Multi-channel adaptive positioning cryoablation balloon

Abstract

The application discloses a kind of multi-channel adaptive positioning cryoablation balloon, belong to medical instrument technical field, it includes main body ablation balloon, outer layer adaptive membrane, multiple local inflation balloon cavity, multi-channel inflation mechanism and angle adjusting assembly.Multiple local inflation balloon cavity is arranged in main body ablation balloon, including local inflation balloon cavity one, local inflation balloon cavity two and inner balloon, by multi-channel independent inflation control, it can be targeted to specific balloon cavity inflation during operation, make it outward inflation fill the irregular gap between balloon and pulmonary vein mouth wall, as far as possible comprehensive cut off abnormal discharge path, reduce the recurrence rate after operation.Angle adjusting assembly can rotate local inflation balloon cavity to the angle matched with anatomical gap according to preoperative image, further improve the plugging pertinence, can effectively improve the fit degree and ablation success rate of cryoablation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically a multi-channel adaptive positioning cryoablation balloon. Background Technology

[0002] Current cryoablation balloons are typically spherical in shape, inflating to block the pulmonary vein orifice and thus delivering cryoenergy. However, the anatomical morphology of the pulmonary vein orifice varies significantly among individuals, often appearing as elliptical, gourd-shaped, or irregular. Complete circumferential adhesion between the inflated spherical balloon and the irregular pulmonary vein orifice wall is difficult to achieve. This leads to leakage of contrast agent along the gap between the balloon and the vessel wall during intraoperative injection. Contrast agent leakage not only interferes with the surgeon's assessment of the balloon's occlusion effectiveness but also signifies discontinuous cryoenergy delivery in the local area, preventing the formation of a transmural circumferential ablation lesion. Consequently, incomplete ablation results in a high recurrence rate of atrial fibrillation postoperatively, with some patients requiring a second ablation procedure. Therefore, improving the adhesion between the cryoablation balloon and the irregular pulmonary vein orifice, and reducing the postoperative arrhythmia recurrence rate, is a core technical problem that urgently needs to be solved in the field of atrial fibrillation ablation. Summary of the Invention

[0003] The purpose of this invention is to provide a multi-channel adaptive positioning cryoablation balloon to solve the problems mentioned in the background art.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a multi-channel adaptive positioning cryoablation balloon, comprising:

[0005] The main ablation balloon has an outer adaptive membrane on its outer surface, which is made of a high-molecular biocompatible elastic material.

[0006] Multiple local expansion cavities are disposed within the main ablation balloon. The multiple local expansion cavities include a first local expansion cavity, a second local expansion cavity, and an inner air bladder. The first local expansion cavity, the second local expansion cavity, and the inner air bladder can expand outward when inflated, pushing the main ablation balloon and the outer adaptive membrane to bulge outward to fill the gaps in irregular anatomical structures.

[0007] A multi-channel inflation mechanism, comprising at least three independent inflation channels, for independently supplying air to the main ablation balloon, the first local expansion bladder, the second local expansion bladder, and the inner balloon;

[0008] The system includes an angle adjustment assembly comprising a connecting seat, a movable shaft, a pawl, and an elastic element. The connecting seat is fixedly installed at the bottom of the main ablation balloon. The top end of the movable shaft passes through the connecting seat and is rotatably connected to it. Multiple sets of oblique protrusions are provided on the outer wall of the top end of the movable shaft. A pawl is hinged to the inner surface of the connecting seat. Multiple sets of pawls are provided and evenly distributed in a ring. Multiple sets of elastic elements are provided, with one end fixedly connected to the bottom of the pawl and the other end fixedly connected to the inner surface of the connecting seat. Under the elastic force of the elastic element, the pawl selectively engages with the oblique protrusions to restrict the rotation direction of the movable shaft. The movable shaft is fixedly connected to the multi-channel inflation mechanism, and the rotation of the movable shaft drives the multi-channel inflation mechanism to rotate synchronously.

[0009] As a further preferred embodiment of this technical solution: the first local expansion bladder and the second local expansion bladder are arranged in an X-shape, and the inner air bladder is located in the innermost layer and inside the first local expansion bladder and the second local expansion bladder.

[0010] As a further preferred embodiment of this technical solution: the multi-channel inflation mechanism includes a first inflation tube, a second inflation tube, and a third inflation tube; the first inflation tube is connected to the main ablation balloon; the second inflation tube is connected to the first local expansion sac; and the third inflation tube is connected to the second local expansion sac.

[0011] As a further preferred embodiment of this technical solution: a connecting inflation tube is fixedly connected between the ends of the second inflation tube and the third inflation tube near the first and second local expansion bladder cavities, and the connecting inflation tube is fixedly connected to the inner air bladder.

[0012] As a further preferred embodiment of this technical solution: the movable shaft is provided with a first inflation channel, a second inflation channel, and a third inflation channel for the first inflation tube, the second inflation tube, and the third inflation tube to pass through; the first inflation tube, the second inflation tube, and the third inflation tube are fixed inside the movable shaft.

[0013] As a further preferred embodiment of this technical solution: the inner air bladder is spherical or approximately spherical; the first and second local expansion bladders are attached to the surface of the inner air bladder when not inflated, and the inner air bladder is used to support the first and second local expansion bladders from the inside when inflated.

[0014] Compared with the prior art, the beneficial effects of the present invention are:

[0015] 1. In this invention, by setting up a local expansion cavity one, a local expansion cavity two, and an inner balloon inside the main ablation balloon, and using multi-channel independent inflation control, when contrast agent leakage is found during the operation, the specific cavity can be inflated in a targeted manner to expand outward and fill the irregular gap between the balloon and the pulmonary vein orifice wall, so as to cut off the abnormal discharge pathway as comprehensively as possible and reduce the recurrence rate of postoperative arrhythmia.

[0016] 2. In this invention, through the angle adjustment component, the doctor can rotate the local expansion cyst to an angle that matches the irregular direction of the pulmonary vein opening outside the body according to the patient's preoperative CT or ultrasound images, so that the expansion direction of the cyst is precisely aligned with the anatomical gap, thereby further improving the targetedness of the closure. Attached Figure Description

[0017] Figure 1 This is a three-dimensional structural schematic diagram of a multi-channel adaptive positioning cryoablation balloon according to the present invention;

[0018] Figure 2 This is a partial structural cross-sectional view of a multi-channel adaptive positioning cryoablation balloon according to the present invention;

[0019] Figure 3 This is a partial three-dimensional schematic diagram of a multi-channel adaptive positioning cryoablation balloon according to the present invention. Figure 1 ;

[0020] Figure 4 This is a partial three-dimensional schematic diagram of a multi-channel adaptive positioning cryoablation balloon according to the present invention. Figure 2 ;

[0021] Figure 5 This is a partial three-dimensional schematic diagram of a multi-channel adaptive positioning cryoablation balloon according to the present invention. Figure 3 .

[0022] Legend:

[0023] 1. Main ablation balloon; 201. Local expansion cavity one; 202. Local expansion cavity two; 203. Inner balloon; 301. Connecting seat; 302. Movable shaft; 3021. Oblique protrusion; 303. Pawl; 304. Elastic element; 401. First inflation tube; 402. Second inflation tube; 403. Third inflation tube; 404. Connecting inflation tube; 501. First inflation channel; 502. Second inflation channel; 503. Third inflation channel. Detailed Implementation

[0024] 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.

[0025] Example

[0026] Please see Figure 1 - Figure 5 As shown, the present invention provides a technical solution: a multi-channel adaptive positioning cryoablation balloon, comprising: a main ablation balloon 1, the outer surface of which is provided with an outer adaptive membrane made of a high-molecular biocompatible elastic material; multiple local expansion cavities disposed within the main ablation balloon 1, the multiple local expansion cavities including a first local expansion cavity 201, a second local expansion cavity 202, and an inner air bladder 203; the first local expansion cavity 201, the second local expansion cavity 202, and the inner air bladder 203 can expand outward during inflation, pushing the main ablation balloon 1 and the outer adaptive membrane outward to fill the gaps of irregular anatomical structures; a multi-channel inflation mechanism, the multi-channel inflation mechanism including at least three independent inflation channels, respectively used to independently supply air to the main ablation balloon 1, the first local expansion cavity 201, the second local expansion cavity 202, and the inner air bladder 203; and so on. The angle adjustment component includes a connecting seat 301, a movable shaft 302, a pawl 303, and an elastic element 304. The connecting seat 301 is fixedly installed at the bottom of the main ablation balloon 1. The top end of the movable shaft 302 passes through the connecting seat 301 and is rotatably connected to it. Multiple sets of oblique protrusions 3021 are provided on the outer wall of the top end of the movable shaft 302. Pawls 303 are hinged to the inner surface of the connecting seat 301. Multiple sets of pawls 303 are provided and are evenly distributed in a ring. Multiple sets of elastic elements 304 are provided. One end of each set of elastic elements 304 is fixedly connected to the bottom of the pawl 303, and the other end is fixedly connected to the inner surface of the connecting seat 301. Under the elastic force of the elastic element 304, the pawl 303 selectively engages with the oblique protrusions 3021 to limit the rotation direction of the movable shaft 302. The movable shaft 302 is fixedly connected to the multi-channel inflation mechanism. The rotation of the movable shaft 302 drives the multi-channel inflation mechanism to rotate synchronously.

[0027] In this embodiment, specifically: the local expansion bladder 1 201 and the local expansion bladder 202 are arranged in an X-shape, and the inner air bladder 203 is located in the innermost layer and inside the local expansion bladder 1 201 and the local expansion bladder 202.

[0028] In this embodiment, specifically: the multi-channel inflation mechanism includes a first inflation tube 401, a second inflation tube 402 and a third inflation tube 403; the first inflation tube 401 is connected to the main ablation balloon 1; the second inflation tube 402 is connected to the first local expansion bladder 201; and the third inflation tube 403 is connected to the second local expansion bladder 202.

[0029] In this embodiment, specifically: a connecting inflation tube 404 is fixedly connected between the ends of the second inflation tube 402 and the third inflation tube 403 near the first local expansion bladder 201 and the second local expansion bladder 202, and the connecting inflation tube 404 is fixedly connected to the inner air bladder 203.

[0030] In this embodiment, specifically: a first inflation channel 501, a second inflation channel 502, and a third inflation channel 503 are provided inside the movable shaft 302 for the first inflation tube 401, the second inflation tube 402, and the third inflation tube 403 to pass through; the first inflation tube 401, the second inflation tube 402, and the third inflation tube 403 are fixed inside the movable shaft 302.

[0031] In this embodiment, specifically: the inner air bladder 203 is spherical or nearly spherical; the first local expansion bladder 201 and the second local expansion bladder 202 are attached to the surface of the inner air bladder 203 when not inflated, and the inner air bladder 203 is used to support the first local expansion bladder 201 and the second local expansion bladder 202 from the inside when inflated.

[0032] Working principle or structural principle: Before surgery, the doctor assesses the shape of the pulmonary vein orifice and the direction of the gap requiring local expansion sac filling based on the patient's CT or ultrasound images. Then, the angle adjustment component is operated externally: The doctor holds the connecting seat 301 and rotates the movable shaft 302. Because the pawl 303 is engaged in the groove of the oblique protrusion 3021 under the action of the elastic element 304, the movable shaft 302 can only rotate in one direction, and the other direction is locked. Through intermittent rotation, the doctor adjusts the movable shaft 302 to the desired angle position. The movable shaft 302 drives the first inflation tube 401, the second inflation tube 402, the third inflation tube 403 fixed inside, as well as the distal local expansion sac 1 201, the local expansion sac 202, and the inner balloon 203 to rotate synchronously, so that the X-shaped crossed sacs are oriented towards the predetermined anatomical gap. During the operation, the balloon catheter is delivered to the target pulmonary vein orifice through a blood vessel. First, the main ablation balloon 1 is inflated through the first inflation tube 401 to initially expand and block the pulmonary vein orifice. Then, contrast agent is injected, and it is observed whether there is any leakage. If leakage is found, the local expansion cavities 1-1, 2-2, and the inner balloon 203 are inflated through the second inflation tube 402 and the third inflation tube 403 according to the location of the leakage. The local expansion cavities 1-1, 2-2, and the inner balloon 203 expand, and the inner balloon 203 supports the local expansion cavities 1-1 and 2-2 from the inside. The local expansion cavities 1-1 and 2-2 continue to expand, pushing the main ablation balloon 1 and the outer adaptive membrane outward, so that they fit tightly against the blood vessel wall until the contrast agent no longer leaks. At this time, the cryotherapy circulation system is activated to perform pulmonary vein isolation cryoablation. After the ablation is completed, all cavities are deflated first, and then the catheter is withdrawn.

[0033] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A multi-channel adaptive positioning cryoablation balloon, characterized in that, include: The main ablation balloon (1) has an outer adaptive membrane on its outer surface, which is made of a high-molecular biocompatible elastic material; Multiple local expansion cavities are disposed within the main ablation balloon (1). The multiple local expansion cavities include a first local expansion cavity (201), a second local expansion cavity (202), and an inner air cavity (203). The first local expansion cavity (201), the second local expansion cavity (202), and the inner air cavity (203) can expand outward when inflated, pushing the main ablation balloon (1) and the outer adaptive membrane to bulge outward to fill the gaps in the irregular anatomical structure. A multi-channel inflation mechanism, comprising at least three independent inflation channels, for independently supplying air to the main ablation balloon (1), the first local expansion bladder (201), the second local expansion bladder (202), and the inner air bladder (203); The device includes an angle adjustment assembly comprising a connecting seat (301), a movable shaft (302), a pawl (303), and an elastic element (304). The connecting seat (301) is fixedly installed at the bottom of the main ablation balloon (1). The top end of the movable shaft (302) passes through the connecting seat (301) and is rotatably connected to it. The outer wall of the top end of the movable shaft (302) is provided with multiple sets of oblique protrusions (3021). The inner surface of the connecting seat (301) is hinged with a pawl (303). The pawl (303) is provided with... Multiple sets of elastic elements (304) are evenly distributed in a ring. One end of each set of elastic elements (304) is fixedly connected to the bottom of the pawl (303), and the other end is fixedly connected to the inner surface of the connecting seat (301). Under the elastic force of the elastic element (304), the pawl (303) selectively engages with the oblique protrusion (3021) to limit the rotation direction of the movable shaft (302). The movable shaft (302) is fixedly connected to the multi-channel inflation mechanism. The rotation of the movable shaft (302) drives the multi-channel inflation mechanism to rotate synchronously.

2. The multi-channel adaptive positioning cryoablation balloon according to claim 1, characterized in that: The first local expansion bladder (201) and the second local expansion bladder (202) are arranged in an X-shape. The inner air bladder (203) is located in the innermost layer and inside the first local expansion bladder (201) and the second local expansion bladder (202).

3. The multi-channel adaptive positioning cryoablation balloon according to claim 2, characterized in that: The multi-channel inflation mechanism includes a first inflation tube (401), a second inflation tube (402), and a third inflation tube (403); the first inflation tube (401) is connected to the main ablation balloon (1); the second inflation tube (402) is connected to the first local expansion bladder (201); and the third inflation tube (403) is connected to the second local expansion bladder (202).

4. The multi-channel adaptive positioning cryoablation balloon according to claim 3, characterized in that: The second inflation tube (402) and the third inflation tube (403) are fixedly connected to a connecting inflation tube (404) at one end near the first local expansion bladder (201) and the second local expansion bladder (202), and the connecting inflation tube (404) is fixedly connected to the inner air bladder (203).

5. A multi-channel adaptive positioning cryoablation balloon according to claim 3, characterized in that: The movable shaft (302) has a first inflation channel (501), a second inflation channel (502), and a third inflation channel (503) for the first inflation tube (401), the second inflation tube (402), and the third inflation tube (403) to pass through; the first inflation tube (401), the second inflation tube (402), and the third inflation tube (403) are fixed inside the movable shaft (302).

6. The multi-channel adaptive positioning cryoablation balloon according to claim 1, characterized in that: The inner air bladder (203) is spherical or nearly spherical; the first local expansion bladder (201) and the second local expansion bladder (202) are attached to the surface of the inner air bladder (203) when not inflated, and the inner air bladder (203) is used to support the first local expansion bladder (201) and the second local expansion bladder (202) from the inside when inflated.

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