Intravascular stent and stent system

Abstract

The utility model provides an intravascular stent, a stent system and a knotting method of the intravascular stent. The intravascular stent comprises a plurality of supporting pieces of an annular waveform structure, and the multiple supporting pieces are arranged at intervals in the axial direction of the intravascular stent; the connecting pieces are of annular wave-shaped structures, and the connecting pieces are connected and fixed to every two axially adjacent supporting pieces, so that the intravascular stent forms a grid structure with grid units; the functional area is a local peripheral wall of the intravascular stent, and the size of a grid unit of the functional area is larger than that of grid units of other areas of the intravascular stent. By means of the intravascular stent, the true cavity can be better expanded, the target blood vessel can recover the correct flow direction, interference of the intravascular stent to the visceral artery can be reduced, and blood flow can flow to the visceral artery more smoothly and unobstructed.

Description

[0001] This application is based on the application with CN application number 2023214330073 and application date 2023-6-6, and claims its priority. The disclosed content of the CN application is hereby introduced into this application as a whole. Technical Field

[0002] The present application relates to the field of medical devices, and in particular to a vascular stent and a stent system. Background Art

[0003] Peripheral vascular disease is a common manifestation of systemic atherosclerosis, and its incidence has increased significantly in recent years. Common diseases include arteriosclerotic occlusive disease, arteriovenous thrombosis, aneurysm and aortic dissection (aortic dissection refers to the formation of true and false lumens in the artery due to the gradual peeling and expansion of the intima due to local tearing of the intima and the strong impact of blood. It can induce systemic arteriosclerosis and cardiovascular morbidity and mortality. After peripheral vascular lesions occur, the blood lumen becomes narrow, and the blood flow injected into the lower limbs or internal organs decreases, causing insufficient blood supply to the lower limbs or internal organs, which may lead to serious consequences.

[0004] Endovascular treatment is one of the main methods for treating peripheral vascular diseases. Endovascular treatment includes EVAR (endovascular aneurysm repair, EVAR) or TEVAR (thoracic endovascular aortic repair, TEVAR). Endovascular treatment refers to the use of corresponding interventional devices to radially compress the stent graft and then deliver it to the location of the vascular lesion and then release it, so that the stent graft can return to the predetermined shape. The implanted stent graft can support the diseased vascular segment, allowing blood to flow through the stent graft to restore the correct flow direction of the blood vessel, maintain smooth blood flow in the vascular lumen, and thus achieve the treatment effect. For Stanford type B aortic dissection, the intimal rupture is located below the aortic isthmus, extending to the descending aorta or extending to the abdominal aorta. Surgical reconstruction is usually performed with a proximal aortic repair-based plan (such as TEVAR technology), which can only close the proximal tear. Usually, complete false lumen thrombosis can only be observed near the proximal stent graft, while part of the false lumen in the thoracic aorta or abdominal aorta still has not been thrombotic. Endovascular treatment provides a PETTICOAT technology to solve the problem of partial false lumen in the thoracic or abdominal aorta that has not been thrombosed. That is, on the basis of the proximal covered stent, a long bare metal stent is connected to the distal end of the covered stent, thereby promoting thrombusization of the distal false lumen of the thoracic and abdominal aorta and achieving a good true lumen remodeling effect.

[0005] However, for certain lesions involving visceral arteries (such as the left and right renal arteries, mesenteric arteries and celiac artery), how to better preserve the blood flow of the visceral arteries remains the focus and difficulty of current endovascular treatment. Summary of the invention

[0006] For certain lesions involving visceral arteries, in order to better ensure the blood flow of the visceral arteries, the present application provides a vascular stent, a stent system and a vascular stent knotting method.

[0007] The present application provides a vascular stent, which includes a proximal opening, a distal opening and an axially extending inner cavity, and the vascular stent is a self-expanding stent; a plurality of support members in an annular corrugated structure, wherein the plurality of support members are arranged at intervals along the axial direction of the vascular stent; and a plurality of connecting members in an annular corrugated structure, wherein the connecting members are connected and fixed to two axially adjacent support members so that the vascular stent forms a grid structure with grid units; a functional area, wherein the functional area is a local peripheral wall of the vascular stent, and the grid unit size of the functional area is larger than the grid unit size of other areas of the vascular stent.

[0008] In a possible implementation manner, the connector or part of the connector is made of a degradable material.

[0009] In a possible implementation manner, the support member or part of the support member is made of a degradable material.

[0010] In a possible implementation, the support member or part of the support member is made of a superelastic shape memory material.

[0011] In a possible implementation manner, at least part of the connecting element is made of polymer fabric, and at least part of the connecting element is made of superelastic shape memory material.

[0012] In a possible implementation manner, the connecting element is made of multiple strands of superelastic material or multiple strands of biocompatible polymer fabric by twisting or weaving together.

[0013] In a possible implementation manner, the connecting element is made of at least one strand of superelastic material and at least one strand of biocompatible polymer fabric by twisting or weaving together.

[0014] In a possible embodiment, the support member includes a plurality of support rods connected in sequence at an angle, and two circumferentially adjacent angles are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; of the two axially adjacent support members, the support crest of the support member close to the proximal end and the support trough of the support member close to the distal end are axially opposite.

[0015] In a possible embodiment, the connecting member includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively a first connecting portion and a second connecting portion; in two axially adjacent support members, the first connecting portion is fixed to a support wave trough of the support member near the proximal end, and the second connecting portion is fixed to a support wave peak of the support member near the distal end.

[0016] In a possible implementation manner, the vascular stent further includes a functional area, which is a local peripheral wall of the vascular stent, and a grid unit size of the functional area is larger than a grid unit size of other areas of the vascular stent.

[0017] In a possible implementation manner, the functional area is located between the proximal opening of the vascular stent and the distal opening of the vascular stent.

[0018] In a possible implementation manner, at least three support members are provided in the axial region where the functional area is located.

[0019] In a possible implementation manner, the functional area is 1 / 2 to 2 / 3 of the circumferential length of the vascular stent, or the circumferential length of the functional area is the circumferential length of the vascular stent.

[0020] In a possible embodiment, the support member includes a plurality of support rods connected in sequence at an angle, and two circumferentially adjacent angles are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; the distance between two circumferentially adjacent support troughs of the support member on the functional area is D1, and the distance between two circumferentially adjacent support troughs of the support member in other areas except the functional area is D2, and D1 is greater than D2.

[0021] In a possible implementation, for two axially adjacent support members on the functional area, the support wave crest of the support member located at the proximal end of the vascular stent and the support wave crest of the support member located at the distal end of the vascular stent are axially opposite.

[0022] In a possible implementation manner, the support wave crests of the support members on the functional area and the support wave crests of the support members in other areas on the proximal side of the functional area are axially opposite.

[0023] In a possible implementation manner, two adjacent support wave crests of the support member on the functional area in the circumferential direction are separated by at least one support wave crest of the support member in another area on the proximal side thereof.

[0024] In a possible implementation manner, the support troughs of the support element on the functional area and the support troughs of the support element in other areas on the distal side of the functional area are axially opposite.

[0025] In a possible implementation manner, two adjacent support wave valleys of the support member on the functional area in the circumferential direction are separated by at least one support wave valley of the support member in another area on the distal side thereof.

[0026] In a possible embodiment, the grid unit includes a first grid and a second grid, the first grid and the second grid are located between the support member on at least one end of the functional area in the axial direction and the support members of other nearby areas, and the size of the first grid is smaller than the size of the second grid.

[0027] In a possible implementation manner, the first grids and the second grids are alternately arranged along the circumferential direction.

[0028] In a possible embodiment, the connecting member between the support member on at least one end of the functional area in the axial direction and the support member of other nearby areas is a discontinuous annular connecting member, which is formed by a plurality of arc segments, each of which includes two connecting segments connected at an angle, and the plurality of arc segments are arranged at intervals along the circumferential direction.

[0029] In a possible embodiment, the non-continuous annular connecting member is formed between the support member near the proximal end of the functional area and the support members in other nearby areas, the angle of the arc segment is fixed to the support crest of the support member near the proximal end of the functional area, and the two ends of the arc segment in the length direction are respectively fixed to the two support troughs in other nearby areas, thereby forming the first grid, and the second grid is formed by two circumferentially adjacent first grids and two axially adjacent support members.

[0030] In a possible embodiment, the non-continuous annular connecting member is formed between the support member near the far end of the functional area and the support members in other nearby areas, the angle of the arc segment is fixed to the support crest of the support member near the proximal end of the functional area, and the two ends of the arc segment in the length direction are respectively fixed to the two support troughs in other nearby areas, thereby forming the first grid, and the second grid is formed by two circumferentially adjacent first grids and two axially adjacent support members.

[0031] In a possible embodiment, the support member includes a plurality of support rods connected in sequence at an angle, and two adjacent angles in the circumferential direction are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; the axial length of the support rod of the support member on the functional area is L1, and the axial length of the support rod of the support member in other areas of the vascular stent is L2, and L1 is greater than L2.

[0032] In a possible embodiment, the connector includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively the first connecting portion and the second connecting portion; the connector includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively the first connecting portion and the second connecting portion; the distance between two circumferentially adjacent second connecting portions of the connector on the functional area is d1, and the distance between two circumferentially adjacent second connecting portions of the connector in other areas of the vascular stent is d2, and d1 is greater than d2.

[0033] In a possible embodiment, the connector includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively a first connecting portion and a second connecting portion; the axial length of the connecting segment of the connector on the functional area is l1, and the axial length of the connecting segment of the connector in other areas of the vascular stent is l2, and l1 is greater than l2.

[0034] In a possible implementation manner, the wire diameter of the support member on the functional area is greater than the wire diameter of the support member in other areas of the vascular stent.

[0035] In a possible implementation manner, the wire diameter of the connector on the functional area is greater than the wire diameter of the connector in other areas of the vascular stent.

[0036] In a possible implementation manner, part of the support members are open-loop wave-shaped structures having open-loop openings, and the projections of the open-loop openings of the support members in the axial direction of the vascular stent overlap, thereby forming a window structure.

[0037] In a possible implementation manner, the circumferential length of the fenestration structure is 1 / 2 to 2 / 3 of the circumferential length of the vascular stent.

[0038] In a possible implementation manner, the axial length of the window structure is 1-3 times the circumferential length of the window structure.

[0039] In a possible embodiment, at least one connecting bone is further included, and the connecting bone is used to connect and fix at least two of the open-ring corrugated support members adjacent to each other in the axial direction.

[0040] In a possible embodiment, the support member includes a plurality of support rods connected in sequence at an angle, and two circumferentially adjacent angles are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; the connecting member includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively a first connecting portion and a second connecting portion; of the two axially adjacent support members, the first connecting portion of the connecting member is knotted and fixed to the support trough of the support member near the proximal end, and the second connecting portion of the connecting member is knotted and fixed to the support crest of the support member near the distal end, and the knot formed by the connecting member being fixed to the support member by knotting is located on the outside of the vascular stent.

[0041] In a possible implementation manner, the vascular stent may further include a plurality of groups of wrapping films, wherein the plurality of groups of wrapping films are respectively used to wrap at least a portion of the connecting member and / or at least a portion of the supporting member.

[0042] In a possible implementation manner, the vascular stent may further include a plurality of groups of wrapping films, wherein the plurality of groups of wrapping films are respectively used to wrap at least a portion of the connecting member and / or at least a portion of the supporting member on the functional area.

[0043] In a possible implementation manner, the wrapping film includes a first film layer, and the first film layer is fixed to the inner side of the connecting member and / or the supporting member.

[0044] In a possible implementation, the wrapping film includes a first film layer and a second film layer, wherein the first film layer is fixed to the inner side of the connecting member and / or the supporting member, and the second film layer is fixed to the outer side of the connecting member and / or the supporting member.

[0045] In a possible embodiment, the shape of the wrapping film on each of the connecting members changes with the shape of the connecting member, and the wrapping film does not cover the opening of the grid unit; and / or, the shape of the wrapping film on each of the supporting members changes with the shape of the supporting member, and the wrapping film does not cover the opening of the grid unit.

[0046] The present application also provides a stent system, including the above-mentioned vascular stent and a coated stent, wherein the coated stent includes a proximal opening, a distal opening and an axially extending lumen, the coated stent is a self-expanding stent, and the coated stent includes a main body coating and a supporting frame fixed to the main body coating.

[0047] The present application further provides a method for tying a vascular stent, comprising the vascular stent, wherein the support member comprises a plurality of support rods connected in sequence at an angle, two adjacent angles in the circumferential direction are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough;

[0048] The connecting member comprises a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two adjacent angles in the circumferential direction are respectively a first connecting portion and a second connecting portion;

[0049] The method for knotting the connecting member to be fixed to the adjacent supporting trough on the proximal side thereof comprises at least the following steps:

[0050] Step 1, one end of the connector in the length direction goes from the distal side of the support trough around the outer side of the support trough and penetrates from the proximal side of the support trough to the inner side of the vascular stent; then, the end of the connector that penetrates to the inner side goes around the inner side of the support trough and around the part of the connector located at the distal side of the support trough to pass out to the outer side of the vascular stent;

[0051] Step 2. After step 1 is completed, one of the ends of the connector located on the outside penetrates from the distal side of the support trough to the inner side of the vascular stent and passes around the inner side surface of the support trough, so that the connector forms a half knot around the support trough located on the outside of the vascular stent, and a gap is formed between the distal side of the support trough and the proximal side of the half knot; then, one of the ends of the connector penetrates from the proximal side of the support trough and passes around the outer side surface of the support trough, and penetrates from the gap to the inner side of the vascular stent to form a knot, thereby knotting and fixing the connector to the support member, and the knot is located on the outside of the vascular stent.

[0052] In a possible implementation manner, the method for knotting the connecting member to be fixed to the adjacent supporting wave crests at the distal end thereof comprises at least the following stages:

[0053] In stage 1, one end of the connector in the length direction passes through the outer side of the support crest from the proximal side of the support crest and penetrates into the inner side of the vascular stent from the distal side of the support crest; subsequently, one end of the connector that penetrates into the inner side passes through the inner side of the support crest and passes through the part of the connector located on the proximal side of the support crest and penetrates into the inner side of the vascular stent;

[0054] Stage 2. After stage 1, one end of the connector located on the inner side passes around the inner side of the support wave crest and passes through the distal side of the support wave crest to the outside of the vascular stent, so that the connector forms a half knot around the support wave crest located on the outside of the vascular stent, and a gap is formed between the proximal side of the support wave crest and the distal side of the half knot; then, one end of the connector passes around the outer side of the support wave crest and passes through the gap to the inner side of the vascular stent to form a knot, thereby knotting and fixing the connector to the support member, and the knot is located on the outside of the vascular stent.

[0055] The present application has at least one of the following beneficial effects: the design of the functional area can help improve the flexibility of the vascular stent, help reduce the need for flexibility to ensure diseased blood vessels, better expand the true lumen, restore the correct flow direction of the target blood vessel, help reduce the problem of the vascular stent being bent and bulged due to bending in the complex vascular anatomical structure, and can help reduce the interference of the vascular stent on the visceral arteries, so that the blood flow can flow more smoothly and unimpeded to the visceral arteries. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 is a schematic structural diagram of a support system according to a first embodiment;

[0057] Figure 2 is a schematic diagram of an exemplary structure of a vascular stent;

[0058] Figure 3 is a schematic structural diagram of another possible implementation of a vascular stent;

[0059] Figure 4 for Figure 3 A planar unfolded view of the vascular stent shown;

[0060] Figure 5 This is a schematic diagram of a structure in which a vascular stent may be provided with a window structure;

[0061] Figure 6 for Figure 5 A planar unfolded view of the vascular stent shown;

[0062] Figure 7 A schematic diagram of a structure in which at least part of the connectors on the vascular stent may be provided with a wrapping film;

[0063] Figure 8 for Figure 7 A planar unfolded view of the vascular stent shown;

[0064] Fig. 9 A schematic diagram of a structure in which at least part of the connecting members and at least part of the supporting members on the vascular stent are provided with a wrapping film;

[0065] Fig.10 for Fig. 9 A planar unfolded view of the vascular stent shown;

[0066] Fig.11 This is a schematic diagram of a scenario in which a stent system provided by an embodiment of the present application is used to reconstruct the thoracic aorta and the abdominal aorta;

[0067] Figure 12a-12f It is a schematic diagram of a partial structure in which some technical connectors are fixed to a support member by knotting, and the knot formed by the knotting is located on the inner side of the vascular stent;

[0068] Figure 13a-13g This is a schematic diagram of the partial structure in which the connecting piece of the second embodiment is fixed to the supporting piece by knotting, and the knot formed by the knotting is located on the outside of the blood vessel stent.

[0069] Description of the accompanying drawings: 10, vascular stent; 11, support member; 111, support rod; 112, support crest; 113, support trough; 12, connector; 121, connecting section; 122, first connecting portion; 123, second connecting portion; 124, arc segment; 125, knot; 126, end; 127, half knot; 128, gap; 13, grid unit; 14, functional area; 141, first grid; 142, second grid Grid; 15. fenestration structure; 16. connecting bone; 17. wrapping membrane; 20. covered stent; 201. main body covering; 202. supporting skeleton; 30. brachiocephalic artery; 40. left common carotid artery; 50. left clavicular artery; 60. left renal artery; 70. right renal artery; 80. mesenteric artery; 90. celiac artery; 100. aneurysm cavity; 101. true cavity; 102. false cavity; 103. proximal rupture; 104. distal rupture. DETAILED DESCRIPTION

[0070] The technical solution of the present application will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

[0071] It should be noted in advance that for the field of interventional medical devices, the proximal end refers to the end of the stent that is close to the heart after the stent is used for interventional treatment, and the distal end refers to the end of the stent that is away from the heart after the stent is used for interventional treatment. The direction of the central axis of rotation of objects such as cylinders and tubes is axial, and the direction perpendicular to the axial direction is radial. The circumferential direction refers to the "circumferential direction", that is, the direction around the axis of the cylinder, tube, etc. (perpendicular to the axis and perpendicular to the cross-sectional radius). "Circumferential", "axial" and "radial" together constitute the three orthogonal directions of the cylindrical coordinates. The circumferential length refers to the extension length of the structure or element along the circumferential direction of the cylinder, tube, etc. The axial length refers to the extension length of the structure or element along the axial direction of the cylinder, tube, etc. In order to distinguish it from the axial length of the support rod itself, the length it occupies in the axial direction of the main stent is referred to as the length along the axial direction of the main stent. This description is only for the convenience of expression and does not constitute a limitation on this application. The following structure refers to the structure of the vascular stent system after expansion.

[0072] For certain lesions involving visceral arteries, in order to better protect the blood flow of visceral arteries, the embodiments of the present application provide a vascular stent and stent system, which can be applied to blood vessels to implement intraluminal treatment to isolate the diseased area in the lumen or isolate the dissection rupture. For example, a vascular stent can be used to isolate the arterial dissection rupture or aneurysm in the lumen of the blood vessel. It can be understood that the blood vessel can be the aortic arch, thoracic aorta or abdominal aorta. Those of ordinary skill in the art should know that the use of blood vessels for illustration is only used as an example and is not a limitation of the present application. The scheme of the present application is applicable to various human or animal cavities, such as the lumen of the digestive tract.

[0073] See also Figure 1 , Figure 1 This is a schematic diagram of the structure of the stent system of the first embodiment of the present application. The first embodiment of the present application provides a stent system, the stent system includes a coated stent 20 and a vascular stent 10, and the vascular stent 10 is connected to the distal end of the coated stent 20. The distal end of the coated stent 20 and the proximal end of the vascular stent 10 have an axially overlapping length. The coated stent 20 includes a proximal opening, a distal opening, and an axially extending lumen, and the coated stent 20 is a self-expanding stent. The coated stent 20 includes a main body coating 201 and a support frame 202 fixed to the main body coating 201. The support frame 202 is one or more of a braided stent, a corrugated annular frame, a cutting stent, etc., which are not limited here.

[0074] See also Figure 2 , Figure 2: is an exemplary structural schematic diagram of a vascular stent 10. The vascular stent 10 includes a proximal opening, a distal opening, and an axially extending inner cavity, and the vascular stent 10 is a self-expanding stent. The vascular stent 10 includes a plurality of support members 11 and a plurality of connectors 12, and both the support members 11 and the connectors 12 can be annular wave structures. The plurality of support members 11 are arranged at intervals along the axial direction of the vascular stent 10, and the connector 12 is connected and fixed to two axially adjacent support members 11, so that the vascular stent 10 forms a proximal opening, a distal opening, and an axially extending inner cavity.

[0075] In some embodiments, the support member 11 is a closed-loop wave-shaped structure, and the support member 11 includes a plurality of support rods 111 connected in sequence at an angle. The two adjacent angles in the circumferential direction are the support crest 112 and the support trough 113, respectively, and the support crest 112 and the support trough 113 are arranged alternately along the circumference of the support member 11. The support crest 112 is closer to the proximal end of the vascular stent 10 than the support trough 113. In two axially adjacent support members 11, the support crest 112 of the support member 11 close to the proximal end and the support trough 113 of the support member 11 close to the distal end are opposite in the axial direction.

[0076] In some embodiments, the connector 12 is a closed-loop corrugated structure, and the connector 12 includes a plurality of connecting segments 121 connected at an angle, and the plurality of connecting segments 121 are sequentially connected at an angle. Two adjacent angles in the circumferential direction are respectively a first connecting portion 122 and a second connecting portion 123, and the first connecting portion 122 and the second connecting portion 123 are alternately arranged along the circumference of the connector 12. It can be understood that the angle can be a chamfer, that is, the angle can be arc-shaped.

[0077] In two axially adjacent support members 11, the first connection portion 122 of the connector 12 is fixed to the support trough 113 of the support member 11 near the proximal end by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suturing, and the second connection portion 123 of the connector 12 is fixed to the support crest 112 of the support member 11 near the distal end by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suturing. The angle arrangement position between the support member 11 and the connector 12 enables the vascular stent 10 to form a grid structure with grid units 13.

[0078] In some embodiments, the grid cells 13 are rhombus-shaped.

[0079] In some embodiments, the first connection portion 122 is closer to the proximal end of the vascular stent 10 than the second connection portion 123 .

[0080] In some embodiments, for the same support member 11, part of the support crests 112 and / or part of the support troughs 113 are not connected to the axially adjacent support members 11 through the connecting member 12. In other words, for the same support member 11, part of the support crests 112 and / or part of the support troughs 113 are suspended.

[0081] In some embodiments, the support member 11 is made of a superelastic shape memory material.

[0082] Generally, a general stent may need to be expanded by balloon expansion technology, which may block blood flow and cause adverse complications. At the same time, due to blood flow blocking, blood flow impacts the stent in one direction, which may also cause inaccurate positioning of the stent, resulting in displacement of the stent and poor stent implantation effect. By using a superelastic shape memory material for the support member 11, the vascular stent 10 can be expanded without the need for balloon expansion technology, and the vascular stent 10 can be self-expanded to fit the inner wall of the blood vessel.

[0083] In some embodiments, the connecting member 12 is made of a superelastic shape memory material. The supporting skeleton 202 is made of a superelastic shape memory material.

[0084] The superelastic shape memory material enables the support member 11 and the connector 12 to contract or expand radially, that is, the support member 11, the connector 12 and the support frame 202 have radial expansion capability, can be compressed under the action of external force and self-expand or mechanically expand to recover to the initial shape and maintain the initial shape after the external force is removed, so that after implantation into the blood vessel, the radial support force can be applied to the blood vessel wall. The shape memory material includes but is not limited to at least one of nickel-titanium alloy, nitinol alloy, nickel-titanium superelastic alloy, cobalt-chromium-nickel-molybdenum alloy, copper-based shape memory alloy, iron-based shape memory alloy, etc.

[0085] In some embodiments, the wire diameter of the connector 12 is smaller than that of the support 11. This is beneficial to ensure the radial support force of the stent 10 and improve the flexibility of the stent 10. The stent 10 has a smaller elongation before and after release and is easier to position.

[0086] In some embodiments, the connector 12 is formed by twisting or weaving together multiple strands of superelastic material, which is beneficial to making the vascular stent 10 have a uniform and reasonable radial support force and good axial support performance, which is beneficial to avoid the stent from stacking and shortening; it is also beneficial to avoid the problem of new interlayer rupture caused by excessive radial support force, and it is also beneficial to ensure that the vascular stent 10 has good bending flexibility and can adapt to various forms of aortic anatomical structures.

[0087] In some embodiments, the connector 12 is a biocompatible polymer fabric in the form of a line, a sheet, or a plurality of lines wound together.

[0088] In some embodiments, the support member 11 is a biocompatible polymer fabric in the form of a line, a sheet, or a plurality of lines wound together.

[0089] In some embodiments, the main body covering 201 is a biocompatible polymer fabric.

[0090] Biocompatible polymer fabrics include, but are not limited to, woven or knitted polyesters, such as polyethylene terephthalate, polyethylene glycol terephthalate, polylactide, polyglycolide and at least one of the copolymers; fluorinated polymers, such as polytetrafluoroethylene, expanded or electrospun polytetrafluoroethylene and polyvinylidene fluoride; polysiloxanes, such as polydimethylsiloxane; polyurethanes, such as polyether polyurethanes, polyurethane ureas, polyether polyurethane ureas, polyurethanes containing carbonate bonds, wound nickel titanium and polyurethanes containing siloxane segments; silicone, ultra-high molecular weight polyethylene, fluorinated ethylene propylene copolymers or other suitable materials. For example, the connector 12 can be made of at least one of PET, PP, PTFE or e-PTFE materials. For example, the main body coating 201 is made of at least one of PET, PP, PTFE or e-PTFE materials.

[0091] The vascular stent 10 may be bent and bulged due to bending in a complex vascular anatomical structure. The bulged vascular stent 10 may hinder the correct flow of blood, may cause unpredictable changes in hemodynamics, and affect the blood supply of the visceral arteries. The connector 12 is designed in a biocompatible polymer fabric manner, which can help improve the flexibility of the vascular stent 10, help reduce the need for flexibility to ensure diseased blood vessels, better expand the true lumen 101, and restore the correct flow direction of the target blood vessel, which can help reduce the problem of the vascular stent 10 being bent and bulged due to bending in a complex vascular anatomical structure, and can help reduce the interference of the vascular stent 10 on the visceral arteries, which can help blood flow to the visceral arteries more smoothly and unimpeded.

[0092] In some embodiments, the connector 12 is made of at least one strand of superelastic material and at least one strand of biocompatible polymer fabric by twisting or weaving together.

[0093] In some embodiments, the connector 12 is made of a degradable material, for example, the degradable material may be at least one of magnesium, iron, zinc, a magnesium-based alloy, an iron-based alloy, a zinc-based alloy, polylactic acid or polycarbonate.

[0094] In some embodiments, in the vascular stent 10, the local connector 12 is made of polymer fabric, and at least part of the connector 12 is made of superelastic shape memory material.

[0095] In some embodiments, see Figure 3 and Figure 4 , Figure 3 is a schematic structural diagram of another possible implementation of the vascular stent 10, Figure 4 for Figure 3 The planar expansion diagram of the vascular stent 10 is shown. The vascular stent 10 also includes a functional area 14, which is a local peripheral wall of the vascular stent 10, and the functional area 14 is used to face the visceral artery. The functional area 14 can be located between the proximal opening and the distal opening. At least three support members 11 are provided in the axial area where the functional area 14 is located.

[0096] In some embodiments, the functional area 14 is used to face at least one of the visceral arteries, such as at least one of the left and right renal arteries 70, the mesenteric artery 80, and the celiac artery 90 (eg, Figure 13a-13g The visceral arteries are, for example, one or more of the brachiocephalic artery 30, the left common carotid artery 40, and the left clavicular artery 50 (e.g. Figure 13a-13g visceral arteries shown).

[0097] In some embodiments, the functional area 14 is used to face all visceral arteries, such as the left and right renal arteries 70, the mesenteric artery 80 and the celiac artery 90. The visceral arteries are, for example, one or more of the brachiocephalic artery 30, the left common carotid artery 40 and the left clavicular artery 50.

[0098] In some embodiments, the functional area 14 is 1 / 2 to 2 / 3 of the circumferential length of the vascular stent 10 , or the circumferential length of the functional area 14 is the circumferential length of the vascular stent 10 .

[0099] The distance between two adjacent support troughs 113 in the circumferential direction of the support member 11 on the functional area 14 is D1, and the distance between two adjacent support troughs 113 in the circumferential direction of the support member 11 in other areas is D2, and D1 can be greater than D2, so that the size of the diamond grid unit 13 in the functional area 14 is greater than the size of the diamond grid unit 13 in other areas. The larger size of the diamond grid unit 13 in the functional area 14 is conducive to reducing the interference of the vascular stent 10 on the visceral artery blood flow. It can be understood that the other area refers to the area of ​​the vascular stent 10 excluding the area where the functional area 14 is located.

[0100] In some embodiments, for two axially adjacent support members 11 on the functional area 14, the support crest 112 of the support member 11 located at the proximal end of the vascular stent 10 and the support crest 112 of the support member 11 located at the distal end of the vascular stent 10 are axially opposite.

[0101] In some embodiments, the support crests 112 of the support member 11 on the functional area 14 and the support crests 112 of the support member 11 in other areas on the proximal side of the functional area 14 are axially opposite. Two circumferentially adjacent support crests 112 of the support member 11 on the functional area 14 are separated by at least one support crest 112 of the support member 11 in other areas on its proximal side. It can be understood that "the support crests 112 of the support member 11 in other areas on its proximal side" is modified by "the support crests 11 of the support member 11 in other areas on its proximal side", that is, at least one of the "support crests 112" is separated.

[0102] In some embodiments, the support trough 113 of the support member 11 on the functional area 14 and the support trough 113 of the support member 11 in other areas on the distal side of the functional area 14 are axially opposite. Two circumferentially adjacent support troughs 113 of the support member 11 on the functional area 14 are separated by at least one support trough 113 of the support member 11 in other areas on its distal side. It can be understood that "the support trough 113 of the support member 11 in other areas on its proximal side" modifies the "support trough 113" by "the support member 11 in other areas on its proximal side", that is, at least one of the "support trough 113" is separated.

[0103] In some embodiments, the grid unit 13 includes a first grid 141 and a second grid 142, and the first grid 141 and the second grid 142 are located between the support member 11 on at least one end of the functional area 14 in the axial direction and the support member 11 in other nearby areas, and the first grid 141 and the second grid 142 are alternately arranged along the circumferential direction, and the size of the first grid 141 is smaller than the size of the second grid 142.

[0104] In some embodiments, the connecting member 12 between the supporting member 11 at least at one end of the functional area 14 in the axial direction and the supporting member 11 in other adjacent areas is a discontinuous annular connecting member 12. In other words, the multiple connecting segments 121 on the discontinuous connecting member 12 are not sequentially connected at an angle along the circumferential direction. The discontinuous annular connecting member 12 is formed by multiple arc segments 124, and the arc segment 124 is formed by two connecting segments 121 connected at an angle. The multiple arc segments 124 are arranged at intervals along the circumferential direction.

[0105] For the non-continuous annular connector 12 between the support member 11 near the proximal end of the functional area 14 and the support members 11 in other adjacent areas, the angle of the arc segment 124 can be fixed to the support crest 112 of the support member 11 near the proximal end of the functional area 14 by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suture, and the two ends of the arc segment 124 in the length direction can be fixed to two adjacent support troughs 113 by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suture, so as to form a first grid 141. The two first grids 141 adjacent to each other in the circumferential direction can be enclosed with the two support members 11 adjacent to each other in the axial direction to form a second grid 142. It can be understood that the "two axially adjacent support members 11" in "two circumferentially adjacent first grids 141 can be enclosed with two axially adjacent support members 11 to form a second grid 142" refers to "the support member 11 close to the proximal end of the functional area 14 and the support members 11 in other nearby areas".

[0106] For the non-continuous annular connector 12 between the support member 11 near the far end of the functional area 14 and the support members 11 in other adjacent areas, the angle of the arc segment 124 is fixed to the support trough 113 of the support member 11 near the far end of the functional area 14 by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suture, and the two ends of the arc segment 124 in the length direction are respectively fixed to two adjacent support crests 112 by one or more methods of winding, knotting, welding, hot pressing, bonding, mechanical fixation (such as steel sleeve) and suture suture, so as to form a first grid 141. The two first grids 141 adjacent to each other in the circumferential direction and the two support members 11 adjacent to each other in the axial direction enclose to form a second grid 142. It can be understood that the "two axially adjacent support members 11" in "two circumferentially adjacent first grids 141 can be enclosed with two axially adjacent support members 11 to form a second grid 142" refers to "the support member 11 close to the proximal end of the functional area 14 and the support members 11 in other nearby areas".

[0107] In some embodiments, the axial length of the support rod 111 of the support member 11 on the functional area 14 is L1, and the axial length of the support rod 111 of the support member 11 in other areas of the vascular stent 10 is L2, and L1 is greater than L2, so that the size of the diamond grid unit 13 on the functional area 14 is further greater than the size of the diamond grid unit 13 in other areas of the vascular stent 10. The larger size of the diamond grid unit 13 on the functional area 14 is conducive to reducing the interference of the vascular stent 10 on the visceral artery blood flow.

[0108] In some embodiments, the distance between two adjacent second connection parts 123 of the connector 12 on the functional area 14 in the circumferential direction is d1, and the distance between two adjacent second connection parts 123 of the connector 12 in other areas of the vascular stent 10 in the circumferential direction is d2, and d1 is greater than d2, so that the size of the diamond grid unit 13 on the functional area 14 is greater than the size of the diamond grid unit 13 in other areas of the vascular stent 10. The larger size of the diamond grid unit 13 on the functional area 14 is conducive to further reducing the interference of the vascular stent 10 on the visceral artery blood flow.

[0109] In some embodiments, the axial length of the connecting segment 121 of the connecting member 12 on the functional area 14 is l1, and the axial length of the connecting segment 121 of the connecting member 12 in other areas of the vascular stent 10 is l2, and l1 is greater than l2, so that the size of the diamond grid unit 13 on the functional area 14 is further greater than the size of the diamond grid unit 13 in other areas of the vascular stent 10. The larger size of the diamond grid unit 13 on the functional area 14 is conducive to further reducing the interference of the vascular stent 10 on the visceral artery blood flow.

[0110] In some embodiments, the wire diameter of the support member 11 on the functional area 14 is greater than the wire diameter of the support member 11 in other areas of the vascular stent 10 .

[0111] In some embodiments, the wire diameter of the connector 12 on the functional area 14 is greater than the wire diameter of the connector 12 in other areas of the vascular stent 10 .

[0112] In some embodiments, at least part of the connectors 12 on the functional area 14 are made of polymer fabric, and the connectors 12 outside the functional area 14 are made of elastic or superelastic shape memory material.

[0113] In some embodiments, at least part of the connectors 12 and / or the support members 11 on the functional area 14 are made of degradable materials, and the connectors 12 and / or the support members 11 outside the functional area 14 are made of non-degradable materials.

[0114] This kind of partially degradable design is conducive to ensuring that the diseased blood vessel initially has the radial support force and axial support performance required by the vascular stent 10, better expanding the true lumen 101, and ensuring that the target blood vessel restores the correct flow direction. After the partial degradation of the vascular stent 10 in the later stage, it can help reduce the interference of the functional area 14 on the visceral artery, which is conducive to the blood flow to the visceral artery more smoothly and unimpeded.

[0115] See also Figure 5 and Figure 6 , Figure 5 The schematic diagram of the structure of the vascular stent 10 with the window structure 15 is shown in FIG. Figure 6 for Figure 5The planar unfolded view of the vascular stent 10 is shown. In some embodiments, part of the support members 11 is an open-loop wave structure with an open-loop opening, and the open-loop openings of multiple support members 11 are all facing the same direction. In other words, the projections of the open-loop openings of multiple support members 11 in the axial direction of the vascular stent 10 overlap, thereby forming a window structure 15. The circumferential length of the window structure 15 is 1 / 2 to 2 / 3 of the circumferential length of the vascular stent 10. The axial length of the window structure 15 is 1-3 times the circumferential length of the window structure 15.

[0116] In some embodiments, the fenestration structure 15 is used to face at least one visceral artery or all visceral arteries. The visceral arteries are, for example, one or more of the left and right renal arteries 70, the mesenteric artery 80, and the celiac artery 90. The visceral arteries are, for example, one or more of the brachiocephalic artery 30, the left common carotid artery 40, and the left clavicular artery 50.

[0117] In some embodiments, the vascular stent 10 further includes at least one connecting bone 16 , and the connecting bone 16 is used to connect at least two axially adjacent open-ring-shaped support members 11 , thereby facilitating maintaining the shape of the fenestration structure 15 .

[0118] There are at least two connecting bones 16 , and the two connecting bones 16 are respectively located on two sides of the fenestration structure 15 in the circumferential direction.

[0119] In some embodiments, the material of the connecting bone 16 is the same as the material of the supporting member 11 or the connecting member 12. For example, the connecting bone 16 can be a biocompatible polymer fabric, or a superelastic nickel-titanium wire, etc.

[0120] In some embodiments, the connecting bone 16 is formed by twisting or braiding a single strand or multiple strands of superelastic material together.

[0121] In some embodiments, the connecting bones 16 are formed by twisting or weaving multiple strands of superelastic material together, so that the vascular stent 10 has better flexibility.

[0122] In some embodiments, in two axially adjacent support members 11, the first connection portion 122 of the connector 12 is knotted and fixed to the support trough 113 of the support member 11 near the proximal end, and the second connection portion 123 of the connector 12 is knotted and fixed to the support peak 112 of the support member 11 near the distal end.

[0123] In some embodiments, among two axially adjacent support members 11, the first connection portion 122 of the connector 12 is knotted and fixed to the support trough 113 of the support member 11 near the proximal end, the second connection portion 123 of the connector 12 is knotted and fixed to the support crest 112 of the support member 11 near the distal end, and the knot 125 formed by the connector 12 being knotted and fixed to the support member 11 is located on the outside of the vascular stent 10.

[0124] The two ends of the connector 12 in the length direction may be fixed to the support member 11 by tying a knot. It can be inferred that the two ends of the connector 12 in the length direction may have protrusions, which may irritate the vascular wall of the target blood vessel. Alternatively, the knot 125 formed by the connector 12 being fixed to the support member 11 by tying a knot is located on the inner side of the vascular stent 10, so that the connecting section 121 on the connector 12 has the problem of being concave toward the inner cavity of the vascular stent 10.

[0125] In order to solve at least one of the above two problems, in some embodiments, the vascular stent 10 further includes a plurality of groups of wrapping films 17. Figure 7 and Figure 8 As shown, Figure 7 It is a schematic diagram of a structure in which at least part of the connecting member 12 on the vascular stent 10 is provided with a wrapping film 17. Figure 8 for Figure 7 The plan view of the vascular stent 10 is shown.

[0126] In some embodiments, a plurality of sets of wrapping films 17 are respectively used to cover at least a portion of the connector 12 .

[0127] In some embodiments, a plurality of sets of wrapping films 17 are respectively used to wrap a plurality of connectors 12 on the functional area 14 .

[0128] In some embodiments, the wrapping film 17 includes a first film layer (not shown in the figure), and the first film layer is fixed to the inner side of the connecting member 12 .

[0129] In some embodiments, the wrapping film 17 includes a first film layer (not shown in the figure) and a second film layer (not shown in the figure). The first film layer is fixed to the inner side of the connector 12, and the second film layer is fixed to the outer side of the connector 12. For example, the first film layer can be fixed to the inner side of the connector 12 by heat pressing, and the second film layer can be fixed to the outer side of the connector 12 by heat pressing; or the first film layer can be fixed to the inner side of the connector 12 by adhesive bonding, and the second film layer can be fixed to the outer side of the connector 12 by adhesive bonding. In other words, the connecting section 121 on the connector 12 is fixed between the first film layer and the second film layer.

[0130] The shape of the wrapping film 17 on each connector 12 changes with the shape of the connector 12, that is, the wrapping film 17 does not cover the opening of the grid unit 13, so as to keep the grid unit 13 of the vascular stent 10 unobstructed. For example, if the connector 12 is a closed-loop wavy structure, the wrapping film 17 can also be a closed-loop wavy structure; if the connector 12 is a discontinuous ring structure, the wrapping film 17 can also be a discontinuous ring structure.

[0131] The design of the wrapping film 17 can help wrap the ends 126 at both ends of the connector 12 in the length direction, reducing the risk of the vascular stent 10 irritating the vascular wall of the target blood vessel. The design of the wrapping film 17 can also help improve the smoothness of the inner circumferential wall of the vascular stent 10, help reduce the friction of the inner circumferential wall of the vascular stent 10, and help reduce the friction between the interventional device and the inner circumferential wall of the vascular stent 10 during the secondary intervention, so that the head end of the interventional device can move more smoothly in the inner cavity of the vascular stent 10, reduce the displacement of the vascular stent 10 or improve the success rate of the intervention of the interventional device, which is conducive to improving the success rate of the secondary intervention or the later intervention.

[0132] In some embodiments, multiple groups of wrapping films 17 are used to cover all the connectors 12 on the vascular stent 10 respectively.

[0133] In some embodiments, a plurality of sets of wrapping films 17 are used to respectively cover at least a portion of the connecting member 12 and at least a portion of the supporting member 11 .

[0134] In some embodiments, see Fig. 9 and Fig.10 , Fig. 9 The schematic diagram is a structural diagram of at least a portion of the connecting member 12 and at least a portion of the supporting member 11 on the vascular stent 10 provided with a wrapping film 17. Fig.10 for Fig. 9 The planar unfolded view of the vascular stent 10 is shown. Multiple groups of wrapping films 17 are used to respectively cover multiple connectors 12 and multiple support members 11 on the functional area 14. The connecting section 121 on the connector 12 is fixed between the first layer of film and the second layer of film. The support rod 111 on the support member 11 is fixed between the first layer of film and the second layer of film. The shape of the wrapping film 17 on each connector 12 changes with the shape of the connector 12, and the shape of the wrapping film 17 on each support member 11 changes with the shape of the support member 11, that is, the wrapping film 17 does not cover the opening of the grid unit 13, so as to keep the grid unit 13 of the vascular stent 10 unobstructed.

[0135] In some embodiments, multiple groups of wrapping films 17 can also be used to respectively wrap multiple connectors 12 and multiple support members 11 on the functional area 14, and also wrap multiple connectors 12 and / or multiple support members 11 in other areas on the distal side of the functional area 14.

[0136] In some embodiments, multiple groups of wrapping films 17 are used to respectively wrap multiple connectors 12 and multiple support members 11 on the functional area 14, and also wrap multiple connectors 12 and / or multiple support members 11 in other areas on the proximal side of the functional area 14.

[0137] In some embodiments, multiple groups of wrapping films 17 are used to respectively cover all the connectors 12 and all the supporting members 11 on the vascular stent 10 .

[0138] For possible application scenarios of the bracket system, please refer to Fig.11 , Fig.11 The schematic diagram is a scene diagram of the stent system used to reconstruct the thoracic aorta and the abdominal aorta. The covered stent 20 is released into the thoracic aorta, and the vascular stent 10 is connected to the distal end of the covered stent 20. The covered stent 20 at least partially isolates the formed aneurysm cavity 100 and the proximal rupture 103. The vascular stent 10 is implanted in the distal aortic true lumen 101. The vascular stent 10 has the effect of isolating the distal rupture 104, which is conducive to solving the problem of distal poor perfusion, and is conducive to promoting complete thrombosis of the false lumen 102, and achieving a good remodeling effect of the true lumen 101; retaining the visceral arteries, reducing long-term and secondary prognosis, and reducing the risk of new dissections induced by the distal vascular stent 10. The introduction of the vascular stent 10 is also conducive to limiting the excessive expansion of the covered stent 20, and preventing the edge of the covered stent 20 from damaging the aortic intima, thereby reducing the incidence of new distal ruptures.

[0139] The second embodiment of the present application provides a knotting method for a vascular stent 10 .

[0140] In some techniques, see for example Figure 12a-12f As shown, the connector 12 is fixed to the support member 11 by knotting, and the knot 125 formed by the knotting is located on the inner side of the vascular stent 10 .

[0141] Figure 12a-Figure 12c FIG. 1 is a schematic diagram of a partial structure in which the connecting member 12 is knotted and fixed to the adjacent supporting trough 113 on the proximal side thereof.

[0142] like Fig.12a As shown, in step 1, one end 126 of the connector 12 in the length direction passes through the inner side of the support trough 113 from the distal side of the support trough 113 and passes through the proximal side of the support trough 113 to the outside of the vascular stent 10; then, the one end 126 of the connector 12 passing through the outer side passes through the outer side of the support trough 113 and passes through the part of the connector 12 located at the distal side of the support trough 113 to pass through to the outside of the vascular stent 10;

[0143] like Figure 12b As shown, step 2, after step 1 is completed, the end 126 of the connector 12 located on the outside passes around the outer side of the support trough 113 and penetrates from the proximal side of the support trough 113 to the inner side of the vascular stent 10, so that the connector 12 surrounds the support trough 113 to form a half knot 127 located on the inner side of the vascular stent 10, and a gap 128 is formed between the distal side of the support trough 113 and the proximal side of the half knot 127; Fig.12cAs shown, subsequently, one end 126 of the connector 12 passes around the inner side of the supporting trough 113 and passes through the gap 128 to the outside of the vascular stent 10 to form a knot 125, thereby knotting and fixing the connector 12 to the supporting member 11.

[0144] like Fig.12d As shown, Fig.12d It is a schematic cross-sectional view of a portion of the connector 12 and the support member 11 . The knot 125 is firmly located on the inner side of the vascular stent 10 , so that the connecting section 121 on the connector 12 has a tendency to be concave toward the central axis of the vascular stent 10 .

[0145] Fig.12d , Fig.12f A schematic diagram of a local structure of the connecting member 12 is shown in which the connecting member 12 is knotted and fixed to the adjacent supporting wave crest 112 on the distal end side thereof, and the knotting direction is opposite to that of the supporting wave trough 113 .

[0146] like Fig.12e As shown, in stage 1, one end 126 of the connector 12 in the length direction passes from the proximal side of the support crest 112 around the inner side of the support crest 112 and passes from the distal side of the support crest 112 to the outside of the vascular stent 10; then, the end 126 of the connector 12 passing out to the outside passes around the outer side of the support crest 112 and around the part of the connector 12 located on the proximal side of the support crest 112 and passes out to the outside of the vascular stent 10;

[0147] like Fig.12f As shown, in stage 2, after stage 1 is completed, one end 126 of the connector 12 located on the outside passes around the outer side of the support crest 112 and penetrates from the distal side of the support crest 112 to the inner side of the vascular stent 10, so that the connector 12 forms a half knot 127 located on the inner side of the vascular stent 10 around the support crest 112, and a gap 128 is formed between the proximal side of the support crest 112 and the distal side of the half knot 127; then, one end 126 of the connector 12 passes around the inner side of the support crest 112 and penetrates from the gap 128 to the outside of the vascular stent 10 to form a knot 125, thereby knotting and fixing the connector 12 to the support member 11.

[0148] like Fig.12d As shown, the knot 125 is firmly located inside the vascular stent 10 .

[0149] The knot 125 formed by the connector 12 being fixed to the support 11 by tying a knot is located on the inner side of the vascular stent 10, so that the connecting section 121 on the connector 12 has a problem of being concave toward the inner cavity of the vascular stent 10. One problem is that it may hinder the blood flow through the inner cavity of the vascular stent 10, which may lead to changes in hemodynamics with difficult to predict consequences; another problem is that the concave connecting section 121 may hinder the interventional instrument from delivering other stents through the vascular stent 10 of the present application. In the case of the interventional instrument delivering other stents, for example, it may be necessary to release an additional bare stent and / or covered stent 20 in the vascular stent 10 of the present application, or it may be necessary to connect the bare stent and / or covered stent 20 at the proximal and / or distal ends of the vascular stent 10. The concave connecting section 121 may hinder the interventional instrument from delivering other stents through the vascular stent 10 of the present application, for example, the head end of the interventional instrument may scrape the concave connecting section 121, causing the vascular stent 10 to move or the intervention of the interventional instrument to fail, affecting secondary intervention or later intervention.

[0150] For the examples in this application, please see Figure 13a-13f As shown, in two axially adjacent support members 11, the first connection portion 122 of the connection member 12 is knotted and fixed to the support trough 113 of the support member 11 near the proximal end, and the second connection portion 123 of the connection member 12 is knotted and fixed to the support crest 112 of the support member 11 near the distal end. The knot 125 formed by the connection member 12 being fixed to the support member 11 by knotting is located outside the blood vessel stent 10 to solve the problem that the connection segment 121 may be concave toward the inner cavity of the blood vessel stent 10.

[0151] Figure 13a-Figure 13c A partial structural schematic diagram is shown in which the connecting member 12 is knotted and fixed to the adjacent supporting trough 113 on the proximal side thereof.

[0152] like Fig.13a As shown, in step 1, one end 126 of the connector 12 in the length direction passes through the outer side of the support trough 113 from the distal side of the support trough 113 and penetrates into the inner side of the vascular stent 10 from the proximal side of the support trough 113; then, the one end 126 of the connector 12 that penetrates into the inner side passes through the inner side of the support trough 113 and passes through the part of the connector 12 located at the distal side of the support trough 113 to pass out to the outer side of the vascular stent 10;

[0153] like Fig.13b As shown, step 2, after step 1 is completed, the end 126 of the connector 12 located on the outside penetrates from the distal side of the support trough 113 to the inside of the vascular stent 10 and passes around the inner side of the support trough 113, so that the connector 12 surrounds the support trough 113 to form a half knot 127 located on the outside of the vascular stent 10, and a gap 128 is formed between the distal side of the support trough 113 and the proximal side of the half knot 127; Fig.13c As shown, subsequently, one end 126 of the connector 12 passes through the proximal side of the support trough 113 and around the outer side of the support trough 113, and passes through the gap 128 to the inner side of the vascular stent 10 to form a knot 125, thereby knotting and fixing the connector 12 to the support 11.

[0154] like Fig.13d As shown, Fig.13d It is a schematic cross-sectional view of a portion of the connector 12 and the support member 11 . The knot 125 is firmly located on the outside of the stent 10 , so that the connecting section 121 on the connector 12 tends to bulge outwards away from the central axis of the stent 10 .

[0155] Fig.13e , Fig.13f The figure shows a partial structural schematic diagram of the connecting member 12 being knotted and fixed to the adjacent supporting wave crests 112 on the distal end side thereof, and the knotting direction is opposite to that of the supporting wave troughs 113 .

[0156] like Fig.13e As shown, in stage 1, one end 126 of the connector 12 in the length direction passes from the proximal side of the support crest 112 around the outer side of the support crest 112 and penetrates from the distal side of the support crest 112 to the inner side of the vascular stent 10; then, the end 126 of the connector 12 that penetrates to the inner side passes around the inner side of the support crest 112 and around the portion of the connector 12 located on the proximal side of the support crest 112 and penetrates to the inner side of the vascular stent 10;

[0157] like Fig.13f As shown, in stage 2, after stage 1 is finished, the end 126 of the connector 12 located on the inner side passes around the inner side of the support crest 112 and passes through the distal side of the support crest 112 to the outer side of the vascular stent 10, so that the connector 12 surrounds the support crest 112 to form a half knot 127 located on the outer side of the vascular stent 10, and a gap 128 is formed between the proximal side of the support crest 112 and the distal side of the half knot 127; then, the end 126 of the connector 12 passes around the outer side of the support crest 112 and passes through the gap 128 to the inner side of the vascular stent 10 to form a knot 125, so that the connector 12 is knotted and fixed to the support member 11. Fig.13d As shown, the knot 125 is firmly located on the outside of the vascular stent 10 .

[0158] The knot 125 formed by the connector 12 being fixed to the support 11 by tying a knot is located on the outside of the vascular stent 10, so that the connecting section 121 on the connector 12 has a tendency to bulge outward in the direction away from the inner cavity of the vascular stent 10, which is conducive to smoother blood flow through the inner cavity of the vascular stent 10; it is also possible to improve the wall adhesion between the vascular stent 10 and the blood vessel wall, so that the vascular stent 10 is more firmly implanted in the target blood vessel, which is conducive to reducing the displacement of the vascular stent 10; it is also possible that the bulging connecting section 121 is conducive to improving the delivery of other stents by interventional instruments through the vascular stent 10 of the present application. In the case of delivering other stents by interventional instruments, for example, it may be necessary to release an additional bare stent and / or covered stent 20 in the vascular stent 10 of the present application, or it may be necessary to connect the bare stent and / or covered stent 20 at the proximal and / or distal ends of the vascular stent 10. The outwardly protruding connecting section 121 is beneficial to improving the ability of interventional instruments to deliver other stents through the vascular stent 10 of the present application. For example, the head end of the interventional instrument can move more smoothly within the inner cavity of the vascular stent 10, thereby reducing the displacement of the vascular stent 10 or improving the success rate of interventional instrument intervention, which is beneficial to improving the success rate of secondary intervention or later intervention.

[0159] In some embodiments, Figure 13a-13f As shown, the connector 12 is formed by twisting or braiding a plurality of strands of material together.

[0160] In some embodiments, Figure 13g As shown, the connector 12 is made of a single strand of material.

[0161] The above implementation modes are merely descriptions of the preferred implementation modes of the present application, and are not intended to limit the scope of the present application. Without departing from the design spirit of the present application, various modifications and improvements made to the technical solutions of the present application by ordinary engineering and technical personnel in the field shall fall within the protection scope determined by the claims of the present application.

Claims

1. A vascular stent, characterized in that: The vascular stent comprises a proximal opening, a distal opening and an axially extending inner cavity, and the vascular stent is a self-expanding stent; A plurality of support members in an annular wave-shaped structure, wherein the plurality of support members are arranged at intervals along the axial direction of the vascular stent; A plurality of connecting members in an annular wave-shaped structure, wherein the connecting members are connected and fixed to two axially adjacent supporting members, so that the vascular stent forms a grid structure having grid units; The functional area is a local peripheral wall of the vascular stent, and the grid unit size of the functional area is larger than the grid unit size of other areas of the vascular stent.

2. The vascular stent according to claim 1, characterized in that: The functional area is located between the proximal opening of the vascular stent and the distal opening of the vascular stent.

3. The vascular stent according to claim 1, characterized in that: At least three supporting members are arranged in the axial region where the functional area is located.

4. The vascular stent according to claim 1, characterized in that: The functional area is 1 / 2 to 2 / 3 of the circumferential length of the vascular stent, or the circumferential length of the functional area is the circumferential length of the vascular stent.

5. The vascular stent according to claim 1, characterized in that: The support member includes a plurality of support rods connected in sequence at an angle, and two circumferentially adjacent angles are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; the distance between two circumferentially adjacent support troughs of the support member on the functional area is D1, and the distance between two circumferentially adjacent support troughs of the support member in other areas except the functional area is D2, and D1 is greater than D2.

6. The vascular stent according to claim 5, characterized in that: For the two axially adjacent support members on the functional area, the support wave crest of the support member located at the proximal end of the vascular stent and the support wave crest of the support member located at the distal end of the vascular stent are axially opposite.

7. The vascular stent according to claim 5, characterized in that: The supporting wave crests of the supporting members on the functional area and the supporting wave crests of the supporting members in other areas on the proximal side of the functional area are opposite in the axial direction.

8. The vascular stent according to claim 7, characterized in that: Two adjacent support wave crests of the support member on the functional area in the circumferential direction are spaced apart from at least one support wave crest of the support member in other areas on the proximal side thereof.

9. The vascular stent according to claim 6, characterized in that: The support troughs of the support member on the functional region and the support troughs of the support member in other regions on the distal side of the functional region are opposite in the axial direction.

10. The vascular stent according to claim 9, characterized in that: Two adjacent support troughs of the support member on the functional area in the circumferential direction are spaced apart from at least one support trough of the support member in another area on the distal end thereof.

11. The vascular stent according to claim 5, characterized in that: The grid unit includes a first grid and a second grid, the first grid and the second grid are located between the support member at least at one end of the functional area in the axial direction and the support members of other adjacent areas, and the size of the first grid is smaller than the size of the second grid.

12. The vascular stent according to claim 11, characterized in that: The first grids and the second grids are alternately arranged along the circumferential direction.

13. The vascular stent according to claim 11, characterized in that: The connecting member between the supporting member on at least one end of the functional area in the axial direction and the supporting member in other adjacent areas is a discontinuous annular connecting member, which is formed by a plurality of arc segments, each of which includes two connecting segments connected at an angle, and the plurality of arc segments are arranged at intervals along the circumferential direction.

14. The vascular stent according to claim 13, characterized in that: The non-continuous annular connecting member is formed between the supporting member near the proximal end of the functional area and the supporting members in other nearby areas. The angle of the arc segment is fixed to the supporting wave crest of the supporting member near the proximal end of the functional area, and the two ends of the arc segment in the length direction are respectively fixed to the two supporting wave troughs in other nearby areas, thereby forming the first grid, and the second grid is formed by two circumferentially adjacent first grids and two axially adjacent supporting members.

15. The vascular stent according to claim 13, characterized in that: The non-continuous annular connecting member is formed between the supporting member near the far end of the functional area and the supporting members in other nearby areas. The angle of the arc segment is fixed to the supporting crest of the supporting member near the proximal end of the functional area, and the two ends of the arc segment in the length direction are respectively fixed to the two supporting troughs in other nearby areas, thereby forming the first grid. The second grid is formed by two circumferentially adjacent first grids and two axially adjacent supporting members.

16. The vascular stent according to claim 1, characterized in that: The support member includes a plurality of support rods connected in sequence at an angle, and two adjacent angles in the circumferential direction are a support crest and a support trough, respectively, and the support crest is closer to the proximal end of the vascular stent than the support trough; the axial length of the support rod of the support member on the functional area is L1, and the axial length of the support rod of the support member in other areas of the vascular stent is L2, and L1 is greater than L2.

17. The vascular stent according to claim 1, characterized in that: The connecting member comprises a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two adjacent angles in the circumferential direction are respectively a first connecting portion and a second connecting portion; The distance between two adjacent second connection parts of the connector on the functional area in the circumferential direction is d1, and the distance between two adjacent second connection parts of the connector in other areas of the vascular stent in the circumferential direction is d2, and d1 is greater than d2.

18. The vascular stent according to claim 10, characterized in that: The connector includes a plurality of connecting segments connected at an angle, and the plurality of connecting segments are connected in sequence at an angle, and two circumferentially adjacent angles are respectively a first connecting portion and a second connecting portion; the axial length of the connecting segment of the connector on the functional area is l1, and the axial length of the connecting segment of the connector in other areas of the vascular stent is l2, and l1 is greater than l2.

19. The vascular stent according to claim 13, characterized in that: The wire diameter of the support member on the functional area is greater than the wire diameter of the support member in other areas of the vascular stent.

20. A support system, characterized in that: It includes the vascular stent and the coated stent according to any one of claims 1 to 19, the coated stent includes a proximal opening, a distal opening and an axially extending lumen, the coated stent is a self-expanding stent, and the coated stent includes a main body coating and a supporting frame fixed to the main body coating.

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