CN-121971784-A - Medicine-carrying balloon catheter for treating pulmonary artery stenosis caused by aortic inflammation

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 aortic arch, which comprises a handle, a plurality of triangular wires and a plurality of balloon wires, wherein one end of the handle is fixedly connected with one end of a proximal rod, the other end of the proximal rod is fixedly connected with one end of a distal rod, the other end of the distal rod is fixedly connected with a balloon, the balloon is divided into a round table shape and a cylindrical shape, the medicine coating is arranged on the outer surface of the balloon and used for carrying therapeutic medicines, and the triangular wires are arranged on the outer side wall of the balloon along the length direction of the balloon. The invention effectively dilates the pulmonary artery stenosis by the balloon dilation and the micro-cutting action of the triangular wire, simultaneously releases anti-inflammatory and antiproliferative drugs in a targeted way, inhibits inflammatory reaction and intimal hyperplasia of blood vessels, reduces the restenosis occurrence rate, and has the advantages of high safety, strong adaptability, obvious treatment effect and the like.

Inventors

• JING ZHICHENG
• JIANG XIN
• ZHANG CAOJIN
• ZHOU YUPING
• ZHU XIJIE
• LI XIANMEI
• LIAN TIANYU
• WANG LITING

Assignees

• 广东省人民医院

Dates

Publication Date

20260505

Application Date

20260327

Claims (10)

1. 1. A drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic inflammation, comprising: the device comprises a handle (6), wherein one end of the handle (6) is fixedly connected with one end of a proximal rod (8), the other end of the proximal rod (8) is fixedly connected with one end of a distal rod (7), and the other end of the distal rod (7) is fixedly connected with a balloon (1); a drug coating (3) arranged outside the balloon (1), wherein the drug coating (3) is used for carrying therapeutic drugs; The triangular wires (4) are arranged on the outer side wall of the balloon (1) along the length direction of the balloon.
2. 2. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 1, wherein two ends of the balloon (1) are of conical structures, the middle of the balloon (1) is of a cylindrical or truncated cone-shaped structure, and the diameter of the distal end of the truncated cone-shaped structure is smaller than that of the proximal end.
3. 3. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 2, wherein the diameter of the balloon (1) is 1.0mm-10.0mm, the length of the balloon (1) is 10mm-50mm, and the difference between the upper and lower bottom diameters of the truncated cone-shaped structure is 0.5mm-1.5mm.
4. 4. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 1, wherein the cross section of the triangular wire (4) is isosceles triangle or equilateral triangle, the length of the base of the triangular wire (4) is 0.2mm-0.6mm, and the height of the triangular wire (4) is 0.2mm-0.8mm.
5. 5. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 1, wherein the triangle wire (4) is made of a high polymer material, and comprises one or more of polyamide, polyethylene or polyurethane.
6. 6. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 1, wherein the number of the triangular wires (4) is 2-6.
7. 7. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch inflammation according to claim 1, wherein the drug coating (3) comprises an antiproliferative drug and an anti-inflammatory drug, wherein the antiproliferative drug comprises one or more of paclitaxel, a paclitaxel derivative, rapamycin and a rapamycin derivative, and the anti-inflammatory drug comprises one or more of prednisone, methotrexate, tofacitinib and Wu Pa tenib.
8. 8. A drug-loaded balloon catheter for treating pulmonary stenosis caused by aortic inflammation according to claim 1, wherein the distal shaft (7) is a two-channel tube, the two-channel tube is a guide wire cavity (2) and a liquid passing cavity (5) respectively, the guide wire cavity (2) is used for guiding the catheter to travel through the guide wire, and the liquid passing cavity (5) is used for conveying liquid to fill the balloon (1).
9. 9. A drug-loaded balloon catheter for treating pulmonary stenosis caused by aortic inflammation according to claim 1 wherein the balloon (1) is a low compliance balloon and the balloon (1) diameter increases by no more than 1% per one atmosphere of inflation and expansion.
10. 10. The drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch according to claim 1, wherein the proximal shaft (8) is a stainless steel single lumen tube or a double lumen tube made of high polymer material.

Description

Medicine-carrying balloon catheter for treating pulmonary artery stenosis caused by aortic inflammation Technical Field The invention belongs to the technical field of minimally invasive interventional medical instruments, and particularly relates to a medicine-carrying balloon catheter for treating pulmonary artery stenosis caused by aortic arch. Background Tab Arteritis (TA) is a chronic inflammatory disease, well developed in young women, and is characterized by granulomatous total arteritis of the aorta and its major branches, the pulmonary arteries. The inflammatory process initially causes thickening of the arterial wall, which in turn may cause lumen stenosis, occlusion, dilation or aneurysm formation. Despite the global distribution of aortic inflammation, the incidence in asia and north african populations is higher than in european or north american populations. Pulmonary arteritis is a subtype of arteritis characterized by pulmonary arterial involvement and pulmonary arterial hypertension (PH), which can lead to right heart failure and premature death. It is reported that 14% -86% of patients with aortic inflammation have pulmonary artery involvement, which behaves like chronic thromboembolic pulmonary arterial hypertension (CTEPH) and is often combined with systemic arterial involvement, and recent guidelines of european cardiology have classified the aortic inflammation-associated pulmonary arterial hypertension (TA-PH) as PH class 4 (CTEPH and other pulmonary obstructive diseases). However, specific therapeutic recommendations for TA-PH are not mentioned in the guidelines. In our recently published national registration study, TA-PH patients were female-based with severely impaired hemodynamics, with survival rates of 94.0%, 83.2% and 77.2% for 1 year, 3 years and 5 years, respectively, inferior to global arteritis patients. In recent years, percutaneous Transluminal Pulmonary Angioplasty (PTPA) has become an important therapeutic option for selective CTEPH patients who are not suitable for pulmonary endarterectomy. The intervention treatment experience of PTPA for TA-PH patients is found in a series of sample cases, and the intervention technology reported in the study shows that the blood dynamics improvement effect is considerable, but the restenosis rate is high and reaches about 30% because the vascular intima is seriously thickened and the simple balloon dilation only temporarily relieves stenosis and can not inhibit smooth muscle proliferation and pulmonary artery wall small vessel hyperplasia, inflammatory reaction and vascular injury repair. There are many drug balloon catheters on the market which are applied to coronary arteries and peripheral arteries, and the clinical effect is better than that of a simple balloon. There are also drug balloon surfaces coated with wire for the purpose of cutting plaque in vascular stenosis, such as CN202122201798.4 a drug-loaded balloon dilation catheter using nitinol wire. However, the existing drug balloon catheter is not specially designed for the characteristics of pulmonary arteries, compared with coronary arteries and other peripheral arteries, the pressure of the pulmonary arteries is small, the wall of a blood vessel is thin, the thicknesses of a medium membrane and an inner membrane are also thin, and the gradient change of the diameter of the arteries is large. The metal wire is too hard, so that the damage to the vascular wall is easily caused, and the conventional cylindrical balloon is also easy to cause the over-expansion of the distal end of the blood vessel, so that the tearing damage to the blood vessel is caused. Therefore, there is a need for a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic inflammation, which solves the above-mentioned problems. Disclosure of Invention The invention aims to provide a drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch, so as to solve the problems in the prior art. In order to achieve the aim, the invention provides the following scheme that the drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic inflammation comprises the following components: The device comprises a handle, a proximal rod, a distal rod and a balloon, wherein one end of the proximal rod is fixedly connected with one end of the proximal rod, the other end of the proximal rod is fixedly connected with one end of the distal rod, and the other end of the distal rod is fixedly connected with the balloon; A drug coating disposed outside the balloon, the drug coating for carrying a therapeutic drug; the triangular wires are arranged on the outer side wall of the balloon along the length direction of the balloon. According to the drug-loaded balloon catheter for treating pulmonary artery stenosis caused by aortic arch, two ends of the balloon are of conical structures, the middle of the balloon is of a cylindrical or truncated con