Pulse and radio frequency ablation all-in-one machine and method of using same

Abstract

The application provides a pulse and radio frequency ablation integrated machine, which comprises a pulse and radio frequency generator, a positive electrode socket and a negative electrode socket, a switching switch, a catheter, a distal head electrode and a proximal head electrode; the pulse and radio frequency generator has both pulse and radio frequency ablation functions, and the interface thereof can select pulse and radio frequency; the distal and proximal head electrodes are connected with the switching switch, and the switching switch controls the conduction and disconnection between the distal and proximal head electrodes; the pulse and radio frequency generator is connected with the distal and proximal head electrodes through the positive electrode socket and the negative electrode socket respectively, so that the positive and negative electrodes can be separated; when the switching switch is disconnected, the distal and proximal head electrodes are disconnected and connected to the pulse and radio frequency generator through the positive electrode socket and the negative electrode socket respectively, and the distal and proximal head electrodes discharge between each other to realize pulse or radio frequency ablation. The application realizes the selective use of pulse and radio frequency ablation and is safer.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular, to a pulse and radio frequency ablation integrated machine and a use method thereof. BACKGROUND

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, which leads to stroke and other thromboembolic events, and is the main cause of death or disability. Clinical studies in many countries show that the total incidence of atrial fibrillation is about 2%, and in recent years, the incidence of atrial fibrillation is gradually increasing. Non-pharmacological treatment of atrial fibrillation is a research hotspot in recent years. Many clinical studies at home and abroad have proved that the application of catheter radiofrequency ablation technology to successfully electrically isolate the pulmonary vein can effectively prevent the recurrence of atrial fibrillation. Studies have shown that catheter ablation is an effective means for atrial fibrillation patients to restore and maintain sinus rhythm. Catheter ablation is mainly based on radiofrequency energy, but also other energy (including freezing, ultrasound and laser ablation, etc.). However, these ablation based on heat / cold conduction have certain limitations, the damage to the ablation area tissue lacks selectivity, and depends on the adhesion of the catheter, so it may cause damage to the adjacent esophagus, coronary artery and phrenic nerve, etc.

[0003] Unlike traditional energy, pulse electric field energy forms irreversible micropores on the cell membrane through instantaneous discharge, causing cell apoptosis, achieving the purpose of non-thermal ablation, also known as irreversible electroporation. At present, electroporation ablation has been used as an effective means to destroy malignant tumor tissue. Pulse electric field ablation can theoretically damage myocardial cells without heating the tissue, and has cell / tissue selectivity to protect surrounding critical structures. There are certain complications in the perioperative period of avoiding radiofrequency ablation and cryoablation for symptomatic atrial fibrillation, and some patients will relapse. Pulse electric field energy can cause cell apoptosis by forming nanoscale pores on the cell membrane, and has the characteristics of non-thermal and tissue selectivity, such as ablation of the left lower esophagus and the right upper phrenic muscle. Using pulse ablation to damage the target tissue has no effect on the esophagus and phrenic muscle.

[0004] However, in the existing treatment, radiofrequency ablation is more secure in some myocardial regions, and in addition, thick-walled regions need to make the ablation lesion deeper to be transmural, and need to use radiofrequency ablation to achieve, so an instrument capable of having these two functions can greatly shorten the operation time, improve success, reduce complications and patient pain, so an instrument capable of compatible pulse and radiofrequency ablation is needed. SUMMARY

[0005] The purpose of the present application is to provide a pulse and radio frequency ablation integrated machine based on the above problems. The problem of the existing heart rate market ablation requiring an instrument capable of having two functions is solved.

[0006] In order to achieve this object, the present application provides a pulse and radio frequency ablation integrated machine, comprising a pulse and radio frequency generator, a positive electrode socket and a negative electrode socket, a switching switch, a catheter, and a distal head electrode and a proximal head electrode; the pulse and radio frequency generator has both pulse and radio frequency ablation functions, and the interface thereof can select pulse and radio frequency; the distal and proximal head electrodes are connected with the switching switch, the switching switch controls the conduction and disconnection between the distal and proximal head electrodes, and the switching switch is not necessarily a switch, but can also be other equivalent components or circuits, such as a capacitor; the pulse and radio frequency generator is connected with the distal and proximal head electrodes through the positive electrode socket and the negative electrode socket respectively, so that the positive and negative electrodes can be separated, and pulse ablation is safer; when the switching switch is disconnected, the distal and proximal head electrodes are disconnected and connected to the pulse and radio frequency generator through the positive electrode socket and the negative electrode socket respectively, and the distal and proximal head electrodes are discharged between each other to realize pulse or radio frequency ablation.

[0007] Further, a detection device is further connected with the pulse and radio frequency generator, when pulse discharge, the detection device controls the circuit to be on or off, and only when the detection device detects P wave, the discharge can be performed. A reference electrode is arranged on the back, when radio frequency ablation is selected, the switching switch is turned on, and the distal and proximal head electrodes are discharged between the back reference electrode as a whole. When radio frequency ablation is selected, the switching switch is disconnected, and the distal head electrode or the proximal head electrode can be discharged between the back reference electrode. The switching switch is a relay or a high-voltage capacitor.

[0008] Optionally, when pulse discharge, the detection device controls the circuit to be on or off, and the discharge is started within 10-200 ms after the detection device detects R wave.

[0009] The distal head electrode and the proximal head electrode are made of metal materials such as platinum or gold, which are used for ablation and marker signals. The distal head electrode and the proximal head electrode are isolated by an insulator, and the insulator is one or several of liquid crystal high molecular polymer, polyether ether ketone, or high-insulation biocompatible material (such as diamond).

[0010] The catheter is a multi-lumen tube, a distal end part of the catheter is a two-way deflectable adjustable bending section, and the distal head electrode and the proximal head electrode are located at the distal end of the catheter. At least two cavities in the multi-lumen tube have control bending springs wrapped control bending pull wires, which prevent the pull wires from being folded or broken due to stress concentration; a spring sleeve covers the outer surface of the control bending spring, which plays a role of protecting the control bending spring and reducing the friction between the control bending spring and the multi-lumen tube and the outer tube; at least two control bending pull wires pass through at least two cavities of the multi-lumen tube and are connected to the control end of the handle, so that the two-way deflection of the adjustable bending section of the catheter can be realized by controlling the handle.

[0011] At least one cavity within the multi-lumen catheter tube houses two head electrode wires, whose insulation layer is made of high-voltage-resistant material. The ring electrode wires and electromagnetic positioning sensor wires are connected through positive and negative sockets, respectively, to the ring electrode and positioning sensor at the distal end of the catheter. These wires are capable of extracting and transmitting ECG signals and building a three-dimensional heart model.

[0012] The present invention also provides a method for using the integrated pulse and radiofrequency ablation device, comprising the following steps:

[0013] Choose pulsed or radiofrequency ablation;

[0014] When pulse ablation is selected as the ablation mode, the switch is turned off to disconnect the distal and proximal electrodes, and detection begins. Discharge and pulse ablation can only be performed within 10-200ms after the detection device detects a P wave or an R wave;

[0015] When radiofrequency ablation is selected, there are three different radiofrequency ablation procedures. Method 1: The switching switch is turned on, and the distal and proximal electrodes are discharged as a whole electrode with the back reference electrode to achieve radiofrequency ablation. Method 2: The switching switch is turned off, and radiofrequency discharge is performed between the distal and proximal electrodes to achieve radiofrequency ablation. Method 3: The switching switch is turned off, and discharge is performed between the distal or proximal electrode and the back reference electrode to achieve radiofrequency ablation.

[0016] The present invention offers the advantage of multiple radiofrequency ablation options, allowing the surgeon to select the appropriate method based on the specific surgical situation. This significantly shortens surgical time, addresses the potential for missed ablation targets, reduces patient pain, and improves surgical safety and effectiveness. The catheter of the present invention provides both radiofrequency ablation and pulsed ablation, allowing the surgeon to select the ablation method based on the lesion's needs, ensuring transmural ablation and avoiding missed targets. Separate positive and negative ablation electrode sockets ensure electrical safety.

[0017] 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

[0018] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0019] Figure 1 is a structural schematic diagram of the present application.

[0020] Figure 2 is Figure 1 is a structural schematic diagram of the present application.

[0021] Figure 3 is Figure 1 is an enlarged schematic diagram of B.

[0022] Figure 4 is Figure 1 is an enlarged schematic diagram of C.

[0023] Figure 5 is a workflow schematic diagram of one embodiment of the present application. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present application will be clearly and completely described with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. The components of the embodiments of the present application described and shown in the accompanying drawings can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application.

[0025] The present application will be further described in detail below so as to enable those skilled in the art to implement it with reference to the description.

[0026] First, refer to Figure 1 , Figure 1 is a structural schematic diagram of the present application. In Figure 1 , a structural schematic diagram of a pulse and radio frequency ablation integrated machine of the present application is given, which includes a handle 1, a catheter main body 2, an adjustable bending section 3, a distal head electrode 4, a proximal head electrode 5, a switching switch 6, a positive electrode socket 7, a negative electrode socket 8, a transmission tail wire 9, a back reference electrode 10, a detection device 11, a pulse and radio frequency generator 12;

[0027] By controlling the knob on the handle 1, the catheter adjustable bending section 3 is deflected in two directions; the catheter main body 2 is mostly inserted into the human body, and the outer side of the main body is made of medical polymer materials, which bears all the internal wires and sensor lines; the distal head electrode 4 and the proximal head electrode 5 are made of platinum or gold, which are used for ablation and signal measurement, and are isolated by an insulator, such as liquid crystal polymer or polyether ether ketone; the distal and proximal head electrodes 4 and 5 are connected through the switching switch (relay or high-voltage capacitor) 6, when the pulse ablation is performed, the distal and proximal head electrodes are disconnected (each is connected to the pulse and radio frequency generator 12 to realize the discharge between the distal and proximal head electrodes), that is, pulse discharge: discharge between the positive electrode 4 and the negative electrode 5; the positive electrode socket 7 and the negative electrode socket 8 are connected to the distal and proximal head electrodes respectively, so that the positive and negative electrodes can be separated, making the pulse ablation safer, in addition, the proximal measurement ring electrode and the electromagnetic double positioning sensor are respectively led out through the sockets 7 and 8; when the pulse discharge is performed, only when the P wave is detected by the detection device 11 can the discharge be performed. The P wave is the atrial depolarization wave, which represents the activation of the left and right atria. Since the sinoatrial node is located under the endocardium of the right atrium, the activation is first transmitted to the right atrium and later to the left atrium. Therefore, the depolarization of the right atrium is slightly earlier than that of the left atrium. In clinical practice, for practical purposes, the front part of the P wave represents the activation of the right atrium, and the back part represents the activation of the left atrium. Analysis of the P wave is of great significance for the diagnosis and differential diagnosis of arrhythmia.

[0028] When the radio frequency discharge is performed, there are three options, according to the specific condition of the patient, three different radio frequency ablation methods are realized, method one: radio frequency discharge between the distal head electrode 4 and the proximal head electrode 5; method two: switching switch (relay or high-voltage capacitor) 6 is turned on, and the distal and proximal head electrodes are discharged with the back reference electrode 11 as a whole electrode; method three: the distal head electrode 4 or the proximal head electrode 5 is discharged with the back reference electrode 11; the pulse and radio frequency generator 12 has the functions of pulse and radio frequency ablation, and the interface can select pulse and radio frequency.

[0029] Next, please refer to Figure 2 , Figure 2 for Figure 1A-A cross-sectional structure schematic diagram. It includes multi-cavity tube 13, control bending spring 14, control bending pull wire 15, control bending spring protection tube 16, head electrode lead 17, its insulating layer is high-voltage resistant material, ring electrode lead, electromagnetic positioning sensor line 18;Wherein the multi-cavity tube 13 is made of medical polymer material with good flexibility, softness and elasticity, such as nylon (Pebax), polyester amine (TPU) and the like, the control bending spring 14 wraps the pull wire 15, prevents the stress concentration of the pull wire from being folded or broken, in addition, the spring sleeve 16 covers the outer surface of the spring 15, plays the role of protecting the spring and reducing the friction between the spring and the multi-cavity tube and the outer tube;Two control bending pull wires (15) pass through two through holes of the multi-cavity tube respectively, are connected to the control end of the handle 1, and the two-way deflection of the adjustable bending section of the catheter is realized by controlling the handle 1;The ring electrode lead and the electromagnetic positioning sensor line 18 can extract and transmit the electrocardio signal and establish a three-dimensional heart model.

[0030] Figure 3 For Figure 1 B is an enlarged schematic view. Figure 3 It includes multi-cavity tube 13, control bending spring 14, control bending pull wire 15, control bending spring protection tube 16, single-cavity tube 20, outer tube 19, stainless steel transition tube 22;Wherein the tail end of the head electrode safety wire 21 is connected with the two control bending pull wires 15 through the stainless steel transition tube 22.

[0031] Figure 4 For Figure 1 C is an enlarged schematic view. Figure 4 The distal end head electrode 4 and the proximal end head electrode 5 are shown, and the insulator 23 therebetween is made of liquid crystal high molecular polymer or polyether ether ketone;The distal end head electrode 4 and the proximal end head electrode 5 and the insulator 23 are connected together through the insulator 24, wherein the material of the insulator 24 can be consistent with that of 23;The distal end head electrode 4 is connected with the positive electrode lead 25, and the proximal end head electrode 5 is connected with the negative electrode lead 26;Wherein the safety wire 29 is connected with the insulator 24 integrally by means of gluing or welding, so as to achieve the purpose of safely fixing the head electrode;The single-cavity tube 28 is connected with the proximal end of the head electrode, and the remaining part is filled with glue;The ring electrode is sleeved on the single-cavity tube, which plays the functions of transmitting the electrocardio signal and electric field positioning.

[0032] The present application realizes that the radio frequency ablation and pulse ablation are integrated on the same catheter through the relay or high-voltage capacitor, the distal end head electrode 4 and the proximal end head electrode 5 are isolated through the insulators 23 and 24, and the pulse discharge or the radio frequency integral, the two-pole interval and the front and rear head electrodes are discharged with the back electrode plate according to the needs.

[0033] Finally, please refer to Figure 5 , Figure 5 It is the working flow diagram of one embodiment of the present application. Figure 5The embodiment pulse and radio frequency generator in the application has both pulse and radio frequency ablation functions, and the interface can select pulse or radio frequency. When the operator selects pulse ablation before starting the operation, the switch is off, and the distal and proximal head electrodes are disconnected. The detection starts, and only when the P wave is detected by the detection device, the discharge can be implemented to perform pulse ablation. Or when the pulse discharge, the detection device control circuit is on-off, and the discharge starts within 10-200 ms after the R wave is detected by the detection device.

[0034] When the operator selects radio frequency ablation, there are three choices, and three different radio frequency ablation operation modes can be realized according to the specific conditions of the patient. Mode one: the switch is on, the distal and proximal head electrodes are used as a whole electrode, and the discharge between the electrode and the back reference electrode is realized to perform radio frequency ablation. Mode two: the switch is off, the radio frequency discharge between the distal head electrode and the proximal head electrode is realized to perform radio frequency ablation. Mode three: the switch is off, the discharge between the distal head electrode or the proximal head electrode and the back reference electrode is realized to perform radio frequency ablation.

[0035] Although the embodiments of the application have been disclosed as above, it is not limited to the application listed in the specification and the embodiments. It can be fully applied to various fields suitable for the application. Additional modifications can be easily realized by those skilled in the art. Therefore, the application is not limited to specific details and the figures shown and described herein without departing from the general concept defined by the claims and the equivalent scope.

Claims

1. An integrated pulse and radiofrequency ablation device, including a pulse and radiofrequency generator, positive and negative electrode sockets, a switching switch, a catheter, and distal and proximal electrode tips; The pulse and radiofrequency generator has two functions: pulse and radiofrequency ablation. Pulse and radiofrequency are selected on its interface. The distal and proximal end electrodes are connected to a switch, and the switch controls conduction and disconnection between the distal and proximal end electrodes; The pulse and radiofrequency generators are connected to the distal head electrode and the proximal head electrode through the positive and negative sockets respectively, thereby separating the positive and negative electrodes and making pulse ablation safer; When the switch is off, the distal and proximal electrodes are disconnected, and the distal and proximal electrodes are connected to the pulse and radiofrequency generators through the positive and negative sockets respectively, and discharge occurs between the distal and proximal electrodes to achieve pulse or radiofrequency ablation; The pulse and radiofrequency ablation all-in-one device also includes a back reference electrode. When radiofrequency ablation is selected, the switch is turned on, and the distal and proximal end electrodes are used as a whole electrode to discharge electricity with the back reference electrode.

2. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that It also includes a detector connected to the pulse and radio frequency generator. When the pulse is discharged, the detector controls the on and off of the circuit. Discharge can only be performed when the detector detects the P wave.

3. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that It also includes a detector connected to the pulse and radio frequency generator. When the pulse is discharged, the detector controls the circuit on and off. The detector starts discharging within 10-200ms after detecting the R wave.

4. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that: When radiofrequency ablation is selected, the switch is disconnected, and discharge is respectively conducted between the distal head electrode or the proximal head electrode and the back reference electrode.

5. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that The switching switch is a relay or a high-voltage capacitor.

6. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that The material of the distal tip electrode and the material of the proximal tip electrode are platinum or gold, which are used as ablation and marking test signals.

7. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that The distal tip electrode and the proximal tip electrode are isolated by an insulator, and the insulator is one or more of liquid crystal polymer, polyetheretherketone, or high-insulation biocompatible material.

8. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that The catheter is a multi-lumen tube, the distal end portion of the catheter is an adjustable curved section capable of bidirectional deflection, and the distal end electrode and the proximal end electrode are located at the distal end of the catheter.

9. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that: The catheter is a multi-lumen tube, and at least two cavities inside the catheter have bending control springs wrapped around bending control pull wires to prevent the pull wires from breaking due to stress concentration. The spring sleeve covers the outer surface of the bending control spring, thereby protecting the bending control spring and reducing the friction between the bending control spring and the multi-lumen tube and the outer tube; At least two bending control wires pass through at least two cavities of the multi-lumen tube respectively and are connected to the control end of the handle, so that the bidirectional deflection of the adjustable bending section of the catheter can be achieved by controlling the handle.

10. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that: The catheter is a multi-lumen tube, at least one cavity inside the catheter accommodates two head electrode wires, and the insulation layer is made of high-voltage resistant material.

11. The integrated pulse and radiofrequency ablation device according to claim 1, characterized in that: The catheter is a multi-lumen tube, and at least one cavity inside the catheter accommodates a ring electrode wire and an electromagnetic positioning sensor wire. The ring electrode wire and the electromagnetic positioning sensor wire are respectively led out through a positive socket and a negative socket to connect to the ring electrode and the positioning sensor at the distal end of the catheter. The ring electrode wire and the electromagnetic positioning sensor wire can extract and transmit electrocardiographic signals and establish a three-dimensional heart model.

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