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    • 专利摘要:
    The biological valve treatment device (10) includes: - an implant (12) having a proximal sleeve (14), deployable between a retracted configuration and an expanded configuration, and including a plurality of proximal arms (32) for resting on a face of a leaflet (18) or on a ring (17) of the valve, - a release tool (14) of the implant (12), the implant (12) being mounted in the release tool (14) in its retracted configuration. The device (10) comprises a push member (16) of the valve leaf face (18) away from a free end of the proximal arms (32), movable relative to the implant (12) maintained in its retracted configuration in the release tool (14) between a retracted position and an advanced thrust position of the face of the sheet (18).
    公开号:FR3058632A1
    申请号:FR1660976
    申请日:2016-11-14
    公开日:2018-05-18
    发明作者:Eric Perouse
    申请人:LABORATOIRES INVALV；
    IPC主号:
    专利说明:

    058 632
    60976 ® FRENCH REPUBLIC
    NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY © Publication number:
    (to be used only for reproduction orders)
    ©) National registration number
    COURBEVOIE © Int Cl 8 : A 61 F2 / 24 (2017.01)
    PATENT INVENTION APPLICATION
    A1
    ©) Date of filing: 14.11.16. © Applicant (s): LABORATOIRES INVALV Company by ©) Priority: simplified actions - FR. @ Inventor (s): PEROUSE ERIC. ©) Date of public availability of the request: 18.05.18 Bulletin 18/20. ©) List of documents cited in the report preliminary research: Refer to end of present booklet (© References to other national documents ® Holder (s): LABORATOIRES INVALV Company by related: simplified actions. ©) Extension request (s): ©) Agent (s): LAVOIX.
    (04) DEVICE FOR TREATING A BIOLOGICAL VALVE WITH A VALVE PUSHING MEMBER.
    FR 3 058 632 - A1
    This device (10) for processing a biological valve comprises:
    an implant (12) comprising a proximal sleeve (14), deployable between a retracted configuration and a deployed configuration, and comprising a plurality of proximal arms (32) intended to bear on one face of a sheet (18) or on a ring (17) of the valve,
    - a release tool (14) of the implant (12), the implant (12) being mounted in the release tool (14) in its retracted configuration.
    The device (10) comprises a pushing member (16) of the face of the valve sheet (18) away from a free end of the proximal arms (32), movable relative to the implant (12) held in its retracted configuration in the release tool (14) between a retracted position and an advanced position for pushing the face of the sheet (18).
    44.56 '54 60 ;
    Device for treating a biological valve with valve thrust member
    The present invention relates to a device for treating a biological valve comprising an implant comprising a proximal sleeve, deployable between a retracted configuration and a deployed configuration, intended to be disposed in a blood circulation passage delimited by the valve, the proximal sleeve comprising a proximal tubular body and a plurality of proximal arms, each extending between a first end connected to the tubular body, and a second free end intended to rest on a first face of a leaflet of the valve or on a ring of the valve, and an implant release tool, extending longitudinally along a central axis between a proximal end and a distal end, the implant being mounted in the release tool in its retracted configuration.
    The implant is in particular intended to replace a native heart valve, in particular a mitral valve. In the case of a mitral valve, the implant is intended to be placed in a blood passage of an atrioventricular valve of a human or animal heart.
    During systole, the blood flow between the left atrium and the left ventricle of the heart is interrupted by the closure of a native heart valve present in a mitral system. This valve ensures an unequivocal circulation of the blood flow, avoiding a reflux at the end of the ventricular contraction.
    The mitral apparatus includes a mitral ring, two valve leaflets connected to this ring, and a subvalvular apparatus comprising ropes and pillars. The valve leaflets include an anterior leaflet, also called a "large mitral valve", and a posterior leaflet, also called a "small mitral valve".
    The connecting part of the ring with the large mitral valve is fibrous, while the connecting part of the ring with the small mitral valve is muscular. The small and large mitral valves are connected to the ventricular part by ropes, themselves connected to the pillars. In diastole, the two sheets open to clear the passage between the atrium and the left ventricle.
    In systole, ventricular contraction causes a sudden rise in left intraventricular pressure, causing blood to flow through the aortic valve. Simultaneously, the contraction of the pillars and the tensioning of the ropes cause the sheets to join together, so as to sealingly isolate the left atrial and ventricular cavities.
    However, the valvular and subvalvular apparatus can be affected by various pathologies and in particular degenerative diseases responsible for regurgitation and mitral insufficiency.
    Chronic mitral insufficiency is responsible for dilation of the left ventricle and impaired ventricular function. In order to avoid this serious progression to heart failure, a restoration of valve continence is necessary.
    The restoration of the valve function is done by a valve replacement, by implanting an artificial valve prosthesis in the atrioventricular orifice. This implantation can be surgical or transcatheter.
    Transcatheter valve implantation is a less invasive technique than surgical valve replacement and can be offered to patients at high surgical risk. In the case of a transcatheter solution, the implant comprises for example a deployable tubular endoprosthesis and a flexible obturator made of a tissue of animal origin. The flexible obturator is permanently fixed in the stent.
    An example of an implant is described in document WO 2014/170463.
    Such an implant comprises a central body provided with a plurality of atrial arms (also called "distal arms >>), and a plurality of ventricular arms (also called" proximal arms >>) arranged opposite the atrial arms to pinch the mitral ring, by resting on the atrial side of the leaflets of the native valve by plicuring it. The ventricular arms are formed by hooks arranged at the ventricular end of the armature and folded back towards the atrial end. The atrial arms are formed by V-shaped loops extending opposite the ventricular arms, in the vicinity thereof, but departing from the armature and the atrial arms.
    The ends of the ventricular arms and the atrial arms are arranged apart from each other and are engaged respectively on an atrial side and on a ventricular side of the mitral ring.
    Note that the installation of a mitral implant to replace the native valve can be performed through the atrial cavity, or alternatively through the ventricular cavity. This installation is generally carried out using a suitable release tool. The structure of this release tool can be different depending on the side (atrial or ventricular) through which we pass to perform this installation.
    The mitral valve implantation procedure and in particular the capture of native valve leaflets between the proximal and distal arms can prove to be difficult to perform and therefore cause the implantation to fail.
    In particular, positioning the valve leaflets within the reception space created by all of the ventricular arms can be difficult to achieve. As a result, part of the valve tissue may be located outside the receiving space.
    The purpose of the invention is in particular to facilitate the installation of a mitral implant, in particular by ensuring a very effective fixing of the implant on the native valve leaflets.
    To this end, the subject of the invention is in particular a treatment device, characterized in that the device comprises a thrust member for the first face of the valve sheet away from the free end of the proximal arms, the pushing member being movable in the direction of the central axis relative to the implant maintained in its retracted configuration in the release tool between a retracted position and an advanced pushing position of the first face of the valve sheet.
    A device according to the invention may also include one or more of the following characteristics, taken in isolation or in any technically conceivable combination:
    - The thrust member comprises at least one deployable element, radially relative to the central axis of the release tool between a contracted state and a deployed state, the deployment of the deployable element being independent of the deployment of the implant;
    - the deployable element in its deployed state comprises an external thrust face directed perpendicularly or away from the central axis of the release tool;
    the proximal arms are movable radially between a configuration contracted in the release tool and a configuration deployed radially outside the release tool, the deployable element in its deployed state being received between or in front of the proximal arms in their radially deployed configuration;
    - the deployable element comprises at least one inflatable lateral balloon regardless of the configuration of the implant;
    - The pushing member comprises at least two lateral balloons distributed symmetrically on either side of the central axis of the release tool;
    - the lateral balloons are capable of being inflated independently or simultaneously;
    the pushing member comprises a deformable hollow tubular external sheath extending to a distal end and having longitudinal slots distributed circumferentially, each pair of adjacent slots delimiting a deployable element, the pushing member comprising a rigid internal rod disposed inside the external sheath and connected to the distal end of the external sheath, the external sheath being movable along the central axis relative to the internal rod to deploy the deployable elements by the displacement of the internal rod by relation to the outer sheath;
    - the number of deployable elements is greater than or equal to two;
    - a central balloon extending along the central axis of the release tool;
    - The pushing member comprises an internal rod, of the same axis as the central axis of the release tool, inserted in the release tool, the deployable element being mounted at a distal end of the internal rod;
    - The release tool comprises a tubular outer sheath movable relative to the proximal sleeve between a position for covering the proximal arms and a position for releasing the proximal arms, the pushing member being movable independently of the sheath;
    - The implant comprises a distal sleeve deployable between a retracted configuration and a deployed configuration intended to be disposed in the blood circulation passage, comprising a distal tubular body suitable for inserting into the proximal tubular body of the proximal sleeve of the implant;
    the distal sleeve comprises a plurality of distal arms each extending between a first end linked to the distal tubular body and a second free end intended to be applied to a second face of a sheet of the valve opposite to the first face, or on the valve ring;
    - The central ball comprises an angular orientation device, comprising several marks, made of radiopaque material, each mark being intended to have an angular position, around the central axis of the implant, fixed relative to the implant , when installing the implant;
    the implant comprises a proximal sleeve, deployable between a retracted configuration and a deployed configuration, the proximal sleeve comprising a proximal tubular body and a plurality of proximal arms, each extending between a first end linked to the proximal tubular body, and a second free end intended to rest on a first face of a leaflet of the valve or on a ring of the valve, and a distal sleeve, deployable between a retracted configuration and a deployed configuration, intended to be assembled with the proximal sleeve to form a tubular reinforcement when the proximal sleeve and the distal sleeve are assembled, each in the deployed configuration, the distal sleeve comprising a distal tubular body and a plurality of distal arms intended to bear on a second face of the valve sheet and / or the ring, so that the valve leaflet or / and the ring are pinched between the proximal arms and the distal arms;
    - Each proximal arm projecting radially away from the proximal tubular body and defines a space for receiving the valve sheet delimited by the proximal arm, without participation of the tubular frame when the proximal sleeve and the distal sleeve are assembled;
    - the linked end of each proximal arm is linked to the distal edge of the proximal sleeve;
    each proximal arm extends along an axis substantially perpendicular to the central axis of the proximal sleeve, in the absence of stress on the proximal arm, each proximal arm preferably having an angle of between 85 ° with the central axis of the proximal sleeve and 95 °, in the absence of stress on the proximal arm;
    - the free end of each proximal arm is disposed beyond a distal edge of the proximal tubular body;
    - the reception space is configured to prevent a valve sheet received in the reception space from coming into contact with the proximal tubular body of the proximal and distal sleeve;
    the receiving space is defined by the proximal arm between its linked end and its free end, and in particular in an intermediate region of the proximal arm defining a gutter for receiving a valve sheet, the gutter having a concave shape in hollow, the gutter being located radially away from the proximal tubular body;
    - the gutter has a U shape opening axially in a distal direction;
    - The gutter has a bottom, delimited between two parts of the intermediate region;
    - The bottom of the gutter is located beyond a distal edge of the proximal tubular body, along the central axis of the proximal sleeve;
    - Each distal arm has a convex region, intended to be attached to the groove of the proximal arm on which the distal arm is attached;
    - the proximal sleeve has an odd number of proximal arms;
    - the proximal arms are not diametrically opposite;
    - the proximal sleeve has, when it is separated from the distal sleeve, and in the absence of external stress, a diameter smaller than that of the distal sleeve in the absence of external stress;
    - The distal tubular body has a cross section at the proximal edge, greater than its cross section at the distal edge; this progressive increase in diameter being intended to ensure permanent clamping of the distal edge of the proximal tubular body towards the distal edge of the distal tubular body; and
    - the proximal sleeve has rods configured to be fixed in the distal sleeve, once assembled one to the other, these rods being intended to ensure the attachment of the proximal sleeve to the distal sleeve.
    The invention also relates to a method of treating a biological organ with a treatment device described above, comprising the following steps:
    - insertion of the release tool into the biological organ,
    - displacement of the pushing member relative to a first face of a biological tissue of the biological organ,
    - deployment of the deployable element until its deployed configuration,
    - pushing of the first face of the fabric in the central axis of the release tool to a retracted position of the first face of the fabric, by means of the pushing member,
    - maintaining the first face of the fabric in the retracted position,
    - deployment of the proximal arms of the implant, advantageously halfway between the insertion of the ropes and the papillary muscles,
    - displacement of the implant to the vicinity of the first face of the tissue, and
    - bringing the proximal arms of the implant into contact with the first face of the tissue,
    - contraction of the pushing member in its contracted configuration.
    The method according to the invention may also include one or more of the following characteristics, taken in isolation or in any technically conceivable combination:
    - the pushing of the first face of the tissue creates a deployment zone for the proximal arms of the implant;
    - The method comprises a step of radial pushing of the valve sheets in the gutter by the pushing member, during which the deployable element is deployed in the deployed configuration, so that the deployable element pushes the valve sheets in the gutters of the proximal arms;
    - the sheets housed in the gutter form a sealing rod around the tubular frame.
    The invention will be better understood on reading the description which follows, given solely by way of example, and made with reference to the appended figures, among which:
    - Figure 1 is a schematic profile view of an implant disposed in a blood circulation passage, in a native mitral valve;
    - Figure 2 is a schematic perspective view of the release tool according to a first embodiment of the invention;
    - Figure 3 is a schematic perspective view of the device according to the first embodiment in which the deployable elements of the pushing member and the proximal sleeve are deployed;
    - Figure 4 is a schematic perspective view of the first embodiment of the thrust member in which the deployable elements are in the contracted state;
    - Figure 5 is a schematic perspective view of the first embodiment of the thrust member in which the deployable elements are in the deployed state;
    - Figure 6 is a schematic view, in axial section, of the thrust member, in which the deployable elements are between the deployed state and the contracted state;
    - Figures 7 to 11 schematically show, in axial section, a treatment device according to the first embodiment, shown in different phases of release of the implant;
    - Figure 12 is a schematic perspective view of the release tool according to a second embodiment of the invention;
    - Figures 13 to 15 schematically show, in axial section, a treatment device according to the second embodiment, shown in different phases of release of the implant;
    - Figures 16 and 17 are schematic views of the processing device according to two other embodiments of the invention;
    - Figure 18 is a schematic view, in axial section, of the thrust member according to another embodiment of the invention;
    - Figure 19 is a side view of the proximal sleeve of the implant of Figure 1;
    - Figure 20 is a top view of the proximal sleeve of the implant of Figure; and,
    - Figure 21 is a side view of the distal sleeve of the implant of Figure 1.
    There is shown in the figures a device 10 for treating a biological organ, for example a heart valve defining a blood circulation passage.
    The treatment device 10 comprises in particular an implant 12, intended to be positioned and deployed in the blood circulation passage of the heart, a release tool 14 of the implant 12 and, a pushing member 16 movable longitudinally relative to the implant 12. The treatment device 10 here further comprises an assembly 20 for producing an opening in a biological wall, here a wall of the heart.
    The implant 12 is advantageously an endovalve, in particular a cardiac endovalve intended to replace a defective native valve. The endovalve is advantageously an endovalve intended to replace a native mitral valve located between a left atrium 22A and a left ventricle 22B of the heart, so as to allow an unequivocal circulation of the blood flow between the left atrium 22A and the left ventricle 22B visible in Figure 1. The left ventricle 22B defines a ventricular cavity. The implant 12 is intended to be fixed on a tissue of the heart, this tissue being in particular formed by a mitral ring 17 from which leaflets 18 of native mitral valve are deployed.
    As a variant, the implant 12 is a valve intended to replace a native tricuspid valve or even a native aortic valve.
    The implant 12 shown in FIG. 1 comprises a tubular frame 24 intended to define an internal blood circulation conduit. The frame 24 is advantageously provided with a shutter (not shown) based on fabric, in particular synthetic or natural fabric, such as bovine, equine and / or porcine pericardium. This obturator is intended to ensure an unequivocal circulation of blood through this frame 24.
    The tubular frame 24 comprises a proximal sleeve 26 and a distal sleeve 28, intended to be inserted into one another and assembled to form the frame 24. The distal sleeve 28 is thus intended to be deployed inside of the proximal sleeve 26.
    The proximal sleeve 26 comprises a proximal tubular body 30A having a generally tubular shape around a central axis (X), and extending longitudinally, in the direction of this central axis (X), between a proximal edge 30B and an edge distal 30C. The proximal sleeve 26 is deployable between a retracted configuration visible in FIG. 2 and a deployed configuration visible in FIGS. 1 and 3.
    The proximal sleeve 26 has rods 31 configured to be fixed in the distal sleeve 28, when assembled together. These rods 31 are intended to secure the proximal sleeve 26 to the distal sleeve 28.
    The implant 12 also comprises a plurality of proximal arms 32, visible in FIG. 20, each projecting radially outwardly apart from the proximal sleeve 26 between a first end linked to the distal edge 30C of the proximal tubular body 30A of the proximal sleeve 26, and a second free end intended to bear on a first face of a leaflet 18 of the valve and / or on the mitral ring 17. The first face corresponds to the ventricular face of the leaflet 18 of the valve.
    The proximal tubular body 30A therefore forms, with the proximal arms 32, a first assembly in one piece. The proximal arms 32 being intended to bear on the sheet 18 and / or on the mitral ring 17 of the valve on the side of the left ventricle 22B, these proximal arms 32 are also called ventricular arms.
    Each proximal arm 32 extends in a direction substantially perpendicular to the direction of the central axis (X). Advantageously, each proximal arm 32 has an angle between 85 ° and 95 ° with the central axis (X), in the absence of stress on the proximal arm 32. More precisely, each proximal arm 32 has with the central axis (X ) an angle so that its free end is disposed beyond the distal edge 30C of the proximal tubular body 30A of the proximal sleeve 26. Each proximal arm 32 is formed by a closed wire forming a loop from the proximal tubular body 30A.
    In the example of FIGS. 1 and 19, each proximal arm 32 comprises, between its linked end and its free end, at least one intermediate region extending along and radially away from the armature 24, to define a gutter 33A for receiving a valve sheet 18. The gutter 33A creates a space for receiving the valve leaflets constituted solely by the proximal arms 32, without the participation of the proximal tubular body 30A of the proximal sleeve 26 or of the distal tubular body 34A of the distal sleeve 28.
    In FIG. 3, the gutter 33A has a concave hollow shape.
    The gutter 33A has a bottom 33B delimited between two parts of the intermediate region located radially away from the proximal tubular body 30A or from the distal tubular body 34A. The bottom 33B is intended to be arranged beyond the distal edge 30C of the proximal tubular body 30A, in the direction of the central axis (X), towards the proximal edge 30B of the proximal tubular body 30A, when the proximal sleeve 26 is in its deployed configuration.
    The gutter 33A has a U shape opening axially towards the distal sleeve 28. The gutter 33A is connected to the proximal tubular body 30A by a transverse region of the arm forming an angle between 85 ° and 95 ° with the central axis ( X).
    The gutter 33A is arranged radially away from the proximal tubular body
    30A.
    The gutter 33A is thus configured to prevent valve leaflets 18 received in the gutter 33A from coming into contact with the tubular body 30A proximal of the proximal sleeve 26 or with the tubular body 34A of the distal sleeve 28.
    The distal sleeve 28 comprises a distal tubular body 34A, visible in FIG. 21, also having a generally tubular shape around the central axis (X). The distal sleeve 28 is also deployable between a retracted configuration and a deployed configuration.
    More particularly, the distal tubular body 34A is capable of fitting into the proximal tubular body 30A of the proximal sleeve 26. The distal sleeve 28 is thus intended to be assembled with the proximal sleeve 26 to form said tubular frame 24 of the implant. 12 when this proximal sleeve 26 and this distal sleeve 28 are assembled, each in the deployed configuration.
    The distal tubular body 34A extends longitudinally, in the direction of the central axis (X), between a proximal edge 34B and a distal edge 34C.
    The distal tubular body 34A has a length, taken along the central axis (X), greater than the length of the proximal tubular body 30A, taken along the central axis (X).
    The distal tubular body 34A has a cross section at the proximal edge 34B, greater than its cross section at the distal edge 34C. This difference in cross section of the distal tubular body 34A makes it possible to push and immobilize the proximal tubular body 34A towards the distal edge 34C, when the proximal sleeve 26 and the distal sleeve 28 are assembled.
    Advantageously, the proximal tubular body 30A of the proximal sleeve 26 has, when the proximal sleeve 26 is separated from the distal sleeve 28, and in the absence of external stress, a diameter less than that of the distal edge 34C of the distal tubular body 34A in l absence of external solicitation. Thus, when the distal sleeve 28 is deployed inside the proximal sleeve 26, it exerts a radial force on an internal surface of this proximal sleeve 26, this radial force being sufficient to ensure the connection between the proximal sleeve 26 and the sleeve distal 28.
    With reference to FIG. 1, the proximal sleeve 26 is intended to be placed on the distal sleeve 28, so that the distal edge 30C of the proximal sleeve 26 is brought closer to the distal edge 34C of the distal sleeve 28, and for example radially aligned by relation to the central axis (X) with this distal edge 34C.
    The implant 12 also comprises a plurality of distal arms 36, each being carried by the distal tubular body 34A of the distal sleeve 28 and extending substantially perpendicular to the central axis (X) when the distal sleeve 28 is in its configuration deployed. Thus, the distal tubular body 34A forms, with the distal arms 36, a second assembly in one piece, intended to be attached to the first assembly.
    In a preferred embodiment, the distal arms 36 join laterally to form a collar.
    The distal arms 36 are intended to bear on a distal face of the leaflet 18 of the valve and / or of the mitral ring 17, that is to say on the side of the left atrium 22A, in the atrial cavity when the valve is a mitral valve. Thus, the distal arms 36 are also called atrial arms.
    When the implant 12 is installed in the blood circulation conduit, advantageously at least one distal arm 36 is attached to a proximal arm 32. The valve leaflets 18 and / or the mitral ring 17 is (are) pinched (s) ) between the proximal arms 32 and the distal arms 36, thus ensuring the anchoring of the implant 12.
    Advantageously, at least one, for example each, distal arm 36 has a convex region, intended to be attached to the groove 33A of the proximal arm 32 on which the distal arm 36 is attached. As a variant, no distal arm 36 has such a convex region.
    It will be noted that this implant 12 is said to be “in the deployed configuration” when the proximal sleeve 26 and the distal sleeve 28 are assembled in the deployed configuration. On the other hand, the implant 10 is said to be "in the retracted configuration" when the proximal sleeves 26 and distal 28 are arranged in the retracted configuration.
    The implant 12 is for example devoid of a plane of symmetry passing through the central axis (X). More specifically, the proximal sleeve 26 comprises an odd number of proximal arms 32. The number of proximal arms 32 is also, for example, different from the number of distal arms 36. The proximal arms 32 are also advantageously not diametrically opposite. In addition, the distance between the linked end and the free end of each proximal arm 32 is different for each proximal arm 32, this distance depending on the shape of the valve leaflets 18.
    Advantageously, each of the proximal 26 and distal 28 sleeves, therefore also the implant 12, is self-expanding, that is to say that its deployed configuration constitutes its rest position. Thus, each of the proximal 26 and distal 28 sleeves, therefore also the implant 10, in its retracted configuration, is urged elastically towards its deployed configuration.
    For example, the proximal sleeve 26, the distal sleeve 28, the proximal arms 32 and the distal arms 36 are formed of stainless steel having elastic properties. As a variant, these elements are formed from a shape memory metal such as nitinol (nickel / titanium) or from a flexible polymer fiber.
    The proximal sleeve 26 is for example formed by a lattice of intertwined filiform elements delimiting meshes, for example polygonal meshes, preferably diamond-shaped meshes visible in the figures.
    Likewise, the distal sleeve 28 is for example formed by a lattice of interlaced filiform elements delimiting meshes, for example polygonal meshes, preferably diamond-shaped meshes visible in the figures.
    In one embodiment of the release of the implant 12, illustrated in the figures, the proximal sleeve 26 and the distal sleeve 28 are brought into the blood circulation passage via two separate access routes. More specifically, the distal sleeve 28 is brought by an antegrade transveinous route and is thus introduced into the atrial cavity without passing through the ventricular cavity, and the proximal sleeve 26 is brought via the transaortic retrograde route, and thus introduced into the ventricular cavity the atrial cavity.
    The treatment device 10 thus comprises a first release tool 14 for the proximal sleeve 26 and a second release tool (not shown) for the distal sleeve 28.
    The first release tool 14, visible in particular in FIGS. 2 and 3, extends longitudinally along a central axis (Y) between a proximal end (not shown) and a distal end 38. It advantageously comprises a guide wire 40 (visible in FIGS. 7 to 11), an external sheath 42 forming a hollow tubular element with a substantially circular cross section and an internal rod 44 disposed in the external sheath 42 movable along the guide wire 40 and extending between a proximal end and a distal end.
    The internal rod 44 is movable relative to the external sheath 42 along the central axis (Y) ·
    The guide wire 40 is for example common to the first release tool 14 to the second release tool.
    Locking elements (not shown) are generally provided between the rod 44 and the outer sheath 42, to prevent spontaneous sliding of these elements with respect to each other.
    As shown in particular in FIG. 2, the external sheath 42 defines with the internal rod 44 an internal annular space receiving the proximal sleeve 26. Thus, the proximal sleeve 26 is maintained in the retracted configuration by this external sheath 42.
    When the proximal sleeve 26 is in the retracted configuration in the first release tool 14, the central axis (X) of the proximal sleeve 26 merges substantially with the central axis (Y) of the first release tool 14.
    In addition, each proximal arm 32 is pressed against the outer sheath 42 as long as it is covered by this outer sheath 42.
    The proximal arms 32 are movable radially between a configuration contracted in the release tool 14 and a configuration deployed radially out of the release tool 14.
    The tubular outer sheath 42 is movable relative to the proximal sleeve 26 along the central axis (Y) between a position for covering the proximal arms 32 and the proximal sleeve 26, an intermediate position for deploying the proximal arms 32 in which the proximal sleeve 26 is always covered by the outer sheath 42 and a position for releasing the proximal sleeve 26.
    The second release tool also extends longitudinally along a second central axis between a proximal end and a distal end.
    This second release tool has characteristics similar to the first release tool 14. Thus, the second release tool comprises at least one outer sheath, an internal rod disposed in this outer sheath and members for locking the movements of these elements each compared to others ; the outer sheath of the second release tool defines an internal annular space intended to receive the distal sleeve 28 which is maintained in the retracted configuration by this outer sheath. Similarly, each distal arm 36 is pressed against the outer sheath of the second release tool as long as it is covered by this outer sheath. The distal arms 36 are thus movable radially between a configuration contracted in the second release tool and a configuration deployed radially outside the second release tool.
    The second release tool is for example similar to that described in WO 2014/170463, Figures 29 to 32.
    The treatment device 10 also comprises a pushing member 16 of the first face of the valve sheet 18 away from the distal end 38 of the release tool 14. The pushing member 16 is inserted into the release tool 14 as illustrated in FIG. 2.
    The pushing member 16 is movable in the direction of the central axis (Y) relative to the outer sheath 42 and relative to the implant 12 maintained in its retracted configuration in the release tool 14, more precisely by relative to the proximal sleeve 26 in the embodiment of the figures, between a retracted position and an advanced position for pushing the first face of the valve sheet 18.
    In the retracted position of the pushing member 16, the outer sheath 42 covers the pushing member 16 as illustrated in FIG. 2.
    In a first embodiment illustrated in FIGS. 2 to 11, the pushing member 16 comprises a deformable hollow tubular outer sheath 48 extending to a distal end 50. As illustrated in FIGS. 4 to 6, the sheath external 48 has longitudinal slots 52 distributed circumferentially, each pair of adjacent slots 52 defining a deployable element 54.
    The number of deployable elements 54 is for example greater than or equal to two.
    The pushing member 16 further comprises a rigid internal rod 56 of the same axis as the central axis (Y), disposed inside the external sheath 48 and connected to the distal end 50 of the external sheath 48.
    The rigid internal rod 56 is for example the internal rod 44 of the first release tool 14. As a variant, the rigid internal rod 56 is hollow, the internal rod 44 of the first release tool 14 then being disposed inside the rod rigid internal 56 and movable relative to the rigid internal rod 56 along the central axis (Y) of the release tool 14.
    The outer sheath 48 is movable along the central axis (Y) relative to the rigid internal rod 56 for deploying the deployable elements 54 by the displacement of the rigid internal rod 56 towards the proximal end of the release tool 14 by compared to the outer sheath 48.
    This deployment is implemented after the pushing member 16 has been moved out of the release tool 14, the outer sheath 42 no longer covering the pushing member 16.
    During this deployment, a first end of the deployable element 54, in particular the distal end of the deployable element 54 remains fixed relative to the rod 56, while a second end, in particular the proximal end of the deployable element 54 is movable relative to the first end in order to approach the first end. The deployable element 54 flexes in its middle part and forms a radially deployed elbow.
    Each deployable element 54 is thus deployable, independently of the deployment of the implant 12, radially with respect to the axis of the first release tool 14 between a contracted state illustrated in FIG. 4 and a deployed state illustrated in FIGS. 3 and 5 .
    In the contracted state, each deployable element 54 is capable of sliding in the proximal sleeve 26 in the retracted or deployed configuration, in order to allow the withdrawal of the pushing member 16 during the installation of the implant 12, for example prior to the insertion of the distal tubular body 34A of the distal sleeve 28 into the proximal tubular body 30A of the proximal sleeve 26.
    In the deployed state, each deployable element 54 comprises an external thrust face 58 directed perpendicularly to the central axis (Y) of the release tool 14.
    In the deployed state, as illustrated in FIGS. 5 and 6, the radially deployed elbow of each deployable element 54 advantageously has one end, intended to radially push the sheets 18 into the gutters 33A of the proximal arms 32.
    By displacement of the pushing member 16, relative to the release tool 14 and to the implant 12 and along the central axis (Y) of the release tool 14, each external push face 58 is suitable pushing the first face of the valve leaflet 18 away from the distal end 38 of the release tool 14 to provide a deployment zone for the proximal arms 32 of the proximal sleeve 26.
    Thus, after the radial deployment of the proximal arms 32 out of the release tool 14, each deployable element 54 in its deployed state is found received in the receiving gutter 33A defined by the proximal arms 32.
    Each deployable element 54, in its deployed state, is thus able to be received at the front or between the proximal arms 32 in their radially deployed configuration.
    The assembly 20 for producing an opening is suitable for providing and widening a passage at the tip of the left ventricle 22B, with a view to the passage of the first release tool 14 into the left ventricle 22B. The opening embodiment assembly 20 is arranged in front of the sleeve 26 and of the thrust member 16.
    The assembly 20 for producing an opening comprises a cutting or perforating element (not shown) capable of making an incision or perforation in the wall of the heart.
    The assembly 20 for producing an opening comprises a central balloon 60 disposed at the distal end of the internal rod 44 of the release tool 14. The central balloon 60 has a substantially circular cross section, inflatable between a deflated configuration , in which the central balloon 60 is suitable for being inserted into a puncture made in the cardiac wall, and an inflated configuration, in which the central balloon 60 has a predetermined diameter corresponding to the diameter of the opening to be produced. The central balloon 60 is arranged at the distal end 16 of the internal rod 44 of the first release tool 14.
    The predetermined diameter of the central balloon 60 in the inflated configuration is greater than or equal to the diameter of the outer sheath 42.
    In the inflated configuration, the central balloon 60 extends partly in the interior space delimited by the external sheath 42, and partly beyond a distal end of the external sheath 42. Thus, the central balloon 60 in configuration inflated is firmly held, under the effect of its internal pressure, to the outer sheath 42, as shown in particular in FIG. 2.
    However, the central balloon 60 is able to slide in the outer sheath 42 in the deflated configuration, more particularly in the proximal sleeve 26 in the retracted configuration, in order to allow the central balloon 60 to be removed during the installation of the implant 12 , for example prior to the insertion of the distal tubular body of the distal sleeve 28 into the proximal tubular body 30A of the proximal sleeve 26.
    Advantageously, the central balloon 60 is filled with a radiopaque material. Its evolution, in particular its position, is thus observable with X-rays.
    As illustrated in FIG. 2, the central balloon 60 also includes an angular orientation device comprising several marks 62, made of radiopaque material. Here, the references 62 are disjoint, aligned along the central axis (Y) of the release tool 14 and applied to the central balloon 60.
    The marks 62 are for example metallic.
    Each reference 62 is intended to present an angular position around the central axis (X) fixed relative to the implant 12, during the installation of the implant 12 on the valve.
    The main steps of a method for treating a blood circulation passage from a mitral valve, by means of the treatment device 10 illustrated in FIGS. 1 to 2, will now be described.
    The treatment method comprises a step of performing a puncture in the heart wall, in particular at the tip of the left ventricle 22B, by means of the cutting or perforating element of the assembly 20 for producing an opening. As a variant, the incision or perforation can be made at another point of entry of the heart, in particular on another part of the left ventricle 22B than the tip, on the left atrium 22A, on the right ventricle, on the atrium right.
    The method then comprises a step of inserting the central balloon 60 into the incision or perforation made and a step of widening the incision or perforation so as to produce an opening, by inflating the central balloon 60. Such a step is illustrated in FIG. 7 and is described for example in the document FR3002084.
    The method then includes a step of inserting the release tool 14 into the ventricular cavity, more precisely into the left ventricle 22B, by moving this release tool 14 through the opening made.
    Note that the central balloon 60 being made of a radiopaque material, it is possible to observe its good development in the left ventricle 22B. By the references 62, it is in particular possible to follow its angular evolution around the central axis (Y).
    The release tool 14 is then advanced towards the left atrium 22A, guided by the guide wire 40, such that the proximal sleeve 26 in the retracted configuration is positioned at a distance from the valve leaflets 18 in the left ventricle 22B.
    The central balloon 60 is at least partially deflated.
    As shown in Figure 8, the central balloon 60 and the thrust member 16 are moved relative to the outer sheath 42 of the release tool 14 towards the mitral valve. The central balloon 60 is then positioned in the mitral valve and the thrust member 16 is thus discovered outside the outer sheath 42.
    The method then includes a step of deploying each deployable element 54 of the pushing member 16. During this step, illustrated in FIG. 9, the rigid internal rod 56 of the pushing member 16 is held in position for that the hollow tubular outer sheath 48 is moved towards the distal end 38 of the release tool 14. Each deployable element 54 thus passes from the contracted state to the deployed state.
    More specifically, a first end of the deployable element 54, in particular the distal end of the deployable element 54 remains fixed relative to the rod 56. A second end, in particular the proximal end of the deployable element 54 approaches the first end. The deployable element 54 flexes in its middle part and forms a radially deployed elbow.
    As a variant, the deployment of each deployable element 54 is carried out by maintaining the hollow tubular outer sheath 48 in position and by moving the rigid internal rod 56 of the pushing member 16 towards the proximal end of the release tool 14.
    The method then comprises a step of pushing the first face of valve leaflet 18. The pushing member 16 is moved in the central axis (Y) of the release tool 14 until each external pushing face 58 comes into contact with the first face of the valve sheet 18. Additional movement of the thrust member 16 in the central axis (Y) of the release tool 14 allows each external face 58 to push the valve leaflet 18 to a retracted position, away from the distal end 38 of the release tool 14, thus providing a clear area for deploying the proximal arms 32 and the proximal sleeve 26.
    The valve leaflet 18 is held in its retracted position by the pushing member 16 at least until the positioning of the proximal arms 32 under the first face of the leaflet 18.
    The method then comprises a step of deploying the proximal arms 32, during which the outer sheath 42 is moved axially towards the proximal end of the release tool 14 from its cover position to its intermediate position of deployment of the proximal arms. 32.
    The proximal arms 32 are then deployed radially in the cleared deployment zone, the proximal sleeve 26 being always covered by the outer sheath 42. The proximal arms 32 thus pass between the cords of the subvalvular apparatus.
    The proximal arms 32 deployed outside the outer sheath 42 and the proximal sleeve 26 received in the outer sheath 42 are then advanced towards the mitral ring so that the receiving gutter 33A defined by the proximal arms 32 is positioned facing the elements deployable 54. The deployable elements 54 are thus received between the valve leaflets 18 and the proximal arms 32, as shown in FIG. 10.
    The pins 62 having a predefined angular position around the central axis (Y) fixed relative to the sleeve 26, the proximal arms 32 are judiciously positioned angularly around the central axis (Y), relative to the first face of the sheet 18 and / or the mitral ring 17.
    The proximal arms 32 are advanced in contact with the first face of the sheet 18 and / or of the mitral ring 17, the thrust member 16 and the valve sheets 18 being found disposed above the receiving gutters 33A defined by the proximal arms 32.
    The proximal arms 32 apply an axial force against the ventricular face of the sheets 18 and / or of the mitral ring 17, this axial force being oriented from the ventricular cavity towards the atrial cavity.
    This being done, when the position of the proximal arms 32 is deemed adequate by the practitioner, the central balloon 60 is deflated. The central balloon 60 and the thrust member 16 are advanced out of the vicinity of the mitral valve in the left atrium 22A.
    Likewise, each deployable element 54 of the pushing member 16 is contracted, by holding the rigid internal rod 56 in position and moving the hollow tubular outer sheath 48 of the pushing member 16 toward the proximal end of the release tool 14.
    As a variant, the contraction of each deployable element 54 is carried out by holding the hollow tubular external sheath 48 in position and by moving the rigid internal rod 56 of the pushing member 16 towards the distal end 38 of the release tool 14 .
    As illustrated in FIG. 11, the method then comprises a step of radial thrust of the valve leaflets 18 in the gutter 33A by the thrust member 16.
    After the contraction of each deployable element 54, the sheets 18 rest on the proximal arms 32. The deployable elements 54 of the pushing member 16 are then deployed again in the left atrium 22A. During this deployment, the conical end bends of the deployable elements 54 push the valve leaflets 18 into the gutters 33A of the proximal arms 32.
    The sheets 18 then form a sealing rod around the implant 12 on the ventricular side and close to the ring 17 thus closing a commissural space.
    The deployable elements 54 are then contracted and the pushing member 16 is moved towards the proximal end of the release tool 14. The central balloon 60 is also then moved towards the proximal end of the release tool 14.
    In this embodiment, simultaneously with or following one of the preceding steps, the method comprises a step, not shown, of introduction of the second release tool into the atrial cavity by a second path different from that by which the first release tool 14 was inserted into the ventricular cavity.
    After the central balloon 60 and the pushing member 16 have been removed, and by moving the second release tool, the distal sleeve 28 in the retracted configuration is moved to the left ventricle 22B so that the distal arms 36 still in configuration contracted are positioned in the left atrium 22A. The distal tubular body of the distal sleeve 28 is thus inserted into the proximal tubular body 30A of the proximal sleeve 26.
    The method then comprises a step, not shown, of deployment of the distal arms 36 during which the distal sleeve 28 is kept in the retracted configuration. The distal arms 36 are deployed and applied to the second face of the valve leaflet 18 and / or of the mitral ring 17 corresponding to the atrial face of the valve leaflet 18 and / or of the mitral ring 17, the distal sleeve 28 retaining its retracted configuration.
    Thus, the distal arms 36 apply an axial force against the atrial face of the sheets 18 and / or of the mitral ring 17, this axial force being oriented from the atrial cavity to the ventricular cavity. The axial force applied by the proximal arms 32 is substantially in the same direction but in the opposite direction to the axial force applied by the distal arms 36.
    The positions of the proximal sleeve 26 and the distal sleeve 28 are adjusted according to the configuration of the blood circulation passage in which the implant 12 is installed.
    When the positions of the proximal sleeve 26 and the distal sleeve 28 are deemed adequate by the practitioner, the outer sheath 42 is moved to its position for releasing the proximal sleeve 26, and the proximal sleeve 26 is released. It deploys radially out of the release tool 14.
    Then, the distal sleeve 28 disposed in the proximal sleeve 26 is deployed.
    As a variant, the proximal sleeve 26 and the distal sleeve 28 are deployed simultaneously or the distal sleeve 28 is deployed inside the proximal sleeve 26 prior to the deployment of the proximal sleeve 26.
    After the distal sleeve 28 has been deployed, the proximal 26 and distal 28 sleeves are assembled by radial contact, thus forming the frame 24. In other words, the frame 24 is formed only in the deployed configuration.
    Once these deployments have been made, the first and second release tools are withdrawn from the patient, each through the corresponding channel.
    In another embodiment, the proximal sleeve 26 and the distal sleeve 28 are brought into the blood circulation passage via the transapical route (apex of the heart) using the same delivery tool 14. The delivery tool 14 comprises then, before they are released, the proximal sleeve 26 and the distal sleeve 28 in retracted configurations, as described in WO 2014/170463, FIGS. 21 to 24. Until the deployment of the proximal arms 32 and the radial thrust of the valve leaflets 18 in the gutter 33A by the pushing member 16, the associated treatment method comprises the same steps as that described above. Then, the distal sleeve 28 is released from the release tool 14 by passing it through the proximal tubular body 30A.
    In another variant, the proximal sleeve 26 and the distal sleeve 28 are brought into the blood circulation passage via a transeptal transfemoral route by an antegrade transvenous route and is thus introduced into the atrial cavity without passing through the ventricular cavity using the same release tool 14.
    Until the deployment of the proximal arms 32 and the radial thrust of the valve leaflets 18 in the gutter 33A by the thrust member 16, the associated treatment method comprises the same steps as that described above, with the difference that during the pushing step of the first face of valve leaflet 18, each external face 58 pushes valve leaflet 18 to a retracted position of the proximal arms 32, towards the distal end 38 of the release tool 14.
    A second embodiment of the device 10 for treating in particular the pushing member 16 is described in FIGS. 12 to 15.
    In the example of FIG. 12, the thrust member 16 has been extracted from the tubular outer sheath 42.
    As illustrated in this figure, the pushing member 16 comprises a rigid internal rod 56 and several deployable elements 54 each comprising an inflatable lateral balloon 64. Each lateral balloon 64 is disposed at the distal end 38 of the release tool 14 and is connected to the rigid internal rod 56.
    In FIG. 12, the pushing member 16 comprises two deployable elements 54. The two lateral balloons 64 are distributed symmetrically on either side of the central axis (Y) of the release tool 14.
    The rigid internal rod 56 is hollow, the internal rod 44 of the first release tool 14 then being disposed inside the rigid internal rod 56 and movable relative to the rigid internal rod 56 along the central axis (Y) of the release tool 14.
    Each lateral balloon 64 is inflatable independently of the configuration of the implant 12, and in particular independently of the configuration of the proximal sleeve 26. Thus, each lateral balloon 64 is deployable radially relative to the central axis (Y) of the release tool 14 between a contracted state (not shown) corresponding to a state where the lateral balloon 64 is deflated, and a deployed state shown in FIG. 12, corresponding to a state where the lateral balloon 64 is inflated.
    The lateral balloons 64 being connected to the same rigid internal rod 56, they are capable of being inflated simultaneously.
    In the contracted state of each lateral balloon 64, that is to say when it is deflated, the lateral balloon 64 is capable of being held in the outer sheath 42 of the release tool 14.
    In addition, each lateral balloon 64 is, in its contracted state, movable relative to the proximal sleeve 26 along the central axis (Y) of the release tool 14, in order to be able to slide in the proximal sleeve 26 in the retracted or deployed configuration. , in order to allow the removal of the pushing member 16 during the installation of the implant 12, for example prior to the insertion of the distal tubular body of the distal sleeve 28 into the proximal tubular body 30A of the proximal sleeve 26.
    Each lateral balloon 64 comprises, in its deployed state, an external thrust face 58 directed distally away from the central axis (Y) of the release tool 14. Each lateral balloon 64 also comprises, in its deployed state , a second external face, advantageously intended to radially push the sheets 18 into the gutters 33A of the proximal arms 32.
    A method of treating a blood circulation passage of a mitral valve, by means of the treatment device 10 of this second embodiment, will now be described. In the description which follows, only the different stages of the method described above are illustrated and described in detail.
    Before the deployment step of each deployable element 54 and as illustrated in FIG. 13, the pushing member 16 is moved relative to the outer sheath 42 of the release tool 14 towards the mitral valve so as to be uncovered outside the outer sheath 42.
    During the deployment step of each deployable element 54 of the pushing member 16, illustrated in FIG. 13, each lateral balloon 64 is inflated simultaneously.
    The method then comprises a step of pushing the first face of valve leaflet 18, illustrated in FIG. 14, during which the pushing member 16 and more precisely each lateral balloon 64, is moved along the central axis ( Y) of the release tool 14 so that the external thrust face 58 of each lateral balloon 64 comes into contact with the first face of the valve sheet 18 and pushes the valve sheet 18 to a retracted position, away from the distal end 38 of the release tool 14.
    The valve leaflet 18 is then held in the retracted position by the pushing member 16 at least until the positioning of the proximal arms 32 on the first face of the leaflet 18.
    The proximal arms 32 are then deployed and their second free ends are positioned on the first face of the sheet 18 and / or on the mitral ring 17, the proximal sleeve 26 still being covered by the outer sheath 42, as illustrated in FIG. 15 .
    Once the proximal arms 32 have been properly positioned, the central balloon 60 and each lateral balloon 64 are then deflated. The central balloon 60 is advanced out of the vicinity of the mitral valve in the left atrium 22A.
    The method then comprises a step of radial pushing of the valve leaflets 18 in the gutter 33A by the pushing member 16.
    Each lateral balloon 64 is inflated again and deploys. During this deployment, the second external faces of the lateral balloons 64 push the valve leaflets 18 into the gutters 33A of the proximal arms 32.
    In a variant of the second embodiment, each deployable element 54 comprises a lateral rod 66. In FIG. 16, the pushing member 16 thus comprises two lateral rods 66 for two deployable elements 54.
    Each lateral rod 66 extends between a proximal end linked to the internal rod 44 of the release tool 14 and a free end 68.
    Each lateral rod 66 is deployable between a contracted configuration, not shown, in which the free end 68 of the lateral rod 66 is attached to the internal rod 44 of the release tool 14 so that the lateral rod 66 is substantially aligned with the central axis (Y), and a deployed configuration in which the lateral rod 66 is distally apart from the internal rod 44.
    Each deployable element 54 comprises a lateral balloon 64 disposed at the free end 68 of each lateral rod 66. Each lateral balloon 64 is inflatable regardless of the configuration of the implant 12, and in particular independently of the configuration of the proximal sleeve 26.
    Thus, each deployable element 54 is deployable radially relative to the central axis (Y) of the release tool 14 between a contracted state (not shown) corresponding to a state where the associated lateral balloon 64 is deflated and where the rod lateral 66 is in its contracted configuration, and a deployed state shown in FIG. 16 corresponding to a state where the associated lateral balloon 64 is inflated and where the lateral rod 66 is in its deployed configuration.
    In the contracted state of each deployable element 54, that is to say when the associated lateral balloon 64 is deflated and when the lateral rod 66 is in its contracted configuration, the deployable element 54 is capable of being held in the tubular outer sheath 48 of the release tool 14. More precisely, each lateral rod 66 is capable of passing from its contracted configuration to its deployed configuration by displacement of the outer sheath 42 of the release tool 14 towards the end proximal of the release tool 14 to its intermediate configuration for discovering the pushing member 16.
    In addition, each deployable element 54 is, in its contracted state, movable relative to the proximal sleeve 26 along the central axis (Y) of the release tool 14, in order to be able to slide in the proximal sleeve 26 in the retracted or deployed configuration. , in order to allow the withdrawal of the pushing member 16 prior to the installation of the implant 12, for example prior to the insertion of the distal tubular body of the distal sleeve 28 into the proximal tubular body 30A of the proximal sleeve 26.
    A method of treating a blood circulation passage of an atrioventricular heart valve, by means of the treatment device 10 of this variant of the second embodiment, is similar to the treatment method for the second embodiment described. previously, with the difference that during the deployment step of each deployable element 54, each lateral rod 66 changes from its contracted configuration to its deployed configuration when the pushing member 16 is moved relative to the outer sheath 42 of the 'release tool 14 towards the mitral valve.
    In another variant of the second embodiment, illustrated in FIG. 17, each lateral balloon 64 is inflatable independently of each other lateral balloon 64 and of the central balloon 60. Thus, each lateral rod 66 is then connected by its proximal end to a auxiliary internal rod 70 independent of the internal rod 44 of the release tool 14.
    In yet another variant illustrated in FIG. 18, the pushing member 16 comprises at least two deployable elements 54 each comprising a whale 72 deployable between a state close to the central axis (Y) not shown when the pushing member 16 is arranged inside the tubular outer sheath 42, and a state distally away from the central axis (Y) illustrated in FIG. 18, when the pushing member 16 is extracted from the outer sheath tubular 42.
    By displacement of the thrust member 16 out of the tubular outer sheath 42 of the release tool 14, each whale 72 is able to pass from the close state to the distally separated state. In the example of FIG. 18, the pushing member 16 is extracted from the tubular outer sheath 42 of the release tool 14.
    Each deployable element 54 also includes a support 74 connecting the internal rod 44 to the whale 72.
    Each whale 72 includes an external thrust face 58 directed distally from the central axis (Y) of the release tool 14.
    Each whale 72 advantageously comprises a second external face intended to push the sheets 18 radially into the gutters 33A of the proximal arms 32.
    In a variant of the second embodiment, the thrust member 16 and the central balloon 60 form only one balloon. Such a balloon then comprises a first central part which, when inflated, corresponds in function to the central balloon 60, and a second inflatable lateral part which, once inflated, corresponds in function to the thrust member 16.
    Such a balloon is then inflatable in several configurations, in particular in a deflated configuration where the first central part and the lateral part are deflated, in a first inflated configuration where only the first central part is inflated, in a second inflated configuration where the first central part and the lateral part are inflated, and a third configuration inflated where only the lateral part is inflated.
    As a variant, the proximal arms 32 comprise, in the configuration deployed radially out of the release tool 14, at least one intermediate region having a substantially straight profile. The proximal arms 32 are here formed based on shape memory materials. The intermediate region is thus able to deform in order to arrange the gutter 33A for receiving the sheets 18.
    In the treatment process, once the proximal arms 32 are adequately positioned on the valve leaflets 18 and / or on the mitral ring 17, the groove 33A for receiving the leaflets 18 is formed by the shape memory, under the effect of temperature. The sheets 18 are then introduced into the gutters 33A, as described above.
    Thanks to the thrust of the valve leaflets 18 in the retracted position by the thrust member 16, the device according to the invention makes it possible to ensure the correct positioning of the proximal arms 32 of the proximal sleeve 26 and therefore the correct installation of the implant 12.
    The different shapes of the pushing member 16 allow it to slide between the cords of the subvalvular apparatus and not to become tangled with the proximal arms 32 of the proximal sleeve 26.
    The angle, with the central axis (X) of the implant 12, presented by the proximal arms 32 makes it possible to provide an additional force for clamping the sheets 18, when the sheets 18 are pinched between the proximal arms 32 and the arms distal 36.
    Finally, the gutter 33A in concave shape makes it possible to prevent contacts between the 10 valve sheets 18 received in the gutters 33A and the proximal tubular body 30A of the proximal sleeve 26.
    In a variant, the proximal arms of the device do not necessarily include a space for receiving the valve sheet delimited by the proximal arm, without the participation of the tubular frame.
    权利要求:
    Claims (15)
    [1" id="c-fr-0001]
    1Device (10) for processing a biological valve comprising:
    - An implant (12) comprising a proximal sleeve (14), deployable between a retracted configuration and a deployed configuration, intended to be disposed in a blood circulation passage delimited by the valve, the proximal sleeve (14) comprising a tubular body proximal (30A) and a plurality of proximal arms (32), each extending between a first end connected to the tubular body (30A), and a second free end intended to rest on a first face of a sheet (18 ) of the valve or on a ring (17) of the valve,
    - an implant release tool (14), extending longitudinally along a central axis (Y) between a proximal end and a distal end (38), the implant (12) being mounted in the release tool (14) in its retracted configuration, characterized in that the device (10) comprises a pushing member (16) of the first face of the valve sheet (18) away from the free end of the arms proximal (32), the pushing member (16) being movable in the direction of the central axis (Y) relative to the implant (12) held in its retracted configuration in the release tool (14) between a retracted position and an advanced position for pushing the first face of the valve sheet (18).
    [2" id="c-fr-0002]
    2, - Device (10) for treatment according to claim 1, wherein the thrust member (16) comprises at least one deployable element (54), radially relative to the central axis (Y) of the tool release (14) between a contracted state and a deployed state, the deployment of the deployable element (54) being independent of the deployment of the implant (12),
    [3" id="c-fr-0003]
    3. - Device (10) for treatment according to claim 2, in which the deployable element (54) in its deployed state comprises an external thrust face (58) directed perpendicularly or distally away from the central axis ( Y) of the release tool (14).
    [4" id="c-fr-0004]
    4, - device (10) for treatment according to claim 3, wherein the proximal arms (32) are radially movable between a configuration contracted in the release tool (14) and a configuration deployed radially out of the release tool (14), the deployable element (54) in its deployed state being received between or in front of the proximal arms (32) in their radially deployed configuration.
    [5" id="c-fr-0005]
    5. - Device (10) for treatment according to any one of the preceding claims, in which the deployable element (54) comprises at least one lateral balloon (64) which can be inflated independently of the configuration of the implant (12).
    [6" id="c-fr-0006]
    6. - Device (10) for treatment according to claim 5, in which the thrust member (16) comprises at least two lateral balloons (64) distributed symmetrically on either side of the central axis (Y) of the release tool (14).
    [7" id="c-fr-0007]
    7. - Device (10) for treatment according to claim 6, wherein the lateral balloons (64) are capable of being inflated independently or simultaneously.
    [8" id="c-fr-0008]
    8. - Device (10) for treatment according to any one of claims 2 to 5, in which the pushing member (16) comprises an external sheath (48) deformable hollow tubular extending to a distal end ( 50) and having longitudinal slots (52) distributed circumferentially, each pair of adjacent slots (52) delimiting a deployable element (54), the pushing member (16) comprising a rigid internal rod (56) disposed inside of the external sheath (48) and connected to the distal end (50) of the external sheath (48), the external sheath (48) being movable along the central axis (Y) relative to the internal rod (56) for deploying the deployable elements (54) by the displacement of the internal rod (56) relative to the external sheath (48).
    [9" id="c-fr-0009]
    9. - Device (10) for treatment according to claim 10, in which the number of deployable elements (54) is greater than or equal to two.
    [10" id="c-fr-0010]
    10. - Device (10) for treatment according to any one of the preceding claims, comprising a central balloon (60) extending along the central axis (Y) of the release tool (14).
    [11" id="c-fr-0011]
    11. - Device (10) for treatment according to any one of the preceding claims, in which the thrust member (16) comprises an internal rod (56), of the same axis as the central axis (Y) of the release tool (14), inserted into the release tool (14), the deployable member (54) being mounted at a distal end of the inner rod (56).
    [12" id="c-fr-0012]
    12, - Device (10) for treatment according to any one of the preceding claims, in which the release tool (14) comprises a tubular outer sheath (42) movable relative to the proximal sleeve (26) between a cover position proximal arms (32) and a release position of the proximal arms (32), the
    5 thrust (16) being movable independently of the sheath (42).
    [13" id="c-fr-0013]
    13, - Device (10) according to any one of the preceding claims, in which the implant (12) comprises a distal sleeve (28) deployable between a retracted configuration and a deployed configuration intended to be disposed in the passage of
    10 blood circulation, comprising a distal tubular body (34A) adapted to be inserted into the proximal tubular body (30A) of the proximal sleeve (26) of the implant (12).
    [14" id="c-fr-0014]
    14, - Device (10) according to claim 13, wherein the distal sleeve (28) comprises a plurality of distal arms (36) each extending between a first
    [15" id="c-fr-0015]
    15 end linked to the distal tubular body (34A) and a second free end intended to be applied to a second face of a sheet (18) of the valve opposite to the first face or to the ring (17) of the valve .
    1/12
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    同族专利:
    公开号 | 公开日
    DE102017126713A1|2018-05-17|
    US20180132999A1|2018-05-17|
    FR3058632B1|2019-01-25|
    US10772726B2|2020-09-15|
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    法律状态:
    2017-10-19| PLFP| Fee payment|Year of fee payment: 2 |
    2018-05-18| PLSC| Search report ready|Effective date: 20180518 |
    2019-10-23| PLFP| Fee payment|Year of fee payment: 4 |
    2021-08-06| ST| Notification of lapse|Effective date: 20210705 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1660976A|FR3058632B1|2016-11-14|2016-11-14|DEVICE FOR TREATING A BIOLOGICAL VALVE WITH PUSH BODY OF THE VALVE|
    FR1660976|2016-11-14|FR1660976A| FR3058632B1|2016-11-14|2016-11-14|DEVICE FOR TREATING A BIOLOGICAL VALVE WITH PUSH BODY OF THE VALVE|
    US15/810,805| US10772726B2|2016-11-14|2017-11-13|Biological valve treatment device with pushing member of the valve|
    DE102017126713.1A| DE102017126713A1|2016-11-14|2017-11-14|Treatment device of a biological valve with thrust member of the flap|
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