Tissue expander having non-metallic injection port and method for using same

Abstract

Provided are a tissue expander and a method for using same, the tissue expander comprising: an elastic shell; an injection port provided on the surface thereof; and a sealing member provided on the surface of the elastic shell, surrounding the injection port, wherein the sealing member comprises a scattering agent.

Description

Tissue expander having an inlet made of non-metallic material and method of using the same

[0001] The present invention relates to a tissue expander having an injection port made of a non-metallic material, so that there are no limitations in imaging such as CT or MRI, and the injection port can be confirmed with the naked eye, thereby maximizing convenience of the procedure when injecting a filler into the tissue expander.

[0002] A tissue expander is a medical device used in tissue expansion surgery to reconstruct a body defect. It is a type of temporary implant inserted subcutaneously to induce tissue expansion. In particular, breast tissue expanders are used in breast reconstruction surgery to reconstruct breast tissue after mastectomy for breast cancer.

[0003] Typically, a breast tissue expander is inserted beneath the pectoralis major muscle after a mastectomy. Saline solution is regularly injected into the expander until the breasts reach the desired volume. The desired size is achieved in approximately 8 to 10 weeks. Once the expander has reached 1.5 times the desired size, the expander is removed and replaced with a permanent implant.

[0004] However, when injecting saline solution into a tissue expander, the saline solution is injected through an injection port formed in the tissue expander. However, since the tissue expander is inserted into the body, the injection port is difficult to find. To solve this problem, the most commonly used method is to form the injection port using a metal material, and then use a magnet to find the injection port and inject the saline solution.

[0005] However, since precise examinations such as MRI or CT are not possible while a metal tissue expander is inserted, it becomes difficult to diagnose and treat side effects caused by the tissue expander. In particular, since most users of breast reconstruction using a tissue expander are patients undergoing breast cancer treatment and tests such as diagnosis of residual cancer cells after cancer surgery are essential, the use of a tissue expander containing a metal material may cause inconvenience.

[0006] As a way to replace this, tissue expanders that minimize materials containing magnetism or metals are being studied and have actually been released, but tissue expanders that use only non-metallic materials are still non-existent.

[0007] Therefore, there is a need for the development of a tissue expander that can easily find the location of the injection port without putting a strain on skin tissue, including an injection port formed of a non-metallic material, and thus facilitates the injection of saline solution.

[0008] The present invention is intended to solve the problems revealed in the above-mentioned prior art, and one of the several objects of the present invention is to provide a tissue expander having an injection port including a non-metallic material so that no problem occurs during imaging device shooting, and the location of the injection port can be identified with the naked eye, thereby ensuring convenience of treatment.

[0009] According to one aspect, a tissue expander is provided, comprising: an elastic shell; an injection port formed on a surface of the elastic shell; and a sealing member formed on the surface of the elastic shell and surrounding the injection port, wherein the sealing member includes a scattering agent.

[0010] In one embodiment, the scattering agent may be at least one selected from the group consisting of polyacrylamide beads, polyethylene beads, polypropylene beads, and polyurethane beads.

[0011] In one embodiment, the particle diameter of the scattering agent may be 10 nm to 1 mm.

[0012] In one embodiment, the scattering agent concentration of the sealing member may be 0.05 to 10 wt%.

[0013] In one embodiment, the injection port may contain a pigment.

[0014] In one embodiment, the pigment concentration of the injection port may be 0.05 to 10 wt%.

[0015] In one embodiment, the difference in brightness between the injection port and the elastic shell may be 50 or more.

[0016] In one embodiment, the inlet may further include one or more selected from the group consisting of silicone, polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polylactic acid (PLA), polycaprolactone (PCL), polymethyl methacrylate (PMMA), and polycarbonate (PC).

[0017] In one embodiment, the elastic shell may comprise at least one selected from the group consisting of silicone and polyurethane.

[0018] In one embodiment, the injection port may include an injection dome and a needle guard.

[0019] In one embodiment, the tissue expander may have at least one cross-sectional shape of a circle, an oval, or a teardrop.

[0020] In one embodiment, the surface of the elastic shell may have an arithmetic mean roughness (Ra) value of 0.01 to 100 μm.

[0021] According to another aspect, a method of using a tissue expander including an elastic shell, an injection port formed on the surface of the elastic shell, and a sealing member formed on the surface of the elastic shell and surrounding the injection port, the method comprising: a step of mounting the tissue expander in a user's body; and a step of irradiating visible light to the tissue expander mounted in the body; wherein the sealing member includes a scattering agent.

[0022] In one embodiment, the method may further include a step of injecting a filler into the elastic shell after the visible light irradiation.

[0023] A tissue expander according to one aspect of the present invention has an injection port containing a non-metallic material, so that no separate problem occurs when taking an image with an imaging device such as a CT or MRI, no problem occurs when performing metal detection, etc., and the location of the injection port can be identified with the naked eye due to the difference in brightness between the injection port and the elastic shell, so that the convenience of the procedure is high.

[0024] It should be understood that the effects of one aspect of the present invention are not limited to the effects described above, but include all effects that can be inferred from the detailed description of the invention or the composition described in the claims of this specification.

[0025] Figure 1 is an exploded perspective view showing each part of the tissue expander of the present invention in an unjoined form.

[0026] Figure 2 is a perspective view showing the combined form of the tissue expander of the present invention.

[0027] Figure 3 is a side view of the shape before and after the injection tool is inserted into the tissue expander of the present invention.

[0028] Fig. 4 is a photograph of a sealing member according to an embodiment of the present invention.

[0029] FIG. 5 is a photograph taken after implanting a tissue expander according to an embodiment of the present invention subcutaneously into a pig and shining visible light having a wavelength of 600 nm on it.

[0030] [Explanation of symbols]

[0031] 1: Elastic shell

[0032] 2: Inlet

[0033] 21: Injection dome

[0034] 22: Needle Guard

[0035] 3: Suture tab

[0036] 4: Sealing member

[0037] Below, aspects of this specification will be described with reference to the attached drawings. However, the contents of this specification may be implemented in various different forms and are therefore not limited to the embodiments described herein.

[0038] Throughout the specification, whenever a part is said to "include" a component, this does not mean that it excludes other components, but rather that it may include other components, unless otherwise stated.

[0039] When a range of numerical values ​​is stated herein, unless the specific range is otherwise specified, the values ​​have the precision of the significant figures provided according to the standard rules in chemistry for significant figures. For example, the number 10 includes the range of 5.0 to 14.9, and the number 10.0 includes the range of 9.50 to 10.49.

[0040] Tissue expander

[0041] According to one aspect of the present disclosure, a tissue expander is provided comprising an elastic shell and an injection port formed on a surface of the elastic shell.

[0042] A tissue expander is a medical device used in breast reconstruction after surgery such as breast cancer. It is inserted into the subcutaneous tissue to create a space for the implant before the insertion of a permanent implant. By regularly injecting liquid to expand it, it can expand to about 1.5 times the size desired by the user over a period of about 8 to 10 weeks, creating a space.

[0043] Conventional tissue expanders are composed of a shell made of a material such as silicone and a separately designed injection port for injecting filler into the shell. The injection port is made of a magnetic metal material so that its location can be easily identified.

[0044] However, when using a magnetic metal, light scattering occurs when taking a 2D image (X-RAY, CT) or the back of the injection port is not captured.

[0045] And, since MRI cannot be performed with magnetic materials installed inside the body when MRI is required for more precise diagnosis and follow-up observation, tissue expanders using metal materials have these various problems.

[0046] Therefore, in order to solve the problems of these existing tissue expanders, if an opaque non-metallic material is used for the injection port and the sealing member in a tissue expander including an injection port and a sealing member made of a non-metallic material to create a color difference from the elastic shell, the above problems can be solved while making it possible to easily identify the injection port simply by irradiating it with visible light, thereby ensuring convenience of treatment.

[0047] Fig. 1 is an exploded perspective view of a tissue expander according to one embodiment of the present invention. The tissue expander of the present invention includes an elastic shell (1), an injection port (2) formed on the surface of the elastic shell, and a sealing member (4) formed on the surface of the elastic shell and surrounding the injection port. Here, the injection port (2) is provided for injecting a filler, and may be made of a soft material so that an injection tool for injecting the filler can pass through, but is not limited thereto.

[0048] The above injection port (2) is formed on the surface of the elastic shell (1) and forms a structure surrounded by a sealing member (4) covering a wide area. The structure is as illustrated in Fig. 2, and may be in a form in which the sealing member (4) surrounds the entire injection port, but is not limited thereto.

[0049] The above tissue expander may include an injection dome (21) formed with a large area to increase the convenience of the worker using the injection tool, and a needle guard (22) may be combined with the injection dome (21) to prevent the injection tool from being bent or broken when inserted into the elastic shell, but is not limited thereto.

[0050] The above sealing member (4) is intended to prevent leakage of the filling material that may occur at the injection port (2) during the procedure, and at the same time, secures the safety of the injection port (2) in case the procedure is not performed at the area where the needle guard (22) exists, and can perform the function of quickly sealing the tissue expander by utilizing a material that can easily fill the micro-holes that may occur after the procedure.

[0051] The above sealing member (4) includes a scattering agent that scatters light. The scattering agent functions to create a color difference between the injection port and the elastic shell by making the sealing member (4) surrounding the injection port (2) over a large area appear opaque and cloudy overall.

[0052] The particle diameter of the above scattering agent may be 10 nm to 1 mm, preferably 10 nm to 100 μm, but is not limited thereto. For example, the particle diameter of the scattering agent is 10 nm, 15 nm, 20 nm, 25 nm, 30 nm, 35 nm, 40 nm, 45 nm, 50 nm, 55 nm, 60 nm, 65 nm, 70 nm, 75 nm, 80 nm, 85 nm, 90 nm, 95 nm, 100 nm, 110 nm, 120 nm, 130 nm, 140 nm, 150 nm, 160 nm, 170 nm, 180 nm, 190 nm, 200 nm, 210 nm, 220 nm, 230 nm, 240 nm, 250 nm, 260 nm, 270 nm, 280 nm, 290 nm, 300 nm, 310 nm, 320 nm, 330nm, 340nm, 350nm, 360nm, 370nm, 380nm, 390nm, 400nm, 410nm, 420nm, 430nm, 440nm, 450nm, 460nm, 470nm, 480nm, 490nm, 500nm, 510nm, 520nm, 530nm, 540nm, 550nm, 560nm, 570nm, 580nm, 590nm, 600nm, 610nm, 620nm, 630nm, 640nm, 650nm, 660nm, 670nm, 680nm, 690nm, 700nm, 710nm, 720nm, 730nm, 740nm, 750nm, 760nm, 770nm, 780nm, 790nm, 800nm, 810nm, 820nm, 830nm, 840nm, 850nm, 860nm, 870nm, 880nm, 890nm, 900nm, 910nm, 920nm, 930nm, 940nm, 950nm, 960nm, 970nm, 980nm, 990nm, 1㎛, 2㎛, 3㎛, ​​4㎛, 5㎛, 6㎛, 7㎛, 8㎛¸ 9㎛, 10㎛, 11㎛, 12㎛, 13㎛, 14㎛, 15㎛, 16㎛, 17㎛, 18㎛, 19㎛, 20㎛, 21㎛, 22㎛, 23㎛, 24㎛, 25㎛, 26㎛, 27㎛, 28㎛, 29㎛, 30㎛, 31㎛, 32㎛, 33㎛, 34㎛, 35㎛, 36㎛,37㎛, 38㎛, 39㎛, 40㎛, 41㎛, 42㎛¸ 43㎛¸ 44㎛, 45㎛, 46㎛, 47㎛, 48㎛, 49㎛, 50㎛, 51㎛, 52㎛, 53㎛, 54㎛, 55㎛, 56㎛, 57㎛, 58㎛, 59㎛¸ 60㎛, 61㎛, 62㎛, 63㎛, 64㎛, 65㎛, 66㎛, 67㎛, 68㎛, 69㎛, 70㎛, 71㎛, 72㎛, 73㎛, 74㎛, 75㎛, 76㎛¸ 77㎛, 78㎛, 79㎛, 80㎛, 81㎛, 82㎛, 83㎛, 84㎛, 85㎛, 86㎛, 87㎛, 88㎛, 89㎛, 90㎛¸ 91㎛, 92㎛, 93㎛, 94㎛, 95㎛, 96㎛, 97㎛, 98㎛, 99㎛, 100㎛, 150㎛, 200㎛, 250㎛, 300㎛, 350㎛, 400㎛, 450㎛, 500㎛, 550㎛, 600㎛, 650㎛, 700㎛, 750㎛, 800㎛, 850㎛, 900㎛, 950㎛, 1mm or a value between two of these values. When the particle diameter of the scattering agent is within the above range, the scattering effect is maximized, so that it can be easier to identify the injection port (2) when irradiated with visible light.

[0053] The above scattering agent may be at least one selected from the group consisting of polyacrylamide beads, polyethylene beads, polypropylene beads, and polyurethane beads, but is not limited thereto. When the scattering agent is made of the polymer beads, the sealing member (4) including the scattering agent can more accurately specify the location of the injection port (2), thereby further improving the convenience of the procedure.

[0054] The scattering agent concentration of the above sealing member (4) may be 0.05 to 10 wt%, preferably 0.1 to 7 wt%, and most preferably 0.5 to 5 wt%, but is not limited thereto. For example, the scattering agent concentration of the sealing member (4) may be 0.05 wt%, 0.06 wt%, 0.07 wt%, 0.08 wt%, 0.09 wt%, 0.1 wt%, 0.2 wt%, 0.3 wt%, 0.4 wt%, 0.5 wt%, 0.6 wt%, 0.7 wt%, 0.8 wt%, 0.9 wt%, 1 wt%, 1.5 wt%, 2 wt%, 2.5 wt%, 3 wt%, 3.5 wt%, 4 wt%, 4.5 wt%, 5 wt%, 5.5 wt%, 6 wt%, 6.5 wt%, 7 wt%, 7.5 wt%, 8 wt%, 8.5 wt%, 9 wt%, 9.5 wt%, 10 wt%, or a value between any two of these values. If the scattering agent concentration of the sealing member (4) is below the above range, the light scattering effect may be very small, making it difficult to identify the location of the injection port (2). If it exceeds the above range, the light may be blocked instead of scattered due to the inclusion of an excessive amount of scattering agent, thereby relatively reducing the difference in brightness and darkness, and thus making it difficult to distinguish between the injection port (2) and the elastic shell (1).

[0055] The above sealing member (4) may contain, but is not limited to, gel-type silicone inside. Gel-type silicone has high elasticity and can perform the function of filling holes at a high speed.

[0056] In Fig. 1, when the injection port (2) and the elastic shell (1) are combined and finally combined with the suture tab (3) to seal them, the final combined state of the tissue expander shown in Fig. 2 appears. As described above, the tissue expander completed in the state of Fig. 2 has the advantage of being able to visually identify the injection port, thereby ensuring convenience of the procedure.

[0057] In addition, the difference in brightness between the injection port (2) and the elastic shell (1) may be 25 or more, and more preferably 50 or more. Here, brightness refers to the concept of color brightness and is expressed as brightness. Brightness is generally expressed as values ​​of Red, Green, Blue (RGB) (0~255, 0~255, 0~255) corresponding to the three primary colors of light.

[0058] In this patent, the brightness is calculated using only the Red value among RGB, and the measured value is set to 0 for black and 255 for red, and the difference is defined as the brightness at the corresponding point, and the difference is defined as the brightness difference. If the brightness difference between the injection port (2) and the elastic shell (1) is less than the above range, it may be difficult to identify the injection port (2) because there is no contrast with the naked eye even when visible light is shone on it, and thus, the procedure to inject the filler into the tissue expander may become impossible.

[0059] The above injection port (2) may contain a pigment. As a result, the injection port (2) may appear opaque and may have a property that can be distinguished with the naked eye from the surrounding elastic shell (1) portion when illuminated with light in the visible light range. Accordingly, unlike the prior art, there is an advantage in that the injection port (2) can be easily identified and an injection tool can be inserted without a separate magnetic material.

[0060] The pigment concentration of the above injection port (2) may be 0.05 to 10 wt%, preferably 0.1 to 7 wt%, and most preferably 0.5 to 5 wt%, but is not limited thereto. For example, the pigment concentration of the injection port (2) may be 0.05 wt%, 0.06 wt%, 0.07 wt%, 0.08 wt%, 0.09 wt%, 0.1 wt%, 0.2 wt%, 0.3 wt%, 0.4 wt%, 0.5 wt%, 0.6 wt%, 0.7 wt%, 0.8 wt%, 0.9 wt%, 1 wt%, 1.5 wt%, 2 wt%, 2.5 wt%, 3 wt%, 3.5 wt%, 4 wt%, 4.5 wt%, 5 wt%, 5.5 wt%, 6 wt%, 6.5 wt%, 7 wt%, 7.5 wt%, 8 wt%, 8.5 wt%, 9 wt%, 9.5 wt%, 10 wt%, or a value between two of these values. If the pigment concentration of the injection port (2) is below the above range, light may be transmitted, making it difficult to distinguish between the injection port (2) and the elastic shell (1). If it exceeds the above range, the mechanical properties of the injection port (2) may deteriorate, and accordingly, after the filler is injected into the tissue expander, problems such as the filler leaking out of the tissue expander due to the microscopic holes present in the injection port (2) not being filled may occur.

[0061] The above injection port (2) may further include at least one selected from the group consisting of silicone, polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polylactic acid (PLA), polycaprolactone (PCL), polymethyl methacrylate (PMMA), and polycarbonate (PC). In particular, when the injection port (2) is made of silicone, it may have the same or similar physical properties as the elastic shell (1), thereby having similar mechanical properties.

[0062] The elastic modulus of the above injection port (2) may be 0.9 MPa or more. For example, the elastic modulus of the injection port may be, but is not limited to, 0.9 MPa, 1 MPa, 1.1 MPa, 1.2 MPa, 1.3 MPa, 1.4 MPa, 1.5 MPa, or a value between any two of these values. If the elastic modulus of the injection port is less than the above range, after the needle is injected and filled with the filler, a problem may occur in which a microscopic hole created after the needle is withdrawn is not sealed due to the elasticity of the material and is maintained, or the area of ​​the hole increases, causing the filler to leak out of the tissue expander.

[0063] The above elastic shell (1) may include at least one selected from the group consisting of silicone and polyurethane, but is not limited thereto. If the above elastic shell (1) includes silicone or polyurethane, the mechanical properties of the elastic shell (1) are excellent, resulting in excellent rupture resistance, and thus preventing problems such as leakage of the filler.

[0064] The thickness of the elastic shell (1) may be 200 to 1000 μm. For example, the thickness of the elastic shell (1) may be 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, 650 μm, 700 μm, 750 μm, 800 μm, 850 μm, 900 μm, 950 μm, 1000 μm, or a value between any two of these values. If the thickness of the elastic shell (1) is less than the above range, the mechanical properties of the elastic shell deteriorate, increasing the risk of it being ruptured even by a small force. On the other hand, if the thickness exceeds the above range, the elastic shell may become excessively thick, causing discomfort to the user, such as an increased foreign body sensation in the affected area.

[0065] The above-mentioned filler may be at least one selected from the group consisting of purified water and saline solution, and is preferably saline solution, but is not limited thereto. When saline solution is used as the above-mentioned filler, the osmotic pressure balance with the tissues in the human body is satisfied, so that the shape of the tissue expander can be stably maintained without separate expansion or contraction. The above-mentioned filler may be filled inside the elastic shell (1), and when the tissue expander is first installed in the user's body, a syringe-shaped needle may be inserted into the injection port (2) and then a set amount may be injected.

[0066] The tissue expander may have at least one cross-sectional shape among circular, oval, and teardrop, but is not limited thereto. Since the shape and form of each user's breasts are generally formed differently, it is desirable to select the type of tissue expander based on the user's natural shape and desired shape, shape, size, etc.

[0067] The surface of the above elastic shell may have an arithmetic mean roughness (Ra) value of 0.01 to 100 μm, preferably 0.1 to 80 μm, and most preferably 0.5 to 50 μm, but is not limited thereto. Here, "arithmetic mean roughness (Ra)" means the average height from the reference plane to the cross-sectional curve. In addition, the arithmetic mean roughness value (Ra) may be defined according to the KS B 0161 standard. For example, the surface of the elastic shell has an arithmetic mean roughness value (Ra) of 0.01 ㎛, 0.05 ㎛, 0.1 ㎛, 0.2 ㎛, 0.3 ㎛, 0.4 ㎛, 0.5 ㎛, 0.6 ㎛, 0.7 ㎛, 0.8 ㎛, 0.9 ㎛, 1 ㎛, 2 ㎛, 3 ㎛, 4 ㎛, 5 ㎛, 6 ㎛, 7 ㎛, 8 ㎛, 9 ㎛, 10 ㎛, 11 ㎛, 12 ㎛, 13 ㎛, 14 ㎛, 15 ㎛, 16 ㎛, 17 ㎛, 18 ㎛, 19 ㎛, 20 ㎛, 21 ㎛, 22 ㎛, 23 ㎛, 24 ㎛, 25 ㎛, 26 ㎛, 27 ㎛, 28 ㎛, 29 ㎛, 30 ㎛, 31 ㎛, 32 ㎛, 33㎛, 34㎛, 35㎛, 36㎛, 37㎛, 38㎛, 39㎛, 40㎛, 41㎛, 42㎛¸ 43㎛¸ 44㎛, 45㎛, 46㎛, 47㎛, 48㎛, 49㎛, 50㎛, 51㎛, 52㎛, 53㎛, 54㎛, 55㎛, 56㎛, 57㎛, 58㎛, 59㎛¸ 60㎛, 61㎛, 62㎛, 63㎛, 64㎛, 65㎛, 66㎛, 67㎛, 68㎛, 69㎛, 70㎛, 71㎛, 72㎛, 73㎛, 74㎛, 75㎛, 76㎛¸ 77㎛, 78㎛, 79㎛, 80㎛, 81㎛, 82㎛, 83㎛, 84㎛, 85㎛, 86㎛, 87㎛, 88㎛, 89㎛, 90㎛¸ 91㎛, 92㎛, 93㎛, 94㎛, 95㎛, 96㎛, 97㎛, 98㎛, 99㎛, 100㎛ or a value between two of these values. When the arithmetic mean roughness value (Ra) of the surface of the elastic shell satisfies the above range, the fixation force of the tissue expander in the body can be improved.

[0068] How to use a tissue expander

[0069] Below, the method of using the tissue expander will be described in detail. However, the description of parts within the same scope as the tissue expander will be omitted.

[0070] According to another aspect of the present disclosure, a method of using a tissue expander including an elastic shell (1), an injection port (2) formed on the surface of the elastic shell, and a sealing member (4) formed on the surface of the elastic shell and surrounding the injection port, the method of using a tissue expander including the steps of: mounting the tissue expander on a user's body; and irradiating visible light to the tissue expander mounted on the body.

[0071] The wavelength of the visible light can range from 400 to 700 nm. Illuminating the injection port and sealing member with ultraviolet or infrared light outside the visible light range can make it difficult to visually identify the injection port and sealing member, making it difficult to use the injection tool.

[0072] After the above visible light irradiation step, a step of injecting a filler into the elastic shell (1) can be performed. Referring to Fig. 3, as shown in (a), before the injection, the tissue expander has a flat shape, but as shown in (b), it can be seen that the volume of the tissue expander increases after the injection.

[0073] Hereinafter, the embodiments of this specification will be described in more detail. However, the experimental results below represent only representative experimental results among the above embodiments, and the scope and content of this specification cannot be interpreted as being reduced or limited by the embodiments, etc. The effects of each of the various implementation examples of this specification that are not explicitly presented below will be specifically described in the relevant sections.

[0074] Examples and Comparative Examples

[0075] A tissue expander having an elastic shell and an injection port made of silicone having the same physical properties was prepared. Then, polyacrylamide beads having the concentrations shown in Table 1 below were injected into a sealing member containing gel-type silicone inside, and these were mounted around the injection port. In the case of Comparative Example 1, a sealing member containing only gel-type silicone without a scattering agent was mounted around the injection port. Figures 4 (a) to (e) are photographs of the sealing members according to Examples 1, 2, 3, 4, and Comparative Example 1, respectively.

[0076] Example 1 Example 2 Example 3 Example 4 Scatter agent concentration (wt%) 0.05 2.55 10.5

[0077] Experimental Example 1: Evaluation of the brightness difference of the inlet of the tissue expander

[0078] Tissue expanders according to Examples 1 to 4 and Comparative Example 1 were implanted into the porcine of a pig, and after being illuminated with visible light having a wavelength of 600 nm, photographs were taken and shown in Fig. 5. The difference in brightness between the injection port and its surroundings was measured and the results are shown in Table 2 below. Fig. 5 (a) to (e) are photographs of tissue expanders according to Examples 1 to 4 and Comparative Example 1, respectively.

[0079] Example 1 Example 2 Example 3 Example 4 Comparative Example 1 Inlet Distinction OOO△X Brightness Difference 30648440

[0080] Referring to Table 2 and FIG. 5, it can be seen that Examples 1 to 3, including the sealing member of the present invention, exhibited a scattering effect of the scattering agent, and accordingly, the brightness around the injection port appeared relatively brighter, so that the location of the injection port could be easily identified with the naked eye. On the other hand, Example 4 exhibited a relatively small difference in brightness because the sealing member included an excessively high concentration of scattering agent, and thus, although it was possible to identify the location of the injection port, a high level of caution was required. In contrast, Comparative Example 1 did not include a scattering agent in the sealing member, making it impossible to identify the location of the injection port.

[0081] The description of this specification above is for illustrative purposes only, and those skilled in the art will readily appreciate that aspects of this specification can be readily modified into other specific forms without altering the technical concepts or essential features described herein. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0082] The scope of this specification is indicated by the claims set forth below, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included within the scope of this specification.

Claims

1. Elastic shell; an injection hole formed on the surface of the elastic shell; and A tissue expander comprising a sealing member formed on the elastic shell surface and surrounding the injection port; The above sealing member is a tissue expander comprising a scattering agent.

2. In paragraph 1, A tissue expander, wherein the above scattering agent is at least one selected from the group consisting of polyacrylamide beads, polyethylene beads, polypropylene beads, and polyurethane beads.

3. In paragraph 1, A tissue expander having a particle diameter of 10 nm to 100 μm of the above scattering agent.

4. In paragraph 1, A tissue expander having a scattering agent concentration of the above sealing member of 0.05 to 10 wt%.

5. In paragraph 1, The above injection port is a tissue expander containing a pigment.

6. In paragraph 5, A tissue expander having a pigment concentration of 0.05 to 10 wt% in the above injection port.

7. In paragraph 1, A tissue expander having a brightness difference of 50 or more between the injection port and the elastic shell.

8. In paragraph 1, A tissue expander, wherein the inlet further comprises at least one selected from the group consisting of silicone, polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polylactic acid (PLA), polycaprolactone (PCL), polymethyl methacrylate (PMMA), and polycarbonate (PC).

9. In paragraph 1, A tissue expander, wherein the elastic shell comprises at least one selected from the group consisting of silicone and polyurethane.

10. In paragraph 1, A tissue expander, wherein the above injection port comprises an injection port dome and a needle guard.

11. In paragraph 1, A tissue expander having at least one cross-sectional shape among circular, oval, and teardrop.

12. In paragraph 1, The surface of the above elastic shell is a tissue expander having an arithmetic mean roughness (Ra) value of 0.01 to 100 μm.

13. A method of using a tissue expander comprising an elastic shell, an injection port formed on the surface of the elastic shell, and a sealing member formed on the surface of the elastic shell and surrounding the injection port, The step of attaching the tissue expander to the user's body; and A step of irradiating visible light to a tissue expander mounted in the body; A method of using a tissue expander, wherein the sealing member comprises a scattering agent.

14. In paragraph 13, A method of using a tissue expander, wherein the above scattering agent is at least one selected from the group consisting of polyacrylamide beads, polyethylene beads, polypropylene beads, and polyurethane beads.

15. In paragraph 13, A method of using a tissue expander, wherein the particle diameter of the above scattering agent is 10 nm to 1 mm.

16. In paragraph 13, A method of using a tissue expander, wherein the concentration of the scattering agent in the above sealing member is 0.05 to 10 wt%.

17. In paragraph 13, A method of using a tissue expander, further comprising the step of injecting a filler into the elastic shell after the above visible light irradiation.

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