Gel pad composition with improved ultrasonic signal transmission efficiency and gel pad using the same, and pad for measuring bone density

Abstract

The present invention relates to a gel pad composition with improved ultrasonic signal transmission efficiency, a gel pad using the same, and a pad for measuring bone density. A gel pad composition with improved ultrasonic signal transmission efficiency according to one embodiment of the present invention may comprise an acoustic enhancing additive selected from the group consisting of finely powdered silica, finely powdered alumina, finely powdered magnesium oxide, finely powdered zinc oxide, finely powdered barium sulfate, finely powdered zeolite, finely powdered silicon carbide, and mixtures thereof.

Description

Technology Field

[0001] The present invention relates to a gel pad composition with improved ultrasonic signal transmission efficiency, a gel pad using the same, and a pad for measuring bone density. More specifically, the present invention provides a gel pad composition that achieves an optimal signal transmission effect for a specific frequency band by increasing the transmission and reflection efficiency of ultrasonic signals, and relates to a gel pad and a pad for measuring bone density using the same. Background Technology

[0002] Ultrasound technology has established itself as an essential diagnostic tool in the field of modern medicine. The basic principle of ultrasound technology involves transmitting high-frequency sound waves through the human body and analyzing the reflected signals to create images. The ultrasound waves used in this process propagate at different speeds within human tissues—specifically soft tissues, liquids, and hard materials—and this information allows for the identification of internal structures. Ultrasound technology possesses notable advantages, particularly in terms of safety and non-invasiveness. Since it allows for tissue exploration without the use of radioactive materials, it is widely utilized for fetal examinations in pregnant women and routine health checkups.

[0003] This ultrasound-based bone density measurement technology plays a crucial role in evaluating bone health. Generally, bone density measurement is performed by analyzing the Speed ​​of Sound (SOS) and Broadband Ultrasound Attenuation (BUA) of ultrasound waves passing through the bone. SOS reflects the speed at which ultrasound waves travel through bone, a high-density material, while BUA indicates how much the signal attenuates as it passes through the bone. This measurement method is useful for diagnosing osteoporosis and offers safety to patients by eliminating the risk of radiation exposure since it does not use radiation.

[0004] However, despite the aforementioned advantages of the ultrasound-based bone density measurement technology, conventional ultrasound gels have limitations in that they merely serve to reduce acoustic impedance and lack an effective design to improve signal accuracy. This results in a disadvantage where interference occurs between the reflected signal and soft tissue, making accurate analysis of bone density difficult.

[0005] Therefore, research aimed at improving the efficiency of ultrasound examinations is continuously advancing, and various approaches are being proposed for this purpose. Liquid gels evaporate easily over time, reducing signal transmission efficiency and potentially causing the inconvenience of reapplication during prolonged examinations. Additionally, they tend to run, which can cause discomfort, and pose a risk of infection when used on multiple patients.

[0006] To address these limitations, solid or semi-solid gel pads are being developed. These pads adhere firmly to the skin, maintaining stability even during movement and improving the ultrasound signal transmission environment. In particular, new gel pads containing acoustic boosting additives are attracting attention, as they make a significant contribution to increasing the efficiency of ultrasound signal transmission and reflection. Acoustic boosting additives can maximize signal transmission performance in specific frequency bands, thereby helping to improve the resolution of ultrasound examinations.

[0007] Reducing acoustic impedance differences is also a critical task. If the impedance differences generated when ultrasound passes through different tissues can be minimized, signal consistency can be enhanced and image clarity improved. Therefore, to increase the accuracy of bone density measurement, research on materials capable of precisely controlling acoustic impedance and reflected signal quality is necessary. Prior art literature

[0008] (Patent Document 0001) KR 10-1725311 B1(Patent Document 0002) KR 10-2022-0096510 A The problem to be solved

[0009] The objective of the present invention is to provide a gel pad composition that is non-sticky, eliminates the air layer between the skin interface and the gel pad, and improves accuracy by enhancing ultrasonic signal transmission efficiency.

[0010] The objective of the present invention is to provide a gel pad with improved ultrasonic signal transmission efficiency that can reduce signal interference or distortion between skin and bone tissue.

[0011] The objective of the present invention is to provide a gel pad with improved ultrasonic signal transmission efficiency that offers excellent portability and can prevent skin irritation and the spread of contamination or infectious agents. means of solving the problem

[0012] To achieve the above objective, a gel pad composition with improved ultrasonic signal transmission efficiency according to one embodiment of the present invention comprises an acoustic enhancing additive selected from the group consisting of finely powdered silica, finely powdered alumina, finely powdered magnesium oxide, finely powdered zinc oxide, finely powdered barium sulfate, finely powdered zeolite, finely powdered silicon carbide, and mixtures thereof.

[0013] The gel pad composition with improved ultrasonic signal transmission efficiency may comprise a temperature-sensitive polymer selected from the group consisting of methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, Pluronic, polyphosphazene, poloxamer, Poly(NIPAAM), PEO-PPO-PEO copolymer, PEG-PLGA-PEG copolymer, MPEG-PCL block copolymer, and mixtures thereof.

[0014] The above gel pad composition with improved ultrasonic signal transmission efficiency comprises: purified water; a viscosity modifier selected from the group consisting of 1,2-hexanediol, glycerol, methylpropanediol, propylene glycol, polyacrylamide, and mixtures thereof; and a calcium compound selected from the group consisting of disodium calcium phosphate, calcium carbonate, calcium sulfate, calcium chloride, calcium oxide, calcium acetate, amorphous calcium phosphate, tricalcium phosphate, calcium phosphate complexes, glycerin calcium, and mixtures thereof. A gelling agent selected from the group consisting of alginate, carrageenan, pectin, gelatin, gellan gum, xanthan gum, agar, and mixtures thereof;and Citric Acid, Sodium Carbonate, Glucono Delta Lactone, Sodium Bicarbonate, Sodium Hydroxide, Phosphoric Acid, Potassium Hydroxide, Acetic Acid, Trichloroacetic Acid, Hydrochloric Acid, Ascorbic Acid, Malic Acid, Limewater, Isobutyl Alcohol, Potassium Hydroxide, Sodium Acid Carbonate, Triethylamine, Furic Acid, Phthalic Acid, 2-Propanol, Butanol, It may include a pH adjuster selected from the group consisting of nicotinic acid and mixtures thereof.

[0015] A gel pad composition with improved ultrasonic signal transmission efficiency may further include antibacterial and skin-soothing plant extracts.

[0016] The above finely powdered silica has an average particle size of 8 to 10 μm and a specific surface area of ​​280 to 320 m² 2 It may be a first fine powder silica with a content of / g.

[0017] Preferably, the finely powdered silica has an average particle size of 8 to 10 μm and a specific surface area of ​​280 to 320 m² 2 First fine powder silica having a g / g and an average particle size of 4 to 6 μm, a specific surface area of ​​280 to 320 m² 2 It may be a mixture of second fine powder silica with a content of / g.

[0018] A method for preparing a gel pad composition with improved ultrasonic signal transmission efficiency according to another embodiment of the present invention may comprise: a step of preparing a gel mixture by mixing purified water, a gelling agent, a calcium compound, and a pH adjuster; a step of adding an acoustic enhancing additive selected from the group consisting of silica, alumina, magnesium oxide, zinc oxide, barium sulfate, zeolite, silicon carbide, and mixtures thereof to the gel mixture; a gelation step of inducing gelation while controlling the stirring speed of the mixture after the addition step; a degassing step of degassing air contained in the gel formed after the gelation step; and a stabilization step of stabilizing the gel after the degassing step by leaving it undisturbed.

[0019] A gel pad according to another embodiment of the present invention may comprise a gel pad composition having improved ultrasonic signal transmission efficiency.

[0020] A bone density measuring pad according to another embodiment of the present invention may comprise a gel pad composition having improved ultrasonic signal transmission efficiency.

[0022] The present invention will be described in more detail below.

[0023] A gel pad composition with improved ultrasonic signal transmission efficiency according to one embodiment of the present invention comprises an acoustic enhancing additive selected from the group consisting of finely powdered silica, finely powdered alumina, finely powdered magnesium oxide, finely powdered zinc oxide, finely powdered barium sulfate, finely powdered zeolite, finely powdered silicon carbide, and mixtures thereof.

[0024] The gel pad referred to in the present invention refers to a form having physical properties having a viscosity of a certain degree or higher as gelation, gelation, or solidification proceeds, and includes a form composed of a single layer or a multilayer structure.

[0025] The ultrasound examination referred to in this invention refers to an examination that utilizes ultrasound to penetrate the interior of the human body and then uses the ultrasound signals that return through reflection, refraction, scattering, attenuation, etc., to create an image of the interior of the human body using grayscale, for use in diagnosis and treatment.

[0026] When performing an ultrasound examination, a material is required to eliminate the air gap existing between the ultrasound transducer and the skin interface in order to effectively transmit the generated ultrasound waves to the human body; gels have been frequently used for this purpose.

[0027] Conventional ultrasound examination gels tended to run or their liquid components evaporate when applied to the human body surface, causing inconvenience and the hassle of having to reuse or reapply the gel during examinations. Furthermore, even when the gel was removed using a towel or paper towel after the examination, it caused skin redness, a residual sensation, or stickiness, leading many patients or subjects to experience discomfort after the procedure.

[0028] The gel pad referred to in the present invention is an improved version of the gel and is intended for use in performing ultrasonic inspection. Through the acoustic enhancement additive, it increases the transmission and reflection efficiency of ultrasonic signals. Unlike conventional ultrasonic gels or gel pads, it provides optimal signal transmission performance in a specific frequency band and can significantly improve the quality of the reflected signal by reducing the acoustic impedance difference.

[0029] More specifically, the aforementioned acoustic enhancing additive is in the form of a microparticle and plays a role in improving the reflection and propagation efficiency that occurs when an ultrasonic signal passes through a medium primarily due to differences in acoustic impedance; the transmission efficiency of ultrasound increases as the impedance difference with the medium decreases.

[0030] The aforementioned microparticle silica possesses translucent properties, enabling it to effectively scatter ultrasound. Consequently, as ultrasound propagates in various directions, signal transmission efficiency can be enhanced. Furthermore, microparticle silica with specific physical properties can provide high acoustic impedance while remaining rigid, thereby reducing signal loss and increasing reflection when ultrasound passes through a medium. Therefore, incorporating microparticle silica adjusted to a specific range of properties allows for efficient control of the ultrasound transmission path within the gel pad, increases the intensity of reflected signals, and minimizes signal distortion, ultimately improving ultrasound signal transmission efficiency and enhancing accuracy.

[0031] The gel pad composition with improved ultrasonic signal transmission efficiency may comprise a temperature-sensitive polymer selected from the group consisting of methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, Pluronic, polyphosphazene, poloxamer, Poly(NIPAAM), PEO-PPO-PEO copolymer, PEG-PLGA-PEG copolymer, MPEG-PCL block copolymer, and mixtures thereof.

[0032] To explain by example, a gel pad to which the gel pad composition with improved ultrasound signal transmission efficiency is applied may comprise: a lower layer that contacts the patient's body; an ultrasound-transmitting gel layer laminated on the upper surface of the lower layer; and an upper layer that contacts a probe during the ultrasound examination. Additionally, any one or more of the lower layer, the gel layer, and the upper layer may be to which the gel pad composition with improved ultrasound signal transmission efficiency is applied.

[0033] The upper and lower layers are characterized by the fact that they can change from a gel form to a sol form depending on pressure and temperature. The gel form refers to a state similar to a solid that has lost its fluidity, and the sol form refers to a state similar to a fluid that has fluidity.

[0034] The pressure referred to herein means the pressure applied by the probe used during ultrasound examination, but is not limited thereto. The temperature mentioned above refers to a range of 30°C to 38°C, which includes the normal body temperature range of the human body. When such pressure or temperature is applied, the shape of the upper and lower layers of the gel pad of the present invention changes from a gel form to a sol form, thereby eliminating the air gap between the gel pad and the skin interface during ultrasound examination, which improves the accuracy of the ultrasound examination and makes the examination easier.

[0035] The upper and lower surfaces of the gel pad can change from a gel to a sol form due to the pressure of the probe and the skin temperature of the examiner, thereby eliminating the air gap between the interface of the examiner's skin to which the gel pad is attached, and thus better transmitting ultrasound to the human body, which can improve the accuracy of the ultrasound examination.

[0036] For example, the upper and lower layers of the gel pad may include the temperature-sensitive polymer.

[0037] The above temperature-responsive polymer is a polymer whose properties change according to external temperature, and a reversible sol-gel phase transition or volume phase transition may occur at a specific temperature. When using the above temperature-responsive polymer, a change from a gel form to a sol form in response to pressure and temperature changes in the upper and lower layers is desirable, thereby eliminating the air gap between the skin interface of the ultrasound examiner and the gel pad containing it, which can produce superior ultrasound examination results. The above upper and lower layers may include additional components beyond the above composition if such components can be added at the level of a person skilled in the art, and are not limited to the above composition.

[0038] The gel layer may include the acoustic reinforcement additive.

[0039] Additionally, the gel layer may, for example, include purified water, a viscosity modifier, a calcium compound, a gelling agent, and a pH modifier. It may further include other neutralizing agents, moisturizers, binders, preservatives, etc. Furthermore, the specific composition of the gel layer is not particularly limited and includes all natural or synthetic materials that a person skilled in the art can select and apply.

[0040] Not limited thereto, but to describe viscosity modifiers, calcium compounds, gelling agents, and pH modifiers by example, viscosity modifiers selected from the group consisting of 1,2-hexanediol, glycerol, methylpropanediol, propylene glycol, polyacrylamide, and mixtures thereof; A calcium compound selected from the group consisting of disodium calcium phosphate, calcium carbonate, calcium sulfate, calcium chloride, calcium oxide, calcium acetate, amorphous calcium phosphate, tricalcium phosphate, calcium phosphate complexes, glycerin calcium, and mixtures thereof; a gelling agent selected from the group consisting of alginate, carrageenan, pectin, gelatin, gellan gum, xanthan gum, agar, and mixtures thereof;and Citric Acid, Sodium Carbonate, Glucono Delta Lactone, Sodium Bicarbonate, Sodium Hydroxide, Phosphoric Acid, Potassium Hydroxide, Acetic Acid, Trichloroacetic Acid, Hydrochloric Acid, Ascorbic Acid, Malic Acid, Limewater, Isobutyl Alcohol, Potassium Hydroxide, Sodium Acid Carbonate, Triethylamine, Furic Acid, Phthalic Acid, 2-Propanol, Butanol, It may be a pH adjuster selected from the group consisting of nicotinic acid and mixtures thereof.

[0041] A gel pad composition with improved ultrasonic signal transmission efficiency may further include antibacterial and skin-soothing plant extracts.

[0042] As used in this specification, the term "extract" has the meaning commonly used in the art as a crude extract, as described above, but in a broader sense, it also includes fractions obtained by further fractionating the extract. That is, the extract includes not only those obtained using the extraction solvent described above, but also those obtained by additionally applying a purification process thereto. For example, fractions obtained through various additional purification methods, such as a fraction obtained by passing the extract through an ultrafiltration membrane having a certain molecular weight cut-off value, or separation by various chromatographs (designed for separation based on size, charge, hydrophobicity, or affinity), are also included in the extract of the present invention.

[0043] The above extract is extracted using an extraction solvent selected from the group consisting of water, alcohols having 1 to 10 carbon atoms, and mixtures thereof.

[0044] The method for preparing the above extract may be a conventional extraction method in the art, such as ultrasonic extraction, leaching, and reflux extraction. Specifically, it may be an extract obtained by extracting a natural product from which foreign substances have been removed by washing and drying with water, an alcohol having 1 to 10 carbon atoms, or a mixture of these solvents, and may be an extract obtained by sequentially applying the solvents to a sample.

[0045] The above ultrasonic extraction method is carried out at 30 to 50°C for 0.5 to 2.5 hours, and the extraction solvent is water or 50 to 100% alcohol having 1 to 10 carbon atoms. Specifically, the extraction is carried out at 40 to 50°C for 1 to 2.5 hours, and the extraction solvent is water or 70 to 80% alcohol having 1 to 10 carbon atoms.

[0046] The above leaching method is carried out at 15 to 30°C for 24 to 72 hours, and water or 50 to 100% alcohol having 1 to 10 carbon atoms is used as the extraction solvent. More specifically, it is carried out at 20 to 25°C for 30 to 54 hours, and the extraction solvent is water or 70 to 80% alcohol having 1 to 10 carbon atoms.

[0047] The above reflux extraction method is based on 100 mL of water, 10 to 30 g of crushed natural product, a reflux time of 1 to 3 hours, and 50 to 100% of alcohol or water having 1 to 10 carbon atoms. More specifically, based on 100 mL of alcohol or water having 1 to 10 carbon atoms, 10 to 20 g of crushed natural product, a reflux time of 1 to 2 hours, and 70 to 90% of alcohol or water having 1 to 10 carbon atoms.

[0048] The above extraction solvent may be used in an amount of 2 to 50 times the weight of the sample, more specifically 2 to 20 times. For extraction, the sample may be left in the extraction solvent for leaching for 1 to 72 hours, more specifically 24 to 48 hours.

[0049] After extraction, the extract can be fractionated by sequentially applying a new fractionation solvent. The fractionation solvent used for fractionation is one or more selected from the group consisting of water, hexane, butanol, ethylacetic acid, ethyl acetate, methylene chloride, and mixtures thereof, and preferably ethyl acetate or methylene chloride.

[0050] After obtaining the extract or fraction, additional methods such as concentration or freeze-drying may be used.

[0051] In the case of ultrasound examinations, examination gel is typically used; however, its use can cause skin redness. Furthermore, even if the probe—the ultrasound device—is cleaned before use, it is used by multiple patients, raising the possibility of cross-contamination by harmful bacteria. Additionally, even when provided in the form of a gel pad, there is a problem that patients with sensitive skin or weakened immune systems may experience contamination or skin irritation from the gel pad. Therefore, by including plant extracts for antibacterial and skin soothing purposes, it is possible to prevent contamination of the gel pad and effectively suppress skin irritation or the spread of infectious agents.

[0052] The above plant extract may be included in a gel pad composition with enhanced ultrasonic signal transmission efficiency to produce a gel pad formulation, or may be included in one or more of the upper layer, lower layer, and gel layer. Additionally, the above plant extract may be applied to the gel pad formulation.

[0053] The above plant extracts may include Acorus calamus L. extract, Sowthistle-leaved hawksbeard extract, and Ligularia fischeri extract. According to the above range, excellent antibacterial and skin moisturizing effects can be achieved within a range of low cytotoxicity, and excellent skin soothing effects can be achieved.

[0054] Preferably, the plant extract comprises sweet flag extract, and may comprise 10 to 30 parts by weight of *Godeulppaegi* extract and 40 to 80 parts by weight of *Gomchwi* extract per 100 parts by weight of sweet flag extract. According to the above range, excellent effects can be produced due to synergistic activity resulting from the interaction of active ingredients contained in each extract.

[0055] More preferably, the plant extract comprises sweet flag extract, and may comprise 10 to 30 parts by weight of *Godeulppaegi* extract, 40 to 80 parts by weight of *Gomchwi* extract, 1 to 10 parts by weight of *Syneilesis aconitifolia* extract, 20 to 40 parts by weight of *Ursuri thistle* extract, and 1 to 10 parts by weight of *Gnaphalium japonicum* extract, based on 100 parts by weight of the sweet flag extract. According to the above range, secondary synergistic effects can be produced through synergistic activity due to interactions and synergistic mechanisms based on different mechanisms. Therefore, it is possible to achieve skin moisturizing and skin soothing effects while exhibiting antibacterial activity at a low content, and it can be easily applied to various patient groups without issues of side effects such as cytotoxicity.

[0056] Therefore, when the above composition is applied to a gel pad, it can exhibit antibacterial, skin soothing, and moisturizing effects, and can prevent skin rashes and redness that may occur depending on the patient while performing ultrasound examinations. In addition, although ultrasound probes inevitably come into contact with the skin of many people, the problem of cross-infection caused by harmful bacteria can be prevented through antibacterial activity.

[0057] The extract used in the present invention can be prepared in a powder state by additional processes such as vacuum distillation, freeze-drying, or spray-drying.

[0058] In this specification, the term "containing as an active ingredient" means containing an amount sufficient to achieve the efficacy or activity of the following natural extracts.

[0059] In the terms used in this specification, when a part is described as "comprising" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0060] The above finely powdered silica has an average particle size of 8 to 10 μm and a specific surface area of ​​280 to 320 m² 2 It may be a first fine powder silica with a content of / g.

[0061] Preferably, the finely powdered silica has an average particle size of 8 to 10 μm and a specific surface area of ​​280 to 320 m² 2 First fine powder silica having a g / g and an average particle size of 4 to 6 μm, a specific surface area of ​​280 to 320 m² 2 It may be a mixture of second fine powder silica with a content of / g.

[0062] The mixture of the first fine powder silica and the second fine powder silica can each influence the transmission and scattering of ultrasonic signals through their unique physical properties, thereby improving the ultrasonic signal transmission efficiency.

[0063] The first fine powder silica and the second fine powder silica may be mixed in a weight ratio of 1:3 to 1:1.

[0064] The mixture of the first finely powdered silica and the second finely powdered silica contains particles of different sizes, which allows the acoustic energy to be evenly distributed by scattering the ultrasonic signal at various paths and angles as it passes through the medium. The first finely powdered silica effectively controls the scattering of low-frequency components of the ultrasound through particles with relatively large diameters, while the second finely powdered silica can induce fine scattering of high-frequency components through particles with relatively small diameters. Such multi-frequency scattering enables the ultrasonic signal to achieve optimal propagation in a specific frequency band.

[0065] In addition, the first fine powder silica and the second fine powder silica must be controlled to have the same specific surface area of ​​280 to 320 m² / g. By providing a large contact area within this range, the interaction with the medium is maximized, and at the same time, the absorption and reflection of ultrasonic signals are effectively controlled to minimize signal transmission loss. Furthermore, by increasing the bonding between silica particles so that they are evenly dispersed within the medium, the gel pad can have uniform signal transmission characteristics.

[0066] Meanwhile, if the particle size and specific surface area of ​​the first fine powder silica and the second fine powder silica fall outside the specified range, there is a problem in that the aforementioned effect is reduced. For example, if the particle size exceeds that of the first fine powder silica, it may block the signal path and cause signal loss; if it is smaller than that of the second fine powder silica, it may fail to induce sufficient scattering, resulting in a failure to obtain the desired acoustic effect. Furthermore, if the particles are mixed with a different particle size range from the first and second fine powder silica, a problem may arise in which the scattering effect decreases in a specific frequency band. Additionally, if the specific surface area falls outside the specified range, problems may occur in which the particles are not uniformly dispersed within the medium or effective signal absorption and reflection do not occur.

[0067] For example, the finely powdered silica may be included in the gel pad composition in an amount of 0.01 to 10 weight percent. Additionally, the finely powdered silica may be included in the lower layer, gel layer, and upper layer in an amount of 0.01 to 10 weight percent relative to the total amount of the composition of each layer. The above-mentioned range may be selected by a person skilled in the art by adjusting an appropriate range and is not particularly limited; however, if it is within the above range, effective scattering as an acoustic enhancer and effective dispersion of fine particles can be achieved.

[0068] A method for preparing a gel pad composition with improved ultrasonic signal transmission efficiency according to another embodiment of the present invention may comprise: a step of preparing a gel mixture by mixing purified water, a gelling agent, a calcium compound, and a pH adjuster; a step of adding an acoustic enhancing additive selected from the group consisting of silica, alumina, magnesium oxide, zinc oxide, barium sulfate, zeolite, silicon carbide, and mixtures thereof to the gel mixture; a gelation step of inducing gelation while controlling the stirring speed of the mixture after the addition step; a degassing step of degassing air contained in the gel formed after the gelation step; and a stabilization step of stabilizing the gel after the degassing step by leaving it undisturbed.

[0069] In addition to the gel that has undergone the above stabilization step being used as a gel pad, a gel pad can be manufactured by using the gel as a gel layer and laminating a temperature-sensitive polymer on the lower and upper parts of the gel layer.

[0070] A gel pad according to another embodiment of the present invention may comprise a gel pad composition having improved ultrasonic signal transmission efficiency.

[0071] A bone density measuring pad according to another embodiment of the present invention may comprise a gel pad composition having improved ultrasonic signal transmission efficiency. Effects of the invention

[0072] The present invention provides a gel pad composition that is non-sticky, eliminates the air layer between the skin interface and the gel pad, and improves accuracy by enhancing ultrasonic signal transmission efficiency.

[0073] The present invention provides a gel pad with improved ultrasonic signal transmission efficiency that can reduce signal interference or distortion between skin and bone tissue.

[0074] The present invention provides a gel pad with improved ultrasonic signal transmission efficiency that offers excellent portability and can prevent skin irritation and the spread of contamination or infectious agents. Specific details for implementing the invention

[0075] Hereinafter, embodiments of the present invention are described in detail so that those skilled in the art can easily implement the invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein.

[0077] [Manufacturing Example: Manufacture of Gel Pad]

[0078] 1. Manufacture of gel pads for ultrasound examination

[0079] 15 to 25 parts by weight of 1,2-hexanediol were added to 100 parts by weight of purified water in a mixer and stirred to completely dissolve it. Next, 7 to 15 parts by weight of disaccharide phosphate were mixed, and then 3 to 10 parts by weight of a mixture of alginic acid and xanthan phosphate were added to induce gelation. A pH adjuster was added to adjust the pH to a range of 6.9 to 7.2. Afterward, a vacuum was applied to degas the bubbles, and then the mixture was left to stand for 5 hours to perform a stabilization step.

[0080] Subsequently, a mixture was prepared by dispersing and dissolving 70 parts by weight of a temperature-sensitive polymer in 100 parts by weight of purified water at a temperature of 70 to 80°C, and then cooling to 40°C to prepare an upper layer and a lower layer, and then laminating the gel layer between the upper layer and the lower layer to prepare a gel pad (PDO).

[0082] 2. Manufacture of acoustic reinforcement additives

[0083] To verify the effect of the acoustic reinforcement additive, finely powdered silica with different physical properties was mixed with the composition shown in Table 1 below, and the finely powdered silica was mixed into the gel layer at 1 w% to prepare gel pads PD 1 to PD 12.

[0084] PD1 PD2 PD3 PD4 PD5 PD6 PD7 PD8 PD9 PD10 PD11 PD12 S1 100 - - - - - - 100 100 - - - S2 - 100 - - - - - 100 - 100 - - S3 - - 100 - - - - - 100 - 100 - S4 - - - 100 - - - - - 100 100 - S5 - - - - 100 - - - - - - 100 S6 - - - - - 100 - - - - - 100 S7 - - - - - - 100 - - - - -

[0085] (Unit: parts by weight)

[0086] S1: Average particle size: 8 to 10 μm, specific surface area: 280 to 320 m² 2 / g

[0087] S2: Average particle size: 4 to 6 μm, specific surface area: 280 to 320 m² 2 / g

[0088] S3: Average particle size: 2 to 3 μm, specific surface area: 280 to 320 m² 2 / g

[0089] S4: Average particle size: 11 to 13 μm, specific surface area: 280 to 320 m² 2 / g

[0090] S5: Average particle size: 8 to 10 μm, specific surface area: 220 to 260 m² 2 / g

[0091] S6: Average particle size: 4 to 6 μm, specific surface area: 250 to 270 m² 2 / g

[0092] S7: Average particle size: 4 to 6 μm, Specific surface area: 530 to 660 m² 2 / g

[0094] 3. Preparation of plant extracts

[0095] (1) Preparation of individual extracts

[0096] Sweet flag was dried and ground, washed, dried, and chopped, extracted with hot water according to the hot water extraction method, and filtered and concentrated to prepare sweet flag extract (AD1). Meanwhile, Godeulppaegi extract (AD2), Gomchwi extract (AD3), Aegisanae extract (AD4), Cirsium extract (AD5), and Pulsatilla extract (AD6) were prepared by the same hot water extraction method.

[0098] (2) Preparation of mixed extract

[0099] In order to confirm the synergistic activity according to the mixed composition of the above extracts, a mixed extract was prepared containing each extract according to the composition in Table 1 below.

[0100] M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 AD1 100 100 100 100 100 100 100 100 100 100 AD2 5 10 20 30 50 20 20 20 20 20 AD3 20 40 60 80 100 60 60 60 60 60 AD4 - - - - - 0.5 1 5 10 20 AD5 - - - - - 10 20 30 40 50 AD6 - - - - - 0.5 1 5 10 20

[0101] (Unit: parts by weight)

[0103] [Experimental Example: Evaluation of Physical Properties]

[0104] 1. Evaluation of acoustic reinforcement additives

[0105] Ultrasound imaging was performed on an ultrasound diagnostic device (GE LOGIQ E9), a 3MHz ultrasound probe, and a self-fabricated 3D-printed artificial bone model using PD0 to PD10 probes fabricated to a thickness of 1mm. After repeating the imaging three times under the same ultrasound settings, image analysis software (ImageJ TM Bone density values ​​were measured using ). Subsequently, the resolution and contrast of the bone density images were evaluated by comparing them with the bone density design values ​​of the 3D model. The results of PDO were fixed at an index of 1, and evaluated as an index according to a 3-point scale. In the above index, a higher number indicates better accuracy; X indicates an effect lower than PD0, and XX indicates an image error that prevents it from being used as a pad, as shown in Table 3 below.

[0107] PD0 PD1 PD2 PD3 PD4 PD5 PD6 PD7 PD8 PD9 PD10 PD11 PD12 Quality of ultrasound imaging 1 2 1 1 X 1 1 XX 3 1 1 X 1

[0108] Referring to Table 3 above, only PD2 and PD8 showed improved image quality when containing silica microparticles compared to cases without them, and in the case of PD8, a noticeable synergistic effect was observed. On the other hand, in the case of PD4 and PD11, the image quality actually deteriorated, and in the case of PD7, there was a problem where the functionality as an ultrasound gel pad was significantly reduced due to the ineffective dispersion of silica particles. Furthermore, in the case of other embodiments, no visibly prominent effect compared to PD0 was observed.

[0110] 2. Evaluation of the activity of plant extracts

[0111] Maple leaf extract (U), which was previously confirmed to have antibacterial, skin moisturizing, and skin soothing effects when applied to a gel pad through other experiments, was used as a positive control (PC), purified water was used as a negative control (NC), and the activities of M1 to M10 were evaluated.

[0113] (1) Cytotoxicity evaluation

[0114] Cell viability according to human epithelial cell extracts was confirmed using MTT analysis. Specifically, HaCaT cells, a skin keratinocyte cell line, were seeded into a 12-well plate at a concentration of 1 × 10⁶ cells / well and cultured for 24 hours, after which they were washed with PBS. Then, negative controls, positive controls, and each sample diluted to various concentrations (0, 20, 40, 60, 80, 100, 120 μg / mL) were added to each well, followed by 24 and 48 hours of incubation. After 24 and 48 hours of incubation, 40 μl of 0.5% MTT solution was added to each well, and the plates were incubated in a 5% CO₂, 37°C incubator for 1 hour. After removing the culture medium, 150 μl of DMSO was added to each well and the plate was shaken for 10 minutes, after which the absorbance was measured at 590 nm using an ELISA plate reader. As a result, it was confirmed that there were no issues with cell proliferation at all concentrations, just like with the purified water used as a negative control.

[0116] (2) Evaluation of moisturizing activity

[0117] To evaluate the skin moisturizing effect of each extract, the skin moisture content of the stratum corneum was measured by measuring the electrical capacitance of the stratum corneum. Thirty healthy subjects were selected, and experimental groups containing 3% (v / v) of PC, NC, and M1 to M10 were applied to the forearm from the elbow to the wrist. The skin electrical capacitance of the subjects was measured after 2, 4, and 6 hours. (moisture checker MY-808S (Scalar, Tokyo)) The measurement results were evaluated as moisture content (%). For objective comparison, the results of the negative control group (NC) were fixed at index 1, and each result was evaluated using an index from 1 to 10, which is shown in Table 4 below. The higher the number of the index, the better the moisturizing activity.

[0118] (3) Evaluation of antimicrobial activity

[0119] Antimicrobial activity was evaluated using a disc diffusion assay against Staphylococcus epidermidis, Staphylococcus aureus, and Pseudomonas aeruginosa. The agar plates used for the antimicrobial test were subcultured

[0120] 100 μl of each strain culture solution was dispensed and prepared by streaking using a sterile cotton swab. Each sample was slowly absorbed onto a paper disc, dried, and then the solvent evaporated. The disc was then placed in close contact with a culture medium and incubated at 37°C for 24 hours. Subsequently, the inhibition zone (clear zone, mm) formed around the disc was measured to compare antimicrobial activity. Purified water was used as the negative control (NC). To objectively evaluate the antimicrobial activity of each composition, the NC result was fixed at 1. The antimicrobial activities against each microorganism of AW and M1 to M12 were combined and evaluated using an index of 1 to 10, which is shown in Table 4 below. A higher number indicates superior antimicrobial activity.

[0122] (4) Evaluation of skin soothing activity

[0123] To evaluate skin-soothing efficacy, the inhibitory effect on the expression of the inflammatory cytokine (IL-1α) in human keratinocyte cells (HaCaT cells) was analyzed. Specifically, HaCaT cells were placed in a 24-well plate at a rate of 2 x 10 5 The cells were inoculated with DMEM medium containing 10 w% FBS at a concentration of cells / well and cultured for 24 hours in a 37°C, 5% CO2 incubator. After removing the medium from the plate, it was washed once with PBS (phosphate buffered saline) and replaced with serum-free DMEM medium without FBS. Then, PC, NC, and M1 to M10 were each treated at 100 ppm and cultured for 24 hours, followed by treatment with SDS (sodium dodecyl sulfate) and culture for an additional 4 hours. After 4 hours, a portion of the culture medium was taken for IL-1α quantification and protein quantification. IL-1α quantification was performed using Endogen’s human IL-1α kit according to the kit’s IL-1α quantification method, and protein quantification was performed using Sigma’s BCA method. The quantified IL-1α was corrected for protein content to measure the IL-1α secretion amount per unit protein, and finally, the IL-1α production rate (%) was evaluated. For objective comparison, the results of the negative control group (NC) were fixed at index 1, and each result was evaluated using an index from 1 to 10, which is shown in Table 4 below. The higher the number of the index, the better the skin soothing activity.

[0124] NC PC M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 Moisturizing Activity 1 5 3 7 7 6 5 7 10 10 10 7 Antibacterial Activity 1 5 3 7 7 7 5 7 9 10 9 6 Skin Soothing Activity 1 5 2 6 7 6 4 6 9 9 9 6

[0125] (Unit: INDEX)

[0126] Referring to Table 4 above, it can be seen that moisturizing, antibacterial, and skin-soothing activities are observed in M1 to M10. In particular, it can be seen that M2 to M4 show superior effects compared to the positive control group (PC). This can be understood as moisturizing, antibacterial, and skin-soothing activities being enhanced through synergistic effects resulting from interactions within the above mixing ranges.

[0127] In particular, it can be confirmed that additional synergistic effects are derived in the case of M7 to M9. This is significantly more effective than the positive control group (PC) in which synergistic activity has already been confirmed, and it can be confirmed that additional synergistic activity appears when compared to M3. It is presumed that additional synergistic effects on moisturizing activity, antibacterial activity, and skin soothing activity are derived through different mechanisms of the active ingredients mixed within the above mixing range.

[0128] Therefore, according to the above range, high effects regarding moisturizing activity, antibacterial activity, and skin soothing activity can be achieved with a relatively low content, and it can be easily applied to gel pads. In particular, since patients with sensitive skin or those suffering from other specific diseases such as low immunity have high sensitivity, it is important to achieve high moisturizing, antibacterial, and skin soothing effects with a low content in gel pads; therefore, according to the above composition, it can be used universally without the need to distinguish the characteristics of the patient.

[0130] Although preferred embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and various modifications and improvements made by a person skilled in the art using the basic concept of the present invention as defined in the following claims are also included within the scope of the present invention.

Claims

Claim 1 A gel pad composition with improved ultrasonic signal transmission efficiency comprising an acoustic reinforcing additive selected from the group consisting of finely powdered silica, finely powdered alumina, finely powdered magnesium oxide, finely powdered zinc oxide, finely powdered barium sulfate, finely powdered zeolite, finely powdered silicon carbide, and mixtures thereof. Claim 2 A gel pad composition with improved ultrasonic signal transmission efficiency according to claim 1, comprising a temperature-sensitive polymer selected from the group consisting of methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, Pluronic, polyphosphazene, poloxamer, Poly(NIPAAM), PEO-PPO-PEO copolymer, PEG-PLGA-PEG copolymer, MPEG-PCL block copolymer, and mixtures thereof. Claim 3 In claim 1, purified water; a viscosity modifier selected from the group consisting of 1,2-hexanediol, glycerol, methylpropanediol, propylene glycol, polyacrylamide, and mixtures thereof; and calcium selected from the group consisting of disodium calcium phosphate, calcium carbonate, calcium sulfate, calcium chloride, calcium oxide, calcium acetate, amorphous calcium phosphate, tricalcium phosphate, calcium phosphate complexes, glycerin calcium, and mixtures thereof. Compound; gelling agent selected from the group consisting of alginate, carrageenan, pectin, gelatin, gellan gum, xanthan gum, agar, and mixtures thereof;and Citric Acid, Sodium Carbonate, Glucono Delta Lactone, Sodium Bicarbonate, Sodium Hydroxide, Phosphoric Acid, Potassium Hydroxide, Acetic Acid, Trichloroacetic Acid, Hydrochloric Acid, Ascorbic Acid, Malic Acid, Limewater, Isobutyl Alcohol, Potassium Hydroxide, Sodium Acid Carbonate, Triethylamine, Furic Acid, Phthalic Acid, 2-Propanol, Butanol, A gel pad composition with improved ultrasonic signal transmission efficiency comprising a pH regulator selected from the group consisting of nicotinic acid and mixtures thereof. Claim 4 A gel pad composition with improved ultrasonic signal transmission efficiency, wherein, in claim 1, it further comprises plant extracts for antibacterial and skin soothing purposes. Claim 5 In claim 1, the fine powder silica has an average particle size of 8 to 10 μm and a specific surface area of ​​280 to 320 m² 2 A gel pad composition with improved ultrasonic signal transmission efficiency, wherein the first fine powder silica is in g. Claim 6 A method for manufacturing a gel pad composition with improved ultrasonic signal transmission efficiency, comprising: a step of preparing a gel mixture by mixing purified water, a gelling agent, a calcium compound, and a pH adjuster; a step of adding an acoustic enhancing additive selected from the group consisting of silica, alumina, magnesium oxide, zinc oxide, barium sulfate, zeolite, silicon carbide, and mixtures thereof to the gel mixture; a gelation step of inducing gelation while controlling the stirring speed of the mixture after the addition step; a degassing step of degassing air contained in the gel formed after the gelation step; and a stabilization step of stabilizing the gel after the degassing step by leaving it to stand. Claim 7 A gel pad comprising a gel pad composition according to any one of claims 1 to 5. Claim 8 A pad for measuring bone density comprising a gel pad composition according to any one of claims 1 to 5.

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