CN216603193U - A temporary valve and aortic filter integrated device - Google Patents

Abstract

A temporary valve and aortic filter integrated device of the utility model is characterized in that: it comprises a first pipeline, a balloon, a valve and a filter, and the first pipeline is communicated with the balloon; the filter is in the shape of a conical bag, and the filter The half perimeter edge of the opening is fixedly connected with the upper end surface of the balloon, and the opening of the filter is located on the inner side of the balloon; the valve is a double leaflet structure, each leaflet is in the shape of a bag, and each leaflet is open The half-circumferential edge of the sac is fixedly connected with the lower end face of the balloon, and is symmetrical about the middle of the balloon. The utility model solves the problem that the filter and the temporary valve do not have both, and makes it compatible to a certain extent, and can be used together with other interventional valves, interventional balloons and other devices; the filter and the valve of the device are an integrated structure and have The structure is relatively simple, and the possibility of failure of the device is low, and because of the relatively simple structure, the diameter of the delivery lumen is required to be small, which can adapt to more people, and is also conducive to reducing manufacturing costs.

Description

A temporary valve and aortic filter integrated device

technical field

The utility model relates to a temporary aortic valve, in particular to a temporary valve and aortic filter integrated device.

Background technique

Heart valve disease is a disease that seriously endangers human life and health. With the advent of the ageing population, more and more patients with aortic valve disease are showing the characteristics of advanced age and high risk. With the development of medical technology, percutaneous aortic valve implantation (TAVR) has appeared, which is more and more used in the treatment of various clinical diseases due to its small incision, low trauma, and quick recovery. However, since this operation is aimed at patients with aortic valve stenosis and requires balloon dilation and other dangerous operations during the operation, it is prone to secondary severe aortic valve regurgitation after valve balloon dilation, which in turn leads to hemodynamic collapse and even death of the patient. Therefore, during this procedure, the placement of a temporary valve to reduce left ventricular regurgitation becomes a possible way to prevent this serious complication. At the same time, due to the severe calcification of valve leaflets in most patients, in the process of balloon expansion, the calcification of valve leaflets may be squeezed off by the balloon and then enter the brain, limbs and other organs through the aorta, resulting in serious complications of embolization and necrosis of related organs. Therefore, the placement of a temporary filter to restrict the shed calcified tissue has become a feasible intervention.

At present, there is no effective temporary valve, which can function as both an arterial filter and a temporary valve, and the existing temporary valve technology is not compatible with other temporary valves. At the same time, the aortic filter used in clinic is often complicated in structure and high in cost. Therefore, the invention of the present application manufactures a simple but effective temporary valve device with a filter, which will provide a key to patients with aortic valve stenosis who need TAVR surgery. effective safeguards.

Utility model content

Aiming at the deficiencies in the prior art, the utility model provides a temporary valve and aortic filter integrated device, so as to solve the problem that the filter and the temporary valve cannot be implanted at the same time and the multiple vascular access paths are occupied, resulting in the inability to perform balloon dilation at the same time. and valve implantation; the device has a certain compatibility and can be used together with other interventional valves, interventional balloons and other devices, and can effectively provide means of protection for patients with aortic valve stenosis who will need TAVR surgery.

To achieve the above object, the utility model adopts the following technical solutions:

A temporary valve and aortic filter integrated device, characterized in that it comprises a first pipeline, a balloon, a valve, and a filter, the inside of the first pipeline is a channel A for conveying a contrast agent, and the balloon is in the shape of "C" , the interior is a cavity, the first pipeline is communicated with the balloon, and is vertically arranged with the "C"-shaped plane of the balloon; the filter is in the shape of a conical pouch, and the pouch is a single-opening structure, The lower end of the cone is an open circular pouch opening, the top of the cone is a closed pouch structure, and the half perimeter edge of the filter opening is fixed with the upper end surface of the balloon connected, and the opening of the filter is located on the inside of the "C"-shaped balloon; the valve contains two leaflets, the leaflets are bag-shaped, and the opening of the one leaflet is half a circumference The long edge is fixedly connected with the lower end face of the balloon, and the connection is located from the middle to the right end of the "C"-shaped balloon, and the other half of the circumference of the opening of the valve leaflet The long edge and the right leaflet 3 are symmetrically fixed on the lower end surface of the balloon from the middle to the left end to form a double leaflet structure, and the openings of the two leaflets are located inside the "C"-shaped balloon .

In order to optimize the above technical solutions, the specific measures taken also include:

Further, the first conduit communicates with the balloon through a connecting pipe, and the connecting pipe is radially arranged with respect to the "C"-shaped balloon and is located inside the "C"-shaped balloon.

Further, the connecting tube is located in the middle of the balloon.

Further, it also includes a second pipe, and a channel B for the guide wire to pass through is opened inside the second pipe; the first pipe is installed and arranged in the inner wall of the second pipe, and the second pipe A through hole is opened for the connecting pipe to protrude.

Further, it also includes a delivery lumen, a large channel C is opened inside the delivery lumen, and the delivery lumen is sleeved on the second pipeline.

The beneficial effects of the present utility model are:

A temporary valve and aortic filter integrated device provided by this application document: 1. Fixing by a balloon, the balloon itself is a soft structure, and it is not easy to cause the edge of the device to rub against the aortic wall and cause damage to the aortic wall. Serious complications such as aortic rupture; 2. The balloon is a "C"-shaped structure, because either end can be bent into the inside of the other end, so that the device can more accurately fit the diameter of the aorta during use, and at the same time Due to the non-uniform diameter of the aorta, it can adapt to changes in the diameter of the aorta in real time during the operation; 3. Since the balloon is a "C"-shaped structure, it is a non-closed loop structure, which can make the interventional valve, interventional balloon and other devices compatible with The device exists in the aorta in parallel and operates independently. At the same time, it can replace the delivery system for moving the interventional valve and the interventional balloon in real time, and can be suitable for the interventional valve and interventional balloon of different diameter delivery systems, and has strong adaptability. , there is no need to produce too many types of equipment, which is conducive to reducing product costs and improving the simplicity and effectiveness of the process of stocking and use of this patent; 4. The filter and valve of the device are an integrated structure, with a relatively simple structure and the possibility of equipment failure. Due to the relatively simple structure, the diameter of the delivery lumen is small, which can adapt to more people, and is also conducive to reducing the manufacturing cost.

Description of drawings

1 is a schematic plan view of a temporary valve and aortic filter integrated device;

Figure 2 is a schematic diagram of the valve part of a temporary valve and aortic filter integrated device;

FIG. 3 is a schematic structural diagram of a filter part of a temporary valve and aortic filter integrated device;

Figure 4 is a side view during use of a temporary integrated valve and aortic filter device.

Reference numerals: 1. First conduit, 2. Balloon, 3. Leaflet, 4. Filter, 5. Second conduit, 6. Delivery lumen, 7. Connecting tube.

Detailed ways

The present utility model will be described in detail below with reference to the accompanying drawings.

It should be noted that the terms such as "up", "down", "left", "right", "front", "rear", etc. quoted in the utility model are only for the convenience of description and clarity, not for use In order to limit the applicable scope of the present invention, the change or adjustment of the relative relationship shall also be regarded as the applicable scope of the present invention without substantially changing the technical content.

As shown in the accompanying drawings, a temporary valve and aortic filter integrated device is characterized in that it includes a first conduit 1 , a balloon 2 , a valve and a filter 4 . The inside of the first pipeline 1 is the channel A for conveying the contrast agent, the balloon 2 is in the shape of "C", and the inside is a cavity; the first pipeline 1 and the balloon 2 are communicated through the connecting pipe 7, and are connected with the connecting pipe 7. The "C"-shaped plane of the balloon 2 is arranged vertically; the connecting pipe 7 is radially arranged with respect to the "C"-shaped balloon 2, and is located inside the "C"-shaped balloon 2, the The connecting tube 7 is located in the middle of the balloon 2 . The filter 4 is in the shape of a conical pouch, the pouch is a single opening structure, the lower end of the cone is an open circular pouch mouth, the top of the cone is a closed pouch structure, the filter 4 The half perimeter edge of the opening is fixedly connected with the upper end surface of the balloon 2 , and the opening of the filter 4 is located inside the "C"-shaped balloon 2 . The valve includes two leaflets 3, and the leaflets 3 are bag-shaped; the half-perimeter edge of the opening of the one leaflet 3 is fixedly connected with the lower end surface of the balloon 2, and the The connection is located from the middle to the right end of the "C"-shaped balloon 2; the half-perimeter edge of the opening of the other leaflet 3 is also fixedly arranged under the balloon 2. From the middle of the end face to the left end, the valve leaflets 3 on the left and right sides are relatively symmetrical with respect to the middle position of the "C"-shaped balloon, and each is connected to one-half the length of the long axis of the balloon, thereby forming a double-leaflet mechanism, To better ensure the functionality of the temporary valve leaflets, the openings of the two valve leaflets 3 are located inside the "C"-shaped balloon 2 . The two leaflets 3 and the filter 4 are both fixed on the "C"-shaped balloon 2 to form an integrated structure.

The device further includes a second pipe 5, and a channel B for the guide wire to pass through is opened inside the second pipe 5; the first pipe 1 is installed in the inner wall of the second pipe 5, and the The second pipe 5 is provided with a through hole through which the connecting pipe 7 extends.

The device further includes a delivery lumen 6 , a large channel C is opened inside the delivery lumen 6 , and the delivery lumen 6 is sleeved on the second pipeline 5 .

The balloon 2 described in this device is a soft structure, and it is not easy to cause the edge of the device to rub against the aortic wall, causing serious complications such as aortic wall damage and aortic rupture; the filter 4 can filter thrombus and aorta. A medical polymer material film made of calcified agglomerates and other substances that fall off during the balloon expansion process. The material film is a perforated film, and the pore size allows normal blood cells to pass through but can block thrombus and aortic valve balloon during balloon expansion. calcified lumps.

A kind of using method of the present utility model:

Step 1, the "C"-shaped balloon 2 in a state of not being filled with a contrast agent is in a crimped state, and the balloon 2 at this time is connected with the filter 4 fixedly connected to the upper end surface of the balloon 2 and the balloon 2. The lower end of the balloon 2 is symmetrically and fixedly connected to the two leaflets 3 around and close to the side wall of the second pipe 5; then the second pipe 5 and the wrapped balloon 2 are placed in the delivery pipe In channel C of cavity 6;

Step 2: The guide wire is inserted into the patient's body through one side of the femoral artery or other vascular access. After reaching the designated position along the aorta, the delivery lumen 6 is connected with the guide wire by the second pipeline 5, and the guide wire is drawn to the patient. The designated position; when the delivery lumen 6 reaches the designated position, the second conduit 5 is extended, and the balloon 2 is partially placed at the ascending aorta of the patient;

Step 3, the aortic valve dilation balloon is inserted into the body of the patient through the other side of the femoral artery or other vascular access and reaches above the diseased aortic valve, the aortic valve dilation balloon is required in the process of interventional valve intervention. A balloon device for dilating a narrowed aortic valve;

Step 4: After the balloon 2 reaches the designated position, the balloon 2 is filled through the first pipeline 1 and the connecting tube 7 used to connect the first pipeline 1 and the balloon 2, and the shriveled balloon 2 passes through the first pipeline 1 and the balloon 2. A pipeline injects contrast agent and expands into a "C" shape due to filling the contrast agent; and due to the "C" shape structure and the soft structure of the balloon 2 itself, either end of the balloon 2 can be bent into the inside of the other end, and the balloon Balloon 2 will more accurately fit the diameter of the aorta, and at the same time, due to the non-uniform diameter of the aorta, it can adapt to changes in the diameter of the aorta in real time during the operation, and will not rub against the aortic wall and cause damage to the aortic wall. Serious complications such as aortic rupture occur; at the same time, the filter 4 connected to the balloon 2 is also stretched due to its flexible structure, and the inner side of the filter 4 is in close contact with the outer wall of the second pipeline 5, and the filter 4 The opening of the valve is opened to enter the operation; the two-leaflet structure valve 3 connected to the balloon 2 is also correspondingly stretched, and the inner side of the two valve leaflets 3 is close to the outer wall of the second pipeline 5, and enters the operation. Temporary working state during the period; at this time, due to the C-shaped balloon structure, the valve and filter of the device wrap the delivery system at the distal end of the aortic valve dilation balloon from outside. Part of the calcified tissue on the autologous valve is loose and falls off, and enters the filter 4 through the valve of the device and is blocked by the filter 4 in the filter, thereby preventing the blood flow of the calcified tissue from entering the brain and other organs and causing cerebral infarction and other organ embolism events. At the same time, because the aortic valve dilation balloon will quickly remove the contrast agent through the external body after filling to restore the forward blood flow of the aortic valve, this operation will also cause serious damage to the aortic valve and cause aortic valve insufficiency. The valve of the device can prevent blood flow from the aortic arch and descending aorta back to the left ventricle, and avoid the serious cardiovascular complication of circulatory collapse caused by the increase of left ventricular blood stasis volume load;

Step 5: After the aortic valve dilation balloon is withdrawn from the body to the outside of the body, the interventional aortic valve delivery system can be paralleled through the guide wire of the original aortic valve dilation balloon and pass through the encircling structure formed by the valve and the filter of the device. And reach the position of the patient's native aortic valve, and release the implanted interventional valve according to the relevant procedures of the interventional valve. Due to the "C"-shaped structure of the balloon 2, the above process can better correspond to the diameter changes of the interventional valve, interventional balloon and other device delivery systems, so that the same temporary valve filter structure can adapt to the diameter changes of different interventional delivery devices during surgery. , and always tightly seal the ascending aorta to ensure the close fit of the valve and filter of the device with the ascending aorta, the interventional valve, and the balloon delivery system;

Step 6: After the operation, the interventional valve delivery system is evacuated, and the inside of the balloon 2 is extracted through the first pipeline 1 to remove the contrast agent, so that the balloon 2 is restored to a shriveled state, and then is collected into the delivery lumen 6 through the second pipeline 5. In the middle, the guide wire is pulled out of the patient's body, and finally the guide wire is pulled out, and the wound is treated accordingly.

The above are only the preferred embodiments of the present utility model, and the protection scope of the present utility model is not limited to the above-mentioned embodiments, and all technical solutions under the idea of the present utility model belong to the protection scope of the present utility model. It should be pointed out that for those skilled in the art, some improvements and modifications without departing from the principle of the present invention should be regarded as the protection scope of the present invention.

Claims (5)

1. A temporary valve and aortic filter integrated device, characterized in that: it comprises a first pipeline (1), a balloon (2), a valve, and a filter (4), and the inside of the first pipeline (1) is used for Channel A for conveying contrast agent, the balloon (2) is in "C" shape with a cavity inside, the first conduit (1) communicates with the balloon (2), and is connected with the balloon (2) The "C"-shaped plane of the filter is arranged vertically; the filter (4) is in the shape of a conical pouch, the pouch is a single-opening structure, the lower end of the cone is an open circular pouch mouth, and the top of the cone It is a closed bag structure, the half perimeter edge at the opening of the filter (4) is fixedly connected with the upper end surface of the balloon (2), and the opening of the filter (4) is located at "C" The inner side of a type of balloon (2); the valve contains two leaflets (3), the leaflets (3) are bag-shaped, and the opening of the one leaflet (3) is half a circumference The long edge is fixedly connected with the lower end surface of the balloon (2), and the connection is located from the middle to the right end of the "C"-shaped balloon (2), and the other leaflet (3) The half perimeter edge of the opening at the opening is symmetrically fixed with the right leaflet (3) from the middle to the left end of the lower end surface of the balloon (2), forming a double leaflet structure. The opening of each leaflet (3) is located inside the "C"-shaped balloon (2). 2. A temporary valve and aortic filter integrated device according to claim 1, characterized in that: the first pipeline (1) and the balloon (2) communicate with each other through a connecting pipe (7) , the connecting pipe (7) is radially arranged with respect to the "C"-shaped balloon (2), and is located inside the "C"-shaped balloon (2). 3 . The temporary valve and aortic filter integrated device according to claim 2 , wherein the connecting tube ( 7 ) is located in the middle position of the balloon ( 2 ). 4 . 4. A temporary valve and aortic filter integrated device according to claim 3, characterized in that it further comprises a second conduit (5), and a guide wire is provided inside the second conduit (5). Passing through channel B; the first pipe (1) is installed in the inner wall of the second pipe (5), and the second pipe (5) is provided with the connecting pipe (7) extending out through holes. 5. A temporary valve and aortic filter integrated device according to claim 4, characterized in that it further comprises a delivery lumen (6), and a large channel C is opened inside the delivery lumen (6). , the delivery lumen (6) is sleeved on the second pipeline (5).

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