CN117982815A - Ultrasonic focusing ablation catheter and equipment - Google Patents

Abstract

The invention discloses an ultrasonic focusing ablation catheter and equipment. The ultrasonic focusing ablation catheter comprises a multi-cavity tube as a catheter body; the first ultrasonic transducer is arranged at the far end of the catheter body and is electrically connected with the control part; the first ultrasonic transducer is parallel to the central axis of the catheter body and is used for measuring the distance and the temperature of the inner wall of the blood vessel, so that an ablation target area is calculated and the temperature of the target area is measured, and the output power calculation of the second ultrasonic transducer and the judgment of the ablation endpoint are used; the at least two second ultrasonic transducers are arranged at the far end of the catheter body and are electrically connected with the control part; the second ultrasonic transducers form a set included angle with the central axis of the catheter body, and at least two second ultrasonic transducers are mutually symmetrical with respect to the first ultrasonic transducer for determining an ablation focus and performing focused ablation. The catheter can be used for focusing the energy transmitted by the sound waves to the focal ablation area without ablating other areas.

Description

Ultrasonic focusing ablation catheter and equipment

Technical Field

The invention relates to an ultrasonic focusing ablation catheter, and also relates to ultrasonic focusing ablation equipment comprising the catheter, belonging to the technical field of medical appliances.

Background

The ultrasonic ablation technology is that an ultrasonic wave is emitted by an internal transducer of a balloon, passes through normal saline, acts on blood vessels and tissues, acts on a specific target area, and gathers energy to enough intensity so that a focus area reaches an ablation target temperature. The temperature is gradually increased to damage the blood vessel and the peripheral nerves, thereby achieving the purpose of damaging the lesion area without damaging the tissues outside the lesion area.

In the Chinese utility model with the patent number ZL 201921533427.2, an ultrasonic ablation device and equipment are provided. The ultrasonic ablation device is used for being selectively placed in a cavity of a human body and performing ultrasonic ablation on tissue to be ablated in the human body, and comprises: a catheter and a deformation transducer; the two ends of the catheter are respectively a liquid inlet end and a liquid outlet end, and a positioning bag is arranged on the outer wall close to the liquid inlet end and used for being placed in the cavity to selectively position the catheter through deformation. The deformation energy transducer is arranged on the periphery of the positioning bag, and can selectively emit ultrasonic energy along a first direction through deformation under the deformation acting force of the positioning bag, and an included angle of 10-90 degrees can be formed between the first direction and the axial direction of the catheter. Therefore, the ultrasonic ablation device can enlarge the size of the deformation transducer, so that the treatment range of the ultrasonic ablation device is wider.

However, the above-mentioned ultrasonic ablation device cannot realize fixed point ablation, the fan-shaped divergence of unfocused ultrasonic energy and the damage of the blood vessel intima and non-target area are easily caused, thereby causing the blood vessel to shrink and narrow deformation to make the blood vessel in a blocking state, so that the patient produces adverse reaction and affects the ablation effect.

Disclosure of Invention

The invention aims to provide an ultrasonic focusing ablation catheter.

Another technical problem to be solved by the present invention is to provide an ultrasonic focusing ablation device.

In order to achieve the technical purpose, the invention adopts the following technical scheme:

According to a first aspect of embodiments of the present invention, there is provided an ultrasound focused ablation catheter comprising:

the catheter body is a multi-cavity tube and at least comprises a guide wire cavity for penetrating a guide wire and a wire cavity for penetrating a wire;

The first ultrasonic transducer is arranged at the far end of the catheter body and is used for being electrically connected with the control part through a wire; wherein the first ultrasonic transducer is parallel to the central axis of the catheter body for measuring the distance to the inner wall of the blood vessel to calculate an ablation target zone; the first ultrasonic transducer is also used for measuring the temperature of a target area so as to be used for calculating the output power of the second ultrasonic transducer and judging the ablation endpoint;

The at least two second ultrasonic transducers are arranged at the far end of the catheter body and are used for being electrically connected with the control part through wires; the second ultrasonic transducers form a set included angle with the central axis of the catheter body, and at least two second ultrasonic transducers are mutually symmetrical with respect to the first ultrasonic transducer and are used for determining an ablation focus and performing focused ablation.

Preferably, the second ultrasonic transducer is rotatably arranged at the distal end of the catheter body so as to adjust the size of the set included angle.

Preferably, the first ultrasonic transducer is used as a center, and at least two second ultrasonic transducers can relatively move along the central axis of the catheter body so as to adjust the relative distance between the at least two ultrasonic transducers.

Wherein, preferably, the plurality of the first ultrasonic transducers are arranged, and the plurality of the first ultrasonic transducers are arranged in a circular ring shape around the circumferential direction of the catheter body; the two sides of each first ultrasonic transducer are symmetrically distributed with two obliquely arranged second ultrasonic transducers.

Wherein preferably, the second ultrasonic transducer is electrically connected with the controller to receive the current output power calculated by the controller based on the current temperature of the ablation target area measured by the first ultrasonic transducer;

And the second ultrasonic transducer releases ultrasonic waves with corresponding intensity according to the current output power so as to perform focusing ablation on the ablation target area.

Wherein preferably, the ultrasonic focusing ablation catheter further comprises:

A tip balloon disposed on an end face of the distal end of the catheter body and in communication with the interior cavity of the catheter body for occluding a blood vessel in a filled state;

the internal cavity comprises a liquid inlet cavity for liquid inlet and a liquid outlet cavity for liquid outlet.

Wherein preferably, a flexible electrode is installed on the outer side of the tip balloon, and a pressure sensor is installed on the inner side of the tip balloon, and the flexible electrode and the pressure sensor are electrically connected with a control part for detecting impedance and water pressure.

According to a second aspect of embodiments of the present invention, there is provided an ultrasonic focus ablation apparatus comprising:

A control part for automatic control of ultrasonic ablation;

An operation handle connected to the control unit;

the proximal end of the ultrasonic focusing ablation catheter is arranged on the operating handle and is electrically connected with the control part;

the control part continuously adjusts the output power of the second ultrasonic transducer according to the measured temperature of the first ultrasonic transducer until reaching an ablation end point; the control part is also used for judging whether the ablation endpoint is reached according to the judgment logic.

Preferably, the judging logic specifically includes:

And when the first ultrasonic transducer detects that the current temperature of the ablation target area reaches a set value and is stable for a preset period of time, and the first ultrasonic transducer detects that the distance to the inner wall of the blood vessel reaches a theoretical value, judging that the ablation end point is reached.

Preferably, the control unit includes at least:

the main control module is used for processing the signals and the data and controlling automatic ablation;

The signal generator is connected with the main control module and is used for receiving and transmitting ultrasonic signals;

The power amplifier is connected with the signal generator and used for amplifying ultrasonic signals;

a gating module connected with the power amplifier for selecting the number of signal channels;

the phase voltage and current module is connected with the main control module and used for detecting parameters and outputting matched ultrasonic frequency;

and the impedance matching module is connected with the main control module and used for detecting matching impedance and outputting ultrasonic signals of matching power.

Compared with the prior art, the invention has the following technical effects:

1. Measuring the distance of the inner wall of the blood vessel through a first ultrasonic transducer which is horizontally arranged, calculating an ablation target area and measuring the temperature of the target area; and the second ultrasonic transducer which is obliquely arranged focuses to concentrate the energy transmitted by the sound wave to the focal point ablation area and does not ablate other areas, so that the intima of the blood vessel is effectively protected.

2. The second ultrasonic transducer can rotate, so that adjustment of different focal lengths can be achieved, and then adaptive adjustment can be carried out according to different ablation positions of blood vessels, so that the applicability of the ultrasonic focusing ablation catheter is improved.

3. The second ultrasonic transducer is movable, so that the size of the focused ablation area can be adjusted, and then the adaptive adjustment can be carried out according to different ablation positions of the blood vessel, so that the applicability of the ultrasonic focused ablation catheter is improved.

4. The plurality of first ultrasonic transducers and the plurality of second ultrasonic transducers can form a plurality of ablation subgroups, any one or a plurality of ablation subgroups can be controlled to enter a working state through the control part, so that the 360-degree omnibearing ablation can be realized without rotating the catheter body, the ablation efficiency is improved, and the convenience of the ablation operation is improved.

Drawings

Fig. 1 is a schematic structural view of an ultrasonic focusing ablation catheter according to a first embodiment of the present invention;

FIG. 2 is a cross-sectional view of a catheter body according to a first embodiment of the present invention;

FIG. 3 is a schematic view of focused ablation in a first embodiment of the invention;

fig. 4A is a schematic structural view of an ultrasonic focusing ablation catheter according to a second embodiment of the present invention;

Fig. 4B is a schematic structural view of an ultrasonic focusing ablation catheter according to a third embodiment of the present invention;

Fig. 5 is a schematic structural view of an ultrasonic focusing ablation catheter according to a fourth embodiment of the present invention;

fig. 6 is a schematic structural view of an ultrasonic focusing ablation catheter according to a fifth embodiment of the present invention;

Fig. 7 is a schematic structural diagram of an ultrasonic focusing ablation device according to a sixth embodiment of the present invention;

fig. 8 is a schematic structural view of a control unit according to a sixth embodiment of the present invention.

Detailed Description

The technical contents of the present invention will be described in detail with reference to the accompanying drawings and specific examples.

First embodiment

As shown in fig. 1, an ultrasonic focusing ablation catheter provided in a first embodiment of the present invention includes a catheter body 1, a first ultrasonic transducer 2, at least two second ultrasonic transducers 3, and a tip balloon 4. Wherein, the catheter body 1 is a multi-lumen tube, and each lumen has different functions, for example: a guide wire cavity for threading a guide wire, a wire cavity for threading a wire, a liquid inlet cavity and a liquid outlet cavity for liquid circulation, etc. And, as shown in the position of fig. 1, the first ultrasonic transducer 2 is horizontally arranged for measuring the distance and temperature of the inner wall of the blood vessel, thereby calculating the ablation target area and measuring the current temperature of the ablation target area. At least two ultrasound transducers 3 are arranged obliquely for determining the ablation focus and for performing focused ablation. A tip balloon 4 is provided at the distal end of the catheter body 1 for occluding a blood vessel in an inflated state.

In this embodiment, the proximal end of the catheter body 1 is adapted to be connected to the control unit 100 (see fig. 7), and the distal end of the catheter body 1 is adapted to extend into a blood vessel. As shown in fig. 2, the catheter body 1 is a multi-lumen tube, and at least includes a guidewire lumen 11, a guide wire lumen 12, a liquid inlet lumen 13, and a liquid outlet lumen 14. The guide wire 10 is arranged in the guide wire cavity 11 in a penetrating way, so that the bending direction of the catheter body 1 is controlled through the guide wire 10, and the catheter body 1 is driven to enter different vascular tissues. The wire cavity 12 is internally penetrated with a wire 20, and the first ultrasonic transducer 2 and the at least two second ultrasonic transducers 3 can be electrically connected with the control part by utilizing the wire 20, so that the ablation control can be carried out on the first ultrasonic transducer 2 and the at least two second ultrasonic transducers 3 through the control part. The liquid inlet chamber 13 and the liquid outlet chamber 14 are respectively communicated with a liquid inlet and a liquid outlet of an external water supply device so as to perform liquid circulation, thereby enabling the tip balloon 4 to be mutually switched between a filling state and a releasing state. It will be appreciated that the catheter body 1 may be provided with other lumens as desired, and is not particularly limited herein.

As shown in fig. 1, a first ultrasonic transducer 2 is provided at the distal end of the catheter body 1 for electrical connection with a control portion through a wire 20. Specifically, referring to the orientation shown in fig. 1, the first ultrasonic transducer 2 is parallel to the central axis O of the catheter body 1, so as to convert the pulsed electrical signal into a mechanical signal and generate a single ultrasonic wave under the control of the control section, to calculate the tissue morphology change and the temperature change by analyzing the echo signal, that is: the first ultrasonic transducer 2 can operate in a measurement mode under the control of the control section. Thus, the distance from the inner wall of the blood vessel can be measured by the first ultrasonic transducer 2, and the ablation target region can be calculated. Also, the first ultrasound transducer 2 is able to measure the current temperature of the ablation target volume.

Furthermore, in another embodiment, an infrared measuring device may be used instead of the first ultrasonic transducer 2 to achieve temperature and distance measurement by infrared rays. It will be appreciated that the measurement of temperature and distance by infrared rays is known in the art, and is not specifically described herein, and the specific type of the infrared measurement device may be adaptively selected as required to meet the use requirements of different measurement scenarios.

As shown in fig. 1, at least two second ultrasonic transducers 3 are provided at the distal end of the catheter body 1 for electrical connection with the control section through wires 20. In the present embodiment, two second ultrasonic transducers 3 are exemplified. Specifically, the second ultrasonic transducers 3 form a set angle α with the central axis 0 of the catheter body 1, and the two second ultrasonic transducers 3 are symmetrical to each other with respect to the first ultrasonic transducer 2, thereby being used for determining an ablation focus and performing focused ablation (refer to fig. 3). Under the control of the control part, the second ultrasonic transducer 3 converts the electrical signal into mechanical vibration to continuously generate ultrasonic waves, and heats the ablation target area within the energy focus range of the acoustic waves, namely: the second ultrasound transducer 3 is capable of operating in an ablation mode under control of the control section. In addition, in the present embodiment, the catheter body 1 can be rotated, so that the first ultrasonic transducer 2 and the second ultrasonic transducer 3 correspond to different positions of the blood vessel, so as to realize 360 ° omnidirectional ablation.

It will be appreciated that as the second ultrasound transducer 3 is continuously ablated, the temperature of the target area is gradually increased. In this process, the first ultrasonic transducer 2 continuously detects the current temperature of the ablation target area and feeds back the current temperature to the control part, and accordingly, the control part calculates the current output power of the second ultrasonic transducer 3 based on a preset algorithm based on the current temperature of the ablation target area. It is known that, in the actual ablation process, the ablation power of the second ultrasonic transducer 3 is continuously changed as the second ultrasonic transducer 3 is continuously ablated until the final control portion determines that the ablation end point is reached (how to determine the ablation end point is described below). Therefore, automatic focusing ablation can be realized, the ablation efficiency is improved, the mode of manually judging the ablation state is replaced by an automatic control mode, the error rate of manually judging the ablation state is reduced, and the consistency of the ablation effect is ensured.

As shown in fig. 1, the tip balloon 4 is disposed at the distal end of the catheter body 1 and communicates with the inlet lumen 13 and the outlet lumen 14. Thus, liquid may be passed into the tip balloon 4 by an external liquid supply, such that the tip balloon 4 is continuously inflated until it abuts against the vessel wall. Also, in the present embodiment, it is preferable that a flexible electrode is installed at the outer side of the tip balloon 4, and a pressure sensor is installed at the inner side of the tip balloon 4, both of which are electrically connected to the control part for detecting impedance and water pressure. Thus, in the process of continuously filling the tip balloon 4, the control part 1 can judge whether the tip balloon 4 is completely adhered by receiving impedance and water pressure so as to ensure the adhesion of the tip balloon 4. Preferably, the tip balloon 4 is made of silica gel, and the flexible electrode is a flexible circuit board (FPC).

In addition, it will be appreciated that during the ablation procedure, the external fluid supply maintains the current pressure for continuous fluid delivery through the catheter body 1, ensuring that the tip balloon 4 remains of the desired size while also cooling the interior of the tip balloon 4. After entering the tip balloon 4 through the liquid inlet cavity 13 of the catheter body 2, the liquid is discharged to the storage device for recycling through the liquid outlet cavity 14.

Second embodiment

As shown in fig. 4A, an ultrasonic focusing ablation catheter according to a second embodiment of the present invention includes a catheter body 1, a first ultrasonic transducer 2, at least two second ultrasonic transducers 3, and a tip balloon 4. Compared with the first embodiment, the present embodiment is different in that: the second ultrasonic transducer 3 is rotatable.

In this embodiment, the second ultrasonic transducer 3 is rotatably disposed at the distal end of the catheter body 1 to adjust the set angle α. Specifically, an additional guide wire (not shown in the figure) is arranged in the wire cavity 12, and the guide wire is connected with the second ultrasonic transducer 3, so that the second ultrasonic transducer 3 is driven to rotate by pulling the guide wire, and the set included angle alpha can be freely adjusted within a certain angle range (for example, 30-60 degrees). It can be understood that when the included angle α varies, the focal points and focal regions of the two second ultrasonic transducers 3 will correspondingly vary, so as to adaptively adjust according to different ablation positions of the blood vessel, so as to improve the applicability of the ultrasonic focusing ablation catheter.

In addition, in this embodiment, the rotation adjustment of the second ultrasonic transducer 3 by setting the guide wire is only one embodiment, and in other embodiments, other adjusting structures may be adaptively replaced as needed to adjust the size of the set included angle α, which is not limited herein.

Except for the above differences, the other structural features of the present embodiment are the same as those of the first embodiment, and will not be described here again.

Third embodiment

As shown in fig. 4B, an ultrasonic focusing ablation catheter according to a third embodiment of the present invention includes a catheter body 1, a first ultrasonic transducer 2, at least two second ultrasonic transducers 3, and a tip balloon 4. Compared with the first embodiment, the present embodiment is different in that: the second ultrasonic transducer 3 is movable.

In the present embodiment, the two second ultrasonic transducers 3 are relatively movable along the central axis of the catheter body 1 centering on the first ultrasonic transducer 2 to adjust the relative distance between the two second ultrasonic transducers 3. Specifically, an additional guide wire (not shown in the figure) is arranged in the wire cavity 12, and the guide wire is connected with the second ultrasonic transducer 3, so that the guide wire is pulled to drive the central axis of the catheter body of the second ultrasonic transducer 3 to move, so that the two second ultrasonic transducers 3 are close to or far away from each other, and the distance between the two second ultrasonic transducers is adjusted. It will be appreciated that when the distance between the two second ultrasound transducers 3 is changed, the size of the ablation target area determined by the two second ultrasound transducers will also be changed, so that the size of the ablation target area can be adaptively adjusted according to different ablation positions of the blood vessel, and the applicability of the ultrasound focusing ablation catheter is improved.

In addition, in this embodiment, the movement adjustment of the second ultrasonic transducers 3 by setting the guide wire is only one implementation, and in other embodiments, other adjustment structures may be adaptively replaced as needed to adjust the distance between the two second ultrasonic transducers 3, which is not limited herein.

Except for the above differences, the other structural features of the present embodiment are the same as those of the first embodiment, and will not be described here again.

Fourth embodiment

As shown in fig. 5, an ultrasonic focusing ablation catheter according to a fourth embodiment of the present invention includes a catheter body 1, a plurality of first ultrasonic transducers 2, a plurality of second ultrasonic transducers 3, and a tip balloon 4. Compared with the first embodiment, the present embodiment is different in that: the number of first ultrasonic transducers 2 and the number of second ultrasonic transducers 3 are different.

Specifically, in the present embodiment, the number of the first ultrasonic transducers 2 is plural, and the plural first ultrasonic transducers 2 are uniformly distributed around the circumferential direction of the catheter body 1 so as to be enclosed in a circular ring shape. Correspondingly, two second ultrasonic transducers 3 with inclined set included angles alpha are symmetrically distributed on two sides of each first ultrasonic transducer 2.

Thus, one ultrasound transducer 2 and the corresponding two ultrasound transducers 3 can be regarded as one ablation subgroup, and a plurality of ablation subgroups are formed on the catheter body 1 in the circumferential direction. When the ablation device is specifically used, any one or a plurality of ablation groups can be controlled to enter a working state through the control part, so that the 360-degree omnibearing ablation can be realized without rotating the catheter body 1, the ablation efficiency is improved on one hand, and the convenience of the ablation operation is improved on the other hand.

It will be appreciated that in another embodiment, the plurality of second ultrasound transducers 2 may also be helically distributed along the axial direction of the catheter body 1 to form a helical structure, thereby enabling a plurality of ablation subgroups to be spaced apart along the length of the catheter body 1. Therefore, on one hand, the convenience of the installation of an ablation group can be improved, and on the other hand, the ultrasonic focusing ablation catheter can correspond to a larger ablatable area, so that the moving times and the moving distance of the catheter body 1 in a blood vessel are reduced.

Except for the above differences, the other structural features of the present embodiment are the same as those of the first embodiment, and will not be described here again.

Fifth embodiment:

As shown in fig. 6, an ultrasonic focusing ablation catheter according to a fifth embodiment of the present invention includes a catheter body 1, a plurality of first ultrasonic transducers 2, a plurality of second ultrasonic transducers 3, and a tip balloon 4. Compared with the first embodiment, the present embodiment is different in that: an outer balloon 5 is also included.

Specifically, in this embodiment, the outer balloon 5 is sleeved on the distal end of the catheter body 1, so as to simultaneously wrap the plurality of first ultrasonic transducers 2, the plurality of second ultrasonic transducers 3 and the tip balloon 4. A water circulation device (not shown in the figure) can be added in the external balloon 5 so as to cool the first ultrasonic transducer 2 and the second ultrasonic transducer 3 by using the water circulation device and ensure the working efficiency of the ultrasonic transducers.

In addition, the external balloon 5 can wrap the first ultrasonic transducer 2, the second ultrasonic transducer 3 and the tip balloon 4 inside, so that after the ultrasonic focusing ablation catheter enters the human blood vessel, vacuum isolation can be formed, the ultrasonic transducer is prevented from being polluted, and the working efficiency of the ultrasonic transducer is improved. Also, it will be appreciated that when the outer balloon 5 is provided, the tip balloon 4 may be removed, and the impedance and water pressure detection may be achieved using the outer balloon 5.

Except for the above differences, the other structural features of the present embodiment are the same as those of the first embodiment, and will not be described here again.

Sixth embodiment

As shown in fig. 7, a sixth embodiment of the present invention provides an ultrasonic focus ablation apparatus including a control section 100, an operation handle 200, and an ultrasonic focus ablation catheter 300 according to any one of the above first to third embodiments.

In this embodiment, the control section 100 is used for automatic control of ultrasonic ablation. Specifically, as shown in fig. 8, the control unit 100 includes a main control module 101, a signal generator 102, a power amplifier 103, a strobe module 104, a phase voltage current module 105, and an impedance matching module 106. The main control module 101 is used for processing signals and data and controlling automatic ablation. The signal generator 102 is connected with the main control module 101 for receiving and transmitting ultrasonic signals. The power amplifier 103 is connected to the signal generator 102 for amplifying the ultrasonic signal. The gating module 104 is connected to the power amplifier 103 for selecting the number of signal channels. The phase voltage current module 105 is connected with the main control module 101 for detecting parameters and outputting matched ultrasonic frequencies. The impedance matching module 106 is connected with the main control module 101, and is used for detecting the matching impedance and outputting an ultrasonic signal of the matching power. The operation handle 200 is connected to the control unit 100 for the operation of the ablation operation by the doctor. The proximal end of the ultrasonic focus ablation catheter 300 is mounted on the operation handle 200 and is electrically connected to the control part 100 to perform ultrasonic focus ablation under the control of the control part 100.

Wherein, the control part 100 continuously adjusts the output power of the second ultrasonic transducer 3 according to the measured temperature of the first ultrasonic transducer 2 until reaching the ablation end point. The control portion 100 is also configured to determine whether an ablation endpoint is reached based on the determination logic.

In this embodiment, the judging logic specifically includes: and when the first ultrasonic transducer 2 detects that the current temperature of the ablation target area reaches a set value and is stable for a preset period of time, and the first ultrasonic transducer 2 detects that the distance to the inner wall of the blood vessel reaches a theoretical value, determining that the ablation end point is reached.

The following describes in detail the specific working steps of the ultrasonic focusing ablation device of the present embodiment:

S1: the equipment self-tests, and sends self-test data to the main control module 11, and visualization is realized through a display.

S2: when the physician delivers the catheter body 1 into the patient's designated tissue, the ablation is manually turned on and fluid is injected into the tip balloon 4 using an external fluid supply. When the liquid injection is started, an air exhaust procedure is performed once for 3-5 seconds, and after the air exhaust procedure is finished, the main control module 11 closes the liquid discharge hole and keeps the liquid injection hole to continuously inject liquid.

In the process, the pressure sensor is used for detecting the change of water pressure, and the flexible electrode 5 is used for detecting the change of impedance, so that the water pressure change and the impedance change are transmitted to the main control module 101 in real time, and the main control module 101 is used for judging whether the tip balloon 4 is completely adhered. After the tip balloon 4 is completely attached to the inner wall of the blood vessel, at this time, ultrasonic ablation is started, the main control module 101 opens the liquid discharge hole, maintains corresponding water pressure, ensures that the tip balloon 4 maintains an attached state, and simultaneously, liquid in the balloon is continuously circulated, so that the tip balloon 4 is cooled.

S3: after the tip balloon 4 is completely adhered, the main control module 101 sends an ultrasonic signal through the signal generator 102, the signal is amplified by the power amplifier 103, meanwhile, the phase voltage current module 105 starts to work, parameters are fed back to the main control module 101 in real time to carry out phase detection, and the main control module 101 adjusts the parameters of the signal generator 102 to complete phase matching.

S4: the phase-matched signals are sent to the first ultrasound transducer 2 and the second ultrasound transducer 3 via the gating module 104 selecting an appropriate number of channels.

S5: the first ultrasound transducer 2 starts measuring the distance to the inner wall of the blood vessel and the current temperature of the ablation target volume and transmits temperature and distance data to the main control module 101. Accordingly, the second ultrasonic transducer 3 releases ultrasonic waves with corresponding intensity according to the current output power sent by the main control module 101 so as to perform focusing ablation on the ablation target area.

S6: in the whole ablation process, the temperature, pressure and impedance data monitored in real time are fed back to the main control module 101, and the main control module 101 processes the data, so that whether the ablation endpoint is reached or not is judged according to judgment logic, and an ablation procedure is completed.

On the basis of the embodiment, the embodiment of the invention also provides an ultrasonic ablation system which comprises the ultrasonic focusing ablation device.

In summary, the ultrasonic focusing ablation catheter and the ultrasonic focusing ablation device provided by the embodiment of the invention have the following beneficial effects:

1. Measuring the distance of the inner wall of the blood vessel through a first ultrasonic transducer 2 which is horizontally arranged, and calculating to obtain an ablation target area and measuring the current temperature of the ablation target area; and focusing is carried out through the second ultrasonic transducer 3 which is obliquely arranged so as to concentrate the energy transmitted by the sound wave to the focal ablation area and not ablate other areas, thereby effectively protecting the intima of the blood vessel.

2. The second ultrasonic transducer 3 can rotate, so that adjustment of different focal lengths can be realized, and adaptive adjustment can be performed according to different ablation positions of blood vessels, so that the applicability of the ultrasonic focusing ablation catheter is improved.

3. The second ultrasonic transducer is movable, so that the size of the focused ablation area can be adjusted, and then the adaptive adjustment can be carried out according to different ablation positions of the blood vessel, so that the applicability of the ultrasonic focused ablation catheter is improved.

4. The plurality of first ultrasonic transducers 2 and the plurality of second ultrasonic transducers 3 can form a plurality of ablation subgroups, and any one or a plurality of ablation subgroups can be controlled to enter a working state through the control part, so that the 360-degree omnibearing ablation can be realized without rotating the catheter body 1, the ablation efficiency is improved, and the convenience of the ablation operation is improved.

5. The ultrasonic focusing ablation equipment monitors the water pressure and the impedance of the operation process and the operation environment in real time, ensures that the tip balloon 4 is completely adhered, improves the adhesion and ensures the ablation effect.

6. The main control module 11 controls the output power of the second ultrasonic transducer 3 to continuously change, realizes automatic ablation, automatically judges the ablation endpoint in the ablation process, shortens the operation time and reduces the adverse reaction of the patient in operation.

It should be noted that the above embodiments are only examples, and the technical solutions of the embodiments may be combined, which are all within the protection scope of the present invention.

It should be understood that the terms "upper," "lower," "horizontal," and the like indicate an orientation or a positional relationship based on that shown in the drawings, and are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

The ultrasonic focusing ablation catheter and the ultrasonic focusing ablation device provided by the invention are described in detail. Any obvious modifications to the present invention, without departing from the spirit thereof, would constitute an infringement of the patent rights of the invention and would take on corresponding legal liabilities.

Claims (10)

1. An ultrasonic focused ablation catheter, comprising:

the catheter body is a multi-cavity tube and at least comprises a guide wire cavity for penetrating a guide wire and a wire cavity for penetrating a wire;

The first ultrasonic transducer is arranged at the far end of the catheter body and is used for being electrically connected with the control part through a wire; wherein the first ultrasonic transducer is parallel to the central axis of the catheter body for measuring the distance to the inner wall of the blood vessel to calculate an ablation target zone; the first ultrasonic transducer is also used for measuring the temperature of a target area so as to be used for calculating the output power of the second ultrasonic transducer and judging the ablation endpoint;

The at least two second ultrasonic transducers are arranged at the far end of the catheter body and are used for being electrically connected with the control part through wires; the second ultrasonic transducers form a set included angle with the central axis of the catheter body, and at least two second ultrasonic transducers are mutually symmetrical with respect to the first ultrasonic transducer and are used for determining an ablation focus and performing focused ablation.

2. The ultrasonic focused ablation catheter of claim 1, wherein:

The second ultrasonic transducer is rotatably arranged at the far end of the catheter body so as to adjust the size of the set included angle.

3. The ultrasonic focused ablation catheter of claim 1, wherein:

And at least two second ultrasonic transducers can relatively move along the central axis of the catheter body by taking the first ultrasonic transducer as a center so as to adjust the relative distance between the at least two ultrasonic transducers.

4. The ultrasonic focused ablation catheter of claim 1, wherein:

The plurality of first ultrasonic transducers are arranged in a circular shape around the circumferential direction of the catheter body; the two sides of each first ultrasonic transducer are symmetrically distributed with two obliquely arranged second ultrasonic transducers.

5. The ultrasonic focused ablation catheter of claim 1, wherein:

the second ultrasonic transducer is electrically connected with the controller to receive the current output power calculated by the controller based on the current temperature of the ablation target area measured by the first ultrasonic transducer;

And the second ultrasonic transducer releases ultrasonic waves with corresponding intensity according to the current output power so as to perform focusing ablation on the ablation target area.

6. The ultrasonic focused ablation catheter of claim 1, further comprising:

A tip balloon disposed on an end face of the distal end of the catheter body and in communication with the interior cavity of the catheter body for occluding a blood vessel in a filled state;

the internal cavity comprises a liquid inlet cavity for liquid inlet and a liquid outlet cavity for liquid outlet.

7. The ultrasonic focused ablation catheter of claim 6, wherein:

The flexible electrode is installed to the outside of tip sacculus to the inboard of tip sacculus is installed pressure sensor, flexible electrode with pressure sensor all with the control portion electricity is connected for detecting impedance and water pressure.

8. An ultrasonic focused ablation device, comprising:

A control part for automatic control of ultrasonic ablation;

An operation handle connected to the control unit;

the ultrasonic focus ablation catheter of any of claims 1-7, wherein the proximal end of the ultrasonic focus ablation catheter is mounted on the operating handle and is electrically connected with the control part;

the control part continuously adjusts the output power of the second ultrasonic transducer according to the measured temperature of the first ultrasonic transducer until reaching an ablation end point; the control part is also used for judging whether the ablation endpoint is reached according to the judgment logic.

9. The ultrasonic focused ablation device of claim 8, wherein the decision logic specifically comprises:

And when the first ultrasonic transducer detects that the current temperature of the ablation target area reaches a set value and is stable for a preset period of time, and the first ultrasonic transducer detects that the distance to the inner wall of the blood vessel reaches a theoretical value, judging that the ablation end point is reached.

10. The ultrasonic focused ablation apparatus of claim 8, wherein the control section comprises at least:

the main control module is used for processing the signals and the data and controlling automatic ablation;

The signal generator is connected with the main control module and is used for receiving and transmitting ultrasonic signals;

The power amplifier is connected with the signal generator and used for amplifying ultrasonic signals;

a gating module connected with the power amplifier for selecting the number of signal channels;

the phase voltage and current module is connected with the main control module and used for detecting parameters and outputting matched ultrasonic frequency;

and the impedance matching module is connected with the main control module and used for detecting matching impedance and outputting ultrasonic signals of matching power.