Expansion balloon and nipple incision system

Abstract

The invention provides an expansion balloon and a nipple incision system, and relates to the technical field of endoscopes. The dilatation balloon comprises a sheath tube and a balloon body, the sheath tube is provided with a guide wire guiding channel, an infusion channel, a far end and a near end, the hole wall of the part, close to the far end, of the guide wire guiding channel is provided with a first side opening, the first side opening penetrates through the hole wall of the guide wire guiding channel, and the size of the first side opening is configured to allow the head end of a visible guide wire to pass through; the balloon is arranged at the far end of the sheathing canal, the balloon and the first side opening are arranged at intervals in the direction away from the far end of the sheathing canal, and the end, located at the far end, of the infusion channel communicates with the balloon. According to the expansion balloon provided by the invention, the separation of the expansion balloon and the visual guide wire is not restrained and limited by the near-end connector, the operation is convenient, and the working efficiency is high.

Description

Technical Field

[0001] The present application relates to the technical field of endoscopes, and in particular to a dilatation balloon and a 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 removal surgery of 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 the present application is to overcome the deficiencies in the prior art and to provide a dilation balloon and papillary incision system, which can enable the separation of the dilation balloon and the visual guidewire to be free from the constraints of the proximal connector, thereby facilitating operation and increasing work efficiency.

[0004] This application provides the following technical solutions:

[0005] The present application embodiment provides a dilatation balloon, the dilatation balloon comprising:

[0006] A sheath tube, the sheath tube having 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 having a first side opening, the first side opening penetrating the hole wall of the guide wire guide channel, the size of the first side opening being configured to allow the tip end of the visual guide wire to pass through;

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

[0008] In some embodiments of the first aspect, one end of the infusion channel penetrates through 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, and the second side opening is connected to the balloon.

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

[0011] A plurality of limiters, wherein the plurality of limiters are arranged at intervals along the extension direction of the sheath tube, the two ends of the limiters are respectively connected to the corresponding side of the sheath tube, a limit hole is formed between the limiter and the sheath tube, and the visual guide wire is movably inserted into the limit hole;

[0012] Or, the expansion balloon further comprises:

[0013] A plurality of limit members are arranged at intervals along the extension direction of the sheath tube, two ends of the limit member are respectively connected to the corresponding side of the sheath tube, a limit hole is formed between the limit member and the sheath tube, and the visual guide wire is movably passed through the limit hole; wherein the portion between the two ends of the limit member is set as a breakable zone, and the breaking of the breakable zone can separate the two ends of the limit 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 is extended along the extension direction of the sheath tube; wherein the size of the third side opening is configured to allow the tip end of a visible guidewire to pass through.

[0015] In some embodiments of the first aspect, one end of the third side opening located at the distal end is communicated with the first side opening, and the third side opening and the first side opening are extended along the 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 visible guidewire, the width of the second sub-segment is less than the outer diameter of the visible guidewire, and two opposite side walls of the second sub-segment are arranged as elastic structures, and the elastic deformation of the side walls of the second sub-segment enables the head end of the visible 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 two ends of the limit member is connected to the side wall of one side of the third side opening, the other end of the two ends 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 comprises 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 comprises 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 along the circumference of the sheath tube;

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

[0022] In some embodiments of the first aspect, when the balloon is in an expanded state and an unexpanded 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 can be separated from the expansion balloon without removing its proximal connector by setting a first side opening on the guide wire guide channel of the sheath. This simplifies the operation steps during the operation and improves the efficiency of the operation. In other words, the design of the first side opening allows the head end of the visual guide wire to pass through, so that the expansion balloon can be more easily removed from the visual guide wire during the operation. This reduces the inconvenience of operation caused by the oversize of the proximal connector. In addition, since the visual guide wire can be more easily separated from the expansion balloon, the surgeon can safely remove the expansion balloon without interfering with the visual guide wire, reducing the risk of damage to the visual guide wire, thereby improving the overall safety of the operation. Furthermore, since the visual guide wire can better maintain stability during the operation and can obtain images in the surgical cavity, the surgeon can more accurately control the operating instrument, 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 understandable, 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 drawings required for use in the embodiments will be briefly introduced below. 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 related drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 A structural schematic diagram of a dilatation balloon provided in Example 1 of the present application from one viewing angle is shown;

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

[0030] Figure 3 A schematic structural diagram of a dilatation 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 the second embodiment of the present application from another perspective is shown;

[0032] Figure 5 A schematic diagram of the assembly structure of a dilatation balloon and a visual guidewire provided in the second embodiment of the present application is shown;

[0033] Figure 6 A structural schematic diagram of a dilatation balloon provided in Example 3 of the present application from one viewing angle is shown;

[0034] Figure 7 A structural schematic diagram of a dilatation balloon provided in a fourth embodiment of the present application from one viewing angle is shown;

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

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

[0037] Fig.10 A structural schematic diagram of a dilatation 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 - guide wire 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 embodiments of the present application are described in detail below, and 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 cannot be understood 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 a central 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 a central element at the same time. In contrast, 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 clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0048] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of the template are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related 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 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 removal surgery of 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 guide wire guide channel 400, an infusion channel 300, a distal end and a proximal end. The hole wall of the guide wire guide channel 400 near the distal end has a first side opening 410, which penetrates the hole wall of the guide wire guide channel 400. The size of the first side opening 410 is configured to allow the head end of the visible guide wire 500 to pass through.

[0052] The balloon 200 is disposed at the distal end of the sheath tube 100 . The balloon 200 and the first side opening 410 are spaced apart in a direction away from the distal end of the sheath tube 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 dilatation balloon from the visual guidewire 500 during ERCP (endoscopic retrograde pancreatocholangiopancreatography) surgery using the visual guidewire 500. In the traditional method, a common guidewire is used in conjunction with the dilatation balloon, and 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 by the dilatation balloon, resulting in complicated operation when the two need to be separated.

[0054] Specifically, the sheath 100 is the main part of the system, and the sheath 100 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 liquid to fill the balloon 200. The guidewire guide channel 400 has a first side opening 410 near the distal end of the sheath 100, and the size of the first side opening 410 is designed to allow the head 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 from the sheath 100 without being restricted by the size of the proximal connector.

[0056] Exemplarily, 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, and the like.

[0057] Furthermore, the balloon 200 is fixed at the distal end of the sheath 100 and is kept at a certain distance from the first side opening 410. One end of the infusion channel 300 is connected to the balloon 200, so that liquid or gas can be injected into the balloon 200 through the infusion channel 300 to expand it, thereby expanding the lesion (nipple incision). This prevents the balloon 200 from squeezing the visual guide wire 500 that has not entered the guide wire guide channel 400 together with the peripheral tissue in the expanded state, causing damage to the visual guide wire 500.

[0058] It should be noted that before performing an examination or surgery, the sheath 100 needs to be connected to the visual guidewire 500 in vitro, that is, the head end of the visual guidewire 500 is inserted into the guidewire guide channel 400 from the first side opening 410, that is, the radial movement of the sheath 100 is completely limited, and the sheath 100 can be controlled 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 in most of the axial range of the sheath 100. When it is necessary to keep the visual guidewire 500 in the target cavity (i.e., the nipple sphincter) but to withdraw the sheath 100, the operator limits the axial movement of the visual guidewire 500 outside the patient's body, and at the same time pushes the sheath 100 forward (i.e., to the distal end) so that the first side opening 410 exceeds the head end of the visual guidewire 500, that is, the visual guidewire 500 is detached from the sheath 100. At this time, the visual guide wire 500 is not subjected to force or position restriction in the radial direction, and the separation can be completed by directly pulling out the sheath tube 100. Such a configuration can also reduce the outer diameter of the portion of the sheath tube 100 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 guide wire 500 to be separated from the expansion balloon without removing its proximal connector, which simplifies the surgical procedure and improves efficiency. Obviously, the structure of directly observing the lesion with the visual guide wire 500 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 tube 100 through the second side opening 310. Such a 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 tube 100 to form a second side opening. This 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 is connected to the inside of the balloon 200. This means that liquid or gas can enter the inside of the balloon 200 through the second side opening 310 to expand it.

[0063] Exemplarily, 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. Among them, 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 the efficiency of the operation. In addition, since the second side opening 310 is formed on the outer wall of the sheath tube 100, rather than being transmitted 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 a narrow passage. Furthermore, the balloon 200 structure formed by the capsule membrane and the outer wall of the sheath tube 100 is more stable and not easy to deform during the filling process, 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, since 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, 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 thermoplastics, etc.

[0067] For ease of understanding, in actual surgery, when the nipple needs to be expanded by an expansion balloon, the balloon 200 can be quickly filled through the second side opening 310. After the surgery is completed, the visual guide wire 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 arranged at intervals along the extension direction of the sheath tube 100 to provide positioning and support for the visible guidewire 500 .

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

[0071] Obviously, the above design improves the stability of the visual guide wire 500: the design of the limiter 600 and the limiter hole makes the position of the visual guide wire 500 outside the sheath 100 more stable, reduces the swing or movement of the visual guide wire 500 during the operation, and thus improves the accuracy of the operation. One of the functions of the limiter 600 is to prevent the visual guide wire 500 from accidentally falling out of the sheath 100 during the operation. Through the constraint of the limiter hole, the visual guide wire 500 will not easily slide out even during the operation, ensuring the safety of the operation. The existence of the limiter 600 makes the movement of the visual guide wire 500 outside the sheath 100 more controllable. The surgeon can easily adjust the position of the visual guide wire 500 through the limiter hole without worrying about the random sliding of the guide wire outside the sheath 100. The design of the limiter hole reduces the friction between the visual guide wire 500 and the patient's body cavity, thereby reducing the wear of the visual guide wire 500 during the movement and extending the service life of the visual guide wire 500.

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

[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 visible 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 zone, and the breaking of the breakable zone 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 arranged at intervals along the extension direction of the sheath 100, and the two ends of the stoppers 600 are respectively connected to the corresponding side of the sheath 100. A limit hole is formed between the stopper 600 and the sheath 100, and the visual guide wire 500 is movably inserted into these limit holes. In particular, the portion between the two ends of the stopper 600 is set as an easy-to-break zone, and the breaking of the easy-to-break zone can separate the two ends of the stopper 600, thereby facilitating the separation of the visual guide wire 500 and the sheath 100.

[0075] A plurality of stoppers 600 are arranged at intervals along the extension direction of the sheath 100, and the two ends of each stopper 600 are respectively connected to one side of the sheath 100 to form a stopper hole. The visual guide wire 500 is movably arranged in the stopper hole, which makes the position of the visual guide wire 500 on the sheath 100 more stable, but still able to move freely. The middle part of the stopper 600 is set as a breakable area, which can be broken under certain conditions, so that the two ends of the stopper 600 are separated.

[0076] The presence of the limiter 600 makes the position of the visual guidewire 500 on the sheath 100 more stable, reduces the swing 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 worrying about the guidewire sliding randomly 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 visible 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 visible guidewire 500 from the expansion balloon, thereby improving surgical efficiency.

[0078] Exemplarily, the breakable area is provided with a score line, that is, one or more fine score lines are provided on the limiter 600, and these score lines make the material thinner at this location and easier to break. Of course, in other embodiments, the breakable area is provided with a microporous structure, and micropores or microcracks are provided in the breakable area of ​​the limiter 600, and these micropores or microcracks will expand and cause breakage when subjected to force. Alternatively, grooves or notches are provided in the breakable area, and grooves or notches are provided in the breakable area of ​​the limiter 600, and 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 breakable material.

[0079] As another option, the stopper 600 and the outer wall of the sheath tube 100 are detachably connected, so that the two can be separated and connected. For example, one end of the stopper 600 is fixedly connected to the outer wall of the sheath tube 100, and the other end is connected to the outer wall of the sheath tube 100 by a tearable adhesive method, so as to facilitate 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 penetrates 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 visible guidewire 500 to pass through.

[0081] In these embodiments, a third side opening 420 is provided in the hole wall of the guidewire guide channel 400 near the proximal end, and the third side opening 420 penetrates the hole 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 head end of the visual guidewire 500 to pass through.

[0082] A third side opening 420 is provided at the portion of the guidewire guide channel 400 near the proximal end, and the third side opening 420 penetrates the hole 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 designed to allow the head end of the visual guidewire 500 to pass through. This means that the head end of the visual guidewire 500 can enter and exit the guidewire guide channel 400 at the third side opening 420.

[0083] That is to say, the design of the third side opening 420 allows the visual guidewire 500 to enter and exit through the side opening at the proximal end, so that during the intubation process, the head end of the visual guidewire 500 can be located in the guidewire guide channel 400 to reduce the outer diameter of the sheath 100 and prevent the sheath 100 and the visual guidewire 500 from being squeezed by the duodenal lifting forceps, resulting in damage to the visual guidewire 500. It should be noted that, although the parallel part of the visual guidewire 500 and the dilation balloon will not enter the nipple, the exposed visual guidewire 500 will be directly stressed when passing through the duodenal lifting forceps in parallel.

[0084] Furthermore, when it is necessary to separate the visual guide wire 500 and the expansion balloon, after the visual guide wire 500 is moved out of the first side opening 410, the presence of the third side opening 420 allows the visual guide wire 500 to be directly moved out from the proximal portion, so that the separation operation can be completed more conveniently and the operation efficiency can be improved.

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

[0086] Illustratively, 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 third side opening 420 is connected to the first side opening 410 at one end located at the distal end, and the third side opening 420 and the first side opening 410 are extended along the same generatrix on the sheath tube 100 .

[0088] In these embodiments, the third side opening 420 is not only disposed at the portion of the guidewire guide channel 400 close to 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 are extended along the same generatrix on the sheath tube 100. This design further optimizes the moving path of the visual guidewire 500 in the sheath tube 100.

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

[0090] The design that the third side opening 420 is connected to the first side opening 410 allows the visual guide wire 500 to move freely within the entire length of the sheath 100, thereby improving the flexibility of the visual guide wire 500. Since the third side opening 420 is connected to the first side opening 410 and is extended along the same generatrix, the visual guide wire 500 can enter and exit through the third side opening 420 at any position at the proximal end or the distal end. In this way, the separation operation can be completed more conveniently, thereby improving the efficiency of the operation.

[0091] Obviously, through the above arrangement, the visible guidewire 500 can be located in the guidewire guide channel 400, avoiding the parallel movement of the visible guidewire 500 and the sheath tube 100, 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 visible guidewire 500, the width of the second sub-segment 422 is less than the outer diameter of the visible guidewire 500, and the two opposite side walls of the second sub-segment 422 are arranged as elastic structures, and the elastic deformation of the side walls of the second sub-segment 422 enables the head end of the visible 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 extension 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 guide wire 500, and the width of the second sub-segment 422 is less than the outer diameter of the visual guide wire 500. The two opposite side walls of the second sub-segment 422 are configured as elastic structures, so that the side walls of the second sub-segment 422 can allow the head end of the visual guide wire 500 to pass through when elastically deformed.

[0094] Specifically, the width of the first sub-segment 421 is not less than the outer diameter of the visual guide wire 500, so that the visual guide wire 500 can pass freely in these sections. The width of the second sub-segment 422 is less than the outer diameter of the visual guide wire 500, but the side wall is an elastic structure, which can allow the head end of the visual guide wire 500 to pass through when elastically deformed. Multiple first sub-segments 421 and multiple second sub-segments 422 are alternately arranged in the extension direction of the third side opening 420, forming a "wide and narrow alternating" structure.

[0095] Obviously, the width of the first sub-segment 421 is large enough to accommodate the visual guide wire 500, so that the visual guide wire 500 is more stable in these sections and reduces 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 elastic deformation when necessary. That is to say, during surgery, the second sub-segment 422 is limited to keep the visual guide wire 500 in the guide wire guide channel 400 to prevent 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 dilation 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] Exemplarily, the third side opening 420 is formed by cutting. Of course, a pre-molding arrangement may 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 tube 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 portion of the limit member 600 located at the third side opening 420 is set as a breakable zone, and the breaking of the breakable zone 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 arranged at intervals along the extension direction of the sheath tube 100, and the two ends of the stoppers 600 are respectively connected to the two side walls of the third side opening 420. In addition, the portion of the stoppers 600 located at the third side opening 420 is set as a breakable area, and the breakage of the breakable area can separate the two ends of the stoppers 600.

[0100] A plurality of stoppers 600 are arranged at intervals along the extension direction of the sheath tube 100 to form a series of stopper structures, so that the visible guidewire 500 is kept in the guidewire guide channel 400. One end of the two ends of the stopper 600 is connected to one side wall of the third side opening 420, and the other end is connected to the other side wall of the third side opening 420. The portion of the stopper 600 located at the third side opening 420 is set as an easy-to-break zone. The easy-to-break zone breaks under specific conditions, so that the two ends of the stopper 600 are separated.

[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 worrying 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] Exemplarily, the breakable area is provided with a score line, that is, one or more fine score lines are provided on the limiter 600, and these score lines make the material thinner at this location and easier to break. Of course, in other embodiments, the breakable area is provided with a microporous structure, and micropores or microcracks are provided in the breakable area of ​​the limiter 600, and these micropores or microcracks will expand and cause breakage when subjected to force. Alternatively, grooves or notches are provided in the breakable area, and grooves or notches are provided in the breakable area of ​​the limiter 600, and 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 breakable 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, and so on.

[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 arranged 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 arranged in the wire slot and abuts against the middle of the stopper 600. When powered on, the electric heating wire can heat the second portion of the stopper 600 to a melting point and fuse.

[0106] Obviously, embedding the electric heating wire in the wire groove makes the whole 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 Fig. 9 As shown, in some embodiments, the sheath 100 includes an insertion section and a connecting section 220, the insertion section and the connecting section 220 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 on the connecting section 220, and the end of the guidewire guide channel 400 located at the distal end is arranged on the insertion section; wherein, the balloon 200 includes a working section 210 and a connecting section, the working section 210 is arranged on the insertion section, the other end of the connecting section is arranged on the connecting section 220, and the connecting section and the infusion channel 300 are connected.

[0108] In these embodiments, the sheath tube 100 is divided into an insertion section and a connection section 220, which are connected in sequence in a direction away from the distal end. The insertion section is a section for inserting into the patient's body, and its outer diameter is smaller so that it can pass through narrow passages more easily. The connection section 220 is located at the proximal end of the insertion section, and its outer diameter is larger than that of the insertion section, and is generally used to connect external devices or provide a larger operating space.

[0109] The distal end of the infusion channel 300 is arranged at the connecting section 220, and is used to deliver liquid or gas into the balloon 200. The distal end of the guide wire guide channel 400 is arranged at the insertion section, and is used to guide the visual guide wire 500 to pass through.

[0110] The working section 210 of the balloon 200 is arranged on the insertion section, and is used to expand to expand the incision when needed. The communication section of the balloon 200 is arranged on the connecting section 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.

[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 guide wire 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 arranged in the connecting section 220, which is 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 guide wire guide channel 400 is arranged 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 knife, thereby reducing surgical costs and patient pain.

[0113] like Fig. 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, and a gap is formed 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 tube 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 length of the working section 210 extending along the circumference of the sheath tube 100 corresponds to a central angle of 360°, forming a body of revolution. Of course, in other embodiments, the central angle corresponding to the length of the working section 210 extending along the circumference of the sheath tube 100 can also be set to extend along the circumference of the sheath tube 100 at 60°, 100°, 120°, 180°, 200°, etc.

[0116] The connecting section of the connecting section balloon 200 is arranged on the connecting section 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 along the circumferential direction: the connecting section 220 is arranged to extend along the circumference of the sheath tube 100 to form an annular structure. The connecting section 220 is formed with two ends in the circumference of the sheath tube 100, and there is a gap between the two ends. This means that the connecting section 220 is not a closed ring, but a certain gap is left between the two ends, which is conducive to reducing 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 extend along the circumference of the sheath tube 100 at 60°, 100°, 120°, 180°, 200°, etc.

[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 direction of the sheath tube 100 is formed on one side of the balloon 200, which can accommodate the visual guide wire 500 and avoidance between the two.

[0119] like Fig.10 As shown, in some embodiments, when the balloon 200 is in an expanded state and an unexpanded state, 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 greater than that of the insertion section, and is generally 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 above working section 210 and connecting section 220 are defined when the balloon 200 is not expanded. After the balloon 200 is expanded, 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, and the initial insertion or initial expansion is provided by reducing the thickness of the working section 210 and the connecting section 220 when the balloon 200 is not expanded. For example, the opening of the patient's nipple sphincter is very small, and the capsule body of the conventional expansion balloon cannot be inserted, but the insertion section of this design can be inserted into the nipple, and then expansion can be performed.

[0122] In some embodiments, the present application also provides a papillary incision system, which comprises 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 repeated here.

[0124] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not as 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, further definition and explanation thereof is not required in subsequent drawings.

[0126] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A dilatation balloon, characterized in that: The expansion balloon comprises: A sheath tube, the sheath tube having 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 having a first side opening, the first side opening penetrating the hole wall of the guide wire guide channel, the size of the first side opening being configured to allow the tip end of the visual guide wire to pass through; A balloon is arranged at the distal end of the sheath tube, the balloon and the first side opening are arranged at intervals in a direction away from the distal end of the sheath tube, and the infusion channel is connected to the balloon at one end located at the distal end.

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, and the second side opening is connected to the balloon.

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

4. The dilatation balloon according to claim 1, characterized in that: The hole wall of the guidewire guide channel near the proximal end has a third side opening, and the third side opening penetrates the hole wall of the guidewire guide channel, and the third side opening is extended 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 visible guidewire to pass through.

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

6. The dilatation balloon according to claim 4 or 5, characterized in that: 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 visible guidewire, the width of the second sub-segment is less than the outer diameter of the visible guidewire, and the two opposite side walls of the second sub-segment are arranged as elastic structures, and the elastic deformation of the side walls of the second sub-segment enables the head end of the visible guidewire to pass through.

7. The dilatation balloon according to claim 4 or 5, 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.

8. The dilatation balloon according to claim 1, characterized in that: The sheath tube comprises 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 on the connecting section, and the end of the guidewire guide channel located at the distal end is arranged on the insertion section; wherein, the balloon comprises a working section and a connecting section, the working section is arranged on the insertion section, the other end of the connecting section is arranged on the connecting section, and the connecting section and the infusion channel are connected.

9. The dilatation balloon according to claim 8, characterized in that: The working section is arranged to extend along the circumference of the sheath tube; The connecting section is extended along the circumferential direction of the sheath tube and is formed with two ends, and a gap is provided between the two ends of the connecting section.

10. The dilatation balloon according to claim 8, 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.

11. A papillary incision system, characterized in that: The papillotomy system comprises the dilation balloon according to any one of claims 1 to 10.

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