A blood vessel occluder

Abstract

The present invention provides a vascular occluder, belonging to the technical field of vascular occluding devices; the vascular occluder is used to block an opening on a blood vessel wall, and the vascular occluder comprises a first occluding disk and a second occluding disk which are arranged in series at one end of a catheter, wherein one end of the first occluding disk facing away from the second occluding disk is detachably connected to the end of the catheter, and the other end is slidably matched with the catheter, and the second occluding disk is slidably matched with the catheter; the opposite ends of the first occluding disk and the second occluding disk can be fixedly connected, and are used to be clamped on both sides of the blood vessel wall to block the opening; the first occluding disk and the second occluding disk both have a cylindrical contracted state and a disc-shaped released state, and the first occluding disk and the second occluding disk are slidably sleeved with a release tube on their outer sides in the contracted state; the vascular occluder is used to solve the technical problems of the existing vascular occluder, such as a small occluding range and a large volume, which easily lead to poor blood flow at the hemostasis position, and easily cause metal poisoning in the human body.

Description

Technical Field

[0001] The present invention belongs to the technical field of vascular occlusion equipment, and in particular relates to a vascular occluder. Background Art

[0002] Femoral artery puncture is the main puncture route for peripheral interventional surgery, and hemostasis at the puncture site is always a problem that cannot be ignored in interventional surgery. If the puncture site is not handled properly, complications such as hematoma, infection, and pseudoaneurysm are prone to occur after the operation, which may endanger the patient's life in severe cases. Manual or mechanical compression is often used to stop bleeding at the puncture site, but this type of hemostasis method usually takes a long time and requires continuous pressing on the puncture site for about 25 minutes. This method is not only inconvenient for medical staff to operate, time-consuming and labor-intensive, but also requires patients to stay in bed for a long time after hemostasis. In order to solve this clinical problem, vascular occluders came into being. Commonly used vascular occluders are sponge plugs and metal clips.

[0003] When using the sponge plug, the absorbable sponge plug needs to be pushed to the outside of the puncture site to assist in coagulation, or the puncture site needs to be closed by a metal closure clip. Its operation is simple and quick, which greatly reduces the operation time and effectively reduces the incidence of bleeding complications. However, with the development of interventional surgery, larger equipment will be used for more difficult interventional surgeries, and usually a puncture site of more than 10F is required. Therefore, the clinical demand for the occlusion of large-caliber vascular puncture sites is increasing. Traditional vascular occluders are only suitable for 5-7F arterial puncture sites. During use, the sponge plug outside the puncture site has limited coagulation ability for the puncture site; when the puncture site is larger than 7F or the arterial blood pressure is high, the sponge plug alone cannot complete the closure of the blood vessel opening, and manual compression hemostasis is required in the future, which greatly increases the cost of the operation and prolongs the treatment cycle; in addition, because the sponge plug is large in size, a larger volume is required for effective hemostasis when the wound is large, and improper operation can easily cause occlusion of the blood vessel position.

[0004] Although metal closure is more effective than sponge plugs in vascular closure, it has a high metal content and cannot be degraded when placed in the human body for a long time, which can cause metal poisoning in the human body due to the release of metals such as nickel ions. At the same time, metals in the body can also affect the patient's suitability for MRI examinations.

[0005] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0006] The purpose of the present invention is to provide a vascular occluder to at least solve one of the technical problems of existing vascular occluders, namely, the occluding range, the large size, which easily leads to poor blood flow at the hemostasis position, and the metal poisoning of the human body.

[0007] In order to achieve the above-mentioned purpose, the vascular occluder of the present invention provides the following technical solutions:

[0008] A vascular occluder is used to block an opening on a blood vessel wall, the vascular occluder comprises a first occluding disk and a second occluding disk which are arranged in series at one end of a catheter, the first occluding disk having one end facing away from the second occluding disk and detachably connected to the end of the catheter, and the other end of the first occluding disk slidingly cooperates with the catheter, and the second occluding disk slidingly cooperates with the catheter; the first occluding disk and the second occluding disk opposite ends can be fixedly connected and used to be clamped on both sides of the blood vessel wall to block the opening; the first occluding disk and the second occluding disk both have a cylindrical contracted state and a disc-shaped released state, and a release tube is provided on the outer sides of the first occluding disk and the second occluding disk when in the contracted state.

[0009] As a further optimized technical solution, both the first occluding disk and the second occluding disk are woven structures with hollow inner cavities, and at least the first occluding disk is made of degradable material; the hollow inner cavities of the first occluding disk and the second occluding disk can be filled with coagulation material.

[0010] As a further optimized technical solution, a first connecting structure is provided at one end of the first sealing disk facing the second sealing disk, and a second connecting structure is provided at one end of the second sealing disk facing the first sealing disk. The first connecting structure can be fixedly connected to the second connecting structure to achieve fixed connection between the first sealing disk and the second sealing disk.

[0011] As a further optimized technical solution, one of the first connecting structure and the second connecting structure has a snap-fit ​​groove, and the other has a snap-fit ​​protrusion that matches the shape of the snap-fit ​​groove, and the snap-fit ​​groove and the snap-fit ​​protrusion are fixedly connected by snapping.

[0012] As a further optimized technical solution, the end of the catheter is detachably connected to the end of the first occluding disk facing away from the second occluding disk by means of a threaded connection.

[0013] As a further optimized technical solution, one end of the first sealing disk facing away from the second sealing disk is fixedly connected with a release structure, a stud with external threads is arranged on the inner side of the release structure, a groove with internal threads is arranged at the end of the catheter, and the internal threads of the groove are threadedly connected with the external threads of the stud.

[0014] As a further optimized technical solution, one end of the first sealing disk facing away from the second sealing disk is fixedly connected with a release structure, a groove with an internal thread is arranged on the inner side of the release structure, a stud with an external thread is arranged at the end of the catheter, and the internal thread of the groove is threadedly connected with the external thread of the stud.

[0015] As a further optimized technical solution, an operating handle is further provided on the catheter, and the operating handle is arranged at an end away from the first occluding disk.

[0016] As a further optimized technical solution, the first occluding disk and the second occluding disk both have a variety of shapes in their released states.

[0017] As a further optimized technical solution, at least the outer sides of the first occluding disk and the second occluding disk are provided with a coating layer to reduce stimulation to the blood vessels.

[0018] Beneficial effects: The present invention provides two occluding disks, which are fixedly connected and clamped on both sides of the opening of the blood vessel wall to seal the opening when in use. The disk-shaped sealing component has a larger cross-sectional area and a smaller thickness than the ball-shaped sponge plug, which effectively achieves the sealing of a wide range of (from small diameter to large diameter) blood vessel puncture openings on the basis of ensuring blood flow. In addition, the first occluding disk, as the part implanted on the inner side of the blood vessel wall, is made of degradable material, which can be safely metabolized by body fluids during the healing process of blood vessels and skin, without any foreign matter remaining and without the need for secondary surgery to remove it. Compared with traditional metal closure clips, there is no risk of metal poisoning, so it is safer and has less impact on the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0020] Figure 1 This is a schematic diagram of the overall structure of the vascular occluder in Example 1 of the present invention;

[0021] Figure 2 This is a partial structural schematic diagram of the vascular occluder in Example 1 of the present invention;

[0022] Figure 3 This is a schematic diagram of the cooperation state between the first connection structure and the second connection structure in Example 1 of the present invention;

[0023] Figure 4 This is a schematic diagram of the release structure in Example 1 of the present invention;

[0024] Figure 5 Schematic diagram of the shapes of the first occluding disk and the second occluding disk in the contracted state in Example 1 of the present invention;

[0025] Figure 6 This is a schematic diagram of the vascular occluder before entering the blood vessel in Example 1 of the present invention;

[0026] Figure 7 It is a schematic diagram of releasing the first blocking disk in Embodiment 1 of the present invention;

[0027] Figure 8 It is a schematic diagram of releasing the second blocking disk in Example 1 of the present invention;

[0028] Fig. 9 This is a schematic diagram of the occlusion of the blood vessel occluder in Example 1 of the present invention;

[0029] Fig.10 This is a schematic diagram of the coordination state between the first connection structure and the second connection structure in Embodiment 2 of the present invention;

[0030] Fig.11 This is a schematic diagram of the release structure in Example 3 of the present invention.

[0031] Figure 1-9 Middle: 1. blood vessel wall; 11. opening; 2. catheter; 2a. groove; 3. first occluding disk; 31a. first connection structure; 32a. release structure; 32a1. stud; 4. second occluding disk; 41a. second connection structure; 5. release tube; 6. operating handle;

[0032] Fig.10 Middle: 31b, first connection structure; 41b, second connection structure;

[0033] Fig.11 Middle: 2b, stud; 32b, release structure; 32b1, groove. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0035] In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, they can be fixed connections or detachable connections; they can be directly connected or indirectly connected through intermediate components. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0036] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0037] The present invention provides a blood vessel occluder, which is provided with two occluding discs connected in series. When the opening on the blood vessel wall is blocked, the two occluding discs are arranged on both sides of the blood vessel wall opening, and the two disc-shaped occluding discs are fixedly connected on both sides of the opening to clamp the opening, thereby achieving the blocking of the opening. The blocking range is large and the influence on blood flow is minimal.

[0038] Example 1

[0039] like Figure 1 As shown, the vascular occluder for blocking the opening 11 on the blood vessel wall 1 includes an operating handle 6, a catheter 2, a first occluding disc 3 and a second occluding disc 4, and a release tube 5. The operating handle 6 is installed at one end of the catheter 2, and the first occluding disc 3 and the second occluding disc 4 are installed in series at the other end, wherein the first occluding disc 3 is used to be implanted inside the blood vessel wall 1, and is therefore installed at the end of the catheter 2, and the second occluding disc 4 is installed inside the first occluding disc 3. Both the first occluding disc 3 and the second occluding disc 4 have self-expansion properties. When not implanted into the human body, the first occluding disc 3 and the second occluding disc 4 maintain a cylindrical contracted state under the restraint of the release tube 5. When freed from the restraint of the release tube 5, the first occluding disc 3 and the second occluding disc 4 can automatically expand into a preset disc shape.

[0040] Specifically, the operating handle 6 is fixedly connected to the catheter 2, and the connection method can be selected from one or more of adhesive bonding, welding, Luer joint, internal and external wire connection, etc. The material of the operating handle 6 is one or more of polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, etc.

[0041] like Figure 2 As shown, when the first occluding disk 3 and the second occluding disk 4 are in the contracted state, a release tube 5 is slidably sleeved on the outside thereof. The release tube 5 is a tubular structure with openings at both ends, and is made of one or more of polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, silicone, rubber, silicone rubber and the like. The main function of the release tube 5 is to constrain the first occluding disk 3 and the second occluding disk 4 into a tubular structure with a smaller diameter before occlusion, so as to facilitate implantation into the blood vessel wall 1. After implantation, the release tube 5 can be slid and withdrawn from the outside of the first occluding disk 3 and the second occluding disk 4 toward the direction close to the operating handle 6 to break away from the restraint on the first occluding disk 3 and the second occluding disk, so as to facilitate the automatic expansion of the first occluding disk 3 and the second occluding disk 4 into a disk shape.

[0042] In addition, the opposite ends of the first occluding disk 3 and the second occluding disk 4 can be fixedly connected, so that the first occluding disk 3 and the second occluding disk 4 can be clamped on both sides of the opening 11 on the blood vessel wall 1 to achieve the blocking of the opening 11. The first occluding disk 3 is fixedly connected with a first connecting structure 31a at one end facing the second occluding disk 4, and the second occluding disk 4 is fixedly connected with a second connecting structure 41a at one end facing the first occluding disk 3. The connection method between the first connecting structure 31a and the first occluding disk 3 can be selected from one or more of the methods such as gluing, welding, and internal and external wire joints, and the connection method between the second connecting structure 41a and the second occluding disk 4 can be selected from one or more of the methods such as gluing, welding, and internal and external wire joints. And the material of the first connecting structure 31a and the second connecting structure 41a is one or more of degradable metal materials such as magnesium alloy, iron alloy, and zinc alloy. One of the first connecting structure 31a and the second connecting structure 41a has a snap-fit ​​groove, and the other has a snap-fit ​​protrusion that matches the shape of the snap-fit ​​groove, and the snap-fit ​​groove and the snap-fit ​​protrusion are fixedly connected by snap-fit. As Figure 3 As shown, in the present embodiment, a conical buckling groove is provided in the first connecting structure 31a, a conical buckling protrusion is provided on the outside of the second connecting structure 41a, a limiting protrusion is provided at the bottom of the buckling groove, and a ring groove is provided on the buckling protrusion corresponding to the position of the limiting protrusion, and the buckling groove and the buckling protrusion are fixedly connected by snap-fit. In other embodiments, the snap-fit ​​protrusion can be provided on the first connecting structure 31a, and the buckling groove can also be provided on the second connecting structure 41a. In this way, the first connecting structure 31a and the second connecting structure 41a are fixedly connected by snap-fitting, so as to realize the fixed connection between the first blocking disk 3 and the second blocking disk 4.

[0043] At the same time, in order to ensure the assembly relationship between the first occluding disk 3, the second occluding disk 4 and the catheter 2, a through hole for the catheter 2 to pass through is provided in the middle of the connection structure with the snap-fit ​​protrusion, and the snap-fit ​​protrusion is arranged around the outside of the through hole.

[0044] In the present invention, the first occluding disk 3 and the second occluding disk 4 are both woven structures with hollow inner cavities, and the woven structures are woven with metal wires with shape memory, and the hollow inner cavities are formed by heat setting after the weaving is completed; the inner diameter of the hollow inner cavity of the woven structure of the first occluding disk 3 is greater than or equal to the inner diameter of the hollow inner cavity of the woven structure of the second occluding disk 4 to ensure the sealing of the inner side of the opening 11; the material of the woven structure of the first occluding disk 3 and the second occluding disk 4 is one or more of degradable metal materials such as magnesium alloy, iron alloy, zinc alloy, etc., or at least the first occluding disk 3 to be implanted in the human body is made of the above-mentioned degradable material.

[0045] In order to ensure the blocking effect, the hollow inner cavity of the first blocking disk 3 and the second blocking disk 4 can be filled with coagulation materials. The coagulation materials can be selected from one or more materials such as thrombin, gelatin, collagen, fibrin, cellulose, polysaccharides (such as starch, chitosan), etc. Specifically, the coagulation materials can be added to a mass or gel-like object and then placed in the hollow cavity. When the first blocking disk 3 and the second blocking disk 4 are placed on both sides of the opening, the coagulation materials in the hollow inner cavity can assist the first blocking disk 3 and the second blocking disk 4 to stop bleeding. In this way, the first blocking disk 3 and the second blocking disk 4 close the opening 11 on the blood vessel wall 1 by physical means, and the coagulation materials assist in rapid coagulation at the opening 11 by chemical means, thereby achieving a rapid hemostasis blocking effect.

[0046] In order to reduce the stimulation to the blood vessels, at least the outer side of the first occluding disk 3 and the second occluding disk 4 is provided with a coating layer, and the material of the coating layer can be selected from one or more biodegradable polymer materials such as polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polyamide, polyanhydride, polyphosphate, polyurethane, polycarbonate, etc. The coating layer adopts one or more processes such as melt spinning, solution spinning, wet spinning, dry spinning, dry-wet spinning, gel spinning, electrospinning, etc. In this embodiment, the coating layer is provided on both the inner and outer sides of the first occluding disk 3 and the second occluding disk 4.

[0047] like Figure 5 As shown, the first sealing disk 3 and the second sealing disk 4 have various shapes in the released state, and a circular shape is common. However, a more suitable shape can also be selected according to the actual situation of the opening.

[0048] In order to facilitate the release of the first blocking disk 3 and the second blocking disk 4 from the catheter 2, the end of the first blocking disk 3 facing away from the second blocking disk 4 is detachably connected to the end of the catheter 2. In this embodiment, the end of the catheter 2 is detachably connected to the end of the first blocking disk 3 facing away from the second blocking disk 4 by a threaded connection. Figure 4 As shown, the first sealing disc 3 is fixedly connected to one end facing away from the second sealing disc 4 with a release structure 32a, and the connection method between the release structure 32a and the first sealing disc 3 can be one or more of adhesive bonding, welding, internal and external thread joints, etc. A stud 32a1 with external threads is arranged inside the release structure 32a, and a groove 2a with internal threads is arranged at the end of the catheter 2, and the internal threads of the groove 2a are threadedly connected with the external threads of the stud 32a1.

[0049] Specifically, when the present invention is used to seal the opening 11, the first sealing disc 3 and the second sealing disc 4 are first retracted into the release tube 5, and then Figure 6As shown, the portion of the release tube 5 carrying the first occluding disk 3 is pushed into the inner side of the opening 11 of the blood vessel wall 1, and the release tube 5 is withdrawn out of the opening 11 while continuing to maintain the pushing posture. After the release tube 5 is withdrawn, the first occluding disk 3 automatically expands and opens into a disk shape due to shape memory, as shown in FIG. Figure 7 As shown, the first blocking disk 3 is attached to the inner side of the opening 11. Then continue to release the second blocking disk 4. After the second blocking disk 4 is released, the front end of the release tube 5 is used to push and squeeze the second blocking disk 4. Figure 8 As shown, until the first connection structure 31a on the first occluding disk 3 and the second connection structure 41a on the second occluding disk 4 are fixedly connected, thereby realizing the final installation state of the first occluding disk 3 and the second occluding disk 4, and then gently rotate the catheter 2 to disengage the catheter 2 from the release structure 32a and withdraw the catheter 2 from between the first occluding disk 3 and the second occluding disk 4. Fig. 9 As shown, the first sealing disk 3 and the second sealing disk 4 are clamped on both sides of the opening 11 to achieve sealing of the opening 11 .

[0050] Example 2

[0051] This embodiment provides a buckling structure with different shapes. Different from the embodiment 1, in this embodiment, Fig.10 As shown, the first connection structure 31b has a cylindrical buckling groove, a limiting step is set on the top of the buckling groove, the second connection structure 41b has a cylindrical buckling protrusion, the top of the buckling protrusion has a ring groove that matches the shape of the limiting step, and the first connection structure 31b and the second connection structure 41b are buckled and connected through the buckling groove and the buckling protrusion. In other embodiments, the buckling protrusion can be set on the first connection structure 31b, and the buckling groove can also be set on the second connection structure 41b.

[0052] Example 3

[0053] This embodiment provides a different thread connection method between the catheter end and the first occluding disk. In this embodiment, Fig.11 As shown, one end of the first sealing disk 3 facing away from the second sealing disk 4 is fixedly connected with a release structure 32b, a groove 32b1 with an internal thread is arranged on the inner side of the release structure 32b, a stud 2b with an external thread is arranged at the end of the catheter 2, and the internal thread of the groove 32b1 is threadedly connected with the external thread of the stud 2b.

[0054] It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

[0055] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims

1. A vascular occluder for occluding an opening (11) on a vascular wall (1), characterized in that: The blood vessel occluder comprises a first occluding disc (3) and a second occluding disc (4) which are arranged in series at one end of a catheter (2); one end of the first occluding disc (3) facing away from the second occluding disc (4) is detachably connected to the end of the catheter (2), and the other end is slidably engaged with the catheter (2); the second occluding disc (4) is slidably engaged with the catheter (2); the first occluding disc (3) and the second occluding disc (4) are fixedly connected at opposite ends thereof, and are used to be clamped on both sides of the blood vessel wall (1) to block the opening (11); The first occluding disc (3) and the second occluding disc (4) both have a cylindrical contracted state and a disc-shaped released state. When in the contracted state, the first occluding disc (3) and the second occluding disc (4) are slidably sleeved with a release tube (5) on their outer sides. The first sealing disk (3) is provided with a first connection structure (31a, 31b) at one end thereof facing the second sealing disk (4), and the second sealing disk (4) is provided with a second connection structure (41a, 41b) at one end thereof facing the first sealing disk (3), and the first connection structure (31a, 31b) can be fixedly connected to the second connection structure (41a, 41b) to achieve fixed connection between the first sealing disk (3) and the second sealing disk (4); After the first sealing disc (3) and the second sealing disc (4) are released, the front end of the release tube (5) is used to push and squeeze the second sealing disc (4) until the first connection structure (31a, 31b) on the first sealing disc (3) and the second connection structure (41a, 41b) on the second sealing disc (4) are fixedly connected.

2. The vascular occluder according to claim 1, characterized in that: The first occluding disc (3) and the second occluding disc (4) are both woven structures with a hollow inner cavity, and at least the first occluding disc (3) is made of a degradable material; the hollow inner cavities of the first occluding disc (3) and the second occluding disc (4) can be filled with coagulation material.

3. The vascular occluder according to claim 1, characterized in that: One of the first connection structure (31a, 31b) and the second connection structure (41a, 41b) has a buckling groove, and the other has a buckling protrusion that matches the shape of the buckling groove, and the buckling groove and the buckling protrusion are fixedly connected by snapping.

4. The vascular occluder according to any one of claims 1 to 3, characterized in that: The end of the catheter (2) is detachably connected to an end of the first sealing disk (3) facing away from the second sealing disk (4) by means of a threaded connection.

5. The vascular occluder according to claim 4, characterized in that: One end of the first sealing disk (3) facing away from the second sealing disk (4) is fixedly connected to a release structure (32a), a stud (32a1) having an external thread is arranged on the inner side of the release structure (32a), and a groove (2a) having an internal thread is arranged at the end of the catheter (2), and the internal thread of the groove (2a) is threadedly connected to the external thread of the stud (32a1).

6. The vascular occluder according to claim 4, characterized in that: One end of the first sealing disk (3) facing away from the second sealing disk (4) is fixedly connected to a release structure (32b), a groove (32b1) having an internal thread is provided on the inner side of the release structure (32b), a stud (2b) having an external thread is provided at the end of the catheter (2), and the internal thread of the groove (32b1) is threadedly connected to the external thread of the stud (2b).

7. The vascular occluder according to any one of claims 1 to 3, characterized in that: The catheter (2) is also provided with an operating handle (6), and the operating handle (6) is arranged at an end away from the first blocking disk (3).

8. The vascular occluder according to any one of claims 1 to 3, characterized in that: The first occluding disc (3) and the second occluding disc (4) both have a variety of shapes in their released states.

9. The vascular occluder according to any one of claims 1 to 3, characterized in that: At least the outer sides of the first occluding disc (3) and the second occluding disc (4) are provided with a coating layer for reducing stimulation to the blood vessels.

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