CN118177909A

CN118177909A - Pulse generator, pulse generating method, pulse generating device and pulse generating system

Info

Publication number: CN118177909A
Application number: CN202211588241.3A
Authority: CN
Inventors: 杨笛; 黄飞虎; 谢磊; 孔令娟; 姬庆茹; 刘梦钦; 郭澜涛
Original assignee: Shanghai Hongmai Medical Technology Co ltd
Current assignee: Shanghai Hongmai Medical Technology Co ltd
Priority date: 2022-12-12
Filing date: 2022-12-12
Publication date: 2024-06-14

Abstract

The application relates to a pulse generator, a pulse generating method, a pulse generating device and a pulse generating system. According to the method, calcification features of a vascular calcification image are acquired, the calcification features are input into a pre-trained data organization model, a target position and pulse signal generation parameters are obtained, then a driving medium is controlled to drive an electrode assembly in an electrode balloon catheter to move to the target position, positioning of a vascular lesion position is achieved, then a pulse signal is provided for the electrode assembly corresponding to the target position according to the pulse signal generation parameters, and the electrode assembly generates shock waves under the action of the pulse signal so as to act on the target position. The prejudgment targeting release shock wave made through image processing has high positioning precision and high energy utilization rate of pulse generation, avoids extended electrode erosion and unnecessary heating of adjacent tissues, shortens the operation time, does not need to intervene in a blood vessel for a plurality of times to draw back a balloon catheter, and greatly reduces the damage to the blood vessel in operation.

Description

Pulse generator, pulse generating method, pulse generating device and pulse generating system

Technical Field

The present application relates to the field of medical technology, and in particular, to a pulse generator, a pulse generating method, a pulse generating device, a pulse generating system, and a computer storage medium.

Background

Angioplasty is a surgical procedure that mechanically restores the original size of a stenosed vessel lumen, and conventional angioplasty often uses balloon catheters to physically dilate stenotic lesions, which allow the vessel to be reopened. But is prone to adventitial injury when the balloon is inflated.

In the medical field, shock wave generating systems have become a novel treatment for percutaneous peripheral arterial calcification diseases. The electrode in the saccule is driven by an external high-voltage source, the electrode generates a high-pressure electric field to form a plasma channel, the plasma channel is broken down to enable surrounding liquid to be gasified to generate shock waves, the shock waves act on calcification to enable the calcification to crack and destroy the calcification focus structure, and the blood vessel blocked by arterial calcification is opened without damaging surrounding soft tissues, so that a smooth blood vessel inner cavity is obtained. Facilitating the subsequent medical equipment such as the saccule or the stent system to pass through the lesion area.

However, the applicant found that the positioning accuracy of the pulse generation is low when the shock wave balloon catheter in the conventional technology is operated.

Disclosure of Invention

In view of the above, it is desirable to provide a pulse generator, a pulse generating method, a pulse generating device, a pulse generating system, and a computer storage medium, which can improve the positioning accuracy of pulse generation.

In a first aspect, a pulse generation method is provided, comprising:

obtaining calcification characteristics of a vascular calcification image;

The calcification features are input into a pre-trained data organization model, and target positions and pulse signal generation parameters are obtained; the data organization model is used for representing the mapping relation between the calcification features and the target positions and the pulse signal generation parameters;

Controlling a transmission part penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission part move to the target position; the transmission part is mechanically connected with the electrode assemblies, the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with a containing space, and the electrode assemblies are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter;

and providing pulse signals for the electrode assemblies corresponding to the target positions according to the pulse signal generation parameters, so that the electrode assemblies generate shock waves under the action of the pulse signals.

In one embodiment, the pulse generation parameter includes a total pulse energy corresponding to the target location;

providing a pulse signal for the electrode assembly corresponding to the target position according to the pulse signal generation parameter, comprising:

and providing a pulse signal with the pulse total energy for the electrode assembly corresponding to the target position according to the pulse total energy corresponding to each target position.

In one embodiment, the pulse generation parameter includes a number of pulse periods corresponding to the target location;

And providing pulse signals of the pulse periods for the electrode assemblies corresponding to the target positions according to the pulse periods corresponding to each target position, wherein each pulse period has a preconfigured pulse number.

In one embodiment, the pulse generation parameters further comprise: pulse release path number; providing pulse signals of the pulse cycle number for the electrode assembly corresponding to the target position according to the pulse cycle number corresponding to each target position, wherein the pulse signals comprise the following components:

And providing pulse signals of the pulse cycle number for the electrode assembly of the pulse release path sequence number according to the pulse cycle number and the pulse release path sequence number corresponding to each target position.

In one embodiment, controlling movement of a driving member penetrating through a balloon such that a plurality of electrode assemblies provided on the driving member are moved to a target position includes:

Controlling a transmission part penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission part correspondingly move to the center position of each target position one by one; or alternatively, the first and second heat exchangers may be,

And controlling the transmission part penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission part move to the middle position of every two adjacent target positions in a one-to-one correspondence manner.

In a second aspect, a pulse generator is provided comprising a memory storing a computer program and a processor implementing the steps of the pulse generating method described above when the computer program is executed by the processor.

In one embodiment, the pulse generator comprises:

a pulse power supply for providing a pulse signal;

The controller comprises a memory and a processor, wherein the memory stores a computer program, and is characterized in that the processor is electrically connected with a pulse power supply, and the following steps are realized when the processor executes the computer program:

obtaining calcification characteristics of a vascular calcification image;

the calcification features are input into a pre-trained data organization model, and target positions and pulse signal generation parameters are obtained;

controlling the transmission member to move so that a plurality of electrode assemblies on the transmission member move to target positions;

outputting a pulse generation instruction to a pulse power supply according to the pulse signal generation parameters;

The pulse generation instruction is used for indicating the pulse power supply to provide a pulse signal for the target electrode assembly, so that the electrode assembly generates shock waves under the action of the pulse signal; the target electrode assembly is an electrode assembly corresponding to the target position.

In one embodiment, each electrode assembly includes a first electrode and a second electrode; the pulse power supply includes:

the direct-current power supply is used for providing direct-current voltage;

the first end of the energy storage element is connected with the first pole of the direct current power supply, and the second end of the energy storage element is respectively connected with the second pole of the direct current power supply and the first electrode of each electrode assembly;

The input end of the gating switch is connected with the first end of the energy storage element, the controlled end of the gating switch is connected with the output end of the controller, and the output ends of the gating switch are respectively connected with the second electrode of each electrode assembly in a one-to-one correspondence manner; and the gating switch is used for switching to a conducting state between an output end connected with the second electrode of the target electrode assembly in the gating switch and an input end of the gating switch under the condition that the pulse generation instruction is received.

In one embodiment, the pulse generator further comprises:

a control handle configured with a movement control;

The controller is electrically connected with the movement control, and the controller is also used for responding to the operation action aiming at the movement control, and controlling the transmission piece to drive the electrode assembly to move to the target position.

In one embodiment, the control handle is further configured with a start button;

the controller is electrically connected with the starting key and is also used for responding to the triggering action aiming at the starting key and outputting a pulse generation instruction to the pulse power supply.

In one embodiment, the control handle is further configured with a pulse parameter adjustment key;

The controller is electrically connected with the pulse parameter adjusting key, and is further used for responding to the parameter adjusting operation of the pulse parameter adjusting key, adjusting the pulse signal generating parameter and outputting a pulse generating instruction to the pulse power supply according to the adjusted pulse signal generating parameter.

In a third aspect, there is provided a pulse generating system comprising:

the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with a containing space, and the electrode assemblies are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter;

the transmission piece is mechanically connected with the electrode assembly;

The pulse generator is in transmission connection with the transmission piece.

In one embodiment, an electrode balloon catheter includes:

a balloon forming a containing space;

an inner extension piece arranged in the accommodating space, wherein a first end of the inner extension piece is fixedly connected with the distal end of the balloon;

The electrode assemblies are used for being driven by the transmission piece to move along the axial direction of the inner extension piece;

The external extension piece is arranged outside the balloon, the first end of the external extension piece is fixedly connected with the proximal end of the balloon, and the second end of the external extension piece is fixedly connected with the pulse generator;

The external extension piece is of a hollow tubular structure, and the transmission piece penetrates through the external extension piece to extend into the accommodating space and is mechanically connected with the electrode assembly in the accommodating space.

In one embodiment, the pulse generating system further comprises:

And the imaging device is used for acquiring the vascular calcification image and is connected with the pulse generator.

In a fourth aspect, there is provided a pulse generating device comprising:

the calcification feature acquisition module is used for acquiring calcification features of the vascular calcification image;

The pulse signal determination parameter acquisition module is used for inputting calcification characteristics into a pre-trained data organization model to obtain target positions and pulse signal generation parameters; the data organization model is used for representing the mapping relation between the calcification features and the target positions and the pulse signal generation parameters;

The targeting movement control module is used for controlling the transmission piece penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission piece move to a target position; the transmission part is mechanically connected with the electrode assemblies, the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with a containing space, and the electrode assemblies are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter;

the pulse signal transmitting module is used for providing pulse signals for the electrode assemblies corresponding to the target positions according to the pulse signal generating parameters, so that the electrode assemblies generate shock waves under the action of the pulse signals.

In a fifth aspect, a computer readable storage medium is provided, on which a computer program is stored which, when executed by a processor, implements the steps of the pulse generating method described above.

The pulse generator, the pulse generating method, the pulse generating device, the pulse generating system, the computer storage medium and the computer storage medium have at least the following beneficial effects:

The method comprises the steps of obtaining calcification features of a vascular calcification image, inputting the calcification features into a pre-trained data organization model, obtaining target positions and pulse signal generation parameters, controlling a transmission piece to drive an electrode assembly in an electrode balloon catheter to move to the target positions, realizing positioning of vascular lesion positions, and providing pulse signals for the electrode assemblies corresponding to the target positions according to the pulse signal generation parameters, so that the electrode assemblies generate shock waves under the action of the pulse signals. The electrode assembly of the electrode balloon catheter can release shock waves in a pre-judging and targeting mode through image processing, the positioning accuracy of pulse generation is high, the energy utilization rate can be improved, and the extended electrode erosion and unnecessary heating of adjacent tissues are avoided. In addition, through prejudgement, the method is favorable for shortening the operation time and avoiding the long-time blockage of blood vessels. Moreover, the position of the electrode assembly in the accommodating space is moved to realize the positioning pulse generation control at the lesion position, the balloon catheter is not required to be drawn back in the blood vessel for multiple times, and the damage to the blood vessel in the operation is greatly reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments or the conventional techniques of the present application, the drawings required for the descriptions of the embodiments or the conventional techniques will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to the drawings without inventive effort for those skilled in the art.

FIG. 1 is a schematic diagram of a pulse generation system in one embodiment;

FIG. 2 is a flow chart of a pulse generation method according to one embodiment;

FIG. 3 is a schematic diagram of a circuit configuration of a pulse power supply according to an embodiment;

FIG. 4 is a schematic diagram of a pulse generator according to another embodiment;

FIG. 5 is a schematic diagram of an electronic device in one embodiment;

FIG. 6 is a schematic illustration of an arrangement of an electrode assembly on an inner elongate member in one embodiment;

FIG. 7 is a schematic diagram of a pulse generating system according to another embodiment;

FIG. 8 is a schematic diagram of a pulse generating system according to yet another embodiment;

FIG. 9 is a schematic illustration of relative positional movement of an electrode assembly outside the body in one embodiment;

Fig. 10 is a schematic diagram of an electrode assembly targeted release pulse performed intravascularly in one embodiment.

Detailed Description

In order that the application may be readily understood, a more complete description of the application will be rendered by reference to the appended drawings. Embodiments of the application are illustrated in the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

It will be understood that the terms first, second, etc. as used herein may be used to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish one element from another element.

Spatially relative terms, such as "under", "below", "beneath", "under", "above", "over" and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements or features described as "under" or "beneath" other elements would then be oriented "on" the other elements or features. Thus, the exemplary terms "below" and "under" may include both an upper and a lower orientation. Furthermore, the device may also include an additional orientation (e.g., rotated 90 degrees or other orientations) and the spatial descriptors used herein interpreted accordingly.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or be connected to the other element through intervening elements. Further, "connection" in the following embodiments should be understood as "electrical connection", "communication connection", and the like if there is transmission of electrical signals or data between objects to be connected.

As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," and/or the like, specify the presence of stated features, integers, steps, operations, elements, components, or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Also, the term "and/or" as used in this specification includes any and all combinations of the associated listed items.

Taking the most severe peripheral arterial disease (PERIPHERAL ARTERY DISEASE, PAD), severe limb ischemia (Critical Limb Ischemia, CLI) as an example:

In severe limb ischemia, vascular wall calcification plays an important role in symptoms, amputation rate, and mortality. The length of the subknee lesion is longer and the distribution is uneven, and the length of the traditional shock wave balloon system is not longer than 60mm, and the length of the shock wave balloon catheter is shorter. Because of uneven energy distribution and overlarge outer diameter, the traditional shock wave balloon system is difficult to treat long-section lesions, and the lesions need to be treated by repeated intervention and withdrawal, so that vascular injury is increased, and a catheter at the joint of a proximal end and a distal end is possibly damaged or the balloon is broken. Second, the electrodes emit pulses indiscriminately, which can result in wasted energy, extended electrode erosion, and unnecessary heating of adjacent tissue, and the inability of calcification to be targeted for removal. And the repeated emission of the shock wave without prejudgment increases the operation time to cause the blockage of the blood vessel.

Based on this, in one embodiment, there is provided a pulse generating method applied to a pulse generator in a pulse generating system as shown in fig. 1, the pulse generating system including: an electrode balloon catheter 12, a transmission (not shown), and a pulse generator 14.

The electrode balloon catheter 12 includes a plurality of electrode assemblies 122 and has a receiving space, and the plurality of electrode assemblies 122 are disposed in the receiving space at intervals along the extending direction of the electrode balloon catheter 12. The transmission is mechanically coupled to the electrode assembly 122; the pulse generator 14 is in driving connection with the driving member.

As shown in fig. 2, the pulse generating method includes:

S202, obtaining calcification features of the vascular calcification image. The vascular calcification image is an image capable of displaying vascular calcification. The acquisition mode can be various, for example, the acquisition can be realized by IVUS (intravenous ultrasound, intravascular ultrasound), OCT (Optical coherence tomography ), CTA (CT angiography, CT angiography) and the like. Calcification features refer to features that characterize whether a blood vessel has a calcified lesion, and the degree of calcification, and may include, for example, the location of the calcified region (target location), and the size, morphology, boundaries, texture, etc. of the calcified lesion location. The target location refers to the location of the target lesion where lesion calcification occurs on the blood vessel.

S204, inputting calcification features into a pre-trained data organization model to obtain target positions and pulse signal generation parameters; the data organization model is used for representing the mapping relation between the calcification features and the target positions and the pulse signal generation parameters. The method is characterized in that the method comprises the steps of realizing directional control of pulse generation, judging calcified lesion positions in advance, and a pre-trained data organization model is a model related to the target positions and pulse signal generation parameters, and can quickly determine the target positions and determine the pulse signal generation parameters of pulse sizes to be applied at each target position based on the input of calcification features.

In one embodiment, the training of the data authority model may be based on a neural network implementation, and may specifically include:

Acquiring sample data, wherein the sample data comprises calcification features of a vascular calcification image, calcification lesion calibration positions of the vascular calcification image and pulse signal generation parameters matched with the calcification lesion calibration positions;

Iteratively executing the calcification features of the vascular calcification image in the sample data to be input into a first neural network model, calculating to obtain a target position and a pulse signal generation parameter, and adjusting the first neural network model according to the deviation between the target position and the calcification lesion calibration position and the deviation between the pulse signal generation parameter matched with the calcification lesion calibration position and the calculated pulse signal generation parameter until the first ending condition is met; the first end condition may be that the maximum number of iterations is reached, or that a deviation between a calibration result of the sample data and a target position determined based on the model and the pulse signal generation parameter is within a preset deviation range.

And taking the trained first neural network model as a data organization model. Is used for the prejudgment of the target position and the determination of the pulse signal generation parameters in the subsequent operation process.

S206, controlling the transmission piece penetrating through the balloon to move so that a plurality of electrode assemblies 122 arranged on the transmission piece reach the target position. There are various control implementations, for example, the movement of the driving member may be driven by a motor, so as to drive the electrode assembly 122 to move to the target position. It should be noted that, when there are multiple target positions in the blood vessel, the driving of the electrode assembly 122 to move to the target position may be understood as controlling the electrode assembly 122 corresponding to the target position to move to the area where each target position is located, so as to perform pulse emission on the multiple target positions simultaneously, so as to improve pulse treatment efficiency and avoid blocking the blood vessel for a long time, where the moving of the electrode assembly 122 may be a part of the electrode assemblies 122 in the electrode balloon catheter 12 or may be all the electrode assemblies 122, and this may be specific according to the determined target position. For example, when the electrode balloon catheter 12 has 3 electrode assemblies 122, and 2 target positions are determined based on image processing, it is only necessary to selectively control two electrode assemblies 122 of the 3 electrode assemblies 122 to move to the two target positions in one-to-one correspondence. In this case, the movement control may be performed based on the principle of minimizing the movement amount for the selection principle of the electrode assembly 122. For driving the electrode assemblies 122 to the target position, the electrode assemblies 122 may be moved to the center of the target position in a one-to-one correspondence, or the electrode assemblies 122 may be moved to the middle position of two adjacent target positions in a correspondence.

And S208, providing pulse signals for the electrode assemblies 122 corresponding to the target positions according to the pulse signal generation parameters, so that the electrode assemblies 122 generate shock waves under the action of the pulse signals. After positioning, pulse signals need to be transmitted according to the pulse signal generation parameters, and the pulse signal transmission is selective transmission, namely, pulse signals are provided for the electrode assemblies 122 corresponding to the target positions, so that shock waves are generated at fixed points and act on the target positions, on one hand, the directional pulse transmission of the target positions is realized, and the targeted treatment is realized. On the other hand, the time in the operation is shortened, the long-time blockage of the blood vessel is avoided, and in addition, the energy waste and the influence on the tissues around the target position can be avoided by the directional treatment mode.

Specifically, in the pulse generating method provided by the embodiment of the application, the calcification characteristics of the calcified blood vessel image are obtained, the calcification characteristics are input into a pre-trained data organization model, the target position and the pulse signal generation parameters are obtained, then the driving medium is controlled to drive the electrode assembly 122 in the electrode balloon catheter 12 to move to the target position, the positioning of the vascular lesion position is realized, then the pulse signal is provided for the electrode assembly 122 corresponding to the target position according to the pulse signal generation parameters, and the electrode assembly 122 generates the shock wave under the action of the pulse signal so as to act on the target position. The electrode assembly 122 of the electrode balloon catheter 12 can release shock waves in a targeted manner through the prejudgment made by image processing, so that the energy utilization rate is improved, the extended electrode erosion and unnecessary heating of adjacent tissues are avoided, the operation duration is shortened through prejudgment, and the long-time blockage of blood vessels is avoided. On the other hand, the electrode assembly 122 in the accommodating space is moved to realize the positioning treatment of the lesion position, and the balloon catheter is not required to be drawn back into the blood vessel for multiple times, so that the damage to the blood vessel in the operation is greatly reduced.

The degree of calcification is different, and the energy required by the shock wave to act on the calcified lesion to crack and destroy the structure of the calcified lesion is different, so in one embodiment, the pulse generation parameter comprises the total pulse energy corresponding to the target position; providing a pulse signal to the electrode assembly 122 corresponding to the target location according to the pulse signal generation parameters, comprising:

the electrode assembly 122 corresponding to the target position is supplied with a pulse signal having the pulse total energy according to the pulse total energy corresponding to each target position.

It should be understood that, after determining the total pulse energy, the process of providing the pulse signal with the total pulse energy to the electrode assembly 122 corresponding to the target position may be implemented through the action of multiple pulses, so as to control the energy of a single pulse, and avoid the vascular injury caused by the excessive single pulse energy.

In one embodiment, the pulse generation parameter includes a number of pulse periods corresponding to the target location; providing a pulse signal to the electrode assembly 122 corresponding to the target location according to the pulse signal generation parameters, comprising:

the electrode assembly 122 corresponding to the target position is provided with a pulse signal with a pulse cycle number according to the pulse cycle number corresponding to each target position, wherein each pulse cycle has a preconfigured pulse number.

Based on the description in the following embodiment, the data organization model may be a correlation model about the pulse cycle number, and the energy of a single pulse and the pulse number of each pulse cycle may be preconfigured, where only the pulse cycle number needs to be determined, and then a reasonable total pulse energy may be applied to the target location to destroy the calcification structure, so as to achieve the therapeutic purpose.

In one embodiment, the pulse generation parameter comprises a single pulse energy, the single pulse having the single pulse energy. The maximum energy of a single pulse can be limited by the single pulse energy, so that vascular damage caused by the over-high single pulse energy is avoided, and the single pulse energy can be generated or preconfigured.

In one embodiment, the pulse generation parameters further include a pulse release path sequence number; providing a pulse signal of the pulse cycle number to the electrode assembly 122 corresponding to the target position according to the pulse cycle number corresponding to each target position, including:

the electrode assembly 122 of the pulse release path sequence number is provided with a pulse signal of the pulse cycle number according to the pulse cycle number and the pulse release path sequence number corresponding to each target position.

When the electrode assemblies 122 are not unique, each electrode assembly 122 corresponds to a different channel sequence number, the electrode assemblies 122 can be selected according to the pulse release channel sequence number, pulse signals can be provided for the target electrode assemblies 122 only, and the number of pulse cycles applied to each target electrode assembly 122 can be independently controlled, so that accurate positioning and pulse emission of the target positions corresponding to the target electrode assemblies 122 are realized.

In one embodiment, controlling movement of a driving member penetrating through the balloon such that a plurality of electrode assemblies provided on the driving member are moved to a target position includes:

And controlling the transmission part penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission part move to the center position of each target position in a one-to-one correspondence manner. The movement to the center position of each target position means that the geometric centers of the electrode assembly 122 and the target position are on a straight line after the movement.

And controlling the transmission part penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission part move to the middle position of every two adjacent target positions in a one-to-one correspondence manner. The intermediate position shifted to each two adjacent target positions refers to a projection position of the midpoint of the geometric center line shifted to the adjacent two target positions in the axial direction of the balloon.

In one embodiment, acquiring calcification features of a vessel calcification image includes:

And analyzing the vascular calcification image by utilizing the vascular calcification model to obtain calcification features. The vascular calcification model relates to the mapping relation between vascular calcification images and calcification features. The vascular calcification model is generated by standard vascular calcification image training of calibrated vascular calcification classification. Vascular calcification typing may be typing in a scoring form.

In one embodiment, the training process of the vascular calcification model may be:

Iteratively executing the steps of inputting the standard vascular calcification image into the second neural network model to obtain a training result, and adjusting the second neural network model according to the training result (vascular calcification type) and the deviation of the calibrated vascular calcification type until a second ending condition is met; the second end condition may be that the maximum number of iterations is met or that the accuracy of the obtained vascular calcification pattern based on the standard vascular calcification image as input to the second neural network model reaches more than 90% (i.e. for more than 90% of the input vascular calcification images, the predicted vascular calcification pattern based on the second neural network model is the same as the calibrated vascular calcification pattern).

And taking the trained second neural network model as a vascular calcification model.

For a better illustration of the training implementation of the vascular calcification model, the description of the training procedure is here given for the vascular calcification image of the IVUS as an example. And determining the standard vascular calcification image marked with the vascular calcification classification as a training sample. Vascular calcification typing can be calibrated by scoring, and calcification lesions of example images (not shown) can be scored according to existing classification methods and clinical scenarios as follows:

since a Grade < 180 ° calcification is mostly not using balloon catheters, such calcifications are not scored here and the lesion is excluded in use.

In the table, score 1 corresponds to image 1, score2 corresponds to image 2, score 3 corresponds to image 3, and Score 4 corresponds to image 4. The corresponding group images are input into the neural network through marking. Setting a second neural network model, performing inspection and classification training on the neural network based on a training sample, adjusting the second neural network model based on a training result, inputting a large number of standard vascular calcification images, and analyzing and comparing the vascular calcification types obtained based on the second neural network model with the calibrated vascular calcification types. And continuously adjusting the second neural network model based on the analysis comparison result until the accuracy of the vascular calcification typing result aiming at the vascular calcification image reaches more than 90%, and obtaining the vascular calcification model after training. The training process may also be to perform training separately according to each type by using the calibrated vascular calcification type, for example, performing training by using a plurality of images 1 corresponding to all Score 1 as input to obtain a vascular calcification model corresponding to Score 1, performing training by using a plurality of images 2 corresponding to all Score2 as input to obtain a vascular calcification model corresponding to Score2, and the like, so as to obtain a vascular calcification model corresponding to the Score. Here, the calcification angle and length of the calcification, i.e. the corresponding calcification Score (based on other imaging devices, the features of size, location, morphology, boundary, texture, etc. may also be extracted). At this point, it can be understood that the calcification Score is used to characterize the degree of calcification.

By constructing the data organization model, the calcification features can be associated with pulse signal generation parameters such as pulse size, pulse energy, pulse release path sequence number and the like corresponding to the pulse power supply, and basic parameters of the pulse power supply can be rapidly preset by utilizing the association relation among data so as to give a pulse generation instruction, so that the pulse power supply provides corresponding pulse signals for the electrode assembly 122 at the target position.

For example, the number of pulses per cycle may be set to 5, 10, 20, or 30 depending on the clinical use scenario.

In one embodiment, the data authority model may include a mapping model of calcification score and pulse cycle number. The calcification score may be proportional to the number of pulse cycles, and the greater the calcification score, the greater the degree of calcification, the greater the total energy of the pulses required, and at a given single pulse energy, the greater the number of pulses required, and if pulses are applied periodically, the greater the number of pulse cycles. For example, the following table may be used:

Score	Pulse cycle number
		1	1 Period
2	2 Periods of
		3	3 Cycles of
4	4 Cycles of

The pulsed power supply may include a plurality of channels, for example, 1 to 3 channels. Each of the passageways is connected one-to-one to an electrode assembly 122 in the electrode balloon catheter 12. The schematic of the circuit of the pulsed power supply is shown in fig. 3. The S point is used for accessing a pulse generation instruction, and selecting a path release pulse corresponding to the target position according to the instruction sent by the controller. In one embodiment, the single pulse energy may be constrained to less than 0.0086mj/mm ² to avoid vessel damage due to excessive energy.

It should be understood that, although the steps in the flowchart are shown in sequence as indicated by the arrows, the steps are not necessarily performed in sequence as indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least a portion of the steps in the figures may include steps or stages that are not necessarily performed at the same time, but may be performed at different times, nor does the order in which the steps or stages are performed necessarily performed in sequence, but may be performed alternately or alternately with other steps or at least a portion of the steps or stages in other steps.

Based on the same conception, an embodiment of the present application provides a pulse generating device, as shown in fig. 4, including: a calcification feature acquisition module 402, a pulse signal determination parameter acquisition module 404, a targeting movement control module 406, and a pulse signal transmission module 408, wherein:

The calcification feature acquisition module 402 is configured to acquire calcification features of a vascular calcification image;

the pulse signal determination parameter acquisition module 404 is configured to input calcification features into a pre-trained data organization model, and obtain a target position and pulse signal generation parameters; the data organization model is used for representing the mapping relation between the calcification features and the target positions and the pulse signal generation parameters;

The targeting movement control module 406 is used for controlling the movement of a transmission member penetrating through the balloon, so that a plurality of electrode assemblies 122 arranged on the transmission member move to a target position; the transmission part is mechanically connected with the electrode assemblies 122, the electrode balloon catheter 12 comprises a plurality of electrode assemblies 122 and is provided with a containing space, and the electrode assemblies 122 are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter 12;

The pulse signal transmitting module 408 is configured to provide a pulse signal to the electrode assembly 122 corresponding to the target position according to the pulse signal generating parameter, so that the electrode assembly 122 generates a shock wave under the action of the pulse signal.

In one embodiment, the pulse generation parameters include: the pulse signal transmitting module 408 includes:

the pulse energy control unit is configured to provide the electrode assembly 122 corresponding to the target position with a pulse signal having the pulse total energy according to the pulse total energy corresponding to each target position.

The periodic pulse control unit is configured to provide the electrode assembly 122 corresponding to the target position with a pulse signal having a pulse number of predetermined pulse periods according to the pulse period number corresponding to each target position.

In one embodiment, the pulse generation parameters include: single pulse energy, a single pulse having single pulse energy.

In one embodiment, the pulse generation parameters further comprise: pulse release path number; the periodic pulse control unit includes:

The strobe period control unit is configured to provide the electrode assembly 122 with a pulse number of pulse periods for the pulse release path sequence number according to the pulse number and the pulse release path sequence number corresponding to each target position.

In one embodiment, the calcification feature acquisition module 402 includes:

And the calcification feature analysis unit is used for analyzing the vascular calcification image by utilizing the vascular calcification model to obtain calcification features.

For specific limitations of the pulse generating means, reference is made to the above limitations of the pulse generating method, and no further description is given here. The respective modules in the above-described pulse generating device may be implemented in whole or in part by software, hardware, and combinations thereof. The above modules may be embedded in hardware or may be independent of a processor in the computer device, or may be stored in software in a memory in the computer device, so that the processor may call and execute operations corresponding to the above modules. It should be noted that, in the embodiment of the present application, the division of the modules is schematic, which is merely a logic function division, and other division manners may be implemented in actual implementation.

In one embodiment, an electronic device is provided, which may be a terminal, and an internal structure diagram thereof may be as shown in fig. 5. The electronic device includes a processor, a memory, a communication interface, a display screen, and an input device connected by a system bus. Wherein the processor of the electronic device is configured to provide computing and control capabilities. The memory of the electronic device includes a nonvolatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of the operating system and computer programs in the non-volatile storage media. The communication interface of the electronic device is used for carrying out wired or wireless communication with an external terminal, and the wireless mode can be realized through WIFI, an operator network, NFC (near field communication) or other technologies. The computer program is executed by a processor to implement a pulse generating method. The display screen of the electronic equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the electronic equipment can be a touch layer covered on the display screen, can also be keys, a track ball or a touch pad arranged on the shell of the electronic equipment, and can also be an external keyboard, a touch pad or a mouse and the like.

It will be appreciated by those skilled in the art that the structure shown in fig. 5 is merely a block diagram of a portion of the structure associated with the present inventive arrangements and is not limiting of the electronic device to which the present inventive arrangements are applied, and that a particular electronic device may include more or fewer components than shown, or may combine certain components, or have a different arrangement of components.

In an embodiment the electronic device may be a pulse generator 14, the pulse generator 14 comprising a memory storing a computer program and a processor implementing the steps of the pulse generating method described above when the processor executes the computer program. At this time, it can be understood that the device having the control function in the pulse generator 14 performs the above-described pulse generating method. The form of the pulse generator 14 is not limited and may include devices capable of performing the above-described pulse generating method steps.

In an embodiment, the processor may further perform other steps in the pulse generating method, and achieve corresponding beneficial effects, which are not described herein.

In one embodiment, the electronic device may be a controller and the pulse generator 14 includes: a pulsed power supply, and the controller.

The pulse power supply is used for providing pulse signals;

obtaining calcification characteristics of a vascular calcification image;

the control driving member drives the electrode assembly 122 to move to the target position;

The pulse generation instruction is used for instructing the pulse power supply to provide a pulse signal for the target electrode assembly 122, so that the electrode assembly 122 generates a shock wave under the action of the pulse signal; the target electrode assembly 122 is the electrode assembly 122 corresponding to the target position.

Wherein, the controller can be the host computer. Specifically, the controller may perform image analysis after receiving the image of the imaging device 16 to extract calcification features. The prediction of calcification lesions may be performed in conjunction with an imaging device 16 such as an IVUS, and the pulse signal emission of the pulse power supply may be controlled in accordance with pulse signal generation parameters further determined based on calcification features.

In one embodiment, as shown in fig. 6, each electrode assembly 122 includes a first electrode 1222 and a second electrode 1224 disposed opposite each other. The opposite arrangement of the first electrode 1222 and the second electrode 1224 of each electrode assembly 122 means that the projection of the first electrode 1222 on the second electrode 1224 is not zero, the electrode pair formed by the first electrode 1222 and the second electrode 1224 can form a high-pressure electric field under the high-pressure pulse loading, the liquid medium rapidly vaporizes to form a vapor bubble and expands outwards under the high-pressure electric field, a strong shock wave is generated outside the rapidly expanding air cavity, and the shock wave propagates through the liquid medium, impacts the balloon wall and calcified lesion to decompose the calcified lesion without damaging surrounding soft tissues. In one embodiment, the first electrode 1222 and the second electrode 1224 may be disposed parallel and opposite (the projection of the first electrode 1222 onto the second electrode 1224 coincides with the area where the second electrode is located), facilitating a miniaturized design of the pulse generator.

As shown in fig. 3, the pulse power supply includes: the device comprises a direct current power supply, an energy storage element and a gating switch. The DC power supply is used for providing DC voltage. The first end of the energy storage element is connected to the first pole of the dc power source, and the second end of the energy storage element is connected to the second pole of the dc power source and the first electrode 1222 of each electrode assembly 122, respectively. The input end of the gating switch is connected with the first end of the energy storage element, the controlled end of the gating switch is connected with the output end of the controller, and the output ends of the gating switch are respectively connected with the second electrode 1224 of each electrode assembly 122 in a one-to-one correspondence manner; and the gate switch is used to switch between an output terminal connected to the second electrode 1224 of the target electrode assembly 122 in the gate switch and an input terminal of the gate switch to a conductive state upon receipt of the pulse generation instruction.

The direct current power supply provides a charging voltage for the energy storage element, the energy storage element stores energy so as to provide pulse voltage for two ends of the electrode assembly 122, when the switch receives a pulse generation instruction, a connecting passage between the input end of the switch and the second electrode 1224 of the target electrode assembly 122 is opened, the energy storage element discharges to the first electrode 1222 and the second electrode 1224 of the target electrode assembly 122, and a high-pressure electric field between the first electrode 1222 and the second electrode 1224 forms a plasma channel. The plasma channel is broken down to vaporize the liquid surrounding the target electrode assembly 122 to generate a shock wave which acts on the calcification to break it open and destroy the structure of the calcified lesion, opening the vessel blocked by the calcification of the artery without damaging the surrounding soft tissue, thereby obtaining a smooth vessel lumen.

In one embodiment, the energy storage element may be an energy storage capacitor.

In one embodiment, as shown in fig. 3, the dc power source may include an autotransformer, a step-up transformer, and a high voltage rectifier T1. The input end of the autotransformer is used for being connected with an alternating current power supply U, the alternating current power supply U is converted into a variable alternating current voltage U1 through the autotransformer, the size of the variable alternating current voltage U1 can be continuously adjusted, and the voltage value of the variable alternating current voltage U1 is determined according to the discharge voltage value required by the energy storage element.

The primary side of the step-up transformer is connected with the output of the autotransformer, the secondary side of the step-up transformer is connected with the high-voltage rectifier T1, the variable alternating-current voltage U1 is stepped up into alternating-current high-voltage U2 through the step-up transformer, and the alternating-current high-voltage U2 is rectified through the high-voltage rectifier T1 to become direct-current high-voltage. Alternatively, the energy storage element may be a storage capacitor. In order to improve the charging stability of the energy storage element, the energy storage capacitor C can be charged via the charging resistor R1. Both ends of the energy storage capacitor C are respectively and correspondingly electrically connected with both ends of the passage 1, the passage 2 and the passage 3 (as shown in the figure). When the two ends of the energy storage capacitor C are charged to the required discharge voltage by the direct-current high-voltage, the arrival of the pulse generation command S is waited. When the voltage across the target electrode assembly 122 reaches the discharge voltage, the aqueous medium between the target electrode assembly 122 breaks down, thereby generating a shock wave.

In one embodiment, the gating switch may be a relay. The individual discharge pulses of the electrode assembly 122 of each path, or the common discharge pulse of the path 1 and the path 2, or the discharge pulse of the path 1 and the path 3, or the common discharge pulse of the paths 1,2, 3, can be realized by relay switching. So that the pulses can be released at fixed points to reduce damage to the tissue. Namely, the pulse generator 14 provided by the embodiment of the application can flexibly control the electrode assemblies 122 of each path to release pulses according to the determined target position so as to perform targeted positioning treatment on calcified lesion sites. It should be emphasized that the 3 paths herein are intended to be illustrative and not limiting to the actual scope of the application.

In one embodiment, as shown in fig. 7, the pulse generator 14 further includes: control handle 142. Control handle 142 is configured with movement control controls. The controller is electrically connected with the movement control, and the controller is further used for controlling the driving member to drive the electrode assembly 122 to move to the target position in response to the operation action aiming at the movement control. And a manual and automatic control double control mode is provided, so that a user can flexibly operate and adjust the double control mode, and the use autonomy is improved. The movement control controls may include forward and reverse control buttons for each electrode assembly 122 to enable individual control of each electrode assembly 122 for ease of precise positioning.

In one embodiment, the control handle 142 is also configured with an actuation key; the controller is electrically connected with the starting key and is also used for responding to the triggering action aiming at the starting key and outputting a pulse generation instruction to the pulse power supply. In order to improve the safety and the reliability, the pulse generation instruction can be output to the pulse power supply when the start button is pressed, so that pulse release is performed, and false triggering when the balloon catheter is led into a blood vessel is avoided.

In one embodiment, the control handle 142 is also configured with a pulse parameter adjustment key;

The controller is electrically connected with the pulse parameter adjusting key, and is further used for responding to the parameter adjusting operation of the pulse parameter adjusting key, adjusting the pulse signal generating parameter and outputting a pulse generating instruction to the pulse power supply according to the adjusted pulse signal generating parameter. The pulse parameter adjustment key may be used to adjust, but is not limited to, the number of pulses, the single pulse energy, and the number of pulse cycles for each electrode assembly 122.

In one embodiment, the present application provides a pulse generating system, as shown in fig. 1 and 7, comprising: the electrode balloon catheter 12, the electrode balloon catheter 12 comprises a plurality of electrode assemblies 122 and is provided with a containing space, and the electrode assemblies 122 are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter 12; a driving member mechanically coupled to the electrode assembly 122; the pulse generator 14, the pulse generator 14 is connected with the transmission member in a transmission way.

The term definitions of the parts can refer to the descriptions of other embodiments, and are not repeated herein. The pulse generating system provided by the embodiment of the application can selectively release pulses by arranging the electrode assembly 122 inside the balloon. And through the pulse generator 14 and the transmission part, the directional shattering calcification structure can be realized, and the energy interference between multiple groups of electrodes can be reduced. When the balloon is used in a blood vessel, the pulse generator 14 pre-determines the target position and pulse signals to be applied according to the calcified blood vessel image, and targets the shattering calcification, so that concentrated energy can prevent the balloon from being broken or the electrode from being damaged due to repeated back suction of the balloon, thereby reducing the operation time and helping the patient relieve pain.

In one embodiment, as shown in fig. 7, the electrode balloon catheter 12 includes: balloon 124, inner elongate member 126, a plurality of electrode assemblies 122, and outer elongate member 128.

Wherein the balloon 124 forms an accommodation space. The inner elongate member 126 is disposed within the receiving space, and a first end of the inner elongate member 126 is fixedly coupled to the distal end of the balloon 124; the electrode assemblies 122 are arranged on the transmission member at intervals, and the electrode assemblies 122 can move along the axial direction of the inner extension member 126 under the drive of the transmission member; a first end of outer elongate member 128 is fixedly coupled to the proximal end of balloon 124 and a second end of outer elongate member 128 is fixedly coupled to pulser 14; the outer extension 128 has a hollow tubular structure, through which the driving member passes, and from the second end of the driving member passes through the outer extension 128 and then extends into the accommodating space, and is in driving connection with the electrode assembly 122 in the accommodating space. For example, the driving member may be disposed on an outer wall of the inner elongate member 126 along an extension direction of the inner elongate member 126. The proximal end of balloon 124 refers to the end that emits the signal proximal to pulser 14 and the distal end of balloon 124 refers to the end that emits the signal distal to pulser 14. A tubular tip is also attached to the distal end of the balloon 124 for the passage of the balloon 124 through the blood vessel. At least a portion of the outer elongate member 128 can extend axially of the inner elongate member 126 for directional threading of a guidewire therethrough.

For example, the transmission member may be a micro screw. The electrodes of the electrode assembly 122 are correspondingly sleeved on the micro screw rods, and when the micro screw rods are controlled to rotate manually or electrically, the first electrode 1222 and the second electrode 1224 are equivalent to nuts which perform linear motion along the extending direction of the inner extension member 126 along with the rotation of the screw rods, so that the movement control of the electrode assembly 122 is realized. In one embodiment, the first electrode 1222 and the second electrode 1224 of each electrode assembly 122 may share a micro-lead screw to maintain synchronous movement. In one embodiment, different electrode assemblies 122 may be correspondingly coupled to different micro-lead screws to individually control movement of each electrode assembly 122 along the inner elongate member 126.

In one embodiment, the inner elongate member 126 is also a hollow tubular structure, the hollow tubular structure of the inner elongate member 126 being adapted for passage of a guidewire.

In one embodiment, as shown in FIG. 7, the controller and/or pulsed power supply may be integrated into the control handle 142.

In one embodiment, as shown in fig. 7, the electrode balloon catheter 12 further comprises: the connector 129, the connector 129 comprising three ports. The first port D1 is fixedly connected to the control handle 142 for passing a connection wire between the control handle 142 and the electrode assembly 122 to deliver the pulse energy. The second port D2 is used to fill the liquid medium into the accommodation space of the balloon 124. The third port D3 is used to pass through the guidewire so that the electrode balloon catheter 12 reaches the lesion smoothly. It should be understood that the connecting member 129 further has a fourth port D4 in communication with the external connecting member 129, and that the first port D1, the second port D2 and the third port D3 are all in communication with the fourth port D4 via internal pipes, and the pipes may be independent of each other or may share at least some of the pipes. The cross section of the pipeline is not limited to a round shape, but can be square or other anisotropic shape.

In one embodiment, outer elongate member 128 and balloon 124 may be sealingly connected, at which point a liquid medium may be injected from second port D2 of connector 129 into the tubing of outer elongate member 128 and into the receiving space of balloon 124, filling balloon 124. The liquid medium may be an aqueous medium. When the procedure is completed, the fluid medium may also be withdrawn through the second port D2, causing the balloon 124 to collapse and be withdrawn. The retraction and inflation of balloon 124 is accomplished.

In one embodiment, the outer elongate member 128 may be comprised of polyetheretherketone and/or PEBAX materials (block polyether amide resin materials). The outer elongate member 128 of this material option has a certain support and passability for the transmission and wires to pass through. Alternatively, the outer diameter of the outer elongate member 128 is less than or equal to 0.066 inches, at which point vessel damage due to thicker tube diameters may be avoided.

The inner elongate member 126 can be formed of a polymeric material such as polyetheretherketone and/or polyethylene or polyamide. At this point, the inner elongate member 126 has some ductility and lubricity. In one embodiment, the inner diameter of the inner elongate member 126 is greater than or equal to 0.014 inches. For passage of a 14-size guidewire. A guidewire may be inserted through the third port D3 of the connector 129, sequentially through the outer elongate member 128, the inner elongate member 126 to the distal end thereof.

In one embodiment, electrode assembly 122 is electrically connected to pulse generator 14 in control handle 142 by wires (not shown) extending from first port D1 of connector 129 to control handle 142. The wires may be provided in a matching number according to the number of the electrode assemblies 122, and each of the wires is provided in the extension direction of the extension member in the piping of the inner extension member 126 and the outer extension member 128, and the plurality of wires are circumferentially arranged between the inner extension member 126 and the outer extension member 128. The proximal end of balloon 124 is fixedly attached to a first end of outer elongate member 128 and the distal end of balloon 124 is fixedly attached to inner elongate member 126. The electrode balloon catheter 12 is connected to the pulser 14 by a control handle 142. The control handle 142 may be provided with an actuation button, and optionally, the control handle 142 may further include a pulse parameter adjustment button for adjusting the released pulse.

In one embodiment, the relative position of the electrode assembly 122 within the blood vessel may be visualized by the electrode assembly 122, or a developable scale provided on the inner elongate member 126, or a sensor (e.g., a pull-wire encoder or a magnetoresistive sensor) may be provided on the electrode assembly 122 at the location of the connection with the balloon 124 and the inner elongate member 126 to sense the relative position.

Preferably, electrode assembly 122 has a thickness of no more than 0.5mm in a direction perpendicular to the axial direction of inner elongate member 126. In one embodiment, the control target electrode assembly 122 is moved to the target position while being moved to the center position of the target position. The center position of the movement to the target position may be that the geometric centers of the first electrode 1222, the second electrode 1224, and the electrode assembly 122 are on a straight line after the movement.

In one embodiment, the control target electrode assembly 122 is moved to a target position when it is moved to an intermediate position between two adjacent target positions. The intermediate position of the two adjacent target positions means that the midpoint of the line connecting the two first electrodes 1222, the midpoint of the line connecting the two second electrodes 1224, and the geometric center of the motor assembly 122 are on a straight line after the movement.

The movement of the control electrode assembly 122, which may be by a control handle 142, by a threaded transmission, is accomplished by manually moving the electrode assembly 122 to the lesion site after viewing using the imaging device 16.

The movement of the electrode assembly 122 may also be controlled by electric control. A motor is provided in the control handle 142, an input end of the motor is connected to the controller, and a rotation shaft of the motor is connected to the screw. The electrode assembly 122 is threadedly coupled to the lead screw. The motor driving signal can be generated and output to the motor through the moving parameter adjusting key on the control handle 142 or based on the target position obtained by the controller, so as to drive the motor to rotate, the output shaft of the motor drives the screw rod to rotate, at this time, the electrode assembly 122 is equivalent to a nut, and the electrode assembly 122 moves along the extending direction of the inner extending member 126 along with the rotation of the screw rod. The controller can also receive the position signal output by the sensor capable of sensing the relative position of the electrode assembly 122 during the rotation process of the motor, and adjust the driving signal output to the motor according to the position signal, and the driving motor controls the lead screw to drive the first electrode 1222 and the second electrode 1224 of the target electrode assembly 122 to move to the target position along the extending direction of the inner extension member 126.

In one embodiment, as shown in FIG. 8, the pulse generating system further comprises an imaging device 16. The imaging device 16 is used to acquire vascular calcification images, and the imaging device 16 is connected to the pulse generator 14. Imaging device 16 includes, but is not limited to IVUS, OCT, CTA and the like, i.e., imaging device 16 is a device that can display an intravascular calcification image.

The imaging device 16 may include a communication interface through which the acquired vascular calcification images are transmitted to the pulser 14, for example, to a controller of the pulser 14 for analysis by the controller to obtain calcification features for determination of vascular calcification location and directional treatment. The communication between the imaging device 16 and the pulse generator 14 may be UART, RS232, RS485, CAN, ethernet, IIC, SPI, etc. The pulse generator 14 transmits pulse energy to the electrode balloon catheter 12, and is electrically connected with electrode plates in the electrode balloon catheter 12, and the electrode plates generate shock waves to act on a target position under the directional throwing action of pulse signals, so that targeted treatment is realized.

For better explanation, the implementation process of the pulse generating system provided in the embodiment of the present application is described herein by taking a specific example as an example:

First a vascular calcification image is obtained by the imaging device 16. The vascular calcification image is processed and analyzed in the pulse generator 14 to output calcification features. The calcification features are correlated to the target location and the pulse signal generation parameters by the data authority model. Alternatively, the display may be based on the display of the imaging device 16 or the display of the pulser 14 or the display of the control handle 142. At this time, the positions of the electrode assemblies 122 can be manually or automatically adjusted in vitro, so that the interval distance between two adjacent electrode assemblies 122 is consistent with the interval distance between two adjacent target positions, then the electrode balloon catheter 12 is guided into the blood vessel, and the movement of the electrode balloon catheter 12 in the blood vessel is controlled by means of a position sensor or a miniature camera and other tools, so that the target electrode assemblies 122 are in one-to-one correspondence with the target positions, and the targeting positioning is realized. Liquid medium is then injected through the second port D2 of the connector 129 to inflate the balloon 124, causing the balloon 124 to reach inflation pressure. At this point, an actuation button on control handle 142 may be depressed, and the pulsed power source delivers pulses to first electrode 1222 and second electrode 1224 of target electrode assembly 122, which release shock waves in the filling fluid for targeting the lesion.

In one embodiment, fig. 9 and 10 illustrate the implementation of a pulse generation system:

The pulse generator 14 determines the target position E, F, G as shown in fig. 9, and the lesion area TA where E, F, G is located; wherein the position of each electrode assembly 122 is individually adjustable;

Then, in vitro, the transmission parts are controlled by a control handle 142 or motor automatic control and the like to drive each electrode assembly 122 to move, so that the relative position relationship of the electrode assemblies 122e, f and g is matched with the relative position relationship of E, F, G; the match here may be that the center of the electrode assembly 122 is directly opposite the center of the target location.

Performing vascular interventional therapy on a point on the lesion area according to the determined lesion area TA, extending the tubular tip into the blood vessel BV, so that the balloon 124, the inner extension 126 and the outer extension 128 of the electrode balloon catheter 12 extend into the blood vessel BV, and moving the electrode balloon catheter 12 to a matching position of e-E, f-F, G-G by means of the arranged sensing device, as shown in FIG. 10;

filling the balloon 124 with a liquid medium through the third port D3 of the connector 129;

The strobe electrode assemblies 122e, f, g target the trigger shock wave at the E, F, G position according to the determined pulse signal generation parameters.

The pulse generation accurate positioning control can be realized, the targeted therapy is facilitated, the intervention operation treatment time can be shortened by adjusting the relative position relation of the electrode assembly 122 in vitro, and the user experience degree is improved.

It should be understood that the pulse generating method provided by the present application may further include the above-mentioned pulse generator 14 and a controller having a control function in the pulse generating system or method steps executed by the pulse generator 14 itself, so as to achieve corresponding beneficial effects, which are not described herein.

In one embodiment, a computer readable storage medium is provided, on which a computer program is stored which, when executed by a processor, implements the steps of the method embodiments described above.

Those skilled in the art will appreciate that implementing all or part of the above described methods may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, may comprise the steps of the embodiments of the methods described above. Any reference to memory, storage, database, or other medium used in embodiments provided herein may include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, or the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory. By way of illustration, and not limitation, RAM can be in various forms such as static random access memory (Static Random Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), etc.

In the description of the present specification, reference to the terms "some embodiments," "other embodiments," "desired embodiments," and the like, means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic descriptions of the above terms do not necessarily refer to the same embodiment or example.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

1. A method of pulse generation comprising:

obtaining calcification characteristics of a vascular calcification image;

Inputting the calcification features into a pre-trained data organization model to obtain target positions and pulse signal generation parameters; the data organization model is used for representing the mapping relation between the calcification features, the target position and the pulse signal generation parameters;

Controlling a transmission piece penetrating through the balloon to move so that a plurality of electrode assemblies arranged on the transmission piece move to the target position; the transmission piece is mechanically connected with the electrode assemblies, the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with accommodating spaces, and the electrode assemblies are arranged in the accommodating spaces at intervals along the extending direction of the electrode balloon catheter;

2. The method of claim 1, wherein the pulse generation parameter comprises a total pulse energy corresponding to the target location;

The step of providing the pulse signal for the electrode assembly corresponding to the target position according to the pulse signal generation parameter includes:

3. The method of claim 1, wherein the pulse generation parameter comprises a number of pulse cycles corresponding to the target location;

4. The method of claim 3, the pulse generation parameters further comprising a pulse release path sequence number;

The step of providing the pulse signals of the pulse cycle numbers for the electrode assemblies corresponding to the target positions according to the pulse cycle numbers corresponding to each target position comprises the following steps:

And providing pulse signals of the pulse cycle numbers for the electrode assemblies of the pulse release channel sequence numbers according to the pulse cycle numbers and the pulse release channel sequence numbers corresponding to each target position.

5. The method of any one of claims 1-4, wherein controlling movement of a driver disposed through a balloon such that a number of electrode assemblies disposed on the driver move to the target location comprises:

controlling a transmission part penetrating through the balloon to move, so that a plurality of electrode assemblies arranged on the transmission part move to the center position of each target position in a one-to-one correspondence manner; or alternatively, the first and second heat exchangers may be,

6. A pulse generator comprising a memory and a processor, the memory storing a computer program, characterized in that the processor implements the steps of the method of any one of claims 1 to 5 when the computer program is executed.

7. The pulse generator of claim 6, comprising:

a pulse power supply for providing a pulse signal;

The controller comprises a memory and a processor, wherein the memory stores a computer program, the processor is electrically connected with the pulse power supply, and the processor realizes the following steps when executing the computer program:

obtaining calcification characteristics of a vascular calcification image;

inputting the calcification features into a pre-trained data organization model to obtain target positions and pulse signal generation parameters;

Controlling the transmission member to move so that a plurality of electrode assemblies on the transmission member move to the target position;

Outputting a pulse generation instruction to the pulse power supply according to the pulse signal generation parameters;

the pulse generation instruction is used for instructing the pulse power supply to provide a pulse signal for a target electrode assembly, so that the electrode assembly generates shock waves under the action of the pulse signal; the target electrode assembly is an electrode assembly corresponding to the target position.

8. The pulser according to claim 7, wherein each of said electrode assemblies comprises a first electrode and a second electrode; the pulse power supply includes:

the direct-current power supply is used for providing direct-current voltage;

9. The pulse generator of claim 7, further comprising:

the control handle is provided with a movement control;

10. The pulser according to claim 7, wherein the control handle is further configured with an actuation key;

The controller is electrically connected with the starting key and is further used for responding to the triggering action of the starting key and outputting the pulse generation instruction to the pulse power supply.

11. The pulser according to claim 10, wherein the control handle is further configured with a pulse parameter adjustment key;

The controller is electrically connected with the pulse parameter adjusting key, and is further used for adjusting the pulse signal generating parameter in response to the parameter adjusting operation of the pulse parameter adjusting key and outputting the pulse generating instruction to the pulse power supply according to the adjusted pulse signal generating parameter.

12. A pulse generating system, comprising:

the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with a containing space, wherein the electrode assemblies are arranged in the containing space at intervals along the extending direction of the electrode balloon catheter;

a transmission member mechanically coupled to the electrode assembly;

a pulser as claimed in any one of claims 6 to 11, in driving connection with the driving member.

13. The system of claim 12, wherein the electrode balloon catheter comprises:

A balloon forming the accommodation space;

An inner extension member disposed within the receiving space, the first end of the inner extension member being fixedly coupled to the distal end of the balloon;

The electrode assemblies are used for moving along the axial direction of the inner extension piece under the drive of the transmission piece;

an outer elongate member, a first end of the outer elongate member fixedly connected to the proximal end of the balloon, a second end of the outer elongate member fixedly connected to the pulse generator;

14. The system of claim 12, further comprising:

15. A pulse generating device, comprising:

The pulse signal determination parameter acquisition module is used for inputting the calcification characteristics into a pre-trained data organization model to obtain target positions and pulse signal generation parameters; the data organization model is used for representing the mapping relation between the calcification features, the target position and the pulse signal generation parameters;

The targeting movement control module is used for controlling the movement of a transmission piece penetrating through the balloon so that a plurality of electrode assemblies arranged on the transmission piece move to the target position; the transmission piece is mechanically connected with the electrode assemblies, the electrode balloon catheter comprises a plurality of electrode assemblies and is provided with accommodating spaces, and the electrode assemblies are arranged in the accommodating spaces at intervals along the extending direction of the electrode balloon catheter;

And the pulse signal transmitting module is used for providing pulse signals for the electrode assemblies corresponding to the target positions according to the pulse signal generation parameters, so that the electrode assemblies generate shock waves under the action of the pulse signals.

16. A computer readable storage medium, on which a computer program is stored, characterized in that the computer program, when being executed by a processor, implements the steps of the method of any of claims 1 to 5.