CN219538476U - Ablation catheter, ablation device and ablation system - Google Patents

Abstract

The utility model provides an ablation catheter, an ablation device and an ablation system, wherein the ablation catheter comprises: a catheter body; and more than two catheter electrodes are arranged on the catheter body, pulse energy can be released between the catheter electrodes, and radio frequency energy can be released between at least one catheter electrode and an external electrode. The ablation catheter, the ablation device and the ablation system provided by the utility model have the two functions of radio frequency ablation and pulse ablation, and can be respectively used for radio frequency ablation or pulse ablation or used in combination in one-time ablation operation, so that the operation risk can be reduced, the operation treatment effect can be improved, and the operation cost can be reduced.

Description

Ablation catheter, ablation device and ablation system

Technical Field

The utility model relates to the technical field of ablation, in particular to an ablation catheter, an ablation device and an ablation system.

Background

Tachycardia (including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, etc.) is a very common heart condition, and radio frequency ablation and cryoablation are two mainstream surgical methods currently used clinically to treat tachycardia, with ablation lesions that must be sufficient to destroy the healthy tissue surrounding the heart and nerve tissue such as phrenic nerves, esophagus and lungs that cause arrhythmic tissue or substantially interfere with or isolate abnormal electrical conduction within the myocardial tissue, but with excessive ablation that may cause unnecessary damage to healthy tissue surrounding the heart and nerve tissue. The advantages of radio frequency ablation during atrial fibrillation operation are mainly as follows: the operation of single point ablation can enable energy to be concentrated on the first electrode, so that a good ablation effect is achieved on thicker tissue of cardiac muscle, and meanwhile, the mode of single point ablation is convenient for carrying out point-compensating ablation on the position of a leakage point during ablation. The disadvantages of radio frequency ablation are mainly: may damage the endothelial surface of the heart, activate the extrinsic coagulation cascade, and may lead to eschar and thrombosis, which may further lead to thromboembolism.

The high-voltage pulse electric field ablation technology (pulse ablation) is a latest atrial fibrillation ablation means, and can generate a local high-voltage electric field of hundreds or even kilovolts per cm near myocardial tissue, form irreversible perforation on a cell membrane to destroy the cell membrane, and cause abnormal exchange of a biological molecular material across the cell membrane, so that cell necrosis or apoptosis is caused. Since different tissue cells have different irreversible voltage penetration thresholds, the high voltage pulsed electric field technique can be selectively applied to cardiomyocytes (relatively low threshold) without affecting other non-target cellular tissues (e.g. nerves, esophagus, blood vessels and blood). In addition, the time for releasing energy when the pulse electric field is applied is very short, and the thermal effect can not be generated, so that the problems of tissue injury, pulmonary vein stenosis and the like are avoided. Thus, pulsed ablation for atrial fibrillation ablation has many advantages including: (1) Has tissue selectivity and can protect surrounding tissues from damage; (2) The pulse electric field can be rapidly released within a few seconds, so that the ablation operation time is shortened; (3) There is no coagulative necrosis and the risk of Pulmonary Vein (PV) stenosis is reduced. Some of the disadvantages of pulsed ablation include: (1) The depth of myocardial damage caused by pulse ablation is smaller than the maximum depth achieved by traditional radio frequency ablation, so that the method is not suitable for ablation of thicker parts of cardiac muscle: (2) The ablation process is prone to nerve stimulation and causes muscle vibration. Particularly in locations close to the nerve such as the phrenic nerve.

In the treatment of atrial fibrillation, in order to isolate the pulmonary veins rapidly, the current pulse ablation catheters mostly adopt a ring-shaped, petal-shaped or balloon-shaped multi-point simultaneous ablation mode, and the ablation catheters can only be used for atrial fibrillation treatment aiming at pulmonary vein isolation, but are not suitable for other arrhythmia diseases. Meanwhile, because the pulmonary vein ports are different in shape, the electrode arms are easy to deform or can not be well attached to the pulmonary vein ports, and are not easy to attach, and at the moment, the multipoint pulse ablation is easy to cause leakage points.

In summary, at present, no device with radiofrequency ablation and pulse ablation functions exists in the market, so that the advantages of radiofrequency ablation and pulse ablation are fully exerted, and the surgical effect can be improved through the combined use of radiofrequency ablation and pulse ablation.

Disclosure of Invention

In order to solve the problems in the prior art, the utility model provides an ablation catheter, an ablation device and an ablation system. The technical scheme of the utility model is as follows:

the present utility model provides an ablation catheter comprising:

a catheter body;

and more than two catheter electrodes are arranged on the catheter body, pulse energy can be released between the catheter electrodes, and radio frequency energy can be released between at least one catheter electrode and an external electrode.

Further, the catheter electrode includes: a first electrode disposed at a distal end of the catheter body, the first electrode capable of releasing radio frequency energy from between an external electrode; a second electrode disposed on a proximal side of the first electrode; wherein pulse energy can be released between the first electrode and at least one of the second electrodes; and/or pulse energy can be released between at least two second electrodes.

Further, the first electrode is provided with an infusion channel to enable delivery of liquid from inside the ablation catheter through the infusion channel to outside the first electrode.

Further, the liquid injection channel includes: the first liquid injection channel is arranged inside the first electrode; the second liquid injection channel is communicated with the outside of the first electrode and the first liquid injection channel.

Further, a plurality of second liquid injection channels communicated with the side surface of the first electrode and the first liquid injection channel are arranged; and/or a plurality of second liquid injection channels which are communicated with the distal end face of the first electrode and the first liquid injection channels are communicated.

Further, the first electrode further includes: three or more temperature sensors provided on the first electrode; preferably, three or more of the temperature sensors are provided on the first electrode in the circumferential direction of the first electrode.

Further, the catheter body includes a first catheter body and a second catheter body, the first catheter body being located at a distal end of the second catheter body; wherein the first catheter body comprises: an optical fiber force sensor capable of detecting an external force received by the first electrode; the soft outer tube is arranged on the outer side of the optical fiber force sensor to isolate the optical fiber force sensor from the external environment.

Further, the optical fiber force sensor includes: the deformation body generates elastic deformation when being stressed; an optical fiber capable of reflecting a deformation amount of the deformation body.

Further, the deformation body includes: a first deformation body, a plurality of the first deformation bodies being disposed along an axial direction of the catheter body; a second deformation body disposed between the first deformation bodies such that openings facing differently are formed between the respective first deformation bodies; wherein the first deformation body and/or the second deformation body is/are provided with an optical fiber groove for placing the optical fiber; preferably, the first variant is annular; further preferably, the first shape is four; still further preferably, the deformation body is of unitary construction.

Further, the ablation catheter further comprises: a magnetic positioning sensor disposed on the catheter body.

Further, the magnetic positioning sensor is a six-degree-of-freedom magnetic positioning sensor;

preferably, the six-degree-of-freedom magnetic positioning sensor is a coil-type magnetic positioning sensor, and the coil-type magnetic positioning sensor is disposed in the catheter body along the axial direction of the catheter body.

The present utility model also provides an ablation device comprising: the ablation catheter described above; and an external electrode.

The present utility model also provides an ablation system comprising: the ablation catheter described above; or, the ablation device described above.

Further, the ablation system further comprises: the ablation instrument is electrically connected with the ablation catheter and can respectively provide radio frequency energy and pulse energy for the ablation catheter; and/or an infusion pump capable of delivering a liquid into the ablation catheter; and/or, a three-dimensional mapping system; and/or a magnetic positioning system.

The ablation catheter, the ablation device and the ablation system provided by the utility model have the functions of radio frequency ablation and pulse ablation. Therefore, the method can be used for radio frequency ablation or pulse ablation respectively, or radio frequency ablation and pulse ablation are combined in one ablation operation, so that the operation risk can be reduced, the operation treatment effect can be improved, and the operation cost can be reduced.

The foregoing description is only an overview of the technical solutions of the present utility model, to the extent that it can be implemented according to the content of the specification by those skilled in the art, and to make the above-mentioned and other objects, features and advantages of the present utility model more obvious, the following description is given by way of example of the present utility model.

Drawings

Fig. 1: the utility model provides a structural schematic diagram of an ablation catheter;

fig. 2: the first electrode is schematically shown in structure, wherein fig. 2 (a) is a front view of the first electrode, fig. 2 (b) is a schematic sectional view A-A' of fig. 2 (a), and fig. 2 (c) is a top view of the first electrode.

Fig. 3: a catheter body structure schematic diagram;

fig. 4: a schematic diagram of a fiber optic force sensor, wherein fig. 4 (a) is a front view of the fiber optic force sensor, fig. 4 (B) is a schematic diagram of section B-B ' in fig. 4 (a), fig. 4 (C) is a schematic diagram of section C-C ' in fig. 4 (a), and fig. 4 (D) is a schematic diagram of section D-D ' in fig. 4 (a);

reference numerals:

1000. a catheter body; 1100. a first catheter body; 1110. an optical fiber force sensor; 1111. a first variant; 1112. a second variant; 1113. an optical fiber groove; 1120. a soft outer tube; 1200. a second catheter body; 1500. a coil type magnetic positioning sensor; 1600. a connecting pipe; 1700. a first connector; 1800. a second connector; 1900. a third connecting member;

2000. a catheter electrode; 2100. a first electrode; 2110. a first liquid injection channel; 2120. a second liquid injection channel; 2130. a temperature sensor; 2200. a second electrode;

3000. a handle;

4000. a push rod;

5000. a filling port;

6000. and an optical fiber sensor interface.

Detailed Description

The following embodiments of the utility model are merely illustrative of specific embodiments for carrying out the utility model and are not to be construed as limiting the utility model. Any other changes, modifications, substitutions, combinations, and simplifications that do not depart from the spirit and principles of the utility model are intended to be equivalent arrangements which are within the scope of the utility model.

In the present utility model, "proximal" refers to an end that is close to an operator (hereinafter referred to as "operator"), and "distal" refers to an end that is far from the operator (an end opposite to "proximal").

This embodiment provides an ablation catheter, as shown in fig. 1, comprising:

a catheter body 1000;

catheter electrodes 2000, two or more of the catheter electrodes 2000 (specifically four catheter electrodes in the present embodiment as shown in fig. 1) are disposed on the catheter body 1000, pulse energy can be released between the catheter electrodes 2000, and radio frequency energy can be released between at least one of the catheter electrodes and an external electrode (not shown in the drawings).

As described in the background art, in the prior art, for atrial fibrillation ablation, a scheme of radio frequency ablation and pulse ablation is mainly adopted.

The radio frequency ablation has the advantages that the single point ablation has a good ablation effect on thicker tissue of cardiac muscle, and meanwhile, the mode of the single point ablation is convenient for carrying out point-supplementing ablation on the position of a leakage point during ablation. The defects are mainly that: may damage the endothelial surface of the heart, activate the extrinsic coagulation cascade, and may lead to eschar and thrombosis, which may further lead to thromboembolism.

The pulse ablation has the advantages of tissue selectivity, capability of protecting surrounding tissues from damage, capability of rapidly releasing a pulse electric field within a few seconds and capability of shortening the ablation operation time; there is no coagulative necrosis and the risk of Pulmonary Vein (PV) stenosis is reduced. The defects are that: the depth of the myocardial injury is smaller than the maximum depth which can be achieved by the traditional radio frequency ablation; is easy to stimulate nerves and causes vibration of muscles; and easy leakage points.

However, currently, either rf ablation or pulsed ablation, only one of which is performed by the ablation device (rf ablation or pulsed ablation) is used. Therefore, two types of devices (a radio frequency ablation device and a pulse ablation device) are often needed to be prepared for different treatment requirements by a medical institution, so that the burden of the medical institution is increased, and the cost of ablation treatment is increased; when a patient is treated, only a more proper mode (radio frequency ablation or pulse ablation) can be selected for treatment, so that the patient must face the negative effects brought by the adopted treatment mode (such as more proper pulse ablation, leakage points are easy to exist at irregular tissue shapes, or partial thicker tissues cannot reach the ablation depth and cannot be thoroughly ablated), or different ablation devices are needed for treatment respectively (such as further radio frequency ablation is needed for ablation of the leakage points or the parts which do not reach the ablation depth), and the medical cost and the risk of treatment are increased.

The ablation catheter provided by the embodiment can release pulse energy between at least two catheter electrodes 2000, so that pulse ablation can be performed during an ablation operation; at least one of the catheter electrodes 2000 and the external electrode can release rf energy so that rf ablation can be performed during an ablation procedure. That is, by using the ablation catheter provided in this embodiment, pulse ablation and radio frequency ablation can be performed, respectively, and a medical institution can perform ablation operations (radio frequency ablation or pulse ablation) in different manners by purchasing only the ablation catheter of the present utility model, thereby contributing to a reduction in the burden of the medical institution and a reduction in the ablation treatment cost. In addition, radiofrequency ablation and pulse ablation can be used in combination in one ablation procedure, for example, in a place in the heart close to peripheral tissues such as phrenic nerve and esophagus (left atrial back wall) and where the tissues are thin, with tissue-selective (and thus higher safety) pulse energy ablation, while in other places such as where the tissues are thick, radiofrequency ablation is performed on the leakage point when the leakage point is generated by using pulse ablation due to irregular shapes of the tissues, thereby thoroughly performing ablation, reducing the cost of ablation treatment and reducing the risk of ablation treatment, and also achieving better ablation effect.

In addition, it should be noted that the present utility model is not particularly limited to the external electrode as long as it can release radio frequency energy with the catheter electrode 2000. In particular, patch return electrodes as used in prior art radio frequency ablation may be used.

As for the catheter electrode, a metallic material (e.g., platinum iridium alloy, gold, etc.) or a nonmetallic material (e.g., graphite, etc.) may be selected, and a metallic material is preferably used in the present utility model.

The ablation catheter of this embodiment needs to be used in connection with an ablation instrument, and as for the ablation instrument, there are an ablation instrument for radiofrequency ablation and an ablation instrument for pulse ablation in the prior art. Therefore, a person skilled in the art can provide an ablation instrument for providing radiofrequency energy and pulse energy according to the existing ablation instrument for radiofrequency ablation and the existing ablation instrument for pulse ablation, and provide radiofrequency energy and pulse energy to the ablation catheter of the present embodiment through the ablation instrument, so that the ablation catheter of the present embodiment is used in combination with an external electrode to implement radiofrequency ablation and pulse ablation, respectively. Specifically, the radio frequency power range of the ablation instrument can be 0-100W, and the minimum adjustable power is 1W; the pulse energy may achieve a steep pulse high voltage output of up to 2400V.

In addition, the ablation catheter provided in this embodiment may further include an interface (not shown in the drawings) for connection with an ablation instrument for electrical connection with the ablation instrument. Regarding the connection manner of the interface and the catheter electrode 2000, the prior art may be adopted, for example, a channel or a pipeline for placing a wire may be provided in the catheter body 1000, so as to realize the electrical connection between the interface and the catheter electrode 2000, and ensure the tightness and insulation of the wire.

The ablation catheter of the embodiment further comprises a bending control structure arranged in the catheter body 1000 to control the bending of the distal end of the ablation catheter, so that the ablation catheter is conveniently placed in a human body during an ablation operation and is controlled during the ablation operation. The bending control structure is a prior art and is not described in detail in the present utility model.

Of course, as shown in fig. 1, the ablation catheter of the utility model may also include a handle 3000, push rod 4000, etc. in prior art ablation catheters.

In one embodiment, as shown in fig. 1, the catheter electrode 2000 includes: a first electrode 2100, the first electrode 2100 being disposed at a distal end of the catheter body 1000, the first electrode 2100 being capable of releasing radio frequency energy from between an external electrode; a second electrode 2200, the second electrode 2200 being disposed at a proximal side of the first electrode 2100; wherein pulse energy can be released between the first electrode 2100 and at least one of the second electrodes 2200; and/or pulse energy can be released between at least two second electrodes 2200.

The present embodiment shows a specific arrangement of the catheter electrode 2000, that is, including a first electrode 2100 (one "end electrode" is used in the present embodiment) provided at a distal end portion and a second electrode 2200 (one "ring electrode" is used in the present embodiment) provided at a proximal side of the first electrode 2100.

Since the first electrode 2100 is positioned at the distal end of the catheter body 1000, it can be conveniently positioned against different ablation sites, it is preferable that rf ablation can be performed by releasing rf energy between the first electrode 2100 and an external electrode, and pulse ablation can be performed by releasing pulse energy between the first electrode 2100 and one or more second electrodes 2200, thereby enabling better rf ablation and pulse ablation for different ablation sites.

In one embodiment, as shown in fig. 1 and 2 (fig. 2 (a) to 2 (c)), the first electrode 2100 is provided with an infusion channel so that liquid can be delivered from inside the ablation catheter to outside the first electrode 2100 through the infusion channel.

By providing the infusion channel in the first electrode 2100, liquid (such as cold physiological saline) can be delivered to the outside of the first electrode 2100, so that when ablation (radiofrequency ablation and pulse ablation) can be performed, the temperature of the contact surface between the electrode and the ablation tissue during ablation can be controlled, the possibility of thrombus and eschar formation during ablation can be reduced, the ablation effect can be improved, and the thromboembolism caused by the ablation operation can be prevented.

With respect to the manner of delivering the liquid (e.g., cold physiological saline) into the infusion channel, the present embodiment is not particularly limited, and, for example, an infusion port 5000 (as shown in fig. 1) may be provided on the ablation catheter, and a channel or a pipeline in which the infusion port 5000 is connected to the infusion channel may be provided in the catheter body 1000, so that the infusion channel may be provided with the liquid (e.g., cold physiological saline) through the infusion port 5000 to cool the ablation tissue.

Specifically, the perfusion port 5000 may be connected to a perfusion pump, by which a liquid (e.g., cold saline) is pumped. In this embodiment, the flow rate of the perfusion pump ranges from 0 to 60ml/min, and the flow rate may be controlled by a flow meter or the like. When the ablation operation needs cooling (especially when radio frequency ablation is performed), the operation is controlled to work at a high flow rate; when the ablation is not performed, the operation is controlled at a low flow rate, so that the pressure in the liquid injection channel is ensured to be larger than the outside of the first electrode 2100, and the backflow of blood is prevented. More specifically, the cold saline infusion pump is equipped with a bubble monitoring sensor that alarms and stops cold saline infusion when bubbles greater than 1mm in diameter pass through the infusion pump in the saline tube. The flow rate is controlled by the flowmeter, the air bubble is monitored by the air bubble monitoring sensor, and the alarm is sent out by the air bubble monitoring sensor, which can be realized by the prior art, for example, the flowmeter, the control valve, the air bubble monitoring sensor and the alarm are respectively and electrically connected with the controller (such as a microprocessor), the controller controls the control valve to control the flow according to the flow information fed back by the flowmeter, the controller can also control the closing of the control valve according to the detected air bubble information fed back by the air bubble monitoring sensor so as to stop cold physiological saline filling, and the alarm is controlled to send out the alarm.

In one embodiment, as shown in fig. 2 (a) to 2 (c)), the liquid injection passage includes: a first filling channel 2110 provided inside the first electrode 2100; a second filling channel 2120, wherein the second filling channel 2120 communicates the exterior of the first electrode 2100 with the first filling channel 2110.

The present embodiment provides a mode of setting a liquid injection channel, which includes a first liquid injection channel 2110 located inside the first electrode 2100 and a second liquid injection channel 2120 communicating the outside of the first electrode 2100 with the first liquid injection channel 2110. Thus, the liquid (such as cold physiological saline) which can be sent in from outside is conveyed to the surface of the ablation tissue after passing through the first liquid injection channel 2110 and the second liquid injection channel 2120 in sequence, so that the surface of the ablation tissue can be cooled, the possibility of thrombus and eschar formation during ablation can be reduced, and the thromboembolism caused by the ablation operation can be better prevented.

In one embodiment, as shown in fig. 2 (a) to 2 (c)), the second liquid injection channel 2120 communicates the side surface of the first electrode 2100 with the first liquid injection channel 2110; preferably, a plurality of second liquid injection channels 2120 are provided, and specifically, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 30, 40, etc. may be provided (27 second liquid injection channels 2120 communicating with the side surface of the first electrode 2100 are provided in this embodiment).

The second priming channel 2120 may also communicate the distal end face of the first electrode 2100 with the first priming channel 2110; preferably, a plurality of second filling passages 2120 are provided for communicating the distal end face of the first electrode 2100 with the first filling passage 2110, and specifically, for example, 3, 4, 5, 6, 7, 8, 9, 10, etc. (in this embodiment, 3 second filling passages 2120 are provided for communicating the distal end face of the first electrode 2100).

That is, the second filling channel 2120 communicates the side surface of the first electrode 2100 with the first filling channel 2110, and can supply liquid to the side surface of the first electrode 2100 for cooling. The second fluid injection channel 2120 communicates the distal end face of the first electrode 2100 with the first fluid injection channel 2110, and can deliver fluid to the distal end face of the first electrode 2100 for cooling.

When the second fluid injection channels 2120 are provided in a plurality, particularly uniformly distributed on the first electrode 2100, cold physiological saline can be more uniformly delivered to different directions of the first electrode 2100, so that the temperature of the contact surface between the electrode and the tissue during ablation can be better controlled, the possibility of thrombus and eschar formation during ablation can be reduced, and thus, thromboembolism caused by an ablation operation can be better prevented.

In one embodiment, as shown in fig. 2 (a), the first electrode 2100 further includes:

three or more temperature sensors 2130, three or more of the temperature sensors 2130 being provided on the first electrode 2100;

preferably, at least three of the temperature sensors 2130 are provided on the first electrode 2100 in the circumferential direction of the first electrode 2100.

In the present embodiment, specifically, 3 temperature sensors 2130 are used, which are uniformly distributed in the circumferential direction of the first electrode 2100.

By the temperature sensors 2130 being arranged at three or more of the first electrode 2100 for one week, on the one hand, a temperature change between the first electrode 2100 and the tissue at the time of ablation can be accurately detected by the temperature sensors 2130, which can effectively prevent the possibility of thrombus and eschar formation at the time of ablation; on the other hand, the highest temperature fed back in the temperature sensor 2130 is the real-time temperature closest to the ablation point, and can accurately reflect the ablation temperature of the leaning place (cardiac muscle) at any leaning position; in a third aspect, the abutting end position and angle of the first electrode 2100 may be determined according to the difference between the temperatures fed back by the temperature sensors 2130, for example, when there is a difference between the temperatures fed back by the temperature sensors 2130, it indicates that the corresponding side of the temperature sensor 2130 with higher feedback temperature is biased to the ablation point, and when the temperatures fed back by the temperature sensors 2130 are the same, it indicates that the end surface of the first electrode 2100 is uniformly abutted to the ablation point, so as to assist the operator to accurately control the first electrode 2100 to perform corresponding ablation operation through different angles.

In the above, it was described that an interface for connection with an ablation instrument is provided, and the temperature sensor in this embodiment may be connected to the interface through a channel or a pipe or the like provided in the ablation catheter, so that a temperature signal is transmitted to the ablation instrument for processing and display.

In one embodiment, as shown in fig. 3, the catheter body 1000 includes a first catheter body 1100 and a second catheter body 1200, the first catheter body 1100 being located at a distal end of the second catheter body 1200;

wherein the first catheter body 1100 comprises:

a fiber optic force sensor 1110, the fiber optic force sensor 1110 being capable of detecting an external force experienced by the first electrode 2100;

a soft outer tube 1120, wherein the soft outer tube 1120 is arranged outside the optical fiber force sensor 1110 to isolate the optical fiber force sensor 1110 from the external environment.

In this embodiment, the catheter body 1000 includes a first catheter body 1100 and a second catheter body 1200, the first catheter body 1100 is located at the distal end of the second catheter body 1200, and the first catheter body 1100 includes an optical fiber force sensor 1110, and the distal end of the catheter body 1000 is provided with the first electrode 2100, so it can be known that the optical fiber force sensor 1110 is located at one side of the proximal end of the first electrode 2100, so that, when the operation is performed, the magnitude and direction of the force applied by the first electrode 2100 against the tissue can be measured by the optical fiber force sensor 1110 and can be fed back, so as to guide the operator to perform ablation better.

The soft outer tube 1120 can prevent external blood and the like from entering the catheter body 1000 to influence measurement, and can ensure that force can not be dispersed to the outer wall of the catheter to influence force analysis of the force sensor when the catheter is stressed. The flexible outer tube 1120 may be made of a flexible medical polymer material.

In addition, as shown in fig. 1, in this embodiment, an optical fiber sensor interface 6000 is further disposed on the ablation catheter, and through a channel or a pipe disposed in the catheter body 1000, an optical fiber can be connected with the optical fiber sensor interface 6000, so that a signal fed back by the optical fiber is conveniently sent to an external device to obtain a stress condition of the distal end of the ablation catheter.

In one embodiment, as shown in fig. 4, the fiber optic force sensor 1110 includes: the deformation body generates elastic deformation when being stressed; an optical fiber capable of reflecting a deformation amount of the deformation body.

Specifically, in the optical fiber force sensor 1110 provided in this embodiment, the deformation body includes:

a first deforming member 1111, a plurality of the first deforming members 1111 being disposed along an axial direction of the catheter body 1000;

a second deformation body 1112, the second deformation body 1112 being disposed between the first deformation bodies 1111 such that openings facing differently are formed between the respective first deformation bodies 1111;

wherein the deformation body is provided with an optical fiber groove 1113 for accommodating the optical fiber.

In this embodiment, the second deformation bodies 1112 are disposed between the first deformation bodies 1111, and openings with different orientations are formed between the first deformation bodies 1111, so that the stress is mainly concentrated on the second deformation bodies 1112, and thus the deformation amount of the whole deformation body can be increased, and the sensitivity of the optical fiber force sensor 1110 can be increased; in addition, the gap between the openings is changed by the deformation of the second deformation body 1112, and in particular, as shown in fig. 4 (a), in the arrangement of the present embodiment, the optical fiber grooves 1113 allow the optical fibers to pass through the openings between the first deformation bodies 1111, so that the shape variable of the optical fibers is further increased, and the sensitivity of the optical fiber force sensor 1110 is further improved.

Preferably, the number of the first deforming bodies 1111 is four. As shown in fig. 4 (a) to 4 (d)) of the present embodiment, that is, four first deformation bodies 1111 are adopted, three second deformation bodies 1112 are disposed between the four first deformation bodies 1111 and three openings with different orientations (specifically, each opening is oriented to be displaced 120 degrees), so that the stress condition (size and direction) of the first electrode 2100 against the tissue can be reflected in three dimensions (i.e., in a three-dimensional space range). Of course, when fewer than four first deformation bodies 1111 are provided, the detected stress situation has fewer dimensions; the provision of more than four of the first deformable bodies 1111 also enables the detection of stress conditions in three dimensions, but increases the complexity of the system.

More specifically, as shown in fig. 4 (a) to 4 (d)), in the present embodiment, the first deforming member 1111 has an annular structure, and the optical fiber groove 1113 is formed in the first deforming member 1111. Thus, in a first aspect, the optical fiber securing arrangement (e.g., with an adhesive) may reflect deformation between the first deformable bodies 1111 after being positioned within the optical fiber channel 1113; in a second aspect, the annular first deformation body 1111 may itself support the soft outer tube 1120, ensuring consistent external dimensions of the catheter body 1000, facilitating in vivo placement of an ablation catheter; in the third aspect, a channel or a pipeline may be conveniently disposed in the middle of the first deformation body 1111 in the annular shape, so that the first electrode 2100 may be conveniently electrically connected to the outside, and the liquid may be conveniently delivered to the first electrode 2100.

It is further preferred that the deformation bodies are of unitary construction, i.e. that the deformation bodies are not assembled from separate, distinct individuals of the first deformation body 1111 and the second deformation body 1112. In the present embodiment, the material of the deformable body is not particularly limited as long as it can be elastically deformed after being subjected to a force, and examples of the material of the deformable body include metal materials such as spring steel.

In one embodiment, as shown in fig. 3, the ablation catheter further comprises:

a magnetic positioning sensor disposed on the catheter body 1000.

The electrical positioning of the ablation catheter can be achieved through the catheter electrode 2000 by using the existing three-dimensional mapping system, especially when more than two catheter electrodes 2000 (including the first electrode 2100 and the second electrode 2200) are provided, for example, when more than 2, 3, 4, 5, 6, 7, 8, 9, 10 or 10 catheter electrodes 2000 are provided, the visualized catheter body of the ablation catheter can be longer, the shape of the catheter in the heart can be better perceived, and meanwhile, the ablation catheter provided by the embodiment has the mapping function.

For convenience of description, 6 catheter electrodes 2000 (including the first electrode 2100 and the second electrode 2200) in fig. 1 are named as M1 electrode to M6 electrode in sequence from the distal end to the proximal end, in this embodiment, the M1 electrode (i.e. the first electrode 2100) and the external electrode are used for radiofrequency ablation, the M1 electrode (i.e. the first electrode 2100) and the M3 electrode are used for pulse ablation, and a plurality of electrodes (specifically four: M2 electrode, M4 electrode to M6 electrode) are specially arranged for electrical positioning, so that electrical positioning can be achieved while ablation discharge.

The ablation catheter of the embodiment is additionally provided with a magnetic positioning sensor, so that the magnetic positioning of the ablation catheter can be realized through the existing magnetic positioning system, such as a magnetic positioning system of radwave company.

Through catheter electrode 2000 (especially set up more than two catheter electrodes 2000) and magnetic positioning sensor, combine current three-dimensional mapping system, magnetic positioning system, can realize the electromagnetism double localization to the ablation catheter, accurately show the position that the catheter arrived the heart, be favorable to the operator to use the ablation catheter to ablate the operation accurately to can reduce the time and the radioactive dose of perspective ray in the operation process.

Specifically, as shown in fig. 3, in the present embodiment, the magnetic sensor is a six-degree-of-freedom magnetic positioning sensor, more specifically, a coil-type magnetic positioning sensor 1500, and the coil-type magnetic positioning sensor 1500 is disposed in the catheter body 1000 along the axial direction of the catheter body 1000. In this embodiment, compared with the current square magnetic positioning sensor 1500, the coil magnetic positioning sensor 1500 can shorten the length of the magnetic positioning sensor when the same positioning sensitivity is achieved, and meanwhile, the middle part of the coil magnetic positioning sensor 1500 can be provided with a channel or a pipeline, so that the catheter electrode 2000 can be conveniently supplied with power and liquid can be conveyed to the first electrode 2100.

In this embodiment, a connection pipe 1600 is further provided, so that the coil type magnetic positioning sensor 1500 is conveniently sleeved outside the connection pipe 1600 to fix, and a channel or a pipeline is conveniently provided in the connection pipe 1600.

In the above, it was described that an interface for connection with an ablation instrument is provided, and the magnetic sensor in this embodiment may be connected to the interface through a channel or a pipe or the like provided in the ablation catheter, so that the magnetic sensor signal is transmitted to the ablation instrument for processing and display.

In addition, as can be seen from fig. 3, in the present embodiment, the magnetic sensor is disposed on the proximal side of the optical fiber sensor 1110, the magnetic sensor and the optical fiber sensor 1110 together form the first catheter body 1100, and the soft outer tube 1120 is disposed outside the magnetic sensor and the optical fiber sensor 1110 to be isolated from the external environment. Wherein the distal end of the optical fiber force sensor 1110 is provided with a first connector 1700 for connecting with the first electrode 2100, the proximal end of the optical fiber force sensor 1110 is provided with a second connector 1800 for connecting with the connection tube 1600, the proximal end of the connection tube 1600 is provided with a third connector 1900 for connecting with the second catheter body 1200, the connections being bonded with an adhesive (not shown in the drawings).

In one embodiment, an ablation device is provided that includes the ablation catheter described above and an external electrode.

Namely, the ablation device provided by the embodiment is a product of the combination of the ablation catheter and the external electrode, so that the ablation catheter and the external electrode are convenient to directly use for performing the ablation operation without additionally matching the corresponding external electrode after purchasing the ablation catheter.

In one embodiment, an ablation system is provided comprising an ablation catheter as described above or an ablation device as described above.

Specifically, the method further comprises the following steps: and the ablation instrument is electrically connected with the ablation catheter and can respectively provide radio frequency energy and pulse energy for the ablation device.

The ablation system may further comprise an infusion pump, with which the ablation tissue can be cooled by delivering liquid (cold saline) into the ablation catheter.

The ablation system described above may also further include existing three-dimensional mapping systems, magnetic positioning systems, to perform electrical positioning as well as magnetic positioning systems.

The ablation catheter, the ablation device and the ablation system provided by the utility model have the functions of radio frequency ablation and pulse ablation. Therefore, the method can be used for radiofrequency ablation or pulse ablation respectively, or can be used for radiofrequency ablation and pulse ablation in one ablation operation (such as pulse ablation at a thinner part of tissue and radiofrequency ablation at a thicker part of tissue, and radiofrequency ablation is carried out on leakage points when the leakage points are generated by the pulse ablation due to irregular shapes of the tissue), so that the operation risk can be reduced, the operation treatment effect can be improved, and the operation cost can be reduced.

Although the embodiments of the present utility model have been described above, the present utility model is not limited to the above-described specific embodiments and application fields, and the above-described specific embodiments are merely illustrative, and not restrictive. Those skilled in the art, having the benefit of this disclosure, may effect numerous forms of the utility model as described herein without departing from the scope of the utility model as claimed.

Claims (19)

1. An ablation catheter, comprising:

a catheter body;

and more than two catheter electrodes are arranged on the catheter body, pulse energy can be released between the catheter electrodes, and radio frequency energy can be released between at least one catheter electrode and an external electrode.

2. The ablation catheter of claim 1, wherein the catheter is configured to,

the catheter electrode includes:

a first electrode disposed at a distal end of the catheter body, the first electrode capable of releasing radio frequency energy from between an external electrode;

a second electrode disposed on a proximal side of the first electrode;

wherein pulse energy can be released between the first electrode and at least one of the second electrodes; and/or the number of the groups of groups,

pulse energy can be released between at least two second electrodes.

3. The ablation catheter of claim 2, wherein the catheter is configured to,

the first electrode is provided with an infusion channel to enable delivery of fluid from inside the ablation catheter through the infusion channel to outside the first electrode.

4. The ablation catheter of claim 3, wherein the catheter is configured to,

the liquid injection channel comprises:

the first liquid injection channel is arranged inside the first electrode;

the second liquid injection channel is communicated with the outside of the first electrode and the first liquid injection channel.

5. The ablation catheter of claim 4, wherein the catheter is configured to,

the side surface communicated with the first electrode is communicated with the second liquid injection channel of the first liquid injection channel; and/or the number of the groups of groups,

the second liquid injection channel communicated with the distal end face of the first electrode is provided with a plurality of liquid injection channels.

6. The ablation catheter of claim 2, wherein the catheter is configured to,

the first electrode further includes:

and more than three temperature sensors, wherein more than three temperature sensors are arranged on the first electrode.

7. The ablation catheter of claim 6, wherein the catheter is configured to,

three or more of the temperature sensors are provided on the first electrode in the circumferential direction of the first electrode.

8. The ablation catheter of claim 2, wherein the catheter is configured to,

the catheter body comprises a first catheter body and a second catheter body, the first catheter body is positioned at the distal end of the second catheter body;

wherein the first catheter body comprises:

an optical fiber force sensor capable of detecting an external force received by the first electrode;

the soft outer tube is arranged on the outer side of the optical fiber force sensor to isolate the optical fiber force sensor from the external environment.

9. The ablation catheter of claim 8, wherein the catheter is configured to,

the optical fiber force sensor includes:

the deformation body generates elastic deformation when being stressed;

an optical fiber capable of reflecting a deformation amount of the deformation body.

10. The ablation catheter of claim 9, wherein the catheter is configured to,

the deformation body includes:

a first deformation body, a plurality of the first deformation bodies being disposed along an axial direction of the catheter body;

a second deformation body disposed between the first deformation bodies such that openings facing differently are formed between the respective first deformation bodies;

wherein the first and/or second deformation bodies are provided with fiber grooves for accommodating the optical fibers.

11. The ablation catheter of claim 10, wherein the catheter is configured to,

the first variation is annular.

12. The ablation catheter of claim 10, wherein the catheter is configured to,

the first deformation body is four.

13. The ablation catheter of claim 10, wherein the catheter is configured to,

the deformation body is of an integrated structure.

14. The ablation catheter of claim 1, wherein the catheter is configured to,

the ablation catheter further comprises:

a magnetic positioning sensor disposed on the catheter body.

15. The ablation catheter of claim 14, wherein the catheter is configured to,

the magnetic positioning sensor is a six-degree-of-freedom magnetic positioning sensor.

16. The ablation catheter of claim 15, wherein the catheter is configured to,

the six-degree-of-freedom magnetic positioning sensor is a coil type magnetic positioning sensor, and the coil type magnetic positioning sensor is arranged in the catheter body along the axial direction of the catheter body.

17. An ablation device, comprising:

the ablation catheter of any of claims 1-16; and, a step of, in the first embodiment,

an external electrode.

18. An ablation system, comprising:

the ablation catheter of any of claims 1-16; or alternatively, the first and second heat exchangers may be,

the ablation device of claim 17.

19. The ablation system of claim 18, wherein the ablation system,

further comprises:

the ablation instrument is electrically connected with the ablation catheter and can respectively provide radio frequency energy and pulse energy for the ablation catheter; and/or the number of the groups of groups,

an infusion pump capable of outputting a liquid into the ablation catheter; and/or the number of the groups of groups,

a three-dimensional mapping system; and/or the number of the groups of groups,

a magnetic positioning system.