EP4084702A1 - Obturateur d'auricule pour fermer l'auricule gauche - Google Patents

Obturateur d'auricule pour fermer l'auricule gauche

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Publication number
EP4084702A1
EP4084702A1 EP20842237.8A EP20842237A EP4084702A1 EP 4084702 A1 EP4084702 A1 EP 4084702A1 EP 20842237 A EP20842237 A EP 20842237A EP 4084702 A1 EP4084702 A1 EP 4084702A1
Authority
EP
European Patent Office
Prior art keywords
occluder
atrial appendage
polymer
occluders
proximal
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.)
Pending
Application number
EP20842237.8A
Other languages
German (de)
English (en)
Inventor
Robert Moszner
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.)
Cormos Medical GmbH
Original Assignee
Cormos Medical GmbH
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 Cormos Medical GmbH filed Critical Cormos Medical GmbH
Publication of EP4084702A1 publication Critical patent/EP4084702A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A61B2017/00871—Material properties shape memory effect polymeric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095—Threaded connection

Definitions

  • the invention relates to a multivalent, novel atrial appendage occluder as a hybrid based on two different atrial appendage occluders, one with a proximal disc-shaped cover and a second version without a proximal cover. Both occluder variants represent application solutions that are relevant in themselves.
  • LAA Left Atrial Apendage
  • LAA occluders made from the devices embody a network of lattice-shaped stent-shaped elements lasered from a metal tube (nitinol), the final shape of which as a closure device of the left atrial appendage is given a suitable shape by means of a reshaping and heat treatment process and is elongated by a catheter is brought into the cardiovascular system.
  • this device When it emerges from the catheter tip, this device assumes its predetermined shape in the atrial appendage and is anchored at the target location and "released” after checking the correct position and location. Over the course of a few weeks, the implant grows in, whereby it is overgrown by the body's own endothelial cells.
  • the catheter introduced into the right atrium from the right inguinal vein must first be guided through a transseptal puncture of the atrial septum into the left atrium.
  • the occluder developed here has self-centering properties.
  • Two such auricular appendage occluders can be used in combination for specially shaped, very open auricular appendages.
  • the atrial appendage occluder without a proximal cover must first be implanted.
  • the heartbeat is induced by regular electrical impulses that originate in the sinus node of the heart.
  • the periodic impulse is superimposed and disrupted by disorganized impulses originating from the roots of the pulmonary veins in the heart muscle.
  • this type of cardiac arrhythmia can also make itself felt through palpitations, syncope or chest pain.
  • Atrial fibrillation is classified into subgroups: paroxysmal atrial fibrillation (converts spontaneously into sinus rhythm when it occurs) persistent atrial fibrillation (atrial fibrillation that has existed for more than seven days; therapy is available) permanent atrial fibrillation (permanent, therapy-resistant atrial fibrillation)
  • a second classification scheme is based on the cause of the arrhythmia: Valvular atrial fibrillation: Starting from the mitral valve or mitral valve regurgitation caused by atrial fibrillation
  • Non-valvular atrial fibrillation Based on other causes (e.g., high blood pressure)
  • Non-valvular atrial fibrillation is the most common form of cardiac arrhythmia, with an incidence of 1 to 2% in the general population. This proportion is likely to increase over the next 50 years due to demographic changes, as the incidence increases with age.
  • AF non-valvular atrial fibrillation
  • the prevalence of typical diseases that favor non-valvular atrial fibrillation also increases with age.
  • 0.5% of all people in the age group from 40 to 50 years and 5 to 15% of all people in the age group over 80 years are affected. Men are affected to a greater extent than women of the same age group.
  • the left atrial appendage is a muscle pocket that connects to the left atrium of the heart. It serves as the origin tissue and reservoir for the atrial natriuretic peptide (ANP).
  • APN atrial natriuretic peptide
  • the LAA is actively contracted and deflated.
  • the blood flow in this appendix is slowed to the point of stasis, with an increased likelihood of thrombus formation.
  • the crypt-rich structure of the individual LAAs is made up of one to three lobes, is highly diverse and offers an ideal environment for thrombus formation, due to the trabecular structure of the inner wall of the left auricular appendage, in contrast to the smooth inner wall of the rest of the left fore-and-throat. Thrombi formed there, released into the circulation, can lead to ischemia in the brain or other organs, such as the kidney.
  • Ischemic stroke is characterized by a rapid loss of neurological functions due to the interruption of the blood supply to affected areas of the brain.
  • the supply deficit is caused by a thrombus or cerebral hemorrhage.
  • AF-associated stroke is also characterized by higher mortality and morbidity compared to strokes without the presence of AF (Landmesser U and Holmes DR, 2012).
  • a stroke is a medical emergency that can cause severe, permanent neurological dysfunction up to and including death.
  • CHADS2 Score The CHADS2 point system
  • CHADS2 Score The CHADS2 point system
  • This score has been expanded to include newly identified risk factors for the CHA2DS2-VASC score. Two or more points indicate a high risk of stroke.
  • the European Society of Cardiology recommends oral anticoagulation.
  • the British NICE (“UK National Institute for Health and Care Excellence”) also considers percutaneous LAA closure as an option for stroke prevention in the event that oral anticoagulation is contraindicated or intolerance is present (National Institute for Health and Care Excellence, 2014, August: Atrial fibrillation: the management of atrial fibrillation - NICE clinical guideline 180).
  • the EHRA (“European Heart Rhythm Association”) already wrote a position paper in 2011 which recommends percutaneous LAA closure as an option for patients with contraindications to oral anticoagulation. Especially in patients with previous episodes of a intracranial hemorrhage, stroke prophylaxis without long-term oral anticoagulation is desirable.
  • Stroke prevention is based on oral anticoagulation with vitamin K antagonists (warfarin, mainly used in the USA and phenprocoumon, mainly used in Europe) and now also with newer drugs.
  • vitamin K antagonists warfarin, mainly used in the USA and phenprocoumon, mainly used in Europe
  • platelet aggregation inhibitors based on acetylsalicylic acid as monotherapy or in combination with clopidogrel is less effective but associated with the same risks as oral anticoagulation. This would be severe bleeding and / or intracranial bleeding. Inhibition of platelet aggregation should be limited wherever possible.
  • Classic oral anticoagulation such as the use of warfarin, has a narrow therapeutic window, is characterized by considerable drug interactions and increases the risk of intracranial and gastrointestinal bleeding, especially in the elderly.
  • Newer preparations such as dabigatran etexilate, rivaroxaban and apixaban show only a slightly reduced risk of intracranial bleeding compared to warfarin. Therefore, despite the better risk profile, there is still a substantial risk of bleeding. These preparations are also not intended for long-term medication. For these reasons, oral anticoagulants are only prescribed cautiously. Another problem is inadequate patient monitoring for effective dosing. A study showed that 44% of the patients only achieve a sub-therapeutic drug level and 19% of the patients achieve a supra-therapeutic drug level.
  • oral anticoagulants are contraindicated from the outset in 14 to 44% of all AF risk patients. This is particularly true of the elderly, but in whom the risk of stroke is complementarily highest. Another important factor that makes pharmacological therapy difficult is poor adherence to therapy on the part of those affected.
  • the use of oral anticoagulants means a big break in the habitual lifestyle.
  • Stroke prevention through an open, surgical closure or removal of the LAA is made more difficult by the high rates of incompletely closed LAAs after the procedure. These are 10 to 80%, depending on the method and the surgeon's level of experience.
  • the LAA excision shows the highest success rate and the suture or clasp closure shows the lowest success rate (Guerios EE et al., 2012).
  • the suturing technique used is very important here.
  • the suture from “inside”, with the LAA being sutured from the left atrium, is certainly to be preferred here.
  • the LAAOSIII study, which will be published shortly, will show better data here.
  • LAA occluder A valid prevention option for patients with a contraindication for oral anticoagulation or other conditions that prevent conservative or surgical therapy is percutaneous closure using a so-called LAA occluder.
  • Transcatheter techniques allow percutaneous access to the LAA and the use of these medical products, which usually consist of expandable nitinol nets.
  • An occluder that is too small allows residual leakage.
  • An occluder that is too large can lead to compression of the adjacent coronary artery or coronary artery (especially the circumflex branch).
  • LAA occluders There are currently two predominant, prototypical LAA occluders on the market:
  • the Watchman LAA system and its successor, the Watchman FLX (Boston Scientific Natick, MA, USA)
  • Rodes-Cabau and colleagues particularly emphasize the ease of use and the correction options of the ACP in the event of an initial misplacement. Montenegro and colleagues also report that misplaced occluders or occluders with incorrect dimensions could be retrieved and replaced without complications. Lam and colleagues in particular also discuss the design advantages of the ACP compared to other regularly used occluder types, which, due to inherent design features, harbor the risk of residual flow.
  • the Watchman is made of a fabric-covered nitinol frame, which has a combined sealing and anchoring function.
  • the left atrial appendage bulges as a result of friction with the pericardium, causing very painful inflammations of the pericardium.
  • the hooks used to attach the occluder can in turn cause perforation of the pericardium;
  • the risk of thrombus formation is relatively high due to the coupling at the proximal end of the occluder, which sometimes protrudes far into the left atrium; Localization problems also occur with the WATCHMAN device.
  • these devices also have the disadvantage that, due to its positioning in the left atrium, the catheter is at an unfavorable angle to the position of the occluder in the end position in the left atrial appendage with respect to the direction of its longitudinal axis (both axes are almost at right angles to one another), which leads to significant obstructions during the course of the implantation and can also lead to perforation of the left pericardium by piercing the wall of the left atrial appendage.
  • the object of the invention is to avoid the disadvantages described in relation to the prior art and, in particular, to achieve an easily manageable implantation process with a secure implantation closure by means of such an LAA occluder.
  • the use of smaller catheters leads to a gentler treatment of the patient.
  • heat treatment devices are used with which laser-cut LAA occluders can be produced from a metal tube, which are self-centering and in various sizes assume an optimally fixed position after the interventional insertion.
  • the basic shape of such an occluder is similar to that of a cylindrical body with rounded edges and an additional membrane located in the middle and further membranes located at the distal end.
  • a coupling with an internal thread was integrated into the proximal end.
  • the hooks provided for secure anchoring of the LAA occluder in the left atrial appendage are axially and radially aligned through the use of these special devices in order to achieve optimal function, safe and gentle placement of the occluder in the holding area of the left atrial appendage and the use of smaller ones Allow catheter.
  • the occluder is largely lasered from a nitinol tube.
  • suitable heat treatment processes are used with the help of these special devices in order to fully exploit the super-elastic material properties of Nitinol (a titanium-nickel alloy, which is about 70 times more elastic than steel) with targeted partial and intermediate processing steps .
  • the occluder blank is introduced into several preliminary, intermediate or end devices in a heating furnace in one processing stage and is there at a temperature of 350 to approx. 600 degrees Celsius for about half an hour to three minutes hold. High temperatures allow short heat treatment times.
  • the device with the occluder located therein must be cooled relatively quickly, for example with appropriately tempered air or liquid nitrogen.
  • the occluders to be manufactured can be introduced into a temperature-controlled, suitable molten salt at around 470 to 550 degrees; the holding times of around 5 to 1 minute are significantly shorter due to the immediate and intensive contact with the melt.
  • a certain number of hooks are located in the proximal retention area of the occluder for secure anchoring of the occluder. About seven times the pipe diameter of the starting pipe makes sense: With a pipe diameter of 3mm, this results in 21 hooks.
  • DACRON is a registered brand name of the manufacturer DuPont for fiber material made from the polyester polyethylene terephthalate (PET).
  • Fiq. 1 (a) a schematic representation of the side view of a base body of the occluder according to the invention required for the first step of the stepwise shaping heat treatment;
  • Fiq. 1 (b) shows a schematic detailed illustration of the side view of the base body according to FIG.
  • Fiq. 2 a schematic representation of a three-dimensional view of an occluder according to the invention to be manufactured with a device during a first step of the heat treatment;
  • Fiq. 3 shows a schematic three-dimensional representation of an inventive occluder to be manufactured with a device during a second step in the course of the heat treatment
  • Fiq. 4 shows a schematic representation of the side view of a further device for a next step of the shaping heat treatment for an occluder according to the invention to be manufactured;
  • Fiq. 5 a schematic representation of the side view of an occluder according to the invention to be manufactured in a further step of the heat treatment with the support of the device according to FIG. 4;
  • Fiq. 6 shows a schematic sectional illustration of the heat treatment device with an occluder according to the invention to be manufactured with a proximal cover in the penultimate working step of the heat treatment;
  • Fiq. 7 shows a schematic representation of a side view of an occluder according to the invention to be manufactured with a proximal cover after the heat treatment with the device according to FIG. 6;
  • Fiq. 8 shows a schematic sectional illustration of a heat treatment device with an occluder according to the invention to be manufactured with a proximal cover in the last working step of the heat treatment;
  • Fiq. 9 (a) shows a schematic detailed view of the heat treatment device
  • Fiq. 9 (b) a schematic detailed view of the heat treatment device with a sectional illustration of the shaping and radial alignment after the last step of the heat treatment of an occluder according to the invention to be manufactured with a proximal cover;
  • Fiq. 10 a schematic side view of an occluder according to the invention to be manufactured with a proximal cover after the last step of the heat treatment according to FIG. 9 (a-b);
  • Fiq. 11 shows a schematic side view of a finished atrial appendage occluder according to the invention with a proximal cover;
  • Fiq. 12 a schematic sectional illustration of the heat treatment device with an occluder according to the invention to be manufactured without a proximal cover in the last step of the heat treatment;
  • Fiq. 13 shows a schematic side view of an occluder according to the invention to be manufactured without a proximal cover after the last step of the heat treatment according to FIG. 12;
  • Fiq. 14 shows a schematic side view of a finished atrial appendage occluder according to the invention without a proximal cover
  • Fiq. 15 (a) a schematic sectional illustration of the left atrial appendage with an implanted atrial appendage occluder according to the invention without a proximal cover according to FIG. 14; Fiq. 15 (b) a schematic sectional illustration of the left atrial appendage with an implanted atrial appendage occluder according to the invention with a proximal cover according to FIG. 11;
  • Fiq. 16 shows a schematic sectional illustration of the left atrial appendage with two implanted atrial appendage occluders according to the invention without a proximal cover according to FIG. 14 and
  • Fiq. 17 is a schematic sectional view of the left atrial appendage with a
  • a preferred embodiment according to the invention of the occluder 1 according to FIG. 11 and Fiq. 14 is preferably made from a common metallic nitinol tube 8.
  • corresponding laser cuts 27 were made in the wall of a nitinol tube in FIGS. 1 (a-b) with a suitable laser.
  • the later final shape of the occluder 1 is already given by predetermined, correspondingly short or longer laser cuts 27 and the narrower, wider, shorter or longer shaped elements 18 resulting therefrom.
  • a 1.5 to 2 mm short tube section remains free from laser production.
  • a small inner cylinder with an M1 thread is inserted into this end pipe piece, which can accommodate an insertion wire with an external thread M1 as a coupling 20.
  • a tool mandrel 28 is inserted into the distal end 12 of the lasered sheath 9 of the nitinol tube 8, which mandrel expands the laser-machined sheath 9.
  • the proximal end of the lasered sheath 9 and the short end piece of the nitinol tube 8 are in turn located in a tool holder 29 in order to ensure the axial alignment of the later final shape of the occluder 1 in this early work step.
  • the first sub-step of the heat treatment process now begins in order to stabilize the first intermediate shape.
  • the next work steps can then be repeated, with further device parts with each further step of the production of intermediate forms required are.
  • the expanded nitinol tube according to FIG. 3 expanded even further, followed by the heat treatment process, etc.
  • These work steps can be carried out several times up to the final shape with other specific work steps for further shaping of intermediate shapes while maintaining the axial alignment.
  • molten salts are preferred because of the higher quality standards.
  • Fiq. 6 is now a schematic device 35 for the penultimate working step of the heat treatment of an occluder 1 according to FIG. 14, the hooks 19 and their repeated axial and, at the same time, radial alignment are prefabricated for the last step of the heat treatment, so that we have the according to Fiq. 7 prefabricated occluder 1 with the later final shape according to Fiq. 14, in which the hooks are still perpendicular to the central axis 36.
  • This prefabricated occluder 1 according to Fiq. 7 is now used for the final heat treatment in a further, end-modified device 35 for the occluder 1 according to FIG. 14 are used to shape the hooks 19, which are aligned axially and radially at the same time.
  • the detailed view 5 according to FIG. 8 in the subsequent schematic representation in Fiq. 9 (ab) the final work step for shaping the hooks and their compulsory radial alignment, which is permanently secured by the subsequent heat treatment.
  • the detailed view 5 according to Fiq. 9 a shows, in the two schematic representations on the left and on the right, a hook 19 that has not yet been formed as an elongated shaped element 18.
  • FIGS. 9 b show the detailed view 5 of the finally modified device in the final assembled state in order to carry out the subsequent heat treatment process:
  • the hook 19 is pressed into the lowest position of the recess 38 by a hold-down device 37 and held in this position by the hold-down device 37 until the last heat treatment step has been completed .
  • the occluder 1 blank receives a final electropolishing and after various final cleanings by means of ultrasound and ultrapure water, two PET patches 21 or similar patches 21 are introduced into the occluder 1 according to their function, as shown in FIG. 11 is shown.
  • the two patches 21 are sewn in by hand with three commercially available surgical threads each, namely one patch 21 in the proximal cover 14 and a second patch 21 in the bulbous area of the occluder 1 immediately after the waist or web 15.
  • the heat treatment device 35 according to FIG. 12 is the equivalent of the device Fiq. 8. With the help of this device 35, the occluder 1 without a proximal cover 14 is finally closed as in FIG. 13 shown manufactured. This occluder 1 according to FIG. 13 required according to Fiq. 14, however, only a patch 21 for sealing off the blood flow as shown in FIG. 15 b can be seen.
  • the finished and sterilized atrial appendage occluders 1 with and without a proximal cover according to FIG. 11 and Fiq. 14 can now be used for interventional stroke prophylaxis as required.
  • the interventional atrial appendage closure is based on a venous, transseptal access, via which a self-expanding device is introduced into the left atrial appendage 24 after fluoroscopic imaging.
  • the patient is treated preoperatively with substances that inhibit platelet aggregation or have an anticoagulant effect.
  • the occluder 1 After puncturing the femoral vein, the occluder 1 is advanced with the aid of an insertion wire over the right atrium and, after a transseptal puncture, into the left atrium 23 and finally released from the sheath in the left atrial appendage 24.
  • the distal spherical body expands in the atrial appendage 24, while the proximal cover 14 seals the atrial appendage entrance 25 from the outside.
  • the occluder After checking the positioning in the LAA, the occluder can be decoupled from the feeder system. The entire procedure takes place under constant TEE control, with the patient lying in mild anesthesia (sleep state in which respiratory and circulatory functions are kept stable).
  • anticoagulants drugs to thin the blood
  • ASA ASA and / or clopidogrel intake. This serves to prevent blood clots from forming.
  • the patient is examined echocardiographically at defined intervals.
  • the hooks 19 located on the circumference of the occluder 1 are in the “rest position” of the occluder 1 during transport in the lock.
  • the latter unfolds during transport in an elongated, tube-like shape in the catheter up to the distal opening without the hooks 19 becoming effective. This also applies until shortly before the end of the implantation process.
  • the hooks 19 emerge from the surface of the occluder 1 and secure a firm anchoring in the left atrial appendage 24 only through the compression present in the left atrial appendage 24 after the complete occluder 1 has been released 24 can position, the occluder 1 to be inserted should according to Fiq.
  • two occluders 1 can be implanted to close the left atrial appendage, the second occluder 1 being inserted about 6 weeks after the first implantation. Examples are in Fiq. 16 two occluders 1 without a proximal cover implanted. In Fiq. 17 there was a real hybrid application through the use of a heart occluder without a proximal cover and then an occluder with a proximal cover.
  • Tool arbor 1 Tool holder Tool arbor 2 Tool arbor 3 Intermediate plate 1 Cover 1

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un nouvel obturateur d'auricule multivalent de conception hybride, basé sur deux obturateurs d'auricule différents, l'un possédant un couvercle discoïde proximal et une seconde version étant dénuée de couvercle proximal. Les deux variantes d'obturateur fournissent chacune des solutions d'application pertinentes en soi. L'invention concerne en outre de multiples dispositifs universels spécifiés, composés de parties individuelles principalement symétriques en rotation pour produire ces différents obturateurs de LAA (LAA = auricule gauche) qui sont classés en différentes tailles, pour la fermeture à base de cathéter interventionnelle de l'auricule gauche. Des crochets orientés axialement et radialement soutiennent l'ancrage sûr et doux des obturateurs 1 dans la zone de retenue de l'auricule 26. Ainsi, l'utilisation de ports d'accès sensiblement plus petits dans l'application d'intervention est possible. Les deux variantes d'obturateur de l'auriculaire, avec et sans couvercle proximal 14, peuvent être insérées par le même orifice d'accès contrôlable et peuvent être implantées dans diverses tailles individuellement ou combinées, et également en tant que variante hybride de deux obturateurs, un sans couvercle proximal (14) et un avec un couvercle proximal (14) dans un seul et même auricule (24) tel que représenté sur la figure 17. Les deux variantes d'obturateur de l'auricule peuvent chacune être libérées pendant la phase d'implantation en trois étapes jusqu'à ce qu'elles soient complètement dépliées.
EP20842237.8A 2019-12-31 2020-12-29 Obturateur d'auricule pour fermer l'auricule gauche Pending EP4084702A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102019009091 2019-12-31
DE102020003145.5A DE102020003145A1 (de) 2019-12-31 2020-05-18 Hybrid Herzohr-Occluder zum Verschluss des linken Herzohres und Vorrichtung zur Herstellung
PCT/EP2020/087953 WO2021136764A1 (fr) 2019-12-31 2020-12-29 Obturateur d'auricule pour fermer l'auricule gauche

Publications (1)

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CN105246540A (zh) 2013-03-13 2016-01-13 阿龙·V·卡普兰 用于除去左心耳的装置和方法
JP7071350B2 (ja) 2016-10-27 2022-05-18 コンフォーマル・メディカル・インコーポレイテッド 左心耳を排除するためのデバイスおよび方法
CN116849750B (zh) * 2023-09-02 2023-11-21 杭州亿科医疗科技有限公司 一种可机械解脱的动脉瘤扰流装置

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US20090171386A1 (en) * 2007-12-28 2009-07-02 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
DE102012003021A1 (de) * 2011-02-15 2012-10-11 Acoredis Gmbh Membrangesteuertes Occlusionsinstrument zum Verschluss des linken Herzohrs
DE102015004535A1 (de) * 2015-04-02 2016-10-20 Acoredis Gmbh Modulare Occlusionsvorrichtung Zum Verschluss des linken Herzrohrs (left atrial appendage, LAA) und dessen Herstellung
DE102016012395A1 (de) * 2016-10-13 2018-05-03 Cormos Medical Gmbh LAA-Occluder zum Verschluß des linken Herzohrs

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DE102020003145A1 (de) 2021-07-01
CA3163559A1 (fr) 2021-07-08
US20220409211A1 (en) 2022-12-29
WO2021136764A1 (fr) 2021-07-08

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