Magnetic thin film robot and preparation method therefor

Abstract

Provided is a magnetic thin film robot, which comprises a cardiac outer wrapping film module and a control module connected to each other. The cardiac outer wrapping film module comprises a non-magnetic supporting part and a magnetic driving part, and the non-magnetic supporting part and the magnetic driving part are mutually coupled. The control module comprises a patch-type magnetic field generator and a power supply assembly connected to each other, and the magnetic field generator in vitro corresponds to the magnetic driving part in vivo in terms of space. A magnetic field is generated through the control module, and the magnetic field drives the cardiac outer wrapping film module to provide heart failure assistance.

Description

A magnetic film robot and its preparation method Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular relates to a magnetic thin film robot and a preparation method thereof. Background Art

[0002] Heart failure, a complex clinical syndrome, can be caused by any structural or functional heart disease that impairs the heart's ability to fill or eject blood, affecting approximately 26 million people worldwide. According to the World Health Organization (WHO) and other relevant research institutions, left ventricular dysfunction is the most common cause of heart failure, accounting for approximately 60% to 70% of heart failure patients. Right ventricular dysfunction and biventricular dysfunction each account for smaller proportions, approximately 10% to 20%.

[0003] Currently, common treatments for heart failure include medication, heart transplantation, and ventricular assist devices (VADs). While medication can help control symptoms, it often carries significant side effects, such as hypotension and renal impairment, and is prone to drug resistance. Heart transplantation is the most effective treatment, but its clinical application is limited by a shortage of donors. VADs are commonly used as a bridge to transplantation or definitive treatment for patients with end-stage heart failure. Existing mechanical devices, invasive and in contact with the heart and bloodstream, are often associated with postoperative complications such as bleeding, infection, and thrombosis / stroke, resulting in a high two-year mortality rate. The few cutting-edge non-invasive approaches often involve full ventricular assist, which involves the normally healthy right ventricle. Therefore, there is an urgent clinical need for non-invasive, left ventricular assist devices. A magnetic thin-film robot, designed for heart failure assistance, is a device that can restore systolic and diastolic pumping function in patients with heart failure. It does not come into direct contact with the bloodstream and is non-invasive. Its structural design provides a stronger compression effect on the single left ventricle, minimizing interference with normal areas. It offers advantages such as fewer complications and individualized design, making it more suitable for clinical application.

[0004] Existing non-invasive ventricular assist devices often use full ventricular wrapping technology. During the treatment of heart failure, they often affect the normal right ventricle, increasing interference with normal areas and easily causing complications.

[0005] Summary of the Invention

[0006] 1. Technical problems to be solved

[0007] Since existing non-invasive ventricular assist devices often use full ventricular wrapping technology, during the treatment of heart failure, the normal right ventricle is often affected, which increases interference with normal areas and is prone to complications. This application provides a magnetic thin film robot and a preparation method thereof.

[0008] 2. Technical solution

[0009] In order to achieve the above-mentioned purpose, the present application provides a magnetic thin film robot, including a cardiac outer wrapping membrane module and a control module connected to each other, the cardiac outer wrapping membrane module including a non-magnetic support part and a magnetic drive part, the non-magnetic support part and the magnetic drive part are coupled to each other, the control module includes a magnetic field generator and a power supply assembly connected to each other, the external magnetic field generator corresponds to the internal magnetic drive part in space, the magnetic field is generated by the control module, and the magnetic field drives the cardiac outer wrapping membrane module to realize the heart failure assistance function.

[0010] Another embodiment provided by the present application is: the non-magnetic support part is a silicone film, and the magnetic drive part is made of a magnetic material. By using a frequency magnetic field, the magnetic drive part is caused to undergo controllable deformation, so that the cardiac outer membrane module assists the heart in completing controllable differential contraction and relaxation movements of the left and right ventricles.

[0011] Another embodiment provided by the present application is that the magnetic material is composed of a liquid silicone rubber base material, a platinum catalyst and magnetic powder, and the mass fraction ratio of the liquid silicone rubber base material: the platinum catalyst: the magnetic powder is 3:3:4.

[0012] Another embodiment provided by the present application is that the magnetic field generator includes a spatial frequency magnetic field model, a magnetic drive magnetization model and a magnetic drive force model.

[0013] Another embodiment provided by this application is: the spatial frequency magnetic field model is

[0014] Where B is the magnetic field generated by the drive module, μ0 is the magnetic permeability of the air, r is the vector of the coordinates of the center of the magnetic generator pointing to the coordinate position of the spatial point where the magnetic field is to be calculated, I is the unit matrix, and M p is the maximum magnetic moment at the magnetic field generator end, and k is used as an adjustment parameter to control the actual working magnetic moment of the magnetic field.

[0015] Another embodiment provided by the present application is: the magnetic drive magnetization model is: M s =m

[0016] Among them, M s is the magnetization curve of the driver, m represents the magnetization intensity of the magnetic field, and since the magnetization is the expanded plane magnetization, the magnetic induction of each unit in the expanded structure has the same magnitude and direction.

[0017] Another embodiment provided by the present application is that the torque and force expressions of the driver in the magnetic drive force model are as follows:

[0018] in,

[0019] Since the magnetic field is uniform,

[0020] That is, the magnetic field force F=0, and the external drive depends on the magnetic torque T.

[0021] Another embodiment provided by the present application is that the non-magnetic support portion includes a left ventricular portion and a right ventricular portion, and the magnetic drive portion is arranged in the left ventricular portion and / or the right ventricular portion.

[0022] The present application also provides a method for preparing the magnetic film robot, which includes design and manufacturing. Among them, the design link mainly includes two modules: mathematical modeling and mathematical optimization calculation: first, a mathematical model is constructed according to the application scenario, the outer wrapping surface of the ventricle is used as the design area, and the specific assistance of heart contraction is used as the design requirement; then, mathematical optimization calculation is performed according to the model to obtain the optimal design result of the required magnetic film. After obtaining the design result, manufacturing is carried out: according to the optimal design result, the magnetic material is taken in proportion and injected into the first mold for solidification, the solidified magnetic material is taken out, the solidified magnetic material is magnetized in the vertical direction, the magnetized magnetic material is cut, and the cut magnetic material is placed in the second mold for non-magnetic material casting to obtain the heart outer wrapping membrane, and the heart outer wrapping membrane is further subjected to three-dimensional bonding treatment to obtain a three-dimensional structure of the heart outer wrapping membrane.

[0023] Another embodiment provided by the present application is: the thickness of the first mold is 2 mm; the vertical magnetization adopts 840 mT; and the casting uses silicone material as the base. 3. Beneficial effects

[0024] Compared with the prior art, the magnetic film robot and its preparation method provided by this application have the following advantages:

[0025] The magnetic film robot provided in this application is a magnetic film robot used for auxiliary treatment of heart failure. It does not come into direct contact with blood and does not invade the heart. Its structural design targets the differential squeezing of the left and right ventricles, increasing the effect on the left ventricle and reducing interference with the normally normal right ventricle.

[0026] The magnetic film robot provided in this application is a magnetic film robot made of silica gel and magnetic particles and is used for auxiliary treatment of heart failure.

[0027] The magnetic film robot provided in this application is based on the function of assisting treatment of heart failure, and its design process is different from the mechanical invasive type (serious damage) used in the existing market or the pneumatic non-invasive type (bulky structure and slow response) used in some studies. This application adopts magnetically controlled non-invasive method to achieve heart failure assistance.

[0028] The magnetic film robot provided in this application takes into account the different force characteristics of the left and right ventricles. It can specifically assist the left ventricle in assisting left ventricular heart failure, reduce interference with the normal right ventricle, and reduce the chance of side effects or sequelae. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG1 is a schematic diagram of the design process of the magnetic film robot of the present application;

[0030] FIG2 is a schematic diagram of the magnetic film robot of the present application;

[0031] FIG3 is a schematic diagram of the magnetic film robot preparation process of the present application;

[0032] FIG4 is a schematic diagram of the magnetic film robot test of the present application. DETAILED DESCRIPTION

[0033] Hereinafter, specific embodiments of the present application will be described in detail with reference to the accompanying drawings. Based on these detailed descriptions, those skilled in the art will be able to clearly understand the present application and implement the present application. Without violating the principles of the present application, the features of different embodiments may be combined to obtain new implementations, or certain features of certain embodiments may be substituted to obtain other preferred implementations.

[0034] Referring to Figures 1 to 4, the present application provides a magnetic thin film robot, comprising an interconnected cardiac exosome module and a control module, wherein the cardiac exosome module comprises a non-magnetic support portion and a magnetic drive portion, wherein the non-magnetic support portion and the magnetic drive portion are coupled to each other, and the control module comprises an interconnected magnetic field generator and a power supply assembly, wherein the external magnetic field generator corresponds spatially to the internal magnetic drive portion, and a magnetic field is generated by the control module, and the magnetic field drives the cardiac exosome module to realize a heart failure assist function.

[0035] The implementation process can be summarized as an external control module generating a magnetic field, which drives the outer membrane of the heart inside the body to achieve specific movement goals. The specific process is as follows: the outer membrane of the heart inside the body is tightly attached to the heart. The membrane has magnetic and non-magnetic parts. The magnetic part will generate magnetic force or magnetic moment when it is subjected to the magnetic field, while the non-magnetic part will not generate magnetic force or magnetic moment. The external control module mainly consists of an external patch-type magnetic field generator and a power supply. The patch-type magnetic field generator is attached to the surface of the human skin (aligned with the heart). Once the power supply is supplied, it can generate the required magnetic field. The magnetic field drives the outer membrane of the heart inside the body to deform, thereby achieving the compression function of the heart.

[0036] Furthermore, the non-magnetic support part is a silicone film, and the magnetic drive part is made of a magnetic material. By using a frequency magnetic field, the magnetic drive part is controllably deformed, so that the cardiac outer membrane module assists the heart in completing controllable differential contraction and relaxation movements of the left and right ventricles.

[0037] Furthermore, the non-magnetic support portion includes a left ventricular portion and a right ventricular portion, and the magnetic driving portion is arranged in the left ventricular portion and / or the right ventricular portion.

[0038] Depending on specific needs, the left ventricle or the right ventricle can be assisted, or both the left and right ventricles can be assisted at the same time. When treating patients with left heart failure, the magnetic driving material in the structure of the magnetic film will be concentrated in the corresponding part of the left ventricle, and the right ventricle only needs to play a fixing role. Therefore, the frequency magnetic field will drive the magnetic film to undergo differential deformation (the corresponding part of the left ventricle produces a large deformation, and the corresponding part of the right ventricle has only a small deformation), thereby assisting the left ventricle to contract and relax, and reducing interference with the normal right ventricular function.

[0039] Furthermore, the magnetic material consists of Ecoflex00-10 component A (liquid silicone rubber base), component B (platinum catalyst) and magnetic powder YMM15-9-300 mesh 50 microns, and the mass fraction ratio of Ecoflex00-10 component A: component B: magnetic powder YMM15-9-300 mesh 50 microns is 3:3:4.

[0040] The present application also provides a method for preparing the magnetic film robot, which includes constructing a mathematical model according to an application scenario, taking the outer wrapping surface of the ventricle as the design area, and specifically assisting heart contraction as a design requirement; performing mathematical optimization calculations according to the model to obtain the required optimal design result of the magnetic film; taking the magnetic material in proportion according to the optimal design result and injecting it into a first mold for solidification, taking out the solidified magnetic material, magnetizing the solidified magnetic material in a vertical direction, cutting the magnetized magnetic material, placing the cut magnetic material into a second mold for casting non-magnetic material to obtain a cardiac outer wrapping membrane, and further performing three-dimensional bonding treatment on the cardiac outer wrapping membrane to obtain a cardiac outer wrapping membrane with a three-dimensional structure.

[0041] Specifically, mathematical modeling is performed based on the left heart failure application scenario, with the ventricular outer wrapping surface as the design area and specific assistance to left ventricular contraction as the design requirement. Mathematical optimization calculations are performed based on these design requirements to obtain the optimal design result of the desired magnetic film. According to the optimal design result, the magnetic material is proportionally injected into a first mold for solidification. The solidified magnetic material is removed and magnetized in a vertical direction. The magnetized magnetic material is cut and placed into a second mold for casting with non-magnetic material to obtain the cardiac outer wrapping membrane. The cardiac outer wrapping membrane is further subjected to a three-dimensional bonding process to obtain a cardiac outer wrapping membrane with a three-dimensional structure.

[0042] The modeling and design process for this application utilizes an optimization calculation method, using the specific deformation of the left ventricle of the magnetic thin-film robot as the optimization target, the volume fraction of the magnetic material in the entire structure as the optimization constraint, and the distribution of the magnetic material as the design variable. This iterative optimization calculation is performed. After multiple iterations, the optimal distribution of the magnetic material is obtained, which is the design of the magnetic thin-film robot required for this application.

[0043] The design process of the magnetic film robot is different from the common bionic design or empirical design of the whole ventricle indiscriminate squeezing. It is designed according to a precise calculation method. Figure 1 is a schematic diagram of the design problem of the magnetic film robot for auxiliary treatment of heart failure in this application (designed according to the diastole and contraction requirements of the heart). The dark part is the magnetic drive part, and the light part is the non-magnetic support part. By applying a frequency magnetic field, the drive part undergoes controllable deformation, so that the entire film assists the heart to complete controllable differential contraction and relaxation movements of the left and right ventricles.

[0044] During the design calculation process, the left ventricular ejection fraction ≥ 30 mmHg was used as the design target, and the optimal design result is shown in Figure 2.

[0045] Specifically, a) preparing magnetic materials (mass fraction ratio of Ecoflex00-10 component A: component B: magnetic powder YMM15-9-300 mesh 50 μm = 3:3:4);

[0046] b) Inject into a 2mm thick mold and solidify;

[0047] c) removing the solidified magnetic material from the mold;

[0048] d) magnetizing the magnetic material at 840 mT in the vertical direction;

[0049] e) Precisely cut the magnetic material into the optimal designed shape;

[0050] f) placing it back into the ventricular expansion mold according to the optimally designed specific position and casting it with Ecoflex00-30 as the base;

[0051] g) taking out the solidified heart membrane and unfolding the structure;

[0052] h) Use silicone rubber glue to stick and seal the unfolded result to form a three-dimensional structure.

[0053] This structure can be produced in batches and repeatedly through molds.

[0054] The magnetic film robotic control system designed in this application for assistive treatment of heart failure primarily uses a frequency magnetic field to deform the magnetic portion of the magnetized cardiac membrane, thereby assisting the heart in completing its contraction and relaxation movements. Therefore, this application requires the construction of a spatial frequency magnetic field model, a magnetically driven magnetization scheme, and a magnetically driven force model. These three models are established as follows:

[0055] a) Spatial frequency magnetic field model:

[0056] The magnetic field generated by the driver module can be calculated using the following formula:

[0057] Where μ0 is the magnetic permeability of air, r is the coordinate of the center of the magnetic generator pointing to the coordinate position of the space point where the magnetic field is to be calculated.

[0058] vector, I is the identity matrix, M p is the maximum magnetic moment at the magnetic field generator end, and k is used as a regulating parameter to control the actual magnetic field.

[0059] The working magnetic moment (k = 0 when kM p is 0, kM when k=1 p =M p ).

[0060] b) Magnetic drive magnetization scheme:

[0061] Regarding the magnetization process, since the magnetic particles are soft magnetic, the internal magnetization direction changes under the action of a large magnetic field, and the residual magnetic field strength is small, it is not easy to produce a permanent magnet. s is the magnetization curve of the driver, and its formula is: s =m

[0062] Among them, m represents the magnetization intensity of the magnetic field, and since the magnetization is the unfolded plane magnetization, the units in the unfolded structure

[0063] The magnitude and direction of the magnetic induction are the same, and the internal magnetization structure is shown in Figure 3-d.

[0064] c) Magnetic drive force model:

[0065] In the magnetic field, the torque and force expressions of the driver are as follows:

[0066] in,

[0067] Since the magnetic field used in this application is a uniform magnetic field,

[0068] That is, the magnetic field force F=0, and the external drive depends on the magnetic torque T.

[0069] In summary, based on the aforementioned drive model, this application uses a directional frequency magnetic field to manipulate a thin-film magnetic robot to achieve targeted contraction and relaxation movements. Actual test results also demonstrate that, with the assistance of magnetic drive, the thin-film magnetic robot can achieve the desired function.

[0070] The magnetic thin film robot of the present application is designed not to come into direct contact with blood, and has the advantages of being non-invasive to the heart and having fewer complications; the design adopts the differential effects of the left and right ventricles to reduce damage to the normal parts; it is driven by an extracorporeal magnetic field, making the system more compact and responsive; it is made of pure soft materials, has a soft material, is safer in contact with biological tissues, and is more suitable for clinical applications.

[0071] Although the present application has been described above with reference to specific embodiments, it should be understood by those skilled in the art that many modifications may be made to the configurations and details disclosed herein within the principles and scope of the present application. The scope of protection of the present application is determined by the appended claims, and the claims are intended to cover all modifications encompassed by the literal meaning or scope of equivalents of the technical features in the claims.

Claims

1. A magnetic thin film robot, characterized in that: It includes an extracardiac envelope module and a control module that are interconnected. The extracardiac envelope module includes a non-magnetic support part and a magnetic drive part, and the non-magnetic support part is coupled with the magnetic drive part. The control module includes a magnetic field generator and a power supply component that are interconnected. The magnetic field generator corresponds to the magnetic drive part in spatial position. By generating a magnetic field through the control module, the magnetic field drives the extracardiac envelope module to achieve the heart failure assistance function.

2. The magnetic thin film robot according to claim 1, wherein: The non-magnetic support part is a silica gel film, and the magnetic drive part is made of a magnetic material. By using a frequency magnetic field, the magnetic drive part undergoes controllable deformation, so that the extracardiac envelope module assists the heart to complete controllable left and right ventricular differential contraction and relaxation movements.

3. The magnetic thin-film robot according to claim 2, wherein: The magnetic material consists of a liquid silicone rubber base material, a platinum catalyst, and magnetic powder. The mass fraction ratio of the liquid silicone rubber base material: the platinum catalyst: the magnetic powder is 3:3:

4.

4. The magnetic thin-film robot according to claim 1, wherein: The magnetic field generator includes a spatial frequency magnetic field model, a magnetic drive magnetization model, and a magnetic drive force model.

5. The magnetic thin film robot according to claim 4, wherein: The spatial frequency magnetic field model is Among them, B is the magnetic field generated by the drive module, μ0 is the magnetic permeability of air, r is the vector from the coordinate of the center of the magnetic generator to the coordinate position of the spatial point where the magnetic field is to be calculated, I is the unit matrix, Mp is the maximum magnetic moment at the end of the magnetic field generator, and k is an adjustment parameter used to control the actual working magnetic moment of the magnetic field.

6. The magnetic thin film robot according to claim 4, wherein: The magnetic drive magnetization model is: Ms = m Among them, M s is the magnetization curve of the driver, m represents the magnetization intensity of the magnetic field, and since the magnetization is planar magnetization, the magnitude and direction of the magnetic induction of each unit in the unfolded structure are the same.

7. The magnetic thin film robot according to claim 4, characterized in that: In the magnetic drive force model described above, the expressions for the torque and force acting on the driver are as follows: Among them, Since the magnetic field is a uniform magnetic field, therefore That is, the magnetic force F = 0, and the external drive depends on the magnetic torque T.

8. The magnetic thin film robot according to claim 1, characterized in that: The non-magnetic support part includes a left ventricle part and a right ventricle part, and the magnetic drive part is arranged in the left ventricle part or / and the right ventricle part.

9. A method for preparing a magnetic thin film robot according to any one of claims 1 to 8, characterized in that: The method includes constructing a mathematical model according to the application scenario, taking the extracardiac surface as the design area, and specific heart contraction assistance as the design requirement; performing mathematical optimization calculation according to the model to obtain the optimal design result of the required magnetic film; taking the magnetic material according to the optimal design result in proportion and injecting it into the first mold for solidification, taking out the solidified magnetic material, magnetizing the solidified magnetic material in the vertical direction, cutting the magnetized magnetic material, putting the cut magnetic material into the second mold for pouring with non-magnetic material to obtain the extracardiac envelope, and performing further three-dimensional bonding treatment on the extracardiac envelope to obtain a three-dimensional extracardiac envelope.

10. The method for preparing a magnetic thin film robot according to claim 9, wherein: The thickness of the first mold is 2 mm; the vertical magnetization is 840 mT; the pouring is based on a silica gel material.

Images