Lumen stent and stent system

Abstract

The application discloses a lumen stent and a stent system, and relates to the technical field of medical devices. The lumen stent comprises a stent body and a covering film arranged on the stent body. The stent body comprises at least one deformed wave ring. The deformed wave ring comprises a plurality of wave crests and wave troughs which are sequentially connected in the circumferential direction. The covering film is at least partially connected with the wave crests and / or the wave troughs. When the lumen stent is in a curved state, the lumen stent comprises a small bending side. The wave crests and / or the wave troughs of the deformed wave ring at the small bending side are raised towards the radial outside of the deformed wave ring. At the position where the wave ring is raised, an outer protrusion is formed. The inner side of the outer protrusion forms a space for accommodating the covering film, thereby reducing the amount of the covering film stacked towards the radial inside of the wave ring, and reducing the obstruction of the lumen stent to blood flow.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a tubular stent and a stent system. BACKGROUND

[0002] This section provides background information only and can not necessarily be prior art.

[0003] For a vascular stent, the vascular stent includes a large bending side and a small bending side when it is bent. When it is bent, the vascular stent is prone to have a fold at the small bending side due to the stacking of the wave coils. In one case, the wave peaks and wave troughs of two adjacent wave coils at the small bending side form a stack, and the covering film is prone to form a fold after the wave peaks are stacked, which hinders blood flow and thus is prone to cause thrombosis. In another case, the bending angle between the two adjacent wave coils is too large, and the covering film is prone to fold inward.

[0004] Reference Figure 1 and Figure 2 As shown in FIGS. 1 and 2, from the outer surface of the vascular stent, the wave peak of the next wave coil is located at the inner side of the previous wave coil. At this time, the wave peak of the next wave coil is tilted inward at the inner side of the vascular stent and tilts in the direction opposite to the blood flow, and a stack is formed on the inner wall in the direction opposite to the blood flow. The stack is the fold described above.

[0005] The stack of the vascular stent hinders blood flow. SUMMARY

[0006] The purpose of the present application is to at least solve the problem that the wave coil stack at the small bending side causes the covering film to tilt inward and hinders blood flow. The purpose is achieved by the following technical solutions:

[0007] The first aspect of the present application provides a tubular stent, comprising:

[0008] a stent body and a covering film arranged on the stent body, the stent body comprising at least one deformed wave coil, the deformed wave coil comprising a plurality of wave peaks and wave troughs connected in sequence in the circumferential direction; and the covering film being connected to at least part of the wave peaks and / or wave troughs.

[0009] When the tubular stent is in a bent state, the tubular stent includes a small bending side, and the wave peak and / or wave trough of the deformed wave coil at the small bending side tilts outward in the radial direction of the deformed wave coil.

[0010] According to the tubular stent of the present application, when the tubular stent is in a bent state, the wave peak and / or wave trough at the small bending side tilts outward in the radial direction of the wave coil. At the tilted part of the wave coil, an outward protrusion is formed, and an inner side of the outward protrusion forms a space for accommodating the covering film, thereby reducing the amount of protrusion of the covering film stacked inward in the radial direction of the wave coil and reducing the hindrance to blood flow.

[0011] In addition, the tubular stent according to the present application can further have the following additional technical features.

[0012] In some embodiments of the present application, the plurality of deformed wave rings comprises a first deformed wave ring and a second deformed wave ring axially adjacent to each other, and at least part of the wave crest of the first deformed wave ring on the side of the smaller curvature is in abutment with at least part of the wave trough of the second deformed wave ring on the side of the smaller curvature.

[0013] In some embodiments of the present application, the plurality of deformed wave rings comprises a first deformed wave ring and a second deformed wave ring axially adjacent to each other, and at least part of the wave trough of the first deformed wave ring on the side of the smaller curvature is located between the two adjacent wave crests of the second deformed wave ring on the side of the smaller curvature.

[0014] In some embodiments of the present application, the covering film comprises an inner layer covering film and an outer layer covering film, the inner layer covering film is located on the inner side of the stent body, and the outer layer covering film is located on the outer side of the stent body, the inner layer covering film is connected to at least part of the wave crest and / or wave trough on the side of the smaller curvature, and the outer layer covering film is provided with at least one opening on the side of the smaller curvature, and at least part of the wave crest and / or wave trough is exposed from the opening.

[0015] In some embodiments of the present application, all the wave crests and / or wave troughs of the deformed wave ring on the side of the smaller curvature are completely exposed from the opening.

[0016] In some embodiments of the present application, the plurality of deformed wave rings comprises a first deformed wave ring and a second deformed wave ring axially adjacent to each other, the first deformed wave ring comprises a first wave trough on the side of the smaller curvature, the second deformed wave ring comprises a first wave crest on the side of the smaller curvature, and the first wave trough is oppositely arranged to the first wave crest.

[0017] In some embodiments of the present application, the angle of the first wave trough relative to the axis of the first deformed wave ring is smaller than the angle of the first wave crest relative to the axis of the second deformed wave ring.

[0018] In some embodiments of the present application, the length of the first wave trough is greater than the length of the first wave crest.

[0019] In some embodiments of the present application, on the side of the smaller curvature, the outer tilt angle of the wave trough of the plurality of deformed wave rings gradually increases from the proximal end to the distal end of the stent body, and the outer tilt angle of the wave crest of the plurality of deformed wave rings gradually increases from the proximal end to the distal end of the stent body.

[0020] In some embodiments of the present application, the deformed wave ring comprises a first state and a second state, when the deformed wave ring is in the first state, the wave crest and / or wave trough on the side of the smaller curvature is tilted towards the radial outside of the deformed wave ring, when the deformed wave ring is in the second state, the wave crest and wave trough on the side of the smaller curvature of the deformed wave ring are arranged along the axial direction of the deformed wave ring; the tubular stent can be switched from the second state to the first state.

[0021] In some embodiments of the present application, the deformation wave ring is switched from the second state to the first state under the control of temperature change of the deformation wave ring.

[0022] In some embodiments of the present application, the deformation temperature point of the deformation wave ring is greater than or equal to human body temperature.

[0023] In some embodiments of the present application, the deformation wave ring is made of one-way shape memory material.

[0024] A second aspect of the present application provides a stent system comprising a delivery device and the lumen stent of the first aspect of the present application, wherein the delivery device is used to deliver the lumen stent into the body.

[0025] The stent system of the present application comprises the lumen stent of the present application, and at least has the beneficial effects of the lumen stent of the present application.

[0026] In addition, the stent system according to the present application can also have the following additional technical features:

[0027] In some embodiments of the present application, the delivery device comprises a pushing part, a loading part, and a heating member, the pushing part is arranged in the loading part, and the heating member is arranged at the front end of the pushing part and / or the loading part; the lumen stent is loaded in the loading part, the pushing part is used to push the lumen stent to move in the loading part, and the heating member is used to heat the deformation wave ring. BRIEF DESCRIPTION OF DRAWINGS

[0028] Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The accompanying drawings are included to provide a description of the preferred embodiments and are not intended to limit the scope of the present application. Moreover, the same reference numerals are used throughout the drawings to represent similar components. In the drawings:

[0029] Figure 1 Shown is a schematic view of the prior art lumen stent arranged in a blood vessel;

[0030] Figure 2 For Figure 1 is an enlarged view of part A of FIG. 1;

[0031] Figure 3 Shown is a schematic view of the lumen stent in the blood vessel in the first embodiment of the present application;

[0032] Figure 4 is an enlarged view of part B of FIG. 2; Figure 3

[0033] Figure 5 Shown is a schematic view of one of the structural forms of the small bending side of the lumen stent provided by the present embodiment;

[0034] Figure 6 ​The diagram shown is a schematic of another structural form of the small bend side of the lumen support provided in Embodiment 1;

[0035] Figure 7 The diagram shown is a schematic diagram of another structural form of the small bend side of the lumen support provided in Embodiment 1;

[0036] Figure 8 The diagram shown is a simplified schematic of the unfolded structure of the wave loop in Embodiment 1;

[0037] Figure 9 The diagram shown is a schematic diagram of the waveguide in the second state according to Embodiment 2 of this application;

[0038] Figure 10 The diagram shown is a schematic diagram of the wave loop in the first state according to Embodiment 2 of this application;

[0039] Figure 11 The diagram shown is a schematic diagram of the structure of the outer film opening in Embodiment 2 of this application;

[0040] Figure 12 The diagram shown is a partial cross-sectional view of the coating in Embodiment 2 of this application;

[0041] Figure 13 The diagram shown is a schematic diagram of the support system provided in Embodiment 3 of this application;

[0042] Figure 14 What is shown is Figure 13 Partial schematic diagram, in which Figure 14 Partial sections are shown in sectional view form;

[0043] Figure 15 for Figure 14 Enlarged view of part E;

[0044] Figure 16 The diagram shown is of another support system provided in this embodiment, wherein... Figure 16 Partial sections are shown in sectional view form;

[0045] Figure 17 for Figure 16 Enlarged view of part D.

[0046] The attached figures are labeled as follows:

[0047] 1. Lumen stent; 2. Blood vessel;

[0048] 100. Deformed wave circle; 101. Trough; 102. Crest; 103. Main body; 110. First deformed wave circle; 111. First trough; 120. Second deformed wave circle; 121. First crest; a. First included angle; b. Second included angle; c. Third included angle; d. Fourth included angle; 130. Supporting wave circle

[0049] 200, film; 201, inner layer film; 202, outer layer film; 210, strip film; 220, pulling wire;

[0050] 300, pushing part; 301, loading part; 302, heating piece; 303, wire; 304, developing ring; 305, outer layer tube; 306, middle layer spring; 307, inner layer tube; 308, first handle; 309, second handle; 310, screw rod; 311, control part; 312, first lumen. DETAILED DESCRIPTION

[0051] Example embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings. While example embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present disclosure to those skilled in the art.

[0052] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order in which they are described, unless specifically identified as an order dependent step. It is also to be understood that additional or alternative steps can be employed.

[0053] Although the terms first, second, third, and the like can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second", and the like are used herein to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of example embodiments.

[0054] For the purposes of the description, a relative spatial term such as "inner", "outer", "lateral", "medial", "lower", "bottom", "upper", "top", and the like can be used herein for describing an element's or feature's relationship to another element or feature as illustrated in the figures. Such relative spatial terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, an element described as "below" or "beneath" another element or feature would then be oriented "above" or "over" the other element or feature. Thus, the example term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0055] As shown in FIG. 1, according to an embodiment of the present application, a luminal stent 1 is provided, which comprises a stent body and a covering 200 disposed on the stent body. The stent body comprises at least one deformed wave coil 100, which comprises a plurality of wave crests 102 and wave troughs 101 connected in sequence in the circumferential direction; the covering 200 is connected at least partially with the wave crests 102 and / or the wave troughs 101; when the luminal stent 1 is in a curved state, the luminal stent 1 comprises a small-bend side, and the wave crests 102 and / or the wave troughs 101 of the deformed wave coil 100 at the small-bend side are raised toward the radial outside of the deformed wave coil 100. Figures 3 to 8 As shown in FIG. 3 and FIG. 4, the stent body is a support structure of the covering 200, which comprises a support wave coil 130 and at least one deformed wave coil 100, the support wave coil 130 and the deformed wave coil 100 are arranged in the axial direction, the support wave coil 130 and the deformed wave coil 100 are both arranged in a ring shape, the deformed wave coil 100 is arranged in a wave shape in the circumferential direction, and the inflection point position at any one end in the axial direction on the deformed wave coil 100 is defined as a wave crest 102, and the inflection point position at the other end in the axial direction is defined as a wave trough 101. In the axial direction, the wave trough 101 of one of the two adjacent deformed wave coils 100 is adjacent to the wave crest 102 of the other deformed wave coil 100. The covering 200 is arranged on the deformed wave coil 100, and under the support of the deformed wave coil 100, the inside of the covering 200 forms a lumen, which forms a blood flow channel. The covering 200 is connected at least partially with the wave crests 102 and / or the wave troughs 101, so that the covering 200 can follow the shape of the wave crests 102 and / or the wave troughs 101 to form a corresponding shape, for example, at the outwardly raised position of the wave crest 102 / or the wave trough 101, the covering 200 is raised toward the radial outside of the deformed wave coil 100 following the outward raising of the wave crest 101 / or the wave trough 101.

[0056] Figure 4 As shown in FIG. 3 and FIG. 4, the stent body is a support structure of the covering 200, which comprises a support wave coil 130 and at least one deformed wave coil 100, the support wave coil 130 and the deformed wave coil 100 are arranged in the axial direction, the support wave coil 130 and the deformed wave coil 100 are both arranged in a ring shape, the deformed wave coil 100 is arranged in a wave shape in the circumferential direction, and the inflection point position at any one end in the axial direction on the deformed wave coil 100 is defined as a wave crest 102, and the inflection point position at the other end in the axial direction is defined as a wave trough 101. In the axial direction, the wave trough 101 of one of the two adjacent deformed wave coils 100 is adjacent to the wave crest 102 of the other deformed wave coil 100. The covering 200 is arranged on the deformed wave coil 100, and under the support of the deformed wave coil 100, the inside of the covering 200 forms a lumen, which forms a blood flow channel. The covering 200 is connected at least partially with the wave crests 102 and / or the wave troughs 101, so that the covering 200 can follow the shape of the wave crests 102 and / or the wave troughs 101 to form a corresponding shape, for example, at the outwardly raised position of the wave crest 102 / or the wave trough 101, the covering 200 is raised toward the radial outside of the deformed wave coil 100 following the outward raising of the wave crest 101 / or the wave trough 101.

[0057] ​The luminal stent 1 can be implanted into a blood vessel 2 or other organs. This embodiment mainly uses the implantation of the luminal stent 1 into a blood vessel 2 as an example. When the luminal stent 1 is in the blood vessel 2, the luminal stent 1 matches the contour of the blood vessel 2. Accordingly, at the bend of the blood vessel 2, the luminal stent 1 is in a bent state. In this bent state, the luminal stent 1 has a relatively large bend side and a small bend side at the bend position. The large bend side refers to the side with a larger bend radius when the luminal stent 1 is implanted into the blood vessel 2 and bends, and the small bend side refers to the side with a smaller bend radius. At the small bend side, the crest 102 can be set to bend radially outward toward the deformed wave loop 100, or the trough 101 can be set to bend radially outward toward the deformed wave loop 100, or both the crest 102 and the trough 101 can be set to bend radially outward toward the deformed wave loop 100.

[0058] It should be noted that the outward curvature of the crest 102 towards the deformed wave ring 100 can be achieved by bending the position of the crest 102 of the deformed wave ring 100 relative to the main body 103 of the deformed wave ring 100 (the main body 103 of the deformed wave ring 100 can be understood as the position between the trough 101 and the crest 102 of the deformed wave ring 100, and the axial extension direction of the main body 103 of the deformed wave ring 100 is consistent with the axial direction of the deformed wave ring 100) away from the center of the deformed wave ring 100, so that the crest 102 curves outward relative to the main body 103 of the deformed wave ring 100; similarly, the outward curvature of the trough 101 towards the deformed wave ring 100 can be achieved by bending the position of the trough 101 of the deformed wave ring 100 relative to the main body 103 of the deformed wave ring 100 away from the center of the deformed wave ring 100, so that the trough 101 curves outward relative to the main body 103 of the deformed wave ring 100.

[0059] The stent 1 tends to accumulate on the lesser bend, causing wrinkles in the diaphragm 200. In this embodiment, the stent 1 is modified by setting the peaks 102 and / or troughs 101 on the lesser bend to curve radially outward toward the deformed wave 100. The curved portion of the deformed wave 100 forms an outward convexity, and the inner side of the outward convexity forms a space to accommodate the diaphragm 200. The diaphragm 200 on the lesser bend curves outward along with the peaks 102 and / or troughs 101 and is located within the space to accommodate the diaphragm 200. The amount of convexity of the diaphragm 200 stacking radially inward on the lesser bend is reduced, thereby reducing obstruction to blood flow.

[0060] According to some embodiments of this application, optionally, in one implementation, such as Figure 5 As shown, on the small bend side, the axially adjacent crests 102 and troughs 101 are at least partially in contact.

[0061] The axially adjacent wave peak 102 and wave trough 101 are the wave peak 102 of one of the two deformed wave rings 100 (the second deformed wave ring 120) and the wave trough 101 of the other deformed wave ring 100 (the first deformed wave ring 110). At the small bending side, in the axially adjacent wave peak 102 and wave trough 101, only the wave peak 102 can be bent outwardly relative to the deformed wave ring 100 where the wave peak 102 is located, the wave trough 101 extends along the axial direction of the deformed wave ring 100 where the wave trough 101 is located, and the outwardly bent wave peak 102 is in contact with the wave trough 101 which is not bent outwardly; or only the wave trough 101 can be bent outwardly relative to the deformed wave ring 100 where the wave trough 101 is located, the wave peak 102 extends along the axial direction of the deformed wave ring 100 where the wave peak 102 is located, and the outwardly bent wave trough 101 is in contact with the wave peak 102 which is not bent outwardly; or both the wave peak 102 and the wave trough 101 can be bent outwardly relative to the deformed wave ring 100 where the wave peak 102 and the wave trough 101 are located, and the outwardly bent wave peak 102 is in contact with the outwardly bent wave trough 101.

[0062] At the small bending side, the axially adjacent wave peak 102 and wave trough 101 can be partially in contact or fully in contact. In the fully in contact mode, the wave peak 102 and the wave trough 101 are usually both bent outwardly relative to the deformed wave ring 100 where the wave peak 102 and the wave trough 101 are located, the axially adjacent wave peak 102 and wave trough 101 are parallel to each other after being bent outwardly and have the same length, and the wave peak 102 and the wave trough 101 are in contact with each other along the parallel direction of the wave peak 102 and the wave trough 101; in the partially in contact mode, one or both of the axially adjacent wave peak 102 and wave trough 101 can be bent outwardly relative to the deformed wave ring 100 where the wave peak 102 and the wave trough 101 are located.

[0063] It should be noted that, at the small bending side, the axially adjacent wave peak 102 and wave trough 101 can be sequentially arranged and in contact along the axial direction, or the axially adjacent wave peak 102 and wave trough 101 can be in contact with each other along the circumferential direction of the stent main body.

[0064] At the small bending side, the axially adjacent wave peak 102 and wave trough 101 are arranged to be at least partially in contact with each other, and the part of the wave peak 102 and the wave trough 101 in contact with each other can support each other, so as to generate sufficient traction on the film 200 at the small bending side, reduce the amount of stacking of the film 200 at the small bending side towards the radial inner side of the deformed wave ring 100, and facilitate the smoothness of blood flow.

[0065] It should be noted that, at the small bending side of the stent 1 of the present embodiment, the axially adjacent wave peak 102 and wave trough 101 are arranged to be in contact with each other only as a preferred implementation mode, and the axially adjacent wave peak 102 and wave trough 101 can also be arranged to be spaced apart from each other at the small bending side. For details, refer to FIG. 2. Figure 4 It should be noted that, at the small bending side of the stent 1 of the present embodiment, the axially adjacent wave peak 102 and wave trough 101 are arranged to be in contact with each other only as a preferred implementation mode, and the axially adjacent wave peak 102 and wave trough 101 can also be arranged to be spaced apart from each other at the small bending side. For details, refer to FIG. 2.

[0066] In an optional implementation of the embodiment, the lumen stent 1 further comprises a pulling wire (not shown in the figure), which is arranged at the crura commissurale side and connected with the covering film 200, and further connected with the wave crests 102 and / or wave troughs 101 at the crura commissurale side.

[0067] The pulling wire can be a braided wire. Among the wave crests 102 and / or wave troughs 101 connected with the pulling wire, at least part of the wave crests 102 and / or wave troughs 101 are tilted towards the radial outside of the deformed wave circle 100, so that the pulling wire can pull the covering film 200 under the action of the tilted wave crests 102 and / or wave troughs 101. Specifically, when the wave crests 102 and wave troughs 101 at the crura commissurale side are both tilted towards the radial outside of the deformed wave circle 100, the pulling wire can be connected with part of the wave troughs 101 or all of the wave troughs 101, or connected with part of the wave crests 102 or all of the wave crests 102; when only one of the wave crests 102 and wave troughs 101 at the crura commissurale side is tilted towards the radial outside of the deformed wave circle 100, the pulling wire 220 is connected with part or all of the tilted one.

[0068] By arranging the pulling wire, when the wave crests 102 or wave troughs 101 connected with the pulling wire are tilted, the wave crests 102 or wave troughs 101 pull the pulling wire, and the pulling wire, wave crests 102 and wave troughs 101 simultaneously drive the covering film 200 to move towards the radial outside of the deformed wave circle 100, increasing the pulling and constraint of the covering film 200.

[0069] According to some embodiments of the present application, optionally, as shown in Figure 6 The deformed wave circle 100 comprises an axially adjacent first deformed wave circle 110 and a second deformed wave circle 120, the first deformed wave circle 110 comprises a first wave trough 111 at the crura commissurale side, the second deformed wave circle 120 comprises a first wave crest 121 at the crura commissurale side, and the first wave trough 111 is arranged opposite to the first wave crest 121. Among them, the included angle of the first wave trough 111 relative to the axis of the first deformed wave circle 110 is smaller than the included angle of the first wave crest 121 relative to the axis of the second deformed wave circle 120.

[0070] Among the plurality of deformed wave circles 100 arranged in sequence along the axial direction, only part of the adjacent two deformed wave circles 100 can form the first deformed wave circle 110 and the second deformed wave circle 120, or any adjacent two deformed wave circles 100 among the plurality of deformed wave circles 100 arranged in sequence along the axial direction can form the first deformed wave circle 110 and the second deformed wave circle 120.

[0071] Referring to Figure 7As shown in FIG. 1, the first deformation wave ring 110 defines a first wave trough 111 at the wave trough 101 on the small bending side, and the second deformation wave ring 120 defines a first wave crest 121 at the wave crest 102 on the small bending side. The angle of the first wave trough 111 relative to the axis of the first deformation wave ring 110 is a first angle a. Since the main part 103 of the first deformation wave ring 110 extends along the axis of the first deformation wave ring 110, the first angle a can also be understood as the angle between the first wave trough 111 and the main part 103 of the first deformation wave ring 110. In other words, the first angle a is the angle of the first wave trough 111 relative to the first wave trough 111 in the outer buckling state. The angle of the first wave crest 121 relative to the axis of the second deformation wave ring 120 is a second angle b. Since the main part 103 of the second deformation wave ring 120 extends along the axis of the second deformation wave ring 120, the second angle b can also be understood as the angle between the first wave crest 121 and the main part 103 of the second deformation wave ring 120. In other words, the second angle b is the angle of the first wave crest 121 relative to the first wave crest 121 in the buckling state.

[0072] The angle of the wave trough 101 relative to the axis of the first deformation wave ring 110 is smaller than the angle of the first wave crest 121 relative to the axis of the second deformation wave ring 120. It is to be noted that the adjacent wave crest 102 and wave trough 101 have different outer buckling angles. Since the axial direction can be the direction along the blood flow or the direction against the blood flow, in this embodiment, the first deformation wave ring 110 and the second deformation wave ring 120 can be sequentially arranged along the blood flow direction.

[0073] The embodiment can provide better adaptability when the lumen stent 1 needs to be bent at a large angle by setting the angle of the first wave trough 111 relative to the axis of the first deformation wave ring 110 to be smaller than the angle of the first wave crest 121 relative to the axis of the second deformation wave ring 120.

[0074] Optionally, as shown in FIG. 1, the length of the first wave trough 111 can also be set to be greater than the length of the first wave crest 121. Figure 6 Figure 7 As shown in FIG. 1, the length of the first wave trough 111 can also be set to be greater than the length of the first wave crest 121.

[0075] As shown in FIG. 1, the length of the first wave trough 111 can also be set to be greater than the length of the first wave crest 121. Figure 8 As shown in FIG. 1, the length of the first wave trough 111 can also be set to be greater than the length of the first wave crest 121.

[0076] According to some embodiments of the present application, as shown in FIG. 1, the length of the first wave trough 111 can also be set to be greater than the length of the first wave crest 121.​Figure 7 As shown, the outer deflection angle of the wave trough 101 of the plurality of deformed wave circles 100 increases in sequence along the distal end direction of the main body stent, and the outer deflection angle of the wave crest 102 of the plurality of deformed wave circles 100 increases in sequence along the distal end direction of the main body stent.

[0077] The outer deflection angle of the wave trough 101 is the included angle of the wave trough 101 relative to the axis of the deformed wave circle 100 in which the wave trough 101 is located, and the outer deflection angle of the wave crest 102 is the included angle of the wave crest 102 relative to the axis of the deformed wave circle 100 in which the wave crest 102 is located.

[0078] The outer deflection angle of the wave trough 101 of the plurality of deformed wave circles 100 can increase in sequence along the blood flow direction; similarly, the outer deflection angle of the wave crest 102 of the plurality of deformed wave circles 100 can increase in sequence along the blood flow direction. In this embodiment, the end where the blood flow of the main body stent flows in is defined as the proximal end, and the end where the blood flow flows out is defined as the distal end, and the distal end direction refers to the direction of the end where the blood flow of the main body stent flows out. In this embodiment, with reference to Figure 7 As shown, the outer deflection angle of the wave crest 102 of the first deformed wave circle 110 is represented by a fourth included angle d, and the outer deflection angle of the wave crest 102 of the second deformed wave circle 120 is represented by a third included angle c, and the fourth included angle d is greater than the third included angle c.

[0079] By increasing the deformation amount of the wave trough 101 of the axially adjacent deformed wave circle 100 in sequence and increasing the deformation amount of the wave crest 102 of the axially adjacent deformed wave circle 100 in sequence, the outer deflection part of the stent main body gradually changes along the axial direction, and the corresponding lumen stent 1 can better adapt to the end of the blood vessel 2.

[0080] According to some embodiments of the present application, optionally, with reference to Figure 8 As shown, the axially adjacent wave crest 102 and wave trough 101 are arranged in sequence and alternately in the circumferential direction of the stent main body.

[0081] For ease of description, the two axially adjacent deformed wave circles 100 are defined as the first deformed wave circle 110 and the second deformed wave circle 120, the first deformed wave circle 110 includes a first wave trough 111 located at the small bending side, and the second deformed wave circle 120 includes a first wave crest 121 located at the small bending side, and the first wave trough 111 and the first wave crest 121 are arranged adjacent to each other.

[0082] The axially adjacent wave crest 102 and wave trough 101 arranged in sequence and alternately in the circumferential direction of the stent main body can be understood as, with reference to Figure 11, on the small bending side, the first wave trough 111 and the first wave peak 121 are alternately arranged along the circumference of the stent main body, that is, any one of the first wave trough 111 is arranged between two first wave peaks 121 arranged along the circumference of the stent main body in sequence, and any one of the first wave peak 121 is arranged between two first wave troughs 111 arranged along the circumference of the stent main body in sequence.

[0083] It should be noted here that, Figure 8 The partial schematic diagram of the first deformed wave ring 110 and the second deformed wave ring 120 on the small bending side is shown in the manner of unfolding the deformed wave ring 100, Figure 11 The first wave trough 111 and the first wave peak 121 on the small bending side are in a state of not yet being outwardly warped. That is, in the axial direction of the stent main body, the first wave trough 111 and the first wave peak 121 can be arranged in sequence, or the first wave trough 111 can extend into the circumferentially adjacent two first wave peaks 121, and the first wave peak 121 can extend into the circumferentially adjacent two first wave troughs 111.

[0084] By alternately arranging the axially adjacent wave peaks 102 and wave troughs 101 along the circumference of the stent main body on the small bending side, the wave peaks 102 and wave troughs 101 on the two deformed wave rings 100 axially adjacent to each other are circumferentially staggered (i.e., there is a wave peak 101 between the circumferentially adjacent two wave troughs 101), so that the wave peaks 102 and wave troughs 101 on the small bending side can more uniformly and densely support the points of the covering film 200 in the circumferential direction, thereby enabling the wave peaks 102 and wave troughs 101 to better support the covering film 200 on the small bending side and generate sufficient traction on the covering film 200 on the small bending side, thereby avoiding the accumulation of the covering film 200 on the small bending side.

[0085] Embodiment Two

[0086] The difference between this embodiment and Embodiment One is that, as shown in Figure 9 , Figure 10 The deformed wave ring 100 includes a first state and a second state. When the deformed wave ring 100 is in the first state, the wave peak 102 and / or the wave trough 101 are warped toward the radial outer side of the deformed wave ring 100. When the deformed wave ring 100 is in the second state, the wave peak 102 and the wave trough 101 of the deformed wave ring 100 are arranged along the axial direction of the deformed wave ring 100; the luminal stent 1 can be switched from the second state to the first state.

[0087] The first state of the deformed wave ring 100 is shown in Figure 9 The first state usually refers to the state of the luminal stent 1 implanted in the blood vessel 2, and can also refer to the state of the wave peak 101 and the wave trough 102 warped toward the radial outer side. The second state of the luminal stent 1 is shown in Figure 10As shown, when the tubular stent 1 is in the second state, the peaks 102 and the troughs 101 of the tubular stent 1 are not outwardly protruded, and the tubular stent 1 can be stored or loaded by a delivery device in the second state. The delivery device is a delivery instrument for implanting the tubular stent 1 into an organ such as a blood vessel 2.

[0088] Specifically, the deformed wave ring 100 can be switched from the second state to the first state under the control of the change of the environment, for example, the deformed wave ring 100 can be switched from the second state to the first state under the control of the change of the environmental temperature or the change of the tension.

[0089] According to the embodiment, when the tubular stent 1 is loaded into the delivery device, the tubular stent 1 is in the second state, and the peaks 102 and the troughs 101 are arranged along the axial direction of the deformed wave ring 100, so as to avoid the outward protrusion of the peaks 102 and the troughs 101, which can cause excessive friction with the sheath of the delivery device and damage the covering film 200. During the release of the tubular stent 1, the tubular stent 1 can be deformed from the second state to the first state, so as to pull the covering film 200 towards the outside of the tubular stent 1, and avoid the inward protrusion of the covering film 200 which can hinder the blood flow.

[0090] Further, in a specific embodiment, the deformed wave ring 100 is switched from the second state to the first state under the control of the change of the temperature of the deformed wave ring 100.

[0091] Specifically, when the deformed wave ring 100 is below the deformation temperature point, the deformed wave ring 100 is in the second state, and when the deformation temperature of the deformed wave ring 100 exceeds the deformation temperature point, the deformed wave ring 100 is switched from the second state to the first state. The change of the temperature of the deformed wave ring 100 can be achieved by the heating element built in the delivery device, or the deformed wave ring 100 can be heated by the temperature of the human body in the blood.

[0092] Preferably, in the embodiment, the deformation temperature point of the deformed wave ring 100 can be greater than or equal to the temperature of the human body.

[0093] By setting the deformation temperature point of the deformed wave ring 100 to be greater than or equal to the temperature of the human body, the deformed wave ring 100 is switched from the second state to the first state only when the temperature of the deformed wave ring 100 is equal to or greater than the temperature of the human body. During the implantation of the tubular stent 1 into the human body, the tubular stent 1 can be stably maintained in the second state, and the deformed wave ring 100 can be heated by the delivery device to force the tubular stent 1 to be switched from the second state to the first state, which has good controllability.

[0094] According to some embodiments of the present application, the deformed wave ring 100 is made of a one-way shape memory material.

[0095] Specifically, the single-pass shape memory material can be a memory material deformed under the control of temperature. Specifically, it can be a titanium-nickel-based shape memory alloy, a copper-based shape memory alloy, an iron-based shape memory alloy, etc. This embodiment takes a nickel-titanium-based shape memory alloy as an example to illustrate the single-pass memory processing: anneal the NiTi alloy material at a high temperature of 800°C or above, then shape it at room temperature, and then place it in a temperature of 200-300°C for several minutes to several tens of minutes. In other embodiments, a single-pass shape memory alloy can also be obtained through processes such as medium-temperature treatment and aging treatment.

[0096] The deformed wave ring 100 is made of a single-pass shape memory material, so that after the lumen stent 1 is switched from the second state to the first state, the lumen stent 1 can maintain a stable shape in the body, improving the stability of the blood vessel 2 stent in the body.

[0097] According to some embodiments of the present application, optionally, referring to Figure 11 、 Figure 12 The coating 200 includes an inner coating 201 and an outer coating 202, the inner coating 201 is located on the inner side of the stent body, and the outer coating 202 is located on the outer side of the stent body. The inner coating 201 is connected to at least part of the wave peaks 102 and / or wave troughs 101 on the small bending side, and the outer coating 202 is provided with at least one opening on the small bending side, and at least part of the wave peaks 102 and / or wave troughs 101 are exposed from the opening.

[0098] The inner side of the stent body is the side of the plurality of deformed wave rings 100 facing the radial center of the deformed wave ring 100, and the outer side of the stent body is the side of the plurality of deformed wave rings 100 away from the radial center of the deformed wave ring 100. The inner coating 201 and the outer coating 202 are both fixed on the stent body, the inner coating 201 is arranged on the inner side of the stent body, and the outer coating 202 is arranged on the outer side of the stent body. The inner coating 201 and the outer coating 202 can be connected to any position of the deformed wave ring 100, and there can be multiple fixed points between the coating 200 and the deformed wave ring 100, so that the inner coating 201 and the outer coating 202 are more stably fixed on the stent body.

[0099] In order to avoid the accumulation of the inner coating 201 on the small bending side, the inner coating 201 is connected to at least part of the wave peaks 102 and / or wave troughs 101 on the small bending side, so that the inner coating 201 at the position of the small bending side can be pulled outward under the action of the outwardly curved wave peaks 102 and / or wave troughs 101.

[0100] It should be noted that, in order to ensure that the outward convexity of the deformed corrugation 100 can have a good pulling effect on the coating 200, when both the crests 102 and troughs 101 on the small bend side are raised radially outward relative to the deformed corrugation 100, the inner coating 201 can be connected to some or all of the crests 102 on the small bend side, or it can be connected to some or all of the troughs 101 on the small bend side; when only the crests 102 on the small bend side are raised... When the trough 101 is raised radially outward relative to the deformed wave ring 100, while the trough 101 is not raised outward, the inner layer coating 201 should at least be connected to part or all of the wave crests 102; when only the trough 101 is raised radially outward relative to the deformed wave ring 100, while the wave crest 102 is not raised outward, the inner layer coating 201 should at least be connected to part or all of the trough 101.

[0101] The outer coating 202 has an opening on the small bend side. Specifically, the outer coating 202 may have an opening at the position of multiple troughs 101 and / or peaks 102 on the small bend side, or the outer coating 200 may have an opening that can cover the entire small bend side, or the outer coating 202 may have an opening at the position of some troughs 101 and / or peaks 102 on the small bend side.

[0102] In one implementation, refer to Figure 11 As shown, Figure 11 The diagram shows the lumen support 1 in an unbent state; the outer membrane 200 is provided with multiple strip membranes 210 on the small bend side, and the multiple strip membranes 210 are arranged sequentially at intervals along the axial direction of the support body, and an opening is formed between adjacent strip membranes 210, which corresponds to the peak 102 or trough 101 of the deformed wave ring 100.

[0103] Understandably, the inner coating 201 is connected to at least a portion of the crests 102 and / or troughs 101 on the small bend side, allowing the inner coating 201 to be pulled by the outwardly curved crests 102 and / or troughs 101, thus preventing the inner coating 201 from accumulating radially inward toward the deformed corrugation 100. Simultaneously, the outer coating 202 has an opening where there is no outer coating 202, preventing the outer coating 202 from accumulating on the small bend side and reducing the constraint of the outer coating 202 on the outward curvature of the crests 102 and / or troughs 101, thereby reducing the deformation effect of the outer coating 202 on the outward curvature of the crests 102 and troughs 101.

[0104] In one implementation, the opening completely covers the portion of the deformed wave ring 100 located on the small bend side.

[0105] That is, no outer film 202 is provided at the position corresponding to the small bend side, so that the part of the deformed wave ring 100 on the small bend side is completely exposed.

[0106] This method can minimize the impact of the outer coating 202 on the outward warping deformation of the crests 102 and / or troughs 101 on the small bend side.

[0107] Example 3

[0108] like Figures 13 to 17 As shown, this application embodiment also provides a stent system, including a delivery device and a lumen stent 1 proposed in this embodiment. The delivery device is used to deliver the lumen stent 1 into the body.

[0109] Among them, such as Figure 13 , 14 As shown, the conveying device includes a pushing part 300 and a loading part 301. The loading part 301 includes a sheath. The pushing part 300 is disposed in the loading part 301. The lumen support 1 is loaded in the loading part 301. The pushing part 300 is used to push the lumen support 1 to move in the loading part 301 so that the lumen support 1 can be released from the front end of the sheath.

[0110] To facilitate the pushing of the lumen support 1 by the pushing unit 300, the loading unit 301 further includes a first handle 308, which is externally disposed and fixedly connected to the sheath. The pushing unit 300 includes a push rod, a screw 310, and a second handle 309. The second handle 309 is connected to the screw 310, and the screw 310 is connected to the push rod. The push rod is used to contact the lumen support 1. The second handle 309 is connected to the first handle 308 and is externally disposed. The second handle 309 can rotate to drive the screw 310 to move the push rod along the axial direction of the sheath, thereby causing the push rod to push the lumen support 1 to move.

[0111] like Figure 15 As shown, in this embodiment, the loading part 301 or the pushing part 300 of the delivery device is also provided with a imaging ring 304 to facilitate observation of the position of the lumen stent 1 during delivery into the body.

[0112] The delivery device of the delivery instrument in this embodiment can deliver the lumen stent 1 into the body, so that the lumen stent 1 can be implanted through minimally invasive surgery, which causes less trauma to the patient.

[0113] Furthermore, in order to facilitate the transformation of the lumen support 1 from the second state to the first state by heating, the conveying device also includes a heating element 302, which is disposed at the front end of the pushing part 300 and / or the loading part 301.

[0114] The front end of the pusher 300 and the loading 301 refers to the end of the pusher 300 and the loading 301 that penetrates into the human body, that is, the end that is far away from the operating end.

[0115] Referring to Figure 13 , Figure 14 and Figure 15 , in one implementation, the sheath tube comprises an outer tube 305, a middle spring 306 and an inner tube 307, wherein the outer tube 305 is sleeved outside the inner tube 307, the middle spring 306 is sleeved outside the inner tube 307 and inside the outer tube 305, the pushing part 300 is arranged inside the inner tube 307 and can move along the axial direction of the inner tube 307. The heating part 302 is arranged at the front end of the loading part 301, specifically, the length of the front end of the outer tube 305 is greater than the length of the inner tube 307 and the middle spring 306, and the inner side of the front end of the outer tube 305 is provided with a developing ring 304, the inner side of the developing ring 304 is provided with the heating part 302, and the heating part 302 is located at the front end of the inner tube 307 and can contact the lumen stent 1. The heating part 302 can be an electrode, and the wire 303 of the electrode is arranged in the sheath tube, one end of the wire 303 is connected with the electrode, and the other end extends to the outside of the body along the axial direction of the sheath tube and is connected with the power supply.

[0116] In another implementation, referring to Figure 17 , the front end of the push rod of the pushing part 300 is provided with a lumen, and the heating part 302 is arranged in the lumen. After the lumen stent 1 is transported into the body and moved to the position, the heating part 302 contacts the deformed wave coil 100 of the lumen stent 1 and heats the deformed wave coil 100. In this implementation, the heating part 302 can also be an electrode, and the wire 303 of the electrode can be arranged in the wall of the push rod.

[0117] By arranging the heating part 302, after the lumen stent 1 is arranged in place, the heating part 302 can heat the deformed wave coil 100, so that the lumen stent 1 is switched from the second state to the first state, which is convenient to operate; and the deformation of the lumen stent 1 is realized by heating the lumen stent 1 by the heating part 302, so that the controllability is higher.

[0118] It should be noted that the lumen stent in Figures 3 to 8 of the present embodiment is exposed to show the structure of the wave coil. Actually, after the preparation is completed, the wave coil is covered in the outer film. Figure 13 and Figure 16 In order to show the position of the lumen stent in the delivery device, the lumen stent

[0119] is exposed; Figure 14 and Figure 16 In order to show the internal structure of the delivery device, it is partially shown in the way of sectional view.

[0120] The above description is only the preferred embodiment of the present application, but the protection scope of the present application is not limited to this, any person skilled in the art can easily think of the changes or replacements within the technical range disclosed by the present application, which should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A lumen stent, characterized in that, include: The support body and the covering film disposed on the support body, the support body including at least one deformable wave ring, the deformable wave ring including a plurality of wave crests and troughs connected sequentially in the circumferential direction; the covering film is at least partially connected to the wave crests and / or the troughs; When the lumen stent is in a bent state, the lumen stent includes a small bend side, and the crest and / or trough of the deformed wave ring at the small bend side is raised radially outward toward the deformed wave ring, and the coating at the small bend side follows the crest and / or trough and is raised outward.

2. The lumen stent according to claim 1, characterized in that, The deformable corrugations are two or more, and the lumen support includes an axially adjacent first deformable corrugation and a second deformable corrugation, wherein the crest of the first deformable corrugation on the small bend side and the trough of the second deformable corrugation on the small bend side are at least partially in contact.

3. The lumen stent according to claim 1, characterized in that, The deformable wave rings are two or more, and the lumen support includes an axially adjacent first deformable wave ring and a second deformable wave ring. On the small bend side, at least a portion of the trough of the first deformable wave ring is located between two adjacent peaks of the second deformable wave ring.

4. The lumen stent according to claim 1, characterized in that, The coating includes an inner coating and an outer coating. The inner coating is located inside the support body, and the outer coating is located outside the support body. The inner coating is connected to at least a portion of the crests and / or troughs on the small bend side. The outer coating has at least one opening on the small bend side, through which at least a portion of the crests and / or troughs are exposed.

5. The lumen stent according to claim 4, characterized in that, All peaks and / or troughs of the deformed wave ring on the small bend side are fully exposed from the opening.

6. The lumen stent according to claim 1, characterized in that, The deformable wave ring includes an axially adjacent first deformable wave ring and a second deformable wave ring. The first deformable wave ring includes a first wave trough located on the small bend side, and the second deformable wave ring includes a first wave peak located on the small bend side. The first wave trough and the first wave peak are arranged opposite to each other. Wherein, the angle between the first trough and the axis of the first deformed wave ring is smaller than the angle between the first crest and the axis of the second deformed wave ring.

7. The lumen stent according to claim 6, characterized in that, The length of the first trough is greater than the length of the first peak.

8. The lumen stent according to claim 1, characterized in that, On the small bend side, the outward tilt angle of the troughs of the multiple deformed wave rings increases sequentially from the near end to the far end of the main support, and the outward tilt angle of the peaks of the multiple deformed wave rings increases sequentially from the near end to the far end of the main support.

9. The lumen stent according to claim 1, characterized in that, The deformable wave ring includes a first state and a second state. When the deformable wave ring is in the first state, the wave crests and / or troughs on the small bend side are raised towards the radially outer side of the deformable wave ring. When the deformable wave ring is in the second state, the wave crests and troughs on the small bend side of the deformable wave ring are both arranged along the axial direction of the deformable wave ring. The lumen support can switch from the second state to the first state.

10. The lumen stent according to claim 9, characterized in that, The deformable waveguide switches from the second state to the first state under the control of the temperature change of the deformable waveguide.

11. The lumen stent according to claim 10, characterized in that, The deformation temperature point of the deformable wave coil is greater than or equal to human body temperature.

12. The lumen stent according to claim 9, characterized in that, The deformable waveband is made of a single-pass shape memory material.

13. A support system, characterized in that, It includes a delivery device and a luminal stent as described in any one of claims 1-12, the delivery device being used to deliver the luminal stent into the body.

14. The support system according to claim 13, characterized in that, The conveying device includes a pushing part, a loading part, and a heating element. The pushing part is disposed within the loading part, and the heating element is disposed at the front end of the pushing part and / or the loading part. The lumen support is loaded within the loading part. The pushing part is used to push the lumen support to move within the loading part, and the heating element is used to heat the deformable wave coil.

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