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WO2025216345A1 - Appareil et procédé de production d'hydrogel de pva pour couplage acoustique ultrasonore - Google Patents

Appareil et procédé de production d'hydrogel de pva pour couplage acoustique ultrasonore

Info

Publication number
WO2025216345A1
WO2025216345A1 PCT/KR2024/004977 KR2024004977W WO2025216345A1 WO 2025216345 A1 WO2025216345 A1 WO 2025216345A1 KR 2024004977 W KR2024004977 W KR 2024004977W WO 2025216345 A1 WO2025216345 A1 WO 2025216345A1
Authority
WO
WIPO (PCT)
Prior art keywords
pva
pva hydrogel
solvent
mold
hydrogel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/KR2024/004977
Other languages
English (en)
Korean (ko)
Inventor
강창호
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Trustra Co Ltd
Original Assignee
Trustra Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Trustra Co Ltd filed Critical Trustra Co Ltd
Priority to PCT/KR2024/004977 priority Critical patent/WO2025216345A1/fr
Publication of WO2025216345A1 publication Critical patent/WO2025216345A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/22—Component parts, details or accessories; Auxiliary operations
    • B29C39/26—Moulds or cores
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
    • C08J3/075—Macromolecular gels
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/09—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in organic liquids
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L29/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers
    • C08L29/02—Homopolymers or copolymers of unsaturated alcohols
    • C08L29/04—Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2029/00—Use of polyvinylalcohols, polyvinylethers, polyvinylaldehydes, polyvinylketones or polyvinylketals or derivatives thereof as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped

Definitions

  • the present invention relates to a device and method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling, and more particularly, to a device and method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling that can manufacture a semi-solid state PVA hydrogel for ultrasonic acoustic coupling so that ultrasonic waves generated from an ultrasonic generator are not scattered and are easily transmitted to living tissue.
  • Ultrasound refers to sound waves with a frequency range above the audible range of humans, and is currently used in various medical diagnoses.
  • the focused ultrasound waves used are generated by an ultrasound generator, and when the ultrasound generator is used on the human body, a space may be created between the device and the human skin, and as a result, the ultrasound waves cannot penetrate the space, so a bag filled with degassed water (degassed water) or a method of immersing the human body in degassed water is used to fill the space.
  • degassed water degassed water
  • a method of immersing the human body in degassed water is used to fill the space.
  • the purpose of the present invention is to provide a device and method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling, which can manufacture a PVA hydrogel for ultrasonic acoustic coupling with various degrees of ultrasonic transmission and transparency by subjecting an environmentally friendly and human-safe polyvinyl alcohol (PVA)-based PVA solution to a curing process and a neutralization process at various temperatures.
  • PVA polyvinyl alcohol
  • a device for producing a PVA hydrogel for ultrasonic acoustic coupling comprises: a solvent generator for producing at least one of a first mixed solvent of water and dimethyl sulfoxide (DMSO) and a second mixed solvent of water and polyethylene glycol (PEG); a stirrer into which a solvent discharged from the solvent generator is introduced, and polyvinyl alcohol (PVA) is introduced through an introduction path different from an introduction path of the solvent, and then the solvent and polyvinyl alcohol are stirred to produce a PVA solution; a deaerator for receiving the PVA solution from the stirrer and removing internal air of the PVA solution; a mold into which the PVA solution discharged from the deaerator is injected into an internal space; And when the mold is inserted, the mold undergoes a hardening process so that PVA hydrogel is formed in the internal space of the mold; and the PVA hydrogel can be neutralized through a neutralization
  • DMSO dimethyl sulfoxide
  • PEG
  • the method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling performed by the above-described device for manufacturing a PVA hydrogel for ultrasonic acoustic coupling comprises the steps of: a) a step in which a solvent generator manufactures at least one of a first mixed solvent of water and dimethyl sulfoxide and a second mixed solvent of water and polyethylene glycol; b) a step in which a stirrer stirs a solvent input from the solvent generator and polyvinyl alcohol input through an input path different from an input path of the solvent to generate a PVA solution; c) a step in which a deaerator receives the PVA solution from the stirrer and removes internal air of the PVA solution; d) a step in which the PVA solution discharged from the deaerator is injected into an internal space of a mold; e) a step in which, when the mold is input into a chamber, the chamber causes the mold to undergo a curing process so that
  • the present invention has the effect of providing a user with an apparatus and method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling, which can manufacture a semi-solid state PVA hydrogel for ultrasonic acoustic coupling so that ultrasonic waves generated from an ultrasonic generator are not scattered and are easily transmitted to living tissues, replacing conventional degassed water that causes inconvenience in generation time and handling.
  • the present invention has the effect of providing a user with a device and method for manufacturing a PVA hydrogel for ultrasonic acoustic coupling, which can manufacture a PVA hydrogel for ultrasonic acoustic coupling with various degrees of ultrasonic transmission and transparency by subjecting an environmentally friendly and human-safe polyvinyl alcohol-based PVA solution to a curing process and a neutralization process at various temperatures.
  • FIG. 1 is a drawing showing components of a PVA hydrogel manufacturing device according to one embodiment of the present invention.
  • FIG 2 is a drawing showing the types of solvents and components of the solvents that can be produced from the solvent generator illustrated in Figure 1.
  • FIG. 3 is a drawing showing the process of producing a first PVA solution based on the first mixed solvent illustrated in FIG. 2.
  • FIG. 4 is a drawing showing the process of producing a second PVA solution based on the second mixed solvent illustrated in FIG. 2.
  • Fig. 5 is a drawing showing an example of the mold shown in Fig. 1.
  • Figure 6 is a drawing showing the types of components and operating modes of the chamber illustrated in Figure 1.
  • Figure 7 is a drawing showing the neutralization process of PVA hydrogel molded from the mold shown in Figure 5.
  • Figure 8 is a diagram showing the state of use of PVA hydrogel molded from the mold shown in Figure 5.
  • FIG. 9 is a drawing showing a PVA hydrogel manufacturing method performed by a PVA hydrogel manufacturing device according to one embodiment of the present invention.
  • Figure 10 is a drawing showing a detailed process of a solvent preparation step for producing a first mixed solvent.
  • Figure 11 is a drawing showing a detailed process of a solvent preparation step for producing a second mixed solvent.
  • Figure 12 is a drawing showing the detailed process of the PVA solution production step illustrated in Figure 9.
  • Figure 13 is a drawing showing the detailed process of the hardening step illustrated in Figure 9.
  • Figure 14 is a drawing showing the detailed process of the neutralization step illustrated in Figure 9.
  • first and second are intended to distinguish one component from another, and the scope of the rights should not be limited by these terms.
  • a first component could be referred to as a second component, and similarly, a second component could also be referred to as a first component.
  • a component When a component is referred to as being “connected” to another component, it should be understood that it may be directly connected to that other component, but there may also be other components in between. Conversely, when a component is referred to as being “directly connected” to another component, it should be understood that there are no other components in between. Meanwhile, other expressions describing the relationship between components, such as “between” and “immediately between” or “adjacent to” and “directly adjacent to”, should be interpreted similarly.
  • FIG. 1 is a drawing showing components of a PVA hydrogel manufacturing device according to one embodiment of the present invention.
  • a PVA hydrogel manufacturing device (1, hereinafter referred to as 'PVA hydrogel manufacturing device (1)') for ultrasonic acoustic coupling includes a solvent manufacturing device (10), a stirrer (20), a defoamer (30), a mold (40), and a chamber (50) to manufacture a semi-solid PVA hydrogel (43).
  • the solvent generator (10) manufactures a solvent to be fed into the stirrer (20) by a method such as heat treatment, and the type of solvent to be manufactured in the solvent generator (10) is as shown in FIG. 2.
  • FIG 2 is a drawing showing the types of solvents and components of the solvents that can be produced from the solvent generator illustrated in Figure 1.
  • the solvents that can be manufactured from the solvent generator (10) may be a first mixed solvent (11) and a second mixed solvent (12).
  • the solvent generator (10) can produce at least one solvent among the first mixed solvent (11) and the second mixed solvent (12), and it is preferable that the solvent mentioned below be understood as at least one among the first mixed solvent (11) and the second mixed solvent (12).
  • the first mixed solvent (11) can be produced from the solvent production device (10) when water (11a), dimethyl sulfoxide (DMSO, hereinafter referred to as '11b') and a preservative (11c) are introduced into the solvent production device (10).
  • DMSO dimethyl sulfoxide
  • '11b' dimethyl sulfoxide
  • 11c preservative
  • the water (11a) may be purified water (or ultrapure water) from which all impurities, such as dissolved ions, solid particles, microorganisms, organic matter, and dissolved gases contained in the water, have been removed.
  • dimethyl sulfoxide (11b) is a colorless liquid and an industrial solvent that has been proposed as an effective analgesic and anti-inflammatory agent for arthritis and bursitis, as well as a penetrating solvent that enhances the absorption of therapeutic agents into the skin.
  • the preservative (11c) may be at least one of hexanediol, parabens, phenoxyethanol, imidazolidinyl urea, sorbic acid, and salicylic acid to prevent shrinkage and decay of the PVA hydrogel (43).
  • the preservative (11c) may be prepared as hexanediol, which is an effective preservative that is both biologically safe and good for the skin.
  • the weight ratio of the first mixed solvent (11) may be 40 to 60 wt% of water (11a), 40 to 60 wt% of dimethyl sulfoxide (11b), and the remainder may be a preservative (11c) based on 100 wt%.
  • the second mixed solvent (12) can be produced from the solvent production device (10) when water (12a), polyethylene glycol (PEG, hereinafter referred to as '12b') and a preservative (12c) are introduced into the solvent production device (10).
  • PEG polyethylene glycol
  • the water (12a) may be purified water identical to the water (11a) used to prepare the first mixed solvent (11).
  • polyethylene glycol (12b) is produced by polycondensation of ethylene glycol and is an amphiphilic polymer that is soluble in organic solvents and water.
  • the preservative (12c) may be at least one of hexanediol, parabens, phenoxyethanol, imidazolidinyl urea, sorbic acid, and salicylic acid, similar to the preservative (11c) for preparing the first mixed solvent (11).
  • the weight ratio of the second mixed solvent (12) may be 70 to 95 wt% of water (12a), 5 to 30 wt% of polyethylene glycol (12b), and the remainder may be a preservative (12c) based on 100 wt%.
  • the stirrer (20) generates a PVA solution by stirring the solvent discharged from the solvent generator (10) and polyvinyl alcohol (PVA, hereinafter referred to as '21').
  • PVA polyvinyl alcohol
  • FIG. 3 is a drawing showing a process for producing a first PVA solution based on the first mixed solvent shown in FIG. 2
  • FIG. 4 is a drawing showing a process for producing a second PVA solution based on the second mixed solvent shown in FIG. 2.
  • the stirrer (20) can input polyvinyl alcohol (21) through an input path different from the input path of the first mixed solvent (11), and then stir the first mixed solvent (11) and polyvinyl alcohol (21) to produce a first PVA solution (22).
  • the stirrer (20) can input polyvinyl alcohol (21) through an input path different from the input path of the second mixed solvent (12), and then stir the second mixed solvent (12) and polyvinyl alcohol (21) to produce a second PVA solution (23).
  • the stirrer (20) can add 5 to 10 wt% of polyvinyl alcohol (21) based on the total weight of the solvent input from the solvent generator (10), and then stir the solvent and polyvinyl alcohol (21) for 90 minutes or more at a temperature between 90° C. and 130° C. to produce a first PVA solution (22) or a second PVA solution (23).
  • the stirrer (20) can produce at least one PVA solution among the first PVA solution (22) and the second PVA solution (23), and it is preferable that the PVA solution mentioned below be understood as at least one among the first PVA solution (22) and the second PVA solution (23).
  • an antifoaming agent (24) is introduced to remove air bubbles (or foam) generated in the PVA solution during the stirring process of the first mixed solvent (11) or the second mixed solvent (12) and polyvinyl alcohol (21).
  • the stirrer (20) prevents the generation of bubbles in the PVA hydrogel (43) by removing bubbles in the PVA solution through the defoaming agent (24), and at the same time improves the subsequent molding process of the PVA hydrogel (43) by destroying bubbles generated in the PVA solution.
  • the stirrer (20) does not necessarily add the antifoaming agent (24) when 100 L or more of the first mixed solvent (11) or the second mixed solvent (12) is added. If the addition is determined based on the amount of bubbles generated in the PVA solution, the antifoaming agent (24) may be added to the PVA solution.
  • whether or not to add a foaming agent (24) to the stirrer (20) can be determined based on the amount of bubbles confirmed through a process in which a user visually checks bubbles generated in the PVA solution from the upper side of the stirrer (20) or through a process in which the PVA solution is photographed using a photographing means (e.g., a video camera, etc.) installed in the stirrer (20).
  • a photographing means e.g., a video camera, etc.
  • the defoaming agent (24) may be at least one of a silicone defoaming agent, a mineral oil defoaming agent, and a polymer defoaming agent.
  • the deaerator (30) removes internal air of the PVA solution discharged from the agitator (20) when the PVA solution is injected into the internal space.
  • the PVA solution may be stabilized by adding a stabilizer selected from the group consisting of urea, thiourea, creatinine, cyanuric acid, alkyl hydantoin, mono- or di-ethanolamine, organic sulfonamide, biuret, sulfamic acid, organic sulfamate, and melamine before being discharged from the stirrer (20) and then introduced into the internal space of the deaerator (30).
  • a stabilizer selected from the group consisting of urea, thiourea, creatinine, cyanuric acid, alkyl hydantoin, mono- or di-ethanolamine, organic sulfonamide, biuret, sulfamic acid, organic sulfamate, and melamine
  • the stabilization time of the PVA solution may be at least 10 minutes or more, and the PVA solution may be maintained at a temperature between 90° C. and 130° C. during the stabilization process.
  • the deaerator (30) may be a vacuum deaerator for removing internal air from the PVA solution.
  • the deaerator (30) is not limited to the vacuum deaerator described above, and may be replaced with another device capable of removing internal air from the PVA solution.
  • the mold (40) is injected with a PVA solution, from which internal air is removed and discharged from a defoamer (30), into its internal space.
  • the structure of the mold (40) for injecting the PVA solution into the internal space is as shown in Fig. 5.
  • Figure 5 is a drawing showing an example of the mold shown in Figure 1.
  • the mold (40) is formed (or converted) into a PVA hydrogel (43) when the PVA solution injected into the internal space undergoes a curing process within the chamber (50).
  • a plurality of mold bodies each having an internal space into which the PVA solution is injected, may be formed into a stack structure in which they are stacked.
  • the mold (40) may be formed in a stack structure in which a first mold body (41) is placed at the bottom layer and a second mold body (42) is stacked on top of the first mold body (41).
  • the mold (40) is described as having the first and second mold bodies (41, 42) stacked for convenience in explaining the stack structure, but is not limited thereto.
  • the mold (40) is provided with a first mold body (41) of the lowest layer forming a stack structure, a second mold body (42) excluding the mold body of the highest layer, and a PVA solution flow unit for receiving PVA solution from the upper mold body and injecting the PVA solution into the lower mold body in the form of an opening on the upper and lower sides of the remaining mold bodies, thereby allowing the PVA solution to be injected into the internal space of each mold body (41, 42) through a single PVA solution injection process.
  • the mold (40) may be provided with an air removal unit having a structure that is connected to the internal space of each mold body (41, 42), although not shown in the drawing.
  • the air removal unit of the mold (40) removes air within the internal space of each mold body (41, 42) before the PVA solution is injected into the internal space of each mold body (41, 42), thereby making the internal space of each mold body (41, 42) into a vacuum state.
  • This configuration is to prevent bubbles from being generated in the PVA solution due to air remaining in the internal space of each mold body (41, 42) when the PVA solution is injected into the internal space of each mold body (41, 42), and to prevent a dead space from being generated in the internal space of each mold body (41, 42) where the PVA solution is not injected into the internal space of each mold body (41, 42) due to air.
  • the mold (40) may be connected to a bubble removal unit for removing residual bubbles of the PVA solution injected into the internal space of each mold body (41, 42) when the internal space of each mold body (41, 42) is made vacuum by an air removal unit, although not shown in the drawing.
  • the bubble removal unit may be equipped with a vacuum pump for treating the PVA solution in a low vacuum state (e.g., 1/1000 mmHg), and when the vacuum pump is in communication with the internal space of each mold body (41, 42), the PVA solution injected into the internal space of each mold body (41, 42) is treated in a low vacuum state so that bubbles in the PVA solution injected into the internal space of each mold body (41, 42) are removed.
  • a vacuum pump for treating the PVA solution in a low vacuum state (e.g., 1/1000 mmHg)
  • the mold (40) is introduced into the internal space of the chamber (50) for molding the PVA hydrogel (43) when the bubbles in the PVA solution injected into the internal space of each mold body (41, 42) are removed by the bubble removal unit.
  • the mold (40) may be provided with a discharge means in each mold body (41, 42) for discharging the PVA hydrogel (43) that has been molded by the chamber (50) to the outside.
  • the chamber (50) be provided with a means for introducing the mold (40) into the internal space so that the mold (40) can be introduced into the internal space.
  • the chamber (50) performs a curing process depending on the type of solvent forming the PVA solution so that a semi-solid PVA hydrogel (43) is formed in the internal space of each mold body (41, 42).
  • the components for forming the PVA hydrogel (43) are as shown in FIG. 6.
  • Figure 6 is a drawing showing the types of components and operating modes of the chamber illustrated in Figure 1.
  • the chamber (50) includes an input unit (51) capable of inputting a signal, operates in a curing mode (52) according to a signal input from the input unit (51), and includes a temperature control unit (53) for controlling the temperature of the internal space of the chamber (50) into which a mold (40) is inserted so that a curing process according to the curing mode (52) is implemented, and a control unit (54) for controlling the operation of the temperature control unit (53).
  • the chamber (50) may be configured to omit the simulation process of the control unit (54) via the input unit (51). That is, the simulation process of the control unit (54) may not necessarily be performed.
  • the curing mode (52) can be divided into a freezing curing mode (52a), a low-temperature curing mode (52b), and a room-temperature curing mode (52c) to produce PVA hydrogels (43) having different degrees of ultrasonic permeability and transparency, respectively.
  • the low-temperature curing mode (52b) may be an operation mode of the chamber (50) to cause the mold (40) inserted into the internal space of the chamber (50) to undergo a low-temperature curing process of 1 to 5° C.
  • the chamber (50) is configured to mold PVA hydrogels (43) having different degrees of ultrasonic penetration and transparency in the mold (40) inserted into the internal space according to the curing mode (52) set by the control unit (54).
  • a PVA hydrogel (43) in a transparent or opaque state e.g., white
  • a transparent or opaque state e.g., white
  • the PVA hydrogel (43) will be described by dividing it into a first PVA hydrogel (43a) formed from a first PVA solution (22) and a second PVA hydrogel (43b) formed from a second PVA solution (23). It is preferable that the PVA hydrogel (43) mentioned below be understood as at least one of the first PVA hydrogel (43a) and the second PVA hydrogel (43b).
  • the chamber (50) of the freeze-curing mode (52a) is configured such that when the first PVA solution (22) is injected into the internal space of the mold (40), a transparent first PVA hydrogel (43a) is formed that reduces the ultrasonic transmission degree in the mold (40) to less than 0.1%, and on the other hand, when the second PVA solution (23) is injected into the internal space of the mold (40), an opaque second PVA hydrogel (43b) is formed that reduces the ultrasonic transmission degree in the mold (40) to less than 0.1%.
  • an opaque PVA hydrogel (43) is formed that reduces the degree of ultrasonic transmission to less than 2% depending on the type of PVA solution injected into the internal space of the mold (40).
  • the chamber (50) of the low-temperature curing mode (52b) causes an opaque first PVA hydrogel (43a) that reduces the ultrasonic transmission rate in the mold (40) to less than 2% when the first PVA solution (22) is injected into the internal space of the mold (40), and, on the other hand, causes an opaque second PVA hydrogel (43b) that has a polyethylene glycol content of 20% or more to be molded while reducing the ultrasonic transmission rate in the mold (40) to less than 2%.
  • the degree of ultrasonic transmission is reduced to less than 5% depending on the type of PVA solution injected into the internal space of the mold (40), thereby forming a PVA hydrogel (43) that is more opaque than the PVA hydrogel (43) formed in the low temperature curing mode (52b).
  • the chamber (50) of the room temperature curing mode (52c) reduces the ultrasonic transmission rate in the mold (40) to less than 5% when the first PVA solution (22) is injected into the internal space of the mold (40), thereby forming a first PVA hydrogel (43a) that is more opaque than the first PVA hydrogel (43a) that is molded in the low temperature curing mode (52b).
  • the mold (40) causes the PVA hydrogel (43) to be discharged to the outside through the discharge means.
  • PVA hydrogel (43) can be neutralized through a neutralization process depending on the type of solvent that makes up the PVA solution before molding.
  • the PVA hydrogel (43) when the PVA hydrogel (43) is formed from the first PVA solution (22) based on the first mixed solvent (11), it can be neutralized through a neutralization process as shown in FIG. 7.
  • Figure 7 is a drawing showing the neutralization process of PVA hydrogel molded from the mold shown in Figure 5.
  • the first PVA hydrogel (43a) formed from the first PVA solution (22) is formed in the mold (40) by the chamber (50), it is discharged from the discharge means of the mold (40) and is sequentially stored in a first container (61) containing acetone, a second container (62) containing ether, and a third container (63) containing the first container (61) or acetone for a certain period of time, and then can be neutralized through a neutralization process in which it is stored in a fourth container (64) containing liquid carbon dioxide heated to 60° C.
  • the time for which the first PVA hydrogel (43a) is immersed in acetone and ether from the first container (61) to the third container (63) may be 1 to 24 hours.
  • the reason why the first PVA hydrogel (43a) must be neutralized through a neutralization process is that when the first PVA hydrogel (43a) in which dimethyl sulfoxide (11b) is used as a solvent is exposed to the air, the dimethyl sulfoxide (11b) rapidly evaporates, reducing the overall volume size of the first PVA hydrogel (43a). By alleviating the volatility of the dimethyl sulfoxide (11b) of the solid gel through neutralization, the volume size of the first PVA hydrogel (43a) is prevented from decreasing.
  • the reason why the first PVA hydrogel (43a) must be neutralized through a neutralization process is that the smell of dimethyl sulfoxide (11b) is unpleasant, and when the first PVA hydrogel (43a) is used as a medical device together with an ultrasonic generator (100), the smell causes discomfort to the patient. This is to prevent this by removing (or deodorizing) the smell of dimethyl sulfoxide (11b) through neutralization.
  • the reason why the first PVA hydrogel (43a) must be neutralized through a neutralization process is that when the first PVA hydrogel (43a) is used as a medical device, a biological stability test is conducted to check whether it is safe for humans.
  • a sample test (In Vitro), which is a very accurate test method that measures the concentration of trace substances in the body by labeling a substance or its antibody with a radioisotope to determine the presence or severity of a disease
  • a biocompatibility test In Vivo Biocompatibility test
  • sample test tests cytotoxicity, skin sensitization, and skin irritation, etc. to check whether the semi-solid first PVA hydrogel (43a) can be used as a medical device.
  • dimethyl sulfoxide (11b) a problem may occur when used in large quantities, so a neutralization process is conducted to pass the biological stability test (sample test). The goal is to transform the work into a biologically safe substance.
  • the second PVA hydrogel (43b) formed from the second PVA solution (23) can be formed without a neutralization process.
  • FIG. 9 is a drawing showing a PVA hydrogel manufacturing method performed by a PVA hydrogel manufacturing device according to one embodiment of the present invention.
  • a method for manufacturing a PVA hydrogel (S10) includes a solvent manufacturing step (S11), a PVA solution production step (S12), a defoaming step (S13), a PVA solution injection step (S14), a curing step (S15), a neutralization step (S16), and a PVA hydrogel manufacturing completion step (S17).
  • the solvent generator (10) can produce at least one solvent among a first mixed solvent (11) in which water (11a) and dimethyl sulfoxide (11b) are mixed, and a second mixed solvent (12) in which water (12a) and polyethylene glycol (12b) are mixed (S11).
  • the stirrer (20) can stir the solvent and polyvinyl alcohol (21) input from the solvent generator (10) to produce at least one PVA solution among the first PVA solution (22) and the second PVA solution (23) (S12).
  • the deaerator (30) can receive the PVA solution from the stirrer (20) and remove the internal air of the PVA solution (S13).
  • the mold (40) can be injected with the PVA solution discharged from the degassing device (30) into the internal space (S14).
  • the chamber (50) causes the mold (40) to undergo a hardening process so that the PVA hydrogel (43) is formed in the internal space of the mold (40) (S15).
  • the PVA hydrogel (43) is discharged from the mold (40) and can be neutralized through a neutralization process depending on the type of solvent forming the PVA solution (S16).
  • the neutralization process of the neutralization step (S16) is not essential, and the PVA hydrogel (43) molded in the inner space of the mold (40) may be omitted in the case of the second PVA hydrogel (43b).
  • the PVA hydrogel (43) can be manufactured by going through a curing step (S15) and a neutralization step (S16), or by going through only the curing step (S15) with the neutralization step (S16) omitted (S17), depending on the type of solvent forming the PVA solution.
  • Figure 10 is a drawing showing a detailed process of a solvent preparation step for producing a first mixed solvent.
  • the solvent manufacturing device (10) can mix 40 to 60 wt% of purified water (11a) and 40 to 60 wt% of dimethyl sulfoxide (11b) based on a weight ratio of 100 wt% of the first mixed solvent (11) (S11a).
  • the solvent generator (10) can additionally add a preservative (11c) to prevent shrinkage and decay of the PVA hydrogel (43) in the remaining weight ratio based on the weight ratio of 100 wt% of the first mixed solvent (11) (S11b).
  • the solvent generator (10) generates the first mixed solvent (11) by heat treatment or the like (S11c).
  • Figure 11 is a drawing showing a detailed process of a solvent preparation step for producing a second mixed solvent.
  • the solvent manufacturing device (10) can mix 70 to 95 wt% of purified water (12a) and 5 to 30 wt% of polyethylene glycol (12b) based on a weight ratio of 100 wt% of the second mixed solvent (12) (S11d).
  • the solvent generator (10) can additionally add a preservative (12c) to prevent shrinkage and decay of the PVA hydrogel (43) in the remaining weight ratio based on the weight ratio of 100 wt% of the second mixed solvent (12) (S11e).
  • the solvent generator (10) generates a second mixed solvent (12) by heat treatment or the like (S11f).
  • Figure 12 is a drawing showing the detailed process of the PVA solution production step illustrated in Figure 9.
  • the PVA solution production step (S12) at least one of the first mixed solvent (11) and the second mixed solvent (12) produced in the solvent generator (10) is introduced into the stirrer (20), and when the introduction of the solvent is completed, 5 to 10 wt% of polyvinyl alcohol (21) based on the total weight of the solvent can be introduced through an introduction path different from the introduction path of the solvent (S12a).
  • the stirrer (20) can stir the solvent and polyvinyl alcohol (21) at a temperature between 90° C. and 130° C. for more than 90 minutes (S12b), thereby generating at least one PVA solution among the first PVA solution (22) and the second PVA solution (23) (S12c).
  • the stirrer (20) can remove the bubbles generated in the PVA solution by injecting a defoaming agent (24) into the PVA solution (S12e).
  • the stirrer (20) can omit the injection of the antifoaming agent (24) into the PVA solution (S12f).
  • Figure 13 is a drawing showing the detailed process of the hardening step illustrated in Figure 9.
  • information on the curing mode (52) for carrying out the curing process can be input through at least one of the first, second, and third signal input means in the input unit (51), and information on the type of solvent forming the PVA solution injected into the internal space of the mold (40) can be input through the fourth signal input means (S15b).
  • the chamber (50) can be operated in the curing mode (52) based on the case where the simulation process of the control unit (54) is performed, but the temperature control unit (53) can control the internal space temperature of the chamber (50).
  • the temperature control unit (53) (S15c-YES)
  • the PVA hydrogel (43) that has undergone the freezing hardening process can be molded in the internal space of the mold (40) (S15f).
  • the PVA hydrogel (43) by the freeze-curing mode (52a) can be formed into a transparent first PVA hydrogel (43a) that reduces the degree of ultrasonic transmission in the mold (40) to less than 0.1% when the first PVA solution (22) is injected into the internal space of the mold (40), and on the other hand, when the second PVA solution (23) is injected into the internal space of the mold (40), the PVA hydrogel (43b) can be formed into an opaque second PVA hydrogel (43b) that reduces the degree of ultrasonic transmission in the mold (40) to less than 0.1%.
  • the chamber (50) can be operated in the low-temperature curing mode (52b) or the room-temperature curing mode (52c) by the temperature control unit (53).
  • the PVA hydrogel (43) by the low-temperature curing mode (52b) can be formed into a first PVA hydrogel (43a) in an opaque state that reduces the degree of ultrasonic transmission in the mold (40) to less than 2% when the first PVA solution (22) is injected into the internal space of the mold (40), and on the other hand, when the second PVA solution (23) is injected into the internal space of the mold (40), the PVA hydrogel (43) can be formed into a second PVA hydrogel (43b) in an opaque state that has a polyethylene glycol content of 20% or more and reduces the degree of ultrasonic transmission in the mold (40) to less than 2%.
  • the chamber (50) can be operated in the room-temperature curing mode (52c).
  • a PVA hydrogel (43) that has undergone a room temperature curing process can be molded in the internal space of the mold (40) (S15f).
  • the PVA hydrogel (43) formed in the room temperature curing mode (52c) can be formed into a first PVA hydrogel (43a) that is more opaque than the first PVA hydrogel (43a) formed in the low temperature curing mode (52b) by reducing the degree of ultrasonic transmission in the mold (40) to less than 5%, and, on the other hand, when the second PVA solution (23) is injected into the internal space of the mold (40), the PVA hydrogel (43b) that is more opaque than the second PVA hydrogel (43b) formed in the low temperature curing mode (52b) while reducing the degree of ultrasonic transmission in the mold (40) to less than 5% and having a polyethylene glycol content of 20% or more.
  • the chamber (50) can communicate with a terminal provided by the user through a display or control unit (54) to inform the user of an operation error and request re-operation of the input unit (51) (S15g).
  • Figure 14 is a drawing showing the detailed process of the neutralization step illustrated in Figure 9.
  • the first PVA hydrogel (43a) formed through a curing process in the curing step (S15), which is a previous step to the neutralization step (S16), can be discharged to the outside through the discharge means of the mold (40) (S16a).
  • the first PVA hydrogel (43a) can be sequentially contained in a first container (61) containing acetone, a second container (62) containing ether, and a third container (63) containing the first container (61) or acetone for a certain period of time (e.g., 1 to 24 hours) (S16b).
  • the first PVA hydrogel (43a) is placed in a fourth container (64) storing liquid carbon dioxide heated to 60° C. (S16c), and can be neutralized through this neutralization process.
  • Polyethylene glycol is a chemical substance belonging to the polyether group of compounds, a polymer formed by the polymerization of ethylene oxide.
  • PEG exists in various forms (liquid, gel, solid) depending on its molecular weight. PEGs with lower molecular weights are more water-soluble and have lower viscosity, while higher molecular weights result in higher viscosity and decreased water solubility.
  • PEG400 can improve the following effects:
  • PEG400 enables various drugs and active ingredients to dissolve, allowing them to be better absorbed in the body.
  • - Drug delivery system Enables specific drugs to reach the target area more effectively, improves drug stability, and increases the efficiency of drug delivery by controlling the viscosity of the formulation.
  • PEG400 has low viscosity and good lubricity, so it is used to provide desired texture and fluidity in pharmaceutical and cosmetic formulations.
  • PEG400 is less irritating to the skin and tends not to cause allergic reactions, so it can be safely used in products that are applied directly to the skin.
  • hydrogels can provide an environment conducive to bacterial growth, measures to prevent bacterial contamination are essential.
  • Neutralization processes are often used to modify the physical properties of hydrogels, and can leave the product susceptible to bacteria.
  • the product can be prevented from being contaminated with bacteria.
  • gamma rays are high energy radiation that can be used to kill bacteria by damaging their DNA, and gamma irradiation can be performed after storage or packaging, which provides additional assurance that the product is free of bacteria before it reaches the user.
  • the PVA hydrogel applied to the present invention has a Shore A durometer hardness value of 40A or less.
  • PVA hydrogel is a material with a hydrated network structure based on polyvinyl alcohol (PVA), and the term “hydrogel” refers to a gel-like material that maintains a solid structure while containing a lot of water. PVA hydrogel can be swelled by water in particular, but does not completely dissolve in water.
  • PVA polyvinyl alcohol
  • PVA hydrogels with a Shore A durometer hardness of 40A or less may exhibit beneficial properties in various ways, particularly in the medical field.
  • the Shore A hardness scale is used to measure the surface hardness of a material, with lower numbers indicating softer materials.
  • PVA hydrogels with a hardness of 40A or less may have the following advantages:
  • Soft materials have properties more similar to human tissue, which means they tend to cause less irritation and inflammatory reactions when inserted into the body.
  • Hydrogels with a hardness value of 40A or less exhibit high flexibility and elasticity, allowing them to follow the body's movements well, making them ideal for medical patches or implants used in areas with a lot of movement.
  • Soft materials can improve pressure distribution, which is important in medical devices or wound dressings that are meant to be worn for long periods of time, and helps prevent problems such as pressure ulcers.
  • Softness can significantly improve comfort, which can increase patient satisfaction and treatment compliance, especially important for products that come into direct contact with the skin or devices that need to be worn for long periods of time.
  • 43a First PVA hydrogel
  • 43b Second PVA hydrogel
  • 52 Hardening mode
  • 52a Freezing hardening mode
  • 52b Low temperature curing mode
  • 52c Room temperature curing mode

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Abstract

Un appareil de production d'hydrogel de PVA pour couplage acoustique ultrasonore, selon un mode de réalisation de la présente invention, comprend : un préparateur de solvant qui prépare un premier solvant mixte dans lequel de l'eau et du diméthylsulfoxyde (DMSO) sont mélangés, et/ou un second solvant mixte dans lequel de l'eau et du polyéthylène glycol (PEG) sont mélangés ; un agitateur dans lequel un solvant sorti du préparateur de solvant est introduit, et dans lequel de l'alcool polyvinylique (PVA) est introduit par une voie différente de la voie d'introduction du solvant, et qui agite ensuite le solvant et le PVA pour ainsi produire une solution de PVA ; un dégazeur qui reçoit la solution de PVA en provenance de l'agitateur et en élimine l'air ; un moule dans lequel la solution de PVA sortie du dégazeur est injectée ; et une chambre dans laquelle le moule, lorsqu'il y est inséré, subit un processus de durcissement de telle sorte que l'hydrogel de PVA est moulé dans l'espace interne du moule, l'hydrogel de PVA pouvant être neutralisé par un procédé de neutralisation en fonction du type de solvant constituant la solution de PVA.
PCT/KR2024/004977 2024-04-12 2024-04-12 Appareil et procédé de production d'hydrogel de pva pour couplage acoustique ultrasonore Pending WO2025216345A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007152121A (ja) * 2005-11-09 2007-06-21 Coopervision Inc シリコーンヒドロゲルコンタクトレンズを滅菌する方法
KR101139434B1 (ko) * 2009-11-24 2012-04-27 주식회사 리온 돼지피부를 이용한 드레싱재의 제조방법
KR101683042B1 (ko) * 2008-04-04 2016-12-06 포사이트 비젼4, 인크. 통증 관리 및 시력을 위한 치료 장치
KR101756493B1 (ko) * 2009-10-29 2017-07-10 아센디스 파마 에이에스 생분해성 하이드로겔의 살균
KR20240034430A (ko) * 2022-09-07 2024-03-14 주식회사 트러스트라 초음파 음향 결합용 pva 하이드로겔 제조 장치 및 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007152121A (ja) * 2005-11-09 2007-06-21 Coopervision Inc シリコーンヒドロゲルコンタクトレンズを滅菌する方法
KR101683042B1 (ko) * 2008-04-04 2016-12-06 포사이트 비젼4, 인크. 통증 관리 및 시력을 위한 치료 장치
KR101756493B1 (ko) * 2009-10-29 2017-07-10 아센디스 파마 에이에스 생분해성 하이드로겔의 살균
KR101139434B1 (ko) * 2009-11-24 2012-04-27 주식회사 리온 돼지피부를 이용한 드레싱재의 제조방법
KR20240034430A (ko) * 2022-09-07 2024-03-14 주식회사 트러스트라 초음파 음향 결합용 pva 하이드로겔 제조 장치 및 방법

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