KR-20260067867-A - ARTIFICIAL PROSTHESIS WITH LIGHT WEIGHT

KR20260067867AKR 20260067867 AKR20260067867 AKR 20260067867AKR-20260067867-A

Abstract

An artificial implant and a method for manufacturing the same are provided, comprising: a silicone shell; and a filler injected into the silicone shell; wherein the silicone shell comprises two or more first silicone layers forming the inner and outer surfaces of the silicone shell and one or more second silicone layers interposed between the two or more first silicone layers, and wherein the second silicone layer comprises pores.

Inventors

홍유림
송주동
장일석
김정주
박신우

Assignees

오스템임플란트 주식회사

Dates

Publication Date: 20260513
Application Date: 20241106

Claims (14)

silicone shell; and It includes a filler injected into the interior of the above silicone shell, and The above silicon shell comprises two or more first silicon layers forming the inner and outer surfaces of the silicon shell, and one or more second silicon layers interposed between the two or more first silicon layers. The above second silicone layer is an artificial implant comprising pores.
In paragraph 1, The first silicone layer is obtained by drying and curing the first silicone compound, and The above first silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (siloxanes and silicones, dimethyl, methyl hydrogen), an artificial implant.
In paragraph 1, The second silicone layer is obtained by drying and curing the second silicone compound, and The above second silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), 0 to 10 parts by weight of octamethylcyclotetrasiloxane, 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol.
In paragraph 1, An artificial implant in which at least a portion of the above silicone shell is formed by stacking two or more first silicone layers and one or more second silicone layers in a continuous or intersecting manner.
In paragraph 1, An artificial implant having an average pore size of 1 to 500 μm in the second silicone layer.
In paragraph 1, An artificial implant having an average pore size of 150 to 400 μm in the second silicone layer.
In paragraph 1, An artificial implant having an average pore size of 200 to 350 μm in the second silicone layer.
In paragraph 1, An artificial implant having an average pore density of 1 to 5 pores/ mm² of the second silicone layer.
(a) A step of forming a first silicone layer by coating a first silicone formulation onto a breast-shaped mold, and then drying and curing it; (b) a step of stirring the second silicone mixture to form pores; (c) a step of forming a second silicone layer by coating a second silicone compound with the pores formed therein onto at least a portion of a breast-shaped mold having the first silicone layer formed thereon, and then drying and curing it; and (d) a step of forming a first silicone layer by coating the first silicone compound on at least a portion of the breast-shaped mold part on which the second silicone layer is formed, and then drying and curing it; The first silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (siloxanes and silicones, dimethyl, methyl hydrogen). The second silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), 0 to 10 parts by weight of octamethylcyclotetrasiloxane, 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol. Method of manufacturing an artificial implant.
In Paragraph 9, A method for manufacturing an artificial implant, characterized in that steps (a) and (c) are each repeated 1 to 10 times.
In Paragraph 9, A method for manufacturing an artificial implant, characterized in that steps (a) and (c) are each performed alternately 1 to 10 times.
In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (a) above is performed at 40 to 60°C for 2 to 4 hours.
In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (c) above is performed at 80 to 200°C for 0.1 to 3 hours.
In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (d) above is performed at 40 to 60°C for 2 to 4 hours.

Description

Lightweight Artificial Prosthesis The present invention relates to an artificial implant having a light weight, wherein pores are formed in at least a portion of a silicone shell. Artificial implants are Class 4 medical devices that exist within the body and are applied to various parts of the body, such as the nose and breasts. In particular, most artificial implants consist of a silicone shell forming the outer layer of the implant filled with a gel or saline solution of appropriate viscosity. Since exceptional stability is required within the body, the implant industry has secured the physical properties required for medical devices by methods such as adjusting the thickness of the silicone shell or changing the composition of the filler. Generally, research and development is underway to achieve a natural shape by adjusting the physical properties of the filler. Artificial implants currently available on the market are manufactured from silicone, which is sized to replace human tissues such as breasts and possesses significant size and weight. Therefore, while they offer the advantage of having characteristics very similar to the shape and physical properties of living tissues, they have a limitation in that they are relatively heavy due to their higher density compared to biological tissues. Therefore, when existing artificial implants are installed in the body, a foreign body sensation may be felt, and they may cause discomfort by imposing an excessive load on the body or induce other diseases such as scoliosis or herniated discs. However, at present, there are no raw materials other than silicone that can be inserted into the body and guarantee safety for more than 10 years, so there is a need to develop artificial implants with a new structure to reduce weight while maintaining the physical properties of such artificial implants. Figure 1 is a schematic diagram of the lamination method for manufacturing an artificial implant according to the present invention. Figure 2(a) is a schematic diagram of a conventional laminated structure artificial implant, and (b) is a schematic diagram of the laminated structure of the lightweight artificial implant of the present invention. Figure 3 (a) is an embodiment of the present invention, and (b) is a photograph of a cross-section of an artificial implant representing a comparative example. Figure 4 is a graph showing the mechanical properties of the artificial implants of the embodiments and comparative examples of the present invention. Hereinafter, one aspect of the present specification will be described with reference to the attached drawings. However, the details described in the present specification may be implemented in various different forms and are therefore not limited to the embodiments described herein. Throughout the specification, when a part is described as "including" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but rather allows for the inclusion of additional components. When a range of numerical values is described in this specification, unless a specific range is otherwise described, the value has the precision of significant figures provided according to the standard rules in chemistry for significant figures. For example, 10 includes a range of 5.0 to 14.9, and the number 10.0 includes a range of 9.50 to 10.49. artificial implants An artificial implant according to one aspect of the present invention comprises a silicone shell; and a filler injected into the silicone shell; wherein the silicone shell comprises two or more first silicone layers forming the inner and outer surfaces of the silicone shell, and one or more second silicone layers interposed between the two or more first silicone layers, and wherein the second silicone layer comprises pores. Conventional artificial implants have the disadvantage of being heavier than human tissue even when having the same volume, because the density of the silicone shell is high. The artificial implant of the present invention is designed with a silicone layer in a multi-layer structure and includes pores in some of them to lower the density of the silicone shell, thereby achieving lightweighting, which can reduce the foreign body sensation and discomfort when inserted into a patient's body. Looking at FIG. 1, it can be seen that a breast-shaped mold (10) is attached to a rod (11), and a first silicone layer (100) is first laminated on the surface of the mold (10) to form the inner surface of the silicone shell, then a second silicone layer (200) is laminated, and then the first silicone layer (100) is laminated again to form the outer surface of the silicone shell. At this time, the method of forming the first silicone layer (100) and the second silicone layer (200) is not limited to this. Additionally, when separating the silicone shell from the mold (10), the silicone shell can be removed by opening the opening formed at the