BREAST IMPLANT HAVING WAVINESS

Abstract

The present application relates to a breast implant having surface roughness and waviness. A breast implant according to an aspect includes: a shell constituting an outer skin; and a filler material accommodated inside the shell, wherein an outer surface of the shell has a concave-convex surface in contact with tissue, and the surface has a certain level of waviness in a filtered waviness curve.

Claims

1. A breast implant comprising: a shell constituting an outer skin; and a filler material accommodated inside the shell, wherein an outer surface of the shell has a concave-convex surface in contact with tissue, and the surface has an arithmetic mean waviness (Wa) value of 3.00 .Math.m or more in a waviness curve filtered under a measurement condition with a cut-off value of 0.08.

2. The breast implant of claim 1, wherein the surface has an arithmetic mean waviness (Wa) value in a range of 3.07 .Math.m to 7.00 .Math.m in the waviness curve filtered under a measurement condition with a cut-off value of 0.08.

3. The breast implant of claim 2, wherein the arithmetic mean waviness (Wa) value is in a range of 3.50 .Math.m to 6.00 .Math.m.

4. The breast implant of claim 2, wherein the surface has a maximum height (Wz) value of 19.16 .Math.m or more in the waviness curve filtered under a measurement condition with a cut-off value of 0.08.

5. The breast implant of claim 4, wherein the maximum height (Wz) value is in a range of 20.00 .Math.m to 44.00 .Math.m in the filtered waviness curve.

6. The breast implant of claim 2, wherein the surface has an arithmetic mean roughness (Ra) value of 1.00 .Math.m or more in a roughness curve filtered under a measurement condition with a cut-off value of 0.08.

7. The breast implant of claim 6, wherein the arithmetic mean roughness (Ra) value is in a range of 1.09 .Math.m to 2.00 .Math.m.

8. The breast implant of claim 2, wherein the surface has a maximum height (Rz) value of 5.84 .Math.m or more in a roughness curve filtered under a measurement condition with a cut-off value of 0.08.

9. The breast implant of claim 8, wherein the maximum height (Rz) value is in a range of 5.84 .Math.m to 10.29 .Math.m in the filtered roughness profile.

10. The breast implant of claim 1, wherein the surface has a skewness (Wsk) value in a range of -0.48 .Math.m to 0.41 .Math.m and a kurtosis (Wku) value in a range of 2.62 .Math.m to 5.28 .Math.m in a waviness curve filtered under a measurement condition with a cut-off value of 0.08.

11. The breast implant of claim 1, wherein the surface has a skewness (Rsk) value in a range of -0.21 .Math.m to 0.22 .Math.m and a kurtosis (Rku) value in a range of 2.72 .Math.m to 3.86 .Math.m in a roughness curve filtered under a measurement condition with a cut-off value of 0.08.

12. The breast implant of claim 1, wherein the shell is formed of silicone material.

13. The breast implant of claim 1, wherein the tissue is one or more selected from the group consisting of thin fascia, muscular fascia, breast fascia, supportive fiber, and transverse fibrolamella.

14. The breast implant of claim 1, wherein the breast implant suppresses breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Description

DESCRIPTION OF DRAWINGS

[0037] FIG. 1 is a diagram showing a breast implant according to an embodiment and a shell surface thereof.

[0038] FIG. 2 is a diagram schematically illustrating a state of a breast implant according to an embodiment after being inserted into a body.

[0039] FIG. 3 is a diagram schematically illustrating a process of measuring surface roughness and waviness of a shell surface of a breast implant according to an embodiment.

[0040] FIG. 4 shows a result of a waveform profile under a measurement condition of a cut-off value of 0.08 with respect to a shell surface of a breast implant according to an embodiment.

[0041] FIG. 5 is a result showing a waveform profile under a measurement condition of a cut-off value of 0.08 with respect to the shell surface of a breast implant according to a Comparative Example.

[0042] FIG. 6 shows a result of a height profile under a measurement condition of a cut-off value of 0.08 with respect to a shell surface of a breast implant according to an embodiment.

[0043] FIG. 7 is a result showing a roughness profile under a measurement condition of a cut-off value of 0.08 with respect to a shell surface of a breast implant according to a Comparative Example.

[0044] FIG. 8 shows a result of a roughness profile under a measurement condition of a cut-off value of 0.08 with respect to a shell surface of a breast implant according to an Example.

[0045] FIG. 9 is a result showing a roughness profile under a measurement condition of a cut-off value of 0.08 with respect to a shell surface of a breast implant according to a Comparative Example.

BEST MODE

[0046] Hereinafter, the present disclosure will be described in detail with reference to Examples below. However, these Examples are provided for illustrative purposes only, and the scope of the present disclosure is not limited thereto.

[0047] Preparation Example 1. Preparation of breast implant according to embodiment

[0048] In the present reparation Example, a breast implant having surface characteristics with a certain level of waviness along with surface roughness was prepared. In detail, after preparing a mandrel housing formed of an aluminum material that is surface-treated by a sandblasting method, a surface of the mandrel was coated with polytetrafluoroethylene (Teflon) to prepare a mandrel having arithmetic mean waviness and arithmetic mean roughness Ra values in a specific range. Afterwards, by repeating a process of dipping the prepared mandrel into a medical solution and drying the same multiple times, a shell of the breast implant was cured, and the cured shell was separated from the mandrel and was turned over again to obtain the shell of the breast implant according to an embodiment. Then, a filler material filled the inside region of the shell to prepare a breast implant according to an embodiment.

Experimental Example 1. Evaluation of Surface Characteristics of Breast Implant According to Embodiment

[0049] In the present Experimental Example, the surface characteristics, specifically, surface roughness and waviness, of the prepared breast implant were evaluated. In detail, as shown in FIG. 3, after measuring a height profile (cross-sectional curve) of the surface of the breast implant, based on the measured height profile distribution, a roughness profile filtered by passing only frequencies exceeding the cut-off frequency, and a waveform profile filtered by passing only frequencies below the cut-off frequency were obtained, respectively. Then, by analyzing the roughness profile and the waveform profile, the surface roughness and waviness of the breast implant were evaluated. Meanwhile, in the present experiment, the surface roughness and waviness were measured according to the ISO 14607:2018 standard by using a 3D laser microscope (Olympus OLS5000), and then calculated according to the ISO 25178-2:2012 standard. The evaluation of the surface characteristics was measured at a cut-off value of 0.08 mm, and a conventional product was used as a comparison group.

1. Evaluation of Waviness

[0050] Based on the height profile data, FIGS. 4 and 5 show results of obtaining waveform profiles with respect to the shell surfaces of the breast implants according to Example 1 and Comparative Example 1. In addition, the results of evaluating the waviness of each of the breast implants according to an Example and a Comparative Example that were measured in the same way as the above, are shown in Table 1 below.

TABLE-US-00001 Division Wa Wz Wsk Wku Example 1 5.358 31.440 0.407 2.719 Example 2 3.074 19.160 0.045 2.768 Example 3 3.789 21.684 -0.141 2.622 Example 4 4.121 24.004 -0.267 2.634 Example 5 4.888 32.638 -0.344 2.803 Example 6 5.993 43.979 1.15 5.272 Example 7 6.386 42.853 -0.481 3.296 Comparative Example 1 1.629 9.856 0.605 2.889 Comparative Example 2 7.598 61.358 0.086 5.193 (unit: .Math.m)

[0051] As a result, as shown in Table 1, it was confirmed that the breast implant according to an embodiment showed a clear difference in the arithmetic mean waviness (Wa) value and the maximum height (Wz) value compared to the breast implant of the comparison group.

[0052] Based on these experimental results, it was found that the surface of the breast implant according to an embodiment had waviness, that is, surface curvature characteristics under the corresponding experimental conditions. That is, in the present experiment, the experiment was conducted on the breast implant having the arithmetic mean waviness (Wa) value in a range of about 3 .Math.m to about 7 .Math.m and the maximum height (Wz) value in a range of about 9 .Math.m to about 61 .Math.m.

2. Evaluation of Surface Roughness

[0053] FIGS. 6 and 7 show results of height profiles under a measurement condition with a cut-off value of 0.08 with respect to the shell surfaces of the breast implants according to Example 1 and a Comparative Example. In addition, based on the height profile data, FIGS. 8 and 9 show results of obtaining roughness profiles with respect to the shell surfaces of the breast implants according to Example 1 and Comparative Examples. In addition, the results of evaluating the roughness of each of the breast implants according to Examples and Comparative Examples, measured in the same way, are shown in Table 2 below.

TABLE-US-00002 Division Ra Rz Rsk Rku Example 1 1.091 6.815 0.181 3.548 Example 2 1.468 9.01 0.037 3.404 Example 3 1.722 10.285 -0.183 3.015 Example 4 1.079 5.845 0.068 2.722 Example 5 1.465 7.607 -0.217 2.914 Example 6 1.045 6.778 0.049 3.854 Example 7 1.671 8.998 0.222 2.978 Comparative Example 1 1.095 6.448 0.146 3.063 Comparative Example 2 1.341 8.249 -0.029 3.423 (unit: .Math.m)

[0054] As a result, as shown in Table 2, the breast implants according to an embodiment and a Comparative Example showed the distribution with the arithmetic mean roughness (Ra) value in a range of about 1.04 .Math.m to about 1.72 .Math.m and the maximum height (Rz) value in a range of about 5.84 .Math.m to about 10.29 .Math.m.

Experimental Example 2. Preparation of Animal Model for Silicone-Filled Implant

[0055] 8-week-old SD rats were anesthetized with a combination of respiratory anesthesia and injection anesthesia before surgery (2 rats per experimental group, 18 rats in total). Before inserting an implant, a surgery site was thoroughly sterilized with betadine, and about a 3 cm incision was made on the back. After the incision, a pocket for implant insertion was formed, and a circular implant with a diameter of 2 cm [Examples 1 to 7 and Comparative Examples 1 and 2] was inserted. After the insertion, the incision site was sutured. After 16 weeks, biopsies were collected and analyzed.

Experimental Example 3. FACS Surface Protein Analysis

[0056] The cells obtained in Experimental Example 1 were collected and washed with PBS. Afterwards, the resultant cells were put into a lysis buffer. While vortexing the buffer solution, a reaction was allowed at 4° C. for 1 hour, followed by centrifugation. Then, the supernatant was quantified with a BCA solution. After subjecting 50 .Math.g of the protein to electrophoresis with 12 % gel and being transferred to a nitrocellulose paper, blocking with 10 % skim milk was performed thereon for 1 hour. Afterwards, cytokines and antibodies to various transcription factors were treated thereon for 1 hour, and then washed with PBS-tween. After treating each with secondary antibodies for 30 minutes, followed by washing, an ECL solution kit was used to detect and obtain data of neoplastic cells, ALK-, and CD30+. The results are shown in Table 3 below.

TABLE-US-00003 Division Neoplastic cells ALK- CD30+ Example 1 - - - Example 2 - - - Example 3 - - - Example 4 - - - Example 5 - - - Example 6 - - - Example 7 - - - Comparative Example 1 - - - Comparative Example 2 + + +

[0057] As a result, as shown in Table 3, it was confirmed that neoplastic cells, ALK-, and CD30+, which are significant ALCL-related factors, were not detected in the breast implants according to Examples 1 to 7. In addition, these experimental results were remarkable compared to the breast implant according to Comparative Example 2.

Experimental Example 4. Gene Expression Analysis Using RT-PCR

[0058] After finely incising the biopsy, an easy-Blue solution was added for homogenization, and chloroform was added to perform centrifugation. 400 .Math.l of the supernatant was mixed with the same amount of ethanol, and the resulting solution was centrifuged and washed with 70 % ethanol. After subjecting to air dry, DEPC water was added thereto, RNA was quantified, and then cDNA was synthesized. Afterwards, each primer and a polymerase were added for amplification. To confirm expression of mRNA, the amplification product was subjected to electrophoresis using an agarose gel. Accordingly, results for the Ahr cell surface proteins were obtained. The results are shown in Table 4 below.

TABLE-US-00004 Division Ahr Example 1 + Example 2 + Example 3 + Example 4 + Example 5 + Example 6 + Example 7 + Comparative Example 1 + Comparative Example 2 +++

[0059] As a result, as shown in Table 4, it was confirmed that the expression of the Ahr cell surface protein, which is an ALCL-related factor, was suppressed by the breast implants according to Examples 1 to 7, resulting in ALCL-negative results, whereas the expression level of Ahr was an ALCL positive level in the breast implant according to Comparative Example 2.

Experimental Example 5. Collagen Density Analysis Using Masson’s Trichrome (MT) Staining

[0060] After MT staining was performed according to the protocols of the manufacturer (Polysciences, Pennsylvania, USA), collagen density was measured. The results are shown in Table 5 below.

TABLE-US-00005 Division Collagen density (%) Example 1 55 Example 2 58 Example 3 57 Example 4 55 Example 5 53 Example 6 54 Example 7 52 Comparative Example 1 67 Comparative Example 2 50

[0061] As a result, as shown in Table 5, it was confirmed that the collagen density in the breast implants according to Examples 1 to 7 was in a range of 52 % to 58%, whereas the collagen density in the breast implant according to Comparative Example 1 was at a level significantly higher than that of Examples.

[0062] The foregoing descriptions are only for illustrating the present disclosure, and it will be apparent to a person having ordinary skill in the art to which the present invention pertains that the embodiments disclosed herein can be easily modified into other specific forms without changing the technical spirit or essential features. Therefore, it should be understood that Examples described herein are illustrative in all respects and are not limited.

EXPLANATION OF REFERENCE NUMERALS

[0063] 100: BREAST IMPLANT [0064] 110: SHELL [0065] 111: WAVINESS [0066] 112: SURFACE ROUGHNESS [0067] 120: FILLER MATERIAL