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WO2016013763A1 - Appareil et procédé de fixation de fil de cerclage mitral - Google Patents

Appareil et procédé de fixation de fil de cerclage mitral Download PDF

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Publication number
WO2016013763A1
WO2016013763A1 PCT/KR2015/006041 KR2015006041W WO2016013763A1 WO 2016013763 A1 WO2016013763 A1 WO 2016013763A1 KR 2015006041 W KR2015006041 W KR 2015006041W WO 2016013763 A1 WO2016013763 A1 WO 2016013763A1
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WO
WIPO (PCT)
Prior art keywords
wire
bolt
fixing
hole
mitral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2015/006041
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English (en)
Korean (ko)
Inventor
김준홍
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tau PNU Medical Co Ltd
Original Assignee
Tau PNU Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tau PNU Medical Co Ltd filed Critical Tau PNU Medical Co Ltd
Publication of WO2016013763A1 publication Critical patent/WO2016013763A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451Inserts in the coronary sinus for correcting the valve shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels
    • A61B2017/00783Valvuloplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22047Means for immobilising the guide wire in the patient

Definitions

  • the present invention relates to a fixing device and a fixing method for fixing both ends of the circular large wire for mitral valve circular surgery, more specifically, in the mitral valve circular surgery for patients with mitral regurgitation
  • the present invention relates to a fixing device and a fixing method for mitral valve circle large wires, which can fix both sides of the large circle wires coming out and release the fixing as necessary.
  • 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 that causes blood to leak completely (closure, regurgitation) and a disease that does not open completely when the valve needs to be closed (stenosis).
  • 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 sinus' after accessing the right atrium through the jugular vein and the 'proximal septal vein'. Pass the thread needed for the circle large with ')'. This thread can easily come out as one of the right ventricular outflow tracts (RVOTs).
  • RVOTs right ventricular outflow tracts
  • the method was named the simple mitral cerclage annuloplasty procedure. 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.
  • tissue protection mechanism of the Korean patent is inserted into the body (heart), it is more flexible and more elastic to minimize damage to the tissues of the body, and to ensure the superiority of the circle large procedure, and the circle large Perfection of the procedure can be achieved.
  • the circle large thread which rotates around the circle like a circle, needs to be fixed inside the body. It may be necessary to refit the thread after it has been repositioned.
  • the present invention is to solve the above problems, an object of the present invention is to conveniently fix both ends of the circle large wire in the mitral valve circle large procedure, at the same time, the fixing is not easily released, if necessary fixed conveniently It is to provide a fixing device and a fixing method for fixing both ends of the mitral valve circle large surgical circle large wire that can be released.
  • the fixing device for fixing the mitral valve circle large wire, the insertion hole into which the wire is inserted and the two exit holes from which the wire comes out respectively A fixed body having a through hole formed therein, the fixed body screwed into the fixed body by the rotating means, a bolt for pressing and fixing the wire inserted into the through hole, and rotation of the fixed body when the bolt is rotated by the rotating means. And a holder fastened to the fixed body to prevent it.
  • the through hole having the insertion hole and the two exit holes has a V shape.
  • the bolt is a tannery wrench bolt rotatable by a wrench which is a rotating means.
  • it has a pointed shape tapered to favor pressurization of the wire of the bolt.
  • the front surface of the holder is formed with a polygonal inner surface
  • the outer surface of the fixing body is formed a polygonal outer surface corresponding to the polygonal inner surface of the holder, the polygonal inner surface of the holder and the polygonal outer surface of the fixing body It is fastened to each other, and the rotation of the fixed body is prevented when the bolt is rotated by the rotating means.
  • the holder has a through-hole formed therein, through which the fixing body and the bolt is inserted.
  • the fixing device for fixing the mitral valve circle large wire the fixing body is formed with a through-hole having an insertion hole into which the wire is inserted and two exit holes from which the wire comes out, and the rotating means And a bolt that is inserted into the fixed body by screwing and presses and fixes the wire inserted into the through hole. .
  • the method for fixing both ends of the mitral valve circle large wire i) First, the circle large wire is inserted through the insertion hole of the fixing body to the circle through the hole of the fixed body so that each exit hole Inserting the large wire, ii) rotating the bolt using the rotating means, the bolt presses and secures the circular large wires at both ends, and iii) removing the rotating means.
  • the bolt is inserted into the fixing body, and the wire is fixed and released by the bolt, so that it can be fixed conveniently. Since it can be re-adjusted, there is an advantage that can increase the safety and success rate of the mitral valve circle large procedure.
  • the fixing device of the present invention is very simple and has a convenient structure, there is an advantage that the fixing and release of the wire can be convenient.
  • the fixing body does not rotate during the rotation of the bolt, there is an advantage that it is possible to secure the circle large wire safely and conveniently.
  • FIG. 1 is a perspective view of a mitral circle large wire fixing device, according to a preferred embodiment of the present invention.
  • FIG. 2 and 3 are views illustrating a process of fixing a wire by using a mitral valve circular wire fixing device and a rotating means, according to a preferred embodiment of the present invention, and FIG. 3 is a state of FIG. Detailed view of.
  • Figure 4 is a flow chart for the method of fixing the mitral circular circle wire, according to a preferred embodiment of the present invention
  • Figure 1 is a perspective view of a fixing device for fixing the mitral valve circle large wire, according to a preferred embodiment of the present invention
  • Figure 3 shows a tissue protection mechanism and circular wire of the fixing device and mitral valve circle large procedure.
  • the mitral valve circle large procedure is a procedure for treating mitral regurgitation and / or angina pectoris.
  • the circle large thread causes the heart to return as a circle, followed by a circle large thread (circle). Large wire) to treat mitral regurgitation and / or angina pectoris.
  • a tissue protective device for protecting body tissues and a coronary artery protector for protecting a coronary artery are required.
  • the circle large thread (10, cerclage suture) is a thin thread of about 0.014 ”used in the mitral cerclage coronary sinus annuloplasty (MVA).
  • MVA mitral cerclage coronary sinus annuloplasty
  • CS coronary sinus, CS part, tricuspid valve (TV) part, ventricular septal part
  • CS coronary sinus, CS
  • TV tricuspid valve
  • ventricular septal part is named after coming out of the body in a circular shape, and when it came out of the body, two strands of one end and the other end becomes That is, as shown in FIG. 3, the circle is drawn to connect one thread.
  • the material of the circle large yarn may be made of synthetic resin such as nylon, or metal (stainless steel, nylon coated metal). It is also possible to use wires made by twisting a plurality of thin wires (also called “circle ropes"). Therefore, it is variously referred to as “circle yarn”, “circle rope”, “circle wire” and the like, all of which
  • Mitral circular circle tissue protection mechanism 20 is to protect the tissue of the heart from the circle large wire, a synthetic resin material such as a rubber material, a soft plastic material, or a metal material such as a coil spring can be used. That is, a rubber tube, a synthetic resin flexible tube, a metal coil spring, or the like can be used.
  • a coil spring is used that is soft and flexible, can move with the beating of the heart, is excellent in resilience with flexibility according to shape deformation, and has excellent deliverability during circular operations.
  • Coil spring tissue protection devices are coated with biocompatible materials (e.g. ePTFE) to prevent direct physical contact with metal coil springs, reduce allergic reactions, and reduce blood allergies between acids and acids in the coil springs. Harmfulness can be prevented.
  • biocompatible materials e.g. ePTFE
  • the arcuate coronary artery protector 30 is arcuate to protect the coronary artery.
  • the circle large rope enters the coronary sinus, and when the circular large wire is confined to block the mitral annulus of the patient with mitral regurgitation, the circle large rope in the coronary venous sinus passing over the coronary artery Pressing results in problems that block the flow of blood in the coronary arteries and damage the coronary arteries. Therefore, in the above-mentioned International Publication (WO2008 / 060553, published May 22, 2008), a technique for protecting a coronary artery by inserting an arch in the coronary artery to protect the coronary artery is disclosed.
  • the arcuate coronary artery protector 30 is also called a "coronary sinus protector” in the sense of being inserted into the coronary sinus or “coronary artery protector” in the sense of protecting the coronary artery.
  • "Archial coronary artery protector” is a name given in the sense of being arched to be inserted into the coronary sinus and to protect the coronary artery.
  • the fixing device for fixing the mitral valve circle large wire includes a fixing body 40, a bolt 50, and a holder 60.
  • the fixing body 40 is a portion corresponding to the outer shape of the fixing device, the through-hole 43 having an insertion hole 41 into which the circle large wire 10 is inserted and two exit holes 42 each of which the wire comes out. Is formed. That is, two exit holes through which a wire comes out are formed, and both wires are comprised, respectively. This is to prevent the wires from being twisted with each other and at the same time to facilitate the pressurization by the bolts 50 so as to be more firmly fixed, thereby preventing the wires from being easily removed from the fixing device by the beating of the heart. Therefore, as shown, it is preferable that the through hole 43 having the insertion hole 41 and the two exit holes 42 has a V shape.
  • the bolt 50 is threaded on the outer surface is screwed into the fixed body 40 by the rotation means 70 is inserted, and fixed by pressing the wire 10 inserted into the through hole 43 of the fixed body 40 It plays a role. That is, the groove 50 is formed in the bolt 50, the rotary means 70 is inserted into the groove 51, and the rotating means rotates the bolt forward and backward to tighten the circle large wire 10 or Used for solving.
  • the bolt has a pointed shape tapered to favor the pressurization of the wire. This is to widen the contact surface with the wire inserted into the fixed body in which the V-shaped through hole is formed so that a tighter coupling is achieved.
  • Wrench bolts boltless wrench bolts, cross bolts, straight bolts, etc. may be used, but most preferably, the boltless wrench bolts will be used since the bolt is inserted into the fixing body.
  • Rotating means 70 is a tool for tightening or loosening the bolt to insert the bolt 50 into the fixed body 40 to press the wire to securely fix or release the wire.
  • the rotating means 70 may be a wrench or a driver corresponding thereto according to the groove of the bolt.
  • the bolt is a tannery wrench bolt is used, the rotation means is used a wrench corresponding thereto. This is because, in the case of the wrench bolt, the fastening by the rotation means is easier, and in the case of the wrenchless bolt, it can be inserted into the fixing body, thereby reducing damage to body tissues. Wrenches will generally be used with 6-head wrenches, but of course, various wrenches can be used.
  • the holder 60 is a part which is fastened to the fixing body to prevent the fixing body from rotating when the bolt is rotated by the rotating means. In other words, the holder is inserted into the body to prevent rotation of the stationary body. As shown, the holder has a through-hole 62 formed therein, the fixing body and the bolt is inserted through the through-hole.
  • a polygonal inner surface 64 is formed on the front surface of the holder, and a polygonal outer surface 44 corresponding to the polygonal inner surface 64 of the holder is formed on the outer surface of the fixing body. That is, the polygonal inner surface 64 of the holder and the polygonal outer surface 44 of the fixing body are fastened to each other to prevent rotation of the fixing body when the bolt is rotated by the rotating means.
  • Figure 2 illustrates the process of fixing the wire, using the mitral valve circle large wire fixing device and the rotating means, according to a preferred embodiment of the present invention
  • Figure 4 is a mitral valve circle, according to a preferred embodiment of the present invention It is a flow chart about the fixing method of a large wire.
  • Sheath which inserts the rotating means into the groove of the bolt, and fits the inner surface of the holder to the outer surface of the fixing body, and then the fixed body, the bolt, the rotating means, and the holder are previously formed and installed as a passage in the circular treatment. Insert into the inside of the sheath. That is, the fixed body is inserted into the inside along the wire.
  • the step of removing the rotating means S30. That is, the step of removing the holder and the rotating means into the body. Since both ends of the holder and the handle portion of the rotating means are rotated in a state that the outside of the body comes out of the body, the holder and the rotating means can be easily removed. Thereafter, the wire is removed at an appropriate position by the cutting means to complete the mitral valve circle large procedure.
  • the present invention can cope with the necessity by loosening by bolts by the rotation means, adjusting and re-tightening the wire properly, thereby further securing the safety of the mitral valve circle large procedure Will be.
  • the present invention relates to a fixing device and a fixing method for fixing both ends of the circular large wire for mitral valve circular surgery, more specifically, in the mitral valve circular surgery for patients with mitral regurgitation It can be used in the field of fixing device and fixing method of mitral valve circular wire, which can fix both sides of the outgoing circular wire and at the same time release the fixing as necessary.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un appareil et un procédé de fixation pour fixer les deux extrémités d'un fil de cerclage mitral utilisé en annuloplastie de sinus coronaire de cerclage mitral et, plus spécifiquement, par rapport à une annuloplastie de sinus coronaire de cerclage mitral réalisée sur un patient présentant une régurgitation mitrale, un appareil et un procédé de fixation de fil de cerclage mitral permettant aux deux extrémités d'un fil de cerclage mitral, qui revient en traçant un cercle, d'être fixées et libérées du support fixe, selon les besoins. L'appareil de fixation pour fixer un fil de cerclage mitral, selon un mode de réalisation préféré de la présente invention, comprend : un corps fixe ayant un trou traversant ayant un trou d'insertion dans lequel est inséré le fil, et deux trous de sortie, à travers lesquels le fil sort ; un boulon inséré dans le corps fixe par couplage par vis à ce dernier au moyen d'un moyen de rotation, pour fixer le fil inséré dans le trou traversant par pression vers le bas sur le fil ; et un support fixé sur le corps fixe de façon à l'empêcher de tourner lorsque le boulon est tourné par le moyen de rotation.
PCT/KR2015/006041 2014-07-22 2015-06-16 Appareil et procédé de fixation de fil de cerclage mitral Ceased WO2016013763A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020140092378A KR20160011381A (ko) 2014-07-22 2014-07-22 승모판막 서클라지 와이어의 고정장치 및 방법
KR10-2014-0092378 2014-07-22

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10433962B2 (en) 2016-05-06 2019-10-08 Transmural Systems Llc Annuloplasty procedures, related devices and methods
CN111839626A (zh) * 2019-04-30 2020-10-30 杭州德晋医疗科技有限公司 改进锁紧方式的缝合线锁结装置及其缝合线锁扣
EP3578137A4 (fr) * 2017-02-01 2021-05-12 Taupnu Medical Co., Ltd. Outil pour une chirurgie de régurgitation tricuspidienne
US11007059B2 (en) 2016-05-06 2021-05-18 Transmural Systems Llc Annuloplasty procedures, related devices and methods
US11039923B2 (en) 2016-05-06 2021-06-22 Transmural Systems Llc Annuloplasty procedures, related devices and methods
US11259926B2 (en) 2017-08-26 2022-03-01 Transmural Systems Llc Cardiac annuloplasty and pacing procedures, related devices and methods
US11980545B2 (en) 2016-05-06 2024-05-14 Transmural Systems Llc Annuloplasty procedures, related devices and methods

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102067989B1 (ko) * 2018-03-26 2020-01-20 (주) 타우피엔유메디칼 심근 전기 신호 감지 캡쳐카테터
KR102207685B1 (ko) * 2019-05-31 2021-01-26 (주) 타우피엔유메디칼 히스 감지 스네어 카테터

Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2001502190A (ja) * 1996-02-22 2001-02-20 スミス アンド ネフュー インコーポレーテッド 縫合糸コレット
JP2004531337A (ja) * 2001-06-27 2004-10-14 イーバルブ・インコーポレーテッド 弁治療においてリーフレットを捕捉しかつ固定する方法およびデバイス
KR20110023094A (ko) * 2009-08-28 2011-03-08 김준홍 관상정맥동과 삼천판막의 조직보호기구, 매듭 전달 기구 및 이들을 포함하는 승모판막 서클라지 시술용 장치

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008060553A1 (fr) 2006-11-14 2008-05-22 The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Annuloplastie de valve mitrale réalisée par transcathéter dans le sinus coronaire et dispositif de protection de l'artère coronaire et du myocarde

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001502190A (ja) * 1996-02-22 2001-02-20 スミス アンド ネフュー インコーポレーテッド 縫合糸コレット
JP2004531337A (ja) * 2001-06-27 2004-10-14 イーバルブ・インコーポレーテッド 弁治療においてリーフレットを捕捉しかつ固定する方法およびデバイス
KR20110023094A (ko) * 2009-08-28 2011-03-08 김준홍 관상정맥동과 삼천판막의 조직보호기구, 매듭 전달 기구 및 이들을 포함하는 승모판막 서클라지 시술용 장치

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10433962B2 (en) 2016-05-06 2019-10-08 Transmural Systems Llc Annuloplasty procedures, related devices and methods
US11007059B2 (en) 2016-05-06 2021-05-18 Transmural Systems Llc Annuloplasty procedures, related devices and methods
US11039923B2 (en) 2016-05-06 2021-06-22 Transmural Systems Llc Annuloplasty procedures, related devices and methods
US11980545B2 (en) 2016-05-06 2024-05-14 Transmural Systems Llc Annuloplasty procedures, related devices and methods
EP3578137A4 (fr) * 2017-02-01 2021-05-12 Taupnu Medical Co., Ltd. Outil pour une chirurgie de régurgitation tricuspidienne
US11259926B2 (en) 2017-08-26 2022-03-01 Transmural Systems Llc Cardiac annuloplasty and pacing procedures, related devices and methods
CN111839626A (zh) * 2019-04-30 2020-10-30 杭州德晋医疗科技有限公司 改进锁紧方式的缝合线锁结装置及其缝合线锁扣

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