Pulse and cryoablation all-in-one machine

Abstract

The present invention provides an integrated pulse and cryoablation machine, including a pulse and cryoablation generator, a connecting cable, a refrigerant medium transmission tube, a catheter, and a balloon; the pulse and cryoablation generator has two functions of pulse and cryoablation, and pulse and cryoablation can be selected on its interface; the connecting cable connects the pulse and cryoablation generator to the catheter to transmit pulse energy, and the refrigerant medium transmission tube delivers the refrigerant generated by the pulse and cryoablation generator to the balloon; the balloon surrounds the catheter, the end of the catheter extends from the far end of the balloon and folds back to surround the outer surface of the balloon, and a plurality of groups of electrodes are provided on the catheter for use as pulse electrodes and extracting electrocardiographic signals; when pulse ablation is selected, discharge occurs between the electrodes to achieve pulse ablation; when cryoablation is selected, the refrigerant is transmitted to the far end of the balloon to produce a freezing effect, and the electrodes extract electrocardiographic signals. The present invention realizes the selective use of pulse and cryoablation and is safer.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, in particular to a pulse and cryoablation integrated machine. Background Art

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. Stroke and other thromboembolic events caused by AF are the main causes of death or disability in patients. Clinical studies in many countries have shown that the total incidence of AF is about 2%, and the incidence of AF has been gradually increasing in recent years. Non-drug treatment of AF has been a research hotspot in recent years. Many clinical studies at home and abroad have shown that successful electrical isolation of pulmonary veins using catheter radiofrequency ablation technology can effectively prevent the recurrence of AF. Studies have shown that catheter ablation is an effective means to restore and maintain sinus rhythm in patients with AF. Catheter ablation is mainly based on radiofrequency energy, but there are also other energy sources (including cryoablation, ultrasound, and laser ablation). However, these ablations based on heat / cold conduction have certain limitations. They lack selectivity in destroying tissues in the ablation area and rely on the adhesion force of the catheter, so they may cause damage to the adjacent esophagus, coronary artery, and phrenic nerve.

[0003] At present, relevant guidelines recommend that catheter ablation can be used as the first-line treatment for patients with symptomatic atrial fibrillation, especially for patients with drug-refractory atrial fibrillation. Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation and the main procedure for atrial fibrillation (AF) ablation. Traditional radiofrequency ablation mainly converts current into heat energy through the impedance of the tissue when the current flows through the affected tissue. This heat energy is then transmitted to the adjacent tissue through conduction and very small radiation, thereby causing a small range of tissue damage, which is the so-called point-by-point ablation. Through point-by-point ablation, segmental or circumferential pulmonary vein electrical isolation is completed to form complete electrical isolation of the pulmonary vein-left atrium, namely PVI. However, this technology is relatively difficult to operate, with a long ablation time and a long learning curve. It has high requirements for operators and patients experience obvious pain during the operation. In addition, some patients cannot form transmural damage during radiofrequency ablation of the pulmonary veins, which easily leads to pulmonary vein leakage points, leading to recurrence of atrial fibrillation. In recent years, cryoballoon ablation has gradually become one of the important means of catheter ablation for atrial fibrillation. As early as 2012, the American Heart Rhythm Society expert consensus pointed out that cryoballoon ablation has become the standard ablation method for atrial fibrillation catheter ablation. The domestic 2015 atrial fibrillation guidelines also pointed out that cryoballoon ablation can be used for PVI. Although the complications of cryoballoon ablation for atrial fibrillation have a tendency to decrease with the accumulation of experience and the continuous improvement of the design and production technology of related cryosystems and cryoballoon catheters, the incidence rate can still be as high as 5%. Once some complications (such as phrenic nerve injury, atrial esophageal fistula, etc.) occur, the consequences are relatively serious. New energy is needed to assist cryoballoon ablation to reduce the incidence of complications with more serious consequences such as esophageal fistula / phrenic nerve. Unlike traditional energy, pulsed electric field energy forms irreversible micropores on the cell membrane through instantaneous discharge, causing cell apoptosis and achieving the purpose of non-thermal ablation, which is also called irreversible electroporation. At present, electroporation ablation has been used as an effective means to destroy malignant tumor tissue. In theory, pulsed electric field ablation can damage myocardial cells without heating the tissue, and has cell / tissue selectivity, protecting surrounding critical structures. Avoid certain perioperative complications of radiofrequency ablation and cryoablation for the treatment of symptomatic atrial fibrillation, and some patients will have relapses. Pulsed electric field energy can cause cell apoptosis by forming nanoscale holes in the cell membrane, and has the characteristics of non-thermal and tissue selectivity. For example, for ablation near the esophagus in the lower left and the diaphragm in the upper right, pulsed ablation is used to damage the target tissue without any effect on the esophagus and diaphragm.

[0004] However, in existing treatments, cryoablation is safer in some myocardial areas. In addition, in thick-walled areas, the ablation lesions need to be deeper to penetrate the wall, which requires cryoablation. Pulse ablation is required for the left inferior pulmonary vein or some abnormal pulmonary veins close to the esophagus. In addition, for the right superior pulmonary vein close to the diaphragm, pulse ablation is used to stimulate the diaphragmatic nerve without the need for an additional catheter such as cryoablation. Therefore, one device that has these two functions can greatly shorten the operation time, improve success, and reduce complications and patient pain. Therefore, it is necessary to invent a device that is compatible with pulse and cryoablation. Summary of the invention

[0005] The purpose of the present invention is to solve the existing ablation problems in the heart rate market and to provide a device that can select a suitable ablation method according to the patient and the lesion condition, thereby reducing the patient's pain and improving the safety and effectiveness of the operation.

[0006] In order to achieve this purpose, the present invention provides an integrated pulse and cryoablation machine, including a pulse and cryoablation generator, a connecting cable, a refrigerant medium transmission tube, a catheter, and a balloon; the pulse and cryoablation generator has two functions of pulse and cryoablation, and pulse and cryoablation can be selected on its interface; the connecting cable connects the pulse and cryoablation generator with the catheter to transmit pulse energy, and the refrigerant medium transmission tube transports the refrigerant generated by the pulse and cryoablation generator to the balloon; the balloon surrounds the catheter, the end of the catheter extends from the distal end of the balloon and folds back to surround the outer surface of the balloon, and a plurality of groups of electrodes are provided on the catheter for use as pulse electrodes and extracting electrocardiographic signals; when pulse ablation is selected, discharge occurs between the electrodes to achieve pulse ablation; when cryoablation is selected, the refrigerant is transmitted to the distal end of the balloon to produce a freezing effect, and the electrodes extract electrocardiographic signals.

[0007] It also includes a detector connected to the pulse and cryo generator. When the pulse is discharged, the detector controls the circuit on and off. The discharge can only be performed when the detector detects the R wave. The pulse and cryo generator are connected to the electrodes through the positive and negative sockets respectively, so that the positive and negative electrodes can be separated, making pulse ablation safer.

[0008] The balloon has two layers, the inner and outer layers, with the outer layer in direct contact with the myocardial tissue. The inner and outer balloons are connected to the catheter at both ends. A sensor is installed between the inner and outer layers of the balloon to sense the pressure changes between the inner and outer layers. A sensor is installed inside the balloon, and the sensor alarms when the balloon is damaged by external force or other reasons. The outer balloon is attached to the pulmonary vein during cryoablation, and the folded back part of the catheter end is tightly attached to the surface of the outer balloon.

[0009] The catheter is a multi-lumen tube, and the distal end of the catheter is an adjustable curved section that can be deflected in both directions. The electrode is located at the distal end of the catheter. At least two cavities inside the multi-lumen tube of the catheter have bending control wires, which are connected to the control end of the handle, and the bidirectional deflection of the adjustable curved section of the catheter is achieved by controlling the handle. The bending control wire is wrapped by the bending control wire cavity to prevent the wire from being bent or broken due to stress concentration. The bending control wire cavity and the multi-lumen tube are bonded together by hot melting or reflow welding, which plays a role in protecting the wire and reducing the friction between the wire and the multi-lumen tube.

[0010] The catheter is a multi-lumen tube, at least one of which is a vacuum chamber. At least one of which is a refrigerant inlet tube, which transmits a refrigerant medium, and its distal end is a spiral structure and is provided with a plurality of small holes. The catheter is a multi-lumen tube, at least one of which accommodates a cryoballoon sensor line. At least one of which accommodates a pulse ablation catheter wire. The pulse ablation catheter wire can emit pulse energy and map intracardiac signals. There is a gap between the pulse ablation catheter wire and the cavity that accommodates it, and physiological saline or contrast agent can pass through.

[0011] The beneficial effect of the present invention is that cryoballoon and pulse ablation can be performed simultaneously on a catheter, and the appropriate ablation method can be selected according to the patient and the lesion condition. The shape of the pulse catheter is designed to fit the balloon well, which increases the success rate of ablation; the balloon is folded at the distal end of the balloon to reduce the length of the distal end of the balloon, which is beneficial to the extraction of pulmonary vein potential. There is a sensor line inside the balloon, which can accurately respond to external force or mechanical damage to the balloon and give an alarm in time. The high and low voltage sockets are separated to reduce the risk of surgery; the electrode surface is insulated to avoid the generation of bubbles when the electrode edge discharges.

[0012] The present invention has both cryoablation and pulse ablation, wherein the surgeon can select the ablation method according to the needs of the lesion, ensuring the transmural property of the ablation and avoiding the omission of the target point. The shape of the pulse catheter is designed to fit well with the balloon, increasing the success rate of ablation. The balloon is folded at the distal end to reduce the length of the distal segment, which is conducive to the improvement of the pulmonary vein potential. The positive and negative sockets of the ablation electrode are separated to ensure electrical safety.

[0013] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

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

[0016] Figure 2 for Figure 1 AA section structure diagram.

[0017] Figure 3 This is a schematic diagram of the enlarged view of balloon segment B.

[0018] Figure 4 This is an enlarged schematic diagram of the catheter end.

[0019] Figure 5 This is a schematic diagram of the distal end of the balloon in use.

[0020] Figure 6 Flow chart of the ablation process. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. The components of the embodiments of the present invention generally described and shown in the drawings herein can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work belong to the scope of protection of the present invention.

[0022] The present invention is further described below in detail so that those skilled in the art can implement it according to the description.

[0023] First, please refer to Figure 1 , Figure 1 The present invention is further described below in conjunction with the accompanying drawings and embodiments. Figure 1 As shown, a schematic diagram of the structure of a pulse and cryoablation integrated machine of the present invention is given, which includes a handle 1, a push rod 2, a double-bend control handle 3, a catheter body 4, an adjustable catheter bend section 5, a balloon 6, a balloon distal end 7, a catheter end 8, a socket anode 9, a socket cathode 10, a connecting cable 11, a refrigerant medium transmission tube 12, a detector 13, and a pulse and cryoablation generator 14.

[0024] The bidirectional deflection of the adjustable curved section 5 of the catheter is achieved by controlling the double-bend control handle 3 on the control handle 1. The function of the push rod 2 is to withdraw the push rod when the balloon is inflated and push the push rod forward when it is deflated; to prevent the balloon from rupturing. The push rod is a hollow structure with a guide wire inside. Most of the length of the catheter body 4 enters the human body. The outer side of the catheter body is made of medical polymer material, which carries all internal wires and sensor wires; the balloon 6 has two layers, the inner and outer layers, and the outer layer is in direct contact with the myocardial tissue; the distal end 7 of the balloon is fixed to the inner tube by folding, and the distal end length is ≤0.5mm. The electrodes at the end of the catheter 8 are respectively connected to the anode socket 9 and the cathode socket 10, so that the positive and negative poles can be separated, making pulse ablation safer, and then connected to the pulse and cryo generator 14 through the connecting tail line 11.

[0025] When pulse discharge is performed, discharge can only be performed when the detector 13 detects R wave; when cryoablation is performed, the operator can choose cryoablation, and the pulse and cryo generator 14 provides nitrous oxide or nitrogen, which is transmitted to the balloon catheter through the refrigerant medium transmission tube 12, so that the surface temperature of the balloon 6 reaches below -45°C; the pulse and cryo generator 14 has two functions of pulse and cryoablation, and pulse and cryoablation can be selected on its interface.

[0026] Please refer to the following Figure 2 , Figure 2 for Figure 1 AA section structure diagram. Figure 2 The AA cross-sectional structure diagram of the adjustable bending section of the catheter includes a multi-lumen tube 15, an inner tube 16, a vacuum chamber 17, a wire chamber 18, a bending control wire 19, a catheter end 8, a refrigerant inlet pipe 21, a cryoballoon sensor line 22, and a pulse ablation catheter guide wire 23. The multi-lumen tube 15 is made of a medical polymer material with good flexibility, softness and elasticity, such as nylon (Pebax), polyester amine (TPU), etc. The wire chamber 18 wraps the bending control wire 19 to prevent the bending control wire 19 from being bent or broken due to stress concentration. In addition, the wire chamber 18 and the multi-lumen tube 15 are bonded together by hot melting or reflow welding to protect the wire and reduce the friction between the wire and the multi-lumen tube 15. The two bending control wires 19 pass through the two through holes of the multi-lumen tube 15 respectively and are connected to the control end of the handle 1. The bidirectional deflection of the adjustable bending section 5 of the catheter is achieved by controlling the handle 3. The inner tube 16 is a hollow structure, and the catheter end 8 can pass through it. The outer tube of the catheter end 8 can be a stainless steel tube (with an inner surface insulated) or a non-metallic tube. There is a wire 23 inside, and the wire 23 can emit pulse energy and mark intracardiac signals; the liquid inlet tube 21 transmits the refrigerant medium, and a plurality of small holes are opened at the far end.

[0027] The ring electrode wire, electromagnetic positioning sensor wire, temperature sensor wire and liquid alarm wire 22 can extract and transmit ECG signals, establish a three-dimensional heart model, transmit the center or surface temperature of the balloon, and alarm for risks inside the balloon.

[0028] Figure 3 It is an enlarged schematic diagram of the balloon segment B. It includes a pulse ablation and mapping integrated catheter end 8, which passes through the middle of the inner tube 16, and there is a gap between the two, through which physiological saline or contrast agent can pass. The outer balloon 24 is made of polymer materials such as TPU or Pebax, and is in direct contact with the myocardial tissue; the inner balloon 25 is made of polymer materials such as PET or TPU; the inner and outer balloons 24 and 25 are folded back and bonded to the distal end 7 of the balloon with glue or heat welding, which can reduce the length of the distal end of the balloon, which is beneficial to the ablation of the catheter end 8 and the extraction of intracardiac signals; the proximal ends of the inner and outer balloons 24 and 25 are connected to the multi-lumen tube 15 by heat welding, and the welding method can be heat welding or laser welding, etc., which can be The heat affected zone 27 is reduced to the minimum; the liquid inlet tube 28 is a hollow structure with an outer diameter of 0.2-1.0mm, an inner diameter of 0.19-0.80mm, and a spiral structure at the distal end. There are 4-12 microholes on it, distributed at 30-90°, with a pore size of 0.01-0.2mm. A refrigerant is passed inside, and the surface temperature of the balloon is reduced to below -30°C through the vaporization or heat transfer absorption of the spray hole 29, thereby achieving the purpose of treatment; the temperature sensor 30 can accurately test the center temperature inside the balloon. Generally, the temperature inside the balloon is an isothermal field. The sensor 31 inside the balloon is used to issue an alarm and stop working when the balloon is damaged by external force or other reasons, thereby minimizing the harm to the patient. An embodiment of the sensor 31 inside the balloon is a resistor unit that encounters a change in liquid resistance. When the balloon is damaged, body fluid enters the balloon, causing a change in resistance to trigger a sensor alarm.

[0029] Figure 4 It is an enlarged schematic diagram of the catheter end. The catheter end 8 is provided with multiple groups of electrodes 36, which can simultaneously realize the functions of pulse ablation and mapping catheter. In the working state, it is attached to the balloon 6, and the balloon is attached to the pulmonary vein 38. There are 2-20 electrodes 36 on the catheter end 8, the electrode length is 1-6mm, and the outer diameter is 0.5-5mm. It is connected to the pull wire or safety wire to protect the myocardial wall from being scratched. The catheter end 8 is folded and attached to the surface of the balloon, with a deflection angle of 5-45°, so that it can better fit to the balloon surface and have better fit.

[0030] Figure 5 The distal end of the balloon is shown in FIG. 8. The distal end of the catheter 8 is provided with multiple sets of electrodes, which simultaneously realize the functions of pulse ablation and mapping catheter. In the working state, it is attached to the balloon 6, and the balloon is attached to the pulmonary vein 38, which is conducive to the extraction of pulmonary vein potential.

[0031] Figure 6 The flowchart of the ablation process is shown below. When the operator selects the ablation method before starting the operation, the specific process is shown in the figure below: When starting the operation, the operator can select the operation method from the user interface of the pulse and cryo generator 14. When cryoablation is selected, cryogas is filled to achieve cryoablation, and the mapping catheter is tested. When pulse ablation is selected, when the R wave is detected, pulse ablation is started, and the mapping catheter is tested for potential.

[0032] Although the embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the description and the embodiments. It can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily realized. Therefore, without departing from the general concept defined by the claims and their equivalents, the present invention is not limited to the specific details and the illustrations shown and described here.

Claims

1. Pulse and cryoablation all-in-one machine, characterized by: Includes pulse and cryo generators, connecting cables, cooling medium transmission tubes, catheters, and balloons; The pulse and cryo generator has two functions: pulse and cryoablation. Pulse and cryo can be selected on its interface; The connecting cable connects the pulse and cryogenerator to the catheter to transmit the pulse energy, and the refrigerant medium transmission tube transmits the refrigerant generated by the pulse and cryogenerator to the balloon; The balloon surrounds the catheter, the end of the catheter extends from the distal end of the balloon and folds back to surround the outer surface of the balloon, and multiple groups of electrodes are arranged on the catheter to serve as pulse electrodes and extract electrocardiographic signals; When pulse ablation is selected, discharge occurs between electrodes to achieve pulse ablation; when cryoablation is selected, refrigerant is delivered to the distal end of the balloon to produce a freezing effect, and the electrodes extract ECG signals; The balloon has two layers, an inner layer and an outer layer, wherein the outer layer is in direct contact with the myocardial tissue, and both ends of the inner and outer balloons are connected to the catheter; The catheter is a multi-lumen tube, the distal end of the catheter is an adjustable curved section capable of bidirectional deflection, and the electrode is located at the distal end of the catheter; At least two cavities inside the multi-lumen tube are provided with bending control wires connected to the control end of the handle, and the bidirectional deflection of the adjustable bending section of the catheter is achieved by controlling the handle.

2. The pulse and cryoablation integrated machine according to claim 1, characterized in that: It also includes a detector connected to the pulse and freezing generator. When the pulse is discharged, the detector controls the circuit on and off. The discharge can only be carried out when the detector detects the R wave.

3. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The pulse and cryo generators are connected to electrodes through the positive and negative sockets respectively, so that the positive and negative electrodes can be separated, making pulse ablation safer.

4. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The balloon has a sensor disposed between the inner and outer layers to sense the pressure change between the inner and outer layers.

5. The pulse and cryoablation integrated machine according to claim 1, characterized in that: A sensor is arranged inside the balloon, and the sensor alarms when the balloon is damaged.

6. The pulse and cryoablation integrated machine according to claim 1, characterized in that: During cryoablation, the outer balloon is placed against the pulmonary vein, and the folded-back portion of the catheter end closely surrounds the surface of the outer balloon.

7. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The bending control wire is wrapped by a bending control wire cavity to prevent the wire from being bent or broken due to stress concentration.

8. The pulse and cryoablation integrated machine according to claim 7, characterized in that: The bending control wire drawing cavity and the multi-cavity tube are bonded together by hot melting or reflow welding, which plays a role in protecting the wire drawing and reducing friction between the wire drawing and the multi-cavity tube.

9. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The catheter is a multi-lumen tube, at least one of which is a vacuum chamber.

10. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The catheter is a multi-lumen tube, at least one of which is a refrigerant inlet tube. The refrigerant inlet tube transmits the refrigerant medium, and the distal end of the refrigerant inlet tube is a spiral structure and is provided with a plurality of small holes.

11. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The catheter is a multi-lumen tube, at least one of which houses the cryoballoon sensor wire.

12. The pulse and cryoablation integrated machine according to claim 1, characterized in that: The catheter is a multi-lumen tube, at least one of which houses a pulsed ablation catheter wire.

13. The pulse and cryoablation integrated machine according to claim 12, characterized in that: The pulse ablation catheter wire can emit pulse energy and map intracardiac signals.

14. The pulse and cryoablation integrated machine according to claim 12, characterized in that: There is a gap between the pulse ablation catheter wire and the cavity accommodating the pulse ablation catheter wire, through which physiological saline or contrast agent can pass.

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