WO2016155847A1 - Dispositif d'occlusion modulaire servant à fermer l'auricule gauche (appendice auriculaire gauche) et fabrication de ce dernier - Google Patents

Dispositif d'occlusion modulaire servant à fermer l'auricule gauche (appendice auriculaire gauche) et fabrication de ce dernier Download PDF

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Publication number
WO2016155847A1
WO2016155847A1 PCT/EP2015/069423 EP2015069423W WO2016155847A1 WO 2016155847 A1 WO2016155847 A1 WO 2016155847A1 EP 2015069423 W EP2015069423 W EP 2015069423W WO 2016155847 A1 WO2016155847 A1 WO 2016155847A1
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WIPO (PCT)
Prior art keywords
modular
occlusion device
atrial appendage
cover
proximal
Prior art date
Application number
PCT/EP2015/069423
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German (de)
English (en)
Inventor
Robert Moszner
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Acoredis Gmbh
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Publication of WO2016155847A1 publication Critical patent/WO2016155847A1/fr

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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
    • A61B17/12131—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
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A61B2017/00477—Coupling
    • 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

Definitions

  • LAA left atrial appendage
  • the present invention relates to a flexible modular intravascular occlusion device (occlusion device, occluder) for the interventional closure of the left atrial appendage.
  • LAA stands for left atrial appendage, a German left atrial appendage, and a manufacturing process for such an occlusion device.
  • a common occlusion device is brought into a defined starting shape by means of transformation and heat treatment and introduced into the cardiovascular system through a catheter or a sluice.
  • the catheter or sluice introduced from the right groin vein into the right atrium is transseptically punctured of the atrial septum into the left atrium of the heart.
  • the corresponding occlusion device is first drawn or loaded into the same from the distal end of a short sluice (loader, to German loader) by means of a corresponding insertion wire or insertion system, whereby the occlusion instrument assumes an elongate shape, which in its outer form passes through the cylindrical body the lock is determined.
  • the short sluice or loader is coupled to the proximal end of a long sluice and over the insertion wire in the
  • the occlusion device in the atrial appendage assumes its predetermined initial shape, is checked there for its anchoring by a slight movement and released. After only a few hours, first endothelial cells settle on the surface of the occluder. After about 12 weeks to 6 months, endothelialization is usually complete. This means that the surface of the Occluder is completely populated with a layer of endothelial cells.
  • Atrial fibrillation there is a stroke every ten seconds as a result of atrial fibrillation.
  • Atrial fibrillation of which about 40000-50000 of them suffer a stroke.
  • About one in four people over the age of 40 will be affected by atrial fibrillation during their lifetime. If the disease remains untreated, the risk of stroke increases up to 8 percent per year. This means that up to 8 out of every 100 people with atrial fibrillation get a stroke every year.
  • LAA occluders With the Percutaneous LAA Transcatheter Occlusion (PLAATO) device from EV3 Inc.) see also EP 1 852 141 A2), the left auricle was successfully closed in 2000 in approximately 100 patients. In particular, due to various perforations of the pericardium caused by located on the implant barbs, but there were no further applications. Starting from the PLAATO device, such closure systems are referred to as LAA occluders.
  • fixative according to WO 2007/140797 A1 with a polymer network preferably formed in the atrial appendage of the patient from a drainable poly-reaction mechanism for forming a frictional connection between the mesh of the occlusion device and the atrial appendage, ie the use of a plastic adhesive, is from a medical point of view differentiated and has not led to any practical deviations.
  • the bulging of the left auricle and friction between the occlusion devices and the pericardium can cause very painful inflammation of the pericardium.
  • the hooks used to fix the occlusion devices may cause perforation of the pericardial sac.
  • the risk of thrombosis due in part to the far left atrium protruding coupling at the proximal end of Occlusionsinstrumente is relatively high.
  • the Watchman device also has localization problems.
  • these devices have the disadvantage that the catheter is in its final position in the left atrial appendage due to its positioning in the left atrium in the direction of its longitudinal axis at an unfavorable angle to the position of the occlusion device, i. both axes are almost at right angles to each other. This positioning leads to significant disability during the course of implantation and can lead to perforation of the left pericardium by piercing the wall of the left atrial appendage.
  • the object of the invention is therefore to avoid the disadvantages described in the prior art and in particular to provide an improved, easily and safely implantable occlusion device.
  • Another object is a simple and cost-effective method for producing such an occlusion device.
  • the object is achieved by an occlusion device according to claim 1 and a manufacturing method according to claim 12.
  • Advantageous embodiments can be found in the dependent claims.
  • the occlusion device according to the invention for closing a cardiac ear comprises at least two modular parts.
  • Closure by the occlusion device is achieved by releasing the distal main body (distal modular unit) in the holding area of a cardiac ear by means of a suitable catheter or sheath.
  • An optimal localization is achieved by placing the guide wire in the middle of the device.
  • the geometry of the distal body is largely determined by the morphology of the auricle.
  • the proximal unit in shape, a narrow circular disc (lid), which is equally pushed over its central passage over the guide wire, placed in the left atrium and placed directly at the atrial appendage.
  • a narrow circular disc which is equally pushed over its central passage over the guide wire, placed in the left atrium and placed directly at the atrial appendage.
  • lids There are several differently sized lids available, they differ in their diameter and thickness.
  • the cover is then moved towards the base body by means of a slight thrust movement, the two mechanical coupling elements, located distally on the proximal modular unit and proximal on the distal modular unit, mechanically connect. This coupling also causes the lid and body to align axially independently according to the nature of the atrial appendage.
  • a membrane located at the distal end of the distal base body is able to realize a certain length compensation.
  • the membrane preferably has a longitudinal structure on its lateral side and a mesh or lattice structure on its front side.
  • the front side thus enables a stable cover (stamping function).
  • the lateral sides are very easy to compress in length and indeed by a slight pressure on the distal end region or twist only to reduce the longitudinal strain.
  • the diaphragms arranged above or behind one another act mechanically like a spring (but the spring action can also be achieved by other design adaptations), which contract by a slight axial pressure.
  • the Occiusionsinstrument fits exactly to the depth of the heart ear, which is different for each cardiac ear, regardless of the diameter of the Herzohreingang, which in turn decisively supports the firm anchoring of the occlusion device in the auricular region. It has been found that different heart ears differ significantly from one another by an individual morphology. In particular, the ratio of atrial appendage diameter divided by the length of the atrial appendage is not a constant. This means that atrial ears with a comparable atrial appendage (diameter) can be different in depth (length).
  • the Occiusionsinstrument present here has a corresponding membrane, which causes at a lower reaction force from the direction of the distal Herzohrendes that the Occiusionsinstrument can reduce in length, so that the located at the opposite proximal end lid the Herzohreingang exactly closes, but in turn ultimately only possible because the coupling located between the cover and body causes additional length compensation and compensated by the possible inclination of the lid a corresponding deviation of the longitudinal axes of the lid and body.
  • the basic form of a cardiac ear occlusion instrument results from the basic conditions of the anatomy of such a cardiac ear. Based on this, a classification into three different types of heart ear is possible:
  • the diameter of the Herzohreingang is smaller than the largest diameter in the Herzohr (type Collar).
  • the diameter of the Herzohreingang is larger than the largest diameter in the subsequent Herzohr (funnel-shaped Herzohr).
  • the diameter of the Herzohreingang is about the same size as in the behind the Herzohr (tubular Herzohr).
  • the occlusion device used in the present invention is able to realize, as far as possible, the closure of all the types of auricular ear listed above, from the combination of different and two independent coupling systems with a corresponding base body.
  • the modular intravascular closure device for the left auricle is universally applicable. This mode of action significantly distinguishes the occlusion device according to the invention from all previously known occlusion devices.
  • An exemplary occlusion device composed of the modular units is rotationally symmetrical in its basic form and has a circular flat stepped lid at the proximal end in order to close off the transition of the left atrium to the entrance of the left atrial appendage.
  • a diameter reduction results initially, which corresponds approximately to the diameter of the atrial appendage.
  • the circumference of the Occiusionsinstruments increases such that the volume of the Occiusionsinstruments in this central area approximately fills the corresponding part of the cardiac ear with the largest inner diameter.
  • the occlusion device is compressed to approx. 12% of the diameter in this area due to an external pressure effect from the atrial appendage.
  • the lid preferably has a z. B. arranged in the center of the coupling, which is formed at the proximal end as a ball to be connected to a suitable insertion system.
  • the intravascular occlusion device is designed so that the occlusion device in the folded state by means of a catheter in the body of the patient is minimally invasive insertable and positionable in the heart of the patient via the modular units in two stages.
  • the catheter inserted into the left atrium is usually at an acute angle to the direction of the atrial appendage.
  • the occlusion Instrument closes flush with its lid the Herzohreingang (ie exactly in the direction of the catheter).
  • the first coupling between the insertion system and the cover enables a first axial directional compensation and the second time (if necessary) via the second coupling to connect the modular units cover and body.
  • a preferred occlusion device is self-expandable, is lasered from a nit-inol tube and then converted by suitable shaping and heat treatment process in a targeted final form.
  • hook elements with a length of approximately 3 mm each on the outer shell of the exemplary occlusion device, more preferably in the transition of the proximal retention area to the distal retention area or in the area of the atrial appendage, which firmly anchor the occlusion instrument in the left auricle can support.
  • the production of the barbs is done so that lasered transverse webs are lasered at one longitudinal end and then placed in the radial direction by bending. The positioning and / or the short length of the barbs prevents perforation of the cardiac pouch.
  • Atrial appendage with a diameter of 10 to 26.5 mm in the atrial appendage and a usable depth of the main canal of the pectoralis of 14 to 30 mm, suitably stepped sizes of suitable cardiac appendage instruments are obtained From an example suitable metallic nitinol tube lasered Occlusionsinstrument compressed in the compressed state.
  • Superelastic metal alloys such as nitinol, a titanium-nickel alloy with an elasticity of 7% maximum elongation to the initial length are particularly well suited to produce such a shaped body.
  • nitinol a titanium-nickel alloy with an elasticity of 7% maximum elongation to the initial length are particularly well suited to produce such a shaped body.
  • nitinol a titanium-nickel alloy with an elasticity of 7% maximum elongation to the initial length are particularly well suited to produce such a shaped body.
  • nitinol a titanium-nickel alloy with an elasticity of 7% maximum elongation to the initial length are particularly well suited to produce such a shaped body.
  • a thin-walled nitinol tube of 1 to 3.5 mm in diameter is used.
  • the heat treatment time is feasible at temperatures of 350 to 600 ° C and a holding time of half an hour to 2 minutes (the shorter times at higher temperatures).
  • one or more layers of medically suitable and / or medically active materials are preferably located in the region of the atrial appendage, eg. As patches to seal the blood flow between the left atrium and the left atrial appendage so that it can no longer pass through the heart ear in the direction of the left atrium.
  • a material is z.
  • Dacron under the chemical name PET (polyethylene terephthalate), suitable.
  • Fig. 1 (a) is a schematic representation of the front view of the modular units lid and body according to the invention
  • Fig. 1 (b) is a schematic representation of the front view of the occlusion device according to the invention, according to FIG. 1 (a);
  • Fig. 2 (a) is a schematic representation of the front view of the modular units basic body and varied lid according to the invention
  • Fig. 2 (b) is a schematic illustration of the front view of the lidded occlusion instrument of the invention shown in Fig. 2 (a);
  • Fig. 3 (a) is a schematic view of the front view of the modular units basic body and reduced lid according to the invention.
  • Fig. 3 (b) is a schematic front elevational view of the reduced cover occlusion device of Fig. 3 (a) according to the present invention
  • Fig. 4 (a) is a schematic representation of the front view of the occlusion device according to the invention according to FIG. 1 (a) and 1 (b); a schematic representation of the bottom view of Occlusionsinstruments invention Fig. 1 (a) and Fig. 1 (b);
  • FIG. 1 a schematic partial sectional view of the left atrium with atrial appendage during a first phase of the invention to be implanted LAA occluder in the left atrial appendage;
  • FIG. 7 a schematic partial sectional view of the left atrium with atrial appendage of Figure 7 (a) with released main body in the left auricle.
  • FIG. 10 a schematic partial sectional view of the side view of another phase of the invention to be implanted LAA occluder in the connection of Figure 10 (a) with the lid left in the left atrium.
  • FIG. 13 (a) a plan view of the coupling elements of FIG. 13 (a);
  • FIG. 11 a schematic representation of a lateral section of the latched according to the detail views Fig. 11 (a) and (b) coupling of an occlusion device according to the invention
  • FIG. 10 a schematic partial sectional view of the side view of FIG. 10 (c) subsequent implantation phase of the LAA occluder to be implanted with retracted lock and uncoupled delivery system;
  • FIG. 15 a schematic partial sectional view of the side view of FIG. 15 (a) subsequent implantation phase of the LAA Occluders to be implanted with returned insertion wire;
  • FIG. 15 a schematic partial sectional view of the side view of an implantation according to Figure 15 (b) subsequent implantation with further return of the lock or catheter and completion of the implantation process; a schematic partial sectional view of the side view of an implantation process according to the invention LAA Occluders according to the invention in the left atrial appendage, but with a funnel-shaped atrial appendage and thus enlarged cover according to FIG. 15 (c);
  • LAA Occluders with coupled delivery system LAA Occluders with coupled delivery system
  • FIG. 8 (a) a further schematic representation of the occlusion device shown in Fig. 8 (a) with the coupled delivery system; a schematic representation of the partial view of the coupling of Figure 8 (a).
  • FIG. 17 a sectional view of the schematic view of the side view in the area coupled insertion system at the proximal end of the lid (ball coupling) to the distal end of the lid with another smaller ball coupling of FIG. 17 (a) for Coupling to the main body of another Occlusionsinstruments invention;
  • Fig. 21 (b) is a sectional view of the detailed view of the coupling elements located at the proximal end of the main body for coupling to the main body according to Fig. 21 (a) and
  • Fig. L (ab) show a schematic representation of a first preferred embodiment of Occluders invention (Occiusionsinstrument) (1) with the corresponding modular units (21) as shown in Fig. 1 (a) with a correspondingly suitable cover (2) and the Spherical modular unit of the main body (3) with the diaphragm (27) located on the distal end (11) for axial length compensation and in the coupled state according to FIG. 1 (b).
  • Occluders invention Occiusionsinstrument
  • FIGS. 2 (a-b) and 3 (a-b) embody further embodiments of the modular series of a specific size of the modular unit of the base body (3) with differently sized cover units (2). Due to different sized heart ears (5), the main body (3) are also sized in different sizes.
  • FIG. 4 (a-b) it can be seen in the lower view (15) in FIG. 4 (b) that the membrane (27) has a circular opening (44) at the distal end (11).
  • laser elements with a longitudinal structure (36) are preferably used for shaping the membrane (27) and laser elements with mesh or lattice structure (37) for stabilization at the distal end of the membrane (27).
  • FIG. 5 (c) makes the basic body unit (3) oval, as shown in the bottom view (15), and thus a further embodiment according to the invention represents.
  • hook elements (26) formed on the outer periphery of the base body (3).
  • these hooks (26) are bent back to the occluder longitudinal axis by a little more than 180 °.
  • this makes it possible to transport the occluder (1) in the sluice or catheter (31) in both directions without the hooks (26) being able to settle in the inner wall of the sluice or of the catheter.
  • a perforation of the pericardium is almost impossible.
  • the occluder (1) is in each case two patches (25) made of PET, as shown, for example, in the first embodiment according to the invention FIG. 1 (a-b).
  • a preferred embodiment according to the invention of the occluder (1) Fig. L (ab) to Fig. 5 (ac) is materially constructed so that the modular units base body (3) and lid (2) consists essentially of a suitable metallic material and preferably of nitinol , a titanium-nickel alloy. Both base body (3) and lid (2) are produced from a nitinol tube by using and combining suitable laser and heat treatment processes. provides. In a first laser processing step, corresponding cuts are made in the wall of the nitinol tube with a suitable laser. The laser cut image is projected from the unwinding of the outer cylinder of the Nitinol tube (3D) onto a surface (2D).
  • the 2D cut pattern (laser construction) is projected back onto the outer contour of the Nitinol tube in the "3D space".
  • a 3D laser processing center then brings the pattern into the Nitinol tube for the base body (3) or cover (2) in a form-fitting manner in one machining step.
  • a 1.5 to 2 mm short tube section remains free from the laser production.
  • the cover (2) is now moved as follows:
  • the mounting pins (34), (35) are also made of Nitinol and are fixed by laser welding to the proximal end tube piece from the proximal end (9) of the lid (2).
  • the ball coupling I (22) is made of medical-approved stainless steel for technological reasons, since the process ball grinding hardly can be technically realized with the material Nitinol.
  • Fig. 21 (ab) and Fig. 22 all metallic parts are replaced by bioresorbable materials.
  • biodegradable synthetic polymers can be used: a) polyesters, such as poly (lactic acid) PLA, poly (glycolic acid) PGA, poly (3-hydroxybutyric acid) PBA, poly (4-hydroxyvaleric acid) PVA or poly (s-caprolaton) PCL or corresponding copolymers, b) polyanhydrides which consist of dicarboxylic acids such as. For example, glutaric, succinic or sebacic acid are formed o- c) poly (amino acid) s or polyamides such. As poly (serine ester) or poly (aspartic acid). These biodegradable materials or polymers contain fissile bonds under physiological conditions, such as amide, ester or acetal bonds.
  • polyesters such as poly (lactic acid) PLA, poly (glycolic acid) PGA, poly (3-hydroxybutyric acid) PBA, poly (4-hydroxyvaleric acid) PVA or poly (s-caprolaton) PCL or corresponding copolymers
  • amorphous polyurethane copolyester polymer networks with shape memory properties with a glass transition temperature T g between 48 and 66 ° C are used.
  • T g glass transition temperature
  • biodegradable shape memory polymers based on covalent networks based on oligo ( ⁇ -caprolactone) dimethacrylate and butyl acrylate are known (A. Lendlein, A. M. Schmidt, R. Langer, Proc. Natl.
  • the network synthesis is done by photopolymerization.
  • the molar mass of the macromolecular oligo ( ⁇ -caprolactone) dimethacrylate and the comonomer n-butyl acrylate content can be used to control the switching temperature and mechanical properties of the covalent network.
  • biodegradable shape-memory polymer networks for the novel be made modularly shaped Herzohroccluder.
  • the modular Herzohroccluder can be produced by generative manufacturing processes, in particular two methods are suitable, on the one hand, the stereolithography (SL) and on the other hand, the printing (2D or 3D).
  • layered liquid resin monomers are cured by photopolymerization and cured by irradiation by means of a laser (laser scanner method) or high-performance beamer or UV lamp (mask method).
  • the molding is made by solidification due to photopolymerization of commercially available monomers which may contain other additives and fillers.
  • Particularly suitable as polymerizable resin monomers are mixtures of monofunctional or polyfunctional acrylates or methacrylates which rapidly cure upon irradiation in the presence of suitable free-radical-forming photoinitiators by radical polymerization.
  • mono- or polyfunctional (meth) acrylates are methyl, benzyl, tetrahydrofurfuryl or
  • FIG. 6 we find a schematic representation of the left ear (5) of the type Collar, as described above. About 70% of all types of heart ear conform to this form. It is characteristic that the diameter of the Herzohreingangs (6) is smaller than the diameter (8) of the holding portion (7) of the atrial appendage (5).
  • FIGS Fig. 22 can be used.
  • the interventional atrial appendage closure is based on a venous, transseptal approach, via which a self-expanding device is introduced into the LAA after fluoroscopic imaging. Preoperatively, the patient is treated with antiplatelet or anticoagulant substances.
  • the occlusion device After puncturing the femoral vein, we advanced the occlusion device over the right atrium with the aid of a feeder system and into the left atrium after a transseptal puncture and finally released it from the sluice at the LAA. In this case, the distal spherical body expands in the LAA, while the proximal lid seals the entrance of the LAAs from the outside. After checking the positioning in the LAA, the occluder can be decoupled from the feeder system. The entire procedure is under constant TEE control, with the patient in mild anesthesia (sleep state, where respiratory and circulatory functions are kept stable). To avoid thrombi, anticoagulants (blood thinning medication) must be taken postoperatively, initially for 24 hours. After complete endothelialization, a 6-month dose of ASA and / or clopidogrel is required. This serves to avoid blood clot formation. Optionally, the patient is examined echocardiographically at defined intervals.
  • the lock system with the dilator is guided over the guide wire into the atrial appendage.
  • the dilator and guide wire are removed from the atrial appendage. Since the atrial appendage is not yet occluded, this early return of the guidewire is especially problematic because thrombi can be expelled during this return procedure, which can lead to a stroke.
  • the guide wire (29) remains in place during the entire implantation procedure left atrial appendage (5).
  • Fig. 7 (a) we see an early stage of implantation of the occluder (1). It can be seen the guide wire (29) with the distal end (11) in the heart ear.
  • the lock or catheter (31) comes from the left atrium (4), wherein the distal end of the lock (31) is also placed in the LAA (5).
  • the lock (31) and the insertion system (30) located therein run centrally over the guide wire (29).
  • the delivery system (30) is firmly connected to the distal modular base body (3), which already partially unfolds in the retention area of the atrial appendage (7).
  • Fig. 8 (a) is a detail view of the gripper (pliers system) (32) at the distal end of the delivery system (30).
  • Fig. 8 (b) is a further detail view of the proximal end (9) tied to the delivery system (30) as shown in Fig. 9.
  • FIG. 10 (a) the base body (3) is already released in the atrial appendage (5), the guide wire (29) still remaining in the base body (3). Further, in Fig. 10 (a), the lid (2) is partially released in the left atrium (4). By the guide wire (29) cover (2) and body (3) remain in an axial connection. After the lid (2) is completely released in Fig. 10 (b), the lid (2) and base body (3) can be connected to each other by a slight pushing movement.
  • the coupling elements at the distal end of the cover from FIG. 11 (a) and detail view in FIG. 12 (ab) connect to the coupling part II (cover / main body) (23) according to FIG. 11 (b) and detailed view in FIG. 13 (ab), as can be seen in the end position in FIG. 14.
  • Fig. 15 (a-c) the individual operations for removing the lock (31), the uncoupling of the insertion system (30) and the lead out of the guide wire (29) are shown schematically.
  • Fig. 15 (a) first, the sluice (31) is returned a little from the occlusion device (1) and the delivery system (30) is separated from the occluder.
  • the guidewire (29) is in the atrial appendage (5).
  • the occluder (1) aligns in the end position and, according to FIG. 15 (b), the guide wire (29) can now likewise be guided into the sheath (31) outside the patient.
  • Fig. 15 (c) finally, the lock (31) is returned.
  • the implantation process is virtually complete.
  • Fig. 16 (a) we see a modular LAA occluder (1) for a funnel-shaped heart ear (5)
  • Fig. 16 (b) a heart ear (5) type collar with a very small diameter of the atrial appendage (6)
  • 16 (c) shows a specific form of a cardiac ear (5) into which a modular basic body (3) without a cover (2) has been implanted.
  • LAA Occluders (1) with a ball coupling I (insertion / lid) (22) and another ball coupling III (cover / body) (24) with an even larger Mobility between cover (2) and body (3).
  • a first implantation step first the insertion system (30) and the base body (3) must be connected again, as shown in FIG. 20.
  • the cover (2) with integrated ball coupling type III cover / main body (24) in still separated state Fig. 21 (ab) cover (2) and body (3) coupled as shown in Fig. 22 can be seen.
  • Occiusionsinstrumenten (1) with the type ball coupling III (24) also continuous through holes (38) are involved.
  • the guide wire (29) remains in the atrial appendage (5) until the end of the implantation procedure.
  • a high flexibility of the delivery system (30) is achieved in the coupled state to the Occluder (1), as shown schematically in Fig. 19 (ab).
  • the tilt angle 2 (42) through the ball coupling (22) in the transition transition insertion system (30) and Lid (2) and the tilt angle of the controllable lock (catheter) (31) results in an angle of more than 180 °, which has a significantly more positive effect on a more effective implantation process.
  • LAA left auricular

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Abstract

L'invention concerne des dispositifs de fermeture modulaires intravasculaires (1) servant à traiter des anomalies dans le cœur d'un patient, en particulier à fermer l'auricule (5) gauche, l'instrument d'occlusion (1) se composant d'au moins deux unités modulaires (21), l'unité modulaire proximale (couvercle) (2) fermant l'entrée de l'auricule (6) à partir de l'atrium gauche (4) et au moins une unité modulaire distale (corps de base) (3) étant positionnée dans la zone de retenue de l'auricule (5) et ancrée solidement dans l'auricule (5) par des crochets (26) correspondants. Le couvercle (2) et le corps de base (3) sont fabriqués principalement par un procédé d'usinage laser adapté. Les matériaux utilisés sont du métal ou des alliages de métal comme par exemple le nitinol ou sont faits de matières plastiques non résorbables choisies dans le groupe des polyesters, des polyamides, des polyoléfines, des polyuréthanes et des polyhalogénoléfines ou des polymères biorésorbables utilisés comme polyesters tels que le poly(acide lactique) PLA, le poly(acide glycolique) PGA et d'autres polyester, polyanhydrides et acides polyamiques comprenant des liaisons clivables telles que des liaisons amide, ester ou acétal et l'enveloppe passée au laser (33) et les patchs (25) présentent une durée de dégradation comprise entre 5 et 50 semaines.
PCT/EP2015/069423 2015-04-02 2015-08-25 Dispositif d'occlusion modulaire servant à fermer l'auricule gauche (appendice auriculaire gauche) et fabrication de ce dernier WO2016155847A1 (fr)

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DE102015004535.0A DE102015004535A1 (de) 2015-04-02 2015-04-02 Modulare Occlusionsvorrichtung Zum Verschluss des linken Herzrohrs (left atrial appendage, LAA) und dessen Herstellung
DE102015004535.0 2015-04-02

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WO2018069523A1 (fr) * 2016-10-13 2018-04-19 Cormos Medical Gmbh Dispositif d'occlusion pour la fermeture de l'auricule cardiaque gauche
CN108567461A (zh) * 2018-03-13 2018-09-25 刘金伟 一种非对称双盘状左心耳封堵器
CN111920460A (zh) * 2020-07-23 2020-11-13 广东脉搏医疗科技有限公司 一种混编封堵器
CN112022246A (zh) * 2020-11-06 2020-12-04 上海介入医疗器械有限公司 一种左心耳封堵器及其使用方法
WO2021136764A1 (fr) * 2019-12-31 2021-07-08 Cormos Medical Gmbh Obturateur d'auricule pour fermer l'auricule gauche
CN114027914A (zh) * 2021-08-24 2022-02-11 上海形状记忆合金材料有限公司 一种编织的单铆可降解植入器械
CN114145802A (zh) * 2021-12-06 2022-03-08 东南大学泰州生物医药与医疗器械研究院 左心耳封堵器成形工装及制作工艺
WO2022148135A1 (fr) * 2021-01-05 2022-07-14 先健科技(深圳)有限公司 Appareil d'occlusion

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US11534175B2 (en) 2020-01-28 2022-12-27 Medtronic, Inc. Modular left atrial appendage closure

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018069523A1 (fr) * 2016-10-13 2018-04-19 Cormos Medical Gmbh Dispositif d'occlusion pour la fermeture de l'auricule cardiaque gauche
CN108567461A (zh) * 2018-03-13 2018-09-25 刘金伟 一种非对称双盘状左心耳封堵器
WO2021136764A1 (fr) * 2019-12-31 2021-07-08 Cormos Medical Gmbh Obturateur d'auricule pour fermer l'auricule gauche
CN111920460A (zh) * 2020-07-23 2020-11-13 广东脉搏医疗科技有限公司 一种混编封堵器
CN112022246A (zh) * 2020-11-06 2020-12-04 上海介入医疗器械有限公司 一种左心耳封堵器及其使用方法
WO2022148135A1 (fr) * 2021-01-05 2022-07-14 先健科技(深圳)有限公司 Appareil d'occlusion
CN114027914A (zh) * 2021-08-24 2022-02-11 上海形状记忆合金材料有限公司 一种编织的单铆可降解植入器械
CN114027914B (zh) * 2021-08-24 2024-04-12 上海形状记忆合金材料有限公司 一种编织的单铆可降解植入器械
CN114145802A (zh) * 2021-12-06 2022-03-08 东南大学泰州生物医药与医疗器械研究院 左心耳封堵器成形工装及制作工艺
CN114145802B (zh) * 2021-12-06 2023-07-14 东南大学泰州生物医药与医疗器械研究院 左心耳封堵器成形工装及制作工艺

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