An arterial opening stent

Abstract

The utility model discloses an artery opening support relates to medical instrument technical field, and this artery opening support, including support main part and anchoring section, support main part and anchoring section are fixedly connected through anchoring bridge muscle, support main part includes the multiple support ring and multiple bridge muscle of parallelly arranged, and the valley of a support ring is connected with the wave crest of another support ring of oolong between the multiple parallel support ring through bridge muscle, anchoring section includes the anchoring bridge muscle of shape as sinusoidal curve and the anchoring ring of long and short staggered double -row structure, and the wave crest of support ring in support main part is connected with the long and short staggered junction point of double -row structure's anchoring ring through anchoring bridge muscle and tail wing.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to an arterial ostium stent. Background Technology

[0002] Currently, atherosclerosis of the vertebral artery system is one of the leading causes of posterior circulation stroke, with approximately one-fifth of posterior circulation strokes occurring in the extracranial segment of the vertebral artery. Surgical procedures are too risky and have too many limitations, making endovascular treatment a growing trend. Currently, there are no stent products specifically designed for treating vertebral artery stenosis, both domestically and internationally. Clinically, intracranial stents are often used to treat vertebral artery stenosis, but the results are unsatisfactory. Plaque that dislodges during stent implantation or service can easily enter the circulatory system, forming thrombi, and it is also difficult to accurately deploy the stent at the lesion site. Utility Model Content

[0003] In view of this, the present invention provides an arterial ostium stent that can solve the problems of existing stents, where plaques dislodged during implantation or service can easily enter the circulatory system, forming thrombi, and the inability to accurately release the stent at the lesion site.

[0004] To achieve the above objectives, this utility model provides an arterial ostium stent, comprising:

[0005] The main body of the support frame and the anchoring section are fixedly connected by anchoring reinforcing bars;

[0006] The main body of the support includes multiple parallel support rings and multiple bridge ribs, and the multiple parallel support rings are connected by bridge ribs to the valley of one support ring and the peak of another misaligned support ring.

[0007] The anchoring section includes an anchoring bridge bar in the shape of a sine curve and an anchoring ring in a double row structure with alternating long and short sections. The crest of the support ring in the main body of the support is connected to the tail fin through the staggered connection points of the anchoring bridge bar and the double row structure of the anchoring ring.

[0008] Optionally, the support ring includes multiple support rib units with a sinusoidal shape, and the support rib units on adjacent support rings are connected by staggered double S-shaped bridge ribs to form a minimum closed loop structure.

[0009] Optionally, the surface of the scaffold body includes nanoscale micropatterns obtained by ion beam bombardment, the micropatterns carrying a positive charge.

[0010] Optionally, the diameter of the support ring at the free end of the stent body matches the diameter of the vertebral artery; the diameter of the support ring connecting the stent body and the tail fin matches the diameter of the subclavian artery.

[0011] Optionally, the number of support rib units in the support ring connected to the tail fin in the support body is greater than the number of support rib units in the free end support ring of the support body.

[0012] Optionally, tantalum or platinum may be electroplated on the surface of the support ring that connects to the tail fin on the main body of the support frame.

[0013] Optionally, the anchoring ring includes leaf-shaped long anchor support bars and short anchor support bars.

[0014] Optionally, the waveform amplitude at both ends of the anchoring reinforcement bar, which has a sinusoidal shape, is smaller than the waveform amplitude in the middle of the anchoring reinforcement bar.

[0015] Optionally, the length of the main body of the support is 8 to 15 mm, the number of support rings is 5 to 7, the number of support rib units in each support ring is 8 to 10, and the length of the anchoring ribs is 3 to 4.5 mm.

[0016] Optionally, the support ring in the main body of the support structure that is connected to the tail fin takes the shape of a trumpet after expansion.

[0017] The present invention has the following advantages or beneficial effects: The arterial ostium stent of the present invention includes a stent body and an anchoring section, which are fixedly connected by anchoring ligatures. The stent body includes multiple parallel support rings and multiple ligatures, and the ligatures connect the troughs of one support ring to the peaks of another misaligned support ring. The anchoring section includes anchoring ligatures in the shape of a sine curve and anchoring rings in a double-row structure with alternating long and short sections. The peaks of the support rings connected to the tail fin in the stent body are connected to the alternating long and short sections of the double-row structure of the anchoring rings via anchoring ligatures. By employing a stent body with a combination of sine and complex curves, small meshes are formed after the stent body expands, thereby preventing plaques dislodged during stent implantation or service from entering the circulatory system, thus preventing thrombosis. The anchoring rings provide precise and stable positioning for the stent body, allowing for accurate release of the stent at the lesion site.

[0018] The further effects of the aforementioned unconventional alternative methods will be explained below in conjunction with specific implementation methods. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1This is a schematic diagram of the unfolded plan of a vertebral artery orifice stent according to an embodiment of the present invention;

[0021] Figure 2 This is a schematic diagram of the structural dimensions of the support unit of the bracket body according to an embodiment of the present utility model;

[0022] Figure 3 This is a schematic diagram of the structural dimensions of the support anchoring bridge reinforcement unit according to an embodiment of the present invention;

[0023] Figure 4 This is a schematic diagram of the structural dimensions of a bracket anchoring ring unit according to an embodiment of the present invention;

[0024] Figure 5 This is a schematic diagram of the position of the vertebral artery ostium stent after implantation according to an embodiment of the present invention.

[0025] The attached figures are labeled as follows:

[0026] 101-Support Body

[0027] 102-Bridge reinforcement

[0028] 103-Support Ring

[0029] 104-Supporting Reinforcement Unit

[0030] 105-Anchoring Section

[0031] 106-Anchoring Ring

[0032] 1061-Long Anchor Support Bar

[0033] 1062-Short Anchor Support Bar

[0034] 107-Anchoring Bridge Reinforcement

[0035] 108-Supporting Ring Valley

[0036] 109 - Another supporting ring peak

[0037] 110 - The crest of the support ring connected to the tail fin in the main body of the support frame.

[0038] 111 - Anchoring ring double-row structure with alternating long and short connection points

[0039] 112-Anchoring reinforcement bars

[0040] 113 - Support ring in the main body of the bracket that connects to the tail fin

[0041] 114 - Free end support ring of the support body

[0042] The apex of the long anchor support bar in the 401-anchoring ring

[0043] 402 - Anchoring ring double-row structure with alternating long and short connection points

[0044] 403 - The apex of the short anchor support bar in the anchoring ring

[0045] 404-Anchoring ring double-row structure with staggered long and short connection points

[0046] 501-Vertebral Artery

[0047] 502 - Support Body

[0048] 503-Shoulder Artery

[0049] 504 - Anchorage graft position after arterial ostium stent implantation

[0050] 505 - Anchoring ring position after arterial ostium stent implantation

[0051] 506 - Free end of the support body

[0052] 507 - Support ring connecting the main body of the bracket and the tail wing

[0053] 508 - Subclavian artery Detailed Implementation

[0054] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. 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 should fall within the protection scope of the present invention.

[0055] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "circumferential", "radial", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0056] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, "a plurality of" means two or more, unless otherwise explicitly specified.

[0057] Figure 1 This is a schematic diagram of the unfolded plan of a vertebral artery orifice stent according to an embodiment of the present invention.

[0058] like Figure 1 As shown, the arterial ostium stent includes a stent body 101 and an anchoring section 105, which are fixedly connected by anchoring ribs 107. The stent body 101 includes multiple parallel support rings 103 and multiple ribs 102, with the ribs 102 connecting the troughs 108 of one support ring to the peaks 109 of another, which are misaligned. The anchoring section 105 includes anchoring ribs 107 and 112 in the shape of a sine curve and anchoring rings 106 arranged in a double-row structure with alternating long and short sections. The peaks 110 of the support rings connected to the tail fin in the stent body 101 are connected to the alternating long and short sections 111 of the double-row structure of anchoring rings via anchoring ribs 112. It can be understood that the tail fin can be the anchoring section 105, which includes anchoring ribs 107 and 112 and anchoring rings 106. The stent support unit (including the support ring and double S-shaped bridging ribs) employs a unidirectional peak-valley structure and S-shaped connection combination. Its function is to effectively shield against potentially dislodged plaques after the arterial ostium stent expands, preventing plaques from entering the circulatory system and reducing the risk of peripheral occlusion. By using a combination of sine and complex curves in the stent body, small meshes are formed after stent expansion, preventing plaques dislodged during stent implantation or service from entering the circulatory system, thus avoiding thrombus formation. The anchoring ring provides precise and stable positioning of the stent body, ensuring accurate stent deployment at the lesion site.

[0059] In some embodiments, the surface of the stent body 101 includes nanoscale micropatterns obtained by ion beam bombardment, the micropatterns carrying a positive charge. Specifically, ion beam bombardment is used to form nanoscale micropatterns on the metal surface of the arterial ostium stent, which are then positively charged. This ion bombardment treatment improves the bonding between the arterial ostium stent and the drug-eluting coating, effectively preventing possible coating detachment during and in the early stages of implantation. After endothelialization, the coating can be safely degraded within the blood vessel, improving the safety of the arterial ostium stent during use.

[0060] Furthermore, a special spraying process ensures that the drug-eluting coating on the arterial ostium stent is relatively thicker on the outer surface and relatively thinner on the inner surface, with the inner surface coating thickness being only 0.1-0.5 micrometers. This further reduces the risk of thrombosis that may occur during stent release or in the early stages of implantation due to coating detachment. After endothelialization, the coating safely degrades within the blood vessel.

[0061] In some embodiments, Figure 1 The number of support rib units in the support ring 113 connected to the tail fin in the stent body 101 is greater than the number of support rib units in the free end support ring 114 of the stent body (this is just an example). In some embodiments, the support ring 113 connected to the tail fin in the stent body 101 is funnel-shaped after expansion. It is understood that the free end support ring of the stent body can be one or more support rings near the free end of the stent body, and may also include support ring 103. For example, the structure of the two support rings connected to the tail fin of the arterial ostium stent is inconsistent with the structure of other parts, and its sinusoidal number is greater. This part of the arterial ostium stent is funnel-shaped after expansion, and its mesh has a suitable size and shape. Its function is that the expanded funnel-shaped opening fits perfectly with the vessel wall at the opening of the blood vessel, effectively preventing the cylindrical stent from being suspended at the end of the opening, interfering with blood flow and thus causing thrombosis. At the same time, the funnel-shaped opening is precisely positioned at the opening of the vertebral artery, which can effectively prevent stent displacement. The flared opening formed by the expansion of the support ring connecting the arterial ostium stent and the tail fin is coated with tantalum (or platinum), which shows good contrast under X-ray. This contrasting layer allows the surgeon to precisely position the stent, ensuring a better fit between the flared opening and the blood vessel opening. The balloon of the stent system has a flared structure that matches the flared opening of the stent. The expansion of the support ring connecting the arterial ostium stent and the tail fin forms the flared opening. This allows the stent to be rapidly deployed and expanded into the predetermined shape without the need for secondary dilation, reducing surgical risks.

[0062] In some embodiments, the support ring connecting the arterial ostium stent to the tail fin and the free-end support ring have different structures, and when expanded to different diameters, the support ring connecting the arterial ostium stent to the tail fin and the free-end support ring have the same blank surface area after expansion. The support ring and anchoring ring connecting the arterial ostium stent to the tail fin are connected as a single unit by two anchoring ligatures, which allow the arterial ostium stent to be bent at the ostium, enabling the stent to be placed into the two vessels at the branch site. Specifically, the surfaces of the two anchoring ligatures are coated with tantalum (or platinum), which is highly radiolucent under X-ray, to ensure precise positioning of the arterial ostium stent at the vessel branch site during implantation.

[0063] In some embodiments, one end of the stent has a tail fin that expands to a larger diameter. This tail fin positions the stent at the opening of the vertebral artery, preventing stent displacement and thrombus formation at the opening. Figure 1 The support ring 113 of the stent body 101, which is connected to the tail fin, is electroplated with tantalum or platinum. This allows the support ring 113 to act as a contrasting layer for doctors to accurately position the arterial ostium stent, thereby increasing the stent's visibility under X-rays and enabling the arterial ostium stent to be accurately released at the lesion site.

[0064] In some embodiments, Figure 1 The length of the support body 101 ranges from 8 to 15 mm, the number of support rings 103 ranges from 5 to 7, the number of support rib units 104 in each support ring ranges from 8 to 10, and the length of the anchoring ribs 107 and 112 ranges from 3 to 4.5 mm.

[0065] In some embodiments, the arterial ostium stent is made of a nickel-free high-nitrogen alloy material, with the main components (by weight percentage): Fe: 58-77, Gr: 17-19, Mn: 14-18, Mo: 1-4, N: 0.8-1.2. The advantages of this material are: it does not contain the harmful nickel element commonly found in traditional implant materials, thus avoiding restenosis of the stent segment due to inflammatory reactions caused by nickel allergy, and also avoiding carcinogenic reactions caused by cell mutations potentially induced by nickel. In addition to its excellent biocompatibility, this material has very good mechanical properties; its high strength and high ductility allow for finer mesh wires in the arterial ostium stent, reducing the stent's footprint within the blood vessel and lowering the stenosis rate. Simultaneously, this material exhibits excellent corrosion resistance, demonstrating superior biocompatibility compared to traditional implant materials in vivo.

[0066] Figure 2 This is a schematic diagram of the structural dimensions of the support unit of the bracket body according to an embodiment of the present utility model.

[0067] In some embodiments, Figure 1 The support ring 103 includes multiple support rib units 104 with a sinusoidal shape. The support rib units on adjacent support rings are connected by staggered double-S-shaped bridge ribs 102 to form a minimum closed-loop structure. For example, the minimum closed-loop structure is as follows: Figure 2 As shown in Figure A, the two supporting rib units are connected by only one double S-bridge, which is spirally distributed on the cylindrical surface of the arterial ostium stent. The purpose of this double S-bridge is that it allows the arterial ostium stent to deform more easily when passing through tortuous lesions, facilitating its passage. Simultaneously, it provides the arterial ostium stent with excellent flexibility in all directions, making it easier to pass through tortuous lesion vessels.

[0068] In some embodiments, the crest and trough ends of the same support rib unit of the arterial ostium stent are connected by a straight line. This serves to prevent deformation of the ends when passing through tortuous lesions.

[0069] In some embodiments, such as Figure 2 As shown, the width of the double-S-shaped bridging rib 102 ranges from 0.05 to 0.10 mm, the bending radius R of the double-S-shaped bridging rib ranges from 0.05 to 0.10 mm, the vertical distance between a trough and a crest of the support rib unit 104 ranges from 0.24 to 0.30 mm, the distance between crests ranges from 0.60 to 0.80 mm, the bending radius R ranges from 0.07 to 0.10 mm, and the width of the support rib unit ranges from 0.07 to 0.10 mm. This achieves the optimal size of the arterial ostium stent, ensuring optimal performance during use.

[0070] Figure 3 This is a schematic diagram of the structural dimensions of a support anchoring bridge reinforcement unit according to an embodiment of the present invention. Figure 3 As shown, the waveform amplitude at both ends of the anchoring reinforcement bar, which has a sinusoidal shape, is smaller than the waveform amplitude in the middle of the anchoring reinforcement bar.

[0071] In some embodiments, the bending radius R of the anchoring ligature 107 ranges from 0.1 to 0.15 mm, the horizontal width of the entire anchoring ligature ranges from 3.0 to 4.5 mm, the distance between the highest peak and the lowest trough of the anchoring ligature ranges from 0.60 to 1.0 mm, the distance between straight segments of anchoring ligatures belonging to the same peak or trough ranges from 0.15 to 0.3 mm, and the width of the anchoring ligature ranges from 0.05 to 0.075 mm. This achieves optimal dimensions for the arterial ostium stent, ensuring optimal performance during use.

[0072] Figure 4 This is a schematic diagram of the structural dimensions of a bracket anchoring ring unit according to an embodiment of the present invention. Figure 4 As shown, the anchoring ring 106 includes leaf-shaped long anchor support ribs 1061 and short anchor support ribs 1062. The leaf-shaped long anchor support ribs 1061 and short anchor support ribs 1062 make the anchoring ring 106 more secure after positioning, improving the safety of the arterial ostium stent during service.

[0073] In some embodiments, such as Figure 4As shown, the horizontal distance from the vertex 401 of the long anchor support rib 1061 to the long-short staggered connection point 402 in the anchoring ring 106 ranges from 1.5 to 2.5 mm, the horizontal distance from the vertex 403 of the short anchor support rib 1062 to the long-short staggered connection point 404 ranges from 1 to 1.5 mm, the width of the long and short anchor support ribs ranges from 0.05 to 0.10 mm, and the bending radius R of the leaf-shaped portion of the long and short anchor support ribs ranges from 0.10 to 0.15 mm. This achieves the optimal size of the arterial ostium stent, ensuring optimal performance during use.

[0074] Figure 5 This is a schematic diagram showing the position of the vertebral artery ostium stent after implantation, according to an embodiment of the present invention. Figure 5 As shown, the diameter of the support ring at the free end 506 of the stent body 502 matches the diameter of the vertebral artery 501, effectively supporting the stenotic vertebral artery. Its unidirectional peak-valley structure effectively blocks plaque that may dislodge at the opening. The diameter of the support ring 507 connecting the stent body 502 and the tail fin matches the diameter of the subclavian artery 508, allowing for positioning within the subclavian artery. Its single-ring wave-like structure prevents stent displacement. The function of this stent structure is that the free end 506 of the stent body 502 effectively supports and covers the stenotic lesion at the opening of the vertebral artery, while the support ring 507 connecting the stent body 502 and the tail fin anchors in the subclavian artery, preventing stent displacement. Figure 5 In this diagram, 503 represents the shoulder artery, 504 represents the anchoring bridging rib position after stent implantation at the arterial ostium, and 505 represents the anchoring ring position after stent implantation at the arterial ostium. The support ring connecting the stent to the tail fin (e.g.) Figure 1 (as shown in 113) and anchoring ring (such as Figure 1 Two anchoring reinforcing bars (as shown in Figure 106) are used between them. Figure 1 As shown in 107 and 112, the connection, with its wavy structure, ensures a tight fit with the vessel wall during stent expansion. Anchoring bridging tendons (such as...) Figure 1 The surface of the stent (as shown in 107 and 112) is coated with tantalum (or platinum). Its function is to facilitate the operator in determining the orientation of the stent during implantation, avoiding the need for anchoring girders (such as...). Figure 1 (As shown in 107 and 112) Interferes with blood flow in the subclavian artery, reducing the risk of potential thrombosis.

[0075] The specific embodiments described above do not constitute a limitation on the scope of protection of this utility model. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can occur depending on design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the scope of protection of this utility model.

Claims

1. An arterial ostium stent, characterized in that, include: The support body and the anchoring section are fixedly connected by anchoring reinforcing bars; The main body of the support includes multiple parallel support rings and multiple bridge ribs, and the multiple parallel support rings are connected by the bridge ribs to the valley of one support ring and the peak of another misaligned support ring. The anchoring section includes an anchoring bridge bar in the shape of a sine curve and an anchoring ring in a double row structure with alternating long and short sections. The crest of the support ring in the main body of the support is connected to the tail fin through the staggered connection point of the double row structure of the anchoring bridge bar and the anchoring ring.

2. The arterial ostium stent according to claim 1, characterized in that, The support ring includes multiple support rib units with a sinusoidal shape. The support rib units on adjacent support rings are connected by staggered double S-shaped bridge ribs to form a minimum closed loop structure.

3. The arterial ostium stent according to claim 1, characterized in that, The surface of the scaffold body includes nanoscale micropatterns obtained by ion beam bombardment, and the micropatterns are positively charged.

4. The arterial ostium stent according to claim 1, characterized in that, The diameter of the support ring at the free end of the stent body matches the diameter of the vertebral artery; the diameter of the support ring connecting the stent body and the tail fin matches the diameter of the subclavian artery.

5. The arterial ostium stent according to claim 4, characterized in that, The number of support rib units in the support ring connected to the tail fin in the main body of the support structure is greater than the number of support rib units in the free end support ring of the main body of the support structure.

6. The arterial ostium stent according to claim 4, characterized in that, The support ring of the main body of the bracket, which is connected to the tail fin, is electroplated with tantalum or platinum.

7. The arterial ostium stent according to claim 1, characterized in that, The anchoring ring includes leaf-shaped long anchor support bars and short anchor support bars.

8. The arterial ostium stent according to claim 1, characterized in that, The waveform amplitude at both ends of the anchoring reinforcement, which is shaped like a sine curve, is smaller than the waveform amplitude in the middle of the anchoring reinforcement.

9. The arterial ostium stent according to claim 1, characterized in that, The length of the main body of the support is 8 to 15 mm, the number of support rings is 5 to 7, the number of support rib units in each support ring is 8 to 10, and the length of the anchoring ribs is 3 to 4.5 mm.

10. The arterial ostium stent according to claim 5, characterized in that, The support ring in the main body of the bracket, which is connected to the tail fin, expands into a trumpet shape.

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