Artificial ear and artificial cartilage tissue skeletal structure

Abstract

To solve the problem that in reconstruction of lost auricle, an implantable regeneration treatment is given, and in that treatment, a skeletal structure using a bioabsorbable material is suggested as a scaffolding material of cells, while a flexible skeletal structure that has strength, is easily deformable, and resilient is expected.SOLUTION: A skeletal structure of an artificial auricle which has a base part of a planar shape formed by a fiber structure using a bioabsorbable material, a helix part arranged on the surface of the base part, and a counter-helix part gives the base part a two-dimensional elastic structure and imparts to the helix part and the counter-helix part a three-dimensional fiber structure formed by a fiber structure. Thus, a flexible skeletal structure can be provided.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a skeletal structure of an artificial auricle used to reconstruct a lost auricle. [Background technology]

[0002] In plastic surgery, reconstruction of the cartilage tissue of the nose and external ear, which have complex three-dimensional structures, is considered one of the greatest challenges. The ear, in particular, has the most complex cartilage structure. Reconstruction of the auricle is required in cases of congenital malformations, microtia, tissue sacrifice related to melanoma, and injuries including accidents and severe burns.

[0003] The most commonly used method for ear reconstruction is the Tanzer method, in which a frame (outline) of the ear is created using costal cartilage harvested from the patient's sixth, seventh, and eighth ribs and implanted under the skin of the temporal region. After several months, the transplanted ear frame and skin are elevated and skin grafts are then placed on the posterior surface of the ear and temporal region.

[0004] However, this method is highly invasive and places a heavy burden on the patient. Therefore, an implant-based regenerative therapy has been developed in which cells are cultured outside the body for a certain period of time and then transplanted into the body. With this method, if the cultured cells cannot maintain a stable tissue shape when transplanted into the body, subsequent tissue regeneration cannot be expected.

[0005] Therefore, artificial auricles made of plastic (polyethylene) have been transplanted as scaffolding materials, but plastic has low biocompatibility and can cause inflammation and protrusion due to a foreign body reaction, which can lead to clinical issues.

[0006] To address this issue, an artificial auricle made of a bioabsorbable material has been proposed as a scaffold for transplanted cells. Patent Document 1 discloses the formation of an artificial auricle using a hydroxyapatite / chondroitin sulfate-collagen complex or a hydroxyapatite-collagen complex as a cell scaffold. This material is a porous carrier and is said to have elasticity and mechanical strength.

[0007] One possible method for adjusting elasticity and mechanical strength is to use composite materials. Patent Document 2 discloses that multiple elements, such as a skin simulation layer (201), a hydrogel layer (202), a hydrogel microcapsule layer (203), and a skeletal simulation layer (204), are assigned the roles required for an artificial auricle, and by combining these elements, a structure resembling a natural auricle can be obtained. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] Japanese Patent Application Laid-Open No. 2012-262 [Patent Document 2] Chinese Patent Application Publication No. 104490491 [Patent Document 3] International Publication No. 2013 / 081103 Summary of the Invention [Problem to be solved by the invention]

[0009] In the artificial auricle of Patent Document 2, the part corresponding to the skeleton is formed from a planar structure with a mesh, so although it has a certain degree of flexibility in the twisting direction, it is subject to stress when subjected to forces in the in-plane direction, making it difficult to achieve flexibility.In addition, since it does not have an antihelical part, there is also the issue that it is difficult for people to recognize it as an ear. [Means for solving the problem]

[0010] The present invention has been conceived in view of the above problems, and provides a skeletal structure for an artificial auricle that closely resembles the natural auricle in appearance and that is strong and flexible.

[0011] More specifically, the skeletal structure of the artificial auricle according to the present invention is as follows: a planar base formed of a fiber structure using a bioabsorbable material; a helix portion disposed on the surface of the base, and an antihelical portion and With death, The helix and the antihelix each have a three-dimensional fiber structure formed of a fiber structure. It is characterized by:

[0012] The skeletal structure of the artificial cartilage tissue according to the present invention is The device is characterized by two wavy layers, one of which is a first layer made of a fibrous structure using a bioabsorbable material and the other of which is a second layer that is adhered to the first layer and has a wavy shape that is out of phase with the first layer, stacked on top of each other.

[0013] Furthermore, the skeletal structure of the artificial cartilage tissue according to the present invention may be characterized by being formed by alternately stacking layers in which fibrous structures made of bioabsorbable materials are arranged vertically and layers in which they are arranged horizontally. [Effects of the Invention]

[0014] The skeletal structure of the artificial auricle according to the present invention is a fiber structure using a bioabsorbable material, and the base, helix, and antihelical portions are formed from these components, which allow for a large amount of interfiber space between the fibers. Therefore, when these components are joined together, each component becomes very flexible, and even if subjected to large displacements, they will not break and can return to their original shape.

[0015] Furthermore, the skeletal structure has many inter-fiber spaces, which has the effect of allowing cells and the like to easily penetrate inside.

[0016] Furthermore, although the base is a planar member, by adding a meander structure formed from a fibrous structure using a bioabsorbable material, it can deform and restore itself to its original shape in response to forces from many directions.

[0017] Furthermore, the helix and antihelical portions have a three-dimensional fiber structure formed from a fiber structure using a bioabsorbable material, so even if the material is a highly hard bioabsorbable material (so-called plastic), it has flexibility overall and can restore its original shape even if it is deformed.

[0018] Furthermore, the three-dimensional fiber structure allows the overall hardness to be adjusted by adjusting the distance between folded fibers within the same layer. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is an assembly diagram of the skeletal structure of the artificial auricle according to the present invention. [Figure 2] FIG. 1 is a plan view of a skeletal structure. [Figure 3] This is a different perspective view of the skeletal structure. [Figure 4] FIG. 2 is an enlarged view of a two-dimensional elastic structure. [Figure 5] FIG. 10 is a diagram showing a combined meander structure. [Figure 6] 10A and 10B are diagrams illustrating other forms of two-dimensional elastic structures. [Figure 7] FIG. 1 is a diagram illustrating a three-dimensional fiber structure (lattice type). [Figure 8] FIG. 1 is a perspective view of the end of a three-dimensional fiber structure (lattice type). [Figure 9] FIG. 10 is a diagram showing another configuration (overlap type) of a three-dimensional fiber structure. [Figure 10] FIG. 1 is a diagram showing the basic structure of a lattice type. [Figure 11] FIG. 1 is a diagram showing the basic structure of a knitted overlay type. [Figure 12] C: A view of the skeletal structure, including the cartilage portion, from multiple viewpoints. [Figure 13] FIG. 1 is a diagram illustrating a mechanical deformation test. DETAILED DESCRIPTION OF THE INVENTION

[0020] The skeletal structure of the artificial auricle according to the present invention will be described below with reference to the drawings. Note that the following description exemplifies one embodiment and one example of the present invention, and the present invention is not limited to the following description. The following description can be modified within the scope of the present invention.

[0021] FIG. 1 shows an assembly diagram of a skeletal structure 1 of an artificial auricle according to the present invention (hereinafter simply referred to as "skeletal structure 1"). The skeletal structure 1 is composed of a helix portion 30, an antihelical portion 20, and a base portion 10. It may also include a C-cartilage portion 40. The helix portion 30 and the antihelical portion 20 are placed on the front side of the planar base portion 10. Note that there is no particular difference in the configuration between the front and back of the base portion 10, so "front" and "back" will be used for the sake of explanation. The C-cartilage portion 40 is a member with an inclined surface, as will be described later, and is used when the skeletal structure 1 is inclined relative to a flat surface.

[0022] Hereinafter, the side on which the helix portion 30 is formed will be referred to as the "upper side," and the opposite side will be referred to as the "lower side." Additionally, the side on which the helix portion 30 and the antihelical portion 20 are placed relative to the base 10 as described above will be referred to as the "front side," and the opposite side will be referred to as the "back side."

[0023] FIG. 2 shows a plan view of the helix portion 30 and the antihelical portion 20 placed on the surface of the base portion 10. FIG. 3 shows the skeletal structure 1 viewed from a different perspective. FIG. 3(a) is a plan view, the same as FIG. 2. FIG. 3(b) is a perspective view of the skeletal structure 1 viewed from the right side, front side. FIG. 3(c) is a side view of the skeletal structure 1 viewed from below. FIG. 3(d) is a perspective view of the skeletal structure 1 viewed from the upper back side. FIG. 3(e) is a perspective view of the skeletal structure 1 viewed from the bottom surface.

[0024] First, referring to Figures 1 to 3, the base 10 is an eggplant-shaped planar member. In Figure 3(c), it can be seen that the back side is flat. Referring to Figure 1, a rim 10a is provided around the periphery of the base 10. The rim 10a may be provided with a bracket 10b having a fixing through-hole 10bh drilled therein. The inside of the rim 10a is formed with a two-dimensional elastic structure 12, which will be described later.

[0025] 2, the helix portion 30 and the antihelical portion 20 are connected to the surface of the base 10. The helix portion 30 is formed along the edge 10a of the base 10 from the helix crus 30a above the region 32 corresponding to the ear canal to the earlobe 25. The helix crus 30a may be extended to a position that covers the fixing through-hole 10bh.

[0026] Meanwhile, the antihelical portion 20 has its upper end, the antihelical upper crus 20a, and its lower crus 20b, which are located close to the helix portion 30 near the center of the top of the base 10. Then, moving downward, the antitragus portion 22 is formed, followed by the earlobe portion 25, which is integrally formed up to the tragus portion 24. The helix portion 30 and the antihelical portion 20 are formed from a three-dimensional fiber structure 50, which will be described later.

[0027] Due to the relative positions of the base 10, the helix 30, and the antihelical portion 20, the scapha 14 is covered by the base 10. In addition, the concha 16 is partially covered by the base 10, and a space is left open from the region 32 corresponding to the external auditory canal to the earlobe 25.

[0028] <Two-dimensional elastic structure> In the present invention, the term "fibrous structure made of bioabsorbable material" refers to a bioabsorbable material formed like a fiber. For example, it may be a gel or molten bioabsorbable material ejected from a nozzle in a long, thin shape, or a granular bioabsorbable material formed like a fiber and then integrated, or a plate-shaped bioabsorbable material formed by removing unnecessary portions to make it appear to be made of fiber. Furthermore, "fiber-like" does not necessarily mean a single fiber; even a fiber composed of multiple fibers may be called a "fibrous structure made of bioabsorbable material." Note that a "fibrous structure made of bioabsorbable material" is also called "fibrous."

[0029] Figure 4 shows an enlarged view of the two-dimensional elastic structure 12 that constitutes the interior of the edge 10a of the base 10. The two-dimensional elastic structure 12 is a planar member made of fibers 60 of a bioabsorbable material, and is a structure that has elasticity in both the vertical and horizontal directions by continuously connecting unit structures 12a. The fibers 60 that constitute it preferably have a diameter of approximately 50 μm to 1 mm. Figure 4 illustrates an example of a combined meander structure.

[0030] Referring to Figure 5, the meander structure is a planar member made by laminating a pattern known as a meander pattern, as shown in Figure 5(a), to a thickness of about 1 mm to 3 mm. The meander structure is a pattern originally known as a Greek lightning bolt, in which a single line is bent to form a spiral shape 12z, which is continued continuously in the longitudinal direction of the line.

[0031] This pattern can be seen as a structure in which wires in the longitudinal direction are bundled together and shortened. Therefore, it has flexibility in both the vertical and horizontal directions. It has particularly large stretching force in the longitudinal direction, and large stretching force in the direction of the arrows when the meander structures are lined up vertically (Figure 5(a)) and horizontally (Figure 5(b)).

[0032] The combined meander structure is a basic unit structure 12zc (Fig. 5(c)) that combines a layered structure of vertical unit pattern 12za in Fig. 5(a) with a layered structure of horizontal unit pattern 12zb in Fig. 5(b), and these are arranged in parallel and connected by connecting parts 12zd (Fig. 5(d)). This corresponds to the part indicated by symbol 12a in Fig. 4.

[0033] The two-dimensional elastic structure 12 may be any structure in which the fibers 60 are gathered two-dimensionally and continuously arranged in the vertical and horizontal directions to form short segments. For example, as shown in Fig. 5(e), a structure with a repeating rectangular pattern in the vertical direction and a structure with a repeating rectangular pattern in the horizontal direction may be used as unit structures, and these may be connected at joints to form a planar structure (Fig. 5(f)).

[0034] FIG. 6 illustrates another configuration of the two-dimensional elastic structure 12. FIGS. 6(a) and 6(b) show cases where the fibrous shapes 60 are formed into a swastika pattern. In FIG. 6(a), the area surrounded by the dotted line is the swastika pattern. FIG. 6(b) shows a pattern in which the swastika pattern of FIG. 6(a) is repeated. FIGS. 6(c) and 6(d) show patterns in which the swastika pattern is slightly distorted. Furthermore, FIGS. 6(e) and 6(f) show patterns in which the intersections 60a of the fibrous shapes 60 are connected by wavy fibrous shapes 60.

[0035] In this way, the length of the fibers 60 between the intersections 60a of the fibers 60 is formed to be longer than the shortest distance between the intersections 60a, thereby forming a two-dimensional elastic structure.

[0036] <Three-dimensional fiber structure> The three-dimensional fiber structure 50 is a structure formed by laminating layers of bioabsorbable material fibers 60 folded so that they pass through the periphery and interior of a desired shape, forming a three-dimensional shape. This may also be called a "woven structure." By ensuring that adjacent layers in the lamination direction do not have the same pattern, a structure with many gaps between the fibers 60 can be obtained. The diameter of the fibers 60 is preferably about 50 μm to 1 mm.

[0037] This structure provides high strength in the lamination direction and elasticity in the plane perpendicular to the lamination direction. Another advantage is that there are many gaps between the fibers 60, which allows cartilage tissue to easily penetrate inside.

[0038] Figure 7 shows an example of a three-dimensional fiber structure 50. This example shows a case where a semi-doughnut-shaped bottom shape, as shown in Figure 7(a), is used to create a three-dimensional structure (from the back of the page to the front) using a three-dimensional fiber structure 50. In this case, as shown in Figure 7(b), a layer is formed by a part of the outer shape 52 and a fiber 60 passing through the interior 54. Note that Figure 7(b) shows the first layer, Figure 7(c) shows the second layer, and Figure 7(e) shows the third layer.

[0039] In this three-dimensional fiber structure 50, it is preferable that the patterns of adjacent layers are different. This is because if the patterns are the same, gaps are less likely to form. Here, the first layer (Fig. 7(b)) and the third layer (Fig. 7(e)) have a repeating rectangular structure, but the phases are different. That is, on the periphery, in the first layer, there is a portion 52z where there is no fibrous material 60, but in the third layer, there is fibrous material 60, but out of phase (symbol 52y). Note that the fibrous material 60 passing through the interior 54 may overlap at the same position.

[0040] Additionally, the three-dimensional fiber structure 50 may include layers in a pattern that runs only around the perimeter of the outer shape or only through the interior 54. Figure 7(c) shows a pattern that runs only through the interior 54 of the desired shape (Figure 7(a)).

[0041] The method for fabricating the three-dimensional fiber structure 50 involves forming the pattern shown in Figure 7(b) on a substrate using fibers 60 of a bioabsorbable material. Next, the pattern shown in Figure 7(c) is laminated as a second layer (Figure 7(d)). Next, the pattern shown in Figure 7(e) is formed on top of the pattern shown in Figure 7(d) (Figure 7(f)).

[0042] When viewed in plan, the three-dimensional fiber structure 50 has a lattice 50L formed by vertical and horizontal fibers 60. The lattice 50L is preferably set to a size of about 10 μm x 10 μm square to 1 mm x 1 mm, allowing cells and extracellular substances to penetrate inside.

[0043] 7(f) shows three layers formed in this way. The portions denoted by reference numerals 50a and 50b are the portions where the fibrous material 60 overlaps in the first and third layers.

[0044] Figure 8 shows a perspective view of a structure in which multiple layers of such patterns are stacked. The structure shows the stacking of patterns from the first to eighth layers. Each layer is indicated by a circle.

[0045] Viewed from the side, the sixth layer is sandwiched between the fourth and eighth layers, forming a portion 52z without the fibrous particles 60. Above and below the portion 52z without the fibrous particles 60, portions 52y with the fibrous particles 60 are formed out of phase with each other.

[0046] In this way, when viewed from the side, the portions 52z without the fibers 60 and the portions 52y of the fibers 60 that are out of phase with each other can be alternated, so that many gaps are formed.

[0047] Here, the portion indicated by the symbol 50c is the portion where each layer is stacked closely or intersectingly from the design stage. Such a portion is called a "pseudo-column portion 50c." The three-dimensional fiber structure 50 may have pseudo-column portions 50c in this manner, where multiple layers are stacked closely together. At the intersection portions, the melted fibers 60 are placed on top of the upper layer in the stacking direction when it is formed, and when the melted fibers 60 cool, the upper and lower layers are bonded together. When the fibers 60 cool and solidify in the pseudo-column portion 50c, the direction of the arrow (thickness direction) has compressive stress consistent with the material properties of the fibers 60. In other words, it is rigid and resistant to deformation.

[0048] On the other hand, as shown in Figure 7(f), the structure as a whole can have elasticity against a force Ft from the side, i.e., it is soft, easily deformed, and easily restored.

[0049] FIG. 9 shows another embodiment of a three-dimensional fiber structure 50. In FIG. 9, layers are stacked to form a desired interior 54 in a triangular wave pattern. While a triangular wave is shown here, any other wave-like shape may be used. FIG. 9(b) shows the first layer, and FIG. 9(c) shows the second layer. Each of these layers passes through a portion 52 of the periphery and the interior 54 of the desired shape (FIG. 9(a)).

[0050] As in this case, part 52 of the outer shape may be a point. When the first and second layers are stacked, pseudo-column portions 50c are formed in the interior 54 where the first and second layers intersect (FIG. 9(d)). Therefore, even with this shape, the structure has compressive stress in the stacking direction in accordance with the material properties of the fibers 60, and elasticity in the in-plane direction Ft and the forming direction (length direction) FL of the three-dimensional fiber structure 50.

[0051] In particular, when a triangular wave pattern is layered, there are no areas that are subjected to tension and compression in the lateral direction (indicated by the arrows), resulting in higher elasticity compared to a pattern based on a rectangular wave, as shown in Figure 7. Therefore, when used in the helix 30, the outer periphery of the auricle is easily deformed, providing a feel that is closer to that of a real auricle. It can also stretch in the longitudinal direction FL. This is because the intersections of the first and second layers are aligned in the forming direction FL of the three-dimensional fiber structure 50.

[0052] The three-dimensional fiber structure 50 can also have low in-plane elasticity by adjusting the distance between the fibers 60. In other words, it becomes less likely to deform.

[0053] <Three-dimensional fiber structure (basic)> More fundamentally, the three-dimensional fiber structure 50 includes two types: a crossed rectangular type (called a "lattice type 56") and a phase-shifted wave-like overlap type (called a "knitted overlap type 58"). Figure 10 shows the basic structure of the lattice type 56. The lattice type 56 is constructed by overlapping rectangular wave layers formed from top to bottom (Figure 10(a)) and rectangular wave layers formed from left to right (Figure 10(b)) formed from fibers 60 of a bioabsorbable material.

[0054] The lattice type 56 is characterized by the presence of intersections 60a of the fibers 60 in both the vertical and horizontal directions, making it difficult to deform in either the vertical or horizontal direction. At the intersections 60a, the upper and lower layers in the stacking direction are connected (Fig. 10(c)). As the intersections 60a exist two-dimensionally, the rigidity is high in both the vertical and horizontal directions. Furthermore, by repeating the above two layers, it is possible to extend the structure in the height direction. The structure in Fig. 7 is an example of a lattice type 56.

[0055] FIG. 11 shows the basic structure of a woven mold 58. The woven mold 58 (FIG. 11(c)) is formed by layering a second layer (FIG. 11(b)) of a corrugated shape on a first layer (FIG. 11(a)) of fibers 60 of a bioabsorbable material extending in one direction, with a second layer (FIG. 11(b)) of a corrugated shape that is out of phase with the first layer. The woven mold 58 has excellent elasticity in the longitudinal direction L and in the direction perpendicular thereto, since the intersections 60a of the fibers 60 between the upper and lower layers are present one-dimensionally. Here, "one-dimensional" means that the intersections 60a of the fibers 60 of adjacent layers in the stacking direction are aligned along the direction in which the three-dimensional fiber structure 50 is formed.

[0056] Furthermore, the basic structure of the overlapping knitting mold 58 can be said to have loop portions 60b without intersections 60a between certain intersections 60a. By having such a basic shape, even if the intersections 60a are spaced apart, the loop portions 60b deform, allowing each portion to follow the overall deformation. Figure 9 shows an example of the overlapping knitting mold 58.

[0057] The lattice type 56 and the overwoven type 58 can be said to have very useful shapes as basic skeletons for cartilage formation. The shapes of each layer forming the lattice type 56 and the overwoven type 58 can be changed based on strength design. Furthermore, when the number of layers is increased, the intersections (connection points) 60a may be slightly misaligned. This is because misalignment makes it possible to adjust the overall elasticity and flexibility. Furthermore, as shown in Figure 1, a skeletal structure 1 of the lattice type 56 and a skeletal structure 1 of the overwoven type 58 can be combined to form a skeletal structure for artificial cartilage (or it can also be called "artificial cartilage tissue").

[0058] As described above, the skeletal structure 1, in which the helix portion 30 and antihelical portion 20, each having a three-dimensional fiber structure 50, are bonded to the base 10 having the two-dimensional elastic structure 12, is elastic as a whole. Moreover, it can return to its original shape even after undergoing large deformation. In other words, despite using a bioabsorbable material, a plastic resin material, it is possible to obtain a flexible skeletal structure 1 for an artificial auricle. Here, flexibility means that it can return to its original shape without being destroyed even after undergoing large deformation.

[0059] Figure 12 shows the state in which the C-cartilage portion 40 is adhered to the back surface of the base 10. The C-cartilage portion 40 is used when the base 10 is angled relative to a plane. Figure 12(a) is a plan view, the same as Figure 2. Figure 12(b) is a perspective view of the skeletal structure 1 as seen from the right side, front side. Figure 12(c) is a side view of the skeletal structure 1 as seen from below. It can be seen that the C-cartilage portion 40 gives an inclination to the skeletal structure 1, which joins the base 10, the helix portion 30, and the antihelical portion 20. Figure 12(d) is a perspective view of the skeletal structure 1 as seen from the upper back surface. Figure 12(e) is a perspective view of the skeletal structure 1 as seen from the bottom surface.

[0060] The C-cartilage portion 40 may also be included in the skeletal structure 1. The C-cartilage portion 40 may also be formed of the three-dimensional fiber structure 50. However, since the C-cartilage portion 40 is disposed between the skull and the auricle, its elasticity in the lateral direction does not need to be as high as that of the base portion 10, the helix portion 30, and the antihelical portion 20.

[0061] <Material> The base 10, helix 30, antihelical 20, and C-cartilage 40 can all be formed from bioabsorbable materials such as polyglycolide, polylactide (D,L,DL), polycaprolactone, glycolic acid-lactide (D,L,DL) copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D,L,DL)-ε-caprolactone copolymer, or poly(p-dioxanone), which are formed into fibers 60. The fibers 60 preferably have a diameter of about 50 μm to 1 mm.

[0062] 3D printers are ideal for these models. The FDM (Fused Deposition Modeling) method is particularly suitable because the above materials are thermoplastic. This does not exclude other methods such as SLS (Sintered Laser Diode Modeling), SLA (Stereolithography), DLP (Digital Light Processing), and others.

[0063] <Artificial auricle> The skeletal structure 1 is wrapped in a bioabsorbable nonwoven fabric, and cartilage cells are seeded and cultured. After culturing, the chondrocytes are implanted into the patient's temporal region. These steps can be carried out using known methods. For example, the following materials and methods described in Patent Document 3 can be suitably used.

[0064] Examples of raw materials for bioabsorbable nonwoven fabrics include polyglycolide, polylactide (D, L, DL), polycaprolactone, glycolic acid-lactide (D, L, DL) copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL)-ε-caprolactone copolymer, and poly(p-dioxanone). These may be used alone or in combination of two or more. Among these, polyglycolide or lactide (D, L, DL)-ε-caprolactone copolymer is preferred.

[0065] Furthermore, the bioabsorbable nonwoven fabric can be suitably made by forming the above-mentioned material into a filamentous nonwoven fabric having an average fiber diameter of 0.90 to 20.00 μm.

[0066] The skeletal structure 1 is wrapped with the nonwoven fabric thus produced. The bioabsorbable nonwoven fabric should cover at least the gaps in the skeletal structure 1, but it is preferable if it covers the entire skeletal structure 1. It is also preferable to wrap the nonwoven fabric so that it is as tightly attached to the skeletal structure 1 as possible. The skeletal structure 1 according to the present invention has the navicular cavity portion 14 filled with the base portion 10, which can provide suitable support for the bioabsorbable nonwoven fabric.

[0067] Auricular chondrocytes can be isolated from human or animal auricles by removing the skin, connective tissue, and perichondrium, cutting the auricles into small pieces of approximately 5 mm x 5 mm, and treating them with collagenase. The isolated auricular chondrocytes can be used as is, or they can be cultured and then grown before use.

[0068] The method for seeding auricular chondrocytes onto a bioabsorbable nonwoven fabric is not particularly limited, and any conventionally known seeding method can be used. The seeding density is not particularly limited, but the preferred lower limit is 2.0 × 10 7cells / cm 2 , the preferred upper limit is 1.0 × 10 8 cells / cm 2 The cell seeding density was 2.0 × 10 7 cells / cm 2 If the concentration is less than 1.0 × 10, it may take a long time for auricular cartilage tissue with sufficient thickness and mechanical strength to be formed. 8 cells / cm 2 If the cells are seeded at a density exceeding this, no further effect is observed. A more preferable lower limit for the cell seeding density is 5.0 × 10 7 cells / cm 2 is.

[0069] As a culture medium for culturing, for example, a serum-supplemented medium prepared by adding about 1 to 10% by weight of fetal bovine serum to a general culture medium such as MEM or DMEM can be used.

[0070] In this way, an artificial auricle in which chondrocytes have been cultured on a bioabsorbable nonwoven fabric wrapped around the skeletal structure 1 can be transplanted into a living body to regenerate auricle cartilage tissue with sufficient strength and elasticity. [Example]

[0071] As shown in Figure 13, a skeletal structure 1 was fabricated by thermally bonding a helix portion 30 and an antihelical portion 20 to a polycaprolactone base portion 10. Mechanical deformation tests were conducted in the thickness direction and in the planar direction. The base portion 10 had a line width of 250 μm, a line spacing of 500 μm, and a thickness of 2 mm. The helix portion 30 was fabricated by stacking 15 layers of 300 μm diameter fibrous fibers 60 in a triangular wave shape with a pitch of approximately 1 mm (based on Figure 9). The antihelical portion 20 was fabricated by stacking 25 layers of square wave shapes with a pitch of 2 to 10 mm (based on Figure 7). These components were then thermally bonded to fabricate the skeletal structure 1 shown in Figure 13(a).

[0072] In the lateral mechanical deformation test shown in Figure 13(a), a commonly used stress-strain measuring device was used to perform a stress-strain test in which a displacement of up to 10 mm was repeated five times, and the recovery rate was calculated from the ratio of the dimensions before and after the compression test. As a result, a force of approximately 20 N (approximately 2 kg weight) was required to displace the specimen 10 mm in the lateral direction, and the recovery rate was 99.6%.

[0073] This shows that the material can be deformed 10 mm in the lateral direction by a force of about 20 N without breaking, and can also return to its original shape almost completely.

[0074] In the mechanical deformation test in the thickness direction (Fig. 13(b)), a stress of 150 N was applied five times using a stress-strain measuring device in the same way as in Fig. 13(a), and the recovery rate was investigated. As a result, a stress of 150 N caused a displacement of approximately 1 mm in the thickness direction, and the recovery rate was 98.8%.

[0075] This shows that even if a force of about 15 kg is applied in the thickness direction, the material can be displaced by about 1 mm without breaking, and when the stress is released, it returns to its original shape almost completely.

[0076] Since a human head weighs approximately 5 kg, even if the weight of the head is directly placed on this skeletal structure 1 when sleeping in a lateral position, the skeletal structure 1 of the artificial auricle according to the present invention will not be destroyed and will return to its original shape.

[0077] Furthermore, even when subjected to a lateral force, it can undergo a large displacement of 10 mm and still return to its original shape. [Industrial Applicability]

[0078] The artificial auricle skeletal structure 1 according to the present invention can be suitably used as a cell scaffold when a lost auricle is reconstructed by implant-type regenerative therapy. [Explanation of symbols]

[0079] 1 Skeletal structure 10 base 10a Edge 10b Bracket 10bh fixing through hole 12 Two-dimensional elastic structure 12a Unit Structure 12za unit pattern 12zb unit pattern 12zc Basic unit structure 12z vortex shape 14 Navicular fossa 16 Concha 20 Antihelix 20a Upper crus of the antihelix 20b Lower crus of the antihelix 22 Taijubu 24 Tragus 25 Ear lobe 30 Helix 30a Helix base 32 Area corresponding to the external auditory canal 40 C cartilage part 50 Three-dimensional fiber structure 50c pseudo column part 52 Part of the exterior 54 Inside 56 Lattice type 58 Overlapped knitting 60 Fibrous 60a intersection

Claims

1. a planar base formed of a fiber structure using a bioabsorbable material; a helix portion and an antihelical portion disposed on a surface of the base, The skeletal structure of the artificial auricle, wherein the helix portion and the antihelix portion each have a three-dimensional fiber structure formed from a fiber structure.

2. 2. The skeletal structure of an artificial auricle according to claim 1, wherein the base is a planar member having a two-dimensional elastic structure formed of a fibrous structure using a bioabsorbable material.

3. 3. The skeletal structure of an artificial auricle according to claim 1, wherein the helix and the antihelix are made of a bioabsorbable material.

4. 4. The skeletal structure of an artificial auricle according to claim 1, wherein the helix and the antihelical portion are welded to the base.

5. A skeletal structure of an artificial auricle described in any one of claims 1 to 4, having a C cartilage portion arranged on the back surface of the base.

6. A skeletal structure of an artificial auricle according to any one of claims 1 to 5; a bioabsorbable nonwoven fabric covering the skeletal structure; The artificial auricle has chondrocytes cultured on the bioabsorbable nonwoven fabric.

Images