A diameter regulator and a diameter-adjustable bracket system

Abstract

The present invention discloses a diameter regulator and a diameter-adjustable bracket system. The diameter regulator is suitable for use with a diameter-adjustable bracket and includes a main body, a plurality of adjustment wires, a damping fixture, and a fixing seat. The damping fixture is connected to a support frame in the diameter-adjustable bracket. The distal end of the adjustment wire is connected to the support frame. The proximal end of the adjustment wire passes through the damping fixture and extends into an adjustment wire channel on the main body. After extending, it connects to an adjustment wire connector. A disconnect node is provided on the portion of the adjustment wire within the adjustment wire channel. The adjustment wire connector is mounted on the fixing seat. Under the action of an external force, the adjustment wire connector rotates so that the adjustment wire disconnects at the disconnect node due to rotational torque. When the fixing seat is driven by an external force to move the adjustment wire connector proximally, the adjustment wire overcomes the damping between the adjustment wire and the damping fixture and moves proximally. The distal end of the adjustment wire drives the support frame connected to it to move toward the damping fixture, thereby reducing the minimum diameter of the diameter-adjustable bracket.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a diameter regulator and a diameter-adjustable bracket system. Background Art

[0002] Portal hypertension is a group of symptoms caused by persistently high portal vein pressure. Most cases are caused by cirrhosis, while a smaller number develop secondary to obstruction of the main portal vein or hepatic vein, as well as other unexplained conditions. The liver is the largest organ in the body, weighing approximately 1.4 kg and performing over 500 functions. Most blood leaving the stomach and small intestine must pass through the liver. Cirrhosis develops when normal liver tissue is damaged and replaced by scar tissue. Most blood flowing through the liver comes from the portal vein, and in cirrhotic livers, scar tissue significantly slows the flow of blood from the portal vein through the liver. High portal vein pressure occurs when portal vein blood cannot flow smoothly through the liver into the inferior vena cava. With reduced blood flow through the liver, blood must find a different way to reach the heart. The body diverts blood away from the liver by increasing blood flow through the blood vessels surrounding the stomach and lower esophagus. This increased blood flow can cause these vessels to become enlarged, twisted, and fragile veins called varicose veins. Varicose veins can rupture, causing bleeding that requires immediate medical attention.

[0003] Currently, in clinical practice, patients with portal hypertension and gastric fundus bleeding caused by portal hypertension often undergo a transjugular intrahepatic puncture procedure. This procedure establishes a pathway between the portal and hepatic veins, implants a covered stent within the liver parenchyma, and creates a new blood flow pathway to reduce portal hypertension. Transjugular intrahepatic portosystemic stent shunt (TIPS) is minimally invasive, has few complications, and is safe. It is an effective treatment for PHT, especially for patients with upper gastrointestinal bleeding caused by ruptured esophageal and gastric varices, and its clinical efficacy has been well established.

[0004] Currently, the best dedicated stent on the market is Gore's Viatorr stent. The diameter of the new generation of stents can be controlled at 8 and 10 mm (controlled at 8 and 10 mm respectively through balloon expansion of different diameters), but it is still not suitable for all people. Excessive shunt flow can easily cause hepatic encephalopathy, and too little shunt flow can easily cause rebleeding (the criterion for judging rebleeding is the portal vein pressure gradient, that is, the pressure difference at both ends of the stent). However, the incidence of rebleeding decreases when the portal vein pressure gradient is ≦12 mmHg.

[0005] Existing stents and auxiliary devices for adjusting their diameter can only expand the stent's effective diameter during use, not reduce it. Due to the differences in the internal environments of different patients, there is no effective solution when the effective diameter needs to be reduced. Currently, the only solution is to replace the stent and expand it to the required effective diameter based on the current diameter requirement. Summary of the Invention

[0006] In view of the above problems, the present invention provides a diameter regulator and a diameter-adjustable bracket system.

[0007] The technical solution of the present invention is:

[0008] A diameter regulator is suitable for a diameter-adjustable bracket, wherein the diameter-adjustable bracket comprises a support frame and a covering film covering the support frame, and the diameter regulator comprises a main body, a plurality of adjustment wires, a damping fixing member and a fixing seat;

[0009] The damping fixing member is connected to the support frame, and the main body is provided with a plurality of adjusting wire channels, each of which corresponds to the adjusting wire. The distal end of the adjusting wire is connected to the support frame, and the proximal end of the adjusting wire passes through the damping fixing member and extends into the corresponding adjusting wire channel and is connected to the adjusting wire connector after extending out. The plurality of adjusting wires are arranged along the circumference of the support frame;

[0010] The adjusting wire is provided with a disconnecting node on a portion inside the adjusting wire channel; the adjusting wire connector is mounted on the fixing seat, and the adjusting wire connector can rotate relative to the fixing seat under the action of an external force to drive the adjusting wire to twist, so that the adjusting wire is disconnected at the disconnecting node due to the rotational torque;

[0011] When the adjusting wire passes through the damping fixing member, there is damping between the adjusting wire and the damping fixing member to keep the relative position of the two unchanged; when the fixing seat moves in the proximal direction relative to the main body under the action of external force, so that all the adjusting wire joints respectively drive all the adjusting wires to overcome the corresponding damping and move in the proximal direction, the distal end of the adjusting wire drives the supporting frame connected thereto to move toward the damping fixing member;

[0012] Wherein, when the distance between the connection point of the support frame with the damping fixing member and the connection point with the distal end of the adjustment wire decreases, the minimum diameter of the adjustable diameter bracket decreases.

[0013] In a diameter adjuster provided in a preferred embodiment, the main body includes a base and several adjustment sleeves, the adjustment sleeves correspond one-to-one to the adjustment wires, and the proximal ends of the adjustment sleeves are connected to the base; the base is provided with several first through holes, the first through holes correspond one-to-one to the adjustment sleeves, and the first through holes are connected to the internal channels of the corresponding adjustment sleeves to form the adjustment wire channels.

[0014] In the diameter adjuster provided in a preferred embodiment, the distal end of the adjusting sleeve abuts against the proximal end of the damping fixing member.

[0015] In the diameter regulator provided in a preferred embodiment, an adjusting member is provided between the main body and the fixed seat, and the adjusting member is used to drive the fixed seat to move in the proximal direction relative to the main body under the action of an external force, so that the adjusting wire connector installed on the fixed seat drives the adjusting wire to overcome the damping and move in the proximal direction.

[0016] In a preferred embodiment of the diameter adjuster, the adjusting member is sleeved on the main body and threadedly connected thereto, and the adjusting member can be moved in a proximal direction relative to the main body through the threaded connection;

[0017] The adjusting member is connected to the fixing seat, and the connection is configured to drive the fixing seat to move in the proximal direction relative to the main body when the adjusting member moves in the proximal direction relative to the main body.

[0018] In the diameter adjuster provided in a preferred embodiment, the adjusting member and the fixing seat are connected in such a manner that a proximal end of the adjusting member abuts against a distal end of the fixing seat.

[0019] In a preferred embodiment of the diameter adjuster, a plurality of mounting grooves are provided on the proximal end surface of the fixing seat, each of which is used to accommodate the adjusting wire connector; a second through hole corresponding to the mounting groove is provided on the fixing seat, and a proximal end of the second through hole is connected to the mounting groove from the bottom surface of the mounting groove; the proximal end of the adjusting wire, after extending out of the adjusting wire channel, passes through the second through hole into the mounting groove, and is connected to the adjusting wire connector from the distal end thereof;

[0020] There is friction between the outer wall of the adjusting wire joint and the inner wall of the mounting groove to prevent the adjusting wire joint from rotating; a connecting portion is provided on the proximal end face of the adjusting wire joint, and the connecting portion is used to connect with an external tool. The adjusting wire joint overcomes the friction force and rotates in the mounting groove under the action of the torque applied by the external tool.

[0021] In the diameter adjuster provided in a preferred embodiment, the damping fixing member is provided with a through hole for the adjusting wire to pass through, each adjusting wire passes through one through hole and the friction resistance between the adjusting wire and the side wall of the through hole forms the damping.

[0022] A diameter-adjustable bracket system, comprising a diameter-adjustable bracket and a diameter adjuster as described in any one of the above;

[0023] The adjustable diameter bracket includes a support frame and a covering film on the support frame, the support frame has an adjustment section along its axial direction, the adjustment section includes a plurality of support rings and a plurality of support members, the plurality of support rings are arranged side by side and spaced apart along the axial direction of the support frame, the support members extend along the axial direction of the support frame and are sequentially connected to the support rings, and the plurality of support members are arranged along the circumference of the support frame;

[0024] The damping fixing member is connected to the proximal end of the support member or / and the support ring located at the most proximal end, and the distal end of the adjusting wire is connected to the distal end of the support member or / and the support ring located at the most distal end;

[0025] When the distance between the connection between the support frame and the damping fixing member and the connection with the distal end of the adjustment wire decreases, the support member deforms inwardly to reduce the minimum diameter of the adjustable diameter bracket in the corresponding area of ​​the adjustment section.

[0026] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0027] The diameter regulator and diameter-adjustable bracket system provided by the present invention have a distal end of the adjustment wire and a support frame, and by driving the fixed seat to move, the adjustment wire is pulled toward the proximal direction, which can make the connection between the support frame and the distal end of the adjustment wire approach the connection with the damping fixture, thereby reducing the minimum diameter of the diameter-adjustable bracket. When the adjustment is completed, the adjustment wire is twisted by rotating the adjustment wire joint, and then the adjustment wire breaks at the disconnection node; after the adjustment wire breaks, the portion relatively located at the distal end remains on the diameter-adjustable bracket, and due to the existence of damping between it and the damping fixture, the diameter-adjustable bracket will remain in its current state, while the portion relatively located at the proximal end is separated from the diameter-adjustable bracket, and this portion is withdrawn together with the other structures of the diameter regulator (excluding the damping fixture). BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various other advantages and benefits will become apparent to those skilled in the art by reading the following detailed description of the preferred embodiment.The accompanying drawings are only for the purpose of illustrating the preferred embodiment and are not to be considered as limiting the present invention.

[0029] Figure 1 This is a schematic structural diagram of a diameter-adjustable bracket in Example 2;

[0030] Figure 2 and Figure 3 This is a schematic diagram of the principle of reducing the diameter of a diameter-adjustable stent in Example 2;

[0031] Figure 4 This is a schematic structural diagram of a diameter-adjustable bracket in Example 3;

[0032] Figure 5 This is a schematic diagram of the principle of reducing the diameter of a diameter-adjustable stent in Example 3;

[0033] Figure 6 This is a schematic structural diagram of a diameter-adjustable bracket system in Example 1;

[0034] Figure 7 This is a structural diagram of a disconnected node on an adjustment wire.

[0035] Description of reference numerals:

[0036] 1: Support member; 2: Support ring; 3: Coating; 4: Adjusting wire; 5: Damping fixing unit; 6: Turning point; 7: Base; 8: Adjusting sleeve; 9: Disconnecting node; 10: Adjusting member; 11: Adjusting wire connector; 12: Fixing seat; 14: Fixing point; D1: Diameter. DETAILED DESCRIPTION

[0037] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other embodiments can be obtained based on these drawings without inventive work.

[0038] To simplify the drawings, only the parts relevant to the present invention are schematically shown in each figure. They do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one of the components with the same structure or function is schematically depicted or labeled. As used herein, "one" not only means "only one" but also "more than one."

[0039] Example 1

[0040] See Figures 1 to 7This embodiment provides a diameter regulator, which is an auxiliary device for adjusting the effective diameter of a stent. The diameter regulator provided in this embodiment is suitable for a diameter-adjustable stent, which includes a support frame and a coating 3 covering the support frame.

[0041] The diameter regulator includes a main body, a plurality of adjustment wires 4, a damping fixture, and a fixing seat 12. The main body is provided with a plurality of adjustment wire channels, which correspond one to one with the adjustment wires 4. The damping fixture is connected to the support frame, and the distal end of the adjustment wire 4 (the distal end refers to the end away from the operator in the conveying direction of the diameter adjustable bracket during surgery, and the proximal end refers to the end close to the operator in the conveying direction of the diameter adjustable bracket during surgery) is connected to the support frame. The proximal end of the adjustment wire 4 passes through the damping fixture, extends into the corresponding adjustment wire channel, and is connected to the adjustment wire connector 11 after extending out. The plurality of adjustment wires 4 are arranged along the circumference of the support frame.

[0042] The portion of the adjusting wire 4 within the adjusting wire channel is provided with a disconnect node 9. An adjusting wire connector 11 is mounted on a mounting base 12. Under the action of an external force, the adjusting wire connector 11 can rotate relative to the mounting base 12, twisting the adjusting wire 4 and causing the adjusting wire 4 to disconnect at the disconnect node 9 due to the rotational torque. In this way, after the diameter of the adjustable diameter stent is adjusted, the adjusting wire 4 can be disconnected by rotating the adjusting wire connector 11. The portion of the adjusting wire 4 near the proximal end can then be withdrawn along with the rest of the diameter adjuster (excluding the damping fixture).

[0043] When the adjusting wire 4 passes through the damping fixing part, there is damping between it and the damping fixing part to keep the relative position of the two unchanged. In this way, after the diameter adjustment of the adjustable diameter bracket is completed and the adjusting wire 4 is disconnected at the disconnection node 9, the relative position between the adjusting wire 4 and the damping fixing part on the adjustable diameter bracket remains unchanged, and the adjustable diameter bracket can maintain the status quo.

[0044] When the fixing seat 12 moves proximally relative to the main body under the action of an external force, causing all the adjusting wire connectors 11 to respectively drive all the adjusting wires 4 to overcome the corresponding damping and move proximally, the distal ends of the adjusting wires 4 drive the support frame connected thereto to move toward the damping fixture. As the distance between the connection point on the support frame with the damping fixture and the connection point with the distal ends of the adjusting wires 4 decreases, the minimum diameter of the adjustable diameter stent decreases. Therefore, by using the diameter adjuster provided in this embodiment, the effective diameter of the adjustable diameter stent can be reduced.

[0045] The diameter regulator of this embodiment is further described below:

[0046] The distal end of the regulating wire 4 is fixedly connected to the support frame, and specifically can be connected by welding, etc. The damping fixing member is fixedly connected to the support frame, and specifically can be connected by welding, etc. A plurality of through holes are provided on the damping fixing member, and the through holes correspond to the regulating wire 4 one by one. The regulating wire 4 can be arranged along the longitudinal structure of the support frame. When the regulating wire 4 extends toward the proximal end along the longitudinal structure of the support frame, when passing through the damping fixing member, the damping fixing member is provided with a corresponding through hole at this position, and the regulating wire 4 is realized by passing through the damping fixing member through the through hole. The friction resistance between the regulating wire 4 and the side wall of the through hole forms the above-mentioned damping. The existence of the damping makes it possible for the regulating wire 4 to slide in the through hole only when the force pulling the regulating wire 4 is greater than a certain value. Therefore, after the effective diameter of the diameter adjustable bracket is adjusted by the diameter regulator and the regulating wire 4 is disconnected at the disconnection node 9, the diameter adjustable bracket can maintain the status quo and will not return to the position before the diameter regulator is adjusted.

[0047] The disconnection node 9 of the regulating wire 4 is designed to be resistant to stretching but not to rotational torque. Therefore, the regulating wire 4 will not break at the disconnection node 9 when subjected to tension, but will easily break when subjected to torsion. As for how to achieve the disconnection node 9 of the regulating wire 4 being resistant to stretching but not to rotational torque, there are many ways to achieve this through the coordination of materials, structures, etc., for example, Figure 7 As shown in the figure, a notch is provided in the middle of the knot, etc., which is not limited here.

[0048] The main body includes a base 7 and a plurality of adjustment sleeves 8, each of which corresponds to the adjustment wire 4 one-to-one, and the proximal end of the adjustment sleeve 8 is connected to the base 7. The base 7 is provided with a plurality of first through holes, each of which corresponds to the adjustment sleeve 8 one-to-one, and the first through holes are connected to the internal passage of the corresponding adjustment sleeve 8 to form an adjustment wire passage. Furthermore, the distal end of the adjustment sleeve 8 can abut the proximal end of the damping fixture. In this way, when the adjustment wire 4 is pulled toward the proximal end by moving the fixing base 12, the adjustment sleeve 8 can apply an abutting force to the damping fixture, so that the position of the damping fixture remains unchanged (of course, the damping fixture is connected to the support frame, and even without the abutting effect of the adjustment sleeve 8, it can remain stationary or move only slightly).

[0049] An adjusting member 10 is provided between the base 7 and the fixed seat 12. The adjusting member 10 is configured to drive the fixed seat 12 to move proximally relative to the main body under the action of an external force, so that the adjusting wire connector 11 mounted on the fixed seat 12 drives the adjusting wire 4 to overcome the damping and move proximally. Specifically, the adjusting member 10 may be sleeved on the base 7 and threadedly connected thereto. When the adjusting member 10 rotates on the base 7 through the threaded connection with the base 7, the adjusting wire 4 can move proximally relative to the base 7. The adjusting member 10 is connected to the fixed seat 12 in a manner configured so that when the adjusting member 10 moves proximally relative to the base 7, the fixed seat 12 is driven to move proximally relative to the base 7. In this embodiment, the adjusting member 10 is connected to the fixed seat 12 in such a manner that the proximal end of the adjusting member 10 abuts the distal end of the fixed seat 12. Of course, other connection methods may also be used in other embodiments, such as a bearing connection.

[0050] The proximal end face of the fixing seat 12 is provided with a plurality of mounting grooves, which are respectively used to accommodate the adjusting wire connector 11, that is, the mounting grooves correspond to the adjusting wire connector 11 one by one. The fixing seat 12 is provided with a second through hole corresponding to the mounting groove, and the proximal end of the second through hole is connected to the mounting groove from the bottom surface of the mounting groove. The proximal end of the adjusting wire 4 passes through the second through hole into the mounting groove after extending out of the adjusting wire channel, and is connected to the adjusting wire connector 11 from the distal end of the adjusting wire connector 11. There is a friction force between the outer side wall of the adjusting wire connector 11 and the inner side wall of the mounting groove to prevent the adjusting wire connector 11 from rotating. A connecting portion is provided on the proximal end face of the adjusting wire connector 11, and the connecting portion is used to connect to an external tool. The adjusting wire connector 11 rotates in the mounting groove by overcoming the friction force under the action of the torque applied by the external tool. The specific structure of the connection portion is designed based on the specific shape of the external tool to be used during the design. For example, if the diameter adjuster is designed to use a star-shaped hexagonal screwdriver to drive the adjustment wire connector 11 to rotate, the connection portion can be a groove provided on the proximal end surface of the adjustment wire connector 11 that matches the shape of the star-shaped hexagonal screwdriver's blade. The friction between the outer wall of the adjustment wire connector 11 and the inner wall of the mounting slot prevents the adjustment wire connector 11 from rotating, effectively preventing improper operation.

[0051] Example 2

[0052] See Figures 1 to 3 、 Figure 5 and Figure 6 This embodiment provides a diameter-adjustable bracket system, including a diameter-adjustable bracket and the diameter regulator described in Example 1, and the diameter regulator is used to adjust the effective diameter of the adjustable bracket.

[0053] The diameter-adjustable bracket includes a support frame and a coating 3 covering the support frame. The support frame has an adjustment section along its axial direction. The adjustment section includes a plurality of support rings 2 and a plurality of support members 1. The plurality of support rings 2 are arranged side by side and spaced apart along the axial direction of the support frame. The support members 1 extend along the axial direction of the support frame and are connected to the support rings 2 in sequence. The plurality of support members 1 are arranged along the circumference of the support frame.

[0054] The damping fixture is connected to the proximal end of the support member 1 and / or the support ring 2 at the closest end, and the distal end of the adjustment wire 4 is connected to the distal end of the support member 1 and / or the support ring 2 at the farthest end. When the distance between the connection point with the damping fixture and the connection point with the distal end of the adjustment wire 4 on the support frame decreases, that is, the axial length of the adjustment section decreases, in order to reduce the axial length of the adjustment section, the support member 1 will deform inwardly. The inward deformation of the support member 1 will reduce the diameter D1 of the deformed part, thereby reducing the minimum diameter of the corresponding area of ​​the adjustment section, and further reducing the effective diameter of the diameter-adjustable stent.

[0055] Specifically, the entire support frame can be laser-cut from a single piece of material, with one section of the entire support frame along its axis serving as the adjustment section. Note that the adjustment section must be located in the middle of the support frame, not at one of its ends. Within the entire support frame, only the structures within the adjustment section are referred to as support rings 2 and support members 1. That is, even if a structure similar to support rings 2 exists outside the adjustment section of the support frame, only the structure within the adjustment section is referred to as support rings 2. The support rings 2 at the proximal and distal ends refer to the structures at the extreme ends of the adjustment section. Even if support member 1 extends beyond the adjustment section at both ends, only the portion within the adjustment section is referred to as support member 1. The proximal and distal ends of support member 1 refer to the proximal and distal ends of the portion of the support member 1 within the adjustment section. The term "ring" for support ring 2 is used only to denote that it is closed circumferentially along the support frame and does not necessarily imply a circular ring shape.

[0056] The adjustment wires 4 are preferably arranged along the longitudinal structure of the support frame. In the adjustment section, the longitudinal structure of the support frame is the support member 1. Therefore, the adjustment wires 4 are preferably arranged along the support member 1 in the adjustment section, with the distal ends of the adjustment wires 4 connected to the support member 1. In this embodiment, each adjustment wire 4 corresponds to a support member 1, and the distal ends of the adjustment wires 4 are connected to the corresponding support member 1. The connection method can be welding, etc.

[0057] The support member 1 is made of elastic material and has elasticity. When the portion of the adjustment section connected to the distal end of the adjustment wire 4 approaches the portion connected to the damping fixing member, the support member 1 is driven to arch inward.

[0058] Specifically, such as Figure 2 and Figure 3 As shown, the support member 1 corresponding to the adjustment wire 4 has multiple deformable sections and multiple non-deformable sections, with the deformable and non-deformable sections spaced apart. The support member 1 corresponding to the adjustment wire 4 has an internal channel. In the non-deformable section, the adjustment wire 4 is located within the internal channel of the support member 1; in the deformable section, the adjustment wire 4 is located outside the support member 1. A conversion hole is provided at the junction of the deformable and non-deformable sections, connecting the internal channel with the exterior. The conversion hole is used to pass the adjustment wire 4 through, allowing the adjustment wire 4 to enter the internal channel of the support member 1 from the exterior or exit from the interior channel of the support member 1. When the portion of the adjustment section connected to the distal end of the adjustment wire 4 approaches the portion connected to the damping fixture, the deformable section of the support member 1 arches inward. Preferably, each support member 1 has a deformable and non-deformable section, and the junction of the deformable and non-deformable sections is located at the connection between the support member 1 and the support ring 2. In support members 1 without corresponding adjustment wires 4, the conversion hole may not be provided at the junction of the deformable and non-deformable sections.

[0059] like Figure 3 As shown, from the distal end of the adjustment wire 4 and the fixed point 13 on the support member 1, the length L9 is constant (that is, the length of the adjustment wire 4 from its connection with the support member 1 to the proximal end is constant). When L1 changes, for example, when L1 increases (pulling the adjustment wire 4 proximally), the sum of L2 + L3 + ... + L7 will inevitably decrease. L2, L3, and L4 are the internal passages of the adjustment wire 4 through the support member 1 (i.e., the non-deformed sections). Therefore, the force required to change L2, L3, and L4 is the force required to flatten the material, tentatively designated as F1. The force required to change L5, L6, and L7 (corresponding to the deformed sections) is the force required to bend and arch the material, tentatively designated as F2. F1 is much greater than F2. According to the principle of "the weaker one changes first," when L1 increases, changes will occur in L5, L6, and L7. L5, L6, and L7 decrease, and the deformed section of the support member 1 arches. For the other support members 1 that do not correspond to the adjusting wires 4 , the deformation sections of the support members 1 will also arch inwards accordingly due to the action of the support rings 2 .

[0060] The damping fixing member can include several damping fixing units 5, and the damping fixing unit 5 corresponds one to one with the adjusting wire 4, and a through hole is set on each damping fixing unit 5 for passing the corresponding adjusting wire 4. The damping fixing unit 5 corresponds one to one with the adjusting wire 4, and the support member 1 also corresponds one to one with the adjusting wire 4, and the damping fixing unit 5 is connected on the support member 1 corresponding to the corresponding adjusting wire 4. The far end of the adjusting wire 4 is connected on the corresponding support member 1, and the adjusting wire 4 is arranged along the support member 1. When the adjusting wire 4 extends to the proximal direction, it passes through the through hole on the corresponding damping fixing unit 5, and then extends into the corresponding adjusting wire channel. Of course, in other embodiments, the damping fixing member can also adopt other structures, for example, it can be an annular structure similar to the support ring 2, on which a plurality of through holes are set according to the position of the adjusting wire 4.

[0061] Preferably, the distal ends of all adjustment wires 4 and the connection points of each support member 1 on the adjustment section are located in the same plane, and the plane is perpendicular to the axis of the adjustment section. The connection points of all damping fixing units 5 and each support member 1 on the adjustment section are located in the same plane, and the axis of the plane adjustment section is perpendicular.

[0062] The coating 3 is arranged inside the supporting frame, and both ends of the coating 3 extend out of the adjustment section and are woven together with the longitudinal structure of the area outside the adjustment section.

[0063] Example 3

[0064] See Figures 4 to 6 This embodiment provides a diameter-adjustable stent system based on Example 2. This embodiment differs from Example 2 in the use of a different diameter-adjustable stent. Specifically, the difference lies in the manner in which the support member 1 deforms inward as the portion of the adjustment section connected to the distal end of the adjustment wire 4 approaches the portion connected to the damping fixture. In other words, the specific design of the support member 1 differs from that of Example 2.

[0065] In this embodiment, the support member 1 has a plurality of turning points 6 arranged at intervals along its extension direction. When the portion of the adjustment section connected to the distal end of the adjustment wire 4 approaches the portion connected to the damping fixing member, the support member 1 deforms inwardly through the turning point 6. Specifically, the support member 1 has a first section, a second section, and a third section along its extension direction, and the second section is located between the first and third sections. On the support member 1 corresponding to the adjustment wire 4, the adjustment wire 4 is passed through the internal channel of the first and third sections; on the corresponding area of ​​the second section, the adjustment wire 4 is located outside the support member 1. The support member 1 portion of the second section is divided into a plurality of rod units connected in sequence, and the rod units are rotationally connected by a rotating shaft, and the rod units at the head and tail ends are respectively rotationally connected to the first and third sections by a rotating shaft. The turning point 6 on the above-mentioned support member 1 is the rotating shaft.

[0066] When the adjustment wire 4 is pulled to move in the proximal direction, the length of the support member 1 in the direction of the axis of the support frame is forced to decrease. At this time, there are two main ways to force the length of the support member 1 in the direction of the axis of the support frame to be forced to decrease, namely: ① flattening the first and third sections of the support member 1, and ② rotating the rod unit in the second section of the support member 1. Compared with the force required to flatten the first and third sections of the support member 1, the force required for the rod unit to overcome the friction force at the rotating shaft to rotate the rod unit is much smaller. Therefore, when the part of the adjustment section that is connected to the distal end of the adjustment wire 4 approaches the part that is connected to the damping fixture, that is, when the adjustment wire 4 is pulled to move in the proximal direction, the rod units in the support member 1 will rotate, causing the support member 1 to deform inward.

[0067] Specifically, the turning point 6 on the support member 1 , that is, the rotation axis, can be set at the connection with the support ring 2 .

[0068] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they still fall within the scope of protection of the present invention.

Claims

1. A diameter regulator, characterized in that: Applicable to a diameter-adjustable bracket, the diameter-adjustable bracket includes a support frame and a covering film covered on the support frame, and the diameter adjuster includes a main body, a plurality of adjustment wires, a damping fixing member and a fixing seat; The damping fixing member is connected to the support frame, and the main body is provided with a plurality of adjusting wire channels, each of which corresponds to the adjusting wire. The distal end of the adjusting wire is connected to the support frame, and the proximal end of the adjusting wire passes through the damping fixing member and extends into the corresponding adjusting wire channel and is connected to the adjusting wire connector after extending out. The plurality of adjusting wires are arranged along the circumference of the support frame; The adjusting wire is provided with a disconnecting node on a portion inside the adjusting wire channel; the adjusting wire connector is mounted on the fixing seat, and the adjusting wire connector can rotate relative to the fixing seat under the action of an external force to drive the adjusting wire to twist, so that the adjusting wire is disconnected at the disconnecting node due to the rotational torque; When the adjusting wire passes through the damping fixing member, there is damping between the adjusting wire and the damping fixing member so as to keep the relative positions of the two unchanged; When the fixing seat moves in the proximal direction relative to the main body under the action of an external force, and all the adjusting wire joints respectively drive all the adjusting wires to overcome the corresponding damping and move in the proximal direction, the distal end of the adjusting wire drives the supporting frame connected thereto to move in the direction of the damping fixing member; Wherein, when the distance between the connection point of the support frame with the damping fixing member and the connection point with the distal end of the adjustment wire decreases, the minimum diameter of the adjustable diameter bracket decreases.

2. The diameter regulator according to claim 1, characterized in that: The main body includes a base and several adjustment sleeves, the adjustment sleeves correspond one-to-one to the adjustment wires, and the proximal ends of the adjustment sleeves are connected to the base; the base is provided with several first through holes, the first through holes correspond one-to-one to the adjustment sleeves, and the first through holes are connected to the internal channels of the corresponding adjustment sleeves to form the adjustment wire channels.

3. The diameter regulator according to claim 2, characterized in that: The distal end of the adjusting sleeve abuts against the proximal end of the damping fixing member.

4. The diameter regulator according to claim 1, characterized in that: An adjusting member is provided between the main body and the fixing seat, and the adjusting member is used to drive the fixing seat to move in the proximal direction relative to the main body under the action of an external force, so that the adjusting wire connector installed on the fixing seat drives the adjusting wire to overcome the damping and move in the proximal direction.

5. The diameter regulator according to claim 4, characterized in that: The adjusting member is sleeved on the main body and is threadedly connected thereto, and the adjusting member can be moved in a proximal direction relative to the main body through the threaded connection; The adjusting member is connected to the fixing seat, and the connection is configured to drive the fixing seat to move in the proximal direction relative to the main body when the adjusting member moves in the proximal direction relative to the main body.

6. The diameter regulator according to claim 5, characterized in that: The adjusting member and the fixing seat are connected in such a manner that the proximal end of the adjusting member abuts against the distal end of the fixing seat.

7. The diameter regulator according to claim 1, characterized in that: A plurality of mounting grooves are provided on the proximal end surface of the fixing seat, each of which is used to accommodate the adjusting wire connector; a second through hole corresponding to the mounting groove is provided on the fixing seat, and the proximal end of the second through hole is connected to the mounting groove from the bottom surface of the mounting groove; the proximal end of the adjusting wire passes through the second through hole into the mounting groove after extending out of the adjusting wire channel, and is connected to the adjusting wire connector from the distal end thereof; There is friction between the outer wall of the adjusting wire joint and the inner wall of the mounting groove to prevent the adjusting wire joint from rotating; a connecting portion is provided on the proximal end face of the adjusting wire joint, and the connecting portion is used to connect with an external tool. The adjusting wire joint overcomes the friction force and rotates in the mounting groove under the action of the torque applied by the external tool.

8. The diameter regulator according to claim 1, characterized in that: The damping fixing member is provided with a through hole for the adjusting wire to pass through, each adjusting wire passes through one through hole and the friction resistance between the adjusting wire and the side wall of the through hole forms the damping.

9. A diameter-adjustable bracket system, characterized in that: It comprises a diameter-adjustable bracket and a diameter regulator according to any one of claims 1 to 8; The adjustable diameter bracket includes a support frame and a covering film on the support frame, the support frame has an adjustment section along its axial direction, the adjustment section includes a plurality of support rings and a plurality of support members, the plurality of support rings are arranged side by side and spaced apart along the axial direction of the support frame, the support members extend along the axial direction of the support frame and are sequentially connected to the support rings, and the plurality of support members are arranged along the circumference of the support frame; The damping fixing member is connected to the proximal end of the support member or / and the support ring located at the most proximal end, and the distal end of the adjusting wire is connected to the distal end of the support member or / and the support ring located at the most distal end; When the distance between the connection between the support frame and the damping fixing member and the connection with the distal end of the adjustment wire decreases, the support member deforms inwardly to reduce the minimum diameter of the adjustable diameter bracket in the corresponding area of ​​the adjustment section.

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