Degradable drug coating coated balloon catheter and use method thereof

Abstract

The invention discloses a degradable drug coating film-covered balloon catheter and a using method thereof, and relates to the field of medical instruments, the degradable drug coating film-covered balloon catheter comprises a Y-shaped connecting valve, a guide catheter is arranged at the connecting end of the Y-shaped connecting valve, the degradable drug coating film-covered balloon catheter further comprises a double-cavity balloon catheter, and the double-cavity balloon catheter is movably installed on the inner side of the guide catheter and can extend to the outer side of the guide catheter; a guide wire cavity and an expansion cavity are formed in the inner side of the double-cavity balloon catheter; the guide wire is movably mounted on the inner side of a guide wire cavity formed in the double-cavity balloon catheter, and the guide wire can extend to the outer side of the double-cavity balloon catheter; according to the degradable drug coating film-covered balloon catheter and the using method thereof, a drug covering film is pasted to an opening, on the inner side of a blood vessel, of an aneurysm body through distraction of a balloon, the drug covering film can completely cover the crevasse, located on the inner side of the blood vessel, of the aneurysm body, so that blood flow in the coronary artery cannot enter the aneurysm body, and the balloon catheter is not prone to falling off. And blood in the tumor stops flowing to solidify thrombus formation, so that the tumor is hardened and does not grow any more.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a degradable drug-coated balloon catheter and a method for using the same. Background Art

[0002] Coronary artery aneurysm is a relatively rare type of cardiovascular disease, but it has potential fatal risks, including: thrombosis, massive bleeding caused by rupture of the aneurysm, and interruption of coronary blood flow caused by compression of the coronary artery by the aneurysm. At present, in the field of cardiovascular medicine, the treatment of coronary artery aneurysm can only be carried out by surgical resection;

[0003] Coronary artery perforation during coronary artery surgery is a serious complication that can lead to acute cardiac tamponade and death. Common causes include: guide wire perforation, rupture of blood vessels caused by occult calcification in the blood vessel, inappropriate balloon selection or excessive pressure during balloon dilation, and rupture of blood vessels caused by stent dilation;

[0004] The treatment methods in the prior art are as follows:

[0005] 1. A common pre-dilation balloon is placed at the coronary artery rupture and inflated to block the rupture. There is a certain probability that the rupture can be blocked;

[0006] However, the following problems exist: it is difficult to block the rupture when the rupture is large. If the blood vessel to be treated was originally unobstructed but only partially stenosed, then when using the balloon to block, the balloon blockage will cause blood interruption, leading to ischemic symptoms, heart failure or malignant arrhythmia. When using a through-balloon catheter for treatment, the model of the prepared through-balloon catheter may not match the size of the rupture of the ruptured blood vessel;

[0007] 2. After the common pre-dilation balloon successfully attempts to block the rupture and the rupture becomes smaller, but there is still blood outflow. At this time, a double-layer stent is often used for secondary blocking;

[0008] However, the following problems exist: the second-layer stent has the problem of difficult delivery, and it is difficult for the double-layer stent to endothelialize, and two antiplatelet drugs need to be used in combination for lifelong treatment;

[0009] 3. A covered stent is used, attached to block the rupture. However, the covered stent is expensive and has the problem of difficult endothelialization in the later stage. There have been literature reports that after using the commercially available covered stent products on the market to deal with this problem, the in-stent restenosis rate of patients has increased significantly within ten years, resulting in patients having to undergo coronary artery surgery again and facing the risks of heart failure, arrhythmia, and recurrent myocardial infarction;

[0010] A self-made covered stent is made by wrapping the outside of the stent with 3M infusion patch film around the middle section of the stent. However, the wrapping position, number of turns, and wrapping strength of the 3M infusion patch film completely depend on individual experience, and it is impossible to make a clear prognosis assessment of the future health status or disease development trend of the patient. It cannot be endothelialized and requires lifelong combined treatment with two antiplatelet drugs. Summary of the Invention

[0011] The purpose of the present invention is to provide a degradable drug-coated covered balloon catheter and its use method to solve the deficiency that it is difficult to stop bleeding at the rupture of the aneurysm located in the blood vessel position during coronary aneurysm surgery in the prior art.

[0012] To achieve the above purpose, the present invention provides the following technical solution: A degradable drug-coated covered balloon catheter includes a Y-shaped connection valve, and a guiding catheter is arranged at the connection end of the Y-shaped connection valve. It further includes:

[0013] A double-lumen balloon catheter is movably installed inside the guiding catheter and can extend to the outside of the guiding catheter. A guide wire lumen and a dilation lumen are arranged inside the double-lumen balloon catheter;

[0014] A guide wire is movably installed inside the guide wire lumen opened in the double-lumen balloon catheter, and the guide wire can extend to the outside of the double-lumen balloon catheter;

[0015] A balloon assembly is arranged at the end of the double-lumen balloon catheter, and a drug covering film is coated on the outside of the balloon assembly.

[0016] Further, the balloon assembly includes:

[0017] A balloon is fixedly installed at the end of the double-lumen balloon catheter. The inner cavity of the balloon is communicated with the dilation lumen of the double-lumen balloon catheter. A drug covering film is coated on the outside of the balloon, and the drug covering film is connected to the outside of the balloon.

[0018] Further, the drug covering film includes a covering film and a drug coating applied on the outside of the covering film.

[0019] Further, the covering film is composed of carboxymethyl chitosan and low molecular weight poly(lactic-co-glycolic acid) copolymer.

[0020] Further, the drug in the drug coating is rapamycin.

[0021] A use method of a degradable drug-coated covered balloon catheter is applicable to a degradable drug-coated covered balloon catheter. This use method of the degradable drug-coated covered balloon catheter is used to use the degradable drug-coated covered balloon catheter, including:

[0022] S1. Prepare a Y-shaped connecting valve, a guiding catheter, a guide wire, and a double-lumen balloon catheter, and ensure that parts such as the balloon with a drug-coated membrane on the Y-shaped connecting valve, guiding catheter, guide wire, and double-lumen balloon catheter are intact, and all connecting parts are firm and reliable;

[0023] S2. Disinfect the Y-shaped connecting valve, guiding catheter, guide wire, and double-lumen balloon catheter to ensure aseptic operation, and check whether the drug coating on the drug-coated membrane is uniform and complete;

[0024] S3. Anesthetize the patient, let the patient adopt an appropriate position, and perform the insertion and operation of the guiding catheter;

[0025] Insert the guide wire into the guide wire lumen of the double-lumen balloon catheter through the Y-shaped connecting valve until the guide wire extends outside the double-lumen balloon catheter and reaches the target position;

[0026] Under the guidance of the guide wire, insert the double-lumen balloon catheter into the body along the guiding catheter until the predetermined treatment site is reached;

[0027] S4. Inject an appropriate amount of liquid into the balloon through the dilation lumen of the double-lumen balloon catheter to expand the balloon assembly and make it close to the blood vessel wall or treatment area, pre-dilate the blood vessel lesion site, and at the same time the drug-coated membrane wrapped outside the balloon adheres to the inner wall of the blood vessel, and the drug on the drug-coated membrane begins to be released and acts on the treatment site;

[0028] S5. Withdraw the liquid in the balloon assembly through the dilation lumen of the double-lumen balloon catheter to retract the balloon assembly and restore it to its original state. The drug-coated membrane adheres and remains on the inner wall of the blood vessel to ensure that the drug is fully released and takes effect, and withdraw the guide wire, double-lumen balloon catheter, and guiding catheter from the patient's body.

[0029] Compared with the prior art, a degradable drug-coated balloon catheter and its usage method provided by the present invention can, for coronary artery rupture during coronary intervention, paste the drug-coated membrane on the coronary artery rupture by balloon dilation to block the coronary artery rupture, reduce the extravasation of blood in the coronary artery, and at the same time reduce the time of coronary blood flow interruption, thereby avoiding the risks brought by coronary blood flow interruption, further preventing serious complications such as ventricular tachycardia and ventricular fibrillation that endanger life. At the same time, complete occlusion can also avoid the risk of secondary coronary artery aneurysm formation that may be left after the operation, further ensuring the health of the patient. For coronary artery aneurysms, the balloon is dilated to paste the drug-coated membrane at the inner opening of the aneurysm body in the blood vessel. The drug-coated membrane can completely cover the rupture at the inner side of the aneurysm body in the blood vessel, causing the blood flow in the coronary artery not to enter the aneurysm body, the blood in the aneurysm body stops flowing and solidifies to form a thrombus, resulting in the hardening of the aneurysm body and no longer growing; for the problem of coronary artery rupture during coronary intervention, specifically, for the coronary artery rupture caused by the guide wire perforating the blood vessel inner wall or occult calcified nodules during coronary artery surgery, resulting in the blood vessel being ruptured when the pre-dilation balloon is dilated, when the coated balloon reaches the rupture and is released, it can firmly adhere to the blood vessel inner wall to block the rupture, preventing serious complications such as acute cardiac tamponade that endanger life, and there is no need to dilate the balloon for a long time, reducing the time of coronary blood flow interruption, thereby avoiding the risks brought by coronary blood flow interruption, and further preventing serious complications such as ventricular tachycardia and ventricular fibrillation that endanger life. Moreover, the coating of the coated balloon has degradable properties, the degradation products are non-toxic to the human body, the degradation time is within 1-3 months, and the coating thickness is very thin, which does not affect the endothelialization of the subsequent implanted stent and the problem of stent apposition to the wall. At the same time, it can also reduce the risk of aneurysm rupture. For coronary artery aneurysms, interventional treatment is adopted, avoiding open surgery and without the use of stents, achieving better fusion of the blood vessel wall, reducing the risks of rejection reaction and thrombus formation, thereby improving the treatment effect and the quality of life of the patient. Furthermore, there is no need to worry about restenosis caused by the use of coated stents, achieving long-term patency of the blood vessel, which helps to reduce the re-treatment rate and complication rate of the patient, and improve the quality of life and prognosis of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required to be used in the embodiments. Obviously, the drawings in the following description are only some embodiments recorded in the present invention. For those of ordinary skill in the art, other drawings can also be obtained according to these drawings.

[0031] Figure 1 It is a schematic diagram of the overall structure provided by an embodiment of the present invention;

[0032] Figure 2 Provided by an embodiment of the present invention Figure 1 An enlarged view of A in

[0033] Description of the reference numerals:

[0034] 1. Y-shaped connecting valve; 2. guiding catheter; 3. double-lumen balloon catheter; 4. guide wire; 5. balloon; 6. drug-coated membrane. Detailed implementation mode

[0035] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0036] Embodiment 1:

[0037] Please refer to Figure 1 and Figure 2 , a degradable drug-coated balloon catheter, including a Y-shaped connecting valve 1, the connecting end of the Y-shaped connecting valve 1 is provided with a guiding catheter 2, characterized in that it further includes:

[0038] A double-lumen balloon catheter 3, which is movably installed inside the guiding catheter 2 and can extend outside the guiding catheter 2, and a guide wire cavity and a dilation cavity are arranged inside the double-lumen balloon catheter 3;

[0039] A guide wire 4, which is movably installed inside the guide wire cavity opened in the double-lumen balloon catheter 3, and the guide wire 4 can extend outside the double-lumen balloon catheter 3;

[0040] A balloon assembly, which is arranged at the end of the double-lumen balloon catheter 3, and a drug-coated membrane 6 is coated on the outside of the balloon assembly.

[0041] The detailed implementation mode is as follows: The Y-shaped connecting valve 1 is used to guide, place and lock the guiding catheter 2 and the guide wire 4. The Y-shaped connecting valve 1 and the guiding catheter 2 are connected through a catheter connector, and the connection method includes but is not limited to rotation, tightening or pressing, etc. to achieve the firmness and tightness of the connection between the two. The double-lumen balloon catheter 3 has two lumens, including a guide wire cavity and a dilation cavity. The guide wire cavity is used to guide the moving path of the guide wire 4, and the dilation cavity is used to inflate and release liquid into the balloon assembly. The drug-coated membrane 6 can adhere to the inner wall of the blood vessel.

[0042] The balloon assembly includes:

[0043] A balloon 5, which is fixedly installed at the end of the double-lumen balloon catheter 3. The inner cavity of the balloon 5 is communicated with the dilation cavity of the double-lumen balloon catheter 3. The drug-coated membrane 6 is coated on the outside of the balloon 5, and the drug-coated membrane 6 is connected to the outside of the balloon 5.

[0044] The specific implementation method is as follows: The balloon 5 is a medical dilation balloon. The balloon 5 is connected to the dilation cavity of the double-lumen balloon catheter 3. By injecting liquid into the dilation cavity of the double-lumen balloon catheter 3, the liquid includes but is not limited to contrast agent. The balloon 5 expands, and while dilating the blood vessel, the drug covering membrane 6 is unfolded and covered on the blood vessel wall and adheres to the blood vessel wall. When the balloon 5 contracts, the drug covering membrane 6 detaches from the balloon 5. The drug covering membrane 6 can cover the rupture opening of the coronary aneurysm, so that the blood in the blood vessel no longer enters the aneurysm body, promoting the formation of spontaneous thrombus in the aneurysm body.

[0045] The drug covering membrane 6 includes a covering membrane and a drug coating applied on the outer side of the covering membrane.

[0046] The covering membrane is composed of carboxymethyl chitosan and low-molecular-weight poly(lactic-co-glycolic acid) copolymer.

[0047] The drug of the drug coating is rapamycin.

[0048] The specific implementation method is as follows: The covering membrane is a high-performance covering membrane material composed of modified chitosan, specifically carboxymethyl chitosan, and low-molecular-weight poly(lactic-co-glycolic acid) copolymer. Among them, carboxymethyl chitosan is the main component, accounting for 60%-70%. Its high degree of substitution >80% ensures the water solubility and adhesiveness of the material, can closely adhere to the inner wall of the blood vessel at 37°C, and is quickly degraded into non-toxic and biocompatible glucosamine, providing support for early repair. The low-molecular-weight PLGA with a molecular weight of 3-5 kDa and a lactic acid / glycolic acid ratio of 50:50 is used as an auxiliary component, accounting for 30%-40%, enhancing the mechanical strength and flexibility of the covering membrane, preventing rupture or deformation during balloon dilation, and controlling the degradation rate so that the covering membrane is completely degraded within 1 month. Its degradation products, lactic acid and glycolic acid, are also non-toxic and have a clear metabolic pathway. The thickness of the covering membrane is controlled between 10-20 μm, which not only ensures good wall adhesion performance but also does not interfere with hemodynamics. The drug coating is a rapamycin coating. The rapamycin coating provides short-term drug release. The rapamycin coating is directly sprayed on the surface of the film to provide short-term drug release at a drug concentration of 1-2 μg / mm 2 and can quickly release 70%-80% of the drug within 1 week, and the remaining drug is completely released within 2 weeks, effectively inhibiting the proliferation of vascular smooth muscle cells, ensuring the problem of in-stent restenosis during the degradation of the covering membrane, and without the need for complex sustained-release technology. Since the covering membrane has water solubility, when the covering membrane contacts the blood and gradually dissolves, its outer surface becomes sticky. When the balloon 5 is expanded, the covering membrane adheres to the opening of the aneurysm on the inner wall of the blood vessel. When the balloon 5 is contracted, because the contact surface between the balloon 5 and the covering membrane is dry, the covering membrane does not move with the contraction of the balloon 5, and the covering membrane separates from the balloon 5.

[0049] Example Two:

[0050] This embodiment provides a technical solution on the basis of Embodiment 1: A method for using a biodegradable drug-coated balloon catheter, which is applicable to a biodegradable drug-coated balloon catheter. This method for using a biodegradable drug-coated balloon catheter is used to use the biodegradable drug-coated balloon catheter, including:

[0051] S1. Prepare a Y-shaped connection valve 1, a guiding catheter 2, a guide wire 4, and a double-lumen balloon catheter 3, and ensure that parts such as the balloon 5 coated with the drug covering film 6 on the Y-shaped connection valve 1, the guiding catheter 2, the guide wire 4, and the double-lumen balloon catheter 3 are intact, and all connection parts are firm and reliable;

[0052] S2. Disinfect the Y-shaped connection valve 1, the guiding catheter 2, the guide wire 4, and the double-lumen balloon catheter 3 to ensure aseptic operation, and check whether the drug coating on the drug covering film 6 is uniform and complete;

[0053] S3. Anesthetize the patient, let the patient take an appropriate position, and insert and operate the guiding catheter 2;

[0054] Insert the guide wire 4 into the guide wire cavity of the double-lumen balloon catheter 3 through the Y-shaped connection valve 1 until the guide wire 4 extends outside the double-lumen balloon catheter 3 and reaches the target position;

[0055] Under the guidance of the guide wire 4, insert the double-lumen balloon catheter 3 into the body along the guiding catheter 2 until it reaches the predetermined treatment site;

[0056] S4. Inject an appropriate amount of liquid into the balloon 5 through the dilation cavity of the double-lumen balloon catheter 3 to expand the balloon assembly and make it close to the blood vessel wall or the treatment area, pre-dilate the blood vessel lesion position. At the same time, the drug covering film 6 coated on the outside of the balloon 5 adheres to the inner wall of the blood vessel, and the drug on the drug covering film 6 begins to be released and acts on the treatment site;

[0057] S5. Withdraw the liquid in the balloon assembly through the dilation cavity of the double-lumen balloon catheter 3 to retract the balloon assembly and restore it to its original state. The drug covering film 6 adheres to and stays on the inner wall of the blood vessel to ensure that the drug is fully released and plays a role, and withdraw the guide wire 4, the double-lumen balloon catheter 3, and the guiding catheter 2 from the patient's body.

[0058] Only some exemplary embodiments of the present invention are described by way of illustration above. Undoubtedly, for those of ordinary skill in the art, without departing from the spirit and scope of the present invention, the described embodiments can be modified in various different ways. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A degradable drug-coated membrane-covered balloon catheter, comprising a Y-shaped connecting valve (1), wherein a guide catheter (2) is provided at a connecting end of the Y-shaped connecting valve (1), characterized in that: Also includes: A double-lumen balloon catheter (3) is movably mounted on the inner side of the guide catheter (2) and is capable of extending to the outer side of the guide catheter (2); a guide wire cavity and an expansion cavity are provided on the inner side of the double-lumen balloon catheter (3); A guide wire (4) is movably mounted on the inner side of a guide wire cavity provided in the double-lumen balloon catheter (3), and the guide wire (4) can extend to the outer side of the double-lumen balloon catheter (3); A balloon component is arranged at the end of a double-lumen balloon catheter (3), and the outer side of the balloon component is coated with a drug covering film (6).

2. The degradable drug-coated balloon catheter according to claim 1, characterized in that: The balloon assembly comprises: A balloon (5) is fixedly mounted on the end of a double-lumen balloon catheter (3); the inner cavity of the balloon (5) is connected to the expansion cavity of the double-lumen balloon catheter (3); the outer side of the balloon (5) is coated with a drug covering film (6), and the drug covering film (6) is connected to the outer side of the balloon (5).

3. The degradable drug-coated balloon catheter according to claim 1, characterized in that: The drug covering film (6) comprises a covering film and a drug coating applied on the outer side of the covering film.

4. The degradable drug-coated balloon catheter according to claim 3, characterized in that: The covering film is composited with carboxymethyl chitosan and low molecular weight polylactic acid-glycolic acid copolymer.

5. The degradable drug-coated balloon catheter according to claim 3, characterized in that: The drug of the drug coating is rapamycin.

6. A method for using a degradable drug-coated coated balloon catheter, applicable to the degradable drug-coated coated balloon catheter according to any one of claims 1 to 5, the method for using the degradable drug-coated coated balloon catheter is used to use the degradable drug-coated coated balloon catheter, characterized in that: include: S1. Prepare the Y-type connecting valve (1), the guiding catheter (2), the guide wire (4), and the double-lumen balloon catheter (3), and ensure that the Y-type connecting valve (1), the guiding catheter (2), the guide wire (4), and the balloon (5) coated with the drug covering film (6) on the double-lumen balloon catheter (3) are intact, and all connecting parts are firm and reliable; S2, disinfecting the Y-type connecting valve (1), the guiding catheter (2), the guide wire (4) and the double-lumen balloon catheter (3) to ensure aseptic operation, and checking whether the drug coating on the drug covering film (6) is uniform and complete; S3, anesthetizing the patient, allowing the patient to take an appropriate body position, and inserting and operating the guide catheter (2); Inserting a guide wire (4) into the guide wire lumen of the double-lumen balloon catheter (3) through the Y-type connecting valve (1) until the guide wire (4) extends to the outside of the double-lumen balloon catheter (3) and reaches the target position; Under the guidance of the guide wire (4), the double-lumen balloon catheter (3) is inserted into the body along the guide catheter (2) until it reaches the predetermined treatment site; S4, injecting a proper amount of liquid into the balloon (5) through the expansion cavity of the double-lumen balloon catheter (3), so that the balloon assembly expands and adheres closely to the blood vessel wall or the treatment area, and pre-expands the location of the vascular lesion. At the same time, the drug covering film (6) coated on the outside of the balloon (5) adheres to the inner wall of the blood vessel, and the drug in the drug covering film (6) begins to be released and acts on the treatment site; S5. The liquid in the balloon assembly is extracted through the expansion cavity of the double-lumen balloon catheter (3), so that the balloon assembly shrinks and returns to its original shape. The drug covering film (6) adheres to and stays on the inner wall of the blood vessel to ensure that the drug is fully released and exerts its effect. The guide wire (4), the double-lumen balloon catheter (3) and the guide catheter (2) are withdrawn from the patient's body.

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