In-situ windowing and membrane breaking device for covered stent

Abstract

The utility model provides an in-situ windowing membrane rupture device for a covered stent, which relates to the field of medical instruments and comprises an outer tube, a middle-layer positioning tube, an inner-layer positioning tube and a membrane rupture guide wire which are sequentially sleeved from outside to inside and can relatively axially slide two by two, an elastic expansion part is connected to the peripheral surface of the far-end section of the middle-layer positioning tube and has an expansion state of expanding in the radial direction to be spherical and a contraction state of contracting in the radial direction; the outer tube can axially slide relative to the middle-layer positioning tube, so that the elastic expansion part is accommodated or released in the outer tube; the far-end face of the inner-layer positioning pipe is provided with concave-convex positioning sawteeth facing the far-end direction. The aorta covered stent at least relieves the technical problem that in the prior art, when an aorta covered stent is subjected to in-situ windowing and membrane rupture, guide wire positioning is not accurate.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of medical apparatus and instruments, especially to a covered stent in-situ windowing and membrane breaking device. BACKGROUND

[0002] The in-situ windowing of the thoracic aortic covered stent is mainly realized by laser membrane breaking and guide wire membrane breaking. Among them, the laser membrane breaking is to break the membrane of the covered stent by introducing the laser membrane breaking device from the branch vessel of the aorta to the branch vessel opening position and then burning the membrane by laser. The guide wire membrane breaking is to introduce the guide wire from the branch vessel of the aorta to the vessel opening position, and to penetrate the membrane of the covered stent by using the density difference between the guide wire and the membrane.

[0003] In the prior art, no matter which way is used to break the membrane, there is a defect of inaccurate positioning. The main reason is that the diameter of the laser membrane breaking device or the membrane breaking guide wire is much smaller than the inner diameter of the branch vessel. The laser membrane breaking device or the guide wire has no support in the branch vessel and cannot control the direction of membrane breaking. The best membrane breaking direction is that the guide wire or the laser membrane breaking device is approximately perpendicular to the surface of the membrane of the covered stent. Among them, when the laser membrane breaking method is used, if the laser membrane breaking device is not positioned accurately, it will cause the burning of the blood vessel. When the guide wire membrane breaking method is used, if the guide wire is not positioned accurately, the guide wire cannot penetrate the membrane, and even it can penetrate into the gap between the covered stent and the blood vessel. Long-term operation error can cause new aortic dissection.

[0004] To this end, in the prior art, the use of a balloon catheter to position the guide wire can alleviate the above problems. The balloon is implanted in the branch vessel of the aorta. After the balloon catheter is positioned, the guide wire is inserted through the inner lumen of the balloon catheter to break the membrane of the stent. However, although this operation method has a certain positioning effect, the prior art still has the following defects:

[0005] ①This method can only position the part of the membrane breaking guide wire close to the proximal end. When the membrane is actually broken, the distal end (front end) of the membrane breaking guide wire is still partially suspended. The membrane breaking guide wire still has no fulcrum point at the actual membrane breaking position, and the positioning is not accurate.

[0006] ②After the balloon is expanded, it will completely block the blood supply of the branch vessel, affecting the blood supply of the patient's head and upper limbs during the operation.

[0007] ③The process of pressurizing and depressurizing the balloon is complex, which will prolong the operation time.

[0008] ④Even after the balloon is depressurized, it still has a large radial size. The process of putting the balloon into the delivery sheath tube is prone to jamming. UTILITY MODEL CONTENTS

[0009] The purpose of this utility model is to provide an in-situ window opening and membrane breaking device for a film-coated support, so as to alleviate at least one of the above-mentioned technical problems existing in the prior art.

[0010] To achieve the above objectives, the embodiments of this utility model adopt the following technical solutions:

[0011] This utility model provides an in-situ fenestration and membrane-breaking device for a membrane-covered stent, comprising an outer tube, a middle positioning tube, an inner positioning tube, and a membrane-breaking guide wire, which are sequentially mounted from the outside to the inside and can slide relative to each other axially. The outer circumferential surface of the distal section of the middle positioning tube is connected to an elastic expansion portion, which has a radially expanding spherical expansion state and a radially contracting contraction state. The outer tube can slide axially relative to the middle positioning tube to accommodate or release the elastic expansion portion within the outer tube. The distal end face of the inner positioning tube is provided with positioning serrations that protrude and retract towards the distal end.

[0012] Compared with the prior art, the in-situ windowing and membrane breaking device for the covered stent provided in this embodiment uses the middle positioning tube to perform the first positioning of the guiding wire's path during membrane breaking, and the inner positioning tube to perform the second positioning of the guiding wire's path during membrane breaking. After two positionings, and with the stabilizing effect of the positioning saw teeth, the distal end of the membrane breaking guide wire can be accurately positioned at the preset windowing position of the covered stent for membrane breaking. The distal end of the membrane breaking guide wire does not suspend or shake, and the positioning is more accurate and reliable.

[0013] Optionally, the positioning saw teeth are tapered with a diameter that gradually decreases from the proximal end to the distal end.

[0014] Optionally, the inner positioning tube includes an inner main tube and an inner end tube, the proximal end of the inner end tube is fixedly connected to the distal end of the inner main tube, the hardness of the inner end tube is greater than the hardness of the inner main tube, and the positioning serrations are provided on the distal end face of the inner end tube.

[0015] Optionally, the distal end of the outer tube is provided with an inner chamfer so that the inner circumferential surface of the distal end of the outer tube forms a frustoconical guide surface with a diameter that gradually decreases from the distal end to the proximal end.

[0016] Optionally, the outer tube includes an outer main tube and an outer end tube, the proximal end of the outer end tube is fixedly connected to the distal end of the outer main tube, the hardness of the outer end tube is greater than the hardness of the outer main tube, and the frustoconical guide surface is provided on the inner circumferential surface of the distal end port of the outer end tube.

[0017] Optionally, the distal end face of the membrane-breaking guidewire is pointed.

[0018] The specific structure of the elastic expansion section at the distal end of the middle positioning tube:

[0019] In a first optional embodiment, the elastic expansion portion is a balloon, and the wall of the middle positioning tube is provided with a fluid cavity communicating with the balloon.

[0020] In a second optional embodiment, the middle layer positioning tube includes a middle layer main tube and a push-pull tube sleeved outside the middle layer main tube, wherein the distal end face of the push-pull tube is located on the proximal side of the distal end face of the middle layer main tube.

[0021] The elastic expansion section is an elastic mesh structure; the distal end of the elastic mesh structure is constricted and fixedly connected to the distal segment of the middle layer main tube, and the proximal end of the elastic mesh structure is constricted and fixedly connected to the distal segment of the push-pull tube; the push-pull tube can slide axially relative to the middle layer main tube so that the elastic mesh structure can switch between an expanded state and a contracted state.

[0022] In this second optional embodiment, the middle positioning tube further includes a fixing ring, which is sleeved on the outer side of the distal end of the middle main tube, and the distal end of the elastic mesh structure is converged and pressed between the outer peripheral surface of the distal end section of the middle main tube and the fixing ring.

[0023] Optionally, the proximal end of the elastic mesh structure is fused to the distal end of the push-pull tube. Attached Figure Description

[0024] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0025] Figure 1 A schematic diagram of the distal structure of the in-situ windowing and membrane-breaking device for the film-coated support provided in this embodiment of the utility model, with the elastic expansion portion in an expanded state.

[0026] Figure 2 A half-sectional view of the distal structure of the in-situ fenestration membrane-breaking device for the membrane-covered support provided in this embodiment of the utility model, with the elastic expansion part in a contracted state (the membrane-breaking guide wire is not shown).

[0027] Figure 3 This is a cross-sectional view of the distal section of the inner positioning tube in an embodiment of the present invention;

[0028] Figure 4 This is a cross-sectional view of the distal section of the outer tube in an embodiment of the present invention;

[0029] Figure 5The steps for using the in-situ windowing and film-breaking device for the film-coated support provided in this embodiment of the utility model Figure 1 ;

[0030] Figure 6 The steps for using the in-situ windowing and film-breaking device for the film-coated support provided in this embodiment of the utility model Figure 2 ;

[0031] Figure 7 The steps for using the in-situ windowing and film-breaking device for the film-coated support provided in this embodiment of the utility model Figure 3 ;

[0032] Figure 8 The steps for using the in-situ windowing and film-breaking device for the film-coated support provided in this embodiment of the utility model Figure 4 .

[0033] Icons: 110-Covered stent; 120-Guide wire; 1-Outer tube; 11-Outer main tube; 12-Outer end tube; 121-Frustoconical guide surface; 2-Middle layer positioning tube; 20-Elastic expansion section; 21-Middle layer main tube; 22-Push-pull tube; 23-Fixing ring; 3-Inner layer positioning tube; 31-Inner layer main tube; 32-Inner layer end tube; 321-Positioning serration; 4-Membrane rupture guide wire. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0035] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0036] It should be noted that similar labels and letters in the accompanying drawings indicate similar items. Therefore, once an item is defined in one accompanying drawing, it does not need to be further defined and explained in subsequent accompanying drawings.

[0037] In the description of this utility model, it should be noted that:

[0038] Unless otherwise expressly specified and limited, the terms "set," "install," and "connect" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0039] The terms “proximal end,” “distal end,” “front end,” “rear end,” “axial,” “radial,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this utility model is usually placed during use. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0040] Below, the end of the medical device closest to the surgeon during surgery is defined as the proximal end of the medical device, and the end of the medical device that enters the patient's blood vessel is defined as the distal end of the medical device (the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end); some embodiments of this utility model will be described in detail with reference to the accompanying drawings.

[0041] This embodiment provides an in-situ windowing and membrane-breaking device for a membrane-covered support, referring to... Figures 1 to 3 The in-situ fenestration device for the membrane-covered support includes an outer tube 1, a middle positioning tube 2, an inner positioning tube 3, and a membrane-breaking guide wire 4, which are sequentially mounted from the outside to the inside and can slide axially relative to each other in pairs. Specifically, the outer peripheral surface of the distal section of the middle positioning tube 2 is connected to an elastic expansion part 20, which has an expansion state that expands radially into a spherical shape and a contraction state that contracts radially; the outer tube 1 can slide axially relative to the middle positioning tube 2 so that the elastic expansion part 20 can be received or released in the outer tube 1; the distal end face of the inner positioning tube 3 is provided with positioning serrations 321 that are concave and convex in the distal direction.

[0042] The usage method of the in-situ windowing and film-breaking device for the film-coated support is as follows: Figures 5 to 8 A covered stent 110 is implanted in the thoracic aorta. Taking the in-situ fenestration of the covered stent 110 at the location corresponding to the opening of the branch vessel of the left subclavian artery as an example, the first step is as follows: Figure 5 As shown, guide wire 120 is inserted along a branch of the left subclavian artery to the pre-ruptured membrane position. From the proximal end of guide wire 120, it is passed through the lumen of the inner positioning tube 3, which is part of a three-layered tubing system consisting of the inner positioning tube 3, the middle positioning tube 2, and the outer tube 1. The second step is as follows... Figure 6As shown, the outer tube 1 is retracted (pulled proximally) relative to the middle layer positioning tube 2, exposing the elastic expansion portion 20 at the distal end of the middle layer positioning tube 2. This allows the elastic expansion portion 20 to expand and support the inner wall of the left subclavian artery branch, achieving the positioning of the middle layer positioning tube 2 (first positioning); the third step, as... Figure 7 As shown, the inner positioning tube 3 is pushed forward (towards the distal end) relative to the middle positioning tube 2 until the positioning serration 321 pierces the film of the film-covered support 110 to complete the positioning of the inner positioning tube 3 (second positioning); the fourth step, as shown... Figure 8 As shown, the guide wire 120 is pulled out, and the membrane-breaking guide wire 4 is inserted through the lumen of the inner positioning tube 3. The membrane-breaking guide wire 4 is used to puncture the membrane of the covered stent 110 to complete the membrane-breaking operation. After that, the outer tube 1 is pushed forward relative to the middle positioning tube 2 to receive the elastic expansion part 20, and the membrane-breaking device of the covered stent is withdrawn from the patient's body.

[0043] Compared with the prior art, the in-situ windowing and membrane breaking device for the covered stent provided in this embodiment uses the middle positioning tube 2 to perform the first positioning of the guiding path of the membrane breaking guide wire 4 during membrane breaking, and uses the inner positioning tube 3 to perform the second positioning of the guiding path of the membrane breaking guide wire 4 during membrane breaking. After two positionings, and with the stabilizing effect of the positioning saw teeth 321, the distal end of the membrane breaking guide wire 4 can be accurately positioned at the preset windowing position of the covered stent 110 for membrane breaking. The distal end of the membrane breaking guide wire 4 does not suspend or shake, and the positioning is more accurate and reliable.

[0044] To increase the positioning stability of the positioning saw teeth 321, in this embodiment, optionally, reference is made to... Figure 3 The positioning saw teeth 321 are cone-shaped with a diameter that gradually decreases from the proximal end to the distal end.

[0045] Additionally, in this embodiment, optionally, reference is made to... Figure 3 The inner positioning tube 3 includes an inner main tube 31 and an inner end tube 32. The proximal end of the inner end tube 32 is fixedly connected to the distal end of the inner main tube 31. The hardness of the inner end tube 32 is greater than that of the inner main tube 31. Positioning serrations 321 are provided on the distal end face of the inner end tube 32 to ensure the flexibility of the inner positioning tube 3 along the blood vessel through the inner main tube 31, and to ensure that the positioning serrations 321 can be quickly punctured onto the endothelial membrane through the inner end tube 32 and to further improve its positioning stability after puncture.

[0046] Optionally, refer to Figure 4 The distal end of the outer tube 1 is provided with an inner chamfer so that the inner circumferential surface of the distal end of the outer tube 1 forms a frustoconical guide surface 121 with a diameter that gradually decreases from the distal end to the proximal end. This design allows the outer tube 1 and the middle positioning tube 2 to slide axially relative to each other so that the elastic expansion part 20 is housed inside the outer tube 1, thus avoiding jamming.

[0047] Optionally, refer to Figure 4The outer tube 1 includes an outer main tube 11 and an outer end tube 12. The proximal end of the outer end tube 12 is fixedly connected to the distal end of the outer main tube 11. The hardness of the outer end tube 12 is greater than that of the outer main tube 11. The aforementioned frustoconical guide surface 121 is provided on the inner circumferential surface of the distal end port of the outer end tube 12 to ensure the flexibility of the outer tube 1 in the blood vessel delivery through the outer main tube 11, and to quickly receive or push out the elastic expansion part 20 through the outer end tube 12 to avoid blockage.

[0048] In addition, to increase the penetration power of the membrane-breaking guidewire 4 during membrane rupture and further improve surgical efficiency, the distal end face of the membrane-breaking guidewire 4 is angular.

[0049] In this embodiment, the specific structure of the elastic expansion portion 20 at the distal end of the middle positioning tube 2 is as follows:

[0050] In a first optional embodiment, the elastic expansion portion 20 is a balloon (not shown), and the inner wall of the middle positioning tube 2 is provided with a fluid cavity communicating with the balloon. The balloon can be an air balloon or a liquid balloon.

[0051] However, while using a balloon can solve the problem of precise positioning, it may lead to other issues. For example, as mentioned in the background art, balloon inflation can completely block the blood supply to branch vessels, affecting blood supply to the patient's head and upper limbs during surgery; the process of inflating and deflating the balloon is complex, prolonging the operation time; and even after deflating, the balloon still has a large radial dimension, making it prone to jamming during the insertion into the delivery sheath. Therefore, this embodiment also provides a second optional implementation of the elastic expansion section 20. In the second optional implementation, refer to... Figure 1 and Figure 2 The middle layer positioning tube 2 includes a middle layer main tube 21 and a push-pull tube 22 sleeved outside the middle layer main tube 21. The distal end face of the push-pull tube 22 is located on the proximal side of the distal end face of the middle layer main tube 21. The elastic expansion part 20 is an elastic mesh structure. The distal end of the elastic mesh structure is constricted and fixedly connected to the distal segment of the middle layer main tube 21, and the proximal end of the elastic mesh structure is constricted and fixedly connected to the distal segment of the push-pull tube 22. The push-pull tube 22 can slide axially relative to the middle layer main tube 21 so that the elastic mesh structure can switch between an expanded state and a contracted state.

[0052] Continue to refer to Figure 1 and Figure 2In this second optional embodiment, the middle positioning tube 2 may further include a fixing ring 23, which is sleeved on the distal end of the middle main tube 21. The distal end of the elastic mesh structure is constricted and pressed between the outer peripheral surface of the distal segment of the middle main tube 21 and the fixing ring 23. The fixing ring 23 and the middle main tube 21 can be fused together, or an annular groove can be provided on the outer peripheral surface of the middle main tube 21, and the fixing ring 23 can be embedded inside the annular groove. Alternatively, the fixing ring 23 can be glued or otherwise connected to the outer peripheral surface of the middle main tube 21. Optionally, the proximal end of the elastic mesh structure is fused to the distal segment of the push-pull tube 22.

[0053] In this second optional embodiment, an elastic mesh structure is used as the elastic expansion part 20. In its expanded state, it allows blood flow without affecting the blood supply of branch vessels. The radial expansion size of the elastic expansion part 20 can be adaptively adjusted according to the different branch vessel sizes of different patients by the push-pull tube 22, avoiding excessive expansion of branch vessels and causing branch vessel dissection. At the same time, in its contracted state, it is significantly closer to the tube wall than the balloon structure in its contracted state, thereby reducing the radial size in the contracted state and making it easier to be accommodated inside the outer tube 1, avoiding blockage.

[0054] Finally, it should be noted that the above embodiments and optional implementations in this specification are only used to illustrate the technical solutions of this utility model, and not to limit it. Although this utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing optional implementations, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model. In addition, it is emphasized again that, in the absence of conflict, the features of the embodiments and optional implementations in the embodiments in this specification can be combined with each other.

Claims

1. A membrane-covered support in-situ windowing and membrane-breaking device, characterized in that: It includes an outer tube (1), a middle positioning tube (2), an inner positioning tube (3), and a membrane rupture guide wire (4), which are sequentially installed from the outside to the inside and can slide axially in pairs. The outer peripheral surface of the distal section of the middle positioning tube (2) is connected to an elastic expansion part (20). The elastic expansion part (20) has an expanded state that expands radially into a spherical shape and a contracted state that contracts radially. The outer tube (1) can slide axially relative to the middle positioning tube (2) so that the elastic expansion part (20) can be received or released in the outer tube (1). The inner positioning tube (3) has positioning serrations (321) that are concave and convex in the direction of the distal end on its distal end face.

2. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The positioning saw teeth (321) are cone-shaped with a diameter that gradually decreases from the proximal end to the distal end.

3. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The inner positioning tube (3) includes an inner main tube (31) and an inner end tube (32). The proximal end of the inner end tube (32) is fixedly connected to the distal end of the inner main tube (31). The hardness of the inner end tube (32) is greater than that of the inner main tube (31). The positioning serration (321) is provided on the distal end face of the inner end tube (32).

4. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The distal end of the outer tube (1) is provided with an inner chamfer so that the inner circumferential surface of the distal end of the outer tube (1) forms a frustoconical guide surface (121) with the diameter gradually decreasing from the distal end to the proximal end.

5. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 4, characterized in that: The outer tube (1) includes an outer main tube (11) and an outer end tube (12). The proximal end of the outer end tube (12) is fixedly connected to the distal end of the outer main tube (11). The hardness of the outer end tube (12) is greater than that of the outer main tube (11). The frustoconical guide surface (121) is provided on the inner circumferential surface of the distal port of the outer end tube (12).

6. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The distal end face of the perforation guidewire (4) is pointed.

7. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The elastic expansion part (20) is a balloon, and the inner wall of the middle positioning tube (2) is provided with a fluid cavity communicating with the balloon.

8. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 1, characterized in that: The middle layer positioning tube (2) includes a middle layer main tube (21) and a push-pull tube (22) sleeved outside the middle layer main tube (21), wherein the distal end face of the push-pull tube (22) is located on the proximal side of the distal end face of the middle layer main tube (21); The elastic expansion section (20) is an elastic mesh structure; the distal end of the elastic mesh structure is constricted and fixedly connected to the distal section of the middle layer main tube (21), and the proximal end of the elastic mesh structure is constricted and fixedly connected to the distal section of the push-pull tube (22); the push-pull tube (22) can slide axially relative to the middle layer main tube (21) so that the elastic mesh structure can switch between an expanded state and a contracted state.

9. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 8, characterized in that: The middle layer positioning tube (2) also includes a fixing ring (23), which is sleeved on the outer side of the distal end of the middle layer main tube (21). The distal end of the elastic mesh structure is gathered and pressed between the outer peripheral surface of the distal end section of the middle layer main tube (21) and the fixing ring (23).

10. The in-situ windowing and membrane-breaking device for the film-coated support according to claim 8, characterized in that: The proximal end of the elastic mesh structure is fused to the distal end of the push-pull tube (22).

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