KR960003508B1 - Sinkhole bileaflet polymer heart valve - Google Patents

Sinkhole bileaflet polymer heart valve

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Publication number
KR960003508B1
KR960003508B1 KR1019930004103A KR930004103A KR960003508B1 KR 960003508 B1 KR960003508 B1 KR 960003508B1 KR 1019930004103 A KR1019930004103 A KR 1019930004103A KR 930004103 A KR930004103 A KR 930004103A KR 960003508 B1 KR960003508 B1 KR 960003508B1
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valve
heart valve
valves
polymer
blood
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KR1019930004103A
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Korean (ko)
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KR940021016A (en
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민병구
김영하
한동근
김철생
이계한
김희찬
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서울대학교 의과대학 의공학연구소
민병구
한국과학기술연구원
서정욱
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Priority to KR1019930004103A priority Critical patent/KR960003508B1/en
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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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415—Manufacturing methods
    • 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615—Measuring means
    • A61F2002/7635—Measuring means for measuring force, pressure or mechanical tension
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • External Artificial Organs (AREA)

Abstract

The sinkhole bileafle polymer heart valve having a blood compatibility and durability, is useful for an artificial heart valve for a blood pump, a total artificial heart valve for substitution and a heart valve of a ventricular assist device. A heart valve frame is prepared by impregnating isoplast having a width of 1 mm and a space of 3 mm into pellethane solution. The pellethane solution in dimethylacetamide is molded a thickness of 0.2 mm on the glass plate, and punched to a round shape to give a leaflet.

Description

수채형 양엽 고분자심장판막Aquarelle Bifocal Polymer Heart Valve

제1도는 본 발명의 수채형 판막의 모식도로서 열림판이 지지대의 가장 긴 길이방향으로 평행하게 접착된 평면도로 열림판이 닫혀 있을 때의 도면.1 is a schematic view of the sink valve of the present invention when the opening plate is closed in a plan view in which the opening plate is bonded in parallel to the longest longitudinal direction of the support.

제2도는 제1도의 정면도로 열림판이 열려 있을 때의 도면.2 is a view when the opening plate is open in the front view of FIG.

제3도는 본 발명의 수채형 판막의 모식도로서 열림판의 가장 긴 부분이 지지대의 길이방향과 직각되게 접착된 평면도로 열림판이 닫혀 있을 때의 도면.3 is a schematic view of the sink valve of the present invention when the opening plate is closed in a plan view in which the longest portion of the opening plate is bonded perpendicular to the longitudinal direction of the support.

제4도는 제3도의 정면도로 열림판이 열려 있을 때의 도면.4 is a front view of FIG. 3 when the opening plate is open.

* 도면의 주요부분에 대한 부호의 설명* Explanation of symbols for main parts of the drawings

1 : 판막틀 2 : 지지대1: valve frame 2: support

3 : 열림판 4 : 지지대 사이간격3: opening plate 4: spacing between supports

5 : 열림판의 지지대 접착부분5: adhesive part of support plate of opening plate

본 발명은 수채형 양엽 고분자심장판막에 관한 것으로, 더욱 상세하게는 일시적인 혈액펌프용 인공판막 뿐만 아니라 치환용 완전인공심판(total artificial heart, TAH) 및 심실보조장치(ventricular assist device, VAD) 등의 심장판막으로 사용가능한 혈액적합성(blood compa-tibility)과 내구성(durability)이 뛰어난 수채형 양엽 고분자심장판막(sinkhole bileafle polymer heart valve, 약칭 수채형 판막)에 관한 것이다.BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a watercolor bifocal polymeric heart valve, and more particularly to a temporary blood pump artificial valve, a total artificial heart (TAH) and a ventricular assist device (VAD). Sinkhole bileafle polymer heart valve (abbreviated watercolor valve) with excellent blood compa-tibility and durability that can be used as a heart valve.

심장판막의 이상에 의하여 발생하는 심장기능의 저하는 적기에 심장 판막을 수술함으로써 심장기능을 개선시킬 수 있으나, 수술이 불가능할 정도로 심한 경우에는 외과적 수술에 의해 인공적으로 제작된 판막을 치환하여 사용하게 된다.Decreased cardiac function caused by abnormal heart valves can improve the cardiac function by operating the heart valve in a timely manner. However, if the operation is severe enough that the operation is impossible, replace the artificially manufactured valve by surgical operation. do.

지난 40여년 전부터 인공판막들의 재질과 설계의 변형에 의해 지금까지 개발되어온 판막들은 수십여종에 달하나 현재 실제로 사용되고 있는 것으로는 기계식 판막(mechanical valve)과 조직판막(tissue valve)이 있다.There are dozens of types of valves that have been developed until the last 40 years, due to variations in the material and design of the artificial valves. However, mechanical valves and tissue valves are currently used.

기계식 판막은 1960년 스타-에드워즈(Starr-Edwards)가 구형판막(caged ball valve)(A. Starr 등, Ann. Surg., 154,726, 1961)을 개발하여 최초로 승모판치환에 성공한 이래 여러형태의 기계식 판막들이 연구되었으나, 이 중 현재 경사판형 판막(tilting disk valve)과 양엽식 판막(bileafle valve)만이 주로 임상적으로 사용되고 있다.Mechanical valves were developed by Starr-Edwards in 1960 in the form of a caged ball valve (A. Starr et al., Ann. Surg., 154,726, 1961), and was the first to succeed in mitral valve replacement. However, of these, only tilting disk valves and bileafle valves are currently used clinically.

이 판막은 장기간 내구성이 양호하고 품질이 균일하나, 혈전과 색전증의 위험을 줄이기 위하여 계속적인 항응고제(anticoagulant)를 복용해야 하며 이로 인한 출혈문제가 유발되고 있다.The valve is durable and uniform in quality for a long time, but continuous anticoagulant should be taken to reduce the risk of thrombosis and embolism, leading to bleeding problems.

또한 혈류학적 기능과 재료가 정상적인 심장판막과 아주 다르고 유연성이 없기 때문에 수충효과(waterhammer effect) 등 여러문제가 야기되고 있고 구조적으로 판막이 닫힐 때 틈새가 있어 그 사이로 내뿜는 혈액의 용혈도 큰 단점으로 알려져 있다.In addition, because hemodynamic function and materials are very different from the normal heart valve and inflexible, various problems such as waterhammer effect are caused, and there is a gap when the valve is closed structurally. have.

조직판막은 1965년 카펜티어(Carpentier)에 의해 성공한 이래(A. Carpentier 등, J. Thorac. Cardiovasc. Surg., 58,467, 1969) 돼지의 대동맥 판막(aortic valve)이나 소의 심낭(pericardium)을 약물로 고정처리하여 만든 생체조직판막이 임상적으로 사용되고 있다.Tissue valves have been developed by carpentier in 1965 (A. Carpentier et al., J. Thorac. Cardiovasc.Surg., 58,467, 1969) with aortic valves of pigs or pericardium of bovine pericardium. Immobilized biotissue valves are used clinically.

이 판막은 생체와 유사한 형태와 기능을 가지고 있고 비교적 항혈전성이 뛰어나기 때문에 장기간 항응고제를 복용하지 않아도 되는 장점이 있으나 내구성이 떨어지고, 병리적 칼슘화(calcification)에 의한 판막기능상실이 큰 문제점으로 남아 있다.This valve has a similar shape and function to living organisms and has excellent antithrombotic properties, so it is not necessary to take anticoagulants for a long time, but the durability is poor and loss of valve function due to pathological calcium is a major problem. Remains.

이러한 기계적 판막과 조직판막의 상호 장단점을 보완하고 보다 저렴한 인공판막을 개발하기 위해 고분자재료의 유연성을 이용한 여러 모양의 고분자 판막이 1960년대 부터 연구되어 왔다. 지금까지 개발된 고분자 판막을 분류해 보면 열림판(leaflet)의 수에 따라 크게 단엽, 양엽 및 삼엽판으로 구분된다.In order to supplement the advantages and disadvantages of mechanical and tissue valves and to develop cheaper artificial valves, various types of polymer valves using flexibility of polymer materials have been studied since the 1960s. The types of polymer valves developed so far are classified into single lobes, bilateral lobes and trilobites according to the number of leaflets.

단엽식 고분자 판막(monoleaflet polymer valve)은 작동원리상 주로 유입판막(inflow valve)에 사용하기 위해 연구되어 왔고 대표적인 것으로는 콜프(Kolff) 등이 개발한 화장실 변기 뚜껑 모양의 토일릿 시트 판막(toilet seat valve), 윌리엄스(Williams) 등의 D-형상 판막(D-shaped valve)(W.G. Williams 등, Trans. Am. Soc. Artif, Intern. Organs, 24,542, 1978) 및 틸먼(Tillman) 등이 개발한 쉘 판막(shell valve)(H. Reul 등, Trans. Am. Soc. Artif. Intern. Organs, 2,434, 1979) 등이 있다.Monoleaflet polymer valves have been studied for use mainly on inflow valves due to the principle of operation, and representative examples are toilet seat lid shaped toilet seat valves developed by Kolff et al. valve, D-shaped valve (WG Williams et al., Trans. Am. Soc. Artif, Intern. Organs, 24,542, 1978) by Williams et al. and Shell developed by Tillman et al. Shell valves (H. Reul et al., Trans. Am. Soc. Artif. Intern. Organs, 2,434, 1979).

대부분 열림판의 모양은 개폐를 용이하게 하기 위해 심실쪽의 면이 오목한 형태로 되어 있으며, 바이오머(Biomer)와 같이 유연한 폴리우레탄 내부에 다공 금속편이 물리적으로 결합되어 있다.Most of the shape of the opening plate is a concave side of the ventricle in order to facilitate the opening and closing, the porous metal piece is physically bonded inside the flexible polyurethane, such as Biomer (Biomer).

단엽 고분자 판막은 혈류방해가 아주 적고 열림판의 방향을 심실측 면으로 향하게 함으로써 심실내의 정체영역을 어느 정도 없앨 수는 있으나, 판막 개폐시간이 길고 구조상 동맥판으로의 사용은 불가능하다는 단점이 있다.Monoleaflet polymer valves have very low blood flow and the opening of the valve to the ventricular side can eliminate some stagnant areas in the ventricles, but the valve opening time is long and structurally impossible to use as an artery plate. .

양엽식 고분자판막(bileafleat polymer valve)의 대표적인 예로는 고트(Gott) 등이 개발한 고트-다겟트 판막(Gott-Dagett valve)이 있으며 그 형태가 나비 모양이어서 일명 버터플라이 판막(butterfly valve)이라 부르고 있다. 이 판막은 개 실험에서 대동맥 및 폐동맥 판막 치환후 수 개월 동안 항응고제 사용없이 생존한 결과보고가 있으나 열림판의 탈구(prolapse)를 막기 위해서 사용한 방사형 모양의 지지대에 의한 혈류 방해와 열림판을 판막 링에 고정시키기 위해 사용한 리벳팅 방법 또는 접착제 사용시 연결부에서 열림판이 찢어지는 문제 등이 발생하였다.A representative example of the bileafleat polymer valve is the Gott-Dagett valve developed by Gott et al. Its butterfly shape is called a butterfly valve. have. Although the valves survived for several months after aortic and pulmonary valve replacement without anticoagulant, blood flow obstruction and opening plate was prevented by the radial support used to prevent the progression of the valve. Riveting method used to fix or when using the adhesive problems such as tearing the opening plate at the connection occurred.

또한 최근 콜프(Kolff) 등이 개발한 중심 유동형태를 갖는 플랩 판막(flap valve)(E.G. Wijsmuller 등, The Int. J. Artif. Organ, 13,503, 1990)이 좌심실 보조장치의 유입판막으로 사용하였으나 동물실험에서 열림판이 열릴 때 굴곡부(flexion)와 혈류정체에 의한 열림판 뒷쪽의 혈액주머니에서 혈전이 형성되는 것으로 보고되었다.In addition, a flap valve (EG Wijsmuller et al., The Int. J. Artif. Organ, 13,503, 1990), developed by Kolff et al., Was used as an inlet valve for left ventricular assist devices. In the experiment, it was reported that thrombus was formed in the blood bag at the back of the opening plate due to flexion and stagnation when the opening plate was opened.

삼엽식 고분자판막(trileaflet polymer valve)은 심장의 대 동맥판과 유사한 모양의 세개의 열림판으로 되어 있으며, 조직판막과 마찬가지로 혈류가 중심유동 형태이며, 역류계수가 낮고 누수가 적다는 장점이 있어 여러 모양의 설계와 제작방법이 개발되어 왔다.The trileaflet polymer valve consists of three open valves that resemble the aortic valve of the heart. Like the tissue valves, the trileaflet polymer valve has the advantage of having a central flow, low backflow coefficient and low leakage. Shape design and fabrication methods have been developed.

그러나 지금까지 개발된 고분자재료들은, 조직판막과 같은 충분한 유연성을 갖지 못하므로 세개의 열림판이 충분히 열리지 못해 판막을 가로지르는 압력차가 다른 판막들에 비해 높고 열림판 뒷면에서의 혈액정체현상 등 개선해야 할 많은 문제점들을 갖고 있다. 뿐만 아니라 열림판의 개폐가 균일하고 쉽게 열릴 수 있도록 열림판의 균일한 두께 조절이 필요하게 되나 형상이 다소 복잡하여 제작이 용이하지 않다.However, the polymer materials developed so far do not have sufficient flexibility as the tissue valve, so the three opening plates are not opened sufficiently, so the pressure difference across the valves is higher than that of other valves, and blood retention on the back of the opening plate needs to be improved. There are many problems. In addition, it is necessary to control the thickness of the opening plate so that opening and closing of the opening plate can be opened easily and easily, but it is not easy to manufacture because the shape is somewhat complicated.

이 외에도 최근에 일본의 이마찌(Imachi) 등은 해파리의 모습과 유사한 젤리피쉬 판막(jellifish valve)(K. Imach 등, Trans. Am. Soc. Artif. Intern. Organs. 37, M220, 1991)을 카디오세인(Cardiothane)이라는 폴리우레탄으로 만들어 동물실험 결과 125일 동안 항응고제 사용없이도 혈전이 형성되지 않았음을 보고하고 있으나 판막의 유효구경(effective orifice area)이 적고 열림판이 반복운동을 계속함에 따라 응력(stress)이 집중되는 단점이 있다.In addition, Imachi et al. Recently released a jellyfish valve (K. Imach et al., Trans. Am. Soc. Artif.Intern. Organs. 37, M220, 1991) that resembles a jellyfish. Animal experiments showed that the blood clot was not formed without anticoagulant for 125 days, but made of polyurethane called cardiothane, but the effective orifice area of the valve was small and the opening plate continued to repeat. There is a disadvantage in that stress is concentrated.

이상과 같은 여러가지 고분자판막이 개발되어 왔으나 혈전성 및 배구성의 제한 때문에 아직까지 판막치환용으로서의 임상적인 응용은 거의 없다. 그러나 이 고분자 판막은 기계식 판막보다 구조가 간단하고 제조가 용이하며 저가이기 때문에 일시적으로 사용하는 혈액펌프용으로 이용가치가 클 뿐만 아니라 인공판막으로서 요구되는 내구성을 갖고 혈액적합성이 높은 고분자재료를 이용한다면 장기간 완전치환용 고분자 판막으로 사용이 가능할 것으로 기대된다.Although various polymer valves have been developed as described above, there are few clinical applications as valve replacements due to limitations of thrombosis and embryonic composition. However, this polymer valve is simpler in structure than mechanical valves, is easier to manufacture, and is cheaper. Therefore, if the polymer valve is not only used for temporary blood pumps but also has high durability and high blood compatibility, it is required as an artificial valve. It is expected to be used as a polymer valve for long-term complete replacement.

본 발명의 수채형 판막은 이와같은 기존의 고분자 판막의 단점을 개선한 것으로서, 기존의 양엽식 고분자 판막에 비해서 열림판의 탈구(prolapse)를 방지하면서 판막의 유효구경(effective orifice area)이 최대가 되고 또한 혈액펌프용으로 사용시 혈액주머니(sac)-판막-혈관(graft)의 일체화가 가능하며 특히 고분자 판막으로서 혈액 적합성과 내구성이 뛰어난 것을 특징으로 하고 있다.The watercolor valve of the present invention improves the disadvantages of the conventional polymer valve, and prevents the opening of the open plate while preventing the prolapse of the open plate compared to the conventional polymer valve, and maximizes the effective orifice area of the valve. In addition, it is possible to integrate blood sacs-valve-grafts when used for blood pumps, and in particular, it is characterized by excellent blood compatibility and durability as a polymer valve.

본 발명의 수채형 판막은 도면 제1∼4도와 같이 판막틀(frame), 지지대(strut) 및 두개의 열림판(leaflet)으로 되어 있으며, 기존의 여러가지 고분자 판막의 단점인 높은 압력하에서의 열림판의 탈구, 판막전후의 압력차에 의한 혈액의 정체, 와류와 혈전형성 및 열림판 고정시의 판막기능저하 등을 고려하여 설계되었다.The sink valve of the present invention is composed of a valve frame, a strut, and two leaflets as shown in FIGS. 1 to 4, and has a disadvantage of a high pressure valve, which is a disadvantage of various polymer valves. It was designed to account for dislocation, stagnation of blood due to pressure difference before and after valve, vortex formation and thrombus formation, and deterioration of valve function during opening plate fixation.

수채형 판막의 두개의 열림판은 0.5∼1.5mm 폭의 지지대의 가장 긴 길이방향으로 평행(도면 제1∼2도) 또는 직각(도면 제3∼4도) 되게 접착되어 있으며, 지지대의 갯수는 1∼5개이고 그 지지대 사이간격은2∼5mm로 되어 있다. 판막틀의 직경과 두께는 각각 15∼30mm와 1∼4mm이고 열림판의 직경과 두께는 각각 12∼25mm와 0.1∼0.4mm로 되어 있다.The two opening plates of the sink valve are bonded in the longest longitudinal direction of the support of 0.5 to 1.5 mm width in parallel (first to second degree) or at right angles (third to fourth degree of drawing). It is 1-5 pieces, and the space | interval between the support stands is 2-5 mm. The diameter and thickness of the valve frame are 15-30 mm and 1-4 mm, respectively, and the diameter and thickness of the opening plate are 12-25 mm and 0.1-0.4 mm, respectively.

사용 용도에 따라 판막틀의 외관은 달라질 수 있고 그 외측홈은 없을 수도 있으며 판막지지대 유입부분은 혈액유동시 저항을 줄이기 위하여 반경 0.5∼1.5mm로 라운딩(rounding) 하였다.The appearance of the valve frame may vary depending on the intended use, and there may be no outer groove, and the inlet of the valve support is rounded to a radius of 0.5 to 1.5 mm to reduce resistance during blood flow.

열림판의 재료는 유연한 폴리우레탄인 펠레탄(Pellethane) 등을 사용하고 판막틀의 재료는 딱딱한 폴리우레탄인 아이소플라스트(Isoplast) 등을 사용하였다. 열림판을 지지대에 고정시 사용한 접착액은 디메털아세트아미드(dimethylacetamide) 등의 용매에 용해된 묽은 펠레탄 등과 같은 폴리우레탄 용액으로, 접착 후 열림판의 기능에 아무런 손상이 없었으며, 특히 혈액펌프용으로 사용하는 일체형 혈액주머니-판막-혈관을 조립시 이 용액을 사용하면 틈이 없이(seamless) 접착시킬 수 있다.The material of the opening plate used a flexible polyurethane (Pellethane) and the like, the material of the valve frame used a rigid polyurethane isoplast (Isoplast) and the like. The adhesive solution used to fix the opening plate to the support is a polyurethane solution such as dilute pellets dissolved in a solvent such as dimethylacetamide, and after adhesion, there is no damage to the function of the opening plate. This solution can be used to assemble seamless blood bag-valve-vessels for use in applications.

[판막의 수력학적 성능실험 및 동물실험][Hydraulic Performance Test and Animal Test of Valve]

본 발명의 수채형 판막의 수력학적 성능을 기존의 비욕실리(Bjork-Shiley) 기계식 판막과 비교하기 위하여, 혈액주머니가 자연심장과 유사한 모형으로 되어 있고 압축공기펌프로 구동되는 모의순환실험장치(mock circulation system)를 이용하여 혈액방출양을 평가하였다.In order to compare the hydraulic performance of the watercolor valve of the present invention with a conventional Bjork-Shiley mechanical valve, a simulated circulatory experiment device in which a blood bag is modeled similar to a natural heart and driven by a compressed air pump The amount of blood released was assessed using the circulation system.

또한 수채형 판막의 판막기능과 혈액적합성 및 내구성은 개를 이용한 우심실과 폐동맥사이의 우회(RV-PA shunt)방법 (J.Y.Lee 등, 대한흉부외과학회지, 20(3), 458, 1987)으로 평가하였다. 약 1개월 동안 이식후 인공 혈관 중앙에 부착된 판막을 꺼내어 전체적인 판막의 기능은 육안으로 확인하였고, 혈액적합성과 생체내 안정성은 주사전자현미경(scanning electron microscopy, SEM)으로 관찰하였으며, 칼슘화에 의한 칼슘침착은 원소분석으로 행하였다.In addition, the valve function, blood compatibility, and durability of the avalanche valves were evaluated by the method of bypassing the right ventricle and pulmonary artery (RV-PA shunt) in dogs (JYLee et al. It was. After transplantation for about 1 month, the valve attached to the center of the artificial blood vessel was taken out and the overall valve function was visually confirmed. Blood compatibility and in vivo stability were observed by scanning electron microscopy (SEM). Calcium deposition was performed by elemental analysis.

다음에 본 발명에서 연구된 수채형 판막에 대한 실시예를 기술하지만 본 발명이 반드시 예시된 예에만 국한되는 것은 아니다.The following describes examples of the watercolor valves studied in the present invention, but the invention is not necessarily limited to the illustrated examples.

[실시예 1]Example 1

수채형 판막은 다음과 같이 제조하였다. 먼저 판막틀은 아이소플 라스트를 기계가공하여 1mm 폭의 지지대와 3mm의 사이간격을 만든 다음 디메틸아세트아미드에 용해된 펠레탄 용액속에 침적하여 제조하였다.Sink valves were prepared as follows. First, the valve frame was manufactured by machining an isoblast to make a 1 mm wide support and a 3 mm gap, and then immersing it in a pellet solution dissolved in dimethylacetamide.

열림판은 디메틸아세트아미드에 용해된 펠레탄 용액을 유리판 위에서 성형하여 0.2mm로 두께를 조절한 다음 적당한 크기의 원형으로 펀칭하여 자른 후 제조된 판막지지대의 가장 긴 길이방향으로 평행하게 디메틸아세트아미드에 용해된 묽은 펠레탄 용액으로 접착시켜서 수채형 판막을 제조하였다.The opening plate is formed on a glass plate of pelletized solution dissolved in dimethylacetamide, adjusted to a thickness of 0.2 mm, and cut into punches of appropriate size and cut into parallel dimethylacetamide in the longest length direction of the manufactured valve support. Sink valves were prepared by adhering with the dissolved dilute pellet solution.

이렇게 제조된 수채형 판막은 수력학적 성능실험 결과 기존의 상품화된 기계식 판막에 비해서 혈액펌프 박출량이 10% 이상 높았다.As a result of the hydrodynamic performance test, the manufactured valve was more than 10% higher than the conventional commercial mechanical valve.

또한 개를 이용한 동물실험으로부터 우수한 판막기능을 보였으며, 혈전이 생성되지 않고 칼슘침착 및 균열이 없는 우수한 혈액적합성과 내구성을 나타내었다.In addition, it showed excellent valve function from animal experiments with dogs, and showed excellent blood compatibility and durability without the formation of blood clots, calcium deposition and cracking.

[실시예 2]Example 2

열림판의 가장 긴 부분을 판막지지대의 길이방향과 직각되게 접착시키는 것 이외는 실시예 1과 같은 방법으로 수채형 판막을 제조하였다. 이렇게 제조된 수채형 판막은 실시예 1과 같은 수력학적 성능과 판막기능, 혈액적합성 및 내구성을 나타내었다.A watercolor valve was prepared in the same manner as in Example 1 except that the longest part of the opening plate was bonded at right angles to the longitudinal direction of the valve support. Thus prepared watercolor valve showed the same hydraulic performance and valve function, blood compatibility and durability as in Example 1.

Claims (1)

양엽식 고분자 판막의 열림판의 탈구를 방지하면서, 판막 유효 구경이 최대가 되고 또한 혈액펌프용으로 사용시 혈액주머니-판막-혈관의 일체화가 가능하며 열림판이 지지대의 가장 긴 길이방향으로 평행 또는 직각되게 접착된 것을 특징으로 하는 혈액적합성과 내구성이 뛰어나고, 혈액펌프용 인공판막뿐만 아니라 치환용 완전인공심장 및 심실보조장치 등의 심장판막으로 사용가능한 수채형 양엽 고분자 심장판막(sinkholebileaflet polymer heart valve).Preventing the dislocation of the opening plate of the double-leaf polymer valve, the valve effective aperture is maximized, and the blood bag-valve-vessel can be integrated when used for the blood pump, and the opening plate is parallel or perpendicular to the longest length of the support. Sinkholebileaflet polymer heart valve with excellent blood compatibility and durability, which can be used as a heart valve, such as a replacement artificial heart and ventricular assist device, as well as a blood pump artificial valve.
KR1019930004103A 1993-03-17 1993-03-17 Sinkhole bileaflet polymer heart valve KR960003508B1 (en)

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