Thrombus driving system

Abstract

The present disclosure provides a thrombus driving system, which comprises a controller, a magnetic field generator, and an implantable stent structure; the magnetic field generator is in communication connection with the controller, is arranged on the body surface of a user, and is arranged in matching with the position of the stent structure implanted in the body; the controller is used for generating a first driving instruction to drive the magnetic field generator to generate an alternating magnetic field with a target driving parameter, drive the stent structure to periodically deform through the alternating magnetic field, and form an ultrasonic mechanical wave to intervene and treat the thrombus in the blood vessel. In the present disclosure, when the user perceives a suspected thrombosis symptom, the system can be actively triggered to start, so as to timely form the ultrasonic mechanical wave to intervene and treat the thrombus, which can timely and effectively stabilize the condition, can gain key time for further treatment of the user, and can maintain the entire treatment process in a set safe intensity range, thereby guaranteeing the safety and use experience of the user.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to a thrombus-driven system. Background Technology

[0002] Percutaneous coronary intervention (PCI) and stent implantation are the main treatments for coronary artery disease. However, after stent implantation, especially in the hours to weeks following the procedure, there is a risk of in-stent thrombosis (ST). Figure 1 and Figure 2 As shown; where, as Figure 3 The diagram illustrates the mechanism of stent embolism. This mechanism leads to acute or subacute in-stent thrombosis after the placement of stents in the heart or other arteries, a life-threatening complication with an extremely high mortality rate.

[0003] However, existing solutions for treating in-stent thrombosis generally suffer from problems such as insufficient timeliness and unsatisfactory treatment results, failing to meet the treatment needs of real-world scenarios. Summary of the Invention

[0004] The technical problem to be solved by this disclosure is to overcome the deficiencies in the prior art and provide a thrombus-driven system.

[0005] This disclosure solves the above-mentioned technical problems through the following technical solution:

[0006] This disclosure provides a thrombus driving system, which includes a controller, a magnetic field generator, and an implantable stent structure; the magnetic field generator is communicatively connected to the controller, and is positioned on the user's body surface and matched with the position of the stent structure implanted in the body;

[0007] The support structure is tubular and is a magnetostrictive mesh structure.

[0008] The controller is used to generate a first drive command and send it to the magnetic field generator;

[0009] The magnetic field generator is used to generate an alternating magnetic field with target driving parameters according to the first driving command. The alternating magnetic field drives the stent structure to undergo periodic deformation, and the ultrasonic mechanical waves generated by the periodic deformation intervene in the thrombus in the blood vessel.

[0010] Optionally, the target portion of the mesh structure is a magnetostrictive structure;

[0011] The target part is a portion or the entire structure of the mesh structure;

[0012] Different magnetic units are formed at each grid intersection point in the magnetized target portion to undergo mechanical vibration under the action of the alternating magnetic field, generating the ultrasonic mechanical wave for intervention treatment of thrombi in blood vessels.

[0013] Optionally, the target portion is formed using a biocompatible magnetostrictive material; and / or, a first material layer is disposed on the surface of the target portion, the first material layer being formed using a biocompatible magnetostrictive material.

[0014] And / or,

[0015] When the target part is a portion of the mesh structure, the remaining structure in the mesh structure other than the target part is formed using a biocompatible alloy material.

[0016] Optionally, the thrombus driving system further includes an interaction module that is communicatively connected to the controller;

[0017] The interaction module is used to receive the user's first interaction operation, and the controller is used to generate the first driving instruction based on the first interaction operation.

[0018] And / or,

[0019] The interaction module is also used to receive a second interaction operation from the user, and the controller is used to generate a second driving instruction based on the second interaction operation.

[0020] The magnetic field generator is used to generate an alternating magnetic field with new target driving parameters according to the second driving command, so as to drive the stent structure to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave generated by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

[0021] Optionally, the interaction module includes physical buttons; and / or a user interface.

[0022] And / or,

[0023] The interaction module is also used to select different preset working modes; wherein, different preset working modes trigger the magnetic field generator to generate different magnetic field intensities.

[0024] Optionally, the controller is configured to generate a third driving instruction and send it to the magnetic field generator after a first preset time for thrombosis intervention based on the first driving instruction;

[0025] The magnetic field generator is used to stop generating an alternating magnetic field according to the third driving command.

[0026] Optionally, the thrombus driving system further includes a signal detection module communicatively connected to the controller;

[0027] The signal detection module is used to detect the activity intensity signal of the magnetic unit formed on the magnetized support structure in the body during the intervention process or within a preset time period after the alternating magnetic field is stopped, and output it to the controller.

[0028] The controller is used to generate a fourth driving command and send it to the magnetic field generator in response to the activity intensity signal exceeding a preset intensity range.

[0029] The magnetic field generator is used to generate an alternating magnetic field with new target driving parameters according to the fourth driving command, so as to drive the stent structure to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave generated by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

[0030] Optionally, the thrombus driving system further includes a status indication module that is communicatively connected to the controller;

[0031] The status indication module is used to receive the status display drive command sent by the controller and output the corresponding status indication signal.

[0032] Optionally, the thrombus driving system further includes a power module for supplying power to the thrombus driving system;

[0033] And / or,

[0034] The thrombus driving system also includes an emergency switch that is communicatively connected to the controller;

[0035] And / or,

[0036] The thrombus-driven system also includes an emergency service activation button that communicates with a cloud server.

[0037] Optionally, the magnetic field generator may include a wearable vest or pad.

[0038] And / or,

[0039] The stretching direction of the mesh structure is along the direction of the blood vessel and / or perpendicular to the direction of the blood vessel.

[0040] Based on common knowledge in the field, the above-mentioned preferred conditions can be combined arbitrarily to obtain various preferred embodiments of this disclosure.

[0041] The positive and progressive effects of this disclosure are as follows:

[0042] In this disclosure, when a user perceives suspected thrombosis symptoms, the thrombosis-driving system can be actively activated in environments such as the home. The controller automatically drives the magnetic field generator to produce an alternating magnetic field, causing periodic deformation of the stent structure. The resulting ultrasonic mechanical waves intervene in the thrombus in the blood vessel. Specifically, the magnetostrictive vibration effect causes the stent structure to produce local micro-vibrations to generate ultrasonic mechanical waves, thereby inhibiting the continued formation of thrombi, ablating or partially ablating existing thrombi, and improving local blood flow. This allows for timely, reliable stabilization of the condition anytime, anywhere, buying crucial time for the user to prepare for surgery or go to the hospital for final treatment. Furthermore, it ensures that the entire treatment process remains within the set safe intensity range, effectively guaranteeing user safety and user experience, and meeting higher practical application requirements.

[0043] Meanwhile, during the operation of this thrombus driving system, the driving parameters can be actively adjusted in a closed loop based on the actual intervention situation to automatically and adaptively adjust the magnetic field energy of the alternating magnetic field, automatically, timely and reliably adjusting the ultrasonic mechanical wave to a reasonable and effective range, thereby further ensuring that the treatment is always maintained within the preset safe intensity range, and further guaranteeing the user's safety and user experience.

[0044] Furthermore, the system's processing is remotely driven by an external magnetic field, avoiding the introduction of wires or complex circuits into blood vessels and the risk of electrical signals interfering with the heart's own electrophysiological activities. The entire process involves non-invasive energy transmission, ensuring high safety.

[0045] Furthermore, it fills a critical gap in pre-hospital emergency care, providing users with a feasible self-intervention method during the golden window between onset of illness and hospital admission. This can significantly reduce mortality and myocardial damage caused by delayed treatment. It can seamlessly integrate with the existing medical system, providing time-saving bridging treatments. It does not replace existing mature in-hospital emergency care programs, but rather creates conditions for them, demonstrating excellent compatibility and operability. Attached Figure Description

[0046] Figure 1 This is a schematic diagram illustrating the first association of existing in-stent thrombosis.

[0047] Figure 2 This is a second-order correlation diagram of existing in-stent thrombosis;

[0048] Figure 3 A schematic diagram illustrating the existing mechanism of stent embolism;

[0049] Figure 4 This is a schematic diagram of the thrombus driving system according to Embodiment 1 of this disclosure;

[0050] Figure 5This is a first structural schematic diagram of the mesh support structure of Embodiment 1 of this disclosure;

[0051] Figure 6 This is a schematic diagram of the second structure of the mesh support structure of Embodiment 1 of this disclosure;

[0052] Figure 7 This is a schematic diagram showing the extension direction of the support structure in Embodiment 1 of this disclosure;

[0053] Figure 8 This is a schematic diagram of the extended state of the support structure according to Embodiment 1 of this disclosure;

[0054] Figure 9 This is a schematic diagram of the distribution of magnetic units in the support structure of Embodiment 1 of this disclosure;

[0055] Figure 10 This is a schematic diagram of the first magnetic field generated by the magnetic field generator in Embodiment 1 of this disclosure.

[0056] Figure 11 This is a schematic diagram of the second magnetic field generated by the magnetic field generator in Embodiment 1 of this disclosure;

[0057] Figure 12 This is a schematic diagram of the third magnetic field generated by the magnetic field generator in Embodiment 1 of this disclosure;

[0058] Figure 13 A schematic diagram of the fourth magnetic field generated after a user wears the vest in Embodiment 1 of this disclosure;

[0059] Figure 14 This is a schematic diagram of the thrombus driving system according to Embodiment 2 of this disclosure. Detailed Implementation

[0060] The present disclosure is further illustrated below by way of embodiments, but the present disclosure is not limited to the scope of the embodiments described herein.

[0061] The prefixes such as "first" and "second" used in this disclosure are merely for distinguishing different descriptive objects and do not limit the position, order, priority, quantity, or content of the described objects. The use of ordinal numbers and other prefixes used to distinguish descriptive objects in this disclosure does not constitute a limitation on the described objects. The description of the described objects is given in the claims or the context of the embodiments, and should not be construed as an unnecessary limitation. Furthermore, in the description of this embodiment, unless otherwise stated, "multiple" means two or more.

[0062] In this embodiment of the disclosure, the collection, storage, use, processing, transmission, provision, and disclosure of user personal information comply with relevant laws and regulations and do not violate public order and good morals.

[0063] Currently, existing solutions for treating in-stent thrombosis generally suffer from problems such as insufficient timeliness and unsatisfactory treatment outcomes, failing to meet the needs of real-world scenarios. Specific solutions for treating in-stent thrombosis are as follows:

[0064] Option 1: Prevention of in-stent thrombosis relies entirely on oral antiplatelet drugs (such as aspirin, clopidogrel, etc.). Treatment depends entirely on emergency medical intervention, requiring the patient to immediately return to the hospital for further procedures in the catheterization lab, including thrombectomy, balloon dilation, or re-stent implantation. However, the "time window" between the onset of symptoms and access to effective treatment is extremely short, and delays during this period are a key factor leading to poor prognosis. Most deaths from embolism are due to the inability to clear the thrombus in time. Furthermore, long-term medication carries a risk of bleeding, and some patients exhibit clopidogrel resistance, resulting in poor preventative effects.

[0065] Option 2: The existing stents used in hospitals that are already permitted for use are all passive devices that only provide mechanical support or slow-release drugs. They do not have the ability to actively clear thrombi and provide timely physical intervention, and therefore still cannot meet the needs of actual use scenarios.

[0066] Option 3: The design concept is to endow the stent itself with active treatment function, such as by integrating an energy generation module inside the stent structure (such as the ultrasound generation module mentioned in patent application number 202411387683.0, invention title: an ultrasound vascular stent device). This type of design attempts to achieve immediate thrombosis intervention in principle.

[0067] However, embedding functional modules within stents requiring percutaneous delivery typically involves balancing the following contradictions: First, the size and structural rigidity of the module conflict with the extremely high compression ratio required for the stent to pass through narrowed blood vessels; second, the fixed connection of the module conflicts with the continuous, non-uniform deformation of the stent's mesh structure during expansion; and third, the energy supply and precise control requirements of the embedded module conflict with the long-term reliability, safety, and simplicity requirements of implantable devices.

[0068] These contradictions pose challenges to achieving stable, safe, and widely applicable active therapy solutions with built-in modules. Therefore, the field still needs to seek a novel active therapy system that can effectively resolve these contradictions.

[0069] Based on this, this disclosure proposes a novel thrombus-driven system, aiming to provide users with timely preoperative or pre-hospital intervention during thrombus formation and occurrence. This system possesses the ability to actively clear thrombi and perform timely physical intervention, thus buying valuable time for subsequent professional treatment; it is particularly suitable for the prevention and treatment of acute or subacute in-stent thrombosis after coronary artery and other vascular stent implantation. Specifically:

[0070] Example 1

[0071] like Figure 4 As shown, the thrombus driving system of this embodiment includes a controller 1, a magnetic field generator 2, and an implantable stent structure 3. The magnetic field generator 2 is communicatively connected to the controller 1.

[0072] The magnetic field generator 2 is used to be placed on the user's body surface and matched with the position of the implanted stent structure 3; the magnetic field generator 2 is used to generate an alternating magnetic field of a specific frequency and intensity.

[0073] The magnetic field generator 2 includes, but is not limited to, a wearable vest (or undershirt) or padding, which can be placed on the surface of the user's torso corresponding to the implanted scaffold structure 3. The alternating magnetic field generated by the magnetic field generator 2 can penetrate human tissue and act on the magnetostrictive scaffold structure 3 implanted in the body.

[0074] Specifically, such as Figure 5 and 6 As shown, the support structure 3 is tubular and is a magnetostrictive mesh structure; the mesh structure can be of various styles, and there is no limitation here, as long as it can achieve the corresponding function in this embodiment.

[0075] The tubular stent structure 3 is used to be placed in a blood vessel at a predetermined location within the user's body. The dimensions of the tubular stent structure 3 (such as the length along the blood vessel direction, the radial length, etc.) are determined or adjusted according to the user's actual situation.

[0076] The reticular structure extends and contracts along the direction of blood vessels and / or perpendicular to the direction of blood vessels.

[0077] Specifically, such as Figure 7 As shown, the shape of the upper part of the image extends perpendicularly to the direction of the blood vessel, as... Figure 8 As shown, the upper part of the figure is related to... Figure 7 The third state of the stent structure after expansion and contraction corresponds to the direction perpendicular to the blood vessel.

[0078] like Figure 7 As shown, the shape of the lower part of the image extends along the direction of the blood vessel, as... Figure 8 As shown, the lower part of the figure is related to... Figure 7 The image shows the third state of the stent structure after expansion and contraction, along the direction of the blood vessel.

[0079] In one feasible solution, the target portion of the mesh structure 3 is a magnetostrictive structure; wherein, the target portion is a partial or integral part of the mesh structure.

[0080] Specifically, such as Figure 9 As shown, this corresponds to the magnetized stent structure 3. Different magnetic units (N pole, S pole) are formed at each grid intersection point in the magnetized target section to mechanically vibrate under the action of an alternating magnetic field, generating ultrasonic mechanical waves for intervention and treatment of thrombi in blood vessels. Among these, Figure 8 Only some of the magnetic poles (magnetic units) are marked in the text; the other locations are similar, so I will not go into detail here.

[0081] In one feasible approach, the target portion is fabricated using a biocompatible magnetostrictive material.

[0082] Alternatively, the surface of the target portion may be provided with a first material layer, which is formed by using a biocompatible magnetostrictive material, i.e., the first material layer is a magnetostrictive functional layer.

[0083] In this embodiment, the magnetostrictive material includes iron-gallium alloy (Fe-Ga) and the like; there are no specific limitations, as long as the corresponding function can be achieved.

[0084] In this scheme, the target part of the stent structure 3 can undergo periodic deformation under the action of an alternating magnetic field, thereby causing the stent structure 3 to generate mechanical vibration as a whole or in part, so that the active intervention of thrombus treatment can be reliably realized.

[0085] In one feasible approach, when the target portion is a part of a mesh structure, the remaining structure in the mesh structure other than the target portion is formed using a biocompatible alloy material.

[0086] The alloy materials include biocompatible cobalt-chromium alloys, nickel-titanium alloys, or high-nitrogen stainless steel, to ensure the overall mechanical properties (such as mechanical support strength) and biosafety of the stent structure 3, so as to meet the actual use requirements of each thrombosis intervention and also ensure the service life of the stent structure 3, which has the advantages of durability.

[0087] For example, the main body of the stent structure 3 is made of L605 cobalt-chromium alloy by laser engraving. On the inner surface of its vascular lumen, a thin film of iron-gallium alloy (Fe-Ga) with a thickness of about 5-20 micrometers is uniformly deposited as a magnetostrictive functional layer by PVD (physical vapor deposition) process.

[0088] Controller 1 is used to generate the first drive command and send it to magnetic field generator 2;

[0089] The first driving command can be triggered by user-initiated actions, that is, timely intervention and treatment of intravascular thrombosis through user-initiated physical intervention. For example, when a user experiences symptoms such as chest pain or chest tightness that are suspected of being acute thrombosis, they can immediately put on or place the magnetic field generator 2 and perform the corresponding activation operation to promptly activate the system and quickly enter the vascular intervention and treatment state.

[0090] The magnetic field generator 2 is used to generate an alternating magnetic field with target driving parameters according to the first driving command. The alternating magnetic field drives the stent structure 3 to undergo periodic deformation, and the ultrasonic mechanical wave generated by the periodic deformation intervenes in the thrombus in the blood vessel.

[0091] Under the action of an alternating magnetic field, the stent structure 3 undergoes magnetostriction and generates mechanical vibration (such as high-frequency micro-vibration or local ultrasound). The mechanical vibration effect includes, but is not limited to: (1) disturbing the blood flow on the surface of the stent structure 3 and inhibiting further platelet aggregation; (2) generating shear force on the already formed fragile thrombus, causing it to partially disintegrate; (3) improving the flow field in the local area of ​​the stent structure 3 and reducing blood stasis.

[0092] The target driving parameters include, but are not limited to, the frequency, intensity, waveform (such as sine wave, pulse wave), and duration of action of the magnetic field. The range of the target driving parameters is designed to ensure that the subsequent ultrasonic mechanical waves effectively intervene in and treat thrombi in blood vessels while also guaranteeing user safety, so as to ensure that the entire treatment process remains within the set safe intensity range.

[0093] In addition, the target-driven parameters can be pre-set parameters, generally determined based on experience or other methods; of course, they can also be redefined or adjusted according to the actual needs of the scenario.

[0094] Among them, combined Figure 10 , Figure 11 and Figure 12 A detailed explanation of the working principle of magnetic field generator 2:

[0095] like Figure 10 The diagram shown is a schematic of the alternating magnetic field generated by the magnetic field coil in the energized magnetic field generator 2 (for illustrative purposes only).

[0096] like Figure 11 and Figure 12As shown, the working principle of the magnetic field coil in the magnetic field generator 2 is as follows: when the currents of the upper and lower coils are synchronized and consistent, the magnetic fields generated by the two coils are consistent, and the magnetic poles in the support structure 3 will be subjected to forces in this magnetic field; assuming that the direction of the magnetic field lines of the initial magnetic field is from bottom to top, the N pole in the support structure 3 will be subjected to an upward force, while the S pole will be subjected to a downward force, and the grid will deform accordingly; then, when the direction of the alternating current changes to the downward direction of the magnetic field lines, the direction of the force on the magnetic poles in the support structure 3 will reverse, with the N pole moving downward and the S pole moving upward; when the driving current in the magnetic field generator 2 changes periodically at the required frequency (ultrasonic segment), the magnetic field changes synchronously, and the magnetic poles in the support structure 3 will continuously change their direction of movement, generating mechanical vibration, thereby forming ultrasonic mechanical waves.

[0097] like Figure 13 The diagram shows the magnetic field distribution after a user wears a vest (such as a lightweight, wearable open vest); the vest has magnetic field coils (or Helmholtz coil sets) embedded on the inner sides of the front and back panels as magnetic field generators 2.

[0098] In this embodiment, when a user perceives suspected thrombosis symptoms, the thrombosis-driving system can be actively activated in environments such as the home. The controller automatically drives the magnetic field generator to produce an alternating magnetic field, causing the stent structure to undergo periodic deformation. The resulting ultrasonic mechanical waves intervene in the thrombus in the blood vessel. Specifically, the magnetostrictive vibration effect is used to induce local micro-vibrations in the stent structure to generate ultrasonic mechanical waves, thereby inhibiting further thrombus formation, ablating or partially ablating existing thrombi, and improving local blood flow. This allows for timely, reliable stabilization of the condition anytime, anywhere, buying crucial time for the user to prepare for surgery or go to the hospital for final treatment. Furthermore, it ensures that the entire treatment process remains within the set safe intensity range, effectively guaranteeing user safety and user experience, and meeting higher practical application requirements.

[0099] Furthermore, the system's processing is remotely driven by an external magnetic field, avoiding the introduction of wires or complex circuits into blood vessels and the risk of electrical signals interfering with the heart's own electrophysiological activities. The entire process involves non-invasive energy transmission, ensuring high safety.

[0100] In addition, it fills a key gap in pre-hospital emergency care, providing users with a feasible self-intervention method during the golden window period between the onset of illness and hospital admission, which can significantly reduce the mortality rate and the degree of myocardial damage caused by treatment delays.

[0101] Example 2

[0102] like Figure 14 As shown, the thrombus driving system in this embodiment is a further improvement on Embodiment 1, specifically:

[0103] In one feasible embodiment, the thrombus-driven system also includes an interactive module 4 that is communicatively connected to the controller 1;

[0104] The interaction module 4 includes physical buttons and a user interface. The user interface has buttons for various operation functions (such as start, stop, etc.).

[0105] In one feasible solution, the interaction module 4 is used to receive the user's first interaction operation, and the controller 1 is used to generate a first driving instruction based on the first interaction operation.

[0106] Of course, interaction module 4 can also be a voice interaction module 4, allowing users to interact via keywords, achieving more intelligent operations and further enhancing the user experience.

[0107] In this solution, users can actively initiate the thrombus-driven system by operating specific physical buttons or the user interface on the display. This ensures that thrombus intervention can be triggered flexibly anytime and anywhere based on user needs, greatly meeting users' actual usage requirements and ensuring their safety in a timely manner.

[0108] In one feasible solution, the interaction module 4 is also used to receive a second interaction operation from the user, and the controller 1 is used to generate a second driving instruction based on the second interaction operation;

[0109] The second interactive operation can be an interactive operation on a specific area of ​​the user interface on the display.

[0110] The magnetic field generator 2 is used to generate an alternating magnetic field with new target driving parameters according to the second driving command, so as to drive the stent structure 3 to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave formed by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

[0111] In this solution, if the user perceives that the thrombus treatment is not meeting their needs during the operation of the thrombus driving system, they can actively trigger the controller 1 to generate a second driving command to adjust the magnetic field energy of the alternating magnetic field. This allows for fine-tuning of the periodic deformation of the stent structure 3 in the next working cycle, thereby fine-tuning the ultrasonic mechanical wave to better intervene in the thrombus in the blood vessel. This further enhances the flexibility of the user's active intervention in thrombus treatment and better meets the user's personalized intervention needs.

[0112] Of course, it is not limited to one interactive adjustment. If the ultrasonic mechanical waves generated by the magnetic field energy of the alternating magnetic field after the current adjustment still cannot meet the user's needs for intervention and treatment of blood vessels, a second or more interactive adjustments can be made. There are no specific restrictions.

[0113] It should be noted that the new target driving parameters adjusted based on user interaction must be within the preset safety driving parameter range; if the new target driving parameters adjusted by user interaction exceed the safety driving parameter range, no response will be given; at the same time, a first interactive reminder message can be generated to inform that the currently adjusted target driving parameters do not meet the conditions, etc.

[0114] Of course, if the new target driving parameter adjusted by the user interaction meets the range of the safety driving parameter, a second interactive reminder message can also be generated to inform that the currently adjusted target driving parameter meets the conditions and has automatically triggered the corresponding automatic adjustment operation, thereby further improving the user's safety; and through interactive reminders, the user's operating experience is further enhanced.

[0115] In this solution, during the operation of the thrombus driving system, the driving parameters can be actively adjusted in a closed loop based on the actual intervention situation to automatically and adaptively adjust the magnetic field energy of the alternating magnetic field. This automatically, timely, and reliably adjusts the ultrasonic mechanical wave to a reasonable and effective range, thereby further ensuring that the treatment is always maintained within the preset safe intensity range, and further guaranteeing the user's safety and user experience.

[0116] In one feasible solution, the interaction module 4 is also used to select different preset working modes; wherein, different preset working modes correspond to triggering the magnetic field generator 2 to generate different magnetic field strengths.

[0117] Specifically, the preset working modes include emergency mode and prevention mode.

[0118] For example, in emergency mode, the corresponding magnetic field strength is higher, and the continuous working time is 10-15 minutes each time; in prevention mode, the corresponding magnetic field strength is lower, and the continuous working time is 5 minutes each time.

[0119] In this solution, users can select the system's emergency mode, prevention mode, and other working modes according to their actual needs. This directly triggers the thrombus-driven system to generate ultrasonic mechanical waves that meet the requirements, thus meeting the user's thrombus intervention needs more quickly and effectively, and further ensuring the user's user experience.

[0120] In one feasible scheme, controller 1 is used to generate a third driving command and send it to magnetic field generator 2 after a first preset time of thrombosis intervention based on the first driving command;

[0121] The first preset duration is determined in advance based on empirical values; of course, it can also be re-determined or adjusted according to the actual needs of the scenario.

[0122] Alternatively, after the first preset duration of thrombosis intervention, the user can trigger the cessation of the alternating magnetic field through active interaction based on their own needs.

[0123] Magnetic field generator 2 is used to stop generating alternating magnetic fields according to the third drive command.

[0124] In this solution, after a period of thrombosis intervention, the controller 1 actively drives the magnetic field generator 2 to stop generating the alternating magnetic field, so that the stent structure 3 is no longer affected by the alternating magnetic field. That is, it is not necessary to continuously drive the magnetic field generator 2 to generate the alternating magnetic field. This ensures the effectiveness of vascular intervention while avoiding unnecessary waste of resources and effectively preventing damage to the user's body due to the duration of the intervention. This further ensures the safety and user experience of the user.

[0125] In one feasible embodiment, the thrombus driving system further includes a signal detection module 5 that is communicatively connected to the controller 1; wherein the signal detection module 5 is located on the user's body surface and is positioned in accordance with the location in the stent structure 3; the signal detection module 5 includes a signal strength sensor for detecting the intensity of the magnetic signal, and one or more signal strength sensors can be set according to actual needs.

[0126] The signal detection module 5 is used to detect the activity intensity signal of the magnetic unit formed on the magnetized support structure 3 in the body during the intervention process or within a preset time period after the alternating magnetic field is stopped, and output it to the controller 1.

[0127] Controller 1 is used to generate a fourth drive command and send it to magnetic field generator 2 in response to the activity intensity signal exceeding the preset intensity range;

[0128] The magnetic field generator 2 is used to generate an alternating magnetic field with new target driving parameters according to the fourth driving command, so as to drive the stent structure 3 to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave formed by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

[0129] In this scheme, during the operation of the thrombus driving system, or after the alternating magnetic field is stopped, the activity intensity signal (vibration state) of each magnetic unit formed on the magnetized stent structure 3 in the body is detected in a timely manner. When the activity intensity signal exceeds the preset intensity range (i.e., the specified safety range), it indicates that timely adjustment is required. At this time, the alternating magnetic field of the next working cycle is adjusted in a timely manner to ensure that the ultrasonic mechanical wave formed by the alternating magnetic field in the next working cycle can intervene in the thrombus in the blood vessel in a reasonable and reliable manner. That is, the driving parameters are actively closed-loop adjusted based on the actual intervention situation to automatically and adaptively adjust the magnetic field energy of the alternating magnetic field, automatically, timely and reliably adjust the ultrasonic mechanical wave to a reasonable and effective range, thereby further ensuring that the treatment is always maintained within the preset safety intensity range, and further ensuring the user's safety and user experience.

[0130] Of course, adjustments can be made once or multiple times depending on the actual situation, so as to dynamically and timely adjust the ultrasonic mechanical waves to meet the requirements, thereby achieving the purpose of effective and reliable intervention and treatment of thrombi in blood vessels.

[0131] In one feasible embodiment, the thrombus-driven system also includes a status indication module 6 that is communicatively connected to the controller 1;

[0132] The status indicator module 6 includes notification messages (such as pop-ups, text, voice, etc.) in the user interface on the display; it can also be an indicator light, a voice player, etc.

[0133] The status indication module 6 is used to receive the status display drive command sent by the controller 1 and output the corresponding status indication signal.

[0134] This solution can display relevant system information (such as normal working status) in a timely manner, or provide instructions through relevant notification messages on the monitor, so that users can clearly understand the relevant situation and perform corresponding operations.

[0135] In one feasible embodiment, the thrombus actuation system further includes a power module 7 for supplying power to the thrombus actuation system.

[0136] In this solution, the power module 7 can be a battery, and the entire thrombus driving system has a portable structure, making it convenient for users to use and operate. Alternatively, the power module 7 can also be a wired charging module or a wireless charging module.

[0137] In one feasible embodiment, the thrombus-driven system also includes an emergency switch 8 that is communicatively connected to the controller 1.

[0138] In this solution, by setting an emergency switch 8, the system can be started in time to enter the working state when the user feels uncomfortable; and during the intervention process, if the user feels uncomfortable or other abnormalities, the entire system can be shut down by operating the emergency switch 8 to ensure the user's needs and safety.

[0139] In one feasible embodiment, the thrombus-driven system also includes an emergency service activation button 9 that communicates with a cloud server.

[0140] In this solution, while actively intervening in blood vessels through the cooperation of the magnetic field generator 2 and the stent structure 3, it also integrates with pre-hospital emergency care functions. Specifically, by setting an emergency service activation button 9, users can trigger a call to emergency service platforms such as hospitals to immediately call for emergency services and achieve linkage with rescue service platforms, aiming to provide bridging treatment that buys time. Users still need to be sent to the hospital for final professional diagnosis and treatment (such as coronary angiography, drug thrombolysis, or mechanical thrombectomy), ensuring the comprehensiveness, rationality, and reliability of the overall process of thrombosis treatment, and further guaranteeing the timeliness, experience, and safety of user treatment.

[0141] Under the guidance of a doctor, users can use this thrombus-driving system regularly for short-term, low-intensity preventive treatment during the high-risk period for thrombosis after surgery (such as within 1 month after surgery) to further effectively reduce the risk of thrombosis.

[0142] Specifically, during the postoperative hospitalization observation period or upon discharge, doctors and other relevant personnel will provide users with an external unit of the thrombus-driven system and conduct usage training. If a user experiences sudden chest pain, they should immediately put on the vest, press the emergency switch 8, and then call a doctor or 120 (emergency services). During the operation of the vest, the internal stent structure 3 generates micro-vibrations at a frequency of 20kHz-50kHz, forming ultrasonic mechanical waves to intervene and treat the thrombus. Based on the ablation mechanism of the ultrasonic mechanical waves, the blood vessels are quickly cleared, blood flow is restored, and the user's life is saved. After the doctor arrives or the user is taken to the hospital, the cardiologist will determine whether further treatment is necessary based on the specific situation.

[0143] The working principle of the thrombus driving system in this embodiment is further explained below:

[0144] When the user presses the emergency switch 8, the power module 7 is turned on to supply power to the entire system, and all devices in the system immediately enter the working state.

[0145] Controller 1 generates a drive command to drive magnetic field generator 2 to generate an alternating magnetic field with the highest drive parameters within a preset safe range (but not exceeding the limit). The strongest working mode is used to urgently eliminate blood clots in order to save lives in an emergency.

[0146] Afterwards, controller 1 will drive magnetic field generator 2 to stop generating alternating magnetic field after a period of time (i.e., stop the magnetic field coil in magnetic field generator 2 from generating current). At this time, the alternating magnetic field disappears, and the magnetized stent structure 3 in the body loses power. However, due to the elastic resonance principle and motion inertia of the stent structure 3, it will still have a brief motion. This motion will in turn generate a changing magnetic field, which will be received by the magnetic field coil outside the body and sent to controller 1. Based on the range of the feedback signal (i.e. magnetic field strength signal), controller 1 determines whether the energy of the ultrasonic mechanical wave on the stent structure 3 in the body exceeds the preset safety range. If it does, it determines to adjust the target driving parameters for the next working cycle, adjusts and re-outputs the required frequency and current intensity to reduce the magnetic field energy of the alternating magnetic field, and enters the next working cycle for thrombosis intervention.

[0147] During each work cycle, the frequency and intensity of the alternating magnetic field can be displayed on the screen. While the user is waiting for the doctor, if they feel that the embolism has been cleared or greatly relieved, they can use the corresponding interactive operation to actively adjust the frequency and intensity of the alternating magnetic field to better adapt to their own feelings and achieve a better treatment effect. After the doctor arrives, they can also take over the operation buttons and other controls as needed to achieve a better and more timely thrombosis treatment effect.

[0148] In this embodiment, the stent structure 3 is transformed from a "passive support" into an "active treatment platform" that can be activated remotely from the outside, that is, an active treatment type stent structure 3 is proposed, which provides a brand-new design idea for solving thrombosis in the stent structure 3.

[0149] The system's processing involves remote drive via an external magnetic field, avoiding the introduction of wires or complex circuits into blood vessels and the risk of electrical signals interfering with the heart's own electrophysiological activity. The entire process is non-invasive and highly safe.

[0150] It fills a critical gap in pre-hospital emergency care, providing users with a feasible self-intervention method during the golden window period between the onset of illness and hospital admission, which can significantly reduce mortality and myocardial damage caused by treatment delays.

[0151] It can seamlessly integrate with the existing medical system, providing bridging treatments that buy time. It does not replace existing mature in-hospital emergency care programs, but rather creates conditions for them, demonstrating excellent compatibility and operability.

[0152] It provides users with a certain degree of proactive handling capability in emergency situations, allowing them to actively intervene in the treatment of thrombosis, which can greatly alleviate their postoperative anxiety and enhance their sense of security and user experience.

[0153] While specific embodiments of this disclosure have been described above, those skilled in the art should understand that these are merely illustrative examples, and the scope of protection of this disclosure is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of this disclosure, but all such changes and modifications fall within the scope of protection of this disclosure.

Claims

1. A thrombus-driven system, characterized in that, The thrombus driving system includes a controller, a magnetic field generator, and an implantable stent structure; the magnetic field generator is communicatively connected to the controller, and the magnetic field generator is located on the user's body surface and is matched to the position of the stent structure implanted in the body; The support structure is tubular and is a magnetostrictive mesh structure. The controller is used to generate a first drive command and send it to the magnetic field generator; The magnetic field generator is used to generate an alternating magnetic field with target driving parameters according to the first driving command. The alternating magnetic field drives the stent structure to undergo periodic deformation, and the ultrasonic mechanical wave generated by the periodic deformation intervenes in the thrombus in the blood vessel. The target portion of the mesh structure is a magnetostrictive structure; The target part is a portion or the entire structure of the mesh structure; Different magnetic units are formed at each grid intersection point in the target portion after magnetization, so as to undergo mechanical vibration under the action of the alternating magnetic field and generate the ultrasonic mechanical wave for intervening in the treatment of thrombi in blood vessels; The controller is used to generate a third driving command and send it to the magnetic field generator after a first preset time of thrombosis intervention based on the first driving command. The magnetic field generator is used to stop generating an alternating magnetic field according to the third driving command; The thrombus driving system also includes a signal detection module that is communicatively connected to the controller; The signal detection module is used to detect the activity intensity signal of the magnetic unit formed on the magnetized support structure in the body during the intervention process or within a preset time period after the alternating magnetic field is stopped, and output it to the controller. The controller is used to generate a fourth driving command and send it to the magnetic field generator in response to the activity intensity signal exceeding a preset intensity range. The magnetic field generator is used to generate an alternating magnetic field with new target driving parameters according to the fourth driving command, so as to drive the stent structure to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave generated by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

2. The thrombus-driven system as described in claim 1, characterized in that, The target portion is formed using a biocompatible magnetostrictive material; or, the surface of the target portion is provided with a first material layer, which is formed using a biocompatible magnetostrictive material.

3. The thrombus-driven system as described in claim 1, characterized in that, When the target part is a portion of the mesh structure, the remaining structure in the mesh structure other than the target part is formed using a biocompatible alloy material.

4. The thrombus-driven system as described in claim 1, characterized in that, The thrombus driving system also includes an interaction module that is communicatively connected to the controller; The interaction module is used to receive the user's first interaction operation, and the controller is used to generate the first driving instruction based on the first interaction operation. And / or, The interaction module is also used to receive a second interaction operation from the user, and the controller is used to generate a second driving instruction based on the second interaction operation. The magnetic field generator is used to generate an alternating magnetic field with new target driving parameters according to the second driving command, so as to drive the stent structure to undergo a new periodic deformation in the next working cycle, and the ultrasonic mechanical wave generated by the new periodic deformation to intervene and treat the thrombus in the blood vessel.

5. The thrombus-driven system as described in claim 4, characterized in that, The interaction module includes a user interface; The interaction module is also used to select different preset working modes; wherein, different preset working modes trigger the magnetic field generator to generate different magnetic field intensities.

6. The thrombus-driven system as described in claim 1, characterized in that, The thrombus driving system also includes a status indication module that is communicatively connected to the controller; The status indication module is used to receive the status display drive command sent by the controller and output the corresponding status indication signal.

7. The thrombus-driven system according to any one of claims 1-6, characterized in that, The thrombus driving system also includes a power module, which is used to supply power to the thrombus driving system. And / or, The thrombus driving system also includes an emergency switch that is communicatively connected to the controller; And / or, The thrombus-driven system also includes an emergency service activation button that communicates with a cloud server.

8. The thrombus-driven system as described in any one of claims 1-6, characterized in that, The magnetic field generator includes a wearable vest or pad; And / or, The expansion and contraction direction of the mesh structure is along the direction of the blood vessel or perpendicular to the direction of the blood vessel.

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