Adjustable bend contrast mapping multi-functional electrophysiological catheter

Abstract

This invention proposes an adjustable-bend angiography mapping multifunctional electrophysiological catheter, comprising a main tube body, an integrally formed bendable segment at the distal end of the main tube body, and several evenly arranged ring electrodes connected to the bendable segment. A handle is fixedly connected to the proximal end of the main tube body. An interventional tube for accommodating a microcatheter is integrally formed within the inner lumen of the main tube body. The distal end of the interventional tube enters the bendable segment. In this adjustable-bend angiography mapping multifunctional electrophysiological catheter, the interventional tube serves as a channel for the microcatheter to pass through the interventional tube from the end of the main tube body and enter the main tube body, and to reach the distal end of the vein along with the bendable segment to facilitate the delivery of anhydrous alcohol for cell rupture and chemical ablation. The interventional tube does not affect the operation of the main tube body and the bendable segment, eliminating the need for multiple long sheaths, JR catheters, guidewires, and many other instruments, improving the stability of the main tube body during the operation, and making the operation convenient and reducing costs.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an adjustable bendable angiography mapping multifunctional electrophysiological catheter. Background Technology

[0002] Atrial fibrillation is the most common type of atrial tachyarrhythmia in clinical practice. Atrial fibrillation can easily cause a variety of serious complications such as thromboembolism (cerebral embolism, systemic embolism), progressive heart failure, and cognitive decline, resulting in high rates of disability and mortality.

[0003] With the development of intracardiac electrophysiology and catheter ablation methods, people have gradually realized that the ligament of Marshall (LOM) is closely related to atrial arrhythmias. Because there is a complex neural network composed of a large number of autonomic nerves in the coronary sinus and it communicates with the adjacent epicardial nerve plexus, the conduction reentry of electrical activity between the coronary sinus and the left and right atria and its own conduction delay are closely related to the formation of atrial fibrillation. This effect is particularly significant in its branch, the Marshall vein.

[0004] As the fetal heart develops, the Marshall vein gradually degenerates and becomes occluded, forming a ligament called the Marshall ligament. It contains small veins (Marshall veins) and myocardial fibers (Marshall bundles) that originate from the muscle tissue proximal to the coronary sinus. It can obliquely insert into the posterior wall of the left atrial appendage, the left superior pulmonary vein, or the free wall of the left atrium. This connection constitutes the anatomical matrix for reentrant excitation.

[0005] Studies have found that autonomous electrical activity can be generated within the Marshall vein. Stimulation of the Marshall ligament can easily induce local electrical activity, leading to atrial fibrillation. Ablation of the Marshall vein can eliminate this electrical activity. In atypical atrial flutter mediated by the mitral isthmus, the Marshall ligament can be an effective target when isthmus ablation is ineffective.

[0006] In catheter ablation for persistent atrial fibrillation, Marshall vein ablation combined with radiofrequency ablation is often used to effectively achieve mitral isthmus block. The principle of Marshall vein anhydrous ethanol ablation is to inject anhydrous ethanol into the Marshall vein to damage the distal capillaries, which then diffuses into the nerves, fiber bundles, and atrial myocardium surrounding the Marshall ligament, thereby destroying the epicardial electrical connection of the mitral isthmus. This can further improve the mitral isthmus block rate from 64% to nearly 100%. Compared to conventional radiofrequency ablation, adding Marshall vein ablation effectively increases the success rate of conventional radiofrequency ablation and reduces the recurrence rate of atrial fibrillation.

[0007] There is no dedicated Marshall vein selective catheter for Marshall vein ablation. It requires the use of many other instruments such as long sheaths, JR catheters, guidewires, etc., in conjunction with disposable adjustable mapping catheters to achieve the purpose of injecting anhydrous ethanol to damage the distal capillaries. This has the problems of surgical instability, complicated operation, and increased cost. Utility Model Content

[0008] To overcome the shortcomings of existing technologies, this utility model proposes an adjustable bendable angiography mapping multifunctional electrophysiological catheter, including a main tube body. The distal end of the main tube body has an integrally formed bendable section tube, on which several uniformly arranged ring electrodes are connected. The proximal end of the main tube body is fixedly connected to a handle. The inner cavity of the main tube body has an integrated interventional tube for accommodating a microcatheter. The distal end of the interventional tube enters the bendable section tube, and the end of the interventional tube entering the bendable section tube has a side hole connecting the outside to the inner cavity of the interventional tube. The proximal end of the interventional tube exits the main tube body.

[0009] To achieve the above objectives, an interventional catheter is placed inside the main tube. The interventional catheter serves as a channel through which a microcatheter exits the main tube and enters the main tube. It then travels along the flexible segment of the catheter to the distal end of the vein to facilitate the delivery of anhydrous alcohol for cell rupture and chemical ablation. The interventional catheter does not interfere with the operation of the main tube or the flexible segment of the catheter, eliminating the need for multiple long sheaths, JR catheters, guidewires, and other instruments. This improves the stability of the main tube during the procedure, making the operation more convenient and reducing costs.

[0010] Furthermore, the interventional tube has an inner diameter of 1.32-1.65 mm, and the interventional tube extends 2-3 cm out of the main tube body.

[0011] With the above technical solution, the interventional tube has an inner diameter of 1.32-1.65 mm, which is convenient for accommodating microcatheters with a diameter of 0.70-1.30 mm. The interventional tube extends 2-3 cm out of the main tube, which makes it convenient for medical staff to insert the microcatheter into the interventional tube, which is convenient for operation and does not affect the stability of the operation.

[0012] Furthermore, the portion of the interventional tube that extends out of the main tube body is close to the handle, and the interventional tube is made of plastic or metal.

[0013] With the above technical solution, the part of the interventional tube that protrudes from the main tube body is close to the handle, which facilitates operation by medical staff without affecting their control of the actuator in the handle. The interventional tube is made of plastic or metal and has strong elasticity and stability, protecting the microcatheter and providing stability.

[0014] Furthermore, one end of the interventional tube protruding from the main tube body is connected to a disposable three-way valve for controlling the opening and closing of the interventional tube pipeline, and the disposable three-way valve is detachably and fixedly connected to one end of the interventional tube protruding from the main tube body.

[0015] The above technical solution uses a disposable three-way valve to control the opening and closing of the interventional tube, which facilitates the insertion of the interventional tube while also facilitating the discharge of gas inside the tube.

[0016] Furthermore, the inner cavity of the main tube is also provided with a calibration signal wire, and the distal end of the calibration signal wire is connected to the ring electrode, while the proximal end passes through the main tube and enters the inner cavity of the handle.

[0017] The above technical solution provides a signal wire with a diameter of 0.01-0.5 mm and an outer coating with an insulation strength of not less than V. This is existing technology and will not be elaborated further here.

[0018] Furthermore, an extension tube is fixed to the end of the handle away from the main tube body, and a connector is fixed to the end of the extension tube away from the handle. The portion of the calibration signal wire that enters the inner cavity of the handle passes through the extension tube and is connected to the connector.

[0019] With the above technical solution, the test signal wire extends beyond the handle and connects to the connector compared to the traditional wire. The extension tube protects the test signal wire, and the connector allows the test signal wire to be connected to the matching equipment.

[0020] In summary, this adjustable-bend angiography mapping multifunctional electrophysiological catheter has the following beneficial effects:

[0021] (1) This adjustable bendable angiography mapping multifunctional electrophysiological catheter has an interventional tube set inside the main tube body. The interventional tube serves as a channel for the microcatheter to pass through the interventional tube from the end of the main tube body and enter the main tube body. It also reaches the distal end of the vein along with the bendable tube to facilitate the delivery of anhydrous alcohol for cell rupture and chemical ablation. It also has the function of coronary sinus mapping. The interventional tube does not affect the operation of the main tube body and the bendable tube, eliminating the need for multiple long sheaths, JR catheters, guidewires and other instruments. This improves the stability of the main tube body during the operation, making the operation convenient and reducing costs.

[0022] (2) The adjustable bend angiography mapping multifunctional electrophysiological catheter has a mapping signal lead that extends beyond the handle and connects to the connector compared to the traditional lead. The extension tube protects the mapping signal lead, and the connector allows the mapping signal lead to be connected to the matching equipment. The mapping signal lead and its related components can be used normally without affecting the stability of the handle held by medical staff. Attached Figure Description

[0023] The present invention will be further described and explained below with reference to the accompanying drawings.

[0024] Figure 1 This is a schematic diagram of the overall structure of the preferred embodiment of this utility model;

[0025] Figure 2 This is a partial cross-sectional view of the main body of this utility model.

[0026] Figure 3 This is a schematic diagram illustrating the structure of the side hole in this utility model.

[0027] Reference numerals: 1. Main tube body; 2. Bendable tube; 3. Ring electrode; 4. Handle; 5. Intervention tube; 6. Side port; 7. Disposable three-way valve; 8. Extension tube; 9. Connector. Detailed Implementation

[0028] The technical solution of this utility model will be more clearly and completely explained below with reference to the accompanying drawings and through the description of the preferred embodiments of this utility model.

[0029] like Figure 1-3 As shown, the adjustable bendable angiography mapping multifunctional electrophysiological catheter of the preferred embodiment of this utility model includes a slender main tube 1, a bendable section tube 2 coaxially fixed at the distal end of the main tube 1, and a handle 4 fixedly connected at the proximal end. The handle 4 is equipped with an actuator for controlling the bending of the bendable section tube 2. This is an existing structure, so it will not be described in detail here.

[0030] like Figure 1 and Figure 2 The main tube 1 has an integrated interventional tube 5 for accommodating the microcatheter. The distal end of the interventional tube 5 enters the flexible tube 2. The end of the interventional tube 5 that enters the flexible tube 2 has a side hole 6 that connects to the outside and the inner cavity of the interventional tube 5. The proximal end of the interventional tube 5 exits the main tube 1.

[0031] like Figure 1 and Figure 2 By setting an interventional tube 5 inside the main tube 1, the interventional tube 5 serves as a channel for the microcatheter to pass through the end of the main tube 1 and enter the main tube 1. It then reaches the distal end of the vein along with the flexible segment tube 2 to facilitate the delivery of anhydrous alcohol for cell rupture and chemical ablation. The interventional tube 5 is fixed inside the main tube 1 and does not affect the operation of the main tube 1 and the flexible segment tube 2. This eliminates the need for multiple long sheaths, JR catheters, guidewires, and many other instruments, improving the stability of the main tube 1 during the operation, making the operation convenient and reducing costs.

[0032] like Figure 1 and Figure 2The interventional tube 5 has an inner diameter of 1.32-1.65 mm, which is convenient for accommodating microcatheters with a diameter of less than 1.30 mm. The interventional tube 5 extends 2-3 cm out of the main tube 1, which is convenient for medical staff to insert the microcatheter into the interventional tube 5, making the operation convenient and not affecting the stability of the operation.

[0033] like Figure 1 and Figure 2 The portion of the interventional tube 5 that protrudes from the main tube 1 is close to the handle 4, which facilitates operation by medical staff without affecting their control of the actuator in the handle 4. The interventional tube 5 is made of plastic or metal and has strong elasticity and stability, protecting the microcatheter and providing stability.

[0034] like Figure 1 and Figure 2 One end of the interventional tube 5 protrudes from the main tube body 1 and is connected to a disposable three-way valve 7 that controls the opening and closing of the interventional tube 5. The disposable three-way valve 7 is inserted and fixed to the end of the interventional tube 5 protruding from the main tube body 1. The opening and closing of the interventional tube 5 is controlled by the disposable three-way valve 7 so that gas inside the interventional tube 5 can be discharged while the microcatheter is inserted into the interventional tube 5. The disposable three-way valve 7 is an existing structure, so it will not be described in detail here.

[0035] like Figure 1 and Figure 2 A number of uniformly arranged ring electrodes 3 are connected to the bendable tube 2. The ring electrodes 3 are arranged in an array along the length of the main tube 1 and fixed to the bendable tube 2. The inner cavity of the main tube 1 is also provided with a mapping signal wire. The distal end of the mapping signal wire is connected to the ring electrode 3, and the proximal end passes through the main tube 1 and enters the inner cavity of the handle 4. The mapping signal wire has a diameter of 0.01-0.5 mm and is coated with an insulation strength of not less than 500V on the outside. It has the function of coronary sinus mapping. This is the prior art, so it will not be described in detail here.

[0036] like Figure 1 and Figure 2 In traditional Marshall intravenous anhydrous alcohol ablation procedures, monitors and other equipment need to be frequently repositioned to observe the procedure. If directly exposed to air, they may become contaminated, affecting the sterility of the procedure. Therefore, to ensure a sterile environment, sterile covers are placed over monitors and other equipment to prevent bacterial contamination and ensure the safety of the procedure.

[0037] like Figure 1 and Figure 2The existing connector is located at the end of the handle. The proximal end of the calibration signal wire is connected to the connector. The connector is connected to devices such as displays via cables. The sterile sleeve covering the display and other devices will wrap around the cables and connectors and extend to the handle. At this time, when medical staff grasp the handle, they will touch the sterile sleeve, affecting the stability of the medical staff's grip on the handle.

[0038] like Figure 1 and Figure 2 To address the aforementioned issues, an extension tube 8 is fixed to the end of the handle 4 furthest from the main tube 1, and a connector 9 is fixed to the end of the extension tube 8 furthest from the handle 4. The mapping signal wire passes through the handle 4 and enters the extension tube 8. The portion of the mapping signal wire inside the extension tube 8 is connected to the connector 9. Compared to traditional wires, the mapping signal wire extends beyond the handle 4 and connects to the connector 9. The extension tube 8 protects the mapping signal wire, and the connector 9 connects the mapping signal wire to the compatible equipment. The extension tube 8 and connector 9 hang below the handle 4. At this time, a sterile sleeve is placed over the connector 9 and extends to the outside of the extension tube 8. The end of the sterile sleeve is tied to the extension tube 8. In this case, the sterile sleeve protects the connector 9 without contacting the handle 4, thus not affecting the gripping of the handle 4 and further improving the stability of the surgery.

[0039] In use, the disposable three-way valve 7 and the end of the interventional tube 5 extending out of the main tube 1 are inserted and fixed. Then, the main tube 1 and the flexible segment tube 2 are passed through the 8F femoral sheath and reach the right atrium via the femoral vein. The actuator is manually controlled to bend and rotate the flexible segment tube 2 into the coronary sinus. The coronary vein potential is recorded in real time. Then, retrograde coronary sinus angiography is performed. Then, the main tube 1 and the flexible segment tube 2 are controlled to retract towards the atrium so that the flexible segment tube 2 reaches the Vieussens valve. Retrograde angiography is performed again to visualize the Marshall vein. Then, the distal end of the flexible segment tube 2 is controlled to reach the opening of the Marshall vein. The disposable three-way valve 7 is opened, and guidewires such as PTCA and balloon catheters such as OTW are inserted into the interventional tube 5. The flexible segment tube 2 extends out from the side hole 6 to perform anhydrous ethanol chemical ablation of the Marshall vein.

[0040] The above-described specific embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Various modifications, substitutions, and improvements made by those skilled in the art to the technical solutions of the present invention based on the provided description and drawings, without departing from the design concept and spirit of the present invention, should all fall within the scope of protection of the present invention. The scope of protection of the present invention is determined by the claims.

Claims

1. An adjustable bend contrast mapping multi-functional electrophysiology catheter, characterized in that, The device includes a main tube (1), a flexible section (2) is integrally formed at the distal end of the main tube (1), a plurality of uniformly arranged ring electrodes (3) are connected to the flexible section (2), a handle (4) is fixedly connected to the proximal end of the main tube (1), an interventional tube (5) for accommodating a microcatheter is integrally formed in the inner cavity of the main tube (1), the distal end of the interventional tube (5) enters into the flexible section (2), and the end of the interventional tube (5) entering the flexible section (2) is provided with a side hole (6) connecting the outside and the inner cavity of the interventional tube (5), and the proximal end of the interventional tube (5) protrudes out of the main tube (1).

2. The adjustable bend contrast mapping multi-functional electrophysiology catheter of claim 1, wherein, The interventional tube (5) has an inner diameter of 1.32-1.65 mm and extends 2-3 cm out of the main tube (1).

3. The adjustable bend contrast mapping multi-functional electrophysiology catheter of claim 1, wherein, The portion of the interventional tube (5) that protrudes from the main tube body (1) is close to the handle (4). The interventional tube (5) is made of plastic or metal.

4. The adjustable bend contrast mapping multi-functional electrophysiology catheter of claim 1, wherein, One end of the interventional tube (5) protruding from the main tube body (1) is connected to a disposable three-way valve (7) that controls the opening and closing of the interventional tube (5) pipeline. The disposable three-way valve (7) is detachably fixedly connected to the end of the interventional tube (5) protruding from the main tube body (1).

5. The adjustable bend contrast mapping multi-functional electrophysiology catheter of claim 1, wherein, The inner cavity of the main tube (1) is also provided with a calibration signal wire, and the far end of the calibration signal wire is connected to the ring electrode (3), while the near end passes through the main tube (1) and enters the inner cavity of the handle (4).

6. The adjustable bend contrast mapping multi-functional electrophysiology catheter of claim 5, wherein, An extension tube (8) is fixed to one end of the handle (4) away from the main tube (1), and a connector (9) is fixed to one end of the extension tube (8) away from the handle (4). The portion of the measuring signal wire that enters the inner cavity of the handle (4) passes through the extension tube (8) and is connected to the connector (9).

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