KR102658754B1 - External ear shaped implant and manufacturing method for the same - Google Patents

Abstract

The purpose of the present invention is to provide an external ear implant with a nanofiber structure similar to the actual external ear shape and a manufacturing method thereof. As a means of solving this problem, the present invention has an external ear shape through a collector formation step and has properties corresponding to the physical properties of the human body. A collector, which is an implant structure with a , Each strand of these nanofibers has an extremely thin thickness at the nano scale, and has a high surface area at the standard volume compared to other materials, performing an excellent buffering action on the collector. Accordingly, the collector is protected from external shocks. It can be effectively protected, and due to the nature of nanofibers, high ventilation is guaranteed, so chemical damage to the collector, such as corrosion, can be minimized.

Description

External ear implant and manufacturing method for external ear implant {External ear shaped implant and manufacturing method for the same}

The present invention relates to an external ear implant and a method of manufacturing an external ear implant, and more specifically, to an implant having the shape of a human external ear and a method of manufacturing the same.

To supplement parts of the human body that are missing due to various congenital or acquired causes, various human implants manufactured in shapes corresponding to the corresponding parts are being used.

And, by implanting such an implant into a defective part of the human body, the functional and aesthetic roles realized by the corresponding human body part can be performed.

There are a variety of methods for manufacturing such implants, such as injection molding, but recently, with the development of 3D printing technology, human implants manufactured based on 3D printing are gaining attention.

According to this 3D printing production method, various beneficial advantages occur, such as reducing production time and man-hours and reducing various wastes generated during manufacturing through the unique additive manufacturing method.

In addition, as 3D printing technology develops, in addition to relatively simple human implants such as teeth or blood vessels, implants for body parts with relatively complex shapes can also be manufactured through 3D printing.

For example, Figure 1 is a diagram showing each main part of the external ear. Referring to Figure 1, it can be seen that the external ear has a significantly curved and inclined structure as a whole.

In this regard, the preceding Korean Patent Publication No. 10-2016-0146568 discloses a device and method for ear reconstruction and the need for reconstruction.

According to the above prior literature, an artificial ear with a 3D shape can be provided through the operation of analyzing a plurality of 2D images of the ear.

Additionally, in addition to 3D printing, methods of manufacturing human implants through the electrospinning process are also emerging.

In detail, Figure 2 is a conceptual diagram explaining nanofiber production based on electrospinning principles. Referring to Figure 2, a needle and a collector can be largely used in the electrospinning process.

More specifically, a voltage difference is formed between the needle and the collector, and through this voltage difference, the polymer solution sprayed from the needle is guided to the collector and then hardened to form a specific fiber.

At this time, the thickness of the polymer solution sprayed from the needle decreases as it approaches the collector, and ultimately has a nanoscale thickness of 100 nm or less, and this final product is called a nanofiber.

These nanofibers are known to have a high surface area at the standard volume compared to other materials due to their extremely thin thickness, and thus have a high cushioning effect and high ventilation properties.

In addition, such nanofibers have been found to have ergonomically advantageous effects such as cell recognition, making them a material that is also in the spotlight as an implant material for the human body.

As an example of this, the preceding US Patent Publication No. 2019-151081 discloses IMPLANT WITH FILLABLE RESERVOIR, and the prior document discloses the composition of a polymer solution for manufacturing human implants through electrospinning.

However, even looking at these prior literature, the composition ratio of the external ear implant material that satisfies both biocompatibility and mechanical rigidity is not disclosed.

In addition, in the case of the electrospinning process, the polymer solution for forming nanofibers is sprayed somewhat randomly, which has the disadvantage of making it difficult to create elaborate products such as the actual external ear shape, but this is also not disclosed in the preceding literature.

As such, there is a problem that there is no method for manufacturing external ear implants that satisfies all of the biocompatibility, mechanical rigidity, and precision of the nanofiber structure.

Republic of Korea Public Patent No. 10-2016-0146568 U.S. Published Patent No. 2019-151081

As part of solving the above-mentioned problems, the purpose of the present invention is to provide an external ear implant with a special composition that satisfies both biocompatibility and mechanical rigidity and a nanofiber structure similar to the actual outer ear shape, and a method of manufacturing the same.

The method of manufacturing an external ear implant according to the present invention includes a collector forming step in which an external ear-shaped 3D collector composed of a material containing a hydrogel is formed, and a polymer solution is sprayed on the surface of the collector according to the principle of electrospinning, thereby forming the shape of the collector. Characterized by comprising an implant manufacturing step in which a 3D implant in the shape of the outer ear is manufactured by depositing a nanofiber mat layer corresponding to the collector on the collector.

In addition, in the implant manufacturing step, at least one edge point of the collector is pulled outward and the collector is flattened by elastic deformation, and then the polymer solution is sprayed on the flattened surface of the collector to conform to the shape of the collector. The implant is manufactured by depositing a corresponding nanofiber mat layer on the surface of the collector, releasing the external force applied to the collector to flatten it, and elastically restoring the collector to its original shape.

The external ear implant according to the present invention is a collector formed in the shape of the external ear and made of a material containing a hydrogel, and a nanofiber mat formed of nanofibers and provided on the surface of the collector, and having a shape corresponding to the shape of the collector. It is characterized by comprising a layer.

In addition, the hydrogel is characterized in that it is formed of a material containing at least one of gelatin or collagen.

In addition, the hydrogel is characterized in that it is formed of a material further containing alginate to have a rigidity corresponding to the mechanical rigidity of human external ear cartilage.

In addition, the nanofiber mat layer is characterized by being formed of a material containing at least one of gelatin or collagen.

According to the external ear implant manufacturing method according to the present invention, a collector, which is an implant structure having the shape of the external ear, is formed through the collector forming step, and in the next process, a polymer solution is sprayed on the surface of the collector to form a nanofiber mat layer on the surface. An electrospinning process is carried out, and each strand of these nanofibers has an extremely thin thickness of the nano scale, so it has a high surface area in the standard volume compared to other materials and performs an excellent buffering action on the collector, Accordingly, the collector can be effectively protected from external shocks, and high ventilation is ensured due to the characteristics of nanofibers, thereby minimizing chemical damage to the collector, such as corrosion.

In addition, as the nanofiber mat layer is provided on the surface of the collector having the outer ear shape, the nanofiber mat layer can also be formed as similar as possible to the actual outer ear shape, so that the nanofibers constituting the surface appearance of the outer ear implant As the sophistication of the mat layer is improved, not only can the various effects of the nanofibers described above be realized with consistent quality, but their aesthetic functions can also be implemented with as little sense of heterogeneity as possible, just like the actual outer ear.

In addition, the collector, which has complex curves, protrusions, etc., like the shape of the actual outer ear, is flattened by elastic deformation, and as the above-described electrospinning process is performed on the flattened collector, the surface is formed in response to the level of flattening of the collector. The nanofiber mat layer provided can also be conformally deposited to have a uniform thickness, resulting in the effect of maintaining constant quality and performance.

At this time, as the collector is elastically restored after the electrospinning process is completed, the nanofiber mat layer provided on its surface is elastically deformed into the actual outer shape like the original shape of the elastically restored collector, and the above-described planarization process is performed. Despite this, a nanofiber mat layer having an actual external shape in three dimensions, such as a protruding structure, can be formed, thereby maximizing precision and improving ease of manufacture.

The external ear implant according to the present invention may be composed of the collector and the interlayer deposited nanofiber mat, and the collector is manufactured with a hydrogel composition ratio that can maximize biocompatibility and elasticity while satisfying the physical properties of the actual external ear, The effect is that an external ear implant optimized for human implantation is provided.

In addition, in the case of the collector, the elasticity is maximized within the range that satisfies the physical properties of the external ear cartilage of the transplant recipient, so that biocompatibility for the transplant recipient is satisfied as much as possible while increasing the collector flattening process in the electrospinning process described above. The effect of satisfying both convenience and precision in manufacturing is that elastic deformation and elastic restoration become easier as they correspond to elasticity.

In addition, when the collector flattened as described above is elastically restored, the nanofiber mat layer provided on the surface is elastically deformed into the outer shape of the collector, which is the original shape of the collector, so that the nanofiber mat layer is made of an elastic material such as gelatin. As it is formed of a material containing, the nanofiber mat layer can be elastically deformed more naturally into the original shape of the collector, that is, the actual outer ear shape, which is elastically restored in response to the increased elasticity, thereby increasing convenience and precision in manufacturing. An improved effect occurs.

1 is a diagram showing each main part of the external ear.
Figure 2 is a conceptual diagram explaining nanofiber production based on electrospinning principles.
Figure 3 is a flow chart showing the method of manufacturing an external ear implant according to the present invention.
Figure 4 is a conceptual diagram showing an example of 3D printing.
Figure 5 is a diagram showing an example of an external ear shape 3D template.
Figure 6 is a diagram showing an example of an external ear-shaped 3D engraved mold.
Figure 7 is a diagram showing an external ear-shaped 3D collector.
Figure 8 is a stress-strain curve for four specimens of the outer ear-shaped 3D collector manufactured with different alginate and gelatin mixing ratios.
Figure 9 is a graph showing the Young's modulus range for each sample shown in Figure 8.
Figure 10 is a conceptual diagram for explaining the electrospinning process in the implant manufacturing stage.
Figure 11 is a diagram showing an example of an external ear-shaped 3D implant manufactured according to an embodiment of the present invention.
FIG. 12 is a graph showing the diameter distribution of the external ear-shaped 3D implant shown in FIG. 11.
Figure 13 is a diagram showing an example of an electric field simulation for a concave-shaped 3D collector formed according to an embodiment of the present invention.
FIG. 14 is an enlarged view of the dotted line area shown in FIG. 13.
FIGS. 15A to 15C are diagrams illustrating an example of an electric field simulation performed in a state in which the two-wheel corresponding region of the dotted line portion shown in FIG. 14 is bent counterclockwise at 0°, 30°, and 60°, respectively.
FIG. 16 is a graph showing electric field angle simulation results for the cases shown in each of FIGS. 15A to 15C.
Figure 17a is a diagram showing an example of the navicular fossa corresponding area among the external ear-shaped implants according to an embodiment of the present invention.
Figure 17b is a diagram showing an example of the navicular fossa corresponding area among the external ear-shaped implants according to another embodiment of the present invention.
Figure 18 is a graph showing the average thickness of the nanofiber mat formed in the dotted line area shown in each of Figures 17a and 17b.
Figure 19 is a diagram showing an example of an external ear-shaped 3D implant formed according to an embodiment of the present invention.
FIG. 20 is a graph showing the average thickness of each main part of the external ear-shaped 3D implant shown in FIG. 19.

Prior to the description of the present invention, specific details for carrying out the present invention are included in the following embodiments and drawings, and like reference numerals used throughout the specification refer to like elements.

In addition, singular expressions in this specification will also include plural forms unless specifically stated in the phrase.

Hereinafter, the external ear implant and the external ear implant manufacturing method according to the present invention will be described with reference to the drawings.

Figure 3 is a flowchart showing the external ear implant manufacturing method according to the present invention, and with reference to this, the external ear implant manufacturing method according to the present invention will be described.

3, the method of manufacturing an external ear implant according to the present invention includes a template forming step (S100), a mold forming step (S200), a collector forming step (S300), and an implant manufacturing step (S400).

First, in the template forming step (S100), a 3D template in the shape of the outer ear, which is a type of mold, is formed, and then in the mold forming step (S200), a 3D engraved mold in the shape of the outer ear is formed based on the template.

Next, in the collector forming step (S300), a 3D collector in the shape of an external ear is formed based on the engraved mold.

Finally, in the implant manufacturing step (S400), a polymer solution is sprayed onto the collector through an electrospinning process, and a nanofiber mat layer with a shape corresponding to the collector is deposited on the surface of the collector, thereby creating an external ear implant. It is manufactured.

In other words, by configuring the collector in the shape of an external ear, the nanofibers deposited on it can also be configured in the shape of an external ear.

At this time, the collector in a typical electrospinning process refers to the target object onto which the polymer solution is sprayed, and the final result of this electrospinning process refers only to nanofibers provided in a nanoscale on the surface of the collector.

However, the external ear implant manufacturing method according to the present invention and the external ear implant manufactured using the same target not only the nanofibers as the final formation, but also the entire nanofibers and the collector deposited body, which will be described in detail later.

Next, each step of the external ear implant manufacturing method will be described in detail with further reference to other drawings.

FIG. 4 is a conceptual diagram showing an example of 3D printing, and FIG. 5 is a drawing showing an example of an external ear-shaped 3D template. To further describe the template forming step (S100) with reference to FIGS. 4 and 5, do.

First, as shown in FIGS. 4 and 5, the template 100 is formed through 3D printing.

At this time, modeling of the template 100 can be customized to correspond to various conditions, such as the human body condition of the implant recipient, and various polymer materials can be used as materials for printing the template 100.

Next, Figure 6 is a diagram showing an example of an external ear-shaped 3D engraved mold, and with further reference to this, the mold forming step (S200) will be described in more detail.

First, the template formed through the template forming step (S100) is immersed in a polydimethylsiloxane (PDMS) mixture.

At this time, in conducting the experiment for the present invention, the PDMS mixture was mixed with PDMS (polydimethylsiloxane) monomer and silicone elastomer curing agent at a ratio of 10:1, manually stirred for 5 minutes to ensure uniform mixing, and then visible bubbles were removed. Those formed by degassing in a vacuum chamber until removed were used.

Next, the PDMS mixture was cured while accommodating the template, and in the experiments of the present invention, this curing process was carried out at 50°C for 24 hours.

Next, when the template is removed from the cured PDMS mixture, the engraved mold 200 is formed as illustrated in FIG. 6.

Next, Figure 7 is a diagram showing an external ear-shaped 3D collector.

And, Figure 8 is a stress-strain curve for four specimens of the outer ear-shaped 3D collector manufactured with mutually different alginate and gelatin mixing ratios, and Figure 9 is a graph showing the Young's modulus range for each specimen shown in Figure 8.

The collector forming step (S300) will be described in more detail with further reference to FIGS. 7 to 9.

In the collector forming step (S300), the hydrogel is poured into the above-mentioned intaglio mold and then hardened, and the cured hydrogel is separated from the intaglio mold to provide an external ear-shaped 3D collector 300 formed of the hydrogel.

At this time, as mentioned above, the collector 300 not only functions as a collector for the electrospinning process in the implant manufacturing step (S400), but is also used as a component of the finished external ear implant, so it is as similar as possible to the physical properties of the actual external ear. It needs to be formed.

Therefore, in order to realize the physical properties of the collector 300, the following four examples in which the production composition ratio of the hydrogel, which is the main raw material of the collector 300, are different from each other were designed, and these will be described in detail.

[Example 1-1]

The engraved mold for forming the collector 300 in this embodiment was used as one formed according to the experimental example mentioned above when explaining the template forming step (S100) and the mold forming step (S200).

In addition, gelatin processed and formulated as follows was used to construct the hydrogel.

In detail, the gelatin was gelatin from bovine skin, dissolved in water at 50°C by magnetic stirring at 300 rpm for 1 hour.

Then, this gelatin solution is poured into the intaglio mold and then ion cross-linked in a 10% w/w calcium chloride solution for 2 hours to form a hydrogel in the intaglio mold.

Thereafter, the hydrogel is separated from the engraved mold to form a collector 300 made of hydrogel.

[Example 1-2]

The process for forming the collector 300 in this embodiment is the same as the process in Example 1-1 described above, but there are the following differences.

In the case of the solution poured into the intaglio mold, it was formed by adding alginate to the above-described gelatin solution and then manually mixing for 5 minutes.

At this time, the composition ratio of alginate and gelatin is 300 parts by weight of gelatin for 100 parts by weight of alginate, which in other words means a ratio of alginate:gelatin = 1:3.

Then, this alginate-gelatin solution is poured into the intaglio mold and then ion cross-linked in a 10% w/w calcium chloride solution for 2 hours to form a hydrogel in the intaglio mold.

Thereafter, the hydrogel is separated from the engraved mold to form a collector 300 made of hydrogel.

[Example 1-3]

The process for forming the collector 300 in this embodiment is the same as the process in Example 1-2 described above, but there are the following differences.

The composition ratio of alginate and gelatin in this example is 100 parts by weight of gelatin per 100 parts by weight of alginate, which in other words means a ratio of alginate:gelatin = 1:1.

[Example 1-4]

The process for forming the collector 300 in this embodiment is the same as the process in Example 1-1 described above, but there are the following differences.

For the solution poured into the intaglio mold, only alginate was used instead of gelatin.

More specifically, the alginate was dissolved in water at 50°C by magnetic stirring at 300 rpm for 1 hour.

Then, this alginate solution is poured into the intaglio mold and then ionically cross-linked in a 10% w/w calcium chloride solution for 2 hours to form a hydrogel in the intaglio mold.

Thereafter, the hydrogel is separated from the engraved mold to form a collector 300 made of hydrogel.

Evaluation of the mechanical properties of the collector 300 for each of the above-described examples was performed through the following method.

Each collector 300 sample was prepared in the form of an ASTM D638 Type IV specimen.

In addition, physical property tests of each of these specimens were performed using general-purpose testing machines under the product names QM100S and QMESYS, and these mechanical tests were performed within a speed of 10 mm/min and a constant displacement.

And, the results of this mechanical property evaluation are as follows.

First, referring to FIG. 8, it was found that the mechanical strength of the collector 300 to which alginate was not added, as in Example 1-1 (A0G100), was the lowest.

However, as in the order of Example 1-2 (A25G100), Example 1-3 (A50G50), and Example 1-4 (A100G0), the mechanical strength of the collector 300 was linear in response to an increase in the relative content of alginate. It can be seen that it increases exponentially.

And, referring to FIG. 9, the Young's modulus of each collector 300 specimen is also similar to Example 1-1 (Gelatin), Example 1-2 (1:3), Example 1-3 (1:1), and Example 1-3 (1:1). It can be seen that it increases in the order of Example 1-4 (Alginate).

At this time, the shading shown horizontally in FIG. 9 represents the Young's modulus range of actual human external ear cartilage (Cartilage).

Summarizing the matters described with reference to FIGS. 8 and 9, it can be seen that the physical strength increases as the proportion of alginate in the composition of the collector 300 increases.

However, in this case, as the gelatin ratio decreases, the unique effects of gelatin, such as bioactive effects that promote cell adhesion and elasticity, decrease.

Therefore, in order to achieve all purposes such as improving physical properties and strength as well as improving bioactivity and elasticity, alginate and gelatin need to be appropriately mixed.

Therefore, as mentioned in the description with reference to FIG. 9, it is desirable that the composition ratio between alginate and gelatin be configured so that the collector 300, which is the final product, has physical properties within the Young's modulus range of actual human external ear cartilage (Cartilage).

In this case, the collector 300 according to Examples 1-2 to 1-4 was analyzed to have physical properties including the Young's modulus range of actual human external ear cartilage (Cartilage), and the collector 300 according to the corresponding embodiments ) was found to have excellent properties in terms of mechanical rigidity.

At this time, more preferably, alginate and gelatin may be mixed in a ratio of 1:3 as in Example 1-2.

In detail, as mentioned above, Example 1-2 is included as one of the embodiments that satisfies the Young's modulus range of actual human external ear cartilage. Accordingly, the collector 300 according to Example 1-2 is an actual human body. Satisfies the physical properties and strengths corresponding to external ear cartilage.

In addition, among the examples that satisfy the Young's modulus range of actual human external ear cartilage, Example 1-2 has the highest gelatin specific gravity, and accordingly, the unique bioactive effect and elasticity effect of gelatin applied to the implant graft part of the recipient. can be secured as much as possible.

At this time, the elasticity effect among the above-mentioned effects includes the effect of making the recipient feel less foreign than the actual cartilage, but the conformal deposition of the nanofiber mat layer on the collector 300 during the implant manufacturing step (S400) It also performs an action suitable for improving performance, and this will be discussed in detail in the detailed description of the implant manufacturing step (S400), which will be described later.

In addition, regarding the composition of a preferred hydrogel that can maximize the unique efficacy of gelatin while satisfying the Young's modulus range of human external ear cartilage, the ratio of alginate:gelatin = 1:3 was explained, but this was used in this experiment and this method. This is only an illustrative example based on a human sample.

In detail, a variety of Young's modulus ranges of human external ear cartilage can be calculated or selected in response to various data related to the human body, such as the age, gender, bone density, dimensions of each part of the human body, and body weight, of the implant recipient.

In other words, what is explained through FIG. 9 is only an example of the Young's modulus range of human external ear cartilage that can exist in various ways, and the alginate:gelatin = 1:3 ratio is only the most preferable example under the conditions of FIG. 9.

Therefore, most preferably, only enough rigid material such as alginate is provided to realize the corresponding physical properties according to the physical properties of the outer ear cartilage of the person being treated, and elastic materials such as gelatin are provided for the rest, thereby satisfying the mechanical strength of the human body of the person being treated. A hydrogel that satisfies maximum elasticity and biocompatibility within this range can be created.

Next, Figure 10 is a conceptual diagram for explaining the electrospinning process in the implant manufacturing stage.

And, FIG. 11 is a diagram showing an example of an external ear-shaped 3D implant manufactured according to an embodiment of the present invention, and FIG. 12 is a graph showing the diameter distribution of the external ear-shaped 3D implant shown in FIG. 11.

The implant manufacturing step (S400) will be described with further reference to FIGS. 10 to 12.

Referring further to FIG. 10, in the implant manufacturing step (S400), an electrospinning process is performed in which a polymer solution is sprayed from a needle to the collector 300 described above.

At this time, in performing the experiment for the present invention, the polymer solution was stirred for 6 hours with PCL (polycaprolactone, Mw 80000) at a concentration of 7.5%, w/v, and then dissolved in chloroform-methanol (3:1). What was provided was put to use.

In addition, the polymer solution may include not only the above-mentioned PCL composition, but also a mixture of gelatin or collagen, and other crosslinked gelatin, PET (polyethylene terephthalate), and PU (Poly). urethane), PLGA (poly(lactic-co-glycolic acid)), etc.

In addition, in performing the experiment for the present invention, a 23 gauge metal needle with an inner diameter of 0.6 mm was used, and the needle was used from the end of the needle where the polymer solution is sprayed to the collector 300. The shortest straight line distance was set at 20cm.

In addition, the injection speed of the polymer solution was kept constant at 0.4 mL/h, and an electric field corresponding to a voltage difference of 19 kV was created and maintained between the metal needle and the collector 300 to implement the electrospinning principle.

Then, the polymer solution is injected into the collector by the electric field described above.

An example of the outer ear-shaped 3D nanofiber mat layer 400 formed through this electrospinning process is shown in (a) of FIG. 11, and although not shown, a collector is provided on the rear surface, and the collector and nano The deposited fiber mat layer 400 integrally constitutes the external ear implant 1000.

In addition, as shown in (b) of FIG. 11, it was confirmed that the nanofiber mat layer 400 was constructed at the nanoscale through an SEM electron microscope.

In addition, as described above with reference to FIGS. 4 and 5, the template 100 has not only the overall structure compared to the actual outer ear, but also the detailed shape of the actual outer ear, such as the helix, antihelix, and scapha. It is reflected in detail.

And, as sequentially explained in FIGS. 5 to 7, the engraved mold 200 and the collector 300 are sequentially formed based on the template 100, so that the collector 300, which is the final target, is also Naturally, like the template 100, it has the detailed shape of the actual outer ear.

In addition, the nanofiber mat layer 400 deposited on the collector 300 through the electrospinning process also has the detailed shape of the actual outer ear, as shown in (a) of FIG. 11.

However, looking at (a) of FIG. 11, the scapha corresponding area of the nanofiber mat layer 400 has relatively darker black contrast than other areas such as the helix corresponding area, which is the scapha ( Scapha) This means that the deposition of nanofibers did not proceed smoothly in the corresponding area.

In addition, with further reference to Figure 12, it can be seen that in the nanofiber mat layer 400, there is a significant proportion of sections where the diameter of the layer is relatively small, such as 200 to 300 nm, which is the area corresponding to the Scapha mentioned above. It was confirmed that it was.

It was found that nanofibers were insufficiently deposited in certain areas, such as the area corresponding to the scapha, due to the structural and morphological specificity of the outer ear.

For a detailed explanation of this, as further referring to Figure 1, the outer ear has curves with various curvatures and shapes, and as a result, it has a quite complex three-dimensional structure, such as various height differences at each location. .

In particular, the scapha, located between the helix and the antihelix, is relatively located closest to the center of the human body, and the inner surface of the helix has a fairly sloping structure.

That is, based on the center of the human body, the helix of the outer ear is relatively protruding, while the adjacent scapha is quite depressed, and various concave or convex structures exist between these protrusions and depressions.

In addition, the collector on which the nanofibers are deposited reflects the actual outer ear structure described above. Due to the structural and morphological complexity of the outer ear, the nanofiber mat layer 400 has relatively insufficient nanofibers in the area corresponding to the scapha. It was found to have been deposited.

More specifically, when the electrospinning process is performed, due to the complex shape structure of the outer ear described above, the electric field drop, propagation angle, etc. are created differently for each position corresponding to each part of the outer ear, and accordingly, like the metal needle, It is understood that conformal deposition of the nanofiber mat layer is difficult to implement because the polymer solution is guided to the collector unevenly, with the polymer solution being sprayed relatively intensively only at the collector area relatively close to the polymer solution spraying area.

In order to solve this problem, a method was sought to create a uniform drop and slope at which nanofibers are deposited by deforming the collector relatively flat so that the electric field can be uniformly distributed over the entire surface of the collector.

For example, as shown in FIG. 10, based on the state in which the collector 300 is provided on a plate, the edge portion of the collector 300 may be pulled outward by a plurality of wires, and thus The protruding portions on the collector may be pulled due to elastic deformation and the inclined portion formed on each protrusion may be flattened.

At this time, if the collector 300 is constructed to have significant elasticity as in the case of Example 1-2 described above, the collector is pulled more flexibly in response to the increased elasticity, so that the above-described flattening process can be performed more easily. .

In addition, after the nanofiber mat layer is deposited on the surface of the collector 300, the external force pulling the edge of the collector 300 outward is released, so that the shape of the flattened collector 300 can be elastically restored to its original state. , in this case, the shape recovery rate can be significantly improved in response to the above-mentioned improvement in elasticity.

In this case, the original shape of the nanofiber mat layer 400 deposited on the surface of the collector 300 is a shape corresponding to the shape of the collector 300 that has been elastically deformed to be flattened, and the collector 300 is as described above. As the elasticity is restored, the final shape of the nanofiber mat layer 400 is formed into the original shape of the collector 300, that is, the actual outer ear shape with various curves.

At this time, in a similar concept to the principle of Example 1-2 described above, if the polymer solution for forming the nanofiber mat layer 400 is formed including a material with relatively high elasticity such as gelatin, the nanofiber mat layer 400 More naturally, the collector 300 can be elastically deformed into its elastically restored shape, that is, into the actual outer ear shape.

In addition, when the collector 300 is flattened as described above, the fact that the electric field created on the surface is uniformly distributed will be explained in detail with further reference to other drawings.

FIG. 13 is a diagram showing an example of an electric field simulation for a concave-shaped 3D collector formed according to an embodiment of the present invention, and FIG. 14 is an enlarged view of the dotted line area shown in FIG. 13.

15A to 15C are diagrams showing an example of an electric field simulation performed in a state in which the two-wheel corresponding region of the dotted line portion shown in FIG. 14 is bent counterclockwise at 0°, 30°, and 60°, respectively; FIG. 16 is a graph showing electric field angle simulation results for the cases shown in each of FIGS. 15A to 15C.

The method for uniformly depositing the nanofiber mat layer will be described in more detail with further reference to FIGS. 13, 14, 15A to 15C, and 16.

First, with further reference to FIG. 13, a virtual simulation was performed to determine whether the electric field distribution formed on the surface of the collector is uniformed when the collector is flattened.

At this time, the simulation was performed using MINITAB v17.1.0 software.

In addition, referring further to FIG. 14, a side view is shown so that the height difference and slope difference between the Scapha corresponding area (s) on the collector and the Helix corresponding area (h) extending therefrom can be reflected in this simulation. Standard 2D collector modeling was used.

And, further referring to FIGS. 15A to 15C, in this simulation, an electric field distribution analysis was performed on collector modeling in which the helix corresponding area (h) was bent at different angles, which is detailed for each embodiment. Let me explain.

[Example 2-1]

As further referring to FIG. 15A, in this embodiment, the electric field (e) distribution analysis was performed in a state in which the helix corresponding area (h) was bent at 0° so that the collector was provided in its original form.

In this case, an inclined surface with a significant bending angle exists between the Helix corresponding area (h) and the Scapha corresponding area (s), like the actual external ear.

[Example 2-2]

As further referring to FIG. 15B, in this embodiment, the Helix corresponding area (h) is rotated 30° counterclockwise in the state of FIG. 15A so that the Helix corresponding area (h) is provided more parallel to the plane. Electric field (e) distribution analysis for the bent state was performed.

In this case, by comparing FIGS. 15A and 15B, it can be seen that the helix corresponding area (h) is relatively flattened with respect to the plane by the corresponding bending angle.

[Example 2-3]

As further referring to FIG. 15C, in this embodiment, the Helix corresponding area (h) is rotated 60° counterclockwise in the state of FIG. 15A so that the Helix corresponding area (h) is provided more parallel to the plane. Electric field (e) distribution analysis for the bent state was performed.

In this case, comparing FIGS. 15A and 15C, the Helix corresponding area (h) and the Scapha corresponding area (s) are integrated and are substantially parallel to the plane by the corresponding bending angle.

And, as a result of analyzing the electric field (e) distribution for each example, as further referring to FIG. 16, the plane reference line (x) in the order of the 2-1st example, the 2-2nd example, and the 2-3 example. It was found that the propagation angle gradient of the electric field (e) along was reduced.

In detail, the moving direction of the reference line (x) refers to the direction from the Helix corresponding area (h) to the Scapha corresponding area (s), and the reference line (x) is the injection direction of the polymer solution. It refers to the reference plane that faces directly.

Referring to FIG. 15A, in the case of Example 2-1, the Helix corresponding area (h) rapidly descends toward the Scapha corresponding area (s) section from approximately 5 mm after the reference line (x). A slope is formed, and in this case, referring to FIG. 16, it can be seen that the progress angle gradient of the electric field (e) increases rapidly from the reference line (x) point.

On the other hand, referring to Figures 15b and 16, in the case of Example 2-2, the slope between the Helix corresponding area (h) and the Scapha corresponding area (s) becomes gentle compared to Example 2-1. Accordingly, it can be seen that the propagation angle gradient of the electric field (e) is significantly reduced.

And, referring to Figures 15c and 16, in the case of Example 2-3, as the slope between the Helix corresponding area (h) and the Scapha corresponding area (s) becomes more gentle, the electric field (e) It can be seen that the progress angle gradient further decreases.

Through this analysis result, as in Example 2-3, the more the helix corresponding area (h) is flattened and provided parallel to the reference plane, the more homogeneous the distribution of the electric field (e) on the surface is. This was proven through virtual simulation.

In addition, in order to prove that the nanofiber mat layer is uniformly and conformally deposited on the collector as the distribution of the electric field (e) formed on the surface of the collector becomes more uniform, external ear implant samples corresponding to the above examples were produced and analyzed. This will be further explained with reference to other drawings.

FIG. 17A is a diagram showing an example of a region corresponding to the navicular fossa among external ear-shaped implants according to an embodiment of the present invention, and FIG. 17B is a diagram showing an example of a region corresponding to the navicular fossa among external ear-shaped implants according to another embodiment of the present invention. am.

And, Figure 18 is a graph showing the average thickness of the nanofiber mat formed in the dotted line area shown in each of Figures 17a and 17b.

First, as shown in Figure 17a, a nanofiber mat layer 410 corresponding to Example 2-1 was produced, and as shown in Figure 17b, a nanofiber mat layer (410) corresponding to Example 2-3 was produced. 420) was produced.

At this time, FIGS. 17A and 17B enlarge and show only the Scapha corresponding area (si) and its peripheral portion of the nanofiber mat layer 420.

In addition, the collector used to manufacture the nanofiber mat layers 410 and 420 for each example was manufactured by a method corresponding to the above-described Example 1-2, and the polymer solution sprayed on the surface and the spray conditions were This is according to the above-described experimental example.

However, as in the description of Example 2-1, the nanofiber mat layer 410 corresponding to Example 2-1 is in a state in which a polymer solution is sprayed on the surface without any shape deformation being applied to the collector. It was produced based on .

On the other hand, the nanofiber mat layer 420 corresponding to Example 2-3, similar to the description of Example 2-3, was manufactured by spraying a polymer solution on a collector whose edge portion was pulled outward, thereby forming two rings. (Helix) The corresponding area is bent 60° counterclockwise to be more parallel to the plane.

In addition, after the nanofiber mat layer 420 corresponding to Example 2-3 is formed, the external force for pulling the collector outward is released, so that the collector is elastically restored to its original shape, and the nanofiber mat layer 420 Additionally, it is provided in a shape corresponding to the original shape of the collector.

And, comparing Figures 17a and 17b, it is visually confirmed that the nanofiber mat layer 420 corresponding to Example 2-3 shown in Figure 17b is thicker in the case of the Scapha corresponding area (si). .

In addition, as further referring to FIG. 18, as a result of checking the thickness of the corresponding region of the scapha, it was confirmed that the nanofiber mat layer 420 corresponding to Example 2-3 was significantly thick.

That is, like the nanofiber mat layer 420 corresponding to Example 2-3, when the polymer solution is sprayed on the surface with the collector flattened, the Scapha corresponding area (si) in the nanofiber mat layer ) It was confirmed that the deposition thickness was sufficiently secured.

Next, FIG. 19 is a diagram showing an example of an external ear-shaped 3D implant formed according to an embodiment of the present invention, and FIG. 20 is a graph showing the average thickness of each main part of the external ear-shaped 3D implant shown in FIG. 19.

Referring further to FIG. 19, an external ear implant 2000 manufactured corresponding to the above-described Example 2-3 is shown, and in the case of FIG. 11, an external ear implant 1000 manufactured corresponding to the above-described Example 2-1 is shown. ) can be indicated.

In addition, in the case of the external ear implant 2000 shown in FIG. 19, during the electrospinning process, the polymer solution is sprayed with an external force pulling outwards applied to the entire edge of the collector at equal intervals. It was done.

In this way, with comparative reference to FIGS. 11 and 19, when the external ear implant 2000 is manufactured corresponding to Example 2-3 described above, the Scapha corresponding area and other areas in the nanofiber mat layer 420 It is visually confirmed that there is almost no difference in thickness between the two layers.

In addition, further referring to Figure 20, as a result of measuring the thickness of each main part of the nanofiber mat layer 420 corresponding to Figure 19, it was confirmed that the thickness distribution was evenly formed.

In this way, if the polymer solution is sprayed onto the flattened collector during the electrospinning process, an external ear implant is provided with a nanofiber mat layer that reflects the complex three-dimensional shape of the actual external ear and minimizes thickness differences at each location. can be seen.

In addition, as compared between the case where electrospinning was performed without flattening the part corresponding to the scapha of the actual external ear among the collector configuration and the vice versa, the collector, which is one of the main features of the implant manufacturing step (S400) As an example to explain the flattening configuration, the part of the outer ear implant that corresponds to the scapha of the actual outer ear was mainly used.

However, this is only an example for explanation, and as previously explained through FIGS. 19 and 20, the flattening process of the collector can be performed on the entire structure, not just the area corresponding to the scapha.

That is, as described above with reference to FIG. 10, if an external force pulling in a direction parallel to the plane is applied to the entire border section of the collector in the implant manufacturing step (S400), all protrusions and depressions on the collector are as close to the plane as possible. It can be flattened, which means that conformal deposition of the nanofiber mat layer can be implemented in any area corresponding to the actual external ear shape.

In addition, the nanofiber mat layer deposition process in the above-mentioned implant manufacturing step (S400) has been described as being performed only on the outer surface of the human body, which is the outer surface of the human body, based on the center of the human body. However, the nanofiber mat layer is applied to the entire surface of the collector. can be deposited.

For example, after the deposition of the nanofiber mat layer on the outer surface of the collector is completed as described above, the collector is turned over so that the inner surface of the collector on which the nanofiber mat layer is not deposited faces the needle through which the polymer solution is sprayed. It can be.

In addition, by performing the same electrospinning process as described above on the inner surface, an external ear implant with a nanofiber mat layer deposited on the entire surface of the collector can be provided.

Additionally, nanofiber mat layer deposition may be performed preferentially on the inner surface as well as the outer surface of the collector.

In addition, since the electrospinning process is performed with a plurality of needles for spraying the polymer solution provided on the outer and inner surfaces of the collector, nanofiber mat layer deposition on the entire surface of the collector can be performed simultaneously.

As described above, according to preferred embodiments of the present invention, an external ear implant in which a nanofiber mat layer is deposited on a collector made of a hydrogel with high cell adhesiveness can be provided.

In addition, each of these collectors and nanofiber mat layers faithfully reflects the shape of the actual outer ear, and can fully perform the role of the actual outer ear in terms of aesthetics and function.

In addition, such a nanofiber mat layer has a high surface area per unit volume due to the nature of nanofibers, and thus has high ventilation and durability.

Therefore, by covering the entire outer surface of the collector with this nanofiber mat layer, the collector can be effectively protected from various impacts. In addition, despite this overall cover, a high ventilation effect is guaranteed to the collector, preventing excessive moisture, rot, etc. from the collector. Various chemical damages that may occur can also be minimized.

In addition, this nanofiber mat layer has a minimized difference in thickness at each location, and thus its quality and functionality can be secured to the maximum.

As described above, the main technical idea of the present invention is to provide an external ear implant and an external ear implant manufacturing method. The embodiment described above with reference to the drawings is only one embodiment, and the true scope of the present invention is the patent. Based on the scope of the claims, it will also extend to various equivalent embodiments that may exist.

1000: External ear implant according to the present invention
100: Template
200: Engraved mold
300: Collector
400: Nanofiber mat layer

Claims (6)

A collector forming step in which an external ear-shaped 3D collector composed of a material containing a hydrogel is formed; and
An implant manufacturing step in which a polymer solution is sprayed on the surface of the collector according to the principle of electrospinning, and a nanofiber mat layer corresponding to the shape of the collector is deposited on the collector to manufacture an external ear-shaped 3D implant,
The implant manufacturing step is,
After at least one edge point of the collector is pulled outward and the collector is flattened by elastic deformation, the polymer solution is sprayed on the surface of the flattened collector to form a nanofiber mat layer corresponding to the shape of the collector. A method of manufacturing an external ear implant, wherein the implant is manufactured by depositing on the surface of a collector and elastically restoring the collector to its original shape by releasing an external force applied to the collector to flatten it.
delete delete According to claim 1,
The hydrogel is,
A method of manufacturing an external ear implant, characterized in that it is formed from a material containing at least one of gelatin or collagen.
According to claim 4,
The hydrogel is,
A method of manufacturing an external ear implant, characterized in that it is formed of a material further containing alginate to have a rigidity corresponding to the mechanical rigidity of human external ear cartilage.

According to claim 5,
The nanofiber mat layer is,
A method of manufacturing an external ear implant, characterized in that it is formed from a material containing at least one of gelatin or collagen.