Stent system

Abstract

The invention relates to the technical field of medical instruments, and discloses a stent system which comprises a covered stent and an adjusting structure, the covered stent comprises a first side and a second side in the circumferential direction, the adjusting structure comprises a first adjusting part, a second adjusting part and a locking ring, the locking ring is arranged at the far end of the first side of the covered stent, and the far end of the second adjusting part comprises a limiting buckle. The far end part of the first adjusting part is sleeved with the limiting buckle to form a sleeving part; one of the first adjusting part and the limiting buckle penetrates through the locking ring, so that the locking ring limits the axial movement of the sleeving part, and when the second adjusting part is pulled, the limiting buckle cannot slide out of the first adjusting part. The position of the far end of the first side can be adjusted by pulling the second adjusting part, so that the first side of the covered stent is attached to the blood vessel wall, the included angle between the first side and the blood vessel wall can be reduced or eliminated, the possibility of internal leakage of the covered stent is reduced, and the application safety of the covered stent is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a stent system. Background Art

[0002] The information provided in this part is only background information related to the present invention, and it is not necessarily prior art.

[0003] Aortic aneurysm and aortic dissection are currently diseases that seriously endanger human life safety. If not actively treated, the aortic aneurysm and dissection will continue to grow and finally rupture, causing serious complications and death. With the continuous increase in the number of patients with hypertension, hyperlipidemia, and hyperglycemia, the current incidence of aortic aneurysm and aortic dissection is also increasing significantly.

[0004] Endovascular exclusion of aortic aneurysm with a covered stent is to implant a covered stent in the aorta to isolate the vascular lesion outside the covered stent and restrict the blood flow to pass through the inside of the covered stent, so as to achieve the purpose of protecting the blood vessel. It has been widely used in the treatment of aneurysms and dissections of the thoracic and abdominal aorta, etc., with definite curative effect, less trauma, quick recovery, and fewer complications.

[0005] Currently, when the anchoring position of the aortic stent is bent, for example, as Figure 1 shown, the anchoring area of the stent 10' for the thoracic aorta is at the position of the aortic arch 20'. After the stent 10' is released, the beak phenomenon is likely to occur on the proximal small bend side, that is, an included angle α is formed between the small bend side 11' of the stent 10' and the aortic arch wall 21'. After the operation, type I endoleak is likely to occur. If intervention is not timely in the long term, the pressure in the aortic aneurysm cavity may continue to increase, which may cause the aneurysm cavity to rupture, or the aortic dissection rupture opening cannot be isolated, and the false lumen cannot be thrombosed. Summary of the Invention

[0006] The purpose of the present invention is to at least alleviate the problem that the beak phenomenon is likely to occur on the small bend side after the stent is released, resulting in type I endoleak after the operation. This purpose is achieved through the following technical solutions:

[0007] In a first aspect of the present invention, a stent system is proposed. The stent system includes a covered stent and an adjusting structure. The covered stent includes a first side and a second side along the circumferential direction. The adjusting structure includes a first adjusting member, a second adjusting member, and a locking ring. The locking ring is disposed at the distal end of the first side of the covered stent. The distal end of the second adjusting member includes a limiting ring buckle, and the limiting ring buckle is sleeved on the distal end portion of the first adjusting member to form a socket; one of the first adjusting member and the limiting ring buckle passes through the locking ring, so that the locking ring limits the axial movement of the socket, and when the second adjusting member is pulled, the limiting ring buckle cannot slide out of the first adjusting member.

[0008] According to the stent system of the present invention, when the covered stent is released into a curved blood vessel, the first side can correspond to the minor curvature side of the blood vessel. Correspondingly, when the covered stent is released, the first side may not be fully attached to the blood vessel wall, that is, an angle is likely to be formed between the first side of the covered stent and the blood vessel wall (i.e., the beak phenomenon). When the covered stent is released into the blood vessel, the limiting loop buckle at the distal end of the second adjusting member cooperates with the distal end of the first adjusting member and is limited by the locking ring, and the locking ring is provided at the distal end of the first side of the covered stent. In this way, by pulling the adjusting member, the position of the distal end of the first side can be adjusted to make the first side of the covered stent fit the blood vessel wall, thereby reducing or eliminating the angle between the first side and the blood vessel wall, reducing the possibility of endoleakage of the covered stent, and improving the application safety of the covered stent.

[0009] In addition, the stent system according to the present invention may further have the following additional technical features:

[0010] In some embodiments of the present invention, the distal end of the first side includes an adjustment area, and the locking ring is provided at the proximal end or the distal end of the adjustment area.

[0011] In some embodiments of the present invention, the covered stent includes a plurality of restraint rings axially spaced along the adjustment area, and the second adjusting member can sequentially pass through the plurality of restraint rings.

[0012] In some embodiments of the present invention, the locking ring is provided on the distal side of the adjustment area, the first adjusting member includes a locking rod, the second adjusting member includes an adjustment wire, and the limiting loop buckle is provided at the distal end of the adjustment wire;

[0013] The locking rod can pass through the inside of the locking ring and extend towards the distal end, and the limiting loop buckle extends towards the proximal end along the outside of the locking ring so that the socket is limited on the distal side of the locking ring;

[0014] Or, the limiting loop buckle axially passes through the inside of the locking ring from the proximal end to the distal end so that the limiting loop buckle is provided on the distal side of the locking ring, and the distal end of the locking rod passes through the limiting loop buckle along the outside of the locking ring so that the socket is limited on the distal side of the locking ring.

[0015] In some embodiments of the present invention, the locking ring is provided on the proximal side of the adjustment area, the first adjusting member includes a locking rod, the second adjusting member includes an adjustment wire, and the limiting loop buckle is provided at the distal end of the adjustment wire;

[0016] The limiting loop buckle axially passes through the inside of the locking ring from the proximal end to the distal end, and the part of the adjusting wire passing through the locking ring is folded back so that the limiting loop buckle is arranged outside the locking ring. The distal end of the locking rod sequentially passes through the limiting loop buckle and the locking ring from the proximal end to the distal end;

[0017] Or, the limiting loop buckle axially straddles the locking ring from the proximal end to the distal end, and the part of the adjusting wire straddling the locking ring is folded back. After folding back, the limiting loop buckle passes through the inside of the locking ring, and the distal end of the locking rod passes through the limiting loop buckle.

[0018] In some embodiments of the present invention, the distal end of the covered stent includes a semi-releasing part and a semi-releasing structure. The semi-releasing structure is arranged on the semi-releasing part. The semi-releasing structure includes a first binding unit at the proximal most end, and the first binding unit is arranged on the distal side of the locking ring.

[0019] In some embodiments of the present invention, the covered stent includes a first imaging element, and the first imaging element is arranged between the first binding unit and the locking ring.

[0020] In some embodiments of the present invention, the semi-releasing structure includes a plurality of binding units axially spaced apart along the semi-releasing part. The binding unit includes a diameter-binding wire and a locking component. The length of the diameter-binding wire is less than the circumference of the semi-releasing part at its corresponding position in the natural state, so that when the locking rod sequentially passes through the locking component axially, the binding unit can radially compress the semi-releasing part.

[0021] In some embodiments of the present invention, the locking ring is arranged on the distal side of the adjusting area. The first adjusting member includes a locking rod, and the second adjusting member includes an adjusting wire. The proximal end of the adjusting wire is connected to the proximal side of the adjusting area, and the limiting loop buckle is arranged at the distal end of the adjusting wire; the adjusting structure further includes a locking sleeve. An opening is provided on the distal side surface of the locking sleeve. The locking rod extends axially in the cavity of the locking sleeve, and the limiting loop buckle can pass through the opening and be sleeved on the locking rod after axially passing through the inside of the locking ring.

[0022] In some embodiments of the present invention, the locking ring is arranged on the inner side or the outer side of the covered stent. Description of the Drawings

[0023] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0024] Figure 1 Structural schematic diagram of the "bird's beak" phenomenon generated by the stent at the aortic arch in the prior art;

[0025] Figure 2 Schematic diagram of the covered stent released to the aortic arch provided by some embodiments of the present invention;

[0026] Figure 3 Schematic structural diagram of the stent system according to some embodiments of the present invention;

[0027] Figure 4 is Figure 3 Partial enlarged view;

[0028] Figure 5 is Figure 3 Adjustment process diagram of the stent system shown;

[0029] Figure 6 Partial enlarged schematic diagram of the stent system according to some embodiments of the present invention;

[0030] Figure 7 Schematic structural diagram of the stent system according to other embodiments of the present invention;

[0031] Figure 8 is Figure 7 Enlarged view of part T1;

[0032] Figure 9 is Figure 7 Enlarged schematic diagram of another implementation of part T1;

[0033] Figure 10 Schematic structural diagram of the covered stent of the stent system according to some embodiments of the present invention in a semi-released state;

[0034] Figure 11 is Figure 10 Partial enlarged view;

[0035] Figure 12 is Figure 11 Partial enlarged view;

[0036] Figure 13 is Figure 10 Adjustment process diagram of the stent system shown;

[0037] Figure 14 Schematic structural diagram of the stent system according to some embodiments of the present invention;

[0038] Figure 15 is Figure 14 Enlarged view;

[0039] Figure 16 is Figure 14 Adjustment process diagram of the stent system shown;

[0040] Figure 17 Partial enlarged view of the stent system according to some embodiments of the present invention;

[0041] Figure 18 Partial enlarged view of the stent system according to some embodiments of the present invention.

[0042] The reference numerals are as follows:

[0043] 10, covered stent; 11, first side; 111, adjustment area; 12, second side; 13, semi-release part; 14, semi-release structure; 141, first binding unit; 142, binding unit; 1421, diameter-binding line; 1422, locking component; 143, first developer;

[0044] 20, aortic arch; 21, aortic arch wall;

[0045] 30, adjustment structure; 31, first adjustment member; 311, locking rod; 32, second adjustment member; 321, limiting loop; 322, adjustment line; 33, locking ring; 34, restraint ring; 341, limiting position; 35, locking sleeve; 351, opening. Detailed implementation manners

[0046] The exemplary embodiments of the present invention will be described in more detail below with reference to the drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided so that the present invention can be more thoroughly understood and the scope of the present invention can be completely conveyed to those skilled in the art.

[0047] It should be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments and are not intended to be limiting. Unless otherwise clearly specified in the context, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "include", "comprise", "contain", and "have" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or their combinations. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps can be used.

[0048] Although terms such as first, second, and third may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms do not imply an order or sequence when used herein. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0049] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature, such as "inside," "outside," "inner side," "outer side," "below," "beneath," "above," "over," etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature will then be oriented "above" or "over" the other element or feature. Thus, the exemplary term "below" may include both the upper and lower orientations.

[0050] Embodiment 1

[0051] As Figure 2 and Figure 3 shown, according to an embodiment of the present invention, this embodiment provides a stent system, including a covered stent 10 and an adjustment structure 30. The covered stent 10 includes a first side 11 and a second side 12 in the circumferential direction. The first side 11 and the second side 12 may be two radially opposite sides. In this embodiment, the first side 11 and the second side 12 may each occupy 180° of the circumference of the covered stent 10. Combining Figure 2 shown, the covered stent 10 may include a support skeleton and a covering film. The covering film covers the support skeleton, and the support skeleton is used to provide a supporting effect for the covering film. The support skeleton may be a plurality of corrugated rings arranged axially in sequence. The inner cavity of the covering film forms a channel for blood flow. When the covered stent 10 is released into a curved blood vessel, the first side 11 may correspond to the small curvature side of the blood vessel, and the second side 12 may correspond to the large curvature side of the blood vessel. Correspondingly, in the covered stent 10, it is usually the case that the first side 11 may not be fully attached to the blood vessel wall, that is, an angle (i.e., the beak phenomenon) is likely to be formed between the first side 11 of the covered stent 10 and the blood vessel wall.

[0052] Combining Figure 3 shown, Figure 3The support framework is not shown, and only the boundary of the membrane is shown. The adjusting structure 30 includes a first adjusting member 31, a second adjusting member 32, and a locking ring 33. The locking ring 33 is disposed on the first side 11 of the membrane stent 10 and can be specifically sutured to the membrane or the support framework through a suture. The distal end of the second adjusting member 32 includes a limit loop buckle 321, and the limit loop buckle 321 is sleeved on the distal end portion of the first adjusting member 31 to form a socket. One of the first adjusting member 31 and the limit loop buckle 321 passes through the locking ring 33, so that the locking ring 33 defines the axial movement of the socket, and when the second adjusting member 32 is pulled, the limit loop buckle 321 cannot slide out of the first adjusting member 31.

[0053] In the prior art, after the release of the membrane stent is completed, if the membrane stent does not completely adhere to the blood vessel wall, it is usually impossible to directly adjust the small curvature side of the membrane stent. Instead, the proximal end of the membrane stent needs to be moved as a whole by withdrawing the delivery device. On the one hand, this method cannot control the adjustment accuracy of the proximal small curvature side of the membrane stent. On the other hand, the sheath core of the delivery device is inside the self-expanding membrane stent and adheres to the large curvature side of the membrane stent. Directly withdrawing the entire delivery device may cause the large curvature side to shift. In the stent system of this embodiment, when the membrane stent 10 is released into the blood vessel, the limit loop buckle 321 at the distal end of the second adjusting member 32 is limited by the locking ring 33 in cooperation with the distal end of the first adjusting member 31, and the locking ring 33 is disposed at the distal end of the first side 11 of the membrane stent 10. In this way, by directly pulling the second adjusting member 32, the distal end of the first side 11 (the first side 11 corresponds to the small curvature side after the release of the membrane stent 10) can be withdrawn proximally to reduce or eliminate the beak phenomenon, that is, the Figure 1 distal end of the membrane stent 10 in the Figure 2 can be adjusted to the state as shown in the figure, reducing the possibility of endoleakage of the membrane stent 10, improving the application safety of the membrane stent 10, and improving the adjustment accuracy of the withdrawal dimension of the small curvature side.

[0054] Among them, the "axial direction" defined in this embodiment generally refers to the length direction of the medical device when it is being delivered, the "radial direction" generally refers to the direction perpendicular to the "axial direction" of the medical device, and the "circumferential direction" generally refers to the extending direction of the contour line of the cross-section perpendicular to the "axial direction" of the medical device. Based on this principle, the "axial direction", "radial direction", and "circumferential direction" of any component of the medical device are defined. In the field of interventional medical devices, generally for a delivery device that delivers a medical device when implanting the medical device into the human body or animal body, the end closer to the operator is defined as the "proximal end", and the end farther from the operator is defined as the "distal end". Based on this principle, the "proximal end" and "distal end" of any component of the delivery device are defined. In this embodiment, the proximal and distal ends of the first adjusting member 31, the second adjusting member 32, and the covered stent 10 are defined in accordance with the proximal and distal ends of the delivery device. That is, the proximal and distal ends of the covered stent 10 are defined with reference to the state of the covered stent 10 in the delivery device. And when the covered stent 10 is located in the delivery device to form a stent system, the end closer to the operator is the proximal end of the covered stent 10, and the end farther from the operator is the distal end of the covered stent 10.

[0055] It can be understood that when one of the first adjusting member 31 and the limit loop buckle 321 passes through the locking ring 33, it means that one of the distal end portion of the first adjusting member 31 and the limit loop buckle 321 is inserted into the locking ring 33, and the other is located outside the locking ring 33. In this way, the locking ring 33 is clamped between the first adjusting member 31 and the second adjusting member 32 to form a stopping effect. When the distal end portion of the first adjusting member 31 and the limit loop buckle 321 are in a sleeved state, pulling the proximal end of the second adjusting member 32 cannot make the socket move axially relative to the locking ring 33. That is to say, in this embodiment, the socket is formed at the distal end of the locking ring 33. When the second adjusting member 32 is pulled, the limit loop buckle 321 cannot slide out of the first adjusting member 31. That is to say, when the second adjusting member 32 is subjected to a pulling force towards the proximal end, the limit loop buckle 321 and the distal end portion of the first adjusting member 31 always remain sleeved. In other embodiments, it is also possible to make the socket formed at the proximal end of the locking ring 33, and when pulling the second adjusting member 32 such that the socket is subjected to a pulling force towards the distal end, the limit loop buckle 321 does not slide out of the first adjusting member 31, which is not limited herein.

[0056] Furthermore, in this embodiment, by pulling the first adjusting member 31, the distal end portion of the first adjusting member 31 can be disengaged from the limit loop buckle 321, so as to facilitate the withdrawal of the first adjusting member 31 and the second adjusting member 32.

[0057] The stent system of this embodiment may include a delivery device. The covered stent 10 can be implanted into a blood vessel through the delivery device for use. This embodiment mainly takes the implantation of the covered stent 10 into the aortic arch 20 as an example for illustration, as Figure 2As shown. The delivery device is used to release the covered stent 10, that is, the device for implanting the covered stent 10 into the aortic arch 20. The delivery device includes a delivery handle, a sheath tube, a push rod, and a sheath core. The sheath tube, the push rod, and the sheath core are sleeved in sequence from the outside to the inside. The distal end of the push rod does not extend beyond the distal end of the sheath core and is spaced from the distal end of the sheath core, so that a loading space for the covered stent 10 is jointly formed in the sheath tube at this interval. The distal end of the delivery handle is connected to the proximal end of the sheath tube. The proximal end of the sheath core passes through the delivery handle. The push rod includes at least two axial channels. The second adjusting member 32 extends along one of the axial channels, and the first adjusting member 31 extends along the other axial channel. Before the covered stent 10 is released, the covered stent 10 is loaded in the loading space. By operating the handle to withdraw the sheath tube and making the sheath tube move axially relative to the sheath core, the covered stent 10 can be released from the loading space into the aortic arch 20.

[0058] As Figure 5 As shown in A of, after the covered stent 10 is released into the blood vessel through the delivery device, since the socket formed by the limiting loop 321 and the distal end portion of the first adjusting member 31 is limited in axial movement by the locking ring 33, and when the second adjusting member 32 is pulled, the limiting loop 321 cannot slide out of the first adjusting member 31. In this way, by pulling the proximal end of the second adjusting member 32, the first side 11 of the covered stent 10 can be moved proximally, alleviating the beak phenomenon between the covered stent 10 and the blood vessel. After the adjustment is completed, as Figure 5 As shown in B of, by pulling the proximal end of the first adjusting member 31 to separate the distal end of the first adjusting member 31 from the limiting loop 321, at this time, the socket formed by the limiting loop 321 and the distal end portion of the first adjusting member 31 is released, and the locking ring 33 can no longer limit the distal ends of the second adjusting member 32 and the first adjusting member 31, as Figure 5 As shown in C of, the first adjusting member 31 and the second adjusting member 32 can be disengaged from the covered stent 10 to facilitate removal from the body.

[0059] For the convenience of description, it is defined that the first side 11 of the covered stent 10 has an adjustment region 111 extending axially. This adjustment region 111 can be the region where the first side 11 of the covered stent 10 can be pulled under the action of the second adjusting member 32. The adjustment region 111 is larger than the axial length of the region of the first side 11 where the beak phenomenon may occur when the covered stent 10 is released. The adjustment region 111 can be within the range of extending 100 millimeters proximally from the most distal end of the covered stent 10, specifically within the range of 35 millimeters to 65 millimeters from the most distal end of the covered stent 10.

[0060] In some embodiments, as Figure 3As shown, the locking ring 33 is provided at the distal end of the adjustment region 111. The distal end of the adjustment region 111 can be at the position corresponding to the farthest end of the covered stent 10, specifically, it can be at the position corresponding to the wave ring at the farthest end of the covered stent 10. For example, the locking ring 33 can be connected to the wave ring at the farthest end of the covered stent 10, or can be connected to the covering film at the corresponding position covered by the wave ring at the farthest end.

[0061] In this embodiment, by arranging the locking ring 33 at the distal end of the adjustment region 111, pulling the second adjustment member 32 can directly act on the first side 11 at the farthest end of the adjustment region 111, so as to adjust the first side 11 of the adjustment region 111, and enable the covering film corresponding to the first side 11 of the adjustment region 111 to fit the aortic arch wall 21 at the small curvature side of the bending part of the aortic arch 20 as the second adjustment member 32 is withdrawn. Adjusting the first side 11 of the covered stent 10 by acting on the distal end of the adjustment region 111 has a better adjustment effect compared with only acting on the proximal end of the adjustment region 111, which is beneficial to improving the fitting effect between the first side 11 of the covered stent 10 and the aortic arch wall 21.

[0062] In some embodiments, reference can be made to Figure 3 - Figure 4 As shown, the covered stent 10 can be provided with restraint rings 34 on the adjustment region 111. One or more restraint rings 34 can be provided. When multiple restraint rings 34 are provided, the multiple restraint rings 34 can be arranged at intervals along the axis of the adjustment region 111, and the second adjustment member 32 can pass through all the restraint rings 34 in sequence.

[0063] The restraint rings 34 can be connected to the covering film of the covered stent 10 or can be connected to the support skeleton. The structures of the restraint rings 34 and the locking ring 33 can be the same. The locking ring 33 can be arranged at intervals at the proximal end of the multiple restraint rings 34, or at the distal end of the multiple restraint rings 34, or can be arranged between two adjacent restraint rings 34.

[0064] The distal end of the second adjustment member 32 can pass through the restraint ring 34. The restraint ring 34 can play a role in limiting and guiding the second adjustment member 32. When pulling the second adjustment member 32, the restraint ring 34 can make the force application direction of the adjustment region 111 along the axis close to the inner wall or outer wall of the first side 11 of the covered stent 10. The direction of the second adjustment member 32 is more definite, and the first side 11 can be adjusted more pertinently, improving the release and adjustment accuracy of the covered stent 10 and making the elimination of the beak more reliable.

[0065] In one embodiment, the first adjusting member 31 includes a locking rod 311, the second adjusting member 32 includes an adjusting wire 322, and a limiting loop 321 is provided at the distal end of the adjusting wire 322. The adjusting wire can be a single or multiple soft silk threads, which can be medical suture threads or metal silk threads that can be inserted into the body. The limiting loop 321 can be a wire loop structure formed by tying a knot in the adjusting wire 322. The locking rod 311 can be a bendable rod with a certain strength, and specifically, a nitinol screw rod can be selected. Whether the nitinol screw rod is hollow or solid is not limited.

[0066] Among them, in one implementation manner, as Figure 3 shown, the locking rod 311 can pass through the inside of the locking ring 33 and extend towards the distal end, and the limiting loop 321 extends towards the proximal end along the outside of the locking ring 33 so that the socket is limited to the distal side of the locking ring 33. In another implementation manner, as Figure 6 shown, it can also be that the limiting loop 321 axially passes through the inside of the locking ring 33 from the proximal end to the distal end so that the limiting loop 321 is provided on the distal side of the locking ring 33, and the distal end of the locking rod 311 passes through the limiting loop 321 along the outside of the locking ring 33 so that the socket is limited to the distal side of the locking ring 33.

[0067] Among them, the distal end of the locking rod 311 extends to the distal side of the locking ring 33, the limiting loop 321 is located on the distal side of the locking ring 33 and is sleeved with the locking rod 311 to form a socket. The proximal end of the locking rod 311 and the proximal end of the adjusting wire 322 connected to the limiting loop 321 can both be located outside the body, so as to facilitate pulling the adjusting wire 322 and the locking rod 311 for adjustment.

[0068] Using the adjusting wire as the second adjusting member 32, due to the flexibility of the adjusting wire 322, when operating on the proximal end of the adjusting wire 322, only a pulling effect can be generated on the distal end of the adjusting wire 322, and no pushing effect can be applied. Therefore, when operating on the adjusting wire 322, the situation where the limiting loop 321 disengages from the locking rod 311 will not occur, avoiding the situation where the membrane stent 10 may not be adjusted in place due to misoperation. And the locking rod 311 has a certain strength. When the locking rod 311 cooperates with the limiting loop 321 formed by the adjusting wire, the situation where the locking rod 311 and the limiting loop 321 are entangled and knotted and cannot be released is not likely to occur, improving the convenience of releasing the locking rod 311 and the adjusting wire 322.

[0069] It should be noted that the locking ring 33 and the restraining ring 34 of the stent system can both be arranged on the outer side of the covered stent 10. Correspondingly, the distal ends of the first adjusting member 31 and the second adjusting member 32 are also located on the outer side of the covered stent 10. In some embodiments, the locking ring 33 and the restraining ring 34 of the stent system can also both be arranged on the inner side of the covered stent 10. Specifically, the support framework of the covered stent 10 can be arranged on the inner side of the film, and the locking ring 33 can be arranged on the support framework. Correspondingly, the first adjusting member 31 and the second adjusting member 32 are also arranged on the inner side of the covered stent 10. In this way, the first adjusting member 31 and the second adjusting member 32 are basically not squeezed between the covered stent 10 and the blood vessel wall (which can be understood by referring to the aortic arch wall 21), which is beneficial to reducing the adjustment resistance.

[0070] The stent system of this embodiment can be provided with a radiopaque member to facilitate positioning the release position of the covered stent 10 through the radiopaque member.

[0071] Embodiment Two

[0072] As Figures 7 to 9 shown, the stent system provided in this embodiment is different from that in Embodiment One in that the locking ring 33 is arranged on the proximal side of the adjustment area 111.

[0073] In some embodiments, the same as in Embodiment One, the first adjusting member 31 can also include a locking rod 311, the second adjusting member 32 can also include an adjusting wire 322, and the limit loop buckle 321 is arranged at the distal end of the adjusting wire 322. Specifically, in one implementation, as Figure 7 and Figure 8 shown, the limit loop buckle 321 axially passes through the inside of the locking ring 33 from the proximal end to the distal end, and a part of the adjusting wire 322 passing through the locking ring 33 is folded back so that the limit loop buckle 321 is arranged outside the locking ring 33, and the distal end of the locking rod 311 passes through the limit loop buckle 321 and the locking ring 33 in sequence from the proximal end to the distal end. In other embodiments, as Figure 9 shown, the limit loop buckle 321 axially straddles the locking ring 33 from the proximal end to the distal end, and a part of the adjusting wire 322 straddling the locking ring 33 is folded back. The folded-back limit loop buckle 321 enters the inside of the locking ring from the distal end of the locking ring and then exits from the proximal side of the locking ring. The distal end of the locking rod 311 passes through the limit loop buckle 321 exiting from the proximal side of the locking ring, and the locking rod does not pass through the inside of the locking ring 33.

[0074] Optionally, in the stent system of this embodiment, a restraint ring 34 may also be provided in the adjustment region 111. The restraint ring 34 may be located on the distal side of the locking ring 33. Specifically, one or more restraint rings 34 may be provided. The distal end of the adjustment wire 322, i.e., the limit ring buckle 321, may pass through the locking ring 33 from the proximal end to the distal end, then pass through the restraint ring 34 from the inside of the restraint ring 34, and then fold back from the outside of the outermost restraint ring 34 and pass through the outside of the restraint ring 34 to reach the locking ring 33, and form a socket joint with the distal end of the locking rod 311 at the locking ring 33.

[0075] It should be noted that the limit ring buckle 321 may also pass along the axis from the proximal end to the distal end outside the locking ring 33, and after passing outside the restraint ring 34, it may fold back from the inside of the restraint ring 34 across the outermost restraint ring 34, and finally form a socket joint with the distal end of the locking rod 311.

[0076] As Figure 7 shown, since the second adjusting member 32 bypasses the outermost restraint ring 34, when the second adjusting member 32 is pulled, two stress points are respectively formed on the outermost restraint ring 34 and the locking ring 33 of the covered stent 10. The two stress points of the covered stent 10 can be simultaneously acted on by the outermost restraint ring 34 and the locking ring 33, so as to adjust the region between the two stress points, which has a better adjusting effect on the covered stent 10, especially for the case where the beak phenomenon is relatively serious, and can be better improved. That is, the outermost restraint ring 34 can be used as the limit position 341 of a stress point, which is different from other restraint rings 34. When there is only one limit position 341, there is only one stress point on the covered stent. When the beak phenomenon is relatively serious, it may lead to serious stacking of the covered stent or incomplete elimination of the beak. However, in this embodiment, there are two limit positions 341, and the stacking of the covered stent 10 can be dispersed in this adjustment region. When adjusting the beak phenomenon to the same degree, the serious stacking phenomenon caused by the adjustment of the covered stent 10 or the incomplete elimination of the beak can be reduced, and the possibility of thrombosis caused by serious stacking of the covered stent 10 can be reduced. At the same time, the distal end of the locking rod 311 may be located at the proximal end of the adjustment region 111, so that the locking rod 311 can avoid the beak adjustment section at the distal end of the covered stent 10, and the influence of the locking rod 311 with a certain stiffness on the beak adjustment effect of the covered stent 10 can be reduced.

[0077] Optionally, in the solution where the restraint ring 34 is provided and the locking ring 33 is located at the proximal end of the adjustment region 111, as Figures 10 to 13As shown, the distal end of the covered stent 10 includes a semi-release portion 13 and a semi-release structure 14, and the semi-release structure 14 is disposed on the semi-release portion 13. For the convenience of description, the restraint unit closest to the proximal end of the semi-release structure 14 is defined as the first restraint unit 141, and the first restraint unit 141 is disposed on the distal side of the locking ring 33.

[0078] The semi-release portion 13 can be a part of the distal end of the covered stent 10. When the covered stent 10 is pushed out from the loading space of the delivery device, the covered stent 10 is released into the body. At this time, the semi-release portion 13 can be in a semi-released state under the action of the semi-release structure 14, as Figure 10 shown. In the semi-released state, since the covered stent 10 has not been closely attached to the blood vessel wall, the position of the covered stent 10 can be adjusted. After the covered stent 10 is adjusted in place, the restraint of the semi-release structure 14 on the semi-release portion 13 can be further released, so that the semi-release portion 13 is completely released. At this time, the covered stent 10 can be over-expanded and anchored in the blood vessel. By providing the semi-release portion 13 and the semi-release structure 14, it is beneficial to adjust the position of the covered stent 10 and improve the release accuracy of the covered stent 10. After the semi-release portion 13 is released, the second adjusting member 32 can be further used to adjust the wall attachment condition of the first side 11 of the covered stent 10 and the small curvature side, so that the covered stent 10 is closely attached to the blood vessel wall.

[0079] In some implementation manners, a first imaging member 143 can be disposed between the first restraint unit 141 and the locking ring 33. The first imaging member 143 can be disposed on the support framework or the covering film. The first imaging member 143 can play a marking role to reduce the situation that the locking rod 311 is withdrawn too much from the limit ring buckle 321, so that the distal end of the locking rod 311 is disengaged from the limit ring buckle 321, resulting in the inability to further adjust the distal end of the first side 11 of the covered stent 10 by pulling the adjustment wire 322 after the semi-release portion 13 is released.

[0080] Optionally, in one implementation manner, continue to refer to Figure 10 、 Figure 11 and in combination with Figure 13 shown, the semi-release structure 14 includes a plurality of restraint units 142 axially spaced along the semi-release portion 13. The restraint unit 142 includes a diameter-restraining wire 1421 and a locking component 1422. The length of the diameter-restraining wire 1421 is less than the circumference of the semi-release portion 13 at its corresponding position in the natural state, so that when the locking rod 311 axially passes through the locking component 1422 in sequence, the restraint unit 142 can radially compress the semi-release portion 13.

[0081] Among them, in one implementation, one end of the beam diameter line 1421 can be a fixed end and connected to the covered stent 10. The other end of the beam diameter line 1421 is a movable end. Locking components 1422 are provided at both the fixed end and the movable end. The distal end of the locking rod 311 can sequentially pass through the two locking components 1422 at the fixed end and the movable end, and the restraint ring 34. Since the restraint ring 34 is relatively fixed to the covered stent 10, the cooperation of the locking rod 311, the restraint ring 34, and the locking component 1422 can relatively fix the movable end and the fixed end of the beam diameter line 1421 in the circumferential direction of the covered stent 10, so that when the locking rod 311 does not disengage from the locking component 1422 and the restraint ring 34, the beam diameter line 1421 can compress the semi-release part 13 in the radial direction, that is, the semi-release part 13 is in a semi-released state. As Figure 12 shown, in another implementation, both ends of the beam diameter line 1421 can be movable ends, and locking components 1422 are provided at both ends. The distal end of the locking rod 311 can pass through the locking components 1422 at both ends of the beam diameter line 1421 and the restraint ring 34. Since the restraint ring 34 is relatively fixed to the covered stent 10, the cooperation of the locking rod 311, the restraint ring 34, and the locking component 1422 can relatively fix the beam diameter line 1421 and the covered stent 10 in the circumferential direction, so that when the locking rod 311 does not disengage from the locking component 1422 and the restraint ring 34, the beam diameter line 1421 can compress the semi-release part 13 in the radial direction, that is, the semi-release part is in a semi-released state.

[0082] As Figure 10 shown, during the release process of the covered stent 10, when the covered stent 10 is released from the sheath tube, the semi-release part 13 at the distal end of the covered stent 10 is still in a semi-released state, and the diameter expansion can be approximately 40% - 80% of the fully expanded diameter; As Figure 13 shown in A, after the covered stent 10 is accurately positioned and adjusted, the locking rod 311 is pulled to disengage the locking rod 311 from the restraint ring 34 and the locking component. At this time, the beam diameter line 1421 is released, and the semi-release part 13 is no longer restricted by the restraint unit 142 and can be fully expanded. The locking rod 311 is pulled until the semi-release part 13 is fully expanded and then stopped. Referring to Figure 13 shown in B, C, and D, after the stent is released and adheres to the wall, the pulling adjustment line 322 can be used to freely adjust the first side 11 at the distal end of the covered stent 10 until it fits well with the blood vessel, then the locking rod 311 can be withdrawn, and then the adjustment line 322 can be withdrawn. The stent system in this embodiment can simultaneously have the functions of semi-release and pulling and adjusting the beak after the covered stent 10 is fully released, and can perform beak adjustment on an adjustment area 111 at the distal end of the covered stent 10, preventing the covered film stacking that may be caused by the beak adjustment at a single force point, so that the covered film stacking caused by the withdrawal is evenly distributed in this area, thereby reducing the influence of the covered film stacking.

[0083] Embodiment 3

[0084] This embodiment provides a stent system. The main difference between this embodiment and Embodiment 1 and Embodiment 2 is that the adjustment structure 30 also includes a locking sleeve 35, and the locking sleeve 35 cooperates with the locking rod 311, the adjustment line 322, etc. to achieve adjustment of the first side 11 of the coated stent 10.

[0085] Specifically, refer to Figure 14 , Figure 15 and Figure 16 As shown, the locking ring 33 of the tubular cavity support in this embodiment is arranged on the distal side of the adjustment area 111, the first adjustment member 31 includes a locking rod 311, and the second adjustment member 32 includes an adjustment line 322. The proximal end of the adjustment line 322 is connected to the proximal side of the adjustment area 111, and the connection point between the proximal end of the adjustment line 322 and the proximal end of the adjustment area 111 can be used as a limiting position 341 of a force point of the adjustment area 111 (the limiting position of another force point is the position of the locking ring 33); the limiting ring buckle 321 is arranged at the distal end of the adjustment line 322, and passes through the locking ring 33 axially from the proximal end to the distal end; the adjustment structure 30 also includes a locking sleeve 35, and the distal side of the locking sleeve 35 is provided with an opening 351, the locking rod 311 extends axially in the cavity of the locking sleeve 35, and passes through the limiting ring buckle 321 at the opening 351.

[0086] Among them, at the opening 351, the locking rod 311 and the limiting ring buckle 321 are sleeved to form a sleeve joint, and the limiting ring buckle 321 passes through the locking ring 33, so that the locking ring 33 can limit the axial movement of the sleeve joint. In this embodiment, since the limiting ring buckle 321 passes through the locking ring from the proximal end to the distal end along the axial direction, it can pass through the opening 351 of the locking sleeve 35 and be sleeved on the locking rod, that is, the limiting ring buckle is passed by the locking rod 311 at the opening, when the locking ring 33 and the limiting ring buckle 321 are sleeved, the locking ring 33 does not separate from the opening 351, and the limiting ring buckle 321 always remains relatively fixed with the locking sleeve 35, such as Figure 16 A, and combined Figure 14 As shown, by pulling the locking sleeve 35 back, the limiting ring buckle 321 can be pulled, and then the limiting position 341 of a force point at the proximal end of the adjustment line 322 and the limiting position 341 of another force point formed by the locking ring 33 are pulled by the limiting ring buckle 321 to adjust the adjustment area 111 at the distal end of the first side 11 of the coated stent 10. After the first side 11 of the coated stent 10 is adjusted to fit the blood vessel wall, as shown in FIG. Figure 16 As shown in FIG. 1B , the locking rod 311 is pulled back relative to the locking sleeve 35, so that the distal end of the locking rod 311 passes through the opening 351 and is withdrawn to the proximal side of the opening 351, so that the limiting ring buckle 321 is released from the locking rod 311; at this time, as shown in FIG. Figure 16As shown in C, by keeping the locking sleeve 35 relatively fixed with respect to the locking rod 311 and then retracting the locking sleeve 35 as a whole, the locking rod 311 and the locking sleeve 35 can be withdrawn from the body together.

[0087] When adjusting the first side 11 of the covered stent 10 in the stent system of this embodiment, a limiting position 341 is formed between the proximal end of the adjusting wire and the fixed end of the covered stent 10, and another limiting position 341 is formed at the locking ring 33. The stacking of the covered stent 10 can be dispersed. When adjusting the same degree of beak phenomenon, the serious stacking phenomenon caused by the adjustment of the covered stent 10 or the situation where the beak is not completely eliminated can be reduced, and the possibility of thrombosis caused by serious stacking of the covered stent 10 can be reduced. Moreover, by combining the locking sleeve 35 and the locking rod 311 to lock the limit loop 321 of the adjusting wire 322, a closed-loop locking structure is formed, which has higher reliability and stability. At the same time, a shorter section of the adjusting wire 322 (about equal to the axial length of the adjusting area) can be set, and then the proximal end of the adjusting wire 322 is fixed on the covered stent 10 without being withdrawn from the body. As Figure 16 shown in C, that is to say, only the locking rod 311 and the locking sleeve 35 need to be withdrawn from the body together, which reduces the withdrawal time of the adjusting structure 30 and is convenient to operate.

[0088] As Figure 14 shown, the covered stent 10 of this embodiment can also be provided with a restraint ring 34. The restraint ring 34 can be arranged between one end where the adjusting wire 322 is connected to the covered stent 10 and the locking ring 33. The adjusting wire 322 can be threaded through the restraint ring 34 to perform guiding and positioning through the restraint ring 34.

[0089] In some implementation manners, as Figure 14 shown, the locking rod 311, the locking ring 33, the locking sleeve 35 and the limit loop 321 can all be located outside the covered stent 10. In this way, the adjusting wire 322 is located outside the covered stent 10, which can avoid the risk of thrombosis formed by the adjusting wire 322 inside the covered stent 10. In other implementation manners, as Figure 17 shown, the locking ring 33, the locking rod 311, the locking sleeve 35 and the limit loop 321 can all be located inside the covered stent 10. In this way, the locking sleeve 35 and the locking rod 311 will not be squeezed between the covered stent 10 and the blood vessel, and the resistance of adjustment is smaller. As Figure 18As shown, in some other implementation manners, the locking sleeve 35 and the locking rod 311 can be disposed inside the covered stent 10, the locking ring 33 is disposed outside the covered stent 10, the proximal end of the adjusting wire 322 is connected to the outside of the covered stent 10, and the other end of the adjusting wire 322 bypasses the distal end of the covered stent 10 and then is connected to the locking rod 311. In this way, the locking sleeve 35 and the locking rod 311 are not squeezed between the covered stent 10 and the blood vessel, the resistance of adjustment is smaller, and after the locking sleeve 35 and the locking rod 311 are withdrawn, the adjusting wire 322 is fixed at the proximal end and mainly floats outside the covered stent 10, which can reduce the risk of thrombosis caused by the floating of the adjusting wire 322 on the inner surface of the covered stent 10. Among them, in Figure 18 the manner shown, the locking ring 33 can also be disposed inside the covered stent 10.

[0090] The above are only the preferred specific implementation manners of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A support system, characterized in that, The stent system includes a covered stent and an adjustment structure. The covered stent includes a first side and a second side in the circumferential direction. The adjustment structure includes a first adjustment member, a second adjustment member, and a locking ring. The locking ring is disposed at the distal end of the first side of the covered stent. The distal end of the second adjustment member includes a limit ring buckle, and the limit ring buckle is sleeved on the distal end portion of the first adjustment member to form a sleeve joint; one of the first adjustment member and the limit ring buckle passes through the locking ring, so that the locking ring limits the axial movement of the sleeve joint, and when the second adjustment member is pulled, the limit ring buckle cannot slide out of the first adjustment member.

2. The stent system according to claim 1, wherein The distal end of the first side includes an adjustment area, and the locking ring is disposed at the proximal end or the distal end of the adjustment area.

3. The bracket system according to claim 2, characterized in that, The covered stent includes a plurality of restraint rings axially spaced along the adjustment area, and the second adjustment member can sequentially pass through the plurality of restraint rings.

4. The stent system according to claim 2 or 3, characterized in that, The locking ring is disposed on the distal side of the adjustment area. The first adjustment member includes a locking rod, and the second adjustment member includes an adjustment wire. The limit ring buckle is disposed at the distal end of the adjustment wire. The locking rod can pass through the inside of the locking ring and extend towards the distal end, and the limit ring buckle extends towards the proximal end along the outside of the locking ring so that the sleeve joint is limited to the distal side of the locking ring. Or, the limit ring buckle axially passes through the inside of the locking ring from the proximal end to the distal end so that the limit ring buckle is disposed on the distal side of the locking ring, and the distal end of the locking rod passes through the limit ring buckle along the outside of the locking ring so that the sleeve joint is limited to the distal side of the locking ring.

5. The stent system according to claim 2 or 3, characterized in that, The locking ring is disposed on the proximal side of the adjustment area. The first adjustment member includes a locking rod, and the second adjustment member includes an adjustment wire. The limit ring buckle is disposed at the distal end of the adjustment wire. The limit ring buckle axially passes through the inside of the locking ring from the proximal end to the distal end, and a part of the adjustment wire passing through the locking ring is folded back so that the limit ring buckle is disposed outside the locking ring. The distal end of the locking rod sequentially passes through the limit ring buckle and the locking ring from the proximal end to the distal end. Or, the limit ring buckle axially straddles the locking ring from the proximal end to the distal end, and a part of the adjustment wire straddling the locking ring is folded back. The folded limit ring buckle enters the inside of the locking ring from the distal end of the locking ring and then exits from the proximal side of the locking ring. The distal end of the locking rod passes through the limit ring buckle exiting from the proximal side of the locking ring, and the locking rod does not pass through the inside of the locking ring.

6. The stent system according to claim 5, wherein, The distal end of the covered stent includes a semi-release portion and a semi-release structure. The semi-release structure is disposed on the semi-release portion. The semi-release structure includes a first restraint unit at the proximal most end, and the first restraint unit is disposed on the distal side of the locking ring.

7. The stent system according to claim 6, wherein, The covered stent includes a first imaging member, and the first imaging member is disposed between the first restraint unit and the locking ring.

8. The stent system according to claim 6, wherein The semi-release structure includes a plurality of restraint units axially spaced along the axial direction of the semi-release portion. The restraint unit includes a beam diameter line and a buckle assembly. The length of the beam diameter line is less than the circumference of the semi-release portion at its corresponding position in the natural state, so that when the locking rod axially passes through the buckle assembly in sequence, the restraint unit can radially compress the semi-release portion.

9. The stent system according to claim 2 or 3, characterized in that, The locking ring is arranged on the distal side of the adjustment area. The first adjustment member includes a locking rod, the second adjustment member includes an adjustment wire, the proximal end of the adjustment wire is connected to the proximal side of the adjustment area, and the limit ring is buckled on the distal end of the adjustment wire; the adjustment structure further includes a locking sleeve. An opening is provided on the distal side surface of the locking sleeve. The locking rod extends axially in the cavity of the locking sleeve. After the limit ring passes through the inside of the locking ring axially from the proximal end to the distal end, it can pass through the opening and be sleeved on the locking rod.

10. The stent system according to claim 1, wherein, The locking ring is arranged on the inner side or the outer side of the covered stent.

Images