WO2016003204A1 - Method for manufacturing compressed receptor for medical prosthesis, compressed receptor using same, and medical prosthesis - Google Patents

Method for manufacturing compressed receptor for medical prosthesis, compressed receptor using same, and medical prosthesis Download PDF

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Publication number
WO2016003204A1
WO2016003204A1 PCT/KR2015/006786 KR2015006786W WO2016003204A1 WO 2016003204 A1 WO2016003204 A1 WO 2016003204A1 KR 2015006786 W KR2015006786 W KR 2015006786W WO 2016003204 A1 WO2016003204 A1 WO 2016003204A1
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WO
WIPO (PCT)
Prior art keywords
receptor
pouch
medical implant
pva
dry
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PCT/KR2015/006786
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French (fr)
Korean (ko)
Inventor
이훈범
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가톨릭관동대학교산학협력단
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Priority claimed from KR1020140082049A external-priority patent/KR101600811B1/en
Priority claimed from KR1020140082050A external-priority patent/KR101600812B1/en
Application filed by 가톨릭관동대학교산학협력단 filed Critical 가톨릭관동대학교산학협력단
Publication of WO2016003204A1 publication Critical patent/WO2016003204A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/12Mammary prostheses and implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials

Definitions

  • the present invention relates to a compression receptor for medical implants and a method for manufacturing the same, and more particularly, to a receptor that can be accommodated in a medical implant and improve touch and human fit, and can be used for the purpose of restoring the human body and cosmetics. It relates to a prosthesis having human compatibility. The present invention relates to a prosthesis having human suitability usable for the purpose of restoring the body, beauty, and the like.
  • Medical implants are used for the purpose of restoring a damaged human body such as depression due to an accident or disease or to improve the appearance of a woman's breast. For example, it can be used to restore the volume of the chest, which may be necessary after tumor removal, or to aesthetically improve the shape of the chest.
  • implants in which a liquid, that is, gel-type silicon is injected into a hard type silicone pouch having a thickness of 1 to 2 mm have been developed.
  • the silicone pouch when the silicone pouch is broken and the internal silicone gel is leaked to the human body, the silicone gel may be absorbed into the human tissue and necrotic the tissue.
  • the implants that replaced the silicone gel with physiological saline caused problems such as poor texture and the subjects felt heterogeneity in their daily lives. There was a problem that the deformation of the shape is so strong that it feels heterogeneous unlike the human body.
  • the implant for human body should have a similar texture to the human body, high human suitability or stability, and should not be heterogeneous because the deformation of the shape according to daily life is similar to the human body.
  • the incision site of the human body should be minimized during surgery.
  • the present invention provides a filling member and a medical implant for medical implants that can simultaneously improve the ease of surgery and spatial efficiency in the manufacturing / distribution process.
  • the present invention provides a filling member and a medical implant to improve the human fit so that problems do not occur even when the implant is damaged and the contents are leaked to the human body.
  • the present invention provides a filling member and a medical implant having improved touch as compared with a implant containing a conventional saline solution or cohesive gel while improving the human fitness.
  • the compression receptor for medical implants comprises a dry substitute which is compressed and dehydrated condensed at a higher shrinkage rate than the shrinkage rate due to simple dehydration condensation from the hydrogel state.
  • the dry substitute may be formed of at least one material of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc).
  • PVA polyvinyl alcohol
  • PVAc polyvinyle acetate
  • the dry substitute may be formed of a porous material.
  • the dry substitute may be formed of a material having biocompatibility.
  • the dry substitute may be manufactured to have a volume larger than the maximum compressible volume and the same or smaller than the volume of the object to be accommodated.
  • the dry substitute may be formed in the shape of any one of a lump, a strap and a plate.
  • the compressed receptor manufacturing method for medical implants provides a step of providing a water-soluble synthetic resin; A softening step of softening the water-soluble synthetic resin through hydrolysis; Compressing the softened water-soluble synthetic resin; And a dehydration condensation step of dehydrating or drying the compressed water-soluble synthetic resin.
  • the providing step may further comprise the step of preparing a PVA sponge from PVA or PVAc.
  • the PVA sponge manufacturing step to obtain a PVA aqueous solution by mixing PVA and water; Adding and stirring a pore-forming agent to the PVA aqueous solution; And acetalizing by heating after the stirring step.
  • the PVA sponge manufacturing step to obtain a PVA aqueous solution by hydrolyzing PVAc; Adding and stirring a pore-forming agent to the PVA aqueous solution; And acetalizing by heating after the stirring step.
  • the softened water-soluble synthetic resin may be compressed by any one of rolling up, folding and pressing or a combination of two or more methods.
  • Medical implants according to the present invention is a pouch; Physiological saline provided in the pouch; And a receptor formed of at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc) and provided in a softened state by the saline solution in the pouch.
  • PVA polyvinyl alcohol
  • PVAc polyvinyle acetate
  • the pouch may be formed of at least one material of silicon and polyurethane.
  • the receptor may be provided in a state in which at least one xerogel of PVA and PVAc is swollen by the saline solution.
  • the dry substitute may be formed of a porous material.
  • the dry substitute may be prepared in a compressed state to have a smaller volume than the volume contracted by dehydration of the hydrogel.
  • the dry substitute may be formed to have a size less than the volume of the pouch.
  • the dry substitute may be formed of at least two separated solids.
  • the size of the sponge may be formed by a combination of two or more types of sizes.
  • the inner surface of the pouch may be attached to at least a portion of the receptor.
  • the receptor attached to the inside of the pouch may be attached by a medical silicone adhesive.
  • medical implants according to the present invention is a pouch; An inlet provided in the pouch and into which the fluid is introduced into the pouch; And a receptor provided as a dry substitute according to dehydration condensation of the water-soluble plastic in the pouch and softened by hydrolysis of the fluid flowing into the pouch.
  • the receptor may be formed of a material having biocompatibility.
  • the receptor may be formed of at least one material of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc).
  • PVA polyvinyl alcohol
  • PVAc polyvinyle acetate
  • the pouch may be formed of at least one material of silicon and polyurethane.
  • the dry substitute may be formed of a porous material.
  • the dry substitute may be prepared in a compressed state to have a smaller volume than the volume contracted by dehydration of the hydrogel.
  • the dry substitute may be formed to have a size of more than the maximum compressible volume and less than the volume of the pouch.
  • the dry substitute may be formed of at least two separated solids.
  • the size of the sponge may be formed by a combination of two or more types of sizes.
  • the dry body may be attached to at least a portion of the inner surface of the pouch.
  • the dry substitute attached to the inside of the pouch may be attached by a medical silicone adhesive.
  • physiological saline that is harmless to the human body and synthetic resin having high human compatibility, there is an effect of preventing problems such as necrosis of tissues of the human body even when the pouch is broken and the contents leak into the human body.
  • the PVA and PVAc in the form of a hydrogel can improve the human compatibility and at the same time can feel the texture similar to the human body compared to the case where only physiological saline is accommodated or strong cohesive gel is received.
  • physiological saline that is harmless to the human body and synthetic resin having high human compatibility, there is an effect of preventing problems such as necrosis of tissues of the human body even when the pouch is broken and the contents leak into the human body.
  • the injection of physiological saline is performed after insertion of the pouch and the receptor into the human body, and the expansion of the receptor is performed according to the injection of the physiological saline, thereby minimizing the size of the human incision during surgery.
  • FIG. 1 is a schematic view showing a state in which a medical implant is applied according to an embodiment of the present invention.
  • Figure 2 is a block diagram showing a method of manufacturing a water-soluble synthetic resin and dry replacement for medical implants according to an embodiment.
  • FIG. 3 is a schematic diagram showing a method of manufacturing and using a dry replacement for a medical implant according to an embodiment.
  • FIG. 4 is a cross-sectional view showing a medical implant according to an embodiment.
  • FIG. 5 is a cross-sectional view showing a medical implant according to another embodiment.
  • 6 and 7 are cross-sectional views showing a medical implant according to another embodiment.
  • FIG. 8 is a cross-sectional view showing a medical implant according to another embodiment.
  • FIGS. 9 and 10 are perspective views schematically showing a state of the conventional medical implant and the medical implant of Figure 8, respectively.
  • 11 and 12 are cross-sectional views illustrating embodiments that can be combined.
  • FIG. 13 is a cross-sectional view showing a medical implant according to another embodiment.
  • the compression receptor for medical implants comprises a dry substitute which is compressed and dehydrated condensed at a higher shrinkage rate than the shrinkage rate due to simple dehydration condensation from the hydrogel state.
  • the compressed receptor manufacturing method for medical implants provides a step of providing a water-soluble synthetic resin; A softening step of softening the water-soluble synthetic resin through hydrolysis; Compressing the softened water-soluble synthetic resin; And a dehydration condensation step of dehydrating or drying the compressed water-soluble synthetic resin.
  • Medical implants according to the present invention is a pouch; Physiological saline provided in the pouch; And a receptor formed of at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc) and provided in a softened state by the saline solution in the pouch.
  • PVA polyvinyl alcohol
  • PVAc polyvinyle acetate
  • medical implants according to the present invention is a pouch; An inlet provided in the pouch and into which the fluid is introduced into the pouch; And a receptor provided as a dry substitute according to dehydration condensation of the water-soluble plastic in the pouch and softened by hydrolysis of the fluid flowing into the pouch.
  • FIG. 1 is a schematic view showing a state in which a medical implant is applied according to an embodiment of the present invention.
  • the medical implant 100 may be inserted into the human body B, particularly in the female breast region. 1 and related descriptions are provided for convenience of description and are not limited to surgery of a woman's chest of the medical implant 100. That is, the medical implant may be applied to various parts of the human body through changes in size and shape in addition to the use for women's chest surgery. For example, it is possible to use the skin recessed portion and wrinkles, etc., and furthermore, it is possible to use for improving the volume sense of cosmetic purposes.
  • Medical implant 100 includes a pouch 110, physiological saline (W) and the receptor (filler member 120).
  • the pouch 110 is formed of a hard type silicon material to form an outer shape of the implant 100, and may have some elasticity or no elasticity according to the purpose.
  • Physiological saline (W) and the receptor 120 is accommodated inside the pouch (110).
  • Receptor 120 inside the pouch 110 is provided in a softened state by physiological saline (W).
  • the receptor 120 may be formed of a water-soluble synthetic resin and hydrolyzed by physiological saline (W) to be provided inside the pouch 110 in a softened state.
  • W physiological saline
  • PVA polyvinyl alcohol
  • PVAc polyvinyle acetate
  • the receptor 120 is made of xerogel and then reacts with physiological saline (W) in the pouch 110 to exist as a hydrogel.
  • Hydrogel refers to a state in which when a substance is placed in a larger amount of water, the substance can swell quickly and maintain a large amount of water in the swollen structure. Substances present in the hydrogel state retain a three-dimensional structure rather than dissolve in water. Gels formed on such aqueous solutions are called hydrogels. Hydrogels are usually made of hydrophilic polymer resins that are crosslinked by other bonding forces such as chemical bonds, ionic interactions, hydrogen bonding or hydrophobic action.
  • hydrogel is applied when the material is already swollen in water. Dried gels are called xerogels or dry gels. During the drying process, moisture evaporates from the gel, and the surface tension causes the gel to crush itself. Thus the gel shrinks to a very small fraction of swollen size. If moisture is removed without disruption of the polymer structure by lyophilization or extraction with organic solvents, then the remaining material has an extremely light weight with high porosity. Such dehydrogenated hydrogels are called xerogels or sponges.
  • a receptor dried in a manufacturing step or in a physiological saline solution is called a dry substitute
  • a receptor in a physiological saline solution is particularly called a hydrogel.
  • polyvinyl alcohol (hereinafter referred to as PVA) is a hydrophilic polymer synthetic resin obtained through hydrolysis of polyvinyl acetate (hereinafter referred to as PVAc).
  • Crosslinking of PVA occurs through chemical and physical methods. In chemical crosslinking, an acidic crosslinking agent binds to a hydroxyl group and an aldehyde solution of PVA to form a gel. Representative methods of physical crosslinking are freeze-thawing. Hydrogels prepared by the freeze thawing method have little toxicity, contain no impurities, and contain about 80 to 90% water. In addition, since it does not use a crosslinking agent, it can be used as an attractive biomedical hydrogel.
  • the silicone gel when the outermost pouch is broken, there is a concern that it may flow to the outside and be absorbed into the biological tissue, causing necrosis, whereas in the case of the PVA hydrogel as in this embodiment, the outermost pouch is broken. Even if it is kept in a certain form is less likely to leak to the outside, even if spilled biocompatibility is high, there is no fear of necrotic tissue.
  • FIG. 2 is a block diagram illustrating a method of manufacturing a water-soluble synthetic resin and a dry replacement for a medical implant according to an embodiment
  • FIG. 3 is a schematic view showing a method of manufacturing and using a dry replacement for a medical implant according to an embodiment.
  • PVA dry substitutes are characterized by excellent elasticity and very softness in wet conditions and hardness in dried conditions, which are not only used for cleaning rollers for semiconductor wafers, glass for TFT LCDs, and for manufacturing rollers. It is also used as a material for medical gauze, beauty towels, sports towels, kitchen scaffolding mats, and microbial tins.
  • PVA a raw material of PVA dry substitute
  • PVA dry substitute is manufactured from the PVA as a raw material (S10). After mixing PVA and water in a certain ratio, the mixture was heated to obtain a PVA aqueous solution, followed by adding corn starch as a pore-forming agent, adding formalin and stirring, and then adding sulfuric acid (H 2 SO 4) as a catalyst. Then, it is injected into a mold prepared in advance, heated and acetalized to form a PVA dry substitute. The acetalized PVA dry substitute is extracted from the mold and thoroughly washed, and then cut and processed according to specifications to produce a product.
  • the PVA sponge manufacturing method has a problem in that even though the use regulation of harmful substances is spread, formalin or paraformaldehyde, which is a use restriction substance, must be used.
  • PVA dry substitutes using the following methods to avoid the use of environmentally regulated materials and to improve the environment of the manufacturing workplace.
  • the PVA resin of 16-21% of the water weight is weighed and mixed with water, and then heated to a temperature of 30 degrees Celsius or more to obtain an aqueous PVA solution, and to the ratio of pores to form corn starch as a pore-forming agent in the PVA aqueous solution. Accordingly 25 to 45% of the PVA aqueous solution.
  • hexamethylene tetramine of 28 to 35% of the weight of water is added to water and heated to a temperature of 40 degrees Celsius or more to obtain an aqueous solution of hexamethylene tetramine.
  • the manufactured dry substitute is softened again for compression.
  • the softening step of the present dry substitute is simply necessary to perform a subsequent compression (S30) step, and the same step as that of providing a water-soluble synthetic resin (S10). It is also possible to be carried out in, and is not necessarily to be performed in a separate step from the water-soluble synthetic resin providing step (S10).
  • a compression process is further performed before drying or dehydrating the hydrogel receptor.
  • the compression process is performed by one or two or more combinations of rolling up, folding, twisting, pressing, and the like in a hydrogel state. It is possible to do
  • the receptor (HG) in the softened state was made into dry substitutes (XG) through compression (II) and dehydration condensation (III) before drying, and then induced hydrolysis when used in the implant. It is converted to the hydrogel (HG) state (IV).
  • FIG. 4 is a cross-sectional view showing a medical implant according to an embodiment.
  • Medical implant 100 is characterized in that the receptor 120 provided inside the pouch 110 is formed of a single solid.
  • the pouch 110 forms the outer shape of the medical implant 100.
  • the pouch 110 is preformed to have a volume and shape according to the desired volume and shape.
  • the pouch 110 may be manufactured using a hard type silicon that is used for medical purposes.
  • the inside of the pouch 110 is provided with a physiological saline (W) similar to the body composition, the physiological saline (W) is provided with a receptor 120 as a single solid.
  • the receptor 120 may be formed in various sizes and shapes according to the volume and elasticity of the desired medical implant 100.
  • the dry replacer is prepared in consideration of the volume to be expanded when the dry replacer is converted into a hydrogel state.
  • it is possible to control such as forming a larger or smaller volume of the dry body.
  • the size of the dry replacement itself is manufactured so as not to exceed the volume of the pouch 110.
  • the dry substitute is preferably manufactured in the form of a porous material, sponge in order to further improve the expansion and shrinkage of the volume.
  • the medical implant 100 prepared as described above has a tactile feeling enhanced by PVA and / or PVAc accommodated in a hydrogel state, unlike a medical implant containing only physiological saline, and even when the pouch 110 is damaged. Since only saline is leaked, it is harmless to the human body, and even when PVA or PVAc hydrogels are leaked, high biocompatibility does not cause problems such as tissue necrosis.
  • FIG. 5 is a cross-sectional view showing a medical implant according to another embodiment.
  • This embodiment is different from the embodiment of FIG. 4 described above in that the receptor 120a included therein is divided into a plurality of solids.
  • the receptor 120a may be accommodated in the pouch 110 as a small mass having a predetermined size instead of being included as a single solid body. In this case, as compared with the above-described embodiment, securing the position of the receptor 120a in the pouch 110 may be more easily performed in the process of expanding the receptor 120a.
  • FIGS. 6 and 7 are cross-sectional views showing a medical implant according to another embodiment.
  • This embodiment is different from the above-described embodiment in that it has a configuration and structure to maximize the ease of surgery.
  • Medical implant 100b does not include physiological saline at the manufacturing stage.
  • the pouch 110 is manufactured in a state where a dry substitute, preferably a compressed dry substitute, of the receptor 120b is accommodated.
  • the inlet 112 is provided on one side of the pouch 110.
  • the inlet 112 serves as a valve through which the fluid can be introduced, and it is preferable to use a one-way valve to facilitate the injection of the fluid and to prevent the inflowed fluid from flowing out.
  • Surgery may be performed using the medical implant 100b manufactured as described above.
  • physiological saline may be injected through the inlet 112 after inserting the medical implant shown in FIG. 6 through the incision site during surgery of the patient.
  • the receptor 120b is swelled by the physiological saline W introduced thereto, and is restored to the volume and shape before compression.
  • the medical implant 100b has an intended volume, shape, and elasticity in the patient's body.
  • the volume is inserted into the patient's body in a state capable of being transformed into a minimized volume and an easy-to-insert shape, whereas after being inserted into the body, physiological saline is injected into the implant. Since the same effect as the above-described embodiments can be obtained by restoring the shape, the incision site of the patient can be minimized.
  • FIGS. 8 to 12 is a cross-sectional view illustrating a medical implant according to still another embodiment
  • FIGS. 9 and 10 are perspective views schematically illustrating a conventional medical implant and a medical implant of FIG. 8, respectively, and FIGS. 11 and 12 may be combined. Sectional drawing showing embodiments.
  • the medical implant 100c has a difference in that a receptor 120c is formed on an inner wall of the pouch 110 as illustrated in FIG. 8.
  • the receptor 120c may be attached to the entire inner wall of the pouch 110, or may be attached only to a part of the inner wall of the pouch 110 where wrinkles are easily formed.
  • the receptor 120c may be formed in the shape of a strap, a plate, or the like.
  • the receptor is present as a hydrogel in physiological saline, it satisfies the criteria in terms of touch and compensates for the thickness of the pouch. Since the effect can be obtained, as shown in FIG. 10, wrinkles can be prevented as much as possible.
  • forming a layer using a separate receptor inside the pouch may be implemented with the above-described embodiments.
  • another receptor 120 formed of a single solid body inside the receptor 120c forming a separate layer, as shown in FIG. 11, and as shown in FIG. 12.
  • further receptors 120a formed of a plurality of solids inside the receptor 120c forming the same.
  • FIG. 13 is a cross-sectional view showing a medical implant according to another embodiment.
  • Medical implant 100f has a unique effect in that it employs two pouches (110a, 110b) to more effectively prevent damage to the pouch (110).
  • the pouch 110 may be configured as two layers of the inner pouch 110b and the outer pouch 110a.
  • the inner pouch 110b and the outer pouch 110a may be formed of the same component, respectively, and may be filled with the silicon gel 115 between the inner pouch 110b and the outer pouch 110a.

Abstract

The present invention relates to a compressed receptor for a medical prosthesis, and a method for manufacturing same, and specifically, to a receptor and a prosthesis, the receptor being accommodated in the medical prosthesis, enabling the improvement of texture and compatibility with the human body, etc., and the prosthesis having compatibility with the human body, and being capable of being used for human body restoration and cosmetic purposes, etc. Provided is a filling member of the medical prosthesis, the filling member enabling the simultaneous improvement of spatial efficiency in the manufacturing/distribution processes, and ease of surgery, etc.

Description

의료 보형물용 압축 수용체 제조방법, 이를 이용한 압축 수용체 및 의료용 보형물Method of manufacturing compression receptor for medical implant, compression receptor and medical implant using same
본 발명은 의료 보형물용 압축 수용체 및 그 제조방법에 관한 것으로서, 구체적으로는 의료 보형물에 수용되어 촉감 및 인체적합성 등을 향상시킬 수 있는 수용체에 관한 것이며, 인체의 복원, 미용 등의 목적으로 이용가능한 인체적합성을 갖는 보형물에 관한 것이다. 인체의 복원, 미용 등의 목적으로 이용가능한 인체적합성을 갖는 보형물에 관한 것이다.The present invention relates to a compression receptor for medical implants and a method for manufacturing the same, and more particularly, to a receptor that can be accommodated in a medical implant and improve touch and human fit, and can be used for the purpose of restoring the human body and cosmetics. It relates to a prosthesis having human compatibility. The present invention relates to a prosthesis having human suitability usable for the purpose of restoring the body, beauty, and the like.
의료용 보형물은 불의의 사고 또는 질병으로 인하여 함몰 등 손상된 인체를 복원하거나 여성의 가슴 등의 외관을 향상시키기 위한 목적으로 이용된다. 예를 들어 종양 제거 후에 필요할 수 있는 가슴의 볼륨 복원, 또는 가슴의 형상을 미적으로 향상시키기 위하여 이용될 수 있다.Medical implants are used for the purpose of restoring a damaged human body such as depression due to an accident or disease or to improve the appearance of a woman's breast. For example, it can be used to restore the volume of the chest, which may be necessary after tumor removal, or to aesthetically improve the shape of the chest.
여성의 가슴을 위한 보형물의 경우 두께 1 내지 2mm의 하드 타입의 실리콘 파우치 내에 액상 즉, 겔 타입의 실리콘이 주입된 보형물이 개발된 바 있다.In the case of implants for female breasts, implants in which a liquid, that is, gel-type silicon is injected into a hard type silicone pouch having a thickness of 1 to 2 mm have been developed.
다만 이러한 타입의 보형물의 경우 실리콘 파우치가 파손되어 내부의 실리콘 겔이 인체로 유출되는 경우 실리콘 겔이 인체의 조직에 흡수되어 해당 조직을 괴사시키는 등의 문제가 발생할 우려가 있었다.However, in the case of this type of prosthesis, when the silicone pouch is broken and the internal silicone gel is leaked to the human body, the silicone gel may be absorbed into the human tissue and necrotic the tissue.
이러한 이유로 하드 타입의 실리콘 파우치를 2겹으로 제조하여 파손 가능성을 줄이거나, 실리콘 겔을 생리 식염수 또는 코히시브젤(cohesive gel)로 대체하여 생체 적합성을 증가시키기 위한 노력들이 있었다.For this reason, efforts have been made to increase the biocompatibility by making hard-type silicone pouches in two layers to reduce the possibility of breakage or to replace the silicone gel with physiological saline or cohesive gel.
그러나 하드타입의 실리콘 파우치를 2 중으로 하는 경우 강도가 강하여 인체의 촉감과는 다른 이질적인 감촉을 유발하는 문제점이 있으며, 여전히 파손 시의 위험성이 잔존하였다.However, when the hard type silicon pouch is doubled, there is a problem that the strength is strong, causing a heterogeneous texture different from the human touch, and there is still a risk of breakage.
또한 생리 식염수로 실리콘 겔을 대체한 보형물의 경우 감촉이 좋지 않고 시술대상자 본인이 일상 생활 시에 이질감을 느끼는 등의 문제가 발생하였으며, 코히시브젤을 이용한 보형물의 경우 촉감이 좋지 않고 일상 생활시에 보형물의 강도가 강하여 모양의 변형이 인체와는 달리 이질적인 느낌이 들도록 하는 문제가 있었다.In addition, the implants that replaced the silicone gel with physiological saline caused problems such as poor texture and the subjects felt heterogeneity in their daily lives. There was a problem that the deformation of the shape is so strong that it feels heterogeneous unlike the human body.
이와 같이 인체용 보형물은 인체와 유사한 감촉이 들어야 하며, 인체적합성 또는 안정성이 높아야 하고, 일상 생활에 따른 모양의 변형이 인체와 유사하여 이질적이지 않아야 한다. 또한 수술 시 인체의 절개부위가 최소화될 수 있어야 한다.In this way, the implant for human body should have a similar texture to the human body, high human suitability or stability, and should not be heterogeneous because the deformation of the shape according to daily life is similar to the human body. In addition, the incision site of the human body should be minimized during surgery.
본 발명은 수술용이성 및 제조/유통과정에서의 공간적인 효율성 등을 동시에 향상시킬 수 있는 의료용 보형물의 충진 부재 및 의료용 보형물을 제공한다.The present invention provides a filling member and a medical implant for medical implants that can simultaneously improve the ease of surgery and spatial efficiency in the manufacturing / distribution process.
또한 본 발명은 보형물이 파손되어 내용물이 인체로 유출되는 경우에도 문제가 발생하지 않도록 인체적합성이 향상된 충진 부재 및 의료용 보형물을 제공한다.In another aspect, the present invention provides a filling member and a medical implant to improve the human fit so that problems do not occur even when the implant is damaged and the contents are leaked to the human body.
또한 본 발명은 이러한 인체적합성이 향상됨과 동시에 종래의 생리 식염수 또는 코히시브 겔이 수용된 보형물에 비하여 촉감이 향상된 충진 부재 및 의료용 보형물을 제공한다.In addition, the present invention provides a filling member and a medical implant having improved touch as compared with a implant containing a conventional saline solution or cohesive gel while improving the human fitness.
본 발명에 따른 의료 보형물용 압축 수용체는 하이드로젤 상태로부터 단순 탈수 축합에 의한 수축율에 비하여 더 큰 수축율로 압축 및 탈수 축합되는 건교체를 포함한다.The compression receptor for medical implants according to the present invention comprises a dry substitute which is compressed and dehydrated condensed at a higher shrinkage rate than the shrinkage rate due to simple dehydration condensation from the hydrogel state.
또한 상기 건교체는 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로 형성될 수 있다.In addition, the dry substitute may be formed of at least one material of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc).
또한 상기 건교체는 다공성 재질로 형성될 수 있다.In addition, the dry substitute may be formed of a porous material.
또한 상기 건교체는 생체 적합성을 갖는 재질로 형성될 수 있다.In addition, the dry substitute may be formed of a material having biocompatibility.
또한 상기 건교체는 최대 압축 가능한 체적보다는 크고 상기 건교체가 수용될 대상물의 체적보다는 같거나 작은 체적을 갖도록 제조될 수 있다.In addition, the dry substitute may be manufactured to have a volume larger than the maximum compressible volume and the same or smaller than the volume of the object to be accommodated.
또한 상기 건교체는 덩어리, 스트랩 및 플레이트 중 어느 하나의 형상으로 형성될 수 있다.In addition, the dry substitute may be formed in the shape of any one of a lump, a strap and a plate.
다른 한편, 본 발명에 따른 의료 보형물용 압축 수용체 제조방법은 수용성 합성수지를 제공하는 제공 단계; 상기 수용성 합성수지를 가수분해를 통하여 연화시키는 연화 단계; 상기 연화된 수용성 합성수지를 압축하는 압축 단계; 및 상기 압축된 수용성 합성수지를 탈수 또는 건조시키는 탈수축합 단계;를 포함한다.On the other hand, the compressed receptor manufacturing method for medical implants according to the present invention provides a step of providing a water-soluble synthetic resin; A softening step of softening the water-soluble synthetic resin through hydrolysis; Compressing the softened water-soluble synthetic resin; And a dehydration condensation step of dehydrating or drying the compressed water-soluble synthetic resin.
또한 상기 제공 단계에는 PVA 또는 PVAc로부터 PVA 스폰지를 제조하는 단계를 더 포함할 수 있다.In addition, the providing step may further comprise the step of preparing a PVA sponge from PVA or PVAc.
또한 상기 PVA 스폰지 제조 단계는, PVA 및 물을 혼합하여 PVA 수용액을 얻는 단계; 상기 PVA 수용액에 기공형성제를 투입 및 교반하는 단계; 상기 교반 단계 후 가열하여 아세탈화시키는 단계;를 포함할 수 있다.In addition, the PVA sponge manufacturing step, to obtain a PVA aqueous solution by mixing PVA and water; Adding and stirring a pore-forming agent to the PVA aqueous solution; And acetalizing by heating after the stirring step.
또한 상기 PVA 스폰지 제조 단계는, PVAc를 가수분해하여 PVA 수용액을 얻는 단계; 상기 PVA 수용액에 기공형성제를 투입 및 교반하는 단계; 상기 교반 단계 후 가열하여 아세탈화시키는 단계;를 포함할 수 있다.In addition, the PVA sponge manufacturing step, to obtain a PVA aqueous solution by hydrolyzing PVAc; Adding and stirring a pore-forming agent to the PVA aqueous solution; And acetalizing by heating after the stirring step.
또한 상기 압축 단계에서는 롤링(rolling up), 폴딩(folding) 및 프레싱(pressing) 중 어느 하나의 방법 또는 둘 이상의 방법을 조합하여 상기 연화된 수용성 합성수지를 압축할 수 있다.In the compressing step, the softened water-soluble synthetic resin may be compressed by any one of rolling up, folding and pressing or a combination of two or more methods.
본 발명에 따른 의료용 보형물은 파우치; 상기 파우치 내에 구비되는 생리 식염수; 및 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로 형성되고, 상기 파우치 내에서 상기 생리 식염수에 의하여 연화된 상태로 구비되는 수용체;를 포함한다.Medical implants according to the present invention is a pouch; Physiological saline provided in the pouch; And a receptor formed of at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc) and provided in a softened state by the saline solution in the pouch.
또한 상기 파우치는 실리콘 및 폴리우레탄 중 적어도 어느 하나의 재질로 형성될 수 있다.In addition, the pouch may be formed of at least one material of silicon and polyurethane.
또한 상기 수용체는 PVA 및 PVAc 중 적어도 어느 하나의 건교체(xerogel)가 상기 생리 식염수에 의하여 팽윤된 상태로 구비될 수 있다.In addition, the receptor may be provided in a state in which at least one xerogel of PVA and PVAc is swollen by the saline solution.
또한 상기 건교체는 다공성 재질로 형성될 수 있다.In addition, the dry substitute may be formed of a porous material.
또한 상기 건교체는 상기 하이드로젤의 탈수축합에 의하여 수축되는 체적보다 더 적은 체적을 갖도록 압축된 상태로 제조될 수 있다.In addition, the dry substitute may be prepared in a compressed state to have a smaller volume than the volume contracted by dehydration of the hydrogel.
또한 상기 건교체는 상기 파우치의 체적 이하의 크기를 갖도록 형성될 수 있다.In addition, the dry substitute may be formed to have a size less than the volume of the pouch.
또한 상기 건교체는 적어도 둘 이상의 분리된 고형물로 형성될 수 있다.In addition, the dry substitute may be formed of at least two separated solids.
또한 상기 스폰지의 크기는 2 종류 이상의 크기의 조합으로 형성될 수 있다.In addition, the size of the sponge may be formed by a combination of two or more types of sizes.
또한 상기 파우치의 내측면에는 적어도 일부에 상기 수용체가 부착될 수 있다.In addition, the inner surface of the pouch may be attached to at least a portion of the receptor.
또한 상기 파우치의 내측에 부착되는 수용체는 의료용 실리콘 접착제에 의하여 부착될 수 있다.In addition, the receptor attached to the inside of the pouch may be attached by a medical silicone adhesive.
다른 한편, 본 발명에 따른 의료용 보형물은 파우치; 상기 파우치에 구비되어, 유체가 상기 파우치 내로 인입되는 유입부; 및 상기 파우치 내에 수용성 플라스틱의 탈수 축합에 따른 건교체로서 구비되고, 상기 파우치 내로 유입되는 유체의 가수분해에 의하여 연화되는 수용체;를 포함한다.On the other hand, medical implants according to the present invention is a pouch; An inlet provided in the pouch and into which the fluid is introduced into the pouch; And a receptor provided as a dry substitute according to dehydration condensation of the water-soluble plastic in the pouch and softened by hydrolysis of the fluid flowing into the pouch.
또한 상기 수용체는 생체 적합성을 갖는 재질로 형성될 수 있다.In addition, the receptor may be formed of a material having biocompatibility.
또한 상기 수용체는 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로 형성될 수 있다.In addition, the receptor may be formed of at least one material of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc).
또한 상기 파우치는 실리콘 및 폴리우레탄 중 적어도 어느 하나의 재질로 형성될 수 있다.In addition, the pouch may be formed of at least one material of silicon and polyurethane.
또한 상기 건교체는 다공성 재질로 형성될 수 있다.In addition, the dry substitute may be formed of a porous material.
또한 상기 건교체는 상기 하이드로젤의 탈수축합에 의하여 수축되는 체적보다 더 적은 체적을 갖도록 압축된 상태로 제조될 수 있다.In addition, the dry substitute may be prepared in a compressed state to have a smaller volume than the volume contracted by dehydration of the hydrogel.
또한 상기 건교체는 최대 압축 가능한 체적 이상 및 상기 파우치의 체적 이하의 크기를 갖도록 형성될 수 있다.In addition, the dry substitute may be formed to have a size of more than the maximum compressible volume and less than the volume of the pouch.
또한 상기 건교체는 적어도 둘 이상의 분리된 고형물로 형성될 수 있다.In addition, the dry substitute may be formed of at least two separated solids.
또한 상기 스폰지의 크기는 2 종류 이상의 크기의 조합으로 형성될 수 있다.In addition, the size of the sponge may be formed by a combination of two or more types of sizes.
또한 상기 파우치의 내측면에는 적어도 일부에 상기 건교체가 부착될 수 있다.In addition, the dry body may be attached to at least a portion of the inner surface of the pouch.
또한 상기 파우치의 내측에 부착되는 건교체는 의료용 실리콘 접착제에 의하여 부착될 수 있다.In addition, the dry substitute attached to the inside of the pouch may be attached by a medical silicone adhesive.
본 발명에 따르면 인위적으로 건교체의 제조 전에 압축 공정을 추가함으로써 수술 시 환자의 절개 부위를 최소화 할 수 있도록 하는 효과가 있다.According to the invention there is an effect to minimize the incision site of the patient during surgery by artificially adding a compression process before the manufacture of dry substitute.
본 발명에 따르면 인체에 무해한 생리 식염수와 인체 적합성이 높은 합성수지를 포함함으로써 파우치가 파손되어 내용물이 인체로 유출되는 경우에도 인체의 조직이 괴사되는 등의 문제가 발생하지 않도록 하는 효과가 있다.According to the present invention, by including physiological saline that is harmless to the human body and synthetic resin having high human compatibility, there is an effect of preventing problems such as necrosis of tissues of the human body even when the pouch is broken and the contents leak into the human body.
또한 본 발명에 따르면 PVA 및 PVAc 등을 하이드로 젤 형태로 포함함으로써 인체적합성이 향상됨과 동시에 단순히 생리 식염수만 수용되었거나 강도가 강한 코히시브젤이 수용된 경우에 비하여 인체와 유사한 감촉을 느낄 수 있다.In addition, according to the present invention by including the PVA and PVAc in the form of a hydrogel can improve the human compatibility and at the same time can feel the texture similar to the human body compared to the case where only physiological saline is accommodated or strong cohesive gel is received.
또한 본 발명에 따르면 점성이 약한 생리 식염수나 점성이 강한 코히시브 젤 등에 비하여 일상생활 시에도 모양의 변형이 자연스럽고 이질적인 느낌을 최소화할 수 있다.In addition, according to the present invention it is possible to minimize the natural and heterogeneous feeling of shape deformation in everyday life as compared to weak viscous saline or viscous strong cohesive gel.
본 발명에 따르면 인체에 무해한 생리 식염수와 인체 적합성이 높은 합성수지를 포함함으로써 파우치가 파손되어 내용물이 인체로 유출되는 경우에도 인체의 조직이 괴사되는 등의 문제가 발생하지 않도록 하는 효과가 있다.According to the present invention, by including physiological saline that is harmless to the human body and synthetic resin having high human compatibility, there is an effect of preventing problems such as necrosis of tissues of the human body even when the pouch is broken and the contents leak into the human body.
또한 본 발명에 따르면 생리 식염수의 주입이 파우치 및 수용체의 인체 내 삽입 이후에 수행되고, 생리 식염수의 주입에 따라 수용체의 팽창이 이루어짐으로써 수술 시에 인체의 절개 크기가 최소화될 수 있다.Further, according to the present invention, the injection of physiological saline is performed after insertion of the pouch and the receptor into the human body, and the expansion of the receptor is performed according to the injection of the physiological saline, thereby minimizing the size of the human incision during surgery.
도 1은 본 발명의 일 실시예에 따른 의료용 보형물이 적용된 모습을 나타내는 개략도이다.1 is a schematic view showing a state in which a medical implant is applied according to an embodiment of the present invention.
도 2는 일 실시예에 따른 수용성 합성수지 및 의료 보형물용 건교체의 제조방법을 나타내는 블록도이다.Figure 2 is a block diagram showing a method of manufacturing a water-soluble synthetic resin and dry replacement for medical implants according to an embodiment.
도 3은 일 실시예에 따른 의료 보형물용 건교체의 제조 및 이용방법을 나타내는 모식도이다.3 is a schematic diagram showing a method of manufacturing and using a dry replacement for a medical implant according to an embodiment.
도 4는 일 실시예에 따른 의료용 보형물을 나타내는 단면도이다.4 is a cross-sectional view showing a medical implant according to an embodiment.
도 5는 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.5 is a cross-sectional view showing a medical implant according to another embodiment.
도 6 및 도 7은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.6 and 7 are cross-sectional views showing a medical implant according to another embodiment.
도 8은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.8 is a cross-sectional view showing a medical implant according to another embodiment.
도 9 및 도 10은 각각 종래의 의료용 보형물과 도 8의 의료용 보형물의 모습을 개략적으로 나타내는 사시도이다.9 and 10 are perspective views schematically showing a state of the conventional medical implant and the medical implant of Figure 8, respectively.
도 11 및 도 12는 조합가능한 실시예들을 나타내는 단면도이다.11 and 12 are cross-sectional views illustrating embodiments that can be combined.
도 13은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.13 is a cross-sectional view showing a medical implant according to another embodiment.
본 발명에 따른 의료 보형물용 압축 수용체는 하이드로젤 상태로부터 단순 탈수 축합에 의한 수축율에 비하여 더 큰 수축율로 압축 및 탈수 축합되는 건교체를 포함한다.The compression receptor for medical implants according to the present invention comprises a dry substitute which is compressed and dehydrated condensed at a higher shrinkage rate than the shrinkage rate due to simple dehydration condensation from the hydrogel state.
다른 한편, 본 발명에 따른 의료 보형물용 압축 수용체 제조방법은 수용성 합성수지를 제공하는 제공 단계; 상기 수용성 합성수지를 가수분해를 통하여 연화시키는 연화 단계; 상기 연화된 수용성 합성수지를 압축하는 압축 단계; 및 상기 압축된 수용성 합성수지를 탈수 또는 건조시키는 탈수축합 단계;를 포함한다.On the other hand, the compressed receptor manufacturing method for medical implants according to the present invention provides a step of providing a water-soluble synthetic resin; A softening step of softening the water-soluble synthetic resin through hydrolysis; Compressing the softened water-soluble synthetic resin; And a dehydration condensation step of dehydrating or drying the compressed water-soluble synthetic resin.
본 발명에 따른 의료용 보형물은 파우치; 상기 파우치 내에 구비되는 생리 식염수; 및 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로 형성되고, 상기 파우치 내에서 상기 생리 식염수에 의하여 연화된 상태로 구비되는 수용체;를 포함한다.Medical implants according to the present invention is a pouch; Physiological saline provided in the pouch; And a receptor formed of at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc) and provided in a softened state by the saline solution in the pouch.
다른 한편, 본 발명에 따른 의료용 보형물은 파우치; 상기 파우치에 구비되어, 유체가 상기 파우치 내로 인입되는 유입부; 및 상기 파우치 내에 수용성 플라스틱의 탈수 축합에 따른 건교체로서 구비되고, 상기 파우치 내로 유입되는 유체의 가수분해에 의하여 연화되는 수용체;를 포함한다.On the other hand, medical implants according to the present invention is a pouch; An inlet provided in the pouch and into which the fluid is introduced into the pouch; And a receptor provided as a dry substitute according to dehydration condensation of the water-soluble plastic in the pouch and softened by hydrolysis of the fluid flowing into the pouch.
이하 첨부된 도면을 참조하여 본 발명의 실시예를 설명한다. 특별한 정의나 언급이 없는 경우에 본 설명에 사용하는 방향을 표시하는 용어는 도면에 표시된 상태를 기준으로 한다. 또한 각 실시예를 통하여 동일한 도면부호는 동일한 부재를 가리킨다. 한편, 도면상에서 표시되는 각 구성은 설명의 편의를 위하여 그 두께나 치수가 과장될 수 있으며, 실제로 해당 치수나 구성간의 비율로 구성되어야 함을 의미하지는 않는다.Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Unless otherwise defined or mentioned, terms indicating directions used in the present description are based on the states shown in the drawings. In addition, the same reference numerals throughout the embodiments indicate the same member. On the other hand, each of the components shown in the drawings may be exaggerated in thickness or dimensions for the convenience of description, and does not mean that actually should be configured by the ratio between the dimensions or configurations.
도 1을 참조하여 본 발명의 일 실시예에 따른 의료용 보형물을 설명한다. 도 1은 본 발명의 일 실시예에 따른 의료용 보형물이 적용된 모습을 나타내는 개략도이다.A medical implant according to an embodiment of the present invention will be described with reference to FIG. 1. 1 is a schematic view showing a state in which a medical implant is applied according to an embodiment of the present invention.
도 1에 도시된 바와 같이 인체(B) 내, 특히 여성의 가슴 부위에 본 실시예에 따른 의료용 보형물(100)이 삽입될 수 있다. 다만, 도 1 및 이와 관련된 설명은 설명의 편의를 위한 예시적인 것으로서, 의료용 보형물(100)의 여성의 가슴의 수술에 한정되는 것은 아니다. 즉, 의료용 보형물은 여성의 가슴 수술을 위한 용도 이외에도 크기 및 형상의 변경을 통하여 인체의 다양한 부분에 적용될 수 있다. 예를 들면, 피부 함몰부 및 주름으로 패인 부위 등에 이용이 가능하며, 더 나아가서는 미용목적의 볼륨감 향상을 위하여 이용이 가능하다.As shown in FIG. 1, the medical implant 100 according to the present embodiment may be inserted into the human body B, particularly in the female breast region. 1 and related descriptions are provided for convenience of description and are not limited to surgery of a woman's chest of the medical implant 100. That is, the medical implant may be applied to various parts of the human body through changes in size and shape in addition to the use for women's chest surgery. For example, it is possible to use the skin recessed portion and wrinkles, etc., and furthermore, it is possible to use for improving the volume sense of cosmetic purposes.
본 실시예에 따른 의료용 보형물(100)은 파우치(110), 생리 식염수(W) 및 수용체(120; filler member)를 포함한다. 파우치(110)는 보형물(100)의 외형을 형성하도록 하드 타입의 실리콘 재질로 형성되며, 목적에 따라 약간의 탄성을 구비하거나 탄성이 없을 수 있다. 생리 식염수(W)와 수용체(120)는 파우치(110)의 내부에 수용된다. 파우치(110)의 내부에서 수용체(120)는 생리 식염수(W)에 의하여 연화된 상태로 구비된다. Medical implant 100 according to the present embodiment includes a pouch 110, physiological saline (W) and the receptor (filler member 120). The pouch 110 is formed of a hard type silicon material to form an outer shape of the implant 100, and may have some elasticity or no elasticity according to the purpose. Physiological saline (W) and the receptor 120 is accommodated inside the pouch (110). Receptor 120 inside the pouch 110 is provided in a softened state by physiological saline (W).
수용체(120)는 수용성 합성수지로 형성되어 생리 식염수(W)에 의하여 가수분해 됨으로써 연화된 상태로 파우치(110)의 내부에 구비될 수 있다. 이 때 수용성 합성수지로는 PVA(polyvinyl alcohol) 및/또는 PVAc(polyvinyle acetate)가 이용될 수 있다. The receptor 120 may be formed of a water-soluble synthetic resin and hydrolyzed by physiological saline (W) to be provided inside the pouch 110 in a softened state. In this case, PVA (polyvinyl alcohol) and / or PVAc (polyvinyle acetate) may be used as the water-soluble synthetic resin.
수용체(120)는 건교체(xerogel)로 제조된 후 파우치(110) 내에서 생리 식염수(W)와 반응하여 하이드로겔(hydrogel)로 존재하게 된다.The receptor 120 is made of xerogel and then reacts with physiological saline (W) in the pouch 110 to exist as a hydrogel.
하이드로겔(hydrogel)이란 어떤 물질을 보다 많은 양의 수분에 놓았을 때, 그 물질은 빠르게 팽윤(swelling)할 수 있고, 팽윤된 구조 내에 많은 양의 물을 유지할 수 있는 상태를 의미한다. 하이드로겔 상태로 존재하는 물질은 수분에 녹는다기 보다, 삼차원적인 구조를 유지한다. 그러한 수용액 상에서 구조를 이룬 젤을 하이드로겔이라 한다. 하이드로겔은 보통 화학적 결합이나 이온간의 상호작용, 수소결합 또는 소수성 작용과 같은 다른 결합력에 의해 가교된 친수성 고분자 합성수지로 만들어진다. Hydrogel refers to a state in which when a substance is placed in a larger amount of water, the substance can swell quickly and maintain a large amount of water in the swollen structure. Substances present in the hydrogel state retain a three-dimensional structure rather than dissolve in water. Gels formed on such aqueous solutions are called hydrogels. Hydrogels are usually made of hydrophilic polymer resins that are crosslinked by other bonding forces such as chemical bonds, ionic interactions, hydrogen bonding or hydrophobic action.
하이드로겔이라는 용어는 물질이 수분에 이미 팽윤되었을 때 적용된다. 건조된 젤은 건교체(xerogel 또는 dry gel)라 부른다. 건조하는 과정동안 수분은 젤로부터 증발하고, 표면장력은 젤 자체의 으스러짐을 야기한다. 따라서 젤은 아주 작은 분율의 팽윤된 크기로 수축된다. 수분이 동결건조나 유기용매를 이용한 추출에 의해 고분자 구조가 흐트러짐 없이 제거된다면, 그 때 남아있는 물질은 높은 다공성을 지닌 극히 가벼운 무게를 갖는다. 그렇게 탈 수소화된 하이드로겔은 건교체(xerogel) 혹은 스폰지(sponge)라 부른다. The term hydrogel is applied when the material is already swollen in water. Dried gels are called xerogels or dry gels. During the drying process, moisture evaporates from the gel, and the surface tension causes the gel to crush itself. Thus the gel shrinks to a very small fraction of swollen size. If moisture is removed without disruption of the polymer structure by lyophilization or extraction with organic solvents, then the remaining material has an extremely light weight with high porosity. Such dehydrogenated hydrogels are called xerogels or sponges.
이하에서는 설명의 편의를 위하여 제조 단계에서의 수용체 또는 생리 식염수에 담기지 않고 건조된 수용체를 특히 건교체라 하고, 생리 식염수에 담긴 수용체를 특히 하이드로겔이라 칭한다.Hereinafter, for convenience of explanation, a receptor dried in a manufacturing step or in a physiological saline solution is called a dry substitute, and a receptor in a physiological saline solution is particularly called a hydrogel.
한편, 폴리비닐 알코올(Polyvinyl alcohol, 이하 PVA)은 폴리비닐 아세테이트(polyvinyl acetate, 이하 PVAc)의 가수분해를 통해 얻어지는 친수성 고분자 합성수지이다. PVA의 가교결합은 화학적인 방법과 물리적인 방법을 통해 이루어진다. 화학적 가교결합은 PVA의 hydroxyl group과 aldehyde계 용액에 산성 상태의 가교제가 결합하여 겔(gel)을 형성한다. 물리적 가교결합의 대표적인 방법으로는 동결 융해법(freeze-thawing)이 있다. 동결융해법으로 제조된 하이드로겔은 독성이 거의 없고, 불순물 또한 포함하지 않으며 약 80 내지 90%의 수분을 함유하고 있다. 또한 가교제를 사용하지 않기 때문에 매력적인 생체의료용 하이드로겔로 사용이 가능하다.Meanwhile, polyvinyl alcohol (hereinafter referred to as PVA) is a hydrophilic polymer synthetic resin obtained through hydrolysis of polyvinyl acetate (hereinafter referred to as PVAc). Crosslinking of PVA occurs through chemical and physical methods. In chemical crosslinking, an acidic crosslinking agent binds to a hydroxyl group and an aldehyde solution of PVA to form a gel. Representative methods of physical crosslinking are freeze-thawing. Hydrogels prepared by the freeze thawing method have little toxicity, contain no impurities, and contain about 80 to 90% water. In addition, since it does not use a crosslinking agent, it can be used as an attractive biomedical hydrogel.
즉, 실리콘겔의 경우 최외곽 파우치가 파손되는 경우 외부로 흘러나가 생체조직에 흡수되어 괴사를 일으킬 수 있는 염려가 있는 반면, 본 실시예에서와 같은 PVA 하이드로겔의 경우에는 최외곽의 파우치가 파손되는 경우에도 일정한 형태를 유지하고 있으므로 외부로 유출될 염려가 적으며 유출되는 경우라도 생체적합성이 높아 생체 조직을 괴사시킬 우려가 없다.That is, in the case of the silicone gel, when the outermost pouch is broken, there is a concern that it may flow to the outside and be absorbed into the biological tissue, causing necrosis, whereas in the case of the PVA hydrogel as in this embodiment, the outermost pouch is broken. Even if it is kept in a certain form is less likely to leak to the outside, even if spilled biocompatibility is high, there is no fear of necrotic tissue.
도 2 및 도 3을 참조하여 일 실시예에 따른 수용체 및 그 제조방법을 설명한다. 도 2는 일 실시예에 따른 수용성 합성수지 및 의료 보형물용 건교체의 제조방법을 나타내는 블록도이고, 도 3은 일 실시예에 따른 의료 보형물용 건교체의 제조 및 이용방법을 나타내는 모식도이다.Referring to Figures 2 and 3 will be described in the receptor and its manufacturing method according to an embodiment. FIG. 2 is a block diagram illustrating a method of manufacturing a water-soluble synthetic resin and a dry replacement for a medical implant according to an embodiment, and FIG. 3 is a schematic view showing a method of manufacturing and using a dry replacement for a medical implant according to an embodiment.
PVA 건교체는 젖은 상태에서는 탄력이 우수하고 매우 부드러운 반면 건조된 상태에서는 딱딱해지는 특징이 있어, 반도체 웨이퍼의 세정용 롤러(roller), TFT LCD용 글라스의 세정 및 반송용 롤러의 제조에 사용될 뿐만 아니라, 의료용 거즈, 미용타올, 스포츠타올, 주방용 발판 매트, 미생물용 담채의 재료로 사용되는 등 그 활용도가 매우 높다.PVA dry substitutes are characterized by excellent elasticity and very softness in wet conditions and hardness in dried conditions, which are not only used for cleaning rollers for semiconductor wafers, glass for TFT LCDs, and for manufacturing rollers. It is also used as a material for medical gauze, beauty towels, sports towels, kitchen scaffolding mats, and microbial tins.
PVA 건교체의 원료인 PVA는 물 이외의 보통의 유기용매에는 녹지 않는 백색 분말로 섭씨 140도 정도까지는 안정한 상태를 유지한다. 직물(織物)의 풀, 종이의 사이징이나 에멀션화안정제(乳化安定劑) 등으로 사용된다. 이러한 PVA를 원료로 PVA 건교체를 제조(S10)한다. PVA와 물을 일정 비율로 섞은 다음 가열하여 PVA 수용액을 얻은 다음에 기공형성제로 옥수수 전분 등을 투입하고, 포르말린(formalin) 등을 투입하여 교반시킨 다음, 촉매재로 황산(H2SO4) 등을 투입한 후, 미리 준비된 금형에 주입하여 가열하여 아세탈화시키면 PVA 건교체가 된다. 이렇게 아세탈화된 PVA 건교체를 금형에서 추출하여 충분히 세척한 후 규격에 따라 절단 및 가공하여 제품화한다.PVA, a raw material of PVA dry substitute, is a white powder that is insoluble in ordinary organic solvents other than water, and remains stable up to about 140 degrees Celsius. It is used as a paste for textiles, sizing of paper or an emulsifying stabilizer. PVA dry substitute is manufactured from the PVA as a raw material (S10). After mixing PVA and water in a certain ratio, the mixture was heated to obtain a PVA aqueous solution, followed by adding corn starch as a pore-forming agent, adding formalin and stirring, and then adding sulfuric acid (H 2 SO 4) as a catalyst. Then, it is injected into a mold prepared in advance, heated and acetalized to form a PVA dry substitute. The acetalized PVA dry substitute is extracted from the mold and thoroughly washed, and then cut and processed according to specifications to produce a product.
이러한 PVA 스폰지 제조방법은 유해물질의 사용 규제가 확산되는 추세에도 불구하고, 사용규제물질인 포르말린(formalin) 또는 파라포름알데히드(paraformaldehyde)를 사용하지 않으면 아니 되는 문제점이 있다.The PVA sponge manufacturing method has a problem in that even though the use regulation of harmful substances is spread, formalin or paraformaldehyde, which is a use restriction substance, must be used.
환경규제물질의 사용을 피하고 제조 작업장의 환경도 개선시킬 수 있도록 다음과 같은 방법을 이용하여 PVA 건교체를 제조하는 것도 가능하다.It is also possible to manufacture PVA dry substitutes using the following methods to avoid the use of environmentally regulated materials and to improve the environment of the manufacturing workplace.
먼저, 물에 물 중량의 16~21%의 PVA 수지를 계량하여 섞은 후 섭씨 30도 이상의 온도로 가열하여 PVA 수용액을 얻고, PVA 수용액에 기공형성제로 옥수수 전분 등을 형성시키고자 하는 기공의 비율에 따라 상기 PVA 수용액의 25~45% 투입한다. 이와 별도로, 물에 물 중량의 28~35%의 헥사메틸렌 테트라민[hexamethylene tetramine]을 투입하여 섭씨 40도 이상의 온도로 가열하여 헥사메틸렌 테트라민 수용액을 얻는다.First, the PVA resin of 16-21% of the water weight is weighed and mixed with water, and then heated to a temperature of 30 degrees Celsius or more to obtain an aqueous PVA solution, and to the ratio of pores to form corn starch as a pore-forming agent in the PVA aqueous solution. Accordingly 25 to 45% of the PVA aqueous solution. Separately, hexamethylene tetramine of 28 to 35% of the weight of water is added to water and heated to a temperature of 40 degrees Celsius or more to obtain an aqueous solution of hexamethylene tetramine.
PVA 수용액에 PVA 수용액의 12~18%의 헥사메틸렌 테트라민 수용액을 투입하여 교반시켜서 PVA 및 헥사메틸렌 테트라민 수용액을 얻은 후, 희석농도가 약 50%인 황산수용액 등 산 계열의 촉매제를 전체 수용액의 19~21% 투입한다. 이후 미리 준비한 금형에 주입하여 오븐에 넣고 섭씨 62~80도의 온도로 29~34 시간 가열(숙성)하여 아세탈화시킨다. 이렇게 아세탈화된 PVA 스폰지를 금형에서 추출하여 충분히 세척한 후 규격에 따라 절단 및 가공하여 제품화한다.12 to 18% hexamethylene tetramine aqueous solution of PVA aqueous solution was added to the PVA aqueous solution, followed by stirring to obtain an aqueous PVA and hexamethylene tetramine aqueous solution. Then, an acid-based catalyst such as an aqueous sulfuric acid solution having a dilution concentration of about 50% was added to the aqueous solution. 19-21% After that, it is injected into a mold prepared in advance, placed in an oven, and heated (aged) for 29 to 34 hours at a temperature of 62 to 80 degrees Celsius to be acetalized. The acetalized PVA sponge is extracted from the mold and thoroughly washed, and then cut and processed according to the specifications to produce a product.
제조된 건교체는 다시 압축을 위하여 연화시킨다.(S20) 다만, 본 건교체의 연화단계는 이후의 압축(S30) 단계를 수행하기 위하여 단순히 필요한 단계로서 수용성 합성수지의 제공 단계(S10)와 동일한 단계에서 수행되는 것도 가능하며, 반드시 수용성 합성수지 제공단계(S10)와 별도의 단계로 수행되어야 하는 것은 아니다.The manufactured dry substitute is softened again for compression. (S20) However, the softening step of the present dry substitute is simply necessary to perform a subsequent compression (S30) step, and the same step as that of providing a water-soluble synthetic resin (S10). It is also possible to be carried out in, and is not necessarily to be performed in a separate step from the water-soluble synthetic resin providing step (S10).
한편, 하이드로겔 상태의 수용체를 탈수 축합하여 건조시키는 경우 앞서 설명한 바와 같이 수분이 빠져나가면서 일정 부피 줄어듦과 동시에 굳은 상태가 된다. 그러나 하이드로젤 상태의 수용체를 단순히 탈수 축합시키는 경우 부피의 감소가 미비한 수준에 그치게 된다. 따라서 본 실시예에서는 하이드로겔 상태의 수용체를 건조 또는 탈수축합시키기 전에 압축공정을 더 수행한다. 본 실시예에 따른 압축 단계(S30)에서는 하이드로겔 상태의 수용체를 롤링(rolling up), 폴딩(folding), 트위스팅(twisting) 및 프레싱(pressing) 등 중 하나 또는 둘 이상의 조합으로 압축공정을 수행하는 것이 가능하다.On the other hand, in the case of drying by dehydrating condensation of the hydrogel receptor as described above, as the water escapes, a certain volume decreases and becomes a solid state. However, simply dehydrating condensate receptors in the hydrogel state results in insignificant volume reduction. Therefore, in the present embodiment, a compression process is further performed before drying or dehydrating the hydrogel receptor. In the compression step S30 according to the present embodiment, the compression process is performed by one or two or more combinations of rolling up, folding, twisting, pressing, and the like in a hydrogel state. It is possible to do
이후 압축된 수용체를 건조 또는 탈수 함으로써 건교체 상태로 만들 수 있다(S40).Thereafter, by drying or dehydrating the compressed receptor, it may be made into a dry state (S40).
도 3을 참조하여 설명하면, 연화된 상태에서의 수용체(HG)를 건조 전에 압축(II)및 탈수 축합(III)을 통하여 건교체(XG)로 만든 후 보형물 내에서 사용시에는 다시 가수분해를 유도하여 하이드로겔(HG) 상태로 변환(IV)시키게 된다.Referring to FIG. 3, the receptor (HG) in the softened state was made into dry substitutes (XG) through compression (II) and dehydration condensation (III) before drying, and then induced hydrolysis when used in the implant. It is converted to the hydrogel (HG) state (IV).
이하에서는 다양한 실시예에 따른 의료용 보형물들을 설명한다. 또한 이하의 실시예에서는 앞서 설명한 압축된 건교체를 이용하여 보형물을 제조하는 것이 바람직하다. 압축된 건교체를 이용하여 의료용 보형물을 제조함으로써 수술 시에 환자의 절개 부위를 최소화하거나 제조 단계에서의 보관, 이송 등의 공간적 효율을 향상시킬 수 있다. Hereinafter, medical implants according to various embodiments will be described. In addition, in the following embodiments it is preferable to manufacture the implant using the compressed dry substitute described above. By manufacturing a medical implant using a compressed dry substitute, it is possible to minimize the incision site of the patient during surgery or to improve spatial efficiency such as storage and transport at the manufacturing stage.
먼저 도 4를 참조하여 일 실시예에 따른 의료용 보형물을 설명한다. 도 4는 일 실시예에 따른 의료용 보형물을 나타내는 단면도이다.First, a medical implant according to an embodiment will be described with reference to FIG. 4. 4 is a cross-sectional view showing a medical implant according to an embodiment.
본 실시예에 따른 의료용 보형물(100)은 파우치(110)의 내측에 구비되는 수용체(120)가 단일의 고형물로 형성된다는 점에서 특징이 있다. Medical implant 100 according to the present embodiment is characterized in that the receptor 120 provided inside the pouch 110 is formed of a single solid.
구체적으로 파우치(110)는 의료용 보형물(100)의 외형을 형성한다. 파우치(110)는 목적하는 용적 및 모양에 따른 체적 및 모양을 갖도록 미리 형성된다. 파우치(110)는 의료용으로 사용되고 있는 하드 타입의 실리콘을 이용하여 제조할 수 있다.Specifically, the pouch 110 forms the outer shape of the medical implant 100. The pouch 110 is preformed to have a volume and shape according to the desired volume and shape. The pouch 110 may be manufactured using a hard type silicon that is used for medical purposes.
파우치(110)의 내측에는 체성분에 유사한 생리 식염수(W)가 구비되며, 생리 식염수(W)에는 단일 고형물로서 수용체(120)가 구비된다.The inside of the pouch 110 is provided with a physiological saline (W) similar to the body composition, the physiological saline (W) is provided with a receptor 120 as a single solid.
수용체(120)는 목적하는 의료용 보형물(100)의 체적 및 탄성에 따라 다양한 크기 및 형상으로 형성될 수 있다. 압축된 건교체를 이용하는 경우 건교체가 하이드로겔 상태로 변환 시에 팽창될 부피를 감안하여 건교체를 제조한다. 이 때 제조된 의료용 보형물(100)의 탄성을 높이거나 낮추기 위해서 건교체의 부피를 더 크게 형성하거나 작게 형성하는 등의 조절이 가능하다. 다만, 건교체가 팽창하는 것을 감안하여 건교체 자체의 크기는 파우치(110)의 체적을 넘지 않도록 제조하는 것이 바람직하다. The receptor 120 may be formed in various sizes and shapes according to the volume and elasticity of the desired medical implant 100. In the case of using a compressed dry replacer, the dry replacer is prepared in consideration of the volume to be expanded when the dry replacer is converted into a hydrogel state. At this time, in order to increase or decrease the elasticity of the manufactured medical implant 100, it is possible to control such as forming a larger or smaller volume of the dry body. However, in consideration of the expansion of the dry replacement, it is preferable that the size of the dry replacement itself is manufactured so as not to exceed the volume of the pouch 110.
한편, 앞서 설명한 바와 같이 건교체는 부피의 팽창 및 수축율을 더 향상시키기 위하여 다공성 재질, 스폰지 형태로 제조하는 것이 바람직하다.On the other hand, as described above, the dry substitute is preferably manufactured in the form of a porous material, sponge in order to further improve the expansion and shrinkage of the volume.
이와 같이 제조된 의료용 보형물(100)은 단순히 생리 식염수만 수용되어 있는 의료용 보형물과는 달리 하이드로겔 상태로 수용된 PVA 및/또는 PVAc에 의하여 향상된 촉감을 갖게 되며, 파우치(110)가 파손되는 경우에도 생리 식염수만 유출되므로 인체에 무해하며, PVA 또는 PVAc 하이드로겔이 유출되는 경우에도 생체 적합성이 높아 조직 괴사 등의 문제가 발생하지 않는다.The medical implant 100 prepared as described above has a tactile feeling enhanced by PVA and / or PVAc accommodated in a hydrogel state, unlike a medical implant containing only physiological saline, and even when the pouch 110 is damaged. Since only saline is leaked, it is harmless to the human body, and even when PVA or PVAc hydrogels are leaked, high biocompatibility does not cause problems such as tissue necrosis.
도 5를 참조하여 다른 실시예에 따른 의료용 보형물을 설명한다. 도 5는 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.A medical implant according to another embodiment will be described with reference to FIG. 5. 5 is a cross-sectional view showing a medical implant according to another embodiment.
본 실시예는 내부에 포함되는 수용체(120a)가 복수개의 고형물로 나누어진다는 점에서 앞서 설명한 도 4의 실시예와 차이가 있다.This embodiment is different from the embodiment of FIG. 4 described above in that the receptor 120a included therein is divided into a plurality of solids.
즉, 수용체(120a)는 단일의 고형체로 포함되는 대신 일정 크기를 갖는 작은 덩어리로서 파우치(110) 내에 수용될 수 있다. 이 경우 앞서 설명한 실시예에 비하여 수용체(120a)가 팽창되는 과정에서 파우치(110) 내에서의 수용체(120a)의 위치 확보가 더욱 용이한 효과가 있다.That is, the receptor 120a may be accommodated in the pouch 110 as a small mass having a predetermined size instead of being included as a single solid body. In this case, as compared with the above-described embodiment, securing the position of the receptor 120a in the pouch 110 may be more easily performed in the process of expanding the receptor 120a.
수용체(120a)의 상태 등 기타 조건들은 앞서 설명한 실시예와 큰 차이가 없다.Other conditions such as the state of the receptor (120a) is not significantly different from the above-described embodiment.
도 6 및 도 7을 참조하여 또 다른 실시예에 따른 의료용 보형물을 설명한다. 도 6 및 도 7은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.A medical implant according to another embodiment will be described with reference to FIGS. 6 and 7. 6 and 7 are cross-sectional views showing a medical implant according to another embodiment.
본 실시예는 수술 시의 용이성을 극대화하기 위한 구성 및 구조를 갖는다는 점에서 앞서 설명한 실시예와 차이가 있다.This embodiment is different from the above-described embodiment in that it has a configuration and structure to maximize the ease of surgery.
본 실시예에 따른 의료용 보형물(100b)은 제조 단계에서는 생리 식염수를 포함하지 않는다. Medical implant 100b according to the present embodiment does not include physiological saline at the manufacturing stage.
구체적으로, 제조 단계에서는 도 6에 도시된 바와 같이 파우치(110) 내에 수용체(120b)의 건교체, 바람직하게는 압축된 건교체가 수용된 상태로 제조된다. 다만, 파우치(110)의 일 측에 유입부(112)가 구비된다. 유입부(112)는 유체가 유입될 수 있는 밸브와 같은 역할을 하며, 유체의 주입은 용이한 동시에 유입된 유체가 외부로 유출되지 않도록 1웨이 밸브(one way valve)를 이용하는 것이 바람직하다.Specifically, in the manufacturing step, as shown in FIG. 6, the pouch 110 is manufactured in a state where a dry substitute, preferably a compressed dry substitute, of the receptor 120b is accommodated. However, the inlet 112 is provided on one side of the pouch 110. The inlet 112 serves as a valve through which the fluid can be introduced, and it is preferable to use a one-way valve to facilitate the injection of the fluid and to prevent the inflowed fluid from flowing out.
이와 같이 제조된 의료용 보형물(100b)을 이용하여 수술을 진행할 수 있다. 예를 들어, 환자의 수술 시 절개부위를 통하여 도 6에 도시된 의료용 보형물을 삽입한 후 유입부(112)를 통하여 생리 식염수를 주입할 수 있다. 이 경우 도 7에 도시된 바와 같이 유입된 생리 식염수(W)에 의하여 수용체(120b)가 팽윤상태가 되어 압축되기 이전의 체적 및 모양으로 복원된다. 파우치(110) 내에 생리 식염수가 유입되고, 내부의 수용체(120b)가 팽창됨에 따라 의료용 보형물(100b)은 환자의 체내에서 의도된 체적, 모양 및 탄성을 갖게 된다. Surgery may be performed using the medical implant 100b manufactured as described above. For example, physiological saline may be injected through the inlet 112 after inserting the medical implant shown in FIG. 6 through the incision site during surgery of the patient. In this case, as shown in FIG. 7, the receptor 120b is swelled by the physiological saline W introduced thereto, and is restored to the volume and shape before compression. As the saline solution is introduced into the pouch 110 and the receptor 120b is expanded, the medical implant 100b has an intended volume, shape, and elasticity in the patient's body.
이와 같이 수술 시에는 도 6에 도시된 바와 같이 최소화된 체적 및 삽입이 용이한 형태로 변형이 가능한 상태로 환자의 체내에 삽입되는 반면, 체내에 삽입된 후에는 생리 식염수를 보형물 내에 주입함으로써 원래 의도된 형상으로 복원되도록 함으로써 앞서 설명한 실시예들과 동일한 효과를 얻을 수 있기 때문에 환자의 절개 부위를 최소화할 수 있다.As such, during surgery, the volume is inserted into the patient's body in a state capable of being transformed into a minimized volume and an easy-to-insert shape, whereas after being inserted into the body, physiological saline is injected into the implant. Since the same effect as the above-described embodiments can be obtained by restoring the shape, the incision site of the patient can be minimized.
도 8 내지 도 12를 참조하여 또 다른 실시예에 따른 의료용 보형물을 설명한다. 도 8은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이고, 도 9 및 도 10은 각각 종래의 의료용 보형물과 도 8의 의료용 보형물의 모습을 개략적으로 나타내는 사시도이며, 도 11 및 도 12는 조합가능한 실시예들을 나타내는 단면도이다.A medical implant according to another embodiment will be described with reference to FIGS. 8 to 12. 8 is a cross-sectional view illustrating a medical implant according to still another embodiment, and FIGS. 9 and 10 are perspective views schematically illustrating a conventional medical implant and a medical implant of FIG. 8, respectively, and FIGS. 11 and 12 may be combined. Sectional drawing showing embodiments.
본 실시예에 따른 의료용 보형물(100c)는 도 8에 도시된 바와 같이 파우치(110)의 내벽에 별도의 층을 형성하는 수용체(120c)가 구비된다는 점에서 차이가 있다. 이 때 수용체(120c)는 파우치(110)의 내벽 전체에 부착되는 것도 가능하며, 파우치(110) 내벽 중 주름이 형성되기 쉬운 위치 등의 일부에만 부착되는 것도 가능하다. 이 때 수용체(120c)는 스트랩(strap), 플레이트(plate) 등의 형상으로 형성될 수 있다.The medical implant 100c according to the present embodiment has a difference in that a receptor 120c is formed on an inner wall of the pouch 110 as illustrated in FIG. 8. In this case, the receptor 120c may be attached to the entire inner wall of the pouch 110, or may be attached only to a part of the inner wall of the pouch 110 where wrinkles are easily formed. In this case, the receptor 120c may be formed in the shape of a strap, a plate, or the like.
단일의 실리콘 파우치를 이용하는 종래의 보형물의 경우 도 9에 도시된 바와 같이 사용 상태에 따라 보형물에 주름이 형성되고, 이러한 주름이 인체의 외형에 그대로 반영되어 외관면에서의 문제점을 유발하는 경우가 있었다. 이를 보완하기 위하여 2겹 이상의 실리콘 파우치를 쓰는 경우에는 앞서 설명한 바와 같이 촉감이나 모양 등의 면에서 문제가 발생할 수 있었다.In the case of a conventional implant using a single silicon pouch, as shown in FIG. 9, wrinkles are formed in the implant according to the use state, and these wrinkles are reflected in the appearance of the human body, causing problems in appearance. . In order to compensate for this, when using two or more layers of silicon pouches, problems such as touch and shape may occur as described above.
그러나 본 실시예와 같이 실리콘 파우치의 내벽에 수용체를 부착하여 별도의 층을 형성하는 경우에는 해당 수용체가 생리 식염수 내에서 하이드로겔로 존재하기 때문에 촉감 면에서의 기준을 만족하면서도 파우치의 두께를 보상하는 효과를 얻을 수 있기 때문에 도 10에 도시된 바와 같이 주름이 형성되는 것을 최대한 방지 할 수 있다.However, in the case of forming a separate layer by attaching a receptor to the inner wall of the silicon pouch as shown in the present embodiment, since the receptor is present as a hydrogel in physiological saline, it satisfies the criteria in terms of touch and compensates for the thickness of the pouch. Since the effect can be obtained, as shown in FIG. 10, wrinkles can be prevented as much as possible.
이와 같이 파우치의 내측에 별도의 수용체를 이용한 층을 형성하는 것은 앞서 설명한 각 실시예들과 함께 구현될 수 있다. 예를 들어 도 11에 도시된 바와 같이 별도의 층을 형성하는 수용체(120c) 내부에 단일의 고형체로 형성된 또 다른 수용체(120)를 구비하는 것도 가능하고, 도 12에 도시된 바와 같이 별도의 층을 형성하는 수용체(120c) 내부에 다수의 고형체로 형성된 또 다른 수용체들(120a)을 구비하는 것도 가능하다.As such, forming a layer using a separate receptor inside the pouch may be implemented with the above-described embodiments. For example, it is possible to have another receptor 120 formed of a single solid body inside the receptor 120c forming a separate layer, as shown in FIG. 11, and as shown in FIG. 12. It is also possible to have further receptors 120a formed of a plurality of solids inside the receptor 120c forming the same.
도 13을 참조하여 다른 형태의 실시예에 따른 의료용 보형물을 설명한다. 도 13은 또 다른 실시예에 따른 의료용 보형물을 나타내는 단면도이다.A medical implant according to another embodiment will be described with reference to FIG. 13. 13 is a cross-sectional view showing a medical implant according to another embodiment.
본 실시예에 따른 의료용 보형물(100f)은 파우치(110)의 파손을 더 효과적으로 방지하기 위하여 두겹의 파우치(110a, 110b)를 채용한다는 점에서 특유의 효과가 있다. Medical implant 100f according to the present embodiment has a unique effect in that it employs two pouches (110a, 110b) to more effectively prevent damage to the pouch (110).
구체적으로, 도 13에 도시된 바와 같이 파우치(110)는 내부 파우치(110b)와 외부 파우치(110a)의 두 겹으로 구성될 수 있다. 내부 파우치(110b)와 외부 파우치(110a)는 각각 동일한 성분으로 형성될 수 있으며, 내부 파우치(110b)와 외부 파우치(110a) 사이에는 실리콘겔(115)로 채워질 수 있다.Specifically, as illustrated in FIG. 13, the pouch 110 may be configured as two layers of the inner pouch 110b and the outer pouch 110a. The inner pouch 110b and the outer pouch 110a may be formed of the same component, respectively, and may be filled with the silicon gel 115 between the inner pouch 110b and the outer pouch 110a.
다만 실리콘겔(115) 대신 촉감의 향상을 위하여 PVA 하이드로겔로 대체하는 것도 가능하다.However, it is also possible to replace with PVA hydrogel instead of the silicone gel 115 to improve the feel.
이외의 내측 구성들은 앞서 설명한 실시예들과 차이가 없으며, 각 실시예가 적용되거나 또는 각 실시예들의 조합에 의하여 구현될 수 있다.Other inner configurations are not different from the above-described embodiments, and each embodiment may be applied or implemented by a combination of the embodiments.
이상 본 발명의 바람직한 실시예에 대하여 설명하였으나, 본 발명의 기술적 사상이 상술한 바람직한 실시예에 한정되는 것은 아니며, 특허청구범위에 구체화된 본 발명의 기술적 사상을 벗어나지 않는 범주에서 다양하게 구현될 수 있다.Although the preferred embodiment of the present invention has been described above, the technical idea of the present invention is not limited to the above-described preferred embodiment, and may be variously implemented in a range without departing from the technical idea of the present invention specified in the claims. have.

Claims (32)

  1. 하이드로젤 상태로부터 단순 탈수 축합에 의한 수축율에 비하여 더 큰 수축율로 압축 및 탈수 축합되는 건교체를 포함하는 의료 보형물용 압축 수용체.A compression receptor for a medical implant comprising a dry substitute which is compressed and dehydrated condensed at a greater shrinkage rate than a shrinkage rate due to simple dehydration condensation from a hydrogel state.
  2. 제1항에 있어서,The method of claim 1,
    상기 건교체는 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로 형성되는 의료 보형물용 압축 수용체.The dry substitute is a compression receptor for medical implants formed of at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc).
  3. 제1항에 있어서,The method of claim 1,
    상기 건교체는 다공성 재질로 형성되는 의료 보형물용 압축 수용체.The dry substitute is a compression receptor for medical implants formed of a porous material.
  4. 제1항에 있어서,The method of claim 1,
    상기 건교체는 생체 적합성을 갖는 재질로 형성되는 의료 보형물용 압축 수용체.The dry substitute is a compression receptor for a medical implant is formed of a material having biocompatibility.
  5. 제1항에 있어서,The method of claim 1,
    상기 건교체는 최대 압축 가능한 체적보다는 크고 상기 건교체가 수용될 대상물의 체적보다는 같거나 작은 체적을 갖도록 제조되는 의료 보형물용 압축 수용체.Wherein said dry replacement is made to have a volume greater than the maximum compressible volume and having a volume equal to or less than the volume of the object to be accommodated.
  6. 제1항에 있어서,The method of claim 1,
    상기 건교체는 덩어리, 스트랩 및 플레이트 중 어느 하나의 형상으로 형성되는 의료 보형물용 압축 수용체.The dry substitute is a compression receptor for a medical implant is formed in the shape of any one of a lump, strap and plate.
  7. 수용성 합성수지를 제공하는 제공 단계;Providing a water-soluble synthetic resin;
    상기 수용성 합성수지를 가수분해를 통하여 연화시키는 연화 단계;A softening step of softening the water-soluble synthetic resin through hydrolysis;
    상기 연화된 수용성 합성수지를 압축하는 압축 단계; 및Compressing the softened water-soluble synthetic resin; And
    상기 압축된 수용성 합성수지를 탈수 또는 건조시키는 탈수축합 단계;를 포함하는 의료 보형물용 압축 수용체 제조 방법.Dehydration or condensation step of dehydrating or drying the compressed water-soluble synthetic resin; Compression receptor manufacturing method for medical implants comprising a.
  8. 제7항에 있어서,The method of claim 7, wherein
    상기 제공 단계에는 PVA 또는 PVAc로부터 PVA 스폰지를 제조하는 단계를 더 포함하는 의료 보형물용 압축 수용체 제조 방법.Said providing step further comprises the step of preparing a PVA sponge from PVA or PVAc.
  9. 제8항에 있어서,The method of claim 8,
    상기 PVA 스폰지 제조 단계는,The PVA sponge manufacturing step,
    PVA 및 물을 혼합하여 PVA 수용액을 얻는 단계;Mixing PVA and water to obtain an aqueous PVA solution;
    상기 PVA 수용액에 기공형성제를 투입 및 교반하는 단계;Adding and stirring a pore-forming agent to the PVA aqueous solution;
    상기 교반 단계 후 가열하여 아세탈화시키는 단계;를 포함하는 의료 보형물용 압축 수용체 제조 방법.Acetalization by heating after the stirring step; Compression receptor manufacturing method for a medical implant comprising a.
  10. 제9항에 있어서,The method of claim 9,
    상기 PVA 스폰지 제조 단계는,The PVA sponge manufacturing step,
    PVAc를 가수분해하여 PVA 수용액을 얻는 단계;Hydrolyzing PVAc to obtain an aqueous PVA solution;
    상기 PVA 수용액에 기공형성제를 투입 및 교반하는 단계;Adding and stirring a pore-forming agent to the PVA aqueous solution;
    상기 교반 단계 후 가열하여 아세탈화시키는 단계;를 포함하는 의료 보형물용 압축 수용체 제조 방법.Acetalization by heating after the stirring step; Compression receptor manufacturing method for a medical implant comprising a.
  11. 제7항에 있어서,The method of claim 7, wherein
    상기 압축 단계에서는 롤링(rolling up), 폴딩(folding) 및 프레싱(pressing) 중 어느 하나의 방법 또는 둘 이상의 방법을 조합하여 상기 연화된 수용성 합성수지를 압축하는 의료 보형물용 압축 수용체 제조 방법.In the compressing step, a method for producing a compression receptor for medical implants which compresses the softened water-soluble synthetic resin by any one of rolling up, folding and pressing or a combination of two or more methods.
  12. 파우치;pouch;
    상기 파우치 내에 구비되는 생리 식염수; 및Physiological saline provided in the pouch; And
    PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로부터 형성되고, 상기 파우치 내에서 상기 생리 식염수에 의하여 연화된 상태로 구비되는 수용체;를 포함하는 의료용 보형물.A medical implant comprising: a receptor formed from at least one of polyvinyl alcohol (PVA) and polyvinyle acetate (PVAc), and being provided in a softened state by the saline solution in the pouch.
  13. 제1항에 있어서,The method of claim 1,
    상기 파우치는 실리콘 및 폴리우레탄 중 적어도 어느 하나의 재질로 형성되는 의료용 보형물.The pouch is medical implants formed of at least one material of silicone and polyurethane.
  14. 제12항에 있어서,The method of claim 12,
    상기 수용체는 PVA 및 PVAc 중 적어도 어느 하나의 건교체(xerogel)가 상기 생리 식염수에 의하여 팽윤된 상태로 구비되는 의료용 보형물.The receptor is a medical implant that is provided with at least one of the xerogel (Serogel) swelled by the physiological saline of PVA and PVAc.
  15. 제14항에 있어서,The method of claim 14,
    상기 건교체는 다공성 재질로 형성되는 의료용 보형물.The dry replacement is a medical implant formed of a porous material.
  16. 제14항에 있어서,The method of claim 14,
    상기 건교체는 상기 하이드로젤의 탈수축합에 의하여 수축되는 체적보다 더 적은 체적을 갖도록 압축된 상태로 제조되는 의료용 보형물.The dry replacement is a medical implant is manufactured in a compressed state to have a volume smaller than the volume shrinked by the dehydration of the hydrogel.
  17. 제14항에 있어서,The method of claim 14,
    상기 건교체는 상기 파우치의 체적 이하의 크기를 갖도록 형성되는 의료용 보형물.The dry replacement is a medical implant is formed to have a size less than the volume of the pouch.
  18. 제14항에 있어서,The method of claim 14,
    상기 건교체는 적어도 둘 이상의 분리된 고형물로 형성되는 의료용 보형물.The dry replacement is a medical implant formed of at least two separated solids.
  19. 제18항에 있어서,The method of claim 18,
    상기 스폰지의 크기는 2 종류 이상의 크기의 조합으로 형성되는 의료용 보형물.The size of the sponge is a medical implant formed by a combination of two or more types of sizes.
  20. 제12항에 있어서,The method of claim 12,
    상기 파우치의 내측면에는 적어도 일부에 상기 수용체가 부착되는 의료용 보형물.Medical implant to which the receptor is attached to at least a portion on the inner side of the pouch.
  21. 제20항에 있어서,The method of claim 20,
    상기 파우치의 내측에 부착되는 수용체는 의료용 실리콘 접착제에 의하여 부착되는 의료용 보형물.Receptacle attached to the inside of the pouch is a medical implant attached by a medical silicone adhesive.
  22. 파우치;pouch;
    상기 파우치에 구비되어, 유체가 상기 파우치 내로 인입되는 유입부; 및An inlet provided in the pouch and into which the fluid is introduced into the pouch; And
    상기 파우치 내에 수용성 플라스틱의 탈수 축합에 따른 건교체로서 구비되고, 상기 파우치 내로 유입되는 유체의 가수분해에 의하여 연화되는 수용체;를 포함하는 의료용 보형물.And a receptor provided as a dry substitute according to dehydration condensation of the water-soluble plastic in the pouch and softened by hydrolysis of the fluid flowing into the pouch.
  23. 제22항에 있어서,The method of claim 22,
    상기 수용체는 생체 적합성을 갖는 재질로 형성되는 의료용 보형물.The receptor is a medical implant formed of a material having biocompatibility.
  24. 제23항에 있어서,The method of claim 23,
    상기 수용체는 PVA(polyvinyl alcohol), PVAc(polyvinyle acetate) 중 적어도 어느 하나의 재질로부터 형성되는 의료용 보형물.The receptor is a medical implant formed from at least one material of polyvinyl alcohol (PVA), polyvinyle acetate (PVAc).
  25. 제22항에 있어서,The method of claim 22,
    상기 파우치는 실리콘 및 폴리우레탄 중 적어도 어느 하나의 재질로 형성되는 의료용 보형물.The pouch is medical implants formed of at least one material of silicone and polyurethane.
  26. 제22항에 있어서,The method of claim 22,
    상기 건교체는 다공성 재질로 형성되는 의료용 보형물.The dry replacement is a medical implant formed of a porous material.
  27. 제22항에 있어서,The method of claim 22,
    상기 건교체는 상기 하이드로젤의 탈수축합에 의하여 수축되는 체적보다 더 적은 체적을 갖도록 압축된 상태로 제조되는 의료용 보형물.The dry replacement is a medical implant is manufactured in a compressed state to have a volume smaller than the volume shrinked by the dehydration of the hydrogel.
  28. 제22항에 있어서,The method of claim 22,
    상기 건교체는 최대 압축 가능한 체적 이상 및 상기 파우치의 체적 이하의 크기를 갖도록 형성되는 의료용 보형물.The dry replaceable body is formed to have a size that is greater than the maximum compressible volume and less than the volume of the pouch.
  29. 제22항에 있어서,The method of claim 22,
    상기 건교체는 적어도 둘 이상의 분리된 고형물로 형성되는 의료용 보형물.The dry replacement is a medical implant formed of at least two separated solids.
  30. 제29항에 있어서,The method of claim 29,
    상기 스폰지의 크기는 2 종류 이상의 크기의 조합으로 형성되는 의료용 보형물.The size of the sponge is a medical implant formed by a combination of two or more types of sizes.
  31. 제22항에 있어서,The method of claim 22,
    상기 파우치의 내측면에는 적어도 일부에 상기 건교체가 부착되는 의료용 보형물.Medical implant to which the dry substitute is attached to at least a portion on the inner surface of the pouch.
  32. 제31항에 있어서,The method of claim 31, wherein
    상기 파우치의 내측에 부착되는 건교체는 의료용 실리콘 접착제에 의하여 부착되는 의료용 보형물.Medical replacement is attached to the inside of the pouch is a medical implant attached by a medical silicone adhesive.
PCT/KR2015/006786 2014-07-01 2015-07-01 Method for manufacturing compressed receptor for medical prosthesis, compressed receptor using same, and medical prosthesis WO2016003204A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2014-0082049 2014-07-01
KR1020140082049A KR101600811B1 (en) 2014-07-01 2014-07-01 Medical implant
KR1020140082050A KR101600812B1 (en) 2014-07-01 2014-07-01 Medical implant having pressed object for medical implant
KR10-2014-0082050 2014-07-01

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6268405B1 (en) * 1999-05-04 2001-07-31 Porex Surgical, Inc. Hydrogels and methods of making and using same
KR20080034089A (en) * 2004-01-29 2008-04-18 스마트 임플란트 피엘씨 A prosthesis and method of manufacturing a prosthesis
US20090326654A1 (en) * 2008-06-30 2009-12-31 Allergan, Inc. Fillable prosthetic implant with gel-like properties
KR20110045734A (en) * 2009-10-27 2011-05-04 이장형 A method for manufacturing of poly vinyl alcohol sponge the insertion type that has poly vinyl alcohol film coated in cavity of the body
KR20130036469A (en) * 2011-10-04 2013-04-12 박승주 Method of producing pva sponge

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6268405B1 (en) * 1999-05-04 2001-07-31 Porex Surgical, Inc. Hydrogels and methods of making and using same
KR20080034089A (en) * 2004-01-29 2008-04-18 스마트 임플란트 피엘씨 A prosthesis and method of manufacturing a prosthesis
US20090326654A1 (en) * 2008-06-30 2009-12-31 Allergan, Inc. Fillable prosthetic implant with gel-like properties
KR20110045734A (en) * 2009-10-27 2011-05-04 이장형 A method for manufacturing of poly vinyl alcohol sponge the insertion type that has poly vinyl alcohol film coated in cavity of the body
KR20130036469A (en) * 2011-10-04 2013-04-12 박승주 Method of producing pva sponge

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