Heart valve balloon dilatation catheter

Abstract

The invention provides a heart valve balloon dilatation catheter which is applied to the technical field of medical instruments and comprises a balloon, a protection net, a supporting net, an inner tube, an outer tube, a connecting structure and a head end structure. The protection net wraps the outer surface of the balloon, supporting legs are arranged on the protection net, the supporting net fixedly surrounds the outer surface of the protection net through the supporting legs, and a target interval is formed between the supporting net and the protection net; the first end of the balloon is fixedly connected with the head end structure, the second end of the balloon is fixedly connected with the first end of the outer tube, the second end of the outer tube is fixedly connected with the connecting structure, the inner tube extends and penetrates through the interior of the balloon, the first end of the inner tube is connected with the head end structure, the second end of the inner tube is fixedly connected with the connecting structure, and the outer tube wraps the outer surface of the inner tube. In the heart valve balloon dilatation catheter, the target interval can provide a blood flowing space, so that blood can smoothly pass through, the risks of ventricular fibrillation and sudden cardiac arrest are reduced, and the safety of cardiac surgery can be improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a heart valve balloon dilatation catheter. Background Art

[0002] In recent years, aortic valve stenosis has become one of the most common valvular heart diseases in clinical practice. For severe aortic valve stenosis, surgical valve replacement has always been the standard treatment option. With the development of transcatheter valve technology, more and more patients are beginning to undergo less invasive transcatheter aortic valve replacement (TAVR). Currently, transcatheter aortic valve replacement can be divided into balloon-expandable interventional valves and self-expanding (self-inflating) interventional valves according to their opening method. The balloon-expandable interventional valve is first mechanically compressed on the delivery system in vitro, and then delivered to the predetermined position, it is expanded and fixed using a high-pressure non-compliant balloon.

[0003] Existing heart valve balloon dilatation catheters cannot allow blood to flow smoothly when the balloon is fully inflated, causing the balloon dilatation process to completely block the left ventricular outflow tract. For patients with low cardiac reserve, this can lead to serious complications such as ventricular fibrillation and cardiac arrest. In addition, a stable pulse pressure level cannot be maintained during the operation, so the safety is relatively low. Summary of the invention

[0004] The embodiment of the present application provides a heart valve balloon dilatation catheter to solve the problem of low safety of existing heart valve balloon dilatation catheters.

[0005] In order to solve the above technical problems, this application is implemented as follows:

[0006] In a first aspect, an embodiment of the present application provides a heart valve balloon dilatation catheter, the heart valve balloon dilatation catheter comprising: a balloon, a protection net, a support net, an inner tube, an outer tube, a connection structure and a head end structure;

[0007] The protective net is wrapped around the outer surface of the balloon, and the protective net is provided with legs, and the supporting net is fixedly surrounded by the outer surface of the protective net through the legs, and a target interval is formed between the supporting net and the protective net;

[0008] The first end of the balloon is fixedly connected to the head end structure, the second end of the balloon is fixedly connected to the first end of the outer tube, the second end of the outer tube is fixedly connected to the connecting structure, the inner tube extends through the interior of the balloon, the first end of the inner tube is connected to the head end structure, the second end of the inner tube is fixedly connected to the connecting structure, and the outer tube is covered on the outer surface of the inner tube.

[0009] Optionally, the balloon includes a cylindrical part, a first conical part and a second conical part, the protective net is wrapped around the outer surface of the cylindrical part, the first conical part is fixedly connected to the head end structure, the protective net extends to the first conical part through a first wire column structure and is fixedly connected to the head end structure, the second conical part is fixedly connected to the first end of the outer tube, the protective net extends to the second conical part through a second wire column structure and is fixedly connected to the first end of the outer tube.

[0010] Optionally, the inner tube is provided with two developing rings formed by forging, and the two developing rings are used to mark the effective length of the balloon.

[0011] Optionally, the connection structure includes a stress dispersion tube and a connection seat, the second end of the inner tube is fixedly connected to the connection seat, the stress dispersion tube is coated on the outer surface of the outer tube, and the stress dispersion tube is fixedly connected to the connection seat.

[0012] Optionally, a guidewire cavity and a filling cavity are provided on the connecting seat, wherein the guidewire cavity is used to push the guidewire to the site of cardiac lesions, and the filling cavity is used to inject liquid into the balloon with a syringe to expand the balloon.

[0013] Optionally, the protection net is made of elastic alloy.

[0014] Optionally, the structure of the support net is a metal wire skeleton structure.

[0015] Optionally, the developing ring is made of platinum-iridium alloy.

[0016] Optionally, the outer tube is made of polyether block amide.

[0017] Optionally, the stress dispersion tube is made of silicone rubber.

[0018] The heart valve balloon dilatation catheter of the embodiment of the present application comprises: a balloon, a protective net, a support net, an inner tube, an outer tube, a connecting structure and a head end structure; the protective net is wrapped around the outer surface of the balloon, and the protective net is provided with legs, and the support net is fixedly surrounded by the outer surface of the protective net through the legs, and a target interval is formed between the support net and the protective net; the first end of the balloon is fixedly connected to the head end structure, the second end of the balloon is fixedly connected to the first end of the outer tube, the second end of the outer tube is fixedly connected to the connecting structure, the inner tube extends through the interior of the balloon, the first end of the inner tube is connected to the head end structure, the second end of the inner tube is fixedly connected to the connecting structure, and the outer tube is coated on the outer surface of the inner tube. In the heart valve balloon dilatation catheter, a protective net is wrapped around the outer surface of the balloon, and a target gap is formed between the supporting net and the protective net through the support legs on the protective net. The target gap can provide a space for blood flow, allowing blood to pass smoothly without blocking the left ventricular outflow tract, reducing the risk of ventricular fibrillation and cardiac arrest, thereby improving the safety of heart surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments of the present application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0020] Figure 1 It is one of the structural diagrams of the heart valve balloon dilatation catheter provided in the embodiment of the present application;

[0021] Figure 2 This is the second structural diagram of the heart valve balloon dilatation catheter provided in the embodiment of the present application;

[0022] Figure 3 This is the third structural diagram of the heart valve balloon dilatation catheter provided in the embodiment of the present application;

[0023] Figure 4 is a structural diagram of the support legs and the protective net provided in the embodiment of the present application;

[0024] Figure 5 It is a schematic diagram of the contraction of the heart valve balloon dilatation catheter provided in the embodiment of the present application;

[0025] Figure 6 This is the fourth structural diagram of the heart valve balloon dilatation catheter provided in the embodiment of the present application;

[0026] Figure 7 is a schematic diagram of a protection net provided in an embodiment of the present application;

[0027] Figure 8 It is an expanded view of the protection net provided in the embodiment of the present application. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0029] The present application embodiment provides a heart valve balloon dilatation catheter. Figures 1 to 4 , Figures 1 to 4 is a structural diagram of a heart valve balloon dilatation catheter provided in an embodiment of the present application, such as Figure 1 As shown, the heart valve balloon dilatation catheter comprises: a balloon 1, a protection net 2, a support net 3, an inner tube 4, an outer tube 5, a connection structure 6 and a head end structure 7;

[0030] The protection net 2 is wrapped around the outer surface of the balloon 1, and the protection net 2 is provided with legs 21, and the support net 3 is fixedly surrounded by the outer surface of the protection net 2 through the legs 21, and a target interval is formed between the support net 3 and the protection net 2;

[0031] The first end of the balloon 1 is fixedly connected to the head end structure 7, the second end of the balloon 1 is fixedly connected to the first end of the outer tube 5, the second end of the outer tube 5 is fixedly connected to the connecting structure 6, the inner tube 4 extends through the interior of the balloon 1, the first end of the inner tube 4 is connected to the head end structure 7, the second end of the inner tube 4 is fixedly connected to the connecting structure 6, and the outer tube 5 is covered on the outer surface of the inner tube 4.

[0032] In one embodiment, the balloon 1 is blown by a polymer material (such as nylon 12, etc.), so it has good elasticity and pressure resistance. The protective net 2 on the outer surface of the balloon 1 can provide a protective function for the balloon 1. The protective net 2 is provided with legs 21. The support net 3 is fixed and surrounded by the outer surface of the protective net 2 through the legs 21, and a target interval is formed between the support net 2 and the protective net 2. The target interval can provide a space for blood flow, so that blood can pass smoothly, reducing the risk of ventricular fibrillation and cardiac arrest. It should be noted that the design of the legs 21 is not limited to the two end edges of the protective net 2. It can be at any position of the protective net 2. The number of legs 21 is arbitrary, and it is only used to connect the support net 3. The legs 21 and the protective net 2 are an integrated structure, see Figure 5 When the protective net 2 shrinks along with the balloon 1 , the supporting legs 21 can also lie flat to shrink the supporting net 3 .

[0033] The first end of the balloon 1 and the head end structure 7 can be fixedly connected together by heat welding. The head end 7 is designed with a soft tip cone, which is convenient for the heart valve balloon dilatation catheter to pass through the blood vessels and heart valves smoothly, and can reduce damage to the tissue. The second end of the balloon 1 and the first end of the outer tube 5 can be fixedly connected together by heat welding. The second end of the outer tube 5 is fixedly connected to the connection structure 6. The connection structure 6 is used to connect the heart valve balloon dilatation catheter with external equipment to facilitate the expansion operation of the balloon. The inner tube 4 extends through the interior of the balloon 1. The first end of the inner tube 4 is connected to the head end structure 7. The second end of the inner tube 4 and the connection structure 6 can be fixedly connected by bonding. The outer tube 5 is coated on the outer surface of the inner tube 4. The main body of the inner tube 4 is composed of a three-layer structure, including an inner layer, a middle layer and an outer layer. The inner layer is smooth, which is convenient for the guide wire to pass through and the expansion of the balloon; the middle layer provides support and strength; the outer layer has a special material to improve the lubricity and anti-thrombotic properties of the heart valve balloon dilatation catheter.

[0034] In this embodiment, the protective net is wrapped around the outer surface of the balloon, and a target gap is formed between the supporting net and the protective net through the support feet on the protective net. The target gap can provide a space for blood flow, allowing blood to pass smoothly, reducing the risk of ventricular fibrillation and cardiac arrest, thereby improving the safety of heart surgery.

[0035] Alternatively, see Figure 6 The balloon 1 includes a cylindrical part 11, a first conical part 12 and a second conical part 13. The protective net 2 is wrapped on the outer surface of the cylindrical part 11. The first conical part 12 is fixedly connected to the head end structure 7. The protective net 2 extends to the first conical part 12 through a first wire column structure 22 and is fixedly connected to the head end structure 7. The second conical part 13 is fixedly connected to the first end of the outer tube 5. The protective net 2 extends to the second conical part 13 through a second wire column structure 23 and is fixedly connected to the first end of the outer tube 5.

[0036] In one embodiment, the protective net 2 extends toward both ends along the cylindrical portion 11 of the balloon 1, extends to the first conical portion 12 through a first wire column structure 22, and is fixedly connected to the head end structure 7 by heat welding, extends to the second conical portion 13 through a second wire column structure 23, and is fixedly connected to the first end of the outer tube 5 by heat welding. This embodiment can enhance the wrapping stability of the protective net on the balloon through the wire column structure.

[0037] Optionally, continue to see Figure 2 There are two developing rings 41 formed by forging on the inner tube 4, and the two developing rings 41 are used to mark the effective length of the balloon.

[0038] In one embodiment, two forged developing rings 41 are provided on the inner tube 4, and the material thereof is a platinum-iridium alloy, which is used to mark the effective length and position of the balloon. By accurately determining the position information of the balloon, the risk of unnecessary damage to the surrounding tissues during the operation can be reduced, thereby improving the safety of the operation.

[0039] Optionally, continue to see Figure 3 The connecting structure 6 includes a stress dispersion tube 61 and a connecting seat 62. The second end of the inner tube 4 is fixedly connected to the connecting seat 62. The stress dispersion tube 61 is covered on the outer surface of the outer tube 5. The stress dispersion tube 61 is fixedly connected to the connecting seat 62.

[0040] In one embodiment, the connection structure 6 includes a stress dispersion tube 61 and a connection seat 62. The stress dispersion tube helps to reduce the local stress concentration suffered by the balloon and catheter materials due to high pressure during the expansion process, thereby reducing the risk of material fatigue, tearing or damage, and ensuring the physical integrity of the device. The connection seat 62 is used to connect the heart valve balloon dilation catheter with external equipment to facilitate the expansion operation of the balloon 1.

[0041] Optionally, continue to see Figure 3 The connecting seat 62 is provided with a guidewire cavity 621 and a filling cavity 622. The guidewire cavity 621 is used to push the guidewire to the site of cardiac lesions, and the filling cavity 622 is used to inject liquid into the balloon 1 with a syringe to expand the balloon 1.

[0042] In one embodiment, two ports are provided on the connecting seat 62, namely a guidewire cavity 621 and a filling cavity 622. The guidewire cavity 621 is used to push the guidewire to the site of the cardiac lesion. The syringe injects liquid into the balloon 1 through the filling cavity 622 to expand the balloon 1, thereby driving the protection net 2 and the support net 3 to expand, thereby completing the operation.

[0043] Optionally, the protection net is made of elastic alloy.

[0044] In one embodiment, see Figure 7 The protective net covering the outer layer of the balloon is cut and processed. The material is a mesh elastic alloy with good elasticity and biocompatibility, such as nickel-titanium material. In addition, this structure can meet the requirements of balloon filling, expansion and contraction, while giving the balloon a certain degree of protection. Figure 8 , the protective net is spread out flat, and the shape of a single grid is rectangular. When the balloon is in a folded state, the protective net can be tightened as the balloon shrinks; when the balloon is filled and expanded, the protective net also becomes larger. In addition, the shape of a single grid of the protective net can also be triangular or circular.

[0045] Optionally, the structure of the support net is a metal wire skeleton structure.

[0046] In one embodiment, the structure of the support mesh is a metal wire skeleton structure, such as cobalt-chromium alloy. The metal wire skeleton structure has good support and biocompatibility, is non-toxic to human tissue and does not induce immune response or allergy, which is beneficial to the safety of patients.

[0047] Optionally, the developing ring is made of platinum-iridium alloy.

[0048] In one embodiment, the material of the developing ring is a platinum-iridium alloy. Both platinum and iridium are precious metals with excellent biocompatibility, non-toxic to human tissues, and will not induce immune reactions or allergies, which is beneficial to the safety of patients. In addition, the platinum-iridium alloy has very good radiographic properties and can be clearly seen under X-ray fluoroscopy. This enables doctors to accurately observe and locate the position of the catheter, ensuring the accuracy of the surgical process.

[0049] Optionally, the outer tube is made of polyether block amide.

[0050] In one embodiment, the outer tube is made of polyether block amide, which has a smooth surface and low friction properties, which helps the catheter to be smoothly inserted and withdrawn from the blood vessel and reduces friction damage to the inner wall.

[0051] Optionally, the stress dispersion tube is made of silicone rubber.

[0052] In one embodiment, the stress dispersing tube is made of silicone rubber, which is soft and elastic and can effectively absorb and disperse mechanical stress, thereby reducing potential damage to the balloon and connection area caused by pressure concentration. This is critical to preventing damage to the device during insertion and operation.

[0053] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0054] Through the description of the above implementation methods, those skilled in the art can clearly understand that the above-mentioned embodiment methods can be implemented by means of software plus a necessary general hardware platform, and of course by hardware, but in many cases the former is a better implementation method. Based on such an understanding, the technical solution of the present application, or the part that contributes to the prior art, can be embodied in the form of a software product, which is stored in a storage medium (such as ROM / RAM, a magnetic disk, or an optical disk), and includes a number of instructions for a terminal (which can be a mobile phone, a computer, a server, an air conditioner, or a network device, etc.) to execute the methods described in each embodiment of the present application.

[0055] The embodiments of the present application are described above in conjunction with the accompanying drawings, but the present application is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present application, ordinary technicians in this field can also make many forms without departing from the purpose of the present application and the scope of protection of the claims, all of which are within the protection of the present application.

Claims

1. A heart valve balloon dilatation catheter, characterized in that: The heart valve balloon dilatation catheter comprises: a balloon, a protection net, a support net, an inner tube, an outer tube, a connection structure and a head end structure; The protective net is wrapped around the outer surface of the balloon, and the protective net is provided with legs, and the supporting net is fixedly surrounded by the outer surface of the protective net through the legs, and a target interval is formed between the supporting net and the protective net; The first end of the balloon is fixedly connected to the head end structure, the second end of the balloon is fixedly connected to the first end of the outer tube, the second end of the outer tube is fixedly connected to the connecting structure, the inner tube extends through the interior of the balloon, the first end of the inner tube is connected to the head end structure, the second end of the inner tube is fixedly connected to the connecting structure, and the outer tube is covered on the outer surface of the inner tube.

2. The heart valve balloon dilatation catheter according to claim 1, characterized in that: The balloon includes a cylindrical part, a first conical part and a second conical part, the protective net is wrapped around the outer surface of the cylindrical part, the first conical part is fixedly connected to the head end structure, the protective net extends to the first conical part through a first wire column structure and is fixedly connected to the head end structure, the second conical part is fixedly connected to the first end of the outer tube, the protective net extends to the second conical part through a second wire column structure and is fixedly connected to the first end of the outer tube.

3. The heart valve balloon dilatation catheter according to claim 1, characterized in that: The inner tube is provided with two developing rings formed by forging, and the two developing rings are used to mark the effective length of the balloon.

4. The heart valve balloon dilatation catheter according to claim 1, characterized in that: The connection structure includes a stress dispersion tube and a connection seat, the second end of the inner tube is fixedly connected to the connection seat, the stress dispersion tube is covered on the outer surface of the outer tube, and the second end of the outer tube is fixedly connected to the connection seat.

5. The heart valve balloon dilatation catheter according to claim 4, characterized in that: The connecting seat is provided with a guidewire cavity and a filling cavity. The guidewire cavity is used to push the guidewire to the site of cardiac lesions, and the filling cavity is used to inject liquid into the balloon with a syringe to expand the balloon.

6. The heart valve balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: The material of the protection net is elastic alloy.

7. The heart valve balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: The structure of the supporting net is a metal wire skeleton structure.

8. The heart valve balloon dilatation catheter according to claim 3, characterized in that: The material of the developing ring is platinum-iridium alloy.

9. The heart valve balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: The material of the outer tube is polyether block amide.

10. The heart valve balloon dilatation catheter according to claim 4, characterized in that: The material of the stress dispersion tube is silicone rubber.

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