Vascular puncture closure device

Abstract

The present application relates to the technical field of medical devices, and particularly relates to a blood vessel puncture plugging device, which comprises: a plugging sheet, which is in a shape of adhering to a blood vessel wall after being unfolded; a suture, one end of which is connected with the plugging sheet, and the other end of which is placed outside the blood vessel wall after passing through a puncture hole; a collagen sponge, which passes through the suture and adheres to the outside of the blood vessel wall; and a lock, which is sleeved on the suture and is used for locking the collagen sponge, so that the plugging sheet tightly adheres to and covers the puncture position of the blood vessel wall; wherein one side of the plugging sheet, which faces the blood vessel wall, is provided with micro-needles in a protruding manner, and the micro-needles are inserted into the blood vessel wall when the plugging sheet adheres to the blood vessel wall. By means of the micro-needles inserted into the inner wall of the blood vessel, the present application provides mechanical fixing force compared with the prior art, prevents the slippage of the plugging sheet, and further improves the reliability of puncture plugging.

Description

Technical Field

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

[0002] Femoral artery puncture is a common site for cardiovascular and peripheral vascular interventions, as well as for procedures requiring intervention, such as coronary angiography and stent implantation, due to its superficial anatomical location and ease of access. Although femoral artery puncture has a high success rate, postoperative hemostasis is difficult, requiring prolonged bed rest and carrying risks such as bleeding, hematoma, arteriovenous fistula, and infection. Traditional compression hemostasis relies heavily on the operator's experience, and prolonged compression can cause patient discomfort and may trigger a vagal reflex. Approximately 2% to 10% of patients using traditional compression hemostasis experience serious complications, such as pseudoaneurysms, requiring secondary treatment.

[0003] In the prior art, such as the Chinese utility model patent with publication number CN216257225U published on April 12, 2022, a vascular closure device is disclosed. Through the cooperation of the umbrella-shaped closure disc and the wire, the closure disc can fully fit the blood vessel wall in the unfolded state, which has a good sealing effect on the puncture site. Compared with the method of pressing to stop bleeding, it can quickly close and stop bleeding.

[0004] However, during the insertion and unfolding of the aforementioned closure device into the blood vessel, the occlusion disc may shift, reducing the success rate of occlusion. Summary of the Invention

[0005] In view of at least one of the above technical problems, the present invention provides a vascular puncture and occlusion device, which adopts structural improvements to enhance the reliability of vascular occlusion.

[0006] According to a first aspect of the present invention, a vascular puncture and occlusion device is provided, comprising:

[0007] An occlusion patch, which, when unfolded, conforms to the vessel wall;

[0008] One end of the suture is connected to the occlusion piece, and the other end passes through the puncture hole and is placed on the outside of the blood vessel wall;

[0009] Collagen sponge, passing through the suture and adhering to the outer side of the blood vessel wall;

[0010] A locking buckle, fitted onto the suture, is used to lock the collagen sponge so that the occlusion patch fits snugly and covers the puncture site of the blood vessel wall;

[0011] The occlusion patch has protruding microneedles on the side facing the blood vessel wall, and the microneedles penetrate into the blood vessel wall when the occlusion patch is attached to the blood vessel wall.

[0012] Furthermore, the sealing plate has a strip-shaped structure, including a sealing part and a first end and a second end extending in the length direction, wherein the length of the second end is greater than the length of the first end.

[0013] Furthermore, when the occlusion patch is unfolded, it has an arc-shaped structure on a cross-section perpendicular to the connection between the first end and the second end, and this arc-shaped structure is fitted to fit the blood vessel wall.

[0014] Furthermore, the sealing portion extends outward in a direction perpendicular to the first end and the second end to form a protective wing portion, the curvature of which is the same as the curvature of the sealing piece.

[0015] Furthermore, the occlusion patch has a raised rib on the edge of the side facing away from the blood vessel wall, which is arranged in the thickness direction and conforms to the outline of the occlusion patch.

[0016] Furthermore, the microneedle includes a needle column portion perpendicular to the inner surface of the sealing sheet and a needle tip portion fixed to the end of the needle column portion. The needle tip portion is conical, and the maximum diameter of the needle tip portion is greater than the diameter of the needle column portion.

[0017] Furthermore, the collagen sponge is folded and threaded through the seam, and the buckle is sleeve-shaped and fits tightly to the seam.

[0018] Furthermore, the sealing portion also has perforations for connecting with the suture, the perforations being symmetrically arranged with respect to the line connecting the first end and the second end.

[0019] Furthermore, the sealing piece also has a receiving cavity with an opening facing the surface where the microneedle is located. A flexible tube communicating with the inside of the receiving cavity is connected to the edge of the receiving cavity. In the initial state, the flexible tube is retracted into the receiving cavity, and the end of the flexible tube is connected to the suture.

[0020] Furthermore, the flexible tube is connected to the accommodating cavity, and the end of the flexible tube has a connecting portion, the size of which is larger than the inner diameter of the latch.

[0021] The beneficial effects of this invention are as follows: This invention achieves synergistic occlusion on both sides of the blood vessel by attaching the occlusion patch to the inner wall of the blood vessel and cooperating with sutures, collagen sponge and buckles. Furthermore, by setting microneedles on the occlusion patch and inserting them into the inner wall of the blood vessel, this invention provides mechanical fixation force compared with the prior art, preventing the occlusion patch from slipping and thus improving the reliability of puncture occlusion. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention 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 recorded in the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the axial cross-sectional structure of the vascular puncture and occlusion device in an embodiment of the present invention;

[0024] Figure 2 This is a radial cross-sectional view of the vascular puncture and occlusion device in an embodiment of the present invention;

[0025] Figure 3 This is a three-dimensional structural diagram of the sealing plate in an embodiment of the present invention;

[0026] Figure 4 As described in the embodiments of the present invention Figure 3 A magnified schematic diagram of the structure at point A in the diagram;

[0027] Figure 5 This is a top view of the sealing plate structure in an embodiment of the present invention;

[0028] Figure 6 This is a three-dimensional structural schematic diagram of the sealing plate from another perspective in an embodiment of the present invention;

[0029] Figure 7 As described in the embodiments of the present invention Figure 2 A magnified schematic diagram of the structure at point B in the diagram;

[0030] Figure 8 This is a schematic diagram of the connection structure between the suture, collagen sponge, and buckle in an embodiment of the present invention;

[0031] Figure 9 This is a schematic diagram of the structure of the sealing piece with a flexible tube in an embodiment of the present invention;

[0032] Figure 10 This is a schematic diagram of the fixing structure of the flexible tube replacing the suture in an embodiment of the present invention.

[0033] Explanation of reference numerals in the attached drawings: 1. Sealing plate; 11. Microneedle; 12. Sealing part; 13. First end; 14. Second end; 15. Wing part; 16. Rib; 17. Perforation; 18. Flexible tube; 18a. Connecting part; 19. Receptacle; 2. Suture; 3. Collagen sponge; 4. Locking buckle. Detailed Implementation

[0034] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0035] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0037] like Figures 1 to 8 The vascular puncture and occlusion device shown includes an occlusion piece 1, a suture 2, a collagen sponge 3, and a locking buckle 4. Please refer to the following for details. Figures 1 to 4 In an embodiment of the present invention, the occlusion patch 1, after unfolding, conforms to the vessel wall. It should be noted that the placement of the occlusion patch 1 can be performed using existing delivery devices, such as microcatheters. Microcatheters are existing technology, and their specific structure and placement process will not be described in detail here. One end of the suture 2 is connected to the occlusion patch 1, and the other end passes through the puncture hole and is placed on the outside of the vessel wall. In an embodiment of the present invention, the suture 2 serves as a connector and is connected to the collagen sponge 3 and the buckle 4 to compress the skin surface from the outside, thereby exerting an outward pulling force on the occlusion patch 1. Collagen sponge 3 passes through suture 2 and adheres to the outer side of the blood vessel wall; buckle 4 is sleeved on suture 2 for locking collagen sponge 3, so that occlusion piece 1 adheres tightly to and covers the puncture site of blood vessel wall; it should be noted that, in the embodiments of the present invention, occlusion piece 1 can be made of biodegradable polymer materials such as polylactic acid, suture 2 can be made of medical polydioxanone, collagen sponge 3 can be made of cross-linked collagen, and buckle 4 can be made of polycarbonate or biocompatible plastic.

[0038] In embodiments of the present invention, to improve the reliability of the connection between the occlusion patch 1 and the blood vessel wall, such as... Figures 1 to 4 As shown, the occlusion piece 1 has protruding microneedles 11 on the side facing the blood vessel wall. When the occlusion piece 1 is attached to the blood vessel wall, the microneedles 11 penetrate into the blood vessel wall.

[0039] During the occlusion process, the occlusion patch 1 is first inserted into the blood vessel through the delivery system. Then, the delivery system is withdrawn, at which point the occlusion patch 1 is unfolded. The occlusion patch 1 is pulled back through the suture 2, causing the microneedles 11 on the occlusion patch 1 to pierce into the blood vessel wall. At the same time, the locking buckle 4 and the collagen sponge 3 are tightened, so that the locking buckle 4, the collagen sponge 3, and the suture 2 apply an outward pulling force. This allows the occlusion patch 1 to remain in close contact with the blood vessel wall under the action of this pulling force, achieving the effect of hemostasis and occlusion.

[0040] In the above embodiments, by attaching the occlusion patch 1 to the inner wall of the blood vessel, and by cooperating with the suture 2, collagen sponge 3, and locking buckle 4, synergistic occlusion on both sides of the blood vessel is achieved. Furthermore, by using the microneedles 11 set on the occlusion patch 1 to puncture the inner wall of the blood vessel, mechanical fixation force is provided compared with the prior art, preventing the slippage of the occlusion patch 1 and thus improving the reliability of puncture occlusion.

[0041] Based on the above embodiments, in some embodiments of the present invention, the specific structure of the sealing piece 1 is as follows: Figure 5 As shown, the occlusion patch 1 has a strip-shaped structure, including an occlusion portion 12 and a first end 13 and a second end 14 extending in the length direction. The length of the second end 14 is greater than the length of the first end 13. The strip-shaped structure facilitates the insertion of the occlusion patch 1 along the direction of the blood vessel. Furthermore, the design of the first end 13 being longer than the second end 14 allows the occlusion patch 1 to form an anchorage in the direction of blood flow. That is, after the occlusion patch 1 enters the blood vessel, under the impact of blood flow, the longer end will cause the line connecting the first end 13 and the second end 14 to gradually become parallel to the direction of the blood vessel. Then, under the tension of the suture 2, the occlusion portion 12 can more easily cover the puncture site.

[0042] In the embodiments of the present invention, please continue to refer to Figure 2 and Figure 3 When unfolded, the occlusion piece 1 has an arc-shaped structure on the cross-section perpendicular to the connection between the first end 13 and the second end 14, and this arc-shaped structure is fitted to fit against the blood vessel wall. The arc-shaped structure allows the occlusion piece 1 to match the circular cross-section of the blood vessel. Furthermore, to increase the contact area of ​​the fitting surface and prevent rotational slippage of the occlusion piece 1, as... Figure 5 and Figure 6 As shown, the sealing portion 12 extends outward in a direction perpendicular to the first end 13 and the second end 14, forming a protective wing portion 15. The curvature of the protective wing portion 15 is the same as the curvature of the sealing piece 1. By providing the protective wing portion 15, the sealing area of ​​the sealing portion 12 against puncture can be increased, further improving the reliability of the sealing.

[0043] Furthermore, in embodiments of the present invention, such as Figure 6As shown, the occlusion patch 1 has a raised rib 16 on the edge of the side facing away from the blood vessel wall, which is arranged along the thickness direction. The raised rib 16 is configured to conform to the contour of the occlusion patch 1. The raised rib 16 strengthens the structural strength at the edge of the occlusion patch 1, which facilitates the insertion of the microneedle 11 at the edge of the occlusion patch 1 into the blood vessel wall, thereby enhancing the friction and adhesion with the inner wall of the blood vessel.

[0044] Please refer to Figure 7 In some embodiments of the present invention, the microneedle 11 includes a needle column portion perpendicular to the inner surface of the sealing piece 1 and a needle tip portion fixed to the end of the needle column portion. The needle tip portion is tapered, and the maximum diameter of the needle tip portion is larger than the diameter of the needle column portion. The tapered needle tip portion facilitates rapid insertion of the microneedle 11 and reduces tissue damage. Furthermore, the smaller diameter of the needle column portion compared to the maximum diameter of the needle tip portion creates a barb structure at the needle tip, further improving the reliability of needle tip attachment.

[0045] In some embodiments of the present invention, the external locking structure has also been optimized, such as... Figure 8 As shown, the collagen sponge 3 is folded and threaded onto the seam 2. The locking buckle 4, in a tubular structure, is fitted onto the seam 2 and fits tightly against it. The folding of the collagen sponge 3 enhances its reverse elasticity, while the tubular locking buckle 4 facilitates locking. The operator simply moves the locking buckle 4 along the seam 2 toward the collagen sponge 3. Due to the tight fit between the locking buckle 4 and the seam 2, the friction between them enables the locking buckle 4 to self-lock when it reaches the set position. It should also be noted that a knot can be tied on the seam 2 to prevent the locking buckle 4 from moving.

[0046] In some embodiments of the present invention, the suture 2 is directly connected to the sealing part 12, specifically as follows: Figure 3 and Figure 5 As shown, the sealing part 12 also has perforations 17 for connecting with the suture 2. The perforations 17 are symmetrically arranged along the line connecting the first end 13 and the second end 14. The symmetrical arrangement of the perforations 17 can achieve a force balance on the sealing piece 1, thereby ensuring a uniform distribution of the force and preventing the sealing piece 1 from being cut or folded due to eccentric tension.

[0047] Please refer to Figure 9 and Figure 10In other embodiments of the present invention, an alternative structure to the suture 2 is also designed. Specifically, the sealing piece 1 also has a receiving cavity 19 with an opening facing the surface where the microneedle 11 is located. A flexible tube 18 communicating with the interior of the receiving cavity 19 is connected to the edge of the receiving cavity 19. The flexible tube 18 is initially retracted into the receiving cavity 19, and its end is connected to the suture 2. By setting the receiving cavity 19 and retracting the flexible tube 18 into the receiving cavity 19 in the initial state, the volume occupied by the sealing piece 1 can be reduced. Furthermore, in embodiments of the present invention, the end of the flexible tube 18 is connected to the suture 2. During the process of pulling the suture 2 outward, such as... Figure 10 As shown, the end of the flexible tube 18 passes through the collagen sponge 3 and the buckle 4. After the flexible tube 18 passes through the buckle 4, it replaces the function of the suture 2 to achieve locking. Through this structural design, the flexible tube 18 fits more closely to the puncture hole, further improving the sealing effect of the puncture hole.

[0048] Furthermore, in an embodiment of the present invention, the flexible tube 18 is connected to the accommodating cavity 19, and the end of the flexible tube 18 has a connecting portion 18a, the size of which is larger than the inner diameter of the latch 4. With the connecting portion 18a, a reliable locking structure is formed when the connecting portion 18a passes through the latch 4 under the tension of the suture 2. In addition, in an embodiment of the present invention, the accommodating cavity 19 can extend in a direction perpendicular to the thickness of the occlusion piece 1. With this configuration, the connecting portion 18a can also be connected to a pressurizing device such as a syringe, allowing external air or liquid to enter the accommodating cavity 19 through the flexible tube 18. At this time, the pressure of the gas or liquid filling the accommodating cavity 19 will exert a pressure towards the inner wall of the occlusion piece 1, thereby further improving the reliability of the microneedle 11 piercing the inner wall of the blood vessel. Furthermore, during the gradual healing process of the puncture site, the pressure of the blood vessel wall can also help to expel the medium in the accommodating cavity 19 through the connecting portion 18a. This structural form is beneficial for improving the reliability of puncture site healing.

[0049] Those skilled in the art should understand that this invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to this invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A vascular puncture and occlusion device, characterized in that, include: An occlusion patch, which, when unfolded, conforms to the vessel wall; Collagen sponge, adhering to the outer side of the blood vessel wall; A locking buckle is used to lock the collagen sponge so that the occlusion patch fits snugly and covers the puncture site of the blood vessel wall; wherein, the occlusion patch has protruding microneedles on the side facing the blood vessel wall, and the microneedles penetrate into the blood vessel wall when the occlusion patch fits against the blood vessel wall; The occlusion patch also includes a receiving cavity, the opening of which faces the surface where the microneedle is located, and a flexible tube communicating with the interior of the receiving cavity is connected to the edge of the receiving cavity, the end of which is connected to a suture. In its initial state, the flexible tube is retracted into the accommodating cavity. During the process of pulling the suture outward, the end of the flexible tube passes through the collagen sponge and the buckle. After the flexible tube passes through the buckle, it is locked. The end of the flexible tube has a connecting part, which is used to fill the accommodating cavity with gas or liquid so that the occlusion piece applies pressure to the inner wall of the blood vessel. The size of the connecting part is larger than the inner diameter of the buckle.

2. The vascular puncture and occlusion device according to claim 1, characterized in that, The sealing plate has a strip-shaped structure, including a sealing part and a first end and a second end extending in the length direction, wherein the length of the second end is greater than the length of the first end.

3. The vascular puncture and occlusion device according to claim 2, characterized in that, When the occlusion patch is unfolded, it has an arc-shaped structure on the cross-section perpendicular to the connection between the first end and the second end, and this arc-shaped structure is fitted to fit the blood vessel wall.

4. The vascular puncture and occlusion device according to claim 3, characterized in that, The sealing portion extends outward in a direction perpendicular to the first end and the second end to form a protective wing portion, the curvature of which is the same as that of the sealing piece.

5. The vascular puncture and occlusion device according to claim 4, characterized in that, The occlusion patch also has a raised rib on the edge of the side facing away from the blood vessel wall, which is arranged in the thickness direction and is contoured to match the outline of the occlusion patch.

6. The vascular puncture and occlusion device according to claim 5, characterized in that, The microneedle includes a needle column portion perpendicular to the inner surface of the sealing sheet and a needle tip portion fixed to the end of the needle column portion. The needle tip portion is conical, and the maximum diameter of the needle tip portion is greater than the diameter of the needle column portion.

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