Artificial implants

Abstract

An artificial implant is disclosed that includes a silicone shell and a filling material filled inside the shell, at least a portion of the shell being a rupture-resistant portion that includes two or more silicone layers and one or more reinforcing material layers interposed therebetween.

Description

[Technical field]

[0001] The present invention relates to artificial implants. [Background technology]

[0002] Artificial breast implants are class 4 medical devices in which the silicone shell that forms the outer covering of the implant is filled with gel or saline of appropriate viscosity, and require special stability in the body. The implant industry has secured the required physical properties for medical devices by adjusting the thickness of the silicone shell or changing the ingredients of the filling, and in general, research and development is underway to adjust the physical properties of the filling to achieve a natural shape.

[0003] However, artificial implants still have the potential risk of side effects after implantation. In particular, the rippling phenomenon occurs frequently due to the folding of the silicone shell. Rippling is a side effect in which wrinkles formed on the surface of the implant appear as a wavy pattern on the skin surface of the chest. Not only does it reduce the aesthetic satisfaction of the user, but it also reduces the durability of the area due to the continuous folding of a specific part of the silicone shell, which is the outer covering of the implant, and can lead to the rupture of the implant.

[0004] When an artificial implant ruptures, the filler inside the implant may leak out. The leakage of the filler may cause an inflammatory reaction inside the human body, which may lead to tissue necrosis, bacterial infection, capsular contracture, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), etc., which may cause severe pain to the user due to an oversensitive immune reaction. In particular, users who experience capsular contracture must undergo reoperation, and users who experience BIA-ALCL may be at risk of death.

[0005] In order to solve the above problems of the conventional artificial implants, it is most important to prevent the implant from bursting. In particular, the rippling phenomenon occurs continuously only in a specific area of ​​the silicone shell, which is the outer cover of the implant, and the durability is reduced, so there is a need to develop an artificial implant that can impart mechanical properties to the specific area and a method for manufacturing the same. Summary of the Invention [Problem to be solved by the invention]

[0006] To provide an artificial implant having improved resistance to rupture. [Means for solving the problem]

[0007] According to one aspect, the present invention includes a silicone shell; and a filler filled inside the shell, and at least a portion of the shell is a rupture prevention portion including two or more silicone layers and one or more reinforcing material layers interposed therebetween. The burst prevention part is composed of silicone and reinforcing material in a weight ratio of 55-95:5-45. , an artificial implant is provided.

[0008] In one embodiment, the thickness of the shell other than the burst prevention portion may be 0.40 to 0.80 mm, and the thickness of the burst prevention portion may be 0.40 to 1.20 mm.

[0009] In one embodiment, the shell may further include a barrier layer.

[0010] In one embodiment, the burst prevention portion may be provided on the side portion.

[0011] In one embodiment, the reinforcing material may be at least one selected from polyester, polyurethane, polyvinyl chloride, nylon, polyethylene glycol, polyethylene oxide, polyhydroxyethyl methacrylate, poly(N-isopropylacrylamide), polycaprolactone, polylactic acid, polyglycolic acid, poly[(lactic-co-(glycolic acid))], polydioxanone, poly[(L-lactide)-co-(caprolactone)], poly(ester urethane), poly[(L-(lactide)-co-(D-lactide)), poly[ethylene-co-(vinyl alcohol)], polyacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, gelatin, alginate, carrageenan, chitosan, hydroxyalkyl cellulose, alkyl cellulose, silicone, rubber, polyacrylacetate, titanium, titanium alloy, zirconia, alumina, nichrome, cochrome, and gold.

[0012] In one embodiment, the reinforcing layer may be at least one selected from the group consisting of a mesh, a woven fabric, a nonwoven fabric, and a sheet.

[0013] In one embodiment, the burst prevention portion may be composed of silicone and reinforcing material in a weight ratio of 55-95:5-45.

[0014] In one embodiment, the burst prevention portion may have a tensile strength of 25N or more.

[0015] In one embodiment, the burst prevention portion may have an elongation rate of 300 to 500%. Effect of the Invention

[0016] According to one aspect, the rupture resistance of the artificial implant can be improved.

[0017] The effects of one aspect of this specification are not limited to the effects described above, but should be understood to include all effects that can be inferred from the configurations described in the detailed description or claims of this specification. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a longitudinal cross-sectional view of a prosthetic implant according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a longitudinal sectional view of an artificial implant having a rupture prevention portion on its side according to one embodiment of the present disclosure. [Diagram 3] FIG. 3 is a longitudinal cross-sectional view of an artificial implant having different thicknesses on the side surfaces according to one embodiment of the present disclosure. [Figure 4] FIG. 4 is a diagram illustrating an example of a burst prevention portion of an artificial implant according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 is a diagram illustrating another example of a rupture prevention portion of an artificial implant according to an embodiment of the present disclosure. [Figure 6] FIG. 6 shows the results of measuring the tensile strength of a test piece related to the bursting prevention portion of an artificial implant according to one embodiment of the present specification. [Figure 7] FIG. 7 shows the results of measuring the elongation rate of a test piece related to a burst prevention portion of an artificial implant according to one embodiment of the present specification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Hereinafter, an aspect of the present specification will be described with reference to the accompanying drawings. However, the description of the present specification may be embodied in various different forms. Therefore, the present specification is not limited to the embodiments described herein. In addition, in order to clearly describe an aspect of the specification in the drawings, parts that are not related to the description are omitted, and similar parts are designated by similar reference numerals throughout the specification.

[0020] Throughout the specification, the term "connected" to another part includes not only "directly connected" but also "indirectly connected" with another member therebetween. In addition, the term "comprises" a certain component means that the part can further include the other component, not excluding the other component, unless otherwise specified.

[0021] When a range of numerical values ​​is recited herein, unless a specific range thereof is stated to the contrary, the values ​​have the precision of significant figures provided by standard rules in chemistry for significant figures, for example, the number 10 includes a range of 5.0 to 14.9, and the number 10.0 includes a range of 9.50 to 10.49.

[0022] Hereinafter, an embodiment of the present specification will be described in detail with reference to the accompanying drawings.

[0023] Artificial Implants 100 According to one aspect, the artificial implant 100 includes a silicone shell 110; and a filling 120 filled inside the silicone shell 110, and at least a portion of the silicone shell 110 may be a rupture-resistant portion including two or more silicone layers 111, 113, 115 and one or more reinforcing material layers 112, 114 interposed therebetween.

[0024] The artificial implant may have different shapes depending on the insertion site or the purpose of the treatment, and may be inserted into many body sites, such as the breast, nose, buttocks, and forehead, but the shape is not particularly limited.

[0025] As a non-limiting example, the artificial implant 100 can function as an implant in the body by injecting a filler 120 into the silicone shell 110. The filler 120 may be a silicone gel, and as an example, the silicone gel may be an organosiloxane polymer (polyorganosiloxane). The organosiloxane polymer may be one selected from the group consisting of dimethylsiloxane, methylhydrogensiloxane, methylphenylsiloxane, diphenylsiloxane, dimethylvinylsiloxane, tri-fluoropropylsiloxane, and a mixture of two or more of these, but the type is not particularly limited as long as the functional characteristics of the artificial implant can be realized.

[0026] When the artificial implant 100 is an artificial breast implant, its cross-sectional shape may be selected from the group consisting of a circle, an oval, and a teardrop, but is not limited thereto. Generally, since the shape and form of a user's breast are different for each user, the shape of the artificial implant can be selected in consideration of the original shape and the user's preference for the shape, shape, size, etc.

[0027] 1 to 3 are cross-sectional views of an artificial implant 100 according to an embodiment. Referring to Fig. 1, the artificial implant 100 may include a filler 120 and a silicone shell 110 surrounding the filler 120. The silicone shell 110 may include a rupture prevention portion having reinforcing material layers 112 and 114 interposed between a plurality of silicone layers 11, 113 and 115.

[0028] The artificial implant 100 may be comprised of an upper portion 101, a lower portion 102, and a side portion 103, and the burst prevention portion may be provided on at least a portion of the silicone shell 110, for example, at least one of the upper portion 101, the lower portion 102, or the side portion 103 of the implant. FIG. 2 shows an example in which the burst prevention portion is provided only on the side portion 103.

[0029] The silicon shell 110 may have a thickness of 0.40 to 0.80 mm, for example, 0.40 mm, 0.45 mm, 0.50 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.70 mm, 0.75 mm, 0.80 mm, or a range between any two of these values. The burst prevention portion of the silicon shell 110 may have a thickness equal to or thicker than the other portions, and may have a thickness of 0.40 to 1.20 mm, for example, 0.40 mm, 0.45 mm, 0.50 mm, 0.55 mm, 0.60 mm, 0.65 mm, 0.70 mm, 0.75 mm, 0.80 mm, 0.85 mm, 0.90 mm, 0.95 mm, 1.00 mm, 1.05 mm, 1.10 mm, 1.15 mm, 1.20 mm, or a range between any two of these values. If the thickness of the silicon shell 110 and the rupture prevention part is less than 0.40 mm, the mechanical properties are insufficient and it may easily cause damage and aesthetic side effects to the artificial implant 100. If the thickness of the silicon shell 110 exceeds 0.80 mm or the thickness of the rupture prevention part exceeds 1.20 mm, the user who has received the artificial implant 100 may feel discomfort such as a foreign body sensation.

[0030] FIG. 3 shows an example of an artificial implant 100 having a reinforced thickness, in which it can be seen that the side portion 103 is thicker than the upper portion 101 and the lower portion 102.

[0031] The rippling phenomenon of artificial breast implants generally occurs primarily from the side portion 103 of the implant, so by applying a rupture prevention portion only to a portion of the implant or by varying the thickness of the side portion 103, it is possible to prevent the artificial implant 100 from folding and rupturing while minimizing the deterioration of the user's convenience, aesthetics, tactile sensation, etc.

[0032] 4 and 5 are views showing an example of the rupture prevention part. Referring to FIG. 4, a shape of a reinforcing material layer 112 interposed between two silicon layers 111 and 113 can be seen. FIG. 5 shows reinforcing material layers 112 and 114 interposed between three silicon layers 11, 113 and 115, each having the same total thickness and a thinner thickness, but the rupture prevention part is not limited thereto. For example, the silicon layer may be composed of 2, 3, 4, 5, 6, 7, 8, 9, 10 or more layers, and the reinforcing material layer may be composed of 1, 2, 3, 4, 5, 6, 7, 8, 9 or more layers.

[0033] The silicone shell 110 may further include a barrier layer. For example, the silicone shell 110 may be composed of a general silicone layer and a barrier layer. The barrier layer may prevent low molecular weight silicone components from the filling 120 inside the artificial implant 100 from leaking out to the outside. For example, the bottom layer of the rupture prevention part adjacent to the filling 120 may be a barrier layer, or may have a structure in which a barrier layer, a reinforcing material layer, and a silicone layer are laminated in this order.

[0034] The reinforcing material may be at least one selected from polyester, polyurethane, polyvinyl chloride, nylon, polyethylene glycol, polyethylene oxide, polyhydroxyethyl methacrylate, poly(N-isopropylacrylamide), polycaprolactone, polylactic acid, polyglycolic acid, poly[(lactic-co-(glycolic acid))], polydioxanone, poly[(L-lactide)-co-(caprolactone)], poly(ester urethane), poly[(L-(lactide)-co-(D-lactide)), poly[ethylene-co-(vinyl alcohol)], polyacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, gelatin, alginate, carrageenan, chitosan, hydroxyalkyl cellulose, alkyl cellulose, silicon, rubber, polyacryl acetate, titanium, titanium alloy, zirconia, alumina, nichrome, cochrome, and gold, but is not limited thereto. The reinforcing material is not limited to its type as long as it has excellent elasticity and recovery rate, is excellent in biocompatibility, and is harmless to the human body.

[0035] The reinforcing material layer may have at least one structure selected from among a mesh, a woven fabric, a nonwoven fabric, and a sheet. The mesh refers to a mesh structure like a sieve, the woven fabric is a form in which a fiber phase structure is woven by crossing according to a certain rule, the nonwoven fabric is a form in which a fiber phase structure is arranged and bonded without a certain rule, and the sheet may have a plate-like structure. The structure of the reinforcing material layer may be freely selected depending on the material of the reinforcing material. For example, it may be a metal mesh such as titanium, a nylon woven fabric, a polyester nonwoven fabric, a rubber sheet, etc., but is not limited thereto.

[0036] The rupture prevention portion may be composed of silicone and reinforcing material in a weight ratio of 55-95:5-45. For example, the weight ratio may be 55:45, 60:40, 65:35, 70:30, 75:25, 80:20, 85:15, 90:10, 95:5, or a range between two of these ratios. If the weight ratio is outside the above range, the artificial implant 100 may become excessively hardened or the mechanical properties may be deteriorated.

[0037] The burst prevention portion may have a tensile strength of 25 N or more, for example, but not limited to, 25 N, 26 N, 27 N, 28 N, 29 N, 30 N, 31 N, 32 N, 33 N, 34 N, 35 N, 36 N, 37 N, 38 N, 39 N, 40 N, 41 N, 42 N, 43 N, 44 N, 45 N, 46 N, 47 N, 48 N, 49 N, or 50 N. The burst prevention portion of the silicone shell 110 forming the outer cover of the artificial implant 100 may enhance durability and burst resistance.

[0038] The burst prevention portion may have an elongation percentage of 300 to 500%, for example, 300%, 310%, 320%, 330%, 340%, 350%, 360%, 370%, 380%, 390%, 400%, 410%, 420%, 430%, 440%, 450%, 460%, 470%, 480%, 490%, 500%, or a range between two of these values. If the elongation percentage is out of this range, the user may feel an increased foreign body sensation with respect to the artificial implant 100, or the artificial implant 100 may not have the required mechanical properties.

[0039] As an example, the artificial implant 100 may be manufactured by immersing a mold having a predetermined shape in a silicone solution, drying and hardening the mold to form a silicone shell 110, forming a reinforcing material layer by applying or laminating a reinforcing material to a desired area on the surface of the silicone shell 110, and then drying and hardening the reinforcing material layer, and then repeating the steps of forming a silicone layer on the surface of the reinforcing material layer, and then injecting a filler 120 into the silicone shell 110, but is not limited thereto.

[0040] The examples of the present specification will be described in more detail below. However, the following experimental results are only representative experimental results among the above examples, and the scope and contents of the present specification should not be construed as being narrowed or limited by the examples. The respective effects of the various embodiments of the present specification that are not explicitly presented below will be specifically described in the relevant parts.

[0041] Comparative Example Shell specimens were fabricated from a single piece of silicon.

[0042] Example 1 Shell specimens were manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 4. The silicone and reinforcing material were used in a weight ratio of 9:1.

[0043] Example 2 A shell specimen was manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 4. The weight ratio of silicone to reinforcing material was 8:2.

[0044] Example 3 Shell specimens were manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 4. The silicone and reinforcing material were used in a weight ratio of 7:3.

[0045] Example 4 Shell specimens were manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 5. The silicone and reinforcing material were used in a weight ratio of 9:1.

[0046] Example 5 Shell specimens were manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 5. The silicone and reinforcing material were used in a weight ratio of 8:2.

[0047] Example 6 Shell specimens were manufactured with a polyester reinforcing layer inserted between the silicone layers, as shown in Figure 5. The weight ratio of silicone to reinforcing material was 7:3.

[0048] The test pieces of the comparative example and examples 1 to 6 were all manufactured to the same thickness, and the weight ratios of the silicone and reinforcing material used therein are as shown in Table 1 below.

[0049] [Table 1]

[0050] Experimental Example 1 The tensile strength and elongation of the test pieces prepared in the Comparative Example and Examples 1 to 6 were measured and are shown in Table 2, Figure 6, and Figure 7. Each test piece was cut into a dumbbell shape according to ISO 37 No. 3 standard, and the tensile strength and elongation of the test piece at the time of cutting were measured using a Universal Test Machine.

[0051] [Table 2]

[0052] The above description of the present specification is merely illustrative, and a person having ordinary skill in the art to which one aspect of the present specification belongs can easily understand that the present specification can be easily modified into other specific forms without changing the technical ideas and essential features described in the present specification. Therefore, the above-described embodiments should be understood to be illustrative in all respects and not limiting. For example, each component described as a single type can be implemented in a distributed form, and similarly, each component described as a distributed type can be implemented in a combined form.

[0053] The scope of this specification is indicated by the claims set forth below, and all modifications and variations derived from the meaning and scope of the claims and their equivalent concepts must be interpreted as being included in the scope of the present invention. [Explanation of symbols]

[0054] 100: Artificial implants 101: Artificial implant upper part 102: Artificial implant lower part 103: Lateral part of artificial implant 110: Silicon shell 111, 113, 115: Silicon layers 112, 114: Reinforcement layers 120: Filling

Claims

1. A filling material is contained within the shell, At least a portion of the shell is a rupture prevention portion including two or more silicone layers and one or more reinforcing material layers interposed therebetween; The artificial implant is characterized in that the rupture prevention portion is composed of silicone and reinforcing material in a weight ratio of 55-95:5-45.

2. 2. The artificial implant of claim 1, wherein the thickness of the shell other than the bursting prevention portion is 0.40 to 0.80 mm, and the thickness of the bursting prevention portion is 0.40 to 1.20 mm.

3. 10. The artificial implant of claim 1, wherein the shell further comprises a barrier layer.

4. 2. The artificial implant according to claim 1, wherein the anti-rupture portion is provided on a side portion.

5. 2. The artificial implant of claim 1, wherein the reinforcing layer is at least one selected from the group consisting of polyester, polyurethane, polyvinyl chloride, nylon, polyethylene glycol, polyethylene oxide, polyhydroxyethyl methacrylate, poly(N-isopropylacrylamide), polycaprolactone, polylactic acid, polyglycolic acid, poly[(lactic-co-(glycolic acid))], polydioxanone, poly[(L-lactide)-co-(caprolactone)], poly(ester urethane), poly[(L-(lactide)-co-(D-lactide)), poly[ethylene-co-(vinyl alcohol)], polyacrylic acid, polyvinyl alcohol, polyvinylpyrrolidone, gelatin, alginate, carrageenan, chitosan, hydroxyalkyl cellulose, alkyl cellulose, silicone, rubber, polyacrylacetate, titanium, titanium alloy, zirconia, alumina, nichrome, cochrome, and gold.

6. 2. The artificial implant of claim 1, wherein the reinforcing layer is at least one selected from the group consisting of a mesh, a woven fabric, a nonwoven fabric, and a sheet.

7. The artificial implant according to claim 1, wherein the burst prevention portion has a tensile strength of 25N or more.

8. The artificial implant according to claim 1, wherein the burst prevention portion has an elongation rate of 300-500%.

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