Soft single-row pulse ablation device and pulse ablation catheter system

Abstract

The invention discloses a soft single-row pulse ablation device and a pulse ablation catheter system. The soft single-row pulse ablation device comprises an electrode structure, a conveying pipe and a handle. Wherein the electrode structure is provided with an insulating conduit and at least one pair of electrode plates, the adjacent electrode plates are insulated and separated, and the electrode plates are spirally wound on the insulating conduit along the axial direction of the insulating conduit to form spiral electrode plates; the far end of the conveying pipe is connected with the near end of the electrode structure; the far end of the handle is connected with the near end of the conveying pipe. The spiral electrode slice of the electrode structure has good flexibility while increasing the ablation depth, and can be well attached to the outer wall of the atrium. The technical problem that an original electrode structure cannot meet the requirements for sufficient ablation depth and good flexibility at the same time is solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a soft single-row pulsed ablation device and a pulsed ablation catheter system. Background Art

[0002] Atrial fibrillation is an arrhythmia accompanied by uncoordinated atrial electrical activity, which leads to ineffective atrial contraction and can clinically cause various serious diseases such as arrhythmia, stroke, heart failure, and even fatal cardiac embolism.

[0003] Due to the existence of pulmonary vein muscle sleeves, the pulmonary veins become the main cause of atrial fibrillation. There are colonies of myocardial cells between the intima and adventitia of the pulmonary veins. Since the cells forming the myocardial sleeves have a different origin from atrial muscle and different electrophysiological characteristics, an abnormal excitation substrate will be formed, leading to atrial fibrillation.

[0004] Advanced atrial fibrillation can lead to heart failure. As an incurable disease, heart failure threatens the lives of patients at all times. There are many reasons affecting heart failure. By unilaterally ablating the greater splanchnic nerve through a catheter, the sympathetic nervous system can be restored to normal, and then the internal organs can return to normal contraction, redistributing the blood in the human body, normalizing the cardiopulmonary pressure, and ultimately reducing the symptoms of heart failure. A new treatment method for heart failure has been developed. Protect the inner wall during the nerve treatment process and transmit more effective content to the nerves on the outer wall of the blood vessels.

[0005] Catheter radiofrequency ablation has obtained more clinical applications due to its simple structure and easy operation. However, as a type of thermal ablation, radiofrequency ablation can cause damage to surrounding tissues during the ablation process, and there will be a problem that ablation is incomplete due to some lesions being located deeper.

[0006] Different tissues have different breakdown voltages. Pulsed ablation is designed based on this characteristic. It applies a voltage around the tissue to form an electric field of a specific intensity, breaking down the tissue that causes abnormal electrical signals and having little impact on other tissues. Moreover, the operation time is short, and patients do not need to be observed in the ICU after the operation.

[0007] Currently, the main methods for treating atrial fibrillation by pulsed ablation are: trans-femoral vein catheter ablation, surgical clamps for surgical operations, etc. These two methods have problems such as a long surgical approach, high requirements for equipment, or the need for thoracotomy surgery, which cause great damage to patients.

[0008] Therefore, it is necessary to develop a pulsed ablation device that can reduce the pain of patients and does not significantly prolong the operation time.

[0009] The Cox Maze IV uses a "cut and suture" method to treat atrial tissue. Although this method can completely block electrical conduction, the accompanying bleeding risk cannot be ignored. In order to achieve the goal of quickly and thoroughly ablating atrial tissue and reducing or eliminating bleeding.

[0010] Pulse Field Ablation (PFA) is a technique that uses high-voltage discharges to cause irreversible electroporation of cells. It can directly act on cells to cause apoptosis and thus achieve the therapeutic purpose. The irreversible electroporation ablation technique used in PFA is a non-thermal ablation technique. It can selectively break down cells by adjusting the voltage magnitude without affecting the surrounding tissues, and there will be no tissue scabbing during and after the operation. Therefore, it will not affect the normal function of the pulmonary trachea. In addition, since the mechanism of cell death caused by irreversible electroporation is apoptosis rather than necrosis. The advantage of apoptosis is that apoptotic cells are cleared through immune intervention while phagocytic cells clear apoptotic cells as the death process of normal cells, thus promoting the regeneration and repair of normal tissues. Therefore, the treatment area can be replaced by normal cells in a short time after treatment with irreversible electroporation to restore its original function.

[0011] In the existing pulse ablation device, the electrodes of the electrode structure are hard blocks. To achieve sufficient ablation depth, the distance between the electrodes needs to be reduced. At this time, the flexibility of the electrode structure will decrease and it cannot fit well with the outer wall of the atrium; if good flexibility is desired, it is difficult to achieve sufficient ablation depth. That is, the electrode structure of the existing pulse ablation device cannot simultaneously meet the requirements of sufficient ablation depth and good flexibility. Therefore, it is necessary to improve it. Summary of the Invention

[0012] Aiming at the technical problem that the electrode structure of the existing technology cannot simultaneously meet the requirements of sufficient ablation depth and good flexibility, the present invention aims to provide a soft single-row pulse ablation device and a pulse ablation catheter system.

[0013] The soft single-row pulse ablation device of the present invention includes:

[0014] An electrode structure having an insulating catheter and at least a pair of electrode plates, with adjacent electrode plates insulated from each other, and the electrode plates are helically wound around the insulating catheter along the axial direction of the insulating catheter to form a helical electrode plate;

[0015] A delivery tube, the distal end of which is connected to the proximal end of the electrode structure;

[0016] A handle, the distal end of which is connected to the proximal end of the delivery tube.

[0017] In a preferred embodiment of the present invention, the paired electrode sheets are helically wound around the outer surface of the distal end of the insulating catheter in a double helix structure.

[0018] In a preferred embodiment of the present invention, the insulating catheter is a soft insulating catheter.

[0019] In a preferred embodiment of the present invention, the lateral spacing between the paired electrode sheets is 1.5 - 2.5 mm, preferably 1.8 - 2.3 mm.

[0020] In a preferred embodiment of the present invention, the helical electrode sheets are wound around the insulating catheter for 3 - 6 turns, preferably 3 - 5 turns.

[0021] In a preferred embodiment of the present invention, the total length of the helical electrode sheets wound around the insulating catheter is 2.5 - 3.5 cm, preferably 2.8 - 3.3 cm.

[0022] In a preferred embodiment of the present invention, the diameter of the insulating catheter is 2 - 4 mm.

[0023] In a preferred embodiment of the present invention, the delivery tube is a rigid delivery tube.

[0024] In a preferred embodiment of the present invention, the distal end of the delivery tube is connected to the proximal end of the insulating catheter.

[0025] The pulsed ablation catheter system of the present invention includes:

[0026] The above-mentioned soft single-row pulsed ablation device;

[0027] A high-energy pulse generator, connected to the soft single-row pulsed ablation device, to generate high-voltage pulses;

[0028] A micro temperature sensor, arranged at the distal end of the insulating catheter in the soft single-row pulsed ablation device, to detect tissue temperature;

[0029] An intelligent control system, communicatively connected to the soft single-row pulsed ablation device, the high-energy pulse generator and the micro temperature sensor, to automatically adjust the output intensity and frequency of the pulses according to temperature changes.

[0030] The positive and progressive effects of the present invention are as follows:

[0031] 1) The electrode sheets of the soft single-row pulsed ablation device of the present invention adopt a double helix structure, which not only increases the ablation depth but also has good flexibility, facilitating bending and thus effectively conforming to the outer wall of the atrium.

[0032] 2) Sufficient safety distance is maintained between the helical electrode sheets to avoid ionization during pulsed treatment and ensure safety under high voltage. Brief Description of the Drawings

[0033] Figure 1 Structural schematic diagram of the electrode structure of the soft single-row pulsed ablation device of the present invention;

[0034] Figure 2 Working schematic diagram of the electrode structure of the soft single-row pulsed ablation device of the present invention;

[0035] Figure 3 Structural schematic diagram of the handle of the soft single-row pulsed ablation device of the present invention. Specific embodiments

[0036] The following uses specific specific examples to illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0037] It should be noted that the terms "distal end", "proximal end", "distal segment", and "proximal segment" are used in the present invention as orientation terms. These orientation terms are conventional terms in the field of interventional medical devices. Among them, "distal end" and "distal segment" refer to the end or segment far from the operator during the surgical process, and "proximal end" and "proximal segment" refer to the end or segment close to the operator during the surgical process. The axial direction refers to the direction parallel to the line connecting the centers of the distal end and the proximal end of the medical device.

[0038] The soft single-row pulsed ablation device of the present invention includes: an electrode structure 10, a delivery tube 20, and a handle 30. The distal end of the delivery tube 20 is connected to the proximal end of the electrode structure 10 and is used to apply pressure to the electrode structure 10. The distal end of the handle 30 is connected to the proximal end of the delivery tube 20, which is convenient for the doctor to hold the soft single-row pulsed ablation device and control the electrode structure 10 to place it on the target tissue and press for ablation treatment surgery.

[0039] Among them, as Figure 1As shown, the electrode structure 10 is composed of an insulating catheter 11 and a pair of electrode plates 12. Here, there is at least one pair of electrode plates, and of course, there can also be multiple pairs of electrode plates. Here, a pair of electrode plates is taken as an example for illustration. The two electrode plates 12 of the pair respectively form a positive electrode plate and a negative electrode plate, and are insulated from each other between adjacent electrode plates 12 to prevent the direct connection between the positive electrode plate and the negative electrode plate from causing a short circuit. In this example, the lateral distance between the pair of electrode plates 12 is 1.5 - 2.5 mm, preferably 1.8 - 2.3 mm, that is, a sufficient safety distance is maintained between the pair of electrode plates 12 to avoid ionization during pulsed treatment. The pair of electrode plates 12 are spirally wound around the insulating catheter 11 along the axial direction of the insulating catheter 11 to form a spiral electrode plate 12. Further preferably, the pair of electrode plates 12 are spirally wound around the outer surface of the distal end of the insulating catheter 11 in a double - helix structure along the axial direction of the insulating catheter 11, and the pitch of the double - helix structure is 1.5 - 2.5 mm, preferably 1.8 - 2.3 mm. In addition, the pair of electrode plates 12 are spirally wound around the outer surface of the distal end of the insulating catheter 11, that is, the pair of electrode plates 12 are insulated from each other by the insulating catheter 11.

[0040] In this example, the insulating catheter is made of high - quality insulating material to avoid current leakage from damaging the surrounding healthy tissues, and the insulating catheter 11 is a soft insulating catheter 11. In this example, the insulating catheter 11 is a slender cylindrical shape with a diameter of 2 - 4 mm, which is used to guide the current safely, and has a smooth head at the distal end to avoid scratching the tissues. When the insulating catheter 11 is placed on the heart surface for pressing, the insulating catheter 11 will bend and fit along with the depression of the heart surface, and thus effectively fit with the outer wall of the patient's atrium. The pair of electrode plates 12 are thin - sheet electrode plates 12 with good flexibility. After the pair of electrode plates 12 are wound around the insulating catheter 11 in a double - helix structure to form the electrode structure 10, it still has good flexibility and can still effectively fit with the outer wall of the patient's atrium.

[0041] In this example, the pair of electrode plates 12 are spirally wound around the outer surface of the distal end of the insulating catheter 11 for several turns to form a spiral electrode plate 12. Further, the spiral electrode plate 12 is wound around the insulating catheter 11 for 3 - 6 turns, preferably 3 - 5 turns, more preferably 3 - 4 turns. In this way, a continuous and flexible spiral electrode plate 12 is formed on the insulating catheter 11, and then the spiral electrode plate 12 can generate a uniform and continuous electric field, thereby increasing the ablation depth. Further, the total length of the spiral electrode plate 12 wound around the insulating catheter 11 is 2.5 - 3.5 cm, preferably 2.8 - 3.3 cm.

[0042] In the prior art, the electrode structure is a rigid or annular electrode wound around a catheter. Since the surface of the heart is an irregular arc, the rigid electrode structure and the annular electrode cannot effectively conform to the outer surface of the heart. In the prior art, in order to make the electrode structure effectively conform to the outer surface of the heart, several annular electrodes are arranged at a certain distance, so that the electrode structure can effectively bend and conform to the outer wall of the heart. However, such a structure will cause the electric field generated by the electrode structure to be discontinuous and uneven, thereby reducing the ablation depth. If a continuous and uniform electric field is to be generated, the adjacent annular electrodes cannot be too far apart. In this way, the flexibility of the electrode structure will be reduced, making the electrode structure unable to effectively conform to the outer wall of the heart. That is, the electrode structure in the prior art cannot satisfy both flexibility and ablation depth at the same time. The electrode structure 10 of the present invention not only has good softness, which is beneficial to bending and conforming to the outer wall of the atrium, but also the double-helix electrode sheet 12 can generate a continuous and uniform electric field, which can increase the ablation depth.

[0043] In this example, the delivery tube 20 is a rigid delivery tube 20, such as made of stainless steel or aluminum alloy and the like. Among them, the distal end of the delivery tube 20 is connected to the proximal end of the insulating catheter 11. A rubber sleeve can be sleeved at the connection transition of the delivery tube 20 and the insulating catheter 11 to protect the connection between the delivery tube 20 and the insulating catheter 11, such as a rubber or silicone rubber sleeve. The delivery tube 20 can apply pressure to the electrode structure 10, so that the spiral electrode sheet 12 on the insulating catheter 11 better conforms to the outer wall of the atrium.

[0044] In this example, as Figure 3 shown, the soft single-row pulsed ablation device of the present invention also has a handle 30, which can be held by a doctor to operate the soft single-row pulsed ablation device of the present invention, thereby controlling the electrode structure 10 to be accurately placed on the target tissue for ablation treatment, and applying pressure to the delivery tube 20, so that the delivery tube 20 applies pressure to the electrode structure 10 to make it effectively conform to the outer wall of the atrium. It should be noted that the shape of the handle 30 is not fixed, as long as it can be held by a doctor to operate the soft single-row pulsed ablation device for ablation treatment surgery.

[0045] In another example, the pulse ablation catheter system includes: a soft single-row pulse ablation device, a high-energy pulse generator, a micro temperature sensor and an intelligent control system. The high-energy pulse generator is connected to the soft single-row pulse ablation device to generate high-voltage pulses, thereby achieving precise attacks on diseased tissues; the micro temperature sensor is located at the distal end of the insulating catheter in the soft single-row pulse ablation device, which can monitor the tissue temperature of the ablation area in real time and provide accurate data for the intelligent control system; the intelligent control system is connected to the soft single-row pulse ablation device, the high-energy pulse generator and the micro temperature sensor, and can automatically adjust the output intensity and frequency of the pulse according to the changes in the tissue temperature in the ablation area, ensuring that the treatment process is accurate and safe.

[0046] When implementing treatment, the soft single-row pulse ablation device is connected to other equipment of the pulse ablation catheter system. First, a high-voltage pulse is generated by a high-energy pulse generating device, and then the insulating catheter 11 of the soft single-row pulse ablation device guides the current safely to avoid damage to surrounding healthy tissue. At the same time, the micro temperature sensor monitors the tissue temperature of the ablation area in real time and feeds the data back to the intelligent control system. The intelligent control system uses the data to control the output intensity and frequency of the pulse generated by the high-energy pulse generator, thereby achieving precise ablation of the target tissue and ensuring the accuracy and reliability of the treatment.

[0047] The present invention is described in detail above in conjunction with the embodiments of the drawings, and those skilled in the art can make various variations of the present invention according to the above description. Therefore, certain details in the embodiments should not constitute limitations on the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. A soft single-row pulse ablation device, characterized in that: The soft single-row pulse ablation device comprises: An electrode structure, comprising an insulating conduit and at least one pair of electrode sheets, wherein adjacent electrode sheets are insulated and separated, and wherein the electrode sheets are spirally wound around the insulating conduit along the axial direction of the insulating conduit to form a spiral electrode sheet; a delivery tube, the distal end of which is connected to the proximal end of the electrode structure; A handle, the distal end of the handle is connected to the proximal end of the delivery tube.

2. The soft single-row pulse ablation device according to claim 1, characterized in that: The paired electrode sheets are spirally wound around the outer surface of the distal end of the insulating catheter in a double helix structure.

3. The soft single-row pulse ablation device according to claim 1, characterized in that: The insulating conduit is a soft insulating conduit.

4. The soft single-row pulse ablation device according to claim 2, characterized in that: The lateral spacing between the paired electrode sheets is 1.5 to 2.5 mm, preferably 1.8 to 2.3 mm.

5. The soft single-row pulse ablation device according to claim 2, characterized in that: The spiral electrode sheet is wound around the insulating conduit for 3 to 6 turns, preferably 3 to 5 turns.

6. The soft single-row pulse ablation device according to claim 2, characterized in that: The total length of the spiral electrode sheet wound on the insulating conduit is 2.5 to 3.5 cm, preferably 2.8 to 3.3 cm.

7. The soft single-row pulse ablation device according to claim 3, characterized in that: The diameter of the insulating conduit is 2-4 mm.

8. The soft single-row pulse ablation device according to claim 1, characterized in that: The delivery pipe is a hard delivery pipe.

9. The soft single-row pulse ablation device according to claim 8, characterized in that: The distal end of the delivery tube is connected to the proximal end of the insulating catheter.

10. A pulse ablation catheter system, characterized in that: include: The soft single-row pulse ablation device according to any one of claims 1 to 9; A high-energy pulse generator, connected to the soft single-row pulse ablation device, generating high-voltage pulses; A micro temperature sensor is disposed at the distal end of the insulating catheter in the soft single-row pulse ablation device to detect tissue temperature; The intelligent control system is connected in communication with the soft single-row pulse ablation device, the high-energy pulse generator and the micro temperature sensor, and automatically adjusts the output intensity and frequency of the pulse according to temperature changes.

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