CN-117838292-B - Ablation catheter and ablation system

CN117838292BCN 117838292 BCN117838292 BCN 117838292BCN-117838292-B

Abstract

The invention relates to the field of medical equipment, and provides an ablation catheter and an ablation system comprising the same, wherein the ablation catheter comprises an extending part, an ablation main body, a catheter main body and a control handle which are sequentially connected; the ablation main body comprises an ablation electrode, a connecting piece and a temperature sensor, the catheter main body comprises a non-ablation electrode and an infusion channel, the non-ablation electrode and the ablation electrode are arranged at intervals, and the non-ablation electrode is not contacted with the target tissue when ablation is performed. By using the ablation catheter and the ablation system, the hypertrophic ventricular septum is screwed into the ablation catheter, so that the screwing speed is easier to control, the depth can be stopped or adjusted in time before the myocardial wall is penetrated, the myocardial perforation can be prevented, and the damage to myocardial tissues is reduced through the temperature detection and perfusion functions.

Inventors

DONG YUANBO
ZHANG MINGFANG

Assignees

苏州赛纳思医疗技术有限公司

Dates

Publication Date: 20260508
Application Date: 20240126

Claims (17)

1. An ablation catheter is characterized by comprising an extending part, an ablation main body, a catheter main body, a control handle and a guide piece which are connected in sequence; Wherein, the The extending part comprises a screwing piece which can be rotationally drilled into and fixed into target tissues under the action of external force, and the screwing piece is in a three-dimensional spiral line shape or a screw shape, and one end far away from the ablation main body is a tip; The ablation main body comprises an ablation electrode, a connecting piece and a temperature sensor, wherein the ablation electrode is provided with a first end connected with the screwing piece, a first cavity arranged opposite to the first end, a second cavity formed by extending from the first cavity to the first end and a perfusion hole penetrating through the circumferential surface of the ablation electrode, the connecting piece is arranged in the first cavity, one end, close to the catheter main body, of the connecting piece extends out of the first cavity and is connected with the catheter main body, the connecting piece is provided with a first channel which is axially communicated with the second cavity, the perfusion hole and a transfusion channel in the catheter main body, the connecting piece and the inner wall of the first cavity form a plurality of second channels, and the temperature sensor is positioned in one second channel; The catheter body comprises a non-ablation electrode and the infusion channel, the non-ablation electrode and the ablation electrode are arranged at intervals, and the non-ablation electrode is not contacted with target tissue when ablation is carried out; The guide piece comprises a connecting part, a guide part and a guide hole penetrating through the connecting part and the guide part, wherein the connecting part is connected with the proximal end of the ablation catheter, the inner wall of the guide part is in a horn mouth shape with gradually reduced diameter from one end far away from the connecting part to one end close to the connecting part, the guide hole is communicated with a lining wire channel in the ablation catheter so as to guide a lining wire to the ablation catheter through the guide hole and the lining wire channel, the lining wire is used for supporting the ablation catheter, and the lining wire channel and the infusion channel are the same channel.
2. The ablation catheter of claim 1, wherein the positional information of the ablation electrode is provided by an impedance difference between the ablation electrode and the non-ablation electrode.
3. The ablation catheter of claim 2, wherein the impedance of the ablation electrode and the non-ablation electrode in blood is substantially the same, wherein the difference in impedance of the ablation electrode and the impedance of the non-ablation electrode is determined based on the difference in electrical conductivity between blood and muscle tissue, and wherein the change in impedance of the ablation electrode is determined based on the difference in electrical conductivity at different locations in the same muscle tissue to obtain the difference in impedance of the ablation electrode at the different locations and the impedance of the non-ablation electrode.
4. The ablation catheter of claim 1, wherein the screw thread pitch of the screw thread tapers from the distal end to the proximal end, the screw thread pitch of the screw thread being 0.25-1.5 times the screw thread diameter.
5. The ablation catheter of claim 1, wherein the screw-in member tapers in diameter from the proximal end to the distal end.
6. The ablation catheter of claim 1, wherein the first end of the ablation electrode has a third lumen, the screw-in member is telescopically coupled within the third lumen, and the screw-in member has a length that is less than or equal to an axial length of the third lumen.
7. The ablation catheter of claim 1, wherein the insertion portion further comprises an insert having a length equal to or less than a length of the screw-in member in the case where the screw-in member is in a three-dimensional spiral shape, the insert being disposed within the screw-in member and not in contact with the screw-in member.
8. The ablation catheter of claim 7, wherein the insert is hollow and has a through-hole extending through a circumferential surface of the insert, a proximal end of the insert being in communication with the second lumen.
9. The ablation catheter of claim 1, wherein the plurality of groups of the perfusion holes are arranged, the plurality of groups of the perfusion holes are distributed on the outer peripheral surface of the second cavity at intervals along the axial direction of the ablation electrode, and projection parts of two adjacent perfusion holes on a plane perpendicular to the axial direction of the ablation electrode are overlapped.
10. The ablation catheter of claim 1, wherein the ablation body further comprises a positioning sensor configured to sense a position of the ablation catheter in a target tissue, the temperature sensor and the positioning sensor being located in different ones of the second channels, respectively.
11. The ablation catheter of claim 1, wherein the guide further comprises a grip located between the connection portion and the guide portion, the guide hole extending through the connection portion, grip and guide portion.
12. The ablation catheter of claim 1, wherein the irrigation hole is disposed on a side of the second lumen adjacent to the first lumen.
13. The ablation catheter of claim 1, further comprising a torque conductor coupled to the guide, the wire liner secured in a central bore of the torque conductor, the wire liner operated by operation of the torque conductor to transfer torque generated by twisting of a proximal end of the wire liner to a distal end of the wire liner.
14. The ablation catheter of claim 13, further comprising a three-way valve connected to the control handle, one opening of the three-way valve for communication with an irrigation device, one end of the guide connected to the other opening of the three-way valve, the other end of the guide connected to the torque conductor.
15. An ablation system comprising the ablation catheter of any of claims 1-14, an integrated ablator, an irrigation device, and an imaging device, the integrated ablator being respectively connected to the ablation catheter, the irrigation device, and the imaging device, the irrigation device being connected to the ablation catheter, the integrated ablator comprising an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation/pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch; wherein the ablation generation module is configured to generate and send ablation energy to the ablation electrode; The temperature detection module is used for receiving the signal of the temperature sensor and feeding back the signal to the MCU central control module; the impedance detection module is used for detecting the impedance of the ablation electrode and/or the non-ablation electrode and feeding back the impedance to the MCU central control module; the ECG signal detection module is used for detecting an electrocardiogram signal and feeding back to the MCU central control module; the electric stimulation/pacing signal module is used for generating and sending electric stimulation/pacing signals through the ablation electrode under the control of the MCU central control module; The MCU central control module is in signal connection with the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation/pacing signal module, the interaction control module, the ablation control switch, the ablation catheter, the perfusion equipment and the imaging equipment, and is used for receiving and processing information of other modules and feeding back and/or displaying the processed information; the interaction control module is used for displaying information and receiving control instructions of a user; The ablation control switch is for controlling application of ablation energy to the target tissue.
16. An ablation system comprising at least two ablation catheters of any one of claims 1-14, an integrated ablator, an irrigation device and an imaging device, the integrated ablator being respectively connected to the at least two ablation catheters, the irrigation device and the imaging device, the irrigation device being respectively connected to the at least two ablation catheters, the integrated ablator comprising an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation/pacing signal module, an MCU central control module, an interactive control module and an ablation control switch; the ablation generation module is used for generating and respectively sending ablation energy to each ablation electrode; The temperature detection module is used for receiving signals of each temperature sensor and feeding back the signals to the MCU central control module; The impedance detection module is used for detecting the impedance of each ablation electrode and/or each non-ablation electrode and feeding back the impedance to the MCU central control module; the ECG signal detection module is used for detecting an electrocardiogram signal and feeding back to the MCU central control module; The electric stimulation/pacing signal module is used for generating and sending electric stimulation/pacing signals through each ablation electrode under the control of the MCU central control module; The MCU central control module is in signal connection with the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation/pacing signal module, the interaction control module, the ablation control switch, at least two ablation catheters, the perfusion equipment and the imaging equipment, and is used for receiving and processing information of other modules and feeding back and/or displaying the processed information; the interaction control module is used for displaying information and receiving control instructions of a user; The ablation control switch is for controlling application of ablation energy to the target tissue.
17. The ablation system of claim 15 or 16, further comprising a position detection module that receives signals from the positioning sensor and feeds back to the MCU central control module.

Description

Ablation catheter and ablation system Technical Field The invention relates to the technical field of medical instruments, in particular to an ablation catheter and an ablation system. Background Hypertrophic Cardiomyopathy (HCM) is a cardiomyopathy characterized by asymmetric hypertrophy of the heart. The typical heart hypertrophy mainly involves the left ventricle, and other rare types are apex hypertrophy, uniform hypertrophy, left anterior wall hypertrophy and the like, and is hereditary cardiomyopathy caused by genetic mutation of structural proteins related to sarcomere/sarcomere. The ultrasonic sound mainly shows that the left ventricular wall thickens, and generally refers to the room interval or the left ventricular wall thickness measured by a two-dimensional ultrasonic cardiac chart is larger than or equal to 15mm, or the thickness of a person with definite family history is larger than or equal to 13mm, and is not accompanied by the enlargement of a left ventricular cavity, and the left ventricular outflow tract of a patient with severe hypertrophy of the room interval can be blocked to cause the disturbance of blood flow dynamics. Currently, treatment regimens for hypertrophic cardiomyopathy include drug therapy, surgical therapy, and the like. Among them, the final therapeutic strategy for refractory HCM patients is room-space volume reduction, but surgical trauma and high technical requirements limit their application. Transluminal coronary chemoablation is a first-line minimally invasive replacement therapy for the compartmental volume reduction of a portion of patients, but is heavily dependent on the compartmental arterial anatomy. Recently, endocardial and intramyocardial radio frequency ablation (rf ablation) has begun to be used to eliminate Left Ventricular Outflow Tract (LVOT) obstruction in HCM patients. Ablation schemes for treating hypertrophic obstructive cardiomyopathy have been disclosed in the prior art, and the schemes in the prior art generally ablate hypertrophic ventricular septum with thickness within 10-20 mm caused by hypertrophic cardiomyopathy. However, a patient clinically has a more hypertrophic ventricular septum which can be up to 30mm in thickness, and at this time, the ablation catheter in the prior art cannot guarantee the overall ablation effect. Meanwhile, in the existing treatment scheme, the detection of the ventricular septum in the experiment depends on an expensive three-dimensional imaging/CT imaging device, which is not beneficial to the wide-range use of the ventricular septum pulse ablation catheter, a smaller medical institution cannot ensure the complete equipment, and in the absence of equipment, the operator can clearly know the ventricular septum condition, and the position of the ventricular septum pulse ablation catheter is clearly known, which is one of the technical problems to be solved in the prior art. Disclosure of Invention In order to solve the technical problems in the prior art, the invention aims to provide an ablation catheter for treating hypertrophic cardiomyopathy and an ablation system comprising the ablation catheter, which can judge the position of the ablation catheter by matching with a simple imaging device and has better ablation effect on a more hypertrophic ventricular septum. In addition, the ablation catheter of the present invention has less damage to normal myocardial tissue when removed. In order to achieve the above object, the technical scheme of the present invention is as follows: one aspect of the present invention provides an ablation catheter comprising an insertion portion, an ablation body, a catheter body, and a control handle connected in sequence; Wherein, the The extending part comprises a screwing piece which can be rotationally drilled into and fixed into target tissues under the action of external force, and the screwing piece is in a three-dimensional spiral line shape or a screw shape, and one end far away from the ablation main body is a tip; The ablation main body comprises an ablation electrode, a connecting piece and a temperature sensor, wherein the ablation electrode is provided with a first end connected with the screwing piece, a first cavity arranged opposite to the first end, a second cavity formed by extending from the first cavity to the first end and a perfusion hole penetrating through the circumferential surface of the ablation electrode, the connecting piece is arranged in the first cavity, one end, close to the catheter main body, of the connecting piece extends out of the first cavity and is connected with the catheter main body, the connecting piece is provided with a first channel which is axially communicated with the second cavity, the perfusion hole and a transfusion channel in the catheter main body, the connecting piece and the inner wall of the first cavity form a plurality of second channels, and the temperature sensor is positioned in one second channel; The catheter bod