Electronic umbrella element for minimally invasive surgery and manufacturing method therefor

Abstract

The present invention discloses an electronic umbrella element for minimally invasive surgery. According to an embodiment of the present disclosure, the electronic umbrella device for minimally invasive surgery comprises: a central support part; and a branch part extending from the central support part. When the element enters an environment between an inner wall of the skull and a surface of the brain, the branch part is unfolded and comes into contact with the surface of the brain to work, followed by being biodegraded and discharged to the outside of the body.

Description

Electronic umbrella device for minimally invasive surgery and method for manufacturing the same

[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.

[0002] Unless otherwise indicated herein, the matters described in this identifier are not prior art to the claims of this application, and their description in this identifier is not intended to be deemed prior art.

[0003] In general, electronic devices used for medical purposes are implanted inside the body through surgery, so they have the disadvantage of being exposed to various side effects during the skin incision and recovery process.

[0004] Therefore, a technology is needed that can reduce the volume of the electronic device during the implantation process to enable implantation of the electronic device through minimally invasive surgery by making an incision in the skin and implanting the electronic device.

[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, existing inventions do not disclose a technology that can minimize incisions in the body by reducing the volume through shape transformation during the transplantation process.

[0007] In addition, existing overseas public technologies only partially disclose the concept of how they can be expanded within the body, and there is no technology that specifically addresses which part of the body can be entered and in what form, or how they can interact with the target object after entry.

[0008] Naturally, bio-implantable electronic devices, for which stability verification is extremely important, have rarely been tested in vivo, and thus, efforts to commercialize bio-implantable electronic devices aimed at minimal invasiveness have been slow.

[0009] The purpose 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 bio-implantable electronic device for minimally invasive procedures for various purposes such as diagnosis, treatment, and research.

[0010] The object of the present invention is to provide an electronic device that is injected into the body using a minimally invasive method in a reduced volume state through a change in the shape of the electronic device, and that automatically changes shape under specific conditions in a target environment.

[0011] In this process, we propose a material and structure for an electronic device that can be folded or crumpled into a narrow-cross-sectional injection device (e.g., a syringe) for minimally invasive surgery and then gently unfolded and settled without causing any abnormality in its shape or structure while being discharged, and without causing damage to the target body part.

[0012] In addition, it aims to transform its shape by itself when injected into the body without the introduction of a separate external signal, spread out to have a large surface area, and interact with parts of the body, such as collecting information from the body or applying stimulation.

[0013] Another goal of this electronic device is to be biodegradable within the body after it has served its intended purpose and to be safely excreted without residue.

[0014] The contents proposed in the present invention below are not limited to the technical problems described above, and it is obvious that other technical problems may be derived from the following description.

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

[0016] In one embodiment of the present invention, a bio-injectable electronic device includes a central support portion and a plurality of branches extending from the central support portion, and when the device enters an environment between the inner wall of the skull and the surface of the brain, the branches unfold and come into contact with the surface of the brain to operate, and then are 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; wherein the cover layer may have an open structure formed so as to include a portion of the electrode exposed to the outside.

[0018] In one embodiment, the branch may include a shape memory polymer whose shape is restored when conditions regarding the surrounding environment are met.

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

[0020] In one embodiment, the branch portion may comprise 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 kPa or more.

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

[0022] In one embodiment, the branch portion may be formed of a material containing DNA only for a portion of the region where the mechanism of shape deformation is required to occur.

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

[0024] According to one embodiment, the network structure may include a plurality of chassis portions radially spread out with the central support portion at the center; and a chassis support portion formed to connect the chassis portions to each other.

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

[0026] According to one embodiment, each of the component parts may be formed at at least a portion of the end and middle points of the chassis portion.

[0027] According to one embodiment, it 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 a light transmission unit.

[0028] In one embodiment, the element portion may be a single element portion that performs multiple functions.

[0029] According to one embodiment, at least two of the above-described individual elements may perform different functions.

[0030] According to one embodiment, each of the chassis sections having the different function-performing elements may be assembled to be connected to the central support.

[0031] According to one embodiment, when the bio-injectable electronic device is injected in a clumped 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 target object may be formed to be 70 degrees or less.

[0032] In one embodiment, the bio-implantable electronic device may include an X-ray marker.

[0033] According to one embodiment, the central support may form a columnar shaft structure in the z-axis direction, and the central support may be provided with a means for enabling wireless communication with the outside or may have a conductive line passing through it for enabling wired communication.

[0034] According to one embodiment, the central support may include a solid support that supports the standing structure of the central support.

[0035]

[0036] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure is proposed as a bio-injectable electronic device, which includes a central support portion; and a branch portion including a plurality of chassis portions extending from the central support portion; and is formed to form a 3D structure in the z-axis direction outside the body, and is injected into an internal environment having a height of less than 5 mm, and then unfolds into a 2D structure in the xy-axis inside the body, thereby enabling a minimally invasive procedure.

[0037] In one embodiment, the electronic umbrella element may have a ratio of an area in an unfolded state to an area in a folded state that is at least 10 times greater.

[0038]

[0039] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure is proposed as a bio-injectable electronic device, comprising: a central support; a branch portion including a plurality of chassis portions extending from the central support portion; and a plurality of chassis supports formed to connect the plurality of chassis portions to each other; and when the branch portions enter an 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, and when the branch portions are injected in a direction in which they come into first contact with the surface of the brain, the structure may be such that the greatest strain is formed in the uppermost support portion formed closest to the central support portion among the supports when they come into contact with the surface of the brain.

[0040]

[0041] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure is proposed as a bio-injectable electronic device, including a central support portion and a branch portion including a plurality of chassis portions extending from the central support portion, and when the branch portion enters an environment between the inner wall of the skull and the surface of the brain, the branch portion unfolds and comes into contact with the surface of the brain to operate, and the branch portion may be encapsulated after a plurality of layers are laminated, and may include at least three layers of a lower cover layer, an electrode, and an upper cover layer.

[0042] According to one embodiment, the branch portion may further include one or more layers of an active layer, an interlayer, a receiver coil layer, and a gate oxide layer.

[0043]

[0044] In addition, another embodiment proposed in another aspect of the present invention relates to a method for manufacturing an electronic umbrella device for minimally invasive surgery.

[0045] In one embodiment of the present invention, a method for manufacturing a bio-injectable electronic device is proposed, wherein the bio-injectable electronic device operates by contacting the brain surface while the branch portions are spread out when entering an environment between the inner wall of the skull and the brain surface, and may include a central support portion; and a branch portion having a plurality of chassis portions extending from the central support portion; and a step of assembling the plurality of prepared chassis portions to the central support portion.

[0046]

[0047] In another embodiment of the present invention, a method for manufacturing a bio-implantable electronic device is proposed, wherein the bio-implantable electronic device operates by contacting the brain surface when the branch portions are spread out when entering an environment between the inner wall of the skull and the brain surface, and includes a central support portion; and a branch portion having a plurality of chassis portions extending from the central support portion; wherein the chassis portions are manufactured by including the steps of: preparing a lower substrate; forming a lower cover layer on the lower substrate; forming a central support portion on the lower cover layer; forming a laminate of prepared electrodes and an 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.

[0048]

[0049] In another embodiment of the present invention, a method for manufacturing a bio-implantable electronic device is proposed, wherein the bio-implantable electronic device is configured to operate by contacting the brain surface when the branch portion is unfolded when entering an environment between the inner wall of the skull and the brain surface, and includes a central support portion; and a branch portion having a plurality of chassis portions extending from the central support portion; and the branch portion is manufactured by including a process of forming a laminated structure including the lower cover layer, an electrode, and an upper cover layer, and the process of forming the laminated structure may include a step of designing the structure of each layer through a laser process.

[0050]

[0051] Another embodiment of the present invention, which is proposed to solve the above-described problem, relates to a method for intra-body injection of an electronic umbrella device for minimally invasive surgery.

[0052] In one embodiment of the present invention, a method for injecting a bio-implantable electronic device into a body is provided, wherein the bio-implantable electronic device operates by contacting the brain surface while the branch portions unfold when entering an environment between the inner wall of the skull and the brain surface, wherein the bio-implantable electronic device includes a central support portion and a branch portion including a plurality of chassis portions extending from the central support portion, and the method comprises the steps of: folding the bio-implantable electronic device into an injection device; injecting the bio-implantable electronic device into a hole drilled in the skull; positioning the bio-implantable electronic device on the brain surface while unfolding inside the skull; and operating the bio-implantable electronic device on the brain surface.

[0053] In one embodiment, the step of the bio-implantable electronic device unfolding inside the skull and positioning itself on the brain surface may include a step of the branch portion of the bio-implantable electronic device unfolding on its own in the environment inside the skull.

[0054] According to one embodiment, the step of folding the bio-implantable electronic device into a sealed injection device including a narrow lung space further includes the step of injecting a lubricant into the sealed injection device together, wherein the lubricant may enable the bio-implantable electronic device to smoothly unfold and slide onto the brain surface during the step of unfolding the bio-implantable electronic device and positioning it on the brain surface.

[0055] According to one embodiment, the step of positioning the bio-implantable electronic device on the brain surface while unfolding may be such that the bio-implantable electronic device adheres well to a target point on the brain surface using an adhesive.

[0056] According to one embodiment disclosed herein, the electronic device has the advantage of providing an implantable electronic device that enables minimally invasive surgery or procedures within the skull.

[0057] The electronic device proposed in the embodiment of the present invention has the advantage of enabling new types of medical treatment, surgery, diagnosis, etc. to be attempted with only a minimal skull incision, instead of conventional attempts to sense brain signals or stimulate the brain from outside the skull due to the risk of having to incise the skull over a large area.

[0058] Furthermore, when utilizing the electronic device, its manufacturing method, and its injection method proposed in the present invention, the electronic device can be folded without problems into a sealed space within an injection tool having a very narrow cross-sectional area, and when it is taken out of the injection tool and back into the open environment outside, it unfolds again in its intended shape without malfunction or abnormality. This enables direct contact with the inside of the skull using a minimally invasive method, thereby enabling direct interaction with the brain surface.

[0059]

[0060] In addition, since the effects of the present invention described as such are naturally exerted by the composition of the described contents regardless of whether the inventor is aware of them, the above-described effects are only a few effects according to the described contents and should not be recognized as describing all effects that the inventor has recognized or actually existed.

[0061] In addition, the effects of the present invention should be additionally understood by the entire description of the specification, and even if not explicitly described in sentences, if a person with ordinary knowledge in the technical field to which the described content belongs can recognize such effects through this specification, then it should be regarded as an effect described in this specification.

[0062] FIG. 1 is a schematic diagram illustrating a process in which an electronic umbrella device according to one embodiment of the present invention is injected into the skull through a syringe in a folded or crumpled state, then unfolds to perform its original function and then biodegrades.

[0063] Figure 2 is a schematic diagram showing a technical solution problem in which plastic deformation occurs within the injection device when the electronic umbrella element is folded or crumpled into a narrow injection device, or the device is damaged due to friction with the inner wall when entering or exiting the injection device, and the shape is not restored to the pre-designed design.

[0064] Figure 3 is a photograph and diagram showing the narrow space between the inner wall of the skull and the surface of the brain, and is a schematic diagram showing the spatial constraints within which an electronic umbrella device, folded or crumpled in a space less than 5 mm high, must be effectively deployed.

[0065] FIG. 4 is a schematic diagram illustrating a structure in which an electronic umbrella device according to one embodiment of the present invention is spread out in two dimensions (xy plane) before injection into the body, then forms a three-dimensional (z plane) structure that enters a narrow space of an injection device for minimal invasion, and then spreads out in two dimensions again inside the skull.

[0066] FIG. 5 is an image showing an example in which different sensors and electrodes are formed in each of the device portions formed at the ends of branches of an electronic umbrella device according to one embodiment of the present invention.

[0067] FIG. 6 is a schematic diagram showing that different electronic modules can be formed in a device portion formed at the end of a branch portion of an electronic umbrella device according to one embodiment of the present invention.

[0068] Fig. 7 is a schematic diagram showing a laminated structure of an electronic umbrella element according to one embodiment of the present invention.

[0069] FIG. 8 is a schematic diagram (upper figure) showing a central support of an electronic umbrella device according to one embodiment of the present invention and an auxiliary support (solid support) that supports the upright structure of the central support, and a cross-sectional view (lower figure) showing a connection structure of a branch portion and the central support of an electronic umbrella device.

[0070] FIG. 9 is an image showing a form in which an electrode is connected by wires through a central support formed with a folded structure of FIG. 8 of an electronic umbrella element according to one embodiment of the present invention and connected to another electronic device outside the body.

[0071] FIG. 10 is an image showing the laminated structure of the element portion formed at the end of the branch portion of the electronic umbrella element according to one embodiment of the present invention and the actual manufactured form and scale of the electronic umbrella element unfolding into its original form in response to temperature.

[0072] Fig. 11 is a schematic diagram showing a laminated structure of an electronic umbrella device equipped with a wireless communication function according to one embodiment of the present invention.

[0073] FIG. 12 is a photographed image and a photographed X-ray image of an example manufactured by including an X-ray marker in an electronic umbrella device according to one embodiment of the present invention.

[0074] FIG. 13 is an FEA simulation image showing that there is a risk of component breakage of the electronic umbrella element due to excessive strain caused by shape deformation when the electronic umbrella element according to one embodiment of the present invention is first injected into an injection device, and an image of an electronic umbrella element that is actually broken with a crack formed.

[0075] FIG. 14 is an FEA simulation image of an electronic umbrella element according to one embodiment of the present invention unfolding as planned when ejected from an injection device, and a captured image of an electronic umbrella element that actually did not unfold and failed.

[0076] Figure 15 shows the results of a Young's modulus experiment testing the conditions of a polymer material to enable an electronic umbrella device according to one embodiment of the present invention to be effectively unfolded in a limited environment.

[0077] FIG. 16 is a simulation image showing the results of searching for the optimal structure of a chassis and a support to enable an electronic umbrella element according to one embodiment of the present invention to effectively unfold in a limited environment while being discharged from an injection device.

[0078] Figure 17 is an image showing each design of an electronic umbrella element according to one embodiment of the present invention and the filling ratio value thereof.

[0079] Fig. 18 is a schematic diagram showing the cross-sectional structure of the lower cover layer and the upper cover layer around the electrode of the branch portion of the electronic umbrella element according to one embodiment of the present invention.

[0080] FIG. 19 is a simulation result analyzing factors that influence the effective unfolding of an electronic umbrella device from a crumpled or folded 3D structure to a 2D structure according to one embodiment of the present invention.

[0081] FIG. 20 is an image showing a problem of compensation of the contact angle at the end of the chassis portion and a change in mechanism resulting therefrom when considering friction of the brain surface of an electronic umbrella device according to one embodiment of the present invention.

[0082] Figure 21 is a schematic diagram illustrating that an electronic umbrella element according to one embodiment of the present invention can be opened more smoothly when a lubricant is present.

[0083] Figure 22 is an image showing the result of an electronic umbrella device according to one embodiment of the present invention being biodegraded as designed after an appropriate period of time.

[0084] Figure 23 is a process diagram showing the manufacturing process of the chassis portion of an electronic umbrella device according to one embodiment of the present invention through a cross-sectional structure of each step.

[0085] Figure 24 is a process diagram illustrating the process of attaching the chassis portion of an electronic umbrella device according to one embodiment of the present invention to a lower substrate and connecting it to a central support portion, through a cross-sectional structure of each step. It can be seen that the chassis portion is attached based on the central support portion, folded into an "L" shape, and extended in the vertical direction (z-axis direction).

[0086] Figures 25 to 27 are images and graphs showing the results of in-vivo experiments on an electronic umbrella device according to one embodiment of the present invention.

[0087] FIG. 25 is an experimental image and graph showing signals transmitted from each element of an electronic umbrella element according to one embodiment of the present invention when each element is attached to different locations on the brain surface of an animal.

[0088] Figure 26 is a graph showing the temperature signal received when an electronic umbrella device according to one embodiment of the present invention, manufactured to enable wireless communication via NFC, is inserted into the brain surface of an animal, and the temperature is controlled by turning the IR lamp on and off. Figure 24 shows that there is no significant difference between a control experiment using a commercially available temperature sensor and a case using the electronic umbrella device of the present invention.

[0089] Figure 27 is an image showing the gradual biodegradation process of an electronic umbrella device according to one embodiment of the present invention over a period of 35 days after being injected onto the surface of an animal. The image in Figure 27 clearly demonstrates that biodegradation is progressing within the target timeframe.

[0090]

[0091] The embodiments of the present invention are provided for the purpose of illustrating the technical concept of the present invention. The scope of the rights of the present invention is not limited to the embodiments presented below or the specific descriptions of these embodiments.

[0092] All technical and scientific terms used in this invention, unless otherwise defined, have the meanings commonly understood by those skilled in the art to which this invention pertains. All terms used in this invention have been selected for the purpose of more clearly explaining the invention and are not intended to limit the scope of the rights provided for in this invention.

[0093] Expressions such as “comprising,” “having,” and the like used in the present invention should be understood as open-ended terms that imply the possibility of including other embodiments, unless otherwise stated in the phrase or sentence in which the expression is included.

[0094] The singular expressions described in the present invention may include plural meanings unless otherwise stated, and this also applies to the singular expressions described in the claims.

[0095] 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 an arbitrary 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. Through this, the xy plane becomes a plane perpendicular to the z-axis, and the branch portion of the electronic umbrella element described later aims for a 2D structure that spreads through the xy plane.

[0096] Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. Furthermore, in the description of the embodiments below, duplicate descriptions of identical or corresponding components may be omitted. However, omission of a description of a component does not imply that such component is not included in any embodiment.

[0097]

[0098] In general, bio-implantable electronic devices used for medical purposes are implanted inside the body through surgery, so they have the disadvantage of being exposed to various side effects during the skin incision and recovery process.

[0099] Therefore, a technology is needed that can reduce the volume of a bio-implantable electronic device during the implantation process to enable the implantation of a bio-implantable electronic device through a minimally invasive method during the process of making an incision in the skin and implanting the bio-implantable electronic device.

[0100] The bio-implantable electronic device intended in the present invention is formed in a folded or crumpled form according to physicochemical environmental conditions in an external environment or inside an injection device, and is manufactured to unfold or unfold when injected into the body and conditions for a specific environment are met, so that it has the advantage of being able to be implanted inside the body through a minimal incision. The electronic umbrella device proposed in the present invention can be applied universally for various purposes, but the present invention more specifically proposes a bio-implantable electronic device that is injected and unfolds in an environment between the inner wall of the skull and the surface of the brain.

[0101] When a bio-implantable electronic device is inserted into the body, the relatively large-area device shape is transformed into a relatively small folded or rolled state and injected into the body through an injection device (such as a syringe). When the device is operated inside the body, the relatively small transformed bio-implantable electronic device is restored to its original shape.

[0102] Bio-injectable electronic devices are biodegraded after a certain period of time inside the body, and biodegraded electronic devices have the advantage of not only having no side effects on the body, but also being discharged from the body along with body fluids.

[0103] Bio-implantable electronic devices can be implanted between the inner skull and the brain surface, in the epidura and subdura environments, enabling accurate measurement of brain signals, as well as treatment by directly delivering electrical stimulation to the brain surface or injecting drugs. The risk of craniotomy has led to the problem that conventional electronic devices applied electrical signals from outside the skull, resulting in insufficient transmission of effects within the brain. However, the electronic umbrella device of the present invention can solve this problem without major surgery.

[0104]

[0105] 1. Concept and structure of electronic umbrella devices

[0106] First, the concept and structure of the electronic umbrella element proposed in the embodiments of the present invention will be described with reference to FIGS. 1 to 22.

[0107] FIG. 1 is a schematic diagram illustrating a process in which an electronic umbrella device according to one embodiment of the present invention is injected into the skull through a syringe in a folded or crumpled state, then unfolds to perform its original function and then biodegrades.

[0108] Figure 1 illustrates the inventors' objectives through an electronic umbrella device proposed in an embodiment of the present invention. The electronic umbrella device is folded into an injection device, passes through a skull with a minimal hole cut into it, and is injected into the epidural environment of the brain surface. After the electronic device performs its intended diagnostic and therapeutic function, it biodegrades.

[0109] To achieve these technical goals, the electronic umbrella element must be well designed to fold effectively into a narrow cross-sectional area injection device, then be ejected without failure from the injection device, and then unfold properly to its original shape after ejection so that the electronic element can function and then be biodegraded.

[0110] Figure 2 is a schematic diagram showing a technical solution problem in which plastic deformation occurs within the injection device when the electronic umbrella element is folded or crumpled into a narrow injection device, or the device is damaged due to friction with the inner wall when entering or exiting the injection device, and the shape is not restored to the pre-designed design.

[0111] However, in order to enable minimally invasive injection as shown in Fig. 2, there is a problem in that the electronic umbrella element must not be subject to problems such as friction, twisting, or binding within the narrow internal space of the injection device, and the electronic element must not be damaged due to friction with the inner wall of the injection device.

[0112] Another technical challenge for the success of this technology lies in the extremely confined environment within the skull. In an embodiment of the present invention, the device is designed to enable the electronic umbrella element to be effectively deployed after injection within a confined space of approximately 5 mm in thickness.

[0113] Figure 3 is a photograph and diagram showing the narrow space between the inner wall of the skull and the surface of the brain, and is a schematic diagram showing the spatial constraints within which an electronic umbrella device, folded or crumpled in a space less than 5 mm high, must be effectively deployed.

[0114] Due to the narrow internal environment, large-area shape restoration can be difficult for electronic devices operating at large motions. Therefore, the minimally invasive electronic umbrella device intended for the present invention must be capable of shape restoration even in a limited, narrow environment.

[0115] The inventors of the present invention recognized these technical goals and studied various element technologies to enable the electronic umbrella element, which was spread out in two dimensions under limited conditions, to be packed into an injection device and then spread out in two dimensions again.

[0116] FIG. 4 is a schematic diagram illustrating a structure in which an electronic umbrella device according to one embodiment of the present invention is spread out in two dimensions (xy plane) before injection into the body, then forms a three-dimensional (z plane) structure that enters a narrow space of an injection device for minimal invasion, and then spreads out in two dimensions again inside the skull.

[0117] The electronic umbrella device of the present invention is injected into the body through an insertion tube with a small diameter but little limitation in length due to the characteristics of an injection device for minimal invasion. 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 is widely unfolded in the xy plane, and shape restoration to a large area is realized through axis transformation in an in vivo environment with limited height along the z-axis.

[0118]

[0119] Below, the structure and materials of the electronic umbrella element that enable the above-described implementation are described in detail.

[0120] In one embodiment of the present invention, a bio-implantable electronic device includes a central support portion and branch portions extending from the central support portion. When the bio-implantable electronic device enters the environment between the inner wall of the skull and the surface of the brain, the branch portions unfold, contact the surface of the brain, operate, and then biodegrade and are discharged from the body. The branch portions may be configured to include a plurality of chassis portions.

[0121] The above-mentioned central support may be designed in a pillar-like shape that rises in the z-axis direction based on a 2D plane (xy plane). The above-mentioned 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 be a space within which wires pass.

[0122]

[0123] According to one embodiment, the branch portion may include an electrode; and a cover layer covering the electrode from above and below. The cover layer may include an upper cover layer and a lower cover layer. The upper cover layer and the lower cover layer may be formed of the same material, or may be formed of different materials as needed.

[0124] The electrode may be formed using any conductive material. For example, it may be formed using one of metal, carbon material, and alloy material. The electrode may be formed to include one or more components from the group consisting of magnesium (Mg), molybdenum (Mo), zinc (Zn), tungsten (W), silicon (Si), and mixtures or alloys thereof. The electrode may be formed using a gel-type conductive material. The electrode is not particularly limited in the present invention as long as it is a conductive material. It may be more preferable that the electrode material is formed of a biodegradable material and biodegrades together with the materials of the cover layer or the central support. The electrode material may be manufactured in the form of a nanowire.

[0125] The above cover layer may be formed of a polymer capable of sealing the electrode. Preferably, the polymer has the property of being effectively folded and unfolded, and must also have biodegradable properties. The cover layer may be formed of a super-soft, highly elastic biodegradable polymer, and in an embodiment of the present invention, an electronic umbrella device was manufactured by blending PLCL and PLGA polymers. Of course, the cover layer material of the present invention is not limited thereto, and any super-soft, highly elastic biodegradable polymer material capable of bonding with various functional groups may be preferable. The polymer material may be formed such that it mainly comprises an ester-linked polymer capable of biodegradation through hydrolysis, and additionally includes a urethane-based polymer capable of enzymatic decomposition.

[0126] The above cover layer may have an open structure formed at least in part, and may include a portion of the electrode exposed to the outside. By exposing the electrode to the outside, the electrode may come into close contact with the upper or lower target object (such as the brain surface or the inner wall of the skull).

[0127]

[0128] In one embodiment, the branch may include a shape memory polymer whose shape is restored when conditions regarding the surrounding environment are met.

[0129] The above polymer material can perform the function of preventing damage to the device by flexibly behaving, such as by being crumpled or folded, while maintaining an arbitrary temporary shape until the conditions of the surrounding environment are met.

[0130] The polymer material should be able to unfold into its original shape after being crumpled or folded within the body. This unfolding process can be designed to unfold into a pre-designed shape when external environmental conditions are met, similar to the self-assembly of a copolymer, and then return to its original structure before being folded or crumpled. It is further desirable for the polymer material to possess the properties of a shape-memory polymer.

[0131]

[0132] According to one embodiment, the conditions for the surrounding 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 surrounding environment.

[0133] The conditions of the above-mentioned surrounding environment may be physical, chemical, or biological. These conditions may include the presence of specific components in the discharged environment. They may also include the presence of light, ultrasound, or electromagnetic fields. They may also include the conditions of the discharged environment itself, such as temperature, humidity, or pH.

[0134]

[0135] Such polymer materials are employed as the main material forming the matrix of the branch portions in the present invention. The branch portions are key components of the electronic umbrella device of the present invention, which must be injected into a narrow space and then released into a wider space, restoring their original shape.

[0136] In one embodiment, the branch portion may include a super-soft polymer having a Young's modulus of 20 kPa or greater.

[0137] FIG. 15 of the present invention illustrates the results of a Young's modulus experiment testing the conditions for a polymer material to enable an electronic umbrella device according to one embodiment of the present invention to effectively unfold in a limited environment. The inventors of the present invention were able to confirm that an ultra-soft polymer material may be necessary to achieve the goal of enabling a crumpled electronic umbrella device of the present invention to smoothly unfold without affecting a target object under limited height conditions.

[0138] At this time, the super-soft polymer material preferably has a Young's modulus of 20 kPa or more so that it can be smoothly positioned on the surface of the target object while performing deformation of the intended shape without being broken. The polymer may more preferably be a material having a Young's modulus of 25 kPa or more.

[0139] When the polymer material is configured to have a Young's modulus of less than 20 kPa, the polymer material may not settle smoothly during the process of being injected into the body and unfolding, or may not unfold according to the intended structure and may be arranged in a folded state.

[0140]

[0141] The above branch portion may also include a polymer having a wide elastic range of 250% or more based on Young's modulus. The polymer may additionally include a polymer component having both ductility and high elasticity properties, or may be configured to include a polymer that satisfies both properties simultaneously.

[0142]

[0143] The polymer material described above may be a shape-memory polymer, capable of self-recovering to its original shape when certain conditions are met. However, if a functional group that aids self-recovery to its original shape is added to the polymer, shape recovery can proceed more smoothly. The inventors of the present invention focused on the temperature sensitivity of DNA as a functional group for this shape recovery.

[0144] In one embodiment, the branch portion further comprises DNA bound to the polymer, and the DNA may comprise a hairpin structure or double-stranded DNA.

[0145] Additionally, the branch portion may be formed of a material containing DNA only in certain areas where the mechanism of shape deformation is required. The certain areas may be areas formed in areas where a large amount of strain is applied during deformation. The certain areas may form areas distinct from other areas of the branch portion.

[0146]

[0147] The above DNA possesses an internal hydrogen bond structure and can react to ambient temperature by unfolding the hairpin structure or separating the double strands. By including DNA, temperature-sensitive structural deformation can achieve more precise shape recovery control.

[0148] The above DNA is an example of a case where a polymer reacts to temperature conditions and a branch is deformed, but if shape restoration of the electron umbrella element occurs under other conditions, other components that help the polymer restore itself when subjected to those conditions can be additionally included in the electron umbrella element.

[0149]

[0150] In one embodiment, the branch portion may form a network structure. In one embodiment, the network structure may include a plurality of chassis portions radially spread out with the central support portion at the center; and a support portion formed to connect the chassis portions to each other.

[0151] The above chassis portion serves to construct the main framework of the branch portion, and various components can be formed on the chassis portion. The support portion can serve to support the chassis portion so that it can be restored to its original shape when folded and unfolded. In addition, the support portion can serve as a passage for a multipurpose circuit or electrode. The support portion can be formed in a wave-like or cylindrical design, and the support portion can form a curved pattern having a symmetrical structure. The support portion can directly or indirectly participate in the behavior of the chassis portion, such as distributing strain or helping to effectively unfold the electronic umbrella component when it is folded and unfolded again.

[0152] According to one embodiment, a component may be formed on at least a portion of a part where the chassis portion and the chassis support portion are connected. The component may be formed on a portion where the chassis portion and the support portion are connected, and may form a structure electrically connected to a component formed on an adjacent chassis portion through the support portion. In addition, according to one embodiment, each component may be formed on at least a portion of an end and a middle point of the chassis portion. That is, the component may be formed at any portion of the chassis portion of the branch portion, whether at the end, the portion connected to the support portion, or the portion not connected to the support portion, according to the design according to the purpose.

[0153] At this time, according to one embodiment, it 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 a light transmission unit.

[0154] The above sensor unit can be interpreted as a general concept and encompasses sensors applicable to various applications. The electrical stimulation unit may serve to promote the transmission of a transducer.

[0155] The above ultrasonic transmission unit can enable the implementation of stimulation or signal transmission through ultrasonic waves, as well as the implementation of treatment or diagnostic functions through the same, in addition to the electrical stimulation generated through the electrical stimulation unit.

[0156] The above optical transmission unit may be configured to include an optical transmission element, such as a light source, a photothermal element, or an optical fiber. If the optical fiber is included in the element unit, it may be utilized as a cooler that cools a specific point in the brain.

[0157] The above-described component may also be configured to include a battery unit that generates electrical energy capable of driving itself in one embodiment. The battery unit may be formed to include a biodegradable battery.

[0158]

[0159] In one embodiment, the element unit may be a single element unit that performs multiple functions. Rather than having to be formed to perform a single function, if the circuit or electrode is formed sufficiently small, a single element unit may include multiple sensors or multiple electrodes. Furthermore, it is also possible to simultaneously form one or more of a drug injection unit, an ultrasound transmission unit, a battery unit, or a light transmission unit.

[0160] In one embodiment, at least two of the above-described components may perform different functions. In a specific embodiment, different stimulations or drug injections may be required depending on the location of the brain. In this case, components in different locations may be designed to perform different functions to provide the diagnosis, treatment, and prescriptions required for each location.

[0161] Fig. 5 is an image showing an example in which different sensors and electrodes are formed on the component portions formed at the ends of the branches of an electronic umbrella component according to one embodiment of the present invention. Looking at Fig. 5, it can be seen that a strain sensor, a temperature sensor, a pH sensor, a passive electrode, an active electrode, etc. are formed at the ends of each chassis portion.

[0162] In addition, in the example image shown in Fig. 5, it can be confirmed that the support connecting each chassis part is formed symmetrically with a wave-like curve. Although this structure is only an example, the introduction of such a support part can enable stable shape deformation despite the strain applied to each part during the folding and unfolding process. Not limited to the example presented in Fig. 5, each single element part may have multiple sensors of various types, and the sensors and electrodes may be formed together. In addition, a drug delivery part or a circuit that can apply electrical stimulation to the brain surface may be formed together.

[0163]

[0164] In one embodiment, each of the chassis sections having the respective components performing the different functions may be assembled to be connected to the central support. In a specific embodiment, each branch may not be manufactured simultaneously with the central support, but may be integrated by mounting the desired components at different locations and then assembling them one by one to the central support.

[0165] FIG. 6 is a schematic diagram showing that different electronic modules can be formed in the component portion formed at the end of the branch portion of the electronic umbrella component according to one embodiment of the present invention. As illustrated in FIG. 6, each chassis portion can be manufactured in a form in which a pre-designed electronic module is mounted and assembled to face the intended direction on the central support portion according to the needs and purposes of the electronic component device. At this time, the lower cover layer (base substrate) of the electronic module can be formed of a material that can be sealed and flexible during the folding and unfolding process. In this embodiment, the substrate was manufactured using a polymer material blended with PLGA and PLCL, but in addition, the lower cover layer and the upper cover layer can be manufactured using any number of flexible and elastic polymer materials.

[0166]

[0167] Fig. 7 is a schematic diagram showing a laminated structure of an electronic umbrella element according to one embodiment of the present invention.

[0168] According to one example, a receiver coil for an electronic communication means may be positioned on a lower cover layer (base substrate) using a flexible material, and a separation layer (interlayer) that separates the upper layer and the lower layer may be formed on top of the lower cover layer. An active layer may be formed on top of the separation layer, and a gate oxide layer and an electrode layer may be formed on top of the active layer. An upper cover layer may be formed symmetrically with respect to the lower base substrate at the uppermost layer, which may serve to seal the lower cover layer and each layer positioned therebetween. Each of the layers described above is only one example for forming the electronic umbrella element of the present invention, and the electronic umbrella element may be manufactured by additionally introducing specific layers as needed, or by omitting some layers.

[0169] FIG. 8 is a schematic diagram (upper figure) showing a central support of an electronic umbrella device according to one embodiment of the present invention and an auxiliary support (solid support) that supports the upright structure of the central support, and a cross-sectional view (lower figure) showing a connection structure of a branch portion and the central support of an electronic umbrella device.

[0170] As shown in the upper drawing of Fig. 8, the auxiliary support not only plays a role in supporting the physical structure of the central support, but also plays a role in maintaining the center of the electronic umbrella element so that it does not fall over when the electronic umbrella element is inserted into the injection device in a crumpled or folded state, and when the electronic umbrella element is ejected from the injection device and unfolded again.

[0171] Referring to the lower drawing of Fig. 8, the branch part supports the central support part and is folded upward in the vertical direction (z-axis direction) in an “L” shape based on the center support part. Through this folded-up structure, a wired connection can be formed with another electronic device outside the body. Of course, the electronic umbrella device of the present invention can also be designed to exchange signals with another electronic device outside the body using wireless communication technology. It can be confirmed that the branch part includes an electrode line using a Mo or Mg metal material inside, and is sealed (encapsulated) with a lower cover layer and an upper cover layer. At this time, a part of the lower cover layer is formed in an open structure, so that a part of the electrode is exposed to the outside, so that it can be formed to make electrical contact with a specific location on the surface of the brain or the inside of the target skull.

[0172]

[0173] FIG. 9 is an image showing a form in which electrodes are connected by wires through a central support formed with the folded structure of FIG. 8 of an electronic umbrella device according to one embodiment of the present invention and connected to another electronic device outside the body. It can be seen that multiple component parts are formed at the ends and middle points of the chassis part in FIG. 9. According to some embodiments, component parts may be formed at multiple points on a single chassis part.

[0174] Figure 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 one embodiment of the present invention, and the actual manufactured form and scale of the electronic umbrella element unfolding to its original shape in response to temperature. As shown in the image on the right side of Figure 10, each element portion can be formed to have a diameter of approximately 1 mm.

[0175] Fig. 11 is a schematic diagram showing a laminated structure of an electronic umbrella device equipped with a wireless communication function according to one embodiment of the present invention.

[0176] If the electronic umbrella device described above is intended to wirelessly exchange signals with external devices, an NFC circuit or capacitor can be incorporated into the central support. The results presented in Fig. 11 demonstrate that the electronic umbrella device of the present invention can be designed to wirelessly exchange signals with external electronic devices.

[0177]

[0178] In many experimental examples conducted by the inventors, folded or crumpled electronic umbrella elements came out of the injection device and did not unfold smoothly into the intended shape, and problems occurred such as the central axis collapsing or some branches not unfolding but folding.

[0179] The inventors of the present invention conducted research to optimize the shape restoration yield through several experiments. In one of the experiments, we focused on the contact angle formed when each end of the chassis part first makes contact with the floor surface to which it is to be attached, and analyzed the sliding motion according to the contact angle. The inventors confirmed that, for shape restoration to occur effectively in the limited height condition environment intended in the present invention, the landing angle of the bottom surface of the chassis part, rather than the support part that can be formed into a curved surface and easily unfolded, is important. Through this experiment, we were able to derive the result that the initial contact angle between each chassis part and the floor surface (brain surface) must be formed at a certain level.

[0180] The contact angle (chassis contact angle) mentioned below in the present invention is a factor directly related to successful shape restoration, and may refer to the angle formed between the element and the surface to which it is to be attached when it touches the surface.

[0181] Referring to Fig. 18, the simulation results analyzing the factors that affect the effective unfolding of an electronic umbrella device from a crumpled or folded 3D structure to a 2D structure according to an embodiment of the present invention are shown. As confirmed in the experimental example of Fig. 18, the inventors of the present invention studied, through discharge and unfolding experiments of various types of electronic umbrella devices, in which direction the electronic umbrella device slides and with what structure and size the radius of the support part can be formed to design a device so that the intended contact angle is achieved.

[0182] As shown in the image of Fig. 18, when the contact angle is formed below 70 degrees, a forward sliding motion like the upper right occurs, and sufficient space for shape restoration is secured in the outward direction, so that successful shape restoration occurs. On the other hand, when an angle exceeding 70 degrees is formed, a backward sliding motion or a mixed sliding motion mixed with other unnecessary behaviors occurs, and a phenomenon occurs in which each chamfer is rolled inward or crumpled. Since the chamfers rolled inward have a very limited restoration space, they buckle and become entangled with each other, which may result in unsuccessful shape restoration.

[0183]

[0184] FIG. 19 is an image showing a problem of compensation of the contact angle at the end of the chassis portion and a change in mechanism resulting therefrom when considering friction of the brain surface of an electronic umbrella device according to one embodiment of the present invention.

[0185] Additionally, considering the friction factor on the brain surface, the desirable range of contact angles for the chassis end to slide properly forward may be somewhat reduced.

[0186] FIG. 20 is an image showing a problem of compensation of the contact angle at the end of the chassis portion and a change in mechanism resulting therefrom when considering friction of the brain surface of an electronic umbrella device according to one embodiment of the present invention.

[0187]

[0188] According to one embodiment, when the bio-injectable electronic device is injected in a clumped state in a direction in which the branch portion first contacts the brain surface, it may be preferable that the contact angle at which the end of the chassis portion first contacts the target object be formed to 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, it is not easy to enter the brain itself when considering a minimally invasive procedure. If the contact angle exceeds 70 degrees, the brain surface may be damaged, or the electronic device may not be able to effectively slide outward and may become crumpled or rolled, resulting in the device not being restored to its intended shape or even causing the device to be damaged.

[0189] At this time, the contact angle is determined based on the acute angle at which the end of the chassis portion enters the target object (e.g., brain surface) as shown in the images of FIGS. 19 and 20.

[0190] In addition, when the contact angle takes into account the friction of the brain surface, the chassis angle is compensated, and thus the appropriate range for forward sliding motion may be further reduced. The contact angle may be more preferably 60 degrees or less.

[0191]

[0192] Meanwhile, according to one embodiment, the bio-injectable electronic device may include an X-ray marker.

[0193] FIG. 12 is a photographed image and a photographed X-ray image of an example manufactured by including an X-ray marker in an electronic umbrella device according to one embodiment of the present invention.

[0194] 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, as shown in FIG. 12, it is easy to check whether the electronic umbrella device has been well injected, well spread out, and well attached to a desired location. In this embodiment, an Iodixanol-based compound was used as an X-ray marker and X-ray photography was performed, but in the spirit of the present invention, not only can various X-ray marker materials be used, but various position detection marker materials that serve as identifiers of various other diagnostic devices can also be included in the manufacturing.

[0195]

[0196] According to one embodiment, the central support portion forms a columnar 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 may have a conductive line passing through it for enabling wired communication. 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 wire, the conductive line may pass through an area inside or adjacent to the central support portion of the electronic umbrella element in a vertical direction (z-axis direction) and extend to the outside of the skull.

[0197]

[0198] According to one embodiment, the central support may include an auxiliary support that supports the upright structure of the central support. The auxiliary support may be formed in an “L” shape as illustrated in FIG. 8, and may be formed as a structure that is bent from the xy plane in the z-axis direction to connect and support the branch portion and the central support.

[0199]

[0200] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure is proposed as a bio-injectable electronic device, which includes a central support portion; and a branch portion including a plurality of chassis portions extending from the central support portion; and is formed to form a 3D structure in the z-axis direction outside the body, and is injected into an internal environment having a height of less than 5 mm, and then unfolds into a 2D structure in the xy-axis inside the body, thereby enabling a minimally invasive procedure.

[0201]

[0202] In one embodiment, the electronic umbrella device may have a ratio of an area in an unfolded state to an area in a folded state that is 10 times or more. The electronic umbrella device of the present invention may have an area in an xy plane in a fully unfolded state that is 10 times or more compared to a cross-sectional area of ​​a central support portion. The area in the folded state may be equal to or smaller than the cross-sectional area of ​​the central support portion. The area in the folded state may be determined based on the cross-sectional area of ​​an injection portion of an injection device (e.g., the cross-sectional area of ​​a syringe discharge portion). The ratio of the areas can be easily expanded to 100 times or more according to embodiments of the present invention. The area in the unfolded state may be expanded to a diameter of about 15 mm, according to one example.

[0203]

[0204] FIG. 16 is a simulation image showing the results of searching for the optimal structure of a chassis and a support to enable an electronic umbrella element according to one embodiment of the present invention to effectively unfold in a limited environment while being discharged from an injection device.

[0205] Figure 17 is an image showing each design of an electronic umbrella element according to one embodiment of the present invention and the filling ratio value thereof.

[0206] In order to quantify the strain applied to the electronic umbrella element discharged from the injection device, the inventors designed various structures of the chassis and the chassis support (branch structure) and confirmed and analyzed the strain applied to each location. By varying the number, width, and length of the chassis and the chassis support, respectively, the maximum strain value occurring in each condition was compared based on the filling area value, which is the area of ​​the actual device (the sum of the cross-sectional areas of the central support and the branch) compared to the coverage area, which is the maximum area when the device is spread out over a large area.

[0207] Through this, the inventors of the present invention have newly derived a parameter called the fraction of filling area, which can determine the optimal value for effectively unfolding the electronic umbrella element discharged from the injection device under a height condition of 5 mm or less.

[0208]

[0209] * Filling Ratio = Filling Area Fraction = Filling Area (AF) / Coverage Area (Ac)

[0210] The inventors were able to define the optimal design structure capable of 2D-3D-2D transformation under limited conditions as the Filling Ratio (Fraction of Filling area).

[0211] In the present invention, the value of the filling area, which is the actual device area compared 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 structure of the chassis parts and the number, width, and length of the support parts structures. As a result of performing an FEA simulation on the maximum strain applied to the device while changing the filling ratio, it was confirmed that as the filling ratio increases, the maximum strain value applied to the device also increases.

[0212] The above-mentioned peeling ratio may refer to an optimal design structure that ensures that electronic components formed on the polymer material of the electronic umbrella component are brittle but not broken during the folding or unfolding process. The above-mentioned peeling ratio may be defined as a value close to the limit that allows the intended behavior of the present invention to occur without breaking, based on the material or structure of the electronic components.

[0213]

[0214] According to one embodiment, the electronic umbrella element may have a filling ratio of 0.6 or less.

[0215] In addition, the above-mentioned filling ratio may be 0.05 or greater. If it is less than 0.05, the area of ​​the electronic umbrella element for mounting electronic components such as electrodes may become too narrow, which may cause a problem in that it is difficult to effectively utilize the electronic umbrella element.

[0216] Meanwhile, if the above filling ratio exceeds 0.6, the strain value applied to the device becomes excessively large, which may cause cracks or damage to the polymer material and electrode material that serve as the basis of the device.

[0217] The above filling ratio may preferably be 0.4 or less. The above filling ratio may more preferably be formed within the range of 0.1 to 0.38.

[0218]

[0219] Fig. 18 is a schematic diagram showing the cross-sectional structure of the lower cover layer and the upper cover layer around the electrode of the branch portion 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 the strain applied to the electrode and electronic device layer.

[0220]

[0221] Meanwhile, Fig. 13 is an FEA simulation image showing that there is a risk of component breakage of the electronic umbrella element due to excessive strain caused by shape deformation when the electronic umbrella element according to one embodiment of the present invention is first injected into an injection device, and an image of an electronic umbrella element in which an actual crack is formed and the element is broken. At this time, the electronic umbrella element is transformed from a two-dimensional structure in the xy plane to a three-dimensional columnar structure that is folded or crumpled to an area approximately the diameter of the central support.

[0222]

[0223] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure may be structured such that, when a branch is injected in a direction in which it makes first contact with the brain surface, the greatest strain is formed in the uppermost chassis support, which is closest to the central support, among the plurality of chassis support parts, when it makes contact with the brain surface. In the electronic umbrella device proposed in the present invention, when a branch is first introduced into the surface of a target object, the greatest strain may be applied to the uppermost chassis support among the chassis support parts formed to connect between chassis parts rather than the chassis parts. In this case, when only one chassis support part is formed to connect between the ends of the chassis parts, the maximum strain may be applied to the end chassis support part connecting between the ends of the chassis parts (see FIG. 13).

[0224]

[0225] FIG. 14 is an FEA simulation image of an electronic umbrella device according to an embodiment of the present invention unfolding as planned when ejected from the injection device, and a captured image of an electronic umbrella device that failed to unfold in reality. In this case, the electronic umbrella device should unfold smoothly from the three-dimensional columnar structure that was folded or crumpled upon ejection from the injection device to the original two-dimensional structure in the xy plane. However, even if the temperature conditions are met using a shape memory material, this experiment confirmed that various conditions must be precisely designed for the electronic umbrella device to be restored to its original structure under limited height conditions.

[0226] At this time, as a result of analysis through the simulation shown in the above-described Figures 13 and 14, it was confirmed that a lot of strain was applied to the part where the central support and the branch parts are connected and the chassis support part connecting the chassis parts.

[0227]

[0228] In another embodiment of the present invention, an electronic umbrella device for a minimally invasive procedure is proposed as a bio-injectable electronic device, including a central support portion; and a branch portion including a plurality of chassis portions extending from the central support portion; and when the branch portions enter an 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, wherein the chassis portion is encapsulated after a plurality of layers are laminated, and may include at least three layers of a lower cover layer, an electrode, and an upper cover layer.

[0229] At this time, as described above, the lower cover layer and the upper cover layer may be formed of a material that seals the electrode and has high elasticity and ultra-softness. 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 crumpled, folded, and then unfolded.

[0230] As previously described, in FIG. 18, when the lower and upper cover layers are formed symmetrically, the sealed electrode or electronic component in the center can be subjected to minimal strain. Therefore, in the present invention, it may be desirable to form the lower and upper cover layers to have the same thickness.

[0231] According to one embodiment, the branch portion may further include one or more layers selected from the group consisting of an active layer, an interlayer, 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 illustrated in FIGS. 7, 10, and 11.

[0232]

[0233] Meanwhile, Fig. 21 is a schematic diagram illustrating that an electronic umbrella device according to one embodiment of the present invention can unfold more smoothly when a lubricant is present. If an appropriate lubricant is injected into the injection device together with the device or injected into the body together with the device using a separate tool, the electronic umbrella device of the present invention can unfold more easily. However, there is a risk that the device part may not be attached to the appropriate point due to the lubricant, as it may deviate from the target position. Therefore, it was recognized that research is needed to find optimal lubricant conditions.

[0234] This will be discussed further when explaining the injection method of the electronic umbrella element.

[0235]

[0236] Figure 22 is an image showing the results of an electronic umbrella device according to one embodiment of the present invention biodegrading as designed after an appropriate period of time. In this embodiment, the electronic umbrella device gradually decomposes over a period of two weeks, and by 45 days, it has been largely decomposed into strands less than 10 mm in length. The decomposition rate of such an electronic umbrella device can be controlled in any way by designing the material composition, such as by combining various biodegradable materials.

[0237]

[0238] 2. Manufacturing method of electronic umbrella element

[0239] Hereinafter, a method for manufacturing an electronic umbrella element of the present invention will be described with reference to FIGS. 23 and 24.

[0240] The electronic umbrella device of the present invention can be manufactured using any method generally applicable in the art, and the present invention does not specifically limit the manufacturing method. However, the description below is intended to illustrate that, in certain embodiments, the electronic umbrella device of the present invention can be manufactured using a somewhat special method, as proposed below.

[0241] In another embodiment of the present invention, in the method for manufacturing an electronic umbrella device for minimally invasive surgery, the electronic umbrella device is not manufactured through a single-step process such as mold extraction. Rather, the electronic umbrella device of the present invention can be manufactured through a multi-step lamination process, similar to a semiconductor process. A characteristic feature of the method for manufacturing the electronic umbrella device of the present invention is clearly revealed in the manufacturing process of the branch portion. Figures 21 and 22 sequentially illustrate and explain the manufacturing process of the chassis portion among the branch portions.

[0242] Fig. 23 is a process diagram showing the manufacturing process of the chassis of an electronic umbrella device according to an embodiment of the present invention through a cross-sectional structure of each step. In the embodiment of the present invention, unlike stents or other surgical tools that restore an intended shape in the body using a shape memory alloy, the electronic device may be a sealed electronic device that embeds electrodes and circuits within a polymer. Therefore, unlike conventional surgical tools that use alloys or metals, the electronic device may be manufactured using a lamination process, a photoresist process, a laser process, or the like used in semiconductor processes. However, the method presented in this drawing is only an example of manufacturing the electronic umbrella device of the present invention, and the technical idea of ​​the present invention is not limited thereto.

[0243] In addition, the above chassis part can be attached in a form in which each component is formed according to its purpose and then assembled to the central support part.

[0244] In this case, the method for manufacturing the electronic umbrella element described above may include a step of assembling a plurality of prepared chassis parts to the central support part.

[0245]

[0246] Figure 24 is a process diagram illustrating the process of attaching the chassis portion of an electronic umbrella device according to one embodiment of the present invention to a lower substrate and connecting it to a central support portion through a cross-sectional structure at each step. Through the image of Figure 24, it can be confirmed that the chassis portion is attached based on the central support portion, folded in an "L" shape, and extended in the vertical direction (z-axis direction).

[0247] In embodiments of the present invention, unlike stents or other surgical instruments that use shape memory alloys to restore themselves to their intended shape within the body, the electronic umbrella device may be a sealed electronic device that embeds electrodes and circuits within a polymer. Therefore, unlike conventional surgical instruments that utilize alloys or metals, the electronic umbrella device may be manufactured using a lamination process, photoresist process, laser process, or other processes used in semiconductor manufacturing. However, the method presented in this drawing is merely an example of manufacturing the electronic umbrella device of the present invention, and the technical concept of the present invention is not limited thereto.

[0248] Although this method is only a simple example of combining the chassis part and the central support part, when the chassis part is combined 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 laminate of prepared electrodes and an upper cover layer on the lower cover layer; and folding up one side of the lower cover layer, the electrode, and the upper cover layer based on the central support part.

[0249]

[0250] In another embodiment of the present invention, a method for manufacturing a bio-injectable electronic device includes manufacturing the branch portion by forming a laminated structure including the lower cover layer, an electrode, and an upper cover layer, and the process of forming the laminated structure may include a step of designing the structure of each layer through a laser process. The process of forming the laminated structure through a laser process is also clearly shown in FIGS. 21 and 22.

[0251]

[0252] 3. Method of injecting electronic umbrella components into the body

[0253] Another aspect of the present invention, which is proposed to achieve the above-described technical objective, relates to a method for intra-body injection of an electronic umbrella device for minimally invasive surgery.

[0254]

[0255] In one embodiment of the present invention, a method for injecting a bio-implantable electronic device into a body is provided, wherein the bio-implantable electronic device operates by contacting the brain surface while the branch portions unfold when entering an environment between the inner wall of the skull and the brain surface, wherein the bio-implantable electronic device includes a central support portion and a branch portion including a plurality of chassis portions extending from the central support portion, and the method comprises the steps of: folding the bio-implantable electronic device into an injection device; injecting the bio-implantable electronic device into a hole drilled in the skull; positioning the bio-implantable electronic device on the brain surface while unfolding inside the skull; and operating the bio-implantable electronic device on the brain surface.

[0256] In one embodiment, the step of the bio-implantable electronic device unfolding inside the skull and positioning itself on the brain surface may include a step of the branch portion of the bio-implantable electronic device unfolding on its own in the environment inside the skull.

[0257]

[0258] According to one embodiment, the step of folding the bio-implantable electronic device into a sealed injection device including a narrow lung space further includes the step of injecting a lubricant into the sealed injection device together, wherein the lubricant not only helps the bio-implantable electronic device to smoothly fold and enter the sealed injection device, but also allows the bio-implantable electronic device to smoothly unfold and slide onto the brain surface when unfolding and positioning itself on the brain surface. At this time, by appropriately selecting the lubricant and the material (including the coating layer material) of the portion of the electronic umbrella device that comes into contact with the brain surface, the friction coefficient can be controlled to be sufficiently low, according to one embodiment.

[0259]

[0260] As described above, the lubricant can help prevent damage to the electronic umbrella element when it is inserted into or discharged from the injection device. Furthermore, the lubricant can alleviate irritation applied to the target surface while allowing it to glide smoothly on the target surface.

[0261] In the embodiments of the present invention, the lubricant used was a glycerol-based organic compound. However, the lubricant need not be limited to this type of material. Any type of lubricant that is harmless to the human body and commonly used for surgical purposes may be selected and used.

[0262]

[0263] In one embodiment, the step of unfolding the bio-implantable electronic device and positioning it on the brain surface may be performed by allowing the bio-implantable electronic device to adhere well to the target location on the brain surface using an adhesive. In addition to the lubricant described above, it may be advantageous to additionally use an adhesive. The adhesive may serve to allow the electronic umbrella device to adhere well to the intended target surface.

[0264] In addition to the aforementioned lubricants and adhesives, a concept of coating the electronic umbrella element with a waterproofing agent may be considered to ensure that the electronic umbrella element operates well in a moisture-containing environment. In particular, if a material is introduced that has a waterproofing coating that prevents moisture from entering until it adheres to the surface of the target object, and then disappears after a certain period of time, the electronic umbrella element can operate more effectively.

[0265]

[0266] 4. In-vivo experiments

[0267] The inventors of the present invention manufactured various electronic umbrella devices using the above-described method and conducted experiments in an in-vivo environment to test whether the purpose of the present invention was actually well implemented.

[0268] Figures 25 to 27 are images and graphs showing the results of in-vivo experiments on an electronic umbrella device according to one embodiment of the present invention.

[0269] FIG. 25 is an experimental image and graph showing signals transmitted from each element of an electronic umbrella element according to one embodiment of the present invention when each element is attached to different locations on the brain surface of an animal.

[0270] Figure 26 is a graph showing the temperature signal received when an electronic umbrella device according to one embodiment of the present invention, manufactured to enable wireless communication via NFC, is inserted into the brain surface of an animal and the temperature is controlled by turning the IR lamp on and off. Figure 24 shows that there is no significant difference between a control experiment using a commercially available temperature sensor and a case using the electronic umbrella device of the present invention.

[0271] Figure 27 is an image showing the gradual biodegradation process of an electronic umbrella device according to one embodiment of the present invention over a period of 35 days after being injected onto the surface of an animal. The image in Figure 27 clearly demonstrates that biodegradation is progressing within the target timeframe.

[0272]

[0273] The above description is merely an illustrative example of the technical idea of ​​the present invention, and those skilled in the art will appreciate that various modifications and variations can be made without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are intended to illustrate rather than limit the technical idea of ​​the present invention, and the scope of the technical idea of ​​the present invention is not limited by these embodiments. The scope of protection of the present invention should be interpreted by the following claims, and all technical ideas within a scope equivalent thereto should be interpreted as being included in the scope of the rights of the present invention.

Claims

1. As a bio-injectable electronic device, central support; and including a branch extending from the central support; When it enters the environment between the inner wall of the skull and the surface of the brain, the above branches spread out, come into contact with the surface of the brain, and then biodegrade and are discharged from the body. Electronic umbrella device for minimally invasive procedures.

2. In paragraph 1, The above branch portion includes an electrode; and a cover layer covering the electrode above and below; The above cover layer has an open structure formed, including a portion of the electrode exposed to the outside. Electronic umbrella device for minimally invasive procedures.

3. In paragraph 1, The above branch includes a shape memory polymer whose shape is restored when conditions regarding the surrounding environment are met. Electronic umbrella device for minimally invasive procedures.

4. In paragraph 3, The conditions for the above surrounding environment are: Including one or more conditions selected from the group consisting of temperature, humidity, pH concentration, light intensity, ultrasound and electromagnetic field of the above surrounding environment, Electronic umbrella device for minimally invasive procedures.

5. In paragraph 1, The above branch comprises a high-elasticity, ultra-soft polymer having a wide elastic range of 250% or more based on Young's modulus and a Young's modulus of 20 kPa or more. Electronic umbrella device for minimally invasive procedures.

6. In paragraph 5, The above branch portion further includes DNA combined with the polymer, The above DNA comprises a hairpin structure or double-stranded DNA, Electronic umbrella device for minimally invasive procedures.

7. In paragraph 6, The above branch portion is formed of a material containing DNA combined with a polymer only in some areas. Electronic umbrella device for minimally invasive procedures.

8. In paragraph 1, The above branch forms a network structure, Electronic umbrella device for minimally invasive procedures.

9. In paragraph 8, The above network structure is A plurality of sash parts spread out radially with the above-mentioned central support part in the center; and It is formed by including a chassis support part formed to connect the above chassis parts to each other; Electronic umbrella device for minimally invasive procedures.

10. In paragraph 9, When the above bio-injectable electronic device is injected in a lumped state in a direction in which the branch part first contacts the brain surface, The contact angle at which the end of the above chassis first comes into contact with the target object is formed to be 70 degrees or less. Electronic umbrella device for minimally invasive procedures.

11. In paragraph 9, At least a portion of the part where the chassis portion and the chassis support portion are connected has a component formed therein. Electronic umbrella device for minimally invasive procedures.

12. In paragraph 9, At least some of the ends and middle points of the above chassis portion are formed with respective component parts. Electronic umbrella device for minimally invasive procedures.

13. In paragraph 12, The above-mentioned element part includes at least one of a sensor part, an electrode part, an electrical stimulation part, a drug injection part, an ultrasonic transmission part, a battery part, and a light transmission part. Electronic umbrella device for minimally invasive procedures.

14. In paragraph 12, The above-mentioned element is a single element that performs multiple functions. Electronic umbrella device for minimally invasive procedures.

15. In paragraph 12, At least two of the above-described individual components perform different functions, Electronic umbrella device for minimally invasive procedures.

16. In paragraph 15, Each of the chassis parts having the different function parts is assembled to be connected to the central support part. Electronic umbrella device for minimally invasive procedures.

17. In paragraph 1, The above bio-injectable electronic device includes a position detection marker, Electronic umbrella device for minimally invasive procedures.

18. In paragraph 1, The above central support portion forms a column-shaped axial structure in the z-axis direction, The above central support is provided with a means for enabling wireless communication with the outside or a conductive line for enabling wired communication passes through it. Electronic umbrella device for minimally invasive procedures.

19. In paragraph 18, The above central support includes an auxiliary support that supports the standing structure of the above central support. Electronic umbrella device for minimally invasive procedures.

20. As a bio-injectable electronic device, central support; and A branch portion including a plurality of chassis portions extending from the central support portion; It is possible to perform a minimally invasive procedure by forming a 3D structure in the z-axis direction outside the body, injecting it into the body environment with a height of less than 5 mm, and then unfolding it into a 2D structure in the xy-axis inside the body. Electronic umbrella device for minimally invasive procedures.

21. In paragraph 20, The above electronic umbrella element has a ratio of the area in the unfolded state to the area in the folded state of 10 times or more. Electronic umbrella device for minimally invasive procedures.

22. In paragraph 20, The above electronic umbrella element has a filling ratio of 0.6 or less. Electronic umbrella device for minimally invasive procedures.

23. As a bio-injectable 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 entering the environment between the inner wall of the skull and the surface of the brain, the above branches unfold and come into contact with the surface of the brain and operate. When the above branch is injected in a direction that makes first contact with the brain surface, the structure is such that the greatest strain is formed in the uppermost chassis support closest to the central support among the chassis support parts when making contact with the brain surface. Electronic umbrella device for minimally invasive procedures.

24. As a bio-injectable electronic device, central support; and A branch portion including a plurality of chassis portions extending from the central support portion; When entering the environment between the inner wall of the skull and the surface of the brain, the above branches unfold and come into contact with the surface of the brain and operate. The above chassis portion is encapsulated after multiple layers are laminated. Containing at least three layers: a lower cover layer, an electrode, and an upper cover layer; Electronic umbrella device for minimally invasive procedures.

25. In paragraph 24, The above chassis portion further includes one or more layers among an active layer, an interlayer, a receiver coil layer, and a gate oxide layer. Electronic umbrella device for minimally invasive procedures.

26. In a method for manufacturing a bio-injectable electronic device, The above bio-injectable electronic device operates by entering the environment between the inner wall of the skull and the surface of the brain and contacting the surface of the brain by unfolding its branches. central support; and A branch portion having a plurality of chassis portions formed extending from the central support portion; comprising a step of assembling a plurality of prepared chassis parts to the above central support; A method for manufacturing an electronic umbrella device for minimally invasive procedures.

27. In a method for manufacturing a bio-injectable electronic device, The above bio-injectable electronic device operates by entering the environment between the inner wall of the skull and the surface of the brain and contacting the surface of the brain by unfolding its branches. central support; and A branch portion having a plurality of chassis portions formed extending from the central support portion; The above chassis part, Step for preparing the lower substrate; A step of forming a lower cover layer on the lower substrate; A step of forming a central support on the lower cover layer; A step of forming a laminate of an electrode prepared on the lower cover layer and an upper cover layer; A step of folding one side of the lower cover layer, electrode and upper cover layer based on the central support; manufactured including; A method for manufacturing an electronic umbrella device for minimally invasive procedures.

28. In a method for manufacturing a bio-injectable electronic device, The above bio-injectable electronic device operates by entering the environment between the inner wall of the skull and the surface of the brain and contacting the surface of the brain by unfolding its branches. It includes a central support portion; and a branch portion having a plurality of chassis portions extending from the central support portion; The above branch portion is manufactured by including a process of forming a laminated structure including the lower cover layer, electrode, and upper cover layer, The process of forming the above laminated structure includes a step of designing the structure of each layer through a laser process. A method for manufacturing an electronic umbrella device for minimally invasive procedures.

29. A method for implanting a bio-implantable electronic device into the body, which operates by contacting the brain surface and spreading out its branches when entering the environment between the inner wall of the skull and the brain surface. The above bio-injectable electronic device is, central support; and A branch portion including a plurality of chassis portions extending from the central support portion; A step of folding the bio-injectable electronic device into an injection device; A step of injecting the bio-implantable electronic device into a hole drilled in the skull; The step of the above bio-injectable electronic device being positioned on the brain surface while being spread inside the skull; and a step of operating the bio-implantable electronic device on the brain surface; A method for intravenous injection of an electronic umbrella device for minimally invasive procedures.

30. In paragraph 29, The step of the above bio-injectable electronic device being positioned on the brain surface while being spread inside the skull; A step in which the branch portion of the above bio-injectable electronic device unfolds itself in the environment inside the skull, A method for intravenous injection of an electronic umbrella device for minimally invasive procedures.

31. In paragraph 29, The step of folding the bio-injectable electronic device into a sealed injection device containing a lung space; Further comprising a step of injecting a lubricant into the sealed injection device; The above lubricant is used to enable the bio-implantable electronic device to smoothly unfold and slide onto the brain surface during the step of unfolding and positioning on the brain surface. A method for intravenous injection of an electronic umbrella device for minimally invasive procedures.

32. In paragraph 29, The step of the above bio-injectable electronic device being spread out and positioned on the brain surface; The bio-injectable electronic device is well attached to the target point on the brain surface by an adhesive. A method for intravenous injection of an electronic umbrella device for minimally invasive procedures.

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