Drug-loaded balloon catheter for treating pulmonary artery stenosis caused by takayasu arteritis

Abstract

The invention belongs to the technical field of minimally invasive interventional medical instruments, and discloses a medicine-carrying balloon catheter for treating pulmonary artery stenosis caused by takayasteritis, which comprises a handle, one end of the handle is fixedly connected with one end of a near-end rod, the other end of the near-end rod is fixedly connected with one end of a far-end rod, the other end of the far-end rod is fixedly connected with a balloon, and the balloon is fixedly connected with a catheter. The balloon is divided into a circular truncated cone shape and a cylindrical shape; the drug coating is arranged on the outer surface of the balloon, and the drug coating is used for carrying treatment drugs; the triangular wires are arranged on the outer side wall of the balloon in the length direction of the balloon. Through balloon dilatation and the micro-cutting effect of the triangular wire, the pulmonary artery stenosis part is effectively dilated, meanwhile, anti-inflammatory and anti-proliferation drugs are released in a targeted mode, inflammatory response and vascular intimal hyperplasia are inhibited, the restenosis occurrence rate is reduced, and the balloon dilatation triangular wire has the advantages of being high in safety and adaptability, remarkable in treatment effect and the like.

Description

Technical Field

[0001] This invention belongs to the field of minimally invasive interventional medical device technology, and in particular relates to a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis. Background Technology

[0002] Takayasu arteritis (TA) is a chronic inflammatory disease that commonly affects young women and is characterized by granulomatous panarteritis of the aorta and its major branches, as well as the pulmonary artery. The inflammatory process initially leads to thickening of the arterial wall, which can then result in stenosis, occlusion, dilation, or aneurysm formation. Although Takayasu arteritis is distributed globally, its incidence is higher in Asian and North African populations than in European or North American populations.

[0003] Pulmonary artery type Takayasu arteritis is a subtype of Takayasu arteritis characterized by pulmonary artery involvement and pulmonary hypertension (PH), which can lead to right heart failure and premature death. It has been reported that 14%–86% of Takayasu arteritis patients have pulmonary artery involvement, presenting similarly to chronic thromboembolic pulmonary hypertension (CTEPH), and often with concurrent systemic artery involvement. The latest European Society of Cardiology guidelines have classified Takayasu arteritis-associated pulmonary hypertension (TA-PH) as a category 4 PH (CTEPH and other pulmonary artery obstructive diseases). However, the guidelines do not mention specific treatment recommendations for TA-PH. In our recently published national registry study, TA-PH patients were predominantly female and had severely impaired hemodynamics; their 1-year, 3-year, and 5-year survival rates were 94.0%, 83.2%, and 77.2%, respectively, which were inferior to those of patients with Takayasu arteritis as a whole.

[0004] In recent years, percutaneous pulmonary artery angioplasty (PTPA) has become an important treatment option for selective CTEPH patients who are not suitable for pulmonary endarterectomy. There is also experience with PTPA in interventional treatment of TA-PH patients reported in a case series study. The interventional technique reported in these studies showed significant hemodynamic improvement; however, due to severe intimal thickening, simple balloon dilation only temporarily relieves the stenosis and cannot inhibit smooth muscle proliferation, pulmonary artery wall microvascular proliferation, inflammatory response, and vascular injury repair, resulting in a high restenosis rate of approximately 30%.

[0005] There are already many drug-eluting balloon catheters on the market for use in coronary and peripheral arteries, achieving better clinical results than simple balloons. Some also have metal wires coated on the surface of the drug-eluting balloon to cut plaque at the site of vascular stenosis; for example, CN202122201798.4 describes a high-performance drug-eluting balloon dilation catheter using nickel-titanium wires.

[0006] However, existing drug-eluting balloon catheters are not specifically designed for the characteristics of the pulmonary artery. Compared to the coronary arteries and other peripheral arteries, the pulmonary artery has lower pressure, a thinner vessel wall, and thinner media and intima, resulting in a greater gradient in arterial diameter. Metal wires are too rigid and can easily damage the vessel wall, and conventional cylindrical balloons can also easily cause excessive dilation of the distal portion of the vessel, leading to vascular tears.

[0007] Therefore, there is an urgent need for a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis to solve the above problems. Summary of the Invention

[0008] The purpose of this invention is to provide a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis, thereby solving the problems existing in the prior art.

[0009] To achieve the above objectives, the present invention provides the following solution: The present invention provides a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis, comprising: A handle, one end of which is fixedly connected to one end of a proximal rod, the other end of which is fixedly connected to one end of a distal rod, and the other end of which is fixedly connected to a balloon; A drug coating is disposed on the outer side of the balloon, the drug coating being used to carry therapeutic drugs; Multiple triangular wires are arranged on the outer wall of the balloon along the length of the balloon.

[0010] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the two ends of the balloon are conical structures, the middle of the balloon is a cylindrical or frustum-shaped structure, and the distal diameter of the frustum-shaped structure is smaller than the proximal diameter.

[0011] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the diameter of the balloon is 1.0 mm-10.0 mm, the length of the balloon is 10 mm-50 mm, and the difference in diameter between the upper and lower bases of the frustum-shaped structure is 0.5 mm-1.5 mm.

[0012] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the cross-sectional shape of the triangular wire is an isosceles triangle or an equilateral triangle, the base length of the triangular wire is 0.2mm-0.6mm, and the height of the triangular wire is 0.2mm-0.8mm.

[0013] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the material of the triangular wire is a polymer material, including one or more of polyamide, polyethylene, or polyurethane.

[0014] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the number of triangular wires is 2-6.

[0015] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the drug coating comprises an antiproliferative drug and an anti-inflammatory drug, wherein the antiproliferative drug comprises one or more of paclitaxel, paclitaxel derivatives, rapamycin and rapamycin derivatives, and the anti-inflammatory drug comprises one or more of prednisone, methotrexate, tofabutin, and utpatinib.

[0016] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the distal rod is a dual-channel tube, the dual channels being a guidewire lumen and a fluid infusion lumen, the guidewire lumen being used to guide the catheter through the guidewire, and the fluid infusion lumen being used to deliver fluid to inflate the balloon.

[0017] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the balloon is a low-compliance balloon, and the balloon diameter increases by no more than 1% for every increase of one atmosphere during inflation.

[0018] According to the present invention, a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis is provided, wherein the proximal rod is a stainless steel single-lumen tube or a polymer material double-lumen tube.

[0019] Compared with the prior art, the present invention has the following advantages and technical effects: This invention provides a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis. The combination of the balloon and triangular wire achieves safe dilation and cutting of the proliferative tissue at the stenotic site, avoiding excessive balloon compliance, the use of a large-diameter balloon during pressure dilation, and damage to the vessel wall from overly rigid metal wires. The drug coating on the balloon contains not only anti-proliferative drugs but also anti-inflammatory drugs. During balloon dilation, the drugs are released in a targeted manner, inhibiting inflammation and endothelial cell proliferation, preventing restenosis, and achieving better therapeutic effects. This invention effectively dilates the stenotic site of the pulmonary artery through balloon dilation and the micro-cutting action of the triangular wire, while simultaneously releasing anti-inflammatory and anti-proliferative drugs in a targeted manner, inhibiting the inflammatory response and vascular intimal hyperplasia, reducing the incidence of restenosis, and has the advantages of high safety, strong adaptability, and significant therapeutic effect. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the first morphological structure of the balloon of the present invention; Figure 3 This is a schematic diagram of the second structural form of the balloon of the present invention; Figure 4 This is a schematic diagram of the cross-section of the balloon of the present invention; The components are: 1. Balloon; 2. Guidewire lumen; 3. Drug-coated tube; 4. Triangular wire; 5. Fluid inlet; 6. Handle; 7. Distal rod; 8. Proximal rod. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0024] Reference Figures 1-4 This invention provides a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis, comprising: Handle 6, one end of which is fixedly connected to one end of proximal rod 8, the other end of proximal rod 8 is fixedly connected to one end of distal rod 7, and the other end of distal rod 7 is fixedly connected to balloon 1; Drug coating 3 is disposed on the outside of balloon 1. Drug coating 3 is used to carry therapeutic drugs. Multiple triangular wires 4 are set on the outer wall of the balloon 1 along the length of the balloon.

[0025] In one embodiment of the present invention, a drug coating is provided on the outer side of the balloon 1, enabling simultaneous interventional treatment and targeted drug delivery. When the balloon expands at the stenosis, the drug comes into close contact with the blood vessel wall and is released rapidly, allowing it to act on the diseased tissue at a high concentration while reducing the side effects of systemic medication and significantly improving the local treatment effect. Triangular wires 4, evenly distributed along the length of the balloon on the outer wall, constitute a micro-cutting structure. During balloon expansion, the edges of the triangular wires 4 create controllable longitudinal cuts or scratches on the proliferating intima or plaque, directionally releasing circumferential stress, thereby achieving effective expansion with lower pressure, reducing diffuse damage to the blood vessel wall, and preventing balloon slippage.

[0026] As an optional implementation, the two ends of the balloon 1 are conical structures, and the middle of the balloon 1 is a cylindrical or frustum-shaped structure, with the distal diameter of the frustum-shaped structure being smaller than the proximal diameter.

[0027] In one embodiment of the present invention, the balloon 1 is tapered at both ends to reduce the risk of vascular tearing. The cylindrical shape in the middle provides uniform radial support; the frustum shape (the distal diameter is smaller than the proximal diameter) better matches the anatomical characteristics of the pulmonary artery, which gradually thickens from distal to proximal, avoiding damage to the distal vessel due to excessive balloon expansion, and achieving a gradient expansion that is more in line with physiological structure.

[0028] As an optional implementation, the diameter of the balloon 1 is 1.0mm-10.0mm, the length of the balloon 1 is 10mm-50mm, and the difference in diameter between the upper and lower bases of the frustum-shaped structure is 0.5mm-1.5mm.

[0029] In one embodiment of the invention, the wide range of balloon diameter and length design allows it to cover various types of pulmonary artery stenosis lesions, from distal small branches to the proximal main trunk. The 0.5mm-1.5mm diameter difference of the frustum shape accurately simulates the natural gradient contour of the pulmonary artery, making the expansion process smoother and safer, and effectively preventing tears in the distal region.

[0030] As an optional implementation, the cross-sectional shape of the triangular wire 4 is an isosceles triangle or an equilateral triangle, the base length of the triangular wire 4 is 0.2mm-0.6mm, and the height of the triangular wire 4 is 0.2mm-0.8mm.

[0031] In one embodiment of the present invention, the length and height of the base of the triangular wire are defined to ensure that the wire has sufficient structural rigidity to achieve effective micro-cutting, while maintaining flexibility to avoid being too stiff and puncturing the blood vessel wall. This size design balances cutting efficiency and safety, and is particularly suitable for the thin-walled and brittle pulmonary artery. Specifically, each of the provided triangular wires 4 is arranged along the length of the balloon 1, and the two ends of the triangular wire 4 are connected to the two ends of the balloon 1, respectively.

[0032] As an optional implementation, the material of the triangular wire 4 is a polymer material, including one or more of polyamide, polyethylene or polyurethane.

[0033] In one embodiment of the present invention, polymeric materials such as polyamide, polyethylene, or polyurethane are used to replace traditional metal wires, significantly reducing the risk of mechanical damage to the blood vessel wall. These polymeric materials possess excellent flexibility and biocompatibility, allowing them to conform to the balloon's shape during expansion, and have an extremely low risk of breakage in vivo, greatly improving the safety of the procedure.

[0034] As an optional implementation, the number of triangular wires 4 is 2-6.

[0035] In one embodiment of the present invention, 2-6 triangular wires 4 are provided, which can form sufficient and uniform cutting points on the surface of the balloon 1.

[0036] As an optional implementation, the drug coating 3 includes an antiproliferative drug and an anti-inflammatory drug. The antiproliferative drug includes one or more of paclitaxel, paclitaxel derivatives, rapamycin, and rapamycin derivatives, and the anti-inflammatory drug includes one or more of prednisone, methotrexate, tofabutin, and utpatinib.

[0037] In one embodiment of the present invention, the drug coating 3 simultaneously comprises an anti-proliferative drug and an anti-inflammatory drug. The anti-inflammatory drug inhibits the inflammatory response of the blood vessel wall, controlling the condition at its source; the anti-proliferative drug inhibits excessive proliferation of smooth muscle cells, preventing restenosis. The synergistic effect of the two significantly improves the long-term vascular patency rate.

[0038] As an optional implementation, the distal rod 7 is a dual-channel tube, which consists of a guidewire lumen 2 and a fluid inlet lumen 5. The guidewire lumen 2 is used to guide the catheter through the guidewire, and the fluid inlet lumen 5 is used to deliver fluid to inflate the balloon 1.

[0039] In one embodiment of the present invention, the distal rod 7 adopts a dual-channel design with independent guidewire cavity 2 and fluid passage cavity 5, achieving functional separation and optimization. Guidewire cavity 2 ensures smooth guidewire passage and rapid exchange; independent fluid passage cavity 5 can quickly and uniformly inflate the balloon, avoiding the drawbacks of mutual interference between the two in a single-lumen design, and improving operational efficiency and safety.

[0040] As an alternative implementation, balloon 1 is a low-compliance balloon, and the diameter of balloon 1 increases by no more than 1% for every increase of one atmosphere during inflation.

[0041] In one embodiment of the present invention, a low-compliance balloon is used, with a diameter increase of ≤1% per atm, resulting in minimal diameter change during high-pressure inflation and strong dimensional controllability. This ensures precise inflation to the target diameter and avoids damage to adjacent healthy blood vessels due to over-inflation of the balloon, making it particularly suitable for the treatment of pulmonary artery stenosis requiring precise quantitative dilation.

[0042] As an alternative implementation, the proximal rod 8 is a stainless steel single-lumen tube or a polymer double-lumen tube.

[0043] In one embodiment of the present invention, the proximal rod 8 offers two options: a stainless steel single-lumen tube provides stronger pushing force and torque transmission, suitable for lesions requiring a more tortuous path; a polymer double-lumen tube offers better flexibility and can simultaneously achieve guidewire passage and fluid delivery, simplifying the catheter structure. This design improves the catheter's adaptability to different lesion complexities and operator habits.

[0044] This invention addresses the characteristics of the pulmonary artery by employing a combination of a low-compliance balloon, a frustum-shaped balloon, and a high-polymer triangular wire. This combination allows for safe dilation and cutting of hyperplasia at the site of vascular stenosis, avoiding the problems of excessive balloon compliance, large-diameter balloons during pressure dilation, and damage to the vessel wall from overly rigid metal wires. The triangular wire is bonded and fixed to the balloon surface, which is superior to conventional methods that fix it at both ends, reducing the risk of movement, uneven wire distribution, and detachment. For pulmonary artery stenosis caused by aortitis, the drug coating on the balloon contains not only anti-proliferative drugs but also anti-inflammatory drugs including prednisone, methotrexate, tofabutic acid, and utpatinib. During balloon dilation, the drugs are released in a targeted manner, inhibiting inflammation and endothelial cell proliferation, preventing restenosis, and achieving better therapeutic effects.

[0045] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0046] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis, characterized in that, include: Handle (6), one end of which is fixedly connected to one end of a proximal rod (8), the other end of which is fixedly connected to one end of a distal rod (7), and the other end of which is fixedly connected to a balloon (1). A drug coating (3) is disposed on the outside of the balloon (1), the drug coating (3) being used to carry therapeutic drugs; Multiple triangular wires (4) are arranged on the outer wall of the balloon (1) along the length of the balloon.

2. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The balloon (1) has conical structures at both ends and a cylindrical or frustum-shaped structure in the middle, with the distal diameter of the frustum-shaped structure being smaller than the proximal diameter.

3. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 2, characterized in that: The diameter of the balloon (1) is 1.0mm-10.0mm, the length of the balloon (1) is 10mm-50mm, and the difference in diameter between the upper and lower bases of the frustum-shaped structure is 0.5mm-1.5mm.

4. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The cross-sectional shape of the triangular wire (4) is an isosceles triangle or an equilateral triangle, the base length of the triangular wire (4) is 0.2mm-0.6mm, and the height of the triangular wire (4) is 0.2mm-0.8mm.

5. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The material of the triangular wire (4) is a polymer material, including one or more of polyamide, polyethylene or polyurethane.

6. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The number of the triangular wires (4) is 2-6.

7. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The drug coating (3) includes antiproliferative drugs and anti-inflammatory drugs. The antiproliferative drugs include one or more of paclitaxel, paclitaxel derivatives, rapamycin and rapamycin derivatives. The anti-inflammatory drugs include one or more of prednisone, methotrexate, tofabutin and utpatinib.

8. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The distal rod (7) is a dual-channel tube, which is a guidewire lumen (2) and a fluid inlet lumen (5). The guidewire lumen (2) is used to guide the catheter through the guidewire, and the fluid inlet lumen (5) is used to deliver liquid to inflate the balloon (1).

9. A drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortitis according to claim 1, characterized in that: The balloon (1) is a low-compliance balloon, and the diameter of the balloon (1) increases by no more than 1% for every additional atmosphere of pressure during inflation.

10. A drug-loaded balloon catheter for treating pulmonary artery stenosis caused by Takayasu arteritis according to claim 1, characterized in that: The proximal rod (8) is a stainless steel single-lumen tube or a polymer material double-lumen tube.

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