Blood vessel closer

Abstract

The invention provides a blood vessel closer which comprises a connecting part and an anchoring part, the anchoring part is made of biodegradable materials and comprises a middle part and wing parts arranged on the two sides of the middle part, and a first hole penetrating in the width direction of the anchoring part is formed in the middle part; at least one wing part is provided with a second hole formed in the thickness direction of the anchoring part, and the anchoring part is connected with the connecting part through the first hole. The implantation amount of degradable materials is reduced through the anchoring part with the holes, then the release amount of degradable products is reduced, the anchoring part can be tightly attached to the blood vessel wall, and meanwhile tissue endothelialization is facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a blood vessel closure device for hemostasis. Background Art

[0002] Interventional surgery has the advantages of less trauma, good treatment effect, and short postoperative recovery time. It is increasingly widely used in the treatment of various heart diseases. However, many new technologies require larger vascular access than conventional interventional surgery, such as endovascular repair of aneurysms, transcatheter aortic valve replacement, mitral valve clamping, percutaneous extracorporeal membrane oxygenation technology and other cardiovascular surgeries. Hemostasis at large-caliber puncture points has higher requirements for vascular closure devices and is more prone to vascular complications such as bleeding, oozing, and hematoma. For a long time, traditional methods such as manual compression and "8" suture were generally used. The disadvantages of these methods are: manual compression takes a long time, and pressure bandages are still required after surgery, which will prolong the patient's bed rest time and occupy medical resources; at the same time, hematomas are easily formed, reducing patient comfort. Therefore, how to achieve rapid hemostasis of large-caliber punctures and postoperative puncture points and reduce vascular complications has become the biggest challenge facing these new technologies.

[0003] Currently, common vascular closure devices can be roughly divided into active vascular closure devices, compression-assisted closure devices, and surface hemostatic patches. Active vascular closure devices use a variety of methods to actively and directly close the puncture hole. Among them, the most commonly used method is to use occlusion to achieve the purpose of hemostasis, which is called occlusion-type vascular closure devices. This type of vascular closure device often uses hemostatic components such as collagen and sponges, anchoring components in the blood vessels, and connecting components in the middle, forming a sandwich-like structure with the blood vessels to compress the puncture point to stop bleeding, and is widely used in clinical practice.

[0004] Some active vascular closure devices include stents implanted in blood vessels, which are covered with a membrane at the puncture site and supported by a frame at other sites. Such vascular closure devices can close the puncture caused by thicker sheath puncture, but because they are stents implanted in blood vessels, they can only remain in the body permanently, which has the risk of causing thrombosis and will affect the second puncture. Some active vascular closure devices require anchoring components to be set inside the blood vessels. In order to avoid residues in the blood vessels, most of the anchoring components are made of degradable materials, such as alloy materials such as magnesium-based alloys, iron-based alloys and zinc-based alloys, as well as polymer materials such as polylactic acid (PLA), polyglycolic acid (PGA) and their copolymers (PLGA) or mixtures, to form block or sheet structures. For larger puncture holes, larger anchoring components need to be made to support and assist in occlusion, resulting in excessive implantation, occupying more space in the blood vessel, and being more likely to cause hemodynamic disorders. At the same time, the amount of degradation products will increase, thereby causing more severe inflammatory reactions. Some active vascular closure structures can stop bleeding at puncture points of different sizes, but the anchoring components inside the blood vessels are easily affected by the blood vessel diameter, blood vessel calcification, blood vessel curvature, etc., and cannot be well attached to the blood vessel wall. The support stability is insufficient, which can easily affect the hemostatic effect of the hemostatic components outside the blood vessels, causing complications such as bleeding. At the same time, such block-shaped or sheet-shaped anchoring components are not conducive to tissue coverage and blood vessel repair. Summary of the invention

[0005] In view of this, the object of the present invention is to provide a vascular closure device to solve the problems of the existing active vascular closure devices, such as excessive implantation of degradable materials, loose fit between the anchoring component and the vascular wall, and poor tissue endothelialization.

[0006] To achieve the above-mentioned object, the present invention provides a vascular closure device, which includes a connecting component and an anchoring component, wherein the material of the anchoring component is a biodegradable material, the anchoring component includes a middle portion and wing portions arranged on both sides of the middle portion, the middle portion is provided with a first hole penetrating along the width direction of the anchoring component, at least one of the wing portions is provided with a second hole arranged along the thickness direction of the anchoring portion, and the anchoring component is connected to the connecting component through the first hole.

[0007] Optionally, the minimum distance between the hole wall of the first hole and the outer contour of the middle portion is greater than or equal to the minimum distance between the hole wall of the second hole and the outer contour of the wing portion.

[0008] Optionally, the second hole is arranged to penetrate along the thickness direction of the anchoring component.

[0009] Optionally, the anchoring component has a first side and a second side opposite to each other along its thickness direction, the first side is used for adhering to the blood vessel wall, and the first side of the middle portion is raised relative to the first side of the wing portion.

[0010] Optionally, an arc-shaped protrusion is formed on the first side of the middle portion, and the center of the arc-shaped protrusion does not coincide with the center of the first hole.

[0011] Optionally, each of the wing portions is provided with the second hole, the number of the second holes on the two wing portions is the same or different, and the structures of the second holes on the two wing portions are the same or different.

[0012] Optionally, the anchoring component has a first side and a second side opposite to each other along its thickness direction, the first side is used to adhere to the blood vessel wall, the minimum distance from the hole wall of the first hole to the first side of the outer contour of the middle part is b1, and the minimum distance from the hole wall of the first hole to the second side of the outer contour of the middle part is b2, wherein b2<b1.

[0013] Optionally, the minimum distance between the hole wall of the second hole and the outer contour of the wing in the length direction of the anchoring component is a1, and the minimum distance between the hole wall of the second hole and the outer contour of the wing in the width direction of the anchoring component is a2, wherein b1>a1, and / or b1>a2.

[0014] Optionally, the minimum distance between the hole wall of the second hole and the outer contour of the wing portion is 0.1 mm to 2.0 mm, and / or the minimum distance between the hole wall of the first hole and the outer contour of the middle portion is 0.1 mm to 2.0 mm.

[0015] Optionally, the total volume of the first hole and the second hole accounts for 26% to 82% of the total volume of the anchoring component.

[0016] Optionally, the anchoring component is made of magnesium alloy or a composite material thereof.

[0017] Optionally, the release amount of the degradation product of the anchoring component does not exceed 40 ml, and the gripping force that the anchoring component can withstand is not less than 200 PSI.

[0018] Optionally, the minimum thicknesses of the wings on both sides are different, and / or the thickness of the anchoring component gradually decreases from the middle portion to both sides.

[0019] Optionally, at least one of the wing portions is provided with a plurality of the second holes, and the plurality of the second holes are arranged in a network structure.

[0020] Optionally, a hemostasis component connected to the connecting component is also included.

[0021] In summary, the vascular closure device provided by the present invention comprises: a connecting component and an anchoring component, wherein the material of the anchoring component is a biodegradable material, the anchoring component comprises a middle portion and wing portions arranged on both sides of the middle portion, the middle portion is provided with a first hole penetrating along the width direction of the anchoring component, at least one of the wing portions is provided with a second hole arranged along the thickness direction of the anchoring portion, and the anchoring component is connected to the connecting component through the first hole.

[0022] In this way, the implantation amount of the anchoring component can be reduced by setting the first hole and the second hole, so as to avoid it occupying too much space in the blood vessel, thereby reducing the impact on hemodynamics. At the same time, the amount of degradation products of the anchoring component is reduced due to the reduction in the implantation amount, and the inflammatory response caused by it is alleviated. Moreover, the setting of the second hole helps endothelial cells to attach, accelerates tissue endothelialization, and increases the stability of endothelialization. In addition, the anchoring component with the first hole and the second hole has a smaller force area and greater pressure under the same pressure, which is conducive to the attachment of the anchoring component to the blood vessel wall and ensures the support stability.

[0023] Furthermore, in the vascular closure device provided by the present invention, the minimum distance between the hole wall of the first hole and the outer contour of the middle part is greater than or equal to the minimum distance between the hole wall of the second hole and the outer contour of the wing part. This arrangement ensures that the middle part will be degraded later than the wing part with the second hole, so that the middle part loses its mechanical properties later than the wing part with the second hole, thereby avoiding the problem of the middle part being degraded first and causing the entire anchoring component to fall off. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 This is a diagram of an application scenario of a blood vessel closure device for closing a puncture hole according to an embodiment of the present invention;

[0026] Figure 2 A top view of an anchoring component provided according to an embodiment of the present invention;

[0027] Figure 3 A front view of an anchoring component provided according to an embodiment of the present invention;

[0028] Figure 4 A top view of an anchoring component provided according to another embodiment of the present invention;

[0029] Figure 5 A front view of an anchoring component provided according to another embodiment of the present invention;

[0030] Figure 6 A top view of an anchoring component provided according to another embodiment of the present invention;

[0031] Figure 7 A front view of an anchoring component provided according to another embodiment of the present invention;

[0032] Figure 8 A top view of an anchoring component provided according to another embodiment of the present invention;

[0033] Fig. 9 It is a front view of an anchoring component provided according to other embodiments of the present invention.

[0034] The following are the descriptions of the reference numerals:

[0035] 1-blood vessel; 2-puncture point; 10-hemostatic component; 20-anchoring component; 210-middle part; 211-first hole; 230-wing; 231-second hole; 232-crossbeam structure; 30-connecting component; W-width of anchoring component; L-length of anchoring component; T1-minimum thickness of the left wing; T2-minimum thickness of the right wing; T3-maximum thickness of the middle part; D-diameter of the first hole; R-radius of the arc-shaped protrusion; e-eccentricity; A-wall of the second hole; B-wall of the first hole. DETAILED DESCRIPTION

[0036] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the present invention will become clearer. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different proportions are used. It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", etc. in the specification are only used to distinguish between the various components, elements, steps, etc. in the specification, and are not used to represent the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0037] In the present application document, the “plurality” mentioned herein refers to two or more than two, and the “several” mentioned herein indicates an indefinite quantity; the “width direction” mentioned herein refers to the extension direction along the hole axis of the first hole; the “length direction” mentioned herein refers to the extension direction along the hole axis perpendicular to the first hole and the second hole; the “thickness direction” mentioned herein refers to the extension direction along the hole axis of the second hole; the “not less than” mentioned herein refers to greater than or equal to, and the “not greater than” mentioned herein refers to less than or equal to; the outer contour of the middle portion refers to the portion of the outer contour of the entire anchoring component where the middle portion is located, and the outer contour of the wing portion refers to the portion of the outer contour of the entire anchoring component where the wing portion is located.

[0038] The object of the present invention is to provide a vascular closure device to solve the problems of the existing active vascular closure devices, such as excessive implantation of degradable materials, loose fit between the anchoring component and the vascular wall, and disadvantageous tissue endothelialization.

[0039] The following description is given with reference to the accompanying drawings.

[0040] refer to Figure 1 , which shows a vascular closure device, including a connecting component 30 and an anchoring component 20. Optionally, the vascular closure device also includes a hemostatic component 10 connected to the connecting component 30. The hemostatic component 10 is mostly made of commonly used hemostatic materials such as collagen and sponge. The connecting component 30 can be degraded and absorbed, and has elasticity and good tensile properties. The connecting component 30 is mostly an absorbable thread, which can be completely absorbed and has good tensile strength. The anchoring component 20 is used to be placed in the blood vessel 1 to anchor and support the entire vascular closure device, and can also play a role in auxiliary occlusion. Figure 1 As shown, during hemostasis, the vascular closure device of the present invention forms a sandwich-like structure with the blood vessel 1 to compress the puncture point 2 to stop bleeding.

[0041] The anchoring component 20 is generally a block structure, and its material is a biodegradable material, for example, alloy materials such as magnesium-based alloys, iron-based alloys and zinc-based alloys, or polymer materials such as polylactic acid (PLA), polyglycolic acid (PGA) and their copolymers (PLGA) or mixtures. Since magnesium alloys have excellent mechanical properties, good biocompatibility and fully absorbable biodegradable properties, it is preferred that the anchoring component 20 is made of magnesium alloy or its composite material. When prepared using magnesium alloy or its composite material, the degradation behavior of the anchoring component 20 is controllable, and it will not suddenly disintegrate but can be gradually degraded, the degradation is uniform, and the degradation cycle is short and the strength is good.

[0042] Furthermore, degradable metal materials such as magnesium-based alloys and iron-based alloys will be accompanied by a large amount of hydrogen gas, a degradation product, during the degradation process, so that it does not have time to diffuse and absorb, and bubbles are formed around the implant. The formation of bubbles will affect the physiological function of the tissues around the implant and the recovery treatment of the implant site to a certain extent. Of course, in addition to degradable metal materials, degradable polymer materials will also generate carbon dioxide during the degradation process. If the release amount is too large, it will also cause a serious inflammatory reaction. In view of the fact that the release amount of degradation products (such as hydrogen, carbon dioxide, etc.) is determined by the implant amount, therefore, the implant amount of the anchoring component 20 needs to be strictly controlled to avoid increasing the amount of degradation products, while also avoiding occupying a larger space in the blood vessel due to an excessive implant amount.

[0043] like Figures 2 to 9As shown, the anchoring component 20 includes a middle portion 210 and wing portions 230 arranged on both sides of the middle portion 210. The middle portion 210 should not be narrowly understood as an absolute central position. The middle portion 210 can be located in the middle or deviated from the middle. The middle portion 210 is provided with a first hole 211, and the number of the first holes 211 is one or more. At least one wing portion 230 is provided with a second hole 231, and the number of the second holes 231 on the wing portion 230 is one or more. Preferably, each wing portion 230 is provided with a second hole 231 to further reduce the amount of implanted degradable material.

[0044] The first hole 211 is arranged to penetrate along the width direction of the anchoring member 20. The anchoring member 20 is connected to the connecting member 30 through the first hole 211. The connecting member 30 can be connected through the first hole 211, which is generally a movable connection. The size of the first hole 211 is larger than the size of the connecting member 30, which is convenient for the connecting member 30 to pass through, and can adapt to connecting members 30 of different sizes. For example, when the diameter of the first hole 211 is 0.8 mm, it can adapt to a connecting member 30 of 0.3 mm or 0.5 mm.

[0045] The second hole 231 is disposed through or not through the thickness direction of the anchoring component 20. Preferably, the second hole 231 is disposed through, and the implantation amount is smaller.

[0046] The provision of the first hole 211 and the second hole 231 can effectively solve the problem of excessive implantation of degradable materials, so that the implantation amount of the anchoring component 20 will not be too large, avoiding it from occupying too much space in the blood vessel, thereby reducing the impact on hemodynamics. At the same time, the reduction in the implantation amount also reduces the amount of degradation products of the anchoring component 20 and reduces the inflammatory response caused thereby.

[0047] Reference Figure 1 It is further understood that when hemostasis occurs, the first side of the anchoring component 20 along its thickness direction needs to be attached to the blood vessel wall. At this time, the second hole 231 opened in the thickness direction helps endothelial cells to climb, accelerates tissue endothelialization, and increases the stability of endothelialization. Therefore, this anchoring component 20 is conducive to tissue coverage and blood vessel repair. Moreover, this anchoring component 20 has a smaller force-bearing area and a greater pressure under the same pressure, which is conducive to the attachment of the anchoring component 20 to the blood vessel wall, ensuring the support stability, reducing the impact on the hemostatic effect of the hemostatic component 10 outside the blood vessel, and avoiding complications such as bleeding.

[0048] The cross-sectional shape of the first hole 211 can be circular, elliptical, polygonal or other regular or irregular shapes, and the present invention is not limited to this, as long as the first hole 211 allows the connecting component 30 to pass through. Taking the sponge as the hemostatic component 10 as an example, the connecting component 30 can pass through the sponge and the first hole 211 in sequence to form a closed loop to achieve a connection effect, but it is not actually limited to the closed loop connection method, as long as the connecting component 30 can be connected to the hemostatic component 10 after passing through the first hole 211.

[0049] The anchoring component 20 has a first side and a second side opposite to each other along the thickness direction thereof, wherein the first side is used to adhere to the blood vessel wall, and the second side is close to the central axis of the blood vessel. Optionally, the first side of the middle portion 210 is raised relative to the first side of the wing portion 230, so that the thickness at the raised part is larger, and thus during the degradation process, the middle portion 210 will not lose its mechanical properties prematurely, and it is also convenient for the connecting component 30 to pass through the first hole 211. Preferably, the first side of the middle portion 210 forms an arc-shaped raised part so as not to damage the blood vessel wall, and more preferably, the first side of the middle portion 210 forms an arc-shaped raised part. However, in other embodiments, the raised part of the first side of the middle portion 210 may be eliminated, for example, the first side of the middle portion 210 is flush with the first side of the wing portion 230.

[0050] The shape of the second hole 231 is also not limited, including but not limited to the shape shown in the figure. The second hole 231 can be a regular shape or an irregular shape, and there is no special requirement for this. For example, a regular geometric shape such as a rectangle, a circle, a polygon, or an irregular geometric shape can be used.

[0051] When the degradation cycles of the two wings 230 need to be equal, a second hole 231 needs to be set on each wing 230. If only the degradation cycle of one side needs to be controlled, only the second hole 231 needs to be set on a single wing 230. The specific setting can be based on actual needs. In this embodiment, the two wings 230 are provided with second holes 231, so that the implantation amount of the anchoring component 20 can be effectively reduced and the release amount of the degradable product can be reduced. The number of the second holes 231 on the two wings 230 is the same or different, the structure of the second holes 231 on the two wings 230 is the same or different, and the second holes 231 on the two wings 230 can be symmetrically arranged or asymmetrically arranged. The second holes 231 can be symmetrically arranged or asymmetrically arranged along the length direction of the anchoring component 20. When the second holes 231 are symmetrically arranged, the two wings 230 are both provided with the second holes 231 ; when the second holes 231 are asymmetrically arranged, only one wing 230 is provided with the second hole 231 , or the two wings 230 are both provided with the second hole 231 .

[0052] Preferably, the middle part 210 needs to be degraded later than the wing part 230 provided with the second hole 231, so as to avoid the middle part 210 being degraded first, resulting in failure of the connection between the connecting part 30 and the anchoring part 20, and causing the risk of the anchoring part 20 falling off as a whole. Therefore, the minimum distance between the hole wall of the first hole 211 and the outer contour of the middle part 210 is greater than or equal to the minimum distance between the hole wall of the second hole 231 and the outer contour of the wing part 230, so that the time when the middle part 210 loses its mechanical properties is later than that of the wing part 230 provided with the second hole 231.

[0053] For reference Figure 2 , Figure 4 and Figure 6 In the exemplary embodiment shown, the minimum distance between the hole wall A of the second hole 231 and the outer contour of the wing 230 in the length direction of the anchoring member 20 is a1, and the minimum distance between the hole wall A of the second hole 231 and the outer contour of the wing 230 in the width direction of the anchoring member 20 is a2. The minimum distance between the hole wall A of the second hole 231 and the outer contour of the wing 230 is at least one of a1 and a2; if a1 and a2 are equal, the minimum distance between the hole wall of the second hole 231 and the outer contour of the wing 230 is a1 and a2; if a1 and a2 are not equal, the minimum distance between the hole wall of the second hole 231 and the outer contour of the wing 230 is the smaller one of a1 and a2. a1 and a2 are equal or unequal.

[0054] like Figure 3 As shown, the minimum distance from the hole wall B of the first hole 211 to the first side of the outer contour of the middle part 210 is b1, and the minimum distance from the hole wall B of the first hole 211 to the second side of the outer contour of the middle part 210 is b2. The minimum distance between the hole wall B of the first hole 211 and the outer contour of the middle part 210 is at least one of b1 and b2; similarly, if b1 and b2 are equal, the minimum distance between the hole wall B of the first hole 211 and the outer contour of the middle part 210 is b1 and b2; if b1 and b2 are not equal, the minimum distance between the hole wall B of the first hole 211 and the outer contour of the middle part 210 is the smaller one of b1 and b2. b1 and b2 are equal or unequal, preferably, b1>b2, so that the first side of the middle part 210 is degraded later than the second side.

[0055] Specifically in this embodiment, b1>a1, and / or, b1>a2. Preferably, the minimum distance between the hole wall of the second hole 231 and the outer contour of the wing portion 230 is 0.1mm-2.0mm, and the minimum distance between the hole wall of the first hole 211 and the outer contour of the middle portion 210 is 0.1mm-2.0mm; this minimum distance is conducive to the rapid endothelialization of the surface of the anchoring component 20, and is conducive to the repair of blood vessels after surgery, and is also conducive to ensuring the strength of the anchoring component 20, and preventing the size of the anchoring component 20 from being too large to occupy the space in the blood vessel.

[0056] In this embodiment, the width of the anchoring part 20 is defined as W, the length of the anchoring part 20 is defined as L, and the thickness of the anchoring part 20 includes T1, T2 and T3, and T1, T2 and T3 can be equal or unequal. Generally, the width of the middle part 210 is the same as the width of the wing part 230. For example, as shown in the figure, the minimum thickness of the wing part 230 on the left is T1, the minimum thickness of the wing part 230 on the right is T2, and the maximum thickness of the middle part 210 is T3. If the end of the wing part 230 forms a chamfer, the minimum thickness is the chamfer size, and if the end of the wing part 230 is hemispherical, the minimum thickness is the semi-plane diameter of the hemispherical shape.

[0057] Preferably, the minimum thicknesses of the two wings 230 are different; thus, the anchoring member 20 can be easily moved through the blood vessel during delivery. Figure 3 , Figure 7 and Fig. 9 As shown, the minimum thickness T1 of the left wing 230 is greater than the minimum thickness T2 of the right wing 230. In an exemplary embodiment, as shown in FIG. Figure 5 As shown, the minimum thickness T1 of the wing portion 230 on the left side is smaller than the minimum thickness T2 of the wing portion 230 on the right side.

[0058] Preferably, the thickness of the anchoring component 20 gradually decreases from the middle portion 210 toward both sides, so that the implantation amount can be further reduced.

[0059] Preferably, the total volume of the first hole 211 and the second hole 231 accounts for 26% to 82% of the total volume of the anchoring component 20; in this way, the total amount of degradable products of the anchoring component 20 is effectively controlled within a preset range while also taking into account the mechanical strength of the anchoring component 20.

[0060] Preferably, the minimum distance from the hole wall of the second hole 231 to the outer contour of the wing 230 is 0.1 mm to 2.0 mm, and the total volume of the first hole 211 and the second hole 231 accounts for 26% to 82% of the total volume of the anchoring component 20, so that the implantation amount of the degradable material and the mechanical strength of the anchoring component 20 are in a better state, so that the entire anchoring component 20 can better meet the expected use requirements.

[0061] Furthermore, considering that the vascular closure device has certain support strength requirements for each component in one or more steps of the processing and forming process, for example, the hemostatic component 10, the anchoring component 20 and the connecting component 30 need to be installed in the sheath for transportation. At this time, the vascular closure device needs to be compressed by a stent crimping machine and other equipment so that it can be smoothly loaded into the sheath for transportation. In this regard, while reducing the implant amount, it is also necessary to ensure that the anchoring component 20 with holes has a certain strength to avoid the anchoring component 20 from being significantly deformed after crimping, which affects its use. The pressure range of a general stent compressor is 0-300PSI. Under this condition, the crimping force that the anchoring component 20 needs to withstand must not be less than 200PSI. While ensuring that the anchoring component 20 does not deform significantly before and after crimping, it can also withstand a larger crimping force. The greater the crimping force, the better the crimping effect. In addition, because the smaller the thinnest dimension of the anchoring component 20 is, the easier it is to deform, so it is necessary to ensure the strength at least at the first hole 211 and the second hole 231. In the actual design process, the gripping force test can be carried out for samples of different sizes and structures, and the maximum gripping force that each sample can withstand while maintaining its shape can be recorded to evaluate whether it meets the requirements. In addition to strength, the implantation amount of the anchoring component 20 must also be considered. The anchoring component 20 should be designed with the smallest implantation amount possible to avoid increasing the release of degradation products.

[0062] In order to evaluate the release amount of the degradation products of the anchoring component 20, an in vitro degradation experiment is further provided. The in vitro degradation experiment is as follows: Taking magnesium alloy or its composite material as an example, at room temperature, the anchoring component 20 is placed in a PE tube (simulating blood vessel) with an inner diameter of 5 mm, and the PE tube is filled with 30 ml of purified water (simulating blood). The two ends of the PE tube are closed. After the anchoring component 20 is completely degraded, the gas in the PE tube is collected and its volume is measured. Studies have shown that an appropriate amount of hydrogen has an effect on improving the endothelial function of peripheral blood vessels. At the same time, considering that the degradation rate of magnesium alloy is relatively fast, the degradation process will be accompanied by a large amount of hydrogen gas released by the degradation product to form bubbles, so the total amount of hydrogen gas released is set to be no more than 40 ml, otherwise it does not meet the requirements. It is understandable that when the degradable metal material is used as a premise, it is necessary to meet the release amount of the degradation products of the anchoring component 20, such as hydrogen, not exceeding 40 ml. If the degradable polymer material is used as a condition, the total amount of degradable product released can be other settings.

[0063] Therefore, in a preferred embodiment, the anchoring component 20 needs to meet the following two usage conditions:

[0064] The first condition is that the gripping force it can withstand must be greater than or equal to 200PSI while maintaining its shape.

[0065] The second condition is that the total amount of hydrogen released as a degradation product is no more than 40 ml.

[0066] In order to simultaneously meet the above two use conditions, the minimum distance from the hole wall of the second hole 231 to the outer contour of the wing 230 is preferably 0.1 mm to 2.0 mm, and the total volume of the first hole 211 and the second hole 231 accounts for 26% to 82% of the total volume of the anchoring component 20. Such a configuration can not only take into account the strength and the amount of degradation product release, but also facilitate the rapid endothelialization of the anchoring component 20 and increase the stability of the endothelialization.

[0067] The following is experimental data of the total amount of hydrogen released and the maximum tolerable compressive gripping force of the anchoring component 20 under different experimental conditions, to further illustrate the advantages of the vascular closure device of the present invention.

[0068] by Figure 4 and Figure 5 Taking the structure shown as an example, in a specific embodiment, a degradable anchoring component 20 is prepared, which uses a magnesium-based alloy or a composite material thereof as a processing material, a first hole 211 is provided in the middle part 210, and the first hole 211 is circular and has a diameter of D. Long waist-shaped second holes 231 are provided on the two wing parts 230, and an arc ridge is formed on the first side of the middle part 210. The radius of the arc ridge is R, and the center of the arc ridge is closer to the first side than the center of the first hole 211. The eccentricity between the two is e, the width of the anchoring component 20 is W, the length is L, the minimum thickness of the left wing 230 is T1, the minimum thickness of the right wing 230 is T2, and the maximum thickness of the middle part 210 is T3, and it is required that the minimum distance from the hole wall of the first hole 211 to the outer contour of the middle part 210 is greater than or equal to the minimum distance from the hole wall of the second hole 231 to the outer contour of the wing 230. In the specific design, by adjusting the minimum distances a1 and a2 of the second holes 231 on the two wings 230, the percentage of the total volume of the first hole 211 and the second hole 231 in the volume of the entire anchoring component 20 is changed, thereby changing the implantation amount of the anchoring component 20, and finally meeting the requirements of the total amount of hydrogen release and the gripping force.

[0069] In this experiment, 7 groups of test samples were provided, see Table 1 for details. Among the 7 groups of test samples, the minimum distance from the hole wall of the second hole 231 to the outer contour of the wing 230 is a (a in this case can be a1 or a2), and a is 0, 0.05mm, 0.1mm, 0.2mm, 1.5mm, 2.0mm, and 2.5mm respectively. The thickness of "0" indicates that there is no second hole 231.

[0070] It can be seen from Table 1 that when a is 0.1mm~2.0mm, the total volume percentage of the first hole 211 and the second hole 231 is between 26% and 82%, the total amount of hydrogen released does not exceed 40ml, and the maximum tolerable compressive grip force is not less than 200PSI; when a is 0, the implantation amount is too large, the total amount of hydrogen released is as high as 52ml, and the above two use conditions cannot be met at the same time; when a is 0.05mm, the maximum tolerable compressive grip force is significantly lower than 200PSI, which indicates that the strength is insufficient and easy to deform; when a is 2.5mm, the total amount of hydrogen released also exceeds 40ml, and there is a certain risk.

[0071] Table 1: Total amount of hydrogen released and maximum tolerable compressive grip force of the anchoring component 20 under different experimental conditions

[0072]

[0073] In addition, Figure 6 and Figure 7 Taking the structure shown in FIG. 1 as an example, in another specific embodiment, a degradable anchoring component 20 is prepared, wherein the biodegradable PLGA polymer material is selected as the processing material, and the middle part 210 is provided with a circular first hole 211, and the diameter of the first hole 211 is D. Figure 4 and Figure 5 The difference is that three second holes 231 are asymmetrically distributed on the two wings 230, two second holes 231 are provided on the left wing 230, and one second hole 231 is provided on the right wing 230. The second hole 231 on the right wing 230 is long waist-shaped, and the two second holes 231 on the left wing 230 can be spliced ​​to form a complete long waist-shaped hole. In this embodiment, it is only necessary to press and hold the left wing 230 of the anchoring component 20 and the hemostatic component 10 into the sheath for delivery, while the right wing 230 is arranged outside the sheath without pressing and holding. In this case, the left wing 230 is required to have higher strength, and a crossbeam structure 232 can be added to the left wing 230 to improve the strength of the pressed part. Since the right wing 230 does not need to be pressed and held in the sheath, there is no need to add a crossbeam structure 232, and the implantation amount can be reduced as much as possible. This delivery method facilitates the support of the wing 230 outside the sheath in the blood vessel, which is conducive to the withdrawal of the sheath to accurately position the hemostatic component 10 to the position where hemostasis is required. Of course, it is not limited to this delivery method. It should also be noted that the number of second holes 231 on the left wing 230 is not limited to two, but can also be three or more.

[0074] See also Figure 8 and Fig. 9As shown, in another specific embodiment, the second holes 231 on the anchoring member 20 are fine holes, with a larger number and a denser arrangement, so as to form a network structure. Although this embodiment is described in conjunction with a network structure arranged in a matrix, it should be understood that the second holes 231 can form a network structure by other forms of arrangement, such as irregular or random arrangement, which is not limited to this. This hole form can also reduce the amount of implanted degradable material.

[0075] In summary, the vascular closure device provided by the present invention has at least the following beneficial effects:

[0076] (1) The provision of the first hole and the second hole can effectively reduce the implantation amount of the anchoring component and reduce the occupation of the intravascular space, while also reducing the amount of degradation products and alleviating the inflammatory response caused thereby.

[0077] (2) By adjusting the shape, size and number of the first hole and the second hole, the amount of implanted degradable material and the mechanical strength of the anchoring component can be balanced so that the entire anchoring component meets the expected use requirements.

[0078] (3) The provision of the first hole and the second hole makes it easier to be covered by tissue, which is conducive to the attachment of the anchoring component to the blood vessel wall, providing a more solid support and better adaptability to the blood vessel.

[0079] (4) The arrangement of the first hole and the second hole also makes it easier for vascular endothelial cells to attach, which is beneficial to the rapid endothelialization of the surface of the anchoring component and the repair of blood vessels after surgery.

[0080] Finally, it should be noted that the vascular closure device provided by the present invention is suitable for the hemostasis needs of different patients and different blood vessels, and is flexible and convenient to use.

[0081] The above description of the embodiments should enable those skilled in the art to better understand the present application, and to reproduce and use the present application. It is obvious that those skilled in the art can make various changes and modifications to the above embodiments according to the principles described herein without departing from the essence and scope of the present application. Therefore, the present application should not be construed as being limited to the above embodiments shown herein, and its protection scope should be defined by the attached claims.

Claims

1. A vascular closure device, characterized in that: It includes a connecting component and an anchoring component. The material of the anchoring component is a biodegradable material. The anchoring component includes a middle part and wing parts arranged on both sides of the middle part. The middle part is provided with a first hole penetrating along the width direction of the anchoring component. At least one of the wing parts is provided with a second hole arranged along the thickness direction of the anchoring part. The anchoring component is connected to the connecting component through the first hole.

2. The vascular closure device according to claim 1, characterized in that: The minimum distance between the hole wall of the first hole and the outer contour of the middle portion is greater than or equal to the minimum distance between the hole wall of the second hole and the outer contour of the wing portion.

3. The vascular closure device according to claim 1 or 2, characterized in that: The second hole is arranged to penetrate along the thickness direction of the anchoring component.

4. The vascular closure device according to claim 1 or 2, characterized in that: The anchoring component has a first side and a second side opposite to each other along a thickness direction thereof, the first side is used for adhering to a blood vessel wall, and the first side of the middle portion is raised relative to the first side of the wing portion.

5. The vascular closure device according to claim 4, characterized in that: An arc-shaped protrusion is formed on the first side of the middle portion, and the center of the arc-shaped protrusion does not coincide with the center of the first hole.

6. The vascular closure device according to claim 1 or 2, characterized in that: Each of the wing parts is provided with the second hole, the number of the second holes on the two wing parts is the same or different, and the structures of the second holes on the two wing parts are the same or different.

7. The vascular closure device according to claim 1 or 2, characterized in that: The anchoring component has a first side and a second side opposite to each other along its thickness direction, the first side is used to adhere to the blood vessel wall, the minimum distance from the hole wall of the first hole to the first side of the outer contour of the middle part is b1, and the minimum distance from the hole wall of the first hole to the second side of the outer contour of the middle part is b2, wherein b2<b1.

8. The vascular closure device according to claim 7, characterized in that: The minimum distance between the hole wall of the second hole and the outer contour of the wing in the length direction of the anchoring component is a1, and the minimum distance between the hole wall of the second hole and the outer contour of the wing in the width direction of the anchoring component is a2, wherein b1>a1, and / or b1>a2.

9. The vascular closure device according to claim 2, characterized in that: The minimum distance between the hole wall of the second hole and the outer contour of the wing portion is 0.1 mm to 2.0 mm, and / or the minimum distance between the hole wall of the first hole and the outer contour of the middle portion is 0.1 mm to 2.0 mm.

10. The vascular closure device according to claim 9, characterized in that: The total volume of the first hole and the second hole accounts for 26% to 82% of the total volume of the anchoring component.

11. The vascular closure device according to claim 1 or 2, characterized in that: The anchoring component is made of magnesium alloy or a composite material thereof.

12. The vascular closure device according to claim 1 or 2, characterized in that: The release amount of the degradation product of the anchoring component does not exceed 40 ml, and the gripping force that the anchoring component can withstand is not less than 200 PSI.

13. The vascular closure device according to claim 1 or 2, characterized in that: The minimum thicknesses of the wings on both sides are different, and / or the thickness of the anchoring component gradually decreases from the middle portion to both sides.

14. The vascular closure device according to claim 1 or 2, characterized in that: At least one of the wing portions is provided with a plurality of the second holes, and the plurality of the second holes are arranged in a network structure.

15. The vascular closure device according to claim 1 or 2, characterized in that: Also included is a hemostatic component connected to the connecting component.

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