A pre-strained magnetic driving microspike device, a microspike system and a pharmaceutical composition

Abstract

The embodiment of the utility model provides a kind of based on magnetic drive microthorn device of prestrain, microthorn system and pharmaceutical composition, it is related to medical robot technical field.Microthorn device includes microneedle, first magnetic deformation layer and second magnetic deformation layer;One side of first magnetic deformation layer is closely connected with second magnetic deformation layer, and the other side of first magnetic deformation layer has microneedle;First magnetic deformation layer and second magnetic deformation layer can be deformed synchronously under the action of magnetic field.Microthorn device simple structure and safe;It is self-bending and gathered state when there is no magnetic field, and it is flat state when there is magnetic field, conducive to realizing long-range wireless magnetic drive navigation and the function of no external magnetic field intestinal anchoring;Mechanical interlocking between it and intestinal tissue, it is expected to realize efficient, accurate drug residence, to provide the function of slow-release drug release, and it is expected to be popularized and applied in treating gastrointestinal diseases.

Description

Technical Field

[0001] This utility model relates to the field of medical robot technology, and more specifically, to a pre-strain-based magnetically driven micro-needling device, micro-needling system, and drug composition. Background Technology

[0002] Gastrointestinal diseases are a significant public health issue, and their treatment has always faced many challenges, especially for patients with chronic gastrointestinal disorders and those with low drug tolerance. Maintaining a consistent drug concentration at the site of infection over a long period is crucial to ensure effective treatment, minimize side effects, and reduce medical risks.

[0003] The core challenge of drug retention therapy lies in overcoming drug loss caused by the periodic self-cleaning properties of the intestinal mucus layer. Current technologies mainly achieve drug anchoring through two methods: passive and active.

[0004] Passive methods primarily rely on modifying the surface of the drug carrier to facilitate rapid drug penetration into areas near the intestinal mucosa, thereby preventing it from being carried away by flowing mucus. For example, existing patents (such as CN117209637A and CN108653719A) demonstrate how to utilize specific materials or structural designs to enhance the contact stability between the drug and the intestinal surface. However, the in vivo toxicity and long-term biocompatibility of these methods still require further verification.

[0005] Active methods involve using a triggering device to anchor the drug delivery device at a specific location within the intestine. Common active anchoring devices include stents and microneedles. Stents achieve positioning through physical expansion, but due to their mechanism of action, they carry a higher risk, potentially leading to intestinal tissue damage, misalignment, or displacement. Microneedles, compared to stents, can be inserted more precisely into the target area and pose lower safety risks, making them considered a more ideal solution. However, ensuring a stable mechanical interlock between the microneedle and the intestinal tissue remains an area of ​​research.

[0006] Existing technologies for microneedle anchoring include the following methods: Anchoring with adhesive microneedles requires colonoscopy, but this is highly invasive and has poor patient compliance; anchoring is achieved by embedding the microneedle into the blood vessel wall using balloon inflation, a method easily implemented wirelessly, but also facing potential risks similar to those associated with stent expansion; Magnetic soft robots, as an emerging technology, can respond to external magnetic field commands to perform deformation movements, but in the absence of an external magnetic field, they cannot provide sufficient force to maintain the pressure loading on the microneedle, which limits their effectiveness in practical clinical applications.

[0007] Therefore, this application is hereby submitted. Utility Model Content

[0008] The purpose of this invention is to provide a pre-strain-based magnetically driven micro-needling device, a micro-needling system, and a drug composition to solve the aforementioned technical problems.

[0009] The embodiments of this utility model can be implemented as follows:

[0010] In a first aspect, this utility model provides a magnetically driven micro-needling device based on pre-strain. The micro-needling device includes micro-needles, a first magnetic deformation layer, and a second magnetic deformation layer. One side of the first magnetic deformation layer is tightly connected to the second magnetic deformation layer, and the other side of the first magnetic deformation layer has micro-needles. The first magnetic deformation layer and the second magnetic deformation layer can deform synchronously under the action of a magnetic field.

[0011] In an alternative embodiment, the shape of the micro-needling device is selected from any one of a cylinder, a prism, and a starfish-like body.

[0012] In an optional embodiment, when the micro-sting device is shaped like a starfish, it includes a tentacle center and multiple tentacles, with the multiple tentacles extending outward from the tentacle center.

[0013] In an optional implementation, the distance between the farthest point of the tentacle and the center of the tentacle is 3.00mm-5.00mm.

[0014] In an alternative implementation, the sides of the multiple tentacles with microneedles bend and converge toward the center of the tentacles.

[0015] In an optional embodiment, the micro-sting device has 3 to 7 tentacles, and the included angle between adjacent tentacles is equal; the tentacles are 3.00 mm to 4.00 mm long and 2.50 mm to 3.50 mm thick.

[0016] In an optional embodiment, the tips of the microneedles are far from the first magnetic deformation layer, and multiple microneedles are arranged in an array on the surface of the first magnetic deformation layer.

[0017] In an optional implementation, the height of the microneedles is 600μm-800μm.

[0018] Secondly, this utility model provides a pre-strain-based magnetically driven micro-needling system, which includes the aforementioned micro-needling device and magnetic field generating device.

[0019] Thirdly, the present invention provides a pharmaceutical composition comprising the aforementioned micro-sting device, wherein a drug film is coated on the outer surface of the micro-sting device.

[0020] The beneficial effects of the pre-strain-based magnetically driven micro-needling device, micro-needling system, and drug composition provided in this embodiment of the invention include:

[0021] The pre-strain-based magnetically driven micro-needling device has a simple and safe structure. It is in a self-bending and converging state when there is no magnetic field and in a flat state when there is a magnetic field, which is conducive to realizing the functions of remote wireless magnetically driven navigation and intestinal anchoring without external magnetic field. Its mechanical interlock with intestinal tissue is expected to achieve efficient and precise drug retention, so as to provide the function of sustained-release drug, and is expected to be widely used in the treatment of gastrointestinal diseases. Attached Figure Description

[0022] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 A schematic diagram of the micro-needling device provided in the first embodiment from multiple perspectives;

[0024] Figure 2 A schematic diagram of the process for preparing the micro-needling device in the first embodiment;

[0025] Figure 3 This is a schematic diagram of the operation process of the micro-needling device in the first application example.

[0026] Icons: 100-Microneedling device; 101-Second magnetic deformation layer; 102-First magnetic deformation layer; 103-Microneedle; 104-Tentacle center; 105-Tentacle; 106-Farthest end of tentacle; 107-Microneedle tip; 108-Bending angle; 109-Bending arc surface; 110-Microneedle height; 111-Tentacle thickness; 200-Preparation process of microneedling device; 300-Operational flowchart of microneedling device; 400-Intestinal epithelium; 500-Magnetic field generating device. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0028] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0029] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0030] In the description of this utility model, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the utility model product is usually placed during use, they are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0031] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0032] It should be noted that, where there is no conflict, the features in the embodiments of this utility model can be combined with each other.

[0033] First Embodiment

[0034] This embodiment provides a pre-strain-based magnetically driven micro-needling system, which includes a micro-needling device 100 and a magnetic field generating device 500.

[0035] Please refer to Figure 1 The microneedling device 100 includes microneedles 103, a first magnetic deformation layer 102 and a second magnetic deformation layer 101; one side of the first magnetic deformation layer 102 is tightly connected to the second magnetic deformation layer 101, and the other side of the first magnetic deformation layer 102 has microneedles 103.

[0036] Specifically, the tips 107 of the microneedles are far from the first magnetic deformation layer 102, and multiple microneedles 103 are arranged in an array on the surface of the first magnetic deformation layer 102. The height of the microneedles 103 is 600μm-800μm, and the specific height is related to the material of the microneedles 103 and the magnitude of the applied magnetic field; in this embodiment, the height 110 of the microneedles is 600μm.

[0037] It should be noted that the materials used to prepare the microneedles 103 in this embodiment include a first magnetic material and a first rubber material; wherein, the first magnetic material is iron(III) oxide, which is a material with low magnetic properties and is easy to form microneedles 103 under the action of a magnetic field; in other embodiments, it can be replaced with a nickel-iron alloy as needed.

[0038] The first rubber material is polydimethylsiloxane (PDMS), which has low elasticity, high hardness and high strength after curing, and is easy to form mechanical interlock with the contacting tissue to achieve stable residence; in other embodiments, it can be replaced with any one of polymethylphenylsiloxane, polydiethylsiloxane, polysiloxane copolymer and rubber-like resin as needed, wherein the rubber-like resin includes natural rubber, styrene-butadiene rubber, chloroprene rubber, EPDM rubber, acrylate rubber, nitrile rubber, ethylene propylene rubber and butyl rubber.

[0039] The materials used to prepare the first magnetic deformation layer 102 and the second magnetic deformation layer 101 are independently a second magnetic material and a second rubber material; wherein, the second magnetic material is neodymium iron boron (NdFeB) with high magnetic properties, which is beneficial for the subsequent manipulation of the shape and movement of the magnetically driven micro-needle device by the external magnetic field; in other embodiments, it can be replaced with samarium cobalt alloy as needed.

[0040] The second rubber material is platinum silicone, which has high elasticity, is easy to bend, and is easy to deform under the action of a magnetic field. In this embodiment, Ecoflex-0030 is specifically used. In other embodiments, it can be replaced with polyurethane or Ecoflex-0050 as needed.

[0041] It should be noted that the thicknesses of the first magnetic deformation layer 102 and the second magnetic deformation layer 101 are independently 0.15mm-4.00mm. The distances between the farthest ends of the first magnetic deformation layer 102 and the center of the second magnetic deformation layer 101 are independently 3.00mm-5.00mm.

[0042] In this embodiment, the micro-sting device 100 is shaped like a starfish, including a tentacle center 104 and a plurality of tentacles 105, with the plurality of tentacles 105 extending outward along the tentacle center 104. In other embodiments, the shape of the micro-sting device 100 can be made into a cylinder or a prism according to actual needs.

[0043] Specifically, there are five tentacles 105, and the included angles between adjacent tentacles 105 are equal. Each tentacle 105 is 3.50 mm long, and the distance between the farthest point 106 and the center 104 of the tentacle is 5.00 mm. Each tentacle 105 includes a microneedle 103, a first magnetic deformation layer 102, and a second magnetic deformation layer 101. Each tentacle has a thickness 111 of 3.00 mm. The height of the microneedle 103 is 600 μm, and the thicknesses of the first magnetic deformation layer 102 and the second magnetic deformation layer 101 are 1.20 mm each.

[0044] It should be noted that in other embodiments, the number of tentacles 105 can be adjusted to other values ​​within the range of 3 to 7 according to actual needs; the width of tentacles 105 is not particularly limited in this utility model, and it is related to the shape of the micro-sting device 100 and the number of tentacles 105; the thickness of the first magnetic deformation layer 102 and the second magnetic deformation layer 101 can be reasonably adjusted according to actual needs.

[0045] Please refer to Figure 2 The preparation process of the micro-sting device 200 includes the following steps:

[0046] (1) Fabrication of the first magnetic deformation layer 102 and the second magnetic deformation layer 101

[0047] NdFeB and Ecoflex-0030 were mixed in a mass ratio of 1:1 and placed in a mold to obtain two magnetic rubber films, which were designated as the first magnetic deformation layer 102 and the second magnetic deformation layer 101, respectively.

[0048] It should be noted that the mass of NdFeB is 0.04 g; the magnetic rubber film prepared in this embodiment is spherical. In other embodiments, the mass of NdFeB can be reasonably adjusted according to the actual size of the deformable layer; the shape of the magnetic rubber film can be reasonably adjusted according to actual needs; the mass ratio of NdFeB to Ecoflex-0030 can also be adjusted to other values ​​within the range of (0.5-2):1 as needed.

[0049] (2) Preparation of microneedles 103

[0050] The mixture of iron oxide, PDMS main agent and PDMS curing agent in a molar ratio of 10:15:1 is uniformly applied to one side of the first magnetic deformation layer 102 to obtain the first composite layer; wherein the mass of iron oxide is 10 μg, and the PDMS main agent and PDMS curing agent are Dow Corning DC184 SYLGARD 184.

[0051] Next, an external gradient magnetic field is applied to the first composite layer, causing the magnetic particles in the mixture, iron(III) oxide, to self-assemble into multiple microneedles 103. After curing, a microneedle 103 thin film layer is obtained, that is, multiple microneedles 103 are arrayed on one side of the first magnetic deformation layer 102.

[0052] Applying an external gradient magnetic field to the first composite layer can increase the pressure of the microneedling device 100 on the target tissue, thereby improving the contact effect between the microneedle 103 and the target tissue, and thus improving the mechanical interlocking effect between the microneedling device 100 and the target tissue; if no gradient magnetic field is applied, the anchoring ability of the microneedling device 100 is weakened.

[0053] (3) Preparation of micro-needling device 100

[0054] Along the radial direction of the first magnetic deformation layer 102, i.e., referring to Figure 3 In the XY plane direction, the first composite layer is stretched to a stretch ratio of 1.25; the second magnetic deformation layer 101 is bonded to the side of the first magnetic deformation layer 102 without microneedles 103 to obtain the second composite layer; the second composite layer is magnetized in the Z-axis direction with a magnetic field strength of 60mT.

[0055] After releasing the tensile force of the first composite layer, the first magnetic deformation layer 102 and the second magnetic deformation layer 101, under the action of internal stress, transform from a cylinder into a dome shape. Then, the dome is cut or trimmed according to the shape of a starfish to obtain the micro-needle device 100; see details... Figure 1 A schematic diagram of the structure of the micro-needling device 100 under multiple perspectives.

[0056] Specifically, the distance between the farthest end 106 of the tentacle and the center 104 of the tentacle is 5.00 mm; the multiple tentacles 105 bend and converge toward the center 104 on the side with microneedles 103, and the tips of the microneedles 103 on the curved surface 109 are inclined toward the center 104 of the tentacle; the bending angle 108 of the curved surface 109 is 25°.

[0057] It should be noted that in other embodiments, the stretching ratio can be reasonably adjusted according to actual needs, and other values ​​within the range of 1.05-2 can be selected. This utility model does not specifically limit the form of dome cutting or trimming; specifically, laser cutting is used in this embodiment, but other embodiments can be selected according to actual needs. The shape of the micro-needling device 100 can also be maintained as a cylinder without cutting, keeping it as a single dome shape, or other shapes, depending on actual needs. The bending angle 108 of the curved surface 109 is related to the tensile force of the first composite layer and its interaction force with the second composite layer.

[0058] First Application Example

[0059] This application example provides an example of the use of a microneedling device 100 for residence at intestinal targets, wherein the drug composition includes a pre-strain-based magnetically driven microneedling device 100. A flowchart of the operation of the microneedling device 300 is shown below. Figure 3 .

[0060] The outer surface of the pre-strained magnetically driven micro-needling device 100 is coated with a drug film, that is, the drug film is coated on the side of the second magnetic deformation layer 101 away from the first magnetic deformation layer 102; and it is loaded into a capsule. After oral administration into the intestine, the micro-needling device 100 is released from the capsule.

[0061] A low-intensity rotating magnetic field drives the magnetically driven microneedling device 100 to move to the target site by rolling. Then, by increasing the magnetic field strength, the magnetically driven microneedling device 100 is flattened, and the magnetic force generated by the magnetic field gradient propels the microneedles 103 into the intestinal epidermis 400. Furthermore, when the applied magnetic field is removed, the microneedling device 100 can self-roll under pre-stress, thereby achieving mechanical interlocking between the microneedles 103 of the magnetically driven microneedling device 100 and the intestinal tissue. Simultaneously, the drug film encapsulating the robot's outer surface facilitates the long-term sustained release of drug at the target site.

[0062] It should be noted that the intensity of a low-intensity magnetic field is 18mT-22mT, and the intensity of a low-intensity magnetic field in this application example is 20mT.

[0063] In summary, the pre-strain-based magnetically driven micro-needling device provided by this invention has a simple and safe structure, achieves efficient and precise drug retention, and provides the function of sustained-release drug delivery. It is expected to be widely used in the treatment of gastrointestinal diseases.

[0064] The above description is only a specific embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model.

Claims

1. A pre-strained based magnetic actuated microspike device, characterized in that, The microneedle device includes microneedles, a first magnetic deformation layer and a second magnetic deformation layer; one side of the first magnetic deformation layer is tightly connected to the second magnetic deformation layer, and the other side of the first magnetic deformation layer has microneedles; the first magnetic deformation layer and the second magnetic deformation layer can deform synchronously under the action of a magnetic field.

2. The microstimulation device of claim 1, wherein, The shape of the micro-sting device is selected from any one of cylinder, prism, and starfish.

3. The microstimulation device of claim 1, wherein, When the micro-sting device is shaped like a starfish, it includes a tentacle center and multiple tentacles, with the multiple tentacles extending outward along the tentacle center.

4. The microstimulation device of claim 3, wherein, The distance between the farthest point of the tentacle and the center of the tentacle is 3.00mm-5.00mm.

5. The microstimulation device of claim 3, wherein, The sides of the multiple tentacles with microneedles bend and converge toward the center of the tentacles.

6. The microstimulation device of claim 3, wherein, The micro-sting device has 3 to 7 tentacles, and the included angle between adjacent tentacles is equal; the tentacles are 3.00mm to 4.00mm long and 2.50mm to 3.50mm thick.

7. The microstimulation device of claim 1, wherein, The tips of the microneedles are far from the first magnetic deformation layer, and a plurality of the microneedles are arranged in an array on the surface of the first magnetic deformation layer.

8. The microstimulation device of claim 1, wherein, The height of the microneedles is 600μm-800μm.

9. A pre-strain-based magnetically driven micro-needling system, characterized in that, The micro-needling system includes the micro-needling device as described in any one of claims 1-8 and the magnetic field generating device.

10. A pharmaceutical composition, characterized by, The pharmaceutical composition includes a micro-sting device as described in any one of claims 1-8, and a drug film is coated on the outer surface of the micro-sting device.

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