KR20080074885A - A tube for connecting marteriovenous and interposition for medical operation - Google Patents

A tube for connecting marteriovenous and interposition for medical operation Download PDF

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KR20080074885A
KR20080074885A KR1020087011695A KR20087011695A KR20080074885A KR 20080074885 A KR20080074885 A KR 20080074885A KR 1020087011695 A KR1020087011695 A KR 1020087011695A KR 20087011695 A KR20087011695 A KR 20087011695A KR 20080074885 A KR20080074885 A KR 20080074885A
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drug
surface treatment
tube
treatment step
tube structure
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김대중
김철수
고재영
박종상
권태근
이병하
이우경
남혜영
임현정
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(주)액세스 플러스
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus

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  • Transplantation (AREA)
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Abstract

A method for manufacturing an arteriovenous connection tube is provided to produce the arteriovenous connection tube capable of sustainedly releasing a surface-treated drug of a tube structure at a proper rate. A method for manufacturing an arteriovenous connection tube(100) includes: a first surface treatment step of dissolving a drug for suppressing the overgrowth of vascular endothelial cells in a solvent in a predetermined concentration, dipping a tube structure or both ends of the tube structure in the solution, taking out the tube structure after the passage of predetermined time, and drying the tube structure; and a second surface treatment step of dipping the first surface-treated tube structure or both ends of the tube structure in a solvent with or without a certain amount of the drug for suppressing the overgrowth of vascular endothelial cells, taking out the tube structure after the passage of predetermined time, and drying the tube structure.

Description

동정맥 연결용 튜브 및 의료시술용 인체 삽입물{A TUBE FOR CONNECTING MARTERIOVENOUS AND INTERPOSITION FOR MEDICAL OPERATION}A TUBE FOR CONNECTING MARTERIOVENOUS AND INTERPOSITION FOR MEDICAL OPERATION}

본 발명은 동정맥 연결용 튜브에 관한 것으로서, 더 구체적으로는 주기적인 혈액투석을 요하는 환자의 동맥과 정맥 사이에 안정적인 혈관접근로를 유지할 수 있으며, 동맥과 정맥 연결부위의 혈관 협착 발생률을 크게 줄일 수 있는 기술에 관계한다.The present invention relates to a tube for arteriovenous connection, more specifically, to maintain a stable vascular access between the arteries and veins of patients requiring periodic hemodialysis, and greatly reduce the incidence of vascular stenosis at the arterial and venous connections It is about technology that can be done.

혈액투석이라 함은 급성 및 만성 신부전(賢

Figure 112008034698349-PCT00001
全)에 대한 치료법으로서, 특히 중증의 신부전증 환자들을 대상으로 주기적으로 시술되고 있으며, 근래에는 혈액투석 대상의 환자가 증가함으로 인하여 그 중요도가 더욱 커지고 있다.Hemodialysis is defined as acute and chronic renal failure.
Figure 112008034698349-PCT00001
As a treatment for the whole, it is periodically performed in patients with severe renal failure, and in recent years, the importance of hemodialysis patients is increasing.

일반적으로 혈액투석 요법을 받고 있는 환자의 대부분은 당뇨 및 고혈압이 원인으로 나타나고 있는데, 이와 같은 환자의 경우에는 심한 동맥 경화증이 동반되는 경우가 많다. 그런데 혈액투석 요법을 받기 위해서는 동맥과 정맥의 연결부위에서 장기간 혈액의 흐름을 방해하는 요소가 발생하지 않아야 하므로 이와 같은 과제를 해결하기 위하여 많은 연구들이 진행되고 있다.In general, the majority of patients undergoing hemodialysis therapy are caused by diabetes and hypertension. In these patients, severe atherosclerosis is often accompanied. However, in order to receive hemodialysis therapy, many studies have been conducted to solve such a problem because an element that prevents blood flow for a long period of time should not occur at the connection between arteries and veins.

한편, 인조혈관(이하 '동정맥 연결용 튜브'라 함)은 환자 자신의 혈관이 어떤 요인에 의하여 좁아진 경우나 그 기능이 현저히 저하된 경우에 혈액의 흐름을 안내할 수 있는 대체 수단으로 개발되었으며, 자체의 화학적 성분, 물리적 특성, 다공성, 탄성, 표면구조 양상에 따라 개통율이 영향을 받게 된다. 일반적으로 동정맥 연결용 튜브의 튜브구조물의 재질은 e-PTFE(Expanded Polytetrafluoroethylene)인데, 이러한 재질을 갖는 튜브구조물은 미세기공을 갖는 박막필름으로서 PTFE를 고온 및 고압의 압출에 의해 여러 방향으로 연신함으로써 얻어진다. 이와 같은 재질은 마찰계수가 대단히 낮아 혈액과 접촉하였을 때 단백질의 흡착을 지연시키는 등 항혈전성이 있으므로 튜브구조물로서 바람직하게 채택될 수 있는 것이다.On the other hand, artificial blood vessels (hereinafter referred to as the 'arterial vein connection tube') has been developed as an alternative means of guiding blood flow when the patient's own blood vessels are narrowed by some factor or their function is significantly degraded. The opening ratio is affected by its chemical composition, physical properties, porosity, elasticity, and surface structure. In general, the tube structure of the arteriovenous connection tube is made of expanded polytetrafluoroethylene (e-PTFE), and the tube structure having such a material is a thin film having micropores, which is obtained by stretching PTFE in various directions by high temperature and high pressure extrusion. Lose. Such a material has an extremely low coefficient of friction and thus can be preferably used as a tube structure because it has antithrombogenic properties such as delaying adsorption of proteins when it comes into contact with blood.

그런데, 동정맥 연결용 튜브는 혈액투석환자가 혈액투석요법을 받기 위하여 자가 혈관을 이용하는 동정맥루에 비하여 유리한 점이 있는 반면에, 이 동정맥 연결용 튜브와 환자의 동정맥을 연결하는 부위에서 혈관이 협착되는 현상을 발생시킴으로서 혈액 흐름의 방해 원인을 야기하게 되고, 그에 따라 동정맥 연결용 튜브의 이식 시술을 다시 한 후 혈액투석을 행해야 되는 문제점을 가지고 있었다.However, while the arteriovenous connection tube has an advantage over the arteriovenous fistula that hemodialysis patients use autologous blood vessels for hemodialysis, the arterial connection tube and the patient's arteriovenous region are connected to the arterial vein. By causing the cause of the blood flow obstruction, accordingly had a problem that hemodialysis should be performed after the implantation procedure of the arteriovenous connection tube again.

따라서 그러한 문제점을 해결하기 위한 연구가 지속적으로 있어 왔으며, 그러한 연구에 따라서 동정맥 연결용 튜브와 동정맥의 연결부위가 협착되는 원인 중 하나가 혈관을 구성하는 내피세포의 과성장인 것으로 밝혀지게 되었다. 그에 따라 본 출원의 발명자는 선출원된 국제출원번호 PCT/KR2005/001633(발명의 명칭 : HEMODIALYSIS TUBE TREATED WITH MEDICAMENT ON SURFACE THEREOF FOR CONNECTING ARTERY TO VEIN, 이하 '선행기술'이라 함)호에 따른 기술을 개발하여 출원한 바 있다.Therefore, there have been continuous studies to solve such problems, and according to such studies, one of the causes of the narrowing of the connection region between the arteriovenous connection tube and the arteriovenous vein was found to be the overgrowth of endothelial cells constituting the blood vessel. Accordingly, the inventor of the present application develops the technology according to the previously filed international application number PCT / KR2005 / 001633 (name of the invention: HEMODIALYSIS TUBE TREATED WITH MEDICAMENT ON SURFACE THEREOF FOR CONNECTING ARTERY TO VEIN) Has been filed.

선행기술은 튜브구조물의 적어도 양 끝단부에 혈관의 내피세포 과증식을 억 제하는 약물을 표면 처리(코팅)하는 기술에 관한 것이다. 이러한 선행기술에 따르면 동정맥 연결용 튜브와 동정맥이 연결되는 연결부위에서 약물이 방출되면서 혈관의 내피세포 과증식을 억제시키기 때문에 혈관이 협착되는 현상을 방지시킬 수 있게 된다.The prior art relates to a technique of surface treatment (coating) a drug that inhibits endothelial cell hyperproliferation of blood vessels at least at both ends of the tube structure. According to this prior art it is possible to prevent the narrowing of blood vessels because it inhibits endothelial cell hyperproliferation of the blood vessels as the drug is released from the connection portion connecting the arteriovenous connecting tube and the arteriovenous vein.

그런데, 위와 같은 선행기술에 따른 동정맥 연결용 튜브구조물을 사용하여 시술을 하는 경우 내피세포의 과증식이 상당히 억제되는 효과가 있었으나, 인체에 삽입된 동정맥 연결용 튜브구조물에 표면 처리된 약물이 어떤 방식으로 방출되느냐에 따라 그 효과가 다르게 됨을 확인할 수 있었다. 대개의 경우는 표면 처리된 약물이 초기에 다량 방출되고, 이렇게 약물이 초기에 다량 방출되게 되면 약물의 효과를 지속적으로 적절히 유지되지 않는다는 문제점이 있었다.By the way, when the procedure using the arteriovenous tube structure according to the prior art as described above had an effect that the hyperproliferation of endothelial cells is significantly suppressed, the drug surface-treated in the arterial arterial tube structure inserted into the human body in some way It was confirmed that the effect is different depending on whether it is released. In most cases, the surface-treated drug is initially released in a large amount, and when the drug is initially released in a large amount, there is a problem in that the effect of the drug is not properly maintained continuously.

기술적 과제Technical challenge

본 발명은 상기의 문제점을 해결하기 위하여 발명된 것으로서, 본 발명은 튜브구조물에 표면 처리된 약물이 적절한 속도를 가지고 지속적으로 방출될 수 있도록 하는 동정맥 연결용 튜브 및 그 제조방법을 제공하는 것을 목적으로 한다.The present invention has been invented to solve the above problems, and the present invention is to provide a tube for arteriovenous connection and a method of manufacturing the same so that the drug surface-treated in the tube structure can be continuously released at an appropriate speed. do.

기술적 해결방법Technical solution

상기 본 발명의 목적을 실현하기 위한 본 발명에 따른 동정맥 연결용 튜브의 제조방법은, 혈관내피세포의 과증식을 억제시키는 약물을 용매에 정해진 농도로 용해시킨 다음, 이 용매에 튜브구조물 또는 튜브구조물의 양 끝단부를 담근 후 일정시간 경과 후 꺼내어 건조시키는 1차표면처리단계; 및Method for producing a tube for arteriovenous connection according to the present invention for realizing the object of the present invention, the drug to inhibit the hyperproliferation of vascular endothelial cells to a predetermined concentration in a solvent, and then the tube structure or tube structure of the solvent A first surface treatment step of immersing both ends and then taking out and drying after a predetermined time; And

혈관내피세포의 과증식을 억제시키는 약물이 임의의 농도로 용해된 용매 또는 약물이 용해되지 않은 용매에 상기 1차표면처리단계에서 1차 표면 처리된 튜브구조물 또는 튜브구조물의 양 끝단부를 담근 후 일정시간 경과 후 꺼내어 건조시키는 2차표면처리단계; 를 포함하는 것을 특징으로 한다.A certain time after immersing both ends of the tube structure or the tube structure that was first surface-treated in the first surface treatment step in a solvent in which the drug that inhibits vascular endothelial cell proliferation in an arbitrary concentration or a solvent in which the drug is not dissolved A secondary surface treatment step of removing and drying after elapsed time; Characterized in that it comprises a.

상기 2차표면처리단계는 적어도 1회 이상 반복하여 실시하는 것을 또 하나의 특징으로 한다.The second surface treatment step is another feature that is repeated at least one or more times.

상기 2차표면처리단계에서 상기 튜브구조물 또는 튜브구조물의 양 끝단부를 담그는 시간은 상기 1차표면처리단계에서 상기 튜브구조물 또는 튜브구조물의 양 끝단부를 담그는 시간보다 짧은 시간인 것을 또 하나의 특징으로 한다.The time for immersing both ends of the tube structure or the tube structure in the second surface treatment step is a time shorter than the time for immersing both ends of the tube structure or the tube structure in the first surface treatment step. .

또한, 상기한 목적을 달성하기 위한 본 발명에 따른 동정맥 연결용 튜브의 제조방법은, 혈관내피세포의 과증식을 억제시키는 약물을 튜브구조물의 표면에 표면 처리하여 코팅한 후, 부착력이 낮게 코팅된 약물을 제거시키는 것을 특징으로 한다. 그리고 부착력이 낮게 코팅된 약물을 제거한 후에는, 혈관내피세포의 과증식을 억제시키는 약물을 상기 튜브구조물의 표면에 재차 표면 처리하여 코팅하는 것을 더 나은 특징으로 한다.In addition, the method of manufacturing a tube for arteriovenous connection according to the present invention for achieving the above object, after coating the drug to inhibit the hyperproliferation of vascular endothelial cells on the surface of the tube structure, the drug coated with low adhesion It characterized in that to remove. And after removing the drug coated with low adhesion, the drug that inhibits the hyperproliferation of vascular endothelial cells is characterized in that the surface treatment of the tube structure again to coat the coating.

또한, 상기한 목적을 달성하기 위한 본 발명에 따른 의료시술용 인체삽입물의 제조방법은, 내피세포의 과증식을 억제시키는 약물을 용매에 정해진 농도로 용해시킨 다음, 이 용매에 구조물을 담근 후 일정시간 경과 후 꺼내어 건조시키는 1차표면처리단계; 및 내피세포의 과증식을 억제시키는 약물이 임의의 농도로 용해된 용매 또는 약물이 용해되지 않은 용매에 상기 1차표면처리단계에서 1차 표면 처리된 구조물을 담근 후 일정시간 경과 후 꺼내어 건조시키는 2차표면처리단계; 를 포함하는 것을 특징으로 한다.In addition, the method of manufacturing a human implant for medical procedures according to the present invention for achieving the above object, after dissolving the drug to inhibit the hyperproliferation of endothelial cells to a predetermined concentration in a solvent, and then immersed the structure in this solvent for a certain time A primary surface treatment step of taking out and drying after elapse of time; And submerging the first surface-treated structure in the first surface treatment step in a solvent in which a drug that inhibits overproliferation of endothelial cells in an arbitrary concentration or in a solvent in which the drug is not dissolved is removed and dried after a predetermined time. Surface treatment step; Characterized in that it comprises a.

상기 2차표면처리단계는 적어도 1회 이상 반복하여 실시하는 것을 또 하나의 특징으로 한다.The second surface treatment step is another feature that is repeated at least one or more times.

상기 2차표면처리단계에서 상기 구조물을 담그는 시간은 상기 1차표면처리단계에서 상기 구조물을 담그는 시간보다 짧은 시간인 것을 더 구체적인 특징으로 한다.The time for immersing the structure in the secondary surface treatment step is more specific than the time for immersing the structure in the primary surface treatment step.

또한, 상기한 목적을 달성하기 위한 본 발명에 따른 의료시술용 인체삽입물의 제조방법은, 내피세포의 과증식을 억제시키는 약물을 구조물의 표면에 표면 처리하여 코팅한 후, 부착력이 낮게 코팅된 약물을 제거시키는 것을 특징으로 한다. 그리고 부착력이 낮게 코팅된 약물을 제거한 후에는, 내피세포의 과증식을 억제시키는 약물을 상기 구조물의 표면에 재차 표면 처리하여 코팅하는 것을 더 나은 특징으로 한다.In addition, the method of manufacturing a human implant for medical procedures according to the present invention for achieving the above object, after coating the surface of the structure with a drug that inhibits the hyperproliferation of endothelial cells, the drug coated with low adhesion It is characterized by removing. After removing the drug coated with low adhesion, the drug that inhibits the hyperproliferation of endothelial cells is surface-treated and coated on the surface of the structure again.

그리고 약물을 녹이는 용매로는 유기용매를 사용하는 것을 원칙으로 하되, 좀 더 나은 효과를 위해서 아세톤을 포함한 용매를 사용하는 것을 또 하나의 특징으로 한다.In addition, as a solvent for dissolving drugs, in principle, an organic solvent is used, but another feature is to use a solvent including acetone for a better effect.

유리한 효과Favorable effect

위에서 설명한 바와 같이 본 발명에 따르면 동정맥 연결용 튜브를 인체에 삽입하여 혈액투석을 시행할 시에 튜브구조물의 표면에 처리된 약물이 서서히 용해되어 나오면서 오랜 시간을 두고 지속적으로 방출되기 때문에 약물의 효과를 오래도록 지속시킬 수 있는 효과가 있으며, 의료시술용 인체삽입물의 경우에도 동일한 효과를 가진다.As described above, according to the present invention, when the hemodialysis is performed by inserting the arteriovenous connection tube into the human body, the drug treated on the surface of the tube structure gradually dissolves and is continuously released for a long time, thereby improving the effect of the drug. There is an effect that can be maintained for a long time, and the same effect in the case of a human implant for medical procedures.

도1은 본 발명의 실시예에 따른 동정맥 연결용 튜브의 제조방법에 대한 흐름도이다.1 is a flowchart illustrating a method of manufacturing a tube for arteriovenous connection according to an embodiment of the present invention.

도2는 도1의 제조방법에 의해 제조된 동정맥 연결용 튜브의 특징을 과장하여 도시한 절개 사시도이다.Figure 2 is a cutaway perspective view showing an exaggerated feature of the tube for arteriovenous connection produced by the manufacturing method of Figure 1;

발명의 실시를 위한 최선의 형태Best Mode for Carrying Out the Invention

이하 본 발명의 바람직한 실시 예를 첨부한 도면을 참조하여 더욱 상세히 설명한다.Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

도1은 본 발명의 실시예에 따른 동정맥 연결용 튜브의 제조방법에 대한 흐름도이고, 도2는 도1의 제조방법에 의해 제조된 본 발명의 실시예에 따른 동정맥 연결용 튜브의 절개사시도이다.1 is a flowchart illustrating a method of manufacturing a tube for arteriovenous connection according to an embodiment of the present invention, and FIG. 2 is a cutaway perspective view of a tube for arteriovenous connection according to an embodiment of the present invention manufactured by the method of FIG. 1.

먼저 본 발명의 실시예에 따른 동정맥 연결용 튜브의 제조방법을 설명하기에 앞서, 제조에 필요한 준비물들에 대하여 살펴보면, 튜브구조물, 약물, 용매 등이 있으며, 약물이나 용매는 각 표면 처리 과정마다 다른 종류의 물질로 구비될 수 있다.First, before describing the manufacturing method of the arteriovenous connection tube according to an embodiment of the present invention, with respect to the preparations required for the preparation, there are tube structures, drugs, solvents, etc., drugs or solvents are different for each surface treatment process It can be provided with a kind of material.

상기 튜브구조물은 대체로 원통 형상이며 미세기공을 갖는 e-PTFE(Expanded Polytetrafluoroethylene)의 박막필름으로써, PTFE를 고온 및 고압의 압출에 의해 여러 방향으로 연신함으로써 얻어질 수 있으며, 보다 바람직하게는 고어텍스 (Goretex)가 원통형상으로 압출되어 만들어질 수 있다.The tubular structure is a thin cylindrical film of e-PTFE (Expanded Polytetrafluoroethylene) having a generally cylindrical shape and micropores, and may be obtained by stretching PTFE in various directions by extrusion of high temperature and high pressure, and more preferably Gore-Tex ( Goretex) can be made by extrusion into a cylindrical shape.

상기 약물은 혈관의 내피세포 과증식을 억제하는 효과를 가지는 물질로서 부작용이 없는 것이 바람직하게 고려될 수 있으며, 파클리탁셀(Paclitaxel) 혹은 라파마이신(Rapamycin) 등과 같은 물질이 바람직하게 채택될 수 있고, 복수의 표면 처리 과정에서 채택되는 약물들은 서로 동일 종류의 것이거나 다른 종류일 수 있다.The drug may be considered to have no side effects as a substance having an effect of inhibiting endothelial cell hyperproliferation of blood vessels, a substance such as paclitaxel or rapamycin may be preferably adopted, and a plurality of The drugs employed in the surface treatment may be the same kind or different kinds.

상기 용매는 상기 약물을 용해시키기 위한 것으로, 아세톤(acetone) 등과 같이 상기한 Paclitaxel 혹은 Rapamycin과 같은 약물을 용해시킬 수 있으면서 다른 문제점을 야기하지 않는 유기용매라면 어느 것이나 바람직하게 적용될 수 있다. 물론 복수의 표면 처리 과정에서 채택되는 용매들의 경우에도 각 과정마다 서로 동일 종류의 것이거나 다른 종류일 수 있다.The solvent is for dissolving the drug, and any solvent may be preferably used as long as it can dissolve the drug such as Paclitaxel or Rapamycin, such as acetone, and does not cause other problems. Of course, the solvents employed in the plurality of surface treatment processes may be the same kind or different kinds for each process.

상기와 같은 준비물이 구비되면, 도1의 흐름도와 같은 순서에 의해 동정맥 연결용 튜브를 제조한다.When the above preparation is provided, a tube for arteriovenous connection is manufactured by the same procedure as in the flowchart of FIG. 1.

1. 1차표면처리1. Primary surface treatment

먼저 용매(S1)에 약물을 정해진 적정 농도(C1)로 용해시킨다.First, the drug is dissolved in the solvent (S1) at a predetermined proper concentration (C1).

그리고 약물이 용해된 용매(S1)에 상기한 튜브구조물을 담근다＜S101＞. 이 때 본 실시예에서는 튜브구조물 전체를 담그는 것을 예로 하고 있지만, 실제 동정맥과 연결되는 부위인 튜브구조물의 양 끝단부만 담그는 것도 바람직하다.Subsequently, the tube structure is immersed in a solvent (S1) in which the drug is dissolved <S101>. At this time, the embodiment of the present invention is to immerse the entire tube structure, but it is also preferable to immerse only both ends of the tube structure, which is a portion that is actually connected to the arteriovenous vein.

튜브구조물을 담근 후 일정시간(T1)이 경과되면, 튜브구조물을 꺼내＜S102＞어 건조시킴＜S103＞으로써 1차 표면 처리를 완료한다.After a predetermined time (T1) has elapsed after the tube structure has been immersed, the primary surface treatment is completed by taking out the tube structure and drying it (S102).

2. 2차표면처리2. Second surface treatment

계속하여 약물이 임의의 농도(C2)로 용해된 용매(S2)에 1차 표면 처리된 튜브구조물을 담근다＜S201＞. 이 과정에서 1차 표면 처리된 튜브구조물이 용매(S2)에 담겨지면, 1차 표면 처리된 튜브구조물에 코팅된 약물 중 쉽게 방출될 정도로 부착된 약물은 쉽게 용해되어 나오게 되고, 코팅된 상태로 계속 남아 있는 약물의 표면으로 용매(S2)에 용해되어 있던 약물이 부착되어 진다.Subsequently, the tube structure subjected to the primary surface treatment is immersed in the solvent (S2) in which the drug is dissolved at an arbitrary concentration (C2) <S201>. In this process, when the first surface-treated tube structure is immersed in the solvent (S2), the drug attached to the first surface-treated tube structure is easily dissolved so that it is easily released and continues to be coated. The drug dissolved in the solvent (S2) is attached to the remaining drug surface.

1차 표면 처리된 튜브구조물을 담근 후 일정시간(T2)이 경과되면, 2차 표면 처리된 튜브구조물을 꺼내＜S202＞어 건조시킴＜S203＞으로써 2차 표면 처리를 완료한다.After a predetermined time (T2) has elapsed after immersing the primary surface-treated tube structure, the secondary surface treatment is completed by taking out the secondary surface treated tube structure <S202> and drying it <S203>.

이와 같은 2차표면처리과정을 적어도 1회 이상 반복하게 되면, 용해되어 나오기 쉬운 상태로 부착된 약물은 지속적으로 용해되어 나오게 되고, 용해되기 어려운 상태로 코팅되어 계속 남아 있는 약물의 표면으로는 용매에 용해되어 있던 약물이 부착됨으로써, 궁극적으로 튜브구조물의 표면에는 부착이 좋은 약물만이 코팅되어지게 되는 것이다.If the second surface treatment process is repeated at least once, the drug attached in a state that is easy to dissolve is continuously dissolved, and the drug is coated in a state that is difficult to dissolve. As the dissolved drug is attached, ultimately only the drug with good adhesion is coated on the surface of the tube structure.

그리고 상기한 1차표면처리과정과 2차표면처리과정에서 사용되는 약물이나 용매는, 상술한 바와 같이, 서로 동일한 것을 사용할 수도 있고 서로 다른 것을 사용할 수도 있다.The drug and the solvent used in the first surface treatment and the second surface treatment may be the same as or different from each other.

또, 2차표면처리과정에서 튜브구조물을 담그는 시간(T2)은 1차코팅과정에서 튜브구조물을 담그는 시간(T1)보다 짧을 수 있다. 현재까지는 시간T2를 시간T1보다 상당히 짧은 시간으로 하여 원하는 결과를 얻고 있으나, 많은 실험을 통하여 가장 바람직한 관계를 설정하는 것은 또 다른 과제로 남아 있다.In addition, the time T2 of dipping the tube structure in the secondary surface treatment may be shorter than the time T1 of dipping the tube structure in the primary coating process. Until now, the time T2 is considerably shorter than the time T1, and the desired result has been obtained. However, establishing the most desirable relationship through many experiments remains another task.

또한, 실시하기에 따라서 2차표면처리과정은 표면 처리된 튜브구조물을 약물이 용해되지 않은 용매에 담그도록 하여 방출되기 쉬운 약물만 용해되어 나오도록 하는 과정을 포함하는 것도, 부착력이 좋은 약물만을 튜브구조물의 표면에 코팅된 채로 남아 있도록 하여 약물이 초기에 과다하게 방출되는 현상을 방지할 수 있어서 바람직하게 고려될 수 있다.In addition, according to the implementation, the second surface treatment process includes the process of dipping the surface-treated tube structure in a solvent in which the drug is not dissolved so that only the drug that is easily released is released. It can be considered advantageous as it can remain coated on the surface of the structure to prevent the initial release of the drug excessively.

위와 같은 방법으로 동정맥 연결용 튜브를 제조하는 경우에 초기 및 이후 방출되는 양의 절대량이 작아질 수 있으나, 1차표면처리과정에서 용매에 용해된 약물의 농도를 늘려서 조절 할 수 있음을 확인할 수 있었다.In the case of manufacturing the arteriovenous connection tube as described above, the absolute amount of the initial and subsequent release may be reduced, but it was confirmed that the first surface treatment can be controlled by increasing the concentration of the drug dissolved in the solvent. .

도2는 상기와 같은 과정을 거쳐 제조된 동정맥 연결용 튜브에 대한 절개 사시도이다.Figure 2 is a perspective view of the incision for the arteriovenous connection tube manufactured through the above process.

도2를 참조하면 본 실시예에 따른 동정맥 연결용 튜브(100)는 대체적으로 원통의 형상을 가지는 튜브구조물(11)과 해당 튜브구조물(11)의 표면에 약물이 코팅된 코팅층(12)을 가진다.Referring to FIG. 2, the tube 100 for arteriovenous connection according to the present embodiment generally has a tube structure 11 having a cylindrical shape and a coating layer 12 coated with a drug on the surface of the tube structure 11. .

본 실시예와 같은 동정맥 연결용 튜브(100)를 인체에 삽입하여 사용할 경우에, 튜브구조물(11)의 표면에 코팅된 약물은 쉽게 용해되어 나오지 못하도록 부착되어 있기 때문에 약물의 방출속도가 느리면서도, 지속적으로 약물이 방출되기 때문에 약물의 효과를 지속적으로 가질 수 있게 되는 것이다.When the tube 100 for arteriovenous connection as in the present embodiment is used to be inserted into the human body, the drug coated on the surface of the tube structure 11 is attached so as not to be easily dissolved, but the release rate of the drug is slow. Since the drug is continuously released, the drug can have a continuous effect.

물론, 상술한 실시예는 동정맥 연결용 튜브를 예로 하여 설명하였지만, 의료시술용으로서 인체에 삽입되는 것이면서 내피세포의 과증식을 억제시킬 수 있는 삽 입물이라면 동일한 표면 처리 과정에 의해 제조될 수 있다.Of course, the above-described embodiment has been described using the arteriovenous connection tube as an example, if the insert is inserted into the human body for medical procedures and can suppress the overgrowth of endothelial cells can be prepared by the same surface treatment process.

한편, 이상에서의 설명은 본 발명의 바람직한 실시예를 들어 설명하였지만, 본 발명이 상술한 실시예들에 한정되는 것으로 해석되어서는 아니 되며, 본 발명은 후술되는 특허청구범위 및 그 등가개념으로 이해되어져야 할 것이다.On the other hand, the above description has been described for the preferred embodiment of the present invention, but the present invention is not to be construed as being limited to the above embodiments, the present invention is understood by the claims and equivalent concepts described below It must be done.

본 발명은, 혈액투석을 받는 환자들의 동정맥을 안정적으로 연결할 수 있으며, 의료분야에서 적절히 사용될 수 있다.The present invention can stably connect the arteriovenous veins of patients undergoing hemodialysis, and can be appropriately used in the medical field.

Claims (12)

혈관내피세포의 과증식을 억제시키는 약물을 용매에 정해진 농도로 용해시킨 다음, 이 용매에 튜브구조물 또는 튜브구조물의 양 끝단부를 담근 후 일정시간 경과 후 꺼내어 건조시키는 1차표면처리단계; 및A first surface treatment step of dissolving a drug that inhibits hyperproliferation of vascular endothelial cells in a solvent at a predetermined concentration, and then immersing both ends of the tube structure or the tube structure in the solvent, and then removing and drying the tube structure after a predetermined time; And 혈관내피세포의 과증식을 억제시키는 약물이 임의의 농도로 용해된 용매 또는 약물이 용해되지 않은 용매에 상기 1차표면처리단계에서 1차 표면 처리된 튜브구조물 또는 튜브구조물의 양 끝단부를 담근 후 일정시간 경과 후 꺼내어 건조시키는 2차표면처리단계; 를 포함하는 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.A certain time after immersing both ends of the tube structure or the tube structure that was first surface-treated in the first surface treatment step in a solvent in which the drug that inhibits vascular endothelial cell proliferation in an arbitrary concentration or a solvent in which the drug is not dissolved A secondary surface treatment step of removing and drying after elapsed time; Method of manufacturing a tube for arteriovenous connection comprising a. 제1항에 있어서,The method of claim 1, 상기 2차표면처리단계는 적어도 1회 이상 반복하여 실시하는 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.The second surface treatment step is a method of manufacturing a tube for arteriovenous connection, characterized in that carried out repeatedly at least one or more times. 제1항에 있어서,The method of claim 1, 상기 2차표면처리단계에서 상기 튜브구조물 또는 튜브구조물의 양 끝단부를 담그는 시간은 상기 1차표면처리단계에서 상기 튜브구조물 또는 튜브구조물의 양 끝단부를 담그는 시간보다 짧은 시간인 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.The time for immersing both ends of the tube structure or the tube structure in the second surface treatment step is a time shorter than the time to immerse both ends of the tube structure or the tube structure in the first surface treatment step. Method of manufacturing the tube. 제1항에 있어서,The method of claim 1, 상기 1차표면처리단계 또는 2차표면처리단계에서 사용되는 용매는 아세톤을 포함하는 유기용매 인 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.The solvent used in the first surface treatment step or the second surface treatment step is a method for producing a tube for arteriovenous connection, characterized in that the organic solvent containing acetone. 혈관내피세포의 과증식을 억제시키는 약물을 튜브구조물의 표면에 표면 처리하여 코팅한 후, 부착력이 낮게 코팅된 약물을 제거시키는 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.Method of producing a tube for arteriovenous connection, characterized in that to remove the drug coated with a low adhesion after coating the surface of the tube structure with a drug that inhibits hyperproliferation of vascular endothelial cells. 제5항에 있어서,The method of claim 5, 부착력이 낮게 코팅된 약물을 제거한 후, 혈관내피세포의 과증식을 억제시키는 약물을 상기 튜브구조물의 표면에 재차 표면 처리하여 코팅하는 것을 특징으로 하는 동정맥 연결용 튜브의 제조방법.After removing the drug coated with a low adhesion, a method for producing a tube for arteriovenous connection, characterized in that the surface treatment of the drug to inhibit the hyperproliferation of vascular endothelial cells to the surface of the tube structure again coating. 내피세포의 과증식을 억제시키는 약물을 용매에 정해진 농도로 용해시킨 다음, 이 용매에 구조물을 담근 후 일정시간 경과 후 꺼내어 건조시키는 1차표면처리단계; 및A first surface treatment step of dissolving a drug that inhibits endothelial cell hyperproliferation at a predetermined concentration in a solvent, and then immersing the structure in this solvent and then removing the product after a predetermined time and drying it; And 내피세포의 과증식을 억제시키는 약물이 임의의 농도로 용해된 용매 또는 약물이 용해되지 않은 용매에 상기 1차표면처리단계에서 1차 표면 처리된 구조물을 담근 후 일정시간 경과 후 꺼내어 건조시키는 2차표면처리단계; 를 포함하는 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.Secondary surface that is immersed in a solvent in which the drug that inhibits endothelial cell proliferation at an arbitrary concentration or in a solvent in which the drug is not dissolved in the primary surface treatment step is removed and dried after a certain time. Processing step; Method of manufacturing a human body insert for medical procedures comprising a. 제7항에 있어서,The method of claim 7, wherein 상기 2차표면처리단계는 적어도 1회 이상 반복하여 실시하는 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.The second surface treatment step is a method for producing a human body insert for medical treatment, characterized in that repeated at least one or more times. 제7항에 있어서,The method of claim 7, wherein 상기 2차표면처리단계에서 상기 구조물을 담그는 시간은 상기 1차표면처리단계에서 상기 구조물을 담그는 시간보다 짧은 시간인 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.And dipping the structure in the second surface treatment step is a time shorter than the time for dipping the structure in the first surface treatment step. 제7항에 있어서,The method of claim 7, wherein 상기 1차표면처리단계 또는 2차표면처리단계에서 사용되는 용매는 아세톤을 포함하는 유기용매 인 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.The solvent used in the first surface treatment step or the second surface treatment step is a method for manufacturing a human body insert for medical procedures, characterized in that the organic solvent containing acetone. 내피세포의 과증식을 억제시키는 약물을 구조물의 표면에 표면 처리하여 코팅한 후, 부착력이 낮게 코팅된 약물을 제거시키는 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.A method of manufacturing a human insert for medical procedures, characterized in that the coating of a drug that inhibits overproliferation of endothelial cells by coating the surface of the structure and removing the coated drug having low adhesion. 제11항에 있어서,The method of claim 11, 부착력이 낮게 코팅된 약물을 제거한 후, 내피세포의 과증식을 억제시키는 약물을 상기 구조물의 표면에 재차 표면 처리하여 코팅하는 것을 특징으로 하는 의료시술용 인체삽입물의 제조방법.After removing the drug coated with a low adhesion, the method of manufacturing a human insert for medical procedures, characterized in that the surface treatment of the drug to inhibit the hyperproliferation of the endothelial cells to the surface of the structure again coating.
KR1020087011695A 2008-05-16 2005-11-17 A tube for connecting marteriovenous and interposition for medical operation KR20080074885A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101240437B1 (en) * 2012-07-05 2013-03-11 주식회사 엠아이텍 Cylindrical structure having a lumen implanted into a human body

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101240437B1 (en) * 2012-07-05 2013-03-11 주식회사 엠아이텍 Cylindrical structure having a lumen implanted into a human body

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