A temporary valve and aortic filter integrated device and method of use thereof

Abstract

The present invention discloses a temporary valve and aortic filter integrated device, characterized in that: it includes a first pipe, a balloon, a valve, and a filter, the first pipe is connected to the balloon; the filter is in the shape of a cone bag, half of the circumference edge of the filter opening is fixedly connected to the upper end face of the balloon, and the opening of the filter is located on the inner side of the balloon; the valve is a bi-leaflet structure, each leaflet is in the shape of a bag, half of the circumference edge of each leaflet opening is fixedly connected to the lower end face of the balloon, and are symmetrical about the middle of the balloon. The present invention solves the problem that the filter and the temporary valve are not compatible, and makes it have a certain compatibility, and can be used with other interventional valves, interventional balloons and other devices; the filter and valve of this device are an integrated structure, which has the characteristics of relatively simple structure and low possibility of device failure. Because of the relatively simple structure, the diameter requirement of the delivery lumen is relatively small, it can adapt to more people and is also conducive to reducing manufacturing costs.

Description

Technical Field

[0001] The present invention relates to a temporary aortic valve, and in particular to a temporary valve and aortic filter integrated device and a use method thereof. Background Art

[0002] Valvular heart disease is a serious threat to human health. With the aging population, aortic valve disease is increasingly common in patients with advanced age and high-risk conditions. Advances in medical technology have led to the emergence of percutaneous aortic valve implantation (TAVR), a procedure that is increasingly used to treat a wide range of conditions due to its small incision, minimal invasiveness, and rapid recovery. However, because this procedure is performed on patients with aortic stenosis and requires risky procedures such as balloon dilation, it is prone to severe aortic regurgitation, which can lead to hemodynamic collapse or even death. Therefore, placement of a temporary valve to reduce left ventricular blood flow during this procedure has become a possible preventative measure. Furthermore, since many patients have severe valvular calcification, calcification can be dislodged by the balloon during dilation and enter the aorta, potentially leading to embolic necrosis and potentially serious complications. Therefore, placement of a temporary filter to throttle the dislodged calcification is a viable intervention.

[0003] Currently, there is no effective temporary valve that can serve as both an arterial filter and a temporary valve, and existing temporary valve technologies are not compatible with other temporary valves. Furthermore, clinically used aortic filters are often complex and costly. Therefore, the present invention aims to create a simple yet effective temporary valve device that also functions as a filter, providing a critical and effective safeguard for patients with aortic stenosis undergoing TAVR. Summary of the Invention

[0004] In response to the deficiencies in the prior art, the present invention provides an integrated temporary valve and aortic filter device to address the problems of the filter and temporary valve being unable to be implanted simultaneously and the inability to perform balloon dilation and valve implantation simultaneously due to the occupation of multiple vascular access routes. This device has a certain degree of compatibility and can be used in conjunction with other interventional valves, interventional balloons and other devices, and can effectively provide protection for patients with aortic valve stenosis who are about to undergo TAVR surgery.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] A temporary valve and aortic filter integrated device, characterized in that it includes a first pipe, a balloon, a valve, and a filter. The interior of the first pipe is a channel A for delivering a contrast agent. The balloon is "C"-shaped and has a cavity inside. The first pipe is connected to the balloon and is arranged perpendicular to the "C"-shaped plane of the balloon. The filter is in the shape of a cone bag, and the bag is a single-opening structure. The lower end of the cone is an open circular bag opening, and the top of the cone is a closed bag structure. The half-circumference edge of the filter opening is aligned with the upper end surface of the balloon. The filter is fixedly connected, and the opening of the filter is located on the inner side of the "C"-shaped balloon; the valve comprises two leaflets, which are bag-shaped, and the half-circumference edge of the opening of one leaflet is fixedly connected to 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 half-circumference edge of the opening of the other leaflet is symmetrically fixed with the leaflet 3 on the right side from the middle to the left end of the lower end face of the balloon to form a double-leaf structure, and the openings of the two leaflets are located on the inner side of the "C"-shaped balloon.

[0007] To optimize the above technical solutions, specific measures taken also include:

[0008] Furthermore, the first conduit is connected to the balloon via a connecting tube, and the connecting tube is radially arranged with respect to the “C”-shaped balloon and is located inside the “C”-shaped balloon.

[0009] Furthermore, the connecting tube is located in the middle of the balloon.

[0010] Furthermore, it also includes a second pipe, wherein a channel B is opened inside the second pipe for the guide wire to pass through; the first pipe is installed in the inner wall of the second pipe, and the second pipe is opened with a through hole for the connecting pipe to extend out.

[0011] Furthermore, 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 pipe.

[0012] Furthermore, the balloon is a soft structure.

[0013] Furthermore, the filter is a flexible structure.

[0014] Furthermore, the filter uses a medical polymer material film that can filter substances such as thrombus and calcified masses detached during aortic valve balloon expansion. The material film is a porous film with a pore size that allows normal blood cells to pass through but can block thrombus and calcified masses detached during aortic valve balloon expansion.

[0015] A method for using a temporary valve and aortic filter integrated device according to any one of the above items, characterized in that:

[0016] Step 1: A "C"-shaped balloon, unfilled with contrast agent, is rolled up. The balloon, along with a filter fixedly connected to the upper end of the balloon and two leaflets symmetrically fixedly connected to the lower end of the balloon, is wrapped around and tightly attached to the sidewall of the second conduit. The second conduit, along with the wrapped balloon, is then placed in channel C of the delivery lumen.

[0017] Step 2: The guide wire is passed into the patient's body through one femoral artery or other vascular access route. After reaching the designated position along the aorta, the delivery lumen is connected to the guide wire via a second tube and is pulled to the designated position by the guide wire. When the delivery lumen reaches the designated position, the second tube is extended to place the balloon portion in the patient's ascending aorta.

[0018] Step 3: inserting an aortic valve dilation balloon into the patient's body through the other femoral artery or other vascular access route and reaching above the diseased aortic valve. The aortic valve dilation balloon is a balloon device used to dilate the stenotic aortic valve during an interventional valve procedure.

[0019] Step 4: After the balloon reaches the designated position, the balloon is filled through the first tube and the connecting tube for connecting the first tube and the balloon. The originally deflated balloon is injected with contrast agent through the first tube and expands into a "C" shape due to the filling of contrast agent. Due to the "C" shape structure and the soft structure of the balloon itself, either end of the balloon can be bent into the inner side of the other end, and the balloon will adapt to the aortic diameter more accurately. At the same time, due to the non-uniform diameter of the aorta, it can adapt to the change of the aortic diameter in real time during the operation, and will not scratch the aortic wall, causing damage to the aortic wall and causing serious complications such as aortic rupture. At the same time, the filter connected to the balloon Due to its flexible structure, the device also expands, and the inner side of the filter is tightly attached to the outer wall of the second tube. The opening of the filter is opened and the operation begins. The leaflets of the bi-leaflet structure connected to the balloon also expand accordingly, and the inner sides of the two leaflets are tightly attached to the outer wall of the second tube, and enter a temporary working state during the operation. At this time, due to the C-shaped balloon structure, the valve and filter of this device wrap the delivery system at the distal end of the aortic valve expansion balloon from the outside. When the aortic valve balloon is filled with contrast agent injected externally, the calcified tissue on the patient's own valve loosens and falls off, passes through the valve of this device, enters the interior of the filter, and is blocked by the filter in the filter mesh.

[0020] Step 5: After the aortic valve expansion balloon is withdrawn from the body, the interventional aortic valve delivery system can be passed through the guide wire of the original aortic valve expansion balloon in parallel and through the valve and filter formed by the device to reach the patient's native aortic valve position, and the implanted interventional valve can be released according to the interventional valve related procedures;

[0021] Step 6. After the operation, the interventional valve delivery system is removed, and the contrast agent inside the balloon is extracted through the first pipe to restore the balloon to a deflated state. The balloon is then returned to the delivery lumen through the second pipe and pulled out of the patient's body by the guide wire. Finally, the guide wire is removed and the wound is treated accordingly.

[0022] The beneficial effects of the present invention are:

[0023] The present application document provides a temporary valve and aortic filter integrated device: 1. It is fixed by a balloon, and the balloon itself is a soft structure, which is not likely to cause the edge of the device to scrape the aortic wall, causing damage to the aortic wall and 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 when the device is in use, it can adapt to the aortic diameter more accurately, and at the same time, due to the non-uniform diameter of the aorta, it can adapt to the changes in the aortic diameter 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 interventional valves and interventional Devices such as balloons exist in the aorta in parallel with this device and operate independently. At the same time, the delivery system of the mobile interventional valve and interventional balloon can be replaced in real time. Moreover, it can be suitable for interventional valves and interventional balloons of delivery systems with different diameters. It has strong adaptability and does not require the production of too many models of equipment, which is conducive to reducing product costs and improving the simplicity and effectiveness of the stocking and use processes of this patent; 4. The filter and valve of this device are an integrated structure with a relatively simple structure and a low possibility of device failure. Due to the relatively simple structure, the diameter requirement of the delivery lumen is smaller, which can adapt to more people and is also conducive to reducing manufacturing costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 A schematic diagram of a temporary integrated valve and aortic filter device;

[0025] Figure 2 A schematic diagram of a partial structure of a valve of a temporary valve and aortic filter integrated device;

[0026] Figure 3 A schematic diagram of a partial structure of a filter of a temporary valve and aortic filter integrated device;

[0027] Figure 4A side view of a temporary integrated valve and aortic filter device during use.

[0028] Reference numerals: 1. first conduit, 2. balloon, 3. leaflet, 4. filter, 5. second conduit, 6. delivery lumen, 7. connecting tube. DETAILED DESCRIPTION

[0029] The present invention will now be described in further detail with reference to the accompanying drawings.

[0030] It should be noted that the terms such as "upper", "lower", "left", "right", "front", "back", etc. cited in the invention are only for the convenience of description and are not used to limit the scope of implementation of the present invention. Changes or adjustments to their relative relationships should be regarded as the scope of implementation of the present invention without substantially changing the technical content.

[0031] As shown in the accompanying drawings, a temporary integrated valve and aortic filter device is characterized by comprising a first conduit 1, a balloon 2, a valve, and a filter 4. The interior of the first conduit 1 is a channel A for delivering contrast agent. The balloon 2 is C-shaped and hollow. The first conduit 1 and the balloon 2 are connected by a connecting tube 7, which is arranged perpendicular to the C-shaped plane of the balloon 2. The connecting tube 7 is radially arranged with respect to the C-shaped balloon 2 and located inside the C-shaped balloon 2, with the connecting tube 7 positioned in the middle of the balloon 2. The filter 4 is in the shape of a conical bag with a single opening. The lower end of the cone is an open circular bag opening, and the top end of the cone is a closed bag structure. Half of the circumference of the opening of the filter 4 is fixedly connected to 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-circumference edge of the opening of one leaflet 3 is fixedly connected to 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; the half-circumference edge of the opening of the other leaflet 3 is also fixedly set from the middle to the left end of the lower end surface of the balloon 2. The leaflets 3 on the left and right sides are symmetrical about the middle position of the "C"-shaped balloon, and are each connected to half the long axis length of the balloon, thereby forming a double-leaf mechanism, which can better ensure the functionality of the temporary leaflets of this device. The openings of the two leaflets 3 are located on the inner side of the "C"-shaped balloon 2. The two leaflets 3 and the filter 4 are fixed on the "C"-shaped balloon 2 to form an integrated structure.

[0032] The device also includes a second pipe 5, which has a channel B inside for the guide wire to pass through; the first pipe 1 is installed in the inner wall of the second pipe 5, and the second pipe 5 has a through hole for the connecting pipe 7 to extend out.

[0033] The device further includes a delivery lumen 6 , wherein a large channel C is opened inside the delivery lumen 6 , and the delivery lumen 6 is sleeved on the second pipe 5 .

[0034] The balloon 2 in this device is a soft structure; the filter 4 is made of a medical polymer film that can filter out thrombus and calcified masses that fall off during the aortic valve balloon expansion process. The material film is a porous film with a pore size that allows normal blood cells to pass through but can block thrombus and calcified masses that fall off during the aortic valve balloon expansion process.

[0035] A method of using the device is characterized by:

[0036] Step 1: The "C"-shaped balloon 2, which is not filled with contrast agent, is rolled up. The balloon 2, together with the filter 4 fixedly connected to the upper end of the balloon 2 and the two leaflets 3 symmetrically fixedly connected to the lower end of the balloon 2, is wrapped around and tightly attached to the side wall of the second tube 5. The second tube 5 and the wrapped balloon 2 are then placed in the channel C of the delivery lumen 6.

[0037] Step 2: The guide wire is inserted into the patient's body through one femoral artery or other vascular access route. After reaching the designated position along the aorta, the delivery lumen 6 is connected to the guide wire via the second tube 5 and is pulled to the designated position by the guide wire. When the delivery lumen 6 reaches the designated position, the second tube 5 is extended to partially place the balloon 2 in the patient's ascending aorta.

[0038] Step 3: inserting an aortic valve dilation balloon into the patient's body through the other femoral artery or other vascular access route and reaching above the diseased aortic valve. The aortic valve dilation balloon is a balloon device used to dilate the stenotic aortic valve during an interventional valve procedure.

[0039] In step 4, after the balloon 2 reaches the designated position, the balloon 2 is filled through the first pipe 1 and the connecting tube 7 for connecting the first pipe 1 and the balloon 2. The originally deflated balloon 2 is injected with contrast agent through the first pipe and expands into a "C" shape due to the filling of contrast agent. Due to the "C"-shaped structure and the soft structure of the balloon 2 itself, either end of the balloon 2 can be bent into the inner side of the other end. The balloon 2 will adapt to the diameter of the aorta more accurately. At the same time, due to the non-uniform diameter of the aorta, it can adapt to the change of the aortic diameter in real time during the operation, and will not scratch the aortic wall, causing damage to the aortic wall and causing serious complications such as aortic rupture. At the same time, the filter 4 connected to the balloon 2 is also expanded due to its flexible structure. The inner side of the filter 4 is tightly attached to the outer wall of the second tube 5, and the opening of the filter 4 is opened to enter the operation; the double-leaflet structure leaflet 3 connected to the balloon 2 is also correspondingly expanded, and the inner side of the two leaflets 3 is tightly attached to the outer wall of the second tube 5, and enters a temporary working state during the operation; at this time, due to the C-type balloon structure, the valve and filter of this device wrap the delivery system of the distal end of the aortic valve expansion balloon from the outside. When the aortic valve balloon is filled with contrast agent injected in vitro, the calcified tissue on the patient's autologous valve partially loosens and falls off, passes through the valve of this device into the interior of the filter 4 and is blocked by the filter 4 in the filter, thereby preventing the calcified tissue from flowing into the brain and other organs and causing organ embolism events such as cerebral infarction. At the same time, since the aortic valve expansion balloon rapidly removes contrast agent from the body after inflation, thereby restoring forward blood flow through the aortic valve, this operation can also cause severe damage to the aortic valve, resulting in aortic regurgitation. The valve of this device can prevent blood from flowing back from the aortic arch and descending aorta into the left ventricle, avoiding circulatory collapse caused by increased left ventricular blood stasis and volume load, a serious cardiovascular complication.

[0040] Step 5, after the aortic valve expansion balloon is withdrawn from the body to the outside of the body, the interventional aortic valve delivery system can pass through the guide wire of the original aortic valve expansion balloon in parallel and through the embracing structure formed by the valve and filter of this device and reach the position of the patient's native aortic valve, and release the implanted interventional valve according to the interventional valve related procedures. Due to the "C"-shaped structure of balloon 2, the above process can better correspond to the diameter changes of the delivery system of the interventional valve, interventional balloon and other devices, so that the same temporary valve filter structure can adapt to the diameter changes of different interventional delivery devices during the operation, and always tightly close the ascending aorta, thereby ensuring that the valve and filter of this device are tightly fitted with the ascending aorta and the interventional valve and balloon delivery system;

[0041] Step 6. After the operation, the interventional valve delivery system is evacuated, and the contrast agent inside the balloon 2 is extracted through the first tube 1 to restore the balloon 2 to a deflated state. The balloon 2 is then received into the delivery lumen 6 through the second tube 5 and pulled out of the patient's body by the guide wire. Finally, the guide wire is removed and the wound is treated accordingly.

[0042] The above are merely preferred embodiments of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions based on the principles of the present invention are within the scope of protection of the present invention. It should be noted that for those skilled in the art, various improvements and modifications that do not depart from the principles of the present invention should be considered within the scope of protection of the present invention.

Claims

1. A temporary integrated valve and aortic filter device, characterized in that: The invention comprises a first pipe (1), a balloon (2), a valve, and a filter (4). The interior of the first pipe (1) is a channel A for conveying a contrast agent. The balloon (2) is in a "C" shape and has a hollow interior. Either end of the balloon (2) can be bent into the inner side of the other end. The first pipe (1) is in communication with the balloon (2) and is arranged perpendicular to the "C"-shaped plane of the balloon (2). The filter (4) is in a conical bag shape. The bag has a single opening structure. The lower end of the cone is an open circular bag opening. The top of the cone is a closed bag structure. The half circumference edge of the opening of the filter (4) is aligned with the upper end surface of the balloon (2). The valve is fixedly connected, and the opening of the filter (4) is located on the inner side of the "C"-shaped balloon (2); the valve comprises two leaflets (3), the leaflets (3) are bag-shaped, and the half-circumference edge of the opening of one leaflet (3) is fixedly connected to 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); the half-circumference edge of the opening of the other leaflet (3) is symmetrically fixed with the leaflet (3) on the right side from the middle to the left end of the lower end surface of the balloon (2), forming a double-leaf structure, and the openings of the two leaflets (3) are located on the inner side of the "C"-shaped balloon (2); The first conduit (1) is connected to the balloon (2) via a connecting tube (7), and the connecting tube (7) is radially arranged with respect to the "C"-shaped balloon (2) and is located inside the "C"-shaped balloon (2); The connecting tube (7) is located in the middle of the balloon (2); The second pipe (5) is provided with a channel B for the guide wire to pass through; the first pipe (1) is installed in the inner wall of the second pipe (5), and the second pipe (5) is provided with a through hole for the connecting pipe (7) to extend out.

2. A temporary valve and aortic filter integrated device according to claim 1, characterized in that: It also 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 pipe (5).

3. A temporary valve and aortic filter integrated device according to claim 2, characterized in that: The balloon (2) is a soft structure.

4. A temporary valve and aortic filter integrated device according to claim 2 or 3, characterized in that: The filter (4) is a flexible structure.

5. A temporary valve and aortic filter integrated device according to claim 4, characterized in that: The filter (4) uses a medical polymer material film that can filter thrombus and calcified masses that fall off during the aortic valve balloon expansion process. The material film is a porous film with a pore size that allows normal blood cells to pass through but can block thrombus and calcified masses that fall off during the aortic valve balloon expansion process.

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