A convenient fixing developing mechanism and a vascular stent thereof

Abstract

The present application provides a vascular stent, which comprises a supporting framework and a developing mechanism, the supporting framework comprises a plurality of annular wave-shaped supporting rods, and the developing mechanism comprises a developing piece made of developing material, which is stably fixed on any position of the supporting framework. The present application also provides a developing mechanism on a vascular stent.

Description

Technical Field

[0001] This invention relates to the field of implantable vascular technology, and more particularly to a radiopaque mechanism that is easy to fix, and a vascular stent provided with the radiopaque mechanism. Background Technology

[0002] With the improvement of people's living standards and changes in lifestyle, the incidence of vascular diseases is increasing. If these diseases are not treated in time, they may lead to vascular blockage, which will seriously endanger human life.

[0003] Minimally invasive interventional procedures are currently available for treating vascular diseases. These methods are minimally invasive, highly safe, and highly effective, thus gaining acceptance from both doctors and patients and becoming an important treatment option for vascular diseases. Interventional treatment involves implanting a vascular stent into the diseased segment of the blood vessel. The implanted stent supports the narrowed or occluded segment, reduces elastic recoil and remodeling of the vessel, maintains unobstructed blood flow, and also helps prevent restenosis.

[0004] Typically, a vascular stent is delivered to the lesion site in a blood vessel via a delivery system, and then the blood vessel is reconstructed through the self-expansion of the stent, thereby treating an aneurysm or arterial stenosis.

[0005] Existing vascular stents fall into two main categories: covered stents and bare stents. The imaging performance of a vascular stent under X-ray or other medical imaging equipment is a crucial characteristic among its many properties, playing a vital role in both the surgical procedure and postoperative clinical outcomes. During surgery, surgeons rely on the stent's imaging performance to accurately locate and deploy it, ensuring precise implantation at the lesion site. In the long-term postoperative period, follow-up is necessary to prevent stent displacement and the formation of new thrombi.

[0006] The radiopaque performance of vascular stents is generally achieved by fixing radiopaque material onto the stent. For example, with covered stents, radiopaque dots made of radiopaque material can be sutured onto the covered stent at suitable locations. However, fixing radiopaque dots is relatively difficult for bare stents. Suturing makes it difficult to stably fix the radiopaque material onto the smooth radiopaque filaments, and punching radiopaque dots onto the stent's support rods may cause the support rods to become thinner at that location, resulting in poor fatigue resistance. Summary of the Invention

[0007] The purpose of this invention is to provide a imaging mechanism that can conveniently fix an imaging element to a vascular stent, and a vascular stent provided with the imaging mechanism.

[0008] To address the aforementioned technical problems, the present invention provides a imaging mechanism disposed on a vascular stent, wherein the vascular stent includes a supporting frame, and the imaging mechanism includes an imaging element made of imaging material, wherein the imaging element can be stably fixed at any position on the supporting frame.

[0009] The present invention also provides a vascular stent, which includes a supporting frame and a imaging mechanism. The supporting frame includes a plurality of annular wave-shaped support rods, and the imaging mechanism includes an imaging element made of imaging material, which can be stably fixed at any position on the supporting frame.

[0010] The vascular stent provided by the present invention includes a supporting frame and a radiopaque element disposed at any position on the supporting frame. When the vascular stent is delivered through a sheath, it can be accurately implanted, released and positioned at the lesion site of the blood vessel under the action of an X-ray machine or other medical imaging equipment. It is convenient to use and greatly improves the success rate of surgery. Attached Figure Description

[0011] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0012] Figure 1 This is a schematic diagram of the vascular stent provided in the first embodiment of the present invention.

[0013] Figure 2 yes Figure 1 A three-dimensional schematic diagram of the annular wave-shaped support rod of the vascular stent.

[0014] Figure 3 yes Figure 1 Enlarged view of Part III.

[0015] Figure 4 yes Figure 1 A three-dimensional structural diagram of the imaging mechanism of a medium-sized vascular stent.

[0016] Figure 5 This is a schematic diagram of the vascular stent provided in the second embodiment of the present invention.

[0017] Figure 6 yes Figure 5 Enlarged view of section VI.

[0018] Figure 7 This is a schematic diagram of the vascular stent provided in the third embodiment of the present invention.

[0019] Figure 8 yes Figure 7 Enlarged view of section VIII.

[0020] Figure 9 This is a schematic diagram of the vascular stent provided in the fourth embodiment of the present invention.

[0021] Figure 10 yes Figure 9 A magnified view of section X in the middle.

[0022] Figure 11 This is a schematic diagram of the vascular stent provided in the fifth embodiment of the present invention.

[0023] Figure 12 yes Figure 11 Enlarged view of section XII.

[0024] Figure 13 This is a schematic diagram of the vascular stent provided in the sixth embodiment of the present invention.

[0025] Figure 14 yes Figure 13 Enlarged view of section XIV.

[0026] Figure 15 This is a schematic diagram of the vascular stent provided in the seventh embodiment of the present invention.

[0027] Figure 16 yes Figure 15 Enlarged view of section XVI.

[0028] Figure 17 This is a schematic diagram of the vascular stent provided in the eighth embodiment of the present invention.

[0029] Figure 18 yes Figure 16 Enlarged view of section XVIII.

[0030] Figure 19 This is a schematic diagram of the vascular stent provided in the ninth embodiment of the present invention.

[0031] Figure 20 yes Figure 19 Enlarged view of section XX.

[0032] Figure 21 This is a schematic diagram of the vascular stent provided in the tenth embodiment of the present invention.

[0033] Figure 22 yes Figure 21 Enlarged view of part XXII.

[0034] Figure 23 This is a schematic diagram of the vascular stent provided in the eleventh embodiment of the present invention.

[0035] Figure 24 yes Figure 23 Enlarged view of section XXIV. Detailed Implementation

[0036] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Furthermore, the following descriptions of the embodiments are made with reference to the accompanying illustrations to illustrate specific embodiments in which the invention can be implemented. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention.

[0038] In the description of this invention, "proximal" refers to the end closer to the heart, and "distal" refers to the end farther from the heart. This definition is for convenience only and should not be construed as a limitation of the invention.

[0039] Please refer to the following: Figures 1 to 4 , Figure 1 This is a schematic diagram of the vascular stent provided in the first embodiment of the present invention; Figure 2 yes Figure 1 A three-dimensional schematic diagram of the annular wave-shaped support rod of the vascular stent in the image; Figure 3 yes Figure 1 Enlarged view of Part III; Figure 4 yes Figure 1 A three-dimensional structural diagram of the imaging mechanism of a vascular stent. This invention provides a vascular stent 100, which includes a supporting frame 20 and an imaging mechanism 40. The imaging mechanism 40 includes an imaging element 42 made of imaging material, and the imaging mechanism 40 is disposed at any position on the supporting frame 20. In this embodiment, the imaging element 42 is disposed at the proximal and / or distal end of the supporting frame 20. During implantation, the position of the imaging element 42 can be clearly observed through imaging equipment, facilitating accurate positioning and release of the vascular stent 100 to the lesion site of the blood vessel.

[0040] The supporting framework 20 is a self-expanding bare stent. The supporting framework 20 can be an elastic metal supporting framework or an elastic non-metallic supporting framework such as a polymer material. In this embodiment, the supporting framework 20 is a nickel-titanium alloy stent. When the supporting framework 20 is delivered through a sheath, its diameter can shrink to a smaller state for delivery within the sheath. When the supporting framework 20 is released within the blood vessel, it can automatically expand to the required shape and size so that it can support the inner wall of the vascular lesion site. The supporting framework 20 provides radial support to the inner wall of the blood vessel, thereby enabling vascular reconstruction and treatment of aneurysms or arterial stenosis.

[0041] The vascular stent 100 of the present invention includes a supporting frame 20 and a radiopaque element 42 disposed at the proximal and / or distal end of the supporting frame 20. When the vascular stent 100 is delivered through a sheath, it can be accurately implanted, released and positioned at the lesion site of the blood vessel under the action of an X-ray machine or other medical imaging equipment. It is convenient to use and thus greatly improves the success rate of surgery.

[0042] The support frame 20 can be laser-cut from a nickel-titanium alloy tube or woven from metal wire such as nickel alloy wire. The density of the mesh structure of the support frame 20 can be set as needed. In this embodiment, the support frame 20 includes a support frame 22 and a connecting frame 24, the connecting frame 24 being used to connect the support frame 22. The support frame 22 includes several Z-shaped or sinusoidal annular wave support rods 220, which are arranged at intervals along the axial direction of the vascular stent 100, i.e., these annular wave support rods 220 are arranged in parallel with gaps from the proximal end to the distal end of the vascular stent 100. The connecting frame 24 includes several sinusoidal annular connecting rods 240, each pair of adjacent annular wave support rods 220 being connected by an annular connecting rod 240, so that these annular connecting rods 240 are also arranged at intervals along the axial direction of the vascular stent 100, i.e., these annular connecting rods 240 are arranged in parallel with gaps from the proximal end to the distal end of the vascular stent 100. The developing element 42 is disposed on the annular wave support rod 220 at the proximal and / or distal ends of the support frame 22.

[0043] The supporting frame 22 and the connecting frame 24 have the same diameter, ranging from 20mm to 35mm. In this embodiment, the diameter of both the supporting frame 22 and the connecting frame 24 is 30mm.

[0044] Each annular waveform support rod 220 can be a high-wave support rod or a high-low waveform support rod, etc. A high-wave support rod refers to a support rod 220 where all peaks and troughs have the same height, meaning all peaks and troughs are on the same plane. A high-low waveform support rod refers to a support rod 220 where all peaks and troughs have different heights. In this embodiment, a high-low waveform support rod is provided at the proximal end of the support frame 20, where the peaks are different and the troughs are the same height; a high-wave support rod is provided at the distal end of the support frame 20, where all peaks and troughs are the same height; a high-wave support rod is also provided in the middle of the support frame 20; the developing element 42 is located at the peaks of the high-low waveform support rods at the proximal end and / or the troughs of the high-wave support rods at the distal end of the support frame 20.

[0045] In other embodiments, a high-low wave support rod may also be provided at the distal end of the support frame 20, wherein the peaks of the high-low wave support rod are of the same height, and the troughs of the high-low wave support rod are of different heights. The developing element 42 is disposed at the peak of the high-low wave support rod at the proximal end and / or at the trough of the high-low wave support rod at the distal end of the support frame 20.

[0046] In other embodiments, the proximal end of the support frame 20 may also be a high-wave support rod, with the developing element 42 disposed at the crest of the high-wave support rod at the proximal end and / or the trough of the high-wave support rod at the distal end of the support frame 20.

[0047] like Figure 2 As shown, each annular wave support rod 220 is composed of several support units connected in a first layer. Each support unit includes a peak 221, a trough 223, and a wave rod 225 connecting the peak 221 and the trough 223. Each annular wave support rod 220 is formed by bending a super-elastic nickel-titanium wire. The diameter of the super-elastic nickel-titanium alloy wire can be selected in the range of 0.1mm to 0.55mm. Each annular wave support rod 220 is provided with a connecting sleeve 227, which connects the opposite ends of the annular wave support rod 220. That is, the opposite ends of the annular wave support rod 220 are both housed in the connecting sleeve 227, and then the two ends of the nickel-titanium wire are fixed inside the connecting sleeve 227 by mechanical pressing or welding.

[0048] In this embodiment, the annular wave support rod 220 is woven from nickel-titanium wire with a diameter of 0.5mm, and the vertical height of the annular wave support rod 220 is 8-15mm.

[0049] In other embodiments, the support frame 20 may be a woven mesh structure or a cut mesh structure.

[0050] In other embodiments, the number of sine waves in the annular waveform support rod 220 can be determined as needed, and the vertical height of the annular waveform support rod 220 can be any height.

[0051] Each support unit of each annular connecting rod 240 also includes a crest, a trough, and a wave rod connecting the crest and the trough. Each annular connecting rod 240 is formed by bending a super-elastic nickel-titanium wire, and each annular connecting rod 240 may also be provided with a connecting sleeve, which can connect the opposite ends of the annular connecting rod 240, or the opposite ends of the annular connecting rod 240 can be connected by winding or welding.

[0052] At least one ring of developing elements 42 is arranged around the circumference of the annular wave support rod 220 at the proximal and / or distal ends of the supporting frame 20. The developing elements 42 on the annular wave support rod 220 at the proximal end of the supporting frame 20 are located at the corresponding wave crests, and the developing elements 42 on the annular wave support rod 220 at the distal end of the supporting frame 20 are located at the corresponding wave troughs.

[0053] In other embodiments, the developing element 42 may also be disposed on the wave rod of the annular wave support rod 220.

[0054] like Figure 3 and Figure 4As shown, in this embodiment, the developing element 42 is a developing cylinder, which is sleeved on the near-end annular wave support rod 220 near the wave crest 221 and / or on the far-end annular wave support rod 220 near the wave trough 223. Specifically, the developing element 42 is sleeved on the corresponding wave rod 225 and is near the corresponding wave crest 221 or wave trough 223. The developing cylinder is a cylinder formed by an alloy sheet doped with developing material. The developing element material can be made of materials with good X-ray opacity, strong corrosion resistance, and good biocompatibility. The developing element material includes, but is not limited to, gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, etc., or alloys or composites of these metals. In this embodiment, the developing cylinder is a nickel-titanium alloy metal sheet containing tantalum. The inner diameter of the developing cylinder is equal to or slightly larger than the diameter of the wave rod 225 to facilitate the sleeved placement of the developing element 42 on the corresponding annular wave support rod 220. The imaging tubes are sleeved around the annular wave support rod 220 at least once in the circumference. Therefore, these imaging tubes form an intermittent annular imaging mechanism. During the operation, the position of the imaging element 42 can be clearly observed through imaging equipment. That is, it can be observed that the imaging element 42 on the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20 is a ring around the edge of the opening of the vascular stent 100. Therefore, it is more convenient and faster to implant the vascular stent 100 at the required position.

[0055] The imaging mechanism 40 further includes a positioning member 44, which is disposed adjacent to the imaging member 42 on the wave rod 225 of the annular wave support rod 220. The positioning member 44 is used to position the imaging member 42. One end of the imaging member 42 located at the proximal end of the vascular stent 100 abuts against the corresponding wave crest 221 on the proximal annular wave support rod 220, and the other end of the imaging member 42 abuts against the corresponding positioning member 44. That is, the imaging member 42 is positioned between the corresponding wave crest 221 and the positioning member 44. Specifically, one end of the imaging tube on the annular wave support rod 220 located at the proximal end of the support frame 20 abuts against the corresponding wave crest 221 of the annular wave support rod 220 to prevent the imaging tube from sliding toward the end of the wave crest 221, and the other end of the imaging tube abuts against the positioning member 44 to prevent the imaging tube from sliding away from the end of the wave crest 221, thereby positioning the imaging tube adjacent to the corresponding wave crest 221. One end of the contrast agent 42 located at the distal end of the vascular stent 100 abuts against the corresponding trough 223 on the distal annular wave support rod 220 to prevent the contrast agent tube from sliding towards the trough 223. The other end of the contrast agent 42 abuts against the positioning member 44 to prevent the contrast agent tube from sliding away from the trough 223, thereby positioning the contrast agent 42 between the corresponding trough 223 and the positioning member 44. Specifically, one end of the contrast agent tube on the wave rod 225 of the annular wave support rod 220 located at the distal end of the support frame 20 abuts against the corresponding trough 223 of the annular wave support rod 220, and the other end of the contrast agent tube abuts against the corresponding positioning member 44, thereby positioning the contrast agent tube adjacent to the corresponding trough 223. The positioning member 44 can be made of shape memory alloy, stainless steel, or other metal materials. In this embodiment, the positioning member 44 is made of stainless steel.

[0056] In this embodiment, the positioning element 44 is a positioning sleeve that is sleeved and fixed to the annular waveform support rod 22. Specifically, the positioning sleeve is fixed to the corresponding wave rod 225 of the annular waveform support rod 22. The positioning sleeve is positioned on the wave rod 225 of the annular waveform support rod 22 by compression. In this embodiment, the positioning sleeve is positioned at the end of the developing element 42 away from the corresponding wave crest 221 or wave trough 223, so that the positioning sleeve abuts against the developing element 42, thereby fixing the developing element 42 between the corresponding wave crest 221 and the positioning sleeve or between the corresponding wave trough 223 and the positioning sleeve.

[0057] In use, the vascular stent 100 is delivered to the lesion site of the blood vessel through a delivery system. The position of the imaging element 42 can be clearly observed under X-ray machine or other medical imaging equipment, so that the vascular stent 100 can be accurately implanted into the lesion site of the blood vessel. Then, through the self-expansion of the vascular stent 100, the blood vessel is reconstructed, thereby treating aneurysm or arterial stenosis.

[0058] The contrast agent 42 on the vascular stent 100 of the present invention is positioned by the peak 221 and positioning agent 44 or the trough 223 corresponding to the annular wave support rod 22, which facilitates and firmly fixes the contrast agent 42 and can effectively prevent the contrast agent 42 from falling off. In addition, the position of the vascular stent 100 where the contrast agent 42 is provided will not become thinner, which can ensure the strong fatigue resistance of the annular wave support rod 22 and achieve better treatment effect.

[0059] The vascular stent 100 can be implanted using either balloon dilation or self-dilation.

[0060] Please refer to the following: Figure 5 and Figure 6 , Figure 5 This is a schematic diagram of the vascular stent provided in the second embodiment of the present invention; Figure 6 yes Figure 5 Enlarged view of section VI. The structure of the vascular stent provided in the second embodiment of the present invention is similar to that of the first embodiment, except that: in the second embodiment, the imaging mechanism 40 includes an imaging element 42 and two positioning elements 44 for positioning the imaging element 42. The imaging element 42 is disposed on the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20. The two positioning elements 44 are located at opposite ends of the imaging element 42 and respectively abut against opposite ends of the imaging element 42, that is, the two positioning elements 44 are used to position the imaging element 42.

[0061] In this embodiment, the developing element 42 is also a developing cylinder, and each positioning element 44 is also a positioning sleeve. The developing cylinder is sleeved on the wave rod 225 of the annular wave support rod 220 at the proximal and / or distal ends of the supporting frame 20. One end of the developing element 42 abuts against one of the positioning elements 44, and the opposite end of the developing element 42 abuts against the other positioning element 44 to prevent the developing element 42 from sliding along the corresponding wave rod 225. That is, the developing element 42 is positioned between the two positioning elements 44. The developing cylinder is sleeved on the wave rod 225, and the positioning sleeves are respectively sleeved and fixed at the opposite ends of the developing cylinder. The opposite ends of the developing cylinder abut against the two positioning sleeves respectively, thereby making the two positioning sleeves firmly position the developing cylinder and prevent the developing cylinder from sliding or falling off.

[0062] In this embodiment, the imaging element 42 on the vascular stent 100 is positioned by two positioning elements 44, which can firmly fix the imaging element 42 and prevent the imaging element 42 from falling off; in addition, the position on the annular wave support rod 22 where the imaging element 42 is located will not become thinner, which can ensure the strong fatigue resistance of the annular wave support rod 22.

[0063] In other embodiments, the developing cylinder can be positioned at any position on the annular wave support rod 220. Simply place the two positioning members 44 at opposite ends of the developing cylinder to position it.

[0064] Please refer to the following: Figure 7 and Figure 8 , Figure 7 This is a schematic diagram of the vascular stent provided in the third embodiment of the present invention; Figure 8 yes Figure 7 Enlarged view of section VIII. The structure of the vascular stent provided in the third embodiment of the present invention is similar to that of the first embodiment, except that: in the third embodiment, the imaging mechanism 40 only includes the imaging element 42, that is, the imaging mechanism 40 omits the positioning element 44; the imaging element 42 is an imaging cylinder sleeved and fixed on the wave rod 225, and the imaging cylinder is positioned on the wave rod 225 by compression.

[0065] In this embodiment, the developing element 42 on the annular wave support rod 220 at the proximal end of the support frame 20 is disposed on the crest 221 of the annular wave support rod 220, that is, the developing cylinder is sleeved on the corresponding crest 221 of the annular wave support rod 220 at the proximal end; the developing element 42 on the annular wave support rod 220 at the distal end of the support frame 20 is disposed on the trough 223 of the annular wave support rod 220, that is, the developing cylinder is sleeved on the corresponding crest 221 or trough 223 of the annular wave support rod 220 at the distal end. The developing cylinder extends along the corresponding crest 221 or trough 223, that is, the shape of the developing cylinder is the same as the shape of the corresponding crest 221 or trough 223. In this embodiment, the shape of the developing cylinder is generally V-shaped or U-shaped.

[0066] In this embodiment, the imaging element 42 is sleeved on the crest 221 or trough 223 of the annular waveform support rod 220 at the proximal and / or distal ends, and the imaging element 42 can be fixed to the annular waveform support rod 220. Therefore, the imaging element 42 can be easily fixed to the annular waveform support rod 220, preventing the imaging element 42 from sliding or falling off; in addition, the positioning element is omitted in this embodiment, which facilitates the delivery of the vascular stent 100 in the delivery device and saves manufacturing costs.

[0067] In other embodiments, medical adhesive may also be provided between the imaging element 42 and the corresponding annular wave support rod 220, that is, the imaging element 42 is fixed to the corresponding annular wave support rod 220 by medical adhesive, so as to facilitate fixing the imaging element 42 to any position on the annular wave support rod 220.

[0068] In other embodiments, the contrast-enhancing tube is disposed on the wave rod 225 corresponding to the annular wave support rod 220 at the proximal and / or distal end of the vascular stent 100, and the contrast-enhancing tube extends along the length direction of the wave rod 225, that is, the shape of the contrast-enhancing tube is the same as the shape of the wave rod.

[0069] Please refer to the following: Figure 9 and Figure 10 , Figure 9 This is a schematic diagram of the vascular stent provided in the fourth embodiment of the present invention; Figure 10 yes Figure 9 Enlarged view of part X in the middle. The structure of the vascular stent provided in the fourth embodiment of the present invention is similar to that of the third embodiment, except that: in the fourth embodiment, the imaging mechanism 40 further includes two positioning members 44 for positioning the imaging element 42. The imaging element 42 is disposed on the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends of the supporting skeleton 20. The two positioning members 44 are respectively disposed at opposite ends of the imaging element 42, that is, the two positioning members 44 are used to position the imaging element 42. The imaging element 42 is an imaging cylinder, which is sleeved on the crest 221 of the annular wave support rod 220 at the proximal end and / or the trough 223 of the annular wave support rod 220 at the distal end; the positioning members 44 are positioning cylinders, which are positioned by compression on the wave rods 225 at both ends of the crest 221 and / or the wave rods 225 at both ends of the trough 223. Positioning cylinders are respectively disposed at opposite ends of the imaging cylinder, and the two positioning cylinders are used to position the imaging cylinder, thereby making the positioning of the imaging cylinder more stable.

[0070] In this embodiment, the developing element 42 is sleeved on the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends, and is positioned by positioning elements 44 located at opposite ends of the developing element 42. Therefore, the developing element 42 can be more firmly fixed to the annular wave support rod 220, preventing the developing element 42 from sliding or falling off.

[0071] Please refer to the following: Figure 11 and Figure 12 , Figure 11 This is a schematic diagram of the vascular stent provided in the fifth embodiment of the present invention; Figure 12 yes Figure 11Enlarged view of section XII. The structure of the vascular stent provided in the fifth embodiment of the present invention is similar to that of the first embodiment, except that the imaging element in the fifth embodiment is different from that in the first embodiment. In the fifth embodiment, the imaging element 42a is an imaging wire wound around the annular wave support rod 220. The imaging wire is an alloy wire doped with imaging material, for example, the imaging wire is a nickel-titanium alloy metal wire, the nickel-titanium alloy metal wire is a tantalum-containing nickel-titanium alloy metal wire, and the diameter of the nickel-titanium alloy metal wire is 0.10-0.40 mm. The imaging element material includes, but is not limited to, gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.

[0072] In this embodiment, the annular wave support rods 220 at both the proximal and distal ends of the vascular stent 100 are intermittently wrapped with the radiopaque elements 42a. These radiopaque elements 42a are arranged at least once around the corresponding annular wave support rods 220. Since these radiopaque elements 42a on the annular wave support rods 220 are radiopaque and annular, their positions can be clearly observed during surgery using imaging equipment. That is, it can be observed that these radiopaque elements 42a surround the annular wave support rods 220 at the proximal and / or distal ends of the vascular stent 100 in a complete circle, rather than being scattered radiopaque points. Therefore, the vascular stent 100 can be conveniently and quickly implanted into the lesion segment of the blood vessel.

[0073] Furthermore, the imaging element 42a is an imaging wire spirally wound around the wave rod 225 of the annular wave support rod 220 and located near the wave crest 221 and / or wave trough 223. One end of the imaging element 42a on the annular wave support rod 220 at the proximal end of the vascular stent 100 abuts against the wave crest 221 of the annular wave support rod 220 to prevent the imaging element 42a from sliding toward the wave crest 221; the other end of the imaging element 42a abuts against the positioning element 44 to prevent the imaging element 42a from sliding toward the end away from the wave crest 221, thereby positioning the imaging wire near the corresponding wave crest 221. One end of the imaging element 42a on the annular wave support rod 220 at the distal end of the vascular stent 100 abuts against the trough 223 of the annular wave support rod 220 to prevent the imaging element 42a from sliding toward the end of the trough 223; the other end of the imaging element 42a abuts against another positioning element 44 to prevent the imaging element 42a from sliding toward the end away from the trough 223, thereby positioning the imaging wire at the adjacent corresponding trough 223.

[0074] The positioning element 44 is a positioning sleeve, and the structure of the positioning sleeve is the same as that of the positioning sleeve in the first embodiment, so it will not be described again here.

[0075] A positioning sleeve on the annular waveform support rod 220 at the proximal end of the vascular stent 100 is disposed at the end of the imaging element 42a away from the corresponding peak 221, so that the positioning sleeve abuts against the imaging element 42a, thereby fixing the imaging element 42a between the corresponding peak 221 and the positioning sleeve; a positioning sleeve on the annular waveform support rod 220 at the distal end of the vascular stent 100 is disposed at the end of the imaging element 42a away from the corresponding trough 223, so that the positioning sleeve abuts against the imaging element 42a, thereby fixing the imaging element 42a between the corresponding trough 223 and the positioning sleeve.

[0076] In use, the vascular stent 100 is delivered to the lesion site of the blood vessel through a delivery system. The position of the imaging element 42a can be clearly observed under X-ray machine or other medical imaging equipment, so that the vascular stent 100 can be accurately implanted into the lesion site of the blood vessel. Then, through the self-expansion of the vascular stent 100, the blood vessel is reconstructed, thereby treating aneurysm or arterial stenosis.

[0077] The imaging element 42a on the vascular stent 100 of the present invention is positioned by the peak 221 and positioning element 44 or trough 223 of the annular wave support rod 22, which facilitates the secure fixation of the imaging element 42a and prevents the imaging element 42a from falling off. In addition, it will not cause the position on the annular wave support rod 22 where the imaging element 42a is provided to become thinner, ensuring the strong fatigue resistance of the annular wave support rod 22.

[0078] Please refer to the following: Figure 13 and Figure 14 , Figure 13 This is a schematic diagram of the vascular stent provided in the sixth embodiment of the present invention; Figure 14 yes Figure 13 Enlarged view of part XIV. The structure of the vascular stent provided in the sixth embodiment of the present invention is similar to that of the fifth embodiment, except that: the imaging element 42 is positioned by two positioning elements 44. The imaging element 42a is disposed on the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20. The two positioning elements 44 are respectively sleeved on the corresponding annular wave support rod 220 and located at opposite ends of the imaging element 42a. The two positioning elements 44 are used to position the imaging element 42a.

[0079] In this embodiment, the developing element 42 is also a developing filament, and each positioning element 44 is a positioning sleeve. The developing filament is spirally wound around the wave rod 225 of the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20. One end of the developing element 42 abuts against one of the positioning elements 44, and the opposite end of the developing element 42 abuts against the other positioning element 44. The two positioning elements 44 jointly position the developing element 42, preventing the developing element 42 from sliding or detaching. Specifically, the developing filament is spirally wound around the wave rod 225, and the positioning sleeves are respectively sleeved and fixed at the opposite ends of the developing filament on the wave rod 225. The opposite ends of the developing filament abut against the two positioning sleeves respectively, thereby making the two positioning sleeves firmly position the developing filament and prevent the developing filament from sliding or falling off.

[0080] In this embodiment, the radiopaque wire on the vascular stent 100 is positioned by two positioning elements 44, which can firmly fix the radiopaque wire to prevent it from falling off; in addition, the position on the annular wave support rod 22 where the radiopaque wire is located will not become thinner, so as to ensure the strong fatigue resistance of the annular wave support rod 22.

[0081] In other embodiments, the developing wire can be positioned at any position on the annular wave support rod 220. Simply place the two positioning members 44 at opposite ends of the developing wire to position it.

[0082] Please refer to the following: Figure 15 and Figure 16 , Figure 15 This is a schematic diagram of the vascular stent provided in the seventh embodiment of the present invention; Figure 16 yes Figure 15 Enlarged view of part XVI. The structure of the vascular stent provided in the seventh embodiment of the present invention is similar to that of the fifth embodiment, except that: in the seventh embodiment, the imaging mechanism 40 only includes the imaging element 42a, that is, the imaging mechanism 40 omits the positioning element 44; the imaging element 42a is an imaging wire wound and fixed on the wave rod 225.

[0083] In this embodiment, the developing element 42a on the annular wave support rod 220 at the proximal end of the support frame 20 is disposed on the crest 221 of the annular wave support rod 220, that is, the developing wire is wound around the corresponding crest 221 on the proximal annular wave support rod 220; the developing element 42a on the annular wave support rod 220 at the distal end of the support frame 20 is disposed on the trough 223 of the annular wave support rod 220, that is, the developing wire is wound around the corresponding trough 223 on the distal annular wave support rod. The developing wire is wound along the extension direction of the corresponding crest 221 or trough 223, thereby making the developing element 42a generally V-shaped or U-shaped.

[0084] In this embodiment, the imaging element 42a is spirally wound around the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends, and the imaging element 42a can be wound and fixed to the annular wave support rod 220. Therefore, the imaging element 42a can be easily fixed to the annular wave support rod 220 to prevent the imaging element 42a from sliding or falling off; in addition, the positioning element is omitted in this embodiment, which facilitates the delivery of the vascular stent 100 in the delivery device and saves manufacturing costs.

[0085] In other embodiments, medical adhesive can also be provided between the imaging wire and the corresponding annular waveform support rod 220, that is, the imaging wire can be fixed to the corresponding annular waveform support rod 220 by medical adhesive, so as to facilitate fixing the imaging wire to any position on the annular waveform support rod 220.

[0086] In other embodiments, the radiopaque filament may be spirally wound around the wave rod 225 corresponding to the annular wave support rod 220 at the proximal and / or distal end of the vascular stent 100, and the radiopaque filament extends along the length direction of the wave rod 225, that is, the shape of the radiopaque filament after winding is the same as the shape of the wave rod.

[0087] Please refer to the following: Figure 17 and Figure 18 , Figure 17 This is a schematic diagram of the vascular stent provided in the eighth embodiment of the present invention; Figure 18 yes Figure 17 Enlarged view of section XVIII. The structure of the vascular stent provided in the eighth embodiment of the present invention is similar to that of the seventh embodiment, except that: in the eighth embodiment, the imaging mechanism 40 further includes two positioning members 44 for positioning the imaging element 42a. The imaging element 42a is disposed on the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends of the supporting skeleton 20. The two positioning members 44 are respectively disposed at opposite ends of the imaging element 42, that is, the two positioning members 44 are used to position the imaging element 42a, thereby making the positioning of the imaging element 42a more stable. The imaging element 42 is an imaging filament, which is spirally wound on the crest 221 of the annular wave support rod 220 at the proximal end and the trough 223 of the annular wave support rod 220 at the distal end; each positioning member 44 is a positioning cylinder, which is positioned on the wave rod 225 at both ends of the crest 221 or the wave rod 225 at both ends of the trough 223 by compression. Positioning cylinders are provided at opposite ends of the developing wire, and the two positioning cylinders are used to position the developing wire.

[0088] In this embodiment, the developing element 42a is spirally wound around the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends, and is positioned by the positioning elements 44 located at opposite ends of the developing element 42a. Therefore, the developing element 42a can be more firmly fixed to the annular wave support rod 220, preventing the developing element 42a from sliding or falling off.

[0089] Please refer to the following: Figure 19 and Figure 20 , Figure 19 This is a schematic diagram of the vascular stent provided in the ninth embodiment of the present invention; Figure 20 yes Figure 19 Enlarged view of part XX in the diagram. The structure of the vascular stent provided in the ninth embodiment of the present invention is similar to that of the sixth embodiment, except that the structure of the radiopaque wire in the ninth embodiment is different from that in the sixth embodiment. In the ninth embodiment, the radiopaque element 42b is a radiopaque wire that is attached to the surface of the wave rod 225 of the annular wave support rod 220 and extends along the axial direction of the wave rod 225. The radiopaque wire is made of an alloy doped with radiopaque material, for example, the radiopaque wire is a nickel-titanium alloy metal wire, the nickel-titanium alloy metal wire is a tantalum-containing nickel-titanium alloy metal wire, and the diameter of the nickel-titanium alloy metal wire is 0.30-0.50 mm. The radiopaque element material includes, but is not limited to, gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.

[0090] In this embodiment, the radiopaque elements 42b are attached to the annular wave support rods 220 at both the proximal and distal ends of the vascular stent 100. These radiopaque elements 42b are arranged in at least one ring around the corresponding annular wave support rods 220. Because these radiopaque elements 42b on the annular wave support rods 220 are radiopaque and are annular, their positions can be clearly observed during surgery using imaging equipment. That is, it can be observed that these radiopaque elements 42b surround the annular wave support rods 220 at both the proximal and distal ends of the vascular stent 100, rather than being scattered radiopaque points. Therefore, the vascular stent 100 can be conveniently and quickly implanted into the lesion segment of the blood vessel.

[0091] Specifically, the imaging element 42b is an imaging filament attached to the surface of the wave rod 225 of the annular wave support rod 220 at the proximal and / or distal end of the vascular stent 100. One end of the imaging element 42b is connected to one of the positioning elements 44, and the opposite end of the imaging element 42b is connected to the other positioning element 44. Specifically, the opposite ends of the imaging element 42b are fixedly connected to the two positioning elements 44 by welding or gluing, and the imaging element 42b is positioned between the two positioning elements 44. That is, the imaging filament is attached to the surface of the wave rod 225, and two positioning sleeves are respectively fixedly connected to the opposite ends of the imaging filament. The two positioning sleeves are sleeved and fixed to the wave rod 225, so that the imaging filament between the two positioning sleeves extends in a straight line along the corresponding wave rod 225. The imaging filament is fixed to the wave rod 225 by the two positioning elements 44, so that the two positioning sleeves can firmly position the imaging filament and prevent the imaging filament from sliding or falling off.

[0092] In this embodiment, the radiopaque wire on the vascular stent 100 is positioned by two positioning elements 44, which can fix the radiopaque wire and prevent it from falling off; in addition, the position on the annular wave support rod 220 where the radiopaque wire is located will not become thinner, which can ensure the strong fatigue resistance of the annular wave support rod 22.

[0093] In other embodiments, medical adhesive is provided between the developing wire and the corresponding wave rod 225, that is, the developing wire is attached to the surface of the wave rod 225 by medical adhesive.

[0094] Please refer to the following: Figure 21 and Figure 22 , Figure 21 This is a schematic diagram of the vascular stent provided in the tenth embodiment of the present invention; Figure 22 yes Figure 21 Enlarged view of part XXII. The structure of the vascular stent provided in the tenth embodiment of the present invention is similar to that of the ninth embodiment, except that in the tenth embodiment, the imaging element 42b is an imaging filament disposed on the crest 221 of the annular wave support rod 220 at the proximal end of the support frame 20 and / or the trough 223 of the annular wave support rod 220 at the distal end of the support frame 20. The imaging filament extends along the corresponding crest 221 or trough 223, that is, the shape of the imaging filament is the same as the shape of the corresponding crest 221 or trough 223. In this embodiment, the shape of the imaging filament is generally V-shaped or U-shaped. A positioning element 44 is provided at each of the opposite ends of the imaging element 42b, that is, the two positioning elements 44 are respectively fixed at the opposite ends of the imaging filament. Each positioning element 44 is a positioning cylinder, which is positioned on the wave rod 225 by compression. The positioning cylinders at the opposite ends of the imaging filament are used to position the imaging filament, thereby making the positioning of the imaging element 42b more stable.

[0095] In this embodiment, the imaging element 42b is attached to the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal end of the vascular stent 100, and is positioned by positioning elements 44 located at opposite ends of the imaging element 42b. Therefore, the imaging element 42b is more firmly fixed to the annular wave support rod 220 to prevent slippage or detachment.

[0096] In other embodiments, the positioning elements 44 at opposite ends of the imaging element 42b can be omitted. The imaging element 42b is bonded to the crest 221 or trough 223 of the annular wave support rod 220 at the proximal and / or distal ends of the vascular stent 100 using medical adhesive. This not only positions the imaging element 42b onto the annular wave support rod 220, preventing it from sliding or falling off, but also eliminates the positioning elements, facilitating the transport of the vascular stent 100 within the delivery device and saving manufacturing costs.

[0097] Please refer to the following: Figure 23 and Figure 24 , Figure 23 This is a schematic diagram of the vascular stent provided in the eleventh embodiment of the present invention; Figure 24 yes Figure 23 Enlarged view of part XXIV. The structure of the vascular stent provided in the eleventh embodiment of the present invention is similar to that of the first embodiment, except that: in the eleventh embodiment, the imaging element 42c is bonded to the imaging point on the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20 by medical adhesive. Specifically, the imaging point can be bonded to the crest or trough of the annular wave support rod 220 at the proximal and / or distal ends of the support frame 20; the imaging point can be located on the outer surface of the crest 221, the outer surface of the wave rod 225 adjacent to the crest 221, or adjacent to the crest 221 between two wave rods 225; the imaging point can also be located on the outer surface of the trough 223, the outer surface of the wave rod 225 adjacent to the trough 223, or adjacent to the trough 223 between two wave rods 225.

[0098] like Figure 24As shown, in this embodiment, the imaging element 42c has circular annular imaging points, which are bonded to the annular wave support rod 220 with medical adhesive. The imaging element material can be made of materials with good X-ray opacity, strong corrosion resistance, and good biocompatibility. The imaging element material includes, but is not limited to, gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, or alloys or composites of these metals. In this embodiment, the imaging points are made of an alloy doped with imaging material, and the alloy is a tantalum-containing nickel-titanium alloy. The imaging points on the annular wave support rod 220 at the proximal end of the vascular stent 100 are arranged in at least one ring around the circumference of the annular wave support rod 220; the imaging points on the annular wave support rod 220 at the distal end of the vascular stent 100 are arranged in at least one ring around the circumference of the annular wave support rod 220. Therefore, these imaging points form an intermittent annular imaging mechanism. During the operation, the position of the imaging element 42c can be clearly observed through imaging equipment. That is, it can be observed that the imaging element 42c on the annular wave support rod 220 at the proximal and / or distal end of the support frame 20 is a ring around the opening of the vascular stent 100. Therefore, the vascular stent 100 can be conveniently and quickly implanted into the required position.

[0099] In use, the vascular stent 100 is delivered to the lesion site of the blood vessel through a delivery system. The position of the imaging element 42c can be clearly observed under X-ray machine or other medical imaging equipment, so that the vascular stent 100 can be accurately implanted into the lesion site of the blood vessel. Then, through the self-expansion of the vascular stent 100, the blood vessel is reconstructed, thereby treating aneurysm or arterial stenosis.

[0100] The imaging element 42c on the vascular stent 100 of the present invention is bonded to the corresponding peak 221 and / or trough 223 of the annular waveform support rod 22 using medical adhesive, which facilitates the fixation of the imaging element 42c and prevents it from falling off. Secondly, it does not cause the annular waveform support rod 22 to become thinner at the location where the imaging element 42c is provided, ensuring the strong fatigue resistance of the annular waveform support rod 22. In addition, the positioning element for auxiliary positioning is omitted, which facilitates the transportation of the vascular stent 100 in the delivery device and saves manufacturing costs.

[0101] In other embodiments, the developing element 42c can be configured as a circle, ellipse, rectangle, irregular shape, etc.

[0102] The above are the embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the embodiments of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A convenient fixing developing mechanism, which is arranged on a vascular stent, the vascular stent comprising a support framework, the support framework comprising a plurality of annular wave-shaped support rods, characterized in that, The developing mechanism comprises a developing piece made of developing material, which is stably fixed on any of the looped wave-shaped support rods of the support framework; The developing mechanism further comprises a positioning piece, which is a positioning sleeve sleeved on the looped wave-shaped support rod, and is used for abutting and fixing the developing piece to prevent the developing piece from sliding or falling off; The support framework is woven by metal wires, and the looped wave-shaped support rod is composed of a plurality of support units connected in a head-to-tail manner, each of the support units comprises a wave crest, a wave trough, and a wave rod connected between the wave crest and the wave trough; the developing piece is arranged at the wave crest or the wave trough of the looped wave-shaped support rod, one end of the developing piece abuts against the corresponding wave crest or wave trough of the looped wave-shaped support rod, and the opposite end of the developing piece abuts against the corresponding positioning piece, and the developing piece is fixed between the corresponding wave crest or wave trough and the positioning piece; or the developing piece is arranged on the wave crest or wave trough of the looped wave-shaped support rod and extends along the corresponding wave crest or wave trough, the developing mechanism comprises two positioning pieces, one end of the developing piece abuts against one of the positioning pieces, and the opposite end of the developing piece abuts against the other positioning piece, and the developing piece is positioned between the two positioning pieces.

2. The developing mechanism according to claim 1, wherein The support framework comprises a plurality of Z-shaped or sinusoidal looped wave-shaped support rods.

3. The developing mechanism according to claim 1, wherein The developing piece is a developing cylinder, which is sleeved on the looped wave-shaped support rod.

4. The developing mechanism according to claim 1, wherein The developing piece is a developing wire wound on the looped wave-shaped support rod.

5. The developing mechanism according to claim 1, wherein The developing piece is a developing wire attached to the surface of the looped wave-shaped support rod and extending along the extension direction of the looped wave-shaped support rod.

6. The developing mechanism according to claim 1, wherein The positioning piece is positioned on the looped wave-shaped support rod by extrusion.

7. The developing mechanism according to claim 6, wherein The positioning piece is made of memory alloy or stainless steel.

8. A vascular stent comprising a support framework comprising a plurality of annular wave-shaped support struts, characterized in that, The blood vessel stent further comprises the developing mechanism according to any one of claims 1 to 7.

Images