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WO2016032177A1 - Cordon pour boucle pour former une boucle pendant une annuloplastie dans le sinus coronaire à cerclage de valve mitrale et appareil de fabrication associé - Google Patents

Cordon pour boucle pour former une boucle pendant une annuloplastie dans le sinus coronaire à cerclage de valve mitrale et appareil de fabrication associé Download PDF

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Publication number
WO2016032177A1
WO2016032177A1 PCT/KR2015/008799 KR2015008799W WO2016032177A1 WO 2016032177 A1 WO2016032177 A1 WO 2016032177A1 KR 2015008799 W KR2015008799 W KR 2015008799W WO 2016032177 A1 WO2016032177 A1 WO 2016032177A1
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WIPO (PCT)
Prior art keywords
rope
loop
coronary artery
coronary
integrated
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/KR2015/008799
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English (en)
Korean (ko)
Inventor
김준홍
신일균
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Tau PNU Medical Co Ltd
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Tau PNU Medical Co Ltd
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Filing date
Publication date
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Publication of WO2016032177A1 publication Critical patent/WO2016032177A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/2442—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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483—Hand-held instruments for holding sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0023—Surgical instruments, devices or methods disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0495—Reinforcements for suture lines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements 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
    • A61B2017/22038—Implements 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0066—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof shrinkable
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter

Definitions

  • the present invention relates to a loop rope used to form a loop in a mitral valve circle large coronary sinus procedure, and a manufacturing apparatus thereof, and more particularly, to a coronary artery protector integrated rope and an mitral valve procedure.
  • the guide wire is connected to a rope for a loop and a device for manufacturing the same.
  • 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 when the valve needs to open (stenosis, 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 'coronary 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 (RVOTs) of the right ventricle.
  • RVOTs 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
  • a large yarn of nylon that is passed through a tissue protection apparatus 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.
  • the circle large nylon yarn is not visible at all in the fluoroscopic image (X-ray) used as an induction image in the mitral circular circle procedure, and thus, the mitral circle circular procedure is not easy and the circle large during the mitral circle circular procedure
  • pushability is weak and it is not easy to deliver.
  • the arch portion which is a coronary sinus protector (coronary artery protector) proposed in the international patent application (International Application No.:PCT/US2007/023836), can be easily moved by the flow of the heart while being loosely fitted in a circle large thread. Im, there was a disadvantage that it does not guarantee safety.
  • FIG. 1 shows a mitral valve circular lodge with integrated arch coronary protection (also referred to as an “integral coronary device integrated circular rope”, “coronary artery integrated rope”, or “unified rope”) and tissue protective device (CSTV).
  • tube Figure 2 shows the procedure. The procedure involves first accessing the right atrium through the jugular vein using a guide wire, then through the coronary sinus and the proximal septal vein, the right ventricular outflow tract of the right ventricle. RVOT) to the right atrium, forming a reverse alpha-shaped loop, and then progressively pushing the microcatheter along the guide wire (a). Next, the guide wire is pulled out of the body (b). Only the microcatheter remains. Then, insert the 'Coronary Artery Protection Integral Rope' into the microcatheter (c).
  • integrated arch coronary protection also referred to as an “integral coronary device integrated circular rope”, “coronary artery integrated rope”, or “unified rope”
  • CSTV tissue protective device
  • CSTV tube tissue protective device
  • the coronary artery protector is not easy to insert into the catheter because it is larger than the microcatheter inner diameter.
  • the microcatheter is inserted into the coronary prosthesis connection portion of the integrated rope, and the microcatheter and the integrated rope are pulled out at the same time so that the coronary prosthesis is in the correct position (when the coronary artery is protected). Only the catheter is pulled towards the inferior vena cava to remove the microcatheter.
  • This method leads to the complexity and inconvenience of the procedure, such as the microcatheter insertion step, the integrated rope insertion and correct positioning step, the microcatheter removal step, in order to put the integrated rope in place.
  • the present invention has been made to solve the above problems, and an object of the present invention is to break away from the conventional method that causes the inconvenience of the procedure, and to form a loop to position the coronary artery protection integrated circular loop in the heart.
  • the present invention is to achieve the above object, characterized in that the coronary artery protector integrated rope and the guide wire 40 used in the mitral valve circle large coronary sinus plastic surgery of the present invention is integrally connected by a single line. .
  • the coronary artery protector integral rope is a coronary artery protector integral rope to which the arcuate coronary artery protector 30 is integrally fixedly coupled to protect the coronary artery, and the guide wire is a thin straight wire.
  • a device for manufacturing a loop rope for forming a loop in mitral valve circle large coronary sinus surgery includes a power supply unit receiving power; And a processing unit which receives power from the power supply unit and generates heat and simultaneously compresses the power.
  • the power supply unit is coupled in a form in which the built-in charging unit can be detachably attached, and the processing unit generates a heat by power supplied from the power supply unit, and a heat generating plate to which heat is generated by transferring heat generated from the heater. (60).
  • the loop rope of the present invention is integrally connected with the guide wire and the coronary artery protector integrated rope, it is not necessary to introduce a catheter for inserting the integrated rope. It can be easily performed, the surgical instruments introduced can also be reduced to increase the economics of the circle large procedure, thereby reducing the economic burden of the patient.
  • FIG. 1 is a perspective view of a circular rope and tissue protective device for mitral valve circle large procedure integrated with an arcuate coronary artery protector proposed by the inventor.
  • Figure 2 is a schematic diagram showing a mitral valve circle large procedure using a circular rope for mitral valve circle large procedure, which has been proposed by the present inventors, an arcuate coronary artery protector.
  • FIG 3 is a perspective view of a rope for a loop, according to a preferred embodiment of the present invention.
  • FIG. 4 is a partial cross-sectional view of the integrated rope and the guide wire inserted into the heat shrink tube according to another preferred embodiment of the present invention, (a) shows the state inserted into the heat shrink tube, (b) is applied to heat shrink The state in which the tube is compressed is shown.
  • Figure 5 is a photograph of the integrated rope and the guide wire inserted into the heat shrink tube as shown in FIG.
  • FIG. 6 is a perspective view of a rope manufacturing apparatus for a loop, according to a preferred embodiment of the present invention.
  • Figure 7 is a perspective view of a rope manufacturing apparatus for a loop, according to another embodiment of the present invention.
  • FIG. 8 is a perspective view of a roof rope manufacturing apparatus according to another preferred embodiment of the present invention.
  • a guide wire (RVOT wire, 40) is a relative venous, coronary sinus, ventricular septum, right ventricle, right atrium, or inferior vena cava (or relative vein) prior to insertion of the circle large thread (circle rope, 10) during mitral circular circle procedure. Turning to form a circle, it means a guide wire for inserting the circle large thread to be inserted later.
  • the guide wire is referred to as the "RVOT wire" in the sense of penetrating the RVOT in the heart.
  • RVOT wire means a wire that enters the right ventriculat outflow tract (RVOT), which is the preferred target structure past the coronary sinus and ventricular septum, and in a broad sense completes a circle in a circular procedure.
  • the guide wire (RVOT wire) is a straight metal wire that is relatively thinner than the circular rope (see FIGS. 3 and 4).
  • a circular 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
  • TV tricuspid valve
  • ventricular septal part is named in the sense of coming out of the body in a circular shape.When it comes out of the body, one end and the other end are connected It becomes a thread. That is, as shown in FIG. 1, a circle is drawn to connect one yarn.
  • 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").
  • the arcuate coronary artery protector 34 has an arch shape and is a portion that protects the coronary artery by the circular rope 10.
  • the circle large rope enters the coronary sinus, and when the circle large rope is confined to block the mitral annulus of the patient with mitral regurgitation, the circle large rope in the coronary sinus passing over the coronary artery presses on the coronary artery. Problems occur that block the flow of blood in the coronary arteries and damage them.
  • WO2008 / 060553 published May 22, 2008
  • a technique for protecting the coronary artery by inserting an arch in the coronary sinus is disclosed. It is.
  • the arcuate coronary artery protector 34 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 arcuate coronary care device may be made of synthetic resin or metal, preferably stainless steel.
  • the coronary artery protector integrated circle large rope (also referred to as "coronary artery protector integrated rope", “unified rope”) 30 means a circular rope that the arcuate coronary artery protector 34 is integrally fixed. . After inserting the arcuate coronary artery protector into the circle large rope, the arcuate coronary artery protector is wrapped with a biocompatible material to complete the integral circular loaf. Integral coronary protection rope eliminates the need to insert a separate arch-type coronary artery through the circular rope during the circle large procedure. The coronary artery is fixed to the circular rope to protect the arch from coronary heartbeat. The bulbs do not move independently, increasing the safety of the circle large procedure.
  • the "rope for loop connecting the coronary artery protector integrated rope and the guide wire for mitral valve procedure" used in the mitral valve circle large coronary sinus plastic surgery to be described in the present invention is a coronary artery protector integrated rope and guide As a rope to which wires are connected, it means that the wires are directly connected to each other or connected by a connecting tube (for example, a medical heat shrink tube, a medical tube, a metal tube, etc.).
  • a connecting tube for example, a medical heat shrink tube, a medical tube, a metal tube, etc.
  • Tissue protection mechanism (20, CSTV tube) is a hollow coronary sinus tube (coronary sinus tube, CS tube, 22) to protect the coronary sinus tissue; Hollow tricuspid valve tubes (TV tubes, 24) to protect the tissues of the three thousand valves and the ventricular septum;
  • the tubular sinus tube and the three thousand valve tube includes a stem portion 26 is coupled to each other side.
  • loop rope also referred to as “circle rope”, “circle wire”
  • a manufacturing apparatus thereof in which a coronary artery protector integrated rope and a guide wire are connected according to the present invention will be described.
  • FIG 3 is a perspective view of a rope for a loop, according to a preferred embodiment of the present invention.
  • the loop rope of the present invention means a rope in which the coronary artery protector integrated rope 30 and the guide wire 40 are integrally connected by one line.
  • the coronary artery protector integral rope 30 is an arcuate coronary artery protector 34 integral circle large rope that protects the coronary artery
  • the guide wire (RVOT wire) is a straight wire that is relatively thinner than the integral circle large rope (Fig. 3). , 4).
  • the unitary circle large rope 30 is an integral circle large rope in which an arcuate coronary artery protector 34 for protecting a coronary artery is integrated, and the circle large rope 32, the arcuate coronary artery protector 34, and the coating unit 36 are formed. Is made of.
  • the circular cladding 32 is composed of a metal wire inside and a coating layer coated with a biocompatible material on the outer surface of the wire.
  • the metal is one or more selected from biocompatible metals such as stainless steel, cobalt chromium, titanium, and nickel cobalt chromium alloy.
  • the biocompatible coating material is at least one selected from nylon, teflon, silicone and polyurethane.
  • the wire is preferably a form made by twisting a plurality of thin wires. This is because the wire is prevented from twisting and the elasticity is high.
  • the arcuate coronary artery protector 34 is inserted into the circular rope and protects the coronary artery, and has an arcuate shape.
  • the coating part 36 is an integral part of the arcuate coronary artery protector 34 and the circular rope 32, and is preferably formed of a biocompatible material.
  • a biocompatible material for example, it is used as medical polyurethane, polyolefin, silicone, stretch molded Teflon (e-PTFE), Teflon (PTFE), etc., which are used as a permanent transplant material in vivo.
  • the method of forming the coating part may be a method of immersion in a coating liquid and drying, a method of thermal fusion after winding in a sheet-type material, a method of using a medical cyanoacrylic instant adhesive, and a method of thermal fusion. Most preferably, after dipping, a drying method will be used.
  • the guide wire (RVOT wire) 40 is a straight wire that is relatively thinner than the circular rope and serves to guide the way before the circular rope is inserted.
  • the loop rope is connected to the guide wire 40 and the coronary artery protector integrated circle large rope 30 integrally, there is no need to insert a microcatheter along the guide wire, and thus the circle (in the heart)
  • a coronary artery protector integrated circle large rope 30 can be inserted directly along the guide wire (RVOT wire) 40 formed with a circle. That is, since the guide wire and the coronary artery protection integrated circle large rope are connected, the continuous pulling of the guide wire naturally inserts the coronary artery protection integrated circle large rope connected to the guide wire into the heart. It can be placed in the heart. Accordingly, the mitral valve procedure can be performed very simply and simply.
  • the loop rope of the present invention may be coupled to each other by means of heat fusion between the coronary artery protector integrated rope and the guide wire without any other medium, but may be coupled to each other through a medium called a connection tube in the middle.
  • a connection tube for example, a medical heat shrink tube, a medical tube, a metal tube and the like are used. 4 shows a case where a medium called a heat shrink tube 50 is used.
  • FIG. 4 is a partial cross-sectional view of the coronary artery protector integrated rope and the guide wire inserted in the heat shrink tube according to another preferred embodiment of the present invention, (a) shows the state inserted into the heat shrink tube, (b) the heat The state in which the heat-shrinkable tube is compressed by adding is shown.
  • the heat shrink tube 50 is a biocompatible material, for example, it may be selected from polyolefin, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK). Medical grade of USP GRADE 6 is used, and one of PEBAX 7233, 7033, 6333, 5533, 4033, 3500 can be used.
  • PTFE polytetrafluoroethylene
  • PEEK polyetheretherketone
  • the heat shrink tube 50 has high flexibility, and has excellent sterilization stability using gamma rays, electron beams, etc., and has excellent dimensional stability with longitudinal shrinkage of 15% or less. do.
  • the heat shrink tube 50 has a diameter of 0.1 to 10 mm, and the heat shrinkage ratio is 2: 1 to 4: 1.
  • the final thickness can be reduced to 1/2 to 1/4 from the original diameter, it is possible to effectively connect the integral rope and the outside of the guide wire to combine.
  • 6 to 8 are perspective views showing examples of the rope manufacturing apparatus for the loop according to the preferred embodiment of the present invention.
  • FIG. 6 is a plier-type device having an X-shaped processing part
  • FIG. 7 is a press-type device, in which a groove 62 is dug in the center with a mold type consisting of an upper mold and a lower mold.
  • the metal tube is placed in the center of the groove in the lower mold, and the corrugated artery integrated rope and the guide wire are overlapped and the press is applied to the upper mold to connect the coronary artery integrated rope and the guide wire to each other.
  • the device is manufactured, and FIG. 8 shows an electric curling iron type device having a straight working part rotated by a hinge part.
  • the rope manufacturing apparatus for the loop may use various types of apparatus.
  • the rope manufacturing apparatus for the loop is applicable to both a device for directly integrating a coronary artery protector rope and a guide wire or a device for contracting / compressing a heat shrink tube. That is, it can be selectively used for two purposes according to the temperature of the heat generating plate heat is generated, or can be used for both purposes by controlling the exothermic temperature by the temperature controller. Compressing the heat shrink tube will require a lower exothermic temperature than direct contact between the coronary articulating body integrated rope and the guide wire.
  • the rope manufacturing apparatus for a loop of the present invention includes a power supply unit capable of controlling the molding temperature, and a processing unit for generating and compressing heat.
  • the power supply unit may receive power from an external source or may be supplied by an internal battery. Of course, batteries can be used for both rechargeable and disposable applications.
  • the power supply unit is coupled in a form in which the built-in charging unit (battery) can be detached to give convenience to the procedure.
  • the power supply unit includes a temperature controller for adjusting the temperature.
  • the processing unit includes a heater generating heat by the supplied power, and a heat generating plate 60 through which heat generated by the heater is transferred to generate heat.
  • the heating plate 60 is formed with a groove 62 into which a rope for loop is inserted. This is to prevent the flat distortion when heat is applied to the heating plate when connecting the coronary protection unitary rope and the guide wire, and to maintain the circular tube shape, so that the heat shrink tube can be easily fixed on the heating plate.
  • the heating plate is detachably configured so that it can be easily replaced according to the size of the groove. That is, although not shown, by forming a bolt hole on the side of the heating plate to fasten the bolt, it can be easily removed.
  • the groove of the detachable heat sink is 0.2mm ⁇ 3mm in length and 3 ⁇ 10cm in length.
  • the present invention relates to a loop rope used to form a loop in a mitral valve circle large coronary sinus procedure, and a manufacturing apparatus thereof, and more particularly, to a coronary artery protector integrated rope and an mitral valve procedure.
  • the guide wire is available in the field of ropes connected to one and the device for manufacturing the same.

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  • Engineering & Computer Science (AREA)
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  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un cordon pour boucle utilisé pour former une boucle au cours d'une annuloplastie dans le sinus coronaire à cerclage de la valve mitrale et un appareil de fabrication associé, et plus particulièrement, un cordon pour boucle et un procédé de fabrication associé, un cordon à protection intégrée pour l'artère coronaire pour annuloplastie de la valve mitrale, ledit cordon ayant une protection d'artère coronaire intégrée de type arc, et un fil-guide étant raccordés d'un seul tenant. La présente invention est caractérisée en ce qu'un cordon à protection intégrée pour l'artère coronaire, qui est utilisé au cours d'une annuloplastie dans le sinus coronaire à cerclage de la valve mitrale, et un fil guide (40) sont raccordés d'un seul tenant par une ligne unique. A cet égard, le cordon à protection intégrée pour l'artère coronaire est un cordon à protection intégrée pour l'artère coronaire, auquel une protection d'artère coronaire de type arc (30) destinée à protéger les artères coronaires est fixée en un seul tenant et couplée, et le fil-guide est un fil fin et droit. Un appareil de fabrication d'un cordon pour boucle pour former une boucle au cours d'une annuloplastie dans le sinus coronaire à cerclage de la valve mitrale, selon un mode de réalisation préféré de la présente invention, comprend : une unité d'alimentation qui reçoit de l'énergie; et une unité de traitement, qui reçoit l'énergie provenant de l'unité d'alimentation, et qui simultanément génère de la chaleur et réalise une compression
PCT/KR2015/008799 2014-08-29 2015-08-24 Cordon pour boucle pour former une boucle pendant une annuloplastie dans le sinus coronaire à cerclage de valve mitrale et appareil de fabrication associé Ceased WO2016032177A1 (fr)

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KR10-2014-0114502 2014-08-29
KR1020140114502A KR101677193B1 (ko) 2014-08-29 2014-08-29 승모판막 서클라지 관상정맥동 성형술에서 루프를 형성하기 위한 루프용 로프

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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

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CN116509479B (zh) * 2023-04-18 2023-11-07 南京思脉德医疗科技有限公司 一种血管缝合器的压线接头及固定缝合线的装置及工艺

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JP2019516527A (ja) * 2016-05-06 2019-06-20 ザ ユナイテッド ステイツ オブ アメリカ， アズ リプレゼンテッド バイ ザ セクレタリー， デパートメント オブ ヘルス アンド ヒューマン サービスＴｈｅ Ｕｎｉｔｅｄ Ｓｔａｔｅｓ Ｏｆ Ａｍｅｒｉｃａ， Ａｓ Ｒｅｐｒｅｓｅｎｔｅｄ Ｂｙ Ｔｈｅ Ｓｅｃｒｅｔａｒｙ， Ｄｅｐａｒｔｍｅｎｔ Ｏｆ Ｈｅａｌｔｈ Ａｎｄ Ｈｕｍａｎ Ｓｅｒｖｉｃｅ 環状形成処置、関連装置及び方法
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EP3451973A4 (fr) * 2016-05-06 2019-12-25 Transmural Systems LLC Procédures d'annuloplastie, dispositifs et procédés associés
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
JP7097351B2 (ja) 2016-05-06 2022-07-07 ザ ユナイテッド ステイツ オブ アメリカ， アズ リプレゼンテッド バイ ザ セクレタリー， デパートメント オブ ヘルス アンド ヒューマン サービス インプラント
JP2022110075A (ja) * 2016-05-06 2022-07-28 ザ ユナイテッド ステイツ オブ アメリカ， アズ リプレゼンテッド バイ ザ セクレタリー， デパートメント オブ ヘルス アンド ヒューマン サービス インプラント
US11980545B2 (en) 2016-05-06 2024-05-14 Transmural Systems Llc Annuloplasty procedures, related devices and methods
JP7530539B2 (ja) 2016-05-06 2024-08-08 ザ ユナイテッド ステイツ オブ アメリカ， アズ リプレゼンテッド バイ ザ セクレタリー， デパートメント オブ ヘルス アンド ヒューマン サービシズ インプラント
US11259926B2 (en) 2017-08-26 2022-03-01 Transmural Systems Llc Cardiac annuloplasty and pacing procedures, related devices and methods

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