Alcohol ablation catheter and its adjustable bending delivery system with mapping electrodes

Abstract

The present invention discloses an alcohol ablation catheter and an adjustable bending delivery system with a mapping electrode, aiming to solve the technical problem of reducing the difficulty of the catheter entering the coronary vein. The first catheter of the present invention is provided with a distal electrode and a double-hole tube starting from the distal end. The wall of the double-hole tube is provided with holes. In the free state, the distal end of the double-hole tube is L-shaped. The surface of the double-hole tube is provided with a first ring electrode. An alcohol ablation catheter is provided, which is provided with a second catheter and a wire splitter from the distal end to the proximal end. The wire splitter is connected with an inflation valve. The outer wall of the second catheter is provided with a second ring electrode, a balloon, and the distal end of the second catheter extends out of the hole. Compared with the prior art, the distal end of the first catheter can more easily enter the coronary sinus orifice. The distal end of the first catheter is provided with holes for injecting contrast agent, and the alcohol ablation catheter can be more easily delivered into the Marshall vein, making the second ring electrode closely adhere to the inner wall of the coronary sinus, with stable electrophysiological signal acquisition, convenient surgical operation, reducing the number of catheters used during the operation, and improving the surgical efficiency.

Description

Technical Field

[0001] The present invention relates to a medical surgical instrument, in particular to a delivery device for delivering an alcohol ablation catheter to the cardiac coronary vein, injecting a contrast agent, and mapping the coronary vein to ablate the Marshall ligament for treating atrial fibrillation. Background Art

[0002] Atrial fibrillation is the most common type of rapid atrial arrhythmia clinically. After the onset of atrial fibrillation, it not only worsens with age, but also increases the mortality rate of patients when they are complicated with other cardiovascular diseases. With the development of intracardiac electrophysiology and catheter ablation methods, people have gradually realized that the Marshall ligament (LOM) is closely related to atrial arrhythmia. Since 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 plexus, the conduction and reentry of electrical activity in the coronary sinus and its own conduction delay are closely related to the formation of atrial fibrillation, and this effect is particularly significant in its branch, the Marshall vein. The Marshall vein gradually degenerates and occludes to form a ligament during fetal heart development, called the Marshall ligament, which contains small veins (Marshall veins) and myocardial fibers (Marshall bundles) originating from the proximal muscle tissue of the coronary sinus and 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, and this connection constitutes the anatomical substrate for the formation of reentrant excitation. Studies have found that spontaneous electrical activity can be generated in the Marshall vein, and local electrical activity is easily induced by stimulating the Marshall ligament, and then atrial fibrillation occurs. Ablation of the Marshall vein can make these electrical activities disappear. In atypical atrial flutter mediated by the mitral isthmus, the Marshall ligament can become an effective target when isthmus ablation is ineffective.

[0003] In the existing alcohol ablation catheter delivery structure, the distal end is straight, while the coronary vein into which the alcohol ablation catheter needs to enter is narrow and curved, making it difficult to enter smoothly. Therefore, it is difficult to enter the coronary vein, and whether it can successfully enter the coronary vein depends very much on the personal skills of the surgeon. Moreover, it has a single function and only has the function of delivering the alcohol ablation catheter. Other functions such as injecting a contrast agent and mapping need to be achieved by delivering multiple catheters together. Summary of the Invention

[0004] The object of the present invention is to provide an alcohol ablation catheter and an adjustable bending delivery system with mapping electrodes, and the technical problem to be solved is to reduce the difficulty of the catheter entering the coronary vein and improve the surgical efficiency.

[0005] The present invention adopts the following technical solutions: An alcohol ablation catheter and an adjustable bending delivery system with mapping electrodes, provided with a first catheter. The first catheter is sequentially provided with a distal electrode and a double-hole tube starting from the distal end. The wall of the double-hole tube is provided with holes, and the double-hole tube has elasticity. In the free state, the distal end of the double-hole tube is in an L shape, and at least three groups of annular first ring electrodes are sleeved on the surface of the double-hole tube at intervals, with two first ring electrodes in each group; An alcohol ablation catheter is arranged in the adjustable bending delivery system with mapping electrodes. The alcohol ablation catheter is sequentially provided with a second catheter and a wire splitter from the distal end to the proximal end. A gas charging valve is connected to the proximal end of the wire splitter. Second ring electrodes are sleeved on the outer wall of the second catheter at intervals, and a balloon is sleeved between the two second ring electrodes at the most distal end. An air charging tube and an alcohol and guide wire delivery tube are arranged along the inside of the second catheter; The distal end of the air charging tube is hermetically connected to the balloon, and the proximal end is connected to the gas charging valve; The distal end of the second catheter extends out of the hole.

[0006] The second catheter of the present invention is provided with a second tube body. Second ring electrodes are sleeved on the outer wall of the second tube body at intervals, and a balloon is sleeved on the outer wall of the second tube body between the two second ring electrodes at the most distal end.

[0007] The first catheter of the present invention is connected with a Luer connector through a handle device, and the distal end of the alcohol and guide wire delivery tube reaches the distal end of the second tube body, and the proximal end is connected to a standard Luer connector.

[0008] The standard Luer connector of the present invention is connected with a flexible tube, and the flexible tube is arranged inside the first catheter and the handle device.

[0009] The double-hole tube of the present invention is bent to form an open ring shape, and the plane formed by the open ring shape forms an angle of 0 to 90 degrees with the axis of the first catheter, forming a spatial bending structure.

[0010] The distal end of the distal electrode of the present invention is hemispherical, and the arc surface of the sphere faces the distal end.

[0011] The double-hole tube of the present invention is tubular, provided with a first lumen and a second lumen. The first lumen and the second lumen are through holes, and the axes of the first lumen and the second lumen are parallel to the axis of the double-hole tube. The hole is located on the wall of the first lumen side, 10 to 64 mm away from the distal end of the distal electrode.

[0012] The distal end of the second tube body of the present invention is hemispherical.

[0013] The balloon of the present invention is made of latex, rubber or nylon.

[0014] The double-hole tube of the present invention is made of block polyether amide resin, polyurethane, block polyamide or nylon. Compared with the prior art, a hole, an end electrode and a first ring electrode are provided at the distal end of the first catheter. The distal end of the double-hole tube is bent into a spatial state, specifically for the shape of the coronary sinus, making it easier for the distal end of the first catheter to enter the coronary sinus orifice. A hole is laterally opened at the distal end of the first catheter, which can be used to inject contrast agent, and can also more easily deliver the alcohol ablation catheter into the Marshall vein, making the second ring electrode closely attached to the inner wall of the coronary sinus, with stable electrophysiological signal acquisition, facilitating surgical operation, reducing the number of catheters used during the operation, reducing the economic burden on patients, making the operation safer and faster, greatly increasing the effectiveness and operability of the operation, reducing the surgical difficulty, and improving the surgical efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a schematic structural diagram of the present invention.

[0016] Figure 2 is a schematic structural diagram of the distal end of the catheter of the present invention.

[0017] Figure 3 is a schematic structural diagram of the catheter body of the present invention after bending.

[0018] Figure 4 is a schematic diagram of the bending of the double-hole tube of the present invention (one).

[0019] Figure 5 is a schematic diagram of the bending of the double-hole tube of the present invention (two).

[0020] Figure 6 is a schematic structural diagram of the double-hole tube of the present invention.

[0021] Figure 7 is an axial sectional view of the catheter body of the present invention.

[0022] Figure 8 is a schematic structural diagram of the handle device of the present invention.

[0023] Figure 9 is a schematic structural diagram of the alcohol ablation catheter of the present invention.

[0024] Figure 10 is a schematic structural diagram of the distal end of the alcohol ablation catheter of the present invention.

[0025] Figure 11 is a schematic diagram of the side hole of the delivery catheter of the alcohol ablation catheter of the present invention extending out.

[0026] Figure 12 is a schematic structural diagram of the distal end of the side hole of the delivery catheter of the alcohol ablation catheter of the present invention extending out. DETAILED DESCRIPTION OF THE INVENTION

[0027] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments.

[0028] As Figure 1 shown, the alcohol ablation catheter of the present invention and its adjustable bending delivery system with mapping electrodes are composed of two parts: an alcohol ablation catheter and a delivery catheter for the alcohol ablation catheter. The delivery catheter of the alcohol ablation catheter is an adjustable bending delivery system with mapping electrodes, and the alcohol ablation catheter is arranged inside the adjustable bending delivery system with mapping electrodes.

[0029] The adjustable bending delivery system with mapping electrodes is sequentially provided with a first catheter 2 and a handle device 1 connected in sequence from the distal end to the proximal end. A connector 7 and a Luer connector 8 are connected to the proximal end of the handle device 1.

[0030] A standard Luer connector 8 is connected to a hose 44, and the hose 44 is arranged inside the first catheter 2 and the handle device 1.

[0031] The first catheter 2 is sequentially provided with a tip electrode 3, a double lumen tube 4, and a first tube body 5 starting from the distal end. A hole 6 is formed in the tube wall of the double lumen tube 4.

[0032] As Figure 2 shown, the distal end of the tip electrode 3 is hemispherical in shape, and the arc surface of the sphere faces the distal end. The proximal end of the tip electrode 3 is embedded and connected to the distal end of the double lumen tube 4 by using the heat fusion process method of the prior art. The length of the tip electrode 3 is 0.3 - 5 mm, preferably 1 - 4 mm, and the outer diameter of the tip electrode 3 is the same as the outer diameter of the double lumen tube 4. The tip electrode 3 is made of platinum iridium alloy or gold.

[0033] The double lumen tube 4 is tubular in shape, and it is provided with two lumens inside, namely a first lumen 41 and a second lumen 42. The first lumen 41 and the second lumen 42 are through holes, and the axes of the first lumen 41 and the second lumen 42 are parallel to the axis of the double lumen tube 4 and communicate with the inner cavity of the first tube body 5.

[0034] The outer diameter of the double lumen tube 4 is 1 - 3.7 mm, preferably 1.6 - 2.7 mm, the length is 20 - 200 mm, preferably 50 - 100 mm, the inner diameter of the first lumen 41 is 0.3 - 1.5 mm, preferably 0.75 - 0.85 mm, and the inner diameter of the second lumen 42 is 0.2 - 1.4 mm, preferably 0.6 - 0.7 mm.

[0035] The hole 6 is located on the tube wall of the double lumen tube 4 on the side of the first lumen 41, with a diameter of 0.3 - 3 mm, preferably 1 - 2 mm, and the hole 6 is 10 - 64 mm away from the distal end of the tip electrode 3.

[0036] The double lumen tube 4 is made of block polyether amide resin PEBAX, polyurethane, block polyamide or nylon, and has elasticity, so that the bending degree of the double lumen tube 4 can be adjusted through the handle device 1.

[0037] As Figure 4 shown, in the free state, the distal end of the double-hole tube 4 is L-shaped.

[0038] As Figure 3 and Figure 5 shown, the bending degree of the double-hole tube 4 is adjusted to make it an open ring shape, and the plane formed by the open ring shape forms an angle of 0 to 90 degrees with the axis of the first catheter 2, forming a space-bent structure.

[0039] At least three groups of annular first ring electrodes 43 are sleeved on the surface of the double-hole tube 4 at intervals. Each group has two first ring electrodes. The inner diameter of the first ring electrode 43 is 0.33 - 4 mm, preferably 1 - 3 mm; the outer diameter is 0.38 - 4.05 mm, preferably 1.05 - 3.05 mm; and the width is 0.2 - 4 mm, preferably 1 mm - 3 mm. The ring electrode 3 is made of platinum-iridium alloy or gold.

[0040] A first wire is connected to the inner side of the first ring electrode 3. The first wire is electrically connected to the connector 7 through the first lumen 41, inside the first body 5, and inside the handle device 1. The first wire is made of copper wire with a diameter of 0.01 - 0.5 mm, preferably 0.1 - 0.2 mm. The copper wire is coated with a coating, and the insulation strength of the coating is not less than 500 V, preferably not less than 2000 V.

[0041] A pull wire 9 is welded and connected to the proximal end of the end electrode 3. The pull wire 9 is connected to the handle device 1 through the second lumen 42 and the first body 5.

[0042] As Figure 6 shown, a tubular riveting tube 10 is provided at the welding joint of the pull wire 9 and the end electrode 3. The riveting tube 10 is sleeved on the pull wire 9 at the welding joint of the end electrode 3 and the pull wire 9 and is welded to the pull wire 9. The riveting tube 10 is located at the distal end face of the second lumen 42, and the surface of the riveting tube 10 is coated with a riveting tube sleeve 101. A pull wire outer tube 11 is sleeved on the surface of the pull wire 9 to prevent the pull wire 7 from rubbing against the inner wall of the second lumen 42 during pulling, which affects the bending of the double-hole tube 4.

[0043] As Figure 7 shown, the first body 5 is tubular. The proximal end of the first body 5 is connected to the distal end of the handle device 1, and the distal end of the first body 5 is connected to the double-hole tube 4.

[0044] The outer diameter of the first body 5 is 0.8 - 5.4 mm, preferably 1.6 - 2.7 mm; the inner diameter is 0.5 - 4 mm, preferably 1 - 2 mm; and the length is 400 - 2100 mm, preferably 800 - 1050 mm.

[0045] The first tube body 5 is made of PEBAX, polyurethane, block polyamide or nylon, and a stainless steel wire mesh 51 is embedded in the tube wall of the first tube body 5 according to the prior art (patent application number 202020703562.3).

[0046] The connector 7 can be placed at the proximal end of the handle device 1 through an extension wire, or can also be placed inside the handle device 1.

[0047] One end of a standard luer connector 8 is connected to a hose 44. The hose 44 can extend out of the hole 6 through the handle device 1, the first tube body 5 and the first lumen 41.

[0048] The hose 44 is made of polyurethane PU, PEBAX, nylon or a composite film PTFEPI with a polyimide-based film and double-sided composite modified polytetrafluoroethylene. The hose 44 forms a sliding fit connection with the inner wall of the first lumen 41 inside the first lumen 41. The outer diameter of the hose 44 is 0.2 - 1.5 mm, preferably 0.5 - 0.75 mm. The hose 44 can inject contrast agent into the blood vessel from the luer connector 8 through the hole 6, or can also input an alcohol ablation catheter from the luer connector 8 and extend it into the blood vessel through the hole 6.

[0049] As Figure 8 As shown, the handle device 1 is provided with a handle housing 13 in the shape of a rotating body according to the prior art (patent application number 202020703562.3). A through hole 12 coaxial with it is opened in the rotating body. The distal outer edge of the handle housing 13 is threadedly connected with a handle cover 14, and a handle cover hole 15 coaxial with the through hole 12 is opened in the handle cover 14. A push rod 16 is arranged inside the distal end of the handle housing 13, and the push rod 16 extends out of the distal end of the handle cover 14.

[0050] The handle device 1 is provided with a limit bolt 17, a locking nut 18 and a wire fixing column 19.

[0051] The axial movement range of the push rod 16 in the handle housing 13 is controlled by the limit bolt 17.

[0052] The locking nut 18 fixedly connects the proximal end of the first tube body 5 to the push rod 16.

[0053] The pull wire 8 passes through the second lumen 42, inside the first tube body 5 and then through the through hole 12 of the handle housing 13, and is connected to the wire fixing column 19.

[0054] Pushing the push rod 16 axially towards the distal end, the push rod 16 extends out of the handle housing 13. The sum of the lengths of the double-hole tube 4, the first tube body 5 and the handle device 1 increases, and the length of the pull wire 8 remains unchanged, causing the elastic double-hole tube 4 to bend, so as to adjust the bending degree of the double-hole tube 4.

[0055] As Figure 9As shown, the alcohol ablation catheter is provided with a second catheter 20 and a splitter 24 connected in sequence from the distal end to the proximal end, and an inflation valve 25 is connected to the proximal end of the splitter 24.

[0056] As Figure 10 shown, the second catheter 20 is provided with a tubular second tube body 22, the distal end of which is hemispherical. A second annular electrode 23 is sleeved at intervals outside the wall of the second tube body 22 on the proximal side of the hemispherical shape. A balloon 21 is sleeved outside the wall of the second tube body 22 between the two most distal second annular electrodes 23. The proximal end of the second tube body 22 is connected to the splitter 24.

[0057] The second tube body 22 is made of segmented polyether block amide resin PEBAX, polyurethane, block polyamide or nylon.

[0058] The number of the second annular electrodes 23 is 2 - 20, preferably 2 - 10. The outer diameter of the second annular electrode 23 is 0.15 - 2.05 mm, preferably 0.35 - 1.05 mm.

[0059] The balloon 21 is made of latex, rubber or nylon.

[0060] Inside the tube of the second tube body 22, there are an inflation tube 221, an alcohol and guide wire delivery tube 222, a second wire 26 and a second wire lumen 27.

[0061] The inflation tube 221 is a hollow tube. The distal end of the inflation tube 221 is hermetically connected to the balloon 21, and the proximal end is connected to the output end of the inflation valve 25 to inflate the balloon 21 through the inflation valve 25.

[0062] The alcohol and guide wire delivery tube 222 is a hollow tube. The distal end of the alcohol and guide wire delivery tube 222 reaches the distal end of the second tube body 22, and the proximal end is connected to the standard Luer connector 8 for delivering alcohol or a guide wire to the coronary vein.

[0063] The second wire 26 is electrically connected to the second annular electrode 23 and the connector 7. The second wire 26 is arranged in the wire lumen 27. The second wire 26 is made of a copper wire with a diameter of 0.01 - 0.5 mm, preferably 0.1 - 0.2 mm. The copper wire is coated with a coating, and the insulation strength of the coating is not less than 500 V, preferably not less than 2000 V.

[0064] As Figure 11 shown, the distal end of the alcohol ablation catheter enters from the Luer connector 8, passes through the flexible tube 44 and enters the adjustable bend delivery system with a mapping electrode. The second catheter 20 finally extends out from the hole 6 and enters the coronary vein for electrophysiological signal detection or treatment.

[0065] Usage method of the present invention: Push the distal end of the adjustable-bending delivery system with mapping electrodes from the femoral artery into the heart, adjust the handle device 1 to control the bending angle of the double-hole tube 4, so that the tip electrode 3 and the double-hole tube 4 smoothly enter the coronary sinus ostium. The first annular electrode 43 abuts against the inner wall of the coronary sinus. Continuously move the adjustable-bending delivery system with mapping electrodes proximally and distally to obtain electrophysiological information at various points. Inject the contrast agent into the coronary vein through the standard Luer connector 8, the hose 44, the second catheter 20, and the hole 6. Subsequently, insert the alcohol ablation catheter into the Marshall vein through the Luer connector 8 and the hole 6. As Figure 12 shown, inflate the balloon 21 by inflating the inflation valve 25. After completely blocking the blood vessel, lock the inflation valve 25, and then obtain the electrophysiological information at various points at the target position through the second annular electrode 23. Subsequently, inject absolute alcohol into the blood vessel through the standard Luer connector 8 to complete the alcohol ablation surgery.

[0066] The present invention simultaneously realizes injecting the contrast agent and delivering the alcohol ablation catheter for alcohol ablation on a single catheter, and has the mapping ability to monitor the ablation effect in real time.

[0067] The present invention can conveniently place the adjustable-bending delivery system with mapping electrodes into the coronary vein. There is a hole 6 at its distal end, which can be used to inject the contrast agent first to display the Marshall vein. The hole 6 makes it easier for the alcohol ablation catheter to enter the Marshall vein, so that the second annular electrode 23 abuts tightly against the inner wall of the coronary sinus, and the electrophysiological signal acquisition is stable. The adjustable-bending delivery system with mapping electrodes is provided with a tip electrode 3 and a first annular electrode 43, which can realize real-time acquisition of electrocardiogram signals during the operation to evaluate the surgical effect. The distal end of the double-hole tube 4 can be released into an L shape (natural state). The plane formed by the bent shape in an open ring shape forms an angle with the first catheter 2, forming a spatial bent state, which is a bent shape specifically for the shape of the coronary sinus, making it easier for the distal end of the first catheter 2 to enter the coronary sinus ostium. The alcohol ablation catheter can ensure a smoother balloon inflation process and facilitate the surgical operation.

[0068] The present invention uses a single catheter to achieve multiple functions, reduces the number of catheters used during the operation, reduces the economic burden on patients, makes the operation safer and faster, greatly increases the effectiveness and operability of the operation clinically, reduces the operation difficulty, saves the operation time, and improves the operation efficiency.

Claims

1. An adjustable bending delivery system with mapping electrodes, provided with a first catheter (2), a tip electrode (3) and a first ring electrode (43), characterized in that: The first catheter (2) is sequentially connected to the end electrode (3) and the double-hole tube (4) starting from the distal end. The wall of the double-hole tube (4) is provided with holes (6) having a diameter of 0.3 to 3 mm. The double-hole tube (4) is elastic. In the free state, the distal end of the double-hole tube (4) is in an L shape. At least three groups of annular first ring electrodes (43), with two first ring electrodes in each group, are sleeved on the surface of the double-hole tube (4) at intervals. An alcohol ablation catheter is arranged in the adjustable bending delivery system with the mapping electrode. The alcohol ablation catheter is sequentially connected with a second catheter (20) and a wire splitter (24) from the distal end to the proximal end. A gas filling valve (25) is connected to the proximal end of the wire splitter (24). Second ring electrodes (23) are sleeved on the outer wall of the second catheter (20) at intervals. A balloon (21) is sleeved between the two second ring electrodes (23) at the most distal end. An air filling tube (221) and an alcohol and guide wire delivery tube (222) are arranged inside the second catheter (20). The distal end of the air filling tube (221) is hermetically connected to the balloon (21), and the proximal end is connected to the gas filling valve (25). The distal end of the second catheter (20) extends out of the hole (6).

2. The adjustable bending delivery system with mapping electrodes according to claim 1, wherein: The second catheter (20) is provided with a second tube body (22). Second ring electrodes (23) are sleeved on the outer wall of the second tube body (22) at intervals. A balloon (21) is sleeved on the outer wall of the second tube body (22) between the two second ring electrodes (23) at the most distal end.

3. The adjustable bending delivery system with a mapping electrode according to claim 2, wherein: The first catheter (2) is connected with a Luer connector (8) through a handle device (1). The distal end of the alcohol and guide wire delivery tube (222) to the distal end of the second tube body (22) is connected to the Luer connector (8) at the proximal end.

4. The adjustable-bend delivery system with mapping electrodes according to claim 3, wherein: The Luer connector (8) is connected with a flexible tube (44). The flexible tube (44) is arranged inside the first catheter (2) and the handle device (1).

5. The adjustable bending delivery system with mapping electrodes according to claim 4, wherein: The double-hole tube (4) is bent to form an open ring shape. The plane formed by the open ring shape forms an angle of 0 to 90 degrees with the axis of the first catheter (2), forming a spatial bent structure.

6. The steerable delivery system with mapping electrodes according to claim 5, wherein: The distal end of the end electrode (3) is hemispherical, and the arc surface of the sphere faces the distal end.

7. The adjustable bending delivery system of the mapping electrode according to claim 6, wherein: The double-hole tube (4) is tubular and is provided with a first lumen (41) and a second lumen (42). The axes of the first lumen (41) and the second lumen (42) are parallel to the axis of the double-hole tube (4). The hole (6) is located on the wall of the first lumen (41) side, 10 to 64 mm away from the distal end of the end electrode (3).

8. The adjustable-bend delivery system with mapping electrodes according to claim 7, wherein: The distal end of the second tube body (22) is hemispherical.

9. The adjustable bending delivery system with a mapping electrode according to claim 8, characterized in that: The balloon (21) is made of rubber or nylon.

10. The adjustable bending delivery system with a mapping electrode according to claim 9, characterized in that: The double-hole tube (4) is made of polyurethane or block polyamide.

Images