Vascular rivet for plugging

Abstract

The invention discloses a vascular rivet for plugging, and belongs to the technical field of medical instruments, the vascular rivet comprises a net-shaped rivet ring body formed by winding a metal wire, and the rivet ring body comprises a first rivet body and a second rivet body which are connected in the axial direction of the rivet ring body; and cilia are arranged on the surface of the first rivet body. The invention solves the problem of accurate plugging of a blood vessel crevasse, and overcomes the problem that blood cannot enter a branch blood vessel to cause various complications such as ischemia of other organs due to the fact that the branch blood vessel is plugged by a covered section of the existing covered stent.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a vascular rivet for occlusion. Background Technology

[0002] With the rising incidence of cardiovascular diseases such as hypertension, the incidence of acute aortic diseases such as aortic dissection and aneurysm has also increased significantly. Among them, acute Stanford type A aortic dissection and other diseases are extremely dangerous, with a very high mortality rate if not treated surgically or interventionally in a timely manner.

[0003] Endovascular interventional repair is an important minimally invasive procedure for treating such diseases, typically involving the implantation of a covered stent to isolate blood flow from the diseased vessel wall. However, for lesions affecting important branch vessels, traditional covered stents, while sealing the rupture, also pose a risk of ischemia due to covering the branch vessel orifice. Once the covered segment of the stent blocks the branch vessel orifice, blood cannot enter the branch vessel, leading to numerous complications such as ischemia in other organs.

[0004] In view of this, the present invention provides a new solution to the above problems. Summary of the Invention

[0005] The purpose of this invention is to provide a vascular rivet for sealing, which solves the problem of precise sealing of vascular ruptures and overcomes the problem that existing covered stents easily cover branch vessel openings.

[0006] The above-mentioned technical objective of the present invention is achieved through the following technical solution.

[0007] A vascular rivet for occlusion includes a mesh rivet ring formed by winding metal wire, the rivet ring comprising a first rivet body and a second rivet body connected along its axial direction; The surface of the first rivet body is provided with fibers.

[0008] A further preferred embodiment is that the diameter of the first rivet body is larger than the diameter of the second rivet body, and the two are axially coaxially connected, together forming a stepped structure that is thinner at the proximal end and thicker at the distal end.

[0009] A further preferred embodiment is that the first rivet body is a large-diameter disc-shaped mesh winding structure, with cilia radially distributed on its outer circumferential surface; The second rivet body is a small-diameter disc-shaped mesh winding structure, which is coaxially fixed to one end face of the first rivet body.

[0010] A further preferred embodiment is that the first rivet body and the second rivet body are formed into an integral structure by heat setting.

[0011] A further preferred embodiment is that the diameter of the first rivet body is 0.5-40 mm and the thickness is 1.0-15 mm; The diameter of the second rivet body is 0.5-10mm, and the thickness is 0.5-10mm.

[0012] A further preferred embodiment is that both the first rivet body and the second rivet body are multi-layer spiral wound annular array structures, with gaps between adjacent wound layers, and the cilia protrude radially from the outer peripheral surface of the first rivet body along the gaps.

[0013] More preferably, the rivet ring body is made of one or more metal wires selected from platinum-tungsten alloy, platinum, tungsten, gold, silver, tantalum, nickel-titanium alloy, cobalt-chromium alloy, or platinum-iridium alloy.

[0014] Further preferably, the fiber material is one or more of polyester fiber, polyamide fiber, polylactic acid, or resin.

[0015] A further preferred embodiment is that the distal end of the rivet ring is provided with a rounded ball head.

[0016] A further preferred embodiment is that the diameter of the metal wire constituting the rivet ring is 0.01-0.2 mm.

[0017] In summary, the present invention has the following beneficial effects: The vascular rivet for occlusion of the present invention includes a mesh rivet ring formed by winding metal wire, wherein the rivet ring includes a first rivet body and a second rivet body connected along its axial direction; the surface of the first rivet body is provided with cilia.

[0018] After implantation, the first rivet, equipped with cilia, is precisely positioned within the vessel wall dissection or rupture. The cilia significantly increase the surface area and packing density of this region, rapidly inducing platelet aggregation and fibrin deposition, forming a fast and stable thrombus at the target rupture site, thus achieving efficient closure. The second rivet, located within the true lumen of the vessel, with its smooth, exposed metal surface, greatly reduces the risk of thrombus formation in a normal blood flow environment. This effectively avoids serious complications such as thrombotic stenosis or occlusion of the target vessel or its downstream branches caused by the device itself, ensuring unobstructed blood flow to the main vessel. Therefore, the combination of the integrated design and functional zoning of the vascular rivet makes it particularly suitable for aortic lesions involving important branch vessels. It can close the rupture while minimizing interference with the blood supply to branch vessels, achieving a balance between localized secure closure and global blood flow protection, expanding the applicable scenarios for minimally invasive interventional therapy, and improving the safety of treatment. This invention can be precisely delivered and positioned at the vascular rupture site. Its design ensures that the thrombotic effect is concentrated in the rupture area, while maintaining low thrombogenicity in the normal vascular lumen, thereby achieving safe and effective local occlusion. It solves the problem of precise occlusion of vascular ruptures and overcomes the problem of existing covered stents easily covering branch vessel openings. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of a preferred embodiment of the vascular rivet forming structure in this invention; Figure 2 This is a schematic diagram of the unfolded structure of a vascular rivet according to a preferred embodiment of the present invention; Figure 3 This is a schematic diagram of a preferred embodiment of the vascular rivet release device in this invention; Figure 4 This is a schematic diagram of a preferred embodiment of the vascular rivet installation structure in this invention.

[0021] In the figure, 1 is the rivet ring body; 101 is the first rivet body; 102 is the second rivet body; 2 is the cilia; 3 is the ball head; 41 is the first release component; 42 is the second release component; 43 is the delivery conduit; and 44 is the push rod. Detailed Implementation

[0022] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0023] Example: A vascular rivet for occlusion, such as Figure 1 , 2 As shown, the rivet ring 1 includes a mesh-like rivet coil body 1 formed by winding metal wire. The rivet ring 1 comprises a first rivet body 101 and a second rivet body 102 connected along its axial direction. The first rivet body 101 and the second rivet body 102 are formed into a single structure through a heat-setting process, without any welding or mechanical connection points, ensuring the overall strength and reliability of the structure. The surface of the first rivet body 101 is provided with fibers 2, while the second rivet body 102 is an exposed metal structure without fibers 2.

[0024] In the above technical solution, the first rivet body 101 and the second rivet body 102 are integrated into a single structure through a heat-setting process, avoiding weak points that may arise from welding or mechanical connections, and ensuring the overall structural strength and reliability of the rivet. After release, the two parts pull on each other, stably embedding themselves on both sides of the vascular rupture, forming a reliable mechanical anchor, resisting the scouring of blood flow, and effectively preventing displacement. After the vascular rivet is implanted, the first rivet body 101 with cilia 2 is precisely located in the vascular wall interlayer or inside the rupture. Cilia 2 significantly increase the surface area and packing density of this area, rapidly inducing platelet aggregation and fibrin deposition, forming a rapid and stable thrombus at the target rupture site, thereby achieving efficient occlusion. The second rivet body 102, located in the true lumen of the blood vessel, has a smooth, exposed metal surface, which greatly reduces the risk of thrombus formation in the normal blood flow environment. This effectively avoids serious complications such as thrombotic stenosis or occlusion of the target blood vessel or its downstream branches caused by the device itself, ensuring the unobstructed flow of blood in the main trunk. Therefore, the combination of the integrated design and functional zoning of the vascular rivet makes it particularly suitable for aortic lesions involving important branch vessels. It can seal the rupture while minimizing interference with the blood supply to the branch vessels, achieving a balance between secure local occlusion and overall blood flow protection. This expands the applicable scenarios for minimally invasive interventional therapy and improves the safety of treatment.

[0025] like Figure 1 , 2 As shown, in one specific embodiment, the diameter of the first rivet body 101 is larger than the diameter of the second rivet body 102, and the two are axially coaxially connected, forming a stepped structure that is thinner at the proximal end and thicker at the distal end. The first rivet body 101 is a large-diameter disc-shaped mesh-like winding structure, with cilia 2 evenly distributed radially on its outer circumference, the cilia 2 being embedded in the gaps of the mesh-like winding structure. The second rivet body 102 is a small-diameter disc-shaped mesh-like winding structure, one end face of which is coaxially fixed to one end face of the first rivet body 101. The metal wire surface of the second rivet body 102 is cleaned and polished, without any cilia 2 or other thrombotic materials adhering to it, maintaining a smooth, exposed metal surface. In the implanted state, the second rivet body 102 will be located within the true lumen of the blood vessel.

[0026] In one specific embodiment, the diameter of the first rivet body 101 ranges from 0.5 to 40 mm, and the thickness ranges from 1.0 to 15 mm, adapting to different sizes of blood vessel wall dissections or blood vessel ruptures; the diameter of the second rivet body 102 ranges from 0.5 to 10 mm, and the thickness ranges from 0.5 to 10 mm, adapting to the size of a normal blood vessel lumen, ensuring that the stepped structure can be stably embedded in the blood vessel rupture position, achieving precise positioning.

[0027] In the above technical solution, the first rivet body 101 and the second rivet body 102 have a significant difference in diameter, together forming a clear "stepped" structure. This structure allows the larger diameter first rivet body 101 to be confined within the blood vessel wall interlayer or rupture after release, while the smaller diameter second rivet body 102 remains in the true lumen of the blood vessel. The two pull on each other, forming a stable "riveting" fixation effect.

[0028] Preferably, both the first rivet body 101 and the second rivet body 102 are multi-layered spirally wound annular array structures, with gaps between adjacent winding layers. The cilia 2 protrude radially from the outer circumferential surface of the first rivet body 101 along these gaps. These cilia 2 are fine and soft, not only filling the internal space of the mesh structure but also protruding radially from its outer surface, making the first rivet body 101 visually and functionally resemble a "fluffy ball" or a highly porosity fibrous mass. This provides a large surface area after implantation into a ruptured blood vessel to rapidly activate the coagulation cascade reaction and form a stable thrombus.

[0029] Preferably, the distal end of the mesh rivet body (i.e., the distal end of the first rivet body 101) is provided with a smooth, rounded ball head 3 to avoid damage to the vascular intima during delivery. The proximal end of the mesh rivet body is used to connect with the release device of the interventional delivery system for precise pushing and controllable release.

[0030] Furthermore, such as Figure 2 , 3 As shown, the matching release device includes a first release component 41, a second release component 42, a delivery conduit 43, and a push rod 44. The first release component 41 has a receiving groove, the second release component 42 is disposed within the receiving groove, the rivet ring 1 is connected to the second release component 42, and the push rod 44 is connected to the first release component 41. During delivery within the conduit, the delivery conduit 43 limits the second release component 42, confining it within the receiving groove. When the release device is outside the delivery conduit 43, the delivery conduit 43 no longer limits the second release component 42, allowing the second release component 42 to detach from the receiving groove, thus completing the release of the rivet from the delivery device.

[0031] In the above technical solution, this release device adopts a mechanical coupling design that allows for both limiting and release. During delivery, when the device is inside the delivery catheter 43, the catheter wall forms a stable radial constraint on the second release element 42, firmly confining it within the receiving groove of the first release element 41. At this time, the operator can precisely position the vascular rivet using the push rod 44, make repeated fine adjustments, or even completely retract it into the catheter, greatly improving the safety and error tolerance of the surgical operation. This allows the operator to make multiple attempts before final confirmation of the position, reducing the risk of accidental release. The release process does not require complex electrolysis, thermal melting, or additional mechanical unlocking actions. Once the device is pushed to the target position and exits the front end of the delivery catheter 43, the constraint of the catheter is automatically released. Under blood flow conditions or with slight manipulation, the second release element 42 can smoothly and naturally detach from the large-opening receiving groove. This release method based on physical constraint removal is direct and reliable, significantly reducing the risk of release failure or difficulty in release due to blood viscosity, and improving the certainty and success rate of release.

[0032] like Figure 1 , 2 As shown, the rivet ring 1 is made of one or more metal wires selected from platinum-tungsten alloy, platinum, tungsten, gold, silver, tantalum, nickel-titanium alloy, cobalt-chromium alloy or platinum-iridium alloy. The diameter of the metal wires constituting the rivet ring 1 is 0.01-0.2 mm, and the overall diameter of the rivet ring 1 formed by winding is 0.1-0.6 mm in its natural state.

[0033] Preferably, the material of the filament 2 is one or more of polyester fiber, polyamide fiber, polyglycolic acid, or resin, and it is fixed in the winding layer gap of the first rivet body 101 by snap-fit, so that it is firmly fixed and not easy to fall off.

[0034] In the above technical solution, the rivet coil 1 is made of biocompatible metal wires such as platinum-tungsten alloy, ensuring the long-term in vivo safety of the device. The ultra-fine wire diameter of 0.01-0.2 mm and the overall coil diameter of 0.1-0.6 mm together give the rivet coil 1 excellent flexibility and minimally invasive delivery capabilities, allowing it to smoothly pass through small, tortuous blood vessel paths to reach the target lesion location, while ensuring sufficient support and morphological stability after unfolding within the blood vessel. The cilia 2 are preferably made of thromboforming materials such as polyester fiber and polyamide fiber, and are precisely fixed to the winding layer gaps of the first rivet body 101 using a snap-fit ​​method. This fixation method not only provides a strong bond and effectively resists continuous blood flow erosion, preventing detachment and avoiding the risk of ciliary 2 displacement, but also maximizes the effective adhesion surface area and space filling rate of the thromboforming material in the target occlusion area, thereby significantly accelerating and enhancing the local thrombus formation efficiency and stability, ensuring rapid and reliable closure of the vascular rupture.

[0035] Working principle: such as Figure 1-4 As shown, during interventional surgery, a compressed vascular rivet is delivered to the target vascular rupture site via a delivery system. Under fluoroscopic guidance, the operator precisely releases the first rivet body 101 (with the ciliated portion 2) into the interstitial space of the vessel wall or the rupture cavity, while the second rivet body 102 (without the ciliated portion 2) remains in the true lumen of the vessel. After release, the stepped structure stabilizes and anchors it. The first rivet body 101 with the ciliated portion 2 rapidly induces local thrombus formation, sealing the rupture; the exposed second rivet body 102 ensures unobstructed blood flow in the true lumen, avoiding the risk of luminal stenosis or thromboembolism caused by the instrument itself.

[0036] When clinicians perform minimally invasive endovascular surgery, they first construct a vascular access system. The catheter tip enters the vascular dissection or aneurysm caused by the rupture. Therefore, the vascular access system is constructed with precise localization of the vascular rupture, eliminating the need for subsequent insertion of products like vascular rivets. In this invention, the vascular rivet is pre-installed within the delivery catheter. Clinicians connect the delivery catheter to the catheter connector, and the vascular rivet is pushed along the delivery catheter. The entire assembly, consisting of the first and second release components, automatically releases itself at the target site after the catheter is pushed out, making it relatively simpler. Existing vascular occlusion devices use more complex delivery and release methods, including thermal release, electrical release, and hydrolysis, requiring additional intervention from the clinician and failing to achieve automatic release.

[0037] When a blood vessel wall ruptures, blood flows into the surrounding tissue, forming a vascular dissection or aneurysm, where blood becomes stagnant. In this invention, the first rivet body 101 is conical (0.5-40 mm in diameter, 1.0-15 mm in thickness) and contains numerous cilia 2. When placed inside a vascular dissection or aneurysm, the cilia 2 rapidly induce platelet aggregation and fibrin deposition, forming a fast and stable thrombus within the dissection or aneurysm. Although gaps exist between the rings, the sealing principle involves the rivet body, cilia 2, and thrombus interwoven within the dissection or aneurysm to form a reinforced concrete-like structure, thereby achieving efficient sealing of larger vascular ruptures.

[0038] The above are merely preferred embodiments of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. A vascular rivet for occlusion, characterized in that: It includes a mesh rivet ring formed by winding metal wire, wherein the rivet ring includes a first rivet body and a second rivet body connected along its axial direction; The surface of the first rivet body is provided with fibers.

2. The vascular rivet for occlusion according to claim 1, characterized in that: The diameter of the first rivet body is larger than that of the second rivet body, and the two are axially coaxially connected, forming a stepped structure that is thinner at the proximal end and thicker at the distal end.

3. The vascular rivet for occlusion according to claim 2, characterized in that: The first rivet body is a large-diameter disc-shaped mesh winding structure, with hairs radially distributed on its outer circumferential surface; The second rivet body is a small-diameter disc-shaped mesh winding structure, which is coaxially fixed to one end face of the first rivet body.

4. A vascular rivet for occlusion according to claim 2, characterized in that: The first rivet body and the second rivet body are formed into an integral structure by heat setting.

5. A vascular rivet for occlusion according to claim 2, characterized in that: The diameter of the first rivet body is 0.5-40mm, and the thickness is 1.0-15mm; The diameter of the second rivet body is 0.5-10mm, and the thickness is 0.5-10mm.

6. A vascular rivet for occlusion according to claim 2, characterized in that: Both the first rivet body and the second rivet body are multi-layer spiral wound annular array structures, with gaps between adjacent wound layers, and the cilia protrude radially from the outer peripheral surface of the first rivet body along the gaps.

7. A vascular rivet for occlusion according to claim 1, characterized in that: The rivet ring is made of one or more metal wires selected from platinum-tungsten alloy, platinum, tungsten, gold, silver, tantalum, nickel-titanium alloy, cobalt-chromium alloy, or platinum-iridium alloy.

8. A vascular rivet for occlusion according to claim 1, characterized in that: The fiber material is one or more of polyester fiber, polyamide fiber, polylactic acid, or resin.

9. A vascular rivet for occlusion according to claim 1, characterized in that: The distal end of the rivet ring is provided with a rounded ball head.

10. A vascular rivet for occlusion according to claim 1, characterized in that: The diameter of the metal wire constituting the rivet ring is 0.01-0.2 mm.

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