Stent system

Abstract

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

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a stent system. Background Technology

[0002] This section provides only background information related to the present invention and is not necessarily prior art.

[0003] Aortic aneurysm and aortic dissection are serious diseases that threaten human life. If left untreated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia and hyperglycemia, the incidence of aortic aneurysm and aortic dissection is also increasing significantly.

[0004] Endovascular aortic stent grafting involves implanting a stent graft in the aorta to isolate vascular lesions outside the stent graft and restrict blood flow through the stent graft, thereby protecting the blood vessel. It has been widely used for lesions such as aneurysms and aortic dissections in the thoracic and abdominal aortas, with definite efficacy, minimal trauma, rapid recovery, and few complications.

[0005] Current aortic stents, when there is a bend in the anchorage position, for example, Figure 1 As shown, the anchoring zone of the stent 10' used for the thoracic aorta is located at the aortic arch 20'. After the stent 10' is released, the proximal lesser curvature side is prone to the "bird's beak" phenomenon, that is, the lesser curvature side 11' of the stent 10' forms an angle α with the aortic arch wall 21'. Postoperatively, type I endoleak is prone to occur. In the long term, if not treated in time, the pressure inside the aortic aneurysm may continue to increase, which may cause the aneurysm to rupture, or the aortic dissection rupture may not be isolated, and the false lumen may not be thrombotic. Summary of the Invention

[0006] The purpose of this invention is to at least alleviate the problem of "bird's beak" phenomenon easily appearing on the lesser bend after stent deployment, which leads to a high likelihood of "I"-shaped endoleak postoperatively. This objective is achieved through the following technical solution:

[0007] A first aspect of the present invention provides a support system comprising a covered support and an adjustment structure. The covered support includes a first side and a second side circumferentially. 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 support. The distal end of the second adjustment member includes a limiting ring buckle, and the limiting ring buckle is sleeved on the distal end of the first adjustment member to form a sleeve connection. One of the first adjustment member and the limiting ring buckle passes through the locking ring, such that the locking ring limits the axial movement of the sleeve connection. When the second adjustment member is pulled, the limiting ring buckle cannot slide out of the first adjustment 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 be aligned with the slightly curved side of the blood vessel. Correspondingly, the first side of the covered stent may not be fully attached to the blood vessel wall, meaning an angle (i.e., the "bird's beak" phenomenon) can easily form between the first side of the covered stent and the blood vessel wall. When the covered stent is released into the blood vessel, the limiting ring at the distal end of the second adjusting member engages with the distal end of the first adjusting member and is limited by a locking ring, which is located at the distal end of the first side of the covered stent. Thus, by pulling the adjusting member, the position of the distal end of the first side can be adjusted, allowing the first side of the covered stent to adhere to the blood vessel wall, thereby reducing or eliminating the angle between the first side and the blood vessel wall, lowering the possibility of endoleak in the covered stent, and improving the safety of the covered stent application.

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

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

[0011] In some embodiments of the present invention, the film-coated support includes a plurality of constraint rings spaced apart along the axial direction of the adjustment region, and the second adjustment member can pass through the plurality of constraint rings in sequence.

[0012] In some embodiments of the present invention, the locking ring is disposed on the distal side of the adjustment area, the first adjustment member includes a locking rod, the second adjustment member includes an adjustment line, and the limiting ring is fastened to the distal end of the adjustment line;

[0013] The locking lever can pass through the inside of the locking ring and extend toward the distal end, and the limiting ring buckle extends along the outside of the locking ring toward the proximal end so that the sleeve is limited to the distal end side of the locking ring.

[0014] Alternatively, the limiting ring passes through the inside of the locking ring axially from the proximal end to the distal end so that the limiting ring is positioned on the distal side of the locking ring, and the distal end of the locking rod passes through the limiting ring along the outside of the locking ring so that the sleeve is limited to the distal side of the locking ring.

[0015] In some embodiments of the present invention, the locking ring is disposed on the proximal side of the adjustment area, the first adjustment member includes a locking rod, the second adjustment member includes an adjustment line, and the limiting ring is fastened to the distal end of the adjustment line;

[0016] The limiting ring buckle passes through the inside of the locking ring from the proximal end to the distal end along the axial direction, and the adjustment line passing through the locking ring is folded back so that the limiting ring buckle is located on the outside of the locking ring. The distal end of the locking rod passes through the limiting ring buckle and the locking ring in sequence from the proximal end to the distal end.

[0017] Alternatively, the limiting ring buckle crosses the locking ring axially from the proximal end to the distal end, and the adjustment line that crosses the locking ring is folded back. After folding back, the limiting ring buckle passes through the inside of the locking ring, and the distal end of the locking rod passes through the limiting ring buckle.

[0018] In some embodiments of the present invention, the distal end of the covered stent includes a semi-release portion and a semi-release structure, the semi-release structure being disposed in the semi-release portion, the semi-release structure including a first restraint unit at the proximal end, the first restraint unit being disposed on the distal side of the locking ring.

[0019] In some embodiments of the present invention, the film-coated support includes a first developing element disposed between the first binding unit and the locking ring.

[0020] In some embodiments of the present invention, the semi-release structure includes a plurality of restraining units spaced apart along the axial direction of the semi-release portion. Each restraining unit includes a beam diameter line and a locking assembly. The length of the beam diameter line is less than the circumference of the semi-release portion in its natural state at its corresponding position, so that when the locking rod passes through the locking assembly sequentially along the axial direction, the restraining unit can radially compress the semi-release portion.

[0021] In some embodiments of the present invention, the locking ring is disposed on the distal side of the adjustment area, the first adjustment member includes a locking rod, the second adjustment member includes an adjustment line, the proximal end of the adjustment line is connected to the proximal side of the adjustment area, and the limiting ring is disposed on the distal end of the adjustment line; the adjustment structure further includes a locking sleeve, the distal side of the locking sleeve has an opening, the locking rod extends axially within the cavity of the locking sleeve, and the limiting ring passes axially from the proximal end to the distal end through the locking ring and then through the opening and is sleeved on the locking rod.

[0022] In some embodiments of the present invention, the locking ring is located on the inner or outer side of the film-covered bracket. Attached Figure Description

[0023] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0024] Figure 1 This is a schematic diagram of the structure in the prior art where the stent produces a "bird's beak" phenomenon at the aortic arch;

[0025] Figure 2 This is a schematic diagram illustrating the deployment of a covered stent into the aortic arch according to some embodiments of the present invention;

[0026] Figure 3 This is a simplified structural diagram of a support system according to some embodiments of the present invention;

[0027] Figure 4 for Figure 3 A magnified view of a portion of the image;

[0028] Figure 5 for Figure 3 The diagram shows the adjustment process of the support system.

[0029] Figure 6 This is a partially enlarged schematic diagram of the support system according to some embodiments of the present invention;

[0030] Figure 7 This is a simplified schematic diagram of the support system according to other embodiments of the present invention;

[0031] Figure 8 for Figure 7 Enlarged view of T1 section;

[0032] Figure 9 for Figure 7 An enlarged schematic diagram of another implementation of the T1 part;

[0033] Figure 10 This is a simplified schematic diagram of the covered stent system of some embodiments of the present invention in a semi-released state;

[0034] Figure 11 for Figure 10 A magnified view of a portion of the image;

[0035] Figure 12 for Figure 11 A magnified view of a portion of the image;

[0036] Figure 13 for Figure 10 The diagram shows the adjustment process of the support system.

[0037] Figure 14 This is a simplified structural diagram of a support system according to some embodiments of the present invention;

[0038] Figure 15 for Figure 14 Enlarged schematic diagram;

[0039] Figure 16 for Figure 14 The diagram shows the adjustment process of the support system.

[0040] Figure 17 This is a partial enlarged view of the support system according to some embodiments of the present invention;

[0041] Figure 18 This is a partial enlarged view of the support system according to some embodiments of the present invention.

[0042] The attached figures are labeled as follows:

[0043] 10. Covering support; 11. First side; 111. Adjustment area; 12. Second side; 13. Partial release section; 14. Partial release structure; 141. First restraint unit; 142. Restraint unit; 1421. Beam diameter line; 1422. Locking assembly; 143. First developing element;

[0044] 20. Aortic arch; 21. Aortic arch wall;

[0045] 30. Adjustment structure; 31. First adjusting component; 311. Locking rod; 32. Second adjusting component; 321. Limiting ring; 322. Adjusting line; 33. Locking ring; 34. Constraint ring; 341. Limiting position; 35. Locking sleeve; 351. Opening. Detailed Implementation

[0046] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0047] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

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

[0049] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations.

[0050] Example 1

[0051] like Figure 2 and Figure 3 As shown, according to an embodiment of the present invention, this embodiment proposes 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 along the circumferential direction. The first side 11 and the second side 12 can be two radially opposite sides. In this embodiment, the first side 11 and the second side 12 can each occupy 180° of the circumference of the covered stent 10. Figure 2 As shown, the covered stent 10 may include a supporting framework and a covering, with the covering over the supporting framework. The supporting framework provides support for the covering and may consist of multiple wave-shaped coils arranged sequentially along the axial direction. The lumen of the covering forms a channel for blood flow. When the covered stent 10 is deployed to a curved blood vessel, the first side 11 may correspond to the lesser curvature of the vessel, and the second side 12 to the greater curvature. Consequently, the first side 11 of the covered stent 10 may not be completely attached to the vessel wall, meaning that an angle (i.e., the bird's beak phenomenon) may easily form between the first side 11 of the covered stent 10 and the vessel wall.

[0052] Combination Figure 3 As shown, Figure 3The supporting frame is not shown; only the membrane boundary is shown. The adjustment structure 30 includes a first adjustment member 31, a second adjustment member 32, and a locking ring 33. The locking ring 33 is disposed on the first side 11 of the membrane support 10, and can be sewn to the membrane or the supporting frame with sutures. The distal end of the second adjustment member 32 includes a limiting ring 321, and the limiting ring 321 is sleeved on the distal end of the first adjustment member 31 to form a sleeve. One of the first adjustment member 31 and the limiting ring 321 passes through the locking ring 33, so that the locking ring 33 limits the axial movement of the sleeve, and when the second adjustment member 32 is pulled, the limiting ring 321 cannot slide out of the first adjustment member 31.

[0053] In existing technologies, if the covered stent does not fully adhere to the vessel wall after deployment, the minor bend of the covered stent cannot usually be adjusted directly. Instead, the entire delivery device must be retracted to move the proximal end of the covered stent. This method, on the one hand, cannot control the adjustment accuracy of the minor bend of the proximal end of the covered stent; on the other hand, since the sheath of the delivery device is inside the self-expanding covered stent and attached to the major bend of the covered stent, directly retracting the entire delivery device may cause displacement of the major bend. However, in the stent system of this embodiment, when the covered stent 10 is deployed into the blood vessel, the limiting ring 321 at the distal end of the second adjusting member 32 cooperates with the distal end of the first adjusting member 31 and is limited by the locking ring 33, which is located at the distal end of the first side 11 of the covered stent 10. Thus, by directly pulling the second adjusting member 32, the distal end of the first side 11 (corresponding to the minor bend after the covered stent 10 is deployed) can be moved proximally to reduce or eliminate the bird-beak phenomenon, i.e., the bird-beak phenomenon can be reduced. Figure 1 The distal end of the membrane-covered stent 10 is adjusted to such a position. Figure 2 In the medium state, the possibility of internal leakage of the covered stent 10 is reduced, the application safety of the covered stent 10 is improved, and the adjustment accuracy of the retraction dimension of the small bend side can be improved.

[0054] In this embodiment, "axial" generally refers to the length direction of the medical device during delivery, "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and "circumferential" generally refers to the extension direction of the outline of the medical device's cross-section perpendicular to its "axial" direction. Based on this principle, the "axial," "radial," and "circumferential" directions of any component of the medical device are defined. In the field of interventional medical devices, for delivery devices used to implant medical devices into the human or animal body, the end closer to the operator is generally 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 support 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 being inside the conveyor, and when the covered stent 10 is located inside the conveyor to form a stent system, the end closer to the operator is the proximal end of the covered stent 10, and the end farther away from the operator is the distal end of the covered stent 10.

[0055] It is understood that the phrase "one of the first adjusting member 31 and the limiting ring 321 passes through the locking ring 33" means that one of the distal end of the first adjusting member 31 and the limiting ring 321 is inserted into the locking ring 33, while the other is located outside the locking ring 33. Thus, the locking ring 33 is sandwiched between the first adjusting member 31 and the second adjusting member 32, forming a stop. When the distal end of the first adjusting member 31 and the limiting ring 321 are in a sleeved state, pulling the proximal end of the second adjusting member 32 will not cause the sleeved portion to move axially relative to the locking ring 33. In other words, in this embodiment, the sleeved portion is formed at the distal end of the locking ring 33. When the second adjusting member 32 is pulled, the limiting ring 321 cannot slide out of the first adjusting member 31. That is, when the second adjusting member 32 is pulled proximally, the limiting ring 321 and the distal end of the first adjusting member 31 remain sleeved. In other embodiments, the sleeve may be formed at the proximal end of the locking ring 33, and when the second adjusting member 32 is pulled so that the sleeve is pulled toward the distal end, the limiting ring 321 will not slide out of the first adjusting member 31, which is not limited here.

[0056] Furthermore, in this embodiment, the distal end of the first adjusting member 31 can be released from the limiting ring 321 by pulling the first adjusting member 31, so as to remove the first adjusting member 31 and the second adjusting member 32.

[0057] This embodiment of the stent system may include a delivery device, and the covered stent 10 can be implanted into a blood vessel for use via the delivery device. This embodiment mainly uses the implantation of the covered stent 10 into the aortic arch 20 as an example for illustration. Figure 2As shown. The delivery device is used to release the covered stent 10, that is, to implant the covered stent 10 into the aortic arch 20. The delivery device includes a delivery handle, a sheath, a push rod, and a sheath core, which are sequentially connected 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 apart from the distal end of the sheath core, so that the spaced portion together forms a loading space for the covered stent 10 within the sheath. The distal end of the delivery handle is connected to the proximal end of the sheath, and the proximal end of the sheath core passes through the delivery handle. The push rod includes at least two axial channels, a second adjusting member 32 extending along one of the axial channels, and a first adjusting member 31 extending along the other axial channel. Before the covered stent 10 is released, the covered stent 10 is loaded into the loading space. By operating the handle to retract the sheath, the sheath moves axially relative to the sheath core, allowing the covered stent 10 to be released from the loading space into the aortic arch 20.

[0058] like Figure 5 As shown in Figure A, after the covered stent 10 is released into the blood vessel via the delivery device, the axial movement is limited by the locking ring 33 at the connection between the limiting ring 321 and the distal end of the first adjusting member 31. Furthermore, when the second adjusting member 32 is pulled, the limiting ring 321 cannot slide out of the first adjusting member 31. Thus, by pulling the proximal end of the second adjusting member 32, the first side 11 of the covered stent 10 can move proximally, alleviating the bird's beak phenomenon between the covered stent 10 and the blood vessel. After adjustment, as... Figure 5 As shown in Figure B, by pulling the proximal end of the first adjusting member 31, the distal end of the first adjusting member 31 is disengaged from the limiting ring 321. At this time, the engagement formed between the limiting ring 321 and the distal end 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. Figure 5 As shown in C, the first adjustment member 31 and the second adjustment member 32 can be detached from the covered stent 10 for easy removal from the body.

[0059] For ease of description, the first side 11 of the covered stent 10 is defined to have an axially extending adjustment region 111. This adjustment region 111 can be the area where the first side 11 of the covered stent 10 can be pulled under the action of the second adjustment member 32. The adjustment region 111 is greater than the axial length of the area of ​​the first side 11 where a bird's beak phenomenon may occur when the covered stent 10 is released. The adjustment region 111 can be within a range of up to 100 mm extending from the farthest end of the covered stent 10 to the proximal end of the covered stent 10, specifically within a range of 35 mm to 65 mm from the farthest end of the covered stent 10.

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

[0061] In this embodiment, by placing the locking ring 33 at the distal end of the adjustment region 111, the second adjusting member 32 can be pulled to directly act on the first side 11 at the distal end of the adjustment region 111, thereby adjusting the first side 11 of the adjustment region 111. This allows the covering corresponding to the first side 11 of the adjustment region 111 to adhere to the aortic arch wall 21 on the lesser curve side of the aortic arch 20 as the second adjusting member 32 is retracted. Adjusting the first side 11 of the covered stent 10 by acting on the distal end of the adjustment region 111 provides a better adjustment effect than acting only on the proximal end of the adjustment region 111, which is beneficial to improving the adhesion between the first side 11 of the covered stent 10 and the aortic arch wall 21.

[0062] In some embodiments, refer to Figures 3-4 As shown, the film-coated support 10 may be provided with a constraint ring 34 on the adjustment area 111. One or more constraint rings 34 may be provided. When multiple constraint rings 34 are provided, the multiple constraint rings 34 may be spaced apart along the axial direction of the adjustment area 111, and the second adjustment member 32 may pass through all the constraint rings 34 in sequence.

[0063] The constraint ring 34 can be connected to the film on the film-covered support 10 or to the support frame. The constraint ring 34 and the locking ring 33 can have the same structure. The locking ring 33 can be spaced apart at the proximal ends of multiple constraint rings 34, or at the distal ends of multiple constraint rings 34, or between two adjacent constraint rings 34.

[0064] The distal end of the second adjusting member 32 can be inserted into the constraint ring 34. The constraint ring 34 can limit and guide the second adjusting member 32. When the second adjusting member 32 is pulled, the constraint ring 34 can make the force direction of the adjusting area 111 adhere to the inner or outer wall of the first side 11 of the film-coated bracket 10 along the axial direction. The direction of the second adjusting member 32 is more certain, and the first side 11 can be adjusted more specifically, which improves the release and adjustment accuracy of the film-coated bracket 10 and makes bird beak elimination more reliable.

[0065] In one embodiment, the first adjusting member 31 includes a locking rod 311, and the second adjusting member 32 includes an adjusting line 322, with a limiting ring 321 disposed at the distal end of the adjusting line 322. The adjusting line can be a single or multiple strands of soft thread, such as medical sutures or implantable metal threads. The limiting ring 321 can be a loop structure formed by knotting the adjusting line 322. The locking rod 311 can be a flexible rod with a certain strength; specifically, a nickel-titanium wire rod can be selected, and whether the nickel-titanium wire rod is hollow or solid is not limited.

[0066] In one implementation method, such as Figure 3 As shown, the locking lever 311 can pass through the inside of the locking ring 33 and extend towards the distal end, while the limiting ring 321 extends along the outside of the locking ring 33 towards the proximal end so that the engagement is limited to the distal side of the locking ring 33. In another implementation, as... Figure 6 As shown, the limiting ring 321 can also pass through the inside of the locking ring 33 along the axial direction from the proximal end to the distal end so that the limiting ring 321 is located on the distal end side of the locking ring 33, and the distal end of the locking rod 311 passes through the limiting ring 321 along the outside of the locking ring 33 so that the socket is limited to the distal end side of the locking ring 33.

[0067] The distal end of the locking rod 311 extends to the distal side of the locking ring 33. The limiting ring buckle 321 is located on the distal side of the locking ring 33 and is sleeved with the locking rod 311 to form a sleeve. The proximal end of the locking rod 311 and the proximal end of the adjustment line 322 connected to the limiting ring buckle 321 can both be located outside the body to facilitate the adjustment line 322 and the locking rod 311 for adjustment.

[0068] Using an adjustment line as the second adjustment element 32, due to the flexibility of the adjustment line 322, when operating the proximal end of the adjustment line 322, only the distal end of the adjustment line 322 can be pulled, but no pushing action can be applied. Therefore, when operating the adjustment line 322, the limiting ring 321 will not disengage from the locking rod 311, avoiding the possibility that the film-coated bracket 10 may not be adjusted to the correct position due to misoperation. The locking rod 311 has a certain strength, and when the locking rod 311 and the limiting ring 321 formed by the adjustment line are engaged, it is less likely that the locking rod 311 and the limiting ring 321 will become entangled and unable to be released, improving the ease of releasing the locking rod 311 from the adjustment line 322.

[0069] It should be noted that the locking ring 33 and the restraint ring 34 of the stent system can both be disposed 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 restraint ring 34 of the stent system can also both be disposed on the inner side of the covered stent 10. Specifically, the support frame of the covered stent 10 can be disposed on the inner side of the covering, and the locking ring 33 can be disposed on the support frame. Correspondingly, the first adjusting member 31 and the second adjusting member 32 are also disposed on the inner side of the covered stent 10. In this way, the first adjusting member 31 and the second adjusting member 32 will not be subjected to compression between the covered stent 10 and the vessel wall (which can be understood with reference to the aortic arch wall 21), which helps to reduce adjustment resistance.

[0070] In this embodiment, the support system may be equipped with a developing element to facilitate positioning the release position of the coated support 10.

[0071] Example 2

[0072] like Figures 7 to 9 As shown, this embodiment provides a support system, which differs from the first embodiment in that the locking ring 33 is located on the proximal side of the adjustment area 111.

[0073] In some embodiments, similar to Embodiment 1, the first adjusting member 31 may also include a locking lever 311, and the second adjusting member 32 may also include an adjusting line 322, with a limiting ring 321 disposed at the distal end of the adjusting line 322. Specifically, in one implementation, such as Figure 7 and Figure 8 As shown, the limiting ring 321 passes axially from the proximal end to the distal end through the inner ring of the locking ring 33, and the portion of the adjusting line 322 passing through the locking ring 33 is folded back so that the limiting ring 321 is located on the outside of the locking ring 33. The distal end of the locking rod 311 passes sequentially from the proximal end to the distal end through the limiting ring 321 and the locking ring 33. In other embodiments, such as Figure 9 As shown, the limiting ring 321 crosses the locking ring 33 axially from the proximal end to the distal end, and the adjustment line 322 that crosses the locking ring 33 is folded back. After folding back, the limiting ring 321 enters the locking ring from the distal end of the locking ring 33 and then exits from the proximal end of the locking ring. The distal end of the locking rod 311 passes through the limiting ring 321 that exits from the proximal end of the locking ring, and the locking rod does not pass through the locking ring 33.

[0074] Optionally, in the support system of this embodiment, a constraint ring 34 can also be provided in the adjustment area 111. The constraint ring 34 can be located on the far end side of the locking ring 33. Specifically, one or more can be provided. The far end of the adjustment line 322, i.e. the limiting ring 321, from the proximal end to the far end, can first pass through the locking ring 33 from inside the locking ring 33, and then pass through the constraint ring 34 from inside the constraint ring 34. After that, it folds back from the outside of the farthest constraint ring 34 and passes through the outside of the constraint ring 34 to the locking ring 33, and then is sleeved with the far end of the locking rod 311 at the locking ring 33 to form a sleeve.

[0075] It should be noted that the limiting ring 321 can also pass through the outside of the locking ring 33 along the axial direction from the near end to the far end, and after passing the outside of the constraint ring 34, it crosses the farthest constraint ring 34 and folds back from the inside of the constraint ring 34, and finally fits onto the far end of the locking rod 311 to form a sleeve.

[0076] like Figure 7 As shown, since the second adjusting member 32 bypasses the farthest constraint ring 34, when the second adjusting member 32 is pulled, the covered bracket 10 forms a force point at the farthest constraint ring 34 and the locking ring 33. The farthest constraint ring 34 and the locking ring 33 can act on the two force points of the covered bracket 10 simultaneously, thereby adjusting the area between the two force points. This provides a better adjustment effect for the covered bracket 10, especially in cases where the bird beak phenomenon is more severe. That is, the farthest constraint ring 34 can be used as a limiting position 341 of a force point, which is different from the other constraint rings 34. When there is only one limiting position 341, the covered stent has only one stress point. When the bird beak phenomenon is severe, it may lead to severe stacking of the covered stent or incomplete elimination of the bird beak. However, this embodiment has two limiting positions 341, and the stacking of the covered stent 10 can be dispersed within the adjustment area. When adjusting the same degree of bird beak phenomenon, it can reduce severe stacking caused by the adjustment of the covered stent 10 or reduce incomplete elimination of the bird beak, and reduce the possibility of thrombosis caused by severe stacking of the covered stent 10. At the same time, the distal end of the locking rod 311 can be located at the proximal end of the adjustment area 111, so that the locking rod 311 can avoid the bird beak adjustment section at the distal end of the covered stent 10, which can reduce the impact of the rigidity of the locking rod 311 on the bird beak adjustment effect of the covered stent 10.

[0077] Alternatively, in a configuration where a constraint ring 34 is provided and a locking ring 33 is located near the end of the adjustment region 111, such 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, with the semi-release structure 14 disposed on the semi-release portion 13. For ease of description, the restraining unit at the nearest end of the semi-release structure 14 is defined as the first restraining unit 141, which is disposed on the distal side of the locking ring 33.

[0078] The partial release portion 13 may be a portion of the distal end of the covered stent 10. When the covered stent 10 is pushed out of the loading space of the delivery system, the covered stent 10 is released into the body. At this time, the partial release portion 13 can be in a partially released state under the action of the partial release structure 14, such as... Figure 10 As shown. In the partially released state, since the covered stent 10 is not yet tightly attached to the vessel wall, the position of the covered stent 10 can be adjusted. After the covered stent 10 is adjusted into place, the restraint on the partially released portion 13 by the partially released structure 14 can be further released, allowing the partially released portion 13 to be completely released. At this time, the covered stent 10 can be interference-anchored in the vessel. By setting the partially released portion 13 and the partially released 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 partially released portion 13 is released, the adhesion of the first side 11 and the lesser curvature side of the covered stent 10 to the vessel wall can be further adjusted by the second adjusting member 32 to ensure that the covered stent 10 adheres tightly to the vessel wall.

[0079] In some implementations, a first developing element 143 can be provided between the first binding unit 141 and the locking ring 33. The first developing element 143 can be provided on the support frame or the coating. The first developing element 143 can serve as a marker to prevent the locking lever 311 from retracting too much and disengaging from the limiting ring 321, causing the distal end of the locking lever 311 to disengage from the limiting ring 321. This results in a situation where, after the partial release portion 13 is released, the distal end of the first side 11 of the coating support 10 cannot be further adjusted by pulling the adjustment line 322.

[0080] Optionally, in one implementation, continue to refer to Figure 10 , Figure 11 and combined Figure 13 As shown, the semi-release structure 14 includes a plurality of restraining units 142 spaced apart along the axial direction of the semi-release portion 13. Each restraining unit 142 includes a binding diameter line 1421 and a locking assembly 1422. The length of the binding diameter line 1421 is less than the circumference of the semi-release portion 13 at its corresponding position in its natural state, so that when the locking rod 311 passes through the locking assembly 1422 in sequence along the axial direction, the restraining unit 142 can radially compress the semi-release portion 13.

[0081] In one implementation, one end of the beam diameter line 1421 can be a fixed end connected to the coating support 10, and the other end of the beam diameter line 1421 is a movable end. Both the fixed end and the movable end are provided with locking assemblies 1422. The distal end of the locking rod 311 can pass through the two locking assemblies 1422 and the constraint ring 34 at the fixed end and the movable end in sequence. Since the constraint ring 34 is relatively fixed to the coating support 10, the locking rod 311, the constraint ring 34, and the locking assembly 1422 cooperate to fix the movable end and the fixed end of the beam diameter line 1421 relatively in the circumferential direction of the coating support 10. This allows the beam diameter line 1421 to compress the semi-released portion 13 radially when the locking rod 311 is not disengaged from the locking assembly 1422 and the constraint ring 34, thus making the semi-released portion 13 in a semi-released state. Figure 12 As shown, in another implementation, the beam diameter line 1421 can also have movable ends at both ends, and each end is provided with a locking assembly 1422. The distal end of the locking rod 311 can pass through the locking assemblies 1422 and the constraint ring 34 at both ends of the beam diameter line 1421. Since the constraint ring 34 is relatively fixed to the film support 10, the locking rod 311, the constraint ring 34 and the locking assembly 1422 can cooperate to fix the beam diameter line 1421 and the film support 10 relatively in the circumferential direction. This allows the beam diameter line 1421 to compress the semi-released portion 13 in the radial direction when the locking rod 311 is not disengaged from the locking assembly 1422 and the constraint ring 34, so that the semi-released portion is in a semi-released state.

[0082] like Figure 10 As shown, during the release of the covered stent 10, when the covered stent 10 is released from the sheath, the distal half-release portion 13 of the covered stent 10 is still in a half-release state, and its diameter can be approximately 40% to 80% of its fully released diameter; as Figure 13 As shown in Figure A, after the film-coated support 10 is accurately positioned, the locking rod 311 is pulled, causing it to disengage from the constraint ring 34 and the locking assembly. At this point, the beam diameter line 1421 is released, and the partially released portion 13 is no longer restrained by the restraint unit 142, allowing it to fully unfold. The locking rod 311 is pulled until the partially released portion 13 is fully unfolded. (Refer to...) Figure 13 As shown in B, C, and D, after the stent is released and adheres to the vessel wall, the traction adjustment line 322 can be freely adjusted to the first side 11 of the distal end of the covered stent 10 until it is perfectly aligned with the blood vessel. Then, the locking rod 311 can be removed, and the adjustment line 322 can be withdrawn. In this embodiment, the stent system can simultaneously function as a traction adjustment "beak" after partial release and complete release of the covered stent 10. It can also perform beak adjustment on an adjustment area 111 at the distal end of the covered stent 10, preventing the covered stent from stacking due to single-point adjustment. This ensures that the stacking caused by withdrawal is evenly distributed within the area, thereby reducing the impact of stacking.

[0083] Example 3

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

[0085] Specifically, refer to Figure 14 , Figure 15 and Figure 16 As shown, the locking ring 33 of the lumen support in this embodiment is located 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 serve as a limiting position 341 for a force point of the adjustment area 111 (the limiting position of the other force point is the position of the locking ring 33). The limiting ring 321 is located at the distal end of the adjustment line 322 and passes through the locking ring 33 along the axial direction from the proximal end to the distal end. The adjustment structure 30 also includes a locking sleeve 35. The distal side of the locking sleeve 35 has an opening 351. The locking rod 311 extends axially within the cavity of the locking sleeve 35 and passes through the limiting ring 321 at the opening 351.

[0086] At the opening 351, the locking rod 311 and the limiting ring 321 are fitted together to form a connection. The limiting ring 321 passes through the locking ring 33, allowing the locking ring 33 to restrict the axial movement of the connection. In this embodiment, since the limiting ring 321 passes through the locking ring from the proximal end to the distal end along the axial direction and then passes through the opening 351 of the locking sleeve 35 and is fitted onto the locking rod, that is, the limiting ring is passed through the locking rod 311 at the opening. When the locking ring 33 and the limiting ring 321 are fitted together, the locking ring 33 does not detach from the opening 351, so the limiting ring 321 always remains relatively fixed to the locking sleeve 35. Figure 16 A, and combined Figure 14 As shown, by pulling the locking cannula 35 back, the limiting ring 321 can be pulled, and then the limiting ring 321 pulls the limiting position 341 of one force point near the proximal end of the adjustment line 322 and the limiting position 341 of another force point formed at the locking ring 33, thereby achieving adjustment within the adjustment area 111 of the distal end of the first side 11 of the covered stent 10. After the first side 11 of the covered stent 10 is adjusted to fit against the vessel wall, as... Figure 16 As shown in Figure B, pulling the locking rod 311 back relative to the locking sleeve 35 causes the distal end of the locking rod 311 to retract through the opening 351 to the proximal end of the opening 351, thereby disengaging the limiting ring 321 from the locking rod 311; at this time, as Figure 16As shown in C, by keeping the locking sleeve 35 and the locking rod 311 relatively fixed, and then retracting the locking sleeve 35 as a whole, the locking rod 311 and the locking sleeve 35 can be removed from the body together.

[0087] In this embodiment, when adjusting the first side 11 of the covered stent 10, the proximal end of the adjustment line and the fixed end of the covered stent 10 form a limiting position 341, and the locking ring 33 forms another limiting position 341. This disperses the stacking of the covered stent 10. When adjusting the same degree of bird-beak phenomenon, it can reduce severe stacking caused by the adjustment of the covered stent 10 or reduce the possibility of incomplete bird-beak elimination, and can also reduce the possibility of thrombosis caused by severe stacking of the covered stent 10. Furthermore, by combining the locking sleeve 35 and the locking rod 311 to lock the limiting ring 321 of the adjustment line 322, a closed-loop locking structure is formed, resulting in higher reliability and stability. Simultaneously, the adjustment line 322 can be set to a shorter section (approximately equal to the axial length of the adjustment area), and then the proximal end of the adjustment line 322 is fixed to the covered stent 10 without needing to be removed from the body. Figure 16 As shown in C, this means that the locking rod 311 and the locking sleeve 35 can be removed from the body together, which reduces the removal time of the adjustment structure 30 and makes the operation convenient.

[0088] like Figure 14 As shown, the film-coated support 10 in this embodiment can also be provided with a constraint ring 34. The constraint ring 34 can be provided between the end of the adjustment line 322 connected to the film-coated support 10 and the locking ring 33. The adjustment line 322 can be passed through the constraint ring 34 to guide and position it.

[0089] In some implementations, such as Figure 14 As shown, the locking rod 311, locking ring 33, locking sleeve 35, and limiting ring 321 can all be located on the outside of the covered stent 10. In this configuration, the adjustment line 322 is located on the outside of the covered stent 10, which avoids the risk of thrombosis forming within the covered stent 10. In other implementations, such as... Figure 17 As shown, the locking ring 33, locking rod 311, locking sleeve 35, and limiting ring 321 can all be located inside the covered stent 10. In this configuration, the locking sleeve 35 and locking rod 311 will not be compressed between the covered stent 10 and the blood vessel, resulting in less resistance to adjustment. Figure 18As shown, in some implementations, the locking cannula 35 and locking rod 311 can be positioned inside the covered stent 10, the locking ring 33 can be positioned outside the covered stent 10, the proximal end of the adjustment line 322 can be connected to the outside of the covered stent 10, and the other end of the adjustment line 322 can be connected to the locking rod 311 after passing around the distal end of the covered stent 10. In this way, the locking cannula 35 and locking rod 311 will not be squeezed between the covered stent 10 and the blood vessel, the adjustment resistance is smaller, and after the locking cannula 35 and locking rod 311 are withdrawn, the adjustment line 322 is fixed proximally and mainly floats outside the covered stent 10, which can reduce the risk of thrombosis caused by the adjustment line 322 floating on the inner surface of the covered stent 10. Figure 18 In the manner shown, the locking ring 33 can also be disposed on the inner side of the film-covered bracket 10.

[0090] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the 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 circumferentially. The adjustment structure includes a first adjustment member, a second adjustment member, and a locking ring. The locking ring is located at the distal end of the first side of the covered stent. The distal end of the second adjustment member includes a limiting ring, and the limiting ring is sleeved on the distal end of the first adjustment member to form a connection. One of the first adjustment member and the limiting ring passes through the locking ring, so that the locking ring limits the axial movement of the connection. When the second adjustment member is pulled, the limiting ring cannot slide out of the first adjustment member. By pulling the second adjustment member, the position of the distal end of the first side can be adjusted so that the first side of the covered stent is in contact with the blood vessel wall.

2. The support system according to claim 1, characterized in that, The distal end of the first side includes an adjustment region, and the locking ring is disposed at the proximal or distal end of the adjustment region.

3. The support system according to claim 2, characterized in that, The film-coated support includes a plurality of constraint rings spaced apart along the axial direction of the adjustment area, and the second adjustment member can pass through the plurality of constraint rings in sequence.

4. The support system according to claim 2 or 3, characterized in that, The locking ring is located on the far side of the adjustment area. The first adjustment member includes a locking rod, the second adjustment member includes an adjustment line, and the limiting ring is fastened to the far end of the adjustment line. The locking lever can pass through the inside of the locking ring and extend toward the distal end, and the limiting ring buckle extends along the outside of the locking ring toward the proximal end so that the sleeve is limited to the distal end side of the locking ring. Alternatively, the limiting ring passes through the inside of the locking ring axially from the proximal end to the distal end so that the limiting ring is positioned on the distal side of the locking ring, and the distal end of the locking rod passes through the limiting ring along the outside of the locking ring so that the sleeve is limited to the distal side of the locking ring.

5. The support system according to claim 2 or 3, characterized in that, The locking ring is located on the proximal side of the adjustment area, the first adjustment member includes a locking rod, the second adjustment member includes an adjustment line, and the limiting ring is fastened to the distal end of the adjustment line; The limiting ring buckle passes through the inside of the locking ring from the proximal end to the distal end along the axial direction, and the adjustment line passing through the locking ring is folded back so that the limiting ring buckle is located on the outside of the locking ring. The distal end of the locking rod passes through the limiting ring buckle and the locking ring in sequence from the proximal end to the distal end. Alternatively, the limiting ring buckle crosses the locking ring axially from the proximal end to the distal end, and the adjustment line that crosses the locking ring is folded back. After folding back, the limiting ring buckle enters the locking ring from the distal end and then exits from the proximal end of the locking ring. The distal end of the locking rod passes through the limiting ring buckle that exits from the proximal end of the locking ring, and the locking rod does not pass through the locking ring.

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

7. The support system according to claim 6, characterized in that, The film-coated support includes a first developing element, which is disposed between the first binding unit and the locking ring.

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

9. The support system according to claim 2 or 3, characterized in that, The locking ring is located on the distal side of the adjustment area. The first adjustment component includes a locking rod, and the second adjustment component includes an adjustment line. The proximal end of the adjustment line is connected to the proximal side of the adjustment area, and the limiting ring is fastened to the distal end of the adjustment line. The adjustment structure also includes a locking sleeve. The distal side of the locking sleeve has an opening. The locking rod extends axially within the cavity of the locking sleeve. The limiting ring passes axially from the proximal end to the distal end through the locking ring and then through the opening and is fitted onto the locking rod.

10. The support system according to claim 1, characterized in that, The locking ring is located on the inner or outer side of the covered support.

Images