A left atrial appendage coagulation device and method

Abstract

The application discloses a left auricle adhesive plugging device and method, relates to left auricle plugging, and has the technical scheme as follows: a balloon is used, the balloon is a multilayer structure, the outer surface of the balloon is a temperature-sensitive adhesive layer, a cover is arranged at the top of the balloon, a connecting port is arranged in the middle of the cover, the connecting port is hollow, and a conveying device is detachably connected to the connecting port. The plugging device and method have the effects of high adaptability, firm fixation, simple operation, good biocompatibility and low cost.

Description

Technical Field

[0001] This invention relates to the field of left atrial appendage occlusion technology, and more specifically, to a left atrial appendage adhesive occlusion device and method. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, significantly increasing the risk of death, stroke, heart failure, cognitive impairment, and dementia, severely impacting patients' quality of life. The prevalence of AF increases with age, and with the accelerating aging of the population, AF will place a heavy burden on society and the healthcare system. Large-scale epidemiological surveys in my country show that the prevalence of AF in the 35-85 age group was 0.61% in 2003, 0.71% in the 35+ age group from 2012 to 2015, and 1.8% in the 45+ age group from 2014 to 2016. In the 75+ age group, the prevalence was 5.4% in men and 4.9% in women. Based on this 2014-2016 study combined with data from my country's 7th National Population Census in 2020, it is estimated that there are approximately 12 million AF patients in my country.

[0003] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, posing a serious threat to human health. Long-term AF alters the hemodynamics of the left atrial appendage, leading to blood stasis and the formation of thrombi. If a thrombus breaks off and travels throughout the body via the bloodstream, it can potentially cause ischemic stroke. Studies show that approximately 90% of thrombi in patients with non-valvular AF originate from the left atrial appendage, and AF-related strokes are often characterized by high rates of disability, mortality, and recurrence, placing a heavy burden on patients' families and society.

[0004] Left atrial appendage occlusion (LAA) is an emerging treatment option that provides new prevention of thromboembolism in patients with atrial fibrillation. This procedure involves placing an occluder at the opening of the left atrial appendage (LAA) to block the blood flow between the LA and the left atrium, thereby eliminating the risk of stroke caused by thrombus detachment. Plug-type occluders are one of the commonly used types of LAA occluders, offering the advantage of better adaptability to the complex anatomical structure of the LA and more precise occlusion. Currently used techniques include: metal-anchored occluders (such as Watchman): relying on barbs for fixation and prone to causing LAA perforation; traditional balloon occluders (such as CN106859722B): relying solely on physical filling, incomplete wall adhesion leading to a residual leakage rate >18%; and bio-adhesive occlusion technology: cyanoacrylate colloids pose a risk of exothermic reactions (temperature >80℃) and residual toxic monomers (exceeding ISO10993-5 standards). Furthermore, the aforementioned existing technologies have the following problems: firstly, they lack an active adhesion mechanism to ensure a tight bond between the occluder and the irregular atrial appendage wall; secondly, they lack immediate postoperative reinforcement methods to prevent early detachment; and thirdly, existing materials cannot balance adhesion strength and biocompatibility. In view of this, the inventors propose a left atrial appendage adhesion occlusion device and method. Summary of the Invention

[0005] The purpose of this invention is to provide a left atrial appendage occlusion device and method to solve the above-mentioned problems.

[0006] The above-mentioned technical objective of the present invention is achieved through the following technical solution:

[0007] The first aspect of the present invention provides a left atrial appendage occlusion device and method, comprising a balloon, the balloon having a multi-layer structure, the outer surface of the balloon being a temperature-sensitive adhesive layer, a cap being provided at the top of the balloon, a connection port being provided in the middle of the cap, the connection port being hollow, and a delivery device being detachably connected to the connection port.

[0008] In conjunction with the first aspect, the present invention is further configured such that: the inner surface of the balloon is a non-adhesive layer, and the material of the non-adhesive layer is a polyurethane matrix.

[0009] In conjunction with the first aspect, the present invention is further configured such that: the temperature-sensitive adhesive layer is a recombinant protein-surfactant temperature-sensitive bio-adhesive.

[0010] In conjunction with the first aspect, the present invention is further configured such that the connection port is threadedly connected to the conveying device.

[0011] In conjunction with the first aspect, the present invention is further configured such that the connection port is snap-fitted to the conveying device.

[0012] In conjunction with the first aspect, the present invention is further configured such that the temperature-sensitive adhesive layer becomes adhesive when the temperature reaches 60°C or above.

[0013] In conjunction with the first aspect, the present invention is further configured such that a temperature valve device is provided at the bottom of the cover.

[0014] A second aspect of the present invention also provides a method for left atrial appendage adhesion occlusion, characterized in that: it employs the occlusion device described in any one of claims 1-7, comprising the following steps:

[0015] The balloon is inserted into the left atrial appendage using a delivery device and adjusted to the appropriate position.

[0016] Then, liquid at 60℃-70℃ is injected into the balloon through the delivery device. The balloon expands rapidly and comes into close contact with the inner wall of the left atrial appendage. The temperature-sensitive adhesive layer is sticky at high temperature and can firmly adhere to the inner wall of the left atrial appendage to achieve occlusion.

[0017] After the occlusion is completed, the fluid inside the balloon is withdrawn and air is drawn back to create negative pressure inside the balloon, which causes the left atrial appendage to retract, further enhancing the adhesion between the balloon and the inner wall of the left atrial appendage, and ensuring the long-term stability and effectiveness of the occluder.

[0018] The delivery device is separated from the balloon, and then the delivery device is withdrawn to complete the sealing process.

[0019] In summary, the present invention has the following beneficial effects:

[0020] 1. Highly adaptable

[0021] By using a balloon-inflated design with heated water, it can fit closely to the inner wall of the left atrial appendage, adapting to different anatomical shapes of the left atrial appendage. This effectively solves the problem that existing occluders are difficult to adapt to complex left atrial appendage structures, improving the success rate and adaptability of occlusion.

[0022] 2. Securely fastened

[0023] The outer surface of the balloon becomes adhesive at temperatures above 60°C, allowing it to adhere firmly to the inner wall of the left atrial appendage, preventing the occluder from falling off during or after the procedure, reducing surgical risks and complexity, and improving the safety and reliability of the surgery.

[0024] 3. Easy to operate

[0025] The entire occlusion process is completed through a delivery device, which is simple and quick to operate, easy for doctors to master and apply, and can shorten the operation time and reduce patient suffering.

[0026] 4. Good biocompatibility

[0027] Biocompatible coatings on the balloon surface can reduce inflammation, improve the safety and durability of the occluder in vivo, and reduce the risk of postoperative complications.

[0028] 5. Lower cost

[0029] The balloon, made of novel biomaterials, is simpler in structure and lower in cost than the shape memory alloy occluders commonly used in existing technologies, which helps to reduce medical expenses and improve patients' economic accessibility. Attached Figure Description

[0030] Figure 1 This is a structural diagram of a left atrial appendage adhesion and occlusion device according to an embodiment of the present invention;

[0031] Figure 2 This is a diagram showing the usage status of a left atrial appendage occlusion device according to an embodiment of the present invention;

[0032] Figure 3 This is a diagram showing the negative pressure state of the left atrial appendage adhesion and occlusion device in an embodiment of the present invention;

[0033] Figure 4 This is a structural diagram of the conveying device in an embodiment of the present invention;

[0034] Figure 5 This is a detailed view of the balloon surface in an embodiment of the present invention.

[0035] In the diagram: 1. Cap; 2. Balloon; 3. Connecting port; 4. Temperature valve device; 5. Delivery device; 6. Left atrial appendage; 201. Temperature-sensitive viscous layer; 202. Non-viscous layer; 501. Common channel; 502. High-temperature saline channel; 503. Negative pressure channel; 504. Fiber optic channel. Detailed Implementation

[0036] 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.

[0037] Example:

[0038] A left atrial appendage adhesive occlusion device and method, such as Figure 1 , Figure 2 As shown, the device includes a balloon, the shape and size of which can be adjusted and optimized according to different anatomical morphologies of the left atrial appendage. The balloon has a multi-layered structure, with a temperature-sensitive adhesive layer on its outer surface. This layer utilizes a recombinant protein-surfactant temperature-sensitive bio-adhesive (intelligent phase-change type), the composite being cross-linked by electron beam irradiation. The temperature-sensitive adhesive layer becomes viscous when the temperature reaches above 60°C. The top of the balloon has a cap with a hollow connection port in the center, which is detachably connected to a delivery device, such as a threaded connection or a snap-fit ​​connection. The balloon surface is made of... Figure 5The papillary design increases surface adhesion.

[0039] The cap can be made of a magnesium alloy biodegradable material, which is lightweight, biodegradable, and biocompatible, and can reduce the formation of thrombi associated with the occluder.

[0040] The delivery device is used to deliver the balloon into the left atrial appendage and inject a mixture of sterile saline and contrast agent at 60℃-70℃ into the balloon, causing it to expand upon heating and adhere to the inner wall of the left atrial appendage. After the occlusion is completed, the liquid inside the balloon is withdrawn, and air is drawn back to create negative pressure inside the balloon, causing the left atrial appendage to retract and adhere more tightly to the outer surface of the balloon. Figure 3 As shown. Simultaneously, the contrast fluid within the balloon can be visualized under X-rays during the procedure, facilitating intraoperative positioning by the surgeon.

[0041] In this embodiment, the delivery device uses a three-lumen conduit, such as... Figure 4 As shown:

[0042] -Cavity A: High-temperature saline channel, lined with PTFE;

[0043] -Cavity B: Negative pressure channel, connected to a vacuum pump (accuracy ±1kPa);

[0044] -Cavity C: Fiber optic channel, with an internal fiber optic temperature sensing bundle, spatial resolution 0.5mm.

[0045] The top of the shared channel is connected to the high-temperature brine channel and the negative pressure channel. Both the high-temperature brine channel and the negative pressure channel are connected and both are equipped with valves. The opening and closing of the channel are controlled by the valves. The tail of the shared channel is fixedly connected to the tail of the optical fiber channel and has a circular cross-section with external threads on the surface.

[0046] In this embodiment, the inner surface of the balloon is a non-adhesive layer made of polyurethane matrix (thickness 80μm, burst pressure > 5atm), and its heat resistance is certified by ISO 594-2.

[0047] In addition, a temperature valve device can be installed at the bottom of the cap to warm the saline solution in the balloon.

[0048] Furthermore, the present invention can be further expanded and improved, for example, by adding a drug coating to the surface of the balloon to achieve drug sustained release function, further reducing the risk of inflammatory response and thrombosis; or by combining imaging technology to develop a more precise occluder delivery and positioning system, thereby improving the accuracy and safety of the surgery.

[0049] The present invention also provides a method for left atrial appendage adhesion occlusion, characterized by: using the above-mentioned occlusion device, comprising the following steps:

[0050] During the procedure, a balloon is first inserted into the left atrial appendage using a delivery device and adjusted to the appropriate position. Then, a mixture of saline solution and contrast agent at 60℃-70℃ is injected into the balloon via the delivery device. The balloon rapidly inflates and comes into close contact with the inner wall of the left atrial appendage. Because the temperature-sensitive adhesive layer remains sticky at high temperatures, it adheres firmly to the inner wall of the left atrial appendage, achieving occlusion.

[0051] After occlusion, the fluid inside the balloon is withdrawn, and air is drawn back to create negative pressure inside the balloon. This causes the left atrial appendage to retract, further enhancing the adhesion between the balloon and the inner wall of the left atrial appendage, ensuring the long-term stability and effectiveness of the occluder. Finally, the delivery device is separated from the balloon and then withdrawn, completing the occlusion process.

[0052] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A left atrial appendage occlusion device, characterized in that: The device includes a balloon with a multi-layer structure. The outer surface of the balloon is a temperature-sensitive adhesive layer. The top of the balloon is provided with a cap, and the middle of the cap is provided with a connection port. The connection port is hollow and can be detachably connected to a delivery device. The temperature-sensitive adhesive layer is made of recombinant protein-surfactant temperature-sensitive bio-adhesive; The conveying device includes a common channel, a high-temperature brine channel, a negative pressure channel, and an optical fiber channel. The top end of the common channel is connected to the high-temperature brine channel and the negative pressure channel. Both the high-temperature brine channel and the negative pressure channel are equipped with valves to control the opening and closing of the channel. The tail end of the common channel is fixedly connected to the tail end of the optical fiber channel, and the cross-section is circular with external threads on the surface.

2. The left atrial appendage occlusion device according to claim 1, characterized in that: The inner surface of the balloon is a non-adhesive layer, and the material of the non-adhesive layer is a polyurethane matrix.

3. The left atrial appendage occlusion device according to claim 1, characterized in that: The connection port is threadedly connected to the conveying device.

4. The left atrial appendage adhesion occlusion device according to claim 1, characterized in that: The connection port is snapped into the conveying device.

5. The left atrial appendage occlusion device according to claim 3, characterized in that: The temperature-sensitive adhesive layer becomes viscous when the temperature reaches 60°C or higher.

6. The left atrial appendage adhesion occlusion device according to claim 1, characterized in that: The bottom of the cover is equipped with a temperature valve device.

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