Double-balloon plugging catheter for alcohol ablation of ventricular arrhythmia

Abstract

The invention discloses a ventricular arrhythmia alcohol ablation double-balloon plugging catheter which comprises a catheter body, and a guide wire channel, a proximal end balloon channel, a distal end balloon channel and an alcohol injection channel are arranged in the catheter body; the proximal end balloon is arranged on the outer wall of the front end of the catheter body, and the proximal end balloon is communicated with the proximal end balloon channel; the telecentric end balloon is arranged on the outer wall of the catheter body and located at the rear portion of the proximal end balloon, and the telecentric end balloon is communicated with the telecentric end balloon channel; the alcohol filling area is arranged on the outer wall of the catheter body and located between the proximal end balloon and the distal end balloon, an alcohol filling hole is formed in the alcohol filling area, and the alcohol filling area is communicated with the alcohol filling channel.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a double balloon occlusion catheter for alcohol ablation of ventricular arrhythmia. BACKGROUND

[0002] Ventricular arrhythmia is a common heart disease, including premature ventricular contraction (premature ventricular contraction), ventricular tachycardia (ventricular tachycardia), ventricular fibrillation (ventricular fibrillation) and other types. Ventricular tachycardia, especially ventricular tachycardia combined with organic heart disease, is a kind of arrhythmia that can cause sudden death and other serious consequences. After timely and clear diagnosis, and judging the cause of ventricular tachycardia, inducement and influence on prognosis, it needs to be handled in time. The traditional treatment method of ventricular tachycardia includes anti-arrhythmic drug treatment. For refractory ventricular tachycardia with poor drug treatment effect, catheter ablation (RFCA) treatment means such as radiofrequency ablation and cryoablation can be used, and has become a standard treatment method for ventricular tachycardia. The success of catheter ablation depends on the anatomical location of the ventricular tachycardia substrate that can be reached during the operation. For ventricular tachycardia originating from the deep area of the ventricular wall or adjacent to the coronary artery, the success rate of RFCA will be greatly affected. Even if the ablation catheter can reach the ventricular wall substrate through the epicardial approach, catheter ablation still faces obstacles such as affecting the coronary artery or damaging the collateral nerve, especially for ventricular tachycardia originating from the summit area. In recent years, alcohol ablation of ventricular tachycardia as a new treatment method has attracted more attention due to its simple operation and exact effect. The specific operation method is to inject a certain amount of alcohol into the target ventricular wall site through the coronary vein in a reverse direction by a catheter. The cytotoxicity of alcohol can cause apoptosis of lesion myocardial cells and tissues by damaging cell membranes and proteins, thereby achieving the effect of terminating ventricular arrhythmia.

[0003] However, the existing alcohol ablation technology still has some problems in the implementation level. During the process of ventricular tachycardia alcohol ablation, accurate positioning is the key. The catheter needs to accurately inject alcohol into the blood vessel branch of the lesion site. The existing catheter may cause incomplete ablation or damage to the surrounding normal tissue. The existing single balloon catheter can only ablate the distal end of the occluded blood vessel segment, resulting in too large an influence range and affecting the normal myocardium. In severe cases, it may cause complications such as myocardial infarction. Therefore, for ventricular tachycardia ablation in special locations such as the summit area, it has always been a difficulty.

[0004] Therefore, it has become the focus of current research to develop an alcohol ablation instrument that can accurately position and effectively control the ablation range. By improving the structure and function of the ablation instrument, the accuracy of positioning and the controllability of the ablation range can be improved, which is expected to provide a new solution for the treatment of epicardial ventricular arrhythmia. SUMMARY

[0005] The present application aims to solve the problems of inaccurate positioning and difficult control of ablation range in epicardial ventricular arrhythmia alcohol ablation process, and provides an instrument capable of accurate positioning and effective control of ablation range and a use method thereof.

[0006] A double-balloon occlusion catheter for ventricular arrhythmia alcohol ablation comprises:

[0007] A catheter body is provided with a guide wire channel, a proximal end balloon channel, a distal end balloon channel and an alcohol injection channel;

[0008] A proximal end balloon is arranged on the outer wall of the front end of the catheter body, and the proximal end balloon is in communication with the proximal end balloon channel;

[0009] A distal end balloon is arranged on the outer wall of the catheter body at a position behind the proximal end balloon, and the distal end balloon is in communication with the distal end balloon channel;

[0010] An alcohol infusion area is arranged on the outer wall of the catheter body at a position between the proximal end balloon and the distal end balloon, and the alcohol infusion area is provided with an alcohol infusion hole, and the alcohol infusion area is in communication with the alcohol injection channel; the alcohol injection channel is used for delivering alcohol to the alcohol infusion area, and the alcohol infusion hole is used for releasing alcohol in the alcohol infusion area to the outside of the catheter body.

[0011] Optionally, the proximal end balloon and the distal end balloon are full-compliance material balloons;

[0012] Preferably, the proximal end balloon and the distal end balloon are made of at least one material of polyurethane, silicone or latex.

[0013] Optionally, the proximal end balloon and the distal end balloon are arranged on the outer wall of the catheter body in a surrounding manner.

[0014] Optionally, the diameter of the proximal end balloon after being filled is smaller than the diameter of the distal end balloon after being filled;

[0015] Preferably, the diameter of the proximal end balloon after being filled is 4mm-6mm;

[0016] The diameter of the distal end balloon after being filled is 2mm-4mm.

[0017] Optionally, a metal-made developing ring is arranged on the position of the proximal end balloon and the distal end balloon on the catheter body;

[0018] Preferably, the front and rear ends of the proximal end balloon and the distal end balloon are both provided with a metal-made developing ring;

[0019] Preferably, the developing ring is made of at least one of stainless steel, platinum, gold and platinum-iridium alloy.

[0020] Optionally, the distance between the proximal balloon and the distal balloon is 1-2 cm, and the length of the alcohol perfusion area is 1-2 cm.

[0021] Preferably, the alcohol perfusion area is uniformly provided with alcohol perfusion holes with a diameter of 0.01-0.1 mm.

[0022] Optionally, the catheter body is made of at least one of polyamide, polyether block polyamide elastomer, polyvinyl chloride and polyurethane.

[0023] Optionally, the guide wire channel is located at the inner center of the catheter body, and the proximal balloon channel, the distal balloon channel and the alcohol injection channel are arranged around the guide wire channel inside the catheter body.

[0024] Optionally, the rear end of the catheter body is provided with a base, and the base is provided with a guide wire inlet, a proximal balloon filling port, a distal balloon filling port and an alcohol perfusion port; the guide wire inlet is in communication with the guide wire channel, the proximal balloon filling port is in communication with the proximal balloon channel, the distal balloon inlet is in communication with the distal balloon channel, and the alcohol perfusion port is in communication with the alcohol injection channel.

[0025] Optionally, the guide wire inlet, the proximal balloon filling port, the distal balloon filling port and the alcohol perfusion port are all screw holes.

[0026] The technical scheme of the present application has the following advantages:

[0027] The application provides a double-balloon occlusion catheter for ventricular arrhythmia alcohol ablation, which comprises a catheter body, a guide wire channel, a proximal end balloon channel, a distal end balloon channel and an alcohol injection channel are arranged in the catheter body; a proximal end balloon is arranged on the outer wall of the front end of the catheter body and communicates with the proximal end balloon channel; a distal end balloon is arranged on the outer wall of the catheter body at a position behind the proximal end balloon and communicates with the distal end balloon channel; an alcohol infusion area is arranged on the outer wall of the catheter body at a position between the proximal end balloon and the distal end balloon, the alcohol infusion area is provided with an alcohol infusion hole, and the alcohol infusion area communicates with the alcohol injection channel; the alcohol injection channel is used for conveying alcohol to the alcohol infusion area, and the alcohol infusion hole is used for releasing alcohol in the alcohol infusion area to the outside of the catheter body. The double-balloon design of the application can occlude the front and rear ends of the ablation area, release all the alcohol in the alcohol infusion area, and realize directional ablation, concentrated and continuous ablation treatment of a specific area, prevention of the influence on other blood vessels and complications.

[0028] In the application, the diameter of the proximal end balloon after being filled is smaller than the diameter of the distal end balloon after being filled; the diameter of the proximal end balloon after being filled is 4 mm to 6 mm; and the diameter of the distal end balloon after being filled is 2 mm to 4 mm. The front small balloon + rear large balloon design can better adapt to the conical gradual change of the inner diameter of the blood vessel and realize occlusion matching different blood vessel structures and sizes. BRIEF DESCRIPTION OF DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed in the specific embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0030] Figure 1 It is a structural schematic diagram of the application;

[0031] Figure 2 It is a schematic diagram of the internal structure of the catheter;

[0032] Figure 3 It is a schematic diagram of the alcohol infusion area;

[0033] Figure 4 It is a schematic diagram of product use;

[0034] Figure 5 It is a schematic diagram of the position of the double-balloon catheter of the application in the epicardial blood vessel.

[0035] The diagram is labeled as follows: 1. Catheter body; 11. Proximal balloon channel; 12. Distal balloon channel; 13. Alcohol injection channel; 14. Guidewire channel; 2. Proximal balloon; 3. Distal balloon; 4. Alcohol infusion area; 41. Alcohol infusion port; 5. Base; 51. Proximal balloon filling port; 52. Distal balloon filling port; 54. Guidewire inlet; 53. Alcohol infusion port; A. Coronary artery; B. Coronary vein; C. Summit area. Detailed Implementation

[0036] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention. It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the present invention.

[0037] Furthermore, regarding the numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, are also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0038] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar to or equivalent to those described herein may be used in the implementation or testing of this invention.

[0039] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0040] It should be noted that in the following description, "rear end" usually refers to the end closer to the doctor during normal operation, and correspondingly, "front end" usually refers to the end farther from the doctor during normal operation. It should also be noted that radial dimension refers to the dimension perpendicular to the axial direction of the catheter body. For example, when the catheter body has a cylindrical structure, the radial dimension is expressed as the outer diameter.

[0041] Example 1

[0042] Figure 1 This is a schematic diagram of the structure of the precision-controlled dual-balloon alcohol ablation device of the present invention. As shown in the figure, it includes:

[0043] The catheter body 1 is provided with a guidewire channel 14, a proximal balloon channel 11, a distal balloon channel 12, and an alcohol injection channel 13.

[0044] a proximal balloon 2 arranged on the outer wall of the catheter body 1 at the front end, the proximal balloon 2 being in communication with the proximal balloon channel 11;

[0045] a distal balloon 3 arranged on the outer wall of the catheter body 1 at a position behind the proximal balloon 2, the distal balloon 3 being in communication with the distal balloon channel 12;

[0046] an alcohol perfusion area 4 arranged on the outer wall of the catheter body 1 at a position between the proximal balloon 2 and the distal balloon 3, the alcohol perfusion area 4 being provided with an alcohol perfusion hole 41; the alcohol perfusion area 4 being in communication with the alcohol injection channel 13.

[0047] The catheter body 1 is made of a high polymer material, and is extruded by using polyamide, polyether block polyamide elastomer, polyvinyl chloride, polyurethane and other materials. The catheter body 1 has four inner cavities, i.e. the proximal balloon channel 11, the distal balloon channel 12, the guide wire channel 14 and the alcohol injection channel 13.

[0048] As shown in FIG. 1, the guide wire channel 14 is arranged at the central position inside the catheter body 1, and the proximal balloon channel 11, the distal balloon channel 12 and the alcohol injection channel 13 are arranged around the guide wire channel 14 inside the catheter body 1. Figure 2

[0049] The guide wire channel 14 in the catheter body 1 is used for inserting a guide wire. In use, under X-ray imaging, the double-balloon catheter is guided by the guide wire to reach the epicardial target position through the coronary blood vessel (artery / vein).

[0050] The proximal balloon 2 is in communication with the proximal balloon channel 11, and the distal balloon 3 is in communication with the distal balloon channel 12. Both of them are used for injecting contrast agent into the proximal balloon 2 and the distal balloon 3 respectively under X-ray imaging, so that the proximal balloon 2 and the distal balloon 3 are filled respectively, and the blood vessels at the proximal end and the distal end of the alcohol perfusion area 4 are blocked respectively, so as to form a closed area for the blood vessel area needing alcohol ablation, so as to perform precise ablation treatment. At the same time, since the proximal balloon 2 and the distal balloon 3 are filled with contrast agent, the proximal balloon 2 and the distal balloon 3 can be developed, so as to facilitate operation.

[0051] ​The proximal balloon 2 and the distal balloon 3 are both circumferential and arranged on the outer wall of the catheter body 1. The proximal balloon 2 and the distal balloon 3 are both made of full-compliant material such as polyurethane, silicone, latex, etc. Full-compliant material refers to those materials that can be significantly deformed under external force and have very low elastic modulus. Such materials are easy to deform under external force and can restore to the original shape after the external force is removed. Typical examples of full-compliant material include rubber, soft plastic and some elastomers. They perform well in applications requiring impact absorption or shock absorption because they can effectively consume energy and reduce vibration and impact. These materials have good compliance to better fit the vessel diameter and achieve complete occlusion.

[0052] The diameter of the proximal balloon 2 after inflation is smaller than the diameter of the distal balloon 3 after inflation, so as to fit the gradual change of the vessel diameter. It should be noted that the size of the balloon is designed to be able to occlude the vessel opening. In this embodiment, the diameter of the proximal balloon 2 after inflation is 4mm-6mm, and the diameter of the distal balloon 3 after inflation is 2mm-4mm.

[0053] The proximal balloon 2 and the distal balloon 3 are both provided with a metal-made developing ring at the front and back ends. The developing ring is made of at least one of stainless steel, platinum, gold and platinum-iridium alloy. The developing ring can be used for positioning under X-ray.

[0054] The alcohol infusion area 4 is arranged on the outer wall of the catheter body 1 between the proximal balloon 2 and the distal balloon 3. The alcohol infusion area 4 is provided with an alcohol infusion hole 41, and the alcohol infusion area 4 is in communication with the alcohol injection channel 13. The alcohol injection channel 13 is used for delivering alcohol to the alcohol infusion area 4, and the alcohol infusion hole 41 is used for releasing alcohol in the alcohol infusion area 4 to the outside of the catheter body 1.

[0055] In this embodiment, as shown in Figure 3 The alcohol infusion hole 41 is a small hole penetrating the outer wall of the catheter body 1 and reaching the alcohol injection channel 13 on the alcohol infusion area 4. Multiple alcohol infusion holes 41 can be arranged on the alcohol infusion area 4, and the alcohol infusion holes 41 with a diameter of 0.01-0.1mm are uniformly arranged on the alcohol infusion area 4. After the proximal balloon 2 and the distal balloon 3 are inflated and occlude the blood vessel from the front and back of the alcohol infusion area 4, alcohol is delivered from the alcohol injection channel 13 to the alcohol infusion area 4, and the alcohol in the alcohol infusion area 4 is released to the blood vessel outside the catheter body 1 through the alcohol infusion hole 41 to perform myocardial ablation.

[0056] The distance between the proximal balloon 2 and the distal balloon 3 is 1-2 cm. In this embodiment, the distance between the proximal balloon 2 and the distal balloon 3 is consistent with the length of the alcohol perfusion area 4, that is, the length of the alcohol perfusion area 4 is 1-2 cm. It should be noted that the alcohol perfusion area 4 can also be smaller than the distance between the proximal balloon 2 and the distal balloon 3.

[0057] The catheter has a base 5 at its rear end. The base 5 has a proximal balloon inflation port 51, a distal balloon inflation port 52, a guidewire inlet 54, and an alcohol infusion port 53. The guidewire inlet 54 communicates with the guidewire channel 14, the proximal balloon inflation port 51 communicates with the proximal balloon channel 11, the distal balloon inflation port 52 communicates with the distal balloon channel 12, and the alcohol infusion port 53 communicates with the alcohol injection channel 13. The guidewire inlet 14, proximal balloon inflation port 51, distal balloon inflation port 52, and alcohol infusion port 53 all have threaded holes, which can be used to connect to a Luer threaded syringe. A Luer threaded syringe is a syringe with a threaded locking mechanism, mainly used to ensure a safe connection with other devices. Its design features include a threaded locking mechanism that requires rotation to lock and ensure a safe connection with other devices. This injection head has good sealing and safety, preventing accidental detachment or loosening. It is suitable for situations requiring a more secure connection and is often used for extracting and injecting liquid drugs. The threaded hole configuration used in this invention can be used with existing injection equipment.

[0058] Figure 4 For product usage diagrams, Figure 5 This is a schematic diagram showing the position of the double-balloon catheter of the present invention in the epicardial vessels, as shown. Figure 4 , Figure 5 As shown, the method of alcohol ablation using the double-balloon occlusion catheter for ventricular arrhythmia ablation of the present invention is as follows: Guided by a guidewire, the double-balloon catheter reaches the target area (C in the figure, the summit area) via the coronary vein B. The proximal balloon 2 and the distal balloon 3 are inflated sequentially to achieve complete occlusion of this segment of the vessel. Then, alcohol is injected into the alcohol perfusion area 4 for ablation. The specific implementation method is as follows:

[0059] 1) Under X-ray imaging, the double balloon catheter is guided by a guidewire to the target location on the epicardium via coronary arteries / veins;

[0060] 2) Use a syringe to inject contrast agent sequentially into the proximal and distal ends of balloon 3 to inflate and block the blood vessels;

[0061] 3) Inject anhydrous alcohol into the alcohol injection cavity to fill the alcohol perfusion area 4 and achieve ablation;

[0062] 4) After ablation, empty the distal and proximal ends of balloon 2 in sequence, and then withdraw the balloon catheter.

[0063] In summary, the present application provides a precise control type double balloon epicardial ventricular arrhythmia alcohol ablation device and its use method, the double balloon design of the present application can block the front and back of the area needing ablation, release all the alcohol in the alcohol infusion area 4, the short distance between the balloons (i.e. the alcohol infusion area 4) and the ablation area blocking design are beneficial to the directional ablation of alcohol, realize the concentrated and continuous ablation treatment of specific area, prevent the influence on other vascular areas and complications. It has the advantages of accurate positioning, controllable ablation range, safety and effectiveness, and is expected to provide a new solution for the treatment of epicardial ventricular arrhythmia.

[0064] Obviously, the above embodiments are only examples for the purpose of clarity, and are not limiting to the embodiments. Based on the above description, other different forms of changes or variations can also be made by those skilled in the art. All the embodiments do not need to be exhausted here. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias, characterized in that, The catheter body is internally provided with a guide wire channel, a proximal balloon channel, a distal balloon channel and an alcohol injection channel. The proximal balloon is arranged on the outer wall of the front end of the catheter body and communicates with the proximal balloon channel. The distal balloon is arranged on the outer wall of the catheter body at a position behind the proximal balloon and communicates with the distal balloon channel. The alcohol injection zone is arranged on the outer wall of the catheter body at a position between the proximal balloon and the distal balloon, is provided with alcohol injection holes and communicates with the alcohol injection channel. The proximal balloon and the distal balloon are made of at least one material selected from polyurethane, silicone and latex.

2. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, Preferably, the proximal balloon and the distal balloon are made of at least one material selected from polyurethane, silicone and latex. The proximal balloon and the distal balloon are arranged in a ring shape on the outer wall of the catheter body.

3. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, The diameter of the inflated proximal balloon is smaller than that of the inflated distal balloon.

4. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, Preferably, the diameter of the inflated proximal balloon is 4-6 mm. Preferably, the diameter of the inflated distal balloon is 2-4 mm. The catheter body is made of at least one material selected from polyamide, polyether block polyamide elastomer, polyvinyl chloride and polyurethane.

5. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, The guide wire channel is arranged at the center of the catheter body, and the proximal balloon channel, the distal balloon channel and the alcohol injection channel are arranged around the guide wire channel. The rear end of the catheter body is provided with a base, and the base is provided with a guide wire inlet, a proximal balloon inflation port, a distal balloon inflation port and an alcohol injection port. The guide wire inlet, the proximal balloon inflation port, the distal balloon inflation port and the alcohol injection port are all threaded holes.

6. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, ​ ​ 7. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, ​ 8. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, ​ 9. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, ​ 10. The dual balloon occlusion catheter for alcohol ablation of ventricular arrhythmias of claim 1, wherein, ​

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