Heart valve balloon dilation catheter

Abstract

The application provides a heart valve balloon dilatation catheter applied to the technical field of medical devices, which comprises a balloon, a protection net, a support net, an inner tube, an outer tube, a connecting structure and a head end structure; the protection net is wrapped on the outer surface of the balloon, the protection net is provided with a supporting leg, the support net is fixedly surrounded on the outer surface of the protection net through the supporting leg, and a target interval is formed between the support 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 through the inside 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 is wrapped on the outer surface of the inner tube.In the heart valve balloon dilatation catheter, the target interval can provide a blood flow space, so that the blood can flow smoothly, the risk of ventricular fibrillation and cardiac arrest is reduced, and therefore the safety of heart surgery can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a heart valve balloon dilation catheter. Background Technology

[0002] In recent years, aortic stenosis has become one of the most common valvular heart diseases in clinical practice. For severe aortic stenosis, surgical valve replacement has traditionally been the standard treatment. However, with the development of transcatheter valve technology, more and more patients are beginning to undergo the less invasive transcatheter aortic valve replacement (TAVR). Currently, TAVR can be categorized based on its opening method into balloon-dilatation TAVR and self-dilatation (self-expansion) TAVR. In balloon-dilatation TAVR, the valve is first mechanically compressed onto the delivery system outside the body, then delivered to the predetermined position, and finally inflated and fixed using a high-pressure, non-compliant balloon.

[0003] Existing heart valve balloon dilation catheters, when the balloon is fully inflated, cannot allow blood to flow smoothly, resulting in complete blockage of the left ventricular outflow tract during the balloon dilation process. This can lead to serious complications such as ventricular fibrillation and cardiac arrest in patients with low cardiac reserve. Furthermore, they cannot maintain a stable pulse pressure level during the procedure, thus having low safety. Summary of the Invention

[0004] This application provides a cardiac valve balloon dilation catheter to address the issue of low safety in existing cardiac valve balloon dilation catheters.

[0005] To solve the above-mentioned technical problems, this application is implemented as follows:

[0006] In a first aspect, embodiments of this application provide a cardiac valve balloon dilation catheter, which includes: a balloon, a protective net, a support net, an inner tube, an outer tube, a connecting structure, and a tip structure;

[0007] The protective net is wrapped around the outer surface of the balloon, and the protective net is provided with legs. The supporting net is fixed around the outer surface of the protective net by the legs and forms a target interval with 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 covers the outer surface of the inner tube.

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

[0010] Optionally, the inner tube has two forged radiopaque rings, which are used to indicate the effective length of the balloon.

[0011] Optionally, the connection structure includes a stress-dispersing tube and a connecting seat, the second end of the inner tube is fixedly connected to the connecting seat, the stress-dispersing tube covers the outer surface of the outer tube, and the stress-dispersing tube is fixedly connected to the connecting seat.

[0012] Optionally, the connector is provided with a guidewire lumen and an inflation lumen. The guidewire lumen is used to push the guidewire to the site of cardiac lesion, and the inflation lumen is used for injecting liquid into the balloon with a syringe to inflate the balloon.

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

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

[0015] Optionally, the developing ring is made of a 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 cardiac valve balloon dilation catheter of this application includes: a balloon, a protective net, a support net, an inner tube, an outer tube, a connecting structure, and a tip structure; the protective net wraps around the outer surface of the balloon, and the protective net is provided with legs; the support net is fixedly surrounded by the outer surface of the protective net by the legs, and a target interval is formed between the support net and the protective net; a first end of the balloon is fixedly connected to the tip structure, a second end of the balloon is fixedly connected to the first end of the outer tube, a second end of the outer tube is fixedly connected to the connecting structure, the inner tube extends through the interior of the balloon, a first end of the inner tube is connected to the tip structure, a second end of the inner tube is fixedly connected to the connecting structure, and the outer tube covers the outer surface of the inner tube. In this heart valve balloon dilation catheter, a protective net is wrapped around the outer surface of the balloon. A target gap is formed between the support net and the protective net by the legs on the protective net. This target gap provides 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. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is one of the structural diagrams of the cardiac valve balloon dilation catheter provided in the embodiments of this application;

[0021] Figure 2 This is the second structural diagram of the cardiac valve balloon dilation catheter provided in the embodiments of this application;

[0022] Figure 3 This is the third structural diagram of the cardiac valve balloon dilation catheter provided in the embodiments of this application;

[0023] Figure 4 This is a structural diagram of the support legs and protective netting provided in the embodiments of this application;

[0024] Figure 5 This is a schematic diagram of the contraction of the cardiac valve balloon dilation catheter provided in the embodiments of this application;

[0025] Figure 6 This is the fourth structural diagram of the cardiac valve balloon dilation catheter provided in the embodiments of this application;

[0026] Figure 7 This is a schematic diagram of the protection network provided in an embodiment of this application;

[0027] Figure 8 This is an unfolded diagram of the protection net provided in the embodiments of this application. Detailed Implementation

[0028] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0029] This application provides a cardiac valve balloon dilation catheter. See also... Figures 1 to 4 , Figures 1 to 4 This is a structural diagram of the cardiac valve balloon dilation catheter provided in the embodiments of this application, as shown below. Figure 1 As shown, the heart valve balloon dilation catheter includes: balloon 1, protective net 2, support net 3, inner tube 4, outer tube 5, connecting structure 6, and tip structure 7;

[0030] The protective net 2 is wrapped around the outer surface of the balloon 1. The protective net 2 is provided with a support leg 21. The support net 3 is fixedly surrounded by the outer surface of the protective net 2 through the support leg 21, and a target interval is formed between the support net 3 and the protective 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 covers the outer surface of the inner tube 4.

[0032] In one embodiment, the balloon 1 is blown from a polymer material (such as nylon 12), thus possessing good elasticity and pressure resistance. A protective net 2 on the outer surface of the balloon 1 provides protection. Support legs 21 are provided on the protective net 2, and a support net 3 is fixedly surrounded by the support legs 21, forming a target gap between them. This target gap provides space for blood flow, allowing blood to pass smoothly and reducing the risk of ventricular fibrillation and cardiac arrest. It should be noted that the design of the support legs 21 is not limited to the two ends of the protective net 2; they can be located at any position on the protective net 2, and the number of support legs 21 is arbitrary, serving only to connect the support net 3. The support legs 21 and the protective net 2 are an integral structure, see [reference needed]. Figure 5 As the protective net 2 contracts with the balloon 1, the support leg 21 can also lie flat to contract the support net 3.

[0033] The first end of balloon 1 can be fixedly connected to the tip structure 7 by heat welding. The tip 7 adopts a soft, tapered design to facilitate the smooth passage of the heart valve balloon dilation catheter through blood vessels and heart valves, reducing tissue damage. The second end of balloon 1 can be fixedly connected to the first end of the outer tube 5 by heat welding. The second end of the outer tube 5 is fixedly connected to the connecting structure 6, which is used to connect the heart valve balloon dilation catheter to external devices, facilitating balloon dilation. The inner tube 4 extends through the interior of balloon 1. The first end of the inner tube 4 is connected to the tip structure 7, and the second end of the inner tube 4 is fixedly connected to the connecting structure 6 by adhesive bonding. The outer tube 5 covers the outer surface of the inner tube 4. The main body of the inner tube 4 consists of a three-layer structure, including an inner layer, a middle layer, and an outer layer. The inner layer is smooth, facilitating guidewire passage and balloon dilation; the middle layer provides support and strength; and the outer layer has a special material to improve the lubrication and antithrombotic properties of the heart valve balloon dilation catheter.

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

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

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

[0037] Optionally, see [link to relevant documentation] Figure 2 The inner tube 4 has two forged imaging rings 41, which are used to mark the effective length of the balloon.

[0038] In one embodiment, the inner tube 4 has two forged imaging rings 41 made of platinum-iridium alloy, which are used to mark the effective length and position of the balloon. By accurately determining the position of the balloon, the risk of unnecessary damage to surrounding tissues during the operation can be reduced, thus improving the safety of the procedure.

[0039] Optionally, see [link to relevant documentation] Figure 3 The connection 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 covers the outer surface of the outer tube 5 and is fixedly connected to the connecting seat 62.

[0040] In one embodiment, the connecting structure 6 includes a stress-dispersing tube 61 and a connecting seat 62. The stress-dispersing tube helps reduce localized stress concentration in the balloon and catheter materials during expansion due to high pressure, thereby reducing the risk of material fatigue, tearing, or breakage and ensuring the physical integrity of the device. The connecting seat 62 is used to connect the cardiac valve balloon dilation catheter to external devices, facilitating the expansion operation of the balloon 1.

[0041] Optionally, see [link to relevant documentation] Figure 3 The connecting seat 62 is provided with a guidewire cavity 621 and an inflation cavity 622. The guidewire cavity 621 is used to push the guidewire to the site of cardiac lesion, and the inflation cavity 622 is used for injecting liquid into the balloon 1 with a syringe to inflate the balloon 1.

[0042] In one embodiment, the connector 62 is provided with two ports, namely a guidewire cavity 621 and an inflation cavity 622. The guidewire cavity 621 is used to push the guidewire to the heart lesion site. The syringe injects liquid into the balloon 1 through the inflation cavity 622, causing the balloon 1 to expand, which in turn causes the protective net 2 and the support net 3 to expand, thereby completing the operation.

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

[0044] In one implementation, see Figure 7 The protective mesh covering the outer layer of the balloon is cut and made of a mesh-like elastic alloy, possessing good elasticity and biocompatibility, such as nickel-titanium. Furthermore, this structure can meet the requirements of balloon inflation and deflation while providing a certain degree of protection for the balloon. See also Figure 8 The protective net is laid flat, with each grid cell being rectangular. When the balloon is folded, the net tightens as the balloon shrinks; when the balloon inflates, the net expands accordingly. Alternatively, the individual grid cells can also be triangular or circular, among other shapes.

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

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

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

[0048] In one embodiment, the imaging ring is made of a platinum-iridium alloy. Both platinum and iridium are precious metals with excellent biocompatibility, are non-toxic to human tissues, and do not trigger immune responses or allergies, thus benefiting patient safety. Furthermore, the platinum-iridium alloy has excellent radiographic properties, making it clearly visible under X-ray fluoroscopy. This allows doctors to accurately observe and locate the catheter, ensuring precision during the procedure.

[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, facilitating smooth insertion and withdrawal of the catheter in the blood vessel and reducing frictional 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. Silicone rubber is soft and elastic, effectively absorbing and dispersing mechanical stress, thereby reducing the potential damage to the balloon and connection area caused by pressure concentration. This is crucial for preventing damage to the device during insertion and operation.

[0053] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0054] Through the above description of the embodiments, those skilled in the art can clearly understand that the methods of the above embodiments can be implemented by means of software plus necessary general-purpose hardware platforms. Of course, they can also be implemented by hardware, but in many cases the former is a better implementation method. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk) and includes several instructions to cause a terminal (which may be a mobile phone, computer, server, air conditioner, or network device, etc.) to execute the methods described in the various embodiments of this application.

[0055] The embodiments of this application have been described above with reference to the accompanying drawings. However, this application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of this application.

Claims

1. A cardiac valve balloon dilation catheter, characterized in that, The heart valve balloon dilation catheter includes: a balloon, a protective net, a support net, an inner tube, an outer tube, a connecting structure, and a tip structure; The protective net is wrapped around the outer surface of the balloon, and the protective net is provided with legs. The support net is fixed around the outer surface of the protective net by the legs and forms a target interval with the protective net. The target interval is used to adapt to the blood flow requirements of the left ventricular outflow tract. 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 covers the outer surface of the inner tube.

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

3. The cardiac valve balloon dilation catheter according to claim 1, characterized in that, The inner tube has two forged imaging rings, which are used to indicate the effective length of the balloon.

4. The cardiac valve balloon dilation catheter according to claim 1, characterized in that, The connection structure includes a stress-dispersing tube and a connecting seat. The second end of the inner tube is fixedly connected to the connecting seat. The stress-dispersing tube covers the outer surface of the outer tube, and the second end of the outer tube is fixedly connected to the connecting seat.

5. The cardiac valve balloon dilation catheter according to claim 4, characterized in that, The connector is provided with a guidewire lumen and an inflation lumen. The guidewire lumen is used to push the guidewire to the site of cardiac lesion, and the inflation lumen is used for injecting liquid into the balloon with a syringe to inflate the balloon.

6. The cardiac valve balloon dilation catheter according to any one of claims 1 to 5, characterized in that, The protective net is made of an elastic alloy.

7. The cardiac valve balloon dilation catheter according to any one of claims 1 to 5, characterized in that, The support mesh has a metal wire skeleton structure.

8. The cardiac valve balloon dilation catheter according to claim 3, characterized in that, The developing ring is made of platinum-iridium alloy.

9. The cardiac valve balloon dilation catheter according to any one of claims 1 to 5, characterized in that, The outer tube is made of polyether block amide.

10. The cardiac valve balloon dilation catheter according to claim 4, characterized in that, The stress dispersion tube is made of silicone rubber.

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