A segmented bare stent

Abstract

The present invention provides a segmented bare stent, the segmented bare stent includes a tubular stent formed by a plurality of axially connected wavy support members, the wavy support members are annular structures arranged in a wave shape; the tubular stent includes a proximal support mechanism, a middle support mechanism and a distal support mechanism connected in sequence; the proximal support mechanism includes a proximal end face, and the proximal end face is perpendicular to the axis of the proximal support mechanism. The tubular stent in the segmented bare stent provided by the present invention is formed by a wavy support member of an annular structure, which has good radial support force, and is flush with the proximal end face of the proximal support mechanism, so that the proximal support structure has a strong support force in the circumferential direction when applied to a bifurcated blood vessel, which can prevent the proximal support mechanism from being deformed by the nearby arterial stent or the hard tissue near the bifurcated blood vessel when used in the bifurcated blood vessel.

Description

Technical Field

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

[0002] With the rapid development of modern society, the aging of the population has intensified, people's work pressure has continued to increase, and their living habits are not healthy enough, resulting in frequent cardiovascular diseases in my country, which have become the number one disease endangering the health of the Chinese people. Its prevention and treatment has become the focus of attention of the medical community at home and abroad. Among them, efficient and minimally invasive interventional treatments such as implantation of vascular stents are currently the most important and effective cardiovascular disease diagnosis and treatment technologies. For vascular stenosis or occlusive lesions, vascular stents can be implanted to support and expand the diseased blood vessels, so that the blood flow of the diseased blood vessels can be restored.

[0003] For example, patients with bifurcated vascular lesions are patients with iliac vein compression syndrome. Since the left common iliac vein is compressed by the right common iliac artery and the fifth lumbar vertebra, this continuous mechanical compression and arterial pulsation cause adhesion, intimal hyperplasia, and fibrosis in the venous cavity, causing stenosis and occlusion of the lumen, resulting in venous reflux obstruction in the left lower limb. Therefore, the stent used here needs to have a strong support force. However, there are few specialized venous stents on the market. Arterial stents are mainly used in the clinical treatment of iliac vein stenosis, and the radial support force of arterial stents is weak and cannot meet the requirements. In addition, the iliac vein runs along the pelvis and has physiological curvature, so it needs to have good flexibility. In order to meet the support force requirements of different sections of the iliac vein area, the stent must have sufficient radial support force in one of the sections to offset the radial pressure applied by the vascular wall; at the same time, the stent must have sufficient flexibility in the axial direction in the other section to prevent kinking at the junction or bending part of the blood vessel, resulting in reduced blood flow in the blood vessel. Therefore, it is necessary to design a stent that takes into account both radial support force and flexibility to adapt to the different requirements of radial support force and flexibility of the stent at different locations of the diseased blood vessels. Summary of the invention

[0004] In view of this, the present invention provides a segmented bare stent suitable for bifurcated vascular lesions. The specific technical solution is as follows.

[0005] A segmented bare stent, the segmented bare stent includes a tubular stent formed by a plurality of axially connected wavy support members, the wavy support members are annular structures arranged in a wave-like shape; the tubular stent includes a proximal support mechanism, a middle support mechanism and a distal support mechanism connected in sequence; the proximal support mechanism includes a proximal end face, and the proximal end face is perpendicular to the axis of the proximal support mechanism.

[0006] Preferably, the wavy support member includes a first wavy support member, a second wavy support member and a third wavy support member; the proximal support mechanism includes a plurality of axially connected first wavy support members, the middle zone support mechanism includes a plurality of axially connected second wavy support members, and the distal support mechanism includes a plurality of axially connected third wavy support members.

[0007] Preferably, the first wave-shaped support member is composed of first support units connected end to end, the first support unit is composed of a first wave crest, a first wave trough, and a first wave rod connected between the first wave crest and the first wave trough, and the first wave crest is arranged closer to the proximal end than the first wave trough;

[0008] The second wave-shaped support member is composed of second support units connected end to end, the second support unit is composed of a second wave crest, a second wave trough, and a second wave rod connected between the second wave crest and the second wave trough, and the second wave crest is arranged closer to the proximal end than the second wave trough;

[0009] The third wave-shaped support member is composed of third support units connected end to end, and the third support unit is composed of a third wave crest, a third wave trough and a third wave rod connected between the third wave crest and the third wave trough, and the third wave crest is arranged closer to the proximal end than the third wave trough.

[0010] Preferably, the first wave crest in the first wave-shaped support member is connected to the first wave trough in the first wave-shaped support member which is axially adjacent and close to the proximal end, so that the proximal support mechanism forms a grid-like structure.

[0011] Preferably, the distance between two adjacent first wave crests in the first wave-shaped support members is equal to the distance between two adjacent first wave troughs in the first wave-shaped support members which are axially adjacent to each other.

[0012] Preferably, the first wave crests in the first wave-shaped support member closest to the proximal end are located on the same plane to form the proximal end surface.

[0013] Preferably, the third wave crest in the third wave-shaped support member is connected to the third wave trough in the third wave-shaped support member which is axially adjacent and close to the proximal end, so that the distal support mechanism forms a grid-like structure.

[0014] Preferably, the distance between two adjacent third wave crests in the third wave-shaped support member is equal to the distance between two adjacent third wave troughs in the third wave-shaped support members which are axially adjacent to each other.

[0015] Preferably, the segmented bare stent also includes a development mark, which is arranged on the first wavy support member connecting the proximal support mechanism and the middle zone support mechanism; or on the third wavy support member connecting the distal support mechanism and the middle zone support mechanism; or on the second wavy support member connecting the middle zone support mechanism and the proximal support mechanism; or on the second wavy support member connecting the middle zone support mechanism and the distal support mechanism.

[0016] Preferably, the development mark is arranged on the first wave-shaped support member connecting the proximal support mechanism and the middle support mechanism, including the development mark being arranged at the first wave valley position of the proximal support mechanism closest to the middle support mechanism;

[0017] The third wave-shaped support member disposed on the connection between the distal support mechanism and the middle support mechanism includes a third wave crest position disposed on the distal support mechanism closest to the middle support mechanism;

[0018] A second wave-shaped support member disposed on the connection between the middle support mechanism and the proximal support mechanism includes a second wave crest position disposed on the middle support mechanism closest to the proximal support mechanism;

[0019] The second wave-shaped support member disposed on the connection between the middle support mechanism and the distal support mechanism includes a second wave valley position disposed on the middle support mechanism closest to the distal support mechanism.

[0020] Preferably, the development mark is fixed on the corrugated support member by stamping, hot pressing, sewing or winding.

[0021] Preferably, the material for forming / making the development mark includes one or more of gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, and tantalum.

[0022] Preferably, the tubular stent further includes a connecting assembly, through which the proximal support mechanism and the middle region support mechanism, the middle region support mechanism and the distal support mechanism, or two adjacent second wavy support members in the middle region support mechanism are connected.

[0023] Preferably, the connecting assembly comprises at least one connecting rod, and the connection between the proximal support mechanism and the middle region support mechanism via the connecting assembly comprises the connection between the first wave crest and / or the first wave trough of the first wave-shaped support member in the proximal support mechanism and the second wave rod of the second wave-shaped support member in the middle region support mechanism via the connecting rod;

[0024] The connection assembly connects two adjacent second wavy support members in the middle zone support mechanism, including the connection between the second wave crest and / or second wave trough of the second wavy support member in the middle zone support mechanism and the second wave bar of the adjacent second wavy support member through the connecting rod;

[0025] The middle area support mechanism and the distal end support mechanism are connected via the connecting assembly, including the connection between the second wave rod of the second wavy support member in the middle area support mechanism and the third wave peak and / or third wave trough of the third wavy support member in the distal end support mechanism via the connecting rod.

[0026] Preferably, the connection components are evenly distributed along the circumference of the tubular support.

[0027] Preferably, the connecting assembly comprises at least two connecting rods.

[0028] Preferably, two adjacent connecting rods are arranged in an eight-shaped or inverted eight-shaped shape.

[0029] Preferably, the distance between two adjacent connecting rods is at least the distance between two adjacent first wave valleys, or at least the distance between two adjacent second wave valleys, or at least the distance between two adjacent third wave peaks.

[0030] Preferably, the projections of the axially adjacent connecting components do not overlap or partially overlap in the axial direction.

[0031] Preferably, the proximal end of the proximal support mechanism gradually extends and expands outside the tubular stent from the distal end to the proximal end.

[0032] Preferably, the proximal end of the proximal support mechanism extends outward from the tubular stent to form an expansion portion, and an angle β between an outer contour line of the expansion portion and a central axis of the stent satisfies: 30°≥β>0°.

[0033] Beneficial effects of the present invention: The tubular stent in the segmented bare stent provided by the present invention is formed by a wavy support member with an annular structure, which has good radial supporting force, and the proximal end face of the proximal supporting mechanism is flush, so that the proximal supporting structure has a strong supporting force in the circumferential direction when applied to a bifurcated blood vessel, and can avoid the proximal supporting mechanism being deformed by the nearby arterial stent or the hard tissue near the bifurcated blood vessel when used in the bifurcated blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic structural diagram of a segmented bare stent provided in the first embodiment of the present invention.

[0035] Figure 2 for Figure 1 Schematic diagram of the expansion.

[0036] Figure 3 for Figure 2 Schematic diagram of the structure of the proximal support mechanism.

[0037] Figure 4 for Figure 2 Schematic diagram of the structure of the distal support mechanism.

[0038] Figure 5 A schematic structural diagram of a segmented bare stent provided for the second embodiment of the present invention.

[0039] Figure 6 for Figure 5 A partial enlarged view of part A.

[0040] Figure 7 A schematic structural diagram of a segmented bare stent provided for the third embodiment of the present invention.

[0041] Figure 8 A schematic structural diagram of a segmented bare stent provided in the fourth embodiment of the present invention.

[0042] Fig. 9 A schematic structural diagram of a segmented bare stent provided for the fifth embodiment of the present invention.

[0043] Fig.10 A schematic structural diagram of a segmented bare stent provided for the sixth embodiment of the present invention.

[0044] Fig.11 A schematic structural diagram of a segmented bare stent provided for the seventh embodiment of the present invention.

[0045] Fig.12 for Fig.11 A partial enlarged view of part B.

[0046] Fig.13 for Fig.11 A partial enlarged view of part C.

[0047] Fig.14 for Fig.11 A partial enlarged view of part D.

[0048] Fig.15 A schematic structural diagram of a segmented bare stent provided for the eighth embodiment of the present invention.

[0049] Fig.16 A schematic structural diagram of a segmented bare stent provided for the ninth embodiment of the present invention.

[0050] Fig.17 A schematic structural diagram of a segmented bare stent provided for the tenth embodiment of the present invention.

[0051] Fig.18 A schematic structural diagram of a segmented bare stent provided for the eleventh embodiment of the present invention.

[0052] Fig.19 A schematic structural diagram of a segmented bare stent provided for the twelfth embodiment of the present invention.

[0053] Fig. 20 A schematic structural diagram of a segmented bare stent provided for the twelfth embodiment of the present invention.

[0054] Fig.21 A schematic structural diagram of a segmented bare stent provided for the twelfth embodiment of the present invention. DETAILED DESCRIPTION

[0055] The following is a preferred embodiment of the present invention. It should be noted that a person skilled in the art may make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

[0056] Definition of orientation: The proximal end in the present invention refers to the end of the stent close to the heart after the stent is implanted in the blood vessel; the following structure refers to the structure of the stent after expansion. The axial direction refers to the central axis direction of the stent, and the direction perpendicular to the central axis is the radial direction.

[0057] See also Figure 1 and Figure 2 The first embodiment of the present invention provides a segmented bare stent 10, which includes a plurality of wavy supports 200 connected together axially, and the wavy supports 200 are annular structures arranged in a wave shape. The tubular stent 100 includes a proximal support mechanism 110, a middle support mechanism 120, and a distal support mechanism 130 connected in sequence. It can be understood that the wavy supports 200 refer to an annular structure formed by connecting the circumferential ends in a wave shape. The entire wavy support 200 can be an integral structure or a fixed connection.

[0058] It can be understood that, since the corrugated support member 200 is an annular structure arranged in a wave shape, the proximal support mechanism 110, the middle support mechanism 120 and the distal support mechanism 130 formed by the corrugated support member 200 are also annular structures in the circumferential direction. The proximal support mechanism 110, the middle support mechanism 120 and the distal support mechanism 130 are arranged in an annular structure in the circumferential direction, which can improve the radial support force of the entire tubular stent 100, and when it is applied to a bifurcated blood vessel, it can improve the compression bearing capacity of the bifurcated blood vessel to the aorta, the arterial stent or the hard tissue near the bifurcated blood vessel.

[0059] The proximal support mechanism 110 includes a proximal end surface 111, and the proximal end surface 111 is perpendicular to the axis 112 of the proximal support mechanism 110 (see Figure 1 ). That is to say, the proximal end surface 111 of the proximal support mechanism 110 is flush, so that the circumferential support force of the proximal support structure 110 at the closest proximal end is uniform. When it is applied to a bifurcated blood vessel, the proximal support structure 110 has a strong circumferential support force, which can prevent the bifurcated blood vessel from being deformed by the nearby arterial stent or the hard tissue near the bifurcated blood vessel.

[0060] The segmented bare stent 10 of the present invention can be made by laser cutting and heat setting, and the material of the stent body can be selected from stainless steel, tantalum, cobalt-based alloy, platinum, nickel-titanium alloy and new titanium alloy, and the preferred material is nickel-titanium alloy.

[0061] See also Figure 2 In a further embodiment, the wavy support member 200 includes a first wavy support member 113, a second wavy support member 121 and a third wavy support member 131. The proximal support mechanism 110 includes a plurality of axially connected first wavy support members 113, the middle support mechanism 120 includes a plurality of axially connected second wavy support members 121, and the distal support mechanism 130 includes a plurality of axially connected third wavy support members 131. It is understandable that the structures of the first wavy support member 113, the second wavy support member 121 and the third wavy support member 131 may be the same or different. It is further understandable that the first wavy support member 113, the second wavy support member 121 and the third wavy support member 131 may be uniformly distributed or non-uniformly distributed, that is, for example, the first wavy support member 113 may be composed of a uniform waveform or a non-uniform waveform, wherein the non-uniform waveform includes waveforms with different axial amplitudes but the same waveform length. The same is true for the second wave-shaped support member 121 and the third wave-shaped support member 131 .

[0062] In a further embodiment, the first wave-shaped support member 113 is composed of first support units 1130 connected end to end, the first support unit 1130 is composed of a first wave crest 1131, a first wave valley 1133, and a first wave rod 1132 connected between the first wave crest 1131 and the first wave valley 1133, and the first wave crest 1131 is arranged closer to the proximal end than the first wave valley 1133. It can be understood that the first wave rods 1132 adjacent to each other in the circumferential direction are connected near the proximal end to form the first wave crest 1131, and the first wave rods 1132 adjacent to each other in the circumferential direction are connected near the distal end to form the first wave valley 1133. The first wave rod 1132, the first wave crest 1131, and the first wave valley 1133 can be an integral structure or fixedly connected.

[0063] The second wave-shaped support member 121 is composed of second support units 1210 connected end to end, and the second support unit 1210 is composed of a second wave crest 1211, a second wave trough 1213, and a second wave rod 1212 connected between the second wave crest 1211 and the second wave trough 1213, and the second wave crest 1211 is arranged closer to the proximal end than the second wave trough 1213. It can be understood that the circumferentially adjacent second wave rods 1212 are connected near the proximal end to form the second wave crest 1211, and the circumferentially adjacent second wave rods 1212 are connected near the distal end to form the second wave trough 1213. The second wave rod 1212, the second wave crest 1211, and the second wave trough 1213 can be an integral structure or fixedly connected.

[0064] The third wave-shaped support member 131 is composed of third support units 1310 connected end to end, and the third support unit 1310 is composed of a third wave crest 1311, a third wave trough 1313, and a third wave rod 1312 connected between the third wave crest 1311 and the third wave trough 1313, and the third wave crest 1311 is arranged closer to the proximal end than the third wave trough 1313. It can be understood that the circumferentially adjacent third wave rods 1312 are connected near the proximal end to form the third wave crest 1311, and the circumferentially adjacent third wave rods 1312 are connected near the distal end to form the third wave trough 1313. The third wave rod 1312, the third wave crest 1311, and the third wave trough 1313 can be an integral structure or fixedly connected.

[0065] It can be understood that the sizes of the first support unit 1130, the second support unit 1210 and the third support unit 1310 can be the same or different, and can be adaptively changed according to different bifurcated blood vessels or actual conditions so that the segmented bare stent 10 can achieve the best effect during the treatment process.

[0066] It can also be understood that the shapes and sizes of the first support units 1130 at different positions in the first wave-shaped support member 113 may be the same or different. Preferably, they are the same to make the axial support force uniform. Alternatively, the first support units 1130 arranged at intervals are arranged in the same shape and size.

[0067] It can be understood that the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312 can be a straight rod, a special-shaped rod with a curved structure or an arc structure, or a combination thereof. The special-shaped rod means that the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312 are non-straight rods, and the special-shaped rod with a curved structure means that a straight rod or an arc rod has a curved structure, and the curved structure means that the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312 have a curved part, and the curved part can enhance the bending or stretching performance of the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312. The curved structure can be set at any position of the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312, and is preferably set in the middle of the first wave rod 1132, the second wave rod 1212 and the third wave rod 1312. Preferably, the special-shaped rod with a curved structure or an arc-shaped structure is an arc-shaped rod, a straight rod with an arc-shaped portion, a Z-shaped rod or an S-shaped rod. In the first embodiment, the first wave rod 1132 and the third wave rod 1312 are both straight rods, and the second wave rod 1212 is a combination of a straight rod and a curved structure. Figure 2 The second wave rod 1212a shown in FIG. 1212a is a curved structure.

[0068] See also Figure 3 In a further embodiment, the first wave crest 1131a in the first wave-shaped support member 113a is connected to the first wave trough 1133 in the axially adjacent first wave-shaped support member 113, so that the proximal support mechanism 110 forms a grid-like structure. Figure 3 The first wave valley 1133 in the first wave-shaped support member 113 in the axial direction is aligned with the first wave peak 1131a in the first wave-shaped support member 113a adjacent to the axial direction.

[0069] In a further embodiment, the distance between two adjacent first wave crests 1131a in the first wave-shaped support member 113a is equal to the distance between two adjacent first wave valleys 1133 in the first wave-shaped support member 113 that are axially adjacent and close to the proximal end, so that the first wave crests 1131a and the first wave valleys 1133 are exactly butted against each other, thereby improving the stability of the entire grid-shaped proximal support mechanism 110.

[0070] In a further embodiment, the first wave crests 1131b in the first wave-shaped support member 113b closest to the proximal end are located on the same plane to form the proximal end surface 111. It can be understood that all the first wave crests 1131b in the first wave-shaped support member 113b are located on the same plane, or the first wave crests 1131b arranged at intervals are located on the same plane.

[0071] See also Figure 4In a further embodiment, the third wave crest 1311a in the third wave-shaped support member 131a is connected to the third wave trough 1313 in the axially adjacent third wave-shaped support member 131, so that the distal support mechanism 130 forms a grid structure. It can be understood that the proximal support mechanism 110 and the distal support mechanism 130 are arranged in a grid shape, and the axially adjacent middle zone support mechanisms 120 are arranged in an open loop structure rather than a grid structure. When the stent is used in a bifurcated blood vessel, the grid-shaped mechanisms at both ends have a good radial support force in the circumferential direction, which can avoid being deformed by the aorta near the bifurcated blood vessel, the arterial stent or the hard tissue near the bifurcated blood vessel. At the same time, the non-grid structure of the middle zone support mechanism 120 has better flexibility than the proximal support mechanism 110 and the distal support mechanism 130, which can make the middle part adapt to the requirements of curved blood vessels.

[0072] In a further embodiment, the distance between two adjacent third wave crests 1311a in the third wave-shaped support member 131a is equal to the distance between two adjacent third wave troughs 1313 in the third wave-shaped support member 131 which are axially adjacent and close to the proximal end.

[0073] See also Figure 5 and Figure 6 The second embodiment of the present invention provides a segmented bare stent 10a, the segmented bare stent 10a further comprising a development mark 140, the development mark 140 is arranged on the first wavy support member 113 connecting the proximal support mechanism 110 and the middle support mechanism 120. The development mark 140 is used to develop the position of the segmented bare stent 10a in the blood vessel during surgery.

[0074] In a further embodiment, the developing mark 140 is disposed on the first wave-shaped support member 113 connecting the proximal supporting mechanism 110 and the middle supporting mechanism 120, including the developing mark 140 being disposed at the first wave valley 1133a of the proximal supporting mechanism 110 closest to the middle supporting mechanism 120. Figure 6, three evenly spaced developing marks 140 are arranged on the first trough 1133a in the first wavy support member 113a closest to the middle support mechanism 120, and the developing marks 140 are fixed in the first trough 1133a position in a dotted form by stamping, hot pressing or suturing, or the developing material can be made into a developing wire, and then the developing marks 140 are wound around the first trough 1133a position in the form of a developing wire. By arranging the developing marks 140 at the intersection of the proximal support mechanism 110 and the middle support mechanism 120, the proximal support mechanism 110 with better support performance can be accurately released in the blood vessel area that is subjected to greater radial compression, and the middle support mechanism 120 can be released in the blood vessel area with greater curvature, and the accuracy of the release of the segmented bare stent 10a in the blood vessel is improved by the developing marks 140, so that the segmented bare stent 10a can give full play to the advantages of the segmented design. It can be understood that in this embodiment, the number of developing marks 140 can be adjusted according to needs.

[0075] See also Figure 7 The third embodiment of the present invention provides a segmented bare stent 10b, wherein the developing mark 140 is arranged on the third wavy support member 131 connecting the distal support mechanism 130 and the middle support mechanism 120.

[0076] In a further embodiment, the third wave-shaped support member 131 connected between the distal support mechanism 130 and the middle support mechanism 120 is arranged at a third wave crest 1311 position of the distal support mechanism 130 closest to the middle support mechanism 120 (see Figure 7 ).

[0077] The development mark 140 may also be a combination of the second embodiment and the third embodiment.

[0078] See also Figure 8The fourth embodiment of the present invention provides a segmented bare stent 10c, in which three evenly spaced development marks 140 are arranged on the first trough 1133a of the first corrugated support rod 113a of the proximal support mechanism 110 closest to the middle support mechanism 120. At the same time, three evenly spaced development marks 140 are also arranged on the third crest 1313 of the third corrugated support rod 131 of the distal support mechanism 130 closest to the middle support mechanism 120 at the intersection of the distal support mechanism 130 and the middle support mechanism 120. By setting the developing mark 140 at the position where the proximal support mechanism 110 or the distal support mechanism 130 respectively intersects with the middle support mechanism 120, the proximal support mechanism 110 and the distal support mechanism 130 with better support performance can be accurately released in the blood vessel area that is subjected to greater radial compression, and the middle support mechanism 120 can be released in the blood vessel area with greater curvature. The developing mark 140 improves the accuracy of the release of the segmented bare stent 10c in the blood vessel, so that the segmented stent can give full play to the advantages of the segmented design. It can be understood that in this embodiment, the number of developing marks 140 can be adjusted according to needs.

[0079] See also Fig. 9 The fifth embodiment of the present invention provides a segmented bare stent 10d, wherein the developing mark 140 is arranged on the second wavy support member 121 connecting the middle support mechanism 120 and the proximal support mechanism 110.

[0080] In a further embodiment, the second wavy support member 121 disposed on the connection between the middle support mechanism 120 and the proximal support mechanism 110 includes a second wave crest 1211 disposed on the middle support mechanism 120 closest to the proximal support mechanism 110 .

[0081] See also Fig.10 The sixth embodiment of the present invention provides a segmented bare stent 10e, wherein the developing mark 140 is arranged on the second wavy support member 121 connecting the middle support mechanism 120 and the distal support mechanism 130.

[0082] In a further embodiment, the second wavy support member 121 disposed on the connection between the middle support mechanism 120 and the distal support mechanism 130 includes a second wave valley 1211 disposed on the middle support mechanism 120 closest to the distal support mechanism 130 .

[0083] It is understandable that the four schemes in the second, third, fifth and sixth embodiments can be combined. It is also understandable that the number of the development marks 140 can be flexibly set as needed. The development marks 140 are set at the segmentation so that the three sections of the segmented bare stent 10 with different radial support forces can be accurately released into the corresponding blood vessels, thereby improving the effect.

[0084] In a further embodiment, the display mark 140 is fixed on the corrugated support member 200 by stamping, hot pressing, sewing or winding. It is understandable that the display mark 140 can have various shapes, including dot, thread, square, circle, fan, etc. The corrugated support member 200 includes the first corrugated support member 113, the second corrugated support member 121 and the third corrugated support member 131.

[0085] In a further embodiment, the material forming / making the development mark includes one or more of gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, and tantalum.

[0086] It is understandable that, in addition to being fixed on the corrugated support member 200 at the connection as described above, the developing mark 140 may also be made of an alloy containing a developing material at the location of the corrugated support member 200 where the developing mark 140 is required to be provided, and the developing material and the material for making the corrugated support member 200 may be integrated into one. In this way, the developing mark 140 made is not easy to fall off.

[0087] Please refer again Figure 2 , a plurality of support points 160 may be further provided at the ends of the proximal support mechanism 110 and the distal support mechanism 130. The support point 160 is a smooth protruding structure provided on the first wave crest 1131 of the first wavy support member 113, and the protruding structure may be a solid structure or a structure with a hole in the center. The number and interval of the protruding structures are set according to actual needs and are not limited here. It is understandable that a developing mark 140 may be provided on the support point 160 to display the position reached by the end of the developing stent in the blood vessel during surgery. In this embodiment, the developing mark 140 is a developing mark 140 formed by filling a developing material in the center hole of the support point 160.

[0088] See also Fig.11 The seventh embodiment of the present invention provides a segmented bare stent 10f, wherein the tubular stent 100 further comprises a connecting assembly 150, and the proximal support mechanism 110 and the middle support mechanism 120, the middle support mechanism 120 and the distal support mechanism 130, or two adjacent second wavy support members 121 in the middle support mechanism 120 are connected via the connecting assembly 150. Preferably, the connecting assembly 150 is evenly distributed along the circumference of the tubular stent 100.

[0089] In a further embodiment, the connection assembly 150 includes at least one connection rod 151, and the connection between the proximal support mechanism 110 and the middle region support mechanism 120 through the connection assembly 150 includes the connection between the first wave crest 1131 and / or the first wave trough 1133 of the first wave-shaped support member 113 in the proximal support mechanism 110 and the second wave rod 1212 of the second wave-shaped support member 121 in the middle region support mechanism 120 through the connection rod 151a. Preferably, the first wave crest 1131 and / or the first wave trough 1133 of the proximal support mechanism 110 closest to the first wave-shaped support member 113 in the middle region support mechanism 120 and the second wave rod 1212 closest to the second wave-shaped support member 121 in the proximal support mechanism 110 are connected through the connection rod 151. Fig.12 As shown, the first wave valley 1133a is connected to the second wave bar 1212a of the second wave-shaped support member 121a closest to the proximal support mechanism 110 through the connecting rod 151a. One end of the connecting rod 151 is connected to the second wave bar 1212 to further hinder the relative movement of the two ends of the connecting rod 151 and strengthen the fixation.

[0090] The connection assembly 150 is used to connect two adjacent second wavy support members 121 in the middle support mechanism 120, including the connection between the second wave crest 1211 and / or the second wave trough 1213 of the second wavy support member 121 in the middle support mechanism 120 and the second wave bar 1212 of the adjacent second wavy support member 121 via a connecting rod 151b. Fig.13 As shown, the second wave valley 1213a is connected to the second wave rod 1212 of the adjacent second wave-shaped support member 121 through a connecting rod 151b.

[0091] The middle support mechanism 120 and the distal support mechanism 130 are connected via the connecting assembly 150, including the second wave rod 1212 of the second wave-shaped support member 121 in the middle support mechanism 120 and the third wave crest 1311 and / or third wave valley 1313 of the third wave-shaped support member 131 in the distal support mechanism 130 being connected via a connecting rod 151c. Fig.14 As shown, the second wave rod 1212b is connected to the third wave peak 1311 in the third wave-shaped support member 131 through a connecting rod 151c.

[0092] In a further embodiment, the connection assembly 150 includes at least two connection rods 151. In a seventh embodiment, the connection assembly 150 includes two connection rods 151 (see Figure 11-Figure 14). It is understandable that the two connecting rods 151 in the same connecting assembly 150 may be arranged in parallel or not in parallel, for example, the two connecting rods 151 are arranged in an eight-shaped or inverted eight-shaped shape. In the present invention, it is preferably arranged in an eight-shaped or inverted eight-shaped shape. This arrangement can enhance the supporting force and improve the radial supporting force with the same number of connecting rods 151. The connecting rods 151 of the central area support mechanism 120 are distributed in pairs, forming a closed-loop connection unit with the connected second wavy support member 121, the first wavy support member 113 or the third wavy support member 131 and are evenly staggered, ensuring good flexibility, scalability and connection strength, and maintaining a good shape of the bracket and the waveform when bent or stretched.

[0093] In the seventh embodiment, two connecting rods 151 are arranged in an eight-shaped manner. It can also be understood that the distance between two axially adjacent connecting components 150 is not equal, see Fig.13 The second wave rod 1212 is connected to the connecting rod 151b and the connecting rod 151b2 at the upper and lower ends respectively, and the other end of the connecting rod 151b2 is connected to the second wave peak 1211 near the far end, and the distance between the two connecting rods 151b2 is greater than the distance between the two connecting rods 151b.

[0094] The arrangement of the connecting rods 1221 can be completely the same, and the completely the same means that the connecting rods 1221 are all arranged in an eight-shaped, inverted eight-shaped or parallel shape. Preferably, the projections of the connecting components 122 arranged between the three adjacent circles of corrugated support members in the axial direction do not overlap or partially overlap.

[0095] See also Figure 16-Figure 18 In a further embodiment, the distance between two adjacent connecting rods 151 is at least the distance between two adjacent first wave valleys 1133, or at least the distance between two adjacent second wave valleys 1213, or at least the distance between two adjacent third wave peaks 1311. That is to say, the parts of two adjacent wavy support members 200 (numbered 113, 121 and 131) that are not connected to the connecting rod 151 are suspended and unconnected, so that there is a large relative movement or bending space between the two adjacent wavy support members 200 in the radial and axial directions, thereby increasing the flexibility of the stent.

[0096] In a further embodiment, the projections of the axially adjacent connection components 150 in the axial direction do not overlap or partially overlap.

[0097] See also Figure 15-18 The present invention also provides different arrangements of the connecting rods 151 in the connecting assembly 150 in other embodiments.

[0098] See also Fig.15, the eighth embodiment of the present invention provides a segmented bare stent 10g. One end of the two connecting rods 150 in the connecting assembly 150 of the segmented bare stent 10g is connected to the same wave crest (including the first wave crest, the second wave crest or the third wave crest) or wave trough (including the first wave trough, the second wave trough or the third wave trough), and the other ends of the two connecting rods 150 are respectively connected to the axially adjacent and circumferentially adjacent wave crests (including the first wave crest, the second wave crest or the third wave crest) or wave troughs (including the first wave trough, the second wave trough or the third wave trough). And the eight-shaped and inverted eight-shaped connecting assemblies 150 are arranged at intervals in the axial direction, for example, the connecting assembly 150a is an eight-shaped, and the connecting assembly 150b is an inverted eight-shaped. In this embodiment, the zone support mechanism 120 includes two second wave-shaped support members 121 arranged in the same row at intervals, which are superimposed and crossed to make the radial support force stronger.

[0099] See also Fig.16 The ninth embodiment of the present invention provides a segmented bare stent 10h. In the connection assembly 150 of the segmented bare stent 10h, two connection rods 150 are arranged in parallel, and the inclination directions of the connection assembly 150 in the axial direction are opposite, for example Fig.16 The connecting assembly 150c in the figure is tilted to the right, and the connecting assembly 150d is tilted to the left. The connecting assembly 150c and the connecting assembly 150d partially overlap in the axial direction.

[0100] See also Fig.17 The tenth embodiment of the present invention provides a segmented bare stent 10i. The axially spaced connection assembly 150e of the segmented bare stent 10h is in an inverted figure eight shape, and two second wave peaks are spaced between the two connection rods 151 in the connection assembly 150e. The axially spaced connection assembly 150f is in an figure eight shape, and three second wave valleys are spaced between the two connection rods 151 in the connection assembly 150f.

[0101] See also Fig.18 The eleventh embodiment of the present invention provides a segmented bare stent 10j. In the segmented bare stent 10j, inverted figure-eight connecting components 150g and figure-eight connecting components 150h are arranged at intervals in the axial direction, and the connecting components 150g and 150h partially overlap in the axial direction.

[0102] See also Fig.19 The twelfth embodiment of the present invention provides a segmented bare stent 10k. The proximal end of the proximal support mechanism 110 in the segmented bare stent 10k gradually extends and expands from the distal end to the proximal end outside the tubular stent 100. The proximal end of the stent achieves a good wall adhesion effect, avoiding the problem in the prior art that the vascular stent has poor wall adhesion after being implanted in the branch blood vessel and cannot completely cover the lesion.

[0103] In a further embodiment, the proximal end of the proximal support mechanism 110 extends outward from the tubular stent 100 to form an expansion portion 114, and the angle β between the outer contour line of the expansion portion 114 and the central axis of the stent satisfies: 30°≥β>0°.

[0104] See also Fig. 20 The thirteenth embodiment of the present invention provides a segmented bare stent 101. The distal end of the distal support mechanism 130 in the segmented bare stent 101 gradually extends and expands from the proximal end to the distal end outside the tubular stent 100. This enables the distal end of the stent to achieve a good wall adhesion effect, avoiding the problem in the prior art that the vascular stent has poor wall adhesion after being implanted into the branch blood vessel and cannot completely cover the lesion.

[0105] In a further embodiment, the proximal end of the distal support mechanism 130 extends outward from the tubular stent 100 to form an expansion portion 114a, and an angle β1 between an outer contour line of the expansion portion 114a and the central axis of the stent satisfies: 30°≥β1>0°.

[0106] See also Fig.21 The fourteenth embodiment of the present invention provides a segmented bare stent 10m. The segmented bare stent 10m is a truncated cone tubular structure. That is, the radial diameter of the segmented bare stent 10m gradually decreases from the proximal end to the distal end.

[0107] It is understood that the tubular stent 100 in the segmented bare stent 10 of the present invention can be a straight tubular structure or a truncated cone tubular structure, and the proximal support mechanism 110 can be set to have a radial diameter that gradually decreases from the proximal end to the distal end, while the middle support mechanism 120 and the distal support mechanism 130 are of equal diameter. It is understood that the diameter of each segment of the tubular stent 100 can be adjusted according to actual conditions to meet the requirements of different blood vessels.

[0108] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A segmented bare stent, characterized in that: The segmented bare stent includes a tubular stent formed by a plurality of axially connected wavy support members, the wavy support member is an annular structure arranged in a wave shape; the tubular stent includes a proximal support mechanism, a middle zone support mechanism and a distal support mechanism connected in sequence; the proximal support mechanism includes a proximal end face, and the proximal end face is perpendicular to the axis of the proximal support mechanism; the wavy support member includes a first wavy support member, a second wavy support member and a third wavy support member; the proximal support mechanism includes a plurality of axially connected first wavy support members, the middle zone support mechanism includes a plurality of axially connected second wavy support members, and the distal support mechanism includes a plurality of axially connected third wavy support members; the first wavy support member is composed of a first support unit connected end to end, and the first support unit is composed of a first wave crest, a first The first wave crest is arranged closer to the proximal end than the first wave trough, and the first support units at different positions in the first wave-shaped support member have the same shape and size; the second wave-shaped support member is composed of second support units connected end to end, the second support unit is composed of a second wave crest, a second wave trough and a second wave rod connected between the second wave crest and the second wave trough, and the second wave crest is arranged closer to the proximal end than the second wave trough; the third wave-shaped support member is composed of a third support unit connected end to end, the third support unit is composed of a third wave crest, a third wave trough and a third wave rod connected between the third wave crest and the third wave trough, and the third wave crest is arranged closer to the proximal end than the third wave trough.

2. The segmented bare stent according to claim 1, characterized in that: The first wave crest in the first wave-shaped support member is connected to the first wave trough in the first wave-shaped support member which is axially adjacent and close to the proximal end, so that the proximal support mechanism forms a grid-like structure.

3. The segmented bare stent according to claim 2, characterized in that: The distance between two adjacent first wave peaks in the first wave-shaped support members is equal to the distance between two adjacent first wave valleys in the first wave-shaped support members that are axially adjacent to each other.

4. The segmented bare stent according to claim 1, characterized in that: The first wave peaks in the first wave-shaped support member closest to the proximal end are located on the same plane to form the proximal end surface.

5. The segmented bare stent according to claim 1, characterized in that: The third wave crest in the third wave-shaped support member is connected to the third wave trough in the third wave-shaped support member axially adjacent and close to the proximal end, so that the distal support mechanism forms a grid-like structure.

6. The segmented bare stent according to claim 5, characterized in that: The distance between two adjacent third wave crests in the third wave-shaped support member is equal to the distance between two adjacent third wave troughs in the third wave-shaped support member that are axially adjacent to each other.

7. The segmented bare stent according to claim 1, characterized in that: The segmented bare stent also includes a development mark, which is arranged on the first wavy support member connecting the proximal support mechanism and the middle zone support mechanism; or on the third wavy support member connecting the distal support mechanism and the middle zone support mechanism; or on the second wavy support member connecting the middle zone support mechanism and the proximal support mechanism; or on the second wavy support member connecting the middle zone support mechanism and the distal support mechanism.

8. The segmented bare stent according to claim 7, characterized in that: The developing mark is arranged on the first wave-shaped support member connecting the proximal supporting mechanism and the middle supporting mechanism, including the developing mark being arranged at the first wave valley position of the proximal supporting mechanism closest to the middle supporting mechanism; The third wave-shaped support member disposed on the connection between the distal support mechanism and the middle support mechanism includes a third wave crest position disposed on the distal support mechanism closest to the middle support mechanism; A second wave-shaped support member disposed on the connection between the middle support mechanism and the proximal support mechanism includes a second wave crest position disposed on the middle support mechanism closest to the proximal support mechanism; The second wave-shaped support member disposed on the connection between the middle support mechanism and the distal support mechanism includes a second wave valley position disposed on the middle support mechanism closest to the distal support mechanism.

9. The segmented bare stent according to claim 8, characterized in that: The developing mark is fixed on the corrugated support member by punching, hot pressing, sewing or winding.

10. The segmented bare stent according to claim 8, characterized in that: The material used to form / make the development mark includes one or more of gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, and tantalum.

11. The segmented bare stent according to claim 1, characterized in that: The tubular stent also includes a connecting component, through which the proximal support mechanism and the middle support mechanism, the middle support mechanism and the distal support mechanism, or two adjacent second wavy support members in the middle support mechanism are connected.

12. The segmented bare stent according to claim 11, characterized in that: The connecting assembly comprises at least one connecting rod, and the proximal support mechanism and the middle region support mechanism are connected via the connecting assembly, including the first wave crest and / or first wave trough of the first wave-shaped support member in the proximal support mechanism and the second wave rod of the second wave-shaped support member in the middle region support mechanism being connected via the connecting rod; The connection assembly connects two adjacent second wavy support members in the middle zone support mechanism, including the connection between the second wave crest and / or second wave trough of the second wavy support member in the middle zone support mechanism and the second wave bar of the adjacent second wavy support member through the connecting rod; The middle area support mechanism and the distal end support mechanism are connected via the connecting assembly, including the connection between the second wave rod of the second wavy support member in the middle area support mechanism and the third wave peak and / or third wave trough of the third wavy support member in the distal end support mechanism via the connecting rod.

13. The segmented bare stent according to claim 11, characterized in that: The connection components are evenly distributed along the circumference of the tubular support.

14. The segmented bare stent according to claim 12, characterized in that: The connecting assembly comprises at least two connecting rods.

15. The segmented bare stent according to claim 14, characterized in that: Two adjacent connecting rods are arranged in an eight-shaped or inverted eight-shaped shape.

16. The segmented bare stent according to claim 14, characterized in that: The distance between two adjacent connecting rods is at least the distance between two adjacent first wave valleys, or at least the distance between two adjacent second wave valleys, or at least the distance between two adjacent third wave peaks.

17. The segmented bare stent according to claim 11, characterized in that: The projections of the axially adjacent connection components in the axial direction do not overlap or partially overlap.

18. The segmented bare stent according to claim 1, characterized in that: The proximal end of the proximal support mechanism gradually extends and expands outside the tubular support in a direction from the distal end to the proximal end.

19. The segmented bare stent according to claim 18, characterized in that: The proximal end of the proximal support mechanism extends outward from the tubular stent to form an expansion portion, and the included angle β between the outer contour line of the expansion portion and the central axis of the stent satisfies: 30°≥β>0°.

Images