Electronic umbrella element for minimally invasive treatment and its manufacturing method

Abstract

The present invention relates to an electronic device for minimally invasive bio-injection, which is intended to be used for various purposes such as diagnosis, treatment, and research through interactions between the internal and external environments in various ways such as detecting internal signals, providing stimulation, and releasing drugs.

Description

[Technical Field]

[0001] The present invention relates to an electronic device and a method for manufacturing the same, and more particularly to a bio-injectable electronic device that can be used for diagnosis, treatment, research, etc., and a method for manufacturing the same. [Background technology]

[0002] Unless otherwise indicated herein, the subject matter described in this identification section is not prior art to the claims of this application and is not admitted to be prior art by virtue of its inclusion in this identification section.

[0003] Generally, electronic devices used for medical purposes are implanted into the body through surgery, which has the disadvantage of exposing the patient to various side effects during the skin incision and recovery process.

[0004] Therefore, there is a need for a technology that can reduce the volume of an electronic device during implantation so that implantation of the electronic device can be performed through minimally invasive surgery by incising the skin.

[0005] In this regard, Korean Patent Publication No. 10-1864033 discloses an invasive bioelectronic device, and Korean Patent Publication No. 10-1744395 discloses a method for manufacturing a transparent substrate for a biodegradable flexible electronic device containing starch.

[0006] However, the existing inventions do not disclose a technology that can reduce the volume through shape transformation during the implantation process, thereby minimizing the incision in the body.

[0007] In addition, existing overseas technologies only partially disclose concepts regarding how they can be expanded inside the body, and do not specifically address which parts of the body they can enter, in what form, or how they can interact with the target body after entering.

[0008] Naturally, verification of the stability aspect of bioimplantable electronic element devices is extremely important, and the reality is that there have been very few cases in which experiments have been expanded to include in vivo experiments, so progress has been slow in commercializing bioimplantable electronic element devices that aim for minimal invasiveness. Summary of the Invention [Problem to be solved by the invention]

[0009] The object of the present invention is to provide an electronic device that can be injected into the environment between the inner wall of the skull and the surface of the brain, and to propose a new type of bioimplantable electronic device for minimally invasive procedures that can be used for various purposes such as treatment and research.

[0010] The goal of the present invention is to provide an electronic element device that can be injected into the body using a minimally invasive method while its volume is reduced through the transformation of the electronic element device, and that automatically changes shape under specific conditions in a target environment.

[0011] In this process, we aim to propose a material and structure for an electronic element device that can be smoothly unfolded and attached without causing any abnormalities in its shape or structure during the process of inserting the electronic element device into an injection device (e.g., a syringe) with a small cross-sectional area used for minimally invasive surgery and then expelling it from the device to the outside, and without causing any damage to the target body part.

[0012] In addition, without introducing a separate external signal, the device changes shape by itself when injected into the body, expands to have a large area, and adheres to the body, aiming to interact with parts of the body by collecting information from the body or applying stimulation.

[0013] Another goal of this electronic element device is to be biodegraded in the body and stably excreted without residue after having performed its intended function.

[0014] The content proposed in the present invention is not limited to the technical problems described above, and it is obvious that other technical problems may be derived from the following explanation. [Means for solving the problem]

[0015] An embodiment according to one aspect of the present invention proposed to solve the above-mentioned problems relates to an electronic umbrella device for minimally invasive surgery.

[0016] The bio-injectable electronic device proposed in one embodiment of the present invention includes a central support part and a plurality of branch parts extending from the central support part. When the device enters the environment between the inner wall of the skull and the surface of the brain, the branch parts spread out and come into contact with the surface of the brain, becoming activated, and then being biodegraded and discharged from the body.

[0017] According to one embodiment, the branch portion includes an electrode; and a cover layer covering the electrode from above and below; and the cover layer may have an open structure to include a portion where the electrode is exposed to the outside.

[0018] According to one embodiment, the branch may include a shape memory polymer that restores its shape when the surrounding environmental conditions are met.

[0019] According to one embodiment, the conditions for the ambient environment may include one or more conditions selected from the group consisting of temperature, humidity, pH concentration, light intensity, ultrasound, and electromagnetic fields of the ambient environment.

[0020] According to one embodiment, the branch portion may include a highly elastic, super-soft polymer having a wide elastic range of 250% or more based on Young's modulus and a Young's modulus of 20 kPaa or more.

[0021] According to one embodiment, the branch portion further includes DNA bound to the polymer, and the DNA may include a hairpin structure or double-stranded DNA.

[0022] According to one embodiment, the branch may be formed of a material containing DNA only in a partial region where the shape transformation mechanism needs to occur.

[0023] According to one embodiment, the branches may form a network structure.

[0024] According to one embodiment, the network structure may include a plurality of chassis parts that radiate from the central support part; and chassis support parts that are formed to connect the chassis parts to each other.

[0025] According to an embodiment, an element unit may be formed in at least a portion of a portion where the chassis unit and the chassis support unit are connected.

[0026] According to an embodiment, at least a portion of the ends and middle of the chassis may have element units formed thereon.

[0027] According to an embodiment, the device may include one or more of a sensor unit, an electrode unit, an electrical stimulation unit, a drug injection unit, an ultrasound transmission unit, a battery unit, and an optical transmission unit.

[0028] According to an embodiment, the device unit may be a single device unit that performs multiple functions.

[0029] According to an embodiment, at least two of the device units may perform different functions.

[0030] According to an embodiment, each chassis part having an element part performing a different function may be assembled to be connected to the central support part.

[0031] According to one embodiment, when the bio-injectable electronic device is injected in a solidified state in a direction in which the branch portion first contacts the brain surface, the contact angle at which the end of the chassis portion first contacts the subject may be formed to be 70 degrees or less.

[0032] According to one embodiment, the bio-injectable electronic device may include an X-ray marker.

[0033] According to one embodiment, the central support portion forms a pillar-shaped axial structure in the z-axis direction, and the central support portion may be provided with a means for enabling wireless communication with the outside, or may have a conductive line passing therethrough for enabling wired communication.

[0034] According to an embodiment, the central support may include a solid support for supporting an upright structure of the central support.

[0035] In another embodiment of the present invention, an electronic umbrella device for minimally invasive treatment is proposed as a biological injection type electronic device, which includes a central support portion and branch portions including a plurality of chassis portions extending from the central support portion, and which is configured as a 3D structure in the z-axis direction outside the body and injected into the body's internal environment with a height of 5 mm or less, and then expanded as a 2D structure in the x- and y-axes inside the body, thereby enabling minimally invasive treatment.

[0036] According to an embodiment, the electronic umbrella element may have an area in an unfolded state that is 10 times or more larger than the area in a folded state.

[0037] In another embodiment of the present invention, an electronic umbrella device for minimally invasive procedures is proposed as a bioinjectable electronic device, comprising: a central support; branch portions including a plurality of chassis portions formed by extending from the central support; and a plurality of chassis supports formed to connect the plurality of chassis portions to one another. When the electronic umbrella device enters the environment between the inner wall of the skull and the brain surface, the branch portions unfold and come into contact with the brain surface to operate. When the branch portions are injected in a direction to first contact the brain surface, the electronic umbrella device may have a structure in which the greatest strain is generated in the uppermost support portion of the support portions formed closest to the central support when it comes into contact with the brain surface.

[0038] Another embodiment of the present invention provides an electronic umbrella device for minimally invasive procedures, which is an implantable electronic device that includes a central support portion and branch portions including a plurality of chassis portions extending from the central support portion. When the electronic umbrella device enters the environment between the inner wall of the skull and the surface of the brain, the branch portions unfold and come into contact with the surface of the brain to operate. The branch portions are formed by stacking a plurality of layers and then encapsulating them, and may include at least three layers: a lower cover layer, an electrode, and an upper cover layer.

[0039] According to an embodiment, the branch portion may further include one or more layers selected from the group consisting of an active layer, an inter-layer, a receiver coil layer, and a gate oxide layer.

[0040] Another embodiment proposed in another aspect of the present invention relates to a method for manufacturing an electronic umbrella device for minimally invasive surgery.

[0041] In one embodiment of the present invention, a method for manufacturing a bio-injectable electronic device is proposed, in which the bio-injectable electronic device enters the environment between the inner wall of the skull and the surface of the brain, and operates by contacting the surface of the brain with the branch portions expanding, and the method may include: a central support portion; and branch portions having a plurality of chassis portions formed by extending from the central support portion; and may include a step of assembling the plurality of prepared chassis portions to the central support portion.

[0042] In another embodiment of the present invention, a method for manufacturing a bio-injectable electronic device is proposed, in which the bio-injectable electronic device enters an environment between the inner wall of the skull and the surface of the brain, and the branch portions unfold to come into contact with the surface of the brain, and the bio-injectable electronic device operates. The bio-injectable electronic device includes a central support portion and branch portions having a plurality of chassis portions formed and extending from the central support portion. The chassis portions may be manufactured by the steps of: preparing a lower substrate; forming a lower cover layer on the lower substrate; forming the central support portion on the lower cover layer; forming a stack of the prepared electrodes and upper cover layer on the lower cover layer; and folding up one side of the lower cover layer, the electrodes, and the upper cover layer based on the central support portion.

[0043] In yet another embodiment of the present invention, there is provided a method for manufacturing a bio-injectable electronic device, in which the bio-injectable electronic device operates by contacting the brain surface while the branch portions are expanded when the bio-injectable electronic device enters an environment between the inner wall of the skull and the surface of the brain, and includes a central support portion; and branch portions each having a plurality of chassis portions formed and extending from the central support portion; the branch portions are manufactured by forming a layered structure including the lower cover layer, electrodes, and an upper cover layer, and the process for forming the layered structure may include a step of designing the structure of each layer through a laser process.

[0044] Another aspect of the present invention, which is proposed to solve the above-mentioned problems, relates to a method for injecting an electronic umbrella device into a body for minimally invasive surgery.

[0045] A method for injecting a bio-injectable electronic device proposed in one embodiment of the present invention relates to a method for injecting a bio-injectable electronic device into the body, which enters the environment between the inner wall of the skull and the surface of the brain, and the branch portions unfold to contact the brain surface and operate, and the bio-injectable electronic device includes a central support portion and branch portions including a plurality of chassis portions extending from the central support portion, and the method includes the steps of folding and inserting the bio-injectable electronic device into an injection device; injecting the bio-injectable electronic device into a hole made in the skull; positioning the bio-injectable electronic device on the brain surface while unfolding inside the skull; and operating the bio-injectable electronic device on the brain surface.

[0046] According to one embodiment, the step of positioning the bio-implantable electronic element on the brain surface while it is being expanded inside the skull may include a step of the branches of the bio-implantable electronic element being expanded by themselves in the environment inside the skull.

[0047] According to one embodiment, the step of folding and placing the bio-implantable electronic device into a sealed injection device including a narrow, closed space may further include the step of injecting a lubricant into the sealed injection device together, and the lubricant may enable the bio-implantable electronic device to be smoothly unfolded and slidably inserted onto the brain surface when the bio-implantable electronic device is unfolded and positioned on the brain surface.

[0048] According to one embodiment, the step of positioning the bio-implantable electronic device on the brain surface while spreading it out may be performed by using an adhesive to ensure that the bio-implantable electronic device is well adhered to a target location on the brain surface. [Effects of the Invention]

[0049] According to one embodiment disclosed herein, an electronic device device advantageously provides an insertable electronic device that allows for minimally invasive surgery or procedures within the skull.

[0050] By using the electronic element device proposed in the embodiment of the present invention, it is possible to attempt new types of medical treatments, surgeries, diagnoses, etc. with only a minimal incision in the skull, instead of the conventional attempt to sense brain signals or stimulate the brain outside the skull, which was unavoidable due to the risk of having to make a large incision in the skull.

[0051] In addition, when using the electronic element device, its manufacturing method, and its injection method proposed in the present invention, the electronic element device can be folded and inserted into the sealed space inside an injection tool having a very narrow cross-sectional area without any problems, and when it is released from inside the injection tool into the open environment outside, it can be expanded again to the intended shape without any malfunction or abnormality. This allows direct contact with the inside of the skull using a minimally invasive method, which has the effect of enabling direct interaction with the brain surface.

[0052] Furthermore, the effects of the present invention described in this way will naturally be achieved by the configuration of the described content regardless of whether the inventor is aware of them or not, and therefore the effects described above are merely some of the effects of the described content and should not be recognized as describing all of the effects that the inventor is aware of or that actually exist.

[0053] Furthermore, the effects of the present invention should be further understood from the overall description of the specification, and even if not explicitly stated, if a person having ordinary skill in the technical field to which the described content belongs would recognize such an effect through this specification, it should be considered to be an effect described in this specification. [Brief explanation of the drawings]

[0054] [Figure 1] FIG. 10 is a schematic diagram illustrating a process in which an electronic umbrella element according to an embodiment of the present invention is injected into the skull through a syringe in a folded or crumpled state, and then unfolded to perform its intended function and then biodegraded. [Figure 2]This is a schematic diagram showing the technical problem that occurs when the electronic umbrella element is folded or crumpled when it is inserted into a narrow injection device, causing plastic deformation inside the injection device, or when it is inserted into or removed from the injection device, the device is damaged by friction with the inner wall, and the shape does not return to the original design as designed. [Figure 3] These are photographs and drawings showing the narrow space between the inner wall of the skull and the surface of the brain, and are schematic diagrams showing the spatial constraints that must be met in order for the electronic umbrella element, which is folded or crumpled into a mass in a space less than 5 mm high, to be able to effectively unfold. [Figure 4] FIG. 1 is a schematic diagram illustrating a structure in which an electronic umbrella element according to an embodiment of the present invention is expanded in two dimensions (xy plane) before injection into the body, then forms a three-dimensional (z plane) structure in a narrow space of an injection device for minimal invasiveness, and then is expanded again in two dimensions inside the skull. [Figure 5] 10 is an image illustrating an example in which different sensors and electrodes are formed in element units formed at the ends of the branches of an electronic umbrella device according to an embodiment of the present invention. [Figure 6] 1 is a schematic diagram illustrating that different electronic modules may be formed in an element portion formed at an end of a branch portion of an electronic umbrella element according to an embodiment of the present invention. [Figure 7] 1 is a schematic diagram showing a layered structure of an electronic umbrella element according to an embodiment of the present invention; [Figure 8] FIG. 1 is a schematic diagram (upper drawing) illustrating a central support part of an electronic umbrella element according to one embodiment of the present invention and an auxiliary support (solid support) that supports the upright structure of the central support part, and FIG. 2 is a cross-sectional view (lower drawing) illustrating a cross section showing the connection structure between the branch parts and the central support part of an electronic umbrella device. [Figure 9] 9 is an image showing a state in which electrodes are connected by wire through a central support part formed in the folded structure of FIG. 8 of an electronic umbrella device according to an embodiment of the present invention and connected to another electronic device outside the body. [Figure 10]10 is an image showing the laminated structure of an element part formed at the end of a branch of an electronic umbrella element according to an embodiment of the present invention, and the actual manufactured shape and scale of the electronic umbrella element that expands to its original shape in response to temperature. [Figure 11] 1 is a schematic diagram showing a stacked structure when a wireless communication function of an electronic umbrella element according to an embodiment of the present invention is installed. FIG. [Figure 12] 10 shows a photographed image and an X-ray image of an embodiment in which an X-ray marker is included in an electronic umbrella device according to an embodiment of the present invention. [Figure 13] 10A and 10B are FEA simulation images showing that when an electronic umbrella element according to an embodiment of the present invention is first injected into an injection device, excessive strain due to deformation of the shape may cause damage to the electronic umbrella element, and an actual image of an electronic umbrella element that has been damaged due to cracks. [Figure 14] 10A and 10B are FEA simulation images of an electronic umbrella element according to an embodiment of the present invention being re-expanded as planned when being ejected from inside an injection device to the outside, and captured images of the electronic umbrella element failing to be expanded in reality. [Figure 15] 10 shows Young's modulus experiment results for testing conditions of a polymer material for enabling an electronic umbrella device according to an embodiment of the present invention to be effectively expanded in a restricted environment. [Figure 16] 10 is a simulation image showing the results of searching for the optimal structure of the chassis and support parts to enable the electronic umbrella element according to one embodiment of the present invention to be effectively expanded in a restricted environment while being ejected from an injection device. [Figure 17] 1 is an image showing respective designs of an electronic umbrella device according to an embodiment of the present invention and corresponding filling ratio values; [Figure 18] 3 is a schematic diagram showing a cross-sectional structure of a lower cover layer and an upper cover layer around the electrodes of the branch portions of an electronic umbrella element according to an embodiment of the present invention; FIG. [Figure 19]10 shows a simulation result of analyzing factors that affect the effective unfolding of an electronic umbrella device according to an embodiment of the present invention from a crumpled or folded 3D structure to a 2D structure. [Figure 20] When considering the friction on the surface of the electronic umbrella element according to one embodiment of the present invention, the compensation of the contact angle at the end of the chassis is caused. This is an image showing the resulting change in mechanism. [Figure 21] 10 is a schematic diagram illustrating that an electronic umbrella element according to an embodiment of the present invention can be expanded more smoothly if a lubricant is present. FIG. [Figure 22] 10 is an image showing the result of an electronic umbrella device according to an embodiment of the present invention being biodegraded as designed after a suitable time has passed. [Figure 23] 3A to 3C are process diagrams illustrating a process for manufacturing a chassis part of an electronic umbrella device according to an embodiment of the present invention through cross-sectional structures of each step. [Figure 24] This is a process diagram illustrating the process of attaching a chassis unit of an electronic umbrella device according to an embodiment of the present invention to a lower substrate and connecting it to a central support unit through cross-sectional structures at each stage. It can be seen that the chassis unit is attached based on the central support unit, folded in an "L" shape, and extends in the vertical direction (z-axis direction). Figures 25 to 27 are images and graphs showing the results of in-vivo experiments on an electronic umbrella device according to an embodiment of the present invention. [Figure 25] 10A and 10B are graphs showing experimental images and signals transmitted from the respective element units of the electronic umbrella element according to an embodiment of the present invention when the element units are attached to different positions on the brain surface of an animal body. [Figure 26] 24 is a graph showing temperature signals received when an electronic umbrella device according to an embodiment of the present invention is manufactured to be capable of wireless communication via NFC and then inserted into the brain surface of an animal, and the temperature is controlled by turning an IR lamp on and off. Figure 24 shows that there is no significant difference between the control experiment using a commercially available temperature sensor and the case where the electronic umbrella device of the present invention is used. [Figure 27] 27 is an image showing the gradual biodegradation process of an electronic umbrella device according to an embodiment of the present invention 35 days after it is injected into the surface of an animal body. The image in FIG. 27 clearly shows that biodegradation is progressing in line with the target time. DETAILED DESCRIPTION OF THE INVENTION

[0055] The examples of the present invention are provided for the purpose of explaining the technical concept of the present invention, and the scope of the present invention is not limited to the examples presented below or the specific descriptions of these examples.

[0056] Unless otherwise defined, all technical and scientific terms used in the present invention have the meanings commonly understood by those of ordinary skill in the art to which the present invention belongs. All terms used in the present invention are selected for the purpose of more clearly describing the present invention, and are not selected to limit the scope of the present invention.

[0057] As used herein, expressions such as "including," "comprises," and "has" should be understood as open-ended terms that include the possibility of including other embodiments, unless otherwise stated in the phrase or sentence containing the expression.

[0058] Unless otherwise specified, singular expressions described in the present invention can include plural meanings, and this also applies to singular expressions described in the claims.

[0059] In the present invention, the height direction of the electronic umbrella element is defined as the vertical direction (z-axis direction), the x-axis direction is defined as any direction perpendicular to the vertical direction (z-axis direction), and the y-axis direction is defined as a direction perpendicular to both the x-axis and z-axis directions. Thus, the xy plane becomes a plane perpendicular to the z-axis, and the branches of the electronic umbrella element (described later) aim for a 2D structure that spreads across the xy plane.

[0060] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, in the following description of the embodiments, duplicated descriptions of identical or corresponding components may be omitted. However, even if technology related to a component is omitted, it is not intended that such component is not included in any embodiment.

[0061] Generally, bio-injectable electronic devices used for medical purposes are implanted into the body through surgery, which has the disadvantage of exposing the body to various side effects during the skin incision and recovery process.

[0062] Therefore, a technology is needed that can reduce the volume of the implantable electronic device during the implantation process so that the implantable electronic device can be implanted in a minimally invasive manner through an incision in the skin.

[0063] The bio-injectable electronic device contemplated by the present invention is formed in a folded or crumpled form depending on the physicochemical environmental conditions in an extracorporeal environment or inside an injection device, and is manufactured to unfold or expand when injected into the body and meets specific environmental conditions, thereby having the advantage of being able to be implanted inside the body with minimal incision. The electronic umbrella device proposed by the present invention can be generally applied in a variety of uses, but more specifically, the present invention proposes a bio-injectable electronic device that is injected and expanded in the environment between the inner wall of the skull and the surface of the brain.

[0064] When a bio-injectable electronic device is inserted into the body, it is deformed from a relatively large device shape into a relatively small folded or rolled state and injected into the body through an injection device (such as a syringe), and when it is operated inside the body, the deformed bio-injectable electronic device is restored to its original shape.

[0065] The bio-injectable electronic device is biodegraded after a certain period of time inside the body, and the biodegraded electronic device has the advantage of not only having no side effects on the body but also being excreted from the body along with bodily fluids.

[0066] The bio-injectable electronic device can be implanted between the inside of the skull and the brain surface, in the epidural or subdural environment, allowing for accurate measurement of brain signals, as well as treatment by delivering direct electrical stimulation to the brain surface or injecting drugs. The electronic umbrella device of the present invention has the advantage of being able to solve the problem of insufficient transmission of effects within the brain by applying electrical signals outside the skull due to the risk of skull incision.

[0067] 1. Concept and structure of electronic umbrella element

[0068] First, the concept and structure of an electronic umbrella element proposed in an embodiment of the present invention will be described with reference to FIGS.

[0069] FIG. 1 is a schematic diagram illustrating the process in which an electronic umbrella element according to an embodiment of the present invention is injected into the skull through a syringe in a folded or crumpled state, unfolded to perform its intended function, and then biodegraded.

[0070] Figure 1 illustrates what the inventors aimed to achieve through the electronic umbrella device proposed in this embodiment of the present invention. The electronic umbrella device is folded and inserted into an injection device, passed through a small incision in the skull, and injected into the epidural environment on the brain surface. After the electronic device performs its intended diagnostic and therapeutic functions, it is biodegraded.

[0071] To achieve this technical goal, the electronic umbrella element must be well designed so that it can be folded effectively into the narrow cross-sectional area of ​​the injection device and then ejected to the outside of the injection device without any problems. After being ejected, it must be able to unfold properly to its original shape, allowing the electronic element to function, and then be biodegraded.

[0072] FIG. 2 is a schematic diagram showing the technical problem that arises when the electronic umbrella element is folded or crumpled inside the narrow interior of the injection device, causing plastic deformation inside the injection device, or when the electronic umbrella element is inserted or removed from the injection device, the element is damaged by friction with the inner wall, and the element is not able to restore its original shape as designed.

[0073] However, as shown in Figure 2, to enable minimally invasive injection, the electronic umbrella element must not experience problems such as friction, tangling, or binding within the small internal space of the injection device, and the electronic element must not be damaged by friction with the inner walls of the injection device.

[0074] Another technical challenge to the success of this technique is the extremely narrow environment inside the skull. In the present embodiment, the device is designed so that the electronic umbrella element can be effectively expanded after injection in a narrow space with a thickness of approximately 5 mm.

[0075] Figure 3 is a photograph and illustration showing the narrow space between the inner wall of the skull and the surface of the brain, and is a schematic diagram illustrating the spatial constraints that must be met in order for the electronic umbrella element, which is folded or crumpled into a mass in a space less than 5 mm high, to be able to effectively unfold.

[0076] Due to the narrow internal body environment, it may be difficult for electronic devices that operate with large motions to restore their shape to a large area. Therefore, the minimally invasive electronic umbrella device contemplated by the present invention must be able to restore its shape even in a restrictive, narrow environment.

[0077] The inventors recognized this technical goal and researched various elemental technologies to enable the electronic umbrella element, which was expanded in two dimensions under limited conditions, to be consolidated inside the injection device and then expanded again in two dimensions.

[0078] FIG. 4 is a schematic diagram illustrating a structure in which an electronic umbrella element according to an embodiment of the present invention is expanded in two dimensions (xy plane) before injection into the body, then forms a three-dimensional structure (z plane) in a narrow space of an injection device for minimal invasiveness, and then is expanded again in two dimensions inside the skull.

[0079] The electronic umbrella device of the present invention is injected into the body through an insertion tube that has a small diameter but no length restrictions due to the characteristics of a minimally invasive injection device. At this time, the electronic umbrella device is inserted into the insertion tube in a form elongated along the z-axis. After the electronic umbrella device is injected into the body, the device that was folded along the z-axis will be expanded widely across the xy plane, and will realize a large-area shape restoration through axis transformation in an intracorporeal environment where the height is limited along the z-axis.

[0080] The structure and materials of the electronic umbrella device that enable the above implementation will be described in detail below.

[0081] A bio-injectable electronic device proposed in one embodiment of the present invention includes a central support portion and branch portions extending from the central support portion. When the bio-injectable electronic device enters the environment between the inner wall of the skull and the brain surface, the branch portions unfold and come into contact with the brain surface, allowing the device to operate, and then be biodegraded and discharged from the body. The branch portions may be configured to include a plurality of chassis portions.

[0082] The central support may be designed to protrude in the form of a pillar in the z-axis direction based on a 2D plane (xy plane). The central support may be designed to accommodate a wired or wireless communication unit. If the central support is designed to accommodate a wired communication unit, the central support may serve as a space through which a wire passes.

[0083] According to one embodiment, the branch portion may include an electrode and cover layers covering the electrode from above and below. The cover layers may include an upper cover layer and a lower cover layer. The upper cover layer and the lower cover layer may be made of the same material or may be made of different materials as needed.

[0084] The electrodes may be made of any conductive material. For example, they may be made of one of metal, carbon material, and alloy material. The electrodes may be made of one or more elements selected from the group consisting of magnesium (Mg), molybdenum (Mo), zinc (Zn), tungsten (W), silicon (Si), and mixtures or alloys thereof. The electrodes may be made of a gel-type conductive material. The present invention is not particularly limited to the electrodes as long as they are made of a conductive material. It may be more preferable that the electrode material is made of a biodegradable material and be biodegraded together with the materials of the cover layer and the central support. The electrode material may be manufactured in the form of nanowires.

[0085] The cover layer may be formed of a polymer capable of sealing the electrodes. The polymer preferably has the ability to be effectively folded and unfolded, and should also possess biodegradable properties. The cover layer may be formed of a highly flexible, highly elastic biodegradable polymer; in an embodiment of the present invention, an electronic umbrella device was fabricated by blending PLCL and PLGA polymers. Of course, the material for the cover layer of the present invention is not limited thereto, and any highly flexible, highly elastic biodegradable polymer material capable of bonding with various functional groups may be suitable. The polymer material may be formed so that it is primarily an ester-linked polymer that can be biodegraded through hydrolysis, and additionally contains a urethane-based polymer that can be enzymatically degraded.

[0086] The cover layer may have an open structure at least partially formed to expose the electrodes to the outside, allowing the electrodes to come into close contact with the upper or lower subject (such as the brain surface or the inner wall of the skull).

[0087] According to one embodiment, the branch may include a shape memory polymer that restores its shape when the surrounding environmental conditions are met.

[0088] The polymer material can perform the function of preventing damage to the device by behaving flexibly, such as by being wrinkled or folded, while maintaining any temporary shape before the ambient environmental conditions are met.

[0089] The polymer material must be able to unfold from its crumpled or folded shape in the body. This unfolding process can be designed to unfold into a pre-designed shape and return to its original structure before being folded or crumpled when the external environmental conditions are right, just like the self-assembly of a copolymer. The polymer material may also preferably have the properties of a shape-memory polymer.

[0090] According to one embodiment, the conditions for the ambient environment may be one or more conditions selected from the group consisting of temperature, humidity, pH concentration, light intensity, ultrasound, and electromagnetic field of the ambient environment.

[0091] The ambient environment condition may be one of physical, chemical, or biological conditions. In this case, the ambient environment condition may be the presence or absence of a specific component present in the discharged environment. It may also be the presence or absence of light, ultrasonic stimulation, or electromagnetic field, or the temperature, humidity, pH concentration, or other conditions of the discharged environment itself.

[0092] Such a polymer material is adopted as the main material forming the matrix of the branch portion in the present invention. The branch portion is a part that plays a key role in the electronic umbrella device of the present invention, being injected into a narrow space, emerging into a wide space, and then restoring to its original shape.

[0093] According to one embodiment, the branch portion may include an ultra-soft polymer having a Young's modulus of 20 kPa or more.

[0094] 15 illustrates the Young's modulus experimental results for testing the conditions for a polymer material that enables an electronic umbrella element according to an embodiment of the present invention to be effectively unfolded in a restricted environment. The inventors have confirmed that an ultra-soft polymer material may be necessary to achieve the objective of the present invention of enabling a crumpled electronic umbrella element to be smoothly unfolded again in a restricted height condition without affecting the target object.

[0095] In this case, the ultra-soft polymer material may preferably have a Young's modulus of 20 kPa or more so that it can be deformed to the intended shape without breaking and can be smoothly placed on the surface of the object, and more preferably, the polymer may be a material that also has a Young's modulus of 25 kPa or more.

[0096] If the polymer material is configured to have a Young's modulus of less than 20 kPa, the polymer material may not be smoothly applied during the process of being injected into the body and expanding, or may be placed in a folded state rather than expanding according to the intended structure.

[0097] The branch portion may also include a polymer having a wide elastic range of 250% or more based on Young's modulus. The polymer may be configured to include an additional polymer component having not only softness but also high elasticity, or to include a polymer satisfying both properties simultaneously.

[0098] The polymer material may be a shape-memory polymer that can restore itself to its original shape under certain conditions. However, if a functional group that can help the polymer restore itself to its original shape is added to the polymer, the restoration of the shape may proceed more smoothly. The present inventors focused on the temperature sensitivity of DNA as a functional group for the restoration of the shape.

[0099] According to one embodiment, the branch portion further includes DNA bound to the polymer, and the DNA may include a hairpin structure or double-stranded DNA.

[0100] Furthermore, the branch may be formed of a material containing DNA only in a partial region where a shape deformation mechanism is required. The partial region may be a region formed in a part that is subject to a large amount of strain during deformation. The partial region may form a region that is separated from other regions of the branch.

[0101] The DNA has an internal hydrogen bond structure, and reactions such as unfolding the hairpin structure or separating the double strands can occur in response to the ambient temperature. By including DNA, the temperature-sensitive structural transformation can be more precisely controlled to restore the shape.

[0102] The DNA is given as an example of a case where the polymer reacts to temperature conditions and the branches are deformed, but if the shape of the electronic umbrella element is restored under other conditions, the electronic umbrella element may additionally contain other components that help the polymer restore when exposed to the corresponding conditions.

[0103] According to one embodiment, the branch portions may form a network structure, which may include a plurality of chassis portions radiating from the central support portion at the center, and support portions formed to connect the chassis portions to each other.

[0104] The chassis portion serves to form the main framework of the branch portion, and various element portions may be formed on the chassis portion. The support portion may support the chassis portion so that it can be restored to its original shape when it is folded and unfolded. The support portion may also serve as a passage through which a multi-purpose circuit or electrode passes. The support portion may be formed in a wavy or circumferential design, or may form a curved pattern having a symmetrical structure. The support portion may directly or indirectly affect the behavior of the chassis portion by dispersing strain or helping the electronic umbrella element to be unfolded effectively when it is folded and unfolded.

[0105] According to one embodiment, an element unit may be formed on at least a portion of a portion where the chassis unit and the chassis support unit are connected. The element unit may be formed on the portion where the chassis unit and the support unit are connected, and may be electrically connected to an element unit formed on an adjacent chassis unit through the support unit. Also, according to one embodiment, element units may be formed on at least a portion of the end and middle of the chassis unit, respectively. That is, the element unit may be formed on any portion of the chassis unit of the branch, whether it is the end, a portion connected to the support unit, or a portion not connected to the support unit, according to a design suited to the purpose.

[0106] In this case, according to an embodiment, the device may include one or more of a sensor unit, an electrode unit, an electrical stimulation unit, a drug injection unit, an ultrasound transmission unit, a battery unit, and an optical transmission unit.

[0107] The sensor unit may be interpreted as a general concept and may include sensors applicable to various applications. The electrical stimulation unit may serve to promote transmission of the electrical stimulation signal to the receiving body.

[0108] The ultrasonic transmitter can transmit stimulation or signals through ultrasonic waves in addition to electrical stimulation generated through the electrical stimulation unit, thereby enabling the realization of treatment or diagnostic functions.

[0109] The optical transmission unit may be configured to include an optical transmitter, such as a light source, a photothermal element, or an optical fiber. When the optical fiber is included in the element unit, it may be used as a cooler to cool a specific point in the brain.

[0110] In one embodiment, the device unit may be configured to include a battery that generates electrical energy for autonomous operation. The battery unit may be formed to include a biodegradable battery.

[0111] According to an embodiment, the element unit may be a single element unit that performs multiple functions. One element unit does not necessarily have to be formed to perform one function, and if circuits or electrodes are formed small enough, one element unit may include multiple sensors or multiple electrodes. In addition, one or more of a drug injection unit, an ultrasound transmission unit, a battery unit, and an optical transmission unit may also be additionally formed.

[0112] According to one embodiment, at least two of the respective element units may perform different functions. In certain embodiments, different stimulations or drug injections may be required depending on the location of the brain. In this case, the element units at other locations may be designed to perform different functions to diagnose, treat, or prescribe the necessary treatment for each location.

[0113] 5 is an image showing an example in which different sensors and electrodes are formed in the element portions formed at the ends of the branches of an electronic umbrella device according to an embodiment of the present invention. As can be seen from FIG. 5, a strain sensor, a temperature sensor, a pH sensor, a passive electrode, an active electrode, etc. are formed at the ends of the respective chassis portions.

[0114] Also, in the image example shown in FIG. 5, it can be seen that the support parts connecting each chassis part are formed symmetrically with wavy curves. This structure is merely an example, and the introduction of such support parts may enable stable shape deformation despite the strain applied to each part during the folding and unfolding process. Without being limited to the example shown in FIG. 5, each single element part may have multiple sensors of various types, or sensors and electrodes may be formed together. Furthermore, a drug delivery part or a circuit capable of applying electrical stimulation to the brain surface may also be formed together.

[0115] According to one embodiment, each chassis part having an element part performing a different function may be assembled to be connected to the central support part. In a specific embodiment, each branch may not be manufactured simultaneously with the central support part, but may be integrated in a form in which the corresponding element part is mounted in a different location and then assembled to the central support part one by one.

[0116] FIG. 6 is a schematic diagram illustrating that different electronic modules may be formed in the device portion formed at the end of the branch portion of an electronic umbrella device according to an embodiment of the present invention. As shown in FIG. 6, each chassis portion may be fabricated in a form in which a pre-designed electronic module is mounted and assembled to face the central support portion in the intended direction according to the needs and purposes of the electronic device device. In this case, the lower cover layer (base substrate) of the electronic module may be formed of a material that is not only hermetically sealed but also flexible during folding and unfolding. In this embodiment, the substrate was fabricated using a polymer material blended with PLGA and PLCL. However, the lower and upper cover layers may be fabricated using any number of polymer materials that are flexible and elastic.

[0117] FIG. 7 is a schematic diagram showing a layered structure of an electronic umbrella element according to one embodiment of the present invention.

[0118] According to one example, a receiver coil for electronic communication means may be located on a lower cover layer (base substrate) made of a flexible material, and a separation layer (interlayer) separating an upper layer from a lower layer may be formed thereon. An active layer may be formed on the separation layer, and a gate oxide layer and an electrode layer may be formed thereon. An upper cover layer may be formed on the uppermost layer, symmetrically with the lower base substrate, and may serve to seal the lower cover layer and each layer located therebetween. The above-mentioned layers are merely examples of forming the electronic umbrella device of the present invention, and an electronic umbrella device may be manufactured by adding specific layers or omitting some layers as needed.

[0119] FIG. 8 is a schematic diagram (upper drawing) illustrating the central support part of an electronic umbrella element according to one embodiment of the present invention and an auxiliary support (solid support) that supports the upright structure of the central support part, and a cross-sectional view (lower drawing) illustrating a cross section showing the connecting structure between the branch parts and the central support part of the electronic umbrella device.

[0120] As can be seen from the top diagram of Figure 8, the auxiliary support not only serves to support the physical structure of the central support part, but also serves to center the electronic umbrella element without it falling over when the electronic umbrella element is inserted inside the injection device in a crumpled or folded state, or when the electronic umbrella element is ejected outside the injection device and then unfolded again.

[0121] Referring to the lower diagram of Figure 8, the branches support the central support and are folded upward in an "L" shape in the vertical direction (z-axis direction) based on the central support. This folded-up structure allows for a wired connection to other electronic devices outside the body. Of course, the electronic umbrella device of the present invention may also be designed to exchange signals with other electronic devices outside the body using wireless communication technology. The branches contain electrode lines made of Mo or Mg metal material inside and are encapsulated between a lower cover layer and an upper cover layer. Part of the lower cover layer is open, exposing part of the electrode to the outside, allowing electrical contact with the brain surface or a specific location inside the skull.

[0122] Figure 9 is an image showing an electronic umbrella device according to an embodiment of the present invention in which electrodes are connected by wires through a central support part formed in the folded structure of Figure 8 and connected to another electronic device outside the body. It can be seen that multiple element parts are formed at the ends and middle points of the chassis part in Figure 9. According to some embodiments, element parts may be formed at multiple points on a single chassis part.

[0123] 10 is an image showing the laminated structure of the element portions formed at the ends of the branches of an electronic umbrella element according to an embodiment of the present invention, and the actual manufactured shape and scale of the electronic umbrella element that expands to its original shape in response to temperature. As can be seen from the image on the right side of FIG. 10, each element portion can be formed with a diameter of around 1 mm.

[0124] FIG. 11 is a schematic diagram showing a stacked structure when a wireless communication function of an electronic umbrella element according to an embodiment of the present invention is installed.

[0125] If the electronic umbrella element is to be designed to wirelessly exchange signals with an external device, an NFC circuit or capacitor can be mounted in the central support. The results shown in Figure 11 confirm that the electronic umbrella device of the present invention can be designed to exchange signals with any number of external electronic devices wirelessly.

[0126] In many of the experiments conducted by the inventors, the electronic umbrella element became folded or crumpled, and when it left the injection device it was unable to unfold smoothly into the desired shape, resulting in problems such as the central axis collapsing or some of the branches not unfolding and becoming folded.

[0127] The inventors conducted various experiments to study the optimization of shape recovery yield. In one experiment, they focused on the contact angle formed when the end of each chassis part first contacted the bottom surface to which it was attached, and analyzed the sliding motion due to the contact angle. The inventors confirmed that in order for shape recovery to occur effectively in the limited height environment intended in this invention, the bottom landing angle of the chassis part is important, rather than the support part, which can be formed into a curved surface and is easily spread. Through this experiment, they were able to derive the result that the initial contact angle between each chassis part and the bottom surface (brain surface) must be formed at a certain level.

[0128] The contact angle (chassis contact angle) referred to hereinafter in the present invention is a factor directly related to successful shape recovery, and may refer to the angle formed between the surface and the element when the element comes into contact with the surface to be attached.

[0129] 18 shows the results of a simulation analyzing factors that affect the effective unfolding of an electronic umbrella element according to an embodiment of the present invention from a crumpled or folded 3D structure to a 2D structure. As can be seen from the experimental example of FIG. 18, the inventors conducted experiments on ejecting and unfolding electronic umbrella elements of various shapes to study the direction in which the electronic umbrella element slides and whether it is possible to design a desired contact angle when a support radius is formed with a certain structure and size.

[0130] Looking at the image in Figure 18, when the contact angle is below 70 degrees, a forward sliding motion like the one shown in the upper right corner occurs, and sufficient space for shape restoration is secured outward, resulting in successful shape restoration. On the other hand, when an angle exceeds 70 degrees, a backward sliding motion or a mixed sliding motion with other unwanted behaviors occurs, causing each chassis to become entangled or crumpled. Because the chassis that are entangled in this way have very limited space for restoration, they buckle and become tangled, which can result in unsuccessful shape restoration.

[0131] FIG. 19 is an image showing the problem of compensation of the contact angle at the end of the chassis when considering the friction on the surface of the electronic umbrella element according to one embodiment of the present invention and the resulting change in mechanism.

[0132] Additionally, when the friction factor on the brain surface is taken into consideration, the preferable range of the contact angle for the end of the chassis portion to slide forward appropriately may be somewhat reduced.

[0133] FIG. 20 is an image showing the problem of compensation of the contact angle at the end of the chassis when considering the friction on the surface of the electronic umbrella element according to one embodiment of the present invention and the resulting change in mechanism.

[0134] According to one embodiment, when the bio-injectable electronic device is injected in a solidified state in a direction in which the branch portion first contacts the brain surface, the contact angle at which the end of the chassis first contacts the subject may be 70 degrees or less, preferably 65 degrees or less. The contact angle may be 0.1 degrees or more. If the contact angle is less than 0.1 degrees, the entry itself is difficult when considering minimally invasive procedures. If the contact angle exceeds 70 degrees, damage may be caused to the brain surface, or the electronic device may not be able to slide outward effectively, resulting in problems such as crumpling or curling, which may prevent the device from restoring its intended shape or even causing damage to the device.

[0135] At this time, as can be seen from the images of FIGS. 19 and 20, the contact angle is determined based on the acute angle at which the end of the chassis part enters the subject (for example, the surface of the brain).

[0136] Furthermore, when the friction of the brain surface is taken into consideration, the appropriate range for the forward sliding motion may be further narrowed due to compensation of the chassis angle, and the contact angle may be more preferably 60 degrees or less.

[0137] Meanwhile, according to one embodiment, the bio-injectable electronic device may include an X-ray marker.

[0138] FIG. 12 shows a photographed image and an X-ray image of an embodiment in which an X-ray marker is included in an electronic umbrella device according to an embodiment of the present invention.

[0139] When manufacturing the electronic umbrella device of the present invention, if an X-ray marker material is included in at least a portion of each layer, it is easy to check whether the electronic umbrella device is properly injected, properly spread, and properly attached to the desired position, as shown in Figure 12. In this example, an iodixanol-based compound was used as an X-ray marker to perform X-ray imaging, but within the scope of the present invention, any number of X-ray marker materials can be used, and various position detection marker materials that serve as identifiers for various other diagnostic devices can also be used.

[0140] According to one embodiment, the central support portion forms a pillar-shaped shaft structure in the z-axis direction, and the central support portion may be provided with a means for enabling wireless communication with the outside, or a conductive line for enabling wired communication may pass through the central support portion. The means for enabling wireless communication is not particularly limited in the present invention, and an NFC chip may be used as an example. When the electronic umbrella element is formed to be connected by a wire, the conductive line may pass through the inside of the central support portion of the electronic umbrella element or an adjacent area in the vertical direction (z-axis direction) and connect to the outside of the skull.

[0141] According to one embodiment, the central support may include an auxiliary support for supporting the upright structure of the central support. The auxiliary support may be formed in an "L" shape, as shown in Fig. 8, and bent from the xy plane in the z-axis direction to connect and support the branch portions and the central support.

[0142] In another embodiment of the present invention, an electronic umbrella device for minimally invasive treatment is proposed as a biological injection type electronic device, which includes a central support portion and branch portions including a plurality of chassis portions extending from the central support portion, and which is configured as a 3D structure in the z-axis direction outside the body and injected into the body's internal environment with a height of 5 mm or less, and then expanded as a 2D structure in the x- and y-axes inside the body, thereby enabling minimally invasive treatment.

[0143] According to one embodiment, the ratio of the area of ​​the electronic umbrella element in an unfolded state to the area of ​​the electronic umbrella element in a folded state may be 10 times or more. The area of ​​the electronic umbrella element of the present invention in an unfolded state on the xy plane may be 10 times or more compared to the cross-sectional area of ​​the central support part. The area in the folded state may be the same as or smaller than the cross-sectional area of ​​the central support part. The area in the folded state may be based on the cross-sectional area of ​​the injection part of the injection device (e.g., the cross-sectional area of ​​the syringe discharge part). According to one embodiment of the present invention, the area in the unfolded state may be easily expanded to 100 times or more. According to one example, the area in the unfolded state may be expanded to a diameter of approximately 15 mm.

[0144] FIG. 16 is a simulation image showing the results of a search for the optimal structure of the chassis and support parts to enable the electronic umbrella element according to one embodiment of the present invention to be effectively expanded in a restricted environment while being ejected from an injection device.

[0145] FIG. 17 is an image showing the respective designs of an electronic umbrella device according to an embodiment of the present invention and the corresponding filling ratio values.

[0146] In order to quantify the strain applied to the electronic umbrella element discharged from the injection device, the inventors designed various chassis and chassis support structure (branch structure) and confirmed and analyzed the strain applied to each position. By varying the number, width, and length of the chassis and chassis support, the inventors compared the maximum strain value generated under each condition based on the filling area value of the actual device area (the sum of the cross-sectional areas of the central support and branches) compared to the coverage area, which is the maximum area when the device is spread out over a large area.

[0147] Through this, the inventors have derived a new parameter called the fraction of filling area, which can determine the optimal value for effectively spreading the electronic umbrella element discharged from the injection device under the condition of a height of 5 mm or less.

[0148] *Filling Ratio = Fraction of Filling Area = Filling Area (AF) / Coverage Area (Ac)

[0149] The inventors were able to define the optimal design structure that allows 2D-3D-2D transformation under limited conditions in terms of the filling ratio (fraction of filling area).

[0150] In the present invention, the ratio of the filling area, which is the area of ​​the actual device, to the total coverage area, which is the area occupied by the device, is defined as the filling ratio. This filling ratio is a value that can be adjusted by changing the number, width, extent, and length of the chassis structure and the support structure. As a result of conducting FEA simulations on the maximum strain applied to the element with different filling ratios, it was confirmed that the larger the filling ratio, the larger the maximum strain value applied to the element.

[0151] The filling ratio may refer to an optimal design structure that prevents brittle breakage during folding or unfolding of an electronic element formed on a polymer material of an electronic umbrella element. The filling ratio may define a value close to a limit value that allows the intended behavior of the present invention to be achieved without breaking, based on the material or structure of the electronic element.

[0152] According to an embodiment, the electronic umbrella element may have a filling ratio of 0.6 or less.

[0153] In addition, the filling ratio may be 0.05 or more. If the filling ratio is less than 0.05, the area of ​​the electronic umbrella element for mounting electronic components such as electrodes may become too small, which may make it difficult to effectively use the electronic umbrella element.

[0154] On the other hand, if the filling ratio exceeds 0.6, the strain applied to the device becomes too large, which may cause cracks or damage to the polymer material and electrode material that form the base of the device.

[0155] The filling ratio is preferably 0.4 or less, and more preferably within the range of 0.1 to 0.38.

[0156] 18 is a schematic diagram showing the cross-sectional structure of the lower cover layer and the upper cover layer around the branch electrode of the electronic umbrella device according to one embodiment of the present invention. In the embodiment shown in FIG. 18, it was confirmed that when the cross-sectional thicknesses of the lower cover layer and the upper cover layer are formed to be the same, a neutral plane is formed, thereby minimizing strain applied to the electrode and the electronic device layer.

[0157] 13 shows an FEA simulation image showing that excessive strain caused by deformation can cause damage to the electronic umbrella element according to an embodiment of the present invention when it is first injected into an injection device, and an actual image of a cracked and damaged electronic umbrella element. At this time, the electronic umbrella element is transformed from a two-dimensional structure on the xy plane into a three-dimensional pillar structure that is folded or crumpled over an area approximately the diameter of the central support.

[0158] In another embodiment of the present invention, an electronic umbrella device for minimally invasive procedures may be configured such that, when the branches are injected in a direction that first contacts the brain surface, the greatest strain is generated in the uppermost chassis support portion of the plurality of chassis supports that is closest to the central support portion when the branches contact the brain surface. In the electronic umbrella device proposed in the present invention, when the branches first enter the surface of the subject, the greatest strain is generated in the uppermost chassis support portion of the chassis supports that are formed to connect chassis portions that are not chassis portions. In this case, if only one chassis support portion is formed to connect the ends of the chassis portions, the greatest strain may be generated in the distal chassis support portion that connects the ends of the chassis portions (see FIG. 13).

[0159] 14 shows an FEA simulation image of an electronic umbrella element according to an embodiment of the present invention unfolding as planned when it is ejected from an injection device to the outside, and a photographed image of the electronic umbrella element that failed to unfold in reality. At this time, the electronic umbrella element must be smoothly unfolded again from its folded or crumpled 3D columnar structure to its existing 2D structure on the xy plane as it is ejected to the outside of the injection device. However, this experiment confirmed that even if a shape-memory material is used to satisfy the temperature condition, various conditions must be precisely designed in order for the electronic umbrella element to restore to its original structure under limited height conditions.

[0160] At this time, as a result of analysis through the simulations shown in Figures 13 and 14, it was confirmed that a large amount of strain is applied to the part where the central support part and the branch part are connected and to the chassis support part that connects the chassis parts.

[0161] In yet another embodiment of the present invention, an electronic umbrella device for minimally invasive treatment is proposed as a bioinjectable electronic device, comprising: a central support portion; and branch portions including a plurality of chassis portions extending from the central support portion; when the electronic umbrella device enters the environment between the inner wall of the skull and the brain surface, the branch portions unfold and come into contact with the brain surface to operate; the chassis portion may be formed by stacking a plurality of layers and then encapsulating them, and may include at least three layers: a lower cover layer, an electrode, and an upper cover layer.

[0162] In this case, as described above, the lower cover layer and the upper cover layer serve to seal the electrodes and may be made of a material that is ultra-soft and highly elastic. The selection of the material for the lower cover layer and the upper cover layer may be an important factor in enabling the electronic umbrella device of the present invention to be unfolded after being crumpled or folded.

[0163] As described above, when the lower and upper cover layers are formed symmetrically in Fig. 18, the electrodes and electronic elements sealed therein may be subjected to minimal strain. Therefore, in the present invention, it may be preferable to form the lower and upper cover layers to the same thickness.

[0164] According to one embodiment, the branch portion may further include one or more layers selected from the group consisting of an active layer, an inter-layer, a receiver coil layer, and a gate oxide layer. The electronic umbrella device of the present invention may be formed by introducing various layers as needed, and various examples thereof are shown in FIGS. 7, 10, and 11.

[0165] 21 is a schematic diagram illustrating that the electronic umbrella element according to one embodiment of the present invention can be spread more smoothly if a lubricant is present. The electronic umbrella element of the present invention can be spread more easily if a suitable lubricant is injected into the injection device or into the body using a separate tool. However, since there is a risk that the lubricant may cause the element to deviate from the target position and not be attached to the appropriate point, it was recognized that research is needed to find the optimal lubricant conditions.

[0166] This will be discussed further when explaining the injection method of the electronic umbrella element.

[0167] 22 is an image showing the results of biodegradation of an electronic umbrella device according to an embodiment of the present invention as designed after an appropriate period of time. In this example, it can be seen that the electronic umbrella device gradually decomposes after two weeks, and after 45 days, most of it has decomposed into strands of 10 mm or less. The decomposition rate of such an electronic umbrella device can be adjusted as desired by designing the material composition using a combination of various biodegradable materials.

[0168] 2. Manufacturing method of electronic umbrella element

[0169] A method for manufacturing the electronic umbrella element of the present invention will be described below with reference to FIGS.

[0170] The electronic umbrella device of the present invention may be manufactured by any method generally applicable in the art, and the present invention does not particularly limit the manufacturing method. However, the following description is intended to illustrate that the electronic umbrella device of the present invention may be manufactured by a somewhat special method as proposed below in a specific embodiment.

[0171] In another embodiment of the present invention, in a method for manufacturing an electronic umbrella element for minimally invasive procedures, the electronic umbrella element is not manufactured in a one-step process such as removing it from a mold. Instead, the electronic umbrella element of the present invention can be manufactured through a multi-step stacking process similar to semiconductor manufacturing processes. A distinctive feature of the method for manufacturing an electronic umbrella element of the present invention is clearly shown in the manufacturing process of the branch portion. Figures 21 and 22 sequentially illustrate and explain the manufacturing process of the chassis portion of the branch portion.

[0172] 23 is a process diagram illustrating the cross-sectional structure of each step in a manufacturing process of a chassis of an electronic umbrella device according to an embodiment of the present invention. Unlike stents and other surgical tools that use shape-memory alloys to restore their intended shape inside the body, this embodiment of the present invention may be a sealed electronic device that encapsulates electrodes and circuits within a polymer. Therefore, unlike conventional surgical tools that use alloys or metals, it may be manufactured using lamination processes, photoresist processes, laser processes, and the like used in semiconductor processes. However, the method presented in this drawing is merely one example of a method for manufacturing the electronic umbrella device of the present invention, and the technical concept of the present invention is not limited thereto.

[0173] Also, the chassis may be attached to the central support in a form in which it is assembled after forming the element part according to its purpose.

[0174] In this case, the manufacturing method of the electronic umbrella device may include assembling a plurality of prepared chassis parts to the central support part.

[0175] 24 is a process diagram illustrating the process of attaching the chassis of the electronic umbrella device to the lower substrate and connecting it to the central support in accordance with an embodiment of the present invention through cross-sectional structures at each stage. From the image in FIG. 24, it can be seen that the chassis is attached based on the central support, folded in an "L" shape, and extends in the vertical direction (z-axis direction).

[0176] Unlike stents and other surgical tools that use shape memory alloys to restore their intended shape inside the body, the electronic umbrella device of the present invention may be a sealed electronic device that encapsulates electrodes and circuits within a polymer. Therefore, unlike conventional surgical tools that use alloys or metals, it can be manufactured using lamination processes, photoresist processes, laser processes, etc., used in semiconductor processes. However, the method presented in the drawings is merely one example of how to manufacture the electronic umbrella device of the present invention, and the technical concept of the present invention is not limited thereto.

[0177] This method is merely one example of connecting the chassis part and the central support part, but when the chassis part is connected to the central support part in this manner, the chassis part may be manufactured by including the steps of: preparing a lower substrate; forming a lower cover layer on the lower substrate; forming a central support part on the lower cover layer; forming a stack of the prepared electrodes and upper cover layer on the lower cover layer; and folding up one side of the lower cover layer, electrodes, and upper cover layer based on the central support part.

[0178] In yet another embodiment of the present invention, a method for manufacturing a bio-injected electronic device includes manufacturing the branch portion by forming a layered structure including the lower cover layer, the electrode, and the upper cover layer, and the layered structure forming process may include designing the structure of each layer through a laser process. The process for forming the layered structure through a laser process is also shown in Figures 21 and 22.

[0179] 3. Method of injecting electronic umbrella elements into the body

[0180] In order to achieve the above technical object, another aspect of the present invention relates to a method for injecting an electronic umbrella element into a body for minimally invasive surgery.

[0181] A method for injecting a bio-injectable electronic device proposed in one embodiment of the present invention relates to a method for injecting a bio-injectable electronic device into the body, which enters the environment between the inner wall of the skull and the surface of the brain, and the branch portions unfold to contact the brain surface and operate, and the bio-injectable electronic device includes a central support portion and branch portions including a plurality of chassis portions extending from the central support portion, and the method includes the steps of folding and inserting the bio-injectable electronic device into an injection device; injecting the bio-injectable electronic device into a hole made in the skull; positioning the bio-injectable electronic device on the brain surface while unfolding inside the skull; and operating the bio-injectable electronic device on the brain surface.

[0182] According to one embodiment, the step of positioning the bio-implantable electronic element on the brain surface while the bio-implantable electronic element is unfolded inside the skull may include a step of the branches of the bio-implantable electronic element unfolding themselves in the environment inside the skull.

[0183] According to one embodiment, the step of folding and inserting the bio-injectable electronic device into a sealed injection device having a narrow, closed space may further include the step of injecting a lubricant into the sealed injection device together, and the lubricant may not only help the bio-injectable electronic device to be smoothly folded and inserted into the sealed injection device, but also allow the bio-injectable electronic device to be smoothly unfolded and slidably inserted onto the brain surface when unfolded again and positioned on the brain surface. In this case, by appropriately selecting the lubricant and the material (including the coating layer material) of the portion of the electronic umbrella device that contacts the brain surface, according to one embodiment, the coefficient of friction can be controlled to be sufficiently low.

[0184] As described above, the lubricant can help prevent damage to the electronic umbrella element when it is inserted into or ejected from the injection device, and can also mitigate irritation applied to the surface of the object so that it can slide smoothly over the surface of the object.

[0185] Although the lubricant used in the embodiment of the present invention is a glycerol-based organic compound, the lubricant is not limited to this type of material and may be any lubricant commonly used in surgery that is harmless to the human body.

[0186] According to one embodiment, the step of spreading the bio-injectable electronic device and positioning it on the brain surface may involve using an adhesive to ensure that the bio-injectable electronic device adheres well to the target location on the brain surface. It may be preferable to use an adhesive in addition to the lubricant. The adhesive may serve to ensure that the electronic umbrella device adheres well to the surface of the intended subject.

[0187] In addition to the lubricant and adhesive, the electronic umbrella element may be coated with a waterproofing agent to ensure that the electronic umbrella element operates well in a moisture-containing environment. In particular, the open structure of the lower cover layer may be coated with a waterproofing agent to prevent moisture from entering before the electronic umbrella element adheres to the surface of the object, and the coating may disappear after a certain period of time. This allows the electronic umbrella element to operate more effectively.

[0188] 4. In vivo experiments

[0189] The present inventors have manufactured various electronic umbrella devices manufactured by the above-described method and conducted experiments in an in vivo environment to test whether the object of the present invention is actually realized.

[0190] 25 to 27 are images and graphs showing in-vivo experimental results of an electronic umbrella device according to an embodiment of the present invention.

[0191] FIG. 25 shows an image and graph of an experiment in which signals transmitted from each element unit of an electronic umbrella element according to an embodiment of the present invention were measured when the elements were attached to different positions on the brain surface of an animal.

[0192] 26 is a graph showing temperature signals received when an electronic umbrella device according to an embodiment of the present invention is manufactured to be capable of wireless communication via NFC and then inserted into the brain surface of an animal, and the temperature is controlled by turning an IR lamp on and off. FIG. 24 shows that there is no significant difference between the control experiment using a commercially available temperature sensor and the case where the electronic umbrella device of the present invention is used.

[0193] Figure 27 is an image showing the gradual biodegradation process of an electronic umbrella device according to an embodiment of the present invention 35 days after it was injected into the surface of an animal body. The image in Figure 27 clearly shows that biodegradation is progressing in line with the target time.

[0194] The above description merely exemplifies the technical concept of the present invention, and various modifications and variations may be made by those skilled in the art without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed herein are for illustrative purposes only and are not intended to limit the technical concept of the present invention. The scope of the present invention should be interpreted by the following claims, and all technical concepts within the scope of the claims should be interpreted as being within the scope of the present invention.

Claims

1. A bio-injected electronic device, central support; and branch portions extending from the central support portion; When the electronic umbrella element for minimally invasive surgery enters the environment between the inner wall of the skull and the surface of the brain, the branch parts spread out and come into contact with the surface of the brain, whereupon they are activated and then biodegraded and expelled from the body.

2. the branch portion includes an electrode; and a cover layer covering the electrode from above and below; The electronic umbrella device for minimally invasive surgery according to claim 1 , wherein the cover layer has an open structure and includes a partial area where the electrode is exposed to the outside.

3. The electronic umbrella device for minimally invasive surgery according to claim 1 , wherein the branch portions include a shape-memory polymer that restores its shape when a condition for the surrounding environment is met.

4. The conditions for the ambient environment are:

4. The electronic umbrella device for minimally invasive surgery according to claim 3, wherein the ambient environment includes one or more conditions selected from the group consisting of temperature, humidity, pH concentration, light intensity, ultrasound, and electromagnetic field.

5. 2. The electronic umbrella device for minimally invasive surgery according to claim 1, wherein the branch portion comprises a highly elastic, ultra-soft polymer having a wide elastic range of 250% or more based on Young's modulus and a Young's modulus of 20 kPAa or more.

6. the branch further comprises DNA bound to the polymer; The electronic umbrella device for minimally invasive surgery according to claim 5 , wherein the DNA comprises a hairpin structure or double-stranded DNA.

7. The electronic umbrella device for minimally invasive surgery according to claim 6 , wherein the branch portion is formed of a material containing DNA bound to a polymer only in a partial region.

8. The electronic umbrella device for minimally invasive surgery according to claim 1 , wherein the branch portions form a network structure.

9. The network structure is a plurality of chassis portions radially extending from the central support portion; and The electronic umbrella device for minimally invasive surgery according to claim 8 , further comprising: a chassis support portion formed to connect the chassis portions to each other.

10. When the bio-injectable electronic device is injected in a solid state in a direction in which the branch first contacts the brain surface, The electronic umbrella device for minimally invasive surgery according to claim 9, wherein a contact angle at which the end of the chassis first comes into contact with the subject is formed to be 70 degrees or less.

11. The electronic umbrella device for minimally invasive surgery according to claim 9 , wherein an element portion is formed on at least a part of a portion where the chassis portion and the chassis support portion are connected.

12. The electronic umbrella device for minimally invasive surgery according to claim 9, wherein the chassis part has element parts formed at least in part at the end and middle points of the chassis part.

13. 13. The electronic umbrella device for minimally invasive surgery according to claim 12, wherein the element unit includes one or more of a sensor unit, an electrode unit, an electrical stimulation unit, a drug injection unit, an ultrasound transmission unit, a battery unit, and an optical transmission unit.

14. The electronic umbrella device for minimally invasive surgery according to claim 12 , wherein the device unit is a single device unit that performs a plurality of functions.

15. The electronic umbrella device for minimally invasive surgery according to claim 12, wherein at least two of the element units perform different functions.

16. The electronic umbrella device for minimally invasive surgery according to claim 15, wherein each chassis part having the element parts performing different functions is assembled to be connected to the central support part.

17. The electronic umbrella device for minimally invasive surgery according to claim 1 , wherein the bio-injected electronic device includes a position detection marker.

18. The central support portion forms a pillar-shaped axial structure in the z-axis direction, The electronic umbrella device for minimally invasive surgery according to claim 1 , wherein the central support portion is provided with a means for enabling wireless communication with the outside or has a conductive line passing therethrough for enabling wired communication.

19. The electronic umbrella device for minimally invasive surgery according to claim 18, wherein the central support includes an auxiliary support for supporting an upright structure of the central support.

20. A bio-injected electronic device, central support; and a branch portion extending from the central support portion and including a plurality of chassis portions; An electronic umbrella element for minimally invasive treatment that can be used for minimally invasive treatment by being solidified in a 3D structure along the z-axis outside the body, injected into an internal environment with a height of 5 mm or less, and then expanding in a 2D structure along the x-y axes inside the body.

21. The electronic umbrella device for minimally invasive surgery according to claim 20, wherein the ratio of the area of ​​the electronic umbrella device in an unfolded state to the area of ​​the electronic umbrella device in a folded state is 10 times or more.

22. The electronic umbrella device for minimally invasive surgery according to claim 20, wherein the electronic umbrella device has a filling ratio of 0.6 or less.

23. A bio-injected electronic device, central support; and a branch portion including a plurality of chassis portions extending from the central support portion; a plurality of chassis supports formed to connect the plurality of chassis parts to each other; When the device enters the environment between the inner wall of the skull and the surface of the brain, the branches are expanded and come into contact with the surface of the brain to operate. An electronic umbrella element for minimally invasive surgery, which has a structure in which, when the branch portions are injected in a direction in which they first contact the brain surface, the most strain is formed on the uppermost chassis support portion of the chassis support portions that is closest to the central support portion when they contact the brain surface.

24. A bio-injected electronic device, central support; and a branch portion extending from the central support portion and including a plurality of chassis portions; When the branch enters the environment between the inner wall of the skull and the surface of the brain, the branch spreads and comes into contact with the surface of the brain to operate, The chassis is made by laminating multiple layers and then encapsulating them. An electronic umbrella element for minimally invasive procedures, comprising at least three layers: a lower cover layer, an electrode, and an upper cover layer.

25. 25. The electronic umbrella device for minimally invasive surgery of claim 24, wherein the chassis part further includes one or more layers selected from the group consisting of an active layer, an inter-layer, a receiver coil layer, and a gate oxide layer.

26. In a method for manufacturing a living body injection type electronic device, When the bio-injected electronic device enters the environment between the inner wall of the skull and the surface of the brain, the branch parts are expanded and come into contact with the surface of the brain to operate, central support; and a branch portion having a plurality of chassis portions extending from the central support portion; assembling a plurality of prepared chassis parts to the central support part.

27. In a method for manufacturing a living body injection type electronic device, When the bio-injected electronic device enters the environment between the inner wall of the skull and the surface of the brain, the branch parts are expanded and come into contact with the surface of the brain to operate, central support; and a branch portion having a plurality of chassis portions extending from the central support portion; The chassis portion includes: providing a lower substrate; forming a lower cover layer on the lower substrate; forming a central support on the lower cover layer; forming a stack of the prepared electrode and an upper cover layer on the lower cover layer; and folding up the lower cover layer, the electrode, and one side of the upper cover layer based on the central support portion.

28. In a method for manufacturing a living body injection type electronic device, When the bio-injected electronic device enters the environment between the inner wall of the skull and the surface of the brain, the branch parts are expanded and come into contact with the surface of the brain to operate, a central support portion; and branch portions each having a plurality of chassis portions extending from the central support portion; The branch portion is manufactured by forming a laminated structure including the lower cover layer, the electrode, and the upper cover layer, The method for manufacturing an electronic umbrella device for minimally invasive surgery, wherein the process for forming the laminated structure includes a step of designing the structure of each layer through a laser process.

29. The present invention relates to a method for injecting a bio-injectable electronic device into a body, which operates by contacting the brain surface while expanding its branches when it enters the environment between the inner wall of the skull and the brain surface, The bio-injected electronic device comprises: central support; and a branch portion extending from the central support portion and including a plurality of chassis portions; folding the bio-injectable electronic device into an injection device; injecting the bio-implantable electronic device into a hole drilled in the skull; the implantable electronic device is positioned on the brain surface while being spread inside the skull; and A method for implanting an electronic umbrella element into the body for minimally invasive surgery, comprising: a step of operating the bio-implanted electronic element on the brain surface.

30. a step in which the bio-implantable electronic device is positioned on the brain surface while being spread inside the skull; The method for injecting an electronic umbrella element into a body for minimally invasive surgery according to claim 29, further comprising a step of allowing the branches of the biologically injected electronic element to unfold themselves in an environment inside the skull.

31. folding the bio-injectable electronic device into a sealed injection device containing a closed space; co-injecting a lubricant into the sealed injection device; 30. The method of injecting an electronic umbrella element into a body for minimally invasive surgery according to claim 29, wherein the lubricant allows the bio-injectable electronic element to be smoothly spread and slide on the brain surface when the bio-injectable electronic element is spread and positioned on the brain surface.

32. a step of positioning the bio-implantable electronic device on the brain surface while spreading it; The method for injecting an electronic umbrella element into the body for minimally invasive surgery according to claim 29, wherein the adhesive allows the bio-injectable electronic element to adhere well to the targeted point on the brain surface.

Images