CN204683686U - A kind of left atrial appendage occlusion device and plugging system - Google Patents

Abstract

The utility model relates to the field of medical equipment, and discloses a left atrial appendage occlusion device, which comprises a supporting frame and a flow blocking membrane, the supporting frame is a hollowed-out spheroid with elasticity, and the flow blocking film is arranged in a cap shape , which is sheathed on the periphery of the proximal end of the support frame; the circumference of the distal end of the support frame is provided with anchor thorns for grasping the inner wall of the left atrial appendage; the utility model also discloses a left atrial appendage sealing system , which includes a delivery device and the left atrial appendage occlusion device described in the above technical solution, the delivery device includes a delivery sheath and a push rod, the left atrial appendage occlusion device is arranged in the delivery sheath, and the push rod One end is arranged in the delivery sheath and is detachably connected to the fixed head end of the left atrial appendage occlusion device. The utility model can reduce the damage to the blood vessel access and reduce the operation risk.

Description

A left atrial appendage occlusion device and occlusion system

technical field

The utility model relates to the technical field of medical devices, in particular to a left atrial appendage blocking device and a blocking system for preventing embolism complications of atrial fibrillation.

Background technique

Atrial fibrillation (Atrial Fibrillation, AF) is one of the most common clinical arrhythmias. In addition to inducing or aggravating the risks of heart failure, it can also cause stroke and other thromboembolic events, resulting in death or disability. Oral anticoagulant drugs can significantly reduce the probability of ischemic stroke in patients with atrial fibrillation, but because their pharmacological effects are affected by many factors (such as drugs, food, etc.), frequent blood sampling is required to monitor coagulation indicators. Even within the appropriate anticoagulation intensity, it will increase the chance of intracranial hemorrhage by 2 to 5 times. Some patients have contraindications such as active bleeding or allergy to coumarin drugs, which limits the clinical use of anticoagulants such as warfarin to a certain extent. In the cases of cerebral arterial embolism caused by non-rheumatic atrial fibrillation, more than 90% of the emboli originate from the left atrial appendage (LAA). Loss of left atrial appendage systolic function and blood stasis in atrial fibrillation are the main causes of left atrial appendage thrombosis. Therefore, isolating the left atrial appendage from the circulatory system can theoretically prevent most arterial system embolism caused by atrial fibrillation.

Studies have shown that after surgical closure of the LAA, the risk of cerebral embolism is reduced to 1/12 of the original. Left atrial appendage occlusion is an interventional therapy developed in recent years to prevent thromboembolism in atrial fibrillation. A number of clinical trials on LAA occluders have shown that LAA occlusion is not inferior to warfarin in preventing atrial fibrillation stroke, but due to safety factors such as pericardial effusion and shedding, the US Food and Drug Administration (Food and Drug Administration) and Drug Administration, FDA) is currently only approved for clinical research. How to reduce the serious complications such as pericardial effusion, heart wall perforation, and device loss, as well as controllable partial or full recovery and repositioning and release of left atrial appendage occluder devices are the focus of work for left atrial appendage occluder manufacturers.

Utility model content

(1) Technical problems to be solved

The technical problem to be solved by the utility model is how to reduce the damage to the blood vessel access and reduce the operation risk.

(2) Technical solution

In order to solve the above technical problems, the utility model provides a left atrial appendage occlusion device, which includes a supporting frame and a flow blocking membrane, the supporting frame is a hollowed-out spheroid with elasticity, and the flow blocking membrane is set in a cap shape , which is sheathed on the periphery of the proximal end of the support frame; the circumference of the distal end of the support frame is provided with an anchor thorn for grasping the inner wall of the left atrial appendage.

Wherein, the support frame includes a proximal blocking member and a distal anchoring member, the proximal blocking member and the distal anchoring member are elastic hollow hemispherical structures respectively, and the proximal blocking member and the distal anchoring The fixed parts are connected together to form the quasi-spherical body; the flow blocking film is sleeved on the periphery of the proximal blocking part, and the anchor thorn is arranged on the circumference of the distal anchoring part.

Wherein, the end of the proximal blocking member is provided with a plurality of buckles, and the opposite end of the distal anchoring member is provided with a corresponding buckle, and the buckle is hooked on the buckle to realize The connection of the proximal blocking member and the distal anchoring member.

Wherein, the distal anchoring piece and the proximal blocking piece are also connected by a connecting rod, the end center of the distal anchoring piece is provided with a distal ring, and the end center of the proximal blocking piece is provided with a There is a proximal ring, the two ends of the connecting rod respectively penetrate into the distal ring and the proximal ring and are fixedly connected, and the proximal ring is provided with a fixed head end for fixing the connecting rod.

Wherein, the fixed head end, the proximal ring and the connecting rod are connected together by welding or the corresponding positions on the fixed head end, the proximal ring and the connecting rod are all provided with pin holes, and the pins pass through the connecting rods in turn. The fixed head end, the near-end ring and the pin hole on the connecting rod are connected together.

Wherein, the expanded shape of the flow blocking membrane is a flower shape with multiple petals, a saw blade shape with multiple saw teeth or other shapes; the cap shape is formed by stitching multiple petals or saw teeth together in sequence.

Wherein, the center of the circle of the choke film is fixed in the proximal ring of the proximal occluder through the fixed head; inside the suture hole provided on the piece.

Wherein, both the proximal blocking member and the distal anchoring member are hollow structures formed by laser cutting and engraving of elastic tubing.

The utility model also provides a left atrial appendage occlusion system, which includes a delivery device and the left atrial appendage occlusion device described in the above technical solution, the delivery device includes a delivery sheath and a push rod, and the left atrial appendage occlusion device is set In the delivery sheath, one end of the push rod is arranged in the delivery sheath, and is detachably connected to the fixed head end of the left atrial appendage occlusion device.

Wherein, the end of the push rod is provided with an external thread, and the end of the fixed head is provided with an internal thread, and the push rod and the fixed head are connected by threads.

(3) Beneficial effects

Compared with the prior art, the utility model has the following advantages:

The utility model provides a left atrial appendage blocking device and a blocking system. The left atrial appendage blocking device sets the supporting frame as a hollowed-out spheroid with elasticity, and sets the blocking film into a cap shape. It is sleeved on the proximal periphery of the supporting frame; the distal circumference of the supporting frame is provided with anchor thorns, which are used to grasp the inner wall of the left atrial appendage; thereby reducing the passing outer diameter of the occluding device and reducing the impact on blood vessels. damage; after the occlusion device is deployed or half-deployed, if the deployed position is not ideal, it can be repositioned and released again, without replacing a new occlusion device, which simplifies the surgical process and reduces surgical risks; the closed spherical structure can Avoid direct action of the tip of the occlusion device on the inner wall of the left atrial appendage, resulting in pericardial effusion or cardiac perforation.

Description of drawings

Fig. 1 is the structural representation of a kind of left atrial appendage blocking device of the present utility model;

Fig. 2 is the top view of Fig. 1;

Fig. 3 is a structural schematic diagram of a supporting frame of a left atrial appendage occlusion device of the present invention;

Figure 4 is a schematic diagram of disassembly of Figure 3;

Fig. 5 is a three-dimensional schematic diagram of a fixed head end of a left atrial appendage occlusion device of the present invention;

Fig. 6 is a schematic diagram showing the expansion of the blocking membrane of a left atrial appendage occlusion device of the present invention;

Fig. 7 is another schematic diagram of expansion of the blocking membrane of a left atrial appendage occlusion device of the present invention;

Fig. 8 is a structural schematic diagram of a left atrial appendage occlusion device of the present invention after suturing the blocking membrane;

Fig. 9 is a structural schematic diagram of a left atrial appendage occlusion system deployed in the left atrial appendage of the present invention;

Fig. 10 is a structural schematic diagram of a left atrial appendage occlusion system of the present invention when it is deployed in the left atrial appendage;

Fig. 11 is a three-dimensional schematic diagram of a pin of a left atrial appendage occlusion device according to the present invention.

In the figure: 10: left atrial appendage occlusion device; 100: supporting frame; 101: distal anchor; 102: proximal occlusion; 110: anchor thorn; 120: buckle connection; 130: distal ring; 140 : connecting rod; 141: pin socket on the connecting rod; 150: clasp; 160: buckle; 170: proximal ring; 171: pin socket on the proximal ring; 180: suture hole; 200, flow resistance Membrane; 201: suture side; 202: fixed side; 300: fixed tip; 301: pin socket on the fixed tip; 400: pin; 500: delivery sheath; 501: push rod; 600: left atrial appendage; 601 : opening of left atrial appendage; 602 : inner wall of left atrial appendage.

Detailed ways

Below in conjunction with accompanying drawing and embodiment, the specific embodiment of the utility model is described in further detail. The following examples are used to illustrate the utility model, but not to limit the scope of the utility model.

In the description of the present utility model, it should be noted that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", The orientations or positional relationships indicated by "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the utility model and simplified descriptions, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and in addition, "far" and "near" are relative to the operator, close to the operator One end is "near", and the end far away from the operator is "far", so it cannot be understood as a limitation of the present utility model.

In the description of the present utility model, it should be noted that, unless otherwise clearly stipulated and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a flexible connection. Detachable connection, or integral connection; it can be mechanical connection or electrical connection; it can be direct connection or indirect connection through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present utility model in specific situations.

In addition, in the description of the present utility model, unless otherwise specified, the meanings of "multiple", "multiple roots" and "multiple groups" are two or more.

As shown in Fig. 1 and Fig. 2, a left atrial appendage occlusion device 10 provided by the present invention includes a support frame 100 and a flow blocking membrane 200, the support frame 100 is a hollowed-out spheroid with elasticity, It can be stretched and contracted, and its structure can be designed according to the requirements of the final product. The flow-blocking membrane 200 is set in the shape of a cap, which is fixedly sleeved on the proximal periphery of the support frame 100; thus, the blocking device can be controlled to pass through The outer diameter of the left atrial appendage further reduces the potential damage to blood vessels caused by the delivery device; the distal circumference of the support frame 100 is provided with an anchor thorn 110, which is used to grasp the inner wall of the left atrial appendage, so that the entire occlusion device can be reliably Secure while facilitating retrieval and repositioning of the closure device.

As shown in FIGS. 3 and 4 , specifically, the support frame 100 includes a proximal blocking member 102 and a distal anchoring member 101, and the proximal blocking member 102 and the distal anchoring member 101 are respectively elastic. Hollow hemispherical structure, the proximal blocking member 102 and the distal anchoring member 101 are connected together to form the spherical body, that is, the support skeleton 100; the flow blocking membrane 200 is sleeved on the proximal blocking The outer periphery of the member 102, the anchoring thorns 110 are arranged on the circumference of the distal anchoring member 101, the number of the anchoring thorns 110 can be multiple, evenly distributed on the circumference of the end anchoring member.

Further, the end of the proximal blocking member 102 is provided with a plurality of buckles 160, and the opposite end of the distal anchoring member 101 is provided with a corresponding buckle 150, and the buckles 160 are hooked on The buckle connection 120 between the proximal blocking member 102 and the distal anchoring member 101 is realized on the buckle 150, and the buckle 160 is designed as a square cone. Once it is buckled into the buckle 150, it will , the buckle 150 will rotate with the buckle 160 as the center of a circle, and go deep into the buckle 160 so as not to slip out of the buckle 160 .

In order to ensure that the supporting frame 100 has a certain support along its length direction, the distal anchor 101 and the proximal blocking member 102 are also connected by connecting rods 140, and the connecting rods 140 are preferably two arranged side by side. , to enhance the support strength; the center of the end of the distal anchor 101 is provided with a distal ring 130, the center of the end of the proximal blocking member 102 is provided with a proximal ring 170, and the connecting rod 140 The two ends respectively pass through the distal ring 130 and the proximal ring 170 and are fixedly connected. The proximal ring 170 is provided with a fixed head end 300, as shown in FIG. 5, for fixing the connecting rod 140, for example , the fixed head end 300, the proximal ring 170 and the connecting rod 140 are connected together by welding or the corresponding positions on the fixed head end 300, the proximal ring 170 and the connecting rod 140 are provided with pin insertion holes 301 , 171, 141, utilize the pin 400 to pass through the pin holes 301, 171, 141 on the fixed head end 300, the proximal ring 170 and the connecting rod 140 to connect together, as shown in Figure 11 is a schematic structural view of the pin 301 ; The connecting rod 140 and the distal ring 130 can also be connected by welding. The connecting rod 140 may be a straight rod or a curved rod, or a combination of the two, or a hollow rod.

As shown in Figures 6-8, wherein, the flow blocking film 200 is engraved into a certain shape by laser cutting, and the expanded shape of the flow blocking film 200 can be a flower shape with multiple petals, a zigzag shape with multiple saw teeth or other shapes; the cap shape is formed by stitching together a plurality of petals or serrated seaming edges 201 in sequence. After the flow blocking film 200 is sewn into a cap shape, the center of the flow blocking film 200 is fixed in the proximal ring 170 of the proximal blocking member 102 through the fixed head end 300; The circumference of 200 , that is, the fixed side 202 is fixed in the suture hole 180 provided on the proximal blocking member 102 by suturing, or fixed on the circumference of the proximal blocking member 102 by bonding.

Wherein, the proximal blocking member 102 and the distal anchoring member 101 are both hollow structures made of elastic tubing through laser cutting and engraving, and then subjected to heat treatment and shaped into a designed shape.

As shown in Figure 9 and Figure 10, the utility model also provides a left atrial appendage occlusion system, which includes a delivery device and the left atrial appendage occlusion device 10 described in the above technical solution, the delivery device includes a delivery sheath 500 and a push rod 501, the left atrial appendage occlusion device 10 is set in the delivery sheath 500, one end of the push rod 501 is set in the delivery sheath 500, and the left atrial appendage occlusion device 10 The fixed head end 300 is detachably connected; specifically, the end of the push rod 501 is provided with external threads, the fixed head end 300 is provided with internal threads, and the push rod 501 and the fixed head end 300 are connected by threads. Put the delivery sheath 500 on the outside of the push rod 501, screw the occlusion device on the outer thread of the distal end of the push rod 501 by fixing the internal thread on the head end 300, fix the delivery sheath 500, Pull the push rod 501 in the direction, and the proximal blocking member 102 of the support frame 100 is compressed and deformed slowly by the delivery sheath 500 under the action of an external force, and the outer diameter becomes smaller, so that it is received into the delivery sheath 500, thus The pre-installation of the blocking device has just been completed. In clinical application, after accurately positioning the position of the delivery sheath 500 in the left atrial appendage 600, fix the push rod 501, and slowly withdraw the delivery sheath 500, the occlusion device that has lost its restraint will automatically move due to the superelasticity of the support frame 100 itself. Expand to conform to the shape of the left atrial appendage 600 and fill in the space of the left atrial appendage; at this time, the proximal blocking member 102 covers the entire opening of the left atrial appendage 601, and the flow blocking membrane 200 covering the proximal blocking member 102 can block blood flow, and the anchor barb 110 on the distal anchor 101 will grasp the tissue of the inner wall 602 of the left atrial appendage to complete the fixation of the occlusion device and prevent the entire occlusion device from being extruded due to the contraction of the left atrial appendage, resulting in its fall off. When the deployment position of the occlusion device is not ideal or the occlusion device cannot completely cover the left atrial appendage opening 601, fix the push rod 501, carefully push the delivery sheath 500 towards the direction of the occlusion device, and elastically support the proximal end of the framework 100 The blocking member 102 is compressed by the delivery sheath 500 under the action of an external force and gradually deformed, and its outer diameter becomes smaller, so that it is retracted into the delivery sheath 500 . The distal anchor 101 is also slowly retracted into the delivery sheath 500 under the action of the connecting rod 140 . When subjected to an external force, the buckle 150 of the distal anchor 101 will rotate with the buckle 160 of the proximal blocking member 102 as the center of a circle due to the tension transmission effect of the connecting rod 140, and the anchor thorn 110 will also rotate. Under the action of the pulling force of the connecting rod 140 , the inner wall 602 of the left atrial appendage is smoothly detached from the tissue along the recovery direction without causing new damage. The occlusion device may then be partially or fully retracted into the delivery sheath 500 . A partially or fully retracted occlusion device can be repositioned and re-deployed for release without damage to the occlusion device and delivery sheath 500 . After the blocking device is positioned accurately, fully deployed, and anchored securely, the pushing rod 501 can be rotated counterclockwise to separate the blocking device from the pushing rod 501 .

It can be seen from the above embodiments that the utility model has a novel structural design, is easy to operate, can reduce damage to blood vessel access, and reduces many risks during surgery.

The above descriptions are only preferred embodiments of the present utility model, and are not intended to limit the present utility model. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present utility model shall be included in the Within the protection scope of the present utility model.

Claims (10)

1. A left atrial appendage occlusion device is characterized in that it comprises a support frame and a flow-blocking membrane, the support frame is an elastic hollowed-out spheroid, and the flow-blocking membrane is set into a cap shape, which is sleeved on The proximal periphery of the supporting frame; the distal periphery of the supporting frame is provided with an anchor thorn for grasping the inner wall of the left atrial appendage. 2. The left atrial appendage occlusion device according to claim 1, wherein the support frame comprises a proximal occluding member and a distal anchor, and the proximal occluding member and the distal anchor are respectively It is an elastic hollow hemispherical structure, the proximal blocking element and the distal anchoring element are connected together to form the spherical body; the flow blocking membrane is sleeved on the periphery of the proximal blocking element, and the anchor Barbs are disposed on the circumference of the distal anchor. 3. The left atrial appendage occlusion device as claimed in claim 2, wherein a plurality of buckles are provided at the end of the proximal occlusion member, and corresponding buckles are provided at the opposite end of the distal anchor member. The clasp is hooked on the clasp to realize the connection between the proximal blocking element and the distal anchoring element. 4. The left atrial appendage occlusion device as claimed in claim 3, wherein the distal anchor and the proximal occluder are also connected by a connecting rod, and the center of the end of the distal anchor is arranged There is a distal ring, and the center of the end of the proximal blocking member is provided with a proximal ring, and the two ends of the connecting rod respectively penetrate the distal ring and the proximal ring and are fixedly connected, and the proximal ring A fixed head end is arranged on the outside for fixing the connecting rod. 5. left atrial appendage occlusion device as claimed in claim 4, is characterized in that, described fixing head end and described near-end ring and connecting rod are connected together by welding or described fixing head end, near-end ring and connection Corresponding positions on the rod are provided with pin holes, and pins are used to pass through the fixed head end, the proximal ring and the pin holes on the connecting rod in turn to connect together. 6. The left atrial appendage occlusion device according to claim 5, wherein the expanded shape of the blocking membrane is a flower shape with a plurality of petals, a zigzag shape with a plurality of saw teeth or other shapes; The petals or serrations are sewn together two by two in turn to form the cap shape. 7. left atrial appendage occlusion device as claimed in claim 6, is characterized in that, the circle center of described choke film is fixed in the near-end ring of described near-end occluder by described fixed head end; The circumference of the flow membrane is fixed in the suture hole provided on the proximal blocking member by suturing. 8 . The left atrial appendage occlusion device according to claim 2 , wherein both the proximal occluding member and the distal anchoring member are hollow structures made of elastic tubing through laser cutting and engraving. 9. A left atrial appendage occlusion system, characterized in that it comprises a delivery device and the left atrial appendage occlusion device as claimed in any one of claims 1-8, said delivery device comprising a delivery sheath and a push rod, said The left atrial appendage occlusion device is arranged in the delivery sheath, and one end of the push rod is arranged in the delivery sheath, and is detachably connected to the fixed head end of the left atrial appendage occlusion device. 10. The left atrial appendage occlusion system according to claim 9, wherein the end of the push rod is provided with an external thread, and the fixed head end is provided with an internal thread, and the push rod and the fixed head end pass through threaded connection.