Plugging device for aortic dissection crevasse repair
By designing a sealing device including stents, barbs, airbags and coating, the problem of poor fit and internal leakage in the repair of aortic dissection rupture is solved, and higher fit and long-term stability are achieved.
Patent Information
- Application Number
- CN202411868847.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-18
- Publication Date
- 2025-03-28
AI Technical Summary
When used, the traditional sealing device used for repairing aortic dissection rupture, the fit between the coated stent and the blood vessel wall is difficult to ensure, resulting in poor fit and internal leakage.
A sealing device including a bracket, a barb, an airbag and a coating is designed. Barbs are installed at both ends of the bracket, and the outer wall of the barbs are bioactive coating; the airbag is symmetrically arranged on the auxiliary bracket, and there are micropores and self-closing valves in the airbag; there is a drug-eluting coating on the surface of the coating. Through the expansion of the airbag and the automatic closing of the self-closing valve, the edge of the bracket is tightly squeezed against the blood vessel wall, improving fit and promoting endothelialization through micropores.
It effectively improves the fit and long-term stability of the sealing device and the blood vessel wall, reduces the risk of internal leakage, and enhances the binding force between the blood vessel wall and the sealing device through endothelialization, solving the problems of poor fitting and internal leakage in traditional devices.
Smart Images
Figure CN119700228A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a blocking device for repairing aortic dissection rupture. Background Art
[0002] The aorta, as the core large blood vessel of the human circulatory system, undertakes the key task of transporting blood rich in oxygen and nutrients pumped by the heart to various organs and tissues throughout the body. Aortic dissection is caused by the tearing of the aortic intima under the influence of certain pathological factors (such as hypertension, atherosclerosis, etc.), which allows blood to rush into the aortic media and expand longitudinally along the media, forming a pathological state of true and false cavities. If this disease is not treated promptly and effectively, the dissection may continue to expand, eventually leading to aortic rupture and massive bleeding, or due to the existence of dissection, the blood supply to important branch blood vessels is affected, resulting in ischemia and hypoxia of important organs such as the heart, brain, and kidneys, triggering a series of serious complications, and seriously threatening the patient's life, health, and quality of life.
[0003] At present, there are two main ways to repair aortic dissection: surgical operation and interventional treatment. Interventional treatment is a relatively minimally invasive treatment method that has gradually developed in recent years. It mainly involves puncturing peripheral blood vessels (such as the femoral artery) to deliver special occlusion devices to the aortic dissection rupture through intravascular routes, and then releasing the occlusion device to seal the rupture and prevent blood from continuing to flow into the dissection.
[0004] Traditional occluding devices used to repair aortic dissection ruptures have difficulty ensuring the fit between the covered stent and the blood vessel wall during use, which may result in poor fit and lead to internal leakage. Summary of the invention
[0005] In view of the deficiencies in the prior art, the present invention provides a closure device for repairing aortic dissection rupture, which solves the problem that the conventional closure device for repairing aortic dissection rupture is difficult to ensure the fit between the coated stent and the blood vessel wall during use, resulting in poor fit and thus internal leakage.
[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions: a closure device for repairing aortic dissection rupture, comprising a stent, both ends of the stent are evenly fixedly installed with barbs, the outer walls of the barbs are provided with a bioactive coating, the outer wall of the stent is symmetrically fixedly connected with an auxiliary stent, one side of the auxiliary stent is provided with a developing marking line, the outer wall of the auxiliary stent is symmetrically provided with an airbag, the outer wall of the airbag is evenly provided with micropores, one side of the airbag is installed with a self-closing valve, the outer wall of the stent is provided with a coating, and the surface of the coating is provided with a drug eluting coating.
[0007] Preferably, the thickness of the airbag is 0.1 mm-0.5 mm, and the material of the airbag is a polymer film material, and the polymer film material includes polyurethane and silicone rubber.
[0008] Preferably, the micropores are circular or elliptical in shape, have a diameter of 1 μm-10 μm, and are in a passivated state at their edges.
[0009] Preferably, both ends of the stent are in a trumpet shape, and the diameter of the stent after expansion is 10%-20% larger than the diameter of the normal section of the aorta. The stent, auxiliary stent, and barb are all made of cobalt-chromium alloy or nickel-titanium alloy. The length of the barb is 2-5 mm, and the barb forms an angle of 30-60 degrees with the aortic vessel wall.
[0010] Preferably, the component of the bioactive coating is vascular endothelial growth factor, and the vascular endothelial growth factor includes VEGF-A and VEGF-B.
[0011] A closure method for repairing aortic dissection rupture, comprising the following steps:
[0012] S1. Rupture confirmation: The data of the aortic dissection rupture are measured by angiography, including the rupture location, size, shape, relationship with surrounding vascular branches, and diameter, length, and curvature of the aorta;
[0013] S2. Puncture and delivery: The patient is anesthetized and then the blood vessel is punctured. A guide wire is inserted through the puncture needle, and the dilatation sheath is inserted along the guide wire. The catheter loaded with the occlusion device is pushed into the blood vessel along the guide wire and observed through X-ray fluoroscopic images. When the occlusion device is located at the rupture, the position and angle of the catheter are adjusted so that the rupture is located in the middle of the stent between the two development marking lines.
[0014] S3, stent release: then withdraw the outer sheath of the catheter to release the occlusion device;
[0015] S4. Inflation fixation: The contrast agent is then injected into the airbag through the self-closing valve using a contrast agent injector and a microcatheter. The microcatheter, catheter and guide wire are then withdrawn in sequence to complete the occlusion.
[0016] Preferably, in step S2, the pushing speed along the guide wire into the blood vessel is 1-2 mm / s.
[0017] Preferably, in step S4, the contrast agent is injected into the airbag at an injection speed of 0.1-0.2 ml / s, and the pressure of the airbag is 2-5 atmospheres.
[0018] Working principle: When in use, the device is delivered to the rupture of aortic dissection through a catheter, and the device is released, and then deployed at a predetermined position through the stent, and the trumpet shape at both ends is used to better fit the aortic wall. At the same time, through the interaction between the barbs and the aortic wall, and forming an angle of 30-60 degrees with the aortic vessel wall, the barbs will pierce into the subintima of the aortic wall under the action of their own elasticity and the impact of blood flow, thereby firmly fixing the stent on the vessel wall, and at the same time, the rupture of aortic dissection is blocked by covering the film to prevent blood from flowing into the dissection, and then the contrast agent injection machine and the microcatheter are used to inject the aortic dissection. Contrast agent is injected into the balloon through a self-sealing valve. When the pressure inside the balloon reaches 2-5 atmospheres, the balloon will expand and squeeze the edge of the stent tightly against the blood vessel wall, further improving the fit between the occluding device and the blood vessel wall. At the same time, the self-sealing valve will automatically close to prevent leakage of contrast agent, and then allow endothelial cell precursor cells to enter the balloon through the micropores to promote endothelialization, thereby improving the fit between the occluding device and the blood vessel wall. When endothelial cell precursor cells enter the micropores and begin to attach and proliferate on the inner surface of the balloon, they will gradually block the micropores to prevent leakage of contrast agent, thereby completing the occlusion.
[0019] The present invention provides a closure device for repairing aortic dissection rupture, which has the following beneficial effects:
[0020] 1. The present invention adopts a polyurethane or silicone rubber material with a thickness of 0.1-0.5mm, is provided with micropores with a diameter of 1-10μm and edge passivation, and has a self-sealing valve installed on one side. After the contrast agent or gas is injected to make the pressure reach 2-5 atmospheres, it expands, thereby tightly squeezing the edge of the stent against the blood vessel wall and reducing the risk of internal leakage. The micropores allow endothelial cell precursor cells to enter to promote endothelialization, and the self-sealing valve prevents leakage, thereby achieving improved fit and long-term stability between the occluding device and the blood vessel wall and reducing the incidence of internal leakage, thereby solving the problem of loose fit between the occluding device and the blood vessel wall and internal leakage.
[0021] 2. The present invention utilizes the good biocompatibility, mechanical strength and corrosion resistance of the stent, auxiliary stent and barbs, as well as the trumpet-shaped design at both ends of the stent and the expanded diameter is 10%-20% larger than the normal section of the aorta, so that it can accurately adapt to the aortic dissection rupture and provide stable supporting force, thereby achieving effective coverage of the rupture and preventing the displacement of the occluding device.
[0022] 3. The present invention adopts a design in which the barb forms an angle of 30-60 degrees with the aortic vessel wall and is 2-5 mm in length. When released, the barb can smoothly penetrate about 0.5-1 mm below the intima, and then promotes endothelial cell proliferation, migration and repair of vessel wall tissue with the help of the bioactive coating containing VEGF-A and VEGF-B on the outer wall of the barb, so that the barb and the vessel wall gradually merge, thereby further enhancing the fixation stability of the occlusion device and reducing complications caused by vessel wall damage, thereby solving the problem that traditional fixation methods are prone to cause vessel wall damage and lack of long-term stability. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 It is a schematic diagram of the support structure of the present invention;
[0024] Figure 2 for Figure 1 The enlarged schematic diagram at A in the middle;
[0025] Figure 3 for Figure 1 The enlarged schematic diagram of point B in the middle;
[0026] Figure 4 The present invention is a flowchart of a method for occluding aortic dissection repair.
[0027] Among them, 1. stent; 2. coating; 3. auxiliary stent; 4. developing marking line; 5. barb; 6. airbag; 7. micropore; 8. self-sealing valve; 9. bioactive coating. DETAILED DESCRIPTION
[0028] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0029] Example:
[0030] Please see attached Figure 1 -Attached Figure 3The embodiment of the present invention provides a closure device for repairing aortic dissection rupture, comprising a stent 1, barbs 5 are evenly fixedly installed at both ends of the stent 1, the outer wall of the barbs 5 is provided with a bioactive coating 9, the outer wall of the stent 1 is symmetrically fixedly connected with an auxiliary stent 3, one side of the auxiliary stent 3 is provided with a developing marking line 4, the outer wall of the auxiliary stent 3 is symmetrically provided with an airbag 6, the outer wall of the airbag 6 is evenly provided with micropores 7, one side of the airbag 6 is provided with a self-sealing valve 8, the outer wall of the stent 1 is provided with a coating 2, and the surface of the coating 2 is provided with a drug eluting coating; the thickness of the airbag 6 is 0.1mm-0.5mm, and the material of the airbag 6 is a polymer Film material, polymer film material includes polyurethane and silicone rubber; the shape of micropore 7 is circular or elliptical, the diameter of micropore 7 is 1μm-10μm, and the edge of micropore 7 is in a passivated state; the two ends of stent 1 are in a trumpet shape, and the diameter of stent 1 after unfolding is 10%-20% larger than the diameter of the normal section of the aorta; the material of stent 1, auxiliary stent 3 and barb 5 are all cobalt-chromium alloy or nickel-titanium alloy, the length of barb 5 is 2-5mm, and barb 5 forms an angle of 30-60 degrees with the aortic vessel wall; the component of bioactive coating 9 is vascular endothelial growth factor, and vascular endothelial growth factor includes VEGF-A and VEGF-B.
[0031] Specifically, the stent 1 is cast from cobalt-chromium alloy or nickel-titanium alloy, and has good biocompatibility, mechanical strength and corrosion resistance. Its two ends are designed to be trumpet-shaped. This unique shape design helps to better fit the shape of the aortic wall when released, and the diameter after expansion is 10%-20% larger than the diameter of the normal section of the aorta, which can effectively cover the rupture of the aortic dissection and prevent blood from continuing to flow into the dissection. When the diameter of the normal section of the aorta is 30 mm, the diameter of the stent 1 after expansion will be between 33-36 mm, ensuring sufficient coverage and support.
[0032] Barbs 5 are evenly fixedly installed at both ends of the stent 1. The length of the barbs 5 is 2-5 mm, and they form an angle of 30-60 degrees with the aortic wall. During the operation, when the stent 1 is pushed to the rupture of the aortic dissection and released, the barbs 5 will penetrate into the subintima of the aortic wall at a suitable angle under the action of their own elasticity and the impact force of blood flow, and the depth is about 0.5-1 mm, thereby firmly fixing the stent 1 on the blood vessel wall and effectively preventing the occlusion device from shifting due to blood flow impact.
[0033] By setting the bioactive coating 9, after the occluding device is implanted in the human body, the vascular endothelial growth factor in the bioactive coating 9 will be gradually released and play a role. VEGF-A can strongly stimulate the proliferation, migration and lumen formation of vascular endothelial cells, prompting endothelial cells to gather around the barbs 5 and begin to repair the vascular wall tissue, so that the barbs 5 gradually merge with the vascular wall, further enhancing the fixation stability of the occluding device, and VEGF-B plays an important role in maintaining the survival and function of vascular endothelial cells, helping to maintain the integrity and normal physiological function of the vascular wall, and reducing complications caused by vascular wall damage, such as thrombosis and vascular stenosis.
[0034] The auxiliary support 3 is symmetrically fixed to the outer wall of the support 1 to strengthen the support and stabilize the structure of the support 1. The position and outline of the auxiliary support 3 can be clearly displayed under X-ray fluoroscopy through the developing marking line 4, thereby determining the position and direction of the entire occluding device, which is crucial for doctors to accurately place the occluding device at the rupture of aortic dissection during surgery. During interventional surgery, doctors can observe the position of the developing marking line 4 in real time through X-ray fluoroscopy equipment, and accurately adjust the pushing direction and depth of the occluding device so that the occluding device can accurately cover the rupture, and the error can be controlled within 1-2mm.
[0035] The airbag 6 is symmetrically arranged on the outer wall of the auxiliary stent 3, and its thickness is 0.1mm-0.5mm. The material is a polymer film material polyurethane or silicone rubber. This material has excellent flexibility and biocompatibility, can adapt to the bending and dynamic changes of the aorta, and will not cause adverse stimulation to the blood vessel wall. The outer wall of the airbag 6 is evenly provided with micropores 7. The shape of the micropores 7 is circular or elliptical, the diameter is 1μm-10μm, and the edges are in a passivated state, so as to allow endothelial cell precursor cells to enter the airbag 6 to promote endothelial , improving the fit between the occluding device and the blood vessel wall, but it has a certain barrier property for contrast agent molecules in a short period of time (such as when the balloon 6 is inflated and plays a fixing role). In addition, during the expansion process of the balloon 6, the internal pressure will make the outer wall of the balloon 6 close to the edge of the stent 1 and the blood vessel wall. This close fit will reduce the possibility of contrast agent leakage from the micropores 7. When endothelial cell precursor cells enter the micropores 7 and begin to attach and proliferate on the inner surface of the balloon 6, they will gradually block the micropores 7, further preventing contrast agent leakage.
[0036] After the occluding device is released, contrast agent is injected into the balloon 6 through the microcatheter. When the pressure in the balloon 6 reaches 2-5 atmospheres, the balloon 6 will expand and squeeze the edge of the stent 1 tightly against the blood vessel wall, further improving the fit between the occluding device and the blood vessel wall and reducing the risk of internal leakage. The self-sealing valve 8 installed on one side of the balloon 6 remains open during the injection process. When the pressure in the balloon 6 reaches the set value, the self-sealing valve 8 will automatically close to prevent leakage of the contrast agent, ensuring that the balloon 6 can continue to maintain an expanded state and stably support the occluding device, thereby solving the problem of traditional occluding devices used for repairing aortic dissection ruptures. During use, it is difficult to ensure the fit between the coated stent and the blood vessel wall, and poor fit will occur, leading to internal leakage.
[0037] A coating 2 is provided on the outer wall of the stent 1. The coating 2 is made of a polymer material with good biocompatibility and can effectively block the rupture of the aortic dissection and prevent blood from flowing into the dissection. A drug eluting coating is provided on the surface of the coating 2. The coating contains antiplatelet aggregation drugs such as aspirin derivatives and smooth muscle cell proliferation inhibitors such as rapamycin derivatives. After the occluding device is implanted, the drugs will be slowly released from the coating. In the early postoperative period, the antiplatelet aggregation drugs can inhibit platelet aggregation, prevent thrombus formation on the surface of the occluding device, and reduce the risk of acute vascular occlusion. As time goes by, the smooth muscle cell proliferation inhibitor begins to take effect, which can effectively prevent the excessive proliferation of vascular smooth muscle cells, prevent restenosis of the blood vessels, and ensure the long-term patency of the aorta.
[0038] Please see attached Figure 4 A method for occluding aortic dissection rupture repair comprises the following steps:
[0039] S1. Confirmation of the rupture: The data of the aortic dissection rupture are measured by angiography, including the location, size, shape, relationship with the surrounding vascular branches, and the diameter, length, and curvature of the aorta;
[0040] S2, puncture and delivery: the patient is anesthetized, and then the blood vessel is punctured, a guide wire is inserted through the puncture needle, and the dilatation sheath is inserted along the guide wire, and the catheter loaded with the occlusion device is pushed into the blood vessel along the guide wire, and the X-ray fluoroscopic image is observed. When the occlusion device is located at the rupture, the position and angle of the catheter are adjusted so that the rupture is located in the middle of the stent 1 between the two development marking lines 4;
[0041] S3, stent release: then withdraw the outer sheath of the catheter to release the occlusion device;
[0042] S4, inflation and fixation: The contrast agent is then injected into the airbag 6 through the self-closing valve 8 by means of a contrast agent injector and a microcatheter, and then the microcatheter, the catheter and the guide wire are withdrawn in sequence to complete the occlusion.
[0043] In step S2, the pushing speed along the guide wire into the blood vessel is 1-2 mm / s.
[0044] In step S4, the contrast agent is injected into the airbag 6 at an injection speed of 0.1-0.2 ml / s, and the pressure of the airbag 6 is 2-5 atmospheres.
[0045] Specifically, the data of aortic dissection rupture is measured by angiography to obtain detailed information of the aortic dissection rupture, including the precise position of the rupture in the three-dimensional space of the aorta (such as the distance from the aortic valve, the specific coordinates in the aortic arch or descending aorta, etc.), size (precise values of the major and minor diameters), shape (regular circle, ellipse or irregular shape and its specific characteristics), spatial relationship with surrounding vascular branches (such as the angle and distance with the coronary artery opening, brachiocephalic trunk branches, etc.), and the overall diameter range, length information and curvature changes of the aorta. Through the collection of these comprehensive and accurate data, key basis is provided for the subsequent selection of appropriate specifications of occlusion devices and the formulation of accurate surgical plans.
[0046] The patient is anesthetized and then a blood vessel puncture is performed. A guide wire is inserted through the puncture needle, and an expansion sheath is sent along the guide wire. The catheter loaded with the occluding device is pushed into the blood vessel along the guide wire and observed through X-ray fluoroscopic images. When the occluding device is located at the rupture, the position and angle of the catheter are adjusted so that the rupture is located in the middle of the stent 1 between the two developing marking lines 4, thereby establishing a channel to the rupture of the aortic dissection in a minimally invasive and safe manner, and the occluding device is accurately sent to the vicinity of the target position under the guidance of the image, thereby ensuring that the occluding device can accurately approach the rupture with minimal trauma, thereby improving the safety and effectiveness of the operation, and reducing damage to the patient's body and postoperative recovery time.
[0047] By withdrawing the outer sheath of the catheter, the occluding device is released, so that the stent 1 is deployed at a predetermined position and interacts with the aortic wall using its own structural characteristics (such as the barbs 5 at both ends), thereby achieving the initial fixation of the occluding device at the rupture of the aortic dissection, starting to play a occluding role and resisting blood flow impact, laying a foundation for further improving the fixation and occluding effects in the future.
[0048] By means of a contrast agent injector and a microcatheter, the contrast agent is injected into the airbag 6 through the self-sealing valve 8, and then the microcatheter, the catheter and the guide wire are withdrawn in sequence to complete the occlusion, so that the airbag 6 expands and fits tightly to the aortic wall, further optimizing the fit between the occluding device and the blood vessel wall. At the same time, the self-sealing valve 8 ensures that the pressure in the airbag 6 is stably maintained, and the relevant equipment is smoothly withdrawn after the inflation is completed, thereby improving the fixing effect of the occluding device, reducing the possibility of internal leakage, and ensuring the integrity and safety of the entire surgical operation process, thereby improving the success rate and long-term stability of aortic dissection repair, reducing the incidence of postoperative complications, and being beneficial to the patient's postoperative recovery and long-term prognosis.
[0049] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A closure device for repairing aortic dissection, comprising a stent (1), characterized in that: Barbs (5) are evenly and fixedly mounted on both ends of the stent (1), and the outer walls of the barbs (5) are provided with a bioactive coating (9). An auxiliary stent (3) is symmetrically and fixedly connected to the outer wall of the stent (1), and a developing marking line (4) is provided on one side of the auxiliary stent (3). An air bag (6) is symmetrically arranged on the outer wall of the auxiliary stent (3), and micropores (7) are evenly arranged on the outer wall of the air bag (6). A self-sealing valve (8) is installed on one side of the air bag (6). A coating (2) is provided on the outer wall of the stent (1), and a drug eluting coating is provided on the surface of the coating (2).
2. A closure device for repairing aortic dissection according to claim 1, characterized in that: The thickness of the airbag (6) is 0.1 mm-0.5 mm, and the material of the airbag (6) is a polymer film material, and the polymer film material includes polyurethane and silicone rubber.
3. The occluding device for repairing aortic dissection according to claim 1, characterized in that: The shape of the micropore (7) is circular or elliptical, the diameter of the micropore (7) is 1 μm-10 μm, and the edge of the micropore (7) is in a passivated state.
4. The occluding device for repairing aortic dissection according to claim 1, characterized in that: The two ends of the stent (1) are in a trumpet shape. The diameter of the stent (1) after expansion is 10%-20% larger than the diameter of the normal section of the aorta. The stent (1), the auxiliary stent (3) and the barb (5) are all made of cobalt-chromium alloy or nickel-titanium alloy. The length of the barb (5) is 2-5 mm, and the barb (5) forms an angle of 30-60 degrees with the aortic vessel wall.
5. The occluding device for repairing aortic dissection according to claim 1, characterized in that: The component of the bioactive coating (9) is vascular endothelial growth factor, and the vascular endothelial growth factor includes VEGF-A and VEGF-B.
6. A method for occluding aortic dissection rupture repair, characterized in that: A closure device for repairing aortic dissection according to any one of claims 1 to 5, comprising the following steps: S1. Rupture confirmation: The data of the aortic dissection rupture are measured by angiography, including the rupture location, size, shape, relationship with surrounding vascular branches, and diameter, length, and curvature of the aorta; S2. Puncture and delivery: The patient is anesthetized and then a blood vessel is punctured. A guide wire is inserted through the puncture needle, and an expansion sheath is inserted along the guide wire. A catheter loaded with the occluding device is pushed into the blood vessel along the guide wire, and an X-ray fluoroscopic image is observed. When the occluding device is located at the rupture, the position and angle of the catheter are adjusted so that the rupture is located in the middle of the stent (1) between the two imaging marking lines (4); S3, stent release: then withdraw the outer sheath of the catheter to release the occlusion device; S4, inflation fixation: The contrast agent is then injected into the airbag (6) through the self-sealing valve (8) using a contrast agent injection machine and a microcatheter, and then the microcatheter, catheter and guide wire are withdrawn in sequence to complete the occlusion.
7. A closure method for repairing aortic dissection according to claim 6, characterized in that: In step S2, the guide wire is pushed into the blood vessel at a speed of 1-2 mm / s.
8. A closure method for repairing aortic dissection according to claim 6, characterized in that: In step S4, the contrast agent is injected into the airbag (6) at an injection speed of 0.1-0.2 ml / s, and the pressure of the airbag (6) is 2-5 atmospheres.