WO2023244186A1 - Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale - Google Patents

Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale Download PDF

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Publication number
WO2023244186A1
WO2023244186A1 PCT/TR2022/050597 TR2022050597W WO2023244186A1 WO 2023244186 A1 WO2023244186 A1 WO 2023244186A1 TR 2022050597 W TR2022050597 W TR 2022050597W WO 2023244186 A1 WO2023244186 A1 WO 2023244186A1
Authority
WO
WIPO (PCT)
Prior art keywords
mitral valve
patient
valve
heart
regurgitation
Prior art date
Application number
PCT/TR2022/050597
Other languages
English (en)
Inventor
Lokman ÇELİK
Berat Arikan AYDIN
İbrahim Hakki TONYALI
Original Assignee
Celik Lokman
Aydin Berat Arikan
Tonyali Ibrahim Hakki
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 Celik Lokman, Aydin Berat Arikan, Tonyali Ibrahim Hakki filed Critical Celik Lokman
Priority to PCT/TR2022/050597 priority Critical patent/WO2023244186A1/fr
Publication of WO2023244186A1 publication Critical patent/WO2023244186A1/fr

Links

Classifications

    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/295—Balloon pumps for circulatory assistance
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/892—Active valves, i.e. actuated by an external force
    • 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
    • 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
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the invention relates to a device in the cardiovascular field that keeps the patient hemodynamically stable until the surgical intervention in mitral valve regurgitation.
  • the invention relates to a device for use in in mitral valve regurgitation such as acute ischemic mitral insufficiency that develops suddenly and requires surgical intervention and the device stabilizes the patient and enables the patient to be taken into surgical operation, by performing a procedure by inserted into one of your arteries through an incision
  • Mitral regurgitation is defined as the inability of the mitral valve to close completely during left ventricular contraction and backflow of blood.
  • MR Mitral regurgitation
  • mitral regurgitation is graded as first, second, and third degree. Increasing degrees indicate that MR is more important.
  • drug therapy is applied to reduce the workload of the left ventricle and to prevent excess fluid retention in the body.
  • severe mitral valve regurgitation surgical intervention is performed to replace or repair the valve.
  • TEER transcatheter edge to edge repair
  • the TEER method is applied with a small latch-like device.
  • the heart is reached by entering the inguinal vein with a catheter and passing through the large vein in the abdomen.
  • the device is inserted to the level of the mitral valve through the catheter channel in the vein and its wings are opened at this point.
  • the problematic mitral valve parts are taken under the wings of the device and the sutures are fixed mutually with the stitch rings that become free.
  • TEER applications cannot be applied in cases where the valve is too flail, such as Chordae tendineae ruptures. Because in this procedure, two valves are stitched together from one or two points to prevent leakage. However, in order to stich, the apparatus must be caught with the device. It is impossible to do this in cases where the valve moves independently.
  • Another procedure, synthetic mitral valve implanting, is a procedure in which a mechanical or tissue valve is implanted in place of the diseased mitral valve in the patient's heart. This method works very inefficiently and the desired benefit cannot be achieved because the tissue on which the mitral valve is seated is not very hard and the said layer is thin.
  • the patient is stabilized with medication, and then the valve is repaired or replaced by surgery.
  • no case of using a device for this stabilization process was encountered.
  • a mitral valve treatment device and method comprising a mitral valve therapy device, a guide wire and a guide tube.
  • the mitral valve therapy device is configured such that the guide wire is fed into the coronary sinus of the heart adjacent to the mitral valve ring to reshape the mitral valve ring of the heart, when placed in the coronary sinus adjacent to the mitral valve ring.
  • the guide tube includes a distal end, a proximal end, and a lumen extending between its distal end and proximal end, and a lateral connection point between the distal and proximal ends communicating with this lumen.
  • the guide tube is slid along the guide wire into the coronary sinus, and the mitral valve therapy device is then delivered by the guide tube to the coronary sinus adjacent to the mitral valve ring.
  • US20020169504A1 generally relates to a device, system and method for treating a deformed heart valve.
  • the said system comprises a guide wire configured to be fed into the coronary sinus of the heart and a mitral valve ring therapy device configured to be slid onto the guide wire and advanced on the guide wire to the coronary sinus of the heart.
  • the said method comprises the following steps; providing an elongated flexible guide wire having a cross-sectional dimension; feeding the guide wire into the coronary sinus of the heart; providing an elongated flexible guide tube with an inner lumen having a cross-sectional dimension greater than the cross-sectional dimension of the guide wire; feeding the guide tube through the guide wire into the coronary sinus of the heart with the guide wire in the inner lumen of the guide tube; providing a mitral valve ring device configured to be slidably received over the guide wire and into the inner lumen of the guide tube, the device including a proximal end; providing a flexible, long inserter configured to be slidably received over the guide wire and into the inner lumen of the guide tube, the inserter having a distal end; placing the device on the guide wire; placing the introducer on the guide wire; connecting the distal end of the introducer with the proximal end of the device; pushing the device with the introducer along the guide wire and in the guide tube in a distal direction until it at least partially surrounds
  • European patent application numbered EP3332744B1 relates to a device for modifying the shape of a body organ.
  • the method and device mentioned in the application comprises the following steps: delivering a tissue shaping device to the patient's coronary sinus in an unexpanded configuration inside a catheter having an outer diameter of not more than nine or ten french, the tissue shaping device comprising a connector positioned between a distal expandable anchor containing flexible wire and a proximal expandable anchor containing flexible wire, the device having a length of 60 mm or less; and placing the device, for example, the flexible wire of the distal expandable anchor in contact with a wall of the coronary sinus, for example, allowing self-expansion of the distal expandable anchor or applying an actuation force to the distal expandable anchor and placing the device to reduce mitral valve regurgitation by securing the distal expandable anchor, possibly by locking the distal expandable anchor after performing the application step.
  • the present invention relates to a device that meets the requirements mentioned above, eliminates all disadvantages and provides some additional advantages, and that stabilizes the patient in mitral valve regurgitation and makes him ready for surgical intervention.
  • the main objective of the invention is to provide a device that brings mechanical relief to the heart immediately with its application, enabling the patient to recover/stabilize quickly and thus to become ready for surgical intervention.
  • the invention is a device that enables the patient to become ready for surgical intervention in mitral valve regurgitation and includes the following: a balloon valve (1), which prevents blood from passing from the left ventricle to the left atrium by inflating and provides the passage of blood from the left atrium to the left ventricle with by relaxing, a catheter (2) placed into the vein that allows the balloon valve (1) to reach the mitral valve level, a monitor that monitors the condition of the heart, and a control unit (3) that enables controlling of the inflation and relaxing movements and position of the balloon valve (1).
  • a balloon valve (1) which prevents blood from passing from the left ventricle to the left atrium by inflating and provides the passage of blood from the left atrium to the left ventricle with by relaxing
  • a catheter (2) placed into the vein that allows the balloon valve (1) to reach the mitral valve level
  • a monitor that monitors the condition of the heart
  • a control unit (3) that enables controlling of the inflation and relaxing movements and position of the balloon valve (1).
  • Figure 1 is the balloon valve relaxing view of the device that prepares the patient for surgical intervention in mitral valve regurgitation.
  • Figure 2 is the balloon valve inflating view of the device that prepares the patient for surgical intervention in mitral valve regurgitation.
  • the invention is a device in the cardiovascular field that prepares the patient for surgical intervention in mitral valve regurgitation.
  • the device of the invention comprises the following; a balloon valve (1), which prevents blood from passing from the left ventricle to the left atrium by inflating and do not obstruct to passage of blood from the left atrium to the left ventricle with by relaxing; a catheter (2) placed into the vein that allows the balloon valve (1) to reach the mitral valve level, a monitor that monitors the condition of the heart; and a control unit (3) that enables controlling of the inflation and relaxing movements and position of the balloon valve (1).
  • Figure 1 shows the view of the device that prepares the patient for surgical intervention in mitral valve regurgitation.
  • the device which is the subject of the invention, is used in the procedure by entering patient from the appropriate vein with invasive intervention.
  • the balloon valve (1) inflates during the contraction phase of the heart muscle (systole), preventing the passage of blood from the ventricle to the atrium.
  • the catheter (2) is placed into the vein. Monitoring of the heart condition during the procedure is provided by the monitor.
  • control unit (3) The function of the control unit (3) mentioned above is to ensure that the balloon valve (1) inflates and relaxes in accordance with the cardiac rhythm.
  • the catheter (2) is inserted by entering the patient through the appropriate vein with an invasive procedure.
  • the balloon valve (1) enters the heart first into the right atrium and then into the left atrium by septostomy.
  • the balloon valve (1) which operates synchronously with the current heart rhythm (sinus rhythm), when the left ventricle is contracts, it prevents blood from entering the left atrium from the left ventricle by acting as a mitral valve, and when the left ventricle relaxes, it shrinks and allows its passage from the left atrium to the left ventricle.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif dans le domaine cardiovasculaire qui maintient le patient hémodynamiquement stable dans la régurgitation de la valve mitrale jusqu'à ce que l'intervention chirurgicale soit effectuée. En particulier, l'invention concerne un dispositif destiné à être utilisé dans la régurgitation de valve mitrale telle qu'une insuffisance mitrale ischémique aiguë qui se développe soudainement et nécessite une intervention chirurgicale qui stabilise le patient et permet au patient d'être pris dans une opération chirurgicale par réalisation d'une procédure par insertion dans l'une de ces artères à travers une incision.
PCT/TR2022/050597 2022-06-16 2022-06-16 Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale WO2023244186A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/TR2022/050597 WO2023244186A1 (fr) 2022-06-16 2022-06-16 Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2022/050597 WO2023244186A1 (fr) 2022-06-16 2022-06-16 Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale

Publications (1)

Publication Number Publication Date
WO2023244186A1 true WO2023244186A1 (fr) 2023-12-21

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2022/050597 WO2023244186A1 (fr) 2022-06-16 2022-06-16 Dispositif pour stabiliser des patients dans une régurgitation de valve mitrale

Country Status (1)

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WO (1) WO2023244186A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020087166A1 (en) * 1998-02-24 2002-07-04 Brock David L. Flexible instrument
US20020156526A1 (en) * 2001-04-24 2002-10-24 Hlavka Edwin J. Method and apparatus for catheter-based annuloplasty
US20190314155A1 (en) * 2018-04-12 2019-10-17 Edwards Lifesciences Corporation Mitral valve spacer device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020087166A1 (en) * 1998-02-24 2002-07-04 Brock David L. Flexible instrument
US20020156526A1 (en) * 2001-04-24 2002-10-24 Hlavka Edwin J. Method and apparatus for catheter-based annuloplasty
US20190314155A1 (en) * 2018-04-12 2019-10-17 Edwards Lifesciences Corporation Mitral valve spacer device

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