connected to the side wall of one side of the third side opening 420, and the other end of the two ends of the limit member 600 is connected to the side wall of the other side of the third side opening 420, and the part of the limit member 600 located at the third side opening 420 is set as a breakable area, and the breaking of the breakable area can separate the two ends of the limit member 600.

[0099] In these embodiments, the expansion balloon further includes a plurality of stoppers 600, which are spaced apart along the extension direction of the sheath tube 100. The ends of the stoppers 600 are respectively connected to the sidewalls of the third side opening 420. Furthermore, the portion of the stoppers 600 located at the third side opening 420 is configured as a breakable region, and the breaking of the breakable region allows the two ends of the stoppers 600 to separate.

[0100] Multiple stoppers 600 are spaced apart along the extension direction of the sheath 100, forming a series of stopper structures that retain the visual guidewire 500 within the guidewire guide channel 400. One end of the stopper 600 is connected to one sidewall of the third side opening 420, and the other end is connected to the other sidewall of the third side opening 420. The portion of the stopper 600 located at the third side opening 420 is configured as a breakable region. Under specific conditions, the breakable region breaks, separating the two ends of the stopper 600.

[0101] Obviously, the presence of the limiter 600 makes the position of the visual guidewire 500 in the sheath 100 more stable, reduces the risk of the visual guidewire 500 swinging during the operation or even falling out of the third side opening 420, thereby improving the accuracy of the operation. The design of the limiter 600 makes the passage of the visual guidewire 500 in the sheath 100 more stable, and the surgeon can easily adjust the position of the visual guidewire 500 through the limiter hole without having to worry about the guidewire falling out of the sheath 100. The design of the breakable area makes it possible to quickly separate the limiter 600 by breaking the breakable area when it is necessary to separate the visual guidewire 500 and the expansion balloon, thereby making it easier to separate the visual guidewire 500 from the expansion balloon, thereby improving the efficiency of the operation.

[0102] For example, the fragile zone is provided with score lines, that is, one or more fine score lines are provided on the limiter 600. These score lines make the material thinner in this area and easier to break. Of course, in other embodiments, the fragile zone is provided with a microporous structure, and micropores or microcracks are provided in the fragile zone of the limiter 600. These micropores or microcracks will expand and cause fracture when subjected to force. Alternatively, the fragile zone is provided with grooves or notches, and grooves or notches are provided in the fragile zone of the limiter 600. These grooves or notches reduce the effective cross-sectional area of ​​the material, making it easier to break. Alternatively, the limiter 600 can also be made of a fragile material.

[0103] For example, the number of the limiting members 600 is 6. Of course, in other embodiments, the number of the limiting members 600 is 3, 4, 7, 8, etc.

[0104] In some embodiments, the two ends of the limit member 600 are respectively a first end and a second end, the first end is connected to the inner wall of one side of the third side opening 420, and the inner wall of the sheath tube 100 connected to the first end is provided with a wire groove, the wire groove is extended along the axial direction of the sheath tube 100, the second end is connected to the other side of the third side opening 420, and the electric heating wire is provided in the wire groove.

[0105] In these embodiments, this design further enhances the compactness and safety of the structure, ensuring that the electric heating wire can effectively heat and fuse the stopper 600. The electric heating wire is disposed within the wire slot and abuts the middle portion of the stopper 600. When powered, the electric heating wire heats the second portion of the stopper 600, causing it to reach its melting point and fuse.

[0106] Obviously, embedding the electric heating wire in the wire groove makes the entire device more compact, reduces the possibility of external interference, and avoids increasing the outer diameter of the sheath tube 100. In addition, the electric heating wire is protected in the wire groove, reducing the risk of accidental contact and improving the safety of the operation.

[0107] like Figure 9 As shown, in some embodiments, the sheath 100 includes an insertion section and a connecting section 220, which are connected in sequence in a direction away from the distal end, the outer diameter of the insertion section is smaller than the outer diameter of the connecting section 220, the end of the infusion channel 300 located at the distal end is arranged at the connecting section 220, and the end of the guidewire guide channel 400 located at the distal end is arranged at the insertion section; wherein, the balloon 200 includes a working section 210 and a connecting section, the working section 210 is arranged at the insertion section, the other end of the connecting section is arranged at the connecting section 220, and the connecting section and the infusion channel 300 are connected.

[0108] In these embodiments, the sheath 100 is divided into an insertion section and a connecting section 220, which are connected in a direction away from the distal end. The insertion section is the portion intended for insertion into the patient's body and has a smaller outer diameter to facilitate passage through narrow passages. The connecting section 220 is located at the proximal end of the insertion section and has a larger outer diameter than the insertion section. It is typically used to connect to external devices or provide a larger operating space.

[0109] The distal end of the infusion channel 300 is arranged at the connecting section 220 for delivering liquid or gas into the balloon 200. The distal end of the guidewire guide channel 400 is arranged at the insertion section for guiding the visual guidewire 500 to pass through.

[0110] The working section 210 of the balloon 200 is disposed on the insertion section and is used to expand when needed to dilate the incision. The communication section of the balloon 200 is disposed on the connecting section 220 and is connected to the infusion channel 300, allowing liquid or gas to enter the working section 210 of the balloon 200 through the infusion channel 300.

[0111] The small diameter design of the insertion section makes it easier to insert the sheath 100 into the patient's body, reducing the resistance and trauma during insertion. The large diameter of the connecting section 220 provides a larger space for setting the infusion channel 300 and the guidewire guide channel 400, which is convenient for connection with external equipment and also convenient for the surgeon to operate. In other words, the infusion channel 300 is set in the connecting section 220, which makes it convenient for the surgeon to transport liquid or gas into the balloon 200 through the connecting section 220 to achieve filling and deflation of the balloon 200. The guidewire guide channel 400 is set in the insertion section and the connecting section 220, which is conducive to reducing the outer diameter of the distal end of the sheath 100.

[0112] Furthermore, the miniaturization of the distal end of the sheath 100 can eliminate the need for a papillotomy, thereby reducing surgical costs and patient pain.

[0113] like Figure 9 As shown, in some embodiments, the working section 210 is extended along the circumference of the sheath tube 100 ; the connecting section 220 is extended along the circumference of the sheath tube 100 and is formed with two ends, with a gap between the two ends of the connecting section 220 .

[0114] In these embodiments, the working section 210 of the balloon 200 is arranged to extend circumferentially along the sheath 100, which means that the working section 210 of the balloon 200 is arranged around the outer wall of the insertion section to ensure uniform expansion when filled.

[0115] For example, the central angle corresponding to the length of the working segment 210 extending along the circumference of the sheath tube 100 is 360°, forming a body of revolution. Of course, in other embodiments, the central angle corresponding to the length of the working segment 210 extending along the circumference of the sheath tube 100 can also be set to 60°, 100°, 120°, 180°, 200°, etc. along the circumference of the sheath tube 100.

[0116] The connecting section of the connecting segment balloon 200 is arranged on the connecting segment 220 and is connected to the infusion channel 300, so that liquid or gas can enter the working section 210 of the balloon 200 through the infusion channel 300. Extending circumferentially: The connecting segment 220 is arranged to extend circumferentially along the sheath tube 100 to form an annular structure. The connecting segment 220 is formed with two ends in the circumference of the sheath tube 100, with a gap between the two ends. This means that the connecting segment 220 is not a closed ring, but a certain gap is left between the two ends, which helps to reduce the overall outer diameter of the balloon 200 and the sheath tube 100.

[0117] For example, the length of the connecting section 220 extending along the circumference of the sheath tube 100 corresponds to a central angle of 260°, forming a body of revolution. Of course, in other embodiments, the central angle corresponding to the length of the connecting section 220 extending along the circumference of the sheath tube 100 can also be set to 60°, 100°, 120°, 180°, 200°, etc. along the circumference of the sheath tube 100.

[0118] It should be noted that the central angle corresponding to the length of the working section 210 and the connecting section 220 extending along the sheath tube 100 is less than 360°. In other words, the balloon 200 is a non-rotating body, and a slot extending along the length of the sheath tube 100 is formed on one side of the balloon 200 to accommodate the visual guidewire 500 and avoidance between the two.

[0119] like Figure 10 As shown, in some embodiments, when the balloon 200 is in the expanded and unexpanded states, the outer diameter of the working section 210 is smaller than the outer diameter of the connecting section 220 .

[0120] In these embodiments, the insertion section is used to be inserted into the patient's body and has a smaller outer diameter so that it can pass through narrow passages more easily. The connecting section 220 is located at the proximal end of the insertion section and has an outer diameter larger than that of the insertion section. It is usually used to connect external devices or provide a larger operating space.

[0121] In this example, a special-shaped balloon 200 is used, which is divided into a working section 210 and a connecting section 220. It should be noted that the working section 210 and the connecting section 220 are defined when the balloon 200 is not inflated. After the balloon 200 is inflated, the expansion coefficient of the balloon 200 in all directions is the same, that is, the actual working surface is the entire surface of the balloon 200. By reducing the thickness of the working section 210 and the connecting section 220 when the balloon 200 is not inflated, initial insertion or initial expansion is provided. For example, if the patient's nipple sphincter opening is very small, the capsule body of a conventional expansion balloon cannot be inserted, but the insertion section of this design can be inserted into the nipple, and expansion can then be performed.

[0122] In some embodiments, the present application also provides a papillary incision system, which includes an expansion balloon as described in any of the above embodiments.

[0123] Since the above-mentioned expansion balloon has the above-mentioned technical effects, the papillary incision system including the expansion balloon should have the same technical effects, which will not be described in detail here.

[0124] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not limiting, and thus other examples of the exemplary embodiments may have different values.

[0125] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0126] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the scope of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. A dilatation balloon, characterized in that: The expansion balloon comprises: A sheath having a guidewire guide channel, an infusion channel, a distal end, and a proximal end; a hole wall of the guidewire guide channel near the distal end has a first side opening, the first side opening penetrates the hole wall of the guidewire guide channel, and the size of the first side opening is configured to allow the tip end of the visual guidewire to pass through; a balloon, the balloon being disposed at the distal end of the sheath, the balloon and the first side opening being spaced apart in a direction away from the distal end of the sheath, and the infusion channel being in communication with the balloon at one end thereof; The guidewire guide channel has a third side opening at a portion of the hole wall near the proximal end thereof, the third side opening penetrating the hole wall of the guidewire guide channel and extending along the extension direction of the sheath; wherein the third side opening is sized to allow the tip end of a visual guidewire to pass through; The guidewire guide channel has a third side opening at a portion of the hole wall near the proximal end thereof, the third side opening penetrating the hole wall of the guidewire guide channel and extending along the extension direction of the sheath; wherein the third side opening is sized to allow the tip end of a visual guidewire to pass through; The third side opening includes a plurality of first sub-segments and a plurality of second sub-segments, and the plurality of first sub-segments and the plurality of second sub-segments are alternately arranged in the extension direction of the third side opening; wherein, the width of the first sub-segment is not less than the outer diameter of the visual guidewire, the width of the second sub-segment is less than the outer diameter of the visual guidewire, and the two opposite side walls of the second sub-segment are set as elastic structures, and the elastic deformation of the side walls of the second sub-segment can enable the head end of the visual guidewire to pass through.

2. The dilatation balloon according to claim 1, characterized in that One end of the infusion channel penetrates the outer wall of the sheath tube and forms a second side opening; The balloon is formed by a capsule membrane and an outer wall of a sheath tube. The second side opening is located in a region of the outer wall of the sheath tube covered by the capsule membrane. The second side opening is communicated with the balloon.

3. The dilatation balloon according to claim 1, characterized in that The expansion balloon further comprises: A plurality of limiting members, the plurality of limiting members are spaced apart along the extension direction of the sheath tube, the two ends of the limiting members are respectively connected to the corresponding side of the sheath tube, a limiting hole is formed between the limiting member and the sheath tube, and the visual guide wire is movably passed through the limiting hole; Alternatively, the expansion balloon further comprises: A plurality of limiting members are arranged at intervals along the extension direction of the sheath tube, the two ends of the limiting member are respectively connected to the corresponding side of the sheath tube, a limiting hole is formed between the limiting member and the sheath tube, and the visual guide wire is movably passed through the limiting hole; wherein, the part between the two ends of the limiting member is set as a breakable area, and the breaking of the breakable area can separate the two ends of the limiting member.

4. The dilatation balloon according to claim 1, characterized in that One end of the third side opening is located at the distal end and is communicated with the first side opening. The third side opening and the first side opening are extended along the same busbar on the sheath tube.

5. The dilatation balloon according to claim 4, characterized in that: The expansion balloon further comprises: A plurality of limit members are arranged at intervals along the extension direction of the sheath tube, one end of the limit member is connected to the side wall of one side of the third side opening, the other end of the limit member is connected to the side wall of the other side of the third side opening, and the portion of the limit member located at the third side opening is set as a breakable zone, and the breaking of the breakable zone can separate the two ends of the limit member.

6. The dilatation balloon according to claim 1, characterized in that The sheath includes an insertion section and a connecting section, the insertion section and the connecting section are connected in sequence in a direction away from the distal end, the outer diameter of the insertion section is smaller than the outer diameter of the connecting section, the end of the infusion channel located at the distal end is arranged at the connecting section, and the end of the guidewire guide channel located at the distal end is arranged at the insertion section; wherein, the balloon includes a working section and a connecting section, the working section is arranged at the insertion section, the other end of the connecting section is arranged at the connecting section, and the connecting section and the infusion channel are connected.

7. The dilatation balloon according to claim 6, characterized in that The working section is arranged to extend along the circumference of the sheath tube; The connecting section is extended along the circumference of the sheath tube and is formed with two ends, with a gap between the two ends of the connecting section.

8. The dilatation balloon according to claim 7, characterized in that: When the balloon is in an expanded state or an unexpanded state, the outer diameter of the working section is smaller than the outer diameter of the connecting section.

9. A papillary incision system, characterized in that: The papillotomy system comprises the dilation balloon according to any one of claims 1 to 8.

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