Human body-implantable interface having 3D structure and manufacturing method thereof

Abstract

A human body-implantable interface having a 3D structure according to an embodiment of the present invention comprises: an interface body having a three-dimensional structure formed of a shape memory polymer material; a plurality of electrode units disposed at a portion of the interface body in contact with a human body; and a connection line connected to the electrode units to transmit biosignals of the human body sensed through the electrode units to the outside. Here, the interface body may be cured into a three-dimensional structure by injecting a shape memory polymer solution into multiple molds manufactured by a 3D printing process of a 3D printer, and may be easily obtained through disassembly of the multiple molds.

Description

3D structured implantable interface and method of manufacturing the same

[0001] The present invention relates to a 3D structured implantable interface and a method for manufacturing the same. More specifically, the invention relates to a 3D structured implantable interface and a method for manufacturing the same, which allows the implantable interface to be easily manufactured into a 3D structure using a multi-molding technique and enables the packaging process to be performed quickly by utilizing a shape-memory polymer solution used in the manufacturing of the multi-molding technique as an adhesive.

[0002]

[0003] Generally, implantable interfaces are implanted into nerve or muscle tissue to acquire biosignals from or provide biosignals to nerve or muscle tissue. As these implantable interfaces are recognized as a core convergence technology in fields such as bionics, neurorehabilitation, and medical assistive devices for an aging society, active technological development is currently underway.

[0004] Conventional implantable interfaces are manufactured using MEMS processes to create 2D structures for ease of fabrication. That is, the process of manufacturing a 2D implantable interface through MEMS processes involves very complex steps, such as coating a lower insulating layer, coating and patterning a conductive layer, coating an upper insulating layer, and opening electrodes by cutting the insulating layer.

[0005] Here, in the conventional manufacturing process for implantable interfaces, the packaging stage for producing the final prototype of the implantable interface requires a process to connect electrodes and thin wires, and also requires a complex packaging process to additionally insulate the connection part.

[0006] In addition, conventional implantable interfaces are manufactured through MEMS processes, so it is very difficult to form them into 3D structures, which limits their practical manufacturing.

[0007] Therefore, there is an urgent need for technology that can easily manufacture implantable interfaces made of biocompatible materials into various types of 3D structures, and there is also an urgent need for technology that can perform the packaging process of implantable interfaces simply and quickly.

[0008]

[0009] An embodiment of the present invention provides a 3D structured implantable interface and a method for manufacturing the same, which can easily produce an implantable interface in various forms of 3D structures using a multi-molding technique of multiple molds.

[0010] In addition, embodiments of the present invention provide a 3D structured implantable interface and a method for manufacturing the same, which can manufacture an implantable interface made of a biocompatible material by injecting and curing a biocompatible shape memory polymer solution into multiple molds, and can perform a packaging process of the implantable interface simply and quickly by utilizing the shape memory polymer solution as an adhesive.

[0011]

[0012] According to one embodiment of the present invention, a 3D structured human implantable interface is provided, comprising: an interface body having a three-dimensional structure formed of a shape-memory polymer material; a plurality of electrode portions disposed in a portion of the interface body that comes into contact with a human body; and a connecting line connected to the electrode portions to transmit a biosignal of the human body detected through the electrode portions to the outside.

[0013] Here, the interface body can be cured into a three-dimensional structure by injecting a shape memory polymer solution into a multi-mold produced by a 3D printing process of a 3D printer, and can be easily obtained through the disassembly of the multi-mold.

[0014] Preferably, the multiple molds may include a plurality of unit molds that are individually produced by the 3D printing process of the 3D printer.

[0015] The above multi-mold can be manufactured by assembling the unit molds such that a cavity corresponding to the interface body is formed inside, and can be disassembled back into the unit molds after the molding of the interface body is completed by curing the shape memory polymer solution injected into the cavity.

[0016] Preferably, the interface body may include a nerve graft formed as a clip structure that wraps around and fixes to the nerve tissue of the human body, and a muscle graft protruding as a projection structure that is integrally connected to the nerve graft and inserted into the muscle tissue of the human body.

[0017] Here, the nerve graft is provided as a ring-shaped structure having a hollow portion formed inside for placing the nerve tissue, and an opening may be formed on one side to insert the nerve tissue into the hollow portion.

[0018] In addition, the muscle graft is provided as a pillar structure for penetrating into the muscle tissue, and the end may be formed pointed to facilitate insertion into the muscle tissue.

[0019] For example, the nerve graft may be formed as a ring-shaped structure having a 'C'-shaped cross-section. The muscle graft may be extended in a structure orthogonal to the nerve graft along the penetration direction of the hollow portion.

[0020] Preferably, a first contact surface that contacts the nerve tissue may be provided on the inner surface forming the hollow portion among the surfaces of the nerve graft. A second contact surface having the same surface shape as the first contact surface may be provided on one side of the surface of the muscle graft that contacts the nerve tissue. In this case, the electrode portion may be disposed at different parts of the second contact surface.

[0021] Preferably, the electrode portion may be provided as an electrode wire made of a biocompatible material that is wrapped around and secured to the muscle graft. A plurality of electrode wires may be arranged spaced apart from each other along the protruding direction of the muscle graft.

[0022] For example, the electrode portions may be provided as a first electrode wire connected along the surface perimeter of the muscle graft at a first position of the muscle graft, and a second electrode wire connected to wrap around the surface of the muscle graft at a second position closer to the nerve graft than the first position of the muscle graft.

[0023] In addition, the above connecting wire may include a first connecting wire made of a biocompatible material connected to the first electrode wire, a second connecting wire made of a biocompatible material connected to the second electrode wire, and a connecting tube made of a biocompatible material into which the first and second connecting wires are inserted.

[0024] Preferably, an insulating adhesive portion made of a shape-memory polymer material may be formed at the connection portion between the electrode portions and the connection line through a process of applying and curing the shape-memory polymer solution. At this time, the insulating adhesive portion may be used as an adhesive for bonding the connection portion.

[0025] A first contact surface that contacts the nerve tissue may be provided on the inner surface forming the hollow portion among the surfaces of the nerve graft. A second contact surface having the same surface shape as the first contact surface may be provided on one side of the surface of the muscle graft that contacts the nerve tissue. At this time, the connection portion between the electrode portions and the connecting line may be disposed on the other surface of the muscle graft excluding the second contact surface.

[0026] The above interface body may have an insulating coating layer made of a shape-memory polymer material coated on all surfaces except for the electrode portions disposed on the second contact surface.

[0027] Preferably, a 3D structured implantable interface is characterized by having a wire coating layer of a material different from that of the electrode wires formed on the surface of the electrode wires to improve the performance of the electrode portion.

[0028] For example, the electrode wires may be formed from any one of platinum, platinum-iridium, and stainless steel. The wire coating layer may be formed from at least one of PEDOT, PEDOT:PSS, and iridium oxide.

[0029] Preferably, a plurality of electrode grooves may be formed in the muscle graft at the location where the electrode wires are fastened. The electrode grooves may be formed with a depth that exposes a portion of the electrode wires to the outside.

[0030] According to another aspect of the present invention, a method for manufacturing an implantable interface is provided, comprising the steps of: manufacturing a plurality of unit molds using a 3D printer; assembling the unit molds to complete a multi-mold; manufacturing a shape-memory polymer solution corresponding to a biocompatible insulating material; injecting the shape-memory polymer solution into the multi-mold; curing the shape-memory polymer solution injected into the multi-mold; disassembling the multi-mold into the unit molds to obtain an interface body made of a shape-memory polymer material; attaching a plurality of electrode portions to the interface body spaced apart from each other; connecting one end of a connecting line to the electrode portions; applying the shape-memory polymer solution to the connection portion between the electrode portions and the connecting line and then curing it; finally curing the interface body connected to the electrode portions and the connecting line to manufacture an implantable interface; and packaging the implantable interface in a packaging bag.

[0031] Here, in the step of preparing the shape memory polymer solution, 1,3,5-Triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trimethylolpropanetris(3-mercaptopropionate), tricyclodecanedimethanoldiacrylate, and 2,2-dimethoxy-2-phenyl-acetophenone can be mixed in a certain ratio to prepare the solution.

[0032] In addition, in the step of curing the shape memory polymer solution, the shape memory polymer solution can be cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 20 to 40 minutes. In the step of curing the shape memory polymer solution after applying it to the connection portion between the electrode portions and the connection line, the shape memory polymer solution can be cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 50 to 70 seconds. In the step of manufacturing the implantable interface by final curing, the implantable interface can be finally cured by heating it to 100 to 140 degrees Celsius for 20 to 30 hours using a vacuum oven.

[0033] In addition, in the step of attaching a plurality of electrode parts to the interface body, the attachment can be performed by tying electrode wires to different locations on the interface body. In the step of connecting one end of a connecting wire to the electrode parts, the connecting wire can be manufactured by inserting a plurality of connecting wires made of biocompatible material into a connecting tube made of biocompatible material, and then connecting the connecting wires to the electrode wires one by one.

[0034]

[0035] The 3D structured human implantable interface and the method for manufacturing the same according to an embodiment of the present invention can easily produce the interface body of the human implantable interface in various forms of 3D structures through a multi-molding technique using multiple molds produced by a 3D printing process of a 3D printer. In particular, in this embodiment, a multiple mold having a cavity of a 3D structure can be easily produced by assembling a plurality of unit molds produced by a 3D printing process of a 3D printer, and the interface body of a 3D structure can be easily obtained by disassembling the multiple mold into a plurality of unit molds.

[0036] In addition, the 3D structured implantable interface and the method for manufacturing the same according to the embodiment of the present invention can manufacture an interface body made of a biocompatible material by injecting and curing a shape-memory polymer solution made of a biocompatible material into multiple molds, and can also use the shape-memory polymer solution as an adhesive to bond the connection portion of the electrode portion and the connection line. Therefore, in this embodiment, the packaging process of the implantable interface can be performed simply and quickly.

[0037] In addition, the 3D structured implantable interface and the method for manufacturing the same according to an embodiment of the present invention are formed such that the nerve graft portion of the interface body is wrapped around and fixed to nerve tissue, and the muscle graft portion of the interface body is formed such that it is inserted into muscle tissue; thus, the implantable interface can selectively perform either direct implantation into a nerve or penetrating implantation into a muscle segment. In particular, since the electrode portion of this embodiment is formed such that wires are fastened to different locations on the muscle graft portion, the performance of the electrode portion can be smoothly improved by coating wires with wire coating layers of various materials.

[0038]

[0039] FIG. 1 is a perspective view schematically illustrating a 3D structured human body implantable interface according to an embodiment of the present invention.

[0040] Figure 2 is a plan view showing a 3D structure of an implantable interface shown in Figure 1.

[0041] Figure 3 is a drawing showing a cross-section according to AA shown in Figure 2.

[0042] FIG. 4 is a side view showing a 3D structured implantable interface according to an embodiment of the present invention.

[0043] FIG. 5 is a flowchart illustrating a method for manufacturing an implantable interface according to an embodiment of the present invention.

[0044] Figure 6 is an image showing a plurality of unit molds manufactured through the 'step of manufacturing a plurality of unit molds with a 3D printer' illustrated in Figure 5.

[0045] Figure 7 is an image showing a multi-mold manufactured through the 'step of assembling a plurality of unit molds to form a multi-mold' illustrated in Figure 5.

[0046] FIG. 8 is an image showing an implantable interface manufactured through the 'step of attaching a plurality of electrode parts to the interface body' illustrated in FIG. 5.

[0047] Figure 9 is an image showing an implantable interface manufactured through the step of ‘applying a shape memory polymer solution to the connection portion between the electrode portions and the connection line and then curing it’ as illustrated in Figure 5.

[0048] Figure 10 is an image showing the packaging of an implantable interface manufactured through the 'step of packaging an implantable interface' illustrated in Figure 5.

[0049]

[0050] Hereinafter, embodiments according to the present invention will be described in detail with reference to the accompanying drawings. However, the present invention is not limited or restricted by the embodiments. Identical reference numerals in each drawing indicate identical components.

[0051]

[0052] FIG. 1 is a schematic perspective view of a 3D structured human body implantable interface (100) according to an embodiment of the present invention, FIG. 2 is a plan view showing the 3D structured human body implantable interface (100) shown in FIG. 1, and FIG. 3 is a cross-sectional view according to AA shown in FIG. 2. FIG. 4 is a side view showing a 3D structured human body implantable interface (100) according to an embodiment of the present invention.

[0053] Referring to FIGS. 1 to 4, a 3D structured human body implantable interface (100) according to one embodiment of the present invention includes a three-dimensional structured interface body (110, 120), a plurality of electrode parts (130), and a connecting line (140).

[0054] The human body implantable interface (100) of the present embodiment may be provided with a structure in which a plurality of electrode parts (130) are formed on an interface body (110, 120) formed in a various three-dimensional structure, and then connecting lines (140) are connected to the electrode parts (130). Here, it is preferable that the interface body (110, 120), the electrode parts (130), and the connecting lines (140) be formed of a biocompatible material for implantation into the human body.

[0055] Additionally, the interface body (110, 120) of the present embodiment can be manufactured by injecting a shape-memory polymer solution of a biocompatible material into a multi-mold (10) produced by a 3D printing process of a 3D printer and curing it into a three-dimensional structure. At this time, the interface body (110, 120) injected and cured inside the multi-mold (10) can be easily obtained by disassembling the multi-mold (10).

[0056] The multi-mold (10) used for manufacturing the interface body (110, 120) as described above may include a plurality of unit molds (12, 14, 16) that are individually produced by a 3D printing process of a 3D printer. That is, the multi-mold (10) of the present embodiment may be manufactured such that a cavity corresponding to the interface body (110, 120) is formed inside through an assembly process of the unit molds (12, 14, 16). Furthermore, when the shape memory polymer solution injected into the cavity of the multi-mold (10) of the present embodiment is cured and the molding of the interface body (110, 120) is completed, the multi-mold (10) can be easily separated from the interface body (110, 120) through a disassembly process of the unit molds (12, 14, 16).

[0057] Accordingly, in this embodiment, since the multi-mold (10) can have cavities of various shapes depending on the shape and combination of the unit molds (12, 14, 16), the interface body (110, 120) can be manufactured into a three-dimensional structure of various shapes. In addition, in this embodiment, since the unit molds (12, 14, 16) can be produced in a desired shape through the 3D printing process of a 3D printer, the multi-mold (10) can be designed and manufactured very quickly and easily.

[0058] Referring to FIGS. 1 to 4, the interface body (110, 120) of the present embodiment may be formed from a shape-memory polymer of a biocompatible material and may be formed as a three-dimensional structure rather than a conventional two-dimensional structure. The interface body (110, 120) as described above may be provided in various forms that can be inserted into the human body, but in the present embodiment, it may be provided in a form that can be implanted into both nerve tissue and muscle tissue of the human body. For example, the interface body (110, 120) of the present embodiment may be provided as a structure that can be selectively implanted into either nerve tissue or muscle tissue. Alternatively, the interface body (110, 120) of the present embodiment may be provided as a dedicated structure that is implanted into only one of nerve tissue or muscle tissue.

[0059] For reference, the implantation method of the human body implantable interface (100) can be classified into a direct implantation method into a nerve and a penetrating implantation method into a muscle segment. Here, the direct implantation method into a nerve can be implanted in a form that binds to nerve tissue, and the penetrating implantation method into a muscle segment can be implanted in a form that penetrates into muscle tissue. In the present embodiment, the human body implantable interface (100) can be formed into a 3D structure capable of both the direct implantation method into a nerve and the penetrating implantation method into a muscle segment.

[0060] For example, the interface body (110, 120) of the present embodiment may include a nerve graft (110) that is implanted into the nerve tissue of the human body, and a muscle graft (120) that is connected to the nerve graft (110) in an integral structure and is implanted into the muscle tissue of the human body.

[0061] The nerve graft (110) may be formed as a clip structure that wraps around and fixes the nerve tissue of the human body. That is, the nerve graft (110) of the present embodiment may be provided as a ring-shaped or cylindrical structure having a hollow portion (116) formed inside for placing nerve tissue. An opening may be formed on one side of the nerve graft (110) to insert nerve tissue into the hollow portion (116). For example, the nerve graft (110) may be formed as a ring-shaped or cylindrical structure having a 'C'-shaped cross-section.

[0062] For example, the nerve graft (110) may include a first clip portion (112), a second clip portion (114), and a hollow portion (116).

[0063] Here, the first clip portion (112) and the second clip portion (114) are formed to have an arc-shaped cross-section and may be arranged symmetrically so as to face each other with respect to the hollow portion (116). One end of the first clip portion (112) and one end of the second clip portion (114) may be formed as an integrated structure connected to each other, and the other end of the first clip portion (112) and the other end of the second clip portion (114) may be arranged as a structure spaced apart from each other. An opening may be formed between the other end of the first clip portion (112) and the other end of the second clip portion (114) for nerve tissue to enter and exit. Such an opening may be instantaneously expanded by spreading the first clip portion (112) and the second clip portion (114).

[0064] Additionally, the hollow portion (116) may be formed in the shape of a passage with a circular cross-section between the first clip portion (112) and the second clip portion (114). When the nerve graft portion (110) is implanted into nerve tissue, the nerve tissue may be positioned so that it penetrates into the interior of the hollow portion (116) through the opening. Accordingly, on the inner surfaces of the first clip portion (112) and the second clip portion (114) forming the hollow portion (116), a first contact surface (110a) that contacts the nerve tissue when the nerve graft portion (110) is implanted into the nerve tissue may be provided.

[0065] The muscle graft (120) is formed as an integral structure with the nerve graft (110), but can be formed to protrude as a projection structure so as to be inserted into the muscle tissue of the human body. That is, the muscle graft (120) can be provided as a pillar structure for penetrating and inserting into the interior of the muscle tissue. The end of the muscle graft (120) as described above can be formed as a point to facilitate the insertion of the muscle graft (120) into the muscle tissue. Meanwhile, the muscle graft (120) can be extended in a long structure that is orthogonal to the first clip portion (112) and the second clip portion (114) of the nerve graft (110) along the penetrating direction of the hollow portion (116) (e.g., the arrangement direction of the nerve tissue).

[0066] A second contact surface (120a) may be provided on one side of the surface of the muscle graft (120) that comes into contact with the nerve tissue when the nerve graft (110) is grafted into the nerve tissue. In practice, the surface of the muscle graft (120) comes into contact with the muscle tissue when the muscle graft (120) is grafted into the muscle tissue, but when the nerve graft (110) is grafted into the nerve tissue, only the second contact surface (120a) may come into structural contact with the nerve tissue. The second contact surface (120a) as described above may be formed to have the same surface shape as the first contact surface (110a).

[0067] Referring to FIGS. 1 to 4, a plurality of electrode portions (130) of the present embodiment may be disposed on the surface of the interface body (110, 120) in a portion that comes into contact with human nerve tissue or muscle tissue. Such a plurality of electrode portions (130) may be disposed spaced apart from each other.

[0068] Specifically, a plurality of electrode portions (130) may be spaced apart from each other on at least one of the first contact surface (110a) and the second contact surface (120a). Hereinafter, in this embodiment, they are described as being placed on the second contact surface (120a) which contacts both nerve tissue and muscle tissue. On the other hand, if a plurality of electrode portions (130) are placed on the first contact surface (110a), the biosignal of the nerve tissue can be detected only when the implantable interface (100) is implanted in the nerve tissue, and when the implantable interface (100) is implanted in the muscle tissue, only the biosignal of the muscle tissue can be detected, and the detection of nerve signals is impossible.

[0069] Meanwhile, the electrode portion (130) of the present embodiment may be provided as an electrode wire (132, 134) made of a biocompatible material that is wound and fastened to the muscle graft portion (120). A plurality of such electrode wires (132, 134) may be arranged spaced apart from each other along the protruding direction of the muscle graft portion (120). Hereinafter, in the present embodiment, two electrode portions (130) are described as being placed on the muscle graft portion (120).

[0070] For example, the electrode portions (130) of the present embodiment may be provided as a first electrode wire (132) and a second electrode wire (134).

[0071] The first electrode wire (132) can be fastened along the surface perimeter of the muscle graft (120) at a first position of the muscle graft (120). The second electrode wire (134) can be fastened to wrap around the surface of the muscle graft (120) at a second position closer to the nerve graft (110) than at the first position of the muscle graft (120).

[0072] At this time, a wire coating layer (not shown) made of a material different from that of the first and second electrode wires (132, 134) may be formed on the surface of the first and second electrode wires (132, 134) to improve the performance of the electrode portion (130). For example, the first and second electrode wires (132, 134) may be formed of any one of platinum, platinum-iridium, and stainless steel, and the wire coating layer may be formed of at least one of PEDOT, PEDOT:PSS, and iridium oxide.

[0073] Additionally, electrode grooves (122, 124) may be formed in the muscle graft (120) at a first position and a second position, respectively, where the first and second electrode wires (132, 134) are fastened. Accordingly, the first and second electrode wires (132, 134) can not only be stably positioned in the muscle graft (120) by means of the electrode grooves (122, 124) but can also be accurately positioned at the first and second positions of the muscle graft (120). The electrode grooves (122, 124) described above may be formed with a depth that exposes a portion of the first and second electrode wires (132, 134) to the outside in order to secure the sensing performance of the first and second electrode wires (132, 134). To this end, it is preferable that the depth of the electrode grooves (122, 124) be formed to be smaller than the thickness of the first and second electrode wires (132, 134).

[0074] For example, the electrode grooves (122, 124) of the present embodiment may include a first electrode groove (122) formed at a first position of the muscle graft (120) into which a first electrode wire (132) is inserted and fastened, and a second electrode groove (124) formed at a second position of the muscle graft (120) into which a second electrode wire (134) is inserted and fastened.

[0075] As illustrated in FIG. 3, an insulating coating layer (160) made of a shape-memory polymer material may be coated on all surfaces of the interface body (110, 120) of the present embodiment, excluding the electrode portions (130) disposed on the second contact surface (120a). Preferably, the insulating coating layer (160) may be coated on the surface of the interface body (110, 120) with a predetermined thickness to insulate a portion of the electrode portions (130) disposed on the surface of the interface body (110, 120). Thus, the electrode portions (130) can detect biological signals from nerve tissue or muscle tissue through the portions not coated with the insulating coating layer (160). The insulating coating layer (160) may be manufactured by a process of applying a biocompatible shape-memory polymer solution, identical to that of the interface body (110, 120), to the surface of the interface body (110, 120).

[0076] Referring to FIG. 4, the connecting line (140) of the present embodiment is electrically connected to the electrode portions (130) and can be formed to be long to perform the function of transmitting the human body's biosignal detected through the electrode portions (130) to the outside. It is preferable to manufacture the connecting line (140) as described above in a structure in which a number of wires made of biocompatible material are arranged within a tube made of biocompatible material in a number corresponding to the electrode portions (130).

[0077] For example, the connecting line (140) of the present embodiment may include a first connecting wire (142), a second connecting wire (144), and a connecting tube (146).

[0078] The first connecting wire (142) may be formed of a biocompatible material wire connected to the first electrode wire (132). The second connecting wire (144) may be formed of a biocompatible material wire connected to the second electrode wire (134). The connecting tube (146) may be formed of a biocompatible material tube into which the first connecting wire (142) and the second connecting wire (144) are inserted.

[0079] Meanwhile, one end of the connecting line (140) may be connected to the electrode portions (130), and an insulating adhesive portion (150) made of a shape-memory polymer material may be formed to cover the connection portion between the electrode portions (130) and the connecting line (140). That is, the insulating adhesive portion (150) may be formed on the surface of the interface body (110, 120) through a process of applying a shape-memory polymer solution to the connection portion between the electrode portions (130) and the connecting line (140) and then curing it. The insulating adhesive portion (150) of this embodiment insulates the connection portion between the electrode portions (130) and the connecting line (140) and can also firmly adhere the connecting line (140) to the interface body (110, 120). The insulating adhesive portion (150) as described above may be provided as a coating layer structure applied to the surface of the interface body (110, 120) with a predetermined thickness. At this time, it is preferable that the connection portion of the electrode portions (130) and the connection line (140) be placed on a different surface of the muscle graft portion (120) excluding the second contact surface (120a) of the muscle graft portion (120), and the insulating adhesive portion (150) be applied to the portion of the connection line (140) among the surfaces of the interface body (110, 120).

[0080] FIG. 4 schematically discloses the arrangement of the connecting line (140) and the coating structure of the insulating adhesive part (150).

[0081] Here, when looking at the arrangement of the connecting line (140), the ends of the first and second connecting wires (142, 144) of the connecting line (140) can be individually connected to the first and second electrode wires (132, 134), and the connecting tube (146) of the connecting line (140) and the first and second connecting wires (142, 144) can be arranged in close contact with the surface of the interface body (110, 120). At this time, the ends of the first and second connecting wires (142, 144) can be connected to the first and second electrode wires (132, 134) by welding or by twisting and connecting to the first and second electrode wires (132, 134). However, this is not limited thereto, and the connecting portions of the first and second connecting wires (142, 144) and the first and second electrode wires (132, 134) can be connected in various ways.

[0082] For reference, the connecting line (140) of the present embodiment may be formed with a tensionable helical structure. Accordingly, the connecting line (140) can be used stably by allowing length adjustment during long-term use.

[0083] Additionally, when looking at the coating structure of the insulating adhesive portion (150), the insulating adhesive portion (150) can be formed in a structure in which a shape memory polymer solution is applied to the surface of the interface body (110, 120) to sufficiently cover the connecting line (140). That is, the insulating adhesive portion (150) is a coating layer structure that is applied to the surface of the interface body (110, 120) to a certain thickness and cured, so that the electrode portions (130) and the connecting line (140) can be safely insulated by the insulating properties of the shape memory polymer, and the connecting line (140) can be firmly adhered to the surface of the interface body (110, 120) by the adhesive properties of the shape memory polymer.

[0084] The insulating adhesive portion (150) described above can be applied in a layer structure capable of covering the connecting line (140) and can be attached and fixed in an integral shape to the surface of the interface body (110, 120). The thickness of the insulating adhesive portion (150) can be formed to a thickness sufficient to accommodate the connecting line (140), the width of the insulating adhesive portion (150) can be formed to a width sufficient to cover the connection between the electrode portions (130) and the connecting line (140), and the length of the insulating adhesive portion (150) can be formed to a length corresponding to the length of the connecting line (140) arranged along the surface of the interface body (110, 120).

[0085] FIG. 5 is a flowchart illustrating a method for manufacturing a human body implantable interface (100) according to an embodiment of the present invention. FIG. 6 is an image showing multiple unit molds (12, 14, 16) manufactured through the step of manufacturing multiple unit molds with a 3D printer as shown in FIG. 5, FIG. 7 is an image showing multiple molds (10) manufactured through the step of assembling multiple unit molds to form multiple molds as shown in FIG. 5, FIG. 8 is an image showing an implantable interface (100) manufactured through the step of attaching multiple electrode parts to an interface body as shown in FIG. 5, FIG. 9 is an image showing an implantable interface (100) manufactured through the step of applying a shape memory polymer solution to the connection part of the electrode parts and the connection line and then curing it as shown in FIG. 5, FIG. 10 is an image showing the packaging of an implantable interface (100) manufactured through the step of packaging an implantable interface as shown in FIG. 5.

[0086] The method for manufacturing a human body implantable interface (100) according to an embodiment of the present invention configured as described above is as follows.

[0087] Referring to FIG. 5, a method for manufacturing a human body implantable interface (100) according to an embodiment of the present invention comprises the steps of: manufacturing a plurality of unit molds (12, 14, 16) using a 3D printer (see S10); assembling the unit molds (12, 14, 16) to complete a multi-mold (10) (see S11); manufacturing a shape-memory polymer solution corresponding to a biocompatible insulating material (see S12); injecting the shape-memory polymer solution into the interior of the multi-mold (10) (see S13); curing the shape-memory polymer solution injected into the interior of the multi-mold (10) (see S14); disassembling the multi-mold (10) into unit molds (12, 14, 16) to obtain an interface body (110, 120) made of a shape-memory polymer material (see S15); and attaching a plurality of electrode parts (130) to the interface body (110, 120). The method includes the steps of: connecting the electrode portions (130) with a gap (see S16); connecting one end of the connecting line (140) to the electrode portions (130) (see S17); applying a shape memory polymer solution to the connection portion between the electrode portions (130) and the connecting line (140) and curing it (see S18); finally curing the interface body (110, 120) in which the electrode portions (130) and the connecting line (140) are connected to manufacture an implantable interface (100) (see S19); and packaging the implantable interface (100) in a packaging bag (20) (see S20).

[0088] In the step of manufacturing multiple unit molds (12, 14, 16) using a 3D printer (see S10), multiple unit molds (12, 14, 16) are produced using the 3D printing process of the 3D printer. At this time, the multiple unit molds (12, 14, 16) are designed and produced with different structures to form a multi-mold (10) of the desired shape. The unit molds (12, 14, 16) produced as described above are immersed in a release agent.

[0089] As illustrated in FIG. 6, a plurality of unit molds (12, 14, 16) produced through a 3D printing process of a 3D printer are shown in FIG. 6. Hereinafter, in this embodiment, a plurality of unit molds (12, 14, 16) may be provided as a first unit mold (10), a second unit mold (20), and a third unit mold (30).

[0090] In the step of completing a multi-mold (10) by assembling unit molds (12, 14, 16) (see S11), a plurality of unit molds (12, 14, 16) are assembled to produce a multi-mold (10). At this time, a cavity corresponding to an interface body (110, 120) is formed inside the multi-mold (10). As shown in FIG. 7, a multi-mold (10) produced by assembling unit molds (12, 14, 16) is shown in FIG. 7.

[0091] In the step of preparing a shape memory polymer solution (see S12), the shape memory polymer solution is prepared as a biocompatible insulating material. For example, the shape memory polymer solution can be prepared by mixing 1,3,5-Triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trimethylolpropanetris(3-mercaptopropionate), tricyclodecanedimethanoldiacrylate, and 2,2-dimethoxy-2-phenyl-acetophenone in a certain ratio.

[0092] In the step of injecting the shape memory polymer solution into the multi-mold (10) (see S13), the shape memory polymer solution is injected into the cavity of the multi-mold (10).

[0093] In the step of curing the injected shape memory polymer solution (see S14), the shape memory polymer solution injected into the cavity of the multi-mold (10) is cured to form an interface body (110, 120). At this time, in this embodiment, the shape memory polymer solution is cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 20 to 40 minutes. Preferably, the shape memory polymer solution is cured by irradiating ultraviolet light having a wavelength of 365 nm for 30 minutes.

[0094] In the step of obtaining an interface body (110, 120) by disassembling the multi-mold (10) (see S15), the multi-mold (10) is again disassembled into unit molds (12, 14, 16) to easily obtain an interface body (110, 120) made of a shape-memory polymer material. Therefore, even if the interface body (110, 120) is formed into a complex 3D structure, it can be reliably obtained from the multi-mold (10).

[0095] In the step of connecting a plurality of electrode portions (130) to the interface body (110, 120) (see S16), electrode portions (130) are formed by connecting electrode wires (132, 134) at different locations on the interface body (110, 120) respectively. In this embodiment, two electrode portions (130) are provided by connecting the first and second electrode wires (132, 134) by inserting them into the first and second electrode grooves (122, 124) formed at the first and second locations of the muscle graft portion (120) of the interface body (110, 120).

[0096] For reference, FIG. 8 illustrates the first and second electrode wires (132, 134) connected to the muscle graft portion (120) of the interface body (110, 120). At this time, the first and second electrode wires (132, 134) are connected to the muscle graft portion (120), and the ends of the first and second electrode wires (132, 134) are extended outward from the muscle graft portion (120).

[0097] In the step of connecting the connecting wire (140) to the plurality of electrode parts (130) (see S17), the first and second connecting wires (142, 144) of the connecting wire (140) are connected to the first and second electrode wires (132, 134). At this time, the connecting wire (140) is manufactured in a structure in which the first and second connecting wires (142, 144) made of biocompatible material are inserted into a connecting tube (146) made of biocompatible material. Once the manufacturing of the connecting wire (140) is completed as described above, the first and second connecting wires (142, 144) are individually connected one by one to the ends of the first and second electrode wires (132, 134).

[0098] In the step of applying and curing a shape memory polymer solution to the connection portion of the electrode portions (130) and the connection line (140) (see S18), the shape memory polymer solution is applied and cured in a shape that completely covers the end portion of the connection line (140) connected to the electrode portions (130) and the connection portion of the first and second electrode wires (132, 134) and the first and second connection wires (142, 144) to form an insulating adhesive portion (150). Accordingly, the end portion of the connection line (140) is fixed in an adhesive state in close contact with the surface of the interface body (110, 120) by the insulating adhesive portion (150) made of a shape memory polymer material, and the connection portion of the electrode portions (130) and the connection line (140) is insulated by the insulating adhesive portion (150) made of a shape memory polymer material.

[0099] At this time, the curing process of the shape memory polymer solution involves curing the shape memory polymer solution by irradiating it with ultraviolet light having a wavelength of 300 to 400 nm for 50 to 70 seconds. Preferably, the shape memory polymer solution is cured by irradiating it with ultraviolet light having a wavelength of 365 nm for 1 minute. Alternatively, it is also possible to irradiate it with ultraviolet light for up to 30 minutes, in which case the shape memory polymer solution is bonded more firmly, and the adhesive performance of the insulating adhesive part (150) can be improved.

[0100] For reference, FIG. 9 illustrates an implantable interface in which a shape-memory polymer solution is applied to and cured at the connection portion of the first and second electrode wires (132, 134) and the first and second connecting wires (142, 144). At this time, the connection portion of the first and second electrode wires (132, 134) and the first and second connecting wires (142, 144) can be stably bonded to the surface of the interface body (110, 120) by means of an insulating adhesive portion (150) using the shape-memory polymer solution as an adhesive.

[0101] In the step of manufacturing the human body implantable interface (100) by final curing (see S19), an insulating coating layer (160) is coated on the surface of the interface body (110, 120) in a state where the first and second electrode wires (132, 134) and the first and second connecting lines (140) are connected, and then the manufacturing of the human body implantable interface (100) is completed by final curing. At this time, the insulating coating layer (160) is coated on the entire surface of the interface body (110, 120), excluding the portion of the first and second electrode wires (132, 134) placed on the second contact surface (120a) of the muscle implantation part (120) of the interface body (110, 120). As described above, the first and second electrode wires (132, 134) placed on the second contact surface (120a) are not insulated by the insulating coating layer (160), so they can detect biosignals when in contact with the human body.

[0102] Meanwhile, when the coating process of the insulating coating layer (160) is completed, the interface body (110, 120) is insulated by the insulating coating layer (160), excluding the portion of the second contact surface (120a) where the first and second electrode wires (132, 134) are placed. When the insulation of the interface body (110, 120) is completed as described above, the insulating coating layer (160) is cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 20 to 40 minutes. Preferably, the interface body (110, 120) coated with the insulating coating layer (160) is cured by irradiating ultraviolet light having a wavelength of 365 nm for 30 minutes.

[0103] Then, the interface body (110, 120) coated and cured with the insulating coating layer (160) is placed in a vacuum oven and heated to 100 to 140 degrees Celsius for 20 to 30 hours to finally cure the human body implantable interface (100). Preferably, the interface body (110, 120) coated and cured with the insulating coating layer (160) is heated to 120 degrees Celsius for 24 hours in a vacuum oven to finally cure it.

[0104] In the step of packaging the implantable interface (100) (see S20), the 3D structured implantable interface (100) is placed in a packaging bag (20) to finally package the 3D structured implantable interface. For reference, FIG. 10 shows the final cured implantable interface (100) packaged in a packaging bag (20).

[0105] In the process of packaging the implantable interface (100) as described above, it is preferable to sterilize the implantable interface (100) through a sterilization process before packaging it in the packaging bag (20). For example, the implantable interface (100) is sterilized by a low-temperature plasma (hydrogen peroxide) sterilization method or an ethylene oxide gas (EO gas) sterilization method, and then finally packaged in the packaging bag (20).

[0106]

[0107] As described above, the embodiments of the present invention have been explained with specific details such as specific components, limited embodiments, and drawings; however, this is provided merely to aid in a more comprehensive understanding of the present invention, and the present invention is not limited to the above embodiments. A person skilled in the art to which the present invention pertains can make various modifications and variations from this description. Accordingly, the scope of the present invention should not be limited to the described embodiments, and all things equivalent to or having equivalent variations to the claims set forth below, as well as the claims themselves, shall be considered to fall within the scope of the concept of the present invention.

Claims

1. An interface body with a three-dimensional structure formed of a shape-memory polymer material; A plurality of electrode portions disposed in the part of the interface body that comes into contact with the human body; and It includes a connecting line connected to the electrodes to transmit the biosignal of the human body detected through the electrodes to the outside; The above interface body is a 3D structured human implantable interface characterized by injecting a shape-memory polymer solution into a multi-mold produced by a 3D printing process of a 3D printer to cure it into a three-dimensional structure, and easily obtaining it through the disassembly of the multi-mold.

2. In Paragraph 1, The above multiple molds include a plurality of unit molds that are individually produced by the 3D printing process of the 3D printer; and A 3D structured implantable interface characterized by the fact that the multi-mold is manufactured by assembling the unit molds such that a cavity corresponding to the interface body is formed inside, and is disassembled back into the unit molds when the molding of the interface body is completed by curing the shape memory polymer solution injected into the cavity.

3. In Paragraph 2, The above interface body is, A nerve graft formed with a clip structure that wraps around and fixes to the nerve tissue of the human body; and A muscle graft portion that is connected to the nerve graft portion in an integral structure and protrudes as a projection structure inserted into the muscle tissue of the human body; A 3D structured implantable interface including 4. In Paragraph 3, The nerve graft is provided in a ring-shaped structure having a hollow portion formed therein for placing the nerve tissue, and an opening is formed on one side to insert the nerve tissue into the hollow portion. A 3D structured human implantable interface characterized in that the muscle graft is provided as a pillar structure for penetrating into the interior of the muscle tissue, and has a pointed end formed to facilitate insertion into the muscle tissue.

5. In Paragraph 4, The above nerve graft is formed as a ring-shaped structure or a cylindrical structure having a 'C'-shaped cross-section, and A 3D structured implantable interface characterized by the muscle graft being extended in a structure orthogonal to the nerve graft along the penetration direction of the hollow portion.

6. In Paragraph 4, On the inner surface forming the hollow portion among the surfaces of the nerve graft, a first contact surface is provided that contacts the nerve tissue, and On one side of the surface of the muscle graft that contacts the nerve tissue, a second contact surface having the same surface shape as the first contact surface is provided. A 3D structured implantable interface characterized in that the electrode portions are respectively disposed at different parts of the second contact surface.

7. In any one of paragraphs 3 through 6, The above electrode portion is provided as an electrode wire made of a biocompatible material that is wrapped around and secured to the muscle graft portion, and A 3D structured implantable interface characterized by the electrode wires being arranged spaced apart from each other along the protruding direction of the muscle graft.

8. In Paragraph 7, The electrode portions are provided with: a first electrode wire connected along the surface perimeter of the muscle graft at a first position of the muscle graft; and a second electrode wire connected to wrap around the surface of the muscle graft at a second position closer to the nerve graft than the first position of the muscle graft. The above connecting wire comprises: a first connecting wire made of a biocompatible material connected to the first electrode wire; a second connecting wire made of a biocompatible material connected to the second electrode wire; and a connecting tube made of a biocompatible material into which the first and second connecting wires are inserted; a 3D structured implantable interface.

9. In Paragraph 7, An insulating adhesive portion made of a shape-memory polymer material is formed at the connection portion between the electrode portions and the connecting line through a process of applying and curing the shape-memory polymer solution. A 3D structured implantable interface characterized in that the insulating adhesive portion is utilized as an adhesive for bonding the connecting portion to the surface of the interface body.

10. In Paragraph 9, On the inner surface forming the hollow portion among the surfaces of the nerve graft, a first contact surface is provided that contacts the nerve tissue, and On one side of the surface of the muscle graft that contacts the nerve tissue, a second contact surface having the same surface shape as the first contact surface is provided. A 3D structured implantable interface characterized in that the connection portion between the electrode portions and the connection line is disposed on a different surface of the muscle implant portion excluding the second contact surface.

11. In Paragraph 10, A 3D structured implantable interface characterized in that the interface body has an insulating coating layer made of a shape-memory polymer material coated on all surfaces except for the electrode portions disposed on the second contact surface.

12. In Paragraph 7, A 3D structured implantable interface characterized by having a wire coating layer of a material different from that of the electrode wires formed on the surface of the electrode wires to improve the performance of the electrode portion.

13. In Paragraph 12, The above electrode wires are formed from any one of platinum, platinum-iridium, and stainless steel, and A 3D structured implantable interface characterized in that the wire coating layer is formed from at least one material selected from PEDOT, PEDOT:PSS, and iridium oxide.

14. In Paragraph 7, In the muscle graft portion, a plurality of electrode grooves are formed at the locations where the electrode wires are fastened, and A 3D structured implantable interface characterized in that the electrode groove is formed with a depth that exposes a portion of the electrode wire to the outside.

15. A step of manufacturing multiple unit molds using a 3D printer; A step of completing a multi-mold by assembling the above unit molds; A step of manufacturing a shape-memory polymer solution corresponding to a biocompatible insulating material; A step of injecting the shape memory polymer solution into the interior of the multiple molds; A step of curing the shape memory polymer solution injected into the interior of the above multiple molds; A step of obtaining an interface body made of a shape-memory polymer material by decomposing the above multi-mold into the above unit molds; A step of attaching a plurality of electrode portions to the interface body at spaced intervals from each other; A step of connecting one end of a connecting line to the above electrode portions; A step of applying the shape memory polymer solution to the connection portion between the electrode portions and the connection line, and then curing it; A step of manufacturing an implantable interface by finally curing the interface body connected to the electrode portions and the connecting line; and A step of packaging the above-mentioned implantable interface in a packaging bag; A method for manufacturing an implantable interface including 16. In Paragraph 15, In the step of manufacturing the above shape memory polymer solution, A method for manufacturing an implantable interface characterized by mixing 1,3,5-Triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trimethylolpropanetris(3-mercaptopropionate), tricyclodecanedimethanoldiacrylate, and 2,2-dimethoxy-2-phenyl-acetophenone in a specific ratio.

17. In Paragraph 15, In the step of curing the shape memory polymer solution, the shape memory polymer solution is cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 20 to 40 minutes. In the step of applying and curing the shape memory polymer solution to the connection portion between the electrode portions and the connection line, the shape memory polymer solution is cured by irradiating ultraviolet light having a wavelength of 300 to 400 nm for 50 to 70 seconds. A method for manufacturing an implantable interface, characterized in that, in the step of manufacturing the implantable interface by final curing, the implantable interface is finally cured by heating it to 100 to 140 degrees Celsius for 20 to 30 hours using a vacuum oven.

18. In Paragraph 15, In the step of attaching a plurality of electrode parts to the interface body, the electrode wires are attached by tying them to different locations on the interface body, and A method for manufacturing an implantable interface, characterized in that, in the step of connecting one end of a connecting wire to the electrode portions, a plurality of connecting wires made of a biocompatible material are inserted into a connecting tube made of a biocompatible material to manufacture the connecting wires, and then the connecting wires are individually connected one by one to the electrode wires.

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