WO2015005690A1 - Cerclage rope for mitral valve cerclage annuloplasty - Google Patents

Cerclage rope for mitral valve cerclage annuloplasty Download PDF

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Publication number
WO2015005690A1
WO2015005690A1 PCT/KR2014/006191 KR2014006191W WO2015005690A1 WO 2015005690 A1 WO2015005690 A1 WO 2015005690A1 KR 2014006191 W KR2014006191 W KR 2014006191W WO 2015005690 A1 WO2015005690 A1 WO 2015005690A1
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Prior art keywords
mitral valve
rope
wire
cerclage
circle
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PCT/KR2014/006191
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French (fr)
Korean (ko)
Inventor
김준홍
김진평
Original Assignee
주식회사 코스와이어
(주) 타우피엔유메디칼
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Publication of WO2015005690A1 publication Critical patent/WO2015005690A1/en

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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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/042—Iron or iron alloys
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves

Definitions

  • the present invention relates to a circular rope for mitral valve circle large procedure used in mitral valve circular large procedure to be performed in patients with mitral regurgitation, and more particularly, to coronary sinus and tricuspid valve and surrounding tissue in mitral valve circular large procedure. It relates to a circular rope for mitral valve circle large procedure which is inserted into a protective tissue protective device and finally has the required proper tension, durability and pushability.
  • the heart is an organ that acts as a blood pump. To operate this muscle pump (heart) requires a valve that allows blood flow to flow in a constant direction rather than backflow.
  • the heart has four rooms, two atriums and two ventricles, which are connected to four vessels: the aorta, veins, pulmonary arteries, and pulmonary veins.
  • the valve between the left atrium and the left ventricle is the mitral valve (MV)
  • the valve between the right atrium and the right ventricle is the tricuspid valve (TV)
  • the valve between the left ventricle and the aorta is the aortic valve
  • the valve between the pulmonary arteries is the pulmonary valve (PV).
  • Heart valve disease can be divided into two types: a disease of leaking blood (regurgitation) that does not close completely when the valve needs to be closed, and a disease that does not open completely (stenosis, stenosis) when the valve needs to open.
  • Mitral regurgitation is a disease in which the mitral valve, the valve between the left atrium and the left ventricle, does not close completely when it is closed, resulting in blood backflow, which results in a burden on the heart, which results in heart failure and eventually causes heart failure.
  • the catheter is placed into the 'tubular venous sinus' after accessing the right atrium through the jugular vein and the 'proximal septal vein' Pass through the yarn needed for the circle large (named 'circle yarn').
  • This thread can easily come out as one of the right ventricular outflow tracts (RVOT) of the right ventricle.
  • RVOT right ventricular outflow tracts
  • mitral cerclage annuloplasty This thread can be easily grasped into the right atrium, thereby placing the circle large yarn in the tissue around the mitral annulus.
  • the circle large yarn is wrapped in a coronary sinus tube (CS Tube) and three thousand valve tube (TV Tube) to protect the tissue damage (ie, tissue protection mechanism to protect the human tissue), circle large A knot tied at the end of the thread was transferred to the upper end of the tissue protection device by using a knot delivery device to complete the circle large procedure.
  • CS Tube coronary sinus tube
  • TV Tube three thousand valve tube
  • Nylon is a material suitable for living beings, does not deform even at a certain portion of tension, and has a durable feature, and is suitable as a circle yarn in a circle large procedure.
  • the circle large nylon yarn is not visible at all in the fluoroscopic image (X-ray) used as an induction image in the mitral valve circle large procedure.
  • X-ray fluoroscopic image
  • pushability is weak and it is not easy to deliver.
  • an object of the present invention is to develop and develop the circle large nylon yarn used in the mitral valve circle large procedure, which is suitable for living body, does not deform under constant tension, and has durability
  • X-ray can be confirmed by visual progress and location can be identified, high pushabiliy, easy to mitral valve circle large procedure, to provide a circular rope for mitral circle large procedure.
  • the present invention is to achieve the above object, the circular rope for mitral valve circle large surgery of the present invention, the stainless steel wire 12 therein; And a coating part 14 coated with a biocompatible nylon on the outer surface of the wire.
  • the wire is characterized in that the form made by twisting a plurality of thin wire.
  • the circular rope has a cross-sectional outer diameter of 0.5 mm or less.
  • the circle large rope of the present invention is formed with a stainless wire therein can visually identify the progress and position of the circle large rope, high flexibility and pushability mitral valve circular surgery It is easy, and the outer surface is coated with a bio-compatible nylon is harmless to the human body has the advantage of high durability.
  • it is possible to manufacture by the existing extrusion molding method has the advantage of high work efficiency and economical.
  • FIG. 1 is a cross-sectional view of a circular rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
  • Figure 2 is a schematic diagram showing a mitral valve circle large procedure using a circular rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
  • FIG. 1 is a cross-sectional view of a circle large rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
  • the circular rope 10 of the present invention has a structure in which a wire 12 made of metal is formed inside, and an outer surface thereof has a coating portion 14 made of nylon. That is, the circle large rope 10 of the present invention is a stainless steel wire (not corrosive) even when the metal is in contact with the human body at the time of partial loss of the coating so that the progress through the X-ray during the mitral valve circle large procedure ( 12) is used, the outer surface surrounding the wire is formed of a coating portion 14 of nylon (nylon) material which is a biocompatible synthetic resin.
  • nylon nylon
  • the circle large rope of the present invention is used to replace the circle large yarn made of nylon.
  • the wire 12 inside the circular rope 10 is made of metal, preferably stainless steel, which is not corrosive even when in contact with the human body.
  • metal preferably stainless steel
  • AISI304 material may be used, but is not limited thereto.
  • the wire 12 may be a single wire, but preferably a form made by twisting a plurality of thin wires is used.
  • Figure 2 shows a circular rope 12 of the most preferred form, which is made of seven strands of thin stainless wire having a cross-sectional diameter of 0.035 mm to 0.06 mm, and twisted the seven strands as shown. You will create a form.
  • the tensile force (breaking strength) of the circle large rope required for the circle large procedure is 100N or more, and the tensile strength (T / S) requires 2250N / m 2 or more. Twice as many circular ropes by twisting a total of 49 (7 * 7) strands of stainless steel wires shown in FIG. 2 will ensure the above tensile and tensile strengths. That is, the circle large rope of the present invention made by twisting a plurality of fine wires, not a single wire, has a high tensile strength and high tensile strength, high flexibility and high pushability.
  • the coating part 14 is a part surrounding the wire 12 and is coated with a biocompatible synthetic resin, preferably nylon.
  • the circular rope overall cross section outer diameter (D) including the coating portion is preferably formed to be 0.5mm or less, and when coated, the surface should be smooth and there should be no traces of burnt material. This is because the circle rope must enter the body through the catheter during the circle large procedure.
  • the method of forming the nylon coating on the wire 12 is made using a conventional extrusion method. That is, a gel type in which solid nylon is dissolved in a state in which the wire is continuously supplied from the extruder is wrapped in the wire surface and then cooled in water.
  • the circle large rope of the present invention is formed with a stainless wire therein can visually identify the progress and position of the circle large rope during the circle large procedure, mitral valve circular large procedure with high flexability and pushability This is easy, and the outer surface is coated with a biocompatible nylon is harmless to the human body has the advantage of high durability.
  • a wire is inserted into the catheter to gradually push the catheter along with the wire into the desired portion of the body tissue (a).
  • the wire has a pushability so that it pushes the wire a little and pushes the next catheter, ie the wire is advanced and the catheter follows, gradually pushing the catheter with the wire to the desired part of the body tissue.
  • the wire used is mainly used in the normal wire (PTCA wire) currently used in cardiac intervention, the material of the catheter is a soft rubber or synthetic resin material is used.
  • the circular rope of the present invention is inserted into the catheter (c).
  • the circular rope of the present invention is smoothly inserted into the catheter due to high flexibility and pushability.
  • a tissue protection device devised by the present invention
  • the tissue protection device (CSTV tube)
  • the tissue protection device (CSTV tube) is not necessarily required and the circle large of the present invention.
  • the rope itself is coated with biocompatible nylon and has high flexability and high pushability, so that the rope can be used alone without a CSTV tube.
  • the circle large rope of the present invention plays a very important role, it will be said that the key to determine the success of the circle large procedure.
  • the present invention relates to a circular rope for mitral valve circle large procedure used in mitral valve circular large procedure to be performed in patients with mitral regurgitation, and more particularly, to coronary sinus and tricuspid valve and surrounding tissue in mitral valve circular large procedure. Inserted into a protective tissue protector, it is available in the field of circular rope for mitral valve circle large procedure with the proper tension, durability and pushability finally required.

Abstract

The present invention relates to a cerclage rope for mitral valve cerclage annuloplasty to be used in mitral valve cerclage annuloplasty for a patient with mitral regurgitation, and more specifically, to a cerclage rope for mitral valve cerclage annuloplasty inserted into a tissue protection device for protecting the coronary artery and vein, the tricuspid valve and the surrounding tissue thereof in mitral valve cerclage annuloplasty to finally have the required suitable tension, and durability and pushability. The cerclage rope for mitral valve cerclage annuloplasty of the present invention comprises: a stainless steel wire (12) therein; and a coating portion (14) coated with a biocompatible nylon, formed on the outer surface of the wire.

Description

승모판막 서클라지 시술용 서클라지 로프Mitral valve circle large circle large rope
본 발명은 승모판 역류증 환자에게 시술되는 승모판막 서클라지 시술에서 사용되는 승모판막 서클라지 시술용 서클라지 로프에 관한 것으로서, 보다 상세하게는 승모판막 서클라지 시술에서 관상정맥동과 삼천판막 및 그 주변 조직을 보호하는 조직 보호기구에 삽입되어, 최종적으로 요구되는 적절한 장력과 내구성 및 pushability를 갖는 승모판막 서클라지 시술용 서클라지 로프에 관한 것이다. The present invention relates to a circular rope for mitral valve circle large procedure used in mitral valve circular large procedure to be performed in patients with mitral regurgitation, and more particularly, to coronary sinus and tricuspid valve and surrounding tissue in mitral valve circular large procedure. It relates to a circular rope for mitral valve circle large procedure which is inserted into a protective tissue protective device and finally has the required proper tension, durability and pushability.
심장은 혈액펌프의 역할을 하는 기관이다. 근육으로 된 이 펌프(심장)가 동작하기 위해서는 혈류가 역류되지않고 일정한 방향으로 흐르게 하는 판막 (valve)이 필요하다. 심장에는 두 개의 심방(atrium)과 두 개의 심실(ventricle) 등 4개의 방이 있으며, 이 방들은 대동맥, 정맥, 폐동맥, 폐정맥 등 4가지 혈관과 연결되어 있다.The heart is an organ that acts as a blood pump. To operate this muscle pump (heart) requires a valve that allows blood flow to flow in a constant direction rather than backflow. The heart has four rooms, two atriums and two ventricles, which are connected to four vessels: the aorta, veins, pulmonary arteries, and pulmonary veins.
좌심방과 좌심실 사이에 있는 판막이 승모판(mitral valve, MV), 우심방과 우심실 사이에 있는 판막이 삼천판(tricuspid valve, TV), 좌심실과 대동맥 사이에 있는 판막이 대동맥판막 (aortic valve), 우심실과 폐동맥 사이에 있는 판막이 폐동맥판막 (pulmonary valve, PV)이다.The valve between the left atrium and the left ventricle is the mitral valve (MV), the valve between the right atrium and the right ventricle is the tricuspid valve (TV), and the valve between the left ventricle and the aorta is the aortic valve, the right ventricle and The valve between the pulmonary arteries is the pulmonary valve (PV).
판막은 심장의 박동에 따라서 완전히 열리고 닫혀야 한다. 완전히 닫히지 않거나 완전히 열리지 않는 등 잘 움직이지 못하면 액이 역류하거나 흐름이 나빠진다. 이것이 심장판막질환이다. 심장판막질환은 크게 판막이 닫혀야 할 때 완전히 닫히지 않아 혈액이 새는 질환(역류, regurgitation)과, 판막이 열려야 할 때 완전히 열리지않는 질환(협착, stenosis) 로 나누어 볼 수 있다.The valve should open and close completely according to the heartbeat. If it does not move properly, such as not fully closed or fully open, fluid will flow back or flow badly. This is heart valve disease. Heart valve disease can be divided into two types: a disease of leaking blood (regurgitation) that does not close completely when the valve needs to be closed, and a disease that does not open completely (stenosis, stenosis) when the valve needs to open.
승모판 역류증이란 좌심방과 좌심실 사이에 있는 판막인 승모판이 닫혀야할 때 완전히 닫히지 않아서 혈액이 역류되고 이러한 결과가 심장에 부담을 줌으로써 심장 기능을 떨어뜨려 결국은 심부전을 야기하게 되는 질환이다.Mitral regurgitation is a disease in which the mitral valve, the valve between the left atrium and the left ventricle, does not close completely when it is closed, resulting in blood backflow, which results in a burden on the heart, which results in heart failure and eventually causes heart failure.
현재까지 승모판 역류증에 대한 치료는 가슴의 흉골을 열고 심장을 절개하여 승모판막을 수선하거나 인공 판막으로 대치하는 수술적 치료가 표준 치료이다. 이는 치료의 효과는 우수하나 수술 자체만으로 인해 환자가 사망할 수 있는 위험이 많게는 5% 까지 발생할 수 있는 아주 침습적인 치료 방법이다. 이러한 한계로 인해 현재까지는 아주 심한 승모판 역류증만 수술로써 치료하는 실정이다.To date, treatment for mitral regurgitation is the standard treatment of surgery, which involves opening the sternum of the chest and opening the heart to repair the mitral valve or replace it with an artificial valve. This is a very invasive method of treatment that is effective but can occur as much as 5% of the risk of death of the patient due to surgery alone. Due to these limitations, until now only very severe mitral regurgitation has been treated with surgery.
이러한 배경에서 최근 환자의 가슴을 열고 심장을 절개를 요구하는 수술을 하지 않고 카테터를 이용한 비교적 간단한 시술을 통해 승모판막을 수선할 수 있는 경피적 승모판 성형술의 개발에 많은 연구가 이루어 지고 있다. 이러한 국제적인 연구의 한 일환으로 최근 본 발명자는 승모판막 서클라지 시술(Mitral cerclage coronarysinus annuloplasty)(MVA)를 국제 논문에 발표한 바 있으며 이는 승모판륜(mitral annulus, MA) 주위로 원형의 압력을 가할 수 있어 치료 효과가 우수함을 증명하였다. 상기 논문의 내용은 국제특허출원(국제출원번호:PCT/US2007/023836)되었으며, 현재 국제사무국에 국제공개되었다(국제공개번호: WO2008/060553).Against this backdrop, many studies have been made on the development of percutaneous mitral valve repair that can repair the mitral valve by relatively simple procedure using a catheter without opening the chest of the patient and requiring the incision of the heart. As part of this international study, we recently published a Mitral cerclage coronarysinus annuloplasty (MVA) in an international paper, which can apply circular pressure around the mitral annulus (MA). It proved that the therapeutic effect is excellent. The contents of the paper have been filed in international patent applications (International Application No .: PCT / US2007 / 023836) and are now published internationally by the International Bureau (International Publication No. WO2008 / 060553).
상기 논문과 상기 특허출원에서 설명되는 경피적 승모판 성형술(승모판 서클라지 시술)에 대해서 간략히 설명하면, 경정맥을 통하여 우심방에 접근한 뒤 '관상 정맥동'으로 카테터를 위치 시키고 '근위부 심실 중격 정맥(proximal septal vein)' 으로 서클라지에 필요한 실('서클라지 실'이라 명명함)을 통과 시킨다. 이러한 실은 '우심실의 페동맥 판막 하부(right ventricular outflow tract, RVOT)' 의 한 곳으로 쉽게 나올 수 있는 데 이러한 시술 방법을 저자는 승모판 서클라지 (mitral cerclage annuloplasty)로 명명하였다. 이 실은 손쉽게 우심방으로 잡아 낼 수 있게 되며 이렇게 함으로써 승모판륜( mitral annulus) 주위의 조직에 서클라지 실이 위치하게 된다. 이때 이 실에 장력을 가하면 승모판륜을 옥죄는 효과를 얻게 되며 이는 승모 판막의 두 판엽을 더욱 가까이 맞붙게 함으로써 판막의 불안전한 폐쇄 (incomplete closure)를 줄이게 된다. 이러한 원리는 승모판막륜을 직접적으로 옥죄는 수술적 치료와 아주 유사한 효과를 얻게 되며 이는 곧바로 승모판막을 통한 혈액의 역류를 줄이는 치료효과로 나타난다.Briefly explaining the percutaneous mitral valve surgery (mitral valve circle large procedure) described in the above paper and the patent application, the catheter is placed into the 'tubular venous sinus' after accessing the right atrium through the jugular vein and the 'proximal septal vein' Pass through the yarn needed for the circle large (named 'circle yarn'). This thread can easily come out as one of the right ventricular outflow tracts (RVOT) of the right ventricle. This method was named mitral cerclage annuloplasty. This thread can be easily grasped into the right atrium, thereby placing the circle large yarn in the tissue around the mitral annulus. Applying tension to the thread gives the effect of imprisoning the mitral valve, which reduces the incomplete closure of the valve by bringing the two valves of the mitral valve closer together. This principle has a very similar effect to the surgical treatment of direct mitral mitral valve repair, which is a therapeutic effect that reduces the backflow of blood through the mitral valve.
그러나, 상기의 국제특허출원에서는 해결하여야 할 과제가 있었다. 첫째는, 서클라지 실에 적절한 장력을 시술의 현장에서 가할 수 있고 이를 유지시킬 수 있는 장력 보존 장치(tension locking device)가 필요하다는 점이고, 둘째는 이러한 장력의 유지가 상대적으로 아주 가는 서클라지 실에 의해 유지가 되므로 -선행 발표한 연구에서는 0.014 인치의 나일론을 사용하였으며 이 굵기는 변화될 수 있음 인접한 조직의 손상을 줄 수 있다는 문제이다.However, the above international patent application has a problem to be solved. First, there is a need for a tension locking device that can apply and maintain proper tension on the circle large yarn at the site of the procedure. The previous study used 0.014 inches of nylon, which can vary in thickness, which can damage adjacent tissues.
이러한 과제를 해결하기 위해서, 본 발명자는 한국특허출원 제2009-0080708호(2009. 08년 28일 출원)(발명의명칭: 관상정맥동과 삼천판막의 조직보호기구, 매듭전달기구 및 이들을 포함하는 승모판막 커클라지 시술용 장치)을 제안한 바 있다. In order to solve this problem, the present inventors have applied Korean Patent Application No. 2009-0080708 (filed on Aug. 28, 2009) (Invention name: tissue protection mechanism of coronary sinus and three thousand valves, knot delivery mechanism and mitral valve including them) Membrane Kirklargi device).
상기 특허출원에서, 서클라지 실은 관상정맥동용 튜브(CS Tube)와 삼천판막용 튜브(TV Tube)로 감싸서 인체조직의 손상을 보호하고(즉, 조직보호기구로 인체조직을 보호하고), 서클라지 실의 끝단을 묶은 매듭을 매듭전달기구를 이용하여 조직보호기구의 상단부에 전달하여 서클라지 시술을 완성하도록 제안하였다.In the patent application, the circle large yarn is wrapped in a coronary sinus tube (CS Tube) and three thousand valve tube (TV Tube) to protect the tissue damage (ie, tissue protection mechanism to protect the human tissue), circle large A knot tied at the end of the thread was transferred to the upper end of the tissue protection device by using a knot delivery device to complete the circle large procedure.
상기 특허출원에서, 조직보호기구(CSTV TUBE)를 통과하는 서클라지 실은 나일론이 사용되었다. 나일론은 생체에 적합한 물질이며, 일정부분의 장력에도 변형되지 아니하며, 내구성이 있는 특징으로 지니고 있음으로, 서클라지 시술에서 서클라지 실로서 적합하다. In this patent application, a large yarn of nylon that is passed through a tissue protection apparatus (CSTV TUBE) is used. Nylon is a material suitable for living beings, does not deform even at a certain portion of tension, and has a durable feature, and is suitable as a circle yarn in a circle large procedure.
그러나, 서클라지 나일론 실은 승모판막 서클라지 시술에서 유도 이미지로 사용되는 fluoroscopic image(X-ray)에 전혀 보이지 않아 승모판막 서클라지 시술이 용이하지 않다는 단점이 있으며, 승모판막 서클라지 시술 과정 중에 서클라지 나일론 실을 심장 내 서클라지 목표 부위에 전달하기 위해 가는 내경을 가지는 카테터를 통해 서클라지 나일론 실을 밀어넣어야 하는 데, 나일론 실의 특성상 pushability 가 약하여 전달이 용이하지 않다는 단점이 있다.However, the circle large nylon yarn is not visible at all in the fluoroscopic image (X-ray) used as an induction image in the mitral valve circle large procedure. In order to deliver the nylon thread to the circle large target area in the heart, it is necessary to push the circle large nylon thread through a catheter having a thin inner diameter. However, due to the nature of the nylon thread, pushability is weak and it is not easy to deliver.
본 발명의 상기의 문제점을 달성하기 위한 것으로서, 본 발명의 목적은 승모판막 서클라지 시술에서 사용되는 서클라지 나일론 실을 개량 발전시킨 것으로, 생체에 적합하며, 일정한 장력에도 변형되지 않으며, 내구성을 지닐 뿐만아니라, X-ray에서 확인할 수 있어 진행여부 및 위치를 육안으로 식별할 수 있으며, pushabiliy가 높아, 승모판막 서클라지 시술에 용이한, 승모판막 서클라지 시술용 서클라지 로프를 제공하는 것이다. In order to achieve the above-mentioned problems of the present invention, an object of the present invention is to develop and develop the circle large nylon yarn used in the mitral valve circle large procedure, which is suitable for living body, does not deform under constant tension, and has durability In addition, X-ray can be confirmed by visual progress and location can be identified, high pushabiliy, easy to mitral valve circle large procedure, to provide a circular rope for mitral circle large procedure.
본 발명의 목적은 이상에서 언급한 목적으로 제한되지 않으며, 언급되지 않은 또다른 목적들은 아래의 기재로부터 명확하게 이해될 수 있을 것이다. The object of the present invention is not limited to the above-mentioned object, and other objects which are not mentioned will be clearly understood from the following description.
본 발명은 상기의 목적을 달성하기 위한 것으로서, 본 발명의 승모판막 서클라지 시술용 서클라지 로프는, 내부에 스테인레스 스틸재의 와이어(12); 및 상기 와이어의 외면에 생체 적합한 나일론으로 코팅된 코팅부(14);를 포함하는 것을 특징으로 한다.The present invention is to achieve the above object, the circular rope for mitral valve circle large surgery of the present invention, the stainless steel wire 12 therein; And a coating part 14 coated with a biocompatible nylon on the outer surface of the wire.
본 발명의 바람직한 실시예에 따르면, 상기 와이어는 다수개의 가는 와이어를 꼬아서 만든 형태인 것을 특징으로 한다. According to a preferred embodiment of the present invention, the wire is characterized in that the form made by twisting a plurality of thin wire.
본 발명의 바람직한 실시예에 따르면, 상기 서클라지 로프의 단면 외경이 0.5mm이하인 것을 특징으로 한다. According to a preferred embodiment of the present invention, the circular rope has a cross-sectional outer diameter of 0.5 mm or less.
이상에서 상술한 바와 같이, 본 발명의 서클라지 로프는 내부에 스테인레스 재질의 와이어가 형성되어 서클라지 로프의 진행여부 및 위치를 육안으로 식별할 수 있으며, flexability와 pushability가 높아 승모판막 서클라지 시술이 용이하며, 외면을 생체 적합한 나일론으로 코팅되어 인체에 무해하며 내구성이 높다는 장점이 있다. 또한, 기존의 압출성형방법으로 제작이 가능함으로 작업효율이 높고 경제적이라는 장점이 있다.As described above, the circle large rope of the present invention is formed with a stainless wire therein can visually identify the progress and position of the circle large rope, high flexibility and pushability mitral valve circular surgery It is easy, and the outer surface is coated with a bio-compatible nylon is harmless to the human body has the advantage of high durability. In addition, it is possible to manufacture by the existing extrusion molding method has the advantage of high work efficiency and economical.
도 1은 본 발명의 바람직한 실시예에 따른, 승모판막 서클라지 시술용 서클라지 로프의 단면도. 1 is a cross-sectional view of a circular rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
도 2는 본 발명의 바람직한 실시예에 따른, 승모판막 서클라지 시술용 서클라지 로프를 이용한 승모판막 서클라지 시술과정을 나타내는 개략도. Figure 2 is a schematic diagram showing a mitral valve circle large procedure using a circular rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
이하에서는 첨부된 도면을 참조로 하여, 본 발명의 승모판막 서클라지 시술용 서클라지 로프를 보다 상세히 설명하기로 한다. Hereinafter, with reference to the accompanying drawings, it will be described in more detail the circular rope for mitral valve circle large procedure of the present invention.
도 1은 본 발명의 바람직한 실시예에 따른, 승모판막 서클라지 시술용 서클라지 로프의 단면도이다. 1 is a cross-sectional view of a circle large rope for mitral valve circle large procedure according to a preferred embodiment of the present invention.
도 1을 참조하면, 본 발명의 서클라지 로프(10)는 내부에는 금속재질의 와이어(12)가 형성되고, 외면은 나일론 재질의 코팅부(14)가 형성된 구조를 지닌다. 즉, 본 발명의 서클라지 로프(10)는 승모판막 서클라지 시술 중에 X-ray를 통해 진행여부를 확인할 수 있도록 금속제 특히 코팅부의 부분 손실시에 인체에 접촉하더라도 부식성이 없는 스테인레스 스틸 재질의 와이어(12)가 사용되며, 와이어를 감싸는 외면은 생체적합한 합성수지인 나일론(nylon)재질의 코팅부(14)가 형성된다. Referring to FIG. 1, the circular rope 10 of the present invention has a structure in which a wire 12 made of metal is formed inside, and an outer surface thereof has a coating portion 14 made of nylon. That is, the circle large rope 10 of the present invention is a stainless steel wire (not corrosive) even when the metal is in contact with the human body at the time of partial loss of the coating so that the progress through the X-ray during the mitral valve circle large procedure ( 12) is used, the outer surface surrounding the wire is formed of a coating portion 14 of nylon (nylon) material which is a biocompatible synthetic resin.
승모판막 서클라지 시술에서 나일론 재질의 서클라지 실을 대체하여, 본 발명의 서클라지 로프가 사용된다. In the mitral valve circle large procedure, the circle large rope of the present invention is used to replace the circle large yarn made of nylon.
서클라지 로프(10) 내부의 와이어(12)는 금속제, 바람직하게는 인체에 접촉하더라도 부식성이 없는 스테인레스 스틸이 사용된다. 예를 들어, AISI304 재질이 사용될 수 있으며, 물론 이에 한정되는 것은 아니다. The wire 12 inside the circular rope 10 is made of metal, preferably stainless steel, which is not corrosive even when in contact with the human body. For example, AISI304 material may be used, but is not limited thereto.
와이어(12)는 단선이 사용될 수도 있으나, 바람직하게는 다수개의 가는 와이어를 꼬아서 만든 형태가 사용된다. 도 2에서는 가장 바람직한 형태의 서클라지 로프(12)를 도시하고 있는 바, 단면 직경 0.035mm ~ 0.06mm의 가는 스테인레스 와이어 7가닥으로 스트란드를 만들고, 이 스트란드 7개를 꼬아서 도시된 바와 같은 형태를 만들게 된다. The wire 12 may be a single wire, but preferably a form made by twisting a plurality of thin wires is used. Figure 2 shows a circular rope 12 of the most preferred form, which is made of seven strands of thin stainless wire having a cross-sectional diameter of 0.035 mm to 0.06 mm, and twisted the seven strands as shown. You will create a form.
서클라지 시술에서 요구되는 서클라지 로프의 인장력(파단강도)은 100N이상이며, 인장강도(T/S)는 2250N/m2 이상을 요구한다. 도 2에서 도시된 총 49(7*7) 가닥의 가는 스테인레스 스틸 와이어를 꼬아서 많든 서클라지 로프는 이상과 같은 인장력과 인장강도를 보장하게 된다. 즉, 단선의 와이어가 아니라 다수개의 가는 와이어를 꼬아서 만든 본 발명의 서클라지 로프는 인장력과 인장강도가 높으며, 유연성(flexiblility)이 높을 뿐만아니라, pushability가 높다는 장점이 있다. The tensile force (breaking strength) of the circle large rope required for the circle large procedure is 100N or more, and the tensile strength (T / S) requires 2250N / m 2 or more. Twice as many circular ropes by twisting a total of 49 (7 * 7) strands of stainless steel wires shown in FIG. 2 will ensure the above tensile and tensile strengths. That is, the circle large rope of the present invention made by twisting a plurality of fine wires, not a single wire, has a high tensile strength and high tensile strength, high flexibility and high pushability.
코팅부(14)는 상기 와이어(12)를 감싸는 부분으로서, 생체적합한 합성수지, 바람직하게는 나일론으로 코팅된다. 코팅부를 포함하는 서클라지 로프 전체 단면 외경(D)은 0.5mm이하로 형성함이 바람직하며, 코팅시 표면은 매끈해야 하며, 재료의 탄 흔적이 없어야 한다. 이는 서클라지 시술시에 서클라지 로프가 카테터를 통해 신체 내부로 들어가야 하기 때문이다. The coating part 14 is a part surrounding the wire 12 and is coated with a biocompatible synthetic resin, preferably nylon. The circular rope overall cross section outer diameter (D) including the coating portion is preferably formed to be 0.5mm or less, and when coated, the surface should be smooth and there should be no traces of burnt material. This is because the circle rope must enter the body through the catheter during the circle large procedure.
와이어(12)에 나일론 코팅부를 형성하는 방법은 통상의 압출성형 방법을 이용하여 이루어진다. 즉, 압출성형기에서 와이어가 계속공급되는 상태에서 고상의나일론을 녹인 젤 타입이 와이어 표면을 감싼 후, 물에 냉각되는 방식으로 제조된다.The method of forming the nylon coating on the wire 12 is made using a conventional extrusion method. That is, a gel type in which solid nylon is dissolved in a state in which the wire is continuously supplied from the extruder is wrapped in the wire surface and then cooled in water.
이상과 같이, 본 발명의 서클라지 로프는 내부에 스테인레스 재질의 와이어가 형성되어 서클라지 시술시 서클라지 로프의 진행여부 및 위치를 육안으로 식별할 수 있으며, flexability와 pushability가 높아 승모판막 서클라지 시술이 용이하며, 외면을 생체 적합한 나일론으로 코팅되어 인체에 무해하며 내구성이 높다는 장점이 있다. As described above, the circle large rope of the present invention is formed with a stainless wire therein can visually identify the progress and position of the circle large rope during the circle large procedure, mitral valve circular large procedure with high flexability and pushability This is easy, and the outer surface is coated with a biocompatible nylon is harmless to the human body has the advantage of high durability.
다음은 본 발명의 서클라지 로프를 이용하여 승모판막 서클라지 시술하는 과정을 설명하기로 한다. Next will be described the process of mitral valve circle large procedure using the circle large rope of the present invention.
먼저, 카테터 내부에 와이어를 삽입하여 와이어와 함께 카테터를 신체 조직 내의 원하는 부분으로 점진적으로 밀어넣는다(a). 와이어는 pushability가 있음으로 와이어를 조금 밀어넣고 다음 카테터를 밀어넣는 방식, 즉 와이어가 앞서가고 카테터가 따라가는 방식으로 점진적으로 신체 조직 내의 원하는 부분으로 와이어와 함께 카테터를 밀어넣는다. 이 때 사용하는 와이어는 심장 중재술에 현재 사용되고 있는 통상의 와이어(PTCA wire)를 주로 사용하며, 카테터의 재질은 연성을 지니는 고무재 또는 합성수지재가 사용된다. First, a wire is inserted into the catheter to gradually push the catheter along with the wire into the desired portion of the body tissue (a). The wire has a pushability so that it pushes the wire a little and pushes the next catheter, ie the wire is advanced and the catheter follows, gradually pushing the catheter with the wire to the desired part of the body tissue. At this time, the wire used is mainly used in the normal wire (PTCA wire) currently used in cardiac intervention, the material of the catheter is a soft rubber or synthetic resin material is used.
다음으로, 와이어를 신체 외부로 빼낸다(b). 그럼 카테터만이 남게 된다. Next, the wire is pulled out of the body (b). Only the catheter remains.
그런 다음, 카테터의 내부로 본 발명의 서클라지 로프를 삽입한다(c). 본 발명의 서클라지 로프는 flexibility와 pushability가 높음으로 원할히 카테터 내를 순환하여 삽입되게 된다. Then, the circular rope of the present invention is inserted into the catheter (c). The circular rope of the present invention is smoothly inserted into the catheter due to high flexibility and pushability.
서클라지 로프가 완전히 삽입되면, 카테터를 신체 외부로 빼낸다(d).Once the circle rope is fully inserted, the catheter is pulled out of the body (d).
그런 다음 마지막으로, 본 발명자가 고안한 조직보호기구(CSTV tube)를 삽입하여(e), 승모판막 서클라지 시술을 완료하게 된다. Then, finally, by inserting the tissue protection mechanism (CSTV tube) devised by the inventor (e), to complete the mitral valve circle large procedure.
앞서 설명한 승모판막 서클라지 시술하는 과정에서, 본 발명자가 고안한 조직보호기구(CSTV tube)를 사용하는 경우에 대해서 설명하였으나, 반드시 조직 보호기구(CSTV tube)가 필요한 것은 아니며, 본 발명의 서클라지 로프는 그 자체가 생체 적합한 나일론으로 코팅되고, 높은 flexability와 높은 pushability를 지님으로, 조직 보호기구(CSTV tube) 없이 단독으로 사용될 수 있음은 물론이다. In the above-described mitral valve circle large procedure, the case of using a tissue protection device (CSTV tube) devised by the present invention has been described. However, the tissue protection device (CSTV tube) is not necessarily required and the circle large of the present invention. The rope itself is coated with biocompatible nylon and has high flexability and high pushability, so that the rope can be used alone without a CSTV tube.
이상과 같이, 승모판막 서클라지 시술에서, 본 발명의 서클라지 로프는 아주 중요한 역할을 하며, 서클라지 시술의 성패를 좌우는 핵심이라 할 것이다. As described above, in the mitral valve circle large procedure, the circle large rope of the present invention plays a very important role, it will be said that the key to determine the success of the circle large procedure.
이상의 설명은 본 발명의 기술 사상을 예시적으로 설명한 것에 불과한 것으로, 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자라면 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 다양한 수정 및 변형이 가능할 것이다. 따라서, 본 발명에 개시된 실시예들은 본 발명의 기술 사상을 한정하기 위한 것이 아니라, 설명하기 위한 것이고, 이러한 실시예에 의하여 본 발명의 기술 사상의 범위가 한정되는 것도 아니다. 본 발명의 보호 범위는 아래 특허청구범위에 의하여 해석되어야 하며, 그와 동등한 범위 내에 있는 모든 기술사상은 본 발명의 권리범위에 포함되는 것으로 해석되어야 할 것이다.The above description is merely illustrative of the technical idea of the present invention, and those skilled in the art to which the present invention pertains may make various modifications and changes without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but are intended to explain, and the scope of the technical spirit of the present invention is not limited by these embodiments. The protection scope of the present invention should be interpreted by the claims below, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of the present invention.
본 발명은 승모판 역류증 환자에게 시술되는 승모판막 서클라지 시술에서 사용되는 승모판막 서클라지 시술용 서클라지 로프에 관한 것으로서, 보다 상세하게는 승모판막 서클라지 시술에서 관상정맥동과 삼천판막 및 그 주변 조직을 보호하는 조직 보호기구에 삽입되어, 최종적으로 요구되는 적절한 장력과 내구성 및 pushability를 갖는 승모판막 서클라지 시술용 서클라지 로프 분야에 이용가능하다.The present invention relates to a circular rope for mitral valve circle large procedure used in mitral valve circular large procedure to be performed in patients with mitral regurgitation, and more particularly, to coronary sinus and tricuspid valve and surrounding tissue in mitral valve circular large procedure. Inserted into a protective tissue protector, it is available in the field of circular rope for mitral valve circle large procedure with the proper tension, durability and pushability finally required.

Claims (5)

  1. 승모판막 서클라지 시술용 서클라지 로프에 있어서, In the circular large rope for mitral valve circular large procedure,
    내부에 스테인레스 스틸재의 와이어(12); 및 A stainless steel wire 12 therein; And
    상기 와이어의 외면에 생체 적합한 나일론으로 코팅된 코팅부(14);를 포함하는 것을 특징으로 하는 승모판막 서클라지 시술용 서클라지 로프. Circle large rope for mitral valve circle large procedure comprising a; coating portion 14 coated with a biocompatible nylon on the outer surface of the wire.
  2. 제 1항에 있어서, The method of claim 1,
    상기 와이어는 다수개의 가는 와이어를 꼬아서 만든 형태인 것을 특징으로 하는 승모판막 서클라지 시술용 서클라지 로프. Circle wire rope for mitral valve circle large procedure, characterized in that the wire is made by twisting a plurality of thin wire.
  3. 제 1항에 있어서, The method of claim 1,
    상기 서클라지 로프의 단면 외경이 0.5mm이하인 것을 특징으로 하는 승모판막 서클라지 시술용 서클라지 로프. Circle large rope for mitral valve circle large procedure, characterized in that the cross-sectional outer diameter of the circle large rope is 0.5mm or less.
  4. 승모판막 서클라지 시술용 서클라지 로프에 있어서, In the circular large rope for mitral valve circular large procedure,
    내부에 금속제 재질의 와이어가 삽입되고, 상기 로프의 외면이 생체적합한 합성수지 재질로 코팅된 것을 특징으로 하는 승모판막 서클라지 시술용 서클라지 로프. A circular wire for mitral valve circle large procedure, characterized in that the wire is made of a metal material is inserted inside, the outer surface of the rope is coated with a biocompatible synthetic resin material.
  5. 제 4항에 있어서, The method of claim 4, wherein
    상기 금속제는 스테인레스 스틸제이며, 상기 합성수지는 나일론인 것을 특징으로 하는 승모판막 서클라지 시술용 서클라지 로프. The metal material is made of stainless steel, the synthetic resin circular large rope for mitral valve circle large procedure, characterized in that the nylon.
PCT/KR2014/006191 2013-07-11 2014-07-10 Cerclage rope for mitral valve cerclage annuloplasty WO2015005690A1 (en)

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