Release mechanism, blood vessel occluder assembly and occluder delivery system
By designing a relief mechanism for vascular occlusion devices, the sliding parts use to drive the flexible parts to deform, the problem of easy disengagement of the vascular occlusion device during delivery is solved, and a safer and more efficient liberation process is achieved.
Patent Information
- Application Number
- CN202421673876.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-15
- Publication Date
- 2025-06-03
- Estimated Expiration
- 2034-07-15
AI Technical Summary
The vascular occlusion device is easily disengaged from the liberation structure during delivery, resulting in misplugging problems.
A relief mechanism is designed, including a handle assembly, a flexible member and a slider, which drives the flexible member to deform through the movement of the slider in the sliding channel, so as to switch from the first form to the second form, thereby achieving a safe relief of the blood vessel occluder.
This relief mechanism improves the operability of the vascular occlusion device and the relief structure, ensures that the vascular occlusion device is not easy to fall off during the retraction process, and can be removed from the vascular occlusion device smoothly when released, simplifying the surgical process and reducing the surgical time.
Smart Images
Figure CN222929789U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical devices, and particularly relates to a release mechanism, a vascular occluder assembly and an occluder delivery system. Background Art
[0002] At present, the relatively common release methods of vascular occlusion devices mainly include electrolytic release and mechanical release. Mechanical release is a method in which components in the delivery system are connected to the proximal end of the occlusion device. Through the operation of the delivery system, the occlusion device moves in the catheter. When the occlusion device reaches the target position, the delivery component in the delivery system will separate from the occlusion device and release it safely to the target position.
[0003] Mechanical release technology also has its limitations. When encountering uncontrollable mechanical release, once the implant of the vascular occlusion device detaches from the delivery tube, it cannot be withdrawn into the delivery tube again, which is very likely to cause the problem of accidental embolism. Summary of the Utility Model
[0004] The main purpose of the utility model is to provide a release mechanism, aiming to solve the problem that the vascular occluder is prone to detach from the release structure during delivery.
[0005] To achieve the above purpose, the release mechanism proposed by the utility model for a vascular occluder includes: a handle assembly having a sliding channel;
[0006] a flexible member having a first connection portion and a second connection portion, the first connection portion being connected to the proximal end of the handle assembly, and the flexible member having a first form and a second form; and
[0007] a sliding member slidably disposed in the sliding channel, the proximal end of the sliding member being connected to the second connection portion, so that the flexible member undergoes flexible deformation under the drive of the sliding member and switches from the first form to the second form;
[0008] In the first form, the flexible member is used to limit and abut against the inner wall of the vascular occluder to limit the separation of the release mechanism from the vascular occluder;
[0009] In the second form, the sliding member moves in the direction from the distal end to the proximal end and drives the flexible member to deform. The flexible member moves towards the sliding member and separates from the inner wall of the vascular occluder, so that the flexible member can be moved out of the inner cavity of the vascular occluder, and the release mechanism is released from the vascular occluder.
[0010] In one embodiment, the first connecting portion and the second connecting portion are respectively located at the distal end and the proximal end of the flexible member. In the first configuration, the flexible member further includes a first limiting portion located between the first connecting portion and the second connecting portion, and the first limiting portion is used for limiting and abutting against the inner wall of the vascular occluder.
[0011] In one embodiment, in the first configuration, the flexible member further includes a second limiting portion located between the first limiting portion and the first connecting portion, and the second limiting portion is used for limiting and abutting against the outer wall of the vascular occluder.
[0012] In one embodiment, the handle assembly includes a delivery steel cable and a release handle. The delivery steel cable and the release handle are respectively provided with a first channel and a second channel therethrough. The distal end of the release handle is provided with a mounting portion having a mounting cavity, and the mounting cavity communicates with the second channel. The distal end of the delivery steel cable is located in the mounting cavity and is detachably connected to the mounting portion, so that the first channel and the second channel communicate to form the sliding channel.
[0013] In one embodiment, a chute communicating with the second channel is provided on the outer side of the release handle. The handle assembly further includes a release button provided at the chute. Part of the release button is located in the second channel and is connected to the sliding member. The release button moves from the proximal end to the distal end of the release handle, driving the sliding member to move.
[0014] In one embodiment, the release mechanism further includes a delivery catheter sleeved outside the delivery steel cable, and a thermoplastic polyurethane elastomer coating or a polytetrafluoroethylene coating is provided on the outer side of the delivery steel cable.
[0015] In one embodiment, the sliding member is a solid metal wire, and the material of the solid metal wire includes one of nitinol alloy, 316L stainless steel, and 304 stainless steel.
[0016] The present utility model further provides a vascular occluder assembly, including a vascular occluder and the above-mentioned release mechanism. The vascular occluder is cylindrically arranged and includes a first fixing portion at the proximal end. The first fixing portion encloses a channel, and an inner tube sleeve and an outer tube sleeve are respectively sleeved on two sides of the first fixing portion close to and away from the channel. The channel is used for the flexible member of the release mechanism to pass through.
[0017] In one embodiment, the vascular occluder includes a second fixing portion at the distal end, and the second fixing portion is provided with a head. Both sides of the vascular occluder close to the first fixing portion and the second fixing portion are recessed.
[0018] The present utility model further provides a delivery system for a plugging device, which includes the vascular plugging device assembly described in any one of the foregoing embodiments.
[0019] In the technical solution of the present utility model, the sliding member moves in the sliding channel to drive the flexible member to deform, so that the flexible member originally in the first form deforms to the second form. Among them, the flexible member in the first form is limited and abuts against the inner wall of the vascular plugging device. When the releasing mechanism retracts the vascular plugging device, that is, when the releasing mechanism moves from the proximal end to the distal end, the flexible member abuts against the vascular plugging device, thereby restricting the separation of the vascular plugging device from the releasing structure and improving the operability of the releasing structure; in the second form, the flexible member deforms toward the sliding member under the drive of the conveying member, that is, the flexible member contracts toward the sliding member, reducing the distance between the flexible member and the sliding member, separating the flexible member from the inner wall of the vascular plugging device, and enabling the flexible member to be removed from the vascular plugging device. The releasing mechanism drives the flexible member to be removed from the vascular plugging device to realize the release of the vascular plugging device, thereby simplifying the operation process of the releasing structure and effectively reducing the operation time. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present utility model or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present utility model. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.
[0021] Figure 1 It is a schematic structural diagram of an embodiment of the delivery system for the plugging device of the present utility model;
[0022] Figure 2 It is a schematic structural diagram of another embodiment of the delivery system for the plugging device of the present utility model;
[0023] Figure 3 It is a schematic structural diagram of still another embodiment of the delivery system for the plugging device of the present utility model;
[0024] Figure 4 It is a schematic structural diagram of an embodiment of the releasing mechanism of the present utility model;
[0025] Figure 5 It is a schematic structural diagram of an embodiment of the vascular plugging device assembly of the present utility model;
[0026] Figure 6 It is a schematic structural diagram of another embodiment of the vascular plugging device assembly of the present utility model.
[0027] Explanation of the reference numerals in the drawings:
[0028] 10 - Delivery system for plugging device;
[0029] 100 - Release mechanism, 110 - Handle assembly, 110a - Sliding channel, 112 - Conveying steel cable, 113 - Release handle, 113a - Chute, 1131 - Mounting portion, 114 - Release button, 120 - Flexible member, 121 - First connection portion, 122 - Second connection portion, 123 - First limiting portion, 124 - Second limiting portion, 130 - Sliding member, 140 - Conveying catheter;
[0030] 200 - Vascular occluder, 210 - First fixing portion, 210a - Third channel, 211 - Inner sleeve, 212 - Outer sleeve, 220 - Second fixing portion, 221 - Head.
[0031] The realization, functional features and advantages of the purpose of the present utility model will be further described in conjunction with the embodiments and with reference to the accompanying drawings. Detailed embodiments
[0032] Next, the technical solutions in the embodiments of the present utility model will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all the embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present utility model.
[0033] It should be noted that all directional indications (such as up, down, left, right, front, back...) in the embodiments of the present utility model are only used to explain the relative positional relationship and movement conditions between components in a specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indications will also change accordingly.
[0034] In addition, the descriptions involving "first", "second", etc. in the present utility model are only for descriptive purposes, and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present utility model.
[0035] It should be noted that in this application, the end closer to the operator during use is referred to as the "proximal end", and the end farther from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the occluder delivery system are defined based on this principle.
[0036] Interventional vascular embolization (occlusion) is a highly precise medical technique. Its core lies in accurately delivering embolization materials or specialized occlusion devices into the target blood vessel through a catheter under the precise monitoring and guidance of DSA (Digital Subtraction Angiography). The purpose of this operation is to reduce or completely block the blood flow in the target area, thereby achieving the therapeutic goal. It can effectively treat arteriovenous aneurysms and arteriovenous fistulas in different parts, which are often caused by abnormal dilation of the blood vessel wall or the formation of abnormal channels inside and outside the blood vessel. In some cases, due to surgical operations or other reasons, certain blood vessels need to be occluded, and at this time, interventional vascular embolization (occlusion) can also play an important role. In short, interventional vascular embolization (occlusion) provides a powerful means for treating various complex vascular diseases through precise operations and effectively blocking abnormal blood flow.
[0037] In the current medical field, when we need to block the blood flow in a blood vessel, there are two main embolization materials to choose from: metallic embolization coils and vascular occluders. The metallic embolization coils will expand and conform to the blood vessel wall when placed at the blood vessel site that needs to be blocked, effectively preventing blood from passing through. The vascular occluder can closely conform to the blood vessel wall, thus preventing blood flow.
[0038] Medical coils are a kind of small medical device. However, when faced with blood vessels with a relatively large diameter that need to be embolized, their small volume means that multiple coils need to be implanted to achieve an effective embolization effect. This process not only increases the complexity of the operation but also prolongs the operation time, bringing additional physical and psychological pressure to the patient. In addition, the price of medical coils is relatively expensive, which is a significant burden for many patients and medical institutions. More problematically, in blood vessels with a relatively fast blood flow rate, the coils are prone to displacement, affecting the embolization effect and even potentially requiring a second operation for correction. In contrast, when dealing with existing congenital heart diseases or abnormal vascular accesses, vascular occluders tend to match the shape of the blood vessel better, with a stable occlusion effect and are not easily prone to residual shunts. Therefore, vascular occluders still have their unique value in the field of vascular embolization.
[0039] Currently, the more common detachment methods for vascular embolization (occlusion) devices mainly include electrolytic detachment and mechanical detachment. Electrolytic detachment is a detachment method based on electrothermal heating. During electrolytic detachment, the electrothermal part is heated, and the heat is then transferred to the polymer core wire in the inner cavity. This heating process causes the core wire to deform or melt, enabling the occlusion device to be detached. Mechanical detachment is a more direct method. It involves connecting components in the delivery system to the proximal end of the occlusion device. Through the operation of the delivery system, the occlusion device moves within the catheter. When the occlusion device reaches the target position, the delivery component in the delivery system separates from the occlusion device and safely releases it to the target position. Compared with electrolytic detachment, mechanical detachment exhibits significant advantages. First, it does not rely on external energy transfer, greatly simplifying the production process flow of the occlusion device delivery system and reducing energy consumption. Second, mechanical detachment reduces the surgical cost and provides a more economical treatment option for patients. More importantly, mechanical detachment significantly reduces the risk of surgical failure that may be caused by the destructiveness of the device itself. Based on these significant advantages, mechanical detachment has become the mainstream detachment method for current occlusion devices and is highly favored by medical professionals.
[0040] However, mechanical detachment technology also has its limitations. Especially when encountering uncontrollable mechanical detachment, once the implant of the vascular occlusion device detaches from the delivery tube, it cannot be withdrawn back into the delivery tube again, which is very likely to cause the problem of misembolization. After misembolization occurs, other complex methods, such as the snare method or other technical means, must be relied on to remove the misreleased medical device implant. These operations are not only complex and cumbersome, not conducive to the rapid completion of the surgery, but also extremely likely to increase the risk of surgical trauma.
[0041] To solve the above problems, please refer to Figures 1 to 4 , the present utility model proposes a detachment mechanism 100 for a vascular occluder 200, comprising: a handle assembly 110 having a sliding channel 110a;
[0042] A flexible member 120 having a first connection portion 121 and a second connection portion 122, the second connection portion 122 being connected to the distal end of the handle assembly 110, and the flexible member 120 having a first form and a second form; and
[0043] A sliding member 130 slidably disposed in the sliding channel 110a, the distal end of the sliding member 130 being connected to the first connection portion 121, so that the flexible member 120 undergoes a flexible deformation under the drive of the sliding member 130 and switches from the first form to the second form;
[0044] In the first form, the flexible member 120 is used to limit and abut against the inner wall of the vascular occluder 200 to limit the separation of the detachment mechanism 100 from the vascular occluder 200;
[0045] In the second form, the sliding member 130 moves in the direction from the proximal end to the distal end and drives the flexible member 120 to deform. The flexible member 120 moves in the direction close to the sliding member 130 and separates from the inner wall of the vascular occluder 200, so that the flexible member 120 can be moved out of the inner cavity of the vascular occluder 200, and the release mechanism 100 is released from the vascular occluder 200.
[0046] In this embodiment, the sliding member 130 moves in the sliding channel 110a to drive the flexible member 120 to deform, so that the flexible member 120 originally in the first state is deformed to the second state, wherein part of the flexible member 120 in the first state is limitedly abutted against the inner wall of the vascular occluder 200, so that when the release mechanism 100 withdraws the vascular occluder 200, that is, when the release mechanism 100 moves from the proximal end to the distal end to drive the vascular occluder 200 to move, part of the flexible member 120 abuts against the vascular occluder 200, thereby limiting the vascular occluder 200 from the release mechanism 100. The structural separation improves the operability of the release structure; in the second form, the flexible member 120 is deformed toward the sliding member 130 under the drive of the conveying member, that is, the flexible member 120 contracts toward the sliding member 130, so that the flexible member 120 is separated from the inner wall of the vascular occluder 200 and can be moved out of the vascular occluder 200. The release mechanism 100 moves from the distal end to the proximal end to drive the flexible member 120 to move out of the vascular occluder 200 to release the vascular occluder 200, thereby simplifying the operation process of the release structure and effectively reducing the operation time.
[0047] It can be understood that the proximal end of the vascular occluder 200 has a channel for the flexible member 120 to pass through, so that the flexible member 120 can pass into or out of the vascular occluder 200 .
[0048] In one embodiment, the flexible member 120 is a mesh buckle designed with a mesh tube woven into a fixed structure, so that it can show good compliance and flexibility inside the catheter and the blood vessel, and can adapt to various complex vascular morphologies; in addition, in order for the flexible member 120 to adapt to the different inner diameters of the proximal end of the vascular occluder 200, the number of metal wires of the flexible member 120 can be flexibly configured, including 16, 24, 36, 48 and other options, preferably developable and elastic metal wires, the material of the flexible member 120 includes one of nickel-titanium alloy wire, cobalt-chromium alloy wire and platinum-core nickel-titanium wire, and the metal wire diameter of the flexible member 120 is between 0.02 mm and 0.05 mm, so as to ensure the best adaptability and operation effect under different conditions.
[0049] In one embodiment, the flexible member 120 may also be formed by precisely laser engraving a nickel-titanium sleeve into a mesh buckle having a mesh tube structure, and then being compressed and formed into a first shape using a heat treatment mold.
[0050] In the embodiments of the present invention, please refer to Figure 4The first connection part 121 and the second connection part 122 are respectively located at the distal end and the proximal end of the flexible member 120. In the first form, the flexible member 120 also includes a first limiting part 123, which is located between the first connection part 121 and the second connection part 122. The first limiting part 123 is used to abut against the inner wall of the vascular occluder 200.
[0051] In the embodiments of the present invention, please refer to Figure 4 In the first form, the flexible member 120 further includes a second limiting portion 124 , which is located between the first limiting portion 123 and the first connecting portion 121 , and is used for limiting contact with the outer wall of the vascular occluder 200 .
[0052] In one embodiment, the flexible member 120 is a mesh buckle designed for a mesh tube braided shaping structure, the first connecting portion 121 has two connecting sections, both connecting sections are connected to the handle assembly 110, and the portion of the flexible member 120 away from the first connecting portion 121 is deformed under the drive of the sliding member 130. In this embodiment, the flexible member 120 is shaped into an "I" shape by a heat treatment mold, that is, the first limiting portion 123, the second limiting portion 124 and the flexible member 120 between the first limiting portion 123 and the second limiting portion 124 form an "I" shape, wherein the sliding member 130 and the first limiting portion 123 and the second limiting portion 124 form an "I" shape. The flexible member 120 between the second limiting parts 124 is arranged in parallel so that the flexible member 120 is in a first form. In this form, the first limiting part 123 and the second limiting part 124 are respectively in contact with the inner wall and the outer wall of the vascular occluder 200, so that when the release mechanism 100 drives the vascular occluder 200 to move from the distal end to the proximal end or from the proximal end to the distal end, the vascular occluder 200 is firmly locked at the distal end of the release mechanism 100, so that the vascular occluder 200 is not easy to fall off during the transportation process, and can be withdrawn before release, and can be repositioned, thereby reducing the risk of the vascular occluder 200 falling off or displacing.
[0053] In the embodiments of the present invention, please refer to Figures 1 to 4 The handle assembly 110 includes a conveying steel cable 112 and a release handle 113. The conveying steel cable 112 and the release handle 113 are respectively provided with a first channel and a second channel. The distal end of the release handle 113 is provided with a mounting portion 1131 having a mounting cavity. The mounting cavity is connected to the second channel. The distal end of the conveying steel cable 112 is located in the mounting cavity and is detachably connected to the mounting portion 1131, so that the first channel and the second channel are connected to form a sliding channel 110a.
[0054] In the present embodiment, the conveying cable 112 is a hollow steel cable or a hollow sea wave tube. The material of the conveying cable 112 is one of 316L stainless steel, 304 stainless steel, and nickel-titanium alloy. The outer diameter of the conveying cable 112 is between 0.60 and 1.10 mm, the inner diameter is between 0.40 and 0.90 mm, and the length is between 1100 mm and 1300 mm. It is made of hollow metal material so that the conveying cable 112 has good bending resistance. In one embodiment, the proximal end of the conveying cable 112 is laser welded with an external thread for connecting with the release handle 113. The material of the external thread can be selected from one of 316L stainless steel, 304 stainless steel, and nickel-titanium alloy. Correspondingly, the distal end of the release handle 113 is provided with an internal thread threadedly connected to the external thread at the proximal end of the conveying cable 112. The release handle 113 is threadedly connected to the conveying cable 112, which ensures that the conveying cable 112 and the release handle 113 are in a locked state to ensure their fixing performance and makes the assembly of the two convenient and quick.
[0055] In the embodiments of the present invention, please refer to Figure 4 The release handle 113 is provided with a slide groove 113a connected to the second channel on the outer side. The handle assembly 110 also includes a release button 114. The release button 114 is provided at the slide groove 113a. Part of the release button 114 is located in the second channel and connected to the sliding member 130. The release button 114 moves along the proximal end of the release handle 113 toward the distal end, driving the sliding member 130 to move toward the distal end.
[0056] In this embodiment, through the single-button setting of the release button 114, the surgeon can operate it with one hand, push the release button 114 to drive the sliding member 130 to slide, so that the flexible member 120 is deformed and switched to the second form, thereby releasing the vascular occluder 200, simplifying the operation method of the release mechanism 100.
[0057] In one embodiment, the portion of the flexible member 120 away from the first connection portion 121 is released into an "I" shape, and the release button 114 is pushed from the proximal end to the distal end. At this time, the flexible member 120 is straightened into an "I" shape from the original "I" shape due to the forward movement of the sliding member 130. At this time, the fixed sliding member 130 does not move, and the release can be completed by retracting the conveying cable 112 backward.
[0058] In the embodiments of the present invention, please refer to Figures 1 to 3 The release mechanism 100 further comprises a delivery conduit 140, which is sleeved on the outside of the delivery cable 112, and the outside of the delivery cable 112 is provided with a thermoplastic polyurethane elastomer coating or a polytetrafluoroethylene coating.
[0059] In this embodiment, the outer surface of the conveying steel cable 112 is coated with a thermoplastic polyurethane elastomer coating or a polytetrafluoroethylene coating, and the coating thickness is between 5 μm and 35 μm, so as to reduce the frictional resistance between the conveying steel cable 112 and the conveying catheter 140 and make the conveying process smoother and unobstructed. At the same time, the coating can also effectively prevent the conveying steel cable 112 from damaging the catheter during the conveying process and avoid potential damage to blood vessels during sheath release. In addition, the conveying catheter 140 is a small catheter of a conventional model, preferably a 2.7F - 5F catheter.
[0060] In an embodiment of the present utility model, the sliding member 130 is a solid metal wire, and the material of the solid metal wire includes one of nickel-titanium alloy, 316L stainless steel, and 304 stainless steel.
[0061] In this embodiment, the sliding member 130 is a metal core wire made of a single solid metal material, and the material is one of nickel-titanium alloy, 316L stainless steel, and 304 stainless steel. The outer diameter of the core wire is between 0.30 and 0.80 mm, and the length is between 1400 and 1500 mm.
[0062] The present utility model also proposes a vascular occluder assembly. Referring to Figure 5 and Figure 6 , the vascular occluder assembly includes a vascular occluder 200 and a release structure 100. The vascular occluder 200 is cylindrically arranged. The vascular occluder 200 includes a first fixing part 210 at the distal end. The first fixing part 210 encloses to form a channel. Inner and outer tube sleeves are respectively sleeved on two sides of the first fixing part 210 close to and far from the channel. The channel is used for the flexible member 120 to pass through.
[0063] In an embodiment of the present utility model, the vascular occluder 200 includes a second fixing part 220 located at the distal end and extending from the proximal end towards the distal end. The second fixing part 220 is provided with a head 221. Both sides of the vascular occluder 200 close to the first fixing part 210 and the second fixing part 220 are recessed.
[0064] In this embodiment, the vascular occluder 200 is mainly a wire braided structure, and a radiopaque and elastic wire is selected. The wire material is one of nitinol wire, cobalt-chromium alloy wire and platinum-core nitinol wire; the wire diameter is between 0.03 mm and 0.08 mm, preferably 0.04 - 0.05 mm; the elastic wire can closely adhere to the inner wall of the abnormal blood vessel, improving the support of the vascular occluder 200 to the blood vessel. In addition, the wire braided mesh structure is unique, and there are no fixed connection points between the wires, so they can slide relatively freely. This design ensures that the mesh structure exhibits excellent compliance and flexibility both in the catheter and inside the blood vessel, enabling it to flexibly adapt to various complex blood vessel morphologies. Regarding the number of wires, various configurations such as 36, 48, 64, 72, 96, 144 or 288 can be selected according to actual needs, and more common preferred configurations include 48, 64, 72, 96 and 144. In addition, according to the morphology of the abnormal blood vessel and the needs of the operator, the mesh tube can be made into a double-layer structure to increase the mesh density of the mesh tube. This flexibility provides doctors with more choices to meet different blood vessel embolization or occlusion needs.
[0065] The braided mesh of the vascular occluder 200 is fixed by sleeve welding to ensure the stability and reliability of the structure. The sleeve is divided into two parts: the distal head 221 sleeve and the proximal inner sleeve 211 and outer sleeve 212. The sleeve material is mainly composed of a solid ring made of high-density materials such as gold, tantalum, platinum-iridium alloy or platinum-tungsten alloy. The selection of these materials not only ensures the firmness and durability of the sleeve, but more importantly, they have the property of being radiopaque, enabling the implementation of the imaging function during the operation, facilitating the doctor to judge the release situation of the device, and thus ensuring the accuracy and safety of the operation.
[0066] With its dense metal coverage, the mesh tube braided structure forms a tight structure after the mesh is unfolded, effectively reducing the blood flow into it and achieving precise occlusion of the abnormal blood vessel. This design can quickly reduce the impact of blood flow on the abnormal blood vessel and protect the blood vessel wall from further damage. The vascular occluder 200 adopts a cylindrical structure design, significantly increasing the contact area with the blood vessel wall, thereby improving the wall adhesion and friction, effectively preventing the risk of displacement or detachment; in addition, in addition to being designed as a cylindrical structure, the distal and proximal heads 221 of the vascular occluder 200 are designed as concave structures, which can prevent the formation of thrombus caused by the protrusion of the head 221; in addition, its unique mesh structure helps the new intima to cover the abnormal blood vessel faster, accelerating the repair process of the blood vessel inner wall. This occlusion method can isolate the blood flow from flowing into the diseased location, achieve the treatment purpose, and bring better treatment effects and faster recovery speed to patients.
[0067] The network tube is shaped into a cylindrical structure, which is designed to increase the contact area with the inner wall of the abnormal blood vessel, thereby enhancing the friction force and effectively preventing displacement or detachment. This structure can closely fit the inner wall of the aneurysm neck and firmly block the entrance of the abnormal blood vessel. The mesh density of the network tube is regulated by the fine weaving count (PPI), ranging from 100 meshes to 300 meshes, and 180 meshes to 200 meshes are proven to be the optimal choice to provide excellent flow-blocking effect. The double-layer mesh disk design further ensures that the metal coverage rate is adjustable between 15% and 45%, and 25% to 40% of the metal coverage rate is regarded as the best to balance the treatment effect and blood flow interference. The vascular occluder 200 is released at the entrance of the abnormal blood vessel, providing an ideal platform for the growth of the new intima, helping it quickly cover the entrance of the abnormal blood vessel, isolating the blood flow between the abnormal blood vessel and the normal blood vessel, and finally achieving the treatment goal.
[0068] The present utility model also provides a delivery system 10 for an occluder, which includes a vascular occluder assembly. The specific structure of the vascular occluder assembly refers to the above embodiments. Since this delivery system 10 for an occluder adopts all the technical solutions of the above embodiments, it at least has all the beneficial effects brought by the technical solutions of the above embodiments, and will not be elaborated herein one by one.
[0069] The vascular occluder 200 is delivered in cooperation with the release mechanism 100, which not only reduces the number of implantations and the operation time, but also meets the embolization of the abnormal blood vessel; the combined design of the flexible member 120 and the delivery steel cable 112 ensures the stability of the vascular occluder 200 during the delivery process, enables accurate positioning in the blood vessel, and has both pushing and retracting performances at the same time; the cylindrical structure of the vascular occluder 200 can fit the blood vessel wall, increasing the friction force and stability with the blood vessel. In addition, the dense woven network tube structure can, on the one hand, quickly trigger thrombosis and form a dense filling in the abnormal blood vessel; on the other hand, the high-density grid is beneficial to the endothelialization of the device and has a prominent effect on restricting the speed and direction of blood flow, achieving effective occlusion; the "I"-shaped structure of the flexible member 120 can firmly lock the proximal sleeve connection part of the vascular occluder 200 in the catheter, realizing controllable mechanical release. During the delivery process of the vascular occluder 200, it is not easy to fall off, and it can be retracted before release, enabling repositioning and reducing the risk of the vascular occluder 200 falling off or displacing. In addition, by adopting the design of the proximal release handle 113, the vascular occluder 200 can achieve one-key rapid release, shortening the operation time and further reducing the operation risk. After the operation, the patient no longer needs to rely on long-term drug treatment, especially avoiding the need for antiplatelet treatment, further improving the patient's postoperative recovery experience. In addition, the vascular occluder 200 has a good imaging effect, ensuring accurate positioning during the operation. Secondly, before release, the occluder can also be repositioned and redeployed, greatly enhancing its positioning and stability, providing greater operation flexibility and safety for doctors.
[0070] The above are only the preferred embodiments of the present utility model, and do not thereby limit the patent scope of the present utility model. Any equivalent structural transformation made under the inventive concept of the present utility model by using the content of the specification and drawings of the present utility model, or any direct / indirect application in other related technical fields shall be included within the patent protection scope of the present utility model.
Claims
1. A release mechanism for a vascular occluder, characterized in that: include: a handle assembly having a sliding channel; a flexible member having a first connection portion and a second connection portion, wherein the first connection portion is connected to the proximal end of the handle assembly, and the flexible member has a first shape and a second shape; and a sliding member, slidably disposed in the sliding channel, wherein a distal end of the sliding member is connected to the second connecting portion, so that the flexible member is deformed and switched from the first form to the second form under the drive of the sliding member; In the first form, the flexible member is used to abut against the inner wall of the vascular occluder to limit the separation of the release mechanism from the vascular occluder; In the second form, the sliding member moves in the direction from the distal end to the proximal end and drives the flexible member to deform, and the flexible member moves toward the direction close to the sliding member and separates from the inner wall of the vascular occluder, so that the flexible member can be moved out of the inner cavity of the vascular occluder, and the release mechanism is released from the vascular occluder.
2. The release mechanism according to claim 1, characterized in that: The first connection part and the second connection part are respectively located at the distal end and the proximal end of the flexible member. In the first form, the flexible member also includes a first limiting part, which is located between the first connection part and the second connection part. The first limiting part is used to abut against the inner wall of the vascular occluder.
3. The release mechanism according to claim 2, characterized in that: In the first form, the flexible member further includes a second limiting portion, the second limiting portion is located between the first limiting portion and the first connecting portion, and the second limiting portion is used for limiting contact with the outer wall of the vascular occluder.
4. The release mechanism according to claim 1, characterized in that: The handle assembly includes a conveying steel cable and a release handle, wherein the conveying steel cable and the release handle are respectively provided with a first channel and a second channel, and the distal end of the release handle is provided with a mounting portion having a mounting cavity, wherein the mounting cavity is connected to the second channel, and the proximal end of the conveying steel cable is located in the mounting cavity and is detachably connected to the mounting portion, so that the first channel and the second channel are connected to form the sliding channel.
5. The release mechanism according to claim 4, characterized in that: The release handle is provided with a slide groove connected to the second channel on its outer side, and the handle assembly also includes a release button, which is provided at the slide groove. Part of the release button is located in the second channel and connected to the sliding member, and the release button moves along the proximal end of the release handle toward the distal end, driving the sliding member to move.
6. The release mechanism according to claim 4, characterized in that: The release mechanism also includes a delivery catheter, which is sleeved on the outside of the delivery steel cable, and the outside of the delivery steel cable is provided with a thermoplastic polyurethane elastomer coating or a polytetrafluoroethylene coating.
7. The release mechanism according to claim 1, characterized in that: The sliding member is a solid metal wire, and the material of the solid metal wire includes one of nickel-titanium alloy, 316L stainless steel and 304 stainless steel.
8. A vascular occluder assembly, characterized in that: It comprises a vascular occluder and the release mechanism as claimed in any one of claims 1 to 7, wherein the vascular occluder is cylindrical and comprises a first fixing portion at the proximal end, the first fixing portion encloses a channel, the first fixing portion is respectively sleeved with an inner tube sleeve and an outer tube sleeve on both sides close to and away from the channel, and the channel is used for the flexible member of the release mechanism to pass through.
9. The vascular occluder assembly according to claim 8, characterized in that: The vascular occluder comprises a second fixing portion at a distal end, the second fixing portion is provided with a sealing head, and both sides of the vascular occluder close to the first fixing portion and the second fixing portion are concavely arranged.
10. An occluder delivery system, characterized in that: Comprising the vascular occluder assembly according to claim 8 or 9.