Luminal stents and stent systems

Abstract

The present invention is applicable to the field of medical devices, and provides a luminal stent, comprising a main stent and at least two legs connected to one axial end of the main stent, the main stent comprising at least one spacing adjustment portion, the spacing adjustment portion being located on the proximal side of the legs, and the spacing adjustment portion being used to adjust the relative spacing between the two axial ends of the main stent. The luminal stent provided by the present invention includes a spacing adjustment portion on the main stent, and the spacing adjustment portion is used to adjust the distance between the two axial ends of the main stent, so that the axial length of the main stent can be changed after the spacing adjustment portion is deformed, so that the end position of the main stent connected to the legs can be extended and abut against the intersection of the main blood vessel and the branch blood vessel, so that the luminal stent can obtain a stable support of the human body's own vascular structure, so that the luminal stent will not be easily displaced even when it is flushed by blood flow.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a lumen stent and a stent system. Background Art

[0002] like Figure 1 As shown, generally, for a stent placed at a bifurcation of a blood vessel, the intersection of the main stent A and the branch stents B1 and B2 usually has a large displacement space H. Under the action of the flushing of blood flow and the obstruction of the intersection of the stent itself, the blood flow forms pressure on the stent toward the intersection. On the one hand, it is easy to cause the stent to shift and form internal leakage. On the other hand, the stent is usually provided with anchoring barbs, and the anchor barbs are easily displaced by the traction of the stent and scratch the inner wall of the blood vessel. Summary of the Invention

[0003] The purpose of the present invention is to provide a luminal stent and a stent system, aiming to solve the technical problem in the prior art that stents are easily displaced under blood flow.

[0004] The present invention is achieved as follows: a luminal stent comprising:

[0005] A main bracket and at least two legs connected to one axial end of the main bracket, the main bracket includes at least one spacing adjustment part, the spacing adjustment part is located on the proximal side of the leg, and the spacing adjustment part is used to adjust the relative spacing between the two axial ends of the main bracket.

[0006] Optionally, the distance adjusting portion includes a first state and a second state. When the distance adjusting portion is deformed from the first state to the second state, the distance adjusting portion drives the distal end of the main bracket to extend toward one side of the leg.

[0007] Optionally, the main support includes a plurality of support structures arranged along the axial direction, the spacing adjustment portion is connected between two axially adjacent support structures, and the spacing adjustment portion is used to drive the two axially adjacent support structures to move away from each other.

[0008] Optionally, when the distance adjusting portion is in the first state, at least a portion of the distance adjusting portion includes a curved structure; and when the distance adjusting portion is in the second state, the curved structure is at least partially straightened.

[0009] Optionally, the spacing adjustment portion includes a mesh structure segment, and the mesh structure segment includes grid units. When the spacing adjustment portion is deformed from the first state to the second state, the endpoints of the grid units at both ends of the main bracket move away from each other.

[0010] Optionally, the distance adjusting portion includes a helical structure segment, and when the distance adjusting portion is deformed from the first state to the second state, the helical structure segment extends toward both axial ends of the main support.

[0011] Optionally, the distance adjusting portion is switched from the first state to the second state under control of a temperature change of the distance adjusting portion, and a deformation temperature point of the distance adjusting portion is greater than or equal to 39 degrees Celsius.

[0012] Optionally, the main stent further includes a main body and an inner covering and / or an outer covering, the inner covering is located on the inner side of the main body, the outer covering is located on the outer side of the main body, and the spacing adjustment portion is suitable for moving relative to the inner covering and / or the outer covering.

[0013] Optionally, the inner coating completely covers the inner wall of the main body, and the outer coating completely covers the outer wall of the main body. At the position where the spacing adjustment part is located, the inner coating and the outer coating form a suspended area, and the spacing adjustment part can move in the suspended area.

[0014] Optionally, the inner covering completely covers the inner wall of the main body, and the outer covering partially covers the outer wall of the main body so that the spacing adjustment part is exposed on the outside of the inner covering; or the outer covering completely covers the outer wall of the main body, and the inner covering partially covers the inner wall of the main body so that the spacing adjustment part is exposed on the inside of the outer covering.

[0015] Optionally, the spacing adjustment portion is located on the main support near the supporting legs.

[0016] Optionally, an anchor barb is provided on the outer side of the main stent, and the anchor barb is closer to the proximal side of the main stent than the spacing adjustment portion.

[0017] The present invention also provides a stent system, including a conveyor, wherein the conveyor includes a sheath tube and a push rod passing through the sheath tube, and is characterized in that it also includes the above-mentioned luminal stent, and the luminal stent is loaded in the sheath tube.

[0018] The luminal stent provided by the present invention is provided with a main stent and at least two legs connected to the main stent, so that the luminal stent can be implanted at the bifurcation of a blood vessel. When there is a distance between the main stent and the blood vessel intersection, the main stent includes at least one distance adjustment part, and the distance adjustment part can adjust the distance between the two axial ends of the main stent, so that the end of the main stent connected to the legs can extend toward the intersection of the blood vessels and abut against the intersection of the main blood vessel and the branch blood vessel, thereby enabling the luminal stent to obtain stable support for the human body's own vascular structure, offsetting the scouring pressure of blood flow on the intersection of the main stent and the legs, and preventing the luminal stent from shifting under the scouring pressure of blood flow or driving the anchor barb to move and scratch the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of a prior art luminal stent located in a blood vessel;

[0020] Figure 2 This is a schematic diagram of the spacing adjustment portion of the luminal stent provided in the first embodiment of the present invention when no deformation occurs in the blood vessel;

[0021] Figure 3 Schematic diagram of the spacing adjustment portion of the luminal stent provided in the first embodiment of the present invention after deformation within a blood vessel;

[0022] Figure 4 1 is a schematic diagram of the spacing adjustment portion provided in the first embodiment of the present invention when it is in an “N” shape and has not been deformed;

[0023] Figure 5 This is a schematic diagram of the spacing adjustment portion provided in the first embodiment of the present invention when it is arc-shaped and not deformed;

[0024] Figure 6 Schematic diagram of the inner and outer coverings of the endoluminal stent provided in the first embodiment of the present invention forming a suspended area at the location of the spacing adjustment portion;

[0025] Figure 7 1 is a cross-sectional schematic diagram of the inner covering and the outer covering of the endoluminal stent provided in the first embodiment of the present invention when they are connected at the position where the spacing adjustment portion is located to form a suspended area;

[0026] Figure 8 2. It is a cross-sectional schematic diagram of the endoluminal stent provided in the first embodiment of the present invention when the outer covering membrane partially covers the outer wall of the main body;

[0027] Figure 9 1 is a cross-sectional schematic diagram of the endoluminal stent provided in Example 1 of the present invention when the inner covering portion covers the inner wall of the main body;

[0028] Figure 10 This is a schematic diagram of a first developing structure provided on a first supporting structure and a second developing structure provided on a second supporting structure according to a first embodiment of the present invention;

[0029] Figure 11 Schematic diagram of an endoluminal stent provided with anchor barbs according to the first embodiment of the present invention;

[0030] Figure 12 This is a schematic diagram of the spacing adjustment portion of the luminal stent provided in the second embodiment of the present invention, including the mesh structure segment, when no deformation occurs;

[0031] Figure 13 yes Figure 12 A schematic diagram of the mesh structure segment of the spacing adjustment portion after deformation;

[0032] Figure 14 is a schematic diagram of a case where the grid unit provided by the second embodiment of the present invention is a diamond grid;

[0033] Figure 15 yes Figure 14 Schematic diagram of the grid unit after deformation;

[0034] Figure 16 is a schematic diagram of a spacing adjustment portion provided in a third embodiment of the present invention;

[0035] Figure 17 yes Figure 16 Schematic diagram of the spacing adjustment portion after deformation;

[0036] Figure 18 is a schematic diagram of a support system provided by a fourth embodiment of the present invention;

[0037] Figure 19 This is a schematic diagram of the endoluminal stent provided by the fourth embodiment of the present invention being installed on the push rod of the conveyor;

[0038] Figure 20 This is a schematic diagram of a heater provided on a push rod according to a fourth embodiment of the present invention.

[0039] Reference numerals:

[0040] 100, luminal stent; 10, main stent; 11, main body; 111, support structure; 1111, first support structure; 1112, second support structure; 12, spacing adjustment portion; 121, bending structure; 122, mesh structure segment; 1221, grid unit; 123, spiral structure segment; 13, inner coating; 14, outer coating; 15, anchor barb; 16, first imaging structure; 17, second imaging structure; 18, suspended area; 20, support leg; 300, stent system; 30, conveyor; 31, sheath; 32, push rod; 33, heating element;

[0041] X, main vessel; Y, branch vessel; W, vascular junction; DETAILED DESCRIPTION

[0042] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0043] It should be noted that when an element is referred to as being “fixed to” or “disposed on” another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or there may be an intermediate element.

[0044] In the field of interventional medical devices, the "distal end" is generally defined as the end away from the operator during surgery, and the "proximal end" is defined as the end closer to the operator. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and "radial" refers to the direction perpendicular to the axial direction. In the present invention, the proximal end is defined as the end of the stent closest to the heart, and the distal end is defined as the end away from the heart.

[0045] It should also be noted that the directional terms such as left, right, up, and down in this embodiment are merely relative concepts or are based on the normal use status of the product, and should not be considered as restrictive.

[0046] Example 1

[0047] like Figure 2 and Figure 3 As shown, the luminal stent 100 includes a main stent 10 and at least two legs 20. The main stent 10 includes at least one spacing adjustment portion 12. The leg 20 is connected to one axial end of the main stent 10. The spacing adjustment portion 12 is located on the proximal side of the leg. The spacing adjustment portion 12 is used to adjust the relative spacing between the two axial ends of the main stent 10.

[0048] The luminal stent 100 includes a main stent 10, a coating provided on the main stent 10, and a leg 20 connected to one axial end of the main stent 10. The main stent 10 can be formed by weaving or cutting a shape memory alloy material. The main stent 10 has a certain degree of elasticity and is generally tubular. The coating is applied to the main stent 10 to form a lumen through which blood can flow. The leg 20 includes a support frame and a coating. The coating is applied to the support frame to form a lumen, and the leg 20 is connected to the lumen within the main stent. When the luminal stent 100 is implanted in the human body, the main stent 10 is located in the main vessel X, and the leg 20 is located in the branch vessel Y. The number of legs 20 can be arranged accordingly based on the number of branch vessels Y. For example, in this embodiment, two branch vessels Y are provided, and accordingly, two legs 20 are provided. In this embodiment, the side of the leg 20 closer to the main stent 10 is the proximal end, and the end farther away from the main stent 10 is the distal end. The end of the main support 10 close to the support leg 20 is the distal end, and the end away from the support leg 20 is the proximal end.

[0049] The main stent 10 includes a main body 11 and a spacing adjustment portion 12. Along the axial direction of the main body 11, the main body 11 includes a first end proximal to the leg 20 and a second end distal to the leg 20. The first end is connected to the leg 20 via a coating. It will be appreciated that in other embodiments, the coating on the main body 11 may be integrally connected to the coating on the leg 20, or may be connected by bonding, sewing, or the like. The spacing adjustment portion 12 may be fixed to the main body 11 or may be detachably connected to the main body 11. For example, in one embodiment, the main body 11 includes a tubular member formed by laser cutting, the side wall of the tubular member is a mesh structure and has a certain elastic force, the spacing adjustment portion 12 can be a constraint that constrains the axial spacing of the main body 11, and the constraint includes a linear object, which constrains the main body 11 in the axial direction and forms a movable knot. When it is necessary to increase the spacing between the two axial ends of the main body 11, the linear object is pulled out to untie the movable knot, releasing the constrained part of the main body 11 so that the main body 11 extends toward the two axial ends, thereby adjusting the position of the first end and the second end. It can be understood that in other embodiments, the spacing adjustment portion 12 can also be formed by being integrally connected with the main body 11. In this embodiment, the integral connection refers to the integral connection of the main body 11 and the spacing adjustment portion 12 by laser cutting the tubular member, or the main body 11 and the spacing adjustment portion 12 can be formed by integrally weaving the braided wire.

[0050] In this embodiment, the number of spacing adjustment parts 12 is not limited. For example, only one spacing adjustment part 12 can be provided, or more than one spacing adjustment part 12 can be provided. Specifically, it can be provided according to the length range that needs to be adjusted. For example, when the length of the main blood vessel X is long, when the position where the main support 10 of the luminal stent 100 is connected to the support leg 20 is released to a position close to the blood vessel intersection W, the position where the main support 10 is connected to the support leg 20 is relatively far from the position of the blood vessel intersection W. At this time, the distance that needs to be adjusted is larger. Therefore, a luminal stent with two or more spacing adjustment parts can be selected.

[0051] When the main bracket 10 is arranged axially, since the spacing adjustment part 12 can adjust the relative spacing between the two axial ends of the main body 11 (that is, adjust the spacing between the two axial ends of the main bracket 10), when the length of the spacing adjustment part 12 in the axial direction of the main body 11 changes, the distance between the two ends of the main bracket 10 in the axial direction will also change accordingly, thereby realizing the adjustment of the relative position of the two axial ends of the main body 11.

[0052] During the actual implantation of the luminal stent into the human body, when the conveyor releases the connection position of the main stent 10 and the support leg 20 to a position close to the blood vessel intersection and the connection position of the main stent 10 and the support leg 20 is at a certain distance from the position of the blood vessel intersection, the distance between the two axial ends of the main body 11 is adjusted by the spacing adjustment part 12, so that the end of the main body 11 connected to the support leg 20 can extend toward the side close to the support leg 20, that is, the main stent 10 can be extended toward the position close to the blood vessel intersection, so that the connection position of the main body 11 and the support leg 20 can be against the position of the blood vessel intersection W. In this way, the luminal stent 100 can be limited and positioned by the blood vessel intersection W, so that the luminal stent 100 will not be easily displaced even if it is flushed by blood flow, thereby preventing the luminal stent 100 from shifting under the flushing pressure of blood flow or driving the anchor barb to move and scratch the blood vessel.

[0053] like Figure 2 、 Figure 3 As shown, the spacing adjustment portion 12 includes a first state and a second state. When the spacing adjustment portion 12 is deformed from the first state to the second state, the spacing adjustment portion 12 drives the end of the main bracket 10 connected to the support leg 20 to extend toward the side close to the support leg 20.

[0054] The first state is the natural state in which the spacing adjustment portion 12 is not deformed, which is the parent state. In the first state, the spacing adjustment portion 12 is not triggered and therefore does not deform. When the spacing adjustment portion 12 is triggered and deformed, it forms the second state, which is the deformed state. During the deformation from the first state to the second state, the spacing adjustment portion 12 drives the end (first end) of the main body 11 near the leg 20 to move toward the side near the leg 20, that is, the overall axial length of the main stent 10 increases. The spacing adjustment portion 12 drives the end of the main body 11 connected to the leg 20 to move toward the side near the leg 20 until the end of the main body 11 connected to the leg 20 abuts the blood vessel intersection W.

[0055] Therefore, the spacing adjustment part 12 includes a first state and a second state, and the first state can be deformed into the second state, so that the spacing adjustment part 12 can realize the relative position of the axial ends of the main bracket 10 by deformation, reducing the difficulty of operation.

[0056] In some embodiments, the spacing adjustment portion 12 is made of a one-way shape memory material. One-way shape memory alloys have the ability to restore their shape after appropriate heat treatment. Metals will deform when subjected to external forces, and the deformation of metals is divided into elastic deformation and plastic deformation. Elastic deformation is when the external force is small, the atomic spacing only changes slightly, and the original shape can be restored after the external force is removed. Plastic deformation is when the external force exceeds a certain critical value, the crystal deforms violently and cannot be restored. There are two types of plastic deformation, one is shearing caused by crystal dislocation slip, and the other is twin deformation or stress-induced martensitic phase transformation. Shape memory alloys belong to thermoelastic martensitic phase transformation. When a shape memory alloy is deformed in the martensitic state, it can restore its shape before deformation without the action of external force after heating, and the shape remains unchanged when cooled again. This shape memory phenomenon is called the one-way shape memory effect. One-way shape memory materials include one-way nickel-titanium-based shape memory alloys, copper-based shape memory alloys or iron-based shape memory alloys. This embodiment uses a nickel-titanium-based shape memory alloy as an example to illustrate the one-way memory process: the NiTi alloy is fully annealed at a high temperature above 800°C, then formed at room temperature, and then held at 200-300°C for several to tens of minutes. In other embodiments, one-way shape memory alloys can also be obtained through processes such as intermediate temperature treatment and aging treatment.

[0057] After the luminal stent 10 is delivered to the target position, the spacing adjustment portion 12 has been deformed so that one end of the main stent 10 rests against the blood vessel bifurcation. By setting the spacing adjustment portion 12 to be made of a one-way deformation memory material, it can be ensured that the spacing adjustment portion 12 can remain in the second form after deformation, avoiding the spacing adjustment portion 12 being affected by the temperature of the blood and returning to the first form.

[0058] The distance adjusting portion 12 is switched from the first state to the second state under the control of the temperature change of the distance adjusting portion 12 . The deformation temperature point of the distance adjusting portion 12 is greater than or equal to the human body temperature.

[0059] The spacing adjustment portion 12 is made of a one-way shape memory alloy material. Its deformation is triggered by temperature changes and requires heating to trigger its deformation. Since it is implanted in the human body's internal blood vessels, its lowest deformation temperature is greater than the normal human body temperature, which is generally in the range of 36-37°C. Of course, the human body may experience changes in temperature due to external stimuli or internal diseases and infections, or the temperature of different individuals may vary slightly. Therefore, the deformation temperature of the spacing adjustment portion 12 may also be greater than the normal human body temperature range. The deformation temperature of the spacing adjustment portion 12 can be between 39°C and 60°C. Specifically, the deformation temperature of the spacing adjustment portion 12 can be 39°C, 40°C, 41°C, 42°C, 45°C, 50°C, or 60°C.

[0060] By setting the deformation temperature of the spacing adjustment portion 12 to be greater than or equal to human body temperature, the spacing adjustment portion 12 requires external heating to trigger its deformation, thereby increasing the controllability of the length adjustment of the main body 11, thereby allowing the length to be adjusted according to different individual conditions. If the deformation temperature of the spacing adjustment portion 12 is lower than human body temperature, the human body will spontaneously transfer its own heat to the spacing adjustment portion 12 due to the heat transfer effect, which may cause deformation during the implantation process, making it impossible to adjust the deformation of the spacing adjustment portion 12 and the length of the main body 11 according to actual needs.

[0061] In some embodiments, see also Figure 4 and Figure 5 The main body 11 includes a plurality of support structures 111 arranged along the axial direction. The spacing adjustment portion 12 is connected to two axially adjacent support structures 111. The spacing adjustment portion 12 is used to drive the two axially adjacent support structures 111 to move away from each other.

[0062] The support structure 111 can be a wavy ring made of a shape memory alloy or medical stainless steel. The spacing adjustment portion 12 is located between two adjacent support structures 111, and the ends of the spacing adjustment portion 12 are respectively connected to the two adjacent support structures 111. The ends of the spacing adjustment portion 12 can be connected to the support structures 111 by welding, crimping, or other methods. When the spacing adjustment portion 12 deforms, the ends of the spacing adjustment portion 12 move away from each other, pushing the two support structures 111 connected to the spacing adjustment portion 12 in opposite directions, thereby achieving spacing adjustment at both ends of the main body 11. In one embodiment, there are two spacing adjustment portions 12, each located on radially opposite sides of the main body 11. It is understood that in other embodiments, there are multiple spacing adjustment portions 12, and the multiple spacing adjustment portions 12 are arranged at equal intervals along the circumference of the main body 11. In this way, multiple spacing adjustment portions 12 on the circumference can simultaneously push the two adjacent support structures 11 to move, avoiding the situation where one side is extended.

[0063] In this way, by connecting the spacing adjustment part 12 to two axially adjacent support structures 111, the spacing adjustment at both axial ends of the main body 11 can be achieved only by deforming the spacing adjustment part 12, thereby reducing the influence of the deformation of the spacing adjustment part 12 on the skeleton forming the main body 11.

[0064] When the distance adjusting portion 12 is in the first state, at least a portion of the distance adjusting portion 12 includes a curved structure 121 . When the distance adjusting portion 12 is in the second state, both ends of the curved structure 121 extend toward the axial direction of the main body 11 .

[0065] When the spacing adjustment portion 12 is in the first state, that is, when it is not deformed, a portion of the spacing adjustment portion 12 may be a straight line, and the other portion may be a curved structure 121. The curved structure 121 may be "S"-shaped, "N"-shaped, "L"-shaped, "V"-shaped, etc., or may be an arc, or a combination of these shapes; of course, in other embodiments, the spacing adjustment portion 12 may also be a curved structure 121, for example, Figure 5 In the embodiment, the distance adjustment portion 12 comprises only a curved structure 121, which is generally arc-shaped and can also adjust the distance between the axial ends of the main body 11. In the second state, the ends of the curved structure 121 extend in opposite directions, i.e., move away from each other along the axial direction of the main body 11. Compared to the first state, the distance between the axial ends is longer. The final shape of the distance adjustment portion 12 is related to the distance between the intersection of the main body 11 and the legs 20 and the blood vessel junction W in the first state. The final shape may be an "S" shape, "N" shape, "L" shape, "V" shape, or an arc, a straight line, etc. For example, when the distance adjustment portion 12 has not yet deformed into a straight line, the end of the main body 11 has already abutted the blood vessel junction W. At this time, the distance adjustment portion 12 still has an "S" shape, "N" shape, "L" shape, "V" shape, or an arc, but the degree of curvature is weaker than in the first state, or the curvature is larger than in the first state. Of course, it is understandable that when the deformation of the spacing adjustment portion 12 is large enough, it may eventually be in a straight line shape.

[0066] The bending structure 121 is provided so that when the spacing adjustment portion 12 changes from the first state to the second state, the bending structure 121 has a tendency to straighten, so that after deformation, the distance between the two ends of the bending structure 121 can be lengthened, thereby making the distance between the axial ends of the main body portion 11 also lengthen accordingly, thereby ultimately achieving the purpose of making the end of the main stent 10 abut against the blood vessel intersection W.

[0067] In some embodiments, as Figure 2 、 Figure 3 As shown, the spacing adjustment portion 12 is located on the main support 10 near the support leg 20 .

[0068] The spacing adjustment portion 12 is arranged adjacent to the support leg 20. For example, in this embodiment, the spacing adjustment portion 12 is located between the two support structures 111 closest to the support leg 20, and the two ends of the spacing adjustment portion 12 are respectively connected to the two support structures 111, and the main stent 10 and the support leg 20 are connected by a covering. The beneficial effect is that during the stent implantation process, by arranging the spacing adjustment portion 12 at a position close to the support leg 20 of the main body 11, on the one hand, it is convenient for the doctor to judge whether it is necessary to control the deformation of the spacing adjustment portion 12 so that the end of the main body 11 abuts against the blood vessel intersection based on the distance between the end of the main body 11 and the blood vessel intersection, thereby increasing the adaptability of the luminal stent. On the other hand, after the spacing adjustment portion 12 is deformed, the intersection of the main stent 10 and the support leg 20 can abut against the blood vessel intersection W as soon as possible to obtain support. At the same time, it can also reduce the influence of other factors on the spacing adjustment portion 12. It is understandable that in other embodiments, the two ends of the spacing adjustment portion 12 can also be connected to the support structure 111 on the main support 10 closest to the leg 20 and the wave ring on the leg 20 closest to the main support 10.

[0069] In some embodiments, see Figure 6 、 Figure 7 The main stent 10 further includes an inner coating 13 and an outer coating 14. The inner coating 13 is located on the inner side of the main body 11, and the outer coating 14 is located on the outer side of the main body 11. The spacing adjustment portion 12 is adapted to move relative to the inner coating 13 and / or the outer coating 14. At the location of the spacing adjustment portion 12, the length of the inner coating 13 and / or the outer coating 14 is greater than the distance between two adjacent support structures 11. Of course, the main stent 10 may be provided with only the inner coating 13 or the outer coating 14.

[0070] Both the inner coating 13 and the outer coating 14 can be made of materials such as polytetrafluoroethylene, dacron, polyester, polyurethane, etc., and are flexible. They can be fixed to the support structure 111 by means of heat pressing, suturing, etc. After the inner coating 13 and the outer coating 14 are fixed to the support structure 111, the inner wall surface of the inner coating 13 constitutes the inner wall surface of the main stent 10, and the outer wall surface of the outer coating 14 constitutes the outer wall surface of the main stent 10. At this time, the main stent 10 has a double-layer coating structure. When only the inner coating 13 is provided, the support structure 111 is located on the outside of the inner coating 13, and the main stent 10 has a single-layer coating structure. When only the outer coating 14 is provided, the support structure 111 is located on the inside of the outer coating 14, and the luminal stent 100 also has a single-layer coating structure.

[0071] In this embodiment, the inner coating 13 completely covers the inner wall of the main body 11, and the outer coating 14 completely covers the outer wall of the main body 11. At the position where the spacing adjustment part 12 is located, the inner coating 13 and the outer coating 14 form a suspended area 18, and the spacing adjustment part 12 can move in the suspended area 18.

[0072] After the inner coating 13 is fixed to the inner wall of the main body 11 and the outer coating 14 covers the outer wall of the main body 11, the inner coating 13 and the outer coating 14 are fixed relative to the support structure 111. The outer wall of the inner coating 13 and the inner wall of the outer coating 14 are adhered and fixed. However, at the position corresponding to the spacing adjustment portion 12, the outer side of the inner coating 13 and the inner side of the outer coating 14 are not adhered and fixed, so that a suspended area 18 is formed there. The spacing adjustment portion 12 can deform in the suspended area 18 without being constrained by the inner coating 13 and the outer coating 14, thereby ensuring that the spacing adjustment portion 12 can be smoothly adjusted.

[0073] In some other embodiments, such as Figure 8 As shown, the inner film 13 completely covers the inner wall of the main body 11 , and the outer film 14 partially covers the outer wall of the main body 11 so that the spacing adjustment portion 12 is exposed outside the inner film 13 .

[0074] The inner covering film 13 completely covers the inner wall of the main body 11, which means that after the inner covering film 13 covers the main body 11, the main body 11 is completely exposed on the outside of the inner covering film 13, and each supporting structure 111 is located on the outside of the inner covering film 13. The outer covering film 14 partially covers the outer wall of the main body 11, which means that the outer covering film 14 is in a hollow state at the position where the spacing adjustment portion 12 is located, and the spacing adjustment portion 12 is exposed on the outside of the inner covering film 13, that is, the outer covering film 14 is not provided in the area corresponding to the spacing adjustment portion 12, but only the inner covering film 13. In the area where the spacing adjustment portion 12 is not provided, the outer covering film 14 covers the outer wall of the main body 11.

[0075] By making the inner coating 13 completely cover the inner wall of the main body 11 and the outer coating 14 partially cover the outer wall of the main body 11, the luminal stent 100 can ensure the isolation effect while the spacing adjustment part 12 can also move freely without being restricted by both the outer coating 14 and the inner coating 13, resulting in deformation failure.

[0076] On the contrary, in other embodiments, such as Figure 9 As shown, the outer film 14 completely covers the outer wall of the main body 11 , and the inner film 13 partially covers the inner wall of the main body 11 so that the spacing adjustment portion 12 is exposed inside the outer film 14 .

[0077] The outer film 14 completely covers the outer wall of the main body 11, which means that after the outer film 14 covers the main body 11, the main body 11 is completely exposed on the inner side of the outer film 14, and all the supporting structures 111 are located on the inner side of the outer film 14. The inner film 13 partially covers the inner wall of the main body 11, which means that the spacing adjustment part 12 is located. The inner film 13 is in a hollow state, that is, the inner film 13 is not set in the area corresponding to the spacing adjustment part 12, and the spacing adjustment part 12 is not restricted by the inner film 13. At the position where the spacing adjustment part 12 is not set, the inner film 13 still covers the inner wall of the main body 11.

[0078] By making the outer film 14 completely cover the inner wall of the main body 11 and the inner film 13 partially cover the inner wall of the main body 11, the luminal stent 100 can ensure the isolation function while the spacing adjustment part 12 can also deform smoothly without being restricted by the outer film 14 and the inner film 13 at the same time, resulting in deformation failure.

[0079] See also Figure 10 The supporting structure 111 includes a first supporting structure 1111 and a second supporting structure 1112. The spacing adjustment portion 12 is respectively connected to the first supporting structure 1111 and the second supporting structure 1112. A first developing structure 16 is provided at the end of the first supporting structure 1111 close to the second supporting structure 1112. A second developing structure 17 is provided at the end of the second supporting structure 1112 close to the first supporting structure 1111.

[0080] The ends of the spacing adjustment portion 12 are respectively connected to the first support structure 1111 and the second support structure 1112. Specifically, the spacing adjustment portion 12 is secured to the main body 11 via the first and second support structures 1111, 1112. The first and second support structures 1111, 1112 are wavy ring structures with alternating peaks and troughs. A first imaging structure 16 can be disposed at the peak of the first support structure 1111, located at the end of the first support structure 1111 facing the second support structure 1112. A second imaging structure 17 can be disposed at the peak of the second support structure 1112, located at the end of the second support structure 1112 facing the first support structure 1111. The ends of the spacing adjustment portion 12 are respectively secured to the peaks of the first and second support structures 1111, 1112. When the endoluminal stent 100 is located within the human body, both the first and second imaging structures 16, 17 are clearly visible under X-ray irradiation.

[0081] By fixing the two ends of the spacing adjustment portion 12 to the first support structure 1111 and the second support structure 1112 respectively, the spacing adjustment portion 12 can be stably fixed to the main body 11, so that there is no need to set up an additional fixing device to fix the spacing adjustment portion 12; the first developing structure 16 is set at the end of the first supporting structure 1111 close to the second supporting structure 1112, and the second developing structure 17 is set at the end of the second supporting structure 1112 close to the first supporting structure 1111, so that the first developing structure 16 and the second developing structure 17 can be located in the same radial plane as the two ends of the spacing adjustment portion 12, so that when the luminal stent 100 is located in the human body, the first developing structure 16 and the second developing structure 17 can be synchronously developed to clearly and intuitively observe the change in the axial length of the main stent 10 caused by the deformation of the spacing adjustment portion 12, so as to timely grasp the condition of the luminal stent 100 in the blood vessel, so that the condition of the luminal stent 100 can be monitored at any time and timely responded to according to the actual situation.

[0082] The first supporting structure 1111 and the second supporting structure 1112 are both annular wave structures, and the wave crests of the first supporting structure 1111 are opposite to the wave troughs of the second supporting structure 1112 , or the wave troughs of the first supporting structure 1111 are opposite to the wave crests of the second supporting structure 1112 .

[0083] Both the first support structure 1111 and the second support structure 1112 are annular wave-shaped structures, each having crests and troughs. The crests and troughs of the first support structure 1111 and the second support structure 1112 are arranged alternately. The crests of the first support structure 1111 are opposite the troughs of the second support structure 1112, and the troughs of the first support structure 1111 are opposite the crests of the second support structure 1112, i.e., the crests and troughs of the first support structure 1111 are offset from each other.

[0084] By making the crest of the first support structure 1111 opposite to the trough of the second support structure 1112, or the trough of the first support structure 1111 opposite to the crest of the second support structure 1112, the length of the spacing adjustment part 12 can be reduced, thereby reducing the impact of the setting of the spacing adjustment part 12 on blood flow.

[0085] See also Figure 11 An anchor thorn 15 is provided on the outside of the main stent 10. The anchor thorn 15 is located on the side of the spacing adjustment portion 12 away from the support leg 20. The anchor thorn 15 is closer to the proximal side of the main stent 10 than the spacing adjustment portion 12.

[0086] The anchor barbs 15 can be made of the same material as the support structure 111. The anchor barbs 15 can be independently provided and fixed to the support structure 111 of the main body 11 by welding, crimping, or the like, or they can be formed by leaving a short free end at the end of the support structure 111. The anchor barbs 15 can penetrate the blood vessel wall. By providing the anchor barbs 15 on the outside of the main stent 10, the support structure 111 can be fixed at the distal end of the spacing adjustment portion 12, thereby enhancing the anchoring effect of the luminal stent 100, thereby making the luminal stent 100 more stable and less likely to shift after implantation.

[0087] Example 2

[0088] like Figures 12 to 15 As shown, the difference between this embodiment and embodiment 1 is that the structure of the spacing adjustment portion 12 is different. The spacing adjustment portion 12 includes a mesh structure segment 122, and the mesh structure segment 122 includes a grid unit 1221. When the spacing adjustment portion 12 is deformed from the first state to the second state, the endpoints of the grid unit 1221 at both ends of the axial direction of the main body 11 move away from each other.

[0089] The spacing adjustment portion 12 is formed by cutting or weaving a one-way shape memory alloy, and the grid unit 1221 can be in a diamond shape, a shuttle shape, or the like. Figure 14 The schematic diagram of the mesh unit 1221 is shown as a diamond. The braided wires of the mesh structure segment 122 are fixedly connected at the intersection. Under the effect of the one-way shape memory property, as shown in FIG. Figure 15 As shown, the mesh units 1221 can expand and elongate toward both ends, allowing the spacing adjustment portion 12 to extend so that the connection between the main body 12 and the legs 20 can abut against the bifurcation of the blood vessel. In the first state, the mesh structure segment 122 is in its undeformed, natural state, the parent state. The second state is its deformed, post-deformation state. From the first to the second state, the axial ends of the spacing adjustment portion 12 extend in opposite directions, increasing the distance between the mesh units 1221 at the axial ends of the main body 11.

[0090] The provision of the mesh structure segment 122 can also enable the spacing adjustment portion 12 to adjust the distance between the axial ends of the main body 11, so that after the luminal stent 100 is implanted in the human body, the spacing adjustment portion 12 is triggered to deform, so that the main body 11 can extend toward the side close to the support leg 20 until it abuts against the intersection of the blood vessels, thereby ensuring that the luminal stent 100 will not be easily displaced even if it is washed by blood flow.

[0091] It can be understood that the arrangement of the inner and outer films in the first embodiment is also applicable to this embodiment, so as to avoid the arrangement of the films constraining the deformation of the spacing adjustment portion 12 .

[0092] It can be understood that the anchor barb arrangement method in the first embodiment is also applicable to this embodiment to enhance the anchoring function of the luminal stent 100 .

[0093] Example 3

[0094] like Figure 16 、 17 As shown, the difference between this embodiment and the first embodiment is that the structure of the spacing adjustment portion 12 is different. The spacing adjustment portion 12 includes a spiral structure segment 123. When the spacing adjustment portion 12 is deformed from the first state to the second state, the spiral structure segment 123 extends toward the axial ends of the main body 11.

[0095] The spiral structure segment 123 is formed by spirally winding a braided wire and is made of a one-way shape memory alloy material. Before the spiral structure segment 123 is deformed, a lumen is formed in the middle thereof. When deformed, the two ends of the spiral structure segment 123 in the axial direction move in opposite directions. After deformation, the distance between the two ends of the spiral structure segment 123 in the axial direction is lengthened (e.g., Figure 17 As shown in the figure, the diameter of the lumen of the spiral structure segment 123 becomes smaller, that is, it deforms from the first state to the second state, and the distance between the two ends of the spiral structure segment 123 in the axial direction becomes longer, and it continues to extend toward one end of the support leg 20 until the main body 11 abuts against the intersection of the blood vessel. At this time, the tubular stent 100 is in a relatively stable state.

[0096] Since the spacing adjustment portion 12 includes a spiral structure segment 123, which is made of a one-way shape memory alloy material, the spacing adjustment portion 12 will deform when heated. When the deformation is large enough, the end of the main body 11 close to the support leg 20 in the axial direction abuts against the intersection of the blood vessels. At this time, the spacing adjustment portion 12 can no longer extend in the axial direction, and the luminal stent 100 is in a relatively stable state. Even if it is affected by blood flow, the luminal stent 100 is supported by the structure of the human blood vessel itself, and the position of the luminal stent 100 will not shift. This can avoid internal leakage, inability to cover the lesion site, and the like.

[0097] It can be understood that the coating arrangement in the first embodiment is also applicable to this embodiment, so that the deformation of the spacing adjustment portion 12 will not be affected by the coating arrangement.

[0098] Example 4

[0099] See also Figures 18 to 20In this embodiment, a stent system 300 is provided, comprising a conveyor 30 including a sheath 31 and a push rod 32 disposed within the sheath 31. The stent system 300 also includes the aforementioned luminal stent 100. The push rod 32 is provided with a heater 33. The luminal stent 100 is loaded within the sheath 31. The heater 33 is used to heat the spacing adjustment portion 12 of the luminal stent 100 to deform the spacing adjustment portion 12. Alternatively, the heater 33 may be provided on both the push rod 32 and the sheath 33, or only on the sheath 31.

[0100] The push rod 32 can be movably inserted into the lumen of the sheath 31, and the luminal stent 100 can be detachably connected to the push rod 32. Both the luminal stent 100 and the push rod 32 are located in the sheath 31. When the luminal stent 100 is being transported, the push rod 32 of the conveyor 30 can be controlled to slide relative to the sheath 31, so that the luminal stent 100 fixed on the push rod 32 can be transported into the diseased blood vessel. The heating element 33 can be a commonly used heating structure on the market. For example, heating can be performed by energizing an electrode. The heating element 33 can be provided on the push rod 32 or on the sheath 31, or on both the push rod 32 and the sheath 31 at the same time, as long as the temperature of the spacing adjustment member 12 can be increased to trigger its deformation. In this embodiment, Figure 20 Schematic diagram showing that the heating element 33 is arranged on the push rod 32 is shown in FIG.

[0101] The heating element 33 gradually heats the spacing adjustment portion 12, gradually raising its temperature. When the spacing adjustment portion 12 reaches its deformation temperature, it deforms, driving the ends of the main body 11 of the stent 100 to extend axially in opposite directions until the stent 100 abuts against the intersection of the blood vessel. In this way, the stent 100 is stably fixed within the blood vessel by leveraging the inherent structure of the human blood vessel, preventing it from shifting even under the influence of blood flow. It is understood that the deformed shape of the spacing adjustment portion 12 may vary from person to person.

[0102] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements or improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A luminal stent, used in a blood vessel having a main blood vessel and branch blood vessels, characterized in that: include: A main stent and at least two legs connected to one axial end of the main stent, the main stent including at least one spacing adjustment portion, the spacing adjustment portion being located on the proximal side of the leg, the spacing adjustment portion being used to adjust the relative spacing between the axial ends of the main stent, the spacing adjustment portion including a first state and a second state, and when the spacing adjustment portion is deformed from the first state to the second state, the spacing adjustment portion drives the distal end of the main stent to extend toward one side of the leg, and the main stent including a plurality of support structures arranged along the axial direction; The spacing adjustment portion is connected between two axially adjacent support structures, and is used to drive the two axially adjacent support structures to move away from each other, wherein the spacing adjustment portion is located between the two support structures closest to the legs, so that after the spacing adjustment portion is deformed, the intersection of the main stent and the legs can quickly abut against the intersection of the main blood vessel and the branch blood vessels to obtain support; Alternatively, the two ends of the spacing adjustment part are connected to the support structure on the main stent closest to the leg and the wave ring on the leg closest to the main stent, so that after the spacing adjustment part is deformed, the intersection of the main stent and the leg can quickly rest against the intersection of the main blood vessel and the branch blood vessel to obtain support.

2. The endoluminal stent according to claim 1, wherein: When the distance adjusting portion is in the first state, at least a portion of the distance adjusting portion includes a bent structure, and when the distance adjusting portion is in the second state, the bent structure is at least partially straightened.

3. The endoluminal stent according to claim 1, wherein: The spacing adjustment portion includes a mesh structure segment, and the mesh structure segment includes grid units. When the spacing adjustment portion is deformed from a first state to a second state, endpoints of the grid units at both ends of the main support axial direction move away from each other.

4. The endoluminal stent according to claim 1, wherein: The distance adjustment portion includes a helical structure segment. When the distance adjustment portion is deformed from a first state to a second state, the helical structure segment extends toward two axial ends of the main support.

5. The endoluminal stent according to claim 1, wherein: The distance adjusting portion is switched from the first state to the second state under control of a temperature change of the distance adjusting portion, and a deformation temperature point of the distance adjusting portion is greater than or equal to 39 degrees Celsius.

6. The endoluminal stent according to claim 1, wherein: The main stent also includes a main body and an inner covering and / or an outer covering, wherein the inner covering is located on the inner side of the main body, and the outer covering is located on the outer side of the main body, and the spacing adjustment portion is suitable for moving relative to the inner covering and / or the outer covering.

7. The endoluminal stent according to claim 6, wherein: The inner film completely covers the inner wall of the main body, and the outer film completely covers the outer wall of the main body. At the position where the spacing adjustment part is located, the inner film and the outer film form a suspended area, and the spacing adjustment part can move in the suspended area.

8. The endoluminal stent according to claim 6, wherein: The inner covering film completely covers the inner wall of the main body, and the outer covering film partially covers the outer wall of the main body so that the spacing adjustment part is exposed on the outside of the inner covering film; or the outer covering film completely covers the outer wall of the main body, and the inner covering film partially covers the inner wall of the main body so that the spacing adjustment part is exposed on the inside of the outer covering film.

9. The endoluminal stent according to claim 1, wherein: Anchor thorns are provided on the outer side of the main stent, and the anchor thorns are closer to the proximal end side of the main stent than the spacing adjustment part.

10. A stent system, comprising a conveyor, wherein the conveyor comprises a sheath tube and a push rod passing through the sheath tube, wherein: It also includes the luminal stent according to any one of claims 1 to 9, wherein the luminal stent is loaded in the sheath.

Images