Wearable magnetic guide lung targeted therapy vest

Abstract

The invention belongs to the technical field of medical instruments, and provides a wearable magnetic guide lung targeted therapy vest aiming at the problems that a current lung disease targeted therapy method cannot cover diseases without clear targets, is lack of universality and has no capability of actively orienting a drug to a certain organ or part to migrate, and the wearable magnetic guide lung targeted therapy vest comprises a therapy vest body, the treatment vest body is in a waistcoat shape, a plurality of flexible magnetic pole pieces are movably arranged in the treatment vest body at intervals in the circumferential direction, and the flexible magnetic pole pieces form a cylindrical Halbach array structure. The magnetic field array is designed based on the lung anatomical features, can cover the double-lung alveolar area, is suitable for various scenes such as chronic lung diseases and acute injuries, and expands the targeting range and universality; in addition, directional migration and local high-concentration enrichment of drugs / cells are achieved through magnetic field guidance, the whole-body exposure amount is reduced, the treatment effect can be achieved under the low dosage, and the side effect risk is remarkably reduced.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a wearable magnetic guidance lung targeted treatment vest. BACKGROUND

[0002] At present, the targeted treatment of lung diseases (such as pulmonary fibrosis, COPD, lung cancer, etc.) mainly adopts traditional drug treatment and molecular targeted treatment; the traditional drug treatment usually adopts intravenous injection, local injection under bronchoscopy and inhalation; after the traditional stem cells or drugs are injected intravenously, they are difficult to effectively enrich in the lung lesion area due to systemic distribution, so only a small amount of them reaches the lung lesion after systemic circulation, resulting in low treatment efficiency, and only about 1%-5% of stem cells can home to lung tissue, so in order to improve the lung targeting effect, the dose needs to be increased to reach the treatment threshold, which increases the burden of liver, spleen and other organs, and causes non-specific inflammation or toxicity reaction, and the non-targeted cells or drugs may be retained in the liver, spleen and other organs, causing resource waste and potential risk. Although the local injection under bronchoscopy can improve the local concentration, it is an invasive operation, which has the risk of bleeding, infection and tissue damage, and it is difficult to cover the whole lung lesion, and its operation is relatively complex, which limits the clinical application scene. The inhalation of the atomization will make the drug easily deposited in the upper respiratory tract, the lung alveolar penetration rate is insufficient (particles with a particle size of >5 μm are difficult to reach the deep alveoli), and the targeted area cannot be accurately controlled.

[0003] The molecular targeted treatment depends on specific targets, for example, EGFR inhibitors are only suitable for lung cancer patients carrying EGFR mutations (about 15%-30% of non-small cell lung cancer), and cannot cover diseases without clear targets (such as idiopathic pulmonary fibrosis), and lack of universality. And it is a passive diffusion mechanism, that is, the drug passively diffuses to the lesion depending on the concentration gradient, without the ability to actively migrate to a certain organ or part, resulting in high dose requirement, significant systemic toxicity and limited treatment effect. SUMMARY

[0004] The purpose of the present application is to overcome the shortcomings of the prior art, and to provide a wearable magnetic guidance lung targeted treatment vest, which realizes the efficiency, safety and universality of lung targeted treatment.

[0005] To achieve the above purpose, the technical scheme adopted by the present application is: A wearable magnetic guiding lung targeted therapy vest comprises a therapy vest body, the therapy vest body is a waistcoat vest shape, a plurality of flexible magnetic pole pieces are movably arranged on the surface of the therapy vest body along the circumferential direction, and the plurality of flexible magnetic pole pieces form a cylindrical Halbach array structure. The cylindrical Halbach array formed by the plurality of flexible magnetic pole pieces realizes targeted enrichment: the strong magnetic field core area attracts magnetized drugs or cells (such as superparamagnetic iron oxide labeled stem cells), so that the drugs or cells are enriched at the lung lesion, and the peripheral magnetic field attenuation avoids non-specific adsorption to healthy tissues.

[0006] Preferably, each flexible magnetic pole piece is made of the following raw materials by weight fraction: 70-90 parts of samarium iron nitrogen magnetic powder, 8 parts of thermoplastic polyurethane elastomer powder, 3 parts of silicone thermoplastic elastomer, 1 part of coupling agent, 0.07 parts of lubricant, 7 parts of polypropylene glue powder and 0.07 parts of toughening agent.

[0007] Preferably, each flexible magnetic pole piece is in the form of an inner buckle tile structure, has a length of 20 cm, a width of 10 cm, a thickness of 0.5 cm and a curvature radius of 15-25 cm.

[0008] Preferably, the inner side area of the cylindrical Halbach array structure has a significantly enhanced and highly uniform magnetic field strength (fluctuation < 5%) to form a strong magnetic field core area (such as the lung lesion) required for targeted therapy; the outer side area of the cylindrical Halbach array structure has a rapidly attenuated magnetic field strength with an attenuation rate > 30%, thereby reducing the interference with non-target tissues.

[0009] Preferably, the therapy vest body comprises an elastic fabric and an inner lining arranged on the inner side of the elastic fabric, and the plurality of flexible magnetic pole pieces are movably arranged on the surface of the elastic fabric. The elastic fabric is made of 80% by mass of nylon and 20% by mass of spandex. The inner lining is made of antibacterial cotton.

[0010] Compared with the prior art, the present application has the following beneficial effects: (1) The wearable magnetic guiding lung targeted therapy vest provided by the present application can realize the directional enrichment of stem cells or drugs to the lung through the body surface magnetic field, without the need for implanting a device in the body, thereby avoiding the problems of bleeding, tissue damage and infection risk caused by the implanted device; (2) The present application designs a magnetic field array based on the anatomical features of the lung, which can cover the alveolar region of both lungs, is suitable for various scenes such as chronic lung disease and acute injury, expands the targeted range and universality, and solves the problems of the molecular targeted therapy mode depending on specific target points, being unable to cover diseases without clear target points and lacking universality; (3) The present application realizes the directional migration and local high-concentration enrichment of drugs / cells through magnetic field guidance, reduces the whole-body exposure amount, and achieves the treatment effect at a low dose, thereby significantly reducing the risk of side effects. BRIEF DESCRIPTION OF DRAWINGS

[0011] Figure 1 A structure schematic diagram of the wearable magnetic guidance lung targeted treatment vest provided by the embodiment of the present application is provided; Figure 2 A local enlarged schematic diagram of part A in the figure is provided; Figure 3 A magnetizing direction diagram of the plurality of flexible magnetic pole pieces is provided; Figure 4 A chest cavity and a magnetic field direction diagram generated by the wearable magnetic guidance lung targeted treatment vest provided by the embodiment of the present application are provided; Figure 5 A live imaging comparison diagram of the magnetic stem cell group and the traditional stem cell group mice is provided; wherein (a) is the magnetic stem cell group; (b) is the traditional stem cell group; 1, the treatment vest body; 2, the flexible magnetic pole piece; 3, the magic tape hair surface; 4, the magic tape hook surface; DETAILED DESCRIPTION

[0012] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings. Figures 1 to 5 The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings.

[0013] As Figure 1 and Figure 2As shown, the embodiment of the present application provides a wearable magnetic guidance lung targeted therapy vest, which comprises a treatment vest body 1, the treatment vest body 1 is a vest shape, and a plurality of flexible magnetic pole pieces 2 are movably arranged on the surface of the treatment vest body 1 along the circumferential direction. In the embodiment of the present application, the treatment vest body 1 comprises an elastic fabric and an inner lining arranged on the inner side of the elastic fabric, and the plurality of flexible magnetic pole pieces 2 are movably arranged on the surface of the elastic fabric. The elastic fabric is made of 80% by mass of nylon and 20% by mass of spandex. The material of the inner lining is antibacterial cotton. The number of the flexible magnetic pole pieces 2 in the embodiment of the present application is preferably 12; in the specific design, the surface of the elastic fabric is provided with a magic tape rough surface 3, the side of the flexible magnetic pole piece 2 close to the elastic fabric is provided with a magic tape hook surface 4, the flexible magnetic pole piece 2 is bonded with the magic tape hook surface 4 and the magic tape rough surface 3 through the magic tape hook surface 4, and the surface of the flexible magnetic pole piece 2 and the elastic fabric are connected. Through the design of the magic tape hook surface 4 and the magic tape rough surface 3, the position and angle of the flexible magnetic pole piece 2 can be flexibly adjusted.

[0014] The plurality of flexible magnetic pole pieces 2 form a cylindrical Halbach array structure, so that the magnetic field coverage range can accurately match the double lung anatomical region, and interference to the heart and other organs is avoided. The cylindrical Halbach array formed by the plurality of flexible magnetic pole pieces 2 realizes targeted enrichment: the strong magnetic field core area attracts magnetized drugs or cells (such as superparamagnetic iron oxide labeled stem cells), so that they are enriched at the lung lesion, and the peripheral magnetic field attenuation avoids non-specific adsorption to healthy tissues. The total weight of the wearable magnetic guidance lung targeted therapy vest provided by the embodiment of the present application is <300 g, the thickness is <5 mm, and the elongation rate is ≥50% (the fitting human body curvature radius is ≥50 mm).

[0015] As shown in the figure, Figure 4 The magnetic field formed by the plurality of flexible magnetic pole pieces 2 is distributed along the cylindrical axis direction, the penetration depth is ≥8 cm, and the chest wall thickness (5-10 cm) is adapted. The magnetic field strength is specifically 50-100 mT at the target area, which can be adjusted according to the magnetic pole material and driving current; the cylindrical Halbach array formed makes the magnetic force lines radially distributed to both sides, forms a uniform directional magnetic field, and enhances the enrichment of magnetic drugs / cells to the lung lobes.

[0016] The embodiment of the present application can allow local magnetic pole angle fine adjustment through the interval and movable design of the plurality of flexible magnetic pole pieces 2, i.e., the segmented movable design of the plurality of flexible magnetic pole pieces 2, control the intensity distribution and uniformity of the magnetic field in the target point area (such as a lung lesion) by adjusting the angle, axial position and relative position of each flexible magnetic pole piece 2 in the array, and individualize the optimization of the magnetic field distribution. Specifically, each flexible magnetic pole piece 2 is removed from the surface of the elastic fabric, and then independently rotated by a certain angle θ or translated by a certain displacement d, so as to dynamically change the magnetic field line density and direction. Specifically, by rotating each flexible magnetic pole piece 2, the angle θ thereof is adjusted, so as to change the magnetization direction of the single segment magnetic pole and control the local magnetic field focusing or diffusion. By translating each flexible magnetic pole piece 2, the position d thereof is adjusted, so as to adjust the magnetic field penetration depth and coverage. After the angle and axial position of each flexible magnetic pole piece 2 are adjusted, the surface of the flexible magnetic pole piece 2 is fixed to the elastic fabric through the adhesion of the hook surface 4 of the magic tape attached thereto and the loop surface 3 of the magic tape arranged on the surface of the elastic fabric.

[0017] In the embodiment of the present application, each flexible magnetic pole piece 2 is made of the following raw materials by weight fraction: 70-90 parts of samarium iron nitride magnetic powder, 8 parts of thermoplastic polyurethane elastomer powder, 3 parts of organic silicon thermoplastic elastomer, 1 part of coupling agent, 0.07 parts of lubricant, 7 parts of polypropylene glue powder, and 0.07 parts of toughening agent.

[0018] In the embodiment, the coupling agent is a silane coupling agent, and the lubricant is zinc stearate. The above raw materials can be obtained on the market.

[0019] In the specific design, the samarium iron nitride magnetic powder is preferably 80 parts, and the flexible magnetic pole piece 2 is specifically made of the above components and prepared by the existing injection molding process. The flexible magnetic pole piece obtained by the cooperation and design of the above components and proportions can achieve the required magnetic field strength and magnetic distribution of the present application.

[0020] In the embodiment of the present application, each flexible magnetic pole piece 2 is in the form of an inner buckle tile structure, with a length of 20 cm, a width of 10 cm, a thickness of 0.5 cm, and a curvature radius of 15-25 cm. By designing the curvature radius to be 15-25 cm, the thoracic curvature can be adapted.

[0021] In the embodiment of the present application, based on the structure of the cylindrical Halbach array structure, the inner side area of the cylindrical Halbach array structure is significantly enhanced and highly uniform (fluctuation < 5%), forming a strong magnetic field core area (such as a lung lesion) required for targeted therapy; the outer side area of the cylindrical Halbach array structure has a rapid decay of magnetic field strength, with a decay rate > 30%, reducing the interference with non-target tissues.

[0022] The penetration depth of the magnetic field generated by the plurality of flexible magnetic pole pieces 2 can specifically reach: in the lung area (depth ≥ 5 cm), the magnetic field strength ≥ 0.5T (decay rate < 20%); the outer side area approaches the ambient magnetic field level. The magnetizing direction of the plurality of flexible magnetic pole pieces 2 provided in the embodiment of the present application is as shown in Figure 3 .

[0023] The therapeutic effect of the wearable magnetic guidance lung targeted therapy vest provided in the embodiment of the present application is studied through animal experiments The human mesenchymal stem cells (hMSCs) are labeled with magnetic nanoparticles, specifically by co-incubating the hMSCs with superparamagnetic iron oxide nanoparticles (SPIONs) for 24 hours to obtain the magnetic stem cells.

[0024] 1. Animal model and grouping (1) Model construction A C57BL / 6 mouse model of pulmonary fibrosis is induced by intratracheal instillation of bleomycin (Bleomycin, 3-5 mg / kg) (n=12). Treatment is started on the 7th day after modeling (at this time, the inflammation peak shifts to fibrosis).

[0025] (2) Grouping design, the specific design conditions are shown in Table 1, and n=6 in each group.

[0026] Table 1: Mouse grouping design table

[0027] After the magnetic stem cell mice are anesthetized, they are fixed on a customized bracket, and the magnetic guidance lung targeted therapy vest provided in the embodiment of the present application is worn. The vest tightness is adjusted according to the size of the mouse, and the position and angle of the plurality of flexible magnetic pole pieces 2 are adjusted. Specifically, the position of the fibrosis lesion is located in combination with CT images, the position and angle of the plurality of flexible magnetic pole pieces 2 are adjusted for the fibrosis lesion, the plurality of flexible magnetic pole pieces 2 form a cylindrical Halbach array structure, and the Halbach array parameters (adjusted according to the depth of the mouse lung tissue) are set as follows: surface magnetic field 0.05T, array inner diameter 2 cm, and focusing depth 1 cm.

[0028] Then, 1×10 6 magnetic stem cells are injected into the tail vein, and the magnetic field is maintained for 2 hours.

[0029] Experimental results By Figure 5 The lung fluorescence intensity of the magnetic stem cell group mice was significantly focused, the lung stem cell enrichment amount was 5 times that of the traditional stem cell group, and the liver and spleen retention amount was reduced by 70%. After 4 weeks of treatment, the alveolar structure repair rate of the pulmonary fibrosis model mice was increased by 40%, the blood oxygen saturation was restored from 85% to 95%. Moreover, no lung inflammation or liver function abnormalities (normal ALT and AST levels) were observed.

[0030] In summary, the embodiment of the present application integrates a plurality of flexible magnetic pole pieces on the vest, guides the directional migration of drugs / stem cells through the body surface gradient magnetic field, and breaks through the infection risk limit of the traditional implantable device. Moreover, the arrangement of a plurality of flexible magnetic pole pieces is designed based on the double lung anatomy, and the magnetic field radiation direction is designed to simulate the lung blood flow path (such as the pulmonary artery branch), so as to realize full lung area coverage. By adjusting the angle and position of the plurality of flexible magnetic pole pieces, different diseases (such as lung tip tumors and lung bottom fibrosis) can be adapted, and the limitation of the prior art to only specific lesions is broken through. Animal experiments show that the lung stem cell enrichment amount is increased by 5 times after wearing the vest provided by the embodiment of the present application, the alveolar repair rate is increased by 40%, and there is no wearing-related adverse reaction.

[0031] Although the embodiments of the present application have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, replacements and variations can be made to these embodiments without departing from the principles and purposes of the present application, and the scope of the present application is defined by the claims and their equivalents.

Claims

1. A wearable magnetically guided lung targeted therapy vest, characterized in that: It includes a treatment vest body, which is in the shape of a vest. A plurality of flexible magnetic pole pieces are arranged on the surface of the treatment vest body at intervals along the circumferential direction, and the plurality of flexible magnetic pole pieces form a cylindrical Halbach array structure.

2. A wearable magnetically guided lung targeted therapy vest according to claim 1, characterized in that: Each flexible magnetic pole piece is made of the following raw materials in parts by weight: 70-90 parts of samarium iron nitrogen magnetic powder, 8 parts of thermoplastic polyurethane elastomer powder, 3 parts of silicone thermoplastic elastomer, 1 part of coupling agent, 0.07 parts of lubricant, 7 parts of polypropylene glue powder, and 0.07 parts of toughening agent.

3. A wearable magnetically guided lung targeted therapy vest according to claim 1, characterized in that: Each flexible magnetic pole piece is an inward-buckling tile-like structure with a length of 20 cm, a width of 10 cm, a thickness of 0.5 cm, and a curvature radius of 15-25 cm.

4. The wearable magnetically guided lung targeted therapy vest according to claim 1, characterized in that: In the inner area of ​​the cylindrical Halbach array structure, the magnetic field strength is significantly enhanced and highly uniform, forming a strong magnetic field core area required for targeted therapy; in the outer area of ​​the cylindrical Halbach array structure, the magnetic field strength decays rapidly, with a decay rate of >30%.

5. The wearable magnetically guided lung targeted therapy vest according to claim 1, characterized in that: The therapeutic vest body comprises an elastic fabric and an inner lining arranged on the inner side of the elastic fabric, and a plurality of flexible magnetic pole pieces are movably arranged on the surface of the elastic fabric.

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