KR101843347B1 - Nano-fiber form for treatment of aneurysm and manufacturing method of the same - Google Patents
Nano-fiber form for treatment of aneurysm and manufacturing method of the same Download PDFInfo
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- KR101843347B1 KR101843347B1 KR1020160159226A KR20160159226A KR101843347B1 KR 101843347 B1 KR101843347 B1 KR 101843347B1 KR 1020160159226 A KR1020160159226 A KR 1020160159226A KR 20160159226 A KR20160159226 A KR 20160159226A KR 101843347 B1 KR101843347 B1 KR 101843347B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
Abstract
Description
본 발명은 동맥류 치료용 나노섬유폼 및 이의 제조방법에 관한 것으로서, 특히 동맥류에 충진되어 동맥류에 공급되는 혈액을 차단하여 동맥류를 제거하는 동맥류 치료용 나노섬유폼 및 이의 제조방법에 관한 것이다.The present invention relates to a nanofiber foam for treating an aneurysm and a method for manufacturing the same, and more particularly, to a nanofiber foam for treating an aneurysm which is filled with an aneurysm and blocks blood supplied to an aneurysm to remove an aneurysm.
최근 협심증, 심근경색 등의 관상동맥질환과 뇌경색, 뇌출혈 등의 뇌혈관 질환이 급증하여 성인사망의 주요원인으로 대두되고 있다.Recently, coronary artery disease such as angina pectoris and myocardial infarction and cerebrovascular disease such as cerebral infarction and cerebral hemorrhage have been rapidly increasing, leading to adult death.
뇌혈관 질환은 뇌에 혈액을 공급하는 혈관에 이상이 생긴 질환을 통칭하는 말로 급작스런 뇌혈류 장애에 의한 의식소실, 반신마비, 언어장애 등의 국소적 신경장애 증상을 유발하며, 심한 경우 죽음을 초래하는 무서운 질병이다.Cerebrovascular disease is a term that refers to a disorder in which blood vessels that supply blood to the brain are termed. It causes local neurological symptoms such as loss of consciousness, hemiplegia, and speech disorder caused by sudden cerebral blood flow disorder, and causes severe death It is a terrible disease.
뇌혈관 질환 중 높은 빈도로 나타나는 뇌경색은 뇌동맥이 좁아진 곳에 혈전이 침착되어 혈관이 막히게 됨에 따라 혈액순환 장해로 인해 발생하는 질환으로 미국 통계에 의하면 연간 약 15만명이 뇌경색 등으로 인해 사망에 이르게 되고, 회복 후에도 대부분의 경우 후유장애를 남기기 때문에 이에 관계되는 사회적, 경제적 손실이 지대하다.Cerebral infarction, which is a high frequency of cerebrovascular disease, is caused by blood circulation disorder due to clotting of blood vessels due to deposition of thrombus in the narrowed cerebral artery. According to US statistics, about 150,000 people die from cerebral infarction per year, In most cases, after the recovery, there is a great deal of social and economic loss due to the problem of leaving behind.
한편, 신체 내의 내강은 크기, 형상, 및/또는 개방성에 있어서 변화할 수 있고, 그러한 변화는 복잡성을 제시하거나 관련된 신체 기능에 영향을 줄 수 있다.On the other hand, the lumen in the body may vary in size, shape, and / or openness, and such changes may present complexity or affect the associated bodily functions.
예를 들어, 혈관의 벽, 특히 동맥 벽은 동맥류로 불리는 병리학적 확장을 발현할 수 있다.For example, the walls of blood vessels, especially the arterial walls, can develop a pathological expansion called aneurysms.
동맥류는 동맥 벽의 부풀음으로서 관찰된다.The aneurysm is observed as swelling of the arterial wall.
이는 혈관 벽이 질병, 손상, 또는 선천성 기형에 의해 약화된 결과이다.This is the result of the vessel wall being weakened by disease, injury, or congenital malformations.
동맥류는 얇고 약한 벽을 가지며, 파열 경향을 갖고, 흔히 고혈압에 의해 야기되거나 악화된다.Aneurysms have thin and weak walls, tend to rupture, and are often caused or exacerbated by hypertension.
동맥류는 신체의 상이한 부위에서 발견될 수 있고, 가장 일반적인 것은 복대동맥류(AAA) 및 뇌 또는 두개 동맥류이다.Aneurysms can be found in different parts of the body, the most common being abdominal aortic aneurysm (AAA) and brain or celiac aneurysms.
동맥류의 단순한 존재가 항상 생명에 위협적이지는 않지만, 이는 뇌 안에서 파열된다면 뇌졸중과 같은 심각한 건강 문제를 가질 수 있다.The mere presence of an aneurysm is not always life-threatening, but it can have serious health problems such as stroke if ruptured in the brain.
추가로, 파열된 동맥류는 사망을 일으킬 수도 있다.In addition, ruptured aneurysms may cause death.
위와 같은 동맥류를 치료하기 위해, 최근에는 동맥류에 풍선, 코일, 팽창되는 와이어 등을 삽입하거나, 스텐트등을 혈관에 장착하여 스텐트로 동맥류를 차단하는 기술 등이 개발되고 있다.In order to treat the above-mentioned aneurysm, recently, a technique of inserting a balloon, a coil, an expanding wire or the like into an aneurysm, or attaching a stent or the like to a blood vessel to block an aneurysm by a stent has been developed.
그러나, 이러한 종래의 동맥류를 치료하기 위한 치료제는 제품이 복잡하여 시술이 어렵거나, 동맥류 이외의 다른 혈과도 고사시키는 문제가 있었다.However, such a therapeutic agent for treating an aneurysm of the prior art is complicated because of its complicated product, and there is a problem in that it is difficult to perform the procedure, or the blood other than the aneurysm is damaged.
본 발명은 전술한 문제점을 해결하기 위한 것으로써, 3차원 형태의 나노섬유폼을 이용하여 동맥류를 용이하고 안전하게 제거할 수 있는 동맥류 치료용 나노섬유폼 및 이의 제조방법을 제공하는데 그 목적이 있다.Disclosure of Invention Technical Problem [8] Accordingly, the present invention has been made to solve the above-mentioned problems, and it is an object of the present invention to provide a nanofiber foam for treating an aneurysm which can easily and safely remove an aneurysm using a three-dimensional nanofiber foam.
상기 목적을 달성하기 위하여 본 발명의 동맥류 치료용 나노섬유폼의 제조방법은, 동맥류에 삽입되어 동맥류에 혈액이 공급되지 않도록 함으로써 동맥류를 치료하는 치료제의 제조방법에 있어서, 탄성을 갖는 3차원 형태의 1차나노섬유폼을 생성하는 3D폼생성단계와; 상기 1차나노섬유폼에 하이드로겔을 주입하여 상기 1차나노섬유폼과 하이드로겔이 상호 가교반응을 일으켜 유동성있는 2차나노섬유폼을 형성하는 하이드로겔주입단계와; 상기 2차나노섬유폼을 몰드에 넣은 후 동결건조시키는 동결건조단계;를 포함하여 이루어지되, 동결건조된 2차나노섬유폼은 동맥류에 삽입되어 혈액이 유입되면 겔 상태로 변화되면서 그 부피가 팽창되는 것을 특징으로 한다.In order to accomplish the above object, the present invention provides a method of manufacturing a therapeutic agent for treating an aneurysm by preventing blood from being supplied to an aneurysm inserted into an aneurysm, A 3D foam generating step of generating a primary nanofiber foam; A hydrogel injection step of injecting a hydrogel into the primary nanofiber foam to form a fluid secondary nanofiber foam by cross-linking the primary nanofiber foam and the hydrogel; Wherein the lyophilized secondary nanofiber foam is inserted into an aneurysm to change into a gel state when the blood flows into the aneurysm and expand the volume of the secondary nanofiber foam. .
상기 3D폼생성단계 이전에 2차원 형태의 2차나노섬유매트를 생성하는 2D매트생성단계;를 더 포함하여 이루어지고, 상기 3D폼생성단계에서는 상기 2차나노섬유매트를 수소가스가 발생되는 용액에 침지시켜 탄성을 갖는 3차원 형태의 1차나노섬유폼을 형성하되, 상기 수소가스는 상기 2차나노섬유매트에 생성된 기공으로 들어가 상기 2차나노섬유매트를 부풀게 하여 3차원 형태의 상기 1차나노섬유폼을 형성한다.And a 2D mat generating step of generating a 2D nanofiber mat before the 3D form generation step, wherein in the 3D form generation step, the secondary nanofiber mat is immersed in a solution To form a three-dimensional primary nanofiber foam having elasticity, wherein the hydrogen gas enters the pores generated in the secondary nanofiber mat to inflate the secondary nanofiber mat, To form a car nanofiber foam.
상기 2D매트생성단계는, PCL(폴리카프로락톤)폴리머 용액과 셀룰로오스아세테이트(CA) 솔루션을 혼합한 후 전기방사하여 1차나노섬유매트를 생성하는 1차매트생성단계와; 상기 1차나노섬유매트를 NaOH용액에 침지시켜 2차나노섬유매트를 생성하는 2차매트생성단계;를 포함하여 이루어지되, 상기 2차매트생성단계에서는, PCL폴리머와 셀룰로오스아세테이트(CA)로 이루어진 1차나노섬유매트가 PCL폴리머와 셀룰로오스(CL)로 이루어진 2차나노섬유매트로 변환된다.The 2D mat generating step may include a primary mat producing step of mixing a PCL (polycaprolactone) polymer solution and a cellulose acetate (CA) solution and electrospun to produce a primary nanofiber mat; And a secondary mat producing step of immersing the primary nanofiber mat in a NaOH solution to produce a secondary nanofiber mat, wherein the secondary mat forming step comprises the steps of: forming the secondary mat by using a mixture of PCL polymer and cellulose acetate (CA) The primary nanofiber mat is converted to a secondary nanofiber mat comprising PCL polymer and cellulose (CL).
상기 3D폼생성단계에서는 수소가스가 발생되는 용액은 NaBH4(수소화붕소나트륨)이다.In the 3D foam generation step, the solution in which hydrogen gas is generated is NaBH4 (sodium borohydride).
상기 2D매트생성단계는, 상기 2차나노섬유매트를 세척하는 세척단계;를 더 포함하여 이루어진다.The 2D mat generating step may further include a washing step of washing the secondary nanofiber mat.
상기 하이드로겔주입단계에서 상기 1차나노섬유폼에 주입되는 하이드로겔은, HA(Hyaluronic Acid, 히알루론산)겔이다.The hydrogel to be injected into the primary nanofiber foam in the step of injecting the hydrogel is HA (Hyaluronic Acid, hyaluronic acid) gel.
상기 2차나노섬유폼에 EDC(1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide)용액을 첨가한다.A solution of EDC (1-ethyl-3- (3-dimethylaminopropyl) carbodiimide) is added to the secondary nanofiber foam.
상기 2차나노섬유폼에 GTA(Glutaraldehyde)가교제를 주입한다.A GTA (Glutaraldehyde) crosslinking agent is injected into the secondary nanofiber foam.
또한, 상기 목적을 달성하기 위하여 본 발명의 동맥류 치료용 나노섬유폼은, 상술한 제조방법 중 어느 하나의 제조방법에 의해 제조되되, 동결건조된 2차나노섬유폼은 동맥류에 삽입되어 혈액이 유입되면 겔 상태로 변화되면서 그 부피가 팽창되는 것을 특징으로 한다.In order to accomplish the above object, the present invention provides a nanofiber foam for treating an aneurysm, which is manufactured by any one of the above-described manufacturing methods, wherein the freeze-dried secondary nanofiber foam is inserted into an aneurysm, The gel is changed to a gel state and its volume is expanded.
이상에서 설명한 바와 같은 본 발명의 동맥류 치료용 나노섬유폼 및 이의 제조방법에 따르면, 3차원 형태의 나노섬유폼을 이용하여 동맥류를 용이하고 안전하게 제거할 수 있다.As described above, according to the nanofiber foam for treating an aneurysm of the present invention and the method for manufacturing the same, the aneurysm can be easily and safely removed using the nanofiber foam of the three-dimensional shape.
도 1은 본 발명의 실시예에 따른 동맥류를 치료하는 치료제의 제조방법의 순서도,
도 2는 본 발명의 실시예에 따른 나노섬유폼의 실제제품 사진
도 3은 본 발명의 실시예에 따른 나노섬유폼의 조직구조를 현미경으로 확대한 사진.
도 4는 본 발명의 실시예에 따른 나노섬유폼의 압축변형률과 압축력의 관계를 도시한 그래프.1 is a flow chart of a method of manufacturing a therapeutic agent for treating an aneurysm according to an embodiment of the present invention,
FIG. 2 is a photograph of an actual product of a nanofiber foam according to an embodiment of the present invention
FIG. 3 is a microscope-enlarged photograph of a tissue structure of a nanofiber foam according to an embodiment of the present invention. FIG.
4 is a graph showing the relationship between compressive strain and compression force of a nanofiber foam according to an embodiment of the present invention.
본 발명은 동맥류에 삽입되어 동맥류에 혈액이 공급되지 않도록 함으로써 동맥류를 치료하는 치료제의 제조방법에 관한 것으로써, 본 발명의 동맥류 치료용 나노섬유폼의 제조방법은 도 1에 도시된 바와 같이, 2D매트생성단계(S10)와, 3D폼생성단계(S20)와, 하이드로겔주입단계(S30)와, 동결건조단계(S40)를 포함하여 이루어진다.The present invention relates to a method of manufacturing a therapeutic agent for treating an aneurysm by preventing an aneurysm from being supplied with blood by being inserted into an aneurysm. The method of manufacturing a nanofiber foam for treating an aneurysm of the present invention comprises the steps of: A mat creation step S10, a 3D form generation step S20, a hydrogel injection step S30, and a lyophilization step S40.
상기 2D매트생성단계(S10)는 2차원 형태의 2차나노섬유매트를 생성하는 단계이다.The 2D mat generation step (S10) is a step of generating a two-dimensional type of secondary nanofiber mat.
본 실시예에서 상기 2D매트생성단계(S10)는 1차매트생성단계(S11)와 2차매트생성단계(S12)와 세척단계(S13)를 포함하여 이루어진다.In the present embodiment, the 2D mat generation step S10 includes a first mat generation step S11, a second mat generation step S12, and a cleaning step S13.
상기 1차매트생성단계(S11)는 PCL(폴리카프로락톤)폴리머 용액과 셀룰로오스아세테이트(CA) 솔루션을 혼합한 후 전기방사하여 PCL/CA 나노섬유매트 즉 1차나노섬유매트를 생성하는 단계이다.The primary mat producing step S11 is a step of mixing a PCL (polycaprolactone) polymer solution and a cellulose acetate (CA) solution and electrospinning to produce a PCL / CA nanofiber mat, that is, a primary nanofiber mat.
상기 2차매트생성단계(S12)는 상기 1차나노섬유매트를 NaOH용액에 침지시켜 2차나노섬유매트를 생성하는 단계이다.The secondary mat generating step S12 is a step of immersing the primary nanofiber mat in an NaOH solution to produce a secondary nanofiber mat.
상기 2차매트생성단계(S12)에서는, PCL폴리머와 셀룰로오스아세테이트(CA)로 이루어진 1차나노섬유매트에서 셀룰로오스아세테이트(CA)가 NaOH와 반응하여 셀루로오스(CL)로 변하게 된다.In the secondary mat production step S12, the cellulose acetate (CA) reacts with NaOH on the primary nanofiber mat comprising the PCL polymer and the cellulose acetate (CA) to convert to cellulose (CL).
따라서, 상기 2차매트생성단계(S12)에서는 PCL폴리머와 셀룰로오스아세테이트(CA)로 이루어진 상기 1차나노섬유매트가 PCL폴리머와 셀룰로오스(CL)로 이루어진 PCL/CL 나노섬유매트 즉 2차나노섬유매트로 변환되게 된다.Therefore, in the secondary mat generation step S12, the primary nanofiber mat made of the PCL polymer and the cellulose acetate (CA) is a PCL / CL nanofiber mat made of a PCL polymer and a cellulose (CL), that is, a secondary nanofiber mat .
상기 세척단계(S13)는 상기 2차나노섬유매트(PCL/CL 나노섬유매트)를 증류수 등으로 세척하는 단계이다.The cleaning step S13 is a step of washing the secondary nanofiber mat (PCL / CL nanofiber mat) with distilled water or the like.
상기 3D폼생성단계(S20)는 2차원 형태로 이루어진 상기 2차나노섬유매트를 3차원 형태의 1차나노섬유폼으로 변환시켜 생성하는 단계이다.The 3D form generation step S20 is a step of converting the secondary nanofiber mat of the two-dimensional form into a three-dimensional primary nanofiber form.
이때, 상기 3D폼생성단계(S20)에서는 상기 2차나노섬유매트를 수소가스가 발생되는 용액에 침지시켜 탄성을 갖는 3차원 형태의 1차나노섬유폼으로 생성한다.At this time, in the 3D form generation step (S20), the secondary nanofiber mat is immersed in a solution in which hydrogen gas is generated to produce an elastic primary three-dimensional nanofiber foam.
상기 2차나노섬유매트를 수소가스가 발생되는 용액에 침지시키게 되면, 상기 수소가스는 상기 2차나노섬유매트에 생성된 기공으로 들어가 상기 2차나노섬유매트를 부풀게 하여 3차원 형태를 갖는 스폰지 타입의 상기 1차나노섬유폼을 형성하게 된다.When the secondary nanofiber mat is immersed in a solution in which hydrogen gas is generated, the hydrogen gas enters the pores generated in the secondary nanofiber mat to inflate the secondary nanofiber mat to form a three-dimensional sponge type Of the primary nanofiber foam.
상기 수소가스를 발생시키는 용액으로는 NaBH4(수소화붕소나트륨) 등이 있다.The solution for generating the hydrogen gas includes NaBH4 (sodium borohydride) and the like.
따라서, 상기 3D폼생성단계(S20)에서는 상기 2차나노섬유매트를 NaBH4(수소화붕소나트륨)용액에 침지시키게 되면, NaBH4용액에 의해 수소가스가 발생되게 되는데, 이렇게 발생된 수소가스가 2차나노섬유매트의 내부에 형성된 기공으로 들어가 2차나노섬유매트를 부풀게 함으로써, 스폰지와 같은 3차원 형태의 상기 1차나노섬유폼을 형성하게 된다.Accordingly, when the secondary nanofiber mat is immersed in the NaBH4 (sodium borohydride) solution in the 3D form generation step S20, hydrogen gas is generated by the NaBH4 solution. And enters the pores formed in the interior of the fiber mat to swell the secondary nanofiber mat to form the primary nanofiber foam in a three-dimensional form such as a sponge.
위와 같이 생성된 상기 1차나노섬유폼은 에틸렌글리콜(ethylene glycol)용액으로 씻은 후 증류수 다시 씻는다.The primary nanofiber foam thus produced is washed with ethylene glycol solution and then washed again with distilled water.
상기 하이드로겔주입단계(S30)는 상기 1차나노섬유폼에 하이드로겔을 주입하여 상기 1차나노섬유폼과 하이드로겔이 상호 가교반응을 일으켜 유동성있는 2차나노섬유폼을 형성하는 단계이다.In the step of injecting the hydrogel (S30), a hydrogel is injected into the primary nanofiber foam to cross-react the primary nanofiber foam and the hydrogel to form a fluid secondary nanofiber foam.
이때, 상기 1차나노섬유폼에 주입되는 하이드로겔은 HA(Hyaluronic Acid, 히알루론산)겔 등으로 이루어짐이 바람직하다.At this time, the hydrogel to be injected into the primary nanofiber foam is preferably HA (Hyaluronic Acid) hyaluronic acid gel or the like.
상기 동결건조단계(S40)는 상기 2차나노섬유폼을 몰드에 넣은 후 동결건조시키는 단계이다.The freeze-drying step (S40) is a step in which the secondary nanofiber foam is put into a mold and freeze-dried.
상기 하이드로겔주입단계(S30)에서 상기 1차나노섬유폼에 하이드로겔을 주입함으로써, 보다 탄성복원력이 우수한 나노섬유폼을 생성할 수 있다.In the hydrogel injecting step (S30), a hydrogel is injected into the primary nanofiber foam, thereby making it possible to produce a nanofiber foam excellent in elastic restoring force.
위와 같은 단계를 통해 만들어진 2차나노섬유폼에 EDC(1-ethyl-3-(3-dimethyl aminopropyl)carbodiimide)용액을 첨가하여 하이드로겔의 가교반응을 향상시킬 수 있다.The crosslinking reaction of the hydrogel can be improved by adding a solution of EDC (1-ethyl-3- (3-dimethyl aminopropyl) carbodiimide) to the secondary nanofiber foam prepared through the above steps.
또한, 상기 2차나노섬유폼에 GTA(Glutaraldehyde)가교제를 주입한 후 씻어지도록 하여, 혈액 안에서 나노섬유폼이 녹는 것을 방지할 수 있다.Also, it is possible to prevent the nanofiber foam from melting in the blood by injecting GTA (Glutaraldehyde) crosslinking agent into the secondary nanofiber foam.
위와 같은 방법에 의해 제조된 나노섬유폼은 도 2에 도시된 바와 사진과 같다.The nanofiber foam prepared by the above method is shown in the photograph as shown in FIG.
이러한 나노섬유폼을 동맥류에 삽입하게 되면, 혈액이 상기 나노섬유폼에 유입될 경우 상기 나노섬유폼은 겔 상태로 변화되면서 그 부피가 팽창하여 동맥류에 혈액이 공급되지 않도록 함으로써 동맥류를 치료하게 된다.When such a nanofiber foam is inserted into the aneurysm, when the blood flows into the nanofiber foam, the nanofiber foam is changed into a gel state and the volume of the nanofiber foam is expanded so that blood is not supplied to the aneurysm.
특히, 본 발명이 나노섬유폼은 탄성을 갖는 3차원 형태로 되어 있기 때문에, 카데터를 이용하여 상기 나노섬유폼을 동맥류에 용이하게 삽입시킬 수 있다.In particular, since the nanofiber foam according to the present invention has a three-dimensional shape having elasticity, the nanofiber foam can be easily inserted into the aneurysm using a catheter.
위 내용중 나노섬유를 동맥류에 넣어 동맥류를 제거하는 방법 등에 대해서는, 본 출원인이 출원하여 등록된 등록특허 제10-1558245호를 참고하면 되는바, 이에 대한 자세한 설명은 생략한다.As for the method of removing the aneurysm by inserting the nanofibers into the aneurysm, reference is made to the registered patent No. 10-1558245 filed by the present applicant, and a detailed description thereof will be omitted.
도 3은 본 발명의 실시예에 따른 나노섬유폼의 조직구조를 현미경으로 확대한 사진이고, 도 4는 본 발명의 실시예에 따른 나노섬유폼의 압축변형률과 압축력의 관계를 도시한 그래프이다.FIG. 3 is a microscopic view of a tissue structure of a nanofiber foam according to an embodiment of the present invention, and FIG. 4 is a graph showing a relationship between compressive strain and compression force of a nanofiber foam according to an embodiment of the present invention.
도 3 및 도 4에서 샘플1은 순수 HA하이드로겔이고, 샘플2는 HA하이드로겔 10ml 당 0.035g의 나노섬유가 혼합된 것이며, 샘플3은 HA하이드로겔 10ml 당 0.070g의 나노섬유가 혼합된 것이고, 샘플4는 HA하이드로겔 10ml 당 0.140g의 나노섬유가 혼합된 것이다.3 and 4,
본 발명의 나노섬유폼은 도 4에 도시된 바와 같이 샘플(순수 HA하이드로겔)과 비교하여 압축력에 따른 압축변형률이 우수하여, 탄성복원력이 매우 좋은 소재임을 알 수 있다.As shown in FIG. 4, the nanofiber foam according to the present invention is superior to the sample (pure HA hydrogel) in terms of compressive strain according to the compressive force, and exhibits excellent elastic restoring force.
따라서, 이러한 나노섬유폼을 압축한 상태로 카데터를 이용하여 동맥류에 삽입할 경우, 우수한 탄성복원력에 의해 신속하게 원래의 3D상태로 복원된다.Therefore, when the nanofiber foam is compressed and inserted into the aneurysm using the catheter, the original 3D state is quickly restored due to the excellent elastic restoring force.
본 발명인 동맥류 치료용 나노섬유폼 및 이의 제조방법은 전술한 실시예에 국한하지 않고, 본 발명의 기술 사상이 허용되는 범위 내에서 다양하게 변형하여 실시할 수 있다.The nanofiber foam for treating an aneurysm of the present invention and the method of manufacturing the same are not limited to the above-described embodiments, and various modifications may be made within the scope of the technical idea of the present invention.
S10 : 2D매트생성단계, S11 : 1차매트생성단계, S12 : 2차매트생성단계, S13 : 세척단계,
S20 : 3D폼생성단계,
S30 : 하이드로겔주입단계,
S40 : 동결건조단계.S10: 2D mat generation step, S11: primary mat generation step, S12: secondary mat generation step, S13: washing step,
S20: 3D form generation step,
S30: hydrogel injection step,
S40: Freeze-drying step.
Claims (9)
2차원 형태의 2차나노섬유매트를 생성하는 2D매트생성단계와;
상기 2차나노섬유매트를 수소가스가 발생되는 용액에 침지시켜 탄성을 갖는 3차원 형태의 1차나노섬유폼을 생성하는 3D폼생성단계와;
상기 1차나노섬유폼에 하이드로겔을 주입하여 상기 1차나노섬유폼과 하이드로겔이 상호 가교반응을 일으켜 유동성있는 2차나노섬유폼을 형성하는 하이드로겔주입단계와;
상기 2차나노섬유폼을 몰드에 넣은 후 동결건조시키는 동결건조단계;를 포함하여 이루어지되,
상기 2D매트생성단계는,
PCL(폴리카프로락톤)폴리머 용액과 셀룰로오스아세테이트(CA) 솔루션을 혼합한 후 전기방사하여 1차나노섬유매트를 생성하는 1차매트생성단계와;
상기 1차나노섬유매트를 NaOH용액에 침지시켜 2차나노섬유매트를 생성하는 2차매트생성단계;를 포함하여 이루어지고,
상기 2차매트생성단계에서는, PCL폴리머와 셀룰로오스아세테이트(CA)로 이루어진 1차나노섬유매트가 PCL폴리머와 셀룰로오스(CL)로 이루어진 2차나노섬유매트로 변환되며,
상기 수소가스는 상기 2차나노섬유매트에 생성된 기공으로 들어가 상기 2차나노섬유매트를 부풀게 하여 3차원 형태의 상기 1차나노섬유폼을 형성하고,
동결건조된 2차나노섬유폼은 동맥류에 삽입되어 혈액이 유입되면 겔 상태로 변화되면서 그 부피가 팽창되는 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.A method for preparing a therapeutic agent for treating an aneurysm by preventing blood supply to an aneurysm inserted into an aneurysm,
A 2D mat generating step of generating a 2D nanofiber mat;
A 3D foam generating step of immersing the secondary nanofiber mat in a solution in which hydrogen gas is generated to produce a three-dimensional primary nanofiber foam having elasticity;
A hydrogel injection step of injecting a hydrogel into the primary nanofiber foam to form a fluid secondary nanofiber foam by cross-linking the primary nanofiber foam and the hydrogel;
And a freeze-drying step of lyophilizing the secondary nanofiber foam in a mold,
The 2D matting step may include:
A primary mat producing step of mixing a PCL (Polycaprolactone) polymer solution with a cellulose acetate (CA) solution and electrospunning to produce a primary nanofiber mat;
And a secondary mat producing step of immersing the primary nanofiber mat in a NaOH solution to produce a secondary nanofiber mat,
In the secondary mat generation step, the primary nanofiber mat made of PCL polymer and cellulose acetate (CA) is converted into a secondary nanofiber mat made of PCL polymer and cellulose (CL)
The hydrogen gas enters the pores generated in the secondary nanofiber mat to bloom the secondary nanofiber mat to form the primary nanofiber foam in a three-dimensional form,
Wherein the freeze-dried secondary nanofiber foam is inserted into the aneurysm, and when the blood flows into the aneurysm, the gel is transformed into the gel, and the volume of the nanofiber foam is expanded.
상기 3D폼생성단계에서는 수소가스가 발생되는 용액은 NaBH4(수소화붕소나트륨)인 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.The method according to claim 1,
Wherein the solution in which hydrogen gas is generated in the 3D foam generation step is NaBH4 (sodium borohydride).
상기 2D매트생성단계는,
상기 2차나노섬유매트를 세척하는 세척단계;를 더 포함하여 이루어진 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.The method according to claim 1,
The 2D matting step may include:
And washing the secondary nanofiber mat. The method of manufacturing a nanofiber foam according to claim 1,
상기 하이드로겔주입단계에서 상기 1차나노섬유폼에 주입되는 하이드로겔은, HA(Hyaluronic Acid, 히알루론산)겔인 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.The method according to claim 1,
Wherein the hydrogel to be injected into the primary nanofiber foam in the hydrogel-injecting step is HA (Hyaluronic Acid) hyaluronic acid gel.
상기 2차나노섬유폼에 EDC(1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide)용액을 첨가하는 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.The method according to claim 1,
Wherein a solution of EDC (1-ethyl-3- (3-dimethyl aminopropyl) carbodiimide) is added to the secondary nanofiber foam.
상기 2차나노섬유폼에 GTA(Glutaraldehyde)가교제를 주입하는 것을 특징으로 하는 동맥류 치료용 나노섬유폼의 제조방법.The method according to claim 1,
Wherein the second nanofiber foam is injected with a GTA (Glutaraldehyde) crosslinking agent.
동결건조된 2차나노섬유폼은 동맥류에 삽입되어 혈액이 유입되면 겔 상태로 변화되면서 그 부피가 팽창되는 것을 특징으로 하는 동맥류 치료용 나노섬유폼.Which is produced by the production method of claim 1,
Wherein the lyophilized secondary nanofiber foam is inserted into the aneurysm and is expanded into a gel state when the blood is introduced, thereby expanding the volume of the nanofiber foam.
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| KR20220169072A (en) * | 2021-06-18 | 2022-12-27 | 우석대학교 산학협력단 | A method for manufacturing 3d transparent nanofibers and the 3d transparent nanofibers thereof |
| KR102598611B1 (en) | 2021-06-18 | 2023-11-03 | 우석대학교 산학협력단 | A method for manufacturing 3d transparent nanofibers for artificial retina and the 3d transparent nanofibers artificial retina thereof |
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