CN113397691A

CN113397691A - Pulse and radio frequency ablation integrated machine and using method thereof

Info

Publication number: CN113397691A
Application number: CN202110059303.0A
Authority: CN
Inventors: 赵乾成; 王慧; 赵峰
Original assignee: Shanghai Shangyang Medical Technology Co ltd
Current assignee: Shanghai Shangyang Medical Technology Co ltd
Priority date: 2020-10-20
Filing date: 2021-01-15
Publication date: 2021-09-17

Abstract

The invention provides a pulse and radio frequency ablation integrated machine which comprises a pulse and radio frequency generator, a positive electrode socket, a negative electrode socket, a change-over switch, a catheter, a far-end head electrode and a near-end head electrode, wherein the pulse and radio frequency generator is connected with the positive electrode socket and the negative electrode socket; the pulse and radio frequency generator has two functions of pulse and radio frequency ablation, and the interface of the pulse and radio frequency generator can select pulse and radio frequency; the far and near end electrodes are connected with a change-over switch which controls the connection and disconnection between the far and near end electrodes; the pulse generator and the radio frequency generator are respectively connected with the far-end head electrode and the near-end head electrode through the positive socket and the negative socket, so that the positive electrode and the negative electrode can be separated; when the switch is switched off, the far and near head electrodes are switched off and are respectively connected to the pulse and radio frequency generator through the positive socket and the negative socket, and the far and near head electrodes discharge electricity to realize pulse or radio frequency ablation. The invention realizes the selective use of pulse and radio frequency ablation and is safer.

Description

Pulse and radio frequency ablation integrated machine and using method thereof

Technical Field

The invention relates to the field of medical instruments, in particular to a pulse and radio frequency ablation integrated machine and a using method thereof.

Background

Atrial Fibrillation (AF) is one of the most common clinical arrhythmias, stroke and other thromboembolic events caused by the atrial fibrillation are the main causes of death or disability of patients, and the total incidence rate of atrial fibrillation is about 2 percent and is gradually increased in recent years according to the clinical research of multiple countries; the non-drug treatment of atrial fibrillation is a research hotspot in recent years, and many clinical studies at home and abroad prove that the recurrence of atrial fibrillation can be effectively prevented by applying a catheter radio frequency ablation technology to successfully electrically isolate pulmonary veins. Catheter ablation is dominated by radio frequency energy, but there are other sources of energy (including cryo-, ultrasound-, and laser ablation, etc.). However, these thermal/cold conduction based ablations have certain limitations, lack of selectivity for tissue destruction in the ablation region, and rely on catheter abutment, which can cause damage to the adjacent esophagus, coronary arteries, phrenic nerve, and the like.

Unlike conventional energy, pulsed electric field energy forms irreversible micropores in cell membranes by transient discharge, causing apoptosis, achieving the goal of non-thermal ablation, also known as irreversible electroporation. Currently, electroporation ablation has been used as an effective means of destroying malignant tumor tissue. Pulsed electric field ablation can theoretically damage myocardial cells without heating the tissue, and has cell/tissue selectivity, protecting surrounding critical structures. The perioperative period of avoiding the radio frequency ablation and cryoablation to treat the symptomatic atrial fibrillation has certain complications, and part of patients can relapse. The pulse electric field energy can cause apoptosis by forming nano-scale pores on cell membranes, and has the characteristics of nonthermal property and tissue selectivity, such as ablation near the esophagus at the lower left and ablation near the diaphragm at the upper right, target tissue damage is caused by using pulse ablation, and the esophagus and the diaphragm are not affected at all.

However, in the existing treatment, in a part of myocardial regions, the radiofrequency ablation is safer, in addition, the thick-wall region needs to be deeper than an ablation focus to penetrate through the wall, and the radiofrequency ablation needs to be used for realizing, so that one instrument has two functions, the operation time can be greatly shortened, the success is improved, and the complications and the pain of a patient are reduced, so that the instrument which can be compatible with the pulse and the radiofrequency ablation needs to be invented.

Disclosure of Invention

The invention aims to provide a pulse and radio frequency ablation integrated machine based on the problems. The problem of the existing heart rate market ablation that an instrument can have two functions is urgently needed is solved.

In order to achieve the purpose, the invention provides a pulse and radio frequency ablation integrated machine, which comprises a pulse and radio frequency generator, a positive socket, a negative socket, a change-over switch, a catheter, a far-end head electrode and a near-end head electrode, wherein the pulse and radio frequency generator is connected with the far-end head electrode and the near-end head electrode; the pulse and radio frequency generator has two functions of pulse and radio frequency ablation, and the interface of the pulse and radio frequency generator can select pulse and radio frequency; the far and near end electrodes are connected with a change-over switch, the change-over switch controls the connection and disconnection of the far and near end electrodes, and the change-over switch is not necessarily a switch and can also be other equivalent components or circuits, such as a capacitor; the pulse generator and the radio frequency generator are respectively connected with the far-end electrode and the near-end electrode through the positive electrode socket and the negative electrode socket, so that the positive electrode and the negative electrode can be separated, and the pulse ablation is safer; when the switch is switched off, the far and near head electrodes are switched off and are respectively connected to the pulse and radio frequency generator through the positive socket and the negative socket, and the far and near head electrodes discharge electricity to realize pulse or radio frequency ablation.

Furthermore, the device also comprises a wave detection device which is connected with the pulse and the radio frequency generator, when the pulse discharges, the wave detection device controls the circuit to be switched on and off, and only the wave detection device detects the P wave can discharge. The back is provided with a reference electrode, a selector switch is switched on when the radio frequency ablation is selected, and the far and near end electrodes are used as an integral electrode to discharge between the back reference electrode. When the radio frequency ablation is selected, the switch is switched off, and the far-end head electrode or the near-end head electrode can discharge with the back reference electrode respectively. The change-over switch is a relay or a high-voltage capacitor.

Optionally, when the pulse discharges, the detector controls the circuit to be switched on and off, and the detector detects that the discharge starts within 10-200ms after the R wave is detected.

The far-end head electrode and the near-end head electrode are made of metal materials such as platinum or gold and the like and are used for melting and marking test signals. The far-end head electrode and the near-end head electrode are separated by an insulator, and the insulator is one or more of liquid crystal high polymer, polyether ether ketone or high-insulation biocompatible materials (such as diamond).

The catheter is a multi-lumen tube, the distal portion of the catheter is a bidirectionally deflectable, adjustable bend segment, and the distal tip electrode and the proximal tip electrode are located at the distal end of the catheter. At least two cavities in the catheter multi-cavity tube are provided with bend-controlling springs to wrap bend-controlling pull wires, so that the pull wires are prevented from being bent or broken due to stress concentration; the spring sleeve covers the outer surface of the bending control spring, so that the effects of protecting the bending control spring and reducing friction between the bending control spring and the multi-cavity tube and the outer tube are achieved; at least two bending control pull wires respectively penetrate through at least two cavities of the multi-cavity tube and are connected to the control end of the handle, and the two-way deflection of the adjustable bending section of the catheter is realized by controlling the handle.

At least one cavity in the multi-cavity tube of the catheter contains two head electrode leads, and the insulating layer of the multi-cavity tube is made of high-pressure resistant materials. At least one cavity in the multi-cavity tube of the catheter contains a ring electrode lead and an electromagnetic positioning sensor wire, the ring electrode lead and the electromagnetic positioning sensor wire are respectively led out and connected with a ring electrode and a positioning sensor which are positioned at the far end of the catheter through a positive socket and a negative socket, and the ring electrode lead and the electromagnetic positioning sensor wire can extract and transmit electrocardiosignals and establish the function of a three-dimensional heart model.

The invention also provides a using method of the pulse and radio frequency ablation integrated machine, which comprises the following steps:

selecting pulse or radio frequency ablation;

when the ablation mode is selected to be pulse ablation, the switch is switched off to disconnect the electrodes of the far head and the near head, the detection is started, and only when the detection device detects P waves or detects R waves, the discharging can be carried out within 10-200ms to implement the pulse ablation;

when radiofrequency ablation is selected, there can be three different radiofrequency ablation procedures, mode one: the switch is switched on to discharge between the far and near end electrodes as a whole electrode and the back reference electrode, so that the radio frequency ablation is realized, and the mode II is as follows: the change-over switch is turned off, and radio frequency discharges between the far-end head electrode and the near-end head electrode to realize radio frequency ablation in a third mode: and the switch is switched off, and the far-end head electrode or the near-end head electrode discharges between the back reference electrode to realize the radio frequency ablation.

The invention has the advantages that the radio frequency mode can be selected in various modes by adopting the scheme provided by the invention, and an operator can select the radio frequency mode according to the actual operation condition, so that the operation time can be greatly shortened, the problem that an ablation target spot is possibly omitted can be solved, the pain of a patient can be reduced, and the safety and the effectiveness of the operation can be improved. The catheter of the invention has both radiofrequency ablation and pulse ablation, wherein, an operator can select an ablation mode according to the needs of a focus, thus ensuring the transmural property of ablation and avoiding the omission of target spots; the positive and negative sockets of the ablation electrode are separated, so that the electrical safety is ensured.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural diagram of the present invention.

FIG. 2 is a schematic cross-sectional view of the structure of FIG. 1A-A.

Fig. 3 is an enlarged schematic view of fig. 1B.

Fig. 4 is an enlarged schematic view of fig. 1C.

Fig. 5 is a schematic workflow diagram of an embodiment of the present invention.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The present invention is described in further detail below to enable those skilled in the art to practice the invention with reference to the description.

Referring to fig. 1, fig. 1 is a schematic structural diagram of the present invention. Fig. 1 is a schematic structural diagram of an integrated pulse and rf ablation apparatus of the present invention, which includes a handle 1, a catheter main body 2, an adjustable bending section 3, a distal tip electrode 4, a proximal tip electrode 5, a switch 6, a positive socket 7, a negative socket 8, a transmission tail 9, a back reference electrode 10, a detector 11, and a pulse and rf generator 12;

the bidirectional deflection of the adjustable bending section 3 of the catheter is realized by controlling a bending knob on the control handle 1; the catheter main body 2 enters the human body in most of the length, and the outer side of the main body is made of medical high polymer materials and bears all internal leads and sensor wires; the far-end head electrode 4 and the near-end head electrode 5 are made of metal materials such as platinum or gold and the like, are used for melting and marking test signals, and are isolated by insulators such as liquid crystal high polymer or polyether ether ketone and the like; the far and

near end electrodes

4 and 5 are respectively connected with a selector switch (relay or high-voltage capacitor) 6, and when the pulse ablation is carried out, the far and near end electrodes are disconnected (respectively connected to the pulse and the radio frequency generator 12 to realize the discharge between the far and near end electrodes), namely, the pulse discharge: discharging between the positive electrode of the far-end head electrode 4 and the negative electrode of the near-end head electrode 5; the positive electrode socket 7 and the negative electrode socket 8 are respectively connected with the far-end and near-end electrode, so that the positive electrode and the negative electrode can be separated, the pulse ablation is safer, and in addition, the near-end mapping ring electrode and the electromagnetic double-positioning sensor are respectively led out through the

sockets

7 and 8; when the pulse discharge is performed, the discharge is performed only when the detector 11 detects the P-wave. The P-wave is an atrial depolarization wave, representing activation of both the left and right atria. Since the sinoatrial node is located under the right atrial subintium, activation passes first to the right atrium and later to the left atrium. The depolarization in the right atrium is thus also completed slightly earlier than in the left atrium. Clinically for practical purposes, the anterior portion of the P-wave represents the right atrial activation and the posterior portion represents the left atrial activation. The analysis of P wave has important significance for the diagnosis and differential diagnosis of arrhythmia.

When the radio frequency discharges, three options can be provided, and three different radio frequency ablation operation modes are realized according to the specific situation of a patient, wherein the first mode is as follows: radio frequency discharge is conducted between the far-end head electrode 4 and the near-end head electrode 5; the second method comprises the following steps: a change-over switch (a relay or a high-voltage capacitor) 6 is switched on, and the far and near end electrode is used as an integral electrode to discharge with the back reference electrode 11; the third method comprises the following steps: discharging between the distal tip electrode 4 or the proximal tip electrode 5 and the back reference electrode 11; the pulse and rf generator 12 has both pulse and rf ablation functions, and the interface is selectable between pulse and rf.

Referring to fig. 2, fig. 2 is a schematic cross-sectional view of fig. 1A-a. The device comprises a multi-cavity tube 13, a bending control spring 14, a bending control pull wire 15, a bending control spring protection tube 16, a head electrode lead 17, an insulating layer of the head electrode lead 17, a ring electrode lead and an electromagnetic positioning sensor wire 18, wherein the insulating layer is made of high-voltage resistant materials; the multi-lumen tube 13 is made of a medical polymer material with good flexibility, softness and elasticity, for example: nylon (Pebax), polyester amine (TPU) and the like, the bending control spring 14 wraps the pull wire 15 to prevent the pull wire from being folded or broken due to stress concentration, and the spring sleeve 16 wraps the outer surface of the spring 15 to protect the spring and reduce friction between the spring and the multi-cavity tube and the outer tube; two bending control pull wires (15) respectively penetrate through two through holes of the multi-cavity tube and 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 wire 18 can extract and transmit electrocardiosignals and establish a three-dimensional heart model.

Fig. 3 is an enlarged schematic view of fig. 1B. FIG. 3 includes a multi-lumen tube 13, a bend-controlling spring 14, a bend-controlling pull wire 15, a bend-controlling spring protection tube 16, a single-lumen tube 20, an outer tube 19, and a stainless steel transition tube 22; wherein the tail end of the head electrode safety wire 21 is connected with the two bending control pull wires 15 through a stainless steel transition pipe 22.

Fig. 4 is an enlarged schematic view of fig. 1C. In fig. 4, the distal tip electrode 4, the proximal tip electrode 5 are shown; an insulator 23 between the two, which is made of liquid crystal high molecular polymer or polyether ether ketone; the distal and

proximal end electrodes

4, 5 and the insulator 23 are connected together by an insulator 24, wherein the insulator 24 may be made of the same material as the insulator 23; the distal end electrode 4 is connected with the positive electrode of the lead 25, and the proximal end electrode 5 is connected with the negative electrode of the lead 26; the safety wire 29 is connected with the insulator 24 into a whole in a gluing or welding mode, so that the purpose of safely fixing the head electrode is achieved; the single-cavity tube 28 is connected with the proximal end of the connector electrode, and the vacant part is filled with glue; the single-cavity tube is sleeved with a ring electrode to play a role in transmitting electrocardiosignals and positioning an electric field.

The invention realizes that the radio frequency ablation and the pulse ablation are integrated on the same catheter through a relay or a high-voltage capacitor, the distal end head electrode 4 and the proximal end head electrode 5 are isolated through

insulators

23 and 24, and pulse discharge is carried out according to requirements or the radio frequency is integrally discharged, and the front and rear head electrodes are respectively discharged with the back plate.

Finally, referring to fig. 5, fig. 5 is a schematic view of a work flow according to an embodiment of the present invention. The embodiment pulse and rf generator of fig. 5 has both pulse and rf ablation functions, with either pulse or rf selectable at the interface. When the operator selects the ablation mode to be pulse ablation before starting the operation, the switch is switched off, and the electrodes at the far head and the near head are disconnected. The detection is started, and only the detection device detects the P wave, the pulse ablation can be carried out by discharging. Or when the pulse discharges, the detection device controls the circuit to be switched on and off, and the detection device detects that the discharge is started within 10-200ms after the R wave is detected.

The operator can select three options when the radio frequency ablation is performed, and three different radio frequency ablation operation modes are realized according to the specific situation of a patient in a first mode: the switch is switched on to conduct the discharge between the far and near end electrodes as a whole electrode and the back reference electrode, so that the radio frequency ablation is realized. The second method comprises the following steps: and the switch is switched off, and radio frequency discharge is carried out between the far-end head electrode and the near-end head electrode, so that radio frequency ablation is realized. The third method comprises the following steps: and the switch is switched off, and the far-end head electrode or the near-end head electrode discharges between the back reference electrode to realize the radio frequency ablation.

While embodiments of the invention have been disclosed above, it is not intended to be limited to the uses set forth in the specification and examples. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. Therefore, the invention is not to be limited to the specific details and illustrations shown and described herein, without departing from the general concept defined by the claims and their equivalents.

Claims

1. The pulse and radio frequency ablation integrated machine comprises a pulse and radio frequency generator, a positive electrode socket, a negative electrode socket, a change-over switch, a catheter, a far-end head electrode and a near-end head electrode;

the pulse and radio frequency generator has two functions of pulse and radio frequency ablation, and the interface of the pulse and radio frequency generator can select pulse and radio frequency; the far and near end electrodes are connected with a change-over switch which controls the connection and disconnection between the far and near end electrodes;

the pulse generator and the radio frequency generator are respectively connected with the far-end electrode and the near-end electrode through the positive electrode socket and the negative electrode socket, so that the positive electrode and the negative electrode can be separated, and the pulse ablation is safer;

when the switch is switched off, the far and near head electrodes are switched off and are respectively connected to the pulse and radio frequency generator through the positive socket and the negative socket, and the far and near head electrodes discharge electricity to realize pulse or radio frequency ablation.

2. The machine of claim 1 further comprising a detector means connected to the pulse and rf generator, wherein the detector means controls the circuit to open and close when the pulse discharges and discharges only when the detector means detects a P-wave.

3. The machine of claim 1, further comprising a detector means connected to the pulse and rf generator, wherein the detector means controls the circuit to open and close when the pulse discharges and the detector means detects that discharge has begun within 10-200ms after the R wave.

4. The machine of claim 1, further comprising a back reference electrode, wherein the switch is turned on when the rf ablation is selected, and the distal and proximal electrodes discharge between the back reference electrode and the distal and proximal electrodes as a single electrode.

5. The machine of claim 1 further comprising a back reference electrode, wherein the switch is turned off when the rf ablation is selected, and wherein the distal tip electrode or the proximal tip electrode is configured to discharge with the back reference electrode.

6. The machine of claim 1, wherein said switch is a relay or a high voltage capacitor.

7. The machine of claim 1 wherein said distal tip electrode and said proximal tip electrode are of platinum or gold, which serve as ablation and target test signals.

8. The machine of claim 1, wherein the distal tip electrode and the proximal tip electrode are separated by an insulator, wherein the insulator is one or more of liquid crystal polymer, polyetheretherketone, or a highly insulating biocompatible material.

9. The integrated pulsing and rf ablation device of claim 1, wherein the catheter is a multi-lumen catheter, the distal portion of the catheter is a bidirectionally deflectable, adjustable bend segment, and the distal tip electrode and the proximal tip electrode are located at the distal end of the catheter.

10. The machine of claim 1, wherein at least two cavities inside the multi-lumen catheter tube have bend-controlling springs to wrap bend-controlling pull wires, preventing the pull wires from being folded or broken due to stress concentration;

the spring sleeve covers the outer surface of the bending control spring, so that the effects of protecting the bending control spring and reducing friction between the bending control spring and the multi-cavity tube and the outer tube are achieved;

at least two bending control pull wires respectively penetrate through at least two cavities of the multi-cavity tube and are connected to the control end of the handle, and the two-way deflection of the adjustable bending section of the catheter is realized by controlling the handle.

11. The machine of claim 1 wherein at least one lumen of the catheter multilumen contains two tip electrode wires and the insulating layer is a high voltage resistant material.

12. The integrated machine of claim 1, wherein at least one of the lumens in the multi-lumen catheter contains a ring electrode lead and an electromagnetic positioning sensor lead, the ring electrode lead and the electromagnetic positioning sensor lead are respectively led out of the ring electrode and the positioning sensor at the distal end of the catheter through a positive socket and a negative socket, and the ring electrode lead and the electromagnetic positioning sensor lead can extract and transmit electrocardiosignals and establish a three-dimensional heart model.

13. The use method of the pulse and radio frequency ablation integrated machine is characterized by comprising the following steps:

selecting pulse or radio frequency ablation;